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query-laysum
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6769
|
[
{
"role": "user",
"content": "Abstract: Background\nTransjugular intrahepatic portosystemic shunt (TIPS) is a widely used procedure for management of uncontrolled upper gastrointestinal bleeding and refractory ascites in people with liver cirrhosis. However, nearly half of the people experience shunt dysfunction and recurrent symptoms within one year of the procedure. Expanded polytetrafluoroethylene (ePTFE)-covered stents are assumed to decrease shunt dysfunction by approximately 20% to 30%.\nObjectives\nTo evaluate the benefits and harms associated with the use of expanded polytetrafluoroethylene (ePTFE)-covered stents versus bare stents in transjugular intrahepatic portosystemic shunts (TIPSs) for managing people with liver cirrhosis.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 28 February 2023.\nSelection criteria\nRandomised clinical trials comparing ePTFE-covered stents versus bare stents in TIPS for treatment of people with liver cirrhosis.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. all-cause mortality, 2. procedure-related complications, and 3. health-related quality of life. Our secondary outcomes were 4. upper gastrointestinal bleeding, 5. recurrence of ascites, 6. hepatic encephalopathy, 7. kidney failure, 8. early thrombosis, 9. non-serious adverse events, and 10. shunt dysfunction. We used GRADE to assess certainty of evidence.\nWe analysed outcome data at the maximum follow-up, except for the 'early thrombosis' outcome for which it was within 12 weeks after the TIPS procedure.\nMain results\nWe included four trials with 565 randomised participants (age range: 18 to 75 years; male range: 63.6% to 75.0%). A total of 527 participants provided data for analyses because of losses to follow-up. Two trials were conducted in China; one in France; and one in France, Spain, and Canada. Participants were classified with cirrhosis Child-Pugh class A, B, or C, and for some, the class was not reported. We used intention-to-treat principle (four trials) and per-protocol analysis (one trial) to meta-analyse the data.\nOne trial compared ePTFE-covered stents versus bare stents of the same diameter and three trials compared ePTFE-covered stents versus stents of different diameters.\nePTFE-covered stents versus bare stents of the same diameter\nOne trial with 258 participants compared 8 mm covered stent versus 8 mm bare stent.\nMortality in the covered stent group is possibly lower than in the bare stent group (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.43 to 0.92; low-certainty evidence). Upper gastrointestinal bleeding (RR 0.54, 95% CI 0.35 to 0.84), recurrence of ascites (RR 0.42, 95% CI 0.20 to 0.87), and shunt dysfunction (RR 0.42, 95% CI 0.28 to 0.61) occurred more often in the bare stent group than in the covered stent group (all low-certainty evidence). There was no difference in hepatic encephalopathy between groups (RR 1.10, 95% CI 0.76 to 1.61; very low-certainty evidence). The trial did not report data on procedure-related complications, health-related quality of life, early thrombosis, and segmental liver ischaemia (a non-serious adverse event).\nePTFE-covered stents versus bare stents of different stent diameters\nThree trials compared ePTFE-covered stents versus bare stents of different diameters (10.5 (standard deviation (SD) 0.9) mm versus 11.7 (SD 0.8) mm; 8 mm versus 10 mm; and one trial used 10-mm stents that could be dilated from 8 mm to 10 mm).\nThere was no evidence of a difference between the ePTFE-covered stents versus bare stents groups in mortality (RR 0.75, 95% CI 0.48 to 1.16; 3 trials, 269 participants), procedure-related complications (RR 0.53, 95% CI 0.05 to 5.57; 1 trial, 80 participants), upper gastrointestinal bleeding (RR 0.46, 95% CI 0.15 to 1.38; 3 trials, 269 participants), hepatic encephalopathy (RR 0.93, 95% CI 0.66 to 1.30; 3 trials, 269 participants), and kidney failure (RR 7.59, 95% CI 0.40 to 143.92; 1 trial, 121 participants) (all very low-certainty evidence). Recurrence of ascites (RR 0.30, 95% CI 0.11 to 0.85; 3 trials, 269 participants; low-certainty evidence), shunt dysfunction (RR 0.50, 95% CI 0.28 to 0.92; 3 trials, 269 participants; low-certainty evidence), and early thrombosis (RR 0.28, 95% CI 0.09 to 0.82; I2 = 0%; 3 trials, 261 participants; very low-certainty evidence) occurred more often in the bare stents group. There was no evidence of a difference in segmental liver ischaemia (RR 5.25, 95% CI 0.26 to 106.01; 1 trial, 80 participants; very low-certainty evidence). No trial presented data on health-related quality of life.\nFunding\nOne trial did not clearly report funding sources. The remaining three trials declared that they had no funding with vested interests.\nAuthors' conclusions\nBased on the small number of trials with insufficient sample size and events, and study limitations, we assessed the overall certainty of evidence in the predefined outcomes as low or very low. Therefore, we are uncertain which of the two interventions (ePTFE-covered stents or bare stents of the same diameter and ePTFE-covered stents versus bare stents of different stent diameters) is effective for the evaluated outcomes. None of the four trials reported data on health-related quality of life, and data on complications were either missing or rarely reported.\nWe lack high-quality trials to evaluate the role of ePTFE-covered stents for TIPS for managing people with liver cirrhosis.\n\nGiven the provided abstract, please respond to the following query: \"Technical terms: ePTFE\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "ePTFE is a variation of polytetrafluoroethylene (PTFE) that has been modified to have a porous structure. The material is created by stretching PTFE, which forms a network of interconnected nodes and fibrils (fibres). This porous structure allows the passage of fluids and gases through the material while retaining the desirable properties of PTFE, such as its chemical resistance."
}
] |
query-laysum
|
6770
|
[
{
"role": "user",
"content": "Abstract: Background\nInhaled corticosteroids (ICS) are the mainstay treatment for persistent asthma. Escalating treatment is required when asthma is not controlled with ICS therapy alone, which would include, but is not limited to, adding a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA) or doubling the dose of ICS.\nObjectives\nTo assess the efficacy and safety of adding a LABA or LAMA to ICS therapy versus doubling the dose of ICS in adolescents and adults whose asthma is not well controlled on medium-dose (MD)-ICS using a network meta-analysis (NMA), and to provide a ranking of these treatments according to their efficacy and safety.\nSearch methods\nWe searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, Global Health, ClinicalTrials.gov, and the World Health Organization ICTRP for pre-registered randomised controlled trials (RCTs) from January 2008 to 19 December 2022.\nSelection criteria\nWe searched for studies including adolescents and adults with uncontrolled asthma who had been treated with or were eligible for MD-ICS, comparing it to high-dose (HD)-ICS, ICS/LAMA, or ICS/LABA. We excluded cluster- and cross-over RCTs. Studies were of at least 12 weeks duration.\nData collection and analysis\nWe conducted a systematic review and network meta-analysis according to a previously published protocol. We used Cochrane’s Screen4ME workflow to assess search results. We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the certainty of evidence. The primary outcome is asthma exacerbations (moderate and severe).\nMain results\nWe included 38,276 participants from 35 studies (median duration 24 weeks (range 12 to 78); mean age 44.1; 38% male; 69% white; mean forced expiratory volume in one second 2.1 litres and 68% of predicted).\nMD- and HD-ICS/LABA likely reduce and MD-ICS/LAMA possibly reduces moderate to severe asthma exacerbations compared to MD-ICS (hazard ratio (HR) 0.70, 95% credible interval (CrI) 0.59 to 0.82; moderate certainty; HR 0.59, 95% CrI 0.46 to 0.76; moderate certainty; and HR 0.56, 95% CrI 0.38 to 0.82; low certainty, respectively), whereas HD-ICS probably does not (HR 0.94, 95% CrI 0.70 to 1.24; moderate certainty). There is no clear evidence to suggest that any combination therapy or HD-ICS reduces severe asthma exacerbations compared to MD-ICS (low to moderate certainty).\nThis study suggests no clinically meaningful differences in the symptom or quality of life score between dual combinations and monotherapy (low to high certainty).\nMD- and HD-ICS/LABA increase or likely increase the odds of Asthma Control Questionnaire (ACQ) responders at 6 and 12 months compared to MD-ICS (odds ratio (OR) 1.47, 95% CrI 1.23 to 1.76; high certainty; and OR 1.59, 95% CrI 1.31 to 1.94; high certainty at 6 months; and OR 1.61, 95% CrI 1.22 to 2.13; moderate certainty and OR 1.55, 95% CrI 1.20 to 2.00; high certainty at 12 months, respectively).\nMD-ICS/LAMA probably increases the odds of ACQ responders at 6 months (OR 1.32, 95% CrI 1.11 to 1.57; moderate certainty). No data were available at 12 months. There is no clear evidence to suggest that HD-ICS increases the odds of ACQ responders or improves the symptom or qualify of life score compared to MD-ICS (very low to high certainty).\nThere is no evidence to suggest that ICS/LABA or ICS/LAMA reduces asthma-related or all-cause serious adverse events (SAEs) compared to MD-ICS (very low to high certainty). HD-ICS results in or likely results in little or no difference in the included safety outcomes compared to MD-ICS as well as HD-ICS/LABA compared to MD-ICS/LABA.\nThe pairwise meta-analysis shows that MD-ICS/LAMA likely reduces all-cause adverse events (AEs) and results in a slight reduction in treatment discontinuation due to AEs compared to MD-ICS (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.77 to 0.96; 4 studies, 2238 participants; moderate certainty; and RR 0.51, 95% CI 0.26 to 0.99; 4 studies, 2239 participants; absolute risk reduction 10 fewer per 1000 participants; moderate certainty, respectively). The NMA evidence is in agreement with the pairwise evidence on treatment discontinuation due to AEs, but very uncertain on all-cause AEs, due to imprecision and heterogeneity.\nAuthors' conclusions\nThe review findings suggest that MD- or HD-ICS/LABA and MD-ICS/LAMA reduce moderate to severe asthma exacerbations and increase the odds of ACQ responders compared to MD-ICS whereas HD-ICS probably does not. The evidence is generally stronger for MD- and HD-ICS/LABA than for MD-ICS/LAMA primarily due to a larger evidence base. There is no evidence to suggest that ICS/LABA, ICS/LAMA, or HD-ICS/LABA reduces severe asthma exacerbations or SAEs compared to MD-ICS. MD-ICS/LAMA likely reduces all-cause AEs and results in a slight reduction in treatment discontinuation due to AEs compared to MD-ICS.\nThe above findings may assist in deciding on a treatment option during the stepwise approach of asthma management. Longer-term safety of higher than medium-dose ICS needs to be addressed in phase 4 or observational studies given that the median duration of included studies was six months.\n\nGiven the provided abstract, please respond to the following query: \"What is asthma, and how is it treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Asthma is a chronic respiratory condition characterised by inflammation and narrowing of the airways that causes symptoms such as wheezing, coughing, chest tightness, and shortness of breath. Treatment involves the use of inhalers, which are relievers (e.g. short-acting bronchodilators) and, if needed, preventers (e.g. ICS), as well as avoiding triggers and maintaining a healthy lifestyle."
}
] |
query-laysum
|
6771
|
[
{
"role": "user",
"content": "Abstract: Background\nContraceptive implants are one of the most effective contraceptive methods, providing a long duration of pregnancy protection and a high safety profile. Hence this method is suitable for optimizing the interpregnancy interval, especially for women undergoing abortion.\nWomen who have had abortions are at high risk of rapid repeat pregnancies. Provision of effective contraception at the time of an abortion visit can be a key strategy to increase access and uptake of contraception. A review of the evidence was needed to evaluate progestin-releasing implants for immediate use at the time of abortion, including whether immediate placement impacts the effectiveness of medical abortion, which relies on antiprogestogens.\nObjectives\nTo compare contraceptive implant initiation rates, contraceptive effectiveness, and adverse outcomes associated with immediate versus delayed insertion of contraceptive implants following abortion.\nSearch methods\nWe searched for all relevant studies regardless of language or publication status up to September 2019, with an update search in March 2021. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Ovid EBM Reviews), MEDLINE ALL (Ovid), Embase.com, CINAHL (EBSCOhost) (Cumulative Index to Nursing and Allied Health Literature), Global Health (Ovid), LILACS (Latin American and Caribbean Health Science Information database), Scopus, ClinicalTrials.gov, and the WHO ICTRP. We examined the reference lists of pertinent articles to identify other studies.\nSelection criteria\nWe sought randomized controlled trials (RCTs) comparing immediate versus delayed insertion of contraceptive implant for contraception following abortion.\nData collection and analysis\nWe followed the standard procedures recommended by Cochrane. To identify potentially relevant studies, two review authors (JS, LS) independently screened the titles, abstracts, and full texts of the search results, assessed trials for risk of bias, and extracted data. We computed the risk ratio (RR) with 95% confidence intervals (CIs) for binary outcomes, and the mean difference (MD) with 95% CIs for continuous variables.\nMain results\nWe found three RCTs including a total of 1162 women. Our GRADE assessment of the overall certainty of the evidence ranged from moderate to very low, downgraded for risk of bias, inconsistency, and imprecision.\nUtilization rate at six months may be slightly higher for immediate compared with delayed insertion (RR 1.10, 95% CI 1.05 to 1.15; 3 RCTs; 1103 women; I2 = 62%; low certainty evidence). Unintended pregnancy within six months after abortion was probably lower with immediate insertion compared with delayed insertion (RR 0.25, 95% CI 0.08 to 0.77; 3 RCTs; 1029 women; I2 = 0%; moderate certainty evidence). Immediate insertion of contraceptive implants probably improves the initiation rate compared to delayed insertion following medical abortion (RR 1.26 for medical abortion, 95% CI 1.21 to 1.32; 2 RCTs; 1014 women; I2 = 89%; moderate certainty evidence) and may also improve initiation following surgical abortion (RR 2.32 for surgical abortion, 95% CI 1.79 to 3.01; 1 RCT; 148 women; I2 = not applicable; low certainty evidence). We did not pool results for the implant initiation outcome over both abortion types because of very high statistical heterogeneity.\nFor medical termination of pregnancy, we found there is probably little or no difference between immediate and delayed insertion in overall failure of medical abortion (RR 1.18, 95% CI 0.58 to 2.40; 2 RCTs; 1001 women; I2 = 68%;moderate certainty evidence).\nThere may be no difference between immediate and delayed insertion on rates of abnormal bleeding at one month after abortion (RR 1.00, 95% CI 0.88 to 1.14; 1 RCT; 462 women; I2 = not applicable; low certainty evidence).\nAuthors' conclusions\nProvision of progestin-releasing implants concurrently with abortifacient agents likely has little or no negative impact on overall failure rate of medical abortion. Immediate insertion probably improves the initiation rate of contraceptive implant, as well as unintended pregnancy rate within six months after abortion, compared to delayed insertion. There may be no difference between immediate and delayed insertion approaches in bleeding adverse effects at one month after abortion.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for randomized controlled trials (studies where participants are randomly assigned to one of two or more treatment groups) up to March 2021. We looked at whether insertion of contraceptive implants at the same visit as abortion compared with at the time women returned for a follow-up visit affected the use of this contraceptive method. We included three studies with a total of 1162 women selecting implant contraception following an abortion assigned to immediate insertion at the visit or at a follow-up visit."
}
] |
query-laysum
|
6772
|
[
{
"role": "user",
"content": "Abstract: Background\nSubfertile women are highly motivated to try different adjunctive therapies to have a baby, and the widespread perception is that dietary supplements such as myo-inositol (MI) and D-chiro-insoitol (DCI) are associated with only benefit, and not with harm. Many fertility clinicians currently prescribe MI for subfertile women with polycystic ovary syndrome (PCOS) as pre-treatment to in vitro fertilisation (IVF) or for ovulation induction; however no high-quality evidence is available to support this practice. This review assessed the evidence for the effectiveness of inositol in subfertile women with a diagnosis of PCOS.\nObjectives\nTo evaluate the effectiveness and safety of oral supplementation of inositol for reproductive outcomes among subfertile women with PCOS who are trying to conceive.\nSearch methods\nWe searched the following databases (to July 2018): Cochrane Gynaecology and Fertility Group (CGFG) Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and AMED. We also checked reference lists and searched the clinical trials registries.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any type, dose, or combination of oral inositol versus placebo, no treatment/standard treatment, or treatment with another antioxidant, or with a fertility agent, or with another type of inositol, among subfertile women with PCOS.\nData collection and analysis\nTwo review authors independently selected eligible studies, extracted data, and assessed risk of bias. The primary outcomes were live birth and adverse effects; secondary outcomes included clinical pregnancy rates and ovulation rates. We pooled studies using a fixed-effect model, and we calculated odds ratios (ORs) with 95% confidence intervals (CIs). We assessed the overall quality of the evidence by applying GRADE criteria.\nMain results\nWe included 13 trials involving 1472 subfertile women with PCOS who were receiving myo-inositol as pre-treatment to IVF (11 trials), or during ovulation induction (two trials). These studies compared MI versus placebo, no treatment/standard, melatonin, metformin, clomiphene citrate, or DCI. The evidence was of 'low' to 'very low' quality. The main limitations were serious risk of bias due to poor reporting of methods, inconsistency, and lack of reporting of clinically relevant outcomes such as live birth and adverse events.\nWe are uncertain whether MI improves live birth rates when compared to standard treatment among women undergoing IVF (OR 2.42, 95% CI 0.75 to 7.83; P = 0.14; 2 RCTs; 84 women; I² = 0%). Very low-quality evidence suggests that for subfertile women with PCOS undergoing pre-treatment to IVF who have an expected live birth rate of 12%, the rate among women using MI would be between 9% and 51%.\nWe are uncertain whether MI may be associated with a decrease in miscarriage rate when compared to standard treatment (OR 0.40, 95% CI 0.19 to 0.86; P = 0.02; 4 RCTs; 535 women; I² = 66%; very low-quality evidence). This suggests that among subfertile women with PCOS with an expected miscarriage rate of 9% who are undergoing pre-treatment to IVF, the rate among women using MI would be between 2% and 8%; however this meta-analysis is based primarily on one study, which reported an unusually high miscarriage rate in the control group, and this has resulted in very high heterogeneity. When we removed this trial from the sensitivity analysis, we no longer saw the effect, and we noted no conclusive differences between MI and standard treatment.\nLow-quality evidence suggests that MI may be associated with little or no difference in multiple pregnancy rates when compared with standard treatment (OR 1.04, 95% CI 0.63 to 1.71; P = 0.89; 2 RCTs; 425 women). This suggests that among subfertile women with PCOS who are undergoing pre-treatment to IVF, with an expected multiple pregnancy rate of 18%, the rate among women using inositol would be between 12% and 27%.\nWe are uncertain whether MI may be associated with an increased clinical pregnancy rate when compared to standard treatment (OR 1.27, 95% CI 0.87 to 1.85; P = 0.22; 4 RCTs; 535 women; I² = 0%; very low-quality evidence). This suggests that among subfertile women with PCOS who are undergoing pre-treatment to IVF, with an expected clinical pregnancy rate of 26%, the rate among women using MI would be between 24% and 40%. Ovulation rates were not reported for this comparison.\nOther comparisons included only one trial in each, so for the comparisons MI versus antioxidant, MI versus an insulin-sensitising agent, MI versus an ovulation induction agent, and MI versus another DCI, meta-analysis was not possible.\nNo pooled evidence was available for women with PCOS undergoing ovulation induction, as only single trials performed comparison of the insulin-sensitising agent and the ovulation induction agent.\nAuthors' conclusions\nIn light of available evidence of very low quality, we are uncertain whether MI improves live birth rate or clinical pregnancy rate in subfertile women with PCOS undergoing IVF pre-treatment taking MI compared to standard treatment. We are also uncertain whether MI decreases miscarriage rates or multiple pregnancy rates for these same women taking MI compared to standard treatment. No pooled evidence is available for use of MI versus placebo, another antioxidant, insulin-sensitising agents, ovulation induction agents, or another type of inositol for women with PCOS undergoing pre-treatment to IVF. No pooled evidence is available for use of MI in women undergoing ovulation induction.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We looked at whether women who have polycystic ovary syndrome (PCOS) and were having difficulty getting pregnant would benefit from taking supplements of inositol."
}
] |
query-laysum
|
6773
|
[
{
"role": "user",
"content": "Abstract: Background\nThe effect of antibiotics with potential antiviral and anti-inflammatory properties are being investigated in clinical trials as treatment for COVID-19. The use of antibiotics follows the intention-to-treat the viral disease and not primarily to treat bacterial co-infections of individuals with COVID-19. A thorough understanding of the current evidence regarding effectiveness and safety of antibiotics as anti-viral treatments for COVID-19 based on randomised controlled trials (RCTs) is required.\nObjectives\nTo assess the efficacy and safety of antibiotics compared to each other, no treatment, standard of care alone, placebo, or any other active intervention with proven efficacy for treatment of COVID-19 outpatients and inpatients.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (including MEDLINE, Embase, ClinicalTrials.gov, WHO ICTRP, medRxiv, CENTRAL), Web of Science and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies to 14 June 2021.\nSelection criteria\nRCTs were included that compared antibiotics with each other, no treatment, standard of care alone, placebo, or another proven intervention, for treatment of people with confirmed COVID-19, irrespective of disease severity, treated in the in- or outpatient settings.\nCo-interventions had to be the same in both study arms. We excluded studies comparing antibiotics to other pharmacological interventions with unproven efficacy.\nData collection and analysis\nWe assessed risk of bias of primary outcomes using the Cochrane risk of bias tool (ROB 2) for RCTs. We used GRADE to rate the certainty of evidence for the following primary outcomes: 1. to treat inpatients with moderate to severe COVID-19: mortality, clinical worsening defined as new need for intubation or death, clinical improvement defined as being discharged alive, quality of life, adverse and serious adverse events, and cardiac arrhythmias; 2. to treat outpatients with asymptomatic or mild COVID-19: mortality, clinical worsening defined as hospital admission or death, clinical improvement defined as symptom resolution, quality of life, adverse and serious adverse events, and cardiac arrhythmias.\nMain results\nWe included 11 studies with 11,281 participants with an average age of 54 years investigating antibiotics compared to placebo, standard of care alone or another antibiotic. No study was found comparing antibiotics to an intervention with proven efficacy. All studies investigated azithromycin, two studies investigated other antibiotics compared to azithromycin. Seven studies investigated inpatients with moderate to severe COVID-19 and four investigated mild COVID-19 cases in outpatient settings. Eight studies had an open-label design, two were blinded with a placebo control, and one did not report on blinding. We identified 19 ongoing and 15 studies awaiting classification pending publication of results or clarification of inconsistencies.\nOf the 30 study results contributing to primary outcomes by included studies, 17 were assessed as overall low risk and 13 as some concerns of bias. Only studies investigating azithromycin reported data eligible for the prioritised primary outcomes. Azithromycin doses and treatment duration varied among included studies.\nAzithromycin for the treatment of COVID-19 compared to placebo or standard of care alone in inpatients\nWe are very certain that azithromycin has little or no effect on all-cause mortality at day 28 compared to standard of care alone (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.90 to 1.06; 8600 participants; 4 studies; high-certainty evidence). Azithromycin probably has little or no effect on clinical worsening or death at day 28 (RR 0.95; 95% CI 0.87 to 1.03; 7311 participants; 1 study; moderate-certainty evidence), on clinical improvement at day 28 (RR 0.96; 95% CI 0.84 to 1.11; 8172 participants; 3 studies; moderate-certainty evidence), on serious adverse events during the study period (RR 1.11; 95% CI 0.89 to 1.40; 794 participants; 4 studies; moderate-certainty evidence), and cardiac arrhythmias during the study period (RR 0.92; 95% CI 0.73 to 1.15; 7865 participants; 4 studies; moderate-certainty evidence) compared to placebo or standard of care alone. Azithromycin may increase any adverse events slightly during the study period (RR 1.20; 95% CI 0.92 to 1.57; 355 participants; 3 studies; low-certainty evidence) compared to standard of care alone. No study reported quality of life up to 28 days.\nAzithromycin for the treatment of COVID-19 compared to placebo or standard of care alone in outpatients\nAzithromycin may have little or no effect compared to placebo or standard of care alone on all-cause mortality at day 28 (RR 1.00 ; 95% CI 0.06 to 15.69; 876 participants; 3 studies; low-certainty evidence), on admission to hospital or death within 28 days (RR 0.94 ; 95% CI 0.57 to 1.56; 876 participants; 3 studies; low-certainty evidence), and on symptom resolution at day 14 (RR 1.03; 95% CI 0.95 to 1.12; 138 participants; 1 study; low-certainty evidence). We are uncertain whether azithromycin increases or reduces serious adverse events compared to placebo or standard of care alone (0 participants experienced serious adverse events; 454 participants; 2 studies; very low-certainty evidence). No study reported on adverse events, cardiac arrhythmias during the study period or quality of life up to 28 days.\nAzithromycin for the treatment of COVID-19 compared to any other antibiotics in inpatients and outpatients\nOne study compared azithromycin to lincomycin in inpatients, but did not report any primary outcome.\nAnother study compared azithromycin to clarithromycin in outpatients, but did not report any relevant outcome for this review.\nAuthors' conclusions\nWe are certain that risk of death in hospitalised COVID-19 patients is not reduced by treatment with azithromycin after 28 days. Further, based on moderate-certainty evidence, patients in the inpatient setting with moderate and severe disease probably do not benefit from azithromycin used as potential antiviral and anti-inflammatory treatment for COVID-19 regarding clinical worsening or improvement. For the outpatient setting, there is currently low-certainty evidence that azithromycin may have no beneficial effect for COVID-19 individuals. There is no evidence from RCTs available for other antibiotics as antiviral and anti-inflammatory treatment of COVID-19.\nWith accordance to the living approach of this review, we will continually update our search and include eligible trials to fill this evidence gap. However, in relation to the evidence for azithromycin and in the context of antimicrobial resistance, antibiotics should not be used for treatment of COVID-19 outside well-designed RCTs.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are very confident in the evidence on azithromycin for COVID-19 inpatients. However, we are less confident in the evidence on azithromycin in outpatients, mainly because there were few studies that also had some flaws, therefore we could not draw reliable conclusions. We found relevant evidence on only one antibiotic, azithromycin, so we do not know the effects of other antibiotics for treating COVID-19. We will continue to search for new studies to fill this evidence gap. Our evidence does not suggest azithromycin is an effective treatment for COVID-19, especially given the danger of antimicrobial resistance. Azithromycin or any other antibiotic should not be used to treat COVID-19 outside well-designed studies."
}
] |
query-laysum
|
6774
|
[
{
"role": "user",
"content": "Abstract: Background\nThe majority of people with epilepsy have a good prognosis and their seizures are controlled by a single antiepileptic drug. However, up to 20% of patients from population-based studies, and up to 30% from clinical series (not population-based), develop drug-resistant epilepsy, especially those with focal-onset seizures. In this review, we summarise the current evidence regarding topiramate, an antiepileptic drug first marketed in 1996, when used as an add-on treatment for drug-resistant focal epilepsy.\nThis is an update of a Cochrane Review first published in 1999, and last updated in 2014.\nObjectives\nTo evaluate the efficacy and tolerability of topiramate when used as an add-on treatment for people with drug-resistant focal epilepsy.\nSearch methods\nFor the latest update of this review we searched the following databases on 2 July 2018: Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (Ovid, 1946- ); ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions. We also contacted the manufacturers of topiramate and researchers in the field to identify any ongoing or unpublished studies.\nSelection criteria\nRandomised, placebo-controlled add-on trials of topiramate, recruiting people with drug-resistant focal epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: (1) 50% or greater reduction in seizure frequency; (2) seizure freedom; (3) treatment withdrawal (any reason); (4) adverse effects. Primary analyses were intention-to-treat (ITT), and summary risk ratios (RRs) with 95% confidence intervals (95% CIs) are presented. We evaluated dose-response in regression models. We carried out a 'Risk of bias' assessment for each included study using the Cochrane 'Risk of bias' tool and assessed the overall certainty of evidence using the GRADE approach.\nMain results\nWe included 12 trials, representing 1650 participants. Baseline phases ranged from four to 12 weeks and double-blind phases ranged from 11 to 19 weeks. The RR for a 50% or greater reduction in seizure frequency with add-on topiramate compared to placebo was 2.71 (95% CI 2.05 to 3.59; 12 studies; high-certainty evidence). Dose regression analysis showed increasing effect with increasing topiramate dose demonstrated by an odds ratio (OR) of 1.45 (95% CI 1.28 to 1.64; P < 0.001) per 200 mg/d increase in topiramate dosage. The proportion of participants achieving seizure freedom was also significantly increased with add-on topiramate compared to placebo (RR 3.67, 95% CI 1.79 to 7.54; 8 studies; moderate-certainty evidence). Treatment withdrawal was significantly higher for add-on topiramate compared to placebo (RR 2.37, 95% CI 1.66 to 3.37; 12 studies; high-certainty evidence). The RRs for the following adverse effects indicate that they are significantly more prevalent with topiramate, compared to placebo: ataxia 2.29 (99% CI 1.10 to 4.77; 4 studies); concentration difficulties 7.81 (99% CI 2.08 to 29.29; 6 studies; moderate-certainty evidence); dizziness 1.52 (99% CI 1.07 to 2.16; 8 studies); fatigue 2.08 (99% CI 1.37 to 3.15; 10 studies); paraesthesia 3.65 (99% CI 1.58 to 8.39; 7 studies; moderate-certainty evidence); somnolence 2.44 (99% CI 1.61 to 3.68; 9 studies); 'thinking abnormally' 5.70 (99% CI 2.26 to 14.38; 4 studies; high-certainty evidence); and weight loss 3.99 (99% CI 1.82 to 8.72; 9 studies; low-certainty evidence). Evidence of publication bias for the primary outcome was found (Egger test, P = 0.001). We rated all studies included in the review as having either low or unclear risk of bias. Overall, we assessed the evidence as moderate to high certainty due to the evidence of publication bias, statistical heterogeneity and imprecision, which was partially compensated for by large effect sizes.\nAuthors' conclusions\nTopiramate has efficacy as an add-on treatment for drug-resistant focal epilepsy as it is almost three times more effective compared to a placebo in reducing seizures. The trials reviewed were of relatively short duration and provided no evidence for the long-term efficacy of topiramate. Short-term use of add-on topiramate was shown to be associated with several adverse events. The results of this review should only be applied to adult populations as only one study included children. Future research should consider further examining the effect of dose.\n\nGiven the provided abstract, please respond to the following query: \"Aim of this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review investigated the effectiveness and tolerability of topiramate when used as an add-on treatment for people with drug-resistant focal epilepsy."
}
] |
query-laysum
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6775
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[
{
"role": "user",
"content": "Abstract: Background\nThis updated Cochrane Review of reminiscence therapy (RT) for dementia was first published in 1998, and last updated in 2005. RT involves the discussion of memories and past experiences with other people using tangible prompts such as photographs or music to evoke memories and stimulate conversation. RT is implemented widely in a range of settings using a variety of formats.\nObjectives\nTo assess the effects of RT on people living with dementia and their carers, taking into account differences in its implementation, including setting (care home, community) and modality (group, individual).\nSearch methods\nWe searched ALOIS (the Cochrane Dementia and Cognitive Improvement Group's Specialized Register) on 6 April 2017 using the search term 'reminiscence.'\nSelection criteria\nWe included all randomised controlled trials of RT for dementia in which the duration of the intervention was at least four weeks (or six sessions) and that had a 'no treatment' or passive control group. Outcomes of interest were quality of life (QoL), cognition, communication, behaviour, mood and carer outcomes.\nData collection and analysis\nTwo authors (LOP and EF) independently extracted data and assessed risk of bias. Where necessary, we contacted study authors for additional information. We pooled data from all sufficiently similar studies reporting on each outcome. We undertook subgroup analysis by setting (community versus care home) and by modality (individual versus group). We used GRADE methods to assess the overall quality of evidence for each outcome.\nMain results\nWe included 22 studies involving 1972 people with dementia. Meta-analyses included data from 16 studies (1749 participants). Apart from six studies with risk of selection bias, the overall risk of bias in the studies was low.\nOverall, moderate quality evidence indicated RT did not have an important effect on QoL immediately after the intervention period compared with no treatment (standardised mean difference (SMD) 0.11, 95% confidence interval (CI) -0.12 to 0.33; I2 = 59%; 8 studies; 1060 participants). Inconsistency between studies mainly related to the study setting. There was probably a slight benefit in favour of RT in care homes post-treatment (SMD 0.46, 95% CI 0.18 to 0.75; 3 studies; 193 participants), but little or no difference in QoL in community settings (867 participants from five studies).\nFor cognitive measures, there was high quality evidence for a very small benefit, of doubtful clinical importance, associated with reminiscence at the end of treatment (SMD 0.11, 95% CI 0.00 to 0.23; 14 studies; 1219 participants), but little or no difference at longer-term follow-up. There was a probable slight improvement for individual reminiscence and for care homes when analysed separately, but little or no difference for community settings or for group studies. Nine studies included the widely used Mini-Mental State Examination (MMSE) as a cognitive measure, and, on this scale, there was high quality evidence for an improvement at the end of treatment (mean difference (MD) 1.87 points, 95% CI 0.54 to 3.20; 437 participants). There was a similar effect at longer-term follow-up, but the quality of evidence for this analysis was low (1.8 points, 95% CI -0.06 to 3.65).\nFor communication measures, there may have been a benefit of RT at the end of treatment (SMD -0.51 points, 95% CI -0.97 to -0.05; I2 = 62%; negative scores indicated improvement; 6 studies; 249 participants), but there was inconsistency between studies, related to the RT modality. At follow-up, there was probably a slight benefit of RT (SMD -0.49 points, 95% CI -0.77 to -0.21; 4 studies; 204 participants). Effects were uncertain for individual RT, with very low quality evidence available. For reminiscence groups, evidence of moderate quality indicated a probable slight benefit immediately (SMD -0.39, 95% CI -0.71 to -0.06; 4 studies; 153 participants), and at later follow-up. Community participants probably benefited at end of treatment and follow-up. For care home participants, the results were inconsistent between studies and, while there may be an improvement at follow-up, at the end of treatment the evidence quality was very low and effects were uncertain.\nOther outcome domains examined for people with dementia included mood, functioning in daily activities, agitation/irritability and relationship quality. There were no clear effects in these domains. Individual reminiscence was probably associated with a slight benefit on depression scales, although its clinical importance was uncertain (SMD -0.41, 95% CI -0.76 to -0.06; 4 studies; 131 participants). We found no evidence of any harmful effects on people with dementia.\nWe also looked at outcomes for carers, including stress, mood and quality of relationship with the person with dementia (from the carer's perspective). We found no evidence of effects on carers other than a potential adverse outcome related to carer anxiety at longer-term follow-up, based on two studies that had involved the carer jointly in reminiscence groups with people with dementia. The control group carers were probably slightly less anxious (MD 0.56 points, 95% CI -0.17 to 1.30; 464 participants), but this result is of uncertain clinical importance, and is also consistent with little or no effect.\nAuthors' conclusions\nThe effects of reminiscence interventions are inconsistent, often small in size and can differ considerably across settings and modalities. RT has some positive effects on people with dementia in the domains of QoL, cognition, communication and mood. Care home studies show the widest range of benefits, including QoL, cognition and communication (at follow-up). Individual RT is associated with probable benefits for cognition and mood. Group RT and a community setting are associated with probable improvements in communication. The wide range of RT interventions across studies makes comparisons and evaluation of relative benefits difficult. Treatment protocols are not described in sufficient detail in many publications. There have been welcome improvements in the quality of research on RT since the previous version of this review, although there still remains a need for more randomised controlled trials following clear, detailed treatment protocols, especially allowing the effects of simple and integrative RT to be compared.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "RT involves discussing events and experiences from the past. It aims to evoke memories, stimulate mental activity and improve well-being. Reminiscence is often assisted by props such as videos, pictures and objects. It can take place in a group or be done with a person on their own, when it often results in some form of life-story book being created. RT helps older people with depression. It may be suitable for people with dementia both because depression is common in dementia and because people with dementia typically have a better memory for the distant past than for recent events."
}
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query-laysum
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6776
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[
{
"role": "user",
"content": "Abstract: Background\nPeople with asthma may experience exacerbations, or 'attacks', during which their symptoms worsen and additional treatment is required. Written action plans sometimes advocate a short-term increase in the dose of inhaled corticosteroids (ICS) at the first sign of an exacerbation to reduce the severity of the attack and to prevent the need for oral steroids or hospital admission.\nObjectives\nTo compare the clinical effectiveness and safety of increased versus stable doses of ICS as part of a patient-initiated action plan for the home management of exacerbations in children and adults with persistent asthma.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register, which is derived from searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL (Cumulative Index to Nursing and Allied Health Literature), and handsearched abstracts to 20 December 2021. We also searched major trial registries for ongoing trials.\nSelection criteria\nWe included parallel and cross-over randomised controlled trials (RCTs) that allocated people with persistent asthma to take a blinded inhaler in the event of an exacerbation which either increased their daily dose of ICS or kept it stable (placebo).\nData collection and analysis\nTwo review authors independently selected trials, assessed quality, and extracted data. We reassessed risk of bias for all studies at the result level using the revised risk of bias tool for RCTs (Risk of Bias 2), and employed the GRADE approach to assess our confidence in the synthesised effect estimates. The primary outcome was treatment failure, defined as the need for rescue oral steroids in the randomised population. Secondary outcomes were treatment failure in the subset who initiated the study inhaler (treated population), unscheduled physician visits, unscheduled acute care, emergency department or hospital visits, serious and non-serious adverse events, and duration of exacerbation.\nMain results\nThis review update added a new study that increased the number of people in the primary analysis from 1520 to 1774, and incorporates the most up-to-date methods to assess the likely impact of bias within the meta-analyses. The updated review now includes nine RCTs (1923 participants; seven parallel and two cross-over) conducted in Europe, North America, and Australasia and published between 1998 and 2018. Five studies evaluated adult populations (n = 1247; ≥ 15 years), and four studies evaluated child or adolescent populations (n = 676; < 15 years). All study participants had mild to moderate asthma. Studies varied in the dose of maintenance ICS, age, fold increase of ICS in the event of an exacerbation, criteria for initiating the study inhaler, and allowed medications. Approximately 50% of randomised participants initiated the study inhaler (range 23% to 100%), and the included studies reported treatment failure in a variety of ways, meaning assumptions were required to permit the combining of data.\nParticipants randomised to increase their ICS dose at the first signs of an exacerbation had similar odds of needing rescue oral corticosteroids to those randomised to a placebo inhaler (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.76 to 1.25; 8 studies; 1774 participants; I2 = 0%; moderate quality evidence). We could draw no firm conclusions from subgroup analyses conducted to investigate the impact of age, time to treatment initiation, baseline dose, smoking history, and fold increase of ICS on the primary outcome. Results for the same outcome in the subset of participants who initiated the study inhaler were unchanged from the previous version, which provides a different point estimate with very low confidence due to heterogeneity, imprecision, and risk of bias (OR 0.84, 95% CI 0.54 to 1.30; 7 studies; 766 participants; I2 = 42%; random-effects model). Confidence was reduced due to risk of bias and assumptions that had to be made to include study data in the intention-to-treat and treated-population analyses. Sensitivity analyses that tested the impact of assumptions made for synthesis and to exclude cross-over studies, studies at overall high risk of bias, and those with commercial funding did not change our conclusions.\nPooled effects for unscheduled physician visits, unscheduled acute care, emergency department or hospital visits, and duration of exacerbation made it very difficult to determine where the true effect may lie, and confidence was reduced by risk of bias. Point estimates for both serious and non-serious adverse events favoured keeping ICS stable, but imprecision and risk of bias due to missing data and outcome measurement and reporting reduced our confidence in the effects (serious adverse events: OR 1.69, 95% CI 0.77 to 3.71; 2 studies; 394 participants; I² = 0%; non-serious adverse events: OR 2.15, 95% CI 0.68 to 6.73; 2 studies; 142 participants; I² = 0%).\nAuthors' conclusions\nEvidence from double-blind trials of adults and children with mild to moderate asthma suggests there is unlikely to be an important reduction in the need for oral steroids from increasing a patient's ICS dose at the first sign of an exacerbation. Other clinically important benefits and potential harms of increased doses of ICS compared with keeping the dose stable cannot be ruled out due to wide confidence intervals, risk of bias in the trials, and assumptions that had to be made for synthesis. Included studies conducted between 1998 and 2018 reflect evolving clinical practice and study methods, and the data do not support thorough investigation of effect modifiers such as baseline dose, fold increase, asthma severity and timing. The review does not include recent evidence from pragmatic, unblinded studies showing benefits of larger dose increases in those with poorly controlled asthma. A systematic review is warranted to examine the differences between the blinded and unblinded trials using robust methods for assessing risk of bias to present the most complete view of the evidence for decision makers.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important for people with asthma?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Asthma attacks are frightening for people with asthma and often require urgent treatment at home or in hospital. Knowing how best to control asthma attacks at the first sign of symptoms is important to avoid the need for oral steroids or emergency treatment in hospital.\nInhaled corticosteroids are a common treatment for asthma that are taken daily to reduce the likelihood of attacks occurring. Written action plans are given to people with asthma to tell them what to do if their symptoms do worsen, and these sometimes recommend a short-term increase in the dose of inhaled corticosteroids to get symptoms back under control."
}
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query-laysum
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6777
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[
{
"role": "user",
"content": "Abstract: Background\nHistologic assessment of mucosal disease activity has been increasingly used in clinical trials of treatment for Crohn's disease. However, the operating properties of the currently existing histologic scoring indices remain unclear.\nObjectives\nA systematic review was undertaken to evaluate the development and operating characteristics of available histologic disease activity indices in Crohn's disease.\nSearch methods\nElectronic searches of MEDLINE, EMBASE, PubMed, and the Cochrane Library (CENTRAL) databases from inception to 20 July 2016 were supplemented by manual reviews of bibliographies and abstracts submitted to major gastroenterology meetings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organisation).\nSelection criteria\nAny study design (e.g. randomised controlled trial, cohort study, case series) that evaluated a histologic disease activity index in patients with Crohn’s disease was considered for inclusion. Study participants included adult patients (> 16 years), diagnosed with Crohn’s disease using conventional clinical, radiographic or endoscopic criteria.\nData collection and analysis\nTwo authors independently reviewed the titles and abstracts of the studies identified from the literature search. The full text of potentially relevant citations were reviewed for inclusion and the study investigators were contacted as needed for clarification. Any disagreements regarding study eligibility were resolved by discussion and consensus with a third author.\nTwo authors independently extracted and recorded data using a standard form. The following data were recorded from each eligible study: number of patients enrolled; number of patients per treatment arm; patient characteristics: age and gender distribution; description of histologic disease activity index utilized; and outcomes such as content validity, construct validity, criterion validity, responsiveness, intra-rater reliability, inter-rater reliability, and feasibility.\nMain results\nSixteen reports of 14 studies describing 14 different numerical histological indices fulfilled the inclusion criteria.\nInter-rater reliability was assessed in one study. For the Naini and Cortina Score, estimates of correlation were 'almost perfect', ranging from r = 0.94 to 0.96. The methodological quality of this study with respect to reliability was 'good'.\nWith respect to validity, correlation estimates between various histological scoring systems and Crohn's disease activity as measured by objective markers of inflammation (including C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin and fecal lactoferrin); endoscopic disease activity scores; clinical disease activity scores; and quality of life questionnaires were reported. Comparisons between histologic scoring indices and endoscopic scoring indices ranged from no correlation to 'substantial' (r = 0.779). The methodological quality of the studies that explored validity ranged form 'poor' to 'good'.\nResponsiveness data were available in seven studies. After subjects were administered a treatment of known efficacy, statistically significant change in the index score was demonstrated in five studies with respect to six indices. Two studies failed to indicate whether there was statistically significant change in the index score post-treatment. With regard to methodological quality, six of the studies were rated as 'poor' and one of the studies was rated as 'fair'.\nFeasibility was assessed by one study. The Naini and Cortina Score was shown to be simple to use and feasible for every given case.\nAuthors' conclusions\nCurrently there is no fully validated histological scoring index for evaluation of Crohn's disease activity. Development of a validated histological scoring index for Crohn’s disease is a clinical and research priority.\n\nGiven the provided abstract, please respond to the following query: \"What is a histological scoring index?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A histological scoring index measures disease activity based on the examination of biopsy specimens from the bowel (small pieces of tissue removed from the bowel) under a microscope. Biopsy specimens are removed from the bowel during colonoscopy (a non-surgical procedure used to view the digestive tract using a camera) with biopsy forceps (instruments to grasp and remove pieces of tissue). Biopsies are then processed and assessed under microscope by a pathologist (a physician who interprets and diagnoses the changes caused by disease in tissues) who then rates disease activity using the index."
}
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query-laysum
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6778
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[
{
"role": "user",
"content": "Abstract: Background\nCentral retinal vein occlusion (CRVO) is a common retinal vascular abnormality associated with conditions such as hypertension, diabetes, glaucoma, and a wide variety of hematologic disorders. Macular edema (ME) represents an important vision-threatening complication of CRVO. Intravitreal steroids (IVS), such as triamcinolone acetonide, have been utilized to treat macular edema stemming from a variety of etiologies and may be a treatment option for CRVO-ME.\nObjectives\nTo explore the effectiveness and safety of intravitreal steroids in the treatment of CRVO-ME.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014 Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2014), EMBASE (January 1980 to November 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 13 November 2014. For all included primary studies, we used The Science Citation Index (3 December 2014) and manually reviewed reference lists to identify other possible relevant trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared intravitreal steroids, of any dosage and duration of treatment of at least six months, with observation for the treatment of CRVO-ME.\nData collection and analysis\nTwo review authors independently screened titles and abstracts identified from the electronic searches and assessed full-text articles from potentially eligible trials. Two review authors independently assessed trial characteristics, risk of bias, and extracted data from included trials. We contacted investigators of included trials for desired data not provided in the trial reports.\nMain results\nWe included two RCTs that enrolled a total of 708 participants with CRVO-ME. SCORE compared triamcinolone acetonide intravitreal injections (n = 165) with observation (n = 72); GENEVA compared dexamethasone intravitreal implants (n = 290) with sham injections (n = 147). We observed characteristics indicative of high risk of bias due to incomplete outcome data in SCORE and selective outcome reporting in GENEVA. Loss to follow-up was high with 10% in the steroid groups and almost twice as much (17%) in the observation group. GENEVA enrolled participants with both branch and central retinal vein occlusion, but did not present subgroup data for the CRVO-ME population. A qualitative assessment of the results from GENEVA indicated that the dexamethasone implant was not associated with improvement in visual acuity after six months among participants with CRVO-ME. Although the SCORE investigators reported that participants treated with 1 mg (n = 82) or 4 mg (n = 83) triamcinolone intravitreal injections were five times more likely to have gained 15 letters or more in visual acuity compared with participants in the observation group (1 mg; risk ratio (RR): 5.27; 95% confidence interval (CI) 1.62 to 17.15; 4 mg RR 4.92; 95% CI 1.50 to 16.10) by the eighth-month follow-up examination, the average visual acuity decreased in all three groups. However, eyes treated with triamcinolone lost fewer letters than participants in the observation group at 8 months (1 mg mean difference (MD): 8.70 letters, 95% CI 1.86 to 15.54; 4 mg MD: 9.80 letters, 95% CI 3.32 to 16.28). A higher incidence of adverse events was noted with IVS therapy when compared with observation alone. As many as 20% to 35% of participants experienced an adverse event in the IVS groups compared with 8% of participants in the observation group of the SCORE study. The GENEVA investigators reported 63% in the treatment arm versus 43% in the observation arm experienced an adverse event. The most commonly encountered adverse events were elevated intraocular pressure, progression of cataracts, and retinal neovascularization. We graded the quality of evidence as low due to study limitations, imprecision of treatment estimates, and selective outcome reporting.\nAuthors' conclusions\nThe two RCTs reviewed herein provide insufficient evidence to determine the benefits of IVS for individuals with CRVO-ME. The improvement in visual acuity noted in the SCORE trial should be interpreted with caution as outcome data were missing for a large proportion of the observation group. Adverse events were observed more often with IVS treatment compared with observation/no treatment.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Neither trial provided sufficient evidence to determine whether steroids had improved visual acuity after six months of treatment. Due to the limited evidence, we are unable to determine reliably whether steroid implants improved vision in eyes with CRVO-ME. Although the SCORE trial showed that more eyes in the steroid injection groups had improvement in vision compared with eyes in the observation group, participants treated with steroids and those not treated with steroids both lost vision on average at eight months. The GENEVA investigators reported no difference in vision outcomes between participants treated with steroids and those not treated with steroids after six months of treatment; however the GENEVA study was not limited to participants with only CRVO-ME and included participants with other retinal disease. Both trials showed that patients treated with steroids were at increased risk for high eye pressure - requiring additional medications to lower the eye pressure - and developing cataracts."
}
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query-laysum
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6779
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[
{
"role": "user",
"content": "Abstract: Background\nIntensive Case Management (ICM) is a community-based package of care aiming to provide long-term care for severely mentally ill people who do not require immediate admission. Intensive Case Management evolved from two original community models of care, Assertive Community Treatment (ACT) and Case Management (CM), where ICM emphasises the importance of small caseload (fewer than 20) and high-intensity input.\nObjectives\nTo assess the effects of ICM as a means of caring for severely mentally ill people in the community in comparison with non-ICM (caseload greater than 20) and with standard community care. We did not distinguish between models of ICM. In addition, to assess whether the effect of ICM on hospitalisation (mean number of days per month in hospital) is influenced by the intervention's fidelity to the ACT model and by the rate of hospital use in the setting where the trial was conducted (baseline level of hospital use).\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register (last update search 10 April 2015).\nSelection criteria\nAll relevant randomised clinical trials focusing on people with severe mental illness, aged 18 to 65 years and treated in the community care setting, where ICM is compared to non-ICM or standard care.\nData collection and analysis\nAt least two review authors independently selected trials, assessed quality, and extracted data. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses.\nWe performed a random-effects meta-regression analysis to examine the association of the intervention's fidelity to the ACT model and the rate of hospital use in the setting where the trial was conducted with the treatment effect. We assessed overall quality for clinically important outcomes using the GRADE approach and investigated possible risk of bias within included trials.\nMain results\nThe 2016 update included two more studies (n = 196) and more publications with additional data for four already included studies. The updated review therefore includes 7524 participants from 40 randomised controlled trials (RCTs). We found data relevant to two comparisons: ICM versus standard care, and ICM versus non-ICM. The majority of studies had a high risk of selective reporting. No studies provided data for relapse or important improvement in mental state.\n1. ICM versus standard care\nWhen ICM was compared with standard care for the outcome service use, ICM slightly reduced the number of days in hospital per month (n = 3595, 24 RCTs, MD -0.86, 95% CI -1.37 to -0.34,low-quality evidence). Similarly, for the outcome global state, ICM reduced the number of people leaving the trial early (n = 1798, 13 RCTs, RR 0.68, 95% CI 0.58 to 0.79, low-quality evidence). For the outcome adverse events, the evidence showed that ICM may make little or no difference in reducing death by suicide (n = 1456, 9 RCTs, RR 0.68, 95% CI 0.31 to 1.51, low-quality evidence). In addition, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment due to very low-quality evidence (n = 1129, 4 RCTs, RR 0.70, 95% CI 0.49 to 1.0, very low-quality evidence).\n2. ICM versus non-ICM\nWhen ICM was compared with non-ICM for the outcome service use, there was moderate-quality evidence that ICM probably makes little or no difference in the average number of days in hospital per month (n = 2220, 21 RCTs, MD -0.08, 95% CI -0.37 to 0.21, moderate-quality evidence) or in the average number of admissions (n = 678, 1 RCT, MD -0.18, 95% CI -0.41 to 0.05, moderate-quality evidence) compared to non-ICM. Similarly, the results showed that ICM may reduce the number of participants leaving the intervention early (n = 1970, 7 RCTs, RR 0.70, 95% CI 0.52 to 0.95,low-quality evidence) and that ICM may make little or no difference in reducing death by suicide (n = 1152, 3 RCTs, RR 0.88, 95% CI 0.27 to 2.84, low-quality evidence). Finally, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment as compared to non-ICM (n = 73, 1 RCT, RR 1.46, 95% CI 0.45 to 4.74, very low-quality evidence).\n3. Fidelity to ACT\nWithin the meta-regression we found that i.) the more ICM is adherent to the ACT model, the better it is at decreasing time in hospital ('organisation fidelity' variable coefficient -0.36, 95% CI -0.66 to -0.07); and ii.) the higher the baseline hospital use in the population, the better ICM is at decreasing time in hospital ('baseline hospital use' variable coefficient -0.20, 95% CI -0.32 to -0.10). Combining both these variables within the model, 'organisation fidelity' is no longer significant, but the 'baseline hospital use' result still significantly influences time in hospital (regression coefficient -0.18, 95% CI -0.29 to -0.07, P = 0.0027).\nAuthors' conclusions\nBased on very low- to moderate-quality evidence, ICM is effective in ameliorating many outcomes relevant to people with severe mental illness. Compared to standard care, ICM may reduce hospitalisation and increase retention in care. It also globally improved social functioning, although ICM's effect on mental state and quality of life remains unclear. Intensive Case Management is at least valuable to people with severe mental illnesses in the subgroup of those with a high level of hospitalisation (about four days per month in past two years). Intensive Case Management models with high fidelity to the original team organisation of ACT model were more effective at reducing time in hospital.\nHowever, it is unclear what overall gain ICM provides on top of a less formal non-ICM approach.\nWe do not think that more trials comparing current ICM with standard care or non-ICM are justified, however we currently know of no review comparing non-ICM with standard care, and this should be undertaken.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 40 trials involving 7524 people. The trials took place in Australia, Canada, China, Europe, and the USA. When ICM was compared to standard care, those in the ICM group were more likely to stay with the service, have improved general functioning, get a job, not be homeless, and have shorter stays in hospital (especially when they had had very long stays in hospital previously). When ICM was compared to non-ICM, the only clear difference was that those in the ICM group were more likely to be kept in care."
}
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query-laysum
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6780
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[
{
"role": "user",
"content": "Abstract: Background\nMyopia is a common refractive error, where elongation of the eyeball causes distant objects to appear blurred. The increasing prevalence of myopia is a growing global public health problem, in terms of rates of uncorrected refractive error and significantly, an increased risk of visual impairment due to myopia-related ocular morbidity. Since myopia is usually detected in children before 10 years of age and can progress rapidly, interventions to slow its progression need to be delivered in childhood.\nObjectives\nTo assess the comparative efficacy of optical, pharmacological and environmental interventions for slowing myopia progression in children using network meta-analysis (NMA). To generate a relative ranking of myopia control interventions according to their efficacy. To produce a brief economic commentary, summarising the economic evaluations assessing myopia control interventions in children. To maintain the currency of the evidence using a living systematic review approach.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE; Embase; and three trials registers. The search date was 26 February 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of optical, pharmacological and environmental interventions for slowing myopia progression in children aged 18 years or younger. Critical outcomes were progression of myopia (defined as the difference in the change in spherical equivalent refraction (SER, dioptres (D)) and axial length (mm) in the intervention and control groups at one year or longer) and difference in the change in SER and axial length following cessation of treatment ('rebound').\nData collection and analysis\nWe followed standard Cochrane methods. We assessed bias using RoB 2 for parallel RCTs. We rated the certainty of evidence using the GRADE approach for the outcomes: change in SER and axial length at one and two years. Most comparisons were with inactive controls.\nMain results\nWe included 64 studies that randomised 11,617 children, aged 4 to 18 years. Studies were mostly conducted in China or other Asian countries (39 studies, 60.9%) and North America (13 studies, 20.3%). Fifty-seven studies (89%) compared myopia control interventions (multifocal spectacles, peripheral plus spectacles (PPSL), undercorrected single vision spectacles (SVLs), multifocal soft contact lenses (MFSCL), orthokeratology, rigid gas-permeable contact lenses (RGP); or pharmacological interventions (including high- (HDA), moderate- (MDA) and low-dose (LDA) atropine, pirenzipine or 7-methylxanthine) against an inactive control. Study duration was 12 to 36 months. The overall certainty of the evidence ranged from very low to moderate.\nSince the networks in the NMA were poorly connected, most estimates versus control were as, or more, imprecise than the corresponding direct estimates. Consequently, we mostly report estimates based on direct (pairwise) comparisons below.\nAt one year, in 38 studies (6525 participants analysed), the median change in SER for controls was −0.65 D. The following interventions may reduce SER progression compared to controls: HDA (mean difference (MD) 0.90 D, 95% confidence interval (CI) 0.62 to 1.18), MDA (MD 0.65 D, 95% CI 0.27 to 1.03), LDA (MD 0.38 D, 95% CI 0.10 to 0.66), pirenzipine (MD 0.32 D, 95% CI 0.15 to 0.49), MFSCL (MD 0.26 D, 95% CI 0.17 to 0.35), PPSLs (MD 0.51 D, 95% CI 0.19 to 0.82), and multifocal spectacles (MD 0.14 D, 95% CI 0.08 to 0.21). By contrast, there was little or no evidence that RGP (MD 0.02 D, 95% CI −0.05 to 0.10), 7-methylxanthine (MD 0.07 D, 95% CI −0.09 to 0.24) or undercorrected SVLs (MD −0.15 D, 95% CI −0.29 to 0.00) reduce progression.\nAt two years, in 26 studies (4949 participants), the median change in SER for controls was −1.02 D. The following interventions may reduce SER progression compared to controls: HDA (MD 1.26 D, 95% CI 1.17 to 1.36), MDA (MD 0.45 D, 95% CI 0.08 to 0.83), LDA (MD 0.24 D, 95% CI 0.17 to 0.31), pirenzipine (MD 0.41 D, 95% CI 0.13 to 0.69), MFSCL (MD 0.30 D, 95% CI 0.19 to 0.41), and multifocal spectacles (MD 0.19 D, 95% CI 0.08 to 0.30). PPSLs (MD 0.34 D, 95% CI −0.08 to 0.76) may also reduce progression, but the results were inconsistent. For RGP, one study found a benefit and another found no difference with control. We found no difference in SER change for undercorrected SVLs (MD 0.02 D, 95% CI −0.05 to 0.09).\nAt one year, in 36 studies (6263 participants), the median change in axial length for controls was 0.31 mm. The following interventions may reduce axial elongation compared to controls: HDA (MD −0.33 mm, 95% CI −0.35 to 0.30), MDA (MD −0.28 mm, 95% CI −0.38 to −0.17), LDA (MD −0.13 mm, 95% CI −0.21 to −0.05), orthokeratology (MD −0.19 mm, 95% CI −0.23 to −0.15), MFSCL (MD −0.11 mm, 95% CI −0.13 to −0.09), pirenzipine (MD −0.10 mm, 95% CI −0.18 to −0.02), PPSLs (MD −0.13 mm, 95% CI −0.24 to −0.03), and multifocal spectacles (MD −0.06 mm, 95% CI −0.09 to −0.04). We found little or no evidence that RGP (MD 0.02 mm, 95% CI −0.05 to 0.10), 7-methylxanthine (MD 0.03 mm, 95% CI −0.10 to 0.03) or undercorrected SVLs (MD 0.05 mm, 95% CI −0.01 to 0.11) reduce axial length.\nAt two years, in 21 studies (4169 participants), the median change in axial length for controls was 0.56 mm. The following interventions may reduce axial elongation compared to controls: HDA (MD −0.47mm, 95% CI −0.61 to −0.34), MDA (MD −0.33 mm, 95% CI −0.46 to −0.20), orthokeratology (MD −0.28 mm, (95% CI −0.38 to −0.19), LDA (MD −0.16 mm, 95% CI −0.20 to −0.12), MFSCL (MD −0.15 mm, 95% CI −0.19 to −0.12), and multifocal spectacles (MD −0.07 mm, 95% CI −0.12 to −0.03). PPSL may reduce progression (MD −0.20 mm, 95% CI −0.45 to 0.05) but results were inconsistent. We found little or no evidence that undercorrected SVLs (MD -0.01 mm, 95% CI −0.06 to 0.03) or RGP (MD 0.03 mm, 95% CI −0.05 to 0.12) reduce axial length.\nThere was inconclusive evidence on whether treatment cessation increases myopia progression. Adverse events and treatment adherence were not consistently reported, and only one study reported quality of life.\nNo studies reported environmental interventions reporting progression in children with myopia, and no economic evaluations assessed interventions for myopia control in children.\nAuthors' conclusions\nStudies mostly compared pharmacological and optical treatments to slow the progression of myopia with an inactive comparator. Effects at one year provided evidence that these interventions may slow refractive change and reduce axial elongation, although results were often heterogeneous. A smaller body of evidence is available at two or three years, and uncertainty remains about the sustained effect of these interventions. Longer-term and better-quality studies comparing myopia control interventions used alone or in combination are needed, and improved methods for monitoring and reporting adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"What is short-sightedness?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Short-sightedness (or near-sightedness or myopia) means people struggle to see objects that are far away clearly, while objects that are near remain clear. It is very common worldwide, and affects more than half of children in China and South-East Asia. Short-sightedness may impair many aspects of life, including educational and occupational activities. Moreover, short-sighted people have longer eyes, which means that the retina is stretched. This puts the eye at greater risk of eye diseases such as glaucoma, maculopathy and retinal detachment later in life."
}
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query-laysum
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6781
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[
{
"role": "user",
"content": "Abstract: Background\nDelirium is defined as a disturbance in attention, awareness and cognition with reduced ability to direct, focus, sustain and shift attention, and reduced orientation to the environment. Critically ill patients in the intensive care unit (ICU) frequently develop ICU delirium. It can profoundly affect both them and their families because it is associated with increased mortality, longer duration of mechanical ventilation, longer hospital and ICU stay and long-term cognitive impairment. It also results in increased costs for society.\nObjectives\nTo assess existing evidence for the effect of preventive interventions on ICU delirium, in-hospital mortality, the number of delirium- and coma-free days, ventilator-free days, length of stay in the ICU and cognitive impairment.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, BIOSIS, International Web of Science, Latin American Caribbean Health Sciences Literature, CINAHL from 1980 to 11 April 2018 without any language limits. We adapted the MEDLINE search for searching the other databases. Furthermore, we checked references, searched citations and contacted study authors to identify additional studies. We also checked the following trial registries: Current Controlled Trials; ClinicalTrials.gov; and CenterWatch.com (all on 24 April 2018).\nSelection criteria\nWe included randomized controlled trials (RCTs) of adult medical or surgical ICU patients receiving any intervention for preventing ICU delirium. The control could be standard ICU care, placebo or both. We assessed the quality of evidence with GRADE.\nData collection and analysis\nWe checked titles and abstracts to exclude obviously irrelevant studies and obtained full reports on potentially relevant ones. Two review authors independently extracted data. If possible we conducted meta-analyses, otherwise we synthesized data narratively.\nMain results\nThe electronic search yielded 8746 records. We included 12 RCTs (3885 participants) comparing usual care with the following interventions: commonly used drugs (four studies); sedation regimens (four studies); physical therapy or cognitive therapy, or both (one study); environmental interventions (two studies); and preventive nursing care (one study). We found 15 ongoing studies and five studies awaiting classification. The participants were 48 to 70 years old; 48% to 74% were male; the mean acute physiology and chronic health evaluation (APACHE II) score was 14 to 28 (range 0 to 71; higher scores correspond to more severe disease and a higher risk of death). With the exception of one study, all participants were mechanically ventilated in medical or surgical ICUs or mixed. The studies were overall at low risk of bias. Six studies were at high risk of detection bias due to lack of blinding of outcome assessors. We report results for the two most commonly explored approaches to delirium prevention: pharmacologic and a non-pharmacologic intervention.\nHaloperidol versus placebo (two RCTs, 1580 participants)\nThe event rate of ICU delirium was measured in one study including 1439 participants. No difference was identified between groups, (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.87 to 1.17) (moderate-quality evidence). Haloperidol versus placebo neither reduced or increased in-hospital mortality, (RR 0.98, 95% CI 0.80 to 1.22; 2 studies; 1580 participants (moderate-quality evidence)); the number of delirium- and coma-free days, (mean difference (MD) -0.60, 95% CI -1.37 to 0.17; 2 studies, 1580 participants (moderate-quality of evidence)); number of ventilator-free days (mean 23.8 (MD -0.30, 95% CI -0.93 to 0.33) 1 study; 1439 participants, (high-quality evidence)); length of ICU stay, (MD 0.18, 95% CI 0.60 to 0.97); 2 studies, 1580 participants; high-quality evidence). None of the studies measured cognitive impairment. In one study there were three serious adverse events in the intervention group and five in the placebo group; in the other there were five serious adverse events and three patients died, one in each group. None of the serious adverse events were judged to be related to interventions received (moderate-quality evidence).\nPhysical and cognitive therapy interventions (one study, 65 participants)\nThe study did not measure the event rate of ICU delirium. A physical and cognitive therapy intervention versus standard care neither reduced nor increased in-hospital mortality, (RR 0.94, 95% CI 0.40 to 2.20, I² = 0; 1 study, 65 participants; very low-quality evidence); the number of delirium- and coma-free days, (MD -2.8, 95% CI -10.1 to 4.6, I² = 0; 1 study, 65 participants; very low-quality evidence); the number of ventilator-free days (within the first 28/30 days) was median 27.4 (IQR 0 to 29.2) and 25 (IQR 0 to 28.9); 1 study, 65 participants; very low-quality evidence, length of ICU stay, (MD 1.23, 95% CI -0.68 to 3.14, I² = 0; 1 study, 65 participants; very low-quality evidence); cognitive impairment measured by the MMSE: Mini-Mental State Examination with higher scores indicating better function, (MD 0.97, 95% CI -0.19 to 2.13, I² = 0; 1 study, 30 participants; very low-quality evidence); or measured by the Dysexecutive questionnaire (DEX) with lower scores indicating better function (MD -8.76, 95% CI -19.06 to 1.54, I² = 0; 1 study, 30 participants; very low-quality evidence). One patient experienced acute back pain accompanied by hypotensive urgency during physical therapy.\nAuthors' conclusions\nThere is probably little or no difference between haloperidol and placebo for preventing ICU delirium but further studies are needed to increase our confidence in the findings. There is insufficient evidence to determine the effects of physical and cognitive intervention on delirium. The effects of other pharmacological interventions, sedation, environmental, and preventive nursing interventions are unclear and warrant further investigation in large multicentre studies. Five studies are awaiting classification and we identified 15 ongoing studies, evaluating pharmacological interventions, sedation regimens, physical and occupational therapy combined or separately, and environmental interventions, that may alter the conclusions of the review in future.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the quality of the evidence as moderate to very low. Several studies had quality shortcomings, including their use of small numbers of participants, and lack of blinding of those assessing effects of interventions for preventing delirium and other outcomes. For the interventions testing sedation approaches, physical and cognitive therapy, and changes in the environment, additional research is required to clarify their effectiveness. The five studies in ‘Studies awaiting classification’ and 15 ongoing studies may alter the conclusions of the review once they are completed and assessed."
}
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query-laysum
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6782
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[
{
"role": "user",
"content": "Abstract: Background\nUrinary tract infection (UTI) is the most common hospital-acquired infection. The major associated cause is indwelling urethral catheters. Several measures have been introduced to reduce catheter-associated urinary tract infections (CAUTIs). One of these measures is the introduction of specialised urethral catheters that have been designed to reduce the risk of infection. These include antiseptic-coated and antimicrobial-impregnated catheters.\nObjectives\nThe primary objective of this review was to compare the effectiveness of different types of indwelling urethral catheters in reducing the risk of UTI and to assess their impact on other outcomes in adults who require short-term urethral catheterisation in hospitals.\nSearch methods\nWe searched the Cochrane Incontinence Group's Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 9 September 2014). We also examined the bibliographies of relevant articles and contacted catheter manufacturer representatives for trials.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs comparing types of indwelling urethral catheters for short-term catheterisation in hospitalised adults. 'Short-term' is defined as a duration of catheterisation which is intended to be less than or equal to 14 days.\nData collection and analysis\nAt least two review authors independently screened abstracts, extracted data and assessed risk of bias of the included trials. Any disagreement was resolved by discussion or consultation with a third party. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed the quality of evidence using the GRADE approach.\nMain results\nTwenty-six trials met the inclusion criteria involving 12,422 hospitalised adults in 25 parallel group trials, and 27,878 adults in one large cluster-randomised cross-over trial. No trials compared one antiseptic catheter versus another, nor an antimicrobial catheter versus another.\nAntiseptic-coated indwelling urethral catheters versus standard indwelling urethral catheters\nThe primary outcome, symptomatic CAUTI was reported in one large trial with a low risk of bias, comparing silver alloy hydrogel-coated latex catheter (antiseptic-coated) against a standard polytetrafluoroethylene (PTFE)-coated latex catheter (control). The trial used a pragmatic, US Centers for Disease Control and Prevention (CDC)-based definition for symptomatic CAUTI. For the comparison between silver alloy-coated catheter versus standard catheter, there was no significant difference in symptomatic CAUTI incidence (RR 0.99, 95% CI 0.85 to 1.16).\nFor secondary outcomes, the included trials reported on two types of antiseptic catheters (coated with either silver oxide or silver alloy). For the outcome of bacteriuria, silver oxide catheters were not associated with any statistically significant reduction (RR 0.90, 95% CI 0.72 to 1.13). These catheters are no longer manufactured. Silver alloy catheters achieved a slight but statistically significant reduction in bacteriuria (RR 0.82, 95% CI 0.73 to 0.92). However, the one large trial with a low risk of bias did not support this finding (RR 0.99, 95% CI 0.85 to 1.16). The randomised cross-over trial of silver alloy catheters versus standard catheters was excluded from the pooled results because data were not available prior to crossover. The results of this trial showed less bacteriuria in the silver alloy catheter group.\nFor the outcome of discomfort whilst the catheter was in-situ, fewer patients with silver alloy catheters complained of discomfort compared with standard catheters (RR 0.84, 95% CI 0.74 to 0.96).\nAntimicrobial-impregnated indwelling urethral catheters versus standard indwelling urethral catheters\nThe primary outcome measure, symptomatic CAUTI was reported in one large trial with a low risk of bias, comparing nitrofurazone-impregnated silicone catheter (antimicrobial-impregnated) against a standard PTFE-coated latex catheter (control). The nitrofurazone catheter achieved a reduction in symptomatic CAUTI incidence which was of borderline statistical significance (RR 0.84, 95% CI 0.71 to 0.99).\nFor secondary outcomes, the included trials reported on two types of antimicrobial catheters (impregnated with either nitrofurazone or minocycline/rifampicin). Antimicrobial-impregnated catheters, compared with standard catheters, were found to lower the rate of bacteriuria in the antimicrobial group for both minocycline and rifampicin (RR 0.36, 95% CI 0.18 to 0.73), and nitrofurazone (RR 0.73, 95% CI 0.64 to 0.85). The minocycline and rifampicin catheter is no longer manufactured.\nFor the outcome of discomfort whilst the catheter was in-situ, more patients with nitrofurazone catheters complained of pain whilst the catheter was in-situ compared with standard catheters (RR 1.26, 95% CI 1.12 to 1.41). For the period after catheter removal, more patients with nitrofurazone catheters complained of pain than standard catheters (RR 1.43, 95% CI 1.30 to 1.57).\nAntimicrobial-impregnated indwelling urethral catheters versus antiseptic-coated indwelling urethral catheters\nOne large trial compared antimicrobial-impregnated (nitrofurazone) catheters versus silver alloy-coated (antiseptic-coated) catheters. The results showed people were less likely to have a symptomatic CAUTI with nitrofurazone-impregnated catheters (228/2153, 10.6%) compared with silver alloy-coated catheters (263/2097, 12.5%), but this was of borderline statistical significance (RR 0.84, 95% CI 0.71 to 1.00). They did, however, have significantly less bacteriuria (RR 0.78, 95% CI 0.67 to 0.91),\nWhile the catheter was in-situ (RR 1.50, 95% CI 1.32 to 1.70), and on removal (RR 1.32, 95% CI 1.20 to 1.45), nitrofurazone catheters were associated with more discomfort compared with silver-coated catheters.\nOne type of standard indwelling urethral catheter versus another type of standard indwelling urethral catheter\nNone of the trials comparing standard catheters versus other types of standard catheters measured symptomatic CAUTI. In terms of reducing bacteriuria, individual trials were too small to show whether one type of standard catheter was superior to another type. For the outcome of urethral reactions, fully siliconised catheters appeared to be superior to latex-based catheters. However, the trials involved small numbers of participants. There were no statistically significant differences between the different catheters for all other outcomes.\nAuthors' conclusions\nSilver alloy-coated catheters were not associated with a statistically significant reduction in symptomatic CAUTI, and are considerably more expensive. Nitrofurazone-impregnated catheters reduced the risk of symptomatic CAUTI and bacteriuria, although the magnitude of reduction was low and hence may not be clinically important. However, they are more expensive than standard catheters. They are also more likely to cause discomfort than standard catheters.\n\nGiven the provided abstract, please respond to the following query: \"Background on the condition\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Urethral catheters are small tubes passed into the bladder via the urethra (outlet for urine). They are often used for a short time after major surgery. Urethral catheters are also used if a person is unable to empty the bladder when they need to (urinary retention). They are also used for monitoring urine output in hospitalised patients. About half of all hospitalised adults who have urethral catheters for longer than a week will get a urinary tract infection (UTI)."
}
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query-laysum
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6783
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[
{
"role": "user",
"content": "Abstract: Background\nCorticosteroid treatment is considered the 'gold standard' for Duchenne muscular dystrophy (DMD); however, it is also known to induce osteoporosis and thus increase the risk of vertebral fragility fractures. Good practice in the care of those with DMD requires prevention of these adverse effects. Treatments to increase bone mineral density include bisphosphonates and vitamin D and calcium supplements, and in adolescents with pubertal delay, testosterone. Bone health management is an important part of lifelong care for patients with DMD.\nObjectives\nTo assess the effects of interventions to prevent or treat osteoporosis in children and adults with DMD taking long-term corticosteroids; to assess the effects of these interventions on the frequency of vertebral fragility fractures and long-bone fractures, and on quality of life; and to assess adverse events.\nSearch methods\nOn 12 September 2016, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus to identify potentially eligible trials. We also searched the Web of Science ISI Proceedings (2001 to September 2016) and three clinical trials registries to identify unpublished studies and ongoing trials. We contacted correspondence authors of the included studies in the review to obtain information on unpublished studies or work in progress.\nSelection criteria\nWe considered for inclusion in the review randomised controlled trials (RCTs) and quasi-RCTs involving any bone health intervention for corticosteroid-induced osteoporosis and fragility fractures in children, adolescents, and adults with a confirmed diagnosis of DMD. The interventions might have included oral and intravenous bisphosphonates, vitamin D supplements, calcium supplements, dietary calcium, testosterone, and weight-bearing activity.\nData collection and analysis\nTwo review authors independently assessed reports and selected potential studies for inclusion, following standard Cochrane methodology. We contacted study authors to obtain further information for clarification on published work, unpublished studies, and work in progress.\nMain results\nWe identified 18 potential studies, of which two, currently reported only as abstracts, met the inclusion criteria for this review. Too little information was available for us to present full results or adequately assess risk of bias. The participants were children aged five to 15 years with DMD, ambulant and non-ambulant. The interventions were risedronate versus no treatment in one trial (13 participants) and whole-body vibration versus a placebo device in the second (21 participants). Both studies reported improved bone mineral density with the active treatments, with no improvement in the control groups, but the abstracts did not compare treatment and control conditions. All children tolerated whole-body vibration treatment. No study provided information on adverse events. Two studies are ongoing: one investigating whole-body vibration, the other investigating zoledronic acid.\nAuthors' conclusions\nWe know of no high-quality evidence from RCTs to guide use of treatments to prevent or treat corticosteroid-induced osteoporosis and reduce the risk of fragility fractures in children and adults with DMD; only limited results from two trials reported in abstracts were available. We await formal trial reports. Findings from two ongoing relevant studies and two trials, for which only abstracts are available, will be important in future updates of this review.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "DMD is an inherited condition, affecting about one in 3500 to one in 6000 newborn boys. DMD causes muscle weakness that becomes more severe with age. Muscle weakness is widespread, affecting movement, the digestive system, breathing, and the heart. The pattern of weakness mainly affects muscles near the trunk, around the shoulders, and at the hips. If untreated, DMD leads to death in the late teens from breathing or heart complications. A child with DMD often shows the first signs of this disease before starting school. If untreated, he will lose the ability to walk by the age of 13 years and need to use a wheelchair. There is no cure for DMD, but medicines called corticosteroids slow muscle damage and enable boys with DMD to walk for longer. Boys with DMD also tend to have weak bones because of their weak muscles and reduced mobility.\nCorticosteroids cause osteoporosis (thinning of the bones), which makes the bones more fragile and liable to fracture (break). Therapies, such as vitamin D and calcium supplements, more calcium in the diet, medicines called bisphosphonates, testosterone, and weight-bearing exercise, might be able to strengthen bone to prevent and treat osteoporosis and prevent fractures in people with DMD who are taking corticosteroids. Investigators use bone density as a measure of how strong the bone is and to measure the effects of therapies to prevent and treat osteoporosis."
}
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query-laysum
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6784
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[
{
"role": "user",
"content": "Abstract: Background\nErysipelas and cellulitis (hereafter referred to as 'cellulitis') are common bacterial skin infections usually affecting the lower extremities. Despite their burden of morbidity, the evidence for different prevention strategies is unclear.\nObjectives\nTo assess the beneficial and adverse effects of antibiotic prophylaxis or other prophylactic interventions for the prevention of recurrent episodes of cellulitis in adults aged over 16.\nSearch methods\nWe searched the following databases up to June 2016: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and LILACS. We also searched five trials registry databases, and checked reference lists of included studies and reviews for further references to relevant randomised controlled trials (RCTs). We searched two sets of dermatology conference proceedings, and BIOSIS Previews.\nSelection criteria\nRandomised controlled trials evaluating any therapy for the prevention of recurrent cellulitis.\nData collection and analysis\nTwo authors independently carried out study selection, data extraction, assessment of risks of bias, and analyses. Our primary prespecified outcome was recurrence of cellulitis when on treatment and after treatment. Our secondary outcomes included incidence rate, time to next episode, hospitalisation, quality of life, development of resistance to antibiotics, adverse reactions and mortality.\nMain results\nWe included six trials, with a total of 573 evaluable participants, who were aged on average between 50 and 70. There were few previous episodes of cellulitis in those recruited to the trials, ranging between one and four episodes per study.\nFive of the six included trials assessed prevention with antibiotics in participants with cellulitis of the legs, and one assessed selenium in participants with cellulitis of the arms. Among the studies assessing antibiotics, one study evaluated oral erythromycin (n = 32) and four studies assessed penicillin (n = 481). Treatment duration varied from six to 18 months, and two studies continued to follow up participants after discontinuation of prophylaxis, with a follow-up period of up to one and a half to two years. Four studies were single-centre, and two were multicentre; they were conducted in five countries: the UK, Sweden, Tunisia, Israel, and Austria.\nBased on five trials, antibiotic prophylaxis (at the end of the treatment phase ('on prophylaxis')) decreased the risk of cellulitis recurrence by 69%, compared to no treatment or placebo (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.13 to 0.72; n = 513; P = 0.007), number needed to treat for an additional beneficial outcome (NNTB) six, (95% CI 5 to 15), and we rated the certainty of evidence for this outcome as moderate.\nUnder prophylactic treatment and compared to no treatment or placebo, antibiotic prophylaxis reduced the incidence rate of cellulitis by 56% (RR 0.44, 95% CI 0.22 to 0.89; four studies; n = 473; P value = 0.02; moderate-certainty evidence) and significantly decreased the rate until the next episode of cellulitis (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.78; three studies; n = 437; P = 0.002; moderate-certainty evidence).\nThe protective effects of antibiotic did not last after prophylaxis had been stopped ('post-prophylaxis') for risk of cellulitis recurrence (RR 0.88, 95% CI 0.59 to 1.31; two studies; n = 287; P = 0.52), incidence rate of cellulitis (RR 0.94, 95% CI 0.65 to 1.36; two studies; n = 287; P = 0.74), and rate until next episode of cellulitis (HR 0.78, 95% CI 0.39 to 1.56; two studies; n = 287). Evidence was of low certainty.\nEffects are relevant mainly for people after at least two episodes of leg cellulitis occurring within a period up to three years.\nWe found no significant differences in adverse effects or hospitalisation between antibiotic and no treatment or placebo; for adverse effects: RR 0.87, 95% CI 0.58 to 1.30; four studies; n = 469; P = 0.48; for hospitalisation: RR 0.77, 95% CI 0.37 to 1.57; three studies; n = 429; P = 0.47, with certainty of evidence rated low for these outcomes. The existing data did not allow us to fully explore its impact on length of hospital stay.\nThe common adverse reactions were gastrointestinal symptoms, mainly nausea and diarrhoea; rash (severe cutaneous adverse reactions were not reported); and thrush. Three studies reported adverse effects that led to discontinuation of the assigned therapy. In one study (erythromycin), three participants reported abdominal pain and nausea, so their treatment was changed to penicillin. In another study, two participants treated with penicillin withdrew from treatment due to diarrhoea or nausea. In one study, around 10% of participants stopped treatment due to pain at the injection site (the active treatment group was given intramuscular injections of benzathine penicillin).\nNone of the included studies assessed the development of antimicrobial resistance or quality-of-life measures.\nWith regard to the risks of bias, two included studies were at low risk of bias and we judged three others as being at high risk of bias, mainly due to lack of blinding.\nAuthors' conclusions\nIn terms of recurrence, incidence, and time to next episode, antibiotic is probably an effective preventive treatment for recurrent cellulitis of the lower limbs in those under prophylactic treatment, compared with placebo or no treatment (moderate-certainty evidence). However, these preventive effects of antibiotics appear to diminish after they are discontinued (low-certainty evidence). Treatment with antibiotic does not trigger any serious adverse events, and those associated are minor, such as nausea and rash (low-certainty evidence). The evidence is limited to people with at least two past episodes of leg cellulitis within a time frame of up to three years, and none of the studies investigated other common interventions such as lymphoedema reduction methods or proper skin care. Larger, high-quality studies are warranted, including long-term follow-up and other prophylactic measures.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "What are the best available treatments to prevent repeated episodes of cellulitis in adults aged over 16 years compared to no treatment, placebo, another intervention, or the same intervention with a different plan of treatment, and what are their side effects?"
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query-laysum
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6785
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[
{
"role": "user",
"content": "Abstract: Background\nSeasonal affective disorder (SAD) is a seasonal pattern of recurrent major depressive episodes that most commonly starts in autumn or winter and remits in spring. The prevalence of SAD depends on latitude and ranges from 1.5% to 9%. The predictable seasonal aspect of SAD provides a promising opportunity for prevention in people who have a history of SAD. This is one of four reviews on the efficacy and safety of interventions to prevent SAD; we focus on agomelatine and melatonin as preventive interventions.\nObjectives\nTo assess the efficacy and safety of agomelatine and melatonin (in comparison with each other, placebo, second-generation antidepressants, light therapy, psychological therapy or lifestyle interventions) in preventing SAD and improving person-centred outcomes among adults with a history of SAD.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 19 June 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 August 2015). Furthermore, we searched the Cumulative Index to Nursing and Allied Health Literature, Web of Science, the Cochrane Library, the Allied and Complementary Medicine Database and international trial registers (to 19 June 2018). We also conducted a grey literature search and handsearched the reference lists of included studies and pertinent review articles.\nSelection criteria\nTo examine efficacy, we included randomised controlled trials (RCTs) on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study. For adverse events, we intended also to include non-randomised studies. We planned to include studies that compared agomelatine versus melatonin, or agomelatine or melatonin versus placebo, any second-generation antidepressant, light therapy, psychological therapies or lifestyle changes. We also intended to compare melatonin or agomelatine in combination with any of the comparator interventions mentioned above versus the same comparator intervention as monotherapy.\nData collection and analysis\nTwo review authors screened abstracts and full-text publications, abstracted data and assessed risk of bias of included studies independently. We intended to pool data in a meta-analysis using a random-effects model, but included only one study.\nMain results\nWe identified 3745 citations through electronic searches and reviews of reference lists after deduplication of search results. We excluded 3619 records during title and abstract review and assessed 126 full-text papers for inclusion in the review. Only one study, providing data of 225 participants, met our eligibility criteria and compared agomelatine (25 mg/day) with placebo. We rated it as having high risk of attrition bias because nearly half of the participants left the study before completion. We rated the certainty of the evidence as very low for all outcomes, because of high risk of bias, indirectness, and imprecision.\nThe main analysis based on data of 199 participants rendered an indeterminate result with wide confidence intervals (CIs) that may encompass both a relevant reduction as well as a relevant increase of SAD incidence by agomelatine (risk ratio (RR) 0.83, 95% CI 0.51 to 1.34; 199 participants; very low-certainty evidence). Also the severity of SAD may be similar in both groups at the end of the study with a mean SIGH-SAD (Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders) score of 8.3 (standard deviation (SD) 9.4) in the agomelatine group and 10.1 (SD 10.6) in the placebo group (mean difference (MD) -1.80, 95% CI -4.58 to 0.98; 199 participants; very low-certainty evidence). The incidence of adverse events and serious adverse events may be similar in both groups. In the agomelatine group, 64 out of 112 participants experienced at least one adverse event, while 61 out of 113 did in the placebo group (RR 1.06, 95% CI 0.84 to 1.34; 225 participants; very low-certainty evidence). Three out of 112 patients experienced serious adverse events in the agomelatine group, compared to 4 out of 113 in the placebo group (RR 0.76, 95% CI 0.17 to 3.30; 225 participants; very low-certainty evidence).\nNo data on quality of life or interpersonal functioning were reported. We did not identify any studies on melatonin.\nAuthors' conclusions\nGiven the uncertain evidence on agomelatine and the absence of studies on melatonin, no conclusion about efficacy and safety of agomelatine and melatonin for prevention of SAD can currently be drawn. The decision for or against initiating preventive treatment of SAD and the treatment selected should consider patient preferences and reflect on the evidence base of all available treatment options.\n\nGiven the provided abstract, please respond to the following query: \"What should happen next?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Review authors recommend that future studies should evaluate the efficacy of agomelatine or melatonin in preventing SAD and should directly compare these interventions against other treatment options, such as light therapy, antidepressants, or psychological therapies to determine the best treatment option for prevention of SAD."
}
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query-laysum
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6786
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[
{
"role": "user",
"content": "Abstract: Background\nAcute bronchiolitis is the leading cause of medical emergencies during winter months in infants younger than 24 months old. Chest physiotherapy is sometimes used to assist infants in the clearance of secretions in order to decrease ventilatory effort. This is an update of a Cochrane Review first published in 2005 and updated in 2006, 2012, and 2016.\nObjectives\nTo determine the efficacy of chest physiotherapy in infants younger than 24 months old with acute bronchiolitis. A secondary objective was to determine the efficacy of different techniques of chest physiotherapy (vibration and percussion, passive exhalation, or instrumental).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Web of Science, PEDro (October 2011 to 20 April 2022), and two trials registers (5 April 2022).\nSelection criteria\nRandomised controlled trials (RCTs) in which chest physiotherapy was compared to control (conventional medical care with no physiotherapy intervention) or other respiratory physiotherapy techniques in infants younger than 24 months old with bronchiolitis.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nOur update of the searches dated 20 April 2022 identified five new RCTs with 430 participants. We included a total of 17 RCTs (1679 participants) comparing chest physiotherapy with no intervention or comparing different types of physiotherapy.\nFive trials (246 participants) assessed percussion and vibration techniques plus postural drainage (conventional chest physiotherapy), and 12 trials (1433 participants) assessed different passive flow-oriented expiratory techniques, of which three trials (628 participants) assessed forced expiratory techniques, and nine trials (805 participants) assessed slow expiratory techniques. In the slow expiratory subgroup, two trials (78 participants) compared the technique with instrumental physiotherapy techniques, and two recent trials (116 participants) combined slow expiratory techniques with rhinopharyngeal retrograde technique (RRT). One trial used RRT alone as the main component of the physiotherapy intervention. Clinical severity was mild in one trial, severe in four trials, moderate in six trials, and mild to moderate in five trials. One study did not report clinical severity. Two trials were performed on non-hospitalised participants.\nOverall risk of bias was high in six trials, unclear in five, and low in six trials.\nThe analyses showed no effects of conventional techniques on change in bronchiolitis severity status, respiratory parameters, hours with oxygen supplementation, or length of hospital stay (5 trials, 246 participants).\nRegarding instrumental techniques (2 trials, 80 participants), one trial observed similar results in bronchiolitis severity status when comparing slow expiration to instrumental techniques (mean difference 0.10, 95% confidence interval (C) −0.17 to 0.37).\nForced passive expiratory techniques failed to show an effect on bronchiolitis severity in time to recovery (2 trials, 509 participants; high-certainty evidence) and time to clinical stability (1 trial, 99 participants; high-certainty evidence) in infants with severe bronchiolitis. Important adverse effects were reported with the use of forced expiratory techniques.\nRegarding slow expiratory techniques, a mild to moderate improvement was observed in bronchiolitis severity score (standardised mean difference −0.43, 95% CI −0.73 to −0.13; I2 = 55%; 7 trials, 434 participants; low-certainty evidence). Also, in one trial an improvement in time to recovery was observed with the use of slow expiratory techniques. No benefit was observed in length of hospital stay, except for one trial which showed a one-day reduction. No effects were shown or reported for other clinical outcomes such as duration on oxygen supplementation, use of bronchodilators, or parents' impression of physiotherapy benefit.\nAuthors' conclusions\nWe found low-certainty evidence that passive slow expiratory technique may result in a mild to moderate improvement in bronchiolitis severity when compared to control. This evidence comes mostly from infants with moderately acute bronchiolitis treated in hospital. The evidence was limited with regard to infants with severe bronchiolitis and those with moderately severe bronchiolitis treated in ambulatory settings.\nWe found high-certainty evidence that conventional techniques and forced expiratory techniques result in no difference in bronchiolitis severity or any other outcome. We found high-certainty evidence that forced expiratory techniques in infants with severe bronchiolitis do not improve their health status and can lead to severe adverse effects.\nCurrently, the evidence regarding new physiotherapy techniques such as RRT or instrumental physiotherapy is scarce, and further trials are needed to determine their effects and potential for use in infants with moderate bronchiolitis, as well as the potential additional effect of RRT when combined with slow passive expiratory techniques. Finally, the effectiveness of combining chest physiotherapy with hypertonic saline should also be investigated.\n\nGiven the provided abstract, please respond to the following query: \"What is acute bronchiolitis, and what is the role of chest physiotherapy in this condition?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acute bronchiolitis is a viral respiratory infection that frequently occurs in infants younger than two years old. Most infants have a mild disease and do not require specific medical treatments or hospitalisation. However, those with moderate or severe disease may present with a build-up of fluid in the airways (mucus secretion), as well as swollen (oedema) or constricted (bronchospasm) airways, that make it difficult to clear phlegm.\nChest physiotherapy may assist in the clearance of respiratory secretions and improve breathing. There are three established types of chest physiotherapy techniques to manage airway clearance: vibration and percussion techniques, forced expiratory techniques, and slow passive expiratory techniques. Additionally, there is emerging evidence on rhinopharyngeal retrograde clearance techniques and instrumental clearance techniques, alone or in combination with other physiotherapy techniques."
}
] |
query-laysum
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6787
|
[
{
"role": "user",
"content": "Abstract: Background\nPancreatic cancer remains one of the five leading causes of cancer deaths in industrialised nations. For adenocarcinomas in the head of the gland and premalignant lesions, partial pancreaticoduodenectomy represents the standard treatment for resectable tumours. The gastro- or duodenojejunostomy after partial pancreaticoduodenectomy can be reestablished via either an antecolic or retrocolic route. The debate about the more favourable technique for bowel reconstruction is ongoing.\nObjectives\nTo compare the effectiveness and safety of antecolic and retrocolic gastro- or duodenojejunostomy after partial pancreaticoduodenectomy.\nSearch methods\nIn this updated version, we conducted a systematic literature search up to 6 July 2021 to identify all randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library 2021, Issue 6, MEDLINE (1946 to 6 July 2021), and Embase (1974 to 6 July 2021). We applied no language restrictions. We handsearched reference lists of identified trials to identify further relevant trials, and searched the trial registries clinicaltrials.govand World Health Organization International Clinical Trials Registry Platform for ongoing trials.\nSelection criteria\nWe considered all RCTs comparing antecolic with retrocolic reconstruction of bowel continuity after partial pancreaticoduodenectomy for any given indication to be eligible.\nData collection and analysis\nTwo review authors independently screened the identified references and extracted data from the included trials. The same two review authors independently assessed risk of bias of included trials, according to standard Cochrane methodology. We used a random-effects model to pool the results of the individual trials in a meta-analysis. We used odds ratios (OR) to compare binary outcomes and mean differences (MD) for continuous outcomes.\nMain results\nOf a total of 287 citations identified by the systematic literature search, we included eight randomised controlled trials (reported in 11 publications), with a total of 818 participants. There was high risk of bias in all of the trials in regard to blinding of participants and/or outcome assessors and unclear risk for selective reporting in six of the trials.\nThere was little or no difference in the frequency of delayed gastric emptying (OR 0.67; 95% confidence interval (CI) 0.41 to 1.09; eight trials, 818 participants, low-certainty evidence) with relevant heterogeneity between trials (I2=40%).\nThere was little or no difference in postoperative mortality (risk difference (RD) -0.00; 95% CI -0.02 to 0.01; eight trials, 818 participants, high-certainty evidence); postoperative pancreatic fistula (OR 1.01; 95% CI 0.73 to 1.40; eight trials, 818 participants, low-certainty evidence); postoperative haemorrhage (OR 0.87; 95% CI 0.47 to 1.59; six trials, 742 participants, low-certainty evidence); intra-abdominal abscess (OR 1.11; 95% CI 0.71 to 1.74; seven trials, 788 participants, low-certainty evidence); bile leakage (OR 0.82; 95% CI 0.35 to 1.91; seven trials, 606 participants, low-certainty evidence); reoperation rate (OR 0.68; 95% CI 0.34 to 1.36; five trials, 682 participants, low-certainty evidence); and length of hospital stay (MD -0.21; 95% CI -1.41 to 0.99; eight trials, 818 participants, low-certainty evidence).\nOnly one trial reported quality of life, on a subgroup of 73 participants, also without a relevant difference between the two groups at any time point. The overall certainty of the evidence was low to moderate, due to some degree of heterogeneity, inconsistency and risk of bias in the included trials.\nAuthors' conclusions\nThere was low- to moderate-certainty evidence suggesting that antecolic reconstruction after partial pancreaticoduodenectomy results in little to no difference in morbidity, mortality, length of hospital stay, or quality of life. Due to heterogeneity in definitions of the endpoints between trials, and differences in postoperative management, future research should be based on clearly defined endpoints and standardised perioperative management, to potentially elucidate differences between these two procedures. Novel strategies should be evaluated for prophylaxis and treatment of common complications, such as delayed gastric emptying.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Antecolic bowel reconstruction may not reduce delayed gastric emptying after partial surgical removal of the pancreatic head and duodenum.\n- Our results do not suggest any relevant differences between both techniques in other morbidity, mortality, length of hospital stay, and quality of life."
}
] |
query-laysum
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6788
|
[
{
"role": "user",
"content": "Abstract: Background\nNon-randomised data have shown a link between hyperuricaemia and the progression or development of chronic kidney disease (CKD). If this is correct, urate lowering therapy might form an important part of chronic kidney disease care, reducing risks for cardiovascular outcomes and end-stage kidney disease.\nObjectives\nThis review aims to study the benefits and harms of uric acid lowering therapy on the progression of CKD and other cardiovascular endpoints.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 20 July 2017 through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials testing primary urate lowering therapy in patients with or without CKD.\nData collection and analysis\nTwo authors independently assessed study quality and extracted data. Statistical analyses were performed using a random effects model and results expressed as risk ratio (RR) with 95% confidence intervals (CI) for dichotomous outcomes or mean difference (MD) for continuous outcomes, or standardised mean difference (SMD) if different scales were used.\nMain results\nTwelve studies (1187 participants) were included in the review. Risk of bias was unclear for the majority of domains in each study.\nUric acid lowering therapy may make little or no difference in death at six months (2 studies, 498 participants: RR 1.66, 95% CI 0.61 to 4.48) or two years (2 studies, 220 participants): RR 0.13, 95% CI 0.02 to 1.06) (low certainty evidence). Uric acid lowering therapy may make little of no difference (low certainty evidence) in the incidence of ESKD at one or two years. Kidney function may be improved by uric acid lowering therapy at one year with a reduction in serum creatinine (2 studies, 83 participants: MD -73.35 µmol/L, 95% CI -107.28 to -39.41) and a rise in eGFR (1 study, 113 participants: MD 5.50 mL/min/1.73 m2, 95% CI 0.59 to 10.41). However it probably makes little or no difference to eGFR at two years (2 studies, 164 participants: MD 4.00 mL/min, 95% CI -3.28 to 11.28). Uric acid lowering therapy reduced uric acid levels at all time points (3, 4, 6, 12 and 24 months) (high certainty evidence).\nThere is insufficient evidence to support an effect on blood pressure, proteinuria or other cardiovascular markers by uric acid lowering therapy. It should be noted that the apparent benefits of treatment were not apparent at all time points, introducing the potential for bias.\nAuthors' conclusions\nThere is limited data which suggests uric acid lowering therapy may prevent progression of chronic kidney disease but the conclusion is very uncertain. Benefits were not observed at all time points and study quality was generally low. Larger studies are required to study the effect of uric acid lowering therapy on CKD progression. Three ongoing studies will hopefully provide much needed high quality data.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We collected all the data from studies that consider patients treated with urate lowering medications for more than 3 months and that report data on death, blood pressure and kidney function in their outcomes.\nTwelve studies comprising 1187 participants were included in the review. Duration of the studies was between four months and two years. The types of patients included varied across the studies including diabetes, heart failure, and chronic kidney disease."
}
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query-laysum
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6789
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[
{
"role": "user",
"content": "Abstract: Background\nCalcineurin inhibitors (CNI) can reduce acute transplant rejection and immediate graft loss but are associated with significant adverse effects such as hypertension and nephrotoxicity which may contribute to chronic rejection. CNI toxicity has led to numerous studies investigating CNI withdrawal and tapering strategies. Despite this, uncertainty remains about minimisation or withdrawal of CNI.\nObjectives\nThis review aimed to look at the benefits and harms of CNI tapering or withdrawal in terms of graft function and loss, incidence of acute rejection episodes, treatment-related side effects (hypertension, hyperlipidaemia) and death.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 11 October 2016 through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) where drug regimens containing CNI were compared to alternative drug regimens (CNI withdrawal, tapering or low dose) in the post-transplant period were included, without age or dosage restriction.\nData collection and analysis\nTwo authors independently assessed studies for eligibility, risk of bias, and extracted data. Results were expressed as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI).\nMain results\nWe included 83 studies that involved 16,156 participants. Most were open-label studies; less than 30% of studies reported randomisation method and allocation concealment. Studies were analysed as intent-to-treat in 60% and all pre-specified outcomes were reported in 54 studies. The attrition and reporting bias were unclear in the remainder of the studies as factors used to judge bias were reported inconsistently. We also noted that 50% (47 studies) of studies were funded by the pharmaceutical industry.\nWe classified studies into four groups: CNI withdrawal or avoidance with or without substitution with mammalian target of rapamycin inhibitors (mTOR-I); and low dose CNI with or without mTOR-I. The withdrawal groups were further stratified as avoidance and withdrawal subgroups for major outcomes.\nCNI withdrawal may lead to rejection (RR 2.54, 95% CI 1.56 to 4.12; moderate certainty evidence), may make little or no difference to death (RR 1.09, 95% CI 0.96 to 1.24; moderate certainty), and probably slightly reduces graft loss (RR 0.85, 95% CI 0.74 to 0.98; low quality evidence). Hypertension was probably reduced in the CNI withdrawal group (RR 0.82, 95% CI 0.71 to 0.95; low certainty), while CNI withdrawal may make little or no difference to malignancy (RR 1.10, 95% CI 0.93 to 1.30; low certainty), and probably makes little or no difference to cytomegalovirus (CMV) (RR 0.87, 95% CI 0.52 to 1.45; low certainty)\nCNI avoidance may result in increased acute rejection (RR 2.16, 95% CI 0.85 to 5.49; low certainty) but little or no difference in graft loss (RR 0.96, 95% CI 0.79 to 1.16; low certainty). Late CNI withdrawal increased acute rejection (RR 3.21, 95% CI 1.59 to 6.48; moderate certainty) but probably reduced graft loss (RR 0.84, 95% CI 0.72 to 0.97, low certainty).\nResults were similar when CNI avoidance or withdrawal was combined with the introduction of mTOR-I; acute rejection was probably increased (RR 1.43; 95% CI 1.15 to 1.78; moderate certainty) and there was probably little or no difference in death (RR 0.96; 95% CI 0.69 to 1.36, moderate certainty). mTOR-I substitution may make little or no difference to graft loss (RR 0.94, 95% CI 0.75 to 1.19; low certainty), probably makes little of no difference to hypertension (RR 0.86, 95% CI 0.64 to 1.15; moderate), and probably reduced the risk of cytomegalovirus (CMV) (RR 0.60, 95% CI 0.44 to 0.82; moderate certainty) and malignancy (RR 0.69, 95% CI 0.47 to 1.00; low certainty). Lymphoceles were increased with mTOR-I substitution (RR 1.45, 95% CI 0.95 to 2.21; low certainty).\nLow dose CNI combined with mTOR-I probably increased glomerular filtration rate (GFR) (MD 6.24 mL/min, 95% CI 3.28 to 9.119; moderate certainty), reduced graft loss (RR 0.75, 95% CI 0.55 to 1.02; moderate certainty), and made little or no difference to acute rejection (RR 1.13 ; 95% CI 0.91 to 1.40; moderate certainty). Hypertension was decreased (RR 0.98, 95% CI 0.80 to 1.20; low certainty) as was CMV (RR 0.41, 95% CI 0.16 to 1.06; low certainty). Low dose CNI plus mTOR-I makes probably makes little of no difference to malignancy (RR 1.22, 95% CI 0.42 to 3.53; low certainty) and may make little of no difference to death (RR 1.16, 95% CI 0.71 to 1.90; moderate certainty).\nAuthors' conclusions\nCNI avoidance increased acute rejection and CNI withdrawal increases acute rejection but reduced graft loss at least over the short-term. Low dose CNI with induction regimens reduced acute rejection and graft loss with no major adverse events, also in the short-term. The use of mTOR-I reduced CMV infections but increased the risk of acute rejection. These conclusions must be tempered by the lack of long-term data in most of the studies, particularly with regards to chronic antibody-mediated rejection, and the suboptimal methodological quality of the included studies.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that the long-term outcomes for stopping or gradually reducing CNI therapy were not clear, and that mTOR inhibitors can reduce CMV infections with a higher risk of acute rejection. There were insufficient studies with long term follow-up to clearly determine which treatment is better for people who receive kidney transplants."
}
] |
query-laysum
|
6790
|
[
{
"role": "user",
"content": "Abstract: Background\nBeta-blockers refer to a mixed group of drugs with diverse pharmacodynamic and pharmacokinetic properties. They have shown long-term beneficial effects on mortality and cardiovascular disease (CVD) when used in people with heart failure or acute myocardial infarction. Beta-blockers were thought to have similar beneficial effects when used as first-line therapy for hypertension. However, the benefit of beta-blockers as first-line therapy for hypertension without compelling indications is controversial. This review is an update of a Cochrane Review initially published in 2007 and updated in 2012.\nObjectives\nTo assess the effects of beta-blockers on morbidity and mortality endpoints in adults with hypertension.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials up to June 2016: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 6), MEDLINE (from 1946), Embase (from 1974), and ClinicalTrials.gov. We checked reference lists of relevant reviews, and reference lists of studies potentially eligible for inclusion in this review, and also searched the the World Health Organization International Clinical Trials Registry Platform on 06 July 2015.\nSelection criteria\nRandomised controlled trials (RCTs) of at least one year of duration, which assessed the effects of beta-blockers compared to placebo or other drugs, as first-line therapy for hypertension, on mortality and morbidity in adults.\nData collection and analysis\nWe selected studies and extracted data in duplicate, resolving discrepancies by consensus. We expressed study results as risk ratios (RR) with 95% confidence intervals (CI) and conducted fixed-effect or random-effects meta-analyses, as appropriate. We also used GRADE to assess the certainty of the evidence. GRADE classifies the certainty of evidence as high (if we are confident that the true effect lies close to that of the estimate of effect), moderate (if the true effect is likely to be close to the estimate of effect), low (if the true effect may be substantially different from the estimate of effect), and very low (if we are very uncertain about the estimate of effect).\nMain results\nThirteen RCTs met inclusion criteria. They compared beta-blockers to placebo (4 RCTs, 23,613 participants), diuretics (5 RCTs, 18,241 participants), calcium-channel blockers (CCBs: 4 RCTs, 44,825 participants), and renin-angiotensin system (RAS) inhibitors (3 RCTs, 10,828 participants). These RCTs were conducted between the 1970s and 2000s and most of them had a high risk of bias resulting from limitations in study design, conduct, and data analysis. There were 40,245 participants taking beta-blockers, three-quarters of them taking atenolol. We found no outcome trials involving the newer vasodilating beta-blockers (e.g. nebivolol).\nThere was no difference in all-cause mortality between beta-blockers and placebo (RR 0.99, 95% CI 0.88 to 1.11), diuretics or RAS inhibitors, but it was higher for beta-blockers compared to CCBs (RR 1.07, 95% CI 1.00 to 1.14). The evidence on mortality was of moderate-certainty for all comparisons.\nTotal CVD was lower for beta-blockers compared to placebo (RR 0.88, 95% CI 0.79 to 0.97; low-certainty evidence), a reflection of the decrease in stroke (RR 0.80, 95% CI 0.66 to 0.96; low-certainty evidence) since there was no difference in coronary heart disease (CHD: RR 0.93, 95% CI 0.81 to 1.07; moderate-certainty evidence). The effect of beta-blockers on CVD was worse than that of CCBs (RR 1.18, 95% CI 1.08 to 1.29; moderate-certainty evidence), but was not different from that of diuretics (moderate-certainty) or RAS inhibitors (low-certainty). In addition, there was an increase in stroke in beta-blockers compared to CCBs (RR 1.24, 95% CI 1.11 to 1.40; moderate-certainty evidence) and RAS inhibitors (RR 1.30, 95% CI 1.11 to 1.53; moderate-certainty evidence). However, there was little or no difference in CHD between beta-blockers and diuretics (low-certainty evidence), CCBs (moderate-certainty evidence) or RAS inhibitors (low-certainty evidence). In the single trial involving participants aged 65 years and older, atenolol was associated with an increased CHD incidence compared to diuretics (RR 1.63, 95% CI 1.15 to 2.32). Participants taking beta-blockers were more likely to discontinue treatment due to adverse events than participants taking RAS inhibitors (RR 1.41, 95% CI 1.29 to 1.54; moderate-certainty evidence), but there was little or no difference with placebo, diuretics or CCBs (low-certainty evidence).\nAuthors' conclusions\nMost outcome RCTs on beta-blockers as initial therapy for hypertension have high risk of bias. Atenolol was the beta-blocker most used. Current evidence suggests that initiating treatment of hypertension with beta-blockers leads to modest CVD reductions and little or no effects on mortality. These beta-blocker effects are inferior to those of other antihypertensive drugs. Further research should be of high quality and should explore whether there are differences between different subtypes of beta-blockers or whether beta-blockers have differential effects on younger and older people.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Millions of people with high blood pressure have strokes, heart attacks, and other diseases, and many of them die. This situation could be prevented with appropriate treatment. Researchers have tried different medicines for treating high blood pressure."
}
] |
query-laysum
|
6791
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[
{
"role": "user",
"content": "Abstract: Background\nPrimary membranous nephropathy (PMN) is a common cause of nephrotic syndrome in adults. Without treatment, approximately 30% of patients will experience spontaneous remission and one third will have persistent proteinuria. Approximately one-third of patients progress toward end-stage kidney disease (ESKD) within 10 years. Immunosuppressive treatment aims to protect kidney function and is recommended for patients who do not show improvement of proteinuria by supportive therapy, and for patients with severe nephrotic syndrome at presentation due to the high risk of developing ESKD. The efficacy and safety of different immunosuppressive regimens are unclear. This is an update of a Cochrane review, first published in 2004 and updated in 2013.\nObjectives\nThe aim was to evaluate the safety and efficacy of different immunosuppressive treatments for adult patients with PMN and nephrotic syndrome.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 1 April 2021 with support from the Cochrane Kidney and Transplant Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) investigating effects of immunosuppression in adults with PMN and nephrotic syndrome were included.\nData collection and analysis\nStudy selection, data extraction, quality assessment, and data synthesis were performed using Cochrane-recommended methods. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nSixty-five studies (3807 patients) were included. Most studies exhibited a high risk of bias for the domains, blinding of study personnel, participants and outcome assessors, and most studies were judged unclear for randomisation sequence generation and allocation concealment.\nImmunosuppressive treatment versus placebo/no treatment/non-immunosuppressive treatment\nIn moderate certainty evidence, immunosuppressive treatment probably makes little or no difference to death, probably reduces the overall risk of ESKD (16 studies, 944 participants: RR 0.59, 95% CI 0.35 to 0.99; I² = 22%), probably increases total remission (complete and partial) (6 studies, 879 participants: RR 1.44, 95% CI 1.05 to 1.97; I² = 73%) and complete remission (16 studies, 879 participants: RR 1.70, 95% CI 1.05 to 2.75; I² = 43%), and probably decreases the number with doubling of serum creatinine (SCr) (9 studies, 447 participants: RR 0.46, 95% CI 0.26 to 0.80; I² = 21%). However, immunosuppressive treatment may increase the number of patients relapsing after complete or partial remission (3 studies, 148 participants): RR 1.73, 95% CI 1.05 to 2.86; I² = 0%) and may lead to a greater number experiencing temporary or permanent discontinuation/hospitalisation due to adverse events (18 studies, 927 participants: RR 5.33, 95% CI 2.19 to 12.98; I² = 0%). Immunosuppressive treatment has uncertain effects on infection and malignancy.\nOral alkylating agents with or without steroids versus placebo/no treatment/steroids\nOral alkylating agents with or without steroids had uncertain effects on death but may reduce the overall risk of ESKD (9 studies, 537 participants: RR 0.42, 95% CI 0.24 to 0.74; I² = 0%; low certainty evidence). Total (9 studies, 468 participants: RR 1.37, 95% CI 1.04 to 1.82; I² = 70%) and complete remission (8 studies, 432 participants: RR 2.12, 95% CI 1.33 to 3.38; I² = 37%) may increase, but had uncertain effects on the number of patients relapsing, and decreasing the number with doubling of SCr. Alkylating agents may be associated with a higher rate of adverse events leading to discontinuation or hospitalisation (8 studies 439 participants: RR 6.82, 95% CI 2.24 to 20.71; I² = 0%). Oral alkylating agents with or without steroids had uncertain effects on infection and malignancy.\nCalcineurin inhibitors (CNI) with or without steroids versus placebo/no treatment/supportive therapy/steroids\nWe are uncertain whether CNI with or without steroids increased or decreased the risk of death or ESKD, increased or decreased total or complete remission, or reduced relapse after complete or partial remission (low to very low certainty evidence). CNI also had uncertain effects on decreasing the number with a doubling of SCr, temporary or permanent discontinuation or hospitalisation due to adverse events, infection, or malignancy.\nCalcineurin inhibitors (CNI) with or without steroids versus alkylating agents with or without steroids\nWe are uncertain whether CNI with or without steroids increases or decreases the risk of death or ESKD. CNI with or without steroids may make little or no difference to total remission (10 studies, 538 participants: RR 1.01, 95% CI 0.89 to 1.15; I² = 53%; moderate certainty evidence) or complete remission (10 studies, 538 participants: RR 1.15, 95% CI 0.84 to 1.56; I² = 56%; low certainty evidence). CNI with or without steroids may increase relapse after complete or partial remission. CNI with or without steroids had uncertain effects on SCr increase, adverse events, infection, and malignancy.\nOther immunosuppressive treatments\nOther interventions included azathioprine, mizoribine, adrenocorticotropic hormone, traditional Chinese medicines, and monoclonal antibodies such as rituximab. There were insufficient data to draw conclusions on these treatments.\nAuthors' conclusions\nThis updated review strengthened the evidence that immunosuppressive therapy is probably superior to non-immunosuppressive therapy in inducing remission and reducing the number of patients that progress to ESKD. However, these benefits need to be balanced against the side effects of immunosuppressive drugs. The number of included studies with high-quality design was relatively small and most studies did not have adequate follow-up. Clinicians should inform their patients of the lack of high-quality evidence.\nAn alkylating agent (cyclophosphamide or chlorambucil) combined with a corticosteroid regimen had short- and long-term benefits, but this was associated with a higher rate of adverse events.\nCNI (tacrolimus and cyclosporin) showed equivalency with alkylating agents however, the certainty of this evidence remains low.\nNovel immunosuppressive treatments with the biologic rituximab or use of adrenocorticotropic hormone require further investigation and validation in large and high-quality RCTs.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Primary membranous nephropathy (PMN) is an autoimmune disease, where the body's immune system attacks the kidneys. The term \"primary\" is used to describe membranous nephropathy that is not caused by another disease in the body. PMN is a leading cause of nephrotic syndrome in adults. Nephrotic syndrome is a condition, where the membrane of the kidney is damaged and becomes permeable for proteins. Primary membranous nephropathy is diagnosed through findings in a kidney biopsy and the presence of nephrotic syndrome.\nPMN is not harmful in about one-third of patients, who will have a spontaneous \"complete remission\", which means that the disease will resolve by itself. However, about another one third will experience spontaneous remission but will have some protein in the urine that continues with normal kidney function. These patients usually only require supportive treatments that do not interact with the immune system. Without treatment, about 15% to 50% of patients progress to end-stage kidney disease (ESKD) within 10 years.\nIn some patients, PMN can be severe or continues to get worse even after using 6 months of supportive treatments. In these patients, extra treatment that dampens the activity of the immune system may be used to reduce damage to the kidney. It is not clear which of these treatment(s) is the most helpful and what side effects can occur. Therefore, the duration and intensity of immunosuppressive treatment need to be balanced against possible side effects. There are different classes of drugs used in immunosuppressive therapy. These drugs may or may not be combined with corticosteroids (drugs based on the body's stress response hormone cortisol)."
}
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query-laysum
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6792
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[
{
"role": "user",
"content": "Abstract: Background\nChronic suppurative otitis media (CSOM) is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antibiotics act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM, such as steroids, antiseptics or ear cleaning (aural toileting). Antibiotics are commonly prescribed in combined preparations with steroids.\nObjectives\nTo assess the effects of adding a topical steroid to topical antibiotics in the treatment of people with chronic suppurative otitis media (CSOM).\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 March 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks.\nThe interventions were any combination of a topical antibiotic agent(s) of any class and a topical corticosteroid (steroid) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure.\nThe two main comparisons were topical antibiotic and steroid compared to a) placebo or no intervention and b) another topical antibiotic.\nData collection and analysis\nWe used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome.\nOur primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks and after four weeks; health-related quality of life; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity.\nMain results\nWe included 17 studies addressing 11 treatment comparisons. A total of 1901 participants were included, with one study (40 ears) not reporting the number of participants recruited, which we therefore could not account for. No studies reported health-related quality of life. The main comparisons were:\n1. Topical antibiotics with steroids versus placebo or no treatment\nThree studies (210 participants) compared a topical antibiotic-steroid to saline or no treatment. Resolution of discharge was not reported at between one to two weeks. One study (50 'high-risk' children) reported results at more than four weeks by ear and we could not adjust the results to by person. The study reported that 58% (of 41 ears) resolved with topical antibiotics compared with 50% (of 26 ears) with no treatment, but the evidence is very uncertain. One study (123 participants) noted minor side effects in 16% of participants in both the intervention and placebo groups (very low-certainty evidence). One study (123 participants) reported no change in bone-conduction hearing thresholds and reported no difference in tinnitus or balance problems between groups (very low-certainty evidence). One study (50 participants) reported serious complications, but it was not clear which group these patients were from, or whether the complications occurred pre- or post-treatment. One study (123 participants) reported that no side effects occurred in any participants (very low-certainty evidence).\n2. Topical antibiotics with steroids versus topical antibiotics (same antibiotics) only\nFour studies (475 participants) were included in this comparison. Three studies (340 participants) compared topical antibiotic-steroid combinations to topical antibiotics alone. The evidence suggests little or no difference in resolution of discharge at one to two weeks: 82.7% versus 76.6% (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.96 to 1.21; 335 participants; 3 studies (4 study arms); low-certainty evidence). No results for resolution of discharge after four weeks were reported. One study (110 participants) reported local itchiness but as there was only one episode in each group it is uncertain whether there is a difference (very low-certainty evidence). Three studies (395 participants) investigated suspected ototoxicity but it was not possible to determine whether there were differences between the groups for this outcome (very low-certainty evidence). No study reported serious complications.\n3. Topical antibiotics with steroids compared to topical antibiotics alone (different antibiotics)\nNine studies (981 participants plus 40 ears) evaluated a range of comparisons of topical non-quinolone antibiotic-steroid combinations versus topical quinolone antibiotics alone. Resolution of discharge may be greater with quinolone topical antibiotics alone at between one to two weeks compared with non-quinolone topical antibiotics with steroids: 82.1% versus 63.2% (RR 0.77, 95% CI 0.71 to 0.84; 7 studies; 903 participants, low-certainty evidence). Results for resolution of ear discharge after four weeks were not reported. One study (52 participants) reported usable data on ear pain, two studies (419 participants) reported hearing outcomes and one study (52 participants) reported balance problems. It was not possible to determine whether there were significant differences between the groups for these outcomes (very low-certainty evidence). Two studies (149 participants) reported no serious complications (very low-certainty evidence).\nAuthors' conclusions\nWe are uncertain about the effectiveness of topical antibiotics with steroids in improving the resolution of ear discharge in patients with CSOM because of the limited amount of low-certainty evidence available. Amongst this uncertainty, we found no evidence that the addition of steroids to topical antibiotics affects the resolution of ear discharge. There is also low-certainty evidence that some types of topical antibiotics (without steroids) may be better than topical antibiotic/steroid combinations in improving resolution of discharge. There is also uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine with any certainty whether or not quinolones are better or worse than aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.\n\nGiven the provided abstract, please respond to the following query: \"How we identified and assessed the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for all relevant studies in the medical literature, compared the results and summarised the evidence from all the studies. We also assessed how certain the evidence was, considering factors such as study size and the way studies were conducted. Based on our assessments, we categorised the evidence as being of very low, low, moderate or high certainty."
}
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query-laysum
|
6793
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[
{
"role": "user",
"content": "Abstract: Background\nGroup therapy offers individuals the opportunity to learn behavioural techniques for smoking cessation, and to provide each other with mutual support.\nObjectives\nTo determine the effect of group-delivered behavioural interventions in achieving long-term smoking cessation.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register, using the terms 'behavior therapy', 'cognitive therapy', 'psychotherapy' or 'group therapy', in May 2016.\nSelection criteria\nRandomized trials that compared group therapy with self-help, individual counselling, another intervention or no intervention (including usual care or a waiting-list control). We also considered trials that compared more than one group programme. We included those trials with a minimum of two group meetings, and follow-up of smoking status at least six months after the start of the programme. We excluded trials in which group therapy was provided to both active therapy and placebo arms of trials of pharmacotherapies, unless they had a factorial design.\nData collection and analysis\nTwo review authors extracted data in duplicate on the participants, the interventions provided to the groups and the controls, including programme length, intensity and main components, the outcome measures, method of randomization, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months follow-up in participants smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically-validated rates where available. We analysed participants lost to follow-up as continuing smokers. We expressed effects as a risk ratio for cessation. Where possible, we performed meta-analysis using a fixed-effect (Mantel-Haenszel) model. We assessed the quality of evidence within each study and comparison, using the Cochrane 'Risk of bias' tool and GRADE criteria.\nMain results\nSixty-six trials met our inclusion criteria for one or more of the comparisons in the review. Thirteen trials compared a group programme with a self-help programme; there was an increase in cessation with the use of a group programme (N = 4395, risk ratio (RR) 1.88, 95% confidence interval (CI) 1.52 to 2.33, I2 = 0%). We judged the GRADE quality of evidence to be moderate, downgraded due to there being few studies at low risk of bias. Fourteen trials compared a group programme with brief support from a health care provider. There was a small increase in cessation (N = 7286, RR 1.22, 95% CI 1.03 to 1.43, I2 = 59%). We judged the GRADE quality of evidence to be low, downgraded due to inconsistency in addition to risk of bias. There was also low quality evidence of benefit of a group programme compared to no-intervention controls, (9 trials, N = 1098, RR 2.60, 95% CI 1.80 to 3.76 I2 = 55%). We did not detect evidence that group therapy was more effective than a similar intensity of individual counselling (6 trials, N = 980, RR 0.99, 95% CI 0.76 to 1.28, I2 = 9%). Programmes which included components for increasing cognitive and behavioural skills were not shown to be more effective than same-length or shorter programmes without these components.\nAuthors' conclusions\nGroup therapy is better for helping people stop smoking than self-help, and other less intensive interventions. There is not enough evidence to evaluate whether groups are more effective, or cost-effective, than intensive individual counselling. There is not enough evidence to support the use of particular psychological components in a programme beyond the support and skills training normally included.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One approach to help people who are trying to quit smoking is to offer them group-based support. Participants meet regularly, with a facilitator who is typically trained in smoking cessation counselling. Programme components are varied. A perceived strength of this approach is that participants provide each other with support and encouragement. The outcome of interest was not smoking at least six months from the start of the group programme."
}
] |
query-laysum
|
6794
|
[
{
"role": "user",
"content": "Abstract: Background\nOvereating and harmful alcohol and tobacco use have been linked to the aetiology of various non-communicable diseases, which are among the leading global causes of morbidity and premature mortality. As people are repeatedly exposed to varying sizes and shapes of food, alcohol and tobacco products in environments such as shops, restaurants, bars and homes, this has stimulated public health policy interest in product size and shape as potential targets for intervention.\nObjectives\n1) To assess the effects of interventions involving exposure to different sizes or sets of physical dimensions of a portion, package, individual unit or item of tableware on unregulated selection or consumption of food, alcohol or tobacco products in adults and children.\n2) To assess the extent to which these effects may be modified by study, intervention and participant characteristics.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PsycINFO, eight other published or grey literature databases, trial registries and key websites up to November 2012, followed by citation searches and contacts with study authors. This original search identified eligible studies published up to July 2013, which are fully incorporated into the review. We conducted an updated search up to 30 January 2015 but further eligible studies are not yet fully incorporated due to their minimal potential to change the conclusions.\nSelection criteria\nRandomised controlled trials with between-subjects (parallel-group) or within-subjects (cross-over) designs, conducted in laboratory or field settings, in adults or children. Eligible studies compared at least two groups of participants, each exposed to a different size or shape of a portion of a food (including non-alcoholic beverages), alcohol or tobacco product, its package or individual unit size, or of an item of tableware used to consume it, and included a measure of unregulated selection or consumption of food, alcohol or tobacco.\nData collection and analysis\nWe applied standard Cochrane methods to select eligible studies for inclusion and to collect data and assess risk of bias. We calculated study-level effect sizes as standardised mean differences (SMDs) between comparison groups, measured as quantities selected or consumed. We combined these results using random-effects meta-analysis models to estimate summary effect sizes (SMDs with 95% confidence intervals (CIs)) for each outcome for size and shape comparisons. We rated the overall quality of evidence using the GRADE system. Finally, we used meta-regression analysis to investigate statistical associations between summary effect sizes and variant study, intervention or participant characteristics.\nMain results\nThe current version of this review includes 72 studies, published between 1978 and July 2013, assessed as being at overall unclear or high risk of bias with respect to selection and consumption outcomes. Ninety-six per cent of included studies (69/72) manipulated food products and 4% (3/72) manipulated cigarettes. No included studies manipulated alcohol products. Forty-nine per cent (35/72) manipulated portion size, 14% (10/72) package size and 21% (15/72) tableware size or shape. More studies investigated effects among adults (76% (55/72)) than children and all studies were conducted in high-income countries - predominantly in the USA (81% (58/72)). Sources of funding were reported for the majority of studies, with no evidence of funding by agencies with possible commercial interests in their results.\nA meta-analysis of 86 independent comparisons from 58 studies (6603 participants) found a small to moderate effect of portion, package, individual unit or tableware size on consumption of food (SMD 0.38, 95% CI 0.29 to 0.46), providing moderate quality evidence that exposure to larger sizes increased quantities of food consumed among children (SMD 0.21, 95% CI 0.10 to 0.31) and adults (SMD 0.46, 95% CI 0.40 to 0.52). The size of this effect suggests that, if sustained reductions in exposure to larger-sized food portions, packages and tableware could be achieved across the whole diet, this could reduce average daily energy consumed from food by between 144 and 228 kcal (8.5% to 13.5% from a baseline of 1689 kcal) among UK children and adults. A meta-analysis of six independent comparisons from three studies (108 participants) found low quality evidence for no difference in the effect of cigarette length on consumption (SMD 0.25, 95% CI -0.14 to 0.65).\nOne included study (50 participants) estimated a large effect on consumption of exposure to differently shaped tableware (SMD 1.17, 95% CI 0.57 to 1.78), rated as very low quality evidence that exposure to shorter, wider bottles (versus taller, narrower bottles) increased quantities of water consumed by young adult participants.\nA meta-analysis of 13 independent comparisons from 10 studies (1164 participants) found a small to moderate effect of portion or tableware size on selection of food (SMD 0.42, 95% CI 0.24 to 0.59), rated as moderate quality evidence that exposure to larger sizes increased the quantities of food people selected for subsequent consumption. This effect was present among adults (SMD 0.55, 95% CI 0.35 to 0.75) but not children (SMD 0.14, 95% CI -0.06 to 0.34).\nIn addition, a meta-analysis of three independent comparisons from three studies (232 participants) found a very large effect of exposure to differently shaped tableware on selection of non-alcoholic beverages (SMD 1.47, 95% CI 0.52 to 2.43), rated as low quality evidence that exposure to shorter, wider (versus taller, narrower) glasses or bottles increased the quantities selected for subsequent consumption among adults (SMD 2.31, 95% CI 1.79 to 2.83) and children (SMD 1.03, 95% CI 0.41 to 1.65).\nAuthors' conclusions\nThis review found that people consistently consume more food and drink when offered larger-sized portions, packages or tableware than when offered smaller-sized versions. This suggests that policies and practices that successfully reduce the size, availability and appeal of larger-sized portions, packages, individual units and tableware can contribute to meaningful reductions in the quantities of food (including non-alcoholic beverages) people select and consume in the immediate and short term. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. We are unable to highlight clear implications for tobacco or alcohol policy due to identified gaps in the current evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence to establish by how much the amounts of food, alcohol or tobacco adults and children select or consume change in response to being presented with larger or smaller-sized (or differently shaped) portions or packages of these products, or of items of tableware (such as plates or glasses) used to consume them."
}
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query-laysum
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6795
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[
{
"role": "user",
"content": "Abstract: Background\nBladder dysfunction is a common complication following radical hysterectomy, caused by the damage to pelvic autonomic nerves that innervate the muscles of the bladder, urethral sphincter, and pelvic floor fasciae. Bladder dysfunction increases the rates of urinary tract infection, hospital visits or admission, and patient dissatisfaction. In addition, bladder dysfunction can also negatively impact patient quality of life (QoL). Several postoperative interventions have been proposed to prevent bladder dysfunction following radical hysterectomy. To our knowledge, there has been no systematic review evaluating the effectiveness and safety of these interventions for preventing bladder dysfunction following radical hysterectomy in women with cervical cancer.\nObjectives\nTo evaluate the effectiveness and safety of postoperative interventions for preventing bladder dysfunction following radical hysterectomy in women with early-stage cervical cancer (stage IA2 to IIA2).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4) in the Cochrane Library, MEDLINE via Ovid (1946 to April week 2, 2020), and Embase via Ovid (1980 to 2020, week 16). We also checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating the effectiveness and safety of any type of postoperative interventions for preventing bladder dysfunction following a radical hysterectomy in women with stage IA2 to IIA2 cervical cancer.\nData collection and analysis\nTwo review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgments on the quality and certainty of the evidence. We resolved any disagreements through discussion or consultation with a third review author. Outcomes of interest consisted of spontaneous voiding recovery one week after the operation, quality of life (QoL), adverse events, post-void residual urine volume one month after the operation, urinary tract infection over the one month following the operation, and subjective urinary symptoms.\nMain results\nWe identified 1464 records as a result of the search (excluding duplicates). Of the 20 records that potentially met the review criteria, we included five reports of four studies. Most of the studies had unclear risks of selection and reporting biases. Of the four studies, one compared bethanechol versus placebo and three studies compared suprapubic catheterisation with intermittent self-catheterisation. We identified two ongoing studies.\nBethanechol versus placebo\nThe study reported no information on the rate of spontaneous voiding recovery at one week following the operation, QoL, adverse events, urinary tract infection in the first month after surgery, and subjective urinary symptoms for this comparison. The volume of post-void residual urine, assessed at one month after surgery, among women receiving bethanechol was lower than those in the placebo group (mean difference (MD) -37.4 mL, 95% confidence interval (CI) -60.35 to -14.45; one study, 39 participants; very-low certainty evidence).\nSuprapubic catheterisation versus intermittent self-catheterisation\nThe studies reported no information on the rate of spontaneous voiding recovery at one week and post-void residual urine volume at one month following the operation for this comparison. There was no difference in risks of acute complication (risk ratio (RR) 0.77, 95% CI 0.24 to 2.49; one study, 71 participants; very low certainty evidence) and urinary tract infections during the first month after surgery (RR 0.77, 95% CI 0.53 to 1.13; two studies, 95 participants; very- low certainty evidence) between participants who underwent suprapubic catheterisation and those who underwent intermittent self-catheterisation. Available data were insufficient to calculate the relative measures of the effect of interventions on QoL and subjective urinary symptoms.\nAuthors' conclusions\nNone of the included studies reported rate of spontaneous voiding recovery one week after surgery, time to a post-void residual volume of urine of 50 mL or less, or post-void residual urine volume at 6 and 12 months after surgery, all of which are important outcomes for assessing postoperative bladder dysfunction.\nLimited evidence suggested that bethanechol may minimise the risk of bladder dysfunction after radical hysterectomy by lowering post-void residual urine volume. The certainty of this evidence, however, was very low. The effectiveness of different types of postoperative urinary catheterisation (suprapubic and intermittent self-catheterisation) remain unproven.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "None of the included studies reported rate of spontaneous voiding recovery one week after surgery, time to a post-void residual volume of urine of 50 mL or less, or post-void residual urine volume at 6 and 12 months after surgery, all of which are important outcomes for assessing postoperative bladder dysfunction. Limited evidence suggested that bethanechol may prevent bladder dysfunction after radical hysterectomy by lowering post-void residual urine volume. The certainty of this evidence, however, was very low. The effectiveness of different types of postoperative urinary catheterisation (suprapubic and intermittent self-catheterisation) remains unproven."
}
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query-laysum
|
6796
|
[
{
"role": "user",
"content": "Abstract: Background\nAmputation is described as the removal of an external part of the body by trauma, medical illness or surgery. Amputations caused by vascular diseases (dysvascular amputations) are increasingly frequent, commonly due to peripheral arterial disease (PAD), associated with an ageing population, and increased incidence of diabetes and atherosclerotic disease. Interventions for motor rehabilitation might work as a precursor to enhance the rehabilitation process and prosthetic use. Effective rehabilitation can improve mobility, allow people to take up activities again with minimum functional loss and may enhance the quality of life (QoL). Strength training is a commonly used technique for motor rehabilitation following transtibial (below-knee) amputation, aiming to increase muscular strength. Other interventions such as motor imaging (MI), virtual environments (VEs) and proprioceptive neuromuscular facilitation (PNF) may improve the rehabilitation process and, if these interventions can be performed at home, the overall expense of the rehabilitation process may decrease. Due to the increased prevalence, economic impact and long-term rehabilitation process in people with dysvascular amputations, a review investigating the effectiveness of motor rehabilitation interventions in people with dysvascular transtibial amputations is warranted.\nObjectives\nTo evaluate the benefits and harms of interventions for motor rehabilitation in people with transtibial (below-knee) amputations resulting from peripheral arterial disease or diabetes (dysvascular causes).\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 9 January 2023.\nSelection criteria\nWe included randomised controlled trials (RCT) in people with transtibial amputations resulting from PAD or diabetes (dysvascular causes) comparing interventions for motor rehabilitation such as strength training (including gait training), MI, VEs and PNF against each other.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. prosthesis use, and 2. adverse events. Our secondary outcomes were 3. mortality, 4. QoL, 5. mobility assessment and 6. phantom limb pain. We use GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included two RCTs with a combined total of 30 participants. One study evaluated MI combined with physical practice of walking versus physical practice of walking alone. One study compared two different gait training protocols. The two studies recruited people who already used prosthesis; therefore, we could not assess prosthesis use. The studies did not report mortality, QoL or phantom limb pain. There was a lack of blinding of participants and imprecision as a result of the small number of participants, which downgraded the certainty of the evidence.\nWe identified no studies that compared VE or PNF with usual care or with each other.\nMI combined with physical practice of walking versus physical practice of walking (one RCT, eight participants) showed very low-certainty evidence of no difference in mobility assessment assessed using walking speed, step length, asymmetry of step length, asymmetry of the mean amount of support on the prosthetic side and on the non-amputee side and Timed Up-and-Go test. The study did not assess adverse events.\nOne study compared two different gait training protocols (one RCT, 22 participants). The study used change scores to evaluate if the different gait training strategies led to a difference in improvement between baseline (day three) and post-intervention (day 10). There were no clear differences using velocity, Berg Balance Scale (BBS) or Amputee Mobility Predictor with PROsthesis (AMPPRO) in training approaches in functional outcome (very low-certainty evidence). There was very low-certainty evidence of little or no difference in adverse events comparing the two different gait training protocols.\nAuthors' conclusions\nOverall, there is a paucity of research in the field of motor rehabilitation in dysvascular amputation. We identified very low-certainty evidence that gait training protocols showed little or no difference between the groups in mobility assessments and adverse events. MI combined with physical practice of walking versus physical practice of walking alone showed no clear difference in mobility assessment (very low-certainty evidence). The included studies did not report mortality, QoL, and phantom limb pain, and evaluated participants already using prosthesis, precluding the evaluation of prosthesis use.\nDue to the very low-certainty evidence available based on only two small trials, it remains unclear whether these interventions have an effect on the prosthesis use, adverse events, mobility assessment, mortality, QoL and phantom limb pain. Further well-designed studies that address interventions for motor rehabilitation in dysvascular transtibial amputation may be important to clarify this uncertainty.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The most recent search was 9 January 2023."
}
] |
query-laysum
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6797
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[
{
"role": "user",
"content": "Abstract: Background\nAdult smoking usually has its roots in adolescence. If individuals do not take up smoking during this period it is unlikely that they ever will. Further, once smoking becomes established, cessation is challenging; the probability of subsequently quitting is inversely proportional to the age of initiation. One novel approach to reducing the prevalence of youth smoking is the use of incentives.\nObjectives\nTo assess the effect of incentives on preventing children and adolescents (aged 5 to 18 years) from starting to smoke. It was also our intention to assess, where possible, the dose-response of incentives, the costs of incentive programmes, whether incentives are more or less effective in combination with other interventions to prevent smoking initiation, and any unintended consequences arising from the use of incentives.\nSearch methods\nFor the original review (published 2012) we searched the Cochrane Tobacco Addiction Group Specialized Register, with additional searches of MEDLINE, Embase, CINAHL, CSA databases and PsycINFO for terms relating to incentives, in combination with terms for smoking and tobacco use, and children and adolescents. The most recent searches were of the Cochrane Tobacco Addiction Group Specialized Register, and were carried out in December 2016.\nSelection criteria\nWe considered randomized controlled trials (RCTs) allocating children and adolescents (aged 5 to 18 years) as individuals, groups or communities to intervention or control conditions, where the intervention included an incentive aimed at preventing smoking uptake. We also considered controlled trials (CTs) with baseline measures and post-intervention outcomes.\nData collection and analysis\nTwo review authors extracted and independently assessed the data. The primary outcome was the smoking status of children or adolescents at follow-up who reported no smoking at baseline. We required a minimum follow-up of six months from baseline and assessed each included study for risks of bias. We used the most rigorous definition of abstinence in each trial; we did not require biochemical validation of self-reported tobacco use for study inclusion. Where possible we combined eligible studies to calculate pooled estimates at the longest follow-up, using the Mantel-Haenszel fixed-effect method, grouping studies by study design.\nMain results\nWe identified three eligible RCTs and five CTs, including participants aged 11 to 14 years, who were non-smokers at baseline. Of the eight trials identified, six had analyzable data relevant for this review, which contributed to meta-analyses (7275 participants in total: 4003 intervention; 3272 control; 2484 participants after adjusting for clustering). All except one of the studies tested the 'Smokefree Class Competition' (SFC), which has been widely implemented throughout Europe. In this competition, classes with youth generally between the ages of 11 and 14 years commit to being smoke-free for a six-month period, and report their smoking status regularly. If 90% or more of the class are non-smokers at the end of the six months, the class goes into a competition to win prizes. The one study that was not a trial of the SFC was a controlled trial in which schools in two communities were assigned to the intervention, with schools in a third community acting as controls. Students in the intervention community with lower smoking rates at the end of the project (one school year) received rewards.\nMost studies resulted in statistically non-significant results. Only one study of the SFC reported a significant effect of the competition on the prevention of smoking at the longest follow-up. However, this study was at risk of multiple biases, and when we calculated the adjusted risk ratio (RR) we no longer detected a statistically significant difference. The pooled RR for the more robust RCTs (3 studies, n = 3056 participants/1107 adjusted for clustering) suggests that there is no statistically significant effect of incentives, in the form of the SFC, to prevent smoking initiation among children and adolescents in the long term (RR 1.00, 95% confidence interval (CI) 0.84 to 1.19). Pooled results from the non-randomized trials also did not detect a significant effect of the SFC, and we were unable to extract data on our outcome of interest from the one trial that did not study the SFC. There is little robust evidence to suggest that unintended consequences (such as making false claims about their smoking status and bullying of smoking students) are consistently associated with such interventions, although this has not been the focus of much research. There was insufficient information to assess the dose-response relationship or to report costs of incentives for preventing smoking uptake.\nWe judged the included RCTs to be at unclear risk of bias, and the non-RCTs to be at high risk of bias. Using GRADE, we rated the overall quality of the evidence for our primary outcome as 'low' (for RCTs) and 'very low' (for non-RCTs), because of imprecision (all studies had wide confidence intervals), and for the risks of bias identified. We further downgraded the non-RCT evidence, due to issues with the non-RCT study design, likely to introduce further bias.\nAuthors' conclusions\nThe very limited evidence currently available suggests that incentive programmes do not prevent smoking initiation among youth. However, there are relatively few published studies and these are of variable quality. In addition, trials included in the meta-analyses were all studies of the SFC, which distributed small to moderately-sized prizes to whole classes, usually through a lottery system. It is therefore possible that other incentive programmes could be more successful at preventing smoking uptake in young people.\nFuture studies might investigate the efficacy of a wider range of incentives, including those given to individual participants to prevent smoking uptake, whilst considering both the effect of incentives on smoking initiation and the progression to smoking. It would be useful if incentives were evaluated in varying populations from different socioeconomic and ethnic backgrounds, and if intervention components were described in detail.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most smokers start smoking before they are 18 years old. Starting smoking earlier in life means a smoker will smoke for more years than someone who starts smoking later, which increases the health risks of smoking. Given the high amount of tobacco use among young people and the poor health outcomes that may result, finding ways to prevent young people from smoking is a public health priority. One new approach to stopping young people from starting to smoke is the use of incentives, where young people or groups of young people are rewarded for being smoke-free. The aim of this review was to assess the effect of incentives on stopping children and adolescents (aged 5 to 18 years) from starting to smoke."
}
] |
query-laysum
|
6798
|
[
{
"role": "user",
"content": "Abstract: Background\nThe management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation.\nObjectives\nTo compare the benefits and harms of endoscopic sphincterotomy and stone removal followed by laparoscopic cholecystectomy (the single-stage rendezvous technique) versus preoperative endoscopic sphincterotomy followed by laparoscopic cholecystectomy (two stages) in people with gallbladder and common bile duct stones.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded Web of Science, and two trials registers (February 2017).\nSelection criteria\nWe included randomised clinical trials that enrolled people with concomitant gallbladder and common bile duct stones, regardless of clinical status or diagnostic work-up, and compared laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy procedures in people undergoing laparoscopic cholecystectomy. We excluded other endoscopic or surgical methods of intraoperative clearance of the bile duct, e.g. non-aided intraoperative endoscopic retrograde cholangiopancreatography or laparoscopic choledocholithotomy (surgical incision of the common bile duct for removal of bile duct stones).\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane.\nMain results\nWe included five randomised clinical trials with 517 participants (257 underwent a laparoscopic-endoscopic rendezvous technique versus 260 underwent a sequential approach), which fulfilled our inclusion criteria and provided data for analysis. Trial participants were scheduled for laparoscopic cholecystectomy because of suspected cholecysto-choledocholithiasis. Male/female ratio was 0.7; age of men and women ranged from 21 years to 87 years. The run-in and follow-up periods of the trials ranged from 32 months to 84 months. Overall, the five trials were judged at high risk of bias. Athough all trials measured mortality, there was just one death reported in one trial, in the laparoscopic-endoscopic rendezvous group (low-quality evidence). The overall morbidity (surgical morbidity plus general morbidity) may be lower with laparoscopic rendezvous (RR 0.59, 95% CI 0.29 to 1.20; participants = 434, trials = 4; I² = 28%; low-quality evidence); the effect was a little more certain when a fixed-effect model was used (RR 0.56, 95% CI 0.32 to 0.99). There was insufficient evidence to determine the effects of the two approaches on the failure of primary clearance of the bile duct (RR 0.55, 95% CI 0.22 to 1.38; participants = 517; trials = 5; I² = 58%; very low-quality evidence). The effects of either approach on clinical post-operative pancreatitis were unclear (RR 0.29, 95% CI 0.07 to 1.12; participants = 517, trials = 5; I² = 24%; low-quality evidence). Hospital stay appeared to be lower in the laparoscopic-endoscopic rendezvous group by about three days (95% CI 3.51 to 2.50 days shorter; 515 participants in five trials; low-quality evidence). There was very low-quality evidence that suggested longer operative time with laparoscopic-endoscopic rendezvous (MD 34.07 minutes, 95% CI 11.41 to 56.74; participants = 313; trials = 3; I² = 93%). The Trial Sequential Analyses of operating time and the length of hospital stay indicated that all the trials crossed the conventional boundaries, suggesting that the sample sizes were adequate, with a low risk of random error.\nAuthors' conclusions\nThere was insufficient evidence to determine the effects of the laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy techniques in people undergoing laparoscopic cholecystectomy on mortality and morbidity. The laparoscopic-endoscopic rendezvous procedure may lead to longer operating times, but it may reduce the length of the hospital stay when compared with preoperative endoscopic sphincterotomy followed by laparoscopic cholecystectomy. However, no firm conclusions could be drawn because the quality of evidence was low or very low. If confirmed by future trials, these data might re-design the scenario of treatment of this condition, albeit requiring greater organisational effort. Future trials should also address issues such as quality of life and cost analysis.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The laparoscopic-endoscopic rendezvous approach could be associated with a lower rate of overall morbidity and clinical post-operative pancreatitis, and a shorter hospital stay. We found no clear differences in overall mortality between the two techniques. Total operative time was longer with the rendezvous approach.\nWe were unable to draw firm conclusions because of the lack of data. Further research is needed to confirm whether the single-stage approach is safer and more efficacious than the two-stage approach, and to address other important issues, such as quality of life and cost analysis."
}
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query-laysum
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6799
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[
{
"role": "user",
"content": "Abstract: Background\nSymptoms of anxiety and depression are common in inflammatory bowel disease (IBD). Antidepressants are taken by approximately 30% of people with IBD. However, there are no current guidelines on treating co-morbid anxiety and depression in people with IBD with antidepressants, nor are there clear data on the role of antidepressants in managing physical symptoms of IBD.\nObjectives\nThe objectives were to assess the efficacy and safety of antidepressants for treating anxiety and depression in IBD, and to assess the effects of antidepressants on quality of life (QoL) and managing disease activity in IBD.\nSearch methods\nWe searched MEDLINE; Embase, CINAHL, PsycINFO, CENTRAL, and the Cochrane IBD Group Specialized Register from inception to 23 August 2018. Reference lists, trials registers, conference proceedings and grey literature were also searched.\nSelection criteria\nRandomised controlled trials (RCTs) and observational studies comparing any type of antidepressant to placebo, no treatment or an active therapy for IBD were included.\nData collection and analysis\nTwo authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. We used the Newcastle-Ottawa Scale to assess quality of observational studies. GRADE was used to evaluate the certainty of the evidence supporting the outcomes. Primary outcomes included anxiety and depression. Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS) or the Hamilton Anxiety Rating Scale (HARS). Depression was assessed using HADS or the Beck Depression Inventory. Secondary outcomes included adverse events (AEs), serious AEs, withdrawal due to AEs, quality of life (QoL), clinical remission, relapse, pain, hospital admissions, surgery, and need for steroid treatment. QoL was assessed using the WHO-QOL-BREF questionnaire. We calculated the risk ratio (RR) and corresponding 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) with 95% CI. A fixed-effect model was used for analysis.\nMain results\nWe included four studies (188 participants). Two studies were double-blind RCTs, one was a non-randomised controlled trial, and one was an observational retrospective case-matched study. The age of participants ranged from 27 to 37.8 years. In three studies participants had quiescent IBD and in one study participants had active or quiescent IBD. Participants in one study had co-morbid anxiety or depression. One study used duloxetine (60 mg daily), one study used fluoxetine (20 mg daily), one study used tianeptine (36 mg daily), and one study used various antidepressants in clinical ranges. Three studies had placebo controls and one study had a no treatment control group. One RCT was rated as low risk of bias and the other was rated as high risk of bias (incomplete outcome data). The non-randomised controlled trial was rated as high risk of bias (random sequence generation, allocation concealment, blinding). The observational study was rated as high methodological quality, but is still considered to be at high risk of bias given its observational design.\nThe effect of antidepressants on anxiety and depression is uncertain. At 12 weeks, the mean anxiety score in antidepressant participants was 6.11 + 3 compared to 8.5 + 3.45 in placebo participants (MD -2.39, 95% -4.30 to -0.48, 44 participants, low certainty evidence). At 12 months, the mean anxiety score in antidepressant participants was 3.8 + 2.5 compared to 4.2 + 4.9 in placebo participants (MD -0.40, 95% -3.47 to 2.67, 26 participants; low certainty evidence). At 12 weeks, the mean depression score in antidepressant participants was 7.47 + 2.42 compared to 10.5 + 3.57 in placebo participants (MD -3.03, 95% CI -4.83 to -1.23, 44 participants; low certainty evidence). At 12 months, the mean depression score in antidepressant participants was 2.9 + 2.8 compared to 3.1 + 3.4 in placebo participants (MD -0.20, 95% -2.62 to 2.22, 26 participants; low certainty evidence).\nThe effect of antidepressants on AEs is uncertain. Fifty-seven per cent (8/14) of antidepressant participants group reported AEs versus 25% (3/12) of placebo participants (RR 2.29, 95% CI 0.78 to 6.73, low certainty evidence). Commonly reported AEs include nausea, headache, dizziness, drowsiness, sexual problems, insomnia, fatigue, low mood/anxiety, dry mouth, muscle spasms and hot flushes. None of the included studies reported any serious AEs. None of the included studies reported on pain.\nOne study (44 participants) reported on QoL at 12 weeks and another study (26 participants) reported on QoL at 12 months. Physical, Psychological, Social and Environmental QoL were improved at 12 weeks compared to placebo (all low certainty evidence). There were no group differences in QoL at 12 months (all low certainty evidence). The effect of antidepressants on maintenance of clinical remission and endoscopic relapse is uncertain. At 12 months, 64% (9/14) of participants in the antidepressant group maintained clinical remission compared to 67% (8/12) of placebo participants (RR 0.96, 95% CI 0.55 to 1.69; low certainty evidence). At 12 months, none (0/30) of participants in the antidepressant group had endoscopic relapse compared to 10% (3/30) of placebo participants (RR 0.14, 95% CI 0.01 to 2.65; very low certainty evidence).\nAuthors' conclusions\nThe results for the outcomes assessed in this review are uncertain and no firm conclusions regarding the efficacy and safety of antidepressants in IBD can be drawn. Future studies should employ RCT designs, with a longer follow-up and develop solutions to address attrition. Inclusion of objective markers of disease activity is strongly recommended as is testing antidepressants from different classes, as at present it is unclear if any antidepressant (or class thereof) has differential efficacy.\n\nGiven the provided abstract, please respond to the following query: \"What did the researchers find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The researchers searched the medical literature up to 23 August 2018. Four published studies, including a total of 188 people, examined antidepressant therapy in people with IBD. The age of participants ranged from 27 to 37.8 years. In three studies participants had IBD in remission and in one study participants had either active IBD or IBD in remission. Participants in one study had co-existing anxiety or depression. One study used duloxetine (60 mg daily), one study used fluoxetine (20 mg daily), one study used tianeptine (36 mg daily), and one study used various antidepressants. Three studies had a placebo (e.g. sugar pill) control group and one study had a no treatment control group.\nThe analysis showed that the symptoms of anxiety and depression were improved in those who took antidepressants compared to placebo. Participants who received antidepressants experienced more side effects than those who received placebo. Side effects reported by those taking antidepressants included: nausea, headache, dizziness, drowsiness, sexual problems, insomnia, fatigue, low mood/anxiety, dry mouth, poor sleep, restless legs and hot flushes. Some aspects of quality of life were improved as was IBD activity in the antidepressant group. The overall quality of the studies included in this review was poor because the studies included small numbers of participants, and involved IBD populations which differed from each other on key characteristics. In addition, different types of antidepressants were assessed so the evidence for any one antidepressant was uncertain. Therefore, future studies are needed to confirm these observations."
}
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query-laysum
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6800
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[
{
"role": "user",
"content": "Abstract: Background\nSince the 2000s, there has been a trend towards decreasing tidal volumes for positive pressure ventilation during surgery. This an update of a review first published in 2015, trying to determine if lower tidal volumes are beneficial or harmful for patients.\nObjectives\nTo assess the benefit of intraoperative use of low tidal volume ventilation (less than 10 mL/kg of predicted body weight) compared with high tidal volumes (10 mL/kg or greater) to decrease postoperative complications in adults without acute lung injury.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 5), MEDLINE (OvidSP) (from 1946 to 19 May 2017), Embase (OvidSP) (from 1974 to 19 May 2017) and six trial registries. We screened the reference lists of all studies retained and of recent meta-analysis related to the topic during data extraction. We also screened conference proceedings of anaesthesiology societies, published in two major anaesthesiology journals. The search was rerun 3 January 2018.\nSelection criteria\nWe included all parallel randomized controlled trials (RCTs) that evaluated the effect of low tidal volumes (defined as less than 10 mL/kg) on any of our selected outcomes in adults undergoing any type of surgery. We did not retain studies with participants requiring one-lung ventilation.\nData collection and analysis\nTwo authors independently assessed the quality of the retained studies with the Cochrane 'Risk of bias' tool. We analysed data with both fixed-effect (I2 statistic less than 25%) or random-effects (I2 statistic greater than 25%) models based on the degree of heterogeneity. When there was an effect, we calculated a number needed to treat for an additional beneficial outcome (NNTB) using the odds ratio. When there was no effect, we calculated the optimum information size.\nMain results\nWe included seven new RCTs (536 participants) in the update.\nIn total, we included 19 studies in the review (776 participants in the low tidal volume group and 772 in the high volume group). There are four studies awaiting classification and three are ongoing. All included studies were at some risk of bias. Participants were scheduled for abdominal surgery, heart surgery, pulmonary thromboendarterectomy, spinal surgery and knee surgery. Low tidal volumes used in the studies varied from 6 mL/kg to 8.1 mL/kg while high tidal volumes varied from 10 mL/kg to 12 mL/kg.\nBased on 12 studies including 1207 participants, the effects of low volume ventilation on 0- to 30-day mortality were uncertain (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.42 to 1.53; I2 = 0%; low-quality evidence). Based on seven studies including 778 participants, lower tidal volumes probably reduced postoperative pneumonia (RR 0.45, 95% CI 0.25 to 0.82; I2 = 0%; moderate-quality evidence; NNTB 24, 95% CI 16 to 160), and it probably reduced the need for non-invasive postoperative ventilatory support based on three studies including 506 participants (RR 0.31, 95% CI 0.15 to 0.64; moderate-quality evidence; NNTB 13, 95% CI 11 to 24). Based on 11 studies including 957 participants, low tidal volumes during surgery probably decreased the need for postoperative invasive ventilatory support (RR 0.33, 95% CI 0.14 to 0.77; I2 = 0%; NNTB 39, 95% CI 30 to 166; moderate-quality evidence). Based on five studies including 898 participants, there may be little or no difference in the intensive care unit length of stay (standardized mean difference (SMD) –0.06, 95% CI –0.22 to 0.10; I2 = 33%; low-quality evidence). Based on 14 studies including 1297 participants, low tidal volumes may have reduced hospital length of stay by about 0.8 days (SMD –0.15, 95% CI –0.29 to 0.00; I2 = 27%; low-quality evidence). Based on five studies including 708 participants, the effects of low volume ventilation on barotrauma (pneumothorax) were uncertain (RR 1.77, 95% CI 0.52 to 5.99; I2 = 0%; very low-quality evidence).\nAuthors' conclusions\nWe found moderate-quality evidence that low tidal volumes (defined as less than 10 mL/kg) decreases pneumonia and the need for postoperative ventilatory support (invasive and non-invasive). We found no difference in the risk of barotrauma (pneumothorax), but the number of participants included does not allow us to make definitive statement on this. The four studies in 'Studies awaiting classification' may alter the conclusions of the review once assessed.\n\nGiven the provided abstract, please respond to the following query: \"Reliability of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the reliability of the evidence as moderate for pneumonia and reduced need for ventilatory support (non-invasive or invasive). Results on these three outcomes may be affected with additional data."
}
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query-laysum
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6801
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[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is an autosomal recessive inherited defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene resulting in abnormal regulation of salt and water movement across the membranes. In the liver this leads to focal biliary fibrosis resulting in progressive portal hypertension and end-stage liver disease in some individuals. This can be asymptomatic, but may lead to splenomegaly and hypersplenism, development of varices and variceal bleeding, and ascites; it has negative impact on overall nutritional status and respiratory function in this population. Prognosis is poor once significant portal hypertension is established. The role and outcome of various interventions for managing advanced liver disease (non-malignant end stage disease) in people with cystic fibrosis is currently unidentified. This is an updated version of a previously published review.\nObjectives\nTo review and assess the efficacy of currently available treatment options for preventing and managing advanced liver disease in children and adults with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books.\nDate of last search: 19 November 2019.\nWe also searched the reference lists of relevant articles and reviews and online trials registries.\nDate of last search: 01 January 2020.\nSelection criteria\nAny published and unpublished randomised controlled trials and quasi-randomised controlled trials of advanced liver disease in cystic fibrosis with cirrhosis or liver failure, portal hypertension or variceal bleeding (or both).\nData collection and analysis\nAuthors independently examined titles and abstracts to identify potentially relevant trials, but none were eligible for inclusion in this review.\nMain results\nA comprehensive search of the literature did not identify any published eligible randomised controlled trials.\nAuthors' conclusions\nIn order to develop the best source of evidence, there is a need to undertake randomised controlled trials of interventions for preventing and managing advanced liver disease in adults and children with cystic fibrosis.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In advanced liver disease in cystic fibrosis, the normal liver tissue is replaced by scar tissue. As the disease progresses, the liver becomes hard and the blood cannot easily flow through the organ leading to increased pressure in an important blood vessel in the liver called the portal vein (portal hypertension). Later on, the veins around the lower part of the oesophagus (gullet) become swollen and torn, resulting in life-threatening bleeding (variceal bleeding). There are several treatments currently available for variceal bleeding and portal hypertension; drug treatments (non-selective beta blockers), endoscopic therapy (e.g. band ligation where tiny elastic bands are placed around the enlarged veins to tie them off so they can't bleed), or sclerotherapy (where a blood-clotting solution is injected directly into a vein and irritates the lining of the blood vessel so it swells and sticks together). The insertion of a transjugular intrahepatic porto-systemic shunt (also known as TIPSS) (an artificial channel within the liver that allows movement between the inflowing and out flowing veins) has been employed in recurrent bleeding or as a bridge to liver transplantation. Surgical porto-systemic shunts have also been used in selected patients with preserved liver function. Liver transplantation is performed in cystic fibrosis patients with decompensated cirrhosis or end-stage liver disease.\nGuidelines for screening and managing portal hypertension have been available for the general population (without cystic fibrosis). However, the optimal treatment for advanced liver disease in cystic fibrosis has not yet been defined, leading to a wide variety of practice among different centres. This is an updated version of a previously published review."
}
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query-laysum
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6802
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[
{
"role": "user",
"content": "Abstract: Background\nInsomnia is a common problem in modern society. It is associated with reduced quality of life and impairments in physical and mental health. Listening to music is widely used as a sleep aid, but it remains unclear if it can actually improve insomnia in adults. This Cochrane Review is an update of a review published in 2015.\nObjectives\nTo assess the effects of listening to music on sleep in adults with insomnia and to assess the influence of specific variables that may moderate the effect.\nSearch methods\nFor this update, we searched CENTRAL, MEDLINE, Embase, nine other databases and two trials registers up to December 2021. In addition, we handsearched reference lists of included studies, and contacted authors of published studies to identify additional studies eligible for inclusion, including any unpublished or ongoing trials.\nSelection criteria\nRandomised controlled trials comparing the effects of listening to music with no treatment or treatment as usual (TAU) in adults complaining of sleep difficulties.\nData collection and analysis\nTwo review authors independently screened records for eligibility, selected studies for inclusion, extracted data and assessed risk of bias of the included studies. We assessed the certainty of the evidence using GRADE. The primary outcomes were sleep quality, insomnia severity, sleep-onset latency, total sleep time, sleep interruption, sleep efficiency and adverse events. Data on the predefined outcome measures were included in meta-analyses when consistently reported by at least two studies that were homogeneous in terms of participants, interventions and outcomes. We undertook meta-analyses using random-effects models.\nMain results\nWe included 13 studies (eight studies new to this update) comprising 1007 participants. The studies examined the effect of listening to prerecorded music daily, for 25 to 60 minutes, for a period of three days to three months. The risk of bias within the studies varied, with all studies being at high risk of performance bias, because of limited possibilities to blind participants to the music intervention. Some studies were at high risk of detection bias or other bias. Four studies reported funding from national research councils, three studies reported financial support from university sources and one study reported a grant from a private foundation. Five studies did not report any financial support.\nAt the end of the intervention, we found moderate-certainty evidence for improved sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI) in themusic groups compared to no intervention or TAU (mean difference (MD) −2.79, 95% confidence interval (CI) −3.86 to −1.72; 10 studies, 708 participants). The PSQI scale ranges from 0 to 21 with higher scores indicating poorer sleep. The size of the effect indicates an increase in sleep quality of the size of about one standard deviation in favour of the intervention. We found no clear evidence of a difference in the effects of listening to music compared to no treatment or TAU on insomnia severity (MD −6.96, 95% CI −15.21 to 1.28; 2 studies, 63 participants; very low-certainty evidence). We found low-certainty evidence that, compared to no treatment or TAU, listening to music may reduce problems with sleep-onset latency (MD −0.60, 95% CI −0.83 to −0.37; 3 studies, 197 participants), total sleep time (MD −0.69, 95% CI −1.16 to −0.23; 3 studies, 197 participants) and sleep efficiency (MD −0.96, 95% CI −1.38 to −0.54; 3 studies, 197 participants), but may have no effect on perceived sleep interruption (MD −0.53, 95% CI −1.47 to 0.40; 3 studies, 197 participants). In addition, three studies (136 participants) included objective measures of sleep-onset latency, total sleep time, sleep efficiency and sleep interruption and showed that listening to music may not improve these outcomes compared to no treatment or TAU. None of the included studies reported any adverse events.\nAuthors' conclusions\nThe findings of this review provide evidence that music may be effective for improving subjective sleep quality in adults with symptoms of insomnia. More research is needed to establish the effect of listening to music on other aspects of sleep as well as the daytime consequences of insomnia.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence from the 10 studies that examined sleep quality was moderate. Our confidence in the evidence for the quality of sleep is only moderate because the people in the studies were aware of which treatment they were getting and the people scoring the data were also sometimes aware of which treatment the participants were getting, which could introduce bias. We have little confidence in the evidence for the severity of insomnia because the studies were very small and were done in different types of people who knew which treatment they were getting. Our confidence in the evidence on sleep-onset latency, sleep duration and sleep efficiency is low because the studies used very different methods to measure these outcomes, and the people in the studies were aware of the nature of the treatment. We have little confidence in the evidence on sleep interruption because the studies used different methods and showed different results. Furthermore, the participants in the studies knew which treatment they were getting.\nFuture studies should assess other aspects of sleep as well as measures of daytime functioning, such as mood, fatigue, concentration, and quality of life."
}
] |
query-laysum
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6803
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[
{
"role": "user",
"content": "Abstract: Background\nAcute pulmonary embolism (APE) is a major cause of acute morbidity and mortality. APE results in long-term morbidity in up to 50% of survivors, known as post-pulmonary embolism (post-PE) syndrome.\nAPE can be classified according to the short-term (30-day) risk of mortality, based on a variety of clinical, imaging and laboratory findings. Most mortality and morbidity is concentrated in high-risk (massive) and intermediate-risk (submassive) APE. The first-line treatment for APE is systemic anticoagulation.\nHigh-risk (massive) APE accounts for less than 10% of APE cases and is a life-threatening medical emergency, requiring immediate reperfusion treatment to prevent death. Systemic thrombolysis is the recommended treatment for high-risk (massive) APE. However, only a minority of the people affected receive systemic thrombolysis, due to comorbidities or the 10% risk of major haemorrhagic side effects. Of those who do receive systemic thrombolysis, 8% do not respond in a timely manner. Surgical pulmonary embolectomy is an alternative reperfusion treatment, but is not widely available.\nIntermediate-risk (submassive) APE represents 45% to 65% of APE cases, with a short-term mortality rate of around 3%. Systemic thrombolysis is not recommended for this group, as major haemorrhagic complications outweigh the benefit. However, the people at higher risk within this group have a short-term mortality of around 12%, suggesting that anticoagulation alone is not an adequate treatment. Identification and more aggressive treatment of people at intermediate to high risk, who have a more favourable risk profile for reperfusion treatments, could reduce short-term mortality and potentially reduce post-PE syndrome.\nCatheter-directed treatments (catheter-directed thrombolysis and catheter embolectomy) are minimally invasive reperfusion treatments for high- and intermediate-risk APE. Catheter-directed treatments can be used either as the primary treatment or as salvage treatment after failure of systemic thrombolysis. Catheter-directed thrombolysis administers 10% to 20% of the systemic thrombolysis dose directly into the thrombus in the lungs, potentially reducing the risks of haemorrhagic side effects. Catheter embolectomy mechanically removes the thrombus without the need for thrombolysis, and may be useful for people with contraindications for thrombolysis.\nCurrently, the benefits of catheter-based APE treatments compared with existing medical and surgical treatment are unclear despite increasing adoption of catheter treatments by PE response teams. This review examines the evidence for the use of catheter-directed treatments in high- and intermediate-risk APE. This evidence could help guide the optimal treatment strategy for people affected by this common and life-threatening condition.\nObjectives\nTo assess the effects of catheter-directed therapies versus alternative treatments for high-risk (massive) and intermediate-risk (submassive) APE.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was 15 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of catheter-directed therapies for the treatment of high-risk (massive) and intermediate-risk (submassive) APE. We excluded catheter-directed treatments for non-PE. We applied no restrictions on participant age or on the date, language or publication status of RCTs.\nData collection and analysis\nWe used standard Cochrane methods. The main outcomes were all-cause mortality, treatment-associated major and minor haemorrhage rates based on two established clinical definitions, recurrent APE requiring retreatment or change to a different APE treatment, length of hospital stay, and quality of life. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified one RCT (59 participants) of (ultrasound-augmented) catheter-directed thrombolysis for intermediate-risk (submassive) APE.\nWe found no trials of any catheter-directed treatments (thrombectomy or thrombolysis) in people with high-risk (massive) APE or of catheter-based embolectomy in people with intermediate-risk (submassive) APE.\nThe included trial compared ultrasound-augmented catheter-directed thrombolysis with alteplase and systemic heparinisation versus systemic heparinisation alone. In the treatment group, each participant received an infusion of alteplase 10 mg or 20 mg over 15 hours. We identified a high risk of selection and performance bias, low risk of detection and reporting bias, and unclear risk of attrition and other bias. Certainty of evidence was very low because of risk of bias and imprecision.\nBy 90 days, there was no clear difference in all-cause mortality between the treatment group and control group. A single death occurred in the control group at 20 days after randomisation, but it was unrelated to the treatment or to APE (odds ratio (OR) 0.31, 95% confidence interval (CI) 0.01 to 7.96; 59 participants).\nBy 90 days, there were no episodes of treatment-associated major haemorrhage in either the treatment or control group. There was no clear difference in treatment-associated minor haemorrhage between the treatment and control group by 90 days (OR 3.11, 95% CI 0.30 to 31.79; 59 participants).\nBy 90 days, there were no episodes of recurrent APE requiring retreatment or change to a different APE treatment in the treatment or control group.\nThere was no clear difference in the length of mean total hospital stay between the treatment and control groups. Mean stay was 8.9 (standard deviation (SD) 3.4) days in the treatment group versus 8.6 (SD 3.9) days in the control group (mean difference 0.30, 95% CI −1.57 to 2.17; 59 participants).\nThe included trial did not investigate quality of life measures.\nAuthors' conclusions\nThere is a lack of evidence to support widespread adoption of catheter-based interventional therapies for APE. We identified one small trial showing no clear differences between ultrasound-augmented catheter-directed thrombolysis with alteplase plus systemic heparinisation versus systemic heparinisation alone in all-cause mortality, major and minor haemorrhage rates, recurrent APE and length of hospital stay. Quality of life was not assessed.\nMultiple small retrospective case series, prospective patient registries and single-arm studies suggest potential benefits of catheter-based treatments, but they provide insufficient evidence to recommend this approach over other evidence-based treatments.\nResearchers should consider clinically relevant primary outcomes (e.g. mortality and exercise tolerance), rather than surrogate markers (e.g. right ventricular to left ventricular (RV:LV) ratio or thrombus burden), which have limited clinical utility. Trials must include a control group to determine if the effects are specific to the treatment.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We performed a detailed literature search for randomised controlled trials (RCTs) of catheter-based treatments of high-risk (massive) and intermediate-risk (submassive) APE. We chose RCTs because these provide the highest standard of evidence to inform treatment guidelines. We compared and summarised the results and rated our confidence in the evidence, based on factors such as trial methods and size."
}
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query-laysum
|
6804
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is a chronic lung condition characterised by persistent respiratory symptoms and limited lung airflow, dyspnoea and recurrent exacerbations. Suboptimal therapy or non-adherence may result in limited effectiveness of pharmacological treatments and subsequently poor health outcomes.\nObjectives\nTo determine the efficacy and safety of interventions intended to improve adherence to single or combined pharmacological treatments compared with usual care or interventions that are not intended to improve adherence in people with COPD.\nSearch methods\nWe identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register, CENTRAL, MEDLINE and Embase (search date 1 May 2020). We also searched web-based clinical trial registers.\nSelection criteria\nRCTs included adults with COPD diagnosed by established criteria (e.g. Global Initiative for Obstructive Lung Disease). Interventions included change to pharmacological treatment regimens, adherence aids, education, behavioural or psychological interventions (e.g. cognitive behavioural therapy), communication or follow-up by a health professional (e.g. telephone, text message or face-to-face), multi-component interventions, and interventions to improve inhaler technique.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Working in pairs, four review authors independently selected trials for inclusion, extracted data and assessed risk of bias. We assessed confidence in the evidence for each primary outcome using GRADE. Primary outcomes were adherence, quality of life and hospital service utilisation. Adherence measures included the Adherence among Patients with Chronic Disease questionnaire (APCD). Quality of life measures included the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ).\nMain results\nWe included 14 trials (2191 participants) in the analysis with follow-up ranging from six to 52 weeks. Age ranged from 54 to 75 years, and COPD severity ranged from mild to very severe. Trials were conducted in the USA, Spain, Germany, Japan, Jordan, Northern Ireland, Iran, South Korea, China and Belgium. Risk of bias was high due to lack of blinding. Evidence certainty was downgraded due to imprecision and small participant numbers.\nSingle component interventions\nSix studies (55 to 212 participants) reported single component interventions including changes to pharmacological treatment (different roflumilast doses or different inhaler types), adherence aids (Bluetooth inhaler reminder device), educational (comprehensive verbal instruction), behavioural or psychological (motivational interview).\nChange in dose of roflumilast may result in little to no difference in adherence (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.22 to 1.99; studies = 1, participants = 55; low certainty). A Bluetooth inhaler reminder device did not improve adherence, but comprehensive verbal instruction from a health professional did improve mean adherence (prescription refills) (mean difference (MD) 1.00, 95% CI 0.46 to 1.54). Motivational interview improved mean adherence scores on the APCD scale (MD 22.22, 95% CI 8.42 to 36.02).\nUse of a single inhaler compared to two separate inhalers may have little to no impact on quality of life (SGRQ; MD 0.80, 95% CI –3.12 to 4.72; very low certainty). A Bluetooth inhaler monitoring device may provide a small improvement in quality of life on the CCQ (MD 0.40, 95% CI 0.07 to 0.73; very low certainty).\nSingle inhaler use may have little to no impact on the number of people admitted to hospital compared to two separate inhalers (OR 1.47, 95% CI 0.75 to 2.90; very low certainty). Single component interventions may have little to no impact on the number of people expereincing adverse events (very low certainty evidence from studies of a change in pharmacotherapy or use of adherence aids). A change in pharmacotherapy may have little to no impact on exacerbations or deaths (very low certainty).\nMulti-component interventions\nEight studies (30 to 734 participants) reported multi-component interventions including tailored care package that included adherence support as a key component or included inhaler technique as a component.\nA multi-component intervention may result in more people adhering to pharmacotherapy compared to control at 40.5 weeks (risk ratio (RR) 1.37, 95% CI 1.18 to 1.59; studies = 4, participants = 446; I2 = 0%; low certainty).\nThere may be little to no impact on quality of life (SGRQ, Chronic Respiratory Disease Questionnaire, CAT) (studies = 3; low to very low certainty).\nMulti-component interventions may help to reduce the number of people admitted to hospital for any cause (OR 0.37, 95% CI 0.22 to 0.63; studies = 2, participants = 877; low certainty), or COPD-related hospitalisations (OR 0.15, 95% CI 0.07 to 0.34; studies = 2, participants = 220; moderate certainty). There may be a small benefit on people experiencing severe exacerbations.\nThere may be little to no effect on adverse events, serious adverse events or deaths, but events were infrequently reported and were rare (low to very low certainty).\nAuthors' conclusions\nSingle component interventions (e.g. education or motivational interviewing provided by a health professional) can help to improve adherence to pharmacotherapy (low to very low certainty). There were slight improvements in quality of life with a Bluetooth inhaler device, but evidence is from one study and very low certainty. Change to pharmacotherapy (e.g. single inhaler instead of two, or different doses of roflumilast) has little impact on hospitalisations or exacerbations (very low certainty). There is no difference in people experiencing adverse events (all-cause or COPD-related), or deaths (very low certainty).\nMulti-component interventions may improve adherence with education, motivational or behavioural components delivered by health professionals (low certainty). There is little to no impact on quality of life (low to very low certainty). They may help reduce the number of people admitted to hospital overall (specifically pharmacist-led approaches) (low certainty), and fewer people may have COPD-related hospital admissions (moderately certainty). There may be a small reduction in people experiencing severe exacerbations, but evidence is from one study (low certainty). Limited evidence found no difference in people experiencing adverse events, serious adverse events or deaths (low to very low certainty).\nThe evidence presented should be interpreted with caution. Larger studies with more intervention types, especially single interventions, are needed. It is unclear which specific COPD subgroups would benefit, therefore discussions between health professionals and patients may help to determine whether they will help to improve health outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included studies comparing simple ways to help improve medication use (e.g. different medication doses or single inhalers instead of two separate inhalers) to usual COPD care. We also included studies that tested combination approaches (e.g. information or training from nurses or pharmacists and monitoring medication use)."
}
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query-laysum
|
6805
|
[
{
"role": "user",
"content": "Abstract: Background\nAcne is an inflammatory disorder with a high global burden. It is common in adolescents and primarily affects sebaceous gland-rich areas. The clinical benefit of the topical acne treatments azelaic acid, salicylic acid, nicotinamide, sulphur, zinc, and alpha-hydroxy acid is unclear.\nObjectives\nTo assess the effects of topical treatments (azelaic acid, salicylic acid, nicotinamide, zinc, alpha-hydroxy acid, and sulphur) for acne.\nSearch methods\nWe searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers.\nSelection criteria\nClinical randomised controlled trials of the six topical treatments compared with other topical treatments, placebo, or no treatment in people with acne.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Key outcomes included participants' global self-assessment of acne improvement (PGA), withdrawal for any reason, minor adverse events (assessed as total number of participants who experienced at least one minor adverse event), and quality of life.\nMain results\nWe included 49 trials (3880 reported participants) set in clinics, hospitals, research centres, and university settings in Europe, Asia, and the USA.\nThe vast majority of participants had mild to moderate acne, were aged between 12 to 30 years (range: 10 to 45 years), and were female. Treatment lasted over eight weeks in 59% of the studies. Study duration ranged from three months to three years.\nWe assessed 26 studies as being at high risk of bias in at least one domain, but most domains were at low or unclear risk of bias.\nWe grouped outcome assessment into short-term (less than or equal to 4 weeks), medium-term (from 5 to 8 weeks), and long-term treatment (more than 8 weeks). The following results were measured at the end of treatment, which was mainly long-term for the PGA outcome and mixed length (medium-term mainly) for minor adverse events.\nAzelaic acid\nIn terms of treatment response (PGA), azelaic acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.95; 1 study, 351 participants), but there is probably little or no difference when comparing azelaic acid to tretinoin (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 289 participants) (both moderate-quality evidence). There may be little or no difference in PGA when comparing azelaic acid to clindamycin (RR 1.13, 95% CI 0.92 to 1.38; 1 study, 229 participants; low-quality evidence), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence).\nLow-quality evidence indicates there may be no differences in rates of withdrawal for any reason when comparing azelaic acid with benzoyl peroxide (RR 0.88, 95% CI 0.60 to 1.29; 1 study, 351 participants), clindamycin (RR 1.30, 95% CI 0.48 to 3.56; 2 studies, 329 participants), or tretinoin (RR 0.66, 95% CI 0.29 to 1.47; 2 studies, 309 participants), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence).\nIn terms of total minor adverse events, we are uncertain if there is a difference between azelaic acid compared to adapalene (1 study; 55 participants) or benzoyl peroxide (1 study, 30 participants) (both very low-quality evidence). There may be no difference when comparing azelaic acid to clindamycin (RR 1.50, 95% CI 0.67 to 3.35; 1 study, 100 participants; low-quality evidence). Total minor adverse events were not reported in the comparison of azelaic acid versus tretinoin, but individual application site reactions were reported, such as scaling.\nSalicylic acid\nFor PGA, there may be little or no difference between salicylic acid and tretinoin (RR 1.00, 95% CI 0.92 to 1.09; 1 study, 46 participants; low-quality evidence); we are not certain whether there is a difference between salicylic acid and pyruvic acid (1 study, 86 participants; very low-quality evidence); and PGA was not measured in the comparison of salicylic acid versus benzoyl peroxide.\nThere may be no difference between groups in withdrawals when comparing salicylic acid and pyruvic acid (RR 0.89, 95% CI 0.53 to 1.50; 1 study, 86 participants); when salicylic acid was compared to tretinoin, neither group had withdrawals (both based on low-quality evidence (2 studies, 74 participants)). We are uncertain whether there is a difference in withdrawals between salicylic acid and benzoyl peroxide (1 study, 41 participants; very low-quality evidence).\nFor total minor adverse events, we are uncertain if there is any difference between salicylic acid and benzoyl peroxide (1 study, 41 participants) or tretinoin (2 studies, 74 participants) (both very low-quality evidence). This outcome was not reported for salicylic acid versus pyruvic acid, but individual application site reactions were reported, such as scaling and redness.\nNicotinamide\nFour studies evaluated nicotinamide against clindamycin or erythromycin, but none measured PGA. Low-quality evidence showed there may be no difference in withdrawals between nicotinamide and clindamycin (RR 1.12, 95% CI 0.49 to 2.60; 3 studies, 216 participants) or erythromycin (RR 1.40, 95% CI 0.46 to 4.22; 1 study, 158 participants), or in total minor adverse events between nicotinamide and clindamycin (RR 1.20, 95% CI 0.73 to 1.99; 3 studies, 216 participants; low-quality evidence). Total minor adverse events were not reported in the nicotinamide versus erythromycin comparison.\nAlpha-hydroxy (fruit) acid\nThere may be no difference in PGA when comparing glycolic acid peel to salicylic-mandelic acid peel (RR 1.06, 95% CI 0.88 to 1.26; 1 study, 40 participants; low-quality evidence), and we are uncertain if there is a difference in total minor adverse events due to very low-quality evidence (1 study, 44 participants). Neither group had withdrawals (2 studies, 84 participants; low-quality evidence).\nAuthors' conclusions\nCompared to benzoyl peroxide, azelaic acid probably leads to a worse treatment response, measured using PGA. When compared to tretinoin, azelaic acid probably makes little or no difference to treatment response. For other comparisons and outcomes the quality of evidence was low or very low.\nRisk of bias and imprecision limit our confidence in the evidence. We encourage the comparison of more methodologically robust head-to-head trials against commonly used active drugs.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acne vulgaris ('acne') is a costly and common skin disorder in which hair follicles become blocked. Acne affects up to 85% of adolescents and young adults. Topical retinoids (treatment derived from vitamin A) and antimicrobials (treatment that kills micro-organisms such as bacteria) are common treatments. Other topical medications are also used, but there are concerns about their efficacy and safety."
}
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query-laysum
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6806
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[
{
"role": "user",
"content": "Abstract: Background\nTransurethral resection of the prostate (TURP) has been the gold-standard treatment for alleviating urinary symptoms and improving urinary flow in men with symptomatic benign prostatic hyperplasia (BPH). However, the morbidity of TURP approaches 20%, and less invasive techniques have been developed for treating BPH. Transurethral microwave thermotherapy (TUMT) is an alternative, minimally-invasive treatment that delivers microwave energy to produce coagulation necrosis in prostatic tissue. This is an update of a review last published in 2012.\nObjectives\nTo assess the effects of transurethral microwave thermotherapy for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.\nSearch methods\nWe performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 31 May 2021, with no restrictions by language or publication status.\nSelection criteria\nWe included parallel-group randomized controlled trials (RCTs) and cluster-RCTs of participants with BPH who underwent TUMT.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias and GRADE assessments of the certainty of the evidence (CoE). We considered review outcomes measured up to 12 months after randomization as short-term and beyond 12 months as long-term. Our main outcomes included: urologic symptoms scores, quality of life, major adverse events, retreatment, and ejaculatory and erectile function.\nMain results\nIn this update, we identified no new RCTs, but we included data from studies excluded in the previous version of this review. We included 16 trials with 1919 participants, with a median age of 69 and moderate lower urinary tract symptoms. The certainty of the evidence for most comparisons was moderate-to-low, due to an overall high risk of bias across studies and imprecision (few participants and events).\nTUMT versus TURP\nBased on data from four studies with 306 participants, when compared to TURP, TUMT probably results in little to no difference in urologic symptom scores measured by the International Prostatic Symptom Score (IPSS) on a scale from 0 to 35, with higher scores indicating worse symptoms at short-term follow-up (mean difference (MD) 1.00, 95% confidence interval (CI) −0.03 to 2.03; moderate certainty). There is likely to be little to no difference in the quality of life (MD −0.10, 95% CI −0.67 to 0.47; 1 study, 136 participants, moderate certainty). TUMT likely results in fewer major adverse events (RR 0.20, 95% CI 0.09 to 0.43; 6 studies, 525 participants, moderate certainty); based on 168 cases per 1000 men in the TURP group, this corresponds to 135 fewer (153 to 96 fewer) per 1000 men in the TUMT group. TUMT, however, probably results in a large increase in the need for retreatment (risk ratio (RR) 7.07, 95% CI 1.94 to 25.82; 5 studies, 337 participants, moderate certainty) (usually by repeated TUMT or TURP); based on zero cases per 1000 men in the TURP group, this corresponds to 90 more (40 to 150 more) per 1000 men in the TUMT group. There may be little to no difference in erectile function between these interventions (RR 0.63, 95% CI 0.24 to 1.63; 5 studies, 337 participants; low certainty). However, TUMT may result in fewer cases of ejaculatory dysfunction compared to TURP (RR 0.36, 95% CI 0.24 to 0.53; 4 studies, 241 participants; low certainty).\nTUMT versus sham\nBased on data from four studies with 483 participants we found that, when compared to sham, TUMT probably reduces urologic symptom scores using the IPSS at short-term follow-up (MD −5.40, 95% CI −6.97 to −3.84; moderate certainty). TUMT may cause little to no difference in the quality of life (MD −0.95, 95% CI −1.14 to −0.77; 2 studies, 347 participants; low certainty) as measured by the IPSS quality-of-life question on a scale from 0 to 6, with higher scores indicating a worse quality of life. We are very uncertain about the effects on major adverse events, since most studies reported no events or isolated lesions of the urinary tract. TUMT may also reduce the need for retreatment compared to sham (RR 0.27, 95% CI 0.08 to 0.88; 2 studies, 82 participants, low certainty); based on 194 retreatments per 1000 men in the sham group, this corresponds to 141 fewer (178 to 23 fewer) per 1000 men in the TUMT group. We are very uncertain of the effects on erectile and ejaculatory function (very low certainty), since we found isolated reports of impotence and ejaculatory disorders (anejaculation and hematospermia).\nThere were no data available for the comparisons of TUMT versus convective radiofrequency water vapor therapy, prostatic urethral lift, prostatic arterial embolization or temporary implantable nitinol device.\nAuthors' conclusions\nTUMT provides a similar reduction in urinary symptoms compared to the standard treatment (TURP), with fewer major adverse events and fewer cases of ejaculatory dysfunction at short-term follow-up. However, TUMT probably results in a large increase in retreatment rates. Study limitations and imprecision reduced the confidence we can place in these results. Furthermore, most studies were performed over 20 years ago. Given the emergence of newer minimally-invasive treatments, high-quality head-to-head trials with longer follow-up are needed to clarify their relative effectiveness. Patients' values and preferences, their comorbidities and the effects of other available minimally-invasive procedures, among other factors, can guide clinicians when choosing the optimal treatment for this condition.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Does transurethral microwave thermotherapy (TUMT) improve bothersome urinary symptoms without unwanted side effects in men with an enlarged prostate?"
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query-laysum
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6807
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[
{
"role": "user",
"content": "Abstract: Background\nProton pump inhibitors (PPIs) are the most effective drugs to reduce gastric acid secretion. PPIs are one of the most commonly prescribed classes of medications worldwide. Apart from short-term application, maintenance therapy with PPIs is recommended and increasingly used in certain diseases, such as Zollinger-Ellison syndrome and gastro-oesophageal reflux disease, especially for people with erosive oesophagitis or Barrett's oesophagus. Although PPIs are generally safe, their efficacy and safety of long-term use remains unclear. The question of whether the long-term use of PPIs could promote the development of gastric pre-malignant lesions has been widely investigated, but results are inconsistent. Limited insight on this problem leads to a dilemma in decision making for long-term PPI prescription.\nObjectives\nTo compare the development or progression of gastric pre-malignant lesions, such as atrophic gastritis, intestinal metaplasia, enterochromaffin-like (ECL) cell hyperplasia, and dysplasia, in people taking long-term (six months or greater) PPI maintenance therapy.\nSearch methods\nWe searched the following databases (from inception to 6 August 2013): the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL. In addition, we searched the reference lists of included trials and contacted experts in the field.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) in adults (aged 18 years or greater) concerning the effects of long-term (six months or greater) PPI use on gastric mucosa changes, confirmed by endoscopy or biopsy sampling (or both).\nData collection and analysis\nTwo review authors independently performed selection of eligible trials, assessment of trial quality, and data extraction. We calculated odds ratios (OR) for analysis of dichotomous data and mean differences for continuous data, with 95% confidence intervals (CI).\nMain results\nWe included seven trials (1789 participants). Four studies had high risk of bias and the risk of bias in the other three trials was unclear. In addition, it was difficult to assess possible reporting bias. We pooled 1070 participants from four RCTs to evaluate corporal atrophy development revealing an insignificantly increased OR of 1.50 (95% CI 0.59 to 3.80; P value = 0.39; low-quality evidence) for long-term PPI users relative to non-PPI users. In five eligible trials, corporal intestinal metaplasia was assessed among 1408 participants, also with uncertain results (OR 1.46; 95% CI 0.43 to 5.03; P value = 0.55; low-quality evidence). However, by pooling data of 1705 participants from six RCTs, our meta-analysis showed that participants with PPI maintenance treatment were more likely to experience either diffuse (simple) (OR 5.01; 95% CI 1.54 to 16.26; P value = 0.007; very-low-quality evidence) or linear/micronodular (focal) ECL hyperplasia (OR 3.98; 95% CI 1.31 to 12.16; P value = 0.02; low-quality evidence) than controls. No participant showed any dysplastic or neoplastic change in any included studies.\nAuthors' conclusions\nThere is presently no clear evidence that the long-term use of PPIs can cause or accelerate the progression of corpus gastric atrophy or intestinal metaplasia, although results were imprecise. People with PPI maintenance treatment may have a higher possibility of experiencing either diffuse (simple) or linear/micronodular (focal) ECL cell hyperplasia. However, the clinical importance of this outcome is currently uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Currently, available evidence was of low or very low quality, due to their study design and the large proportion of missing data. We therefore suggest future well-designed clinical trials should be performed for providing better understandings regarding this question."
}
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query-laysum
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6808
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[
{
"role": "user",
"content": "Abstract: Background\nKidney transplantation is the therapy of choice for many patients with end-stage kidney disease (ESKD) with an improvement in survival rates and satisfactory short term graft survival. However, there has been little improvement in long-term survival. The place of target of rapamycin inhibitors (TOR-I) (sirolimus, everolimus), which have different modes of action from other commonly used immunosuppressive agents, in kidney transplantation remains uncertain. This is an update of a review first published in 2006.\nObjectives\nTo evaluate the short and long-term benefits and harms of TOR-I (sirolimus and everolimus) when used in primary immunosuppressive regimens for kidney transplant recipients.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 20 September 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs in which drug regimens, containing TOR-I commenced within seven days of transplant, were compared to alternative drug regimens, were included without age restriction, dosage or language of report.\nData collection and analysis\nThree authors independently assessed study eligibility, risk of bias, and extracted data. Results were reported as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) with 95% CI for continuous outcomes. Statistical analyses were performed using the random-effects model. The certainty of the evidence was assessed using GRADE\nMain results\nSeventy studies (17,462 randomised participants) were included; eight studies included two comparisons to provide 78 comparisons. Outcomes were reported at six months to three years post transplant.\nRisk of bias was judged to be low for sequence generation in 25 studies, for allocation concealment in 23 studies, performance bias in four studies, detection bias in 65 studies, attrition bias in 45 studies, selective reporting bias in 48 studies, and for other potential bias in three studies. Risk of bias was judged to be at high risk of bias for sequence generation in two studies, allocation concealment in two studies, performance bias in 61 studies, detection bias in one study, attrition bias in four studies, for selective reporting bias in 11 studies and for other potential risk of bias in 46 studies.\nCompared with CNI and antimetabolite, TOR-I with antimetabolite probably makes little or no difference to death (RR 1.31, 95% CI 0.87 to 1.98; 19 studies) or malignancies (RR 0.86, 95% CI 0.50 to 1.48; 10 studies); probably increases graft loss censored for death (RR 1.32, 95% CI 0.96 to 1.81; 15 studies), biopsy-proven acute rejection (RR 1.60, 95% CI 1.25 to 2.04; 15 studies), need to change treatment (RR 2.42, 95% CI 1.88 to 3.11; 14 studies) and wound complications (RR 2.56, 95% CI 1.94 to 3.36; 12 studies) (moderate certainty evidence); but reduces CMV infection (RR 0.43, 95% CI 0.29 to 0.63; 13 studies) (high certainty evidence).\nCompared with antimetabolites and CNI, TOR-I with CNI probably makes little or no difference to death (RR 1.06, 95% CI 0.84 to 1.33; 31 studies), graft loss censored for death (RR 1.09, 95% CI 0.82 to 1.45; 26 studies), biopsy-proven acute rejection (RR 0.95, 95% CI 0.81 to 1.12; 24 studies); and malignancies (RR 0.83, 95% CI 0.64 to 1.07; 17 studies); probably increases the need to change treatment (RR 1.56, 95% CI 1.28 to 1.90; 25 studies), and wound complications (RR 1.56, 95% CI 1.28 to 1.91; 17 studies); but probably reduces CMV infection (RR 0.44, 95% CI 0.34 to 0.58; 25 studies) (moderate certainty evidence).\nLower dose TOR-I and standard dose CNI compared with higher dose TOR-I and reduced dose CNI probably makes little or no difference to death (RR 1.07, 95% CI 0.64 to 1.78; 9 studies), graft loss censored for death (RR 1.09, 95% CI 0.54 to 2.20; 8 studies), biopsy-proven acute rejection (RR 0.87, 95% CI 0.67 to 1.13; 8 studies), and CMV infection (RR 1.42, 95% CI 0.78 to 2.60; 5 studies) (moderate certainty evidence); and may make little or no difference to wound complications (RR 0.95, 95% CI 0.53 to 1.71; 3 studies), malignancies (RR 1.04, 95% CI 0.36 to 3.04; 7 studies), and the need to change treatments (RR 1.18, 95% CI 0.58 to 2.42; 5 studies) (low certainty evidence).\nLower dose of TOR-I compared with higher doses probably makes little or no difference to death (RR 0.84, 95% CI 0.67 to 1.06; 13 studies), graft loss censored for death (RR 0.92, 95% CI 0.71 to 1.19; 12 studies), biopsy-proven acute rejection (RR 1.26, 95% CI 1.10 to 1.43; 11 studies), CMV infection (RR 0.87, 95% CI 0.63 to 1.21; 9 studies), wound complications (RR 0.92, 95% CI 0.66 to 1.29; 7 studies), and malignancy (RR 0.84, 95% CI 0.54 to 1.32; 10 studies) (moderate certainty evidence); and may make little or no difference to the need to change treatments (RR 0.91, 95% CI 0.78 to 1.05; 10 studies) (low certainty evidence).\nIt is uncertain whether sirolimus and everolimus differ in their effects on kidney function and lipid levels because the certainty of the evidence is very low based on a single small study with only three months of follow-up.\nAuthors' conclusions\nIn studies with follow-up to three years, TOR-I with an antimetabolite increases the risk of graft loss and acute rejection compared with CNI and an antimetabolite. TOR-I with CNI potentially offers an alternative to an antimetabolite with CNI as rates of graft loss and acute rejection are similar between interventions and TOR-I regimens are associated with a reduced risk of CMV infections. Wound complications and the need to change immunosuppressive medications are higher with TOR-I regimens. While further new studies are not required, longer-term follow-up data from participants in existing methodologically robust RCTs are needed to determine how useful immunosuppressive regimens, which include TOR-I, are in maintaining kidney transplant function and survival beyond three years.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Kidney transplantation is the treatment of choice for many patients with end-stage kidney disease. However, some kidney transplants do not work for long periods so it is important to find ways to improve long-term transplant function by choosing the best therapies to maintain kidney function and keep transplant recipients healthy with minimal side effects."
}
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query-laysum
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6809
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[
{
"role": "user",
"content": "Abstract: Background\nThe sudden loss of blood supply in ischemic stroke is associated with an increase of calcium ions within neurons. Inhibiting this increase could protect neurons and might reduce neurological impairment, disability, and handicap after stroke.\nObjectives\nTo assess the effects of calcium antagonists for reducing the risk of death or dependency after acute ischemic stroke. We investigated the influence of different drugs, dosages, routes of administration, time intervals after stroke, and trial design on the outcomes.\nSearch methods\nThe evidence is current to 6 February 2018. We searched the Cochrane Stroke Group Trials Register (6 February 2018), Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 2), MEDLINE Ovid (1950 to 6 February 2018), Embase Ovid (1980 to 6 February 2018), and four Chinese databases (6 February 2018): Chinese Biological Medicine Database (CBM-disc), China National Knowledge Infrastructure (CNKI), Chinese Scientific Periodical Database of VIP information, and Wanfang Data. We also searched the following trials registers: ClinicalTrials.gov, EU Clinical Trials Register, Stroke Trials Registry, ISRCTN registry, WHO International Clinical Trials Registry Platform, and Chinese Clinical Trial Registry, and we contacted trialists and researchers.\nSelection criteria\nRandomized controlled trials comparing a calcium antagonist versus control in people with acute ischemic stroke.\nData collection and analysis\nTwo review authors independently selected trials, extracted data, assessed risk of bias, and applied the GRADE approach to assess the quality of the evidence. We used death or dependency at the end of long-term follow-up (at least three months) in activities of daily living as the primary outcome. We used standard Cochrane methodological procedures.\nMain results\nWe included 34 trials involving 7731 participants. All the participants were in the acute stage of ischemic stroke, and their age ranged from 18 to 85 years, with the average age ranging from 52.3 to 74.6 years across different trials. There were more men than women in most trials. Twenty-six trials tested nimodipine, and three trials assessed flunarizine. One trial each used isradipine, nicardipine, PY108-608, fasudil, and lifarizine. More than half of these trials followed participants for at least three months. Calcium antagonists showed no effects on the primary outcome (risk ratio (RR) 1.05; 95% confidence interval (CI) 0.98 to 1.13; 22 trials; 22 studies; 6684 participants; moderate-quality evidence) or on death at the end of follow-up (RR 1.07, 95% CI 0.98 to 1.17; 31 trials; 7483 participants; moderate-quality evidence). Thirteen trials reported adverse events, finding no significant differences between groups. Most trials did not report the allocation process or how they managed missing data, so we considered these at high risk of selection and attrition bias. Most trials reported double-blind methods but did not state who was blinded, and none of the trial protocols were available.\nAuthors' conclusions\nWe found no evidence to support the use of calcium antagonists in people with acute ischemic stroke.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "BackgroundMost strokes are due to reduced blood flow with obstruction of large and small arteries. As a result, calcium ions flood into the brain cells and contribute to brain cell death. Calcium antagonists may reduce the damage by preventing the influx of calcium ions. In the past 20 years, there have been many clinical trials focusing on various calcium antagonists for acute ischemic stroke. We reviewed the evidence about the effects of these medicines compared with placebo or control in people with acute ischemic stroke.Study characteristicsWe identified 34 studies to February 6, 2018 that met our inclusion criteria; they involved 7731 participants and investigated different kinds of drugs. Twenty-six trials tested nimodipine, and three trials assessed flunarizine. One trial each used isradipine, nicardipine, PY108-608, fasudil, and lifarizine.Key resultsThere was no difference in deaths or dependency between participants who received calcium antagonists or not.Quality of the evidenceThere is no evidence that calcium antagonists after acute ischemic stroke could save lives or reduce disability. The evidence was moderately reliable, which means that further research is unlikely to change our conclusions."
}
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query-laysum
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6810
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[
{
"role": "user",
"content": "Abstract: Background\nCataract surgery is the most common incisional surgical procedure in ophthalmology and is important in ophthalmic graduate medical education. Although most ophthalmology training programs in the United States (US) include virtual reality (VR) training for cataract surgery, comprehensive reviews that detail the impact of VR training on ophthalmology trainee performance are lacking.\nObjectives\nTo assess the impact of VR training for cataract surgery on the operating performance of postgraduate ophthalmology trainees, measured by operating time, intraoperative complications, postoperative complications, supervising physician ratings, and VR simulator task ratings.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), Ovid MEDLINE, Embase.com, PubMed, LILACS, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 14 June 2021.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing VR training to any other method of training, including non-VR simulation training (e.g., wet laboratory training), didactics training, or no supplementary training in postgraduate ophthalmology trainees.\nData collection and analysis\nWe used standard Cochrane methodology. Primary outcomes were operating times in the operating room and intraoperative complications. Secondary outcomes were operating times in simulated settings, simulator task ratings, and supervising physician ratings, either in the operating room or simulated settings.\nMain results\nWe included six RCTs with a total of 151 postgraduate ophthalmology trainees ranging from 12 to 60 participants in each study. The included studies varied widely in terms of geography: two in the US, and one study each in China, Germany, India, and Morocco. Three studies compared VR training for phacoemulsification cataract surgery on the Eyesi simulator (VRmagic, Mannheim, Germany) with wet laboratory training and two studies compared VR training with no supplementary training. One study compared trainees who received VR training with those who received conventional training for manual small incision cataract surgery on the HelpMeSee simulator (HelpMeSee, New York, NY). Industry financially supported two studies. All studies had at least three domains judged at high or unclear risks of bias. We did not conduct a meta-analysis due to insufficient data (i.e., lack of precision measurements, or studies reported only P values). All evidence was very low-certainty, meaning that any estimates were unreliable.\nThe evidence for the benefits of VR training for trainees was very uncertain for primary outcomes. VR-trained trainees relative to those without supplementary training had shorter operating times (mean difference [MD] −17 minutes, 95% confidence interval [CI] −21.62 to −12.38; 1 study, n = 12; very low-certainty evidence). Results for operating time were inconsistent when comparing VR and wet laboratory training: one study found that VR relative to wet laboratory training was associated with longer operating times (P = 0.038); the other reported that two training groups had similar operating times (P = 0.14). One study reported that VR-trained trainees relative to those without supplementary training had fewer intraoperative complications (P < 0.001); in another study, VR and conventionally trained trainees had similar intraoperative complication rates (MD −8.31, 95% CI −22.78 to 6.16; 1 study, n = 19; very low-certainty evidence).\nFor secondary outcomes, VR training may have similar impact on trainee performance compared to wet laboratory and greater impact compared to no supplementary training, but the evidence was very uncertain. One study reported VR-trained trainees relative to those without supplementary training had significantly reduced operating time in simulated settings (P = 0.0013). Another study reported that VR-trained relative to wet laboratory-trained trainees had shorter operating times in VR settings (MD −1.40 minutes, 95% CI −1.96 to −0.84; 1 study, n = 60) and similar times in wet laboratory settings (MD 0.16 minutes, 95% CI −0.50 to 0.82; 1 study, n = 60). This study also found the VR-trained trainees had higher VR simulator ratings (MD 5.17, 95% CI 0.61 to 9.73; 1 study, n = 60). Results for supervising physician ratings in the operating room were inconsistent: one study reported that VR- and wet laboratory-trained trainees received similar supervising physician ratings for cataract surgery (P = 0.608); another study reported that VR-trained trainees relative to those without supplementary training were less likely to receive poor ratings by supervising physicians for capsulorhexis construction (RR 0.29, 95% CI 0.15 to 0.57). In wet laboratory settings, VR-trained trainees received similar supervising physician ratings compared with wet laboratory-trained trainees (MD −1.50, 95% CI −6.77 to 3.77; n = 60) and higher supervising physician ratings compared with trainees without supplementary training (P < 0.0001). However, the results for all secondary outcomes should be interpreted with caution because of very low-certainty evidence.\nAuthors' conclusions\nCurrent research suggests that VR training may be more effective than no supplementary training in improving trainee performance in the operating room and simulated settings for postgraduate ophthalmology trainees, but the evidence is uncertain. The evidence comparing VR with conventional or wet laboratory training was less consistent.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current up to 14 June 2021."
}
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query-laysum
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6811
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[
{
"role": "user",
"content": "Abstract: Background\nAlmost 358,000 women die each year in childbirth, mainly in low-income countries. More than half of all maternal deaths occur within 24 hours of giving birth; severe bleeding in the postpartum period is the single most important cause. Depending on the rate of blood loss and other factors, such as pre-existing anaemia, untreated postpartum haemorrhage (PPH) can lead to hypovolaemic shock, multi-organ dysfunction, and maternal death, within two to six hours.\nThis review investigated different methods for estimating blood loss. The most common method of measuring blood loss during the third stage of labour is visual estimation, during which the birth attendant makes a quantitative or semi-quantitative estimate of the amount of blood lost. In direct blood collection, all blood lost during the third stage of labour (except for the placenta and membranes) is contained in a disposable, funnelled, plastic collector bag, which is attached to a plastic sheet, and placed under the woman's buttocks. When the bleeding stops, there are two options: the bag can be weighed (also called gravimetric technique), or the bag can be calibrated, allowing for a direct measurement. A more precise measurement of blood loss is haemoglobin concentration (Hb) in venous blood sampling and spectrophotometry. With the dye dilution technique, a known quantity of dye is injected into the vein and its plasmatic concentration is monitored after the uterus stops bleeding. Using nuclear medicine, a radioactive tracer is injected, and its concentration is monitored after the uterus stops bleeding. Although hypothetically, these advanced methods could provide a better quantification of blood loss, they are difficult to perform and are not accessible in most settings.\nObjectives\nTo evaluate the effect of alternative methods to estimate blood loss during the third stage of labour, to help healthcare providers reduce the adverse consequences of postpartum haemorrhage after vaginal birth.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (2 February 2018), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP; 21 March 2018), and reference lists of retrieved studies.\nSelection criteria\nAll randomised trials, including cluster-randomised trials, evaluating methods for estimating blood loss after vaginal birth.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy.\nMain results\nThe search retrieved 62 reports in total. Of these, we assessed 12 reports in full, corresponding to six trials. We included three trials and excluded one; two trials are ongoing.\nThe included trials were conducted in hospital settings. Two trials were conducted in India; the third trial was a large cluster-randomised trial, which took place in 13 European countries. Overall, we judged the included trials to be at a low risk of bias. One study evaluated the use of calibrated drapes versus visual estimation, another evaluated the use of calibrated drapes versus the gravimetric technique (weight of blood-soaked materials), therefore, we were unable to pool the data from the two studies. The third study did not measure any of the outcomes of interest, so did not contribute data to the analyses.\nDirect measurement using calibrated drapes versus visual estimation\nOne cluster-randomised controlled trial in 13 western European countries, with over 25,000 women, examined this comparison.\nThe trial did not report on postpartum anaemia (defined as Hb lower than 9 mg/dL), blood loss greater than 500 mL, or maternal infection.\nModerate-quality evidence suggests there is probably little or no difference between groups in: severe morbidity (coagulopathy, organ failure, intensive care unit admission; adjusted risk ratio (RR) 0.82, 95% confidence interval (CI) 0.48 to 1.39); the risk of blood transfusion (adjusted RR 0.82, 95% CI 0.46 to 1.46); the use of plasma expanders (adjusted RR 0.77, 95% CI 0.42 to 1.42); and the use of therapeutic uterotonics (adjusted RR 0.87, 95% CI 0.42 to 1.76).\nDirect measurement using calibrated drapes (Excellent BRASSS-V Drape™) versus gravimetric technique\nOne randomised controlled trial in India, with 900 women, examined this comparison.\nThe trial did not report on postpartum anaemia (defined as Hb lower than 9 mg/dL), severe morbidity, or maternal infection.\nHigh-quality evidence showed that using calibrated drapes improved the detection of blood loss greater than 500 mL when compared with the gravimetric technique (RR 1.86, 95% CI 1.11 to 3.11). Low-quality evidence suggests there may be little or no difference in the risk of blood transfusion between the two groups (RR 1.00, 95% CI 0.06 to 15.94), or in the use of plasma expanders, reported as intravenous fluids given for PPH treatment (RR 0.67; 95% CI 0.19 to 2.35). High-quality evidence showed little or no difference in the use of therapeutic uterotonics (RR 1.01, 95% CI 0.90 to 1.13), but the use of therapeutic uterotonics was extremely high in both arms of the study (57% and 56%).\nAuthors' conclusions\nOverall, the evidence in this review is insufficient to support the use of one method over another for blood loss estimation after vaginal birth. In general, the quality of evidence for our predefined outcomes ranged from low to high quality, with downgrading decisions due to imprecision. The included trials did not report on many of our primary and secondary outcomes.\nIn trials that evaluate methods for estimating blood loss during vaginal birth, we believe it is important to measure their impact on clinical maternal and neonatal outcomes, along with their diagnostic accuracy. This body of knowledge needs further, well designed, appropriately powered, randomised controlled trials that correlate blood loss with relevant clinical outcomes, such as those listed in this review.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "While postpartum haemorrhage (PPH) is one of the leading causes of maternal death worldwide, it mostly occurs in low-income countries. It frequently occurs during the third stage of labour, the period of time from delivery of the baby to the expulsion of the placenta and membranes. During this period, the birth attendant evaluates how much blood the mother has lost."
}
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query-laysum
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6812
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[
{
"role": "user",
"content": "Abstract: Background\nPsoriasis is a chronic skin disease that affects approximately two per cent of the general population. Plaque psoriasis is the most common form: it usually appears as raised, red patches of inflamed skin, covered with silvery white scales. The patches often occur in a symmetrical pattern. Guttate psoriasis is a particular form of psoriasis with widespread, small erythematosquamous lesions. Streptococcal infection is suspected to be a triggering factor for the onset of guttate psoriasis, and flare-up of chronic plaque psoriasis. The previous Cochrane Review on this topic was published in 2000; it required an update because antistreptococcal treatment continues to be used to treat psoriasis, especially for the acute form of guttate psoriasis.\nObjectives\nTo assess the effects of antistreptococcal interventions for guttate and chronic plaque psoriasis.\nSearch methods\nWe searched Cochrane Skin Specialised Register, Cochrane Register of Studies Online, CENTRAL, MEDLINE, Embase, LILACS, and five trials registers (January 2019). We checked the reference lists of included and excluded studies and searched conference proceedings from the American Academy of Dermatology, Society for Investigative Dermatology, and European Academy of Dermatology and Venereology.\nSelection criteria\nWe considered randomised controlled trials (RCTs) assessing antistreptococcal interventions (tonsillectomy or systemic antibiotic treatment) in people with clinically diagnosed acute guttate and chronic plaque psoriasis compared with placebo, no intervention, or each other.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcome measures were: 1) time-to-resolution; achieving clear or almost clear skin (Physician Global Assessment (PGA) 0 or 1 or Psoriasis Area and Severity Index (PASI) 90 or 100); 2) proportion of participants with adverse effects and severe adverse effects. Secondary outcomes were: 1) proportion of participants achieving clear or almost clear skin; 2) proportion of participants achieving PASI 75 or PGA 1 to 2; 3) risk of having at least one relapse at long-term follow-up. Short-term assessment was defined as within eight weeks of the start of treatment; long-term was at least one year after the start of treatment.\nMain results\nWe included five trials (162 randomised participants); three were conducted in a hospital dermatology department. One study declared funding by a pharmaceutical company. Participants' ages ranged from 12 to 77 years; only two participants were younger than 15 years. Mean PASI score at baseline varied from 5.7 (i.e. mild) to 23 (i.e. severe) in four studies. Twenty-three of 162 participants had streptococcus-positive throat swab culture. We did not perform a meta-analysis due to heterogeneity of participants' characteristics and interventions.\nNone of the trials measured our efficacy primary outcome, time-to-resolution, or the secondary outcome, risk of having at least one relapse at long-term follow-up.\nWe rated the quality of the results as very low-quality evidence, due to high risk of bias (absence of blinding of participants and caregivers, and high risk of outcome reporting bias) and imprecision (single study data with a low number of events). Hence, we are very uncertain about the results presented.\nGuttate psoriasis\nOne three-armed trial (N = 43) assessed penicillin (50,000 international units (IU)/kg/day in three doses) versus erythromycin (250 mg four times per day) versus no treatment (treatment for 14 days, with six-week follow-up from start of treatment). Adverse events and the proportion of participants achieving clear or almost clear skin were not measured.\nOne trial (N = 20) assessed penicillin (1.6 MU (million units) intramuscularly once a day) versus no treatment (six weeks of treatment, with eight-week follow-up from start of treatment). At six-week (short-term) follow-up, no adverse events were observed in either group, and there was no statistically significant difference between the two groups in the proportion of participants with clear or almost clear skin (risk ratio (RR) 2.00, 95% confidence interval (CI) 0.68 to 5.85).\nOne trial (N = 20) assessed rifampicin (300 mg twice daily) versus placebo (14-day treatment duration; six-week follow-up from start of treatment); none of the review outcomes were measured.\nThese trials did not measure the proportion of participants achieving PASI 75 or PGA 1 to 2.\nChronic plaque psoriasis\nOne trial (N = 50) assessed long-term azithromycin treatment (500 mg daily dose) versus vitamin C. Adverse events were reported in the azithromycin group (10 out of 30 had nausea and mild abdominal upset), but not in the vitamin C group. The proportion of participants who achieved clear or almost clear skin was not measured. In the azithromycin group, 18/30 versus 0/20 participants in the vitamin C group reached PASI 75 at the end of 48 weeks of treatment (RR 25.06, 95% CI 1.60 to 393.59).\nOne trial (N = 29) assessed tonsillectomy versus no treatment, with 24-month follow-up after surgery. One participant in the tonsillectomy group had minor bleeding. At eight-week follow-up, 1/15 in the tonsillectomy group, and 0/14 in the no treatment group achieved PASI 90; and 3/15 participants in the tonsillectomy group, and 0/14 in the no treatment group achieved PASI 75 (RR 6.56, 95% CI 0.37 to 116.7).\nAuthors' conclusions\nWe found only five trials (N = 162), which assessed the effects of five comparisons (systemic antibiotic treatment (penicillin, azithromycin) or tonsillectomy). Two comparisons (erythromycin compared to no treatment, and rifampicin compared to placebo) did not measure any of the outcomes of interest. There was very low-quality evidence for the outcomes that were measured, Therefore, we are uncertain of both the efficacy and safety of antistreptococcal interventions for guttate and chronic plaque psoriasis.\nThe included trials were at unclear or high risk of bias and involved only a small number of unrepresentative participants, with limited measurement of our outcomes of interest. The studies did not allow investigation into the influence of Streptococcal infection, and a key intervention (amoxicillin) was not assessed.\nFurther trials assessing the efficacy and tolerance of penicillin V or amoxicillin are needed in children and young adults with guttate psoriasis.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to January 2019.\nWe included five studies (162 participants); three were conducted in hospital dermatology departments. Participants were 12 to 77 years old (100 males; 62 females). One study was funded by a pharmaceutical company. The severity of the condition ranged from mild to severe. Streptococcus bacteria were found in the throats of 14% of people.\nWe classed outcomes measured within eight weeks of the start of treatment as short-term, and those measured at least one year after the start of treatment as long-term. The antibiotic trials in guttate psoriasis patients were all short-term in duration; the antibiotic trial in chronic plaque psoriasis was 48 weeks long.\nThree studies included participants with guttate psoriasis, and assessed the short-term effects of antibiotics: penicillin (20 participants), or erythromycin compared to no treatment (43 participants), and rifampicin compared to placebo (20 participants).\nTwo studies included participants with chronic plaque psoriasis. One study assessed azithromycin (antibiotic) versus vitamin C at 48 weeks (50 participants); one assessed tonsillectomy versus no intervention at eight weeks and 24 months (29 participants)."
}
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query-laysum
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6813
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[
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory distress syndrome (ARDS) is a critical condition that is associated with high mortality and morbidity. Aerosolized prostacyclin has been used to improve oxygenation despite the limited evidence available so far.\nThis review was originally published in 2010 and updated in 2017.\nObjectives\nTo assess the benefits and harms of aerosolized prostacyclin in adults and children with ARDS.\nSearch methods\nIn this update, we searched CENTRAL (2017, Issue 4); MEDLINE (OvidSP), Embase (OvidSP), ISI BIOSIS Previews, ISI Web of Science, LILACS, CINAHL (EBSCOhost), and three trials registers. We handsearched the reference lists of the latest reviews, randomized and non-randomized trials, and editorials, and cross-checked them with our search of MEDLINE. We contacted the main authors of included studies to request any missed, unreported or ongoing studies. The search was run from inception to 5 May 2017.\nSelection criteria\nWe included all randomized controlled trials (RCTs), irrespective of publication status, date of publication, blinding status, outcomes published or language. We contacted trial investigators and study authors to retrieve relevant and missing data.\nData collection and analysis\nThree authors independently abstracted data and resolved any disagreements by discussion. Our primary outcome measure was all-cause mortality. We planned to perform subgroup and sensitivity analyses to assess the effect of aerosolized prostacyclin in adults and children, and on various clinical and physiological outcomes. We assessed the risk of bias through assessment of methodological trial components and the risk of random error through trial sequential analysis.\nMain results\nWe included two RCTs with 81 participants.\nOne RCT involved 14 critically ill children with ARDS (very low quality of evidence), and one RCT involved 67 critically ill adults (very low quality evidence).\nOnly one RCT (paediatric trial) provided data on mortality and found no difference between intervention and control. However, this trial was eligible for meta-analysis due to a cross-over design.\nWe assessed the benefits and harms of aerosolized prostacyclin. One RCT found no difference in improvement of partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio (mean difference (MD) -25.35, 95% confidence interval (CI) -60.48 to 9.78; P = 0.16; 67 participants, very low quality evidence).\nThere were no adverse events such as bleeding or organ dysfunction in any of the included trials. Due to the limited number of RCTs, we were unable to perform the prespecified subgroup and sensitivity analyses or trial sequential analysis.\nAuthors' conclusions\nWe are unable to tell from our results whether the intervention has an important effect on mortality because the results were too imprecise to rule out a small or no effect. Therefore, no current evidence supports or refutes the routine use of aerosolized prostacyclin for people with ARDS. There is an urgent need for more RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Only the RCT involving children provided data on deaths, with no clear difference with and without prostacyclin.\nThe RCT in adults reported a trend towards improved blood oxygen levels, for participants who were treated with alprostadil (prostaglandin E1).\nTherefore, we could not identify a clear advantage of the use of aerosolized prostacyclin in critically ill children or adults with low blood oxygen levels."
}
] |
query-laysum
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6814
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[
{
"role": "user",
"content": "Abstract: Background\nDespite improvements in medical care, the quality of life of adults and adolescents with congenital heart disease remains strongly affected by their condition, often leading to depression. Psychotherapy, cognitive behavioural therapy, and other talking therapies may be effective in treating depression in both adults and young adults with congenital heart disease. The aim of this review was to assess the effects of treatments, such as psychotherapy, cognitive behavioural therapies, and talking therapies for treating depression in this population.\nObjectives\nTo evaluate the effects (both harms and benefits) of psychological interventions for reducing symptoms of depression in adolescents (aged 10 to 17 years) and adults with congenital heart disease. Psychological interventions include cognitive behavioural therapy, psychotherapy, or 'talking/counselling' therapy for depression.\nSearch methods\nWe updated searches from the 2013 Cochrane Review by searching CENTRAL, four other databases, and Conference Proceedings Citation Index to 7 March 2023, and two clinical trial registers to February 2021. We applied no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) comparing psychological interventions to no intervention in the congenital heart disease population, aged 10 years and older, with depression.\nData collection and analysis\nTwo review authors independently screened titles and abstracts, and independently assessed full-text reports for inclusion. Further information was sought from the authors if needed. Data were extracted in duplicate. We used standard Cochrane methods. Our primary outcome was a change in depression. Our secondary outcomes were: acceptability of treatment, quality of life, hospital re-admission, non-fatal cardiovascular events, cardiovascular behavioural risk factor, health economics, cardiovascular mortality, all-cause mortality. We used GRADE to assess the certainty of evidence for our primary outcome only.\nMain results\nWe identified three new RCTs (480 participants). Participants were adults with congenital heart disease. Included studies varied in intervention length (90 minutes to 3 months) and follow-up (3 to 12 months), with depression assessed post-intervention and at follow-up. Risk of bias assessment identified an overall low risk of bias for the main outcome of depression.\nPsychological interventions (talking/counselling therapy) may reduce depression more than usual care at both three-month (mean difference (MD) -1.07, 95% confidence interval (CI) -1.84 to -0.30; P = 0.006; I2 = 0%; 2 RCTs, 156 participants; low-certainty evidence), and 12-month follow-up (MD -1.02, 95% CI -1.92 to -0.13; P = 0.02; I2 = 0%; 2 RCTs, 287 participants; low-certainty evidence).\nThere was insufficient evidence to draw conclusions about the impact of psychological interventions on quality of life.\nNone of the included studies reported on our other outcomes of interest.\nDue to the low number of studies included, we did not undertake any subgroup analyses. One study awaits classification.\nAuthors' conclusions\nPsychological interventions may reduce depression in adults with congenital heart disease compared to usual care. However, the certainty of the evidence is low.\nFurther research is needed to establish the role of psychological interventions in this population, defining the optimal duration, method of administration, and number of sessions required to obtain the greatest benefit.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We updated the searches of the medical literature to March 2023. We selected studies that met our criteria, assessed the risk of bias for depression, compared the results of these studies, and rated our confidence in the evidence based on these studies (e.g. assessment methods and size of the sample)."
}
] |
query-laysum
|
6815
|
[
{
"role": "user",
"content": "Abstract: Background\nThe rising prevalence of autism spectrum disorders (ASD) increases the need for evidence-based behavioral treatments to lessen the impact of symptoms on children's functioning. At present, there are no curative or psychopharmacological therapies to effectively treat all symptoms of the disorders. Early intensive behavioral intervention (EIBI) is a treatment based on the principles of applied behavior analysis. Delivered for multiple years at an intensity of 20 to 40 hours per week, it is one of the more well-established treatments for ASD. This is an update of a Cochrane review last published in 2012.\nObjectives\nTo systematically review the evidence for the effectiveness of EIBI in increasing functional behaviors and skills, decreasing autism severity, and improving intelligence and communication skills for young children with ASD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, 12 additional electronic databases and two trials registers in August 2017. We also checked references and contacted study authors to identify additional studies.\nSelection criteria\nRandomized control trials (RCTs), quasi-RCTs, and controlled clinical trials (CCTs) in which EIBI was compared to a no-treatment or treatment-as-usual control condition. Participants must have been less than six years of age at treatment onset and assigned to their study condition prior to commencing treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nWe synthesized the results of the five studies using a random-effects model of meta-analysis, with a mean difference (MD) effect size for outcomes assessed on identical scales, and a standardized mean difference (SMD) effect size (Hedges' g) with small sample correction for outcomes measured on different scales. We rated the quality of the evidence using the GRADE approach.\nMain results\nWe included five studies (one RCT and four CCTs) with a total of 219 children: 116 children in the EIBI groups and 103 children in the generic, special education services groups. The age of the children ranged between 30.2 months and 42.5 months. Three of the five studies were conducted in the USA and two in the UK, with a treatment duration of 24 months to 36 months. All studies used a treatment-as-usual comparison group.\nPrimary outcomes\nWe found evidence at post-treatment that EIBI improves adaptive behaviour (MD 9.58 (assessed using Vineland Adaptive Behavior Scale (VABS) Composite; normative mean = 100, normative SD = 15), 95% confidence interval (CI) 5.57 to 13.60, P < 0.001; 5 studies, 202 participants; low-quality evidence; lower values indicate positive effects). We found no evidence at post-treatment that EIBI improves autism symptom severity (SMD −0.34, 95% CI −0.79 to 0.11, P = 0.14; 2 studies, 81 participants; very low-quality evidence).\nNo adverse effects were reported across studies.\nSecondary outcomes\nWe found evidence at post-treatment that EIBI improves IQ (MD 15.44 (assessed using standardized IQ tests; scale 0 to 100, normative SD = 15), 95% CI 9.29 to 21.59, P < 0.001; 5 studies, 202 participants; low-quality evidence) and expressive (SMD 0.51, 95% CI 0.12 to 0.90, P = 0.01; 4 studies, 165 participants; low-quality evidence) and receptive (SMD 0.55, 95% CI 0.23 to 0.87, P = 0.001; 4 studies, 164 participants; low-quality evidence) language skills. We found no evidence at post-treatment that EIBI improves problem behaviour (SMD −0.58, 95% CI −1.24 to 0.07, P = 0.08; 2 studies, 67 participants; very low-quality evidence).\nAuthors' conclusions\nThere is weak evidence that EIBI may be an effective behavioral treatment for some children with ASD; the strength of the evidence in this review is limited because it mostly comes from small studies that are not of the optimum design. Due to the inclusion of non-randomized studies, there is a high risk of bias and we rated the overall quality of evidence as 'low' or 'very low' using the GRADE system, meaning further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.\nIt is important that providers of EIBI are aware of the current evidence and use clinical decision-making guidelines, such as seeking the family’s input and drawing upon prior clinical experience, when making recommendations to clients on the use EIBI. Additional studies using rigorous research designs are needed to make stronger conclusions about the effects of EIBI for children with ASD.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review was to find out whether early intensive behavioral intervention (EIBI) can improve functional behaviors and skills, reduce the severity of autism, and improve intelligence and communication skills for young children (less than six years old) with autism spectrum disorders, also called ASD. Cochrane researchers gathered and analysed all relevant studies to answer this question and found five relevant studies."
}
] |
query-laysum
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6816
|
[
{
"role": "user",
"content": "Abstract: Background\nA key function of health systems is implementing interventions to improve health, but coverage of essential health interventions remains low in low-income countries. Implementing interventions can be challenging, particularly if it entails complex changes in clinical routines; in collaborative patterns among different healthcare providers and disciplines; in the behaviour of providers, patients or other stakeholders; or in the organisation of care. Decision-makers may use a range of strategies to implement health interventions, and these choices should be based on evidence of the strategies' effectiveness.\nObjectives\nTo provide an overview of the available evidence from up-to-date systematic reviews about the effects of implementation strategies for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on alternative implementation strategies and informing refinements of the framework for implementation strategies presented in the overview.\nMethods\nWe searched Health Systems Evidence in November 2010 and PDQ-Evidence up to December 2016 for systematic reviews. We did not apply any date, language or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of implementation strategies on professional practice and patient outcomes and that were published after April 2005. We excluded reviews with limitations important enough to compromise the reliability of the review findings. Two overview authors independently screened reviews, extracted data and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence) and assessments of the relevance of findings to low-income countries.\nMain results\nWe identified 7272 systematic reviews and included 39 of them in this overview. An additional four reviews provided supplementary information. Of the 39 reviews, 32 had only minor limitations and 7 had important methodological limitations. Most studies in the reviews were from high-income countries. There were no studies from low-income countries in eight reviews.\nImplementation strategies addressed in the reviews were grouped into four categories – strategies targeting:\n1. healthcare organisations (e.g. strategies to change organisational culture; 1 review);\n2. healthcare workers by type of intervention (e.g. printed educational materials; 14 reviews);\n3. healthcare workers to address a specific problem (e.g. unnecessary antibiotic prescription; 9 reviews);\n4. healthcare recipients (e.g. medication adherence; 15 reviews).\nOverall, we found the following interventions to have desirable effects on at least one outcome with moderate- or high-certainty evidence and no moderate- or high-certainty evidence of undesirable effects.\n1.Strategies targeted at healthcare workers: educational meetings, nutrition training of health workers, educational outreach, practice facilitation, local opinion leaders, audit and feedback, and tailored interventions.\n2.Strategies targeted at healthcare workers for specific types of problems: training healthcare workers to be more patient-centred in clinical consultations, use of birth kits, strategies such as clinician education and patient education to reduce antibiotic prescribing in ambulatory care settings, and in-service neonatal emergency care training.\n3. Strategies targeted at healthcare recipients: mass media interventions to increase uptake of HIV testing; intensive self-management and adherence, intensive disease management programmes to improve health literacy; behavioural interventions and mobile phone text messages for adherence to antiretroviral therapy; a one time incentive to start or continue tuberculosis prophylaxis; default reminders for patients being treated for active tuberculosis; use of sectioned polythene bags for adherence to malaria medication; community-based health education, and reminders and recall strategies to increase vaccination uptake; interventions to increase uptake of cervical screening (invitations, education, counselling, access to health promotion nurse and intensive recruitment); health insurance information and application support.\nAuthors' conclusions\nReliable systematic reviews have evaluated a wide range of strategies for implementing evidence-based interventions in low-income countries. Most of the available evidence is focused on strategies targeted at healthcare workers and healthcare recipients and relates to process-based outcomes. Evidence of the effects of strategies targeting healthcare organisations is scarce.\n\nGiven the provided abstract, please respond to the following query: \"Strategies targeted at healthcare workers for specific types of problems\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Interventions to improve handwashing.\n- Interventions to reduce unnecessary caesarean section rates.\n- Training of traditional birth attendants.\n- Skilled birth attendance.\n- Training of traditional healers about STD and HIV medicine."
}
] |
query-laysum
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6817
|
[
{
"role": "user",
"content": "Abstract: Background\nTreament-related diarrhoea is one of the most common and troublesome adverse effects related to chemotherapy or radiotherapy in people with cancer. Its reported incidence has been as high as 50% to 80%. Severe treatment-related diarrhoea can lead to fluid and electrolyte losses and nutritional deficiencies and could adversely affect quality of life (QoL). It is also associated with increased risk of infection in people with neutropenia due to anticancer therapy and often leads to treatment delays, dose reductions, or treatment discontinuation. Probiotics may be effective in preventing or treating chemotherapy- or radiotherapy-induced diarrhoea.\nObjectives\nTo evaluate the clinical effectiveness and side effects of probiotics used alone or combined with other agents for prevention or treatment of chemotherapy- or radiotherapy-related diarrhoea in people with cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 7), MEDLINE (1946 to July week 2, 2017), and Embase (1980 to 2017, week 30). We also searched prospective clinical trial registers and the reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) investigating the effects of probiotics for prevention or treatment of chemotherapy- or radiotherapy-related diarrhoea in people with cancer.\nData collection and analysis\nTwo review authors independently selected studies, extracted data, and assessed risk of bias. We used random-effects models for all meta-analyses. If meta-analysis was not possible, we summarised the results narratively.\nMain results\nWe included 12 studies involving 1554 participants. Eleven studies were prevention studies, of which seven compared probiotics with placebo (887 participants), one compared two doses of probiotics with each other and with placebo (246 participants), and three compared probiotics with another active agent (216 participants).The remaining study assessed the effectiveness of probiotics compared with placebo for treatment of radiotherapy-related diarrhoea (205 participants).\nFor prevention of radiotherapy (with or without chemotherapy)-induced diarrhoea, review authors identified five heterogeneous placebo-controlled studies (with 926 participants analysed). Owing to heterogeneity, we could not carry out a meta-analysis, except for two outcomes. For occurrence of any diarrhoea, risk ratios (RRs) ranged from 0.35 (95% confidence interval (CI) 0.26 to 0.47) to 1.0 (95% CI 0.94 to 1.06) (three studies; low-certainty evidence). A beneficial effect of probiotics on quality of life could neither be demonstrated nor refuted (two studies; low-certainty evidence). For occurrence of grade 2 or higher diarrhoea, the pooled RR was 0.75 (95% CI 0.55 to 1.03; four studies; 420 participants; low-certainty evidence), and for grade 3 or higher diarrhoea, RRs ranged from 0.11 (95% CI 0.06 to 0.23) to 1.24 (95% CI 0.74 to 2.08) (three studies; low-certainty evidence). For probiotic users, time to rescue medication was 36 hours longer in one study (95% CI 34.7 to 37.3), but another study reported no difference (moderate-certainty evidence). For the need for rescue medication, the pooled RR was 0.50 (95% CI 0.15 to 1.66; three studies; 194 participants; very low-certainty evidence). No study reported major differences between groups with respect to adverse effects. Although not mentioned explicitly, no studies reported deaths, except one in which one participant in the probiotics group died of myocardial infarction after three sessions of radiotherapy.\nThree placebo-controlled studies, with 128 analysed participants, addressed prevention of chemotherapy-induced diarrhoea. For occurrence of any diarrhoea, the pooled RR was 0.59 (95% CI 0.36 to 0.96; two studies; 106 participants; low-certainty evidence). For all other outcomes, a beneficial effect of probiotics could be neither demonstrated nor refuted (one to two studies; 46 to 106 participants; all low-certainty evidence). Studies did not address quality of life nor time to rescue medication.\nThree studies compared probiotics with another intervention in 213 participants treated with radiotherapy (with or without chemotherapy). One very small study (21 participants) reported less diarrhoea six weeks after treatment when dietary counselling was provided (RR 0.30, 95% CI 0.11 to 0.81; very low-certainty evidence). In another study (148 participants), grade 3 or 4 diarrhoea occurred less often in the probiotics group than in the control group (guar gum containing nutritional supplement) (odds ratio (OR) 0.38, 95% CI 0.16 to 0.89; low-certainty evidence), and two studies (63 participants) found less need for rescue medication of probiotics versus another active treatment (RR 0.44, 95% CI 0.22 to 0.86; very low-certainty evidence). Studies did not address quality of life nor time to rescue medication.\nOne placebo-controlled study with 205 participants addressed treatment for radiotherapy-induced diarrhoea and could not demonstrate or refute a beneficial effect of probiotics on average diarrhoea grade, time to rescue medication for diarrhoea (13 hours longer in the probiotics group; 95% CI -0.9 to 26.9 hours), or need for rescue medication (RR 0.74, 95% CI 0.53 to 1.03; moderate-certainty evidence). This study did not address quality of life.\nNo studies reported serious adverse events or diarrhoea-related deaths.\nAuthors' conclusions\nThis review presents limited low- or very low-certainty evidence supporting the effects of probiotics for prevention and treatment of diarrhoea related to radiotherapy (with or without chemotherapy) or chemotherapy alone, need for rescue medication, or occurrence of adverse events. All studies were underpowered and heterogeneous. Severe side effects were absent from all studies.\nRobust evidence on this topic must be provided by future methodologically well-designed trials.\n\nGiven the provided abstract, please respond to the following query: \"Main findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, the studies we found do not give a clear answer on whether probiotics reduce the occurrence or severity of diarrhoea, improve quality of life, or reduce the need for other medication. However, an analysis of only well-performed studies demonstrated a beneficial effect for some outcomes.\nWith regard to prevention of diarrhoea compared with placebo in participants treated with radiotherapy with or without chemotherapy, we are not able to conclude whether use of probiotics would be beneficial based on the five relevant studies.\nFor prevention of diarrhoea due to chemotherapy alone, three studies suggested that use of probiotics may not reduce diarrhoea, and one study reported use of less rescue medication for diarrhoea.\nThree studies that compared probiotics with another agent for preventing diarrhoea in patients treated with radiotherapy with or without chemotherapy found beneficial effects of probiotics for the occurrence and severity of diarrhoea and the need for rescue medication.\nWith respect to treatment of diarrhoea due to radiotherapy, we found only one study that did not demonstrate a clear effect of probiotics compared with placebo.\nNo study reported serious adverse events nor deaths related to diarrhoea."
}
] |
query-laysum
|
6818
|
[
{
"role": "user",
"content": "Abstract: Background\nThe long-term risk of stroke increases with age, and stroke is a common cause of disability in the community. Spasticity is considered a significantly disabling impairment that develops in people who have had a stroke. The burden of care is higher in stroke survivors who have spasticity when compared with stroke survivors without spasticity with regard to treatment costs, quality of life, and caregiver burden.\nObjectives\nTo assess if pharmacological interventions for spasticity are more effective than no intervention, normal practice, or control at improving function following stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 5), MEDLINE (1946 to May 2016), Embase (2008 to May 2016), CINAHL (1982 to May 2016), AMED (1985 to May 2016), and eight further databases and trial registers. In an effort to identify further studies, we undertook handsearches of reference lists and contacted study authors and commercial companies.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any systemically acting or locally acting drug versus placebo, control, or comparative drug with the aim of treating spasticity.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion and extracted the data. We assessed the included studies for both quality and risk of bias. We contacted study authors to request further information when necessary.\nMain results\nWe included seven RCTs with a total 403 participants. We found a high risk of bias in all but one RCT. Two of the seven RCTs assessed a systemic drug versus placebo. We pooled data on an indirect measure of spasticity (160 participants) from these two studies but found no significant effect (odds ratio (OR) 1.66, 95% confidence interval (CI) 0.21 to 13.07; I2 = 85%). We identified a significant risk of adverse events per participant occurring in the treatment group versus placebo group (risk ratio (RR) 1.65, 95% CI 1.12 to 2.42; 160 participants; I2 = 0%). Only one of these studies used a functional outcome measure, and we found no significant difference between groups.\nOf the other five studies, two assessed a systemic drug versus another systemic drug, one assessed a systemic drug versus local drug, and the final two assessed a local drug versus another local drug.\nAuthors' conclusions\nThe lack of high-quality RCTs limited our ability to make specific conclusions. Evidence is insufficient to determine if systemic antispasmodics are effective at improving function following stroke.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included seven studies involving a total of 403 participants. The evidence is current to May 2016. There were variations among the included studies. Two of the studies were placebo controlled, while the rest compared one drug to another drug. Two studies compared two systemic drugs against each other; two studies compared two local drugs against each other; and the fifth study compared a systemic drug against a local drug."
}
] |
query-laysum
|
6819
|
[
{
"role": "user",
"content": "Abstract: Background\nVitamin A deficiency (VAD) is a major public health problem in low- and middle-income countries, affecting 190 million children under five years of age and leading to many adverse health consequences, including death. Based on prior evidence and a previous version of this review, the World Health Organization has continued to recommend vitamin A supplementation (VAS) for children aged 6 to 59 months. The last version of this review was published in 2017, and this is an updated version of that review.\nObjectives\nTo assess the effects of vitamin A supplementation (VAS) for preventing morbidity and mortality in children aged six months to five years.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, six other databases, and two trials registers up to March 2021. We also checked reference lists and contacted relevant organisations and researchers to identify additional studies.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-RCTs evaluating the effect of synthetic VAS in children aged six months to five years living in the community. We excluded studies involving children in hospital and children with disease or infection. We also excluded studies evaluating the effects of food fortification, consumption of vitamin A rich foods, or beta-carotene supplementation.\nData collection and analysis\nFor this update, two review authors independently assessed studies for inclusion resolving discrepancies by discussion. We performed meta-analyses for outcomes, including all-cause and cause-specific mortality, disease, vision, and side effects. We used the GRADE approach to assess the quality of the evidence.\nMain results\nThe updated search identified no new RCTs.\nWe identified 47 studies, involving approximately 1,223,856 children. Studies were set in 19 countries: 30 (63%) in Asia, 16 of these in India; 8 (17%) in Africa; 7 (15%) in Latin America, and 2 (4%) in Australia. About one-third of the studies were in urban/periurban settings, and half were in rural settings; the remaining studies did not clearly report settings. Most studies included equal numbers of girls and boys and lasted about one year. The mean age of the children was about 33 months. The included studies were at variable overall risk of bias; however, evidence for the primary outcome was at low risk of bias.\nA meta-analysis for all-cause mortality included 19 trials (1,202,382 children). At longest follow-up, there was a 12% observed reduction in the risk of all-cause mortality for VAS compared with control using a fixed-effect model (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.83 to 0.93; high-certainty evidence).\nNine trials reported mortality due to diarrhoea and showed a 12% overall reduction for VAS (RR 0.88, 95% CI 0.79 to 0.98; 1,098,538 children; high-certainty evidence). There was no evidence of a difference for VAS on mortality due to measles (RR 0.88, 95% CI 0.69 to 1.11; 6 studies, 1,088,261 children; low-certainty evidence), respiratory disease (RR 0.98, 95% CI 0.86 to 1.12; 9 studies, 1,098,538 children; low-certainty evidence), and meningitis. VAS reduced the incidence of diarrhoea (RR 0.85, 95% CI 0.82 to 0.87; 15 studies, 77,946 children; low-certainty evidence), measles (RR 0.50, 95% CI 0.37 to 0.67; 6 studies, 19,566 children; moderate-certainty evidence), Bitot's spots (RR 0.42, 95% CI 0.33 to 0.53; 5 studies, 1,063,278 children; moderate-certainty evidence), night blindness (RR 0.32, 95% CI 0.21 to 0.50; 2 studies, 22,972 children; moderate-certainty evidence), and VAD (RR 0.71, 95% CI 0.65 to 0.78; 4 studies, 2262 children, moderate-certainty evidence). However, there was no evidence of a difference on incidence of respiratory disease (RR 0.99, 95% CI 0.92 to 1.06; 11 studies, 27,540 children; low-certainty evidence) or hospitalisations due to diarrhoea or pneumonia. There was an increased risk of vomiting within the first 48 hours of VAS (RR 1.97, 95% CI 1.44 to 2.69; 4 studies, 10,541 children; moderate-certainty evidence).\nAuthors' conclusions\nThis update identified no new eligible studies and the conclusions remain the same. VAS is associated with a clinically meaningful reduction in morbidity and mortality in children. Further placebo-controlled trials of VAS in children between six months and five years of age would not change the conclusions of this review, although studies that compare different doses and delivery mechanisms are needed. In populations with documented VAD, it would be unethical to conduct placebo-controlled trials.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the overall certainty of evidence using the GRADE approach, which considers methodological flaws within studies, consistency in reporting of results across studies, extent to which results apply to other settings, and effectiveness of treatments. Based on these criteria, we judged the overall certainty of evidence to be high for benefits of VAS against overall risk of death and death due to diarrhoea. For the other outcomes, we rated the evidence as low or moderate. One large, recently conducted study, which included about one million children, did not show any effect of VAS; however, when this study was combined with other, well-conducted studies, VAS still had beneficial effects for the prevention of death and illness. In summary, VAS can reduce risk of illness and death in children aged 6 to 59 months of age who are at risk of VAD. This update did not identify and new eligible studies and the conclusions remain the same."
}
] |
query-laysum
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6820
|
[
{
"role": "user",
"content": "Abstract: Background\nAgeing populations globally have contributed to increasing numbers of people living with frailty, which has significant implications for use of health and care services and costs. The British Geriatrics Society defines frailty as \"a distinctive health state related to the ageing process in which multiple body systems gradually lose their inbuilt reserves\". This leads to an increased susceptibility to adverse outcomes, such as reduced physical function, poorer quality of life, hospital admissions, and mortality. Case management interventions delivered in community settings are led by a health or social care professional, supported by a multidisciplinary team, and focus on the planning, provision, and co-ordination of care to meet the needs of the individual. Case management is one model of integrated care that has gained traction with policymakers to improve outcomes for populations at high risk of decline in health and well-being. These populations include older people living with frailty, who commonly have complex healthcare and social care needs but can experience poorly co-ordinated care due to fragmented care systems.\nObjectives\nTo assess the effects of case management for integrated care of older people living with frailty compared with usual care.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Health Systems Evidence, and PDQ Evidence and databases from inception to 23 September 2022. We also searched clinical registries and relevant grey literature databases, checked references of included trials and relevant systematic reviews, conducted citation searching of included trials, and contacted topic experts.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared case management with standard care in community-dwelling people aged 65 years and older living with frailty.\nData collection and analysis\nWe followed standard methodological procedures recommended by Cochrane and the Effective Practice and Organisation of Care Group. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 20 trials (11,860 participants), all of which took place in high-income countries. Case management interventions in the included trials varied in terms of organisation, delivery, setting, and care providers involved. Most trials included a variety of healthcare and social care professionals, including nurse practitioners, allied healthcare professionals, social workers, geriatricians, physicians, psychologists, and clinical pharmacists. In nine trials, the case management intervention was delivered by nurses only. Follow-up ranged from three to 36 months. We judged most trials at unclear risk of selection and performance bias; this consideration, together with indirectness, justified downgrading the certainty of the evidence to low or moderate.\nCase management compared to standard care may result in little or no difference in the following outcomes.\n• Mortality at 12 months' follow-up (7.0% in the intervention group versus 7.5% in the control group; risk ratio (RR) 0.98, 95% confidence interval (CI) 0.84 to 1.15; I2 = 11%; 14 trials, 9924 participants; low-certainty evidence)\n• Change in place of residence to a nursing home at 12 months' follow-up (9.9% in the intervention group versus 13.4% in the control group; RR 0.73, 95% CI 0.53 to 1.01; I2 = 0%; 4 trials, 1108 participants; low-certainty evidence)\n• Quality of life at three to 24 months' follow-up (results not pooled; mean differences (MDs) ranged from −6.32 points (95% CI −11.04 to −1.59) to 6.1 points (95% CI −3.92 to 16.12) when reported; 11 trials, 9284 participants; low-certainty evidence)\n• Serious adverse effects at 12 to 24 months' follow-up (results not pooled; 2 trials, 592 participants; low-certainty evidence)\n• Change in physical function at three to 24 months' follow-up (results not pooled; MDs ranged from −0.12 points (95% CI −0.93 to 0.68) to 3.4 points (95% CI −2.35 to 9.15) when reported; 16 trials, 10,652 participants; low-certainty evidence)\nCase management compared to standard care probably results in little or no difference in the following outcomes.\n• Healthcare utilisation in terms of hospital admission at 12 months' follow-up (32.7% in the intervention group versus 36.0% in the control group; RR 0.91, 95% CI 0.79 to 1.05; I2 = 43%; 6 trials, 2424 participants; moderate-certainty evidence)\n• Change in costs at six to 36 months' follow-up (results not pooled; 14 trials, 8486 participants; moderate-certainty evidence), which usually included healthcare service costs, intervention costs, and other costs such as informal care.\nAuthors' conclusions\nWe found uncertain evidence regarding whether case management for integrated care of older people with frailty in community settings, compared to standard care, improved patient and service outcomes or reduced costs. There is a need for further research to develop a clear taxonomy of intervention components, to determine the active ingredients that work in case management interventions, and identify how such interventions benefit some people and not others.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 20 relevant trials conducted in high-income countries in Europe, North America, Asia, and Oceania. This represented 11,860 people living with frailty."
}
] |
query-laysum
|
6821
|
[
{
"role": "user",
"content": "Abstract: Background\nThe mean age of women undergoing local treatment for pre-invasive cervical disease (cervical intra-epithelial neoplasia; CIN) or early cervical cancer (stage IA1) is around their 30s and similar to the age of women having their first child. Local cervical treatment has been correlated to adverse reproductive morbidity in a subsequent pregnancy, however, published studies and meta-analyses have reached contradictory conclusions.\nObjectives\nTo assess the effect of local cervical treatment for CIN and early cervical cancer on obstetric outcomes (after 24 weeks of gestation) and to correlate these to the cone depth and comparison group used.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library, 2017, Issue 5), MEDLINE (up to June week 4, 2017) and Embase (up to week 26, 2017). In an attempt to identify articles missed by the search or unpublished data, we contacted experts in the field and we handsearched the references of the retrieved articles and conference proceedings.\nSelection criteria\nWe included all studies reporting on obstetric outcomes (more than 24 weeks of gestation) in women with or without a previous local cervical treatment for any grade of CIN or early cervical cancer (stage IA1). Treatment included both excisional and ablative methods. We excluded studies that had no untreated reference population, reported outcomes in women who had undergone treatment during pregnancy or had a high-risk treated or comparison group, or both\nData collection and analysis\nWe classified studies according to the type of treatment and the obstetric endpoint. Studies were classified according to method and obstetric endpoint. Pooled risk ratios (RR) and 95% confidence intervals (CIs) were calculated using a random-effects model and inverse variance. Inter-study heterogeneity was assessed with I2 statistics. We assessed maternal outcomes that included preterm birth (PTB) (spontaneous and threatened), preterm premature rupture of the membranes (pPROM), chorioamnionitis, mode of delivery, length of labour, induction of delivery, oxytocin use, haemorrhage, analgesia, cervical cerclage and cervical stenosis. The neonatal outcomes included low birth weight (LBW), neonatal intensive care unit (NICU) admission, stillbirth, perinatal mortality and Apgar scores.\nMain results\nWe included 69 studies (6,357,823 pregnancies: 65,098 pregnancies of treated and 6,292,725 pregnancies of untreated women). Many of the studies included only small numbers of women, were of heterogenous design and in their majority retrospective and therefore at high risk of bias. Many outcomes were assessed to be of low or very low quality (GRADE assessment) and therefore results should be interpreted with caution. Women who had treatment were at increased overall risk of preterm birth (PTB) (less than 37 weeks) (10.7% versus 5.4%, RR 1.75, 95% CI 1.57 to 1.96, 59 studies, 5,242,917 participants, very low quality), severe (less than 32 to 34 weeks) (3.5% versus 1.4%, RR 2.25, 95% CI 1.79 to 2.82), 24 studies, 3,793,874 participants, very low quality), and extreme prematurity (less than 28 to 30 weeks) (1.0% versus 0.3%, (RR 2.23, 95% CI 1.55 to 3.22, 8 studies, 3,910,629 participants, very low quality), as compared to women who had no treatment.\nThe risk of overall prematurity was higher for excisional (excision versus no treatment: 11.2% versus 5.5%, RR 1.87, 95% CI 1.64 to 2.12, 53 studies, 4,599,416 participants) than ablative (ablation versus no treatment: 7.7% versus 4.6%, RR 1.35, 95% CI 1.20 to 1.52, 14 studies, 602,370 participants) treatments and the effect was higher for more radical excisional techniques (less than 37 weeks: cold knife conisation (CKC) (RR 2.70, 95% CI 2.14 to 3.40, 12 studies, 39,102 participants), laser conisation (LC) (RR 2.11, 95% CI 1.26 to 3.54, 9 studies, 1509 participants), large loop excision of the transformation zone (LLETZ) (RR 1.58, 95% CI 1.37 to 1.81, 25 studies, 1,445,104 participants). Repeat treatment multiplied the risk of overall prematurity (repeat versus no treatment: 13.2% versus 4.1%, RR 3.78, 95% CI 2.65 to 5.39, 11 studies, 1,317,284 participants, very low quality). The risk of overall prematurity increased with increasing cone depth (less than 10 mm to 12 mm versus no treatment: 7.1% versus 3.4%, RR 1.54, 95% CI 1.09 to 2.18, 8 studies, 550,929 participants, very low quality; more than 10 mm to 12 mm versus no treatment: 9.8% versus 3.4%, RR 1.93, 95% CI 1.62 to 2.31, 8 studies, 552,711 participants, low quality; more than 15 mm to 17 mm versus no treatment: 10.1 versus 3.4%, RR 2.77, 95% CI 1.95 to 3.93, 4 studies, 544,986 participants, very low quality; 20 mm or more versus no treatment: 10.2% versus 3.4%, RR 4.91, 95% CI 2.06 to 11.68, 3 studies, 543,750 participants, very low quality). The comparison group affected the magnitude of effect that was higher for external, followed by internal comparators and ultimately women with disease, but no treatment. Untreated women with disease and the pre-treatment pregnancies of the women who were treated subsequently had higher risk of overall prematurity than the general population (5.9% versus 5.6%, RR 1.24, 95% CI 1.14 to 1.34, 15 studies, 4,357,998 participants, very low quality).\npPROM (6.1% versus 3.4%, RR 2.36, 95% CI 1.76 to 3.17, 21 studies, 477,011 participants, very low quality), low birth weight (7.9% versus 3.7%, RR 1.81, 95% CI 1.58 to 2.07, 30 studies, 1,348,206 participants, very low quality), NICU admission rate (12.6% versus 8.9%, RR 1.45, 95% CI 1.16 to 1.81, 8 studies, 2557 participants, low quality) and perinatal mortality (0.9% versus 0.7%, RR 1.51, 95% CI 1.13 to 2.03, 23 studies, 1,659,433 participants, low quality) were also increased after treatment.\nAuthors' conclusions\nWomen with CIN have a higher baseline risk for prematurity. Excisional and ablative treatment appears to further increases that risk. The frequency and severity of adverse sequelae increases with increasing cone depth and is higher for excision than it is for ablation. However, the results should be interpreted with caution as they were based on low or very low quality (GRADE assessment) observational studies, most of which were retrospective.\n\nGiven the provided abstract, please respond to the following query: \"Selection criteria\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included all studies that investigated the effect of treatment of CIN and early cervical cancer on late pregnancy outcomes (beyond 24 weeks of gestation) in women who had been treated previously for CIN and early cervical cancer, as compared to women who had not been treated. We excluded studies that had no untreated comparison group, reported pregnancy outcomes in women who had undergone treatment during pregnancy, or had a high-risk treated, comparison group or both."
}
] |
query-laysum
|
6822
|
[
{
"role": "user",
"content": "Abstract: Background\nRoutine monitoring of gastric residual in preterm infants on gavage feeds is a common practice used to guide initiation and advancement of feeds. It is believed that an increase in or an altered gastric residual may be predictive of necrotising enterocolitis (NEC). Withholding monitoring of gastric residual may take away the early indicator and thus may increase the risk of NEC. However, routine monitoring of gastric residual as a guide, in the absence of uniform standards, may lead to unnecessary delay in initiation and advancement of feeds and hence might result in a delay in establishing full enteral feeds. This in turn may increase the duration of total parenteral nutrition (TPN) and central venous line usage, increasing the risk of associated complications. Furthermore, delays in establishing full enteral feeds increase the risk of extrauterine growth restriction and neurodevelopmental impairment.\nObjectives\n• To assess the efficacy and safety of routine monitoring versus no monitoring of gastric residual in preterm infants\n• To assess the efficacy and safety of routine monitoring of gastric residual based on two different criteria for interrupting feeds or decreasing feed volume in preterm infants\nSearch methods\nWe conducted searches in Cochrane CENTRAL via CRS, Ovid MEDLINE, Embase and CINAHL in February 2022. We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs), quasi- and cluster-RCTs.\nSelection criteria\nWe selected RCTs that compared routine monitoring versus no monitoring of gastric residual and trials that used two different criteria for gastric residual to interrupt feeds in preterm infants.\nData collection and analysis\nTwo authors independently assessed trial eligibility, risk of bias and extracted data. We analysed treatment effects in individual trials and reported risk ratio (RR) for dichotomous data, and mean difference (MD) for continuous data, with respective 95% confidence intervals (CI). We calculated the number needed to treat for an additional beneficial/harmful outcome (NNTB/NNTH) for dichotomous outcomes with significant results. We used GRADE to assess the certainty of evidence.\nMain results\nWe included five studies (423 infants) in this updated review.\nRoutine monitoring versus no routine monitoring of gastric residual in preterm infants\nFour RCTs with 336 preterm infants met the inclusion criteria for this comparison. Three studies were performed in infants with birth weight of < 1500 g, while one study included infants with birth weight between 750 g and 2000 g. The trials were unmasked but were otherwise of good methodological quality.\nRoutine monitoring of gastric residual:\n- probably has little or no effect on the risk of NEC (RR 1.08, 95% CI 0.46 to 2.57; 334 participants, 4 studies; moderate-certainty evidence);\n- probably increases the time to establish full enteral feeds (MD 3.14 days, 95% CI 1.93 to 4.36; 334 participants, 4 studies; moderate-certainty evidence);\n- may increase the time to regain birth weight (MD 1.70 days, 95% CI 0.01 to 3.39; 80 participants, 1 study; low-certainty evidence);\n- may increase the number of infants with feed interruption episodes (RR 2.21, 95% CI 1.53 to 3.20; NNTH 3, 95% CI 2 to 5; 191 participants, 3 studies; low-certainty evidence);\n- probably increases the number of TPN days (MD 2.57 days, 95% CI 1.20 to 3.95; 334 participants, 4 studies; moderate-certainty evidence);\n- probably increases the risk of invasive infection (RR 1.50, 95% CI 1.02 to 2.19; NNTH 10, 95% CI 5 to 100; 334 participants, 4 studies; moderate-certainty evidence);\n- may result in little or no difference in all-cause mortality before hospital discharge (RR 2.14, 95% CI 0.77 to 5.97; 273 participants, 3 studies; low-certainty evidence).\nQuality and volume of gastric residual compared to quality of gastric residual alone for feed interruption in preterm infants\nOne trial with 87 preterm infants met the inclusion criteria for this comparison. The trial included infants with 1500 g to 2000 g birth weight.\nUsing two different criteria of gastric residual for feed interruption:\n- may result in little or no difference in the incidence of NEC (RR 5.35, 95% CI 0.26 to 108.27; 87 participants; low-certainty evidence);\n- may result in little or no difference in time to establish full enteral feeds (MD -0.10 days, 95% CI -0.91 to 0.71; 87 participants; low-certainty evidence);\n- may result in little or no difference in time to regain birth weight (MD 1.00 days, 95% CI -0.37 to 2.37; 87 participants; low-certainty evidence);\n- may result in little or no difference in number of TPN days (MD 0.80 days, 95% CI -0.78 to 2.38; 87 participants; low-certainty evidence);\n- may result in little or no difference in the risk of invasive infection (RR 5.35, 95% CI 0.26 to 108.27; 87 participants; low-certainty evidence);\n- may result in little or no difference in all-cause mortality before hospital discharge (RR 3.21, 95% CI 0.13 to 76.67; 87 participants; low-certainty evidence).\n- we are uncertain about the effect of using two different criteria of gastric residual on the risk of feed interruption episodes (RR 3.21, 95% CI 0.13 to 76.67; 87 participants; very low-certainty evidence).\nAuthors' conclusions\nModerate-certainty evidence suggests routine monitoring of gastric residual has little or no effect on the incidence of NEC. Moderate-certainty evidence suggests monitoring gastric residual probably increases the time to establish full enteral feeds, the number of TPN days and the risk of invasive infection. Low-certainty evidence suggests monitoring gastric residual may increase the time to regain birth weight and the number of feed interruption episodes, and may have little or no effect on all-cause mortality before hospital discharge. Further RCTs are warranted to assess the effect on long-term growth and neurodevelopmental outcomes.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The search is up-to-date as of February 2022."
}
] |
query-laysum
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6823
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[
{
"role": "user",
"content": "Abstract: Background\nPlatelet transfusions are used in modern clinical practice to prevent and treat bleeding in people with thrombocytopenia. Although considerable advances have been made in platelet transfusion therapy since the mid-1970s, some areas continue to provoke debate especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding.\nObjectives\nTo determine whether agents that can be used as alternatives, or adjuncts, to platelet transfusions for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation are safe and effective at preventing bleeding.\nSearch methods\nWe searched 11 bibliographic databases and four ongoing trials databases including the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 4), MEDLINE (OvidSP, 1946 to 19 May 2016), Embase (OvidSP, 1974 to 19 May 2016), PubMed (e-publications only: searched 19 May 2016), ClinicalTrials.gov, World Health Organization (WHO) ICTRP and the ISRCTN Register (searched 19 May 2016).\nSelection criteria\nWe included randomised controlled trials in people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation who were allocated to either an alternative to platelet transfusion (artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, recombinant activated factor VII, desmopressin (DDAVP), or thrombopoietin (TPO) mimetics) or a comparator (placebo, standard care or platelet transfusion). We excluded studies of antifibrinolytic drugs, as they were the focus of another review.\nData collection and analysis\nTwo review authors screened all electronically derived citations and abstracts of papers identified by the review search strategy. Two review authors assessed risk of bias in the included studies and extracted data independently.\nMain results\nWe identified 16 eligible trials. Four trials are ongoing and two have been completed but the results have not yet been published (trial completion dates: April 2012 to February 2017). Therefore, the review included 10 trials in eight references with 554 participants. Six trials (336 participants) only included participants with acute myeloid leukaemia undergoing intensive chemotherapy, two trials (38 participants) included participants with lymphoma undergoing intensive chemotherapy and two trials (180 participants) reported participants undergoing allogeneic stem cell transplantation. Men and women were equally well represented in the trials. The age range of participants included in the trials was from 16 years to 81 years. All trials took place in high-income countries. The manufacturers of the agent sponsored eight trials that were under investigation, and two trials did not report their source of funding.\nNo trials assessed artificial platelet substitutes, fibrinogen concentrate, recombinant activated factor VII or desmopressin.\nNine trials compared a TPO mimetic to placebo or standard care; seven of these used pegylated recombinant human megakaryocyte growth and differentiation factor (PEG-rHuMGDF) and two used recombinant human thrombopoietin (rhTPO).\nOne trial compared platelet-poor plasma to platelet transfusion.\nWe considered that all the trials included in this review were at high risk of bias and meta-analysis was not possible in seven trials due to problems with the way data were reported.\nWe are very uncertain whether TPO mimetics reduce the number of participants with any bleeding episode (odds ratio (OR) 0.40, 95% confidence interval (CI) 0.10 to 1.62, one trial, 120 participants, very low quality evidence). We are very uncertain whether TPO mimetics reduce the risk of a life-threatening bleed after 30 days (OR 1.46, 95% CI 0.06 to 33.14, three trials, 209 participants, very low quality evidence); or after 90 days (OR 1.00, 95% CI 0.06 to 16.37, one trial, 120 participants, very low quality evidence). We are very uncertain whether TPO mimetics reduce platelet transfusion requirements after 30 days (mean difference -3.00 units, 95% CI -5.39 to -0.61, one trial, 120 participants, very low quality evidence). No deaths occurred in either group after 30 days (one trial, 120 participants, very low quality evidence). We are very uncertain whether TPO mimetics reduce all-cause mortality at 90 days (OR 1.00, 95% CI 0.24 to 4.20, one trial, 120 participants, very low quality evidence). No thromboembolic events occurred for participants treated with TPO mimetics or control at 30 days (two trials, 209 participants, very low quality evidence). We found no trials that looked at: number of days on which bleeding occurred, time from randomisation to first bleed or quality of life.\nOne trial with 18 participants compared platelet-poor plasma transfusion with platelet transfusion. We are very uncertain whether platelet-poor plasma reduces the number of participants with any bleeding episode (OR 16.00, 95% CI 1.32 to 194.62, one trial, 18 participants, very low quality evidence). We are very uncertain whether platelet-poor plasma reduces the number of participants with severe or life-threatening bleeding (OR 4.00, 95% CI 0.56 to 28.40, one trial, 18 participants, very low quality evidence). We found no trials that looked at: number of days on which bleeding occurred, time from randomisation to first bleed, number of platelet transfusions, all-cause mortality, thromboembolic events or quality of life.\nAuthors' conclusions\nThere is insufficient evidence to determine if platelet-poor plasma or TPO mimetics reduce bleeding for participants with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation. To detect a decrease in the proportion of participants with clinically significant bleeding from 12 in 100 to 6 in 100 would require a trial containing at least 708 participants (80% power, 5% significance). The six ongoing trials will provide additional information about the TPO mimetic comparison (424 participants) but this will still be underpowered to demonstrate this level of reduction in bleeding. None of the included or ongoing trials include children. There are no completed or ongoing trials assessing artificial platelet substitutes, fibrinogen concentrate, recombinant activated factor VII or desmopressin in people undergoing intensive chemotherapy or stem cell transplantation for haematological malignancies.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Approximately one in eight cancers arise from the blood, bone marrow, or lymph nodes. These cancers are divided into many different types that are treated differently. Examples include acute myeloid leukaemia and lymphoma. Some of these cancers can be cured with high-dose (intensive) chemotherapy or stem cell transplantation. These treatments destroy the cancer but can also damage the normal blood-producing cells. One consequence of this is a reduction in the number of platelets in the blood. Platelets are essential to make the blood clot normally. Consequently, people receiving these treatments are vulnerable to bleeding until their platelets increase in number.\nPlatelet transfusions (taken from a blood donor) are often given to try to prevent people with blood cancer from bleeding. We do not know how well these transfused platelets work. We know that there are risks from platelet transfusion, such as transmission of infections. It is possible that there are better ways to prevent bleeding in this setting. In this review, we examined whether other agents could be used instead of (or as well as) platelet transfusion to prevent bleeding. We also assessed the risk of serious side effects, such as forming abnormal blood clots (thromboembolic events). Potential agents include artificial platelets, platelet-poor plasma, fibrinogen concentrate, recombinant activated factor VII, desmopressin and thrombopoietin mimetics. Terms and treatments are described in the glossary in the 'Published notes' section of this review)."
}
] |
query-laysum
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6824
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[
{
"role": "user",
"content": "Abstract: Background\nHip fracture is a major injury that causes significant problems for affected individuals and their family and carers. Over 40% of people with hip fracture have dementia or cognitive impairment. The outcomes of these individuals after surgery are poorer than for those without dementia. It is unclear which care and rehabilitation interventions achieve the best outcomes for these people. This is an update of a Cochrane Review first published in 2013.\nObjectives\n(a) To assess the effectiveness of models of care including enhanced rehabilitation strategies designed specifically for people with dementia following hip fracture surgery compared to usual care.\n(b) To assess for people with dementia the effectiveness of models of care including enhanced rehabilitation strategies that are designed for all older people, regardless of cognitive status, following hip fracture surgery, compared to usual care.\nSearch methods\nWe searched ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group Specialised Register, MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 16 October 2019.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials evaluating the effectiveness of any model of enhanced care and rehabilitation for people with dementia after hip fracture surgery compared to usual care.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted data. We assessed risk of bias of the included trials. We synthesised data only if we considered the trials to be sufficiently homogeneous in terms of participants, interventions, and outcomes. We used the GRADE approach to rate the overall certainty of evidence for each outcome.\nMain results\nWe included seven trials with a total of 555 participants. Three trials compared models of enhanced care in the inpatient setting with conventional care. Two trials compared an enhanced care model provided in inpatient settings and at home after discharge with conventional care. Two trials compared geriatrician-led care in-hospital to conventional care led by the orthopaedic team. None of the interventions were designed specifically for people with dementia, therefore the data included in the review were from subgroups of people with dementia or cognitive impairment participating in randomised controlled trials investigating models of care for all older people following hip fracture. The end of follow-up in the trials ranged from the point of acute hospital discharge to 24 months after discharge.\nWe considered all trials to be at high risk of bias in more than one domain. As subgroups of larger trials, the analyses lacked power to detect differences between the intervention groups. Furthermore, there were some important differences in baseline characteristics of participants between the experimental and control groups. Using the GRADE approach, we downgraded the certainty of the evidence for all outcomes to low or very low.\nThe effect estimates for almost all comparisons were very imprecise, and the overall certainty for most results was very low. There were no data from any study for our primary outcome of health-related quality of life. There was only very low certainty for our other primary outcome, activities of daily living and functional performance, therefore we were unable to draw any conclusions with confidence. There was low-certainty that enhanced care and rehabilitation in-hospital may reduce rates of postoperative delirium (odds ratio 0.04, 95% confidence interval (CI) 0.01 to 0.22, 2 trials, n = 141) and very low-certainty associating it with lower rates of some other complications. There was also low-certainty that, compared to orthopaedic-led management, geriatrician-led management may lead to shorter hospital stays (mean difference 4.00 days, 95% CI 3.61 to 4.39, 1 trial, n = 162).\nAuthors' conclusions\nWe found limited evidence that some of the models of enhanced rehabilitation and care used in the included trials may show benefits over usual care for preventing delirium and reducing length of stay for people with dementia who have been treated for hip fracture. However, the certainty of these results is low. Data were available from only a small number of trials, and the certainty for all other results is very low. Determining the optimal strategies to improve outcomes for this growing population of patients should be a research priority.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There may be some benefits from the care models studied, but the currently available research is insufficient to determine the best ways to care for people with dementia after a hip fracture operation."
}
] |
query-laysum
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6825
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[
{
"role": "user",
"content": "Abstract: Background\nDiet plays a major role in the aetiology of cardiovascular disease (CVD) and as a modifiable risk factor is the focus of many prevention strategies. Recently vegan diets have gained popularity and there is a need to synthesise existing clinical trial evidence for their potential in CVD prevention.\nObjectives\nTo determine the effectiveness of following a vegan dietary pattern for the primary and secondary prevention of CVD.\nSearch methods\nWe searched the following electronic databases on 4 February 2020: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Web of Science Core Collection. We also searched ClinicalTrials.gov in January 2021. We applied no language restrictions.\nSelection criteria\nWe selected randomised controlled trials (RCTs) in healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention). A vegan dietary pattern excludes meat, fish, eggs, dairy and honey; the intervention could be dietary advice, provision of relevant foods, or both. The comparison group received either no intervention, minimal intervention, or another dietary intervention. Outcomes included clinical events and CVD risk factors. We included only studies with follow-up periods of 12 weeks or more, defined as the intervention period plus post-intervention follow-up.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data and assessed risks of bias. We used GRADE to assess the certainty of the evidence. We conducted three main comparisons:\n1. Vegan dietary intervention versus no intervention or minimal intervention for primary prevention;\n2. Vegan dietary intervention versus another dietary intervention for primary prevention;\n3. Vegan dietary intervention versus another dietary intervention for secondary prevention.\nMain results\nThirteen RCTs (38 papers, 7 trial registrations) and eight ongoing trials met our inclusion criteria. Most trials contributed to primary prevention: comparisons 1 (four trials, 466 participants randomised) and comparison 2 (eight trials, 409 participants randomised). We included only one secondary prevention trial for comparison 3 (63 participants randomised).\nNone of the trials reported on clinical endpoints. Other primary outcomes included lipid levels and blood pressure.\nFor comparison 1 there was moderate-certainty evidence from four trials with 449 participants that a vegan diet probably led to a small reduction in total cholesterol (mean difference (MD) −0.24 mmol/L, 95% confidence interval (CI) −0.36 to −0.12) and low-density lipoprotein (LDL) cholesterol (MD −0.22 mmol/L, 95% CI −0.32 to −0.11), a very small decrease in high-density lipoprotein (HDL) levels (MD −0.08 mmol/L, 95% CI −0.11 to −0.04) and a very small increase in triglyceride levels (MD 0.11 mmol/L, 95% CI 0.01 to 0.21). The very small changes in HDL and triglyceride levels are in the opposite direction to that expected. There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI −1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD −0.27 mmHg, 95% CI −1.67 to 1.12; 3 trials, 372 participants) (low-certainty evidence).\nFor comparison 2 there was a lack of evidence for an effect of the vegan dietary intervention on total cholesterol levels (MD −0.04 mmol/L, 95% CI −0.28 to 0.20; 4 trials, 163 participants; low-certainty evidence). There was probably little or no effect of the vegan dietary intervention on LDL (MD −0.05 mmol/L, 95% CI −0.21 to 0.11; 4 trials, 244 participants) or HDL cholesterol levels (MD −0.01 mmol/L, 95% CI −0.08 to 0.05; 5 trials, 256 participants) or triglycerides (MD 0.21 mmol/L, 95% CI −0.07 to 0.49; 5 trials, 256 participants) compared to other dietary interventions (moderate-certainty evidence). We are very uncertain about any effect of the vegan dietary intervention on systolic blood pressure (MD 0.02 mmHg, 95% CI −3.59 to 3.62) or diastolic blood pressure (MD 0.63 mmHg, 95% CI −1.54 to 2.80; 5 trials, 247 participants (very low-certainty evidence)).\nOnly one trial (63 participants) contributed to comparison 3, where there was a lack of evidence for an effect of the vegan dietary intervention on lipid levels or blood pressure compared to other dietary interventions (low- or very low-certainty evidence).\nFour trials reported on adverse events, which were absent or minor.\nAuthors' conclusions\nStudies were generally small with few participants contributing to each comparison group. None of the included studies report on CVD clinical events. There is currently insufficient information to draw conclusions about the effects of vegan dietary interventions on CVD risk factors. The eight ongoing studies identified will add to the evidence base, with all eight reporting on primary prevention. There is a paucity of evidence for secondary prevention.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most studies had limitations in study design, so the evidence should be interpreted cautiously. In particular, the overall number of people who took part in the studies was too small to rule out the possibility of chance findings, and too small to pick up any differences in effect on our measures."
}
] |
query-laysum
|
6826
|
[
{
"role": "user",
"content": "Abstract: Background\nElbow supracondylar fractures are common, with treatment decisions based on fracture displacement. However, there remains controversy regarding the best treatments for this injury.\nObjectives\nTo assess the effects (benefits and harms) of interventions for treating supracondylar elbow fractures in children.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase in March 2021. We also searched trial registers and reference lists. We applied no language or publication restrictions.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials comparing different interventions for the treatment of supracondylar elbow fractures in children. We included studies investigating surgical interventions (different fixation techniques and different reduction techniques), surgical versus non-surgical treatment, traction types, methods of non-surgical intervention, and timing and location of treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We collected data and conducted GRADE assessment for five critical outcomes: functional outcomes, treatment failure (requiring re-intervention), nerve injury, major complications (pin site infection in most studies), and cosmetic deformity (cubitus varus).\nMain results\nWe included 52 trials with 3594 children who had supracondylar elbow fractures; most were Gartland 2 and 3 fractures. The mean ages of children ranged from 4.9 to 8.4 years and the majority of participants were boys. Most studies (33) were conducted in countries in South-East Asia.\nWe identified 12 different comparisons of interventions: retrograde lateral wires versus retrograde crossed wires; lateral crossed (Dorgan) wires versus retrograde crossed wires; retrograde lateral wires versus lateral crossed (Dorgan) wires; retrograde crossed wires versus posterior intrafocal wires; retrograde lateral wires in a parallel versus divergent configuration; retrograde crossed wires using a mini-open technique or inserted percutaneously; buried versus non-buried wires; external versus internal fixation; open versus closed reduction; surgical fixation versus non-surgical immobilisation; skeletal versus skin traction; and collar and cuff versus backslab.\nWe report here the findings of four comparisons that represent the most substantial body of evidence for the most clinically relevant comparisons.\nAll studies in these four comparisons had unclear risks of bias in at least one domain. We downgraded the certainty of all outcomes for serious risks of bias, for imprecision when evidence was derived from a small sample size or had a wide confidence interval (CI) that included the possibility of benefits or harms for both treatments, and when we detected the possibility of publication bias.\nRetrograde lateral wires versus retrograde crossed wires (29 studies, 2068 children)\nThere was low-certainty evidence of less nerve injury with retrograde lateral wires (RR 0.65, 95% CI 0.46 to 0.90; 28 studies, 1653 children). In a post hoc subgroup analysis, we noted a greater difference in the number of children with nerve injuries when lateral wires were compared to crossed wires inserted with a percutaneous medial wire technique (RR 0.41, 95% CI 0.20 to 0.81, favours lateral wires; 10 studies, 552 children), but little difference when an open technique was used (RR 0.91, 95% CI 0.59 to 1.40, favours lateral wires; 11 studies, 656 children). Although we noted a statistically significant difference between these subgroups from the interaction test (P = 0.05), we could not rule out the possibility that other factors could account for this difference.\nWe found little or no difference between the interventions in major complications, which were described as pin site infections in all studies (RR 1.08, 95% CI 0.65 to 1.79; 19 studies, 1126 children; low-certainty evidence). For functional status (1 study, 35 children), treatment failure requiring re-intervention (1 study, 60 children), and cosmetic deformity (2 studies, 95 children), there was very low-certainty evidence showing no evidence of a difference between interventions.\nOpen reduction versus closed reduction (4 studies, 295 children)\nType of reduction method may make little or no difference to nerve injuries (RR 0.30, 95% CI 0.09 to 1.01, favours open reduction; 3 studies, 163 children). However, there may be fewer major complications (pin site infections) when closed reduction is used (RR 4.15, 95% CI 1.07 to 16.20; 4 studies, 253 children). The certainty of the evidence for these outcomes is low. No studies reported functional outcome, treatment failure requiring re-intervention, or cosmetic deformity. The four studies in this comparison used direct visualisation during surgery. One additional study used a joystick technique for reduction, and we did not combine data from this study in analyses.\nSurgical fixation using wires versus non-surgical immobilisation using a cast (3 studies, 140 children)\nThere was very low-certainty evidence showing little or no difference between interventions for treatment failure requiring re-intervention (1 study, 60 children), nerve injury (3 studies, 140 children), major complications (3 studies, 126 children), and cosmetic deformity (2 studies, 80 children). No studies reported functional outcome.\nBackslab versus sling (1 study, 50 children)\nNo nerve injuries or major complications were experienced by children in either group; this evidence is of very low certainty. Functional outcome, treatment failure, and cosmetic deformity were not reported.\nAuthors' conclusions\nWe found insufficient evidence for many treatments of supracondylar fractures. Fixation of displaced supracondylar fractures with retrograde lateral wires compared with crossed wires provided the most substantial body of evidence in this review, and our findings indicate that there may be a lower risk of nerve injury with retrograde lateral wires. In future trials of treatments, we would encourage the adoption of a core outcome set, which includes patient-reported measures. Evaluation of the effectiveness of traction compared with surgical fixation would provide a valuable addition to this clinical field.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "- A child with a supracondylar elbow fracture (a broken bone in the upper elbow, approximately 5 cm above the elbow joint) may have a lower risk of nerve injury if two or more wires are inserted from the outside of the elbow rather than having one wire inserted from the inside of the elbow and one from the outside (crossed wires). The method used by the doctor to manually move the bones back into position may not increase or reduce the risk of nerve injury, but using a closed method may reduce the risk of an infection.\n- Because we did not find enough studies about other treatments for these elbow fractures, their benefits and risks are unclear.\n- More, well-designed studies are needed to give better estimates of the benefits and harms of other treatments. These studies should focus on outcomes related to elbow movement, as well as quality of life and how upset the child is."
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query-laysum
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6827
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[
{
"role": "user",
"content": "Abstract: Background\nAdrenaline and vasopressin are widely used to treat people with cardiac arrest, but there is uncertainty about the safety, effectiveness and the optimal dose.\nObjectives\nTo determine whether adrenaline or vasopressin, or both, administered during cardiac arrest, afford any survival benefit.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase and DARE from their inception to 8 May 2018, and the International Liaison Committee on Resuscitation 2015 Advanced Life Support Consensus on Science and Treatment Recommendations. We also searched four trial registers on 5 September 2018 and checked the reference lists of the included studies and review papers to identify potential papers for review.\nSelection criteria\nAny randomised controlled trial comparing: standard-dose adrenaline versus placebo; standard-dose adrenaline versus high-dose adrenaline; and adrenaline versus vasopressin, in any setting, due to any cause of cardiac arrest, in adults and children. There were no language restrictions.\nData collection and analysis\nTwo review authors independently identified trials for review, assessed risks of bias and extracted data, resolving disagreements through re-examination of the trial reports and by discussion. We used risk ratios (RRs) with 95% confidence intervals (CIs) to compare dichotomous outcomes for clinical events. There were no continuous outcomes reported. We examined groups of trials for heterogeneity. We report the quality of evidence for each outcome, using the GRADE approach.\nMain results\nWe included 26 studies (21,704 participants).\nModerate-quality evidence found that adrenaline increased survival to hospital discharge compared to placebo (RR 1.44, 95% CI 1.11 to 1.86; 2 studies, 8538 participants; an increase from 23 to 32 per 1000, 95% CI 25 to 42). We are uncertain about survival to hospital discharge for high-dose compared to standard-dose adrenaline (RR 1.10, 95% CI 0.75 to 1.62; participants = 6274; studies = 10); an increase from 33 to 36 per 1000, 95% CI 24 to 53); standard-dose adrenaline versus vasopressin (RR 1.25, 95% CI 0.84 to 1.85; 6 studies; 2511 participants; an increase from 72 to 90 per 1000, 95% CI 60 to 133); and standard-dose adrenaline versus vasopressin plus adrenaline (RR 0.76, 95% CI 0.47 to 1.22; 3 studies; 3242 participants; a possible decrease from 24 to 18 per 1000, 95% CI 11 to 29), due to very low-quality evidence.\nModerate-quality evidence found that adrenaline compared with placebo increased survival to hospital admission (RR 2.51, 95% CI 1.67 to 3.76; 2 studies, 8489 participants; an increase from 83 to 209 per 1000, 95% CI 139 to 313). We are uncertain about survival to hospital admission when comparing standard-dose with high-dose adrenaline, due to very low-quality evidence. Vasopressin may improve survival to hospital admission when compared with standard-dose adrenaline (RR 1.27, 95% CI 1.04 to 1.54; 3 studies, 1953 participants; low-quality evidence; an increase from 260 to 330 per 1000, 95% CI 270 to 400), and may make little or no difference when compared to standard-dose adrenaline plus vasopressin (RR 0.95, 95% CI 0.83 to 1.08; 3 studies; 3249 participants; low-quality evidence; a decrease from 218 to 207 per 1000 (95% CI 181 to 236).\nThere was no evidence that adrenaline (any dose) or vasopressin improved neurological outcomes.\nThe rate of return of spontaneous circulation (ROSC) was higher for standard-dose adrenaline versus placebo (RR 2.86, 95% CI 2.21 to 3.71; participants = 8663; studies = 3); moderate-quality evidence; an increase from 115 to 329 per 1000, 95% CI 254 to 427). We are uncertain about the effect on ROSC for the comparison of standard-dose versus high-dose adrenaline and standard-does adrenaline compared to vasopressin, due to very low-quality evidence. Standard-dose adrenaline may make little or no difference to ROSC when compared to standard-dose adrenaline plus vasopressin (RR 0.97, 95% CI 0.87 to 1.08; 3 studies, 3249 participants; low-quality evidence; a possible decrease from 299 to 290 per 1000, 95% CI 260 to 323).\nThe source of funding was not stated in 11 of the 26 studies. The study drugs were provided by the manufacturer in four of the 26 studies, but neither drug represents a profitable commercial option. The other 11 studies were funded by organisations such as research foundations and government funding bodies.\nAuthors' conclusions\nThis review provides moderate-quality evidence that standard-dose adrenaline compared to placebo improves return of spontaneous circulation, survival to hospital admission and survival to hospital discharge, but low-quality evidence that it did not affect survival with a favourable neurological outcome. Very low -quality evidence found that high-dose adrenaline compared to standard-dose adrenaline improved return of spontaneous circulation and survival to admission. Vasopressin compared to standard dose adrenaline improved survival to admission but not return of spontaneous circulation, whilst the combination of adrenaline and vasopressin compared with adrenaline alone had no effect on these outcomes. Neither standard dose adrenaline, high-dose adrenaline,vasopressin nor a combination of adrenaline and vasopressin improved survival with a favourable neurological outcome. Many of these studies were conducted more than 20 years ago. Treatment has changed in recent years, so the findings from older studies may not reflect current practice.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The source of funding was not stated in 11 of the 26 studies. The study drugs were provided by the manufacturer in four of the 26 studies, but neither drug represents a profitable commercial option. The other 11 studies were funded by organisations such as research foundations and government funding bodies."
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query-laysum
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6828
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[
{
"role": "user",
"content": "Abstract: Background\nThe partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a pictorial overview of labour, and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. Charts have traditionally contained pre-printed alert and action lines. An alert line, which is based on the slowest 10% of primigravid women's labours, signifies slow progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.\nThis review is an update of a review last published in 2013.\nObjectives\nThe primary objective was to determine the effectiveness and safety of partograph use on perinatal and maternal morbidity and mortality. The secondary objective was to determine which partograph design is most effective for perinatal and maternal morbidity and mortality outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 August 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised, cluster-randomised, and quasi-randomised controlled trials involving a comparison of partograph use with no partograph, or comparison between different partograph designs.\nData collection and analysis\nThree review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining review authors assessed the studies independently. We assessed the evidence using the GRADE approach.\nMain results\nWe have included 11 studies, involving 9475 women in this review; three studies assessed partograph use versus no partograph, seven assessed different partograph designs, and one assessed partograph use versus labour scale. Risk of bias varied in all studies. It was infeasible to blind staff or women to the intervention. Two studies did not adequately conceal allocation. Loss to follow-up was low in all studies. We assessed the evidence for partograph use versus no partograph using the GRADE approach; downgrading decisions were due to study design, inconsistency, indirectness, and imprecision of effect estimates.\nMost trials reported caesarean section rates and Apgar scores less than 7 at five minutes; all other outcomes were not consistently reported (e.g. duration of first stage of labour and maternal experience of childbirth).\nPartograph versus no partograph (3 trials, 1813 women)\nIt is uncertain whether there is any clear difference between partograph use and no partograph in caesarean section rates (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.40 to 1.46; n = 1813; 3 trials; I² = 87%; very low-quality evidence); oxytocin augmentation (RR 1.02, 95% CI 0.95 to 1.10; n = 1156; 1 trial; moderate-quality evidence); duration of first stage of labour (mean difference (MD) 0.80 hours, 95% CI -0.06 to 1.66; n = 1156; 1 trial; low-quality evidence); or Apgar score less than 7 at five minutes (RR 0.76, 95% CI 0.29 to 2.03; n = 1596; 2 trials; I² = 87%; very low-quality evidence).\nPartograph with different placement of action lines (4 trials, 5051 women)\nWhen compared to a four-hour action line, women in the two-hour action line group were more likely to receive oxytocin augmentation (average RR 2.44, 95% CI 1.36 to 4.35; n = 4749; 4 trials; I² = 96%). There was no clear difference in caesarean section rates (RR 1.06, 95% CI 0.88 to 1.28; n = 4749; 4 trials); duration of first stage of labour (RR 0.81 hours, 95% CI 0.32 to 2.04; n = 948; 1 trial); maternal experience of childbirth (average RR 0.61, 95% CI 0.28 to 1.35; n = 2269; 2 trials; I² = 83%); or Apgar score less than 7 at five minutes (RR 0.93, 95% CI 0.61 to 1.42; n = 4749; 4 trials) between the two- and four-hour action line.\nThe following comparisons only include data from single studies. Fewer women reported negative childbirth experiences in the two-hour action line group compared to the three-hour action line group (RR 0.49, 95% CI 0.27 to 0.90; n = 348; 1 trial). When we compared the three- and four-hour action line groups, the caesarean section rate was higher in the three-hour action line group (RR 1.70, 95% CI 1.07 to 2.70; n = 613; 1 trial). We did not observe any clear differences in any of the other outcomes in these comparisons.\nPartograph with alert line only versus partograph with alert and action line (1 trial, 694 women)\nThe caesarean section rate was lower in the alert line only group (RR 0.68, 95% CI 0.50 to 0.93). There were no clear differences between groups for oxytocin augmentation, low Apgar score, instrumental vaginal birth and perinatal death.\nPartograph with latent phase (composite) versus partograph without latent phase (modified) (1 trial, 743 women)\nThe caesarean section and oxytocin augmentation rates were higher in the partograph with a latent phase (RR 2.45, 95% CI 1.72 to 3.50; and RR 2.18, 95% CI 1.67 to 2.83, respectively). There were no clear differences between groups for oxytocin augmentation, and Apgar score less than 7 at five minutes.\nPartograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women)\nFewer women received oxytocin augmentation in the dystocia line group (RR 0.62, 95% CI 0.39 to 0.98). We did not observe any clear differences in any of the other primary outcomes in this comparison.\nPartograph versus labour scale (1 trial, 122 women)\nThe use of the partograph compared with the labour scale resulted in fewer women receiving oxytocin augmentation (RR 0.32, 95% CI 0.18 to 0.54), but did not produce any clear differences for any of the other primary outcomes.\nAuthors' conclusions\nOn the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour management and care, or which design, if any, are most effective. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "A partograph is usually a pre-printed form, the aim of which is to provide a pictorial overview of labour progress and to alert health professionals to any problems with the mother or baby. It has been unclear whether a partograph should be used and, if so, which design of partograph is better for women and babies."
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query-laysum
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6829
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[
{
"role": "user",
"content": "Abstract: Background\nBurn injuries are an important health problem. They occur frequently in the head and neck region. The face is the area central to a person's identity that provides our most expressive means of communication. Topical interventions are currently the cornerstone of treatment of burns to the face.\nObjectives\nTo assess the effects of topical interventions on wound healing in people with facial burns of any depth.\nSearch methods\nIn December 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nRandomised controlled trials (RCTs) that evaluated the effects of topical treatment for facial burns were eligible for inclusion in this review.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction, risk of bias assessment and GRADE assessment of the certainty of the evidence.\nMain results\nIn this first update, we included 12 RCTs, comprising 507 participants.\nMost trials included adults admitted to specialised burn centres after recent burn injuries.\nTopical agents included antimicrobial agents (silver sulphadiazine (SSD), Aquacel-Ag, cerium-sulphadiazine, gentamicin cream, mafenide acetate cream, bacitracin), non-antimicrobial agents (Moist Exposed Burn Ointment (MEBO), saline-soaked dressings, skin substitutes (including bioengineered skin substitute (TransCyte), allograft, and xenograft (porcine Xenoderm), and miscellaneous treatments (growth hormone therapy, recombinant human granulocyte-macrophage colony-stimulating factor hydrogel (rhGMCS)), enzymatic debridement, and cream with Helix Aspersa extract).\nAlmost all the evidence included in this review was assessed as low or very low-certainty, often because of high risk of bias due to unclear randomisation procedures (i.e. sequence generation and allocation concealment); lack of blinding of participants, providers and sometimes outcome assessors; and imprecision resulting from few participants, low event rates or both, often in single studies.\nTopical antimicrobial agents versus topical non-antimicrobial agents\nThere is moderate-certainty evidence that there is probably little or no difference between antimicrobial agents and non-antimicrobial agents (SSD and MEBO) in time to complete wound healing (hazard ratio (HR) 0.84 (95% confidence interval (CI) 0.78 to 1.85, 1 study, 39 participants). Topical antimicrobial agents may make little or no difference to the proportion of wounds completely healed compared with topical non-antimicrobial agents (comparison SSD and MEBO, risk ratio (RR) 0.94, 95% CI 0.68 to 1.29; 1 study, 39 participants; low-certainty evidence). We are uncertain whether there is a difference in wound infection (comparison topical antimicrobial agent (Aquacel-Ag) and MEBO; RR 0.38, 95% CI 0.12 to 1.21; 1 study, 40 participants; very low-certainty evidence). No trials reported change in wound surface area over time or partial wound healing. There is low-certainty evidence for the secondary outcomes scar quality and patient satisfaction. Two studies assessed pain but it was incompletely reported.\nTopical antimicrobial agents versus other topical antimicrobial agents\nIt is uncertain whether topical antimicrobial agents make any difference in effects as the evidence is low to very low-certainty. For primary outcomes, there is low-certainty evidence for time to partial (i.e. greater than 90%) wound healing (comparison SSD versus cerium SSD: mean difference (MD) –7.10 days, 95% CI –16.43 to 2.23; 1 study, 142 participants). There is very low-certainty evidence regarding whether topical antimicrobial agents make a difference to wound infection (RR 0.73, 95% CI 0.46 to 1.17; 1 study, 15 participants). There is low to very low-certainty evidence for the proportion of facial burns requiring surgery, pain, scar quality, adverse effects and length of hospital stay.\nSkin substitutes versus topical antimicrobial agents\nThere is low-certainty evidence that a skin substitute may slightly reduce time to partial (i.e. greater than 90%) wound healing, compared with a non-specified antibacterial agent (MD –6.00 days, 95% CI –8.69 to –3.31; 1 study, 34 participants).\nWe are uncertain whether skin substitutes in general make any other difference in effects as the evidence is very low certainty. Outcomes included wound infection, pain, scar quality, adverse effects of treatment and length of hospital stay.\nSingle studies showed contrasting low-certainty evidence. A bioengineered skin substitute may slightly reduce procedural pain (MD –4.00, 95% CI –5.05 to –2.95; 34 participants) and background pain (MD –2.00, 95% CI –3.05 to –0.95; 34 participants) compared with an unspecified antimicrobial agent. In contrast, a biological dressing (porcine Xenoderm) might slightly increase pain in superficial burns (MD 1.20, 95% CI 0.65 to 1.75; 15 participants (30 wounds)) as well as deep partial thickness burns (MD 3.00, 95% CI 2.34 to 3.66; 10 participants (20 wounds)), compared with antimicrobial agents (Physiotulle Ag (Coloplast)).\nMiscellaneous treatments versus miscellaneous treatments\nSingle studies show low to very low-certainty effects of interventions. Low-certainty evidence shows that MEBO may slightly reduce time to complete wound healing compared with saline soaked dressing (MD –1.7 days, 95% CI –3.32 to –0.08; 40 participants). In addition, a cream containing Helix Aspersa may slightly increase the proportion of wounds completely healed at 14 days compared with MEBO (RR 4.77, 95% CI 1.87 to 12.15; 43 participants). We are uncertain whether any miscellaneous treatment in the included studies makes a difference in effects for the outcomes wound infection, scar quality, pain and patient satisfaction as the evidence is low to very low-certainty.\nAuthors' conclusions\nThere is mainly low to very low-certainty evidence on the effects of any topical intervention on wound healing in people with facial burns. The number of RCTs in burn care is growing, but the body of evidence is still hampered due to an insufficient number of studies that follow appropriate evidence-based standards of conducting and reporting RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We reviewed the evidence about the effects of topical (applied to the surface of the skin) treatments for healing burn wounds on the face or neck. We wanted to find out which treatments were most effective at healing these wounds and improving the appearance of scars, which is a particularly important issue in relation to facial burn injuries. We also wanted to find out how topical treatments affected the risk of complications such as infection and pain, and how they impacted on peoples' quality of life."
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query-laysum
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6830
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[
{
"role": "user",
"content": "Abstract: Background\nJellyfish envenomation is common in many coastal regions and varies in severity depending upon the species. Stings cause a variety of symptoms and signs including pain, dermatological reactions, and, in some species, Irukandji syndrome (which may include abdominal/back/chest pain, tachycardia, hypertension, cardiac phenomena, and, rarely, death). Many treatments have been suggested for these symptoms, but their effectiveness is unclear. This is an update of a Cochrane Review last published in 2013.\nObjectives\nTo determine the benefits and harms associated with the use of any intervention, in both adults and children, for the treatment of jellyfish stings, as assessed by randomised and quasi-randomised trials.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and Web of Science up to 27 October 2022. We searched clinical trials registers and the grey literature, and conducted forward-citation searching of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs of any intervention given to treat stings from any species of jellyfish stings. Interventions were compared to another active intervention, placebo, or no treatment. If co-interventions were used, we included the study only if the co-intervention was used in each group.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included nine studies (six RCTs and three quasi-RCTs) involving a total of 574 participants. We found one ongoing study. Participants were either stung accidentally, or were healthy volunteers exposed to stings in a laboratory setting. Type of jellyfish could not be confirmed in beach settings and was determined by investigators using participant and local information.\nWe categorised interventions into comparison groups: hot versus cold applications; topical applications. A third comparison of parenteral administration included no relevant outcome data: a single study (39 participants) evaluated intravenous magnesium sulfate after stings from jellyfish that cause Irukandji syndrome (Carukia). No studies assessed a fourth comparison group of pressure immobilisation bandages.\nWe downgraded the certainty of the evidence due to very serious risk of bias, serious and very serious imprecision, and serious inconsistency in some results.\nApplication of heat versus application of cold\nFour studies involved accidental stings treated on the beach or in hospital. Jellyfish were described as bluebottles (Physalia; location: Australia), and box jellyfish that do not cause Irukandji syndrome (Hawaiian box jellyfish (Carybdea alata) and major box jellyfish (Chironex fleckeri, location: Australia)). Treatments were applied with hot packs or hot water (showers, baths, buckets, or hoses), or ice packs or cold packs.\nThe evidence for all outcomes was of very low certainty, thus we are unsure whether heat compared to cold leads to at least a clinically significant reduction in pain within six hours of stings from Physalia (risk ratio (RR) 2.25, 95% confidence interval (CI) 1.42 to 3.56; 2 studies, 142 participants) or Carybdea alata and Chironex fleckeri (RR 1.66, 95% CI 0.56 to 4.94; 2 studies, 71 participants). We are unsure whether there is a difference in adverse events due to treatment (RR 0.50, 95% CI 0.05 to 5.19; 2 studies, 142 participants); these were minor adverse events reported for Physalia stings. We are also unsure whether either treatment leads to a clinically significant reduction in pain in the first hour (Physalia: RR 2.66, 95% CI 1.71 to 4.15; 1 study, 88 participants; Carybdea alata and Chironex fleckeri: RR 1.16, 95% CI 0.71 to 1.89; 1 study, 42 participants) or cessation of pain at the end of treatment (Physalia: RR 1.63, 95% CI 0.81 to 3.27; 1 study, 54 participants; Carybdea alata and Chironex fleckeri: RR 3.54, 95% CI 0.82 to 15.31; 1 study, 29 participants). Evidence for retreatment with the same intervention was only available for Physalia, with similar uncertain findings (RR 0.19, 95% CI 0.01 to 3.90; 1 study, 96 participants), as was the case for retreatment with the alternative hot or cold application after Physalia (RR 1.00, 95% CI 0.55 to 1.82; 1 study, 54 participants) and Chironex fleckeri stings (RR 0.48, 95% CI 0.02 to 11.17; 1 study, 42 participants). Evidence for dermatological signs (itchiness or rash) was available only at 24 hours for Physalia stings (RR 1.02, 95% CI 0.63 to 1.65; 2 studies, 98 participants).\nTopical applications\nOne study (62 participants) included accidental stings from Hawaiian box jellyfish (Carybdea alata) treated on the beach with fresh water, seawater, Sting Aid (a commercial product), or Adolph's (papain) meat tenderiser. In another study, healthy volunteers (97 participants) were stung with an Indonesian sea nettle (Chrysaora chinensis from Malaysia) in a laboratory setting and treated with isopropyl alcohol, ammonia, heated water, acetic acid, or sodium bicarbonate. Two other eligible studies (Carybdea alata and Physalia stings) did not measure the outcomes of this review.\nThe evidence for all outcomes was of very low certainty, thus we could not be certain whether or not topical applications provided at least a clinically significant reduction in pain (1 study, 62 participants with Carybdea alata stings, reported only as cessation of pain). For adverse events due to treatment, one study (Chrysaora chinensis stings) withdrew ammonia as a treatment following a first-degree burn in one participant. No studies evaluated clinically significant reduction in pain, retreatment with the same or the alternative treatment, or dermatological signs.\nAuthors' conclusions\nFew studies contributed data to this review, and those that did contribute varied in types of treatment, settings, and range of jellyfish species. We are unsure of the effectiveness of any of the treatments evaluated in this review given the very low certainty of all the evidence. This updated review includes two new studies (with 139 additional participants). The findings are consistent with the previous review.\n\nGiven the provided abstract, please respond to the following query: \"Topical treatments\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Four studies compared topical treatments that were applied to the skin on and around the sting site. In one study, people were treated on the beach after accidental stings by Hawaiian box jellyfish in Hawaii. In the remaining three studies, people volunteered to be stung in a laboratory setting.\nTreatments included: fresh water, seawater, Sting Aid (a commercial product), Adolph's meat tenderiser (papain, an enzyme present in papaya), isopropyl alcohol, ammonia, heated water, acetic acid, or sodium bicarbonate. In some of these treatments, vinegar was also applied to the sting site.\nDue to our low confidence in the available evidence, we cannot tell whether applying any of these treatments to a jellyfish sting reduces or stops pain within six hours of treatment, or causes harm. One study withdrew a treatment (ammonia) because one participant had a chemical burn after this treatment. This finding relates directly to the types of jellyfish described in this section. These studies did not measure retreatment, switching to alternative study treatment, or skin reactions."
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query-laysum
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6831
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[
{
"role": "user",
"content": "Abstract: Background\nFinancial incentives, monetary or vouchers, are widely used in an attempt to precipitate, reinforce and sustain behaviour change, including smoking cessation. They have been used in workplaces, in clinics and hospitals, and within community programmes.\nObjectives\nTo determine the long-term effect of incentives and contingency management programmes for smoking cessation.\nSearch methods\nFor this update, we searched the Cochrane Tobacco Addiction Group Specialised Register, clinicaltrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The most recent searches were conducted in July 2018.\nSelection criteria\nWe considered only randomised controlled trials, allocating individuals, workplaces, groups within workplaces, or communities to smoking cessation incentive schemes or control conditions. We included studies in a mixed-population setting (e.g. community, work-, clinic- or institution-based), and also studies in pregnant smokers.\nData collection and analysis\nWe used standard Cochrane methods. The primary outcome measure in the mixed-population studies was abstinence from smoking at longest follow-up (at least six months from the start of the intervention). In the trials of pregnant women we used abstinence measured at the longest follow-up, and at least to the end of the pregnancy. Where available, we pooled outcome data using a Mantel-Haenzel random-effects model, with results reported as risk ratios (RRs) and 95% confidence intervals (CIs), using adjusted estimates for cluster-randomised trials. We analysed studies carried out in mixed populations separately from those carried out in pregnant populations.\nMain results\nThirty-three mixed-population studies met our inclusion criteria, covering more than 21,600 participants; 16 of these are new to this version of the review. Studies were set in varying locations, including community settings, clinics or health centres, workplaces, and outpatient drug clinics. We judged eight studies to be at low risk of bias, and 10 to be at high risk of bias, with the rest at unclear risk. Twenty-four of the trials were run in the USA, two in Thailand and one in the Phillipines. The rest were European. Incentives offered included cash payments or vouchers for goods and groceries, offered directly or collected and redeemable online. The pooled RR for quitting with incentives at longest follow-up (six months or more) compared with controls was 1.49 (95% CI 1.28 to 1.73; 31 RCTs, adjusted N = 20,097; I2 = 33%). Results were not sensitive to the exclusion of six studies where an incentive for cessation was offered at long-term follow up (result excluding those studies: RR 1.40, 95% CI 1.16 to 1.69; 25 RCTs; adjusted N = 17,058; I2 = 36%), suggesting the impact of incentives continues for at least some time after incentives cease.\nAlthough not always clearly reported, the total financial amount of incentives varied considerably between trials, from zero (self-deposits), to a range of between USD 45 and USD 1185. There was no clear direction of effect between trials offering low or high total value of incentives, nor those encouraging redeemable self-deposits.\nWe included 10 studies of 2571 pregnant women. We judged two studies to be at low risk of bias, one at high risk of bias, and seven at unclear risk. When pooled, the nine trials with usable data (eight conducted in the USA and one in the UK), delivered an RR at longest follow-up (up to 24 weeks post-partum) of 2.38 (95% CI 1.54 to 3.69; N = 2273; I2 = 41%), in favour of incentives.\nAuthors' conclusions\nOverall there is high-certainty evidence that incentives improve smoking cessation rates at long-term follow-up in mixed population studies. The effectiveness of incentives appears to be sustained even when the last follow-up occurs after the withdrawal of incentives. There is also moderate-certainty evidence, limited by some concerns about risks of bias, that incentive schemes conducted among pregnant smokers improve smoking cessation rates, both at the end of pregnancy and post-partum. Current and future research might explore more precisely differences between trials offering low or high cash incentives and self-incentives (deposits), within a variety of smoking populations.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "General trials: Six months or more after the beginning of the trial, people receiving rewards were more likely to have stopped smoking than those in the control groups. Success rates continued beyond when the incentives had ended. Studies varied in the total amounts of rewards that were paid. There was no noticeable difference between trials paying smaller amounts (less than USD 100 (US dollars)) compared to those paying larger amounts (more than USD 700).\nPregnancy trials: Combining data from nine trials showed that women in the rewards groups were more likely to stop smoking than those in the control groups, both at the end of the pregnancy and after the birth of the baby."
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query-laysum
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6832
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[
{
"role": "user",
"content": "Abstract: Background\nCough causes concern for parents and is a major cause of outpatient visits. Cough can impact quality of life, cause anxiety, and affect sleep in children and their parents. Honey has been used to alleviate cough symptoms. This is an update of reviews previously published in 2014, 2012, and 2010.\nObjectives\nTo evaluate the effectiveness of honey for acute cough in children in ambulatory settings.\nSearch methods\nWe searched CENTRAL (2018, Issue 2), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (2014 to 8 February 2018), Embase (2014 to 8 February 2018), CINAHL (2014 to 8 February 2018), EBSCO (2014 to 8 February 2018), Web of Science (2014 to 8 February 2018), and LILACS (2014 to 8 February 2018). We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trial Registry Platform (WHO ICTRP) on 12 February 2018. The 2014 review included searches of AMED and CAB Abstracts, but these were not searched for this update due to lack of institutional access.\nSelection criteria\nRandomised controlled trials comparing honey alone, or in combination with antibiotics, versus no treatment, placebo, honey-based cough syrup, or other over-the-counter cough medications for children aged 12 months to 18 years for acute cough in ambulatory settings.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included six randomised controlled trials involving 899 children; we added three studies (331 children) in this update.\nWe assessed two studies as at high risk of performance and detection bias; three studies as at unclear risk of attrition bias; and three studies as at unclear risk of other bias.\nStudies compared honey with dextromethorphan, diphenhydramine, salbutamol, bromelin (an enzyme from the Bromeliaceae (pineapple) family), no treatment, and placebo. Five studies used 7-point Likert scales to measure symptomatic relief of cough; one used an unclear 5-point scale. In all studies, low score indicated better cough symptom relief.\nUsing a 7-point Likert scale, honey probably reduces cough frequency better than no treatment or placebo (no treatment: mean difference (MD) -1.05, 95% confidence interval (CI) -1.48 to -0.62; I² = 0%; 2 studies; 154 children; moderate-certainty evidence; placebo: MD -1.62, 95% CI -3.02 to -0.22; I² = 0%; 2 studies; 402 children; moderate-certainty evidence). Honey may have a similar effect as dextromethorphan in reducing cough frequency (MD -0.07, 95% CI -1.07 to 0.94; I² = 87%; 2 studies; 149 children; low-certainty evidence). Honey may be better than diphenhydramine in reducing cough frequency (MD -0.57, 95% CI -0.90 to -0.24; 1 study; 80 children; low-certainty evidence).\nGiving honey for up to three days is probably more effective in relieving cough symptoms compared with placebo or salbutamol. Beyond three days honey probably had no advantage over salbutamol or placebo in reducing cough severity, bothersome cough, and impact of cough on sleep for parents and children (moderate-certainty evidence). With a 5-point cough scale, there was probably little or no difference between the effects of honey and bromelin mixed with honey in reducing cough frequency and severity.\nAdverse events included nervousness, insomnia, and hyperactivity, experienced by seven children (9.3%) treated with honey and two children (2.7%) treated with dextromethorphan (risk ratio (RR) 2.94, 95% Cl 0.74 to 11.71; I² = 0%; 2 studies; 149 children; low-certainty evidence). Three children (7.5%) in the diphenhydramine group experienced somnolence (RR 0.14, 95% Cl 0.01 to 2.68; 1 study; 80 children; low-certainty evidence). When honey was compared with placebo, 34 children (12%) in the honey group and 13 (11%) in the placebo group complained of gastrointestinal symptoms (RR 1.91, 95% CI 1.12 to 3.24; I² = 0%; 2 studies; 402 children; moderate-certainty evidence). Four children who received salbutamol had rashes compared to one child in the honey group (RR 0.19, 95% CI 0.02 to 1.63; 1 study; 100 children; moderate-certainty evidence). No adverse events were reported in the no-treatment group.\nAuthors' conclusions\nHoney probably relieves cough symptoms to a greater extent than no treatment, diphenhydramine, and placebo, but may make little or no difference compared to dextromethorphan. Honey probably reduces cough duration better than placebo and salbutamol. There was no strong evidence for or against using honey. Most of the children received treatment for one night, which is a limitation to the results of this review. There was no difference in occurrence of adverse events between the honey and control arms.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched databases to 8 February 2018 and trial registers to 12 February 2018."
}
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query-laysum
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6833
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[
{
"role": "user",
"content": "Abstract: Background\nCurrent cancer care increasingly incorporates psychosocial interventions. Cancer patients use dance/movement therapy to learn to accept and reconnect with their bodies, build new self-confidence, enhance self-expression, address feelings of isolation, depression, anger and fear and to strengthen personal resources.\nObjectives\nTo update the previously published review that examined the effects of dance/movement therapy and standard care versus standard care alone or standard care and other interventions on psychological and physical outcomes in patients with cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 6), MEDLINE (OvidSP, 1950 to June week 4, 2014), EMBASE (OvidSP, 1980 to 2014 week 26), CINAHL (EBSCOhost, 1982 to July 15 2014), PsycINFO (EBSCOhost, 1806 to July 15 2014), LILACS (Virual Health Library, 1982 to July 15 2014), Science Citation Index (ISI, 1974 to July 15 2014), CancerLit (1983 to 2003), International Bibliography of Theatre and Dance (1989 to July 15 2014), the National Research Register (2000 to September 2007), Proquest Digital Dissertations, ClinicalTrials.gov, and Current Controlled Trials (all to July 15 2014). We handsearched dance/movement therapy and related topics journals, reviewed reference lists and contacted experts. There was no language restriction.\nSelection criteria\nWe included all randomized and quasi-randomized controlled trials of dance/movement therapy interventions for improving psychological and physical outcomes in patients with cancer. We considered studies only if dance/movement therapy was provided by a formally trained dance/movement therapist or by trainees in a formal dance/movement therapy program.\nData collection and analysis\nTwo review authors independently extracted the data and assessed the methodological quality, seeking additional information from the trial researchers when necessary. Results were presented using standardized mean differences.\nMain results\nWe identified one new trial for inclusion in this update. In total, the evidence for this review rests on three studies with a total of 207 participants.\nWe found no evidence for an effect of dance/movement therapy on depression (standardized mean difference (SMD) = 0.02, 95% confidence interval (CI) -0.28 to 0.32, P = 0.89, I2 = 0%) (two studies, N = 170), stress (SMD = -0.18, 95% CI -0.48 to 0.12, P = 0.24, I2 = 0%) (two studies, N = 170), anxiety (SMD = 0.21, 95% CI -0.09 to 0.51 P = 0.18, I2 = 0%) (two studies, N = 170), fatigue (SMD = -0.36, 95% -1.26 to 0.55, P = 0.44, I² = 80%) (two studies, N = 170) and body image (SMD = -0.13, 95% CI -0.61 to 0.34, P = 0.58, I2 = 0%) (two studies, N = 68) in women with breast cancer. The data of one study with moderate risk of bias suggested that dance/movement therapy had a large beneficial effect on 37 participants' quality of life (QoL) (SMD = 0.89, 95% CI 0.21 to 1.57). One study with a high risk of bias reported greater improvements in vigor and greater reduction in somatization in the dance/movement therapy group compared to a standard care control group (N = 31). The individual studies did not find support for an effect of dance/movement therapy on mood, mental health, and pain. It is unclear whether this was due to ineffectiveness of the treatment, inappropriate outcome measures or limited power of the trials. Finally, the results of one study did not find evidence for an effect of dance/movement therapy on shoulder range of motion (ROM) or arm circumference in 37 women who underwent a lumpectomy or breast surgery. However, this was likely due to large within-group variability for shoulder ROM and a limited number of participants with lymphedema.\nTwo studies presented moderate risk of bias and one study high risk of bias. Therefore, overall, the quality of the evidence is very low.\nAuthors' conclusions\nWe did not find support for an effect of dance/movement therapy on depression, stress, anxiety, fatigue and body image. The findings of individual studies suggest that dance/movement therapy may have a beneficial effect on QoL, somatization, and vigor. However, the limited number of studies prevents us from drawing conclusions concerning the effects of dance/movement therapy on psychological and physical outcomes in cancer patients.\n\nGiven the provided abstract, please respond to the following query: \"What are the main findings?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified one new study for this update. The three studies included a a total of 207 participants, which were women with breast cancer. The studies were small in size. We found no evidence of an effect for depression, stress, anxiety, fatigue, and body image. The findings of individual studies suggest that dance/movement therapy may have a beneficial effect on the quality of life, somatization (i.e. distress arising from perceptions of bodily dysfunction) and vigor of women with breast cancer. No adverse effects of dance/movement therapy interventions were reported."
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query-laysum
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6834
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[
{
"role": "user",
"content": "Abstract: Background\nSystem change interventions for smoking cessation are policies and practices designed by organizations to integrate the identification of smokers and the subsequent offering of evidence-based nicotine dependence treatments into usual care. Such strategies have the potential to improve the provision of smoking cessation support in healthcare settings, and cessation outcomes among those who use them.\nObjectives\nTo assess the effectiveness of system change interventions within healthcare settings, for increasing smoking cessation or the provision of smoking cessation care, or both.\nSearch methods\nWe searched databases including the Cochrane Tobacco Addiction Group Specialized Register, CENTRAL, MEDLINE, Embase, CINAHL, and PsycINFO in February 2016. We also searched clinical trial registries: WHO clinical trial registry, US National Institute of Health (NIH) clinical trial registry. We checked ‘grey' literature, and handsearched bibliographies of relevant papers and publications.\nSelection criteria\nRandomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs and interrupted time series studies that evaluated a system change intervention, which included identification of all smokers and subsequent offering of evidence-based nicotine dependence treatment.\nData collection and analysis\nUsing a standardized form, we extracted data from eligible studies on study settings, participants, interventions and outcomes of interest (both cessation and system-level outcomes). For cessation outcomes, we used the strictest available criteria to define abstinence. System-level outcomes included assessment and documentation of smoking status, provision of advice to quit or cessation counselling, referral and enrolment in quitline services, and prescribing of cessation medications. We assessed risks of bias according to the Cochrane Handbook and categorized each study as being at high, low or unclear risk of bias. We used a narrative synthesis to describe the effectiveness of the interventions on various outcomes, because of significant heterogeneity among studies.\nMain results\nWe included seven cluster-randomized controlled studies in this review. We rated the quality of evidence as very low or low, depending on the outcome, according to the GRADE standard. Evidence of efficacy was equivocal for abstinence from smoking at the longest follow-up (four studies), and for the secondary outcome ‘prescribing of smoking cessation medications' (two studies). Four studies evaluated changes in provision of smoking cessation counselling and three favoured the intervention. There were significant improvements in documentation of smoking status (one study), quitline referral (two studies) and quitline enrolment (two studies). Other secondary endpoints, such as asking about tobacco use (three studies) and advising to quit (three studies), also indicated some positive effects.\nAuthors' conclusions\nThe available evidence suggests that system change interventions for smoking cessation may not be effective in achieving increased cessation rates, but have been shown to improve process outcomes, such as documentation of smoking status, provision of cessation counselling and referral to smoking cessation services. However, as the available research is limited we are not able to draw strong conclusions. There is a need for additional high-quality research to explore the impact of system change interventions on both cessation and system-level outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to February 2016.\nOur search identified seven studies which investigated changes made to the way organizations offered stop-smoking support in healthcare settings; six studies were conducted in the USA and one in Spain. Two studies evaluated the changes implemented in primary care clinics and another two studies evaluated changes in dental clinics. One study each evaluated changes in community pharmacy, Veterans Affairs Medical Center and pediatric practice. All included studies were supported or funded by government agencies.\nNone of the studies implemented all the recommended changes or activities listed above. Five studies implemented four types of changes and two studies implemented three types of changes. Identifying all smokers, training health professionals and advising smokers to quit were part of all included studies."
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query-laysum
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6835
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[
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"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) is a common medical condition that complicates pregnancy and causes adverse maternal and fetal outcomes. At present, most treatment strategies focus on normalisation of maternal blood glucose values with use of diet, lifestyle modification, exercise, oral anti-hyperglycaemics and insulin. This has been shown to reduce the incidence of adverse outcomes, such as birth trauma and macrosomia. However, this involves intensive monitoring and treatment of all women with GDM. We propose that using medical imaging to identify pregnancies displaying signs of being affected by GDM could help to target management, allowing low-risk women to be spared excessive intervention, and facilitating better resource allocation.\nObjectives\nWe wanted to address the following question: in women with gestational diabetes, does the use of fetal imaging plus maternal blood glucose concentration to indicate the need for medical management compared with glucose concentration alone reduce the risk of adverse perinatal outcomes?\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register (29 January 2019), ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) (both on 29 January 2019), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials, including those published in abstract form only. Studies using a cluster-randomised design and quasi-randomised controlled trials were both eligible for inclusion, but we didn't identify any. Cross-over trials were not eligible for inclusion in our review.\nWe included women carrying singleton pregnancies who were diagnosed with GDM, as defined by the trials' authors. The intervention of interest was the use of fetal biometry on imaging methods in addition to maternal glycaemic values for indicating the use of medical therapy for GDM. The control group was the use of maternal glycaemic values alone for indicating the use of such therapy.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors extracted data and checked them for accuracy.\nMain results\nThree randomised controlled trials met the inclusion criteria for our systematic review - the studies randomised a total of 524 women.\nWe assessed the three included studies as being at a low to moderate risk of bias; the nature of the intervention made it difficult to achieve blinding of participants and personnel and none of the trial reports contained information about methods of allocation concealment (and were therefore assessed as being at an unclear risk of selection bias).\nIn all studies, the intervention was the use of fetal biometry on ultrasound to identify fetuses displaying signs of fetal macrosomia, and the use of this information to indicate the use of medical anti-hyperglycaemic treatments. Those pregnancies were subject to more stringent blood glucose targets than those without signs of fetal macrosomia.\nMaternal outcomes\nThe use of fetal biometry in addition to maternal blood glucose concentration (compared with maternal blood glucose concentration alone) may make little or no difference to the incidence of caesarean delivery (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.59 to 1.10; 2 trials, 428 women; low-certainty evidence). We are unclear about the results for hypertensive disorders of pregnancy (RR 0.80, 95% CI 0.34 to 1.89; 2 trials, 325 women) due to very low-certainty evidence. The included trials did not report on development of type 2 diabetes in the mother or maternal hypoglycaemia.\nFetal and neonatal outcomes\nThe use of fetal biometry may make little or no difference to the incidence of neonatal hypoglycaemia (RR 0.90, 95% CI 0.57 to 1.42; 3 trials, 524 women; low-certainty evidence). Very low-certainty evidence means that we are unclear about the results for large-for-gestational age (RR 0.81, 95% CI 0.38 to 1.74; 3 trials, 524 women); shoulder dystocia (RR 0.33, 95% CI 0.01 to 7.98; 1 trial, 96 women); a composite measure of perinatal morbidity or mortality (RR 1.00, 95% CI 0.21 to 4.71; 1 study, 96 women); or perinatal mortality (RR 0.33, 95% CI 0.01 to 7.98; 1 trial, 96 women).\nAuthors' conclusions\nThis review is based on evidence from three trials involving 524 women. The trials did not report some important outcomes of interest to this review, and the majority of our secondary outcomes were also unreported. The available evidence ranged from low- to very low-certainty, with downgrading decisions based on limitations in study design, imprecision and inconsistency.\nThere is insufficient evidence to evaluate the use of fetal biometry (in addition to maternal blood glucose concentration values) to assist in guiding the medical management of GDM, on either maternal or perinatal health outcomes, or the associated costs.\nMore research is required, ideally larger randomised studies which report the maternal and infant short- and long-term outcomes listed in this review, as well as those outcomes relating to financial and resource implications.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review was based on limited evidence from three trials (involving 524 women). The trials did not report some important outcomes of interest to this review, and the majority of our secondary outcomes were also unreported. The certainty of the available evidence ranged from low to very low. There was insufficient evidence to evaluate the use of ultrasound (in addition to maternal blood glucose concentration values) to assist in guiding the medical management of GDM, and the effect on important short- and long-term outcomes for the mother or her baby, or the associated costs.\nLarge, randomised trials are needed. Such trials could consider important short- and long-term outcomes (as listed in this review) for the mother, her baby, and resource use."
}
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query-laysum
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6836
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[
{
"role": "user",
"content": "Abstract: Background\nSolid organ transplant recipients are at high risk for infections due to the complexity of surgical procedures combined with the impact of immunosuppression. No consensus exists on the role of antibiotics for surgical site infections in solid organ transplant recipients.\nObjectives\nTo assess the benefits and harms of prophylactic antimicrobial agents for preventing surgical site infections in solid organ transplant recipients.\nSearch methods\nThe Cochrane Kidney and Transplant Register of Studies was searched up to 21 April 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs in any language assessing prophylactic antibiotics in preventing surgical site infections in solid organ transplant recipients at any time point after transplantation.\nData collection and analysis\nTwo authors independently determined study eligibility, assessed quality, and extracted data. Primary outcomes were surgical site infections and antimicrobial resistance. Other outcomes included urinary tract infections, pneumonias and septicaemia, death (any cause), graft loss, graft rejection, graft function, adverse reactions to antimicrobial agents, and outcomes identified by the Standardised Outcomes of Nephrology Group (SONG), specifically graft health, cardiovascular disease, cancer and life participation. Summary effect estimates were obtained using a random-effects model and results were expressed as risk ratios (RR) and 95% confidence intervals (CI). The quality of the evidence was assessed using the risk of bias and the GRADE approach.\nMain results\nWe identified eight eligible studies (718 randomised participants). Overall, five studies (248 randomised participants) compared antibiotics versus no antibiotics, and three studies (470 randomised participants) compared extended duration versus short duration antibiotics. Risk of bias was assessed as high for performance bias (eight studies), detection bias (eight studies) and attrition bias (two studies).\nIt is uncertain whether antibiotics reduce the incidence of surgical site infections as the certainty of the evidence has been assessed as very low (RR 0.42, 95% CI 0.21 to 0.85; 5 studies, 226 participants; I2 = 25%). The certainty of the evidence was very low for all other reported outcomes (death, graft loss, and other infections). It is uncertain whether extended duration antibiotics reduces the incidence of surgical site infections in either solid organ transplant recipients (RR 1.19, 95% CI 0.58 to 2.48; 2 studies, 302 participants; I2 = 0%) or kidney-only transplant recipients (RR 0.50, 95% CI 0.05 to 5.48; 1 study, 205 participants) as the certainty of the evidence has been assessed as very low. The certainty of the evidence was very low for all other reported outcomes (death, graft loss, and other infections). None of the eight included studies evaluated antimicrobial agent adverse reactions, graft health, cardiovascular disease, cancer, life participation, biochemical and haematological parameters, intervention cost, hospitalisation length, or overall hospitalisation costs.\nAuthors' conclusions\nDue to methodological limitations, risk of bias and significant heterogeneity, the current evidence for the use of prophylactic perioperative antibiotics in transplantation is of very low quality. Further high quality, adequately powered RCTs would help better inform clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People receiving organ transplants are at high risk of infections due to the complex surgery and the weakening of the body’s immune defence against infection by anti-rejection drugs. The germs causing infection around the time of transplantation may come from the person’s body, the transplanted organ, or the environment. Depending on the type of organ transplanted and the era in which the transplant took place, surgical site infections have been reported to occur following 3% to 53% of transplant operations. A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. This could include redness of the wound and/or a discharge of pus, which, if not treated with antibiotics or further surgery, could lead to bloodstream infection, infection of other organs in the body (including the transplant organ) or even death. Avoiding surgical site infection may improve patient and transplant survival. Giving antibiotics around the time of the transplant surgery may help to prevent surgical site infections but has not been studied in a systematic way. Giving antibiotics is also not without risk of harm since antibiotics are known to encourage the develop of antibiotic-resistant germs, cause side effects like diarrhoea, and cost money."
}
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query-laysum
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6837
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[
{
"role": "user",
"content": "Abstract: Background\nIntermediate hyperglycaemia (IH) is characterised by one or more measurements of elevated blood glucose concentrations, such as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and elevated glycosylated haemoglobin A1c (HbA1c). These levels are higher than normal but below the diagnostic threshold for type 2 diabetes mellitus (T2DM). The reduced threshold of 5.6 mmol/L (100 mg/dL) fasting plasma glucose (FPG) for defining IFG, introduced by the American Diabetes Association (ADA) in 2003, substantially increased the prevalence of IFG. Likewise, the lowering of the HbA1c threshold from 6.0% to 5.7% by the ADA in 2010 could potentially have significant medical, public health and socioeconomic impacts.\nObjectives\nTo assess the overall prognosis of people with IH for developing T2DM, regression from IH to normoglycaemia and the difference in T2DM incidence in people with IH versus people with normoglycaemia.\nSearch methods\nWe searched MEDLINE, Embase, ClincialTrials.gov and the International Clinical Trials Registry Platform (ICTRP) Search Portal up to December 2016 and updated the MEDLINE search in February 2018. We used several complementary search methods in addition to a Boolean search based on analytical text mining.\nSelection criteria\nWe included prospective cohort studies investigating the development of T2DM in people with IH. We used standard definitions of IH as described by the ADA or World Health Organization (WHO). We excluded intervention trials and studies on cohorts with additional comorbidities at baseline, studies with missing data on the transition from IH to T2DM, and studies where T2DM incidence was evaluated by documents or self-report only.\nData collection and analysis\nOne review author extracted study characteristics, and a second author checked the extracted data. We used a tailored version of the Quality In Prognosis Studies (QUIPS) tool for assessing risk of bias. We pooled incidence and incidence rate ratios (IRR) using a random-effects model to account for between-study heterogeneity. To meta-analyse incidence data, we used a method for pooling proportions. For hazard ratios (HR) and odds ratios (OR) of IH versus normoglycaemia, reported with 95% confidence intervals (CI), we obtained standard errors from these CIs and performed random-effects meta-analyses using the generic inverse-variance method. We used multivariable HRs and the model with the greatest number of covariates. We evaluated the certainty of the evidence with an adapted version of the GRADE framework.\nMain results\nWe included 103 prospective cohort studies. The studies mainly defined IH by IFG5.6 (FPG mmol/L 5.6 to 6.9 mmol/L or 100 mg/dL to 125 mg/dL), IFG6.1 (FPG 6.1 mmol/L to 6.9 mmol/L or 110 mg/dL to 125 mg/dL), IGT (plasma glucose 7.8 mmol/L to 11.1 mmol/L or 140 mg/dL to 199 mg/dL two hours after a 75 g glucose load on the oral glucose tolerance test, combined IFG and IGT (IFG/IGT), and elevated HbA1c (HbA1c5.7: HbA1c 5.7% to 6.4% or 39 mmol/mol to 46 mmol/mol; HbA1c6.0: HbA1c 6.0% to 6.4% or 42 mmol/mol to 46 mmol/mol). The follow-up period ranged from 1 to 24 years. Ninety-three studies evaluated the overall prognosis of people with IH measured by cumulative T2DM incidence, and 52 studies evaluated glycaemic status as a prognostic factor for T2DM by comparing a cohort with IH to a cohort with normoglycaemia. Participants were of Australian, European or North American origin in 41 studies; Latin American in 7; Asian or Middle Eastern in 50; and Islanders or American Indians in 5. Six studies included children and/or adolescents.\nCumulative incidence of T2DM associated with IFG5.6, IFG6.1, IGT and the combination of IFG/IGT increased with length of follow-up. Cumulative incidence was highest with IFG/IGT, followed by IGT, IFG6.1 and IFG5.6. Limited data showed a higher T2DM incidence associated with HbA1c6.0 compared to HbA1c5.7. We rated the evidence for overall prognosis as of moderate certainty because of imprecision (wide CIs in most studies). In the 47 studies reporting restitution of normoglycaemia, regression ranged from 33% to 59% within one to five years follow-up, and from 17% to 42% for 6 to 11 years of follow-up (moderate-certainty evidence).\nStudies evaluating the prognostic effect of IH versus normoglycaemia reported different effect measures (HRs, IRRs and ORs). Overall, the effect measures all indicated an elevated risk of T2DM at 1 to 24 years of follow-up. Taking into account the long-term follow-up of cohort studies, estimation of HRs for time-dependent events like T2DM incidence appeared most reliable. The pooled HR and the number of studies and participants for different IH definitions as compared to normoglycaemia were: IFG5.6: HR 4.32 (95% CI 2.61 to 7.12), 8 studies, 9017 participants; IFG6.1: HR 5.47 (95% CI 3.50 to 8.54), 9 studies, 2818 participants; IGT: HR 3.61 (95% CI 2.31 to 5.64), 5 studies, 4010 participants; IFG and IGT: HR 6.90 (95% CI 4.15 to 11.45), 5 studies, 1038 participants; HbA1c5.7: HR 5.55 (95% CI 2.77 to 11.12), 4 studies, 5223 participants; HbA1c6.0: HR 10.10 (95% CI 3.59 to 28.43), 6 studies, 4532 participants. In subgroup analyses, there was no clear pattern of differences between geographic regions. We downgraded the evidence for the prognostic effect of IH versus normoglycaemia to low-certainty evidence due to study limitations because many studies did not adequately adjust for confounders. Imprecision and inconsistency required further downgrading due to wide 95% CIs and wide 95% prediction intervals (sometimes ranging from negative to positive prognostic factor to outcome associations), respectively.\nThis evidence is up to date as of 26 February 2018.\nAuthors' conclusions\nOverall prognosis of people with IH worsened over time. T2DM cumulative incidence generally increased over the course of follow-up but varied with IH definition. Regression from IH to normoglycaemia decreased over time but was observed even after 11 years of follow-up. The risk of developing T2DM when comparing IH with normoglycaemia at baseline varied by IH definition. Taking into consideration the uncertainty of the available evidence, as well as the fluctuating stages of normoglycaemia, IH and T2DM, which may transition from one stage to another in both directions even after years of follow-up, practitioners should be careful about the potential implications of any active intervention for people 'diagnosed' with IH.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for observational studies (studies where no intervention takes place but people are observed over prolonged periods of time) that investigated how many people with prediabetes at the beginning of the study developed type 2 diabetes. We also evaluated studies comparing people with prediabetes to people with normoglycaemia. Prediabetes was defined by different blood glucose measurements.\nWe found 103 studies, monitoring people over 1 to 24 years. More than 250,000 participants began the studies. In 41 studies the participants were of Australian, European or North American origin, in 7 studies participants were primarily of Latin American origin and in 50 studies participants were of Asian or Middle Eastern origin. Three studies had American Indians as participants, and one study each invited people from Mauritius and Nauru. Six studies included children, adolescents or both as participants.\nThis evidence is up to date as of 26 February 2018."
}
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query-laysum
|
6838
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[
{
"role": "user",
"content": "Abstract: Background\nOral lichen planus (OLP) is a relatively common chronic T cell-mediated disease, which can cause significant pain, particularly in its erosive or ulcerative forms. As pain is the indication for treatment of OLP, pain resolution is the primary outcome for this review. This review is an update of a version last published in 2011, but focuses on the evidence for corticosteroid treatment only. A second review considering non-corticosteroid treatments is in progress.\nObjectives\nTo assess the effects and safety of corticosteroids, in any formulation, for treating people with symptoms of oral lichen planus.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases to 25 February 2019: Cochrane Oral Health's Trials Register, CENTRAL (2019, Issue 1), MEDLINE Ovid, and Embase Ovid. ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. There were no restrictions on language or date of publication.\nSelection criteria\nWe considered randomised controlled clinical trials (RCTs) of any local or systemic corticosteroid treatment compared with a placebo, a calcineurin inhibitor, another corticosteroid, any other local or systemic (or both) drug, or the same corticosteroid plus an adjunctive treatment.\nData collection and analysis\nThree review authors independently scanned the titles and abstracts of all reports identified, and assessed risk of bias using the Cochrane tool and extracted data from included studies. For dichotomous outcomes, we expressed the estimates of effects of an intervention as risk ratios (RR), with 95% confidence intervals (CI). For continuous outcomes, we used mean differences (MD) and 95% CI. The statistical unit of analysis was the participant. We conducted meta-analyses only with studies of similar comparisons reporting the same outcome measures. We assessed the overall certainty of the evidence using GRADE.\nMain results\nWe included 35 studies (1474 participants) in this review. We assessed seven studies at low risk of bias overall, 11 at unclear and the remaining 17 studies at high risk of bias. We present results for our main outcomes, pain and clinical resolution measured at the end of the treatment course (between one week and six months), and adverse effects. The limited evidence available for comparisons between different corticosteroids, and corticosteroids versus alternative or adjunctive treatments is presented in the full review.\nCorticosteroids versus placebo\nThree studies evaluated the effectiveness and safety of topical corticosteroids in an adhesive base compared to placebo. We were able to combine two studies in meta-analyses, one evaluating clobetasol propionate and the other flucinonide. We found low-certainty evidence that pain may be more likely to be resolved when using a topical corticosteroid rather than a placebo (RR 1.91, 95% CI 1.08 to 3.36; 2 studies, 72 participants; I² = 0%). The results for clinical effect of treatment and adverse effects were inconclusive (clinical resolution: RR 6.00, 95% CI 0.76 to 47.58; 2 studies, 72 participants; I² = 0%; very low-certainty evidence; adverse effects RR 1.48, 95% 0.48 to 4.56; 3 studies, 88 participants, I² = 0%, very low-certainty evidence).\nCorticosteroids versus calcineurin inhibitors\nThree studies compared topical clobetasol propionate versus topical tacrolimus. We found very low-certainty evidence regarding any difference between tacrolimus and clobetasol for the outcomes pain resolution (RR 0.45, 95% CI 0.24 to 0.88; 2 studies, 100 participants; I² = 80%), clinical resolution (RR 0.61, 95% CI 0.38 to 0.99; 2 studies, 52 participants; I² = 95%) and adverse effects (RR 0.05, 95% CI 0.00 to 0.83; 2 studies, 100 participants; very low-certainty evidence) .\nOne study (39 participants) compared topical clobetasol and ciclosporin, and provided only very low-certainty evidence regarding the rate of clinical resolution with clobetasol (RR 3.16, 95% CI 1.00 to 9.93), pain resolution (RR 2.11, 95% CI 0.76 to 5.86) and adverse effects (RR 6.32, 95% CI 0.84 to 47.69).\nTwo studies (60 participants) that compared triamcinolone and tacrolimus found uncertain evidence regarding the rate of clinical resolution (RR 0.86, 95% CI 0.55 to 1.35; very low-certainty evidence) and that there may be a lower rate of adverse effects in the triamcinolone group (RR 0.47, 95% CI 0.22 to 0.99; low-certainty evidence). These studies did not report on pain resolution.\nAuthors' conclusions\nCorticosteroids have been first line for the treatment of OLP. This review found that these drugs, delivered topically as adhesive gels or similar preparations, may be more effective than placebo for reducing the pain of symptomatic OLP; however, with the small number of studies and participants, our confidence in the reliability of this finding is low. The results for clinical response were inconclusive, and we are uncertain about adverse effects. Very low-certainty evidence suggests that calcineurin inhibitors, specifically tacrolimus, may be more effective at resolving pain than corticosteroids, although there is some uncertainty about adverse effects and clinical response to tacrolimus showed conflicting results.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Are corticosteroids effective and safe for the treatment of oral lichen planus that is causing pain?"
}
] |
query-laysum
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6839
|
[
{
"role": "user",
"content": "Abstract: Background\nOn the American continent, cutaneous and mucocutaneous leishmaniasis (CL and MCL) are diseases associated with infection by several species of Leishmania parasites. Pentavalent antimonials remain the first-choice treatment. There are alternative interventions, but reviewing their effectiveness and safety is important as availability is limited. This is an update of a Cochrane Review first published in 2009.\nObjectives\nTo assess the effects of interventions for all immuno-competent people who have American cutaneous and mucocutaneous leishmaniasis (ACML).\nSearch methods\nWe updated our database searches of the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, LILACS and CINAHL to August 2019. We searched five trials registers.\nSelection criteria\nRandomised controlled trials (RCTs) assessing either single or combination treatments for ACML in immuno-competent people, diagnosed by clinical presentation and Leishmania infection confirmed by smear, culture, histology, or polymerase chain reaction on a biopsy specimen. The comparators were either no treatment, placebo only, or another active compound.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our key outcomes were the percentage of participants 'cured' at least three months after the end of treatment, adverse effects, and recurrence. We used GRADE to assess evidence certainty for each outcome.\nMain results\nWe included 75 studies (37 were new), totalling 6533 randomised participants with ATL. The studies were mainly conducted in Central and South America at regional hospitals, local healthcare clinics, and research centres. More male participants were included (mean age: roughly 28.9 years (SD: 7.0)). The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana. The most assessed interventions and comparators were non-antimonial systemics (particularly oral miltefosine) and antimonials (particularly meglumine antimoniate (MA), which was also a common intervention), respectively.\nThree studies included moderate-to-severe cases of mucosal leishmaniasis but none included cases with diffuse cutaneous or disseminated CL, considered the severe cutaneous form. Lesions were mainly ulcerative and located in the extremities and limbs. The follow-up (FU) period ranged from 28 days to 7 years. All studies had high or unclear risk of bias in at least one domain (especially performance bias). None of the studies reported the degree of functional or aesthetic impairment, scarring, or quality of life.\nCompared to placebo, at one-year FU, intramuscular (IM) MA given for 20 days to treat L. braziliensis and L. panamensis infections in ACML may increase the likelihood of complete cure (risk ratio (RR) 4.23, 95% confidence interval (CI) 0.84 to 21.38; 2 RCTs, 157 participants; moderate-certainty evidence), but may also make little to no difference, since the 95% CI includes the possibility of both increased and reduced healing (cure rates), and IMMA probably increases severe adverse effects such as myalgias and arthralgias (RR 1.51, 95% CI 1.17 to 1.96; 1 RCT, 134 participants; moderate-certainty evidence). IMMA may make little to no difference to the recurrence risk, but the 95% CI includes the possibility of both increased and reduced risk (RR 1.79, 95% CI 0.17 to 19.26; 1 RCT, 127 participants; low-certainty evidence).\nCompared to placebo, at six-month FU, oral miltefosine given for 28 days to treat L. mexicana, L. panamensis and L. braziliensis infections in American cutaneous leishmaniasis (ACL) probably improves the likelihood of complete cure (RR 2.25, 95% CI 1.42 to 3.38), and probably increases nausea rates (RR 3.96, 95% CI 1.49 to 10.48) and vomiting (RR 6.92, 95% CI 2.68 to 17.86) (moderate-certainty evidence). Oral miltefosine may make little to no difference to the recurrence risk (RR 2.97, 95% CI 0.37 to 23.89; low-certainty evidence), but the 95% CI includes the possibility of both increased and reduced risk (all based on 1 RCT, 133 participants).\nCompared to IMMA, at 6 to 12 months FU, oral miltefosine given for 28 days to treat L. braziliensis, L. panamensis, L. guyanensis and L. amazonensis infections in ACML may make little to no difference to the likelihood of complete cure (RR 1.05, 95% CI 0.90 to 1.23; 7 RCTs, 676 participants; low-certainty evidence). Based on moderate-certainty evidence (3 RCTs, 464 participants), miltefosine probably increases nausea rates (RR 2.45, 95% CI 1.72 to 3.49) and vomiting (RR 4.76, 95% CI 1.82 to 12.46) compared to IMMA. Recurrence risk was not reported.\nFor the rest of the key comparisons, recurrence risk was not reported, and risk of adverse events could not be estimated.\nCompared to IMMA, at 6 to 12 months FU, oral azithromycin given for 20 to 28 days to treat L. braziliensis infections in ACML probably reduces the likelihood of complete cure (RR 0.51, 95% CI 0.34 to 0.76; 2 RCTs, 93 participants; moderate-certainty evidence).\nCompared to intravenous MA (IVMA) and placebo, at 12 month FU, adding topical imiquimod to IVMA, given for 20 days to treat L. braziliensis, L. guyanensis and L. peruviana infections in ACL probably makes little to no difference to the likelihood of complete cure (RR 1.30, 95% CI 0.95 to 1.80; 1 RCT, 80 participants; moderate-certainty evidence).\nCompared to MA, at 6 months FU, one session of local thermotherapy to treat L. panamensis and L. braziliensis infections in ACL reduces the likelihood of complete cure (RR 0.80, 95% CI 0.68 to 0.95; 1 RCT, 292 participants; high-certainty evidence).\nCompared to IMMA and placebo, at 26 weeks FU, adding oral pentoxifylline to IMMA to treat CL (species not stated) probably makes little to no difference to the likelihood of complete cure (RR 0.86, 95% CI 0.63 to 1.18; 1 RCT, 70 participants; moderate-certainty evidence).\nAuthors' conclusions\nEvidence certainty was mostly moderate or low, due to methodological shortcomings, which precluded conclusive results. Overall, both IMMA and oral miltefosine probably result in an increase in cure rates, and nausea and vomiting are probably more common with miltefosine than with IMMA.\nFuture trials should investigate interventions for mucosal leishmaniasis and evaluate recurrence rates of cutaneous leishmaniasis and its progression to mucosal disease.\n\nGiven the provided abstract, please respond to the following query: \"How-up-to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence in this Cochrane Review is current to August 2019."
}
] |
query-laysum
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6840
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[
{
"role": "user",
"content": "Abstract: Background\nAsthma remains a significant cause of avoidable morbidity and mortality. Regular check-ups with a healthcare professional are essential to monitor symptoms and adjust medication.\nHealth services worldwide are considering telephone and internet technologies as a way to manage the rising number of people with asthma and other long-term health conditions. This may serve to improve health and reduce the burden on emergency and inpatient services. Remote check-ups may represent an unobtrusive and efficient way of maintaining contact with patients, but it is uncertain whether conducting check-ups in this way is effective or whether it may have unexpected negative consequences.\nObjectives\nTo assess the safety and efficacy of conducting asthma check-ups remotely versus usual face-to-face consultations.\nSearch methods\nWe identified trials from the Cochrane Airways Review Group Specialised Register (CAGR) up to 24 November 2015. We also searched www.clinicaltrials.gov, the World Health Organization (WHO) trials portal, reference lists of other reviews and contacted trial authors for additional information.\nSelection criteria\nWe included parallel randomised controlled trials (RCTs) of adults or children with asthma that compared remote check-ups conducted using any form of technology versus standard face-to-face consultations. We excluded studies that used automated telehealth interventions that did not include personalised contact with a health professional. We included studies reported as full-text articles, as abstracts only and unpublished data.\nData collection and analysis\nTwo review authors screened the literature search results and independently extracted risk of bias and numerical data. We resolved any disagreements by consensus, and we contacted study authors for missing information.\nWe analysed dichotomous data as odds ratios (ORs) using study participants as the unit of analysis, and continuous data as mean differences using the random-effects models. We rated all outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nSix studies including a total of 2100 participants met the inclusion criteria: we pooled four studies including 792 people in the main efficacy analyses, and presented the results of a cluster implementation study (n = 1213) and an oral steroid tapering study (n = 95) separately. Baseline characteristics relating to asthma severity were variable, but studies generally recruited people with asthma taking regular medications and excluded those with COPD or severe asthma. One study compared the two types of check-up for oral steroid tapering in severe refractory asthma and we assessed it as a separate question. The studies could not be blinded and dropout was high in four of the six studies, which may have biased the results.\nWe could not say whether more people who had a remote check-up needed oral corticosteroids for an asthma exacerbation than those who were seen face-to-face because the confidence intervals (CIs) were very wide (OR 1.74, 95% CI 0.41 to 7.44; 278 participants; one study; low quality evidence). In the face-to-face check-up groups, 21 participants out of 1000 had exacerbations that required oral steroids over three months, compared to 36 (95% CI nine to 139) out of 1000 for the remote check-up group. Exacerbations that needed treatment in the Emergency Department (ED), hospital admission or an unscheduled healthcare visit all happened too infrequently to detect whether remote check-ups are a safe alternative to face-to-face consultations. Serious adverse events were not reported separately from the exacerbation outcomes.\nThere was no difference in asthma control measured by the Asthma Control Questionnaire (ACQ) or in quality of life measured on the Asthma Quality of Life Questionnaire (AQLQ) between remote and face-to-face check-ups. We could rule out significant harm of remote check-ups for these outcomes but we were less confident because these outcomes are more prone to bias from lack of blinding.\nThe larger implementation study that compared two general practice populations demonstrated that offering telephone check-ups and proactively phoning participants increased the number of people with asthma who received a review. However, we do not know whether the additional participants who had a telephone check-up subsequently benefited in asthma outcomes.\nAuthors' conclusions\nCurrent randomised evidence does not demonstrate any important differences between face-to-face and remote asthma check-ups in terms of exacerbations, asthma control or quality of life. There is insufficient information to rule out differences in efficacy, or to say whether or not remote asthma check-ups are a safe alternative to being seen face-to-face.\n\nGiven the provided abstract, please respond to the following query: \"Take-home message\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Studies that tried to answer this research question did not show important differences between the two types of check-up. However, there is not enough information to rule out differences in their harms or benefits. At this stage, we cannot say whether or not asthma check-ups conducted over the phone or internet are a safe alternative to usual face-to-face consultations."
}
] |
query-laysum
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6841
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[
{
"role": "user",
"content": "Abstract: Background\nOlfactory dysfunction is a common consequence of COVID-19 infection and persistent symptoms can have a profound impact on quality of life. At present there is little guidance on how best to treat this condition. A variety of interventions have been suggested to promote recovery, including medication and olfactory training. However, it is uncertain whether any intervention is of benefit. This is an update of the 2021 review with one additional study added.\nObjectives\n1) To evaluate the benefits and harms of any intervention versus no treatment for people with persisting olfactory dysfunction due to COVID-19 infection.\n2) To keep the evidence up-to-date, using a living systematic review approach.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the latest search was 20 October 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) in people with COVID-19 related olfactory disturbance that had persisted for at least four weeks. We included any intervention compared to no treatment or placebo.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were the recovery of sense of smell, disease-related quality of life and serious adverse effects. Secondary outcomes were the change in sense of smell, general quality of life, prevalence of parosmia and other adverse effects (including nosebleeds/bloody discharge). We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included two studies with 30 participants. The studies evaluated the following interventions: systemic corticosteroids plus intranasal corticosteroid/mucolytic/decongestant and palmitoylethanolamide plus luteolin.\nSystemic corticosteroids plus intranasal corticosteroid/mucolytic/decongestant compared to no intervention\nWe included a single RCT with 18 participants who had anosmia for at least 30 days following COVID-19 infection. Participants received a 15-day course of oral corticosteroids combined with nasal irrigation (consisting of an intranasal corticosteroid/mucolytic/decongestant solution) or no intervention. Psychophysical testing was used to assess olfactory function at 40 days. This is a single, small study and for all outcomes the certainty of evidence was very low. We are unable to draw meaningful conclusions from the numerical results.\nPalmitoylethanolamide plus luteolin compared to no intervention\nWe included a single RCT with 12 participants who had anosmia or hyposmia for at least 90 days following COVID-19 infection. Participants received a 30-day course of palmitoylethanolamide and luteolin or no intervention. Psychophysical testing was used to assess olfactory function at 30 days. This is a single, small study and for all outcomes the certainty of evidence was very low. We are unable to draw meaningful conclusions from the numerical results.\nAuthors' conclusions\nThere is very limited evidence available on the efficacy and harms of treatments for persistent olfactory dysfunction following COVID-19 infection. However, we have identified a number of ongoing trials in this area. As this is a living systematic review we will update the data regularly, as new results become available.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found two small studies to include in the review, including a total of 30 people. All participants had problems with their sense of smell that had lasted for at least four weeks, and started after a COVID-19 infection. Problems with the sense of smell were identified using special smell identification tests carried out by the research team. The patients were randomly divided into two groups: those who would receive treatment and those who would not.\nThe treatment in one study was a course of corticosteroid tablets ('systemic') and nasal irrigation (with a wash consisting of a mix of corticosteroids, decongestant and an agent that breaks down mucus). The second study used a course of a supplement known as palmitoylethanolamide and luteolin.\nSystemic corticosteroids and nasal irrigation (intranasal corticosteroids/decongestant/mucolytic) compared to no treatment\nWe do not know whether corticosteroid tablets with nasal irrigation is better or worse than no treatment at:\n- restoring the sense of smell back to normal after 40 days;\n - changing the sense of smell after 40 days;\n - causing any unwanted side effects.\nThis is because the evidence that we found was of very low certainty, mainly due to the fact that only one study was identified and it included a small number of patients.\nPalmitoylethanolamide and luteolin compared to no treatment\nWe do not know whether palmitoylethanolamide and luteolin is better or worse than no treatment at:\n- restoring the sense of smell back to normal after 30 days;\n - changing the sense of smell after 30 days;\n - causing any unwanted side effects.\nThis is because the evidence that we found was of very low certainty, mainly due to the fact that only one study was identified and it included a small number of patients.\nWe did find a number of other studies that are being carried out, but no results from these studies are yet available to be included in this review."
}
] |
query-laysum
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6842
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[
{
"role": "user",
"content": "Abstract: Background\nBronchiectasis is characterised by excessive sputum production, chronic cough, and acute exacerbations and is associated with symptoms of dyspnoea and fatigue, which reduce exercise tolerance and impair quality of life. Exercise training in isolation or in conjunction with other interventions is beneficial for people with other respiratory diseases, but its effects in bronchiectasis have not been well established.\nObjectives\nTo determine effects of exercise training compared to usual care on exercise tolerance (primary outcome), quality of life (primary outcome), incidence of acute exacerbation and hospitalisation, respiratory and mental health symptoms, physical function, mortality, and adverse events in people with stable or acute exacerbation of bronchiectasis.\nSearch methods\nWe identified trials from the Cochrane Airways Specialised Register, ClinicalTrials.gov, and the World Health Organization trials portal, from their inception to October 2020. We reviewed respiratory conference abstracts and reference lists of all primary studies and review articles for additional references.\nSelection criteria\nWe included randomised controlled trials in which exercise training of at least four weeks' duration (or eight sessions) was compared to usual care for people with stable bronchiectasis or experiencing an acute exacerbation. Co-interventions with exercise training including education, respiratory muscle training, and airway clearance therapy were permitted if also applied as part of usual care.\nData collection and analysis\nTwo review authors independently screened and selected trials for inclusion, extracted outcome data, and assessed risk of bias. We contacted study authors for missing data. We calculated mean differences (MDs) using a random-effects model. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included six studies, two of which were published as abstracts, with a total of 275 participants. Five studies were undertaken with people with clinically stable bronchiectasis, and one pilot study was undertaken post acute exacerbation. All studies included co-interventions such as instructions for airway clearance therapy and/or breathing strategies, provision of an educational booklet, and delivery of educational sessions. The duration of training ranged from six to eight weeks, with a mix of supervised and unsupervised sessions conducted in the outpatient or home setting. No studies of children were included in the review; however we identified two studies as currently ongoing. No data were available regarding physical activity levels or adverse events.\nFor people with stable bronchiectasis, evidence suggests that exercise training compared to usual care improves functional exercise tolerance as measured by the incremental shuttle walk distance, with a mean difference (MD) between groups of 87 metres (95% confidence interval (CI) 43 to 132 metres; 4 studies, 161 participants; low-certainty evidence). Evidence also suggests that exercise training improves six-minute walk distance (6MWD) (MD between groups of 42 metres, 95% CI 22 to 62; 1 study, 76 participants; low-certainty evidence). The magnitude of these observed mean changes appears clinically relevant as they exceed minimal clinically important difference (MCID) thresholds for people with chronic lung disease. Evidence suggests that quality of life improves following exercise training according to St George's Respiratory Questionnaire (SGRQ) total score (MD -9.62 points, 95% CI -15.67 to -3.56 points; 3 studies, 160 participants; low-certainty evidence), which exceeds the MCID of 4 points for this outcome. A reduction in dyspnoea (MD 1.0 points, 95% CI 0.47 to 1.53; 1 study, 76 participants) and fatigue (MD 1.51 points, 95% CI 0.80 to 2.22 points; 1 study, 76 participants) was observed following exercise training according to these domains of the Chronic Respiratory Disease Questionnaire. However, there was no change in cough-related quality of life as measured by the Leicester Cough Questionnaire (LCQ) (MD -0.09 points, 95% CI -0.98 to 0.80 points; 2 studies, 103 participants; moderate-certainty evidence), nor in anxiety or depression. Two studies reported longer-term outcomes up to 12 months after intervention completion; however exercise training did not appear to improve exercise capacity or quality of life more than usual care. Exercise training reduced the number of acute exacerbations of bronchiectasis over 12 months in people with stable bronchiectasis (odds ratio 0.26, 95% CI 0.08 to 0.81; 1 study, 55 participants).\nAfter an acute exacerbation of bronchiectasis, data from a single study (N = 27) suggest that exercise training compared to usual care confers little to no effect on exercise capacity (MD 11 metres, 95% CI -27 to 49 metres; low-certainty evidence), SGRQ total score (MD 6.34 points, 95%CI -17.08 to 29.76 points), or LCQ score (MD -0.08 points, 95% CI -0.94 to 0.78 points; low-certainty evidence) and does not reduce the time to first exacerbation (hazard ratio 0.83, 95% CI 0.31 to 2.22).\nAuthors' conclusions\nThis review provides low-certainty evidence suggesting improvement in functional exercise capacity and quality of life immediately following exercise training in people with stable bronchiectasis; however the effects of exercise training on cough-related quality of life and psychological symptoms appear to be minimal. Due to inadequate reporting of methods, small study numbers, and variation between study findings, evidence is of very low to moderate certainty. Limited evidence is available to show longer-term effects of exercise training on these outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with bronchiectasis suffer from chronic cough and sputum production. They have increased risk of developing acute exacerbations that contribute to poor exercise tolerance and quality of life. When performed by people with other chronic lung conditions, exercise training improves exercise tolerance and reduces symptoms. However, little is understood about the effect of exercise training specifically in bronchiectasis."
}
] |
query-laysum
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6843
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the Cochrane review published in Issue 5, 2011.\nWorldwide, cervical cancer is the fourth commonest cancer affecting women. High-risk human papillomavirus (HPV) infection is causative in 99.7% of cases. Other risk factors include smoking, multiple sexual partners, the presence of other sexually transmitted diseases and immunosuppression. Primary prevention strategies for cervical cancer focus on reducing HPV infection via vaccination and data suggest that this has the potential to prevent nearly 90% of cases in those vaccinated prior to HPV exposure. However, not all countries can afford vaccination programmes and, worryingly, uptake in many countries has been extremely poor. Secondary prevention, through screening programmes, will remain critical to reducing cervical cancer, especially in unvaccinated women or those vaccinated later in adolescence. This includes screening for the detection of pre-cancerous cells, as well as high-risk HPV.\nIn the UK, since the introduction of the Cervical Screening Programme in 1988, the associated mortality rate from cervical cancer has fallen. However, worldwide, there is great variation between countries in both coverage and uptake of screening. In some countries, national screening programmes are available whereas in others, screening is provided on an opportunistic basis. Additionally, there are differences within countries in uptake dependent on ethnic origin, age, education and socioeconomic status. Thus, understanding and incorporating these factors in screening programmes can increase the uptake of screening. This, together with vaccination, can lead to cervical cancer becoming a rare disease.\nObjectives\nTo assess the effectiveness of interventions aimed at women, to increase the uptake, including informed uptake, of cervical screening.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 6, 2020. MEDLINE, Embase and LILACS databases up to June 2020. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.\nSelection criteria\nRandomised controlled trials (RCTs) of interventions to increase uptake/informed uptake of cervical screening.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. Where possible, the data were synthesised in a meta-analysis using standard Cochrane methodology.\nMain results\nComprehensive literature searches identified 2597 records; of these, 70 met our inclusion criteria, of which 69 trials (257,899 participants) were entered into a meta-analysis. The studies assessed the effectiveness of invitational and educational interventions, lay health worker involvement, counselling and risk factor assessment. Clinical and statistical heterogeneity between trials limited statistical pooling of data.\nOverall, there was moderate-certainty evidence to suggest that invitations appear to be an effective method of increasing uptake compared to control (risk ratio (RR) 1.71, 95% confidence interval (CI) 1.49 to 1.96; 141,391 participants; 24 studies). Additional analyses, ranging from low to moderate-certainty evidence, suggested that invitations that were personalised, i.e. personal invitation, GP invitation letter or letter with a fixed appointment, appeared to be more successful. More specifically, there was very low-certainty evidence to support the use of GP invitation letters as compared to other authority sources' invitation letters within two RCTs, one RCT assessing 86 participants (RR 1.69 95% CI 0.75 to 3.82) and another, showing a modest benefit, included over 4000 participants (RR 1.13, 95 % CI 1.05 to 1.21). Low-certainty evidence favoured personalised invitations (telephone call, face-to-face or targeted letters) as compared to standard invitation letters (RR 1.32, 95 % CI 1.11 to 1.21; 27,663 participants; 5 studies). There was moderate-certainty evidence to support a letter with a fixed appointment to attend, as compared to a letter with an open invitation to make an appointment (RR 1.61, 95 % CI 1.48 to 1.75; 5742 participants; 5 studies).\nLow-certainty evidence supported the use of educational materials (RR 1.35, 95% CI 1.18 to 1.54; 63,415 participants; 13 studies) and lay health worker involvement (RR 2.30, 95% CI 1.44 to 3.65; 4330 participants; 11 studies). Other less widely reported interventions included counselling, risk factor assessment, access to a health promotion nurse, photo comic book, intensive recruitment and message framing. It was difficult to deduce any meaningful conclusions from these interventions due to sparse data and low-certainty evidence. However, having access to a health promotion nurse and attempts at intensive recruitment may have increased uptake.\nOne trial reported an economic outcome and randomised 3124 participants within a national screening programme to either receive the standard screening invitation, which would incur a fee, or an invitation offering screening free of charge. No difference in the uptake at 90 days was found (574/1562 intervention versus 612/1562 control, (RR 0.94, 95% CI: 0.86 to 1.03).\nThe use of HPV self-testing as an alternative to conventional screening may also be effective at increasing uptake and this will be covered in a subsequent review. Secondary outcomes, including cost data, were incompletely documented. The majority of cluster-RCTs did not account for clustering or adequately report the number of clusters in the trial in order to estimate the design effect, so we did not selectively adjust the trials. It is unlikely that reporting of these trials would impact the overall conclusions and robustness of the results. Of the meta-analyses that could be performed, there was considerable statistical heterogeneity, and this should be borne in mind when interpreting these findings. Given this and the low to moderate evidence, further research may change these findings. The risk of bias in the majority of trials was unclear, and a number of trials suffered from methodological problems and inadequate reporting. We downgraded the certainty of evidence because of an unclear or high risk of bias with regards to allocation concealment, blinding, incomplete outcome data and other biases.\nAuthors' conclusions\nThere is moderate-certainty evidence to support the use of invitation letters to increase the uptake of cervical screening. Low-certainty evidence showed lay health worker involvement amongst ethnic minority populations may increase screening coverage, and there was also support for educational interventions, but it is unclear what format is most effective. The majority of the studies were from developed countries and so the relevance of low- and middle-income countries (LMICs), is unclear. Overall, the low-certainty evidence that was identified makes it difficult to infer as to which interventions were best, with exception of invitational interventions, where there appeared to be more reliable evidence.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"content": "The aim of this review was to look at the methods used to encourage women to undergo cervical screening. These included invitations, reminders, education, message framing, counselling, risk factor assessment, procedures and economic interventions."
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"content": "Abstract: Background\nPulmonary transplantation is the final treatment option for people with end-stage respiratory diseases. Evidence suggests that exercise training may contribute to speeding up physical recovery in adults undergoing lung transplantation, helping to minimize or resolve impairments due to physical inactivity in both the pre- and post-transplant stages. However, there is a lack of detailed guidelines on how exercise training should be carried out in this specific sub-population.\nObjectives\nTo determine the benefits and safety of exercise training in adult patients who have undergone lung transplantation, measuring the maximal and functional exercise capacity; health-related quality of life; adverse events; patient readmission; pulmonary function; muscular strength; pathological bone fractures; return to normal activities and death.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register up to 6 October 2020 using relevant search terms for this review. Studies in the CKTR are identified through CENTRAL, MEDLINE, and EMBASE searches, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) were included comparing exercise training with usual care or no exercise training, or with another exercise training program in terms of dosage, modality, program length, or use of supporting exercise devices. The study population comprised of participants older than 18 years who underwent lung transplantation independent of their underlying respiratory pathology.\nData collection and analysis\nTwo authors independently reviewed all records identified by the search strategy and selected studies that met the eligibility criteria for inclusion in this review. In the first instance, the disagreements were resolved by consensus, and if this was not possible the decision was taken by a third reviewer. The same reviewers independently extracted outcome data from included studies and assessed risk of bias. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nEight RCTs (438 participants) were included in this review. The median sample size was 60 participants with a range from 16 to 83 participants. The mean age of participants was 54.9 years and 51.9% of the participants were male. The median duration of the exercise training programs for the groups undergoing the intervention was 13 weeks, and the median duration of training in the active control groups was four weeks. Overall the risk of bias was considered to be high, mainly due to the inability to blind the study participants and the selective reporting of the results.\nDue to small number of studies included in this review, and the heterogeneity of the intervention and outcomes, we did not obtain a summary estimate of the results.\nTwo studies comparing resistance exercise training with no exercise reported increases in muscle strength and bone mineral density (surrogate outcomes for pathological bone fractures) with exercise training (P > 0.05), but no differences in adverse events. Exercise capacity, health-related quality of life (HRQoL), pulmonary function, and death (any cause) were not reported.\nThree studies compared two different resistant training programs. Two studies comparing squats using a vibration platform (WBVT) compared to squats on the floor reported an improvement in 6-minute walk test (6MWT) (28.4 metres, 95% CI 3 to 53.7; P = 0.029; and 28.3 metres, 95% CI 10.0 to 46.6; P < 0.05) with the WBVT. Supervised upper limb exercise (SULP) program improved 6MWT at 6 months compared to no supervised upper limb exercise (NULP) (SULP group: 561.2 ± 83.6 metres; NULP group: 503.5 ± 115.2 metres; P = 0.01). There were no differences in HRQoL, adverse events, muscular strength, or death (any cause). Pulmonary function and pathological bone fractures were not reported.\nTwo studies comparing multimodal exercise training with no exercise reported improvement in 6MWT at 3 months (P = 0.008) and at 12-months post-transplant (P = 0.002) and muscular strength (quadriceps force (P = 0.001); maximum leg press (P = 0.047)) with multimodal exercise, but no improvement in HRQoL, adverse events, pulmonary function, pathological bone fractures (lumbar T-score), or death (any cause).\nOne study comparing the same multimodal exercise programs given over 7 and 14 weeks reported no differences in 6MWT, HRQoL, adverse events, pulmonary function, muscle strength, or death (any cause). Pathological bone fractures were not reported.\nAccording to GRADE criteria, we rated the certainty of the evidence as very low, mainly due to the high risk of bias and serious imprecision.\nAuthors' conclusions\nIn adults undergoing lung transplantation the evidence about the effects of exercise training is very uncertain in terms of maximal and functional exercise capacity, HRQoL and safety, due to very imprecise estimates of effects and high risk of bias.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "We found eight studies that met the requirements to be included in this review. Two studies compared resistance exercise training with usual care or no exercise training, three studies compared resistance exercise training with another type of resistance exercise training, two studies compared a multimodal exercise training (several different exercises) with usual care or no exercise training, and one study compared the same multimodal exercise training program undertaken for 7 and 14 weeks.\nWe are very uncertain about the effects of exercise training for any of our outcomes. While some studies reported improvement in the distance walked over 6 minutes (exercise versus no exercise, different exercise programs) muscle strength (exercise or multimodal exercise versus no exercise) and bone mineral density (exercise versus no exercise), most reported no differences in adverse events, quality of life, pulmonary function, or the risk of death.\nThe quality of evidence of the included studies was very low. Participants and study personnel were not blinded to the treatment they received due to the nature of the physical interventions and there was a frequent reporting bias. Besides, all estimates of results were imprecise mainly due to the small number of participants."
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"content": "Abstract: Background\nThe benefits of adding upfront whole-brain radiotherapy (WBRT) to surgery or stereotactic radiosurgery (SRS) when compared to surgery or SRS alone for treatment of brain metastases are unclear.\nObjectives\nTo compare the efficacy and safety of surgery or SRS plus WBRT with that of surgery or SRS alone for treatment of brain metastases in patients with systemic cancer.\nSearch methods\nWe searched MEDLINE, EMBASE and The Cochrane Central Register of Controlled Trials (CENTRAL) up to May 2013 and annual meeting proceedings of ASCO and ASTRO up to September 2012 for relevant studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing surgery or SRS plus WBRT with surgery or SRS alone for treatment of brain metastases.\nData collection and analysis\nTwo review authors undertook the quality assessment and data extraction. The primary outcome was overall survival (OS). Secondary outcomes include progression free survival (PFS), local and distant intracranial disease progression, neurocognitive function (NF), health related quality of life (HRQL) and neurological adverse events. Hazard ratios (HR), risk ratio (RR), confidence intervals (CI), P-values (P) were estimated with random effects models using Revman 5.1\nMain results\nWe identified five RCTs including 663 patients with one to four brain metastases. The risk of bias associated with lack of blinding was high and impacted to a greater or lesser extent on the quality of evidence for all of the outcomes. Adding upfront WBRT decreased the relative risk of any intracranial disease progression at one year by 53% (RR 0.47, 95% CI 0.34 to 0.66, P value < 0.0001, I2 =34%, Chi2 P value = 0.21, low quality evidence) but there was no clear evidence of a difference in OS (HR 1.11, 95% CI 0.83 to 1.48, P value = 0.47, I2 = 52%, Chi2 P value = 0.08, low quality evidence) and PFS (HR 0.76, 95% CI 0.53 to 1.10, P value = 0.14, I2 = 16%, Chi2 P value = 0.28, low quality evidence). Subgroup analyses showed that the effects on overall survival were similar regardless of types of focal therapy used, number of brain metastases, dose and sequence of WBRT. The evaluation of the impact of upfront WBRT on NF, HRQL and neurological adverse events was limited by the unclear and high risk of reporting, performance and detection bias, and inconsistency in the instruments and methods used to measure and report results across studies.\nAuthors' conclusions\nThere is low quality evidence that adding upfront WBRT to surgery or SRS decreases any intracranial disease progression at one year. There was no clear evidence of an effect on overall and progression free survival. The impact of upfront WBRT on neurocognitive function, health related quality of life and neurological adverse events was undetermined due to the high risk of performance and detection bias, and inconsistency in the instruments and methods used to measure and report results across studies\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Adding whole brain radiotherapy to surgery or radiosurgery reduces brain metastases progression rates substantially but there was no clear evidence of an effect on survival and it is unclear whether it may cause side effects such as memory loss."
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"content": "Abstract: Background\nThis is an update of the original Cochrane review, last published in 2009 (Huertas-Ceballos 2009). Recurrent abdominal pain (RAP), including children with irritable bowel syndrome, is a common problem affecting between 4% and 25% of school-aged children. For the majority of such children, no organic cause for their pain can be found on physical examination or investigation. Many dietary inventions have been suggested to improve the symptoms of RAP. These may involve either excluding ingredients from the diet or adding supplements such as fibre or probiotics.\nObjectives\nTo examine the effectiveness of dietary interventions in improving pain in children of school age with RAP.\nSearch methods\nWe searched CENTRAL, Ovid MEDLINE, Embase, eight other databases, and two trials registers, together with reference checking, citation searching and contact with study authors, in June 2016.\nSelection criteria\nRandomised controlled trials (RCTs) comparing dietary interventions with placebo or no treatment in children aged five to 18 years with RAP or an abdominal pain-related, functional gastrointestinal disorder, as defined by the Rome III criteria (Rasquin 2006).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We grouped dietary interventions together by category for analysis. We contacted study authors to ask for missing information and clarification, when needed. We assessed the quality of the evidence for each outcome using the GRADE approach.\nMain results\nWe included 19 RCTs, reported in 27 papers with a total of 1453 participants. Fifteen of these studies were not included in the previous review. All 19 RCTs had follow-up ranging from one to five months. Participants were aged between four and 18 years from eight different countries and were recruited largely from paediatric gastroenterology clinics. The mean age at recruitment ranged from 6.3 years to 13.1 years. Girls outnumbered boys in most trials. Fourteen trials recruited children with a diagnosis under the broad umbrella of RAP or functional gastrointestinal disorders; five trials specifically recruited only children with irritable bowel syndrome. The studies fell into four categories: trials of probiotic-based interventions (13 studies), trials of fibre-based interventions (four studies), trials of low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diets (one study), and trials of fructose-restricted diets (one study).\nWe found that children treated with probiotics reported a greater reduction in pain frequency at zero to three months postintervention than those given placebo (standardised mean difference (SMD) -0.55, 95% confidence interval (CI) -0.98 to -0.12; 6 trials; 523 children). There was also a decrease in pain intensity in the intervention group at the same time point (SMD -0.50, 95% CI -0.85 to -0.15; 7 studies; 575 children). However, we judged the evidence for these outcomes to be of low quality using GRADE due to an unclear risk of bias from incomplete outcome data and significant heterogeneity.\nWe found that children treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (odds ratio (OR) 1.63, 95% CI 1.07 to 2.47; 7 studies; 722 children). The estimated number needed to treat for an additional beneficial outcome (NNTB) was eight, meaning that eight children would need to receive probiotics for one to experience improvement in pain in this timescale. We judged the evidence for this outcome to be of moderate quality due to significant heterogeneity.\nChildren with a symptom profile defined as irritable bowel syndrome treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (OR 3.01, 95% CI 1.77 to 5.13; 4 studies; 344 children). Children treated with probiotics were more likely to experience improvement in pain at three to six months postintervention compared to those receiving placebo (OR 1.94, 95% CI 1.10 to 3.43; 2 studies; 224 children). We judged the evidence for these two outcomes to be of moderate quality due to small numbers of participants included in the studies.\nWe found that children treated with fibre-based interventions were not more likely to experience an improvement in pain at zero to three months postintervention than children given placebo (OR 1.83, 95% CI 0.92 to 3.65; 2 studies; 136 children). There was also no reduction in pain intensity compared to placebo at the same time point (SMD -1.24, 95% CI -3.41 to 0.94; 2 studies; 135 children). We judged the evidence for these outcomes to be of low quality due to an unclear risk of bias, imprecision, and significant heterogeneity.\nWe found only one study of low FODMAP diets and only one trial of fructose-restricted diets, meaning no pooled analyses were possible.\nWe were unable to perform any meta-analyses for the secondary outcomes of school performance, social or psychological functioning, or quality of daily life, as not enough studies included these outcomes or used comparable measures to assess them.\nWith the exception of one study, all studies reported monitoring children for adverse events; no major adverse events were reported.\nAuthors' conclusions\nOverall, we found moderate- to low-quality evidence suggesting that probiotics may be effective in improving pain in children with RAP. Clinicians may therefore consider probiotic interventions as part of a holistic management strategy. However, further trials are needed to examine longer-term outcomes and to improve confidence in estimating the size of the effect, as well as to determine the optimal strain and dosage. Future research should also explore the effectiveness of probiotics in children with different symptom profiles, such as those with irritable bowel syndrome.\nWe found only a small number of trials of fibre-based interventions, with overall low-quality evidence for the outcomes. There was therefore no convincing evidence that fibre-based interventions improve pain in children with RAP. Further high-quality RCTs of fibre supplements involving larger numbers of participants are required. Future trials of low FODMAP diets and other dietary interventions are also required to facilitate evidence-based recommendations.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found some evidence suggesting that probiotics may be helpful in relieving pain in children with RAP in the short term. Clinicians may therefore consider probiotic interventions as part of the management strategy for RAP. Further trials are needed to find out how effective probiotics are over longer periods of time and which probiotics might work best.\nWe did not find convincing evidence that fibre supplements are effective in improving pain in children with RAP. Future larger, high-quality studies are needed to test the effectiveness of fibre and low FODMAP diet treatments."
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"content": "Abstract: Background\nCongenital cataracts are lens opacities in one or both eyes of babies or children present at birth. These may cause a reduction in vision severe enough to require surgery. Cataracts are proportionally the most treatable cause of visual loss in childhood, and are a particular problem in low-income countries, where early intervention may not be possible. Paediatric cataracts provide different challenges to those in adults. Intense inflammation, amblyopia (vision is obstructed by cataract from birth which prevents normal development of the visual system), posterior capsule opacification and uncertainty about the final trajectory of ocular growth parameters can affect results of treatment. Two options currently considered for children under 2 years of age with bilateral congenital cataracts are: (i) intraocular lens (IOL) implantation; or (ii) leaving a child with primary aphakia (no lens in the eye), necessitating the need for contact lenses or aphakic glasses. Other important considerations regarding surgery include the prevention of visual axis opacification (VAO), glaucoma and the route used to perform lensectomy.\nObjectives\nTo assess the effectiveness of infant cataract surgery or lensectomy to no surgery for bilateral congenital cataracts in children aged 2 years and under.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 1); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 25 January 2022.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared infant cataract surgery or lensectomy to no surgery, in children with bilateral congenital cataracts aged 2 years and younger. This update (of a review published in 2001 and updated in 2006) does not include children over 2 years of age because they have a wider variety of aetiologies, and are therefore managed differently, and have contrasting outcomes.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two review authors extracted data independently. We assessed the risk of bias of included studies using RoB 1 and assessed the certainty of the evidence using GRADE.\nMain results\nWe identified three RCTs that met our inclusion criteria with each trial comparing a different aspect of surgical intervention for this condition. The trials included a total of 79 participants under 2 years of age, were conducted in India and follow-up ranged from 1 to 5 years. Study participants and outcome assessors were not masked in these trials.\nOne study (60 children) compared primary IOL implantation with primary aphakia. The results from this study suggest that there may be little or no difference in visual acuity at 5 years comparing children with pseudophakia (mean logMAR 0.50) and aphakia (mean logMAR 0.59) (mean difference (MD) -0.09 logMAR, 95% confidence intervals (CIs) -0.24 to 0.06; 54 participants; very low-certainty evidence), but the evidence is very uncertain. The evidence is very uncertain as to the effect of IOL implantation compared with aphakia on visual axis opacification (VAO) (risk ratio (RR) 1.29, 95% CI 0.23 to 7.13; 54 participants; very low-certainty evidence). The trial investigators did not report on the cases of amblyopia. There was little evidence of a difference betwen the two groups in cases of glaucoma at 5 years follow-up (RR 0.86, 95% CI 0.24 to 3.10; 54 participants; very low-certainty evidence). Cases of retinal detachment and reoperation rates were not reported. The impact of IOL implantation on adverse effects is very uncertain because of the sparse data available: of the children who were pseudophakic, 1/29 needed a trabeculectomy and 8/29 developed posterior synechiae. In comparison, no trabeculectomies were needed in the aphakic group and 2/25 children had posterior synechiae (54 participants; very low-certainty evidence).\nThe second study (14 eyes of 7 children under 2 years of age) compared posterior optic capture of IOL without vitrectomy versus endocapsular implantations with anterior vitrectomy (commonly called 'in-the-bag surgery'). The authors did not report on visual acuity, amblyopia, glaucoma and reoperation rate. They had no cases of VAO in either group. The evidence is very uncertain as to the effect of in-the-bag implantation in children aged under 1 year. There was a higher incidence of inflammatory sequelae: 4/7 in-the-bag implantation eyes and 1/7 in optic capture eyes (P = 0.04, 7 participants; very low-certainty evidence). We graded the certainty of evidence as low or very low for imprecision in all outcomes because their statistical analysis reported that a sample size of 13 was needed in each group to achieve a power of 80%, whereas their subset of children under the age of 1 year had only 7 eyes in each group.\nThe third study (24 eyes of 12 children) compared a transcorneal versus pars plana route using a 25-gauge transconjunctival sutureless vitrectomy system. The evidence is very uncertain as to the effect of the route chosen on the incidence of VAO, with no cases reported at 1 year follow-up in either group. The investigators did not report on visual acuity, amblyopia, glaucoma, retinal detachment and reoperation rate. The pars plana route had the adverse effects of posterior capsule rupture in 2/12 eyes, and 1/12 eyes needing sutures. Conversely, 1/12 eyes operated on by the transcorneal route needed sutures. We graded the outcomes with very low-certainty because of the small sample size and the absence of a priori sample size calculation.\nAuthors' conclusions\nThere is no high level evidence for the effectiveness of one type of surgery for bilateral congenital cataracts over another, or whether surgery itself is better than primary aphakia. Further RCTs are required to inform modern practice about concerns, including the timing of surgery, age at which surgery should be undertaken, age for implantation of an IOL and development of complications, such as reoperations, glaucoma and retinal detachment. Standardising the methods used to measure visual function, along with objective monitoring of compliance with the use of aphakic glasses/contact lenses would greatly improve the quality of study data and enable more reliable interpretation of outcomes.\n\nGiven the provided abstract, please respond to the following query: \"How is a cataract treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "Cataracts can affect visual development, so surgery is often recommended to remove the cloudy lens. Removing the cataract means that the eye cannot focus. This must be corrected by either replacing the affected lens with an artificial one, known as an intraocular lens, a contact lens or spectacles, or a combination of these. There is no worldwide agreement on which of these is best for children under 2 years of age.\nSurgery can lead to complications, such as reoperations, retinal detachment (when light-sensitive tissue at the back of the eye, called the retina, pulls away from its normal position), and glaucoma. Glaucoma is a condition where the pressure in the eye gets too high. This can damage the optic nerve and cause blindness if untreated. Glaucoma is a lifelong risk after cataract surgery for children under 2 years of age, and can develop, whether or not an intraocular lens is implanted.\nThe centre of the eye may become cloudy again after intraocular lens implantation. This causes blurred vision and requires laser treatment or further surgery. Different techniques to implant the intraocular lens can reduce reclouding. However, reclouding is a common complication when the cataract is removed, whether or not it’s replaced with an intraocular lens.\nSurgeons access the cataract from in front (anterior route) or behind (posterior route) the lens. The two routes have different rates of complications."
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"content": "Abstract: Background\nGastric cancer is the third most common cause of cancer death worldwide. Individuals infected with Helicobacter pylori have a higher likelihood of developing gastric cancer than individuals who are not infected. Eradication of H. pylori in healthy asymptomatic individuals in the general population may reduce the incidence of gastric cancer, but the magnitude of this effect is unclear.\nObjectives\nTo assess the effectiveness of eradication of H. pylori in healthy asymptomatic individuals in the general population in reducing the incidence of gastric cancer.\nSearch methods\nWe identified trials by searching the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 1), MEDLINE (1946 to February 2020), and EMBASE (1974 to February 2020). We handsearched reference lists from trials selected by electronic searching to identify further relevant trials. We handsearched published abstracts from conference proceedings from the United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) between 2001 and 2019. We contacted members of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Review Group and experts in the field and asked them to provide details of outstanding clinical trials and any relevant unpublished materials.\nSelection criteria\nWe analysed randomised controlled trials comparing at least one week of H. pylori therapy with placebo or no treatment in preventing subsequent development of gastric cancer in otherwise healthy and asymptomatic H. pylori-positive adults. Trials had to follow up participants for at least two years and needed to have at least two participants with gastric cancer as an outcome. We defined gastric cancer as any gastric adenocarcinoma, including intestinal (differentiated) or diffuse (undifferentiated) type, with or without specified histology.\nData collection and analysis\nWe collected data on incidence of gastric cancer, incidence of oesophageal cancer, deaths from gastric cancer, deaths from any cause, and adverse effects arising due to therapy.\nMain results\nSix trials met all our eligibility criteria and provided extractable data in the previous version. Following our updated search, one new RCT was identified, meaning that seven trials were included in this updated review. In addition, one previously included trial provided fully published data out to 10 years, and another previously included trial provided fully published data out to 22 years of follow-up. Four trials were at low risk of bias, one trial was at unclear risk, and two trials were at high risk of bias. Six trials were conducted in Asian populations.\nIn preventing development of subsequent gastric cancer, H. pylori eradication therapy was superior to placebo or no treatment (RR 0.54, 95% confidence interval (CI) 0.40 to 0.72, 7 trials, 8323 participants, moderate certainty evidence). Only two trials reported the effect of eradication of H. pylori on the development of subsequent oesophageal cancer. Sixteen (0.8%) of 1947 participants assigned to eradication therapy subsequently developed oesophageal cancer compared with 13 (0.7%) of 1941 participants allocated to placebo (RR 1.22, 95% CI 0.59 to 2.54, moderate certainty evidence). H. pylori eradication reduced mortality from gastric cancer compared with placebo or no treatment (RR 0.61, 95% CI 0.40 to 0.92, 4 trials, 6301 participants, moderate certainty evidence). There was little or no evidence in all-cause mortality (RR 0.97, 95% CI 0.85 to 1.12, 5 trials, 7079 participants, moderate certainty evidence). Adverse events data were poorly reported.\nAuthors' conclusions\nWe found moderate certainty evidence that searching for and eradicating H. pylori reduces the incidence of gastric cancer and death from gastric cancer in healthy asymptomatic infected Asian individuals, but we cannot necessarily extrapolate this data to other populations.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"content": "We found that antibiotics for H. pylori have a small benefit in preventing gastric cancer (68 (1.6%) of 4206 participants given treatment developed gastric cancer subsequently, compared with 125 (3.0%) of 4117 given no treatment or a placebo), and in decreasing the number of deaths from gastric cancer (36 (1.1%) of 3154, compared with 59 (1.9%) of 3147); but it is unclear whether or not they increase or decrease the number of deaths due to any cause, or increase or decrease the number of cases of oesophageal cancer. Data about side effects of treatment were poorly reported."
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"role": "user",
"content": "Abstract: Background\nVitrectomy is an established treatment for the complications of proliferative diabetic retinopathy (PDR). However, a number of complications can occur during and after vitrectomy for PDR. These include bleeding and the creation of retinal holes during surgery, and bleeding, retinal detachment and scar tissue on the retina after surgery. These complications can limit vision, require further surgery and delay recovery. The use of anti-vascular endothelial growth factor (anti-VEGF) agents injected into the eye before surgery has been proposed to reduce the occurrence of these complications. Anti-VEGF agents can reduce the amount and vascularity of abnormal new vessels associated with PDR, facilitating their dissection during surgery, reducing intra- and postoperative bleeding, and potentially improving outcomes.\nObjectives\nTo assess the effects of perioperative anti-VEGF use on the outcomes of vitrectomy for the treatment of complications for proliferative diabetic retinopathy (PDR).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 6); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 22 June 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that looked at the use of anti-VEGFs and the incidence of complications in people undergoing vitrectomy for PDR.\nData collection and analysis\nTwo review authors independently assessed and extracted the data. We used the standard methodological procedures expected by Cochrane.\nThe critical outcomes of the review were the mean difference in best corrected visual acuity (BCVA) between study arms at six (± three) months after the primary vitrectomy, the incidence of early postoperative vitreous cavity haemorrhage (POVCH, within four weeks postoperatively), the incidence of late POVCH (occurring more than four weeks postoperatively), the incidence of revision surgery for POVCH within six months, the incidence of revision surgery for recurrent traction/macular pucker of any type and/or rhegmatogenous retinal detachment within six months and vision-related quality of life (VRQOL) measures. Important outcomes included the proportion of people with a visual acuity of counting fingers (1.8 logMAR or worse), the number of operative retinal breaks reported and the frequency of silicone oil tamponade required at time of surgery.\nMain results\nThe current review includes 28 RCTs that looked at the pre- or intraoperative use of intravitreal anti-VEGFs to improve the outcomes of pars plana vitrectomy for complications of PDR. The studies were conducted in a variety of countries (11 from China, three from Iran, two from Italy, two from Mexico and the remaining studies from South Korea, the UK, Egypt, Brazil, Japan, Canada, the USA, Indonesia and Pakistan). The inclusion criteria for entry into the studies were the well-recognised complications of proliferative retinopathy: non-clearing vitreous haemorrhage, tractional retinal detachment involving the macula or combined tractional rhegmatogenous detachment. The included studies randomised a total of 1914 eyes.\nWe identified methodological issues in all of the included studies. Risk of bias was highest for masking of participants and investigators, and a number of studies were unclear when describing randomisation methods and sequence allocation.\nParticipants receiving intravitreal anti-VEGF in addition to pars plana vitrectomy achieved better BCVA at six months compared to people undergoing vitrectomy alone (mean difference (MD) -0.25 logMAR, 95% confidence interval (CI) -0.39 to -0.11; 13 studies, 699 eyes; low-certainty evidence).\nPre- or intraoperative anti-VEGF reduced the incidence of early POVCH (12% versus 31%, risk ratio (RR) 0.44, 95% CI 0.34 to 0.58; 14 studies, 1038 eyes; moderate-certainty evidence).\nPerioperative anti-VEGF use was also associated with a reduction in the incidence of late POVCH (10% versus 23%, RR 0.47, 95% CI 0.30 to 0.74; 11 studies, 579 eyes; high-certainty evidence).\nThe need for revision surgery for POVCH occurred less frequently in the anti-VEGF group compared with control, but the confidence intervals were wide and compatible with no effect (4% versus 13%, RR 0.44, 95% CI 0.15 to 1.28; 4 studies 207 eyes; moderate-certainty evidence). Similar imprecisely measured effects were seen for revision surgery for rhegmatogenous retinal detachment (5% versus 11%, RR 0.50, 95% CI 0.15 to 1.66; 4 studies, 145 eyes; low-certainty evidence).\nAnti-VEGFs reduce the incidence of intraoperative retinal breaks (12% versus 31%, RR 0.37, 95% CI 0.24 to 0.59; 12 studies, 915 eyes; high-certainty evidence) and the need for silicone oil (19% versus 41%, RR 0.46, 95% CI 0.27 to 0.80; 10 studies, 591 eyes; very low-certainty evidence).\nNo data were available on quality of life outcomes or the proportion of participants with visual acuity of counting fingers or worse.\nAuthors' conclusions\nThe perioperative use of anti-VEGF reduces the risk of late POVCH, probably results in lower early POVCH risk and may improve visual outcomes. It also reduces the incidence of intraoperative retinal breaks. The evidence is very uncertain about its effect on the need for silicone oil tamponade. The reported complications from its use appear to be low. Agreement on variables included and outcome standardisation is required in trials studying vitrectomy for PDR.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The additional use of anti-VEGFs in diabetic vitrectomy may improve visual outcomes at six months postoperatively. Their use also reduces the risk of late POVCH and probably reduces the risk of early POVCH. Anti-VEGFs reduce intraoperative retinal breaks and may reduce the requirement for silicone oil tamponade.\nAnti-VEGF use probably results in a lower need for revision vitrectomy for POVCH, and may reduce the need for revision surgery for recurrent traction and/or retinal detachment.\nWe found no studies to help us answer our question about quality of life and the proportion of people with visual acuity of counting fingers or less."
}
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query-laysum
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6850
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[
{
"role": "user",
"content": "Abstract: Background\nThe number of people living with dementia is increasing rapidly. Clinical dementia does not develop suddenly, but rather is preceded by a period of cognitive decline beyond normal age-related change. People at this intermediate stage between normal cognitive function and clinical dementia are often described as having mild cognitive impairment (MCI). Considerable research and clinical efforts have been directed toward finding disease-modifying interventions that may prevent or delay progression from MCI to clinical dementia.\nObjectives\nTo evaluate the effects of at least 12 weeks of computerised cognitive training (CCT) on maintaining or improving cognitive function and preventing dementia in people with mild cognitive impairment.\nSearch methods\nWe searched to 31 May 2018 in ALOIS (www.medicine.ox.ac.uk/alois) and ran additional searches in MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov, and the WHO portal/ICTRP (www.apps.who.int/trialsearch) to identify published, unpublished, and ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in which cognitive training via interactive computerised technology was compared with an active or inactive control intervention. Experimental computerised cognitive training (CCT) interventions had to adhere to the following criteria: minimum intervention duration of 12 weeks; any form of interactive computerised cognitive training, including computer exercises, computer games, mobile devices, gaming console, and virtual reality. Participants were adults with a diagnosis of mild cognitive impairment (MCI) or mild neurocognitive disorder (MND), or otherwise at high risk of cognitive decline.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias of the included RCTs. We expressed treatment effects as mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes and as risk ratios (RRs) for dichotomous outcomes. We used the GRADE approach to describe the overall quality of evidence for each outcome.\nMain results\nEight RCTs with a total of 660 participants met review inclusion criteria. Duration of the included trials varied from 12 weeks to 18 months. Only one trial used an inactive control. Most studies were at unclear or high risk of bias in several domains. Overall, our ability to draw conclusions was hampered by very low-quality evidence. Almost all results were very imprecise; there were also problems related to risk of bias, inconsistency between trials, and indirectness of the evidence.\nNo trial provided data on incident dementia. For comparisons of CCT with both active and inactive controls, the quality of evidence on our other primary outcome of global cognitive function immediately after the intervention period was very low. Therefore, we were unable to draw any conclusions about this outcome.\nDue to very low quality of evidence, we were also unable to determine whether there was any effect of CCT compared to active control on our secondary outcomes of episodic memory, working memory, executive function, depression, functional performance, and mortality. We found low-quality evidence suggesting that there is probably no effect on speed of processing (SMD 0.20, 95% confidence interval (CI) -0.16 to 0.56; 2 studies; 119 participants), verbal fluency (SMD -0.16, 95% CI -0.76 to 0.44; 3 studies; 150 participants), or quality of life (mean difference (MD) 0.40, 95% CI -1.85 to 2.65; 1 study; 19 participants).\nWhen CCT was compared with inactive control, we obtained data on five secondary outcomes, including episodic memory, executive function, verbal fluency, depression, and functional performance. We found very low-quality evidence; therefore, we were unable to draw any conclusions about these outcomes.\nAuthors' conclusions\nCurrently available evidence does not allow us to determine whether or not computerised cognitive training will prevent clinical dementia or improve or maintain cognitive function in those who already have evidence of cognitive impairment. Small numbers of trials, small samples, risk of bias, inconsistency between trials, and highly imprecise results mean that it is not possible to derive any implications for clinical practice, despite some observed large effect sizes from individual studies. Direct adverse events are unlikely to occur, although the time and sometimes the money involved in computerised cognitive training programmes may represent significant burdens. Further research is necessary and should concentrate on improving methodological rigour, selecting suitable outcomes measures, and assessing generalisability and persistence of any effects. Trials with long-term follow-up are needed to determine the potential of this intervention to reduce the risk of dementia.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The terms 'cognition' and 'cognitive function' describe all of the mental activities related to thinking, learning, remembering, and communicating. There are normal changes in cognition with age, There are also diseases that affect cognition, principally dementia, in which cognition is impaired to the point of affecting a person's ability to manage daily activities. More common than dementia is a condition often described as mild cognitive impairment (MCI), in which mild impairment of cognition, more than expected from age alone, can be detected on testing, but by which daily functioning is largely unaffected. For some people, MCI is a stage on the way to developing dementia. There is a lot of interest in anything that might prevent further decline in cognition in people with MCI. One thing that has been suggested as a means of doing this is computerised cognitive training (CCT). Cognitive training consists of a set of standardised tasks intended to 'exercise the brain' in various ways. These days, cognitive training exercises are often delivered via computers or mobile technology, so that people can do them on their own at home. We wanted to know whether CCT is an effective way for people with MCI to maintain their cognitive function and reduce their risk of going on to develop dementia."
}
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query-laysum
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6851
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[
{
"role": "user",
"content": "Abstract: Background\nPost-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. The current standard care for the prevention of PTS following DVT is elastic compression stockings. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the prevention of PTS. This is the second update of the review first published in 2013.\nObjectives\nTo determine the effectiveness and safety of rutosides for prevention of post-thrombotic syndrome (PTS) in patients with deep vein thrombosis (DVT), compared to placebo, no intervention, or reference medication.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 21 August 2018.\nSelection criteria\nWe planned to include trials of rutosides versus any alternative (placebo, no intervention, or reference medication) in the prevention of PTS in patients with DVT.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and intended to extract information from the trials.\nMain results\nNo studies were identified comparing rutosides versus any alternative in the prevention of PTS.\nAuthors' conclusions\nAs there were no studies identified in this review there is currently insufficient evidence to determine the effectiveness and safety of rutosides for prevention of PTS in patients with DVT. Some studies suggest that rutosides may provide short-term relief of PTS symptoms. However, there is nothing published on their use as a preventative therapy for PTS. High quality randomised controlled trials of rutoside versus any alternative are required to build the evidence base in this area.\n\nGiven the provided abstract, please respond to the following query: \"Search methods and selection of studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched existing databases (current until 21 August 2018) for trials relating to the use of rutosides for the prevention of PTS following DVT. Two authors independently reviewed trials for inclusion and intended to extract results in line with prescribed criteria."
}
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query-laysum
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6852
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[
{
"role": "user",
"content": "Abstract: Background\nStillbirth affects at least 2.6 million families worldwide every year and has enduring consequences for parents and health services. Parents entering a subsequent pregnancy following stillbirth face a risk of stillbirth recurrence, alongside increased risks of other adverse pregnancy outcomes and psychosocial challenges. These parents may benefit from a range of interventions to optimise their short- and longer-term medical health and psychosocial well-being.\nObjectives\nTo assess the effects of different interventions or models of care prior to and during subsequent pregnancies following stillbirth on maternal, fetal, neonatal and family health outcomes, and health service utilisation.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 June 2018), along with ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (18 June 2018).\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised controlled trials (qRCTs). Trials using a cluster-randomised design were eligible for inclusion, but we found no such reports. We included trials published as abstract only, provided sufficient information was available to allow assessment of trial eligibility and risk of bias. We excluded cross-over trials.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and undertook data extraction and 'Risk of bias' assessments. We extracted data from published reports, or sourced data directly from trialists. We checked the data for accuracy and resolved discrepancies by discussion or correspondence with trialists, or both. We conducted an assessment of the quality of the evidence using the GRADE approach.\nMain results\nWe included nine RCTs and one qRCT, and judged them to be at low to moderate risk of bias. Trials were carried out between the years 1964 and 2015 and took place predominantly in high-income countries in Europe. All trials assessed medical interventions; no trials assessed psychosocial interventions or incorporated psychosocial aspects of care. Trials evaluated the use of antiplatelet agents (low-dose aspirin (LDA) or low-molecular-weight heparin (LMWH), or both), third-party leukocyte immunisation, intravenous immunoglobulin, and progestogen. Trial participants were women who were either pregnant or attempting to conceive following a pregnancy loss, fetal death, or adverse outcome in a previous pregnancy.\nWe extracted data for 222 women who had experienced a previous stillbirth of 20 weeks' gestation or more from the broader trial data sets, and included them in this review. Our GRADE assessments of the quality of evidence ranged from very low to low, due largely to serious imprecision in effect estimates as a result of small sample sizes, low numbers of events, and wide confidence intervals (CIs) crossing the line of no effect. Most of the analyses in this review were not sufficiently powered to detect differences in the outcomes assessed. The results presented are therefore largely uncertain.\nMain comparisons\nLMWH versus no treatment/standard care (three RCTs, 123 women, depending on the outcome)\nIt was uncertain whether LMWH reduced the risk of stillbirth (risk ratio (RR) 2.58, 95% CI 0.40 to 16.62; 3 trials; 122 participants; low-quality evidence), adverse perinatal outcome (RR 0.81, 95% CI 0.20 to 3.32; 2 trials; 77 participants; low-quality evidence), adverse maternal psychological effects (RR 1.00, 95% CI 0.07 to 14.90; 1 trial; 40 participants; very low-quality evidence), perinatal mortality (RR 2.58, 95% CI 0.40 to 16.62; 3 trials; 122 participants; low-quality evidence), or any preterm birth (< 37 weeks) (RR 1.01, 0.58 to 1.74; 3 trials; 114 participants; low-quality evidence). No neonatal deaths were reported in the trials assessed and no data were available for maternal-infant attachment. There was no clear evidence of a difference between the groups among the remaining secondary outcomes.\nLDA versus placebo (one RCT, 24 women)\nIt was uncertain whether LDA reduced the risk of stillbirth (RR 0.85, 95% CI 0.06 to 12.01), neonatal death (RR 0.29, 95% CI 0.01 to 6.38), adverse perinatal outcome (RR 0.28, 95% CI 0.03 to 2.34), perinatal mortality, or any preterm birth (< 37 weeks) (both of the latter RR 0.42, 95% CI 0.04 to 4.06; all very low-quality evidence). No data were available for adverse maternal psychological effects or maternal-infant attachment. LDA appeared to be associated with an increase in birthweight (mean difference (MD) 790.00 g, 95% CI 295.03 to 1284.97 g) when compared to placebo, but this result was very unstable due to the extremely small sample size. Whether LDA has any effect on the remaining secondary outcomes was also uncertain.\nOther comparisons\nLDA appeared to be associated with an increase in birthweight when compared to LDA + LMWH (MD −650.00 g, 95% CI −1210.33 to −89.67 g; 1 trial; 29 infants), as did third-party leukocyte immunisation when compared to placebo (MD 1195.00 g, 95% CI 273.35 to 2116.65 g; 1 trial, 4 infants), but these results were again very unstable due to extremely small sample sizes. The effects of the interventions on the remaining outcomes were also uncertain.\nAuthors' conclusions\nThere is insufficient evidence in this review to inform clinical practice about the effectiveness of interventions to improve care prior to and during subsequent pregnancies following a stillbirth. There is a clear and urgent need for well-designed trials addressing this research question. The evaluation of medical interventions such as LDA, in the specific context of stillbirth prevention (and recurrent stillbirth prevention), is warranted. However, appropriate methodologies to evaluate such therapies need to be determined, particularly where clinical equipoise may be lacking. Careful trial design and multicentre collaboration is necessary to carry out trials that would be sufficiently large to detect differences in statistically rare outcomes such as stillbirth and neonatal death. The evaluation of psychosocial interventions addressing maternal-fetal attachment and parental anxiety and depression is also an urgent priority. In a randomised-trial context, such trials may allocate parents to different forms of support, to determine which have the greatest benefit with the least financial cost. Importantly, consistency in nomenclature and in data collection across all future trials (randomised and non-randomised) may be facilitated by a core outcomes data set for stillbirth research. All future trials should assess short- and longer-term psychosocial outcomes for parents and families, alongside economic costs of interventions.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence from randomised controlled trials published up to June 2018. We included 10 studies at low to moderate risk of bias. All but one study were from high-income countries, mainly in developed areas of Europe. The women in the studies were either pregnant or attempting to conceive after having a miscarriage, a stillborn baby, or a serious complication in a previous pregnancy. The interventions included two types of drugs (low-dose aspirin and low-molecular-weight heparin) that reduce blood clotting and may help the placenta to function (six trials), pre-conception injection of blood cells (third-party leukocyte immunisation) to help mothers' immune systems to cope with pregnancy (one trial), a special type of antibody (intravenous immunoglobulin) given into a vein to improve the functioning of the pregnant woman's immune system (two trials), and injections of a medication (progestogen) that acts like the pregnancy hormone progesterone (one trial). We evaluated data from 222 women who had previously had a stillborn baby at 20 weeks' gestation or more.\nWe were unable to determine whether any of these interventions reduced the chance of having another stillborn baby in the subsequent pregnancy; or whether the interventions reduced the chances of babies dying or having serious complications in the first month of life, because the studies not large enough for us to have confidence in the findings. Largely because of this, we judged the quality of evidence in this review to be very low to low. Two interventions (low-dose aspirin and third-party leukocyte immunisation) appeared to increase the birthweight of babies, but these findings are not reliable due to the small numbers of babies included.\nThe included studies provided very little information about psychological outcomes of parents or longer-term outcomes of children and families."
}
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query-laysum
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6853
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[
{
"role": "user",
"content": "Abstract: Background\nIllness-related absenteeism is an important problem among preschool and school children for low-, middle- and high- income countries. Appropriate hand hygiene is one commonly investigated and implemented strategy to reduce the spread of illness and subsequently the number of days spent absent. Most hand hygiene strategies involve washing hands with soap and water, however this is associated with a number of factors that act as a barrier to its use, such as requiring running water, and the need to dry hands after cleaning. An alternative method involves washing hands using rinse-free hand wash. This technique has a number of benefits over traditional hand hygiene strategies and may prove to be beneficial in reducing illness-related absenteeism in preschool and school children.\nObjectives\n1. To assess the effectiveness of rinse-free hand washing for reducing absenteeism due to illness in preschool and school children compared to no hand washing, conventional hand washing with soap and water or other hand hygiene strategies.\n2. To determine which rinse-free hand washing products are the most effective (if head-to-head comparisons exist), and what effect additional strategies in combination with rinse-free hand washing have on the outcomes of interest.\nSearch methods\nIn February 2020 we searched CENTRAL, MEDLINE, Embase, CINAHL, 12 other databases and three clinical trial registries. We also reviewed the reference lists of included studies and made direct contact with lead authors of studies to collect additional information as required. No date or language restrictions were applied.\nSelection criteria\nRandomized controlled trials (RCTs), irrespective of publication status, comparing rinse-free hand wash in any form (hand rub, hand sanitizer, gel, foam etc.) with conventional hand washing using soap and water, other hand hygiene programs (such as education alone), or no intervention. The population of interest was children aged between two and 18 years attending preschool (childcare, day care, kindergarten, etc.) or school (primary, secondary, elementary, etc.). Primary outcomes included child or student absenteeism for any reason, absenteeism due to any illness and adverse skin reactions.\nData collection and analysis\nFollowing standard Cochrane methods, two review authors (out of ZM, CT, CL, CS, TB), independently selected studies for inclusion, assessed risk of bias and extracted relevant data. Absences were extracted as the number of student days absent out of total days. This was sometimes reported with the raw numbers and other times as an incidence rate ratio (IRR), which we also extracted. For adverse event data, we calculated effect sizes as risk ratios (RRs) and present these with 95% confidence intervals (CIs). We used standard methodological procedures expected by Cochrane for data analysis and followed the GRADE approach to establish certainty in the findings.\nMain results\nThis review includes 19 studies with 30,747 participants. Most studies were conducted in the USA (eight studies), two were conducted in Spain, and one each in China, Colombia, Finland, France, Kenya, Bangladesh, New Zealand, Sweden, and Thailand. Six studies were conducted in preschools or day-care centres (children aged from birth to < five years), with the remaining 13 conducted in elementary or primary schools (children aged five to 14 years).\nThe included studies were judged to be at high risk of bias in several domains, most-notably across the domains of performance and detection bias due to the difficulty to blind those delivering the intervention or those assessing the outcome. Additionally, every outcome of interest was graded as low or very low certainty of evidence, primarily due to high risk of bias, as well as imprecision of the effect estimates and inconsistency between pooled data. For the outcome of absenteeism for any reason, the pooled estimate for rinse-free hand washing was an IRR of 0.91 (95% CI 0.82 to 1.01; 2 studies; very low-certainty evidence), which indicates there may be little to no difference between groups. For absenteeism for any illness, the pooled IRR was 0.82 (95% CI 0.69 to 0.97; 6 studies; very low-certainty evidence), which indicates that rinse-free hand washing may reduce absenteeism (13 days absent per 1000) compared to those in the 'no rinse-free' group (16 days absent per 1000). For the outcome of absenteeism for acute respiratory illness, the pooled IRR was 0.79 (95% CI 0.68 to 0.92; 6 studies; very low-certainty evidence), which indicates that rinse-free hand washing may reduce absenteeism (33 days absent per 1000) compared to those in the 'no rinse-free' group (42 days absent per 1000). When evaluating absenteeism for acute gastrointestinal illness, the pooled estimate found an IRR of 0.79 (95% CI 0.73 to 0.85; 4 studies; low-certainty evidence), which indicates rinse-free hand washing may reduce absenteeism (six days absent per 1000) compared to those in the 'no rinse-free' group (eight days absent per 1000). There may be little to no difference between rinse-free hand washing and 'no rinse-free' group regarding adverse skin reactions with a RR of 1.03 (95% CI 0.8 to 1.32; 3 studies, 4365 participants; very low-certainty evidence). Broadly, compliance with the intervention appeared to range from moderate to high compliance (9 studies, 10,749 participants; very-low certainty evidence); narrativley, no authors reported substantial issues with compliance. Overall, most studies that included data on perception reported that teachers and students perceived rinse-free hand wash positively and were willing to continue its use (3 studies, 1229 participants; very-low certainty evidence).\nAuthors' conclusions\nThe findings of this review may have identified a small yet potentially beneficial effect of rinse-free hand washing regimes on illness-related absenteeism. However, the certainty of the evidence that contributed to this conclusion was low or very low according to the GRADE approach and is therefore uncertain. Further research is required at all levels of schooling to evaluate rinse-free hand washing regimens in order to provide more conclusive, higher-certainty evidence regarding its impact. When considering the use of a rinse-free hand washing program in a local setting, there needs to be consideration of the current rates of illness-related absenteeism and whether the small beneficial effects seen here will translate into a meaningful reduction across their settings.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review was designed to investigate if the use of rinse-free hand wash can reduce the number of days spent absent from school in preschool and school children compared to no rinse-free hand wash usage."
}
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query-laysum
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6854
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[
{
"role": "user",
"content": "Abstract: Background\nAlthough pain is common in osteoarthritis, most people fail to achieve adequate analgesia. Increasing acknowledgement of the contribution of pain sensitisation has resulted in the investigation of medications affecting pain processing with central effects. Antidepressants contribute to pain management in other conditions where pain sensitisation is present.\nObjectives\nTo assess the benefits and harms of antidepressants for the treatment of symptomatic knee and hip osteoarthritis in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was January 2021.\nSelection criteria\nWe included randomised controlled trials of adults with osteoarthritis that compared use of antidepressants to placebo or alternative comparator. We included trials that focused on efficacy (pain and function), treatment-related adverse effects and had documentation regarding discontinuation of participants. We excluded trials of less than six weeks of duration or had participants with concurrent mental health disorders.\nData collection and analysis\nWe used standard Cochrane methods. Major outcomes were pain; responder rate; physical function; quality of life; and proportion of participants who withdrew due to adverse events, experienced any adverse events or had serious adverse events. Minor outcomes were proportion meeting the OARSI (Osteoarthritis Research Society International) Response Criteria, radiographic joint structure changes and proportion of participants who dropped out of the study for any reason. We used GRADE to assess certainty of evidence.\nMain results\nNine trials (2122 participants) met the inclusion criteria. Seven trials examined only knee osteoarthritis. Two also included participants with hip osteoarthritis. All trials compared antidepressants to placebo, with or without non-steroidal anti-inflammatory drugs. Trial sizes were 36 to 388 participants. Most participants were female, with mean ages of 54.5 to 65.9 years. Trial durations were 8 to 16 weeks. Six trials examined duloxetine. We combined data from nine trials in meta-analyses for knee and hip osteoarthritis.\nOne trial was at low risk of bias in all domains. Five trials were at risk of attrition and reporting bias.\nHigh-certainty evidence found that antidepressants resulted in a clinically unimportant improvement in pain compared to placebo. Mean reduction in pain (0 to 10 scale, 0 = no pain) was 1.7 points with placebo and 2.3 points with antidepressants (mean difference (MD) −0.59, 95% confidence interval (CI) −0.88 to −0.31; 9 trials, 2122 participants).\nClinical response was defined as achieving a 50% or greater reduction in 24-hour mean pain. High-certainty evidence demonstrated that 45% of participants receiving antidepressants had a clinical response compared to 28.6% receiving placebo (RR 1.55, 95% CI 1.32 to 1.82; 6 RCTs, 1904 participants). This corresponded to an absolute improvement in pain of 16% more responders with antidepressants (8.9% more to 26% more) and a number needed to treat for an additional beneficial effect (NNTB) of 6 (95% CI 4 to 11).\nHigh-certainty evidence showed that the mean improvement in function (on 0 to 100 Western Ontario and McMaster Universities Arthritis Index, 0 = best function) was 10.51 points with placebo and 16.16 points with antidepressants (MD −5.65 points, 95% CI −7.08 to −4.23; 6 RCTs, 1909 participants). This demonstrates a small, clinically unimportant response.\nModerate-certainty evidence (downgraded for imprecision) showed that quality of life measured using the EuroQol 5-Dimension scale (−0.11 to 1.0, 1.0 = perfect health) improved by 0.07 points with placebo and 0.11 points with antidepressants (MD 0.04, 95% CI 0.01 to 0.07; 3 RCTs, 815 participants). This is clinically unimportant.\nHigh-certainty evidence showed that total adverse events increased in the antidepressant group (64%) compared to the placebo group (49%) (RR 1.27, 95% CI 1.15 to 1.41; 9 RCTs, 2102 participants). The number needed to treat for an additional harmful outcome (NNTH) was 7 (95% CI 5 to 11).\nLow-certainty evidence (downgraded twice for imprecision for very low numbers of events) found no evidence of a difference in serious adverse events between groups (RR 0.94, 95% CI 0.46 to 1.94; 9 RCTs, 2101 participants). The NNTH was 1000.\nModerate-certainty evidence (downgraded for imprecision) showed that 11% of participants receiving antidepressants withdrew from trials due to an adverse event compared to 5% receiving placebo (RR 2.15, 95% CI 1.56 to 2.97; 6 RCTs, 1977 participants). The NNTH was 17 (95% CI 10 to 35).\nAuthors' conclusions\nThere is high-certainty evidence that use of antidepressants for knee osteoarthritis leads to a non-clinically important improvement in mean pain and function. However, a small number of people will have a 50% or greater important improvement in pain and function. This finding was consistent across all trials. Pain in osteoarthritis may be due to a variety of causes that differ between individuals. It may be that the cause of pain that responds to this therapy is only present in a small number of people. There is moderate-certainty evidence that antidepressants have a small positive effect on quality of life with heterogeneity between trials.\nHigh-certainty evidence indicates antidepressants result in more adverse events and moderate-certainty evidence indicates more withdrawal due to adverse events. There was little to no difference in serious adverse events (low-certainty evidence due to low numbers of events). This suggests that if antidepressants were being considered, there needs to be careful patient selection to optimise clinical benefit given the known propensity for adverse events with antidepressant use. Future trials should include alternative antidepressant agents or phenotyping of pain in people with osteoarthritis, or both.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Osteoarthritis is a disease of the joints characterised by reduced cartilage and narrowing of the space between the joints. It may result in pain, deformity and disability.\nAntidepressant medicines are thought to affect pain by modulating nerve pathways in the central nervous system.\nWe aimed to evaluate the clinical benefits and harms of antidepressants for knee and hip osteoarthritis pain."
}
] |
query-laysum
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6855
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[
{
"role": "user",
"content": "Abstract: Background\nThe consequences of influenza in children and adults are mainly absenteeism from school and work. However, the risk of complications is greatest in children and people over 65 years of age. This is an update of a review published in 2011. Future updates of this review will be made only when new trials or vaccines become available. Observational data included in previous versions of the review have been retained for historical reasons but have not been updated because of their lack of influence on the review conclusions.\nObjectives\nTo assess the effects (efficacy, effectiveness, and harm) of vaccines against influenza in healthy children.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 12), which includes the Cochrane Acute Respiratory Infections Group Specialised Register, MEDLINE (1966 to 31 December 2016), Embase (1974 to 31 December 2016), WHO International Clinical Trials Registry Platform (ICTRP; 1 July 2017), and ClinicalTrials.gov (1 July 2017).\nSelection criteria\nRandomised controlled trials comparing influenza vaccines with placebo or no intervention in naturally occurring influenza in healthy children under 16 years. Previous versions of this review included 19 cohort and 11 case-control studies. We are no longer updating the searches for these study designs but have retained the observational studies for historical purposes.\nData collection and analysis\nReview authors independently assessed risk of bias and extracted data. We used GRADE to rate the certainty of evidence for the key outcomes of influenza, influenza-like illness (ILI), complications (hospitalisation, ear infection), and adverse events. Due to variation in control group risks for influenza and ILI, absolute effects are reported as the median control group risk, and numbers needed to vaccinate (NNVs) are reported accordingly. For other outcomes aggregate control group risks are used.\nMain results\nWe included 41 clinical trials (> 200,000 children). Most of the studies were conducted in children over the age of two and compared live attenuated or inactivated vaccines with placebo or no vaccine. Studies were conducted over single influenza seasons in the USA, Western Europe, Russia, and Bangladesh between 1984 and 2013. Restricting analyses to studies at low risk of bias showed that influenza and otitis media were the only outcomes where the impact of bias was negligible. Variability in study design and reporting impeded meta-analysis of harms outcomes.\nLive attenuated vaccines\nCompared with placebo or do nothing, live attenuated influenza vaccines probably reduce the risk of influenza infection in children aged 3 to 16 years from 18% to 4% (risk ratio (RR) 0.22, 95% confidence interval (CI) 0.11 to 0.41; 7718 children; moderate-certainty evidence), and they may reduce ILI by a smaller degree, from 17% to 12% (RR 0.69, 95% CI 0.60 to 0.80; 124,606 children; low-certainty evidence). Seven children would need to be vaccinated to prevent one case of influenza, and 20 children would need to be vaccinated to prevent one child experiencing an ILI. Acute otitis media is probably similar following vaccine or placebo during seasonal influenza, but this result comes from a single study with particularly high rates of acute otitis media (RR 0.98, 95% CI 0.95 to 1.01; moderate-certainty evidence). There was insufficient information available to determine the effect of vaccines on school absenteeism due to very low-certainty evidence from one study. Vaccinating children may lead to fewer parents taking time off work, although the CI includes no effect (RR 0.69, 95% CI 0.46 to 1.03; low-certainty evidence). Data on the most serious consequences of influenza complications leading to hospitalisation were not available. Data from four studies measuring fever following vaccination varied considerably, from 0.16% to 15% in children who had live vaccines, while in the placebo groups the proportions ranged from 0.71% to 22% (very low-certainty evidence). Data on nausea were not reported.\nInactivated vaccines\nCompared with placebo or no vaccination, inactivated vaccines reduce the risk of influenza in children aged 2 to 16 years from 30% to 11% (RR 0.36, 95% CI 0.28 to 0.48; 1628 children; high-certainty evidence), and they probably reduce ILI from 28% to 20% (RR 0.72, 95% CI 0.65 to 0.79; 19,044 children; moderate-certainty evidence). Five children would need to be vaccinated to prevent one case of influenza, and 12 children would need to be vaccinated to avoid one case of ILI. The risk of otitis media is probably similar between vaccinated children and unvaccinated children (31% versus 27%), although the CI does not exclude a meaningful increase in otitis media following vaccination (RR 1.15, 95% CI 0.95 to 1.40; 884 participants; moderate-certainty evidence). There was insufficient information available to determine the effect of vaccines on school absenteeism due to very low-certainty evidence from one study. We identified no data on parental working time lost, hospitalisation, fever, or nausea.\nWe found limited evidence on secondary cases, requirement for treatment of lower respiratory tract disease, and drug prescriptions. One brand of monovalent pandemic vaccine was associated with a sudden loss of muscle tone triggered by the experience of an intense emotion (cataplexy) and a sleep disorder (narcolepsy) in children. Evidence of serious harms (such as febrile fits) was sparse.\nAuthors' conclusions\nIn children aged between 3 and 16 years, live influenza vaccines probably reduce influenza (moderate-certainty evidence) and may reduce ILI (low-certainty evidence) over a single influenza season. In this population inactivated vaccines also reduce influenza (high-certainty evidence) and may reduce ILI (low-certainty evidence). For both vaccine types, the absolute reduction in influenza and ILI varied considerably across the study populations, making it difficult to predict how these findings translate to different settings. We found very few randomised controlled trials in children under two years of age. Adverse event data were not well described in the available studies. Standardised approaches to the definition, ascertainment, and reporting of adverse events are needed. Identification of all global cases of potential harms is beyond the scope of this review.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 41 randomised studies. Most studies included children older than two years of age and were conducted in the USA, Western Europe, Russia, and Bangladesh.\nCompared with placebo or do nothing, live attenuated vaccines probably reduced the proportion of children who had confirmed influenza from 18% to 4% (moderate-certainty evidence), and may reduce ILI from 17% to 12% (low-certainty evidence). Seven children would need to be vaccinated for one child to avoid influenza, and 20 children would need to prevent one child from experiencing an ILI. We found data from one study that showed similar risk of ear infection in the two groups. There was insufficient information available to assess school absence and parents needing to take time off work. We found no data on hospitalisation, and harms were not consistently reported.\nCompared with placebo or no vaccination, inactivated vaccines reduce the risk of influenza from 30% to 11% (high-certainty evidence), and they probably reduce ILI from 28% to 20% (moderate-certainty evidence). Five children would need to be vaccinated for one child to avoid influenza, and 12 children would need to be vaccinated to prevent one case of ILI. The risk of otitis media is probably similar between vaccinated children and unvaccinated children (31% versus 27%, moderate-certainty evidence). There was insufficient information available to assess school absenteeism due to very low-certainty evidence from one study. We identified no data on parental working time lost, hospitalisation, fever, or nausea.\nOne brand of monovalent pandemic vaccine was associated with a sudden loss of muscle tone triggered by the experience of an intense emotion (cataplexy) and a sleep disorder (narcolepsy) in children.\nOnly a few studies were well designed and conducted, and the impact of studies at high risk of bias varied across the outcomes evaluated. Influenza and otitis media were the only outcomes where our confidence in the results was not affected by bias."
}
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query-laysum
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6856
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[
{
"role": "user",
"content": "Abstract: Background\nPrelabour rupture of membranes (PROM) at term is managed expectantly or by planned early birth. It is not clear if waiting for birth to occur spontaneously is better than intervening, e.g. by inducing labour.\nObjectives\nThe objective of this review is to assess the effects of planned early birth (immediate intervention or intervention within 24 hours) when compared with expectant management (no planned intervention within 24 hours) for women with term PROM on maternal, fetal and neonatal outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (9 September 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised or quasi-randomised controlled trials of planned early birth compared with expectant management (either in hospital or at home) in women with PROM at 37 weeks' gestation or later.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted the data, and assessed risk of bias of the included studies. Data were checked for accuracy.\nMain results\nTwenty-three trials involving 8615 women and their babies were included in the update of this review. Ten trials assessed intravenous oxytocin; 12 trials assessed prostaglandins (six trials in the form of vaginal prostaglandin E2 and six as oral, sublingual or vaginal misoprostol); and one trial each assessed Caulophyllum and acupuncture. Overall, three trials were judged to be at low risk of bias, while the other 20 were at unclear or high risk of bias.\nPrimary outcomes: women who had planned early birth were at a reduced risk of maternal infectious morbidity (chorioamnionitis and/or endometritis) than women who had expectant management following term prelabour rupture of membranes (average risk ratio (RR) 0.49; 95% confidence interval (CI) 0.33 to 0.72; eight trials, 6864 women; Tau² = 0.19; I² = 72%; low-quality evidence), and their neonates were less likely to have definite or probable early-onset neonatal sepsis (RR 0.73; 95% CI 0.58 to 0.92; 16 trials, 7314 infants;low-quality evidence). No clear differences between the planned early birth and expectant management groups were seen for the risk of caesarean section (average RR 0.84; 95% CI 0.69 to 1.04; 23 trials, 8576 women; Tau² = 0.10; I² = 55%; low-quality evidence); serious maternal morbidity or mortality (no events; three trials; 425 women; very low-quality evidence); definite early-onset neonatal sepsis (RR 0.57; 95% CI 0.24 to 1.33; six trials, 1303 infants; very low-quality evidence); or perinatal mortality (RR 0.47; 95% CI 0.13 to 1.66; eight trials, 6392 infants; moderate-quality evidence).\nSecondary outcomes: women who had a planned early birth were at a reduced risk of chorioamnionitis (average RR 0.55; 95% CI 0.37 to 0.82; eight trials, 6874 women; Tau² = 0.19; I² = 73%), and postpartum septicaemia (RR 0.26; 95% CI 0.07 to 0.96; three trials, 263 women), and their neonates were less likely to receive antibiotics (average RR 0.61; 95% CI 0.44 to 0.84; 10 trials, 6427 infants; Tau² = 0.06; I² = 32%). Women in the planned early birth group were more likely to have their labour induced (average RR 3.41; 95% CI 2.87 to 4.06; 12 trials, 6945 women; Tau² = 0.05; I² = 71%), had a shorter time from rupture of membranes to birth (mean difference (MD) -10.10 hours; 95% CI -12.15 to -8.06; nine trials, 1484 women; Tau² = 5.81; I² = 60%), and their neonates had lower birthweights (MD -79.25 g; 95% CI -124.96 to -33.55; five trials, 1043 infants). Women who had a planned early birth had a shorter length of hospitalisation (MD -0.79 days; 95% CI -1.20 to -0.38; two trials, 748 women; Tau² = 0.05; I² = 59%), and their neonates were less likely to be admitted to the neonatal special or intensive care unit (RR 0.75; 95% CI 0.66 to 0.85; eight trials, 6179 infants), and had a shorter duration of hospital (-11.00 hours; 95% CI -21.96 to -0.04; one trial, 182 infants) or special or intensive care unit stay (RR 0.72; 95% CI 0.61 to 0.85; four trials, 5691 infants). Women in the planned early birth group had more positive experiences compared with women in the expectant management group.\nNo clear differences between groups were observed for endometritis; postpartum pyrexia; postpartum antibiotic usage; caesarean for fetal distress; operative vaginal birth; uterine rupture; epidural analgesia; postpartum haemorrhage; adverse effects; cord prolapse; stillbirth; neonatal mortality; pneumonia; Apgar score less than seven at five minutes; use of mechanical ventilation; or abnormality on cerebral ultrasound (no events).\nNone of the trials reported on breastfeeding; postnatal depression; gestational age at birth; meningitis; respiratory distress syndrome; necrotising enterocolitis; neonatal encephalopathy; or disability at childhood follow-up.\nIn subgroup analyses, there were no clear patterns of differential effects for method of induction, parity, use of maternal antibiotic prophylaxis, or digital vaginal examination. Results of the sensitivity analyses based on trial quality were consistent with those of the main analysis, except for definite or probable early-onset neonatal sepsis where no clear difference was observed.\nAuthors' conclusions\nThere is low quality evidence to suggest that planned early birth (with induction methods such as oxytocin or prostaglandins) reduces the risk of maternal infectious morbidity compared with expectant management for PROM at 37 weeks' gestation or later, without an apparent increased risk of caesarean section. Evidence was mainly downgraded due to the majority of studies contributing data having some serious design limitations, and for most outcomes estimates were imprecise.\nAlthough the 23 included trials in this review involved a large number of women and babies, the quality of the trials and evidence was not high overall, and there was limited reporting for a number of important outcomes. Thus further evidence assessing the benefits or harms of planned early birth compared with expectant management, considering maternal, fetal, neonatal and longer-term childhood outcomes, and the use of health services, would be valuable. Any future trials should be adequately designed and powered to evaluate the effects on short- and long-term outcomes. Standardisation of outcomes and their definitions, including for the assessment of maternal and neonatal infection, would be beneficial.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Planned early birth (compared with expectant management) after PROM at term may help to reduce infection for women without increasing the need for a caesarean section, and neonatal infection may also be reduced. However, evidence about longer-term effects on children is needed."
}
] |
query-laysum
|
6857
|
[
{
"role": "user",
"content": "Abstract: Background\nTuberculosis causes more deaths than any other infectious disease worldwide, with pulmonary tuberculosis being the most common form. Standard first-line treatment for drug-sensitive pulmonary tuberculosis for six months comprises isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE) for two months, followed by HRE (in areas of high TB drug resistance) or HR, given over a four-month continuation phase. Many people do not complete this full course. Shortened treatment regimens that are equally effective and safe could improve treatment success.\nObjectives\nTo evaluate the efficacy and safety of shortened treatment regimens versus the standard six-month treatment regimen for individuals with drug-sensitive pulmonary tuberculosis.\nSearch methods\nWe searched the following databases up to 10 July 2019: the Cochrane Infectious Diseases Group Specialized Register; the Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE (PubMed); Embase; the Latin American Caribbean Health Sciences Literature (LILACS); Science Citation Index-Expanded; Indian Medlars Center; and the South Asian Database of Controlled Clinical Trials. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform, ClinicalTrials.gov, the Clinical Trials Unit of the International Union Against Tuberculosis and Lung Disease, the UK Medical Research Council Clinical Trials Unit, and the Clinical Trials Registry India for ongoing trials. We checked the reference lists of identified articles to find additional relevant studies.\nSelection criteria\nWe searched for randomized controlled trials (RCTs) or quasi-RCTs that compared shorter-duration regimens (less than six months) versus the standard six-month regimen for people of all ages, irrespective of HIV status, who were newly diagnosed with pulmonary tuberculosis by positive sputum culture or GeneXpert, and with presumed or proven drug-sensitive tuberculosis. The primary outcome of interest was relapse within two years of completion of anti-tuberculosis treatment (ATT).\nData collection and analysis\nTwo review authors independently selected trials, extracted data, and assessed risk of bias for the included trials. For dichotomous outcomes, we used risk ratios (RRs) with 95% confidence intervals (CIs). When appropriate, we pooled data from the included trials in meta-analyses. We assessed the certainty of evidence using the GRADE approach.\nMain results\nWe included five randomized trials that compared fluoroquinolone-containing four-month ATT regimens versus standard six-month ATT regimens and recruited 5825 adults with newly diagnosed drug-sensitive pulmonary tuberculosis from 14 countries with high tuberculosis transmission in Asia, Africa, and Latin Ameria. Three were multi-country trials that included a total of 572 HIV-positive people. These trials excluded children, pregnant or lactating women, people with serious comorbid conditions, and those with diabetes mellitus. Four trials had multiple treatment arms.\nMoxifloxacin replaced ethambutol in standard four-month, daily or thrice-weekly ATT regimens in two trials; moxifloxacin replaced isoniazid in four-month ATT regimens in two trials, was given daily in one trial, and was given with rifapentine instead of rifampicin daily for two months and twice weekly for two months in one trial. Moxifloxacin was added to standard ATT drugs for three to four months in one ongoing trial that reported interim results. Gatifloxacin replaced ethambutol in standard ATT regimens given daily or thrice weekly for four months in two trials. Follow-up ranged from 12 months to 24 months after treatment completion for the majority of participants.\nMoxifloxacin-containing four-month ATT regimens\nMoxifloxacin-containing four-month ATT regimens that replaced ethambutol or isoniazid probably increased the proportions who experienced relapse after successful treatment compared to standard ATT regimens (RR 3.56, 95% CI 2.37 to 5.37; 2265 participants, 3 trials; moderate-certainty evidence). For death from any cause, there was probably little or no difference between the two regimens (2760 participants, 3 trials; moderate-certainty evidence). Treatment failure was rare, and there was probably little or no difference in proportions with treatment failure between ATT regimens (2282 participants, 3 trials; moderate-certainty evidence). None of the participants given moxifloxacin-containing regimens developed resistance to rifampicin, and these regimens may not increase the risk of acquired resistance (2282 participants, 3 trials; low-certainty evidence). Severe adverse events were probably little or no different with moxifloxacin-containing four-month regimens that replaced ethambutol or isoniazid, and with three- to four-month regimens that augmented standard ATT with moxifloxacin, when compared to standard six-month ATT regimens (3548 participants, 4 trials; moderate-certainty evidence).\nGatifloxacin-containing four-month ATT regimens\nGatifloxacin-containing four-month ATT regimens that replaced ethambutol probably increased relapse compared to standard six-month ATT regimens in adults with drug-sensitive pulmonary tuberculosis (RR 2.11, 95% CI 1.56 to 2.84; 1633 participants, 2 trials; moderate-certainty evidence). The four-month regimen probably made little or no difference in death compared to the six-month regimen (1886 participants, 2 trials; moderate-certainty evidence). Treatment failure was uncommon and was probably little or no different between the four-month and six-month regimens (1657 participants, 2 trials; moderate-certainty evidence). Acquired resistance to isoniazid or rifampicin was not detected in those given the gatifloxacin-containing shortened ATT regimen, but we are uncertain whether acquired drug resistance is any different in the four- and six-month regimens (429 participants, 1 trial; very low-certainty evidence). Serious adverse events were probably no different with either regimen (1993 participants, 2 trials; moderate-certainty evidence).\nAuthors' conclusions\nEvidence to date does not support the use of shortened ATT regimens in adults with newly diagnosed drug-sensitive pulmonary tuberculosis. Four-month ATT regimens that replace ethambutol with moxifloxacin or gatifloxacin, or isoniazid with moxifloxacin, increase relapse substantially compared to standard six-month ATT regimens, although treatment success and serious adverse events are little or no different. The results of six large ongoing trials will help inform decisions on whether shortened ATT regimens can replace standard six-month ATT regimens.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to find out if the duration of anti-tuberculosis treatment (ATT) for people with newly diagnosed drug-sensitive pulmonary tuberculosis can be shortened to less than six months. Cochrane Review authors collected and analysed all relevant studies to answer this question and found five relevant studies."
}
] |
query-laysum
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6858
|
[
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. It is often treated with medication, but different interventions are sometimes used. Positive pressure therapy is a treatment that creates small pressure pulses, generated by a pump that is attached to tubing placed in the ear canal. It is typically used for a few minutes, several times per day. The underlying cause of Ménière's disease is unknown, as is the way in which this treatment may work. The efficacy of this intervention at preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of positive pressure therapy versus placebo or no treatment in people with Ménière's disease.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with a diagnosis of Ménière's disease comparing positive pressure therapy with either placebo or no treatment. We excluded studies with follow-up of less than three months.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included three studies with a total of 238 participants, all of which compared positive pressure using the Meniett device to sham treatment. The duration of follow-up was a maximum of four months.\nImprovement in vertigo\nA single study assessed whether participants had an improvement in the frequency of their vertigo whilst using positive pressure therapy, therefore we are unable to draw meaningful conclusions from the results.\nChange in vertigo\nOnly one study reported on the change in vertigo symptoms using a global score (at 3 to < 6 months), so we are again unable to draw meaningful conclusions from the numerical results. All three studies reported on the change in the frequency of vertigo. The summary effect showed that people receiving positive pressure therapy had, on average, 0.84 fewer days per month affected by vertigo (95% confidence interval from 2.12 days fewer to 0.45 days more; 3 studies; 202 participants). However, the evidence on the change in vertigo frequency was of very low certainty, therefore there is great uncertainty in this estimate.\nSerious adverse events\nNone of the included studies provided information on the number of people who experienced serious adverse events. It is unclear whether this is because no adverse events occurred, or whether they were not assessed and reported.\nAuthors' conclusions\nThe evidence for positive pressure therapy for Ménière's disease is very uncertain. There are few RCTs that compare this intervention to placebo or no treatment, and the evidence that is currently available from these studies is of low or very low certainty. This means that we have very low confidence that the effects reported are accurate estimates of the true effect of these interventions. Consensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analyses of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.\n\nGiven the provided abstract, please respond to the following query: \"What is Ménière's disease?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Ménière's disease is a condition that affects the inner ear. It causes repeated attacks of dizziness or vertigo (a spinning sensation), together with hearing problems, tinnitus (ringing, humming or buzzing noises in the ears) and a feeling of fullness or pressure in the ear. It usually affects adults, and starts in middle age."
}
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query-laysum
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6859
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[
{
"role": "user",
"content": "Abstract: Background\nImmune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 axis have changed the first-line treatment of people with advanced non-small cell lung cancer (NSCLC). Single-agent pembrolizumab (a PD-1 inhibitor) is currently the standard of care as monotherapy in patients with PD-L1 expression ≥ 50%, either alone or in combination with chemotherapy when PD-L1 expression is less than 50%. Atezolizumab (PD-L1 inhibitor) has also been approved in combination with chemotherapy and bevacizumab (an anti-angiogenic antibody) in first-line NSCLC regardless of PD-L1 expression. The combination of first-line PD-1/PD-L1 inhibitors with anti-CTLA-4 antibodies has also been shown to improve survival compared to platinum-based chemotherapy in advanced NSCLC, particularly in people with high tumour mutational burden (TMB). The association of ipilimumab (an anti CTLA4) and nivolumab (PD-1 inhibitor) has been approved by the US Food and Drug Administration (FDA) in all patients with PD-L1 expression ≥1%. Although these antibodies are currently used in clinical practice, some questions remain unanswered, such as the best-treatment strategy, the role of different biomarkers for treatment selection and the effectiveness of immunotherapy according to specific clinical characteristics.\nObjectives\nTo determine the effectiveness and safety of first-line immune checkpoint inhibitors (ICIs), as monotherapy or in combination, compared to platinum-based chemotherapy, with or without bevacizumab for people with advanced NSCLC, according to the level of PD-L1 expression.\nSearch methods\nWe performed an electronic search of the main databases (Cochrane Central Register of Controlled Trials, MEDLINE, Embase) from inception until 31 December 2020 and conferences meetings from 2015 onwards.\nSelection criteria\nWe included randomised controlled trials (RCTs) reporting on the efficacy or safety of first-line ICI treatment for adults with advanced NSCLC who had not previously received any anticancer treatment. We included trials comparing single- or double-ICI treatment to standard first-line therapy (platinum-based chemotherapy +/- bevacizumab). All data come from ‘international multicentre studies involving adults, age 18 or over, with histologically-confirmed stage IV NSCLC.\nData collection and analysis\nThree review authors independently assessed the search results and a fourth review author resolved any disagreements. Primary outcomes were overall survival (OS) and progression-free survival (PFS); secondary outcomes were overall objective response rate (ORR) by RECIST v 1.1, grade 3 to 5 treatment-related adverse events (AEs) (CTCAE v 5.0) and health-related quality of life (HRQoL). We performed meta-analyses where appropriate using the random-effects model for hazard ratios (HRs) or risk ratios (RRs), with 95% confidence intervals (95% CIs), and used the I² statistic to investigate heterogeneity.\nMain results\nMain results\nWe identified 15 trials for inclusion, seven completed and eight ongoing trials. We obtained data for 5893 participants from seven trials comparing first-line single- (six trials) or double- (two trials) agent ICI with platinum-based chemotherapy, one trial comparing both first-line single- and double-agent ICsI with platinum-based chemotherapy. All trials were at low risk of selection and detection bias, some were classified at high risk of performance, attrition or other source of bias. The overall certainty of evidence according to GRADE ranged from moderate-to-low because of risk of bias, inconsistency, or imprecision. The majority of the included trials reported their outcomes by PD-L1 expressions, with PD-L1 ≥ 50 being considered the most clinically useful cut-off level for decision makers. Also, iIn order to avoid overlaps between various PDL-1 expressions we prioritised the review outcomes according to PD-L1 ≥ 50.\nSingle-agent ICI\nIn the PD-L1 expression ≥ 50% group single-agent ICI probably improved OS compared to platinum-based chemotherapy (hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.60 to 0.76, 6 RCTs, 2111 participants, moderate-certainty evidence). In this group, single-agent ICI also may improve PFS (HR: 0.68, 95% CI 0.52 to 0.88, 5 RCTs, 1886 participants, low-certainty evidence) and ORR (risk ratio (RR):1.40, 95% CI 1.12 to 1.75, 4 RCTs, 1672 participants, low-certainty evidence). HRQoL data were available for only one study including only people with PD-L1 expression ≥ 50%, which suggested that single-agent ICI may improve HRQoL at 15 weeks compared to platinum-based chemotherapy (RR: 1.51, 95% CI 1.08 to 2.10, 1 RCT, 297 participants, low-certainty evidence).\nIn the included studies, treatment-related AEs were not reported according to PD-L1 expression levels. Grade 3-4 AEs may be less frequent with single-agent ICI compared to platinum-based chemotherapy (RR: 0.41, 95% CI 0.33 to 0.50, I² = 62%, 5 RCTs, 3346 participants, low-certainty evidence).\nMore information about efficacy of single-agent ICI compared to platinum-based chemotherapy according to the level of PD-L1 expression and to TMB status or specific clinical characteristics is available in the full text.\nDouble-agent ICI \nDouble-ICI treatment probably prolonged OS compared to platinum-based chemotherapy in people with PD-L1 expression ≥50% (HR: 0.72, 95% CI 0.59 to 0.89 2 RCTs, 612 participants, moderate-certainty evidence).\nTrials did not report data on HRQoL, PFS and ORR according to PD-L1 groups.\nTreatment related AEs were not reported according to PD-L1 expression levels. The frequency of grade 3-4 AEs may not differ between double-ICI treatment and platinum-based chemotherapy (RR: 0.78, 95% CI 0.55 to 1.09, I² = 81%, 2 RCTs, 1869 participants, low-certainty evidence).\nMore information about efficacy of double-agent ICI according to the level of PD-L1 expression and to TMB status is available in the full text.\nAuthors' conclusions\nAuthors' conclusions\nThe evidence in this review suggests that single-agent ICI in people with NSCLC and PD-L1 ≥50% probably leads to a higher overall survival rate and may lead to a higher progression-free survival and overall response rate when compared to platinum-based chemotherapy and may also lead to a lower rate of adverse events and higher HRQoL. Combined ICI in people with NSCLC and PD-L1 ≥50% also probably leads to a higher overall survival rate when compared to platinum-based chemotherapy, but its effect on progression-free survival, overall response rate and HRQoL is unknown due to a lack of data. The rate of adverse events may not differ between groups.\nThis review used to be a living review. It is transitioned out of living mode because current research is exploring ICI in association with chemotherapy or other immunotherapeutic drugs versus ICI as single agent rather than platinum based chemotherapy.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, the certainty of the evidence ranged from moderate to low."
}
] |
query-laysum
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6860
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[
{
"role": "user",
"content": "Abstract: Background\nFoot infection is the most common cause of non-traumatic amputation in people with diabetes. Most diabetic foot infections (DFIs) require systemic antibiotic therapy and the initial choice is usually empirical. Although there are many antibiotics available, uncertainty exists about which is the best for treating DFIs.\nObjectives\nTo determine the effects and safety of systemic antibiotics in the treatment of DFIs compared with other systemic antibiotics, topical foot care or placebo.\nSearch methods\nIn April 2015 we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library); Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE, and EBSCO CINAHL. We also searched in the Database of Abstracts of Reviews of Effects (DARE; The Cochrane Library), the Health Technology Assessment database (HTA; The Cochrane Library), the National Health Service Economic Evaluation Database (NHS-EED; The Cochrane Library), unpublished literature in OpenSIGLE and ProQuest Dissertations and on-going trials registers.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating the effects of systemic antibiotics (oral or parenteral) in people with a DFI. Primary outcomes were clinical resolution of the infection, time to its resolution, complications and adverse effects.\nData collection and analysis\nTwo review authors independently selected studies, assessed the risk of bias, and extracted data. Risk ratios (RR) were estimated for dichotomous data and, when sufficient numbers of comparable trials were available, trials were pooled in a meta-analysis.\nMain results\nWe included 20 trials with 3791 participants. Studies were heterogenous in study design, population, antibiotic regimens, and outcomes. We grouped the sixteen different antibiotic agents studied into six categories: 1) anti-pseudomonal penicillins (three trials); 2) broad-spectrum penicillins (one trial); 3) cephalosporins (two trials); 4) carbapenems (four trials); 5) fluoroquinolones (six trials); 6) other antibiotics (four trials).\nOnly 9 of the 20 trials protected against detection bias with blinded outcome assessment. Only one-third of the trials provided enough information to enable a judgement about whether the randomisation sequence was adequately concealed. Eighteen out of 20 trials received funding from pharmaceutical industry-sponsors.\nThe included studies reported the following findings for clinical resolution of infection: there is evidence from one large trial at low risk of bias that patients receiving ertapenem with or without vancomycin are more likely to have resolution of their foot infection than those receiving tigecycline (RR 0.92, 95% confidence interval (CI) 0.85 to 0.99; 955 participants). It is unclear if there is a difference in rates of clinical resolution of infection between: 1) two alternative anti-pseudomonal penicillins (one trial); 2) an anti-pseudomonal penicillin and a broad-spectrum penicillin (one trial) or a carbapenem (one trial); 3) a broad-spectrum penicillin and a second-generation cephalosporin (one trial); 4) cephalosporins and other beta-lactam antibiotics (two trials); 5) carbapenems and anti-pseudomonal penicillins or broad-spectrum penicillins (four trials); 6) fluoroquinolones and anti-pseudomonal penicillins (four trials) or broad-spectrum penicillins (two trials); 7) daptomycin and vancomycin (one trial); 8) linezolid and a combination of aminopenicillins and beta-lactamase inhibitors (one trial); and 9) clindamycin and cephalexin (one trial).\nCarbapenems combined with anti-pseudomonal agents produced fewer adverse effects than anti-pseudomonal penicillins (RR 0.27, 95% CI 0.09 to 0.84; 1 trial). An additional trial did not find significant differences in the rate of adverse events between a carbapenem alone and an anti-pseudomonal penicillin, but the rate of diarrhoea was lower for participants treated with a carbapenem (RR 0.58, 95% CI 0.36 to 0.93; 1 trial). Daptomycin produced fewer adverse effects than vancomycin or other semi-synthetic penicillins (RR 0.61, 95%CI 0.39 to 0.94; 1 trial). Linezolid produced more adverse effects than ampicillin-sulbactam (RR 2.66; 95% CI 1.49 to 4.73; 1 trial), as did tigecycline compared to ertapenem with or without vancomycin (RR 1.47, 95% CI 1.34 to 1.60; 1 trial). There was no evidence of a difference in safety for the other comparisons.\nAuthors' conclusions\nThe evidence for the relative effects of different systemic antibiotics for the treatment of foot infections in diabetes is very heterogeneous and generally at unclear or high risk of bias. Consequently it is not clear if any one systemic antibiotic treatment is better than others in resolving infection or in terms of safety. One non-inferiority trial suggested that ertapenem with or without vancomycin is more effective in achieving clinical resolution of infection than tigecycline. Otherwise the relative effects of different antibiotics are unclear. The quality of the evidence is low due to limitations in the design of the included trials and important differences between them in terms of the diversity of antibiotics assessed, duration of treatments, and time points at which outcomes were assessed. Any further studies in this area should have a blinded assessment of outcomes, use standardised criteria to classify severity of infection, define clear outcome measures, and establish the duration of treatment.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We identified 20 relevant randomised controlled trials, with a total of 3791 participants. Eighteen of the 20 studies were funded by pharmaceutical companies. All trials compared systemic antibiotics with other systemic antibiotics."
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6861
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[
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"role": "user",
"content": "Abstract: Background\nGlobally, cannabis use is prevalent and widespread. There are currently no pharmacotherapies approved for treatment of cannabis use disorders.\nThis is an update of a Cochrane Review first published in the Cochrane Library in Issue 12, 2014.\nObjectives\nTo assess the effectiveness and safety of pharmacotherapies as compared with each other, placebo or no pharmacotherapy (supportive care) for reducing symptoms of cannabis withdrawal and promoting cessation or reduction of cannabis use.\nSearch methods\nWe updated our searches of the following databases to March 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO and Web of Science.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs involving the use of medications to treat cannabis withdrawal or to promote cessation or reduction of cannabis use, or both, in comparison with other medications, placebo or no medication (supportive care) in people diagnosed as cannabis dependent or who were likely to be dependent.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 21 RCTs involving 1755 participants: 18 studies recruited adults (mean age 22 to 41 years); three studies targeted young people (mean age 20 years). Most (75%) participants were male. The studies were at low risk of performance, detection and selective outcome reporting bias. One study was at risk of selection bias, and three studies were at risk of attrition bias.\nAll studies involved comparison of active medication and placebo. The medications were diverse, as were the outcomes reported, which limited the extent of analysis.\nAbstinence at end of treatment was no more likely with Δ9-tetrahydrocannabinol (THC) preparations than with placebo (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.64 to 1.52; 305 participants; 3 studies; moderate-quality evidence). For selective serotonin reuptake inhibitor (SSRI) antidepressants, mixed action antidepressants, anticonvulsants and mood stabilisers, buspirone and N-acetylcysteine, there was no difference in the likelihood of abstinence at end of treatment compared to placebo (low- to very low-quality evidence).\nThere was qualitative evidence of reduced intensity of withdrawal symptoms with THC preparations compared to placebo. For other pharmacotherapies, this outcome was either not examined, or no significant differences was reported.\nAdverse effects were no more likely with THC preparations (RR 1.02, 95% CI 0.89 to 1.17; 318 participants; 3 studies) or N-acetylcysteine (RR 0.94, 95% CI 0.71 to 1.23; 418 participants; 2 studies) compared to placebo (moderate-quality evidence). For SSRI antidepressants, mixed action antidepressants, buspirone and N-acetylcysteine, there was no difference in adverse effects compared to placebo (low- to very low-quality evidence).\nThere was no difference in the likelihood of withdrawal from treatment due to adverse effects with THC preparations, SSRIs antidepressants, mixed action antidepressants, anticonvulsants and mood stabilisers, buspirone and N-acetylcysteine compared to placebo (low- to very low-quality evidence).\nThere was no difference in the likelihood of treatment completion with THC preparations, SSRI antidepressants, mixed action antidepressants and buspirone compared to placebo (low- to very low-quality evidence) or with N-acetylcysteine compared to placebo (RR 1.06, 95% CI 0.93 to 1.21; 418 participants; 2 studies; moderate-quality evidence). Anticonvulsants and mood stabilisers appeared to reduce the likelihood of treatment completion (RR 0.66, 95% CI 0.47 to 0.92; 141 participants; 3 studies; low-quality evidence).\nAvailable evidence on gabapentin (anticonvulsant), oxytocin (neuropeptide) and atomoxetine was insufficient for estimates of effectiveness.\nAuthors' conclusions\nThere is incomplete evidence for all of the pharmacotherapies investigated, and for many outcomes the quality of the evidence was low or very low. Findings indicate that SSRI antidepressants, mixed action antidepressants, bupropion, buspirone and atomoxetine are probably of little value in the treatment of cannabis dependence. Given the limited evidence of efficacy, THC preparations should be considered still experimental, with some positive effects on withdrawal symptoms and craving. The evidence base for the anticonvulsant gabapentin, oxytocin, and N-acetylcysteine is weak, but these medications are also worth further investigation.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Cannabis use is relatively common and widespread worldwide. Demand by cannabis users for treatment has been increasing in most regions of the world. Moves in some countries to decriminalise or legalise cannabis use is likely to result in this trend continuing. Currently there are no medicines specifically for the treatment of cannabis use. This review sought to assess the effectiveness and safety of medicines for the treatment of cannabis dependence."
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6862
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"role": "user",
"content": "Abstract: Background\nDiaphragm-triggered non-invasive respiratory support, commonly referred to as NIV-NAVA (non-invasive neurally adjusted ventilatory assist), uses the electrical activity of the crural diaphragm to trigger the start and end of a breath. It provides variable inspiratory pressure that is proportional to an infant's changing inspiratory effort. NIV-NAVA has the potential to provide effective, non-invasive, synchronised, multilevel support and may reduce the need for invasive ventilation; however, its effects on short- and long-term outcomes, especially in the preterm infant, are unclear.\nObjectives\nTo assess the effectiveness and safety of diaphragm-triggered non-invasive respiratory support in preterm infants (< 37 weeks' gestation) when compared to other non-invasive modes of respiratory support (nasal intermittent positive pressure ventilation (NIPPV); nasal continuous positive airway pressure (nCPAP); high-flow nasal cannulae (HFNC)), and to assess preterm infants with birth weight less than 1000 grams or less than 28 weeks' corrected gestation at the time of intervention as a sub-group.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 5), MEDLINE via PubMed (1946 to 10 May 2019), Embase (1947 to 10 May 2019), and CINAHL (1982 to 10 May 2019). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared diaphragm-triggered non-invasive versus other non-invasive respiratory support in preterm infants.\nData collection and analysis\nTwo review authors independently selected trials, assessed trial quality and extracted data from included studies. We performed fixed-effect analyses and expressed treatment effects as mean difference (MD), risk ratio (RR), and risk difference (RD) with 95% confidence intervals (CIs). We used the generic inverse variance method to analyse specific outcomes for cross-over trials. We used the GRADE approach to assess the certainty of evidence.\nMain results\nThere were two small randomised controlled trials including a total of 23 infants eligible for inclusion in the review. Only one trial involving 16 infants included in the analysis reported on either of the primary outcomes of the review. This found no difference in failure of modality between NIV-NAVA and NIPPV (RR 0.33, 95% CI 0.02 to 7.14; RD −0.13, 95% CI -0.41 to 0.16; 1 study, 16 infants; heterogeneity not applicable).\nBoth trials reported on secondary outcomes of the review, specific for cross-over trials (total 22 infants; 1 excluded due to failure of initial modality). One study involving seven infants reported a significant reduction in maximum FiO₂ with NIV-NAVA compared to NIPPV (MD −4.29, 95% CI −5.47 to −3.11; heterogeneity not applicable). There was no difference in maximum electric activity of the diaphragm (Edi) signal between modalities (MD −1.75, 95% CI −3.75 to 0.26; I² = 0%) and a significant increase in respiratory rate with NIV-NAVA compared to NIPPV (MD 7.22, 95% CI 0.21 to 14.22; I² = 72%) on a meta-analysis of two studies involving a total of 22 infants. The included studies did not report on other outcomes of interest.\nAuthors' conclusions\nDue to limited data and very low certainty evidence, we were unable to determine if diaphragm-triggered non-invasive respiratory support is effective or safe in preventing respiratory failure in preterm infants. Large, adequately powered randomised controlled trials are needed to determine if diaphragm-triggered non-invasive respiratory support in preterm infants is effective or safe.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "In preterm infants, does diaphragm-triggered non-invasive respiratory support compared with other modes of non-invasive respiratory support prevent respiratory failure?"
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6863
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[
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"role": "user",
"content": "Abstract: Background\nAsthma is a common respiratory condition in children that is characterised by symptoms including wheeze, shortness of breath, chest tightness, and cough. Children with asthma may be able to manage their condition more effectively by improving inhaler technique, and by recognising and responding to symptoms. Schools offer a potentially supportive environment for delivering interventions aimed at improving self-management skills among children. The educational ethos aligns with skill and knowledge acquisition and makes it easier to reach children with asthma who do not regularly engage with primary care. Given the multi-faceted nature of self-management interventions, there is a need to understand the combination of intervention features that are associated with successful delivery of asthma self-management programmes.\nObjectives\nThis review has two primary objectives.\n• To identify the intervention features that are aligned with successful intervention implementation.\n• To assess effectiveness of school-based interventions provided to improve asthma self-management among children.\nWe addressed the first objective by performing qualitative comparative analysis (QCA), a synthesis method described in depth later, of process evaluation studies to identify the combination of intervention components and processes that are aligned with successful intervention implementation.\nWe pursued the second objective by undertaking meta-analyses of outcomes reported by outcome evaluation studies. We explored the link between how well an intervention is implemented and its effectiveness by using separate models, as well as by undertaking additional subgroup analyses.\nSearch methods\nWe searched the Cochrane Airways Trials Register for randomised studies. To identify eligible process evaluation studies, we searched MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Database of Systematic Reviews (CDSR), Web of Knowledge, the Database of Promoting Health Effectiveness Reviews (DoPHER), the Database of Abstracts of Reviews of Effects (DARE), the International Biography of Social Science (IBSS), Bibliomap, Health Technology Assessment (HTA), Applied Social Sciences Index and Abstracts (ASSIA), and Sociological Abstracts (SocAbs). We conducted the latest search on 28 August 2017.\nSelection criteria\nParticipants were school-aged children with asthma who received the intervention in school. Interventions were eligible if their purpose was to help children improve management of their asthma by increasing knowledge, enhancing skills, or changing behaviour. Studies relevant to our first objective could be based on an experimental or quasi-experimental design and could use qualitative or quantitative methods of data collection. For the second objective we included randomised controlled trials (RCTs) where children were allocated individually or in clusters (e.g. classrooms or schools) to self-management interventions or no intervention control.\nData collection and analysis\nWe used qualitative comparative analysis (QCA) to identify intervention features that lead to successful implementation of asthma self-management interventions. We measured implementation success by reviewing reports of attrition, intervention dosage, and treatment adherence, irrespective of effects of the interventions.\nTo measure the effects of interventions, we combined data from eligible studies for our primary outcomes: admission to hospital, emergency department (ED) visits, absence from school, and days of restricted activity due to asthma symptoms. Secondary outcomes included unplanned visits to healthcare providers, daytime and night-time symptoms, use of reliever therapies, and health-related quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ).\nMain results\nWe included 55 studies in the review. Thirty-three studies in 14,174 children provided information for the QCA, and 33 RCTs in 12,623 children measured the effects of interventions. Eleven studies contributed to both the QCA and the analysis of effectiveness. Most studies were conducted in North America in socially disadvantaged populations. High school students were better represented among studies contributing to the QCA than in studies contributing to effectiveness evaluations, which more commonly included younger elementary and junior high school students. The interventions all attempted to improve knowledge of asthma, its triggers, and stressed the importance of regular practitioner review, although there was variation in how they were delivered.\nQCA results highlighted the importance of an intervention being theory driven, along with the importance of factors such as parent involvement, child satisfaction, and running the intervention outside the child's own time as drivers of successful implementation.\nCompared with no intervention, school-based self-management interventions probably reduce mean hospitalisations by an average of about 0.16 admissions per child over 12 months (SMD –0.19, 95% CI -0.35 to -0.04; 1873 participants; 6 studies, moderate certainty evidence). They may reduce the number of children who visit EDs from 7.5% to 5.4% over 12 months (OR 0.70, 95% CI 0.53 to 0.92; 3883 participants; 13 studies, low certainty evidence), and probably reduce unplanned visits to hospitals or primary care from 26% to 21% at 6 to 9 months (OR 0.74, 95% CI 0.60 to 0.90; 3490 participants; 5 studies, moderate certainty evidence). Self-management interventions probably reduce the number of days of restricted activity by just under half a day over a two-week period (MD 0.38 days 95% CI -0.41 to -0.18; 1852 participants; 3 studies, moderate certainty evidence). Effects of interventions on school absence are uncertain due to the variation between the results of the studies (MD 0.4 fewer school days missed per year with self-management (-1.25 to 0.45; 4609 participants; 10 studies, low certainty evidence). Evidence is insufficient to show whether the requirement for reliever medications is affected by these interventions (OR 0.52, 95% CI 0.15 to 1.81; 437 participants; 2 studies; very low-certainty evidence). Self-management interventions probably improve children's asthma-related quality of life by a small amount (MD 0.36 units higher on the Paediatric AQLQ(95% CI 0.06 to 0.64; 2587 participants; 7 studies, moderate certainty evidence).\nAuthors' conclusions\nSchool-based asthma self-management interventions probably reduce hospital admission and may slightly reduce ED attendance, although their impact on school attendance could not be measured reliably. They may also reduce the number of days where children experience asthma symptoms, and probably lead to small improvements in asthma-related quality of life. Many of the studies tested the intervention in younger children from socially disadvantaged populations. Interventions that had a theoretical framework, engaged parents and were run outside of children's free time were associated with successful implementation.\n\nGiven the provided abstract, please respond to the following query: \"Background to the question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Asthma is a common condition among children. Schools are potential sites for developing self-management skills, but evidence that school-based interventions improve asthma control has not been reviewed systematically."
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6864
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"role": "user",
"content": "Abstract: Background\nVenous leg ulcers (VLUs) or varicose ulcers are the final stage of chronic venous insufficiency (CVI), and are the most common type of leg ulcer. The development of VLUs on ankles and lower legs can occur spontaneously or after minor trauma. The ulcers are often painful and exudative, healing is often protracted and recurrence is common. This cycle of healing and recurrence has a considerable impact on the health and quality of life of individuals, and healthcare and socioeconomic costs. VLUs are a common and costly problem worldwide; prevalence is estimated to be between 1.65% to 1.74% in the western world and is more common in adults aged 65 years and older. The main treatment for a VLU is a firm compression bandage. Compression assists by reducing venous hypertension, enhancing venous return and reducing peripheral oedema. However, studies show that it only has moderate effects on healing, with up to 50% of VLUs unhealed after two years of compression. Non-adherence may be the principal cause of these poor results, but presence of inflammation in people with CVI may be another factor, so a treatment that suppresses inflammation (healing ulcers more quickly) and reduces the frequency of ulcer recurrence (thereby prolonging time between recurrent episodes) would be an invaluable intervention to complement compression treatments. Oral aspirin may have a significant impact on VLU clinical practice worldwide. Evidence for the effectiveness of aspirin on ulcer healing and recurrence in high quality RCTs is currently lacking.\nObjectives\nTo assess the benefits and harms of oral aspirin on the healing and recurrence of venous leg ulcers.\nSearch methods\nIn May 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. Additional searches were made in trial registers and reference lists of relevant publications for published or ongoing trials. There were no language or publication date restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared oral aspirin with placebo or no drug intervention (in the presence or absence of compression therapy) for treating people with venous leg ulcers. Our main outcomes were time to complete ulcer healing, rate of change in the area of the ulcer, proportion of ulcers healed in the trial period, major bleeding, pain, mortality, adverse events and ulcer recurrence (time for recurrence and proportion of recurrence).\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data, assessed the risk of bias of each included trial and assessed overall quality of evidence for the main outcomes in the 'Summary of findings' table.\nMain results\nThe electronic search located 62 studies. We included two RCTs of oral aspirin (300 mg/daily) given in addition to compression compared with compression and placebo, or compression alone. To date, the impact of aspirin on VLUs has been examined by only two randomised clinical trials, both with a small number of participants. The first RCT was conducted in the United Kingdom (n=20) and reported that daily administration of aspirin (300mg) in addition to compression bandages increased both the rate of healing, and the number of participants healed when compared to placebo in addition to compression bandaging over a four month period. Thirty-eight per cent of the participants given aspirin reported complete healing compared with 0% in the placebo group . Improvement (assessed by reduction in wound size) occurred in 52% of the participants taking aspirin compared with 26% in those taking placebo). The study identified potential benefits of taking aspirin as an adjunct to compression but the sample size was small, and neither the mechanism by which aspirin improved healing nor its effects on recurrence were investigated.\nIn 2012 an RCT in Spain (n=51) compared daily administration of aspirin (300mg) in addition to compression bandages with compression alone over a five month period. There was little difference in complete healing rates between groups (21/28 aspirin and 17/23 compression bandages alone) but the average time to healing was shorter (12 weeks in the treated group vs 22 weeks in the compression only group) and the average time for recurrence was longer in the aspirin group (39 days: [SD 6.0] compared with 16.3 days [SD 7.5] in the compression only group). Although this trial provides some limited data about the potential use of aspirin therapy, the sample size (only 20 patients) was too small for us to draw meaningful conclusions. In addition, patients were only followed up for 4 months and no information on placebo was reported.\nAuthors' conclusions\nLow quality evidence from two trials indicate that there is currently insufficient evidence for us to draw definitive conclusions about the benefits and harms of oral aspirin on the healing and recurrence of venous leg ulcers. We downgraded the evidence to low quality due to potential selection bias and imprecision due to the small sample size. The small number of participants may have a hidden real benefit, or an increase in harm. Due to the lack of reliable evidence, we are unable to draw conclusions about the benefits and harms of oral daily aspirin as an adjunct to compression in VLU healing or recurrence. Further high quality studies are needed in this area.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "We identified only two randomised controlled trials that compared oral aspirin (300mg daily) plus compression with compression and placebo, or compression alone. One study conducted in UK included 20 participants (ten in the aspirin group and ten in the control group) and followed people for four months. This trial reported that the ulcer area had reduced (by 6.5 cm², a 39.4% reduction) in the aspirin group compared with no reduction in ulcer area in the control group, and that a higher proportion of the ulcers (38%) in the aspirin group had completely healed compared with none in the control group. Recurrence was not investigated in this study. Another study conducted in Spain included 51 participants (23 in the aspirin group and 28 in the control group) and followed people until their ulcers had healed. The study reported that the average time for healing was 12 weeks in the aspirin group and 22 weeks in the control group, and that there was no real difference between the proportion of people with ulcers healed (17 (74%) out 23 people in the aspirin group and 21 (75%) out 28 people in the control group). The average time for recurrence was longer in the aspirin group (39 days) compared with (16.3 days) in group of compression alone. Adverse events were not reported in either trial.\nWe considered these two studies too small and low quality for us to draw definitive conclusions about the benefits and harms of oral aspirin on the healing and recurrence of venous leg ulcers. The UK study provides only limited data about the potential benefits of daily oral aspirin therapy with compression due to a small sample size of only 20 participants and short follow up. The Spanish study provides limited data on 51 participants comparing aspirin and compression to a control group. The fact that no information was reported regarding placebo in the control group means the estimate of effect is uncertain. Further high quality studies are needed in this area.\nThis plain language summary is up to date as of 27 May 2015."
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6865
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"role": "user",
"content": "Abstract: Background\nIn response to the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the impact of coronavirus disease 2019 (COVID-19), governments have implemented a variety of measures to control the spread of the virus and the associated disease. Among these, have been measures to control the pandemic in primary and secondary school settings.\nObjectives\nTo assess the effectiveness of measures implemented in the school setting to safely reopen schools, or keep schools open, or both, during the COVID-19 pandemic, with particular focus on the different types of measures implemented in school settings and the outcomes used to measure their impacts on transmission-related outcomes, healthcare utilisation outcomes, other health outcomes as well as societal, economic, and ecological outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Educational Resources Information Center, as well as COVID-19-specific databases, including the Cochrane COVID-19 Study Register and the WHO COVID-19 Global literature on coronavirus disease (indexing preprints) on 9 December 2020. We conducted backward-citation searches with existing reviews.\nSelection criteria\nWe considered experimental (i.e. randomised controlled trials; RCTs), quasi-experimental, observational and modelling studies assessing the effects of measures implemented in the school setting to safely reopen schools, or keep schools open, or both, during the COVID-19 pandemic. Outcome categories were (i) transmission-related outcomes (e.g. number or proportion of cases); (ii) healthcare utilisation outcomes (e.g. number or proportion of hospitalisations); (iii) other health outcomes (e.g. physical, social and mental health); and (iv) societal, economic and ecological outcomes (e.g. costs, human resources and education). We considered studies that included any population at risk of becoming infected with SARS-CoV-2 and/or developing COVID-19 disease including students, teachers, other school staff, or members of the wider community.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full texts. One review author extracted data and critically appraised each study. One additional review author validated the extracted data. To critically appraise included studies, we used the ROBINS-I tool for quasi-experimental and observational studies, the QUADAS-2 tool for observational screening studies, and a bespoke tool for modelling studies. We synthesised findings narratively. Three review authors made an initial assessment of the certainty of evidence with GRADE, and several review authors discussed and agreed on the ratings.\nMain results\nWe included 38 unique studies in the analysis, comprising 33 modelling studies, three observational studies, one quasi-experimental and one experimental study with modelling components.\nMeasures fell into four broad categories: (i) measures reducing the opportunity for contacts; (ii) measures making contacts safer; (iii) surveillance and response measures; and (iv) multicomponent measures. As comparators, we encountered the operation of schools with no measures in place, less intense measures in place, single versus multicomponent measures in place, or closure of schools.\nAcross all intervention categories and all study designs, very low- to low-certainty evidence ratings limit our confidence in the findings. Concerns with the quality of modelling studies related to potentially inappropriate assumptions about the model structure and input parameters, and an inadequate assessment of model uncertainty. Concerns with risk of bias in observational studies related to deviations from intended interventions or missing data. Across all categories, few studies reported on implementation or described how measures were implemented. Where we describe effects as 'positive', the direction of the point estimate of the effect favours the intervention(s); 'negative' effects do not favour the intervention.\nWe found 23 modelling studies assessing measures reducing the opportunity for contacts (i.e. alternating attendance, reduced class size). Most of these studies assessed transmission and healthcare utilisation outcomes, and all of these studies showed a reduction in transmission (e.g. a reduction in the number or proportion of cases, reproduction number) and healthcare utilisation (i.e. fewer hospitalisations) and mixed or negative effects on societal, economic and ecological outcomes (i.e. fewer number of days spent in school).\nWe identified 11 modelling studies and two observational studies assessing measures making contacts safer (i.e. mask wearing, cleaning, handwashing, ventilation). Five studies assessed the impact of combined measures to make contacts safer. They assessed transmission-related, healthcare utilisation, other health, and societal, economic and ecological outcomes. Most of these studies showed a reduction in transmission, and a reduction in hospitalisations; however, studies showed mixed or negative effects on societal, economic and ecological outcomes (i.e. fewer number of days spent in school).\nWe identified 13 modelling studies and one observational study assessing surveillance and response measures , including testing and isolation, and symptomatic screening and isolation. Twelve studies focused on mass testing and isolation measures, while two looked specifically at symptom-based screening and isolation. Outcomes included transmission, healthcare utilisation, other health, and societal, economic and ecological outcomes. Most of these studies showed effects in favour of the intervention in terms of reductions in transmission and hospitalisations, however some showed mixed or negative effects on societal, economic and ecological outcomes (e.g. fewer number of days spent in school).\nWe found three studies that reported outcomes relating to multicomponent measures , where it was not possible to disaggregate the effects of each individual intervention, including one modelling, one observational and one quasi-experimental study. These studies employed interventions, such as physical distancing, modification of school activities, testing, and exemption of high-risk students, using measures such as hand hygiene and mask wearing. Most of these studies showed a reduction in transmission, however some showed mixed or no effects.\nAs the majority of studies included in the review were modelling studies, there was a lack of empirical, real-world data, which meant that there were very little data on the actual implementation of interventions.\nAuthors' conclusions\nOur review suggests that a broad range of measures implemented in the school setting can have positive impacts on the transmission of SARS-CoV-2, and on healthcare utilisation outcomes related to COVID-19. The certainty of the evidence for most intervention-outcome combinations is very low, and the true effects of these measures are likely to be substantially different from those reported here. Measures implemented in the school setting may limit the number or proportion of cases and deaths, and may delay the progression of the pandemic. However, they may also lead to negative unintended consequences, such as fewer days spent in school (beyond those intended by the intervention). Further, most studies assessed the effects of a combination of interventions, which could not be disentangled to estimate their specific effects. Studies assessing measures to reduce contacts and to make contacts safer consistently predicted positive effects on transmission and healthcare utilisation, but may reduce the number of days students spent at school. Studies assessing surveillance and response measures predicted reductions in hospitalisations and school days missed due to infection or quarantine, however, there was mixed evidence on resources needed for surveillance. Evidence on multicomponent measures was mixed, mostly due to comparators. The magnitude of effects depends on multiple factors. New studies published since the original search date might heavily influence the overall conclusions and interpretation of findings for this review.\n\nGiven the provided abstract, please respond to the following query: \"2. Measures making contacts safer\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Measures making contacts safer: by putting measures in place such as face masks, improving ventilation by opening windows or using air purifiers, cleaning, handwashing, or modifying activities like sports or music, contacts can be made safer."
}
] |
query-laysum
|
6866
|
[
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic, relapsing and remitting disease of the gastrointestinal tract that can cause significant morbidity and disability. Current treatment guidelines recommend early intervention with immunosuppressant or biological therapy in high-risk patients with a severe disease phenotype at presentation. The feasibility of therapeutic de-escalation once remission is achieved is a commonly encountered question in clinical practice, driven by patient and clinician concerns regarding safety, adverse events, cost and national regulations. Withdrawal of immunosuppressant and biologic drugs in patients with quiescent CD may limit adverse events and reduce healthcare costs. Alternatively, stopping these drug therapies may result in negative outcomes such as disease relapse, drug desensitization, bowel damage and need for surgery.\nObjectives\nTo assess the feasibility and safety of discontinuing immunosuppressant or biologic drugs, administered alone or in combination, in patients with quiescent CD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and the Cochrane IBD Group Specialized Register from inception to 19 December 2017. We also searched the reference lists of potentially relevant manuscripts and conference proceedings to identify additional studies.\nSelection criteria\nRandomized controlled trials (RCTs) and prospective cohort studies that followed patients for a minimum duration of six months after drug discontinuation were considered for inclusion. The patient population of interest was adults (> 18 years) with CD (as defined by conventional clinical, endoscopic or histologic criteria) who had achieved remission while receiving immunosuppressant or biologic drugs administered alone or in combination. Patients then discontinued the drug regimen following a period of maintenance therapy of at least six months. The comparison was usual care (i.e. continuation of the drug regimen).\nData collection and analysis\nThe primary outcome measure was the proportion of patients who relapsed following discontinuation of immunosuppressant or biologic drugs, administered alone or in combination. Secondary outcomes included: the proportion of patients who responded to the reintroduction of immunosuppressant or biologic drugs, given as monotherapy or combination therapy; the proportion of patients who required surgery following relapse; the proportion of patients who required hospitalization for CD following relapse; the proportion of patients who developed new CD-related complications (e.g. fistula, abscesses, strictures) following relapse; the proportion of patients with elevated biomarkers of inflammation (CRP, fecal calprotectin) in those who stop and those who continue therapy; the proportion of patients with anti-drug antibodies and low serum trough drug levels; time to relapse; and the proportion of patients with adverse events, serious adverse events and withdrawal due to adverse events. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (95% CI). Data were analyzed on an intention-to-treat basis where patients with missing outcome data were assumed to have relapsed. The overall quality of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria.\nMain results\nA total of six RCTs (326 patients) evaluating therapeutic discontinuation in patients with quiescent CD were eligible for inclusion. In four RCTs azathioprine monotherapy was discontinued, and in two RCTs azathioprine was discontinued from a combination therapy regimen consisting of azathioprine with infliximab. No studies of biologic monotherapy withdrawal were eligible for inclusion. The majority of studies received unclear or low risk of bias ratings, with the exception of three open-label RCTs, which were rated as high risk of bias for blinding. Four RCTs (215 participants) compared discontinuation to continuation of azathioprine monotherapy, while two studies (125 participants) compared discontinuation of azathioprine from a combination regimen to continuation of combination therapy. Continuation of azathioprine monotherapy was shown to be superior to withdrawal for risk of clinical relapse. Thirty-two per cent (36/111) of azathioprine withdrawal participants relapsed compared to 14% (14/104) of participants who continued with azathioprine therapy (RR 0.42, 95% CI 0.24 to 0.72, GRADE low quality evidence). However, it is uncertain if there are any between-group differences in new CD-related complications (RR 0.34, 95% CI 0.06 to 2.08, GRADE low quality evidence), adverse events (RR 0.88, 95% CI 0.67 to 1.17, GRADE low quality evidence), serious adverse events (RR 3.29, 95% CI 0.35 to 30.80, GRADE low quality evidence) or withdrawal due to adverse events (RR 2.59, 95% CI 0.35 to 19.04, GRADE low quality evidence). Common adverse events included infections, mild leukopenia, abdominal symptoms, arthralgias, headache and elevated liver enzymes. No differences between azathioprine withdrawal from combination therapy versus continuation of combination therapy were observed for clinical relapse. Among patients who continued combination therapy with azathioprine and infliximab, 48% (27/56) had a clinical relapse compared to 49% (27/55) of patients discontinued azathioprine but remained on infliximab (RR 1.02, 95% CI 0.68 to 1.52, P = 0.32; GRADE low quality evidence). The effects on adverse events (RR 1.11, 95% CI 0.44 to 2.81, GRADE low quality of evidence) or serious adverse events are uncertain (RR 1.00, 95% CI 0.21 to 4.66; GRADE very low quality of evidence). Common adverse events in the combination therapy studies included infections, liver test elevations, arthralgias and infusion reactions.\nAuthors' conclusions\nThe effects of withdrawal of immunosuppressant therapy in people with quiescent Crohn's disease are uncertain. Low quality evidence suggests that continuing azathioprine monotherapy may be superior to withdrawal for avoiding clinical relapse, while very low quality evidence suggests that there may be no difference in clinical relapse rates between discontinuing azathioprine from a combination therapy regimen, compared to continuing combination therapy. It is unclear whether withdrawal of azathioprine, initially administered alone or in combination, impacts on the development of CD-related complications, adverse events, serious adverse events or withdrawal due to adverse events. Further high-quality research is needed in this area, particularly double-blind RCTs in which biologic therapy or an immunosuppressant other than azathioprine is withdrawn.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Crohn's disease is a serious, chronic, inflammatory disease of the small and large intestine. Symptoms include abdominal pain, diarrhea, bleeding and weight loss. When people with Crohn's disease are experiencing symptoms the disease is 'active'. When the symptoms stop, it is called 'remission'. When people in remission experience symptoms it is called a 'relapse'. Immunosuppressant drugs (e.g. azathioprine, 6-mercaptopurine and methotrexate) and biologic medications (e.g. infliximab, adalimumab, vedolizumab and ustekinumab) are commonly used alone or in combination to treat Crohn's disease. While effective for initially controlling disease (i.e. inducing remission), there are safety and cost concerns regarding the long-term use of these drugs for the prevention of relapse in people with Crohn's disease in remission."
}
] |
query-laysum
|
6867
|
[
{
"role": "user",
"content": "Abstract: Background\nDry eye syndrome is a disorder of the tear film that is associated with symptoms of ocular discomfort. Punctal occlusion is a mechanical treatment that blocks the tear drainage system in order to aid in the preservation of natural tears on the ocular surface.\nObjectives\nTo assess the effects of punctal plugs versus no punctal plugs, different types of punctal plugs, and other interventions for managing dry eye.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 11), MEDLINE Ovid (1946 to 8 December 2016), Embase.com (1947 to 8 December 2016), PubMed (1948 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com; last searched 18 November 2012 - this resource is now archived), ClinicalTrials.gov (www.clinicaltrials.gov; searched 8 December 2016), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en; searched 8 December 2016). We did not use any date or language restrictions in the electronic searches for trials. We also searched the Science Citation Index-Expanded database and reference lists of included studies. The evidence was last updated on 8 December 2016\nSelection criteria\nWe included randomized and quasi-randomized controlled trials of collagen or silicone punctal plugs in symptomatic participants diagnosed with aqueous tear deficiency or dry eye syndrome.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study investigators for additional information when needed.\nMain results\nWe included 18 trials (711 participants, 1249 eyes) from Austria, Canada, China, Greece, Japan, Mexico, Netherlands, Turkey, the UK, and the USA in this review. We also identified one ongoing trial. Overall we judged these trials to be at unclear risk of bias because they were poorly reported. We assessed the evidence for eight comparisons.\nFive trials compared punctal plugs with no punctal plugs (control). Three of these trials employed a sham treatment and two trials observed the control group. Two trials did not report outcome data relevant to this review. There was very low-certainty evidence on symptomatic improvement. The three trials that reported this outcome used different scales to measure symptoms. In all three trials, there was little or no improvement in symptom scores with punctal plugs compared with no punctal plugs. Low-certainty evidence from one trial suggested less ocular surface staining in the punctal plug group compared with the no punctal plug group however this difference was small and possibly clinically unimportant (mean difference (MD) in fluorescein staining score -1.50 points, 95% CI -1.88 to -1.12; eyes = 61). Similarly there was a small difference in tear film stability with people in the punctal plug group having more stability (MD 1.93 seconds more, 95% CI 0.67 to 3.20; eyes = 28, low-certainty evidence). The number of artificial tear applications was lower in the punctal plug group compared with the no punctal plugs group in one trial (MD -2.70 applications, 95% CI -3.11 to -2.29; eyes = 61, low-certainty evidence). One trial with low-certainty evidence reported little or no difference between the groups in Schirmer scores, but did not report any quantitative data on aqueous tear production. Very low-certainty evidence on adverse events suggested that events occurred reasonably frequently in the punctal plug group and included epiphora, itching, tenderness and swelling of lids with mucous discharge, and plug displacement.\nOne trial compared punctal plugs with cyclosporine (20 eyes) and one trial compared punctal plugs with oral pilocarpine (55 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nFive trials compared punctal plugs with artificial tears. In one of the trials punctal plugs was combined with artificial tears and compared with artificial tears alone. There was very low-certainty evidence on symptomatic improvement. Low-certainty evidence of little or no improvement in ocular surface staining comparing punctal plugs with artificial tears (MD right eye 0.10 points higher, 0.56 lower to 0.76 higher, MD left eye 0.60 points higher, 0.10 to 1.10 higher) and low-certainty evidence of little or no difference in aqueous tear production (MD 0.00 mm/5 min, 0.33 lower to 0.33 higher)\nThree trials compared punctal plugs in the upper versus the lower puncta, and none of them reported the review outcomes at long-term follow-up. One trial with very low-certainty evidence reported no observed complications, but it was unclear which complications were collected.\nOne trial compared acrylic punctal plugs with silicone punctal plugs and the trial reported outcomes at approximately 11 weeks of follow-up (36 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nOne trial compared intracanalicular punctal plugs with silicone punctal plugs at three months follow-up (57 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nFinally, two trials with very low-certainty evidence compared collagen punctal plugs versus silicone punctal plugs (98 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nAuthors' conclusions\nAlthough the investigators of the individual trials concluded that punctal plugs are an effective means for treating dry eye signs and symptoms, the evidence in this systematic review suggests that improvements in symptoms and commonly tested dry eye signs are inconclusive. Despite the inclusion of 11 additional trials, the findings of this updated review are consistent with the previous review published in 2010. The type of punctal plug investigated, the type and severity of dry eye being treated, and heterogeneity in trial methodology confounds our ability to make decisive statements regarding the effectiveness of punctal plug use. Although punctal plugs are believed to be relatively safe, their use is commonly associated with epiphora and, less commonly, with inflammatory conditions such as dacryocystitis.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review included 18 trials with 711 participants (1249 eyes), most of whom were women. The trials took place from March 1998 to May 2014 and included participants from Austria, Canada, China, Greece, Japan, Mexico, Netherlands, Turkey, the UK, and the USA. The 18 trials differed greatly in design; they compared different types of punctal plugs and reported results in different ways.\nThe evidence from this review suggests that punctal plugs do not conclusively improve dry eye symptoms. No type of punctal plug used in the trials we examined was significantly better than another for relieving symptoms of dry eye. It is still unclear if punctal plugs are better than oral treatment (oral pilocarpine) or eye drops such as cyclosporine or artificial tears.\nThe evidence from this review suggests that punctal plugs may be associated with watery eyes and sometimes with more serious conditions such as infection or swelling in the tear sac (part of the eye where tears drain).\nThe conclusions of this updated review are similar to the original review published in 2010, though 11 new trials were included."
}
] |
query-laysum
|
6868
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute anterior shoulder dislocation, which is the most common type of dislocation, usually results from an injury. Subsequently, the shoulder is less stable and is more susceptible to re-dislocation or recurrent instability (e.g. subluxation), especially in active young adults. After closed reduction, most of these injuries are treated with immobilisation of the injured arm in a sling or brace for a few weeks, followed by exercises. This is an update of a Cochrane Review first published in 2006 and last updated in 2014.\nObjectives\nTo assess the effects (benefits and harms) of conservative interventions after closed reduction of traumatic anterior dislocation of the shoulder. These might include immobilisation, rehabilitative interventions or both.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, PEDro and trial registries. We also searched conference proceedings and reference lists of included studies. Date of last search: May 2018.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials comparing conservative interventions with no treatment, a different intervention or a variant of the intervention (e.g. a different duration) for treating people after closed reduction of a primary traumatic anterior shoulder dislocation. Inclusion was regardless of age, sex or mechanism of injury. Primary outcomes were re-dislocation, patient-reported shoulder instability measures and return to pre-injury activities. Secondary outcomes included participant satisfaction, health-related quality of life, any instability and adverse events.\nData collection and analysis\nBoth review authors independently selected studies, assessed risk of bias and extracted data. We contacted study authors for additional information. We pooled results of comparable groups of studies. We assessed risk of bias with the Cochrane 'Risk of bias' tool and the quality of the evidence with the GRADE approach.\nMain results\nWe included seven trials (six randomised controlled trials and one quasi-randomised controlled trial) with 704 participants; three of these trials (234 participants) are new to this update. The mean age across the trials was 29 years (range 12 to 90 years), and 82% of the participants were male. All trials compared immobilisation in external rotation (with or without an additional abduction component) versus internal rotation (the traditional method) following closed reduction. No trial evaluated any other interventions or comparisons, such as rehabilitation. All trials provided data for a follow-up of one year or longer; the commonest length was two years or longer.\nAll trials were at some risk of bias, commonly performance and detection biases given the lack of blinding. Two trials were at high risk of selection bias and some trials were affected by attrition bias for some outcomes. We rated the certainty of the evidence as very low for all outcomes.\nWe are uncertain whether immobilisation in external rotation makes a difference to the risk of re-dislocation after 12 months' or longer follow-up compared with immobilisation in internal rotation (55/245 versus 73/243; risk ratio (RR) 0.67, 95% confidence interval (CI) 0.38 to 1.19; 488 participants; 6 studies; I² = 61%; very low certainty evidence). In a moderate-risk population with an illustrative risk of 312 per 1000 people experiencing a dislocation in the internal rotation group, this equates to 103 fewer (95% CI 194 fewer to 60 more) re-dislocations after immobilisation in external rotation. Thus this result covers the possibility of a benefit for each intervention.\nIndividually, the four studies (380 participants) reporting on validated patient-reported outcome measures for shoulder instability at a minimum of 12 months' follow-up found no evidence of a clinically important difference between the two interventions.\nWe are uncertain of the relative effects of the two methods of immobilisation on resumption of pre-injury activities or sports. One study (169 participants) found no evidence of a difference between interventions in the return to pre-injury activity of the affected arm. Two studies (135 participants) found greater return to sports in the external rotation group in a subgroup of participants who had sustained their injury during sports activities.\nNone of the trials reported on participant satisfaction or health-related quality of life.\nWe are uncertain whether there is a difference between the two interventions in the number of participants experiencing instability, defined as either re-dislocation or subluxation (RR 0.84, 95% CI 0.62 to 1.14; 395 participants, 3 studies; very low certainty evidence).\nData on adverse events were collected only in an ad hoc way in the seven studies. Reported \"transient and resolved adverse events\" were nine cases of shoulder stiffness or rigidity in the external rotation group and two cases of axillary rash in the internal rotation group. There were three \"important\" adverse events: hyperaesthesia and moderate hand pain; eighth cervical dermatome paraesthesia; and major movement restriction between 6 and 12 months. It was unclear to what extent these three events could be attributed to the treatment.\nAuthors' conclusions\nThe available evidence from randomised trials is limited to that comparing immobilisation in external versus internal rotation. Overall, the evidence is insufficient to draw firm conclusions about whether immobilisation in external rotation confers any benefit over immobilisation in internal rotation.\nConsidering that there are several unpublished and ongoing trials evaluating immobilisation in external versus internal rotation, the main priority for research on this question consists of the publication of completed trials and the completion and publication of ongoing trials. Meanwhile, evaluation of other interventions, including rehabilitation, is warranted. There is a need for sufficiently large, good-quality, well-reported randomised controlled trials with long-term follow-up. Future research should aim to determine the optimal immobilisation duration, precise indications for immobilisation, optimal rehabilitation interventions, and the acceptability of these different interventions.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What are the benefits and harms of different conservative interventions for treating people after closed reduction of a primary traumatic anterior shoulder dislocation?\nThis is an update of a review that was first published in 2006 and last updated in 2014. We reviewed the evidence from clinical studies comparing any conservative intervention (e.g. immobilisation, rehabilitation) versus no treatment or a different intervention, or comparing different variants of an intervention (e.g. different duration). The primary outcomes of interest were re-dislocation, patient-reported shoulder instability measures (usually questionnaires) and return to pre-injury activities. Further outcomes of interest included patients’ satisfaction with the intervention, health-related quality of life and adverse events."
}
] |
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