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query-laysum | 5354 | [
{
"role": "user",
"content": "Abstract: Background\nMedication-related adverse events in primary care represent an important cause of hospital admissions and mortality. Adverse events could result from people experiencing adverse drug reactions (not usually preventable) or could be due to medication errors (usually preventable).\nObjectives\nTo determine the effectiveness of professional, organisational and structural interventions compared to standard care to reduce preventable medication errors by primary healthcare professionals that lead to hospital admissions, emergency department visits, and mortality in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, three other databases, and two trial registries on 4 October 2016, together with reference checking, citation searching and contact with study authors to identify additional studies. We also searched several sources of grey literature.\nSelection criteria\nWe included randomised trials in which healthcare professionals provided community-based medical services. We also included interventions in outpatient clinics attached to a hospital where people are seen by healthcare professionals but are not admitted to hospital. We only included interventions that aimed to reduce medication errors leading to hospital admissions, emergency department visits, or mortality. We included all participants, irrespective of age, who were prescribed medication by a primary healthcare professional.\nData collection and analysis\nThree review authors independently extracted data. Each of the outcomes (hospital admissions, emergency department visits, and mortality), are reported in natural units (i.e. number of participants with an event per total number of participants at follow-up). We presented all outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). We used the GRADE tool to assess the certainty of evidence.\nMain results\nWe included 30 studies (169,969 participants) in the review addressing various interventions to prevent medication errors; four studies addressed professional interventions (8266 participants) and 26 studies described organisational interventions (161,703 participants). We did not find any studies addressing structural interventions. Professional interventions included the use of health information technology to identify people at risk of medication problems, computer-generated care suggested and actioned by a physician, electronic notification systems about dose changes, drug interventions and follow-up, and educational interventions on drug use aimed at physicians to improve drug prescriptions. Organisational interventions included medication reviews by pharmacists, nurses or physicians, clinician-led clinics, and home visits by clinicians.\nThere is a great deal of diversity in types of professionals involved and where the studies occurred. However, most (61%) of the interventions were conducted by pharmacists or a combination of pharmacists and medical doctors. The studies took place in many different countries; 65% took place in either the USA or the UK. They all ranged from three months to 4.7 years of follow-up, they all took place in primary care settings such as general practice, outpatients' clinics, patients' homes and aged-care facilities. The participants in the studies were adults taking medications and the interventions were undertaken by healthcare professionals including pharmacists, nurses or physicians. There was also evidence of potential bias in some studies, with only 18 studies reporting adequate concealment of allocation and only 12 studies reporting appropriate protection from contamination, both of which may have influenced the overall effect estimate and the overall pooled estimate.\nProfessional interventions\nProfessional interventions probably make little or no difference to the number of hospital admissions (risk ratio (RR) 1.24, 95% confidence interval (CI) 0.79 to 1.96; 2 studies, 3889 participants; moderate-certainty evidence). Professional interventions make little or no difference to the number of participants admitted to hospital (adjusted RR 0.99, 95% CI 0.92 to 1.06; 1 study, 3661 participants; high-certainty evidence). Professional interventions may make little or no difference to the number of emergency department visits (adjusted RR 0.71, 95% CI 0.50 to 1.02; 2 studies, 1067 participants; low-certainty evidence). Professional interventions probably make little or no difference to mortality in the study population (adjusted RR 0.98, 95% CI 0.82 to 1.17; 1 study, 3538 participants; moderate-certainty evidence).\nOrganisational interventions\nOverall, it is uncertain whether organisational interventions reduce the number of hospital admissions (adjusted RR 0.85, 95% CI 0.71 to 1.03; 11 studies, 6203 participants; very low-certainty evidence). Overall, organisational interventions may make little difference to the total number of people admitted to hospital in favour of the intervention group compared with the control group (adjusted RR 0.92, 95% CI 0.86 to 0.99; 13 studies, 152,237 participants; low-certainty evidence. Overall, it is uncertain whether organisational interventions reduce the number of emergency department visits in favour of the intervention group compared with the control group (adjusted RR 0.75, 95% CI 0.49 to 1.15; 5 studies, 1819 participants; very low-certainty evidence. Overall, it is uncertain whether organisational interventions reduce mortality in favour of the intervention group (adjusted RR 0.94, 95% CI 0.85 to 1.03; 12 studies, 154,962 participants; very low-certainty evidence.\nAuthors' conclusions\nBased on moderate- and low-certainty evidence, interventions in primary care for reducing preventable medication errors probably make little or no difference to the number of people admitted to hospital or the number of hospitalisations, emergency department visits, or mortality. The variation in heterogeneity in the pooled estimates means that our results should be treated cautiously as the interventions may not have worked consistently across all studies due to differences in how the interventions were provided, background practice, and culture or delivery of the interventions. Larger studies addressing both professional and organisational interventions are needed before evidence-based recommendations can be made. We did not identify any structural interventions and only four studies used professional interventions, and so more work needs to be done with these types of interventions. There is a need for high-quality studies describing the interventions in more detail and testing patient-related outcomes.\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": "Prescribing medications is one of the most powerful tools available to general practitioners (GPs) in the prevention and treatment of disease. Medication-related adverse events could be the result of people either experiencing adverse drug reactions (not usually preventable) or as a result of medication errors (usually preventable). We studied the effectiveness of professional and organisational methods compared to standard care in primary care settings (examples of primary care settings include general practices, community pharmacies, patient homes, community settings, outpatient clinics, and aged-care facilities) to reduce preventable medication errors that lead to hospital admissions, emergency department visits, and death in adults who are prescribed medication in primary care."
}
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query-laysum | 5355 | [
{
"role": "user",
"content": "Abstract: Background\nAlthough routine administration of pharmacologic sedation or analgesia during mechanical ventilation in preterm neonates is not recommended, its use in clinical practice remains common. Alpha-2 agonists, mainly clonidine and dexmedetomidine, are used as adjunctive (or alternative) sedative agents alongside opioids and benzodiazepines. Clonidine has not been systematically assessed for use in neonatal sedation during ventilation.\nObjectives\nTo assess whether clonidine administered to term and preterm newborn infants receiving mechanical ventilation reduces morbidity and mortality rates. To compare the intervention versus placebo, no treatment, and dexmedetomidine; and to assess the safety of clonidine infusion for potential harms.\nTo perform subgroup analyses according to gestational age; birth weight; administration method (infusion or bolus therapy); dose, duration, and route of clonidine administration; and pharmacologic sedation as a co-intervention.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 12) in the Cochrane Library, MEDLINE via PubMed (1966 to January 10, 2017), Embase (1980 to January 10, 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to January 10, 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nWe searched for randomized controlled trials, quasi-randomized controlled trials, and cluster trials comparing clonidine versus placebo, no treatment, or dexmedetomidine administered to term and preterm newborns receiving mechanical ventilation via an endotracheal tube.\nData collection and analysis\nFor the included trial, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, all-cause death during initial hospitalization, duration of respiratory support, sedation scale, duration of hospital stay) and assessed risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). This review considered primary outcomes of all-cause neonatal death, all-cause death during initial hospitalization, and duration of mechanical ventilation in days.\nMain results\nOne trial, which included 112 infants, met the inclusion criteria for this review. Term newborn infants on mechanical ventilation with the need for continuous analgesia and sedation with fentanyl and midazolam were eligible for enrollment during the first 96 hours of ventilation. Study authors administered clonidine 1 μg/kg/h or placebo on day 4 after intubation.\nWe found no differences between the two groups in all-cause death during hospitalization (risk ratio [RR] 0.69, 95% confidence interval [CI] 0.12 to 3.98). The quality of the evidence supporting these findings is low owing to imprecision of the estimates (one study; few events). The median (interquartile range) duration of mechanical ventilation was 7.1 days (5.7 to 9.1 days) in the clonidine group and 5.8 days (4.9 to 7.9 days) in the placebo group, respectively (P = 0.070). Among secondary outcomes, we found no differences in terms of duration of stay in the intensive care unit. Sedation scale values (COMFORT) and analgesia scores (Hartwig) during the first 72 hours of infusion of study medication were lower in the clonidine group than in the placebo group.\nAuthors' conclusions\nAt present, evidence is insufficient to show the efficacy and safety of clonidine for sedation and analgesia in term and preterm newborn infants receiving mechanical ventilation.\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": "Owing to the small number of newborns included in the single included trial, we are uncertain as to whether clonidine is effective or safe in providing analgesia and sedation for mechanically ventilated neonates."
}
]
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query-laysum | 5356 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for gynaecological cancer. RAS is a relatively new innovation in laparoscopic surgery that enables the surgeon to conduct the operation from a computer console, situated away from the surgical table. RAS is already widely used in the United States for hysterectomy and has been shown to be feasible for other gynaecological procedures. However, the clinical effectiveness and safety of RAS compared with conventional laparoscopic surgery (CLS) have not been clearly established and require independent review.\nObjectives\nTo assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, and EMBASE via Ovid, on 8 January 2018. We searched www.ClinicalTrials.gov. on 16 January 2018.\nSelection criteria\nRandomised controlled trials (RCTs) comparing RAS versus CLS or open surgery in women requiring surgery for gynaecological disease.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and risk of bias, and extracted study data and entered them into an Excel spreadsheet. We examined different procedures in separate comparisons and for hysterectomy subgrouped data according to type of disease (non-malignant versus malignant). When more than one study contributed data, we pooled data using random-effects methods in RevMan 5.3.\nMain results\nWe included 12 RCTs involving 1016 women. Studies were at moderate to high overall risk of bias, and we downgraded evidence mainly due to concerns about risk of bias in the studies contributing data and imprecision of effect estimates. Procedures performed were hysterectomy (eight studies) and sacrocolpopexy (three studies). In addition, one trial examined surgical treatment for endometriosis, which included resection or hysterectomy. Among studies of women undergoing hysterectomy procedures, two studies involved malignant disease (endometrial cancer); the rest involved non-malignant disease.\n• RAS versus CLS (hysterectomy)\nLow-certainty evidence suggests there might be little or no difference in any complication rates between RAS and CLS (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.54 to 1.59; participants = 585; studies = 6; I² = 51%), intraoperative complication rates (RR 1.05, 95% CI 0.31 to 3.56; participants = 487; studies = 5; I² = 28%), postoperative complications (RR 0.82, 95% CI 0.42 to 1.59; participants = 533; studies = 5; I2 = 51%), and blood transfusions (RR 2.49, 95% CI 0.75 to 8.23; participants = 346; studies = 4; I2 = 0%)). There was no statistical difference between malignant and non-malignant disease subgroups with regard to complication rates. Survival outcomes for women with malignant disease were not reported.\nMean total operating time was longer on average in the RAS arm than in the CLS arm (mean difference (MD) 41.18 minutes, 95% CI -6.17 to 88.53; participants = 148; studies = 2; I² = 80%; very low-certainty evidence), and the mean length of hospital stay was slightly shorter with RAS than with CLS (MD -0.30 days, 95% CI -0.53 to -0.07; participants = 192; studies = 2; I² = 0%; very low-certainty evidence).\n• RAS versus CLS (sacrocolpopexy)\nVery low-certainty evidence suggests little or no difference in rates of any complications between women undergoing sacrocolpopexy by RAS or CLS (RR 0.95, 95% CI 0.21 to 4.24; participants = 186; studies = 3; I² = 78%), nor in intraoperative complications (RR 0.82, 95% CI 0.09 to 7.59; participants = 108; studies = 2; I² = 47%). Low-certainty evidence on postoperative complications suggests these might be higher with RAS (RR 3.54, 95% CI 1.31 to 9.56; studies = 1; participants = 68). Researchers did not report blood transfusions and deaths up to 30 days.\nLow-certainty evidence suggests that RAS might be associated with increased operating time (MD 40.53 min, 95% CI 12.06 to 68.99; participants = 186; studies = 3; I² = 73%). Very low-certainty evidence suggests little or no difference between the two techniques in terms of duration of stay (MD 0.26 days, 95% CI -0.15 to 0.67; participants = 108; studies = 2; I² = 0%).\n• RAS versus open abdominal surgery (hysterectomy)\nTwo studies of 20 and 96 participants with non-malignant disease and malignant disease, respectively, compared RAS with open surgery. For most outcomes only one study contributed data, with most evidence assessed as very low-certainty. Low-certainty evidence from the study among women with endometrial cancer suggests that lymph node yields may be lower with RAS (MD -8.00, 95% CI -14.97 to -1.03), operating time may be longer (233 minutes (range 166 to 320 minutes) compared with 187 minutes (range 109 to 300), hospital stays may be shorter (mean of 2 days [1 to 5] versus 5 days [4 to 9]; P<0.001), and overall costs may be less (MD -1568.00 US dollars, 95% CI -3100.75 to -35.25) than open surgery. Survival outcomes were not reported.\n• RAS versus CLS for endometriosis\nA single study with data for 73 women was included in this comparison; women with endometriosis underwent procedures ranging from relatively minor endometrial resection through hysterectomy; many of the women included in this study had undergone previous surgery for their condition. For most outcomes, event rates were low, and the sample size was insufficient to detect potential differences between groups.\nAuthors' conclusions\nEvidence on the effectiveness and safety of RAS compared with CLS for non-malignant disease (hysterectomy and sacrocolpopexy) is of low certainty but suggests that surgical complication rates might be comparable. Evidence on the effectiveness and safety of RAS compared with CLS or open surgery for malignant disease is more uncertain, particularly because survival data are lacking. RAS is an operator-dependent expensive technology; therefore evaluating the safety of this technology independently will present challenges.\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": "Complication rates (during and after surgery) for RAS might be similar to those for CLS; however, the evidence is generally of low quality/certainty. Evidence on its use for gynaecological cancer surgery is more uncertain because we found no comparative evidence on cancer recurrence or survival after cancer surgery. As RAS depends on the skill and experience of the surgeon and is an expensive technology, evaluating its effectiveness and safety independently will present challenges."
}
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query-laysum | 5357 | [
{
"role": "user",
"content": "Abstract: Background\nAcute upper respiratory tract infections (URTIs) are frequently managed in primary care settings. Although many are viral, and there is an increasing problem with antibiotic resistance, antibiotics continue to be prescribed for URTIs. Written patient information may be a simple way to reduce antibiotic use for acute URTIs.\nObjectives\nTo assess if written information for patients (or parents of child patients) reduces the use of antibiotics for acute URTIs in primary care.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Web of Science, clinical trials.gov, and the World Health Organization (WHO) trials registry up to July 2016 without language or publication restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) involving patients (or parents of child patients) with acute URTIs, that compared written patient information delivered immediately before or during prescribing, with no information. RCTs needed to have measured our primary outcome (antibiotic use) to be included.\nData collection and analysis\nTwo review authors screened studies, extracted data, and assessed study quality. We could not meta-analyse included studies due to significant methodological and statistical heterogeneity; we summarised the data narratively.\nMain results\nTwo RCTs met our inclusion criteria, involving a total of 827 participants. Both studies only recruited children with acute URTIs (adults were not involved in either study): 558 children from 61 general practices in England and Wales; and 269 primary care doctors who provided data on 33,792 patient-doctor consultations in Kentucky, USA. The UK study had a high risk of bias due to lack of blinding and the US cluster-randomised study had a high risk of bias because the methods to allocate participants to treatment groups was not clear, and there was evidence of baseline imbalance.\nIn both studies, clinicians provided written information to parents of child patients during primary care consultations: one trained general practitioners (GPs) to discuss an eight-page booklet with parents; the other conducted a factorial trial with two comparison groups (written information compared to usual care and written information plus prescribing feedback to clinicians compared to prescribing feedback alone). Doctors in the written information arms received 25 copies of two-page government-sponsored pamphlets to distribute to parents.\nCompared to usual care, we found moderate quality evidence (one study) that written information significantly reduced the number of antibiotics used by patients (RR 0.53, 95% CI 0.35 to 0.80; absolute risk reduction (ARR) 20% (22% versus 42%)) and had no significant effect on reconsultation rates (RR 0.79, 95% CI 0.47 to 1.32), or parent satisfaction with consultation (RR 0.95, 95% CI 0.87 to 1.03). Low quality evidence (two studies) demonstrated that written information also reduced antibiotics prescribed by clinicians (RR 0.47, 95% CI 0.28 to 0.78; ARR 21% (20% versus 41%); and RR 0.84, 95% CI 0.81 to 0.86; 9% ARR (45% versus 54%)). Neither study measured resolution of symptoms, patient knowledge about antibiotics for acute URTIs, or complications for this comparison.\nCompared to prescribing feedback, we found low quality evidence that written information plus prescribing feedback significantly increased the number of antibiotics prescribed by clinicians (RR 1.13, 95% CI 1.09 to 1.17; absolute risk increase 6% (50% versus 44%)). Neither study measured reconsultation rate, resolution of symptoms, patient knowledge about antibiotics for acute URTIs, patient satisfaction with consultation or complications for this comparison.\nAuthors' conclusions\nCompared to usual care, moderate quality evidence from one study showed that trained GPs providing written information to parents of children with acute URTIs in primary care can reduce the number of antibiotics used by patients without any negative impact on reconsultation rates or parental satisfaction with consultation. Low quality evidence from two studies shows that, compared to usual care, GPs prescribe fewer antibiotics for acute URTIs but prescribe more antibiotics when written information is provided alongside prescribing feedback (compared to prescribing feedback alone). There was no evidence addressing resolution of patients' symptoms, patient knowledge about antibiotics for acute URTIs, or frequency of complications.\nTo fill evidence gaps, future studies should consider testing written information on antibiotic use for adults with acute URTIs in high- and low-income settings provided without clinician training and presented in different formats (such as electronic). Future study designs should endeavour to ensure blinded outcome assessors. Study aims should include measurement of the effect of written information on the number of antibiotics used by patients and prescribed by clinicians, patient satisfaction, reconsultation, patients' knowledge about antibiotics, resolution of symptoms, and complications.\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": "Providing a booklet and explanation by a specially-trained doctor reduced the number of antibiotics children consumed by 20% (from 42% to 22%) without affecting parent satisfaction with consultation or numbers of return visits for the same illness. Compared to the doctor’s usual practice, two studies showed that providing a booklet reduced the proportion of children prescribed an antibiotic by 9% to 21%. When doctors were also given feedback on their antibiotic prescribing along with providing a booklet to parents, the proportion of children prescribed an antibiotic increased by 6% (from 44% to 50%). None of the included studies assessed if people were better informed, how long symptoms lasted, or if people had complications."
}
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query-laysum | 5358 | [
{
"role": "user",
"content": "Abstract: Background\nOral mucositis is a side effect of chemotherapy, head and neck radiotherapy, and targeted therapy, affecting over 75% of high risk patients. Ulceration can lead to severe pain and difficulty eating and drinking, which may necessitate opioid analgesics, hospitalisation and nasogastric or intravenous nutrition. These complications may lead to interruptions or alterations to cancer therapy, which may reduce survival. There is also a risk of death from sepsis if pathogens enter the ulcers of immunocompromised patients. Ulcerative oral mucositis can be costly to healthcare systems, yet there are few preventive interventions proven to be beneficial. Oral cryotherapy is a low-cost, simple intervention which is unlikely to cause side-effects. It has shown promise in clinical trials and warrants an up-to-date Cochrane review to assess and summarise the international evidence.\nObjectives\nTo assess the effects of oral cryotherapy for preventing oral mucositis in patients with cancer who are receiving treatment.\nSearch methods\nWe searched the following databases: the Cochrane Oral Health Group Trials Register (to 17 June 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 5), MEDLINE via Ovid (1946 to 17 June 2015), EMBASE via Ovid (1980 to 17 June 2015), CANCERLIT via PubMed (1950 to 17 June 2015) and CINAHL via EBSCO (1937 to 17 June 2015). We searched the US National Institutes of Health Trials Registry, and the WHO Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching databases.\nSelection criteria\nWe included parallel-design randomised controlled trials (RCTs) assessing the effects of oral cryotherapy in patients with cancer receiving treatment. We used outcomes from a published core outcome set registered on the COMET website.\nData collection and analysis\nTwo review authors independently screened the results of electronic searches, extracted data and assessed risk of bias. We contacted study authors for information where feasible. For dichotomous outcomes, we reported risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, we reported mean differences (MD) and 95% CIs. We pooled similar studies in random-effects meta-analyses. We reported adverse effects in a narrative format.\nMain results\nWe included 14 RCTs analysing 1280 participants. The vast majority of participants did not receive radiotherapy to the head and neck, so this review primarily assesses prevention of chemotherapy-induced oral mucositis. All studies were at high risk of bias. The following results are for the main comparison: oral cryotherapy versus control (standard care or no treatment).\nAdults receiving fluorouracil-based (5FU) chemotherapy for solid cancers\nOral cryotherapy probably reduces oral mucositis of any severity (RR 0.61, 95% CI 0.52 to 0.72, 5 studies, 444 analysed, moderate quality evidence). In a population where 728 per 1000 would develop oral mucositis, oral cryotherapy would reduce this to 444 (95% CI 379 to 524). The number needed to treat to benefit one additional person (NNTB), i.e. to prevent them from developing oral mucositis, is 4 people (95% CI 3 to 5).\nThe results were similar for moderate to severe oral mucositis (RR 0.52, 95% CI 0.41 to 0.65, 5 studies, 444 analysed, moderate quality evidence). NNTB 4 (95% CI 4 to 6).\nSevere oral mucositis is probably reduced (RR 0.40, 95% CI 0.27 to 0.61, 5 studies, 444 analysed, moderate quality evidence). Where 300 per 1000 would develop severe oral mucositis, oral cryotherapy would reduce this to 120 (95% CI 81 to 183), NNTB 6 (95% CI 5 to 9).\nAdults receiving high-dose melphalan-based chemotherapy before haematopoietic stem cell transplantation (HSCT)\nOral cryotherapy may reduce oral mucositis of any severity (RR 0.59, 95% CI 0.35 to 1.01, 5 studies, 270 analysed, low quality evidence). Where 824 per 1000 would develop oral mucositis, oral cryotherapy would reduce this to 486 (95% CI reduced to 289 to increased to 833). The NNTB is 3, although the uncertainty surrounding the effect estimate means that the 95% CI ranges from 2 NNTB, to 111 NNTH (number needed to treat in order to harm one additional person, i.e. for one additional person to develop oral mucositis).\nThe results were similar for moderate to severe oral mucositis (RR 0.43, 95% CI 0.17 to 1.09, 5 studies, 270 analysed, low quality evidence). NNTB 3 (95% CI 2 NNTB to 17 NNTH).\nSevere oral mucositis is probably reduced (RR 0.38, 95% CI 0.20 to 0.72, 5 studies, 270 analysed, moderate quality evidence). Where 427 per 1000 would develop severe oral mucositis, oral cryotherapy would reduce this to 162 (95% CI 85 to 308), NNTB 4 (95% CI 3 to 9).\nOral cryotherapy was shown to be safe, with very low rates of minor adverse effects, such as headaches, chills, numbness/taste disturbance, and tooth pain. This appears to contribute to the high rates of compliance seen in the included studies.\nThere was limited or no evidence on the secondary outcomes of this review, or on patients undergoing other chemotherapies, radiotherapy, targeted therapy, or on comparisons of oral cryotherapy with other interventions or different oral cryotherapy regimens. Therefore no further robust conclusions can be made. There was also no evidence on the effects of oral cryotherapy in children undergoing cancer treatment.\nAuthors' conclusions\nWe are confident that oral cryotherapy leads to large reductions in oral mucositis of all severities in adults receiving 5FU for solid cancers. We are less confident in the ability of oral cryotherapy to reduce oral mucositis in adults receiving high-dose melphalan before HSCT. Evidence suggests that it does reduce oral mucositis in these adults, but we are less certain about the size of the reduction, which could be large or small. However, we are confident that there is an appreciable reduction in severe oral mucositis in these adults.\nThis Cochrane review includes some very recent and currently unpublished data, and strengthens international guideline statements for adults receiving the above cancer treatments.\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 has been produced to assess whether or not keeping the mouth cold during cancer treatment, by using ice, ice-cold water, ice cream or ice lollies/popsicles, can help prevent mouth soreness and ulcers in children and adults."
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query-laysum | 5359 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review first published in 2014 and last updated in 2020.\nFor nearly 30% of people with epilepsy, current treatments do not control seizures. Stiripentol is an antiepileptic drug (AED) that was developed in France and was approved by the European Medicines Agency (EMA) in 2007 as an adjunctive therapy with valproate and clobazam for the treatment of Dravet syndrome.\nObjectives\nTo evaluate the efficacy and tolerability of stiripentol as add-on treatment for people with drug-resistant focal epilepsy who are taking AEDs.\nSearch methods\nFor the latest update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE on 28 March 2022. We contacted the manufacturer of stiripentol and epilepsy experts to identify published, unpublished and ongoing trials.\nSelection criteria\nRandomised controlled trials of add-on stiripentol in people with drug-resistant focal epilepsy.\nData collection and analysis\nReview authors independently selected trials for inclusion and extracted data. We investigated outcomes including 50% or greater reduction in seizure frequency, seizure freedom, adverse effects, treatment withdrawal and changes in quality of life.\nMain results\nOn the basis of our selection criteria, we included no new studies in the present review update. We included only one study from the original review (32 children with focal epilepsy). This study adopted a responder-enriched design and found no clear evidence of a reduction of 50% or more in seizure frequency (risk ratio (RR) 1.51, 95% confidence interval (CI) 0.81 to 2.82; low-certainty evidence) and no clear evidence of seizure freedom (RR 1.18, 95% CI 0.31 to 4.43; low-certainty evidence) when comparing add-on stiripentol with placebo.\nStiripentol led to a greater risk of adverse effects considered as a whole (RR 2.65, 95% CI 1.08 to 6.47; low-certainty evidence). When we considered specific adverse effects, CIs were very wide and showed the possibility of substantial increases and small reductions in risks of neurological adverse effects (RR 2.65, 95% CI 0.88 to 8.01; low-certainty evidence). Researchers noted no clear reduction in the risk of study withdrawal (RR 0.66, 95% CI 0.30 to 1.47; low-certainty evidence), which was high in both groups (53.3% in placebo group and 35.3% in stiripentol group; low-certainty evidence).\nThe external validity of this study was limited because only responders to stiripentol (i.e. participants experiencing a decrease in seizure frequency of 50% or greater during an open prerandomisation phase compared with baseline) were included in the randomised, add-on, placebo-controlled, double-blind phase. Furthermore, carry-over and withdrawal effects probably influenced outcomes related to seizure frequency. Very limited information derived from the only included study shows that adverse effects considered as a whole may occur more often with add-on stiripentol than with add-on placebo.\nAuthors' conclusions\nWe have found no new studies since the last version of this review was published. Hence, we have made no changes to the conclusions as presented in previous versions. We can draw no conclusions to support the use of stiripentol as add-on treatment for drug-resistant focal epilepsy. Additional large, randomised, well-conducted trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Antiepileptic medicines can be used singularly (as monotherapy) or in combination (polytherapy). Stiripentol is an antiepileptic medicine that was developed in France and was approved in 2007 by the European Medicines Agency as add-on therapy with valproate and clobazam for the treatment of Dravet syndrome (a rare, drug-resistant epilepsy that begins in the first year of life in an otherwise healthy infant). This review assesses the evidence for the use of stiripentol as add-on treatment for drug-resistant focal epilepsy in people taking antiepileptic medicines."
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query-laysum | 5360 | [
{
"role": "user",
"content": "Abstract: Background\nPre-eclampsia is associated with deficient intravascular production of prostacyclin, a vasodilator, and excessive production of thromboxane, a vasoconstrictor and stimulant of platelet aggregation. These observations led to the hypotheses that antiplatelet agents, low-dose aspirin in particular, might prevent or delay development of pre-eclampsia.\nObjectives\nTo assess the effectiveness and safety of antiplatelet agents, such as aspirin and dipyridamole, when given to women at risk of developing pre-eclampsia.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (30 March 2018), and reference lists of retrieved studies. We updated the search in September 2019 and added the results to the awaiting classification section of the review.\nSelection criteria\nAll randomised trials comparing antiplatelet agents with either placebo or no antiplatelet agent were included. Studies only published in abstract format were eligible for inclusion if sufficient information was available. We would have included cluster-randomised trials in the analyses along with individually-randomised trials, if any had been identified in our search strategy. Quasi-random studies were excluded. Participants were pregnant women at risk of developing pre-eclampsia. Interventions were administration of an antiplatelet agent (such as low-dose aspirin or dipyridamole), comparisons were either placebo or no antiplatelet.\nData collection and analysis\nTwo review authors assessed trials for inclusion and extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For this update we incorporated individual participant data (IPD) from trials with this available, alongside aggregate data (AD) from trials where it was not, in order to enable reliable subgroup analyses and inclusion of two key new outcomes. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.\nMain results\nSeventy-seven trials (40,249 women, and their babies) were included, although three trials (relating to 233 women) did not contribute data to the meta-analysis. Nine of the trials contributing data were large (> 1000 women recruited), accounting for 80% of women recruited. Although the trials took place in a wide range of countries, all of the nine large trials involved only women in high-income and/or upper middle-income countries. IPD were available for 36 trials (34,514 women), including all but one of the large trials. Low-dose aspirin alone was the intervention in all the large trials, and most trials overall. Dose in the large trials was 50 mg (1 trial, 1106 women), 60 mg (5 trials, 22,322 women), 75mg (1 trial, 3697 women) 100 mg (1 trial, 3294 women) and 150 mg (1 trial, 1776 women). Most studies were either low risk of bias or unclear risk of bias; and the large trials were all low risk of bas.\nAntiplatelet agents versus placebo/no treatment\nThe use of antiplatelet agents reduced the risk of proteinuric pre-eclampsia by 18% (36,716 women, 60 trials, RR 0.82, 95% CI 0.77 to 0.88; high-quality evidence), number needed to treat for one women to benefit (NNTB) 61 (95% CI 45 to 92). There was a small (9%) reduction in the RR for preterm birth <37 weeks (35,212 women, 47 trials; RR 0.91, 95% CI 0.87 to 0.95, high-quality evidence), NNTB 61 (95% CI 42 to 114), and a 14% reduction infetal deaths, neonatal deaths or death before hospital discharge (35,391 babies, 52 trials; RR 0.85, 95% CI 0.76 to 0.95; high-quality evidence), NNTB 197 (95% CI 115 to 681). Antiplatelet agents slightly reduced the risk of small-for-gestational age babies (35,761 babies, 50 trials; RR 0.84, 95% CI 0.76 to 0.92; high-quality evidence), NNTB 146 (95% CI 90 to 386), and pregnancies with serious adverse outcome (a composite outcome including maternal death, baby death, pre-eclampsia, small-for-gestational age, and preterm birth) (RR 0.90, 95% CI 0.85 to 0.96; 17,382 women; 13 trials, high-quality evidence), NNTB 54 (95% CI 34 to 132). Antiplatelet agents probably slightly increase postpartum haemorrhage > 500 mL (23,769 women, 19 trials; RR 1.06, 95% CI 1.00 to 1.12; moderate-quality evidence due to clinical heterogeneity), and they probably marginally increase the risk of placental abruption, although for this outcome the evidence was downgraded due to a wide confidence interval including the possibility of no effect (30,775 women; 29 trials; RR 1.21, 95% CI 0.95 to 1.54; moderate-quality evidence).\nData from two large trials which assessed children at aged 18 months (including results from over 5000 children), did not identify clear differences in development between the two groups.\nAuthors' conclusions\nAdministering low-dose aspirin to pregnant women led to small-to-moderate benefits, including reductions in pre-eclampsia (16 fewer per 1000 women treated), preterm birth (16 fewer per 1000 treated), the baby being born small-for-gestational age (seven fewer per 1000 treated) and fetal or neonatal death (five fewer per 1000 treated). Overall, administering antiplatelet agents to 1000 women led to 20 fewer pregnancies with serious adverse outcomes. The quality of evidence for all these outcomes was high. Aspirin probably slightly increased the risk of postpartum haemorrhage of more than 500 mL, however, the quality of evidence for this outcome was downgraded to moderate, due to concerns of clinical heterogeneity in measurements of blood loss. Antiplatelet agents probably marginally increase placental abruption, but the quality of the evidence was downgraded to moderate due to low event numbers and thus wide 95% CI.\nOverall, antiplatelet agents improved outcomes, and at these doses appear to be safe. Identifying women who are most likely to respond to low-dose aspirin would improve targeting of treatment. As almost all the women in this review were recruited to the trials after 12 weeks' gestation, it is unclear whether starting treatment before 12 weeks’ would have additional benefits without any increase in adverse effects. While there was some indication that higher doses of aspirin would be more effective, further studies would be warranted to examine this.\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"
},
{
"role": "assistant",
"content": "Pre-eclampsia is a condition experienced by some women during pregnancy and is evident as high blood pressure and protein in the urine. This condition can lead to serious complications for the mother and her baby (in fact, it is one of the leading causes of illness and death in pregnancy). The mother’s placenta may not be functioning properly, which limits the blood supply to the unborn baby so that it is at risk of poor growth and being born early as a result of preterm labour, or needing to be delivered early. Pre-eclampsia affects the platelets in the women’s blood so that they are more ready to clump and cause the blood to clot. Antiplatelet drugs like aspirin prevent blood clotting and have a role in preventing pre-eclampsia and its complications."
}
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query-laysum | 5361 | [
{
"role": "user",
"content": "Abstract: Background\nCarpal tunnel syndrome is a common problem and surgical decompression of the carpal tunnel is the most effective treatment. After surgical decompression, the palmar skin may be closed using either absorbable or non-absorbable sutures. To date, there is conflicting evidence regarding the ideal suture material and this formed the rationale for our review.\nObjectives\nTo assess the effects of absorbable versus non-absorbable sutures for skin closure after elective carpal tunnel decompression surgery in adults on postoperative pain, hand function, scar satisfaction, wound inflammation and adverse events.\nSearch methods\nWe searched the following databases on 30 October 2017: the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, and Embase. We searched two clinical trials registries on 30 October 2017.\nSelection criteria\nWe considered all randomised or quasi-randomised controlled trials comparing absorbable and non-absorbable sutures for skin closure after any form of carpal tunnel decompression surgery in adults.\nData collection and analysis\nThe unit of analysis was the hand rather than the patient. We performed meta-analysis of direct comparisons to generate standardised mean differences (SMDs) with 95% confidence intervals (CIs) in pain scores and risk ratios (RRs) with 95% CIs for dichotomous outcomes, such as wound inflammation. The primary outcome was postoperative pain. Secondary outcomes included hand function, scar satisfaction, scar inflammation and adverse events (complications). We assessed the quality of evidence for key outcomes using GRADE.\nMain results\nWe included five randomised trials (255 participants). The trials were all European (UK, Republic of Ireland, Denmark and the Netherlands). Where quoted, the mean age of participants was between 48 and 53 years. The trials measured outcomes between one and 12 weeks postoperatively.\nMeta-analysis of postoperative pain scores for absorbable versus non-absorbable sutures at 10 days following open carpal tunnel decompression (OCTD) produced a SMD of 0.03 (95% CI -0.43 to 0.48; 3 studies, number of participants (N) = 137; I2 = 43%); the SMD suggests little or no difference, but with a high degree of uncertainty because of very low-quality evidence. At 10 days following endoscopic carpal tunnel decompression (ECTD), the SMD for postoperative pain with use of absorbable versus non-absorbable sutures was -0.81 (95% CI -1.36 to -0.25; 1 study; N = 54); although the SMD is consistent with a large effect, the very low-quality evidence means the results are very uncertain. Only the OCTD studies provided pain data at 6 weeks, when the SMD was 0.06 (95% CI -0.72 to 0.84; 4 studies; N = 175; I2 = 84%), which indicates little or no evidence of difference, but with a high degree of uncertainty (very low-quality evidence). The RR for wound inflammation using absorbable versus non-absorbable sutures after OCTD was 2.28 (95% CI 0.24 to 21.91; N = 95; I2 = 90%) and after ECTD 0.93 (95% CI 0.06 to 14.09; 1 study, N = 54). Any difference in effect on wound inflammation is uncertain because the quality of evidence is very low. One study reported postoperative hand function but found no evidence of a difference between suture types at two weeks (mean difference (MD) -0.10, 95% CI -0.53 to 0.33, N = 36), with similar findings at six and 12 weeks. Only the ECTD trial reported scar satisfaction, with 25 out of 28 people reporting a 'nice' result in the absorbable-suture group, versus 18 out of 26 in the group who received non-absorbable sutures (RR 1.29, 95% CI 0.97 to 1.72, N = 54). These findings are also very uncertain as we judged the quality of the evidence to be very low. All studies were at high risk of bias for most domains. No trials reported adverse events.\nAuthors' conclusions\nIt is uncertain whether absorbable sutures confer better, worse or equivalent outcomes compared to non-absorbable sutures following carpal tunnel decompression, because the quality of evidence is very low. Use of absorbable suture eliminates the need for suture removal, which could confer considerable savings to patients and healthcare providers alike. We need rigorously-performed, non-inferiority randomised trials with economic analyses to inform choice of suture.\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": "We do not know whether absorbable or non-absorbable stitches are better for closing the wound after surgery for carpal tunnel syndrome (CTS). The studies we found only provide very low-quality evidence, which does not allow a conclusion to be made.\nOnly one study reported on hand function and scar satisfaction after surgery, and none provided data on side effects. We have no evidence of sufficient quality to assist choice of suture following surgery for CTS. However, absorbable stitches do not require removal and so time and cost savings could be made."
}
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query-laysum | 5362 | [
{
"role": "user",
"content": "Abstract: Background\nHerpes simplex labialis (HSL), also known as cold sores, is a common disease of the lips caused by the herpes simplex virus, which is found throughout the world. It presents as a painful vesicular eruption, forming unsightly crusts, which cause cosmetic disfigurement and psychosocial distress. There is no cure available, and it recurs periodically.\nObjectives\nTo assess the effects of interventions for the prevention of HSL in people of all ages.\nSearch methods\nWe searched the following databases up to 19 May 2015: the Cochrane Skin Group Specialised Register, the Oral Health Group Specialised Register, CENTRAL in the Cochrane Library (Issue 4, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), the China National Knowledge Infrastructure (CNKI) database, Airiti Library, and 5 trial registers. To identify further references to relevant randomised controlled trials, we scanned the bibliographies of included studies and published reviews, and we also contacted the original researchers of our included studies.\nSelection criteria\nRandomised controlled trials (RCTs) of interventions for preventing HSL in immunocompetent people.\nData collection and analysis\nTwo authors independently selected trials, extracted data, and assessed the risk of bias. A third author was available for resolving differences of opinion.\nMain results\nThis review included 32 RCTs, with a total of 2640 immunocompetent participants, covering 19 treatments. The quality of the body of evidence was low to moderate for most outcomes, but was very low for a few outcomes. Our primary outcomes were 'Incidence of HSL' and 'Adverse effects during use of the preventative intervention'.\nThe evidence for short-term (≤ 1 month) use of oral aciclovir in preventing recurrent HSL was inconsistent across the doses used in the studies: 2 RCTs showed low quality evidence for a reduced recurrence of HSL with aciclovir 400 mg twice daily (risk ratio (RR) 0.26, 95% confidence interval (CI) 0.13 to 0.51; n = 177), while 1 RCT testing aciclovir 800 mg twice daily and 2 RCTs testing 200 mg 5 times daily found no similar preventive effects (RR 1.08, 95% CI 0.62 to 1.87; n = 237; moderate quality evidence and RR 0.46, 95% CI 0.20 to 1.07; n = 66; low quality evidence, respectively). The direction of intervention effect was unrelated to the risk of bias. The evidence from 1 RCT for the effect of short-term use of valaciclovir in reducing recurrence of HSL by clinical evaluation was uncertain (RR 0.55, 95% CI 0.23 to 1.28; n = 125; moderate quality evidence), as was the evidence from 1 RCT testing short-term use of famciclovir.\nLong-term (> 1 month) use of oral antiviral agents reduced the recurrence of HSL. There was low quality evidence from 1 RCT that long-term use of oral aciclovir reduced clinical recurrences (1.80 versus 0.85 episodes per participant per a 4-month period, P = 0.009) and virological recurrence (1.40 versus 0.40 episodes per participant per a 4-month period, P = 0.003). One RCT found long-term use of valaciclovir effective in reducing the incidence of HSL (with a decrease of 0.09 episodes per participant per month; n = 95). One RCT found that a long-term suppressive regimen of valaciclovir had a lower incidence of HSL than an episodic regimen of valciclovir (difference in means (MD) -0.10 episodes per participant per month, 95% CI -0.16 to -0.05; n = 120).\nThese trials found no increase in adverse events associated with the use of oral antiviral agents (moderate quality evidence).\nThere was no evidence to show that short-term use of topical antiviral agents prevented recurrent HSL. There was moderate quality evidence from 2 RCTs that topical aciclovir 5% cream probably has little effect on preventing recurrence of HSL (pooled RR 0.91, 95% CI 0.48 to 1.72; n = 271). There was moderate quality evidence from a single RCT that topical foscarnet 3% cream has little effect in preventing HSL (RR 1.08, 95% CI 0.82 to 1.40; n = 295).\nThe efficacy of long-term use of topical aciclovir cream was uncertain. One RCT found significantly fewer research-diagnosed recurrences of HSL when on aciclovir cream treatment than on placebo (P < 0.05), but found no significant differences in the mean number of participant-reported recurrences between the 2 groups (P ≥ 0.05). One RCT found no preventive effect of topical application of 1,5-pentanediol gel for 26 weeks (P > 0.05). Another RCT found that the group who used 2-hydroxypropyl-β-cyclo dextrin 20% gel for 6 months had significantly more recurrences than the placebo group (P = 0.003).\nThese studies found no increase in adverse events related to the use of topical antiviral agents.\nTwo RCTs found that the application of sunscreen significantly prevented recurrent HSL induced by experimental ultraviolet light (pooled RR 0.07, 95% CI 0.01 to 0.33; n = 111), but another RCT found that sunscreen did not prevent HSL induced by sunlight (RR 1.13, 95% CI 0.25 to 5.06; n = 51). These RCTs did not report adverse events.\nThere were very few data suggesting that thymopentin, low-level laser therapy, and hypnotherapy are effective in preventing recurrent HSL, with one to two RCTs for each intervention. We failed to find any evidence of efficacy for lysine, LongoVital® supplementation, gamma globulin, herpes simplex virus (HSV) type I subunit vaccine, and yellow fever vaccine in preventing HSL. There were no consistent data supporting the efficacy of levamisole and interferon, which were also associated with an increased risk of adverse effects such as fever.\nAuthors' conclusions\nThe current evidence demonstrates that long-term use of oral antiviral agents can prevent HSL, but the clinical benefit is small. We did not find evidence of an increased risk of adverse events. On the other hand, the evidence on topical antiviral agents and other interventions either showed no efficacy or could not confirm their efficacy in preventing HSL.\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 examined the research published up to 19 May 2015. We wanted to include studies only if receiving one preventative measure or another was decided by chance. This research method, termed randomised controlled trial (RCT), is the best way to test that a preventive effect is caused by the measure being tested. We found 32 RCTs that included 2640 people and examined 19 preventative measures. The drug manufacturer funded a total of 18 out of 32 studies, non-profit organisations funded 4, and we do not know how the other 10 were funded."
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query-laysum | 5363 | [
{
"role": "user",
"content": "Abstract: Background\nThe final adult height of untreated girls aged up to 18 years with Turner syndrome (TS) is approximately 20 cm shorter compared with healthy females. Treatment with growth hormone (GH) increases the adult height of people with TS. The effects of adding the androgen, oxandrolone, in addition to GH are unclear. Therefore, we conducted this systematic review to investigate the benefits and harms of oxandrolone as an adjuvant therapy for people with TS treated with GH.\nObjectives\nTo assess the effects of oxandrolone on growth hormone-treated girls aged up to 18 years with Turner syndrome.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, the ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was October 2018. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled clinical trials (RCTs) that enrolled girls aged up to 18 years with TS who were treated with GH and oxandrolone compared with GH only treatment.\nData collection and analysis\nThree review authors independently screened titles and abstracts for relevance, selected trials, extracted data and assessed risk of bias. We resolved disagreements by consensus, or by consultation with a fourth review author. We assessed trials for overall certainty of the evidence using the GRADE instrument.\nMain results\nWe included six trials with 498 participants with TS, 267 participants were randomised to oxandrolone plus GH treatment and 231 participants were randomised to GH only treatment. The individual trial sample size ranged between 22 and 133 participants. The included trials were conducted in 65 different paediatric endocrinology healthcare facilities including clinics, centres, hospitals and academia in the USA and Europe. The duration of interventions ranged between 3 and 7.6 years. The mean age of participants at start of therapy ranged from 9 to 12 years. Overall, we judged only one trial at low risk of bias in all domains and another trial at high risk of bias in most domains. We downgraded the level of evidence mainly because of imprecision (low number of trials, low number of participants or both).\nComparing oxandrolone plus GH with GH only for final adult height showed a mean difference (MD) of 2.7 cm in favour of oxandrolone plus GH treatment (95% confidence interval (CI) 1.3 to 4.1; P < 0.001; 5 trials, 270 participants; moderate-quality evidence). The 95% prediction interval ranged between 0.3 cm and 5.1 cm. For adverse events, we based our main analysis on reliable date from two trials with overall low risk of bias. There was no evidence of a difference between oxandrolone plus GH and GH for adverse events (RR 1.81, 95% CI 0.83 to 3.96; P = 0.14; 2 trials, 170 participants; low-quality evidence). Six out of 86 (18.6%) participants receiving oxandrolone plus GH compared with 8/84 (9.5%) participants receiving GH only reported adverse events, mainly signs of virilisation (e.g. deepening of the voice). One trial each investigated the effects of treatments on speech (voice frequency; 88 participants), cognition (51 participants) and psychological status (106 participants). The overall results for these comparisons were inconclusive (very low-quality evidence). No trial reported on health-related quality of life or all-cause mortality.\nAuthors' conclusions\nAddition of oxandrolone to the GH therapy led to a modest increase in the final adult height of girls aged up to 18 years with TS. Adverse effects identified included virilising effects such as deepening of the voice, but reporting was inadequate in some trials.\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 included six randomised controlled trials (clinical trials where people are randomly put into one of two or more treatment groups). The duration of the treatments ranged between 3 and 7.6 years. Study authors allocated 498 participants to treatment groups, 267 participants to oxandrolone plus growth hormone treatment and 231 participants to growth hormone only treatment. The average age of the children at begin of treatment ranged from 9 to 12 years.\nThis evidence is up to date as of October 2018."
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query-laysum | 5364 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin D is a secosteroid hormone that is important for its role in calcium homeostasis to maintain skeletal health. Linear growth faltering and stunting remain pervasive indicators of poor nutrition status among infants and children under five years of age around the world, and low vitamin D status has been linked to poor growth. However, existing evidence on the effects of vitamin D supplementation on linear growth and other health outcomes among infants and children under five years of age has not been systematically reviewed.\nObjectives\nTo assess effects of oral vitamin D supplementation on linear growth and other health outcomes among infants and children under five years of age.\nSearch methods\nIn December 2019, we searched CENTRAL, PubMed, Embase, 14 other electronic databases, and two trials registries. We also searched the reference lists of relevant publications for any relevant trials, and we contacted key organisations and authors to obtain information on relevant ongoing and unpublished trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs assessing the effects of oral vitamin D supplementation, with or without other micronutrients, compared to no intervention, placebo, a lower dose of vitamin D, or the same micronutrients alone (and not vitamin D) in infants and children under five years of age who lived in any country.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nOut of 75 studies (187 reports; 12,122 participants) included in the qualitative analysis, 64 studies (169 reports; 10,854 participants) contributed data on our outcomes of interest for meta-analysis. A majority of included studies were conducted in India, USA, and Canada. Two studies reported for-profit funding, two were categorised as receiving mixed funding (non-profit and for-profit), five reported that they received no funding, 26 did not disclose funding sources, and the remaining studies were funded by non-profit funding. Certainty of evidence varied between high and very low across outcomes (all measured at endpoint) for each comparison.\nVitamin D supplementation versus placebo or no intervention (31 studies)\nCompared to placebo or no intervention, vitamin D supplementation (at doses 200 to 2000 IU daily; or up to 300,000 IU bolus at enrolment) may make little to no difference in linear growth (measured length/height in cm) among children under five years of age (mean difference (MD) 0.66, 95% confidence interval (CI) -0.37 to 1.68; 3 studies, 240 participants; low-certainty evidence); probably improves length/height-for-age z-score (L/HAZ) (MD 0.11, 95% CI 0.001 to 0.22; 1 study, 1258 participants; moderate-certainty evidence); and probably makes little to no difference in stunting (risk ratio (RR) 0.90, 95% CI 0.80 to 1.01; 1 study, 1247 participants; moderate-certainty evidence).\nIn terms of adverse events, vitamin D supplementation probably makes little to no difference in developing hypercalciuria compared to placebo (RR 2.03, 95% CI 0.28 to 14.67; 2 studies, 68 participants; moderate-certainty evidence). It is uncertain whether vitamin D supplementation impacts the development of hypercalcaemia as the certainty of evidence was very low (RR 0.82, 95% CI 0.35 to 1.90; 2 studies, 367 participants).\nVitamin D supplementation (higher dose) versus vitamin D (lower dose) (34 studies)\nCompared to a lower dose of vitamin D (100 to 1000 IU daily; or up to 300,000 IU bolus at enrolment), higher-dose vitamin D supplementation (200 to 6000 IU daily; or up to 600,000 IU bolus at enrolment) may have little to no effect on linear growth, but we are uncertain about this result (MD 1.00, 95% CI -2.22 to 0.21; 5 studies, 283 participants), and it may make little to no difference in L/HAZ (MD 0.40, 95% CI -0.06 to 0.86; 2 studies, 105 participants; low-certainty evidence). No studies evaluated stunting.\nAs regards adverse events, higher-dose vitamin D supplementation may make little to no difference in developing hypercalciuria (RR 1.16, 95% CI 1.00 to 1.35; 6 studies, 554 participants; low-certainty evidence) or in hypercalcaemia (RR 1.39, 95% CI 0.89 to 2.18; 5 studies, 986 participants; low-certainty evidence) compared to lower-dose vitamin D supplementation.\nVitamin D supplementation (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s) (9 studies)\nSupplementation with a higher dose of vitamin D (400 to 2000 IU daily, or up to 300,000 IU bolus at enrolment) plus micronutrients, compared to a lower dose (200 to 2000 IU daily, or up to 90,000 IU bolus at enrolment) of vitamin D with the same micronutrients, may make little to no difference in linear growth (MD 0.60, 95% CI −3.33 to 4.53; 1 study, 25 participants; low-certainty evidence). No studies evaluated L/HAZ or stunting.\nIn terms of adverse events, higher-dose vitamin D supplementation with micronutrients, compared to lower-dose vitamin D with the same micronutrients, may make little to no difference in developing hypercalciuria (RR 1.00, 95% CI 0.06 to 15.48; 1 study, 86 participants; low-certainty evidence) and probably makes little to no difference in developing hypercalcaemia (RR 1.00, 95% CI 0.90, 1.11; 2 studies, 126 participants; moderate-certainty evidence).\nFour studies measured hyperphosphataemia and three studies measured kidney stones, but they reported no occurrences and therefore were not included in the comparison for these outcomes.\nAuthors' conclusions\nEvidence suggests that oral vitamin D supplementation may result in little to no difference in linear growth, stunting, hypercalciuria, or hypercalcaemia, compared to placebo or no intervention, but may result in a slight increase in length/height-for-age z-score (L/HAZ). Additionally, evidence suggests that compared to lower doses of vitamin D, with or without micronutrients, vitamin D supplementation may result in little to no difference in linear growth, L/HAZ, stunting, hypercalciuria, or hypercalcaemia. Small sample sizes, substantial heterogeneity in terms of population and intervention parameters, and high risk of bias across many of the included studies limit our ability to confirm with any certainty the effects of vitamin D on our outcomes. Larger, well-designed studies of long duration (several months to years) are recommended to confirm whether or not oral vitamin D supplementation may impact linear growth in children under five years of age, among both those who are healthy and those with underlying infectious or non-communicable health conditions.\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 included 187 reports representing 75 studies (12,122 participants), conducted most frequently in India, USA, and Canada, among children under five years of age. In addition, 33 studies were classified as currently being conducted (ongoing) and 21 studies as 'awaiting classification' because they did not provide enough information to be categorised as included, ongoing, or excluded. Comparisons included oral vitamin D supplementation versus placebo (dummy pill) or no intervention; higher-dose vitamin D versus lower-dose vitamin D; vitamin D plus micronutrients (vitamins or minerals or both) compared to the same micronutrients alone; and higher-dose vitamin D plus micronutrients (vitamins or minerals or both) compared to lower-dose vitamin D plus the same micronutrients. Two studies reported for-profit funding, two were categorised as mixed funding (non-profit and for-profit), five reported that they had received no funding, 26 did not disclose funding sources, and the remaining studies were supported by non-profit funding."
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query-laysum | 5365 | [
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"role": "user",
"content": "Abstract: Background\nRegularly transfused people with sickle cell disease (SCD) and people with thalassaemia are at risk of iron overload. Iron overload can lead to iron toxicity in vulnerable organs such as the heart, liver and endocrine glands, which can be prevented and treated with iron-chelating agents. The intensive demands and uncomfortable side effects of therapy can have a negative impact on daily activities and wellbeing, which may affect adherence.\nObjectives\nTo identify and assess the effectiveness of different types of interventions (psychological and psychosocial, educational, medication interventions, or multi-component interventions) and interventions specific to different age groups, to improve adherence to iron chelation therapy compared to another listed intervention, or standard care in people with SCD or thalassaemia.\nSearch methods\nWe searched CENTRAL (Cochrane Library), MEDLINE, PubMed, Embase, CINAHL, PsycINFO, ProQuest Dissertations & Global Theses, Web of Science & Social Sciences Conference Proceedings Indexes and ongoing trial databases (13 December 2021). We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register (1 August 2022).\nSelection criteria\nFor trials comparing medications or medication changes, only randomised controlled trials (RCTs) were eligible for inclusion.\nFor studies including psychological and psychosocial interventions, educational interventions, or multi-component interventions, non-randomised studies of interventions (NRSIs), controlled before-after studies, and interrupted time series studies with adherence as a primary outcome were also eligible for inclusion.\nData collection and analysis\nFor this update, two authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 19 RCTs and one NRSI published between 1997 and 2021. One trial assessed medication management, one assessed an education intervention (NRSI) and 18 RCTs were of medication interventions. Medications assessed were subcutaneous deferoxamine, and two oral chelating agents, deferiprone and deferasirox.\nWe rated the certainty of evidence as very low to low across all outcomes identified in this review.\nFour trials measured quality of life (QoL) with validated instruments, but provided no analysable data and reported no difference in QoL.\nWe identified nine comparisons of interest.\n1. Deferiprone versus deferoxamine\nWe are uncertain whether or not deferiprone affects adherence to iron chelation therapy (four RCTs, unpooled, very low-certainty evidence), all-cause mortality (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.18 to 1.21; 3 RCTs, 376 participants; very low-certainty evidence), or serious adverse events (SAEs) (RR 1.43, 95% CI 0.83 to 2.46; 1 RCT, 228 participants; very low-certainty evidence).\nAdherence was reported as \"good\", \"high\" or \"excellent\" by all seven trials, though the data could not be analysed formally: adherence ranged from 69% to 95% (deferiprone, mean 86.6%), and 71% to 93% (deferoxamine, mean 78.8%), based on five trials (474 participants) only.\n2. Deferasirox versus deferoxamine\nWe are uncertain whether or not deferasirox affects adherence to iron chelation therapy (three RCTs, unpooled, very low-certainty evidence), although medication adherence was high in all trials.\nWe are uncertain whether or not there is any difference between the drug therapies in serious adverse events (SAEs) (SCD or thalassaemia) or all-cause mortality (thalassaemia).\n3. Deferiprone versus deferasirox\nWe are uncertain if there is a difference between oral deferiprone and deferasirox based on a single trial in children (average age 9 to 10 years) with any hereditary haemoglobinopathy in adherence, SAEs and all-cause mortality.\n4. Deferasirox film-coated tablet (FCT) versus deferasirox dispersible tablet (DT)\nOne RCT compared deferasirox in different tablet forms. There may be a preference for FCTs, shown through a trend for greater adherence (RR 1.10, 95% CI 0.99 to 1.22; 1 RCT, 88 participants), although medication adherence was high in both groups (FCT 92.9%; DT 85.3%). We are uncertain if there is a benefit in chelation-related AEs with FCTs.\nWe are uncertain if there is a difference in the incidence of SAEs, all-cause mortality or sustained adherence.\n5. Deferiprone and deferoxamine combined versus deferiprone alone\nWe are uncertain if there is a difference in adherence, though reporting was usually narrative as triallists report it was \"excellent\" in both groups (three RCTs, unpooled).\nWe are uncertain if there is a difference in the incidence of SAEs and all-cause mortality.\n6. Deferiprone and deferoxamine combined versus deferoxamine alone\nWe are uncertain if there is a difference in adherence (four RCTs), SAEs (none reported in the trial period) and all-cause mortality (no deaths reported in the trial period). There was high adherence in all trials.\n7. Deferiprone and deferoxamine combined versus deferiprone and deferasirox combined\nThere may be a difference in favour of deferiprone and deferasirox (combined) in rates of adherence (RR 0.84, 95% CI 0.72 to 0.99) (one RCT), although it was high (> 80%) in both groups.\nWe are uncertain if there is a difference in SAEs, and no deaths were reported in the trial, so we cannot draw conclusions based on these data (one RCT).\n8. Medication management versus standard care\nWe are uncertain if there is a difference in QoL (one RCT), and we could not assess adherence due to a lack of reporting in the control group.\n9. Education versus standard care\nOne quasi-experimental (NRSI) study could not be analysed due to the severe baseline confounding.\nAuthors' conclusions\nThe medication comparisons included in this review had higher than average adherence rates not accounted for by differences in medication administration or side effects, though often follow-up was not good (high dropout over longer trials), with adherence based on a per protocol analysis.\nParticipants may have been selected based on higher adherence to trial medications at baseline. Also, within the clinical trial context, there is increased attention and involvement of clinicians, thus high adherence rates may be an artefact of trial participation.\nReal-world, pragmatic trials in community and clinic settings are needed that examine both confirmed or unconfirmed adherence strategies that may increase adherence to iron chelation therapy.\nDue to lack of evidence this review cannot comment on intervention strategies for different age groups.\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 the literature for both randomised and non-randomised trials, and found 19 randomised trials and one non-randomised trial, totalling 1525 participants, published between 1997 and 2021."
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query-laysum | 5367 | [
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been regularly used to reduce respiratory distress and improve oxygenation in hospitalised patients. Due to the association of prone positioning (lying on the abdomen) with sudden infant death syndrome (SIDS) within the first six months, it is recommended that young infants be placed on their back (supine). However, prone positioning may be a non-invasive way of increasing oxygenation in individuals with acute respiratory distress, and offers a more significant survival advantage in those who are mechanically ventilated. There are substantial differences in respiratory mechanics between adults and infants. While the respiratory tract undergoes significant development within the first two years of life, differences in airway physiology between adults and children become less prominent by six to eight years old. However, there is a reduced risk of SIDS during artificial ventilation in hospitalised infants. Thus, an updated review focusing on positioning for infants and young children with ARDS is warranted. This is an update of a review published in 2005, 2009, and 2012.\nObjectives\nTo compare the effects of different body positions in hospitalised infants and children with acute respiratory distress syndrome aged between four weeks and 16 years.\nSearch methods\nWe searched CENTRAL, which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, Embase, and CINAHL from January 2004 to July 2021.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs comparing two or more positions for the management of infants and children hospitalised with ARDS.\nData collection and analysis\nTwo review authors independently extracted data from each study. We resolved differences by consensus, or referred to a third contributor to arbitrate. We analysed bivariate outcomes using an odds ratio (OR) and 95% confidence interval (CI). We analysed continuous outcomes using a mean difference (MD) and 95% CI. We used a fixed-effect model, unless heterogeneity was significant (I2 statistic > 50%), when we used a random-effects model.\nMain results\nWe included six trials: four cross-over trials, and two parallel randomised trials, with 198 participants aged between 4 weeks and 16 years, all but 15 of whom were mechanically ventilated. Four trials compared prone to supine positions. One trial compared the prone position to good-lung dependent (where the person lies on the side of the healthy lung, e.g. if the right lung was healthy, they were made to lie on the right side), and independent (or non-good-lung independent, where the person lies on the opposite side to the healthy lung, e.g. if the right lung was healthy, they were made to lie on the left side) position. One trial compared good-lung independent to good-lung dependent positions.\nWhen the prone (with ventilators) and supine positions were compared, there was no information on episodes of apnoea or mortality due to respiratory events. There was no conclusive result in oxygen saturation (SaO2; MD 0.40 mmHg, 95% CI -1.22 to 2.66; 1 trial, 30 participants; very low certainty evidence); blood gases, PCO2 (MD 3.0 mmHg, 95% CI -1.93 to 7.93; 1 trial, 99 participants; low certainty evidence), or PO2 (MD 2 mmHg, 95% CI -5.29 to 9.29; 1 trial, 99 participants; low certainty evidence); or lung function (PaO2/FiO2 ratio; MD 28.16 mmHg, 95% CI -9.92 to 66.24; 2 trials, 121 participants; very low certainty evidence). However, there was an improvement in oxygenation index (FiO2% X MPAW/ PaO2) with prone positioning in both the parallel trials (MD -2.42, 95% CI -3.60 to -1.25; 2 trials, 121 participants; very low certainty evidence), and the cross-over study (MD -8.13, 95% CI -15.01 to -1.25; 1 study, 20 participants).\nDerived indices of respiratory mechanics, such as tidal volume, respiratory rate, and positive end-expiratory pressure (PEEP) were reported. There was an apparent decrease in tidal volume between prone and supine groups in a parallel study (MD -0.60, 95% CI -1.05 to -0.15; 1 study, 84 participants; very low certainty evidence). When prone and supine positions were compared in a cross-over study, there were no conclusive results in respiratory compliance (MD 0.07, 95% CI -0.10 to 0.24; 1 study, 10 participants); changes in PEEP (MD -0.70 cm H2O, 95% CI -2.72 to 1.32; 1 study, 10 participants); or resistance (MD -0.00, 95% CI -0.05 to 0.04; 1 study, 10 participants).\nOne study reported adverse events. There were no conclusive results for potential harm between groups in extubation (OR 0.57, 95% CI 0.13 to 2.54; 1 trial, 102 participants; very low certainty evidence); obstructions of the endotracheal tube (OR 5.20, 95% CI 0.24 to 111.09; 1 trial, 102 participants; very low certainty evidence); pressure ulcers (OR 1.00, 95% CI 0.41 to 2.44; 1 trial, 102 participants; very low certainty evidence); and hypercapnia (high levels of arterial carbon dioxide; OR 3.06, 95% CI 0.12 to 76.88; 1 trial, 102 participants; very low certainty evidence).\nOne study (50 participants) compared supine positions to good-lung dependent and independent positions. There was no conclusive evidence that PaO2 was different between supine and good-lung dependent positioning (MD 3.44 mm Hg, 95% CI -23.12 to 30.00; 1 trial, 25 participants; very low certainty evidence). There was also no conclusive evidence for supine position and good-lung independent positioning (MD -2.78 mmHg, 95% CI -28.84, 23.28; 25 participants; very low certainty evidence); or between good-lung dependent and independent positioning (MD 6.22, 95% CI -21.25 to 33.69; 1 trial, 25 participants; very low certainty evidence).\nAs most trials did not describe how possible biases were addressed, the potential for bias in these findings is unclear.\nAuthors' conclusions\nAlthough included studies suggest that prone positioning may offer some advantage, there was little evidence to make definitive recommendations. There appears to be low certainty evidence that positioning improves oxygenation in mechanically ventilated children with ARDS. Due to the increased risk of SIDS with prone positioning and lung injury with artificial ventilation, it is recommended that hospitalised infants and children should only be placed in this position while under continuous cardiorespiratory monitoring.\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"
},
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"role": "assistant",
"content": "The findings of this review are limited by the small number of identified trials, five of which had fewer than 40 participants; the short duration of the interventions; and the lack of description of how the study authors addressed the risk of bias in their trials. Overall, we are uncertain how different positions affect our main outcomes, such as oxygenation levels. This means that future research is needed to improve the certainty of our results."
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query-laysum | 5368 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in Issue 10, 2014. There is a need to expand monotherapy options available to a clinician for the treatment of new focal or generalized seizures. A Cochrane systematic review for clobazam monotherapy is expected to define its place in the treatment of new-onset or untreated seizures and highlight gaps in evidence.\nObjectives\nTo evaluate the efficacy, effectiveness, tolerability and safety of clobazam as monotherapy in people with new-onset focal or generalized seizures.\nSearch methods\nFor the latest update we searched the following databases on 19 March 2018: the 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- ), BIOSIS Previews (1969- ), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (ICTRP). There were no language restrictions.\nSelection criteria\nRandomized or quasi-randomized controlled trials comparing clobazam monotherapy versus placebo or other anti-seizure medication in people with two or more unprovoked seizures or single acute symptomatic seizure requiring short-term continuous anti-seizure medication, were eligible for inclusion.\nData collection and analysis\nPrimary outcome measure was time on allocated treatment (retention time), reflecting both efficacy and tolerability. Secondary outcomes included short- and long-term effectiveness measures, tolerability, quality of life, and tolerance measures. Two authors independently extracted the data.\nMain results\nWe identified three trials fulfilling the review criteria, which included 206 participants. None of the identified studies reported the preselected primary outcome measure. A meta-analysis was not possible. Lack of detail regarding allocation concealment and a high risk of performance and detection bias in two studies prompted us to downgrade the quality of evidence (by using the GRADE approach) for some of our results due to risk of bias.\nRegarding retention at 12 months, we detected no evidence of a statistically significant difference between clobazam and carbamazepine (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.61 to 1.12; low-quality evidence). There was low-quality evidence that clobazam led to better retention compared with phenytoin (RR 1.43, 95% CI 1.08 to 1.90). We could not determine whether participants receiving clobazam were found to be less likely to discontinue it due to adverse effects as compared to phenytoin (RR 0.10, 95% CI 0.01 to 1.65, low-quality evidence).\nAuthors' conclusions\nWe found no advantage for clobazam over carbamazepine for retention at 12 months in drug-naive children and a slight advantage of clobazam over phenytoin for retention at six months in adolescents and adults with neurocysticercosis in a single clinical trial each. At present, the available evidence is insufficient to inform clinical practice.\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": "Our searches identified three studies of low quality comparing clobazam with carbamazepine and phenytoin for monotherapy of seizures. They included a multi-center study that compared the effectiveness of clobazam and carbamazepine monotherapy in 115 children with untreated epilepsy; a single-center study comparing clobazam with phenytoin in 48 adolescents and adults with neurocysticercosis; and a single-center study comparing clobazam with carbamazepine monotherapy in 43 children with benign childhood epilepsy with centrotemporal spikes (BCECTS). In clinical trials with anti-seizure medications, effectiveness is conventionally measured by the time a person remains on the allocated treatment, which reflects that the person will stop taking medicine either if it is ineffective or if there are unacceptable adverse effects."
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query-laysum | 5369 | [
{
"role": "user",
"content": "Abstract: Background\nLow back pain (LBP) is the leading cause of disability globally. It generates considerable direct costs (healthcare) and indirect costs (lost productivity). The many available treatments for LBP include exercise therapy, which is practised extensively worldwide.\nObjectives\nTo evaluate the benefits and harms of exercise therapy for acute non-specific low back pain in adults compared to sham/placebo treatment or no treatment at short-term, intermediate-term, and long-term follow-up.\nSearch methods\nThis is an update of a Cochrane Review first published in 2005. We conducted an updated search for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We screened the reference lists of all included studies and relevant systematic reviews published since 2004.\nSelection criteria\nWe included RCTs that examined the effects of exercise therapy on non-specific LBP lasting six weeks or less in adults. Major outcomes for this review were pain, functional status, and perceived recovery. Minor outcomes were return to work, health-related quality of life, and adverse events. Our main comparisons were exercise therapy versus sham/placebo treatment and exercise therapy versus no treatment.\nData collection and analysis\nWe used standard Cochrane methods. We evaluated outcomes at short-term follow-up (time point within three months and closest to six weeks after randomisation; main follow-up), intermediate-term follow-up (between nine months and closest to six months), and long-term follow-up (after nine months and closest to 12 months); and we used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 23 studies (13 from the previous review, 10 new studies) that involved 2674 participants and provided data for 2637 participants. Three small studies are awaiting classification, and four eligible studies are ongoing. Included studies were conducted in Europe (N = 9), the Asia-Pacific region (N = 9), and North America (N = 5); and most took place in a primary care setting (N = 12), secondary care setting (N = 6), or both (N = 1). In most studies, the population was middle-aged and included men and women. We judged 10 studies (43%) at low risk of bias with regard to sequence generation and allocation concealment. Blinding is not feasible in exercise therapy, introducing performance and detection bias.\nThere is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain scores in the short term (mean difference (MD) −0.80, 95% confidence interval (CI) −5.79 to 4.19; 1 study, 299 participants). The absolute difference was 1% less pain (95% CI 4% more to 6% less), and the relative difference was 4% less pain (95% CI 20% more to 28% less). The mean pain score was 20.1 (standard deviation (SD) 21) for the intervention group and 20.9 (SD 23) for the control group.\nThere is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on functional status scores in the short term (MD 2.00, 95% CI −2.20 to 6.20; 1 study, 299 participants). The absolute difference was 2% worse functional status (95% CI 2% better to 6% worse), and the relative difference was 15% worse (95% CI 17% better to 47% worse). The mean functional status score was 15.3 (SD 19) for the intervention group and 13.3 (SD 18) for the control group.\nWe downgraded the certainty of the evidence for pain and functional status by one level for risk of bias and by two levels for imprecision (only one study with fewer than 400 participants).\nThere is very low-certainty evidence that exercise therapy compared with no treatment has no clinically relevant effect on pain or functional status in the short term (2 studies, 157 participants). We downgraded the certainty of the evidence by two levels for imprecision and by one level for inconsistency. One study associated exercise with small benefits and the other found no differences. The first study was conducted in an occupational healthcare centre, where participants received one exercise therapy session. The other study was conducted in secondary and tertiary care settings, where participants received treatment three times per week for six weeks. We did not pool data from these studies owing to considerable clinical heterogeneity.\nIn two studies, there were no reported adverse events. One study reported adverse events unrelated to exercise therapy. The remaining studies did not report whether any adverse events had occurred. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy.\nAuthors' conclusions\nExercise therapy compared to sham/placebo treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Exercise therapy compared to no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. We downgraded the certainty of the evidence to very low for inconsistency, risk of bias concerns, and imprecision (few participants).\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"
},
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"role": "assistant",
"content": "We searched for evidence up to 18 November 2021."
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query-laysum | 5370 | [
{
"role": "user",
"content": "Abstract: Background\nDialysis treatments weigh heavily on patients' physical and psychosocial health. Multiple studies have assessed the potential for exercise training to improve outcomes in adults undergoing dialysis. However, uncertainties exist in its relevance and sustainable benefits for patient-important outcomes. This is an update of a review first published in 2011.\nObjectives\nTo assess the benefits and safety of regular structured exercise training in adults undergoing dialysis on patient-important outcomes including death, cardiovascular events, fatigue, functional capacity, pain, and depression. We also aimed to define the optimal prescription of exercise in adults undergoing dialysis.\nSearch methods\nIn this update, we conducted a systematic search of the Cochrane Kidney and Transplant Register of Studies up to 23 December 2020. The Register includes studies identified from CENTRAL, MEDLINE, EMBASE, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov as well as kidney-related journals and the proceedings of major kidney conferences.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs of any structured exercise programs of eight weeks or more in adults undergoing maintenance dialysis compared to no exercise or sham exercise.\nData collection and analysis\nTwo authors independently assessed the search results for eligibility, extracted the data and assessed the risk of bias using the Cochrane risk of bias tool. Whenever appropriate, we performed random-effects meta-analyses of the mean difference in outcomes. The primary outcomes were death (any cause), cardiovascular events and fatigue. Secondary outcomes were health-related quality of life (HRQoL), depression, pain, functional capacity, blood pressure, adherence to the exercise program, and intervention-related adverse events.\nMain results\nWe identified 89 studies involving 4291 randomised participants, of which 77 studies (3846 participants) contributed to the meta-analyses. Seven studies included adults undergoing peritoneal dialysis. Fifty-six studies reported aerobic exercise interventions, 21 resistance exercise interventions and 19 combined aerobic and resistance training within the same study arm. The interventions lasted from eight weeks to two years and most often took place thrice weekly during dialysis treatments. A single study reported death and no study reported long-term cardiovascular events. Five studies directly assessed fatigue, 46 reported HRQoL and 16 reported fatigue or pain through their assessment of HRQoL. Thirty-five studies assessed functional capacity, and 21 reported resting peripheral blood pressure. Twelve studies reported adherence to exercise sessions, and nine reported exercise-related adverse events. Overall, the quality of the included studies was low and blinding of the participants was generally not feasible due to the nature of the intervention.\nExercise had uncertain effects on death, cardiovascular events, and the mental component of HRQoL due to the very low certainty of evidence. Compared with sham or no exercise, exercise training for two to 12 months may improve fatigue in adults undergoing dialysis, however, a meta-analysis could not be conducted. Any exercise training for two to 12 months may improve the physical component of HRQoL (17 studies, 656 participants: MD 4.12, 95% CI 1.88 to 6.37 points on 100 points-scale; I² = 49%; low certainty evidence). Any exercise training for two to 12 months probably improves depressive symptoms (10 studies, 441 participants: SMD -0.65, 95% CI -1.07 to -0.22; I² = 77%; moderate certainty evidence) and the magnitude of the effect may be greater when maintaining the exercise beyond four months (6 studies, 311 participants: SMD -0.30, 95% CI 0.14 to -0.74; I² = 71%). Any exercise training for three to 12 months may improve pain (15 studies, 872 participants: MD 5.28 95% CI -0.12 to 10.69 points on 100 points-scale; I² = 63%: low certainty evidence) however, the 95% CI indicates that exercise training may make little or no difference in the level of pain. Any exercise training for two to six months probably improves functional capacity as it increased the distance reached during six minutes of walking (19 studies, 827 participants: MD 49.91 metres, 95% CI 37.22 to 62.59; I² = 34%; moderate certainty evidence) and the number of sit-to-stand cycles performed in 30 seconds (MD 2.33 cycles, 95% CI 1.71 to 2.96; moderate certainty evidence). There was insufficient evidence to assess the safety of exercise training for adults undergoing maintenance dialysis. The results were similar for aerobic exercise, resistance exercise, and a combination of both aerobic and resistance exercise.\nAuthors' conclusions\nIt is uncertain whether exercise training improves death, cardiovascular events, or the mental component of HRQoL in adults undergoing maintenance dialysis. Exercise training probably improves depressive symptoms, particularly when the intervention is maintained beyond four months. Exercise training is also likely to improve functional capacity. Low certainty evidence suggested that exercise training may improve fatigue, the physical component of quality of life, and pain. The safety of exercise training for adults undergoing dialysis remains uncertain.\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 searched the medical literature for all randomised trials that assessed structured exercise programs in people undergoing dialysis. We then assessed the quality of those studies and combined their results to draw conclusions regarding the effect of exercise training to improve aspects of physical and mental health that are important to patients undergoing dialysis."
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query-laysum | 5371 | [
{
"role": "user",
"content": "Abstract: Background\nEarly discharge of stable preterm infants still requiring gavage feeds offers the benefits of uniting families sooner and reducing healthcare and family costs compared with discharge home when on full sucking feeds. Potential disadvantages of early discharge include increased care burden for the family and risk of complications related to gavage feeding.\nObjectives\nTo determine the effects of a policy of early discharge of stable preterm infants with home support of gavage feeding compared with a policy of discharge of such infants when they have reached full sucking feeds.\nWe planned subgroup analyses to determine whether safety and efficacy outcomes are altered by the type of support received (outpatient visits vs home support) or by the maturity of the infants discharged (gestational age ≤ 28 weeks at birth or birth weight ≤ 1000 grams).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group, together with searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to March 2015), EMBASE (1980 to March 2015) and MEDLINE (1950 to March 2015). We found no new trials.\nSelection criteria\nWe included all randomised and quasi-randomised trials among infants born at < 37 weeks and requiring no intravenous nutrition at the point of discharge. Trials were required to compare early discharge home with gavage feeds and healthcare support versus later discharge home when full sucking feeds were attained.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We conducted study authors for additional information. We performed data analysis in accordance with the standards of the Cochrane Neonatal Review Group.\nMain results\nWe included in the review data from one quasi-randomised trial with 88 infants from 75 families. Infants in the early discharge programme with home gavage feeding had a mean hospital stay that was 9.3 days shorter (mean difference (MD) -9.3, 95% confidence interval (CI) -18.49 to -0.11) than that of infants in the control group. Infants in the early discharge programme also had lower risk of clinical infection during the home gavage period compared with those in the control group spending corresponding time in hospital (risk ratio 0.35, 95% CI 0.17 to 0.69). No significant differences were noted between groups in duration and extent of breast feeding, weight gain, re-admission within the first 12 months post discharge from the home gavage programme or from hospital, scores reflecting parental satisfaction or overall health service use.\nAuthors' conclusions\nExperimental evidence on the benefits and risks for preterm infants of early discharge from hospital with home gavage feeding compared with later discharge upon attainment of full sucking feeds is limited to the results of one small quasi-randomised controlled trial. High-quality trials with concealed allocation, complete follow-up of all randomly assigned infants and adequate sample size are needed before practice recommendations can be made.\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": "Babies born preterm (before 37 weeks) are not usually discharged from hospital until they are able to suck all their feeds. Early discharge of babies who are stable but still need gavage (tube) feeds could unite families sooner and might reduce costs. These babies could graduate to full sucking feeds at home with some professional support. However, this practice could present a burden for the family and might increase complications during the transition from tube feeding."
}
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query-laysum | 5372 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is one in a series of Cochrane Reviews of interventions for shoulder disorders.\nObjectives\nTo synthesise the available evidence regarding the benefits and harms of rotator cuff repair with or without subacromial decompression in the treatment of rotator cuff tears of the shoulder.\nSearch methods\nWe searched the CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry unrestricted by date or language until 8 January 2019.\nSelection criteria\nRandomised controlled trials (RCTs) including adults with full-thickness rotator cuff tears and assessing the effect of rotator cuff repair compared to placebo, no treatment, or any other treatment were included. As there were no trials comparing surgery with placebo, the primary comparison was rotator cuff repair with or without subacromial decompression versus non-operative treatment (exercises with or without glucocorticoid injection). Other comparisons were rotator cuff repair and acromioplasty versus rotator cuff repair alone, and rotator cuff repair and subacromial decompression versus subacromial decompression alone. Major outcomes were mean pain, shoulder function, quality of life, participant-rated global assessment of treatment success, adverse events and serious adverse events. The primary endpoint for this review was one year.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane.\nMain results\nWe included nine trials with 1007 participants. Three trials compared rotator cuff repair with subacromial decompression followed by exercises with exercise alone. These trials included 339 participants with full-thickness rotator cuff tears diagnosed with magnetic resonance imaging (MRI) or ultrasound examination. One of the three trials also provided up to three glucocorticoid injections in the exercise group. All surgery groups received tendon repair with subacromial decompression and the postoperative exercises were similar to the exercises provided for the non-operative groups. Five trials (526 participants) compared repair with acromioplasty versus repair alone; and one trial (142 participants) compared repair with subacromial decompression versus subacromial decompression alone.\nThe mean age of trial participants ranged between 56 and 68 years, and females comprised 29% to 56% of the participants. Symptom duration varied from a mean of 10 months up to 28 months. Two trials excluded tears with traumatic onset of symptoms. One trial defined a minimum duration of symptoms of six months and required a trial of conservative therapy before inclusion. The trials included mainly repairable full-thickness supraspinatus tears, six trials specifically excluded tears involving the subscapularis tendon.\nAll trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding, but also for other reasons such as unclearly reported methods of random sequence generation or allocation concealment (six trials), incomplete outcome data (three trials), selective reporting (six trials), and other biases (six trials).\nOur main comparison was rotator cuff repair with or without subacromial decompression versus non-operative treatment. We identified three trials for this comparison, that compared rotator cuff repair with subacromial decompression followed by exercises with exercise alone with or without glucocorticoid injections, and results are reported here for the 12 month follow up.\nAt one year, moderate-certainty evidence (downgraded for bias) from 3 trials with 258 participants indicates that surgery probably provides little or no improvement in pain; mean pain (range 0 to 10, higher scores indicate more pain) was 1.6 points with non-operative treatment and 0.87 points better (0.43 better to 1.30 better) with surgery. Mean function (zero to 100, higher score indicating better outcome) was 72 points with non-operative treatment and 6 points better (2.43 better to 9.54 better) with surgery (3 trials; 269 participants), low-certainty evidence (downgraded for bias and imprecision). Participant-rated global success rate was 48/55 after non-operative treatment and 52/55 after surgery corresponding to risk ratio (RR) 1.08, 95% confidence interval (CI) 0.96 to 1.22; low-certainty evidence (downgraded for bias and imprecision). Health-related quality of life was 57.5 points (SF-36 mental component score, 0 to 100, higher score indicating better quality of life) with non-operative treatment and 1.3 points worse (4.5 worse to 1.9 better) with surgery (1 trial; 103 participants), low-certainty evidence (downgraded for bias and imprecision).\nWe were unable to estimate the risk of adverse events and serious adverse events as only one event was reported across the trials (very low-certainty evidence; downgraded once due to bias and twice due to very serious imprecision).\nAuthors' conclusions\nAt the moment, we are uncertain whether rotator cuff repair surgery provides clinically meaningful benefits to people with symptomatic tears; it may provide little or no clinically important benefits with respect to pain, function, overall quality of life or participant-rated global assessment of treatment success when compared with non-operative treatment. Surgery may not improve shoulder pain or function compared with exercises, with or without glucocorticoid injections.\nThe trials included have methodology concerns and none included a placebo control. They included participants with mostly small degenerative tears involving the supraspinatus tendon and the conclusions of this review may not be applicable to traumatic tears, large tears involving the subscapularis tendon or young people. Furthermore, the trials did not assess if surgery could prevent arthritic changes in long-term follow-up. Further well-designed trials in this area that include a placebo-surgery control group and long follow-up are needed to further increase certainty about the effects of surgery for rotator cuff tears.\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": "As compared with non-operative treatment, moderate-certainty evidence (downgraded due to risk of bias) indicates that surgery (rotator cuff repair with or without subacromial decompression) probably provides little or no benefit in pain and low-certainty evidence indicates that it may provide little or no improvement in function, participant-rated global treatment success or overall quality of life (downgraded due to bias and imprecision) in people with rotator cuff tears. Due to only one reported adverse event across the trials, we cannot estimate if there is higher risk for adverse events after either treatment (very low-certainty evidence)."
}
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query-laysum | 5373 | [
{
"role": "user",
"content": "Abstract: Background\nCataract and glaucoma are leading causes of blindness worldwide, and their co-existence is common in elderly people. Glaucoma surgery can accelerate cataract progression, and performing both surgeries may increase the rate of postoperative complications and compromise the success of either surgery. However, cataract surgery may independently lower intraocular pressure (IOP), which may allow for greater IOP control among patients with co-existing cataract and glaucoma. The decision between undergoing combined glaucoma and cataract surgery versus cataract surgery alone is complex. Therefore, it is important to compare the effectiveness of these two interventions to aid clinicians and patients in choosing the better treatment approach.\nObjectives\nTo assess the relative effectiveness and safety of combined surgery versus cataract surgery (phacoemulsification) alone for co-existing cataract and glaucoma. The secondary objectives include cost analyses for different surgical techniques for co-existing cataract and glaucoma.\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 October 2014), EMBASE (January 1980 to October 2014), PubMed (January 1948 to October 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to October 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 3 October 2014.\nWe checked the reference lists of the included trials to identify further relevant trials. We used the Science Citation Index to search for references to publications that cited the studies included in the review. We also contacted investigators and experts in the field to identify additional trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) of participants who had open-angle, pseudoexfoliative, or pigmentary glaucoma and age-related cataract. The comparison of interest was combined cataract surgery (phacoemulsification) and any type of glaucoma surgery versus cataract surgery (phacoemulsification) alone.\nData collection and analysis\nTwo review authors independently assessed study eligibility, collected data, and judged risk of bias for included studies. We used standard methodological procedures expected by the Cochrane Collaboration.\nMain results\nWe included nine RCTs, with a total of 655 participants (657 eyes), and follow-up periods ranging from 12 to 30 months. Seven trials were conducted in Europe, one in Canada and South Africa, and one in the United States. We graded the overall quality of the evidence as low due to observed inconsistency in study results, imprecision in effect estimates, and risks of bias in the included studies.\nGlaucoma surgery type varied among the studies: three studies used trabeculectomy, three studies used iStent® implants, one study used trabeculotomy, and two studies used trabecular aspiration. All of these studies found a statistically significant greater decrease in mean IOP postoperatively in the combined surgery group compared with cataract surgery alone; the mean difference (MD) was -1.62 mmHg (95% confidence interval (CI) -2.61 to -0.64; 489 eyes) among six studies with data at one year follow-up. No study reported the proportion of participants with a reduction in the number of medications used after surgery, but two studies found the mean number of medications used postoperatively at one year was about one less in the combined surgery group than the cataract surgery alone group (MD -0.69, 95% CI -1.28 to -0.10; 301 eyes). Five studies showed that participants in the combined surgery group were about 50% less likely compared with the cataract surgery alone group to use one or more IOP-lowering medications one year postoperatively (risk ratio (RR) 0.47, 95% CI 0.28 to 0.80; 453 eyes). None of the studies reported the mean change in visual acuity or visual fields. However, six studies reported no significant differences in visual acuity and two studies reported no significant differences in visual fields between the two intervention groups postoperatively (data not analyzable). The effect of combined surgery versus cataract surgery alone on the need for reoperation to control IOP at one year was uncertain (RR 1.13, 95% CI 0.15 to 8.25; 382 eyes). Also uncertain was whether eyes in the combined surgery group required more interventions for surgical complications than those in the cataract surgery alone group (RR 1.06, 95% CI 0.34 to 3.35; 382 eyes). No study reported any vision-related quality of life data or cost outcome. Complications were reported at 12 months (two studies), 12 to 18 months (one study), and two years (four studies) after surgery. Due to the small number of events reported across studies and treatment groups, the difference between groups was uncertain for all reported adverse events.\nAuthors' conclusions\nThere is low quality evidence that combined cataract and glaucoma surgery may result in better IOP control at one year compared with cataract surgery alone. The evidence was uncertain in terms of complications from the surgeries. Furthermore, this Cochrane review has highlighted the lack of data regarding important measures of the patient experience, such as visual field tests, quality of life measurements, and economic outcomes after surgery, and long-term outcomes (five years or more). Additional high-quality RCTs measuring clinically meaningful and patient-important outcomes are required to provide evidence to support treatment recommendations.\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 nine studies in which a total of 655 people (657 eyes) were enrolled. Participants had glaucoma and age-related cataract, and each study compared combined cataract and glaucoma surgery versus cataract surgery alone. Seven trials were conducted in Europe, one in Canada and South Africa, and one in the United States. Three trials were conducted at multiple centers, and the follow-up period ranged from 12 to 30 months after surgery. The evidence is current to 3 October 2014."
}
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query-laysum | 5374 | [
{
"role": "user",
"content": "Abstract: Background\nInclusion body myositis (IBM) is a late-onset inflammatory muscle disease (myopathy) associated with progressive proximal and distal limb muscle atrophy and weakness. Treatment options have attempted to target inflammatory and atrophic features of this condition (for example with immunosuppressive and immunomodulating drugs, anabolic steroids, and antioxidant treatments), although as yet there is no known effective treatment for reversing or minimising the progression of inclusion body myositis. In this review we have considered the benefits, adverse effects, and costs of treatment in targeting cardinal effects of the condition, namely muscle atrophy, weakness, and functional impairment.\nObjectives\nTo assess the effects of treatment for IBM.\nSearch methods\nOn 7 October 2014 we searched the Cochrane Neuromuscular Disease Group Specialized Register, the Cochrane Central Register for Controlled Trials (CENTRAL), MEDLINE, and EMBASE. Additionally in November 2014 we searched clinical trials registries for ongoing or completed but unpublished trials.\nSelection criteria\nWe considered randomised or quasi-randomised trials, including cross-over trials, of treatment for IBM in adults compared to placebo or any other treatment for inclusion in the review. We specifically excluded people with familial IBM and hereditary inclusion body myopathy, but we included people who had connective tissue and autoimmune diseases associated with IBM, which may or may not be identified in trials. We did not include studies of exercise therapy or dysphagia management, which are topics of other Cochrane systematic reviews.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nThe review included 10 trials (249 participants) using different treatment regimens. Seven of the 10 trials assessed single agents, and 3 assessed combined agents. Many of the studies did not present adequate data for the reporting of the primary outcome of the review, which was the percentage change in muscle strength score at six months. Pooled data from two trials of interferon beta-1a (n = 58) identified no important difference in normalised manual muscle strength sum scores from baseline to six months (mean difference (MD) -0.06, 95% CI -0.15 to 0.03) between IFN beta-1a and placebo (moderate-quality evidence). A single trial of methotrexate (MTX) (n = 44) provided moderate-quality evidence that MTX did not arrest or slow disease progression, based on reported percentage change in manual muscle strength sum scores at 12 months. None of the fully published trials were adequately powered to detect a treatment effect.\nWe assessed six of the nine fully published trials as providing very low-quality evidence in relation to the primary outcome measure. Three trials (n = 78) compared intravenous immunoglobulin (combined in one trial with prednisone) to a placebo, but we were unable to perform meta-analysis because of variations in study analysis and presentation of trial data, with no access to the primary data for re-analysis. Other comparisons were also reported in single trials. An open trial of anti-T lymphocyte immunoglobulin (ATG) combined with MTX versus MTX provided very low-quality evidence in favour of the combined therapy, based on percentage change in quantitative muscle strength sum scores at 12 months (MD 12.50%, 95% CI 2.43 to 22.57). Data from trials of oxandrolone versus placebo, azathioprine (AZA) combined with MTX versus MTX, and arimoclomol versus placebo did not allow us to report either normalised or percentage change in muscle strength sum scores. A complete analysis of the effects of arimoclomol is pending data publication. Studies of simvastatin and bimagrumab (BYM338) are ongoing.\nAll analysed trials reported adverse events. Only 1 of the 10 trials interpreted these for statistical significance. None of the trials included prespecified criteria for significant adverse events.\nAuthors' conclusions\nTrials of interferon beta-1a and MTX provided moderate-quality evidence of having no effect on the progression of IBM. Overall trial design limitations including risk of bias, low numbers of participants, and short duration make it difficult to say whether or not any of the drug treatments included in this review were effective. An open trial of ATG combined with MTX versus MTX provided very low-quality evidence in favour of the combined therapy based on the percentage change data given. We were unable to draw conclusions from trials of IVIg, oxandrolone, and AZA plus MTX versus MTX. We need more randomised controlled trials that are larger, of longer duration, and that use fully validated, standardised, and responsive outcome 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"
},
{
"role": "assistant",
"content": "We reviewed the evidence from clinical trials about the effects of drug treatments for inclusion body myositis (IBM). We did not include trials of exercise or management of swallowing difficulties, as these are subjects of other Cochrane reviews."
}
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query-laysum | 5375 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculosis and malnutrition are linked in a complex relationship. Tuberculosis may cause undernutrition through increased metabolic demands and decreased intake, and nutritional deficiencies may worsen the disease, or delay recovery by depressing important immune functions. At present, there is no evidence-based nutritional guidance for adults and children being treated for tuberculosis.\nObjectives\nTo assess the effects of oral nutritional supplements in people being treated with antituberculous drug therapy for active tuberculosis.\nSearch methods\nWe searched the Cochrane Infectious Disease Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1, 2016), MEDLINE (from 1946 to 4 February 2016), EMBASE (from 1980 to 4 February 2016), LILACS (from 1982 to 4 February 2016), the metaRegister of Controlled Trials (mRCT), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and the Indian Journal of Tuberculosis up to 4 February 2016, and checked the reference lists of all included studies.\nSelection criteria\nRandomized controlled trials that compared any oral nutritional supplement given for at least four weeks with no nutritional intervention, placebo, or dietary advice only for people being treated for active tuberculosis. The primary outcomes of interest were all-cause death, and cure at six and 12 months.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, and extracted data and assessed the risk of bias in the included trials. We presented the results as risk ratios (RR) for dichotomous variables, and mean differences (MD) for continuous variables, with 95% confidence intervals (CIs). Where appropriate, we pooled data from trials with similar interventions and outcomes. We assessed the quality of the evidence using the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach.\nMain results\nThirty-five trials, including 8283 participants, met the inclusion criteria of this review.\nMacronutrient supplementation\nSix trials assessed the provision of free food, or high-energy supplements. Only two trials measured total dietary intake, and in both trials the intervention increased calorie consumption compared to controls.\nThe available trials were too small to reliably prove or exclude clinically important benefits on mortality (RR 0.34, 95% CI 0.10 to 1.20; four trials, 567 participants, very low quality evidence), cure (RR 0.91, 95% CI 0.59 to 1.41; one trial, 102 participants, very low quality evidence), or treatment completion (data not pooled; two trials, 365 participants, very low quality evidence).\nSupplementation probably produces a modest increase in weight gain during treatment for active tuberculosis, although this was not seen consistently across all trials (data not pooled; five trials, 883 participants, moderate quality evidence). Two small studies provide some evidence that quality of life may also be improved but the trials were too small to have much confidence in the result (data not pooled; two trials, 134 participants, low quality evidence).\nMicronutrient supplementation\nSix trials assessed multi-micronutrient supplementation in doses up to 10 times the dietary reference intake, and 18 trials assessed single or dual micronutrient supplementation.\nRoutine multi-micronutrient supplementation may have little or no effect on mortality in HIV-negative people with tuberculosis (RR 0.86, 95% CI 0.46 to 1.6; four trials, 1219 participants, low quality evidence), or HIV-positive people who are not taking antiretroviral therapy (RR 0.92, 95% CI 0.69 to 1.23; three trials, 1429 participants, moderate quality evidence). There is insufficient evidence to know if supplementation improves cure (no trials), treatment completion (RR 0.99, 95% CI 0.95 to 1.04; one trial, 302 participants, very low quality evidence), or the proportion of people who remain sputum positive during the first eight weeks (RR 0.92, 95% CI 0.63 to 1.35; two trials, 1020 participants, very low quality evidence). However, supplementation may have little or no effect on weight gain during treatment (data not pooled; five trials, 2940 participants, low quality evidence), and no studies have assessed the effect on quality of life.\nPlasma levels of vitamin A appear to increase following initiation of tuberculosis treatment regardless of supplementation. In contrast, supplementation probably does improve plasma levels of zinc, vitamin D, vitamin E, and selenium, but this has not been shown to have clinically important benefits. Of note, despite multiple studies of vitamin D supplementation in different doses, statistically significant benefits on sputum conversion have not been demonstrated.\nAuthors' conclusions\nThere is currently insufficient research to know whether routinely providing free food, or energy supplements improves tuberculosis treatment outcomes, but it probably improves weight gain in some settings.\nAlthough blood levels of some vitamins may be low in people starting treatment for active tuberculosis, there is currently no reliable evidence that routinely supplementing above recommended daily amounts has clinical benefits.\n\nGiven the provided abstract, please respond to the following query: \"What is active tuberculosis and how might nutritional supplements work?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Tuberculosis is a bacterial infection which most commonly affects the lungs. Most people who get infected never develop symptoms as their immune system manages to control the bacteria. Active tuberculosis occurs when the infection is no longer contained by the immune system, and typical symptoms are cough, chest pain, fever, night sweats, weight loss, and sometimes coughing up blood. Treatment is with a combination of antibiotic drugs, which must be taken for at least six months.\nPeople with tuberculosis are often malnourished, and malnourished people are at higher risk of developing tuberculosis as their immune system is weakened. Nutritional supplements could help people recover from the illness by strengthening their immune system, and by improving weight gain, and muscle strength, allowing them to return to an active life. Good nutrition requires a daily intake of macronutrients (carbohydrate, protein, and fat), and micronutrients (essential vitamins and minerals)."
}
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query-laysum | 5376 | [
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding and pain are common reasons women discontinue intrauterine device (IUD) use. Copper IUD (Cu IUD) users tend to experience increased menstrual bleeding, whereas levonorgestrel IUD (LNG IUD) users tend to have irregular menstruation. Medical therapies used to reduce heavy menstrual bleeding or pain associated with Cu and LNG IUD use include non-steroidal anti-inflammatory drugs (NSAIDs), anti-fibrinolytics and paracetamol. We analysed treatment and prevention interventions separately because the expected outcomes for treatment and prevention interventions differ. We did not combine different drug classes in the analysis as they have different mechanisms of action. This is an update of a review originally on NSAIDs. The review scope has been widened to include all interventions for treatment or prevention of heavy menstrual bleeding or pain associated with IUD use.\nObjectives\nTo evaluate all randomized controlled trials (RCTs) that have assessed strategies for treatment and prevention of heavy menstrual bleeding or pain associated with IUD use, for example, pharmacotherapy and alternative therapies.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and CINAHL to January 2021.\nSelection criteria\nWe included RCTs in any language that tested strategies for treatment or prevention of heavy menstrual bleeding or pain associated with IUD (Cu IUD, LNG IUD or other IUD) use. The comparison could be no intervention, placebo or another active intervention.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, and extracted data. Primary outcomes were volume of menstrual blood loss, duration of menstruation and painful menstruation. We used a random-effects model in all meta-analyses. Review authors assessed the certainty of evidence using GRADE.\nMain results\nThis review includes 21 trials involving 3689 participants from middle- and high-income countries. Women were 18 to 45 years old and either already using an IUD or had just had one placed for contraception. The included trials examined NSAIDs and other interventions. Eleven were treatment trials, of these seven were on users of the Cu IUD, one on LNG IUD and three on an unknown type. Ten were prevention trials, six focused on Cu IUD users, and four on LNG IUD users. Sixteen trials had high risk of detection bias due to subjective assessment of pain and bleeding.\nTreatment of heavy menstrual bleeding\nCu IUD\nVitamin B1 resulted in fewer pads used per day (mean difference (MD) −7.00, 95% confidence interval (CI) −8.50 to −5.50) and fewer bleeding days (MD −2.00, 95% CI –2.38 to −1.62; 1 trial; 110 women; low-certainty evidence) compared to placebo. The evidence is very uncertain about the effect of naproxen on the volume of menstruation compared to placebo (odds ratio (OR) 0.09, 95% CI 0.00 to 1.78; 1 trial, 40 women; very low-certainty evidence).\nTreatment with mefenamic acid resulted in less volume of blood loss compared to tranexamic acid (MD −64.26, 95% CI −105.65 to −22.87; 1 trial, 94 women; low-certainty evidence). However, there was no difference in duration of bleeding with treatment of mefenamic acid or tranexamic acid (MD 0.08 days, 95% CI −0.27 to 0.42, 2 trials, 152 women; low-certainty evidence).\nLNG IUD\nThe use of ulipristal acetate in LNG IUD may not reduce the number of bleeding days in 90 days in comparison to placebo (MD −9.30 days, 95% CI −26.76 to 8.16; 1 trial, 24 women; low-certainty evidence).\nUnknown IUD type\nMefenamic acid may not reduce volume of bleeding compared to Vitex agnus measured by pictorial blood assessment chart (MD −2.40, 95% CI −13.77 to 8.97; 1 trial; 84 women; low-certainty evidence).\nTreatment of pain\nCu IUD\nTreatment with tranexamic acid and sodium diclofenac may result in little or no difference in the occurrence of pain (OR 1.00, 95% CI 0.06 to 17.25; 1 trial, 38 women; very low-certainty evidence).\nUnknown IUD type\nNaproxen may reduce pain (MD 4.10, 95% CI 0.91 to 7.29; 1 trial, 33 women; low-certainty evidence).\nPrevention of heavy menstrual bleeding\nCu IUD\nWe found very low-certainty evidence that tolfenamic acid may prevent heavy bleeding compared to placebo (OR 0.54, 95% CI 0.34 to 0.85; 1 trial, 310 women). There was no difference between ibuprofen and placebo in blood volume reduction (MD −14.11, 95% CI −36.04 to 7.82) and duration of bleeding (MD −0.2 days, 95% CI −1.40 to 1.0; 1 trial, 28 women, low-certainty evidence).\nAspirin may not prevent heavy bleeding in comparison to paracetamol (MD −0.30, 95% CI −26.16 to 25.56; 1 trial, 20 women; very low-certainty evidence).\nLNG IUD\nUlipristal acetate may increase the percentage of bleeding days compared to placebo (MD 9.50, 95% CI 1.48 to 17.52; 1 trial, 118 women; low-certainty evidence). There were insufficient data for analysis in a single trial comparing mifepristone and vitamin B.\nThere were insufficient data for analysis in the single trial comparing tranexamic acid and mefenamic acid and in another trial comparing naproxen with estradiol.\nPrevention of pain\nCu IUD\nThere was low-certainty evidence that tolfenamic acid may not be effective to prevent painful menstruation compared to placebo (OR 0.71, 95% CI 0.44 to 1.14; 1 trial, 310 women). Ibuprofen may not reduce menstrual cramps compared to placebo (OR 1.00, 95% CI 0.11 to 8.95; 1 trial, 20 women, low-certainty evidence).\nAuthors' conclusions\nFindings from this review should be interpreted with caution due to low- and very low-certainty evidence. Included trials were limited; the majority of the evidence was derived from single trials with few participants. Further research requires larger trials and improved trial reporting. The use of vitamin B1 and mefenamic acid to treat heavy menstruation and tolfenamic acid to prevent heavy menstruation associated with Cu IUD should be investigated. More trials are needed to generate evidence for the treatment and prevention of heavy and painful menstruation associated with LNG IUD.\n\nGiven the provided abstract, please respond to the following query: \"Copper IUD\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Treatment with tranexamic acid and sodium diclofenac may not reduce the occurrence of painful menstruation associated with copper IUD."
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query-laysum | 5377 | [
{
"role": "user",
"content": "Abstract: Background\nCollagenous colitis is a cause of chronic diarrhea. This updated review was performed to identify therapies for collagenous colitis that have been assessed in randomized controlled trials (RCTs).\nObjectives\nThe primary objective was to assess the benefits and harms of treatments for collagenous colitis.\nSearch methods\nWe searched CENTRAL, the Cochrane IBD Group Specialized Register, MEDLINE and EMBASE from inception to 7 November 2016.\nSelection criteria\nWe included RCTs comparing a therapy with placebo or active comparator for the treatment of active or quiescent collagenous colitis.\nData collection and analysis\nData were independently extracted by two authors. The primary outcome was clinical response or maintenance of response as defined by the included studies. Secondary outcome measures included histological response, quality of life and the occurrence of adverse events. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The Cochrane risk of bias tool was used to assess bias. The overall quality of the evidence was assessed using the GRADE criteria.\nMain results\nTwelve RCTs (476 participants) were included. These studies assessed bismuth subsalicylate, Boswellia serrata extract, mesalamine, cholestyramine, probiotics, prednisolone and budesonide therapy. Four studies were low risk of bias. One study assessing mesalamine and cholestyramine was judged to be high risk of bias due to no blinding. The other studies had an unclear risk of bias for random sequence generation (five studies) allocation concealment (six studies), blinding (one study), incomplete outcome data (one study) and selective outcome reporting (one study). Clinical response occurred in 100% (4/4) of patients who received bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks) compared to 0% (0/5) of patients who received placebo (1 study; 9 participants; RR 10.80, 95% CI 0.75 to 155.93; GRADE = very low). Clinical response occurred in 44% (7/16) of patients who received Boswellia serrata extract (three 400 mg/day capsules for 8 weeks) compared to 27% (4/15) of patients who received placebo (1 study; 31 participants; RR 1.64, 95% CI 0.60 to 4.49; GRADE = low). Clinical response occurred in 80% (24/30) of budesonide patients compared to 44% (11/25) of mesalamine patients (1 study; 55 participants; RR 1.82, 95% CI 1.13 to 2.93; GRADE = low). Histological response was observed in 87% (26/30) of budesonide patients compared to 44% (11/25) of mesalamine patients (1 study, 55 participants; RR 1.97, 95% CI 1.24 to 3.13; GRADE = low). There was no difference between the two treatments with respect to adverse events (RR 0.69, 95% CI 0.43 to 1.10; GRADE = low), withdrawals due to adverse events (RR 0.09, 95% CI 0.01 to 1.65; GRADE = low) and serious adverse events (RR 0.12, 95% CI 0.01 to 2.21; GRADE = low). Clinical response occurred in 44% (11/25) of mesalamine patients (3 g/day) compared to 59% (22/37) of placebo patients (1 study; 62 participants; RR 0.74, 95% CI 0.44 to 1.24; GRADE = low). Histological response was observed in 44% (11/25) and 51% (19/37) of patients receiving mesalamine and placebo, respectively (1 study; 62 participants; RR 0.86, 95% CI 0.50 to 1.47; GRADE = low). There was no difference between the two treatments with respect to adverse events (RR 1.26, 95% CI 0.84 to 1.88; GRADE = low), withdrawals due to adverse events (RR 5.92, 95% CI 0.70 to 49.90; GRADE = low) and serious adverse events (RR 4.44, 95% CI 0.49 to 40.29; GRADE = low). Clinical response occurred in 63% (5/8) of prednisolone (50 mg/day for 2 weeks) patients compared to 0% (0/3) of placebo patients (1 study, 11 participants; RR 4.89, 95% CI 0.35 to 68.83; GRADE = very low). Clinical response occurred in 29% (6/21) of patients who received probiotics (2 capsules containing 0.5 x 1010 CFU each of L. acidophilus LA-5 and B. animalis subsp. lactis strain BB-12 twice daily for 12 weeks) compared to 13% (1/8) of placebo patients (1 study, 29 participants, RR 2.29, 95% CI 0.32 to 16.13; GRADE = very low). Clinical response occurred in 73% (8/11) of patients who received mesalamine (800 mg three times daily) compared to 100% (12/12) of patients who received mesalamine + cholestyramine (4 g daily) (1 study, 23 participants; RR 0.74, 95% CI 0.50 to 1.08; GRADE = very low). Clinical response occurred in 81% (38/47) of patients who received budesonide (9 mg daily in a tapering schedule for 6 to 8 weeks) compared to 17% (8/47) of placebo patients (3 studies; 94 participants; RR 4.56, 95% CI 2.43 to 8.55; GRADE = low). Histological response was higher in budesonide participants (72%, 34/47) compared to placebo (17%, 8/47) (RR 4.15, 95% CI 2.25 to 7.66; GRADE = low). Clinical response was maintained in 68% (57/84) of budesonide patients compared to 20% (18/88) of placebo patients (3 studies, 172 participants, RR 3.30 95% CI 2.13 to 5.09; GRADE = low). Histological response was maintained in 48% (19/40) of budesonide patients compared to 15% (6/40) of placebo patients (2 studies; 80 participants; RR 3.17, 95% CI 1.44 to 6.95; GRADE = very low). No difference was found between budesonide and placebo for adverse events (5 studies; 290 participants; RR 1.18, o95% CI 0.92 to 1.51; GRADE = low), withdrawals due to adverse events (5 studies, 290 participants; RR 0.97, 95% CI 0.43 to 2.17; GRADE = very low) or serious adverse events (4 studies, 175 participants; RR 1.11, 95% CI 0.15 to 8.01; GRADE = very low). Adverse effects reported in the budesonide studies include nausea, vomiting, neck pain, abdominal pain, excessive sweating and headache. Adverse effects reported in the mesalamine studies included nausea and skin rash. Adverse effects in the prednisolone study included abdominal pain, headache, sleep disturbance, mood change and weight gain.\nAuthors' conclusions\nLow quality evidence suggests that budesonide may be effective for inducing and maintaining clinical and histological response in patients with collagenous colitis. We are uncertain about the benefits and harms of therapy with bismuth subsalicylate, Boswellia serrata extract, mesalamine with or without cholestramine, prednisolone and probiotics. These agents and other therapies require further study.\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": "Twelve studies (476 participants) were identified. Four studies were high quality. One study assessing mesalamine and cholestyramine was judged to be low quality and the other studies were judged to be of unclear quality due to poor reporting of methods.\nDiarrhea resolved in 100% (4/4) of Pepto-Bismol® (nine 262 mg tablets daily for 8 weeks) participants compared to 0% (0/5) of placebo participants (1 study; very low quality evidence). Diarrhea resolved in 44% (7/16) of Boswellia serrata participants (three 400 mg/day capsules for 8 weeks) compared to 27% (4/15) of placebo participants (1 study; low-quality evidence). Diarrhea resolved in 80% (24/30) of budesonide participants compared to 44% (11/25) of mesalamine participants (1 study; low-quality evidence). There was no difference between the two treatments with respect to side effects. Diarrhea resolved in 44% (11/25) of mesalamine (3 g/day) participants compared to 59% (22/37) of placebo participants (1 study; low-quality evidence). There was no difference between the two treatments with respect to side effects. Diarrhea resolved in 63% (5/8) of prednisolone (50 mg/day for 2 weeks) participants compared to 0% (0/3) of placebo participants (1 study, low-quality evidence). Diarrhea resolved in 29% (6/21) of participants who received probiotics (2 capsules containing probiotics twice daily for 12 weeks) compared to 13% (1/8) of placebo participants (1 study, very low-quality evidence). Diarrhea resolved in 73% (8/11) of mesalamine (800 mg three times daily) participants compared to 100% (12/12) of mesalamine + cholestyramine participants (4 g daily) (1 study, very low-quality evidence). Diarrhea resolved in 81% (38/47) of budesonide (9 mg daily for 6-8 weeks) participants compared to 17% (8/47) of placebo participants (3 studies; low-quality evidence). Improvement in microscopic inflammation occurred in 72% (34/47) of budesonide participants compared to 17% (8/47) placebo participants (low-quality evidence). Resolution of diarrhea was maintained over 6 months in 68% (57/84) of budesonide participants compared to 20% (18/88) of placebo participants (3 studies, low-quality evidence). Improvement in microscopic inflammation was maintained in 48% (19/40) of budesonide participants compared to 15% (6/40) of placebo participants (2 studies; very low-quality evidence). No difference was found between budesonide and placebo for side effects (low-quality evidence) or serious side effects (very low-quality evidence). Side effects reported in the budesonide studies include nausea, vomiting, neck pain, abdominal pain, excessive sweating and headache. Side effects reported in the mesalamine studies included nausea and skin rash. Side effects in the prednisolone study included abdominal pain, headache, sleep disturbance, mood change and weight gain.\nIn conclusion, low quality evidence suggests that budesonide may be an effective therapy for active and inactive collagenous colitis. Due to small sample sizes and low study quality we are uncertain about the benefits and harms of therapy with Pepto-Bismol®, Boswellia serrata extract, mesalamine with or without cholestramine, prednisolone and probiotics. These agents and other therapies require further study."
}
]
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query-laysum | 5378 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin D deficiency is often reported in people with chronic liver diseases. Improving vitamin D status could therefore be beneficial for people with chronic liver diseases.\nObjectives\nTo assess the beneficial and harmful effects of vitamin D supplementation in adults with chronic liver diseases.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index-Science. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We scanned bibliographies of relevant publications and enquired experts and pharmaceutical companies as to additional trials. All searches were up to November 2020.\nSelection criteria\nRandomised clinical trials that compared vitamin D at any dose, duration, and route of administration versus placebo or no intervention in adults with chronic liver diseases. Vitamin D could have been administered as supplemental vitamin D (vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol)), or an active form of vitamin D (1α-hydroxyvitamin D (alfacalcidol), 25-hydroxyvitamin D (calcidiol), or 1,25-dihydroxyvitamin D (calcitriol)).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of evidence.\nMain results\nWe included 27 randomised clinical trials with 1979 adult participants. This review update added 12 trials with 945 participants. We assessed all trials at high risk of bias. All trials had a parallel-group design. Eleven trials were conducted in high-income countries and 16 trials in middle-income countries. Ten trials included participants with chronic hepatitis C, five trials participants with liver cirrhosis, 11 trials participants with non-alcoholic fatty liver disease, and one trial liver transplant recipients. All of the included trials reported the baseline vitamin D status of participants. Participants in nine trials had baseline serum 25-hydroxyvitamin D levels at or above vitamin D adequacy (20 ng/mL), whilst participants in the remaining 18 trials were vitamin D insufficient (less than 20 ng/mL). Twenty-four trials administered vitamin D orally, two trials intramuscularly, and one trial intramuscularly and orally. In all 27 trials, the mean duration of vitamin D supplementation was 6 months, and the mean follow-up of participants from randomisation was 7 months. Twenty trials (1592 participants; 44% women; mean age 48 years) tested vitamin D3 (cholecalciferol); three trials (156 participants; 28% women; mean age 54 years) tested vitamin D2; four trials (291 participants; 60% women; mean age 52 years) tested 1,25-dihydroxyvitamin D; and one trial (18 participants; 0% women; mean age 52 years) tested 25-hydroxyvitamin D. One trial did not report the form of vitamin D. Twelve trials used a placebo, whilst the other 15 trials used no intervention in the control group. Fourteen trials appeared to be free of vested interest. Eleven trials did not provide any information on clinical trial support or sponsorship. Two trials were funded by industry.\nWe are very uncertain regarding the effect of vitamin D versus placebo or no intervention on all-cause mortality (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.51 to 1.45; 27 trials; 1979 participants). The mean follow-up was 7 months (range 1 to 18 months). We are very uncertain regarding the effect of vitamin D versus placebo or no intervention on liver-related mortality (RR 1.62, 95% CI 0.08 to 34.66; 1 trial; 18 participants) (follow-up: 12 months); serious adverse events such as hypercalcaemia (RR 5.00, 95% CI 0.25 to 100.8; 1 trial; 76 participants); myocardial infarction (RR 0.75, 95% CI 0.08 to 6.81; 2 trials; 86 participants); thyroiditis (RR 0.33, 95% CI 0.01 to 7.91; 1 trial; 68 participants); circular haemorrhoidal prolapse (RR 3.00, 95% CI 0.14 to 65.9; 1 trial; 20 participants); bronchopneumonia (RR 0.33, 95% CI 0.02 to 7.32; 1 trial 20 participants); and non-serious adverse events. The certainty of evidence for all outcomes is very low.\nWe found no data on liver-related morbidity such as gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, ascites, or liver cancer. There were also no data on health-related quality of life.\nThe evidence is also very uncertain regarding the effect of vitamin D versus placebo or no intervention on rapid, early, and sustained virological response in people with chronic hepatitis C.\nAuthors' conclusions\nGiven the high risk of bias and insufficient power of the included trials and the very low certainty of the available evidence, vitamin D supplementation versus placebo or no intervention may increase or reduce all-cause mortality, liver-related mortality, serious adverse events, or non-serious adverse events in adults with chronic liver diseases. There is a lack of data on liver-related morbidity and health-related quality of life. Further evidence on clinically important outcomes analysed in this review is needed.\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": "There is not enough evidence to determine whether vitamin D has beneficial or harmful effects, or has little to no effect on chronic liver diseases in adults. There were too few participants in the individual trials as well as in our evidence synthesis. The trials were at high risk of bias so we lack fair assessments of the benefits and harms of vitamin D in this population. Neither benefits nor harms of vitamin D supplementation in people with chronic liver diseases can be excluded. There were no trials including people with chronic hepatitis B and inherited liver diseases."
}
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query-laysum | 5379 | [
{
"role": "user",
"content": "Abstract: Background\nLower limb peripheral arterial disease (PAD) is a type of cardiovascular disease where the blood vessels that carry the blood to the legs are hardened and narrowed. The most severe manifestation of PAD is critical limb ischaemia (CLI). This condition results in symptoms of intractable rest pain, non-healing wounds and ulceration, gangrene or both. PAD affects more than 200 million people worldwide and approximately 3% to 5% of people aged over 40 have PAD, rising to 18% in people over 70 years of age. Between 5% to 10% of symptomatic PAD patients will progress to CLI over a five-year period and the five year cumulative incidence rate for asymptomatic patients with PAD deteriorating to intermittent claudication is 7%, with 21% of these progressing to CLI. Treatment options include angioplasty, bypass or amputation of the limb, when life or limb is threatened. People with CLI have a high risk of mortality and morbidity. The mortality rates during a surgical admission are approximately 5%. Within one year of surgery, the mortality rate rises to 22%. Postoperative complications are as high as 30% and readmission rates vary between 7% to 18% in people with CLI.\nDespite recent advances in surgical technology, anaesthesia and perioperative care, a proportion of surgical patients have a suboptimal recovery. Presurgery conditioning (prehabilitation) is a multimodal conditioning intervention carried out prior to surgery using a combination of exercise, with or without nutritional or psychological interventions, or both. The use of prehabilitation is gaining momentum, particularly in elderly patients undergoing surgery and patients undergoing colorectal cancer surgery, as a means of optimising fitness to improve the prognosis for people undergoing the physiological stress of surgery. People with PAD are characterised by poor mobility and physical function and have a lower level of fitness as a result of disease progression. Therefore, prehabilitation may be an opportunity to improve their recovery following surgery. However, as multimodal prehabilitation requires considerable resources, it is important to assess whether it is superior to usual care.\nThis review aimed to compare prehabilitation with usual care (defined as a preoperative assessment, including blood and urine tests). The key outcomes were postoperative complications, mortality and readmissions within 30 days of the surgical procedure, and one-year survival rates.\nObjectives\nTo assess the effectiveness of prehabilitation (preoperative exercise, either alone or in combination with nutritional or psychological interventions, or both) on postoperative outcomes in adults with PAD undergoing open lower limb surgery.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 25 September 2019.\nSelection criteria\nWe considered all published and unpublished randomised controlled trials (RCTs) comparing presurgery interventions and usual care. Primary outcomes were postoperative complications, mortality and readmission to hospital within 30 days of the surgical procedure.\nData collection and analysis\nTwo review authors independently reviewed all records identified by the searches conducted by the Cochrane Vascular Information Specialist. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe found no RCTs that met the inclusion criteria for this review.\nAuthors' conclusions\nWe found no RCTs conducted to determine the effects of prehabilitation on mortality or other postoperative outcomes when compared to usual care for patients with PAD. As a consequence, we were unable to provide any evidence to guide the treatment of patients with PAD undergoing surgery. To perform a randomised controlled trial of presurgery conditioning would be challenging but trials are warranted to provide solid evidence on this topic.\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": "We found no studies undertaken to address our objectives; therefore we were not able to assess the certainty of the evidence."
}
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query-laysum | 5380 | [
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. First-line treatments often involve dietary or lifestyle changes, medication or local (intratympanic) treatments. However, surgery may also be considered for people with persistent or severe symptoms. The efficacy of different surgical interventions at preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of surgical interventions versus placebo or no treatment in people with Ménière's disease.\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 search was 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable Ménière's disease comparing ventilation tubes, endolymphatic sac surgery, semi-circular canal plugging/obliteration, vestibular nerve section or labyrinthectomy with either placebo (sham surgery) or no treatment. We excluded studies with follow-up of less than three months, or with a cross-over design (unless data from the first phase of the study could be identified).\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 two studies with a total of 178 participants. One evaluated ventilation tubes compared to no treatment, the other evaluated endolymphatic sac decompression compared to sham surgery.\nVentilation tubes\nWe included a single RCT of 148 participants with definite Ménière's disease. It was conducted in a single centre in Japan from 2010 to 2013. Participants either received ventilation tubes with standard medical treatment, or standard medical treatment alone, and were followed up for two years. Some data were reported on the number of participants in whom vertigo resolved, and the effect of the intervention on hearing. Our other primary and secondary outcomes were not reported in this study. This is a single, small study and for all outcomes the certainty of evidence was low or very low. We are unable to draw meaningful conclusions from the numerical results.\nEndolymphatic sac decompression\nWe also included one RCT of 30 participants that compared endolymphatic sac decompression with sham surgery. This was a single-centre study conducted in Denmark during the 1980s. Follow-up was predominantly conducted at one year, but additional follow-up continued for up to nine years in some participants. Some data were reported on hearing and vertigo (both improvement in vertigo and change in vertigo), but our other outcomes of interest were not reported. Again, this is a single, very small study and we rated the certainty of the evidence as very low for all outcomes. We are therefore unable to draw meaningful conclusions from the numerical results.\nAuthors' conclusions\nWe are unable to draw clear conclusions about the efficacy of these surgical interventions for Ménière's disease. We identified evidence for only two of our five proposed comparisons, and we assessed all the evidence as 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. Many of the outcomes that we planned to assess were not reported by the studies, such as the impact on quality of life, and adverse effects of the 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 are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We have very little confidence in the evidence because the two studies conducted were small and had problems in their conduct, which means that the results may be unreliable. Larger, well-conducted studies are needed to try and work out how effective the different treatments really are."
}
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query-laysum | 5381 | [
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization recommends routine vitamin A supplementation during pregnancy or lactation in areas with endemic vitamin A deficiency (where night blindness occurs), based on the expectation that supplementation will improve maternal and newborn outcomes including mortality, morbidity and prevention of anaemia or infection.\nObjectives\nTo review the effects of supplementation of vitamin A, or one of its derivatives, during pregnancy, alone or in combination with other vitamins and micronutrients, on maternal and newborn clinical outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 March 2015) and reference lists of retrieved studies.\nSelection criteria\nAll randomised or quasi-randomised trials, including cluster-randomised trials, evaluating the effect of vitamin A supplementation in pregnant women.\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\nWe reviewed 106 reports of 35 trials, published between 1931 and 2015. We included 19 trials including over 310,000 women, excluded 15 trials and one is ongoing. Overall, seven trials were judged to be of low risk of bias, three were high risk of bias and for nine it was unclear.\n1) Vitamin A alone versus placebo or no treatment\nOverall, when trial results are pooled, vitamin A supplementation does not affect the risk of maternal mortality (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.65 to 1.20; four trials Ghana, Nepal, Bangladesh, UK, high quality evidence), perinatal mortality (RR 1.01, 95% CI 0.95 to 1.07; one study, high quality evidence), neonatal mortality, stillbirth, neonatal anaemia, preterm birth (RR 0.98, 95% CI 0.94 to 1.01, five studies, high quality evidence), or the risk of having a low birthweight baby.\nVitamin A supplementation reduces the risk of maternal night blindness (RR 0.79, 95% CI 0.64 to 0.98; two trials). There is evidence that vitamin A supplements may reduce maternal clinical infection (RR 0.45, 95% CI 0.20 to 0.99, five trials; South Africa, Nepal, Indonesia, Tanzania, UK, low quality evidence) and maternal anaemia (RR 0.64, 95% CI 0.43 to 0.94; three studies, moderate quality evidence).\n2) Vitamin A alone versus micronutrient supplements without vitamin A\nVitamin A alone compared to micronutrient supplements without vitamin A does not decrease maternal clinical infection (RR 0.99, 95% CI 0.83 to 1.18, two trials, 591 women). No other primary or secondary outcomes were reported\n3) Vitamin A with other micronutrients versus micronutrient supplements without vitamin A\nVitamin A supplementation (with other micronutrients) does not decrease perinatal mortality (RR 0.51, 95% CI 0.10 to 2.69; one study, low quality evidence), maternal anaemia (RR 0.86, 95% CI 0.68 to 1.09; three studies, low quality evidence), maternal clinical infection (RR 0.95, 95% CI 0.80 to 1.13; I² = 45%, two studies, low quality evidence) or preterm birth (RR 0.39, 95% CI 0.08 to 1.93; one study, low quality evidence).\nIn HIV-positive women vitamin A supplementation given with other micronutrients was associated with fewer low birthweight babies (< 2.5 kg) in the supplemented group in one study (RR 0.67, 95% CI 0.47 to 0.96; one study, 594 women).\nAuthors' conclusions\nThe pooled results of three large trials in Nepal, Ghana and Bangladesh (with over 153,500 women) do not currently suggest a role for antenatal vitamin A supplementation to reduce maternal or perinatal mortality. However, the populations studied were probably different with regard to baseline vitamin A status and there were problems with follow-up of women. There is good evidence that antenatal vitamin A supplementation reduces maternal night blindness, maternal anaemia for women who live in areas where vitamin A deficiency is common or who are HIV-positive. In addition the available evidence suggests a reduction in maternal infection, but these data are not of a high quality.\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": "Vitamin A is a fat-soluble vitamin found in liver, kidney, eggs, and dairy produce. Low dietary fat intake or intestinal infections may interfere with the absorption of vitamin A. Natural retinoids are required for a wide range of biological processes including vision, immune function, bone metabolism and blood production. In pregnancy, extra vitamin A may be required. Currently, the World Health Organization (WHO) and other international agencies recommend routine vitamin A supplementation during pregnancy or at any time during lactation in areas with endemic vitamin A deficiency (where night blindness occurs)."
}
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query-laysum | 5382 | [
{
"role": "user",
"content": "Abstract: Background\nAlthough superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the forearm or hand, no consensus exists on the optimal management of this condition in clinical practice.\nObjectives\nTo summarise the evidence from randomised clinical trials (RCTs) concerning the efficacy and safety of (topical, oral or parenteral) medical therapy of superficial thrombophlebitis of the upper extremity.\nSearch methods\nThe Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and the Cochrane Register of Studies (2015, Issue 3). Clinical trials registries were searched up to April 2015.\nSelection criteria\nRCTs comparing any (topical, oral or parenteral) medical treatment to no intervention or placebo, or comparing two different medical interventions (e.g. a different variant scheme or regimen of the same intervention or a different pharmacological type of treatment).\nData collection and analysis\nWe extracted data on methodological quality, patient characteristics, interventions and outcomes, including improvement of signs and symptoms as the primary effectiveness outcome, and number of participants experiencing side effects of the study treatments as the primary safety outcome.\nMain results\nWe identified 13 studies (917 participants). The evaluated treatment modalities consisted of a topical treatment (11 studies), an oral treatment (2 studies) and a parenteral treatment (2 studies). Seven studies used a placebo or no intervention control group, whereas all others also or solely compared active treatment groups. No study evaluated the effects of ice or the application of cold or hot bandages. Overall, the risk of bias in individual trials was moderate to high, although poor reporting hampered a full appreciation of the risk in most studies. The overall quality of the evidence for each of the outcomes varied from low to moderate mainly due to risk of bias and imprecision, with only single trials contributing to most comparisons. Data on primary outcomes improvement of signs and symptoms and side effects attributed to the study treatment could not be statistically pooled because of the between-study differences in comparisons, outcomes and type of instruments to measure outcomes.\nAn array of topical treatments, such as heparinoid or diclofenac gels, improved pain compared to placebo or no intervention. Compared to placebo, oral non-steroidal anti-inflammatory drugs reduced signs and symptoms intensity. Safety issues were reported sparsely and were not available for some interventions, such as notoginseny creams, parenteral low-molecular-weight heparin or defibrotide. Although several trials reported on adverse events with topical heparinoid creams, Essaven gel or phlebolan versus control, the trials were underpowered to adequately measure any differences between treatment modalities. Where reported, adverse events with topical treatments consisted mainly of local allergic reactions. Only one study of 15 participants assessed thrombus extension and symptomatic venous thromboembolism with either oral non-steroidal anti-inflammatory drugs or low-molecular-weight heparin, and it reported no cases of either. No study reported on the development of suppurative phlebitis, catheter-related bloodstream infections or quality of life.\nAuthors' conclusions\nThe evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality. Data appear too preliminary to assess the effectiveness and safety of topical treatments, systemic anticoagulation or oral non-steroidal anti-inflammatory drugs.\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": "Some of the included studies may have been biased due to design limitations, but we could not always assess this risk because the original researchers did not always provide enough information to judge. The overall quality of the evidence for each of the outcomes varied from low to moderate, mainly because the studies had design flaws or were very small. We could not analyse data on primary outcomes together because the trials examined different treatments, in different ways, looking at different outcomes. In short, the evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality, and we do not have enough information to recommend the use of any of the treatments studied."
}
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query-laysum | 5383 | [
{
"role": "user",
"content": "Abstract: Background\nNeck pain is common, disabling and costly. Exercise is one treatment approach.\nObjectives\nTo assess the effectiveness of exercises to improve pain, disability, function, patient satisfaction, quality of life and global perceived effect in adults with neck pain.\nSearch methods\nWe searched MEDLINE, MANTIS, ClinicalTrials.gov and three other computerized databases up to between January and May 2014 plus additional sources (reference checking, citation searching, contact with authors).\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing single therapeutic exercise with a control for adults suffering from neck pain with or without cervicogenic headache or radiculopathy.\nData collection and analysis\nTwo review authors independently conducted trial selection, data extraction, 'Risk of bias' assessment and clinical relevance. The quality of the evidence was assessed using GRADE. Meta-analyses were performed for relative risk and standardized mean differences (SMD) with 95% confidence intervals (CIs) after judging clinical and statistical heterogeneity.\nMain results\nTwenty-seven trials (2485 analyzed /3005 randomized participants) met our inclusion criteria.\nFor acute neck pain only, no evidence was found.\nFor chronic neck pain, moderate quality evidence supports 1) cervico-scapulothoracic and upper extremity strength training to improve pain of a moderate to large amount immediately post treatment [pooled SMD (SMDp) -0.71 (95% CI: -1.33 to -0.10)] and at short-term follow-up; 2) scapulothoracic and upper extremity endurance training for slight beneficial effect on pain at immediate post treatment and short-term follow-up; 3) combined cervical, shoulder and scapulothoracic strengthening and stretching exercises varied from a small to large magnitude of beneficial effect on pain at immediate post treatment [SMDp -0.33 (95% CI: -0.55 to -0.10)] and up to long-term follow-up and a medium magnitude of effect improving function at both immediate post treatment and at short-term follow-up [SMDp -0.45 (95%CI: -0.72 to -0.18)]; 4) cervico-scapulothoracic strengthening/stabilization exercises to improve pain and function at intermediate term [SMDp -14.90 (95% CI:-22.40 to -7.39)]; 5) Mindfulness exercises (Qigong) minimally improved function but not global perceived effect at short term. Low evidence suggests 1) breathing exercises; 2) general fitness training; 3) stretching alone; and 4) feedback exercises combined with pattern synchronization may not change pain or function at immediate post treatment to short-term follow-up. Very low evidence suggests neuromuscular eye-neck co-ordination/proprioceptive exercises may improve pain and function at short-term follow-up.\nFor chronic cervicogenic headache, moderate quality evidence supports static-dynamic cervico-scapulothoracic strengthening/endurance exercises including pressure biofeedback immediate post treatment and probably improves pain, function and global perceived effect at long-term follow-up. Low grade evidence supports sustained natural apophyseal glides (SNAG) exercises.\nFor acute radiculopathy, low quality evidence suggests a small benefit for pain reduction at immediate post treatment with cervical stretch/strengthening/stabilization exercises.\nAuthors' conclusions\nNo high quality evidence was found, indicating that there is still uncertainty about the effectiveness of exercise for neck pain. Using specific strengthening exercises as a part of routine practice for chronic neck pain, cervicogenic headache and radiculopathy may be beneficial. Research showed the use of strengthening and endurance exercises for the cervico-scapulothoracic and shoulder may be beneficial in reducing pain and improving function. However, when only stretching exercises were used no beneficial effects may be expected. Future research should explore optimal dosage.\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": "Results showed that exercise is safe, with temporary and benign side effects, although more than half of the trials did not report on adverse effects. An exercise classification system was used to ensure similarity between protocols when looking at the effects of different types of exercises. Some types of exercise did show an advantage over the other comparison groups. There appears to be a role for strengthening exercises in the treatment of chronic neck pain, cervicogenic headache and cervical radiculopathy if these exercises are focused on the neck, shoulder and shoulder blade region. Furthermore, the use of strengthening exercises, combined with endurance or stretching exercises has also been shown to be beneficial. There is some evidence to suggest the beneficial effects of specific exercises (e.g. sustained natural apophyseal glides) with cervicogenic headaches and mindfulness exercises (e.g. Qigong) for chronic mechanical neck pain. There appears to be minimal effect on neck pain and function when only stretching or endurance type exercises are used for the neck, shoulder and shoulder blade region."
}
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query-laysum | 5384 | [
{
"role": "user",
"content": "Abstract: Background\nBronchiolitis is the leading cause of hospitalisation among infants in high-income countries. Acute viral bronchiolitis is associated with airway obstruction and turbulent gas flow. Heliox, a mixture of oxygen and the inert gas helium, may improve gas flow through high-resistance airways and decrease the work of breathing. In this review, we selected trials that objectively assessed the effect of the addition of heliox to standard medical care for acute bronchiolitis.\nObjectives\nTo assess heliox inhalation therapy in addition to standard medical care for acute bronchiolitis in infants with respiratory distress, as measured by clinical endpoints (in particular the rate of endotracheal intubation, the rate of emergency department discharge, the length of treatment for respiratory distress) and pulmonary function testing (mainly clinical respiratory scores).\nSearch methods\nWe searched CENTRAL (2015, Issue 2), MEDLINE (1966 to March week 3, 2015), EMBASE (1974 to March 2015), LILACS (1982 to March 2015) and the National Institutes of Health (NIH) website (May 2009).\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs of heliox in infants with acute bronchiolitis.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality.\nMain results\nWe included seven trials involving 447 infants younger than two years with respiratory distress secondary to viral bronchiolitis. All children were recruited from a paediatric intensive care unit (PICU; 378 infants), except in one trial (emergency department; 69 infants). All children were younger than two (under nine months in two trials and under three months in one trial). Positive tests for respiratory syncytial virus (RSV) were required for inclusion in five trials. The two other trials were carried out in the bronchiolitis seasons. Seven different protocols were used for inhalation therapy with heliox.\nWhen heliox was used in the PICU, we observed no significant reduction in the rate of intubation: risk ratio (RR) 2.73 (95% confidence interval (CI) 0.96 to 7.75, four trials, 408 infants, low quality evidence). When heliox inhalation was used in the emergency department, we observed no increase in the rate of discharge: RR 0.51 (95% CI 0.17 to 1.55, one trial, 69 infants, moderate quality evidence).\nThere was no decrease in the length of treatment for respiratory distress: mean difference (MD) -0.19 days (95% CI -0.56 to 0.19, two trials, 320 infants, moderate quality evidence). However, in the subgroup of infants who were started on nasal continuous positive airway pressure (nCPAP) right from the start, because of severe respiratory distress, heliox therapy reduced the length of treatment: MD -0.76 days (95% CI -1.45 to -0.08, one trial, 21 infants, low quality evidence). No adverse events related to heliox inhalation were reported.\nWe found that infants treated with heliox inhalation had a significantly lower mean clinical respiratory score in the first hour after starting treatment when compared to those treated with air or oxygen inhalation: MD -1.04 (95% CI -1.60 to -0.48, four trials, 138 infants, moderate quality evidence). This outcome had statistical heterogeneity, which remained even after removing the study using a standard high-concentration reservoir mask. Several factors may explain this heterogeneity, including first the limited number of patients in each trial, and the wide differences in the baseline severity of disease between studies, with the modified Wood Clinical Asthma Score (m-WCAS) in infants treated with heliox ranging from less than two to more than seven.\nAuthors' conclusions\nCurrent evidence suggests that the addition of heliox therapy may significantly reduce a clinical score evaluating respiratory distress in the first hour after starting treatment in infants with acute RSV bronchiolitis. We noticed this beneficial effect regardless of which heliox inhalation protocol was used. Nevertheless, there was no reduction in the rate of intubation, in the rate of emergency department discharge, or in the length of treatment for respiratory distress. Heliox could reduce the length of treatment in infants requiring CPAP for severe respiratory distress. Further studies with homogeneous logistics in their heliox application are needed. Inclusion criteria must include a clinical severity score that reflects severe respiratory distress to avoid inclusion of children with mild bronchiolitis who may not benefit from heliox inhalation. Such studies would provide the necessary information as to the appropriate place for heliox in the therapeutic schedule for severe bronchiolitis.\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 effect of heliox inhalation therapy in infants with airway obstruction due to winter viral pulmonary infection."
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query-laysum | 5385 | [
{
"role": "user",
"content": "Abstract: Background\nNon-selective beta-blockers are recommended for the prevention of bleeding in people with cirrhosis, portal hypertension and gastroesophageal varices. Carvedilol is a non-selective beta-blocker with additional intrinsic alpha1-blocking effects, which may be superior to traditional, non-selective beta-blockers in reducing portal pressure and, therefore, in reducing the risk of upper gastrointestinal bleeding.\nObjectives\nTo assess the beneficial and harmful effects of carvedilol compared with traditional, non-selective beta-blockers for adults with cirrhosis and gastroesophageal varices.\nSearch methods\nWe combined searches in the Cochrane Hepato-Biliary's Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, and Science Citation Index with manual searches. The last search update was 08 May 2018.\nSelection criteria\nWe included randomised clinical trials comparing carvedilol versus traditional, non-selective beta-blockers, irrespective of publication status, blinding, or language. We included trials evaluating both primary and secondary prevention of upper gastrointestinal bleeding in adults with cirrhosis and verified gastroesophageal varices.\nData collection and analysis\nThree review authors (AZ, RJ and LH), independently extracted data. The primary outcome measures were mortality, upper gastrointestinal bleeding and serious adverse events. We undertook meta-analyses and presented results using risk ratios (RR) or mean differences (MD), both with 95% confidence intervals (CIs), and I2 values as a marker of heterogeneity. We assessed bias control using the Cochrane Hepato-Biliary domains and the quality of the evidence with GRADE.\nMain results\nEleven trials fulfilled our inclusion criteria. One trial did not report clinical outcomes. We included the remaining 10 randomised clinical trials, involving 810 participants with cirrhosis and oesophageal varices, in our analyses. The intervention comparisons were carvedilol versus propranolol (nine trials), or nadolol (one trial). Six trials were of short duration (mean 6 (range 1 to 12) weeks), while four were of longer duration (13.5 (6 to 30) months). Three trials evaluated primary prevention; three evaluated secondary prevention; while four evaluated both primary and secondary prevention. We classified all trials as at 'high risk of bias'. We gathered mortality data from seven trials involving 507 participants; no events occurred in four of these. Sixteen of 254 participants receiving carvedilol and 19 of 253 participants receiving propranolol or nadolol died (RR 0.86, 95% CI 0.48 to 1.53; I2 = 0%, low-quality evidence). There appeared to be no differences between carvedilol versus traditional, non-selective beta-blockers and the risks of upper gastrointestinal bleeding (RR 0.77, 95% CI 0.43 to 1.37; 810 participants; 10 trials; I2 = 45%, very low-quality evidence) and serious adverse events (RR 0.97, 95% CI 0.67 to 1.42; 810 participants; 10 trials; I2 = 14%, low-quality evidence). Significantly more deaths, episodes of upper gastrointestinal bleeding and serious adverse events occurred in the long-term trials but there was not enough information to determine whether there were differences between carvedilol and traditional, non-selective beta-blockers, by trial duration. There was also insufficient information to detect differences in the effects of these interventions in trials evaluating primary or secondary prevention. There appeared to be no differences in the risk of non-serious adverse events between carvedilol versus its comparators (RR 0.55, 95% CI 0.23 to 1.29; 596 participants; 6 trials; I2 = 88%; very low-quality evidence). Use of carvedilol was associated with a greater reduction in hepatic venous pressure gradient than traditional, non-selective beta-blockers both in absolute (MD -1.75 mmHg, 95% CI -2.60 to -0.89; 368 participants; 6 trials; I2 = 0%; low-quality evidence) and percentage terms (MD -8.02%, 95% CI -11.49% to -4.55%; 368 participants; 6 trials; I2 = 0%; low-quality evidence). However, we did not observe a concomitant reduction in the number of participants who failed to achieve a sufficient haemodynamic response (RR 0.76, 95% CI 0.57 to 1.02; 368 participants; 6 trials; I2 = 42%; very low-quality evidence) or in clinical outcomes.\nAuthors' conclusions\nWe found no clear beneficial or harmful effects of carvedilol versus traditional, non-selective beta-blockers on mortality, upper gastrointestinal bleeding, serious or non-serious adverse events despite the fact that carvedilol was more effective at reducing the hepatic venous pressure gradient. However, the evidence was of low or very low quality, and hence the findings are uncertain. Additional evidence is required from adequately powered, long-term, double-blind, randomised clinical trials, which evaluate both clinical and haemodynamic 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"
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"role": "assistant",
"content": "Cirrhosis is a chronic disorder of the liver that results in an increase in its stiffness. As a result of the increased stiffness, the pressure in the blood vessels draining into the liver - the portal system - is increased. The increased portal blood pressure can result in the development of abnormally dilated blood vessels or varicose veins in the stomach and oesophagus (gastroesophageal varices). These varices can burst and the bleeding that follows can be life-threatening. Drugs that reduce the portal blood pressure can help deflate the gastroesophageal varices and hence reduce the risk of bleeding. The drugs most commonly used are called non-selective beta-blockers. A newer drug, carvedilol, is also a beta blocker but has additional actions and may be more effective at reducing the portal pressure and hence the risk of variceal bleeding."
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query-laysum | 5386 | [
{
"role": "user",
"content": "Abstract: Background\nDevelopmental dysplasia of the hip (DDH) describes the abnormal development of a hip in childhood, ranging from complete dislocation of the hip joint to subtle immaturity of a hip that is enlocated and stable within the socket. DDH occurs in around 10 per 1000 live births, though only one per 1000 are completely dislocated. There is variation in treatment pathways for DDH, which differs between hospitals and even between clinicians within the same hospital. The variation is related to the severity of dysplasia that is believed to require treatment, and the techniques used to treat dysplasia.\nObjectives\nTo determine the effectiveness of splinting and the optimal treatment strategy for the non-operative management of DDH in babies under six months of age.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, seven other electronic databases, and two trials registers up to November 2021. We also checked reference lists, contacted study authors, and handsearched relevant meetings abstracts.\nSelection criteria\nRandomised controlled trials (RCTs), including quasi-RCTs, as well as non-RCTs and cohort studies conducted after 1980 were included. Participants were babies with all severities of DDH who were under six months of age. Interventions included dynamic splints (e.g. Pavlik harness), static splints (e.g Fixed abduction brace) or double nappies (diapers), compared to no splinting or delayed splinting.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and performed risk of bias and GRADE assessments. The primary outcomes were: measurement of acetabular index at years one, two and five, as determined by radiographs (angle): the need for operative intervention to achieve reduction and to address dysplasia; and complications. We also investigated other outcomes highlighted by parents as important, including the bond between parent and child and the ability of mothers to breastfeed.\nMain results\nWe included six RCTs or quasi-RCTs (576 babies). These were supported by 16 non-RCTs (8237 babies). Five studies had non-commercial funding, three studies stated 'no funding' and 14 studies did not state funding source. The RCTs were generally at unclear risk of bias, although we judged three RCTs to be at high risk of bias for incomplete outcome data. The non-RCTs were of moderate and critical risk of bias. We did not undertake meta-analysis due to methodological and clinical differences between studies; instead, we have summarised the results narratively.\nDynamic splinting versus delayed or no splinting\nFour RCTs and nine non-RCTs compared immediate dynamic splinting and delayed dynamic splinting or no splinting. Of the RCTs, two considered stable hips and one considered unstable (dislocatable) hips and one jointly considered unstable and stable hips. No studies considered only dislocated hips.\nTwo RCTs (265 babies, very low-certainty evidence) reported acetabular index at one year amongst stable or dislocatable hips. Both studies found there may be no evidence of a difference in splinting stable hips at first diagnosis compared to a strategy of active surveillance: one reported a mean difference (MD) of 0.10 (95% confidence interval (CI) −0.74 to 0.94), and the other an MD of 0.20 (95% CI −1.65 to 2.05). Two RCTs of stable hips (181 babies, very low-certainty evidence) reported there may be no evidence of a difference between groups for acetabular index at two years: one study reported an MD of −1.90 (95% CI −4.76 to 0.96), and another study reported an MD of −0.10 (95% CI −1.93 to 1.73), but did not take into account hips from the same child. No study reported data at five years.\nFour RCTs (434 babies, very low-certainty evidence) reported the need for surgical intervention. Three studies reported that no surgical interventions occurred. In the remaining study, two babies in the dynamic splinting group developed instability and were subsequently treated surgically. This study did not explicitly state if this treatment was to achieve concentric reduction or address residual dysplasia.\nThree RCTs (390 babies, very low-certainty evidence) reported no complications (avascular necrosis and femoral nerve palsy).\nDynamic splinting versus static splinting\nOne RCT and five non-RCTs compared dynamic versus static splinting. The RCT (118 hips) reported no occurrences of avascular necrosis (very low-certainty evidence) and did not report radiological outcomes or need for operative intervention.\nOne quasi-RCT compared double nappies versus delayed or no splinting but reported no outcomes of interest.\nOther comparisons\nNo RCTs compared static splinting versus delayed or no splinting or staged weaning versus immediate removal.\nAuthors' conclusions\nThere is a paucity of RCT evidence for splinting for the non-operative management of DDH: we included only six RCTs with 576 babies. Moreover, there was considerable heterogeneity between the studies, precluding meta-analysis. We judged the RCT evidence for all primary outcomes as being of very low certainty, meaning we are very uncertain about the true effects.\nResults from individual studies provide limited evidence of intervention effects on different severities of DDH. Amongst stable dysplastic hips, there was no evidence to suggest that treatment at any stage expedited the development of the acetabulum. For dislocatable hips, a delay in treatment onset to six weeks does not appear to result in any evidence of a difference in the development of the acetabulum at one year or increased risk of surgery. However, delayed splinting may reduce the number of babies requiring treatment with a harness.\nNo RCTs compared static splinting with delayed or no splinting, staged weaning versus immediate removal or double nappies versus delayed or no splinting.\nThere were few operative interventions or complications amongst the RCTs and the non-randomised studies. There's no apparent signal to indicate a higher frequency of either outcome in either intervention group.\nGiven the frequency of this disease, and the fact that many countries undertake mandatory DDH screening, there is a clear need to develop an evidence-based pathway for treatment. Particular uncertainties requiring future research are the effectiveness of splinting amongst stable dysplastic hips, the optimal timing for the onset of splinting, the optimal type of splint to use and the need for 'weaning of splints'. Only once a robust pathway for treatment is established, can we properly assess the cost-effectiveness of screening interventions for DDH.\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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"role": "assistant",
"content": "We found six studies that used randomization and included 576 babies and 16 studies that did not use randomization and included 8237 babies.\nFive studies had non-commercial funding, three studies stated that there was no funding and 14 studies did not state the funding source."
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query-laysum | 5387 | [
{
"role": "user",
"content": "Abstract: Background\nAvascular necrosis of bone is a frequent and severe complication of sickle cell disease and its treatment is not standardised. This is an update of a previously published Cochrane Review.\nObjectives\nTo determine the impact of any surgical procedure compared with other surgical interventions or non-surgical procedures, on avascular necrosis of bone in people with sickle cell disease in terms of efficacy and safety.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Additional trials were sought from both ongoing trial registries and the reference lists of papers identified by the search strategy.\nDate of the most recent search of the Group's Haemoglobinopathies Trials Register: 17 September 2019.\nSelection criteria\nRandomized clinical trials comparing specific therapies for avascular necrosis of bone in people with sickle cell disease.\nData collection and analysis\nEach author independently extracted data and assessed trial quality. The quality of the evidence was assessed using GRADE. Given only one trial was identified, meta-analyses were not possible.\nMain results\nOne trial (46 participants) was eligible for inclusion. After randomization eight participants were withdrawn, mainly because they declined to participate in the trial. Data were analysed for 38 participants at the end of the trial. After a mean follow-up of three years, hip core decompression and physical therapy did not show clinical improvement when compared with physical therapy alone using the score from the original trial (an improvement of 18.1 points for those treated with intervention therapy versus an improvement of 15.7 points with control therapy). We are very uncertain whether there is any difference between groups regarding major complications (hip pain, risk ratio 0.95 (95% confidence interval 0.56 to 1.60; vaso-occlusive crises, risk ratio 1.14 (95% confidence interval 0.72 to 1.80; very low quality of evidence); and acute chest syndrome, risk ratio 1.06 (95% confidence interval 0.44 to 2.56; very low quality of evidence)). This trial did not report results on mortality or quality of life.\nAuthors' conclusions\nWe found no evidence that adding hip core decompression to physical therapy achieves clinical improvement in people with sickle cell disease with avascular necrosis of bone compared to physical therapy alone. However, we highlight that our conclusion is based on one trial with high attrition rates. Further randomized controlled trials are necessary to evaluate the role of hip-core depression for this clinical condition. Endpoints should focus on participants' subjective experience (e.g. quality of life and pain) as well as more objective 'time-to-event' measures (e.g. mortality, survival, hip longevity). The availability of participants to allow adequate trial power will be a key consideration for endpoint choice.\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": "Many people with sickle cell disease experience bone death due to temporary or permanent loss of blood supply to parts of their bones. This can be very painful. The bones usually affected are the thigh bones at the hip joint and the arm bones at the shoulder joint. The aim of treatment is to stop the pain and maintain a mobile joint. Treatments include resting the joint, physiotherapy, the use of pain relief, joint replacements and bone grafts. However, complications from surgery may be more frequent in people with sickle cell disease. This is an update of a previously published Cochrane Review."
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query-laysum | 5388 | [
{
"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 did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 11 studies with 11,281 people that investigated antibiotics to treat COVID-19. All 11 studies investigated azithromycin. Nine studies (10,807 people) compared azithromycin to no treatment, placebo or usual care alone. Two studies compared azithromycin to another antibiotic: lincomycin (1 study, 24 people) and clarithromycin (1 study, 450 people), however, they did not report data that we could use in this review, so our results apply to azithromycin only.\nSeven studies included people with moderate to severe COVID-19 in hospital and four studies included outpatients with mild COVID-19. The studies used different doses of azithromycin and different durations of treatment.\nWe found 19 ongoing studies. We have not classified 15 completed studies because we are waiting for more information from the authors, or they have not yet been published."
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query-laysum | 5389 | [
{
"role": "user",
"content": "Abstract: Background\nBotulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane Review.\nObjectives\nTo assess the effects of all commercially available botulinum toxin type A products for the treatment of any type of facial wrinkles.\nSearch methods\nWe searched the following databases up to May 2020: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nWe included RCTs with over 50 participants, comparing BontA versus placebo, other types of BontA, or fillers (hyaluronic acid), for treating facial wrinkles in adults.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcomes were participant assessment of success and major adverse events (AEs) (eyelid ptosis, eyelid sensory disorder, strabismus). Secondary outcomes included physician assessment of success; proportion of participants with at least one AE and duration of treatment effect. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 65 RCTs, involving 14,919 randomised participants. Most participants were female, aged 18 to 65 years. All participants were outpatients (private office or day clinic). Study duration was between one week and one year. No studies were assessed as low risk of bias in all domains; the overall risk of bias was unclear for most studies.\nThe most common comparator was placebo (36 studies). An active control was used in 19 studies. There were eight dose-ranging studies of onabotulinumtoxinA, and a small number of studies compared against fillers. Treatment was given in one cycle (54 studies), two cycles (three studies), or three or more cycles (eight studies).\nThe treated regions were glabella (43 studies), crow's feet (seven studies), forehead (two studies), perioral (two studies), full face (one study), or more than two regions (nine studies). Most studies analysed moderate to severe wrinkles; mean duration of treatment was 20 weeks.\nThe following results summarise the main comparisons, based on studies of one treatment cycle for the glabella. AEs were collected over the duration of these studies (over four to 24 weeks).\nCompared to placebo, onabotulinumtoxinA-20 U probably has a higher success rate when assessed by participants (risk ratio (RR) 19.45, 95% confidence interval (CI) 8.60 to 43.99; 575 participants; 4 studies; moderate-certainty evidence) or physicians (RR 17.10, 95% CI 10.07 to 29.05; 1339 participants; 7 studies; moderate-certainty evidence) at week four. Major AEs are probably higher with onabotulinumtoxinA-20 U (Peto OR 3.62, 95% CI 1.50 to 8.74; 1390 participants; 8 studies; moderate-certainty evidence), but there may be no difference in any AEs (RR 1.14, 95% CI 0.89 to 1.45; 1388 participants; 8 studies; low-certainty evidence).\nCompared to placebo, abobotulinumtoxinA-50 U has a higher participant-assessed success rate at week four (RR 21.22, 95% CI 7.40 to 60.56; 915 participants; 6 studies; high-certainty evidence); and probably has a higher physician-assessed success rate (RR 14.93, 95% CI 8.09 to 27.55; 1059 participants; 7 studies; moderate-certainty evidence). There are probably more major AEs with abobotulinumtoxinA-50 U (Peto OR 3.36, 95% CI 0.88 to 12.87; 1294 participants; 7 studies; moderate-certainty evidence). Any AE may be more common with abobotulinumtoxinA-50 U (RR 1.25, 95% CI 1.05 to 1.49; 1471 participants; 8 studies; low-certainty evidence).\nCompared to placebo, incobotulinumtoxinA-20 U probably has a higher participant-assessed success rate at week four (RR 66.57, 95% CI 13.50 to 328.28; 547 participants; 2 studies; moderate-certainty evidence), and physician-assessed success rate (RR 134.62, 95% CI 19.05 to 951.45; 547 participants; 2 studies; moderate-certainty evidence). Major AEs were not observed (547 participants; 2 studies; moderate-certainty evidence). There may be no difference between groups in any AEs (RR 1.17, 95% CI 0.90 to 1.53; 547 participants; 2 studies; low-certainty evidence).\nAbobotulinumtoxinA-50 U is no different to onabotulinumtoxinA-20 U in participant-assessed success rate (RR 1.00, 95% CI 0.92 to 1.08, 388 participants, 1 study, high-certainty evidence) and physician-assessed success rate (RR 1.01, 95% CI 0.95 to 1.06; 388 participants; 1 study; high-certainty evidence) at week four. Major AEs are probably more likely in the abobotulinumtoxinA-50 U group than the onabotulinumtoxinA-20 U group (Peto OR 2.65, 95% CI 0.77 to 9.09; 433 participants; 1 study; moderate-certainty evidence). There is probably no difference in any AE (RR 1.02, 95% CI 0.67 to 1.54; 492 participants; 2 studies; moderate-certainty evidence).\nIncobotulinumtoxinA-24 U may be no different to onabotulinumtoxinA-24 U in physician-assessed success rate at week four (RR 1.01, 95% CI 0.96 to 1.05; 381 participants; 1 study; low-certainty evidence) (participant assessment was not measured). One participant reported ptosis with onabotulinumtoxinA, but we are uncertain of the risk of AEs (Peto OR 0.02, 95% CI 0.00 to 1.77; 381 participants; 1 study; very low-certainty evidence).\nCompared to placebo, daxibotulinumtoxinA-40 U probably has a higher participant-assessed success rate (RR 21.10, 95% CI 11.31 to 39.34; 683 participants; 2 studies; moderate-certainty evidence) and physician-assessed success rate (RR 23.40, 95% CI 12.56 to 43.61; 683 participants; 2 studies; moderate-certainty evidence) at week four. Major AEs were not observed (716 participants; 2 studies; moderate-certainty evidence). There may be an increase in any AE with daxibotulinumtoxinA compared to placebo (RR 2.23, 95% CI 1.46 to 3.40; 716 participants; 2 studies; moderate-certainty evidence).\nMajor AEs reported were mainly ptosis; BontA is also known to carry a risk of strabismus or eyelid sensory disorders.\nAuthors' conclusions\nBontA treatment reduces wrinkles within four weeks of treatment, but probably increases risk of ptosis. We found several heterogeneous studies (different types or doses of BontA, number of cycles, and different facial regions) hindering meta-analyses. The certainty of the evidence for effectiveness outcomes was high, low or moderate; for AEs, very low to moderate. Future RCTs should compare the most common BontA (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, daxibotulinumtoxinA, prabotulinumtoxinA) and evaluate long-term outcomes. There is a lack of evidence about the effects of multiple cycles of BontA, frequency of major AEs, duration of effect, efficacy of recently-approved BontA and comparisons with other treatments.\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 65 studies in 14,919 people (mostly women) who went to a day clinic or private office for treatment. The studies lasted from one week to one year; the average length of treatment was 20 weeks. The studies compared one type of botulinum toxin against another type, against a placebo (an injection that did not contain any botulinum toxin), or against an alternative treatment. Several studies were funded by pharmaceutical companies.\nThe studies tested four types of botulinum toxin that were licensed for use and some other types that were not yet licensed.\nAll studies assessed the success of treatment by measuring wrinkles and lines when facial muscles were at their most tense. Most studies treated wrinkles that develop between the eyebrows, known as 'glabellar lines'."
}
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query-laysum | 5390 | [
{
"role": "user",
"content": "Abstract: Background\nDisease-modifying pharmacological agents for transthyretin (TTR)-related familial amyloid polyneuropathy (FAP) have become available in the last decade, but evidence on their efficacy and safety is limited. This review focuses on disease-modifying pharmacological treatment for TTR-related and other FAPs, encompassing amyloid kinetic stabilisers, amyloid matrix solvents, and amyloid precursor inhibitors.\nObjectives\nTo assess and compare the efficacy, acceptability, and tolerability of disease-modifying pharmacological agents for familial amyloid polyneuropathies (FAPs).\nSearch methods\nOn 18 November 2019, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase. We reviewed reference lists of articles and textbooks on peripheral neuropathies. We also contacted experts in the field. We searched clinical trials registries and manufacturers' websites.\nSelection criteria\nWe included randomised clinical trials (RCTs) or quasi-RCTs investigating any disease-modifying pharmacological agent in adults with FAPs.\nDisability due to FAP progression was the primary outcome. Secondary outcomes were severity of peripheral neuropathy, change in modified body mass index (mBMI), quality of life, severity of depression, mortality, and adverse events during the trial.\nData collection and analysis\nWe followed standard Cochrane methodology.\nMain results\nThe review included four RCTs involving 655 people with TTR-FAP. The manufacturers of the drugs under investigation funded three of the studies. The trials investigated different drugs versus placebo and we did not conduct a meta-analysis.\nOne RCT compared tafamidis with placebo in early-stage TTR-FAP (128 randomised participants). The trial did not explore our predetermined disability outcome measures. After 18 months, tafamidis might reduce progression of peripheral neuropathy slightly more than placebo (Neuropathy Impairment Score (NIS) in the lower limbs; mean difference (MD) -3.21 points, 95% confidential interval (CI) -5.63 to -0.79; P = 0.009; low-certainty evidence). However, tafamidis might lead to little or no difference in the change of quality of life between groups (Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) total score; MD -4.50 points, 95% CI -11.27 to 2.27; P = 0.19; very low-certainty evidence). No clear between-group difference was found in the numbers of participants who died (risk ratio (RR) 0.65, 95% CI 0.11 to 3.74; P = 0.63; very low-certainty evidence), who dropped out due to adverse events (RR 1.29, 95% CI 0.30 to 5.54; P = 0.73; very low-certainty evidence), or who experienced at least one severe adverse event during the trial (RR 1.16, 95% CI 0.37 to 3.62; P = 0.79; very low-certainty evidence).\nOne RCT compared diflunisal with placebo (130 randomised participants). At month 24, diflunisal might reduce progression of disability (Kumamoto Score; MD -4.90 points, 95% CI -7.89 to -1.91; P = 0.002; low-certainty evidence) and peripheral neuropathy (NIS plus 7 nerve tests; MD -18.10 points, 95% CI -26.03 to -10.17; P < 0.001; low-certainty evidence) more than placebo. After 24 months, changes from baseline in the quality of life measured by the 36-Item Short-Form Health Survey score showed no clear difference between groups for the physical component (MD 6.10 points, 95% CI 2.56 to 9.64; P = 0.001; very low-certainty evidence) and the mental component (MD 4.40 points, 95% CI -0.19 to 8.99; P = 0.063; very low-certainty evidence). There was no clear between-group difference in the number of people who died (RR 0.46, 95% CI 0.15 to 1.41; P = 0.17; very low-certainty evidence), in the number of dropouts due to adverse events (RR 2.06, 95% CI 0.39 to 10.87; P = 0.39; very low-certainty evidence), and in the number of people who experienced at least one severe adverse event (RR 0.77, 95% CI 0.18 to 3.32; P = 0.73; very low-certainty evidence) during the trial.\nOne RCT compared patisiran with placebo (225 randomised participants). After 18 months, patisiran reduced both progression of disability (Rasch-built Overall Disability Scale; least-squares MD 8.90 points, 95% CI 7.00 to 10.80; P < 0.001; moderate-certainty evidence) and peripheral neuropathy (modified NIS plus 7 nerve tests - Alnylam version; least-squares MD -33.99 points, 95% CI -39.86 to -28.13; P < 0.001; moderate-certainty evidence) more than placebo. At month 18, the change in quality of life between groups favoured patisiran (Norfolk QOL-DN total score; least-squares MD -21.10 points, 95% CI -27.20 to -15.00; P < 0.001; low-certainty evidence). There was little or no between-group difference in the number of participants who died (RR 0.61, 95% CI 0.21 to 1.74; P = 0.35; low-certainty evidence), dropped out due to adverse events (RR 0.33, 95% CI 0.13 to 0.82; P = 0.017; low-certainty evidence), or experienced at least one severe adverse event (RR 0.91, 95% CI 0.64 to 1.28; P = 0.58; low-certainty evidence) during the trial.\nOne RCT compared inotersen with placebo (172 randomised participants). The trial did not explore our predetermined disability outcome measures. From baseline to week 66, inotersen reduced progression of peripheral neuropathy more than placebo (modified NIS plus 7 nerve tests - Ionis version; MD -19.73 points, 95% CI -26.50 to -12.96; P < 0.001; moderate-certainty evidence). At week 65, the change in quality of life between groups favoured inotersen (Norfolk QOL-DN total score; MD -10.85 points, 95% CI -17.25 to -4.45; P < 0.001; low-certainty evidence). Inotersen may slightly increase mortality (RR 5.94, 95% CI 0.33 to 105.60; P = 0.22; low-certainty evidence) and occurrence of severe adverse events (RR 1.48, 95% CI 0.85 to 2.57; P = 0.16; low-certainty evidence) compared to placebo. More dropouts due to adverse events were observed in the inotersen than in the placebo group (RR 8.57, 95% CI 1.16 to 63.07; P = 0.035; low-certainty evidence).\nThere were no studies addressing apolipoprotein AI-FAP, gelsolin-FAP, and beta-2-microglobulin-FAP.\nAuthors' conclusions\nEvidence on the pharmacological treatment of FAPs from RCTs is limited to TTR-FAP. No studies directly compare disease-modifying pharmacological treatments for TTR-FAP. Results from placebo-controlled trials indicate that tafamidis, diflunisal, patisiran, and inotersen may be beneficial in TTR-FAP, but further investigations are needed. Since direct comparative studies for TTR-FAP will be hampered by sample size and costs required to demonstrate superiority of one drug over another, long-term non-randomised open-label studies monitoring their efficacy and safety are needed.\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 assess whether drugs to treat familial amyloid polyneuropathies (FAPs) reduce disability due to nerve damage, reduce the severity of nerve damage, and improve nutritional status, quality of life, and depression. We also reviewed evidence on side effects."
}
]
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query-laysum | 5391 | [
{
"role": "user",
"content": "Abstract: Background\nAutologous whole blood or platelet-rich plasma (PRP) injections are commonly used to treat lateral elbow pain (also known as tennis elbow or lateral epicondylitis or epicondylalgia). Based on animal models and observational studies, these injections may modulate tendon injury healing, but randomised controlled trials have reported inconsistent results regarding benefit for people with lateral elbow pain.\nObjectives\nTo review current evidence on the benefit and safety of autologous whole blood or platelet-rich plasma (PRP) injection for treatment of people with lateral elbow pain.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase for published trials, and Clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal for ongoing trials, on 18 September 2020.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs comparing autologous whole blood or PRP injection therapy to another therapy (placebo or active treatment, including non-pharmacological therapies, and comparison between PRP and autologous blood) for lateral elbow pain. The primary comparison was PRP versus placebo. Major outcomes were pain relief (≥ 30% or ≥ 50%), mean pain, mean function, treatment success, quality of life, withdrawal due to adverse events, and adverse events; the primary time point was three months.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 32 studies with 2337 participants; 56% of participants were female, mean age varied between 36 and 53 years, and mean duration of symptoms ranged from 1 to 22 months. Seven trials had three intervention arms. Ten trials compared autologous blood or PRP injection to placebo injection (primary comparison). Fifteen trials compared autologous blood or PRP injection to glucocorticoid injection. Four studies compared autologous blood to PRP. Two trials compared autologous blood or PRP injection plus tennis elbow strap and exercise versus tennis elbow strap and exercise alone. Two trials compared PRP injection to surgery, and one trial compared PRP injection and dry needling to dry needling alone. Other comparisons include autologous blood versus extracorporeal shock wave therapy; PRP versus arthroscopic surgery; PRP versus laser; and autologous blood versus polidocanol.\nMost studies were at risk of selection, performance, and detection biases, mainly due to inadequate allocation concealment and lack of participant blinding.\nWe found moderate-certainty evidence (downgraded for bias) to show that autologous blood or PRP injection probably does not provide clinically significant improvement in pain or function compared with placebo injection at three months. Further, low-certainty evidence (downgraded for bias and imprecision) suggests that PRP may not increase risk for adverse events. We are uncertain whether autologous blood or PRP injection improves treatment success (downgraded for bias, imprecision, and indirectness) or withdrawals due to adverse events (downgraded for bias and twice for imprecision). No studies measured health-related quality of life, and no studies reported pain relief (> 30% or 50%) at three months.\nAt three months, mean pain was 3.7 points (0 to 10; 0 is best) with placebo and 0.16 points better (95% confidence interval (CI) 0.60 better to 0.29 worse; 8 studies, 523 participants) with autologous blood or PRP injection, for absolute improvement of 1.6% better (6% better to 3% worse). At three months, mean function was 27.5 points (0 to 100; 0 is best) with placebo and 1.86 points better (95% CI 4.9 better to 1.25 worse; 8 studies, 502 participants) with autologous blood or PRP injection, for absolute benefit of 1.9% (5% better to 1% worse), and treatment success was 121 out of 185 (65%) with placebo versus 125 out of 187 (67%) with autologous blood or PRP injection (risk ratio (RR) 1.00; 95% CI 0.83 to 1.19; 4 studies, 372 participants), for absolute improvement of 0% (11.1% lower to 12.4% higher).\nRegarding harm, we found very low-certainty evidence to suggest that we are uncertain whether withdrawal rates due to adverse events differed. Low-certainty evidence suggests that autologous blood or PRP injection may not increase adverse events compared with placebo injection. Withdrawal due to adverse events occurred in 3 out of 39 (8%) participants treated with placebo versus 1 out of 41 (2%) treated with autologous blood or PRP injection (RR 0.32, 95% CI 0.03 to 2.92; 1 study), for an absolute difference of 5.2% fewer (7.5% fewer to 14.8% more). Adverse event rates were 35 out of 208 (17%) with placebo versus 41 out of 217 (19%) with autologous blood or PRP injection (RR 1.14, 95% CI 0.76 to 1.72; 5 studies; 425 participants), for an absolute difference of 2.4% more (4% fewer to 12% more).\nAt six and twelve months, no clinically important benefit for mean pain or function was observed with autologous blood or PRP injection compared with placebo injection.\nAuthors' conclusions\nData in this review do not support the use of autologous blood or PRP injection for treatment of lateral elbow pain. These injections probably provide little or no clinically important benefit for pain or function (moderate-certainty evidence), and it is uncertain (very low-certainty evidence) whether they improve treatment success and pain relief > 50%, or increase withdrawal due to adverse events. Although risk for harm may not be increased compared with placebo injection (low-certainty evidence), injection therapies cause pain and carry a small risk of infection. With no evidence of benefit, the costs and risks are not justified.\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 MEDLINE, CENTRAL, Embase, Clinicaltrials.gov, and WHO trials registries, unrestricted by date or language, on 18 September 2020.\nWe included 32 trials with 2337 participants. Mean age varied between 36 years and 53 years, and mean duration of symptoms ranged from 1 month to 22 months. Of 21 studies that reported gender, 56% of participants were female. Among the included studies, three studies were funded by manufacturers of the PRP centrifugation system; two studies were provided PRP kits; and one study received funding from PRP kit manufacturers."
}
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query-laysum | 5392 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with chronic obstructive pulmonary disease (COPD) are believed be at higher risk of problems with sexual function than age-matched peers. Problems with sexuality or sexual function associated with COPD may arise as a results of hormonal, physiological, or psychological problems, or as a result of changes in intimate relationships arising from the chronic nature of the condition.\nObjectives\nTo evaluate the effectiveness of interventions for sexual dysfunction in people with COPD.\nSearch methods\nWe searched the Cochrane Airways Group's Specialised Register on 8 July 2015 and conducted supplementary searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, four other databases, and two trials registers to July 2015, together with reference checking, citation searching, and contact with study authors to identify additional studies. We used no language or date restrictions.\nSelection criteria\nRandomised controlled trials (RCTs), cluster RCTs, and quasi-RCTs evaluating the effects of pharmacological, mechanical, psychological, or educational interventions to address problems with sexual well-being in people with COPD and their partners.\nData collection and analysis\nTwo review authors independently reviewed search results against predetermined inclusion criteria. Two review authors independently extracted data and assessed risk of bias for included studies. We contacted study authors for additional information.\nMain results\nWe included two studies involving a total of 48 participants. One of these studies (an RCT) investigated the effect of a pharmacological intervention (testosterone therapy) compared to a placebo over a four-month period. The other study (a quasi-RCT) compared one month of long-term oxygen therapy to a single 24-hour dose of oxygen therapy over a one-month period. Both studies only included men with moderate to very severe COPD (mean FEV1% across both studies 41%; standard deviation (SD) 11.7%) who were under the age of 74 (mean age across both studies 65 years; SD 7.1). We found low-quality evidence that testosterone therapy for men with COPD results in improvements in erectile function, but no evidence of effect regarding overall satisfaction with sexual function. There is insufficient data to draw conclusions regarding the possibility of adverse events arising from testosterone therapy for COPD or the effect of oxygen therapy on erectile dysfunction. Neither study provided additional data on sexual function, other than erectile function.\nAuthors' conclusions\nThere is currently insufficient evidence from clinical trials at present to inform the best way of providing interventions to improve sexual function and sexual satisfaction for people with COPD and their partners. Consequently, clinicians need to rely on clinical trials involving people without COPD and expert opinion in order to guide clinical practice in this area. Considerably more trials need to be conducted in this area of clinical practice.\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 found two studies published before December 2014 involving a total of 48 people with COPD (men only) who received a medical intervention for problems with sexual function. These medical interventions included testosterone therapy and oxygen therapy. One of these studies provided low-quality evidence that testosterone injections help some men with COPD improve their ability to get and maintain an erection. However, there was not enough information to evaluate whether testosterone therapy improved overall sexual satisfaction or resulted in other health problems, or whether oxygen therapy improved erectile dysfunction for men with COPD."
}
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query-laysum | 5393 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers are treated by reducing pressure on the areas of damaged skin. Special support surfaces (including beds, mattresses and cushions) designed to redistribute pressure, are widely used as treatments. The relative effects of different support surfaces are unclear. This is an update of an existing review.\nObjectives\nTo assess the effects of pressure-relieving support surfaces in the treatment of pressure ulcers.\nSearch methods\nIn September 2017 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\nWe included published or unpublished randomised controlled trials (RCTs), that assessed the effects of support surfaces for treating pressure ulcers, in any participant group or setting.\nData collection and analysis\nData extraction, assessment of 'Risk of bias' and GRADE assessments were performed independently by two review authors. Trials with similar participants, comparisons and outcomes were considered for meta-analysis. Where meta-analysis was inappropriate, we reported the results of the trials narratively. Where possible, we planned to report data as either risk ratio or mean difference as appropriate.\nMain results\nFor this update we identified one new trial of support surfaces for pressure ulcer treatment, bringing the total to 19 trials involving 3241 participants. Most trials were small, with sample sizes ranging from 20 to 1971, and were generally at high or unclear risk of bias.\nPrimary outcome: healing of existing pressure ulcers\nLow-tech constant pressure support surfaces\nIt is uncertain whether profiling beds increase the proportion of pressure ulcer which heal compared with standard hospital beds as the evidence is of very low certainty: (RR 3.96, 95% CI 1.28 to 12.24), downgraded for serious risk of bias, serious imprecision and indirectness (1 study; 70 participants).\nThere is currently no clear difference in ulcer healing between water-filled support surfaces and foam replacement mattresses: (RR 0.93, 95% CI 0.63 to 1.37); low-certainty evidence downgraded for serious risk of bias and serious imprecision (1 study; 120 participants).\nFurther analysis could not be performed for polyester overlays versus gel overlays (1 study; 72 participants), non-powered mattresses versus low-air-loss mattresses (1 study; 20 participants) or standard hospital mattresses with sheepskin overlays versus standard hospital mattresses (1 study; 36 participants).\nHigh-tech pressure support surfaces\nIt is currently unclear whether high-tech pressure support surfaces (such as low-air-loss beds, air suspension beds, and alternating pressure surfaces) improve the healing of pressure ulcers (14 studies; 2923 participants) or which intervention may be more effective. The certainty of the evidence is generally low, downgraded mostly for risk of bias, indirectness and imprecision.\nSecondary outcomes\nNo analyses were undertaken with respect to secondary outcomes including participant comfort and surface reliability and acceptability as reporting of these within the included trials was very limited.\nOverall, the evidence is of low to very low certainty and was primarily downgraded due to risk of bias and imprecision with some indirectness.\nAuthors' conclusions\nBased on the current evidence, it is unclear whether any particular type of low- or high-tech support surface is more effective at healing pressure ulcers than standard support surfaces.\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": "Pressure ulcers (also called pressure sores, decubitus ulcers and bed sores) are wounds to the skin and underlying tissue caused by pressure or rubbing. They typically form at points on the body which are bony or which bear weight or pressure, such as the hips, buttocks, heels and elbows. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers. A range of treatments, including wound dressings and support surfaces like special mattresses and cushions, are used to treat pressure ulcers.\nSupport surfaces for pressure ulcer treatment can include specially-designed beds, mattresses, mattress overlays and cushions that are used to protect vulnerable parts of the body and distribute the surface pressure more evenly. Low-tech support surfaces include mattresses filled with foam, fluid, beads or air; and alternative foam mattresses and overlays. High-tech support surfaces include mattresses and overlays that are electrically powered to alternate the pressure within the surface, beds that are powered to have air mechanically circulated within them and low-air-loss beds that contain warm air moving within pockets inside the bed. Other support surfaces include sheepskins, cushions and operating table overlays.\nWe wanted to find out which support surfaces were most effective in helping pressure ulcers to heal. We also wanted to compare different support surfaces in terms of cost, reliability, durability, and the benefits or harms for patients using them."
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query-laysum | 5394 | [
{
"role": "user",
"content": "Abstract: Background\nPain is a common symptom with cancer, and 30% to 50% of all people with cancer will experience moderate to severe pain that can have a major negative impact on their quality of life. Non-opioid drugs are commonly used to treat cancer pain, and are recommended for this purpose in the World Health Organization (WHO) cancer pain treatment ladder, either alone or in combination with opioids.\nA previous Cochrane review that examined the evidence for nonsteroidal anti-inflammatory drugs (NSAIDs) or paracetamol, alone or combined with opioids, for cancer pain was withdrawn in 2015 because it was out of date; the date of the last search was 2005. This review, and another on paracetamol, updates the evidence.\nObjectives\nTo assess the efficacy of oral NSAIDs for cancer pain in adults, and the adverse events reported during their use in clinical trials.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to April 2017, together with reference lists of retrieved papers and reviews, and two online study registries.\nSelection criteria\nWe included randomised, double-blind, single-blind, or open-label studies of five days' duration or longer, comparing any oral NSAID alone with placebo or another NSAID, or a combination of NSAID plus opioid with the same dose of the opioid alone, for cancer pain of any pain intensity. The minimum study size was 25 participants per treatment arm at the initial randomisation.\nData collection and analysis\nTwo review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nEleven studies satisfied inclusion criteria, lasting one week or longer; 949 participants with mostly moderate or severe pain were randomised initially, but fewer completed treatment or had results of treatment. Eight studies were double-blind, two single-blind, and one open-label. None had a placebo only control; eight compared different NSAIDs, three an NSAID with opioid or opioid combination, and one both. None compared an NSAID plus opioid with the same dose of opioid alone. Most studies were at high risk of bias for blinding, incomplete outcome data, or small size; none was unequivocally at low risk of bias.\nIt was not possible to compare NSAIDs as a group with another treatment, or one NSAID with another NSAID. Results for all NSAIDs are reported as a randomised cohort. We judged results for all outcomes as very low-quality evidence.\nNone of the studies reported our primary outcomes of participants with pain reduction of at least 50%, and at least 30%, from baseline; participants with Patient Global Impression of Change (PGIC) of much improved or very much improved (or equivalent wording). With NSAID, initially moderate or severe pain was reduced to no worse than mild pain after one or two weeks in four studies (415 participants in total), with a range of estimates between 26% and 51% in individual studies.\nAdverse event and withdrawal reporting was inconsistent. Two serious adverse events were reported with NSAIDs, and 22 deaths, but these were not clearly related to any pain treatment. Common adverse events were thirst/dry mouth (15%), loss of appetite (14%), somnolence (11%), and dyspepsia (11%). Withdrawals were common, mostly because of lack of efficacy (24%) or adverse events (5%).\nAuthors' conclusions\nThere is no high-quality evidence to support or refute the use of NSAIDs alone or in combination with opioids for the three steps of the three-step WHO cancer pain ladder. There is very low-quality evidence that some people with moderate or severe cancer pain can obtain substantial levels of benefit within one or two weeks.\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": "In this review we set out to examine the evidence on how well NSAIDs worked (alone or with morphine-like drugs) in adults with cancer pain. We also wanted to know how many people had side effects, and how severe they were.\nIn April 2017, we found 11 studies with 949 participants. They compared NSAID with NSAID, or NSAID with opioid drug (morphine or codeine). No studies looked at using NSAID together with an opioid-like morphine, which is how they are often used. The studies were small and of poor quality. They used different designs and different ways of showing their pain results. Outcomes important to people with cancer pain were often not reported. Many different NSAIDs were tested, and it was not possible to make sensible comparisons."
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query-laysum | 5395 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoporosis is an abnormal reduction in bone mass and bone deterioration leading to increased fracture risk. Alendronate belongs to the bisphosphonate class of drugs, which act to inhibit bone resorption by interfering with the activity of osteoclasts.\nObjectives\nTo assess the efficacy of alendronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women.\nSearch methods\nWe searched CENTRAL, MEDLINE and EMBASE for relevant randomized controlled trials published between 1966 to 2007.\nSelection criteria\nWomen receiving at least one year of alendronate, for postmenopausal osteoporosis, were compared to those receiving placebo and/or concurrent calcium/vitamin D. The outcome was fracture incidence.\nData collection and analysis\nWe undertook study selection and data abstraction in duplicate. We performed meta-analysis of fracture outcomes using relative risks and a > 15% relative change was considered clinically important. We assessed study quality through reporting of allocation concealment, blinding and withdrawals.\nMain results\nEleven trials representing 12,068 women were included in the review.\nRelative (RRR) and absolute (ARR) risk reductions for the 10 mg dose were as follows. For vertebral fractures, a significant 45% RRR was found (RR 0.55, 95% CI 0.45 to 0.67). This was significant for both primary prevention, with 45% RRR (RR 0.55, 95% CI 0.38 to 0.80) and 2% ARR, and secondary prevention with 45% RRR (RR 0.55, 95% CI 0.43 to 0.69) and 6% ARR. For non-vertebral fractures, a significant 16% RRR was found (RR 0.84, 95% CI 0.74 to 0.94). This was significant for secondary prevention, with 23% RRR (RR 0.77, 95% CI 0.64 to 0.92) and 2% ARR, but not for primary prevention (RR 0.89, 95% CI 0.76 to 1.04). There was a significant 40% RRR in hip fractures (RR 0.60, 95% CI 0.40 to 0.92), but only secondary prevention was significant with 53% RRR (RR 0.47, 95% CI 0.26 to 0.85) and 1% ARR. The only significance found for wrist was in secondary prevention, with a 50% RRR (RR 0.50 95% CI 0.34 to 0.73) and 2% ARR.\nFor adverse events, we found no statistically significant differences in any included study. However, observational data raise concerns regarding potential risk for upper gastrointestinal injury and, less commonly, osteonecrosis of the jaw.\nAuthors' conclusions\nAt 10 mg per day, both clinically important and statistically significant reductions in vertebral, non-vertebral, hip and wrist fractures were observed for secondary prevention ('gold' level evidence, www.cochranemsk.org). We found no statistically significant results for primary prevention, with the exception of vertebral fractures, for which the reduction was clinically important ('gold' level evidence).\n\nGiven the provided abstract, please respond to the following query: \"The best estimate of what happens to women whose bone density is closer to normal or who may not yet have had a fracture in the bones of their spine\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Fracture of the spine\n- 3 out of 100 women had a fracture when taking a placebo\n- 1 out of 100 women had a fracture when taking alendronate\nFractures in bones other than the spine:\n- 1 out of 100 women had a hip fracture when taking a placebo\n- 1 out of 100 women had a hip fracture when taking alendronate\n- 3 out of 100 women had a wrist fracture when taking a placebo\n- 4 out of 100 women had a wrist fracture when taking alendronate\n\n- 13 out of 100 women had a fracture somewhere other than the spine when taking a placebo\n- 12 out of 100 women had a fracture somewhere other than the spine when taking alendronate"
}
]
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query-laysum | 5396 | [
{
"role": "user",
"content": "Abstract: Background\nThe female genital tract is not exposed to seminal plasma during standard assisted reproductive technology (ART) cycles. However, it is thought that the inflammatory reaction triggered by seminal plasma may be beneficial by inducing maternal tolerance to paternal antigens expressed by the products of conception, and may increase the chance of successful implantation and live birth.\nObjectives\nTo assess the effectiveness and safety of application of seminal plasma to the female genital tract prior to embryo transfer in ART cycles.\nSearch methods\nWe searched the following databases from inception to October 2017: Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, Cochrane Central Register of Studies Online (CRSO), MEDLINE, Embase, CINAHL and PsycINFO. We also searched trial registers for ongoing trials, including International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov. Other sources searched were; Web of Knowledge, OpenGrey, LILACS, PubMed, Google Scholar, and the reference lists of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) conducted among women undergoing ART, comparing any procedure that would expose the female genital tract to seminal plasma during the period starting five days before embryo transfer and ending two days after it versus no seminal plasma application.\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias, and extracted data. We pooled data to calculate relative risks (RRs) and 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I2 statistic. We assessed the overall quality of the evidence for the main outcomes using GRADE methods. Our primary outcomes were live birth rate and miscarriage rate. Secondary outcomes were live birth/ongoing pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, ectopic pregnancy rate, and the incidence of other adverse events.\nMain results\nWe included 11 RCTs (3215 women). The quality of the evidence ranged from very low to low. The main limitations were risk of bias (associated with poor reporting of allocation concealment and other methods) and imprecision for the primary outcome of live birth rate.\nLive birth rates: Seminal plasma application made little or no difference in live birth rates (RR 1.10, 95% CI 0.86 to 1.43; 948 participants; 3 studies; I2 = 0%). Low-quality evidence suggested that if the live birth rate following standard ART was 19%, it would be between 16% and 27% with seminal plasma application.\nMiscarriage rate: Seminal plasma application made little or no difference in miscarriage rates (RR 1.01, 95% CI 0.57 to 1.79; 1209 participants; 4 studies; I2 = 0%). Low-quality evidence suggested that if the miscarriage rate following standard ART was 3.7%, the miscarriage rate following seminal plasma application would be between 2.1% and 6.6%.\nLive birth or ongoing pregnancy rates: Seminal plasma application made little or no difference in live birth or ongoing pregnancy rates (RR 1.19, 95% CI 0.95 to 1.49; 1178 participants; 4 studies; I2 = 4%, low-quality evidence). The evidence suggested that if the live birth or ongoing pregnancy rate following standard ART was 19.5%, it would be between 18.5% and 29% with seminal plasma application.\nClinical pregnancy rates: We are uncertain whether seminal plasma application increases clinical pregnancy rates (RR 1.15, 95% CI 1.01 to 1.31; 2768 participants; 10 studies; I2 = 0%). Very low-quality evidence suggested that if the clinical pregnancy rate following standard ART was 22.0%, it would be between 22.2% and 28.8% with seminal plasma application. This finding should be regarded with caution, as a post hoc sensitivity analysis restricted to studies at overall low risk of bias did not find a significant difference between the groups (RR 1.06, 95% CI 0.81 to 1.39; 547 participants; 3 studies; I2 = 0%).\nMultiple pregnancy rate: Seminal plasma application may make little or no difference to multiple pregnancy rates (RR 1.11, 95% CI 0.76 to 1.64; 1642 participants; 5 studies; I2 = 9%). Low-quality evidence suggested that if the multiple pregnancy rate following standard ART was 7%, the multiple pregnancy rate following seminal plasma application would be between 5% and 11.4%.\nEctopic pregnancy: There was insufficient evidence to determine whether seminal plasma application influenced the risk of ectopic pregnancy (RR 1.59, 95% CI 0.20 to 12.78, 1521 participants; 5 studies; I2 = 0%) .\nInfectious complications or other adverse events: No data were available on these outcomes\nAuthors' conclusions\nIn women undergoing ART, there was insufficient evidence to determine whether there was a difference between the seminal plasma and the standard ART group in rates of live birth (low-quality evidence) or miscarriage (low-quality evidence). There was low-quality evidence suggesting little or no difference between the groups in rates of live birth or ongoing pregnancy (composite outcome). We found low-quality evidence that seminal plasma application may be associated with more clinical pregnancies than standard ART. There was low-quality evidence suggesting little or no difference between the groups in rates of multiple pregnancy. There was insufficient evidence to reach any conclusions about the risk of ectopic pregnancy, and no data were available on infectious complications or other adverse events.\nWe conclude that seminal plasma application is worth further investigation, focusing on live birth and miscarriage rates.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence ranged from very low to low.The main limitations were risk of bias (associated with poor reporting of study methods) and lack of data for the primary outcome of live birth rate."
}
]
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query-laysum | 5397 | [
{
"role": "user",
"content": "Abstract: Background\nSitting can be viewed as a therapeutic intervention and an important part of a person's recovery process; but the risk of ulceration must be mitigated. Interventions for ulcer prevention in those at risk from prolonged sitting include the use of specialist cushions and surfaces, especially for wheelchair users. Whilst there is interest in the effects of different pressure redistributing cushions for wheelchairs, the benefits of pressure redistributing static chairs, compared with standard chairs, for pressure ulcer development in at-risk people are not clear.\nObjectives\nTo assess the effects of pressure redistributing static chairs on the prevention of pressure ulcers in health, rehabilitation and social care settings, and places of residence in which people may spend their day.\nSearch methods\nIn June 2021 we searched the following electronic databases to identify reports of relevant randomised clinical trials: the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus (Cumulative Index to Nursing and Allied Health Literature). We also searched clinical trials registers for ongoing and unpublished studies, and reference lists of relevant systematic reviews, meta-analyses and health technology reports. There were no restrictions by language, date of publication or study setting.\nSelection criteria\nWe sought to include published or unpublished randomised controlled trials that assessed pressure redistributing static chairs in the prevention or management of pressure ulcers.\nData collection and analysis\nTwo review authors independently performed study selection. We planned that two review authors would also assess the risk of bias, extract study data and assess the certainty of evidence according to GRADE methodology.\nMain results\nWe did not identify any studies that met the review eligibility criteria, nor any registered studies investigating the role of pressure redistributing static chairs in the prevention or management of pressure ulcers.\nAuthors' conclusions\nCurrently, there is no randomised evidence that supports or refutes the role of pressure redistributing static chairs in the prevention or management of pressure ulcers. This is a priority area and there is a need to explore this intervention with rigorous and robust research.\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 searched for published and unpublished studies that assessed pressure redistributing static chairs for preventing or managing pressure ulcers. There were no restrictions on language, date of publication or study setting."
}
]
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query-laysum | 5398 | [
{
"role": "user",
"content": "Abstract: Background\nSeveral types of pressure sources, including underwater bubble devices, mechanical ventilators, and the Infant Flow Driver, are used for providing continuous positive airway pressure (CPAP) to preterm infants with respiratory distress. It is unclear whether the use of bubble CPAP versus other pressure sources is associated with lower rates of CPAP treatment failure, or mortality and other morbidity.\nObjectives\nTo assess the benefits and harms of bubble CPAP versus other pressure sources (mechanical ventilators or Infant Flow Driver) for reducing treatment failure and associated morbidity and mortality in newborn preterm infants with or at risk of respiratory distress.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2023, Issue 1); MEDLINE (1946 to 6 January 2023), Embase (1974 to 6 January 2023), Maternity & Infant Care Database (1971 to 6 January 2023), and the Cumulative Index to Nursing and Allied Health Literature (1982 to 6 January 2023). We searched clinical trials databases and the reference lists of retrieved articles.\nSelection criteria\nWe included randomised controlled trials comparing bubble CPAP with other pressure sources (mechanical ventilators or Infant Flow Driver) for the delivery of nasal CPAP to preterm infants.\nData collection and analysis\nWe used standard Cochrane methods. Two review authors separately evaluated trial quality, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference. We used the GRADE approach to assess the certainty of the evidence for effects on treatment failure, all-cause mortality, neurodevelopmental impairment, pneumothorax, moderate-severe nasal trauma, and bronchopulmonary dysplasia.\nMain results\nWe included 15 trials involving a total of 1437 infants. All trials were small (median number of participants 88). The methods used to generate the randomisation sequence and ensure allocation concealment were unclear in about half of the trial reports. Lack of measures to blind caregivers or investigators was a potential source of bias in all of the included trials. The trials took place during the past 25 years in care facilities internationally, predominantly in India (five trials) and Iran (four trials). The studied pressure sources were commercially available bubble CPAP devices versus a variety of mechanical ventilator (11 trials) or Infant Flow Driver (4 trials) devices.\nMeta-analyses suggest that the use of bubble CPAP compared with mechanical ventilator or Infant Flow Driver CPAP may reduce the rate of treatment failure (RR 0.76, 95% confidence interval (CI) 0.60 to 0.95; (I² = 31%); RD −0.05, 95% CI −0.10 to −0.01; number needed to treat for an additional beneficial outcome 20, 95% CI 10 to 100; 13 trials, 1230 infants; low certainty evidence). The type of pressure source may not affect mortality prior to hospital discharge (RR 0.93, 95% CI 0.64 to 1.36 (I² = 0%); RD −0.01, 95% CI −0.04 to 0.02; 10 trials, 1189 infants; low certainty evidence). No data were available on neurodevelopmental impairment. Meta-analysis suggests that the pressure source may not affect the risk of pneumothorax (RR 0.73, 95% CI 0.40 to 1.34 (I² = 0%); RD −0.01, 95% CI −0.03 to 0.01; 14 trials, 1340 infants; low certainty evidence). Bubble CPAP likely increases the risk of moderate-severe nasal injury (RR 2.29, 95% CI 1.37 to 3.82 (I² = 17%); RD 0.07, 95% CI 0.03 to 0.11; number needed to treat for an additional harmful outcome 14, 95% CI 9 to 33; 8 trials, 753 infants; moderate certainty evidence). The pressure source may not affect the risk of bronchopulmonary dysplasia (RR 0.76, 95% CI 0.53 to 1.10 (I² = 0%); RD −0.04, 95% CI −0.09 to 0.01; 7 trials, 603 infants; low certainty evidence).\nAuthors' conclusions\nGiven the low level of certainty about the effects of bubble CPAP versus other pressure sources on the risk of treatment failure and most associated morbidity and mortality for preterm infants, further large, high-quality trials are needed to provide evidence of sufficient validity and applicability to inform context- and setting-relevant policy and practice.\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": "Bubble continuous positive airway pressure (CPAP) may reduce the risk of CPAP treatment failure when compared with CPAP delivered by mechanical ventilators or Infant Flow Driver. Bubble CPAP probably has little or no impact on the risk of death or other complications associated with premature birth but likely increases the risk of moderate-severe nasal injury."
}
]
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query-laysum | 5399 | [
{
"role": "user",
"content": "Abstract: Background\nTransient tachypnea of the newborn (TTN) is characterized by tachypnea and signs of respiratory distress. Transient tachypnea typically appears within the first two hours of life in term and late preterm newborns. Supportive management might be sufficient. Non-invasive (i.e. without endotracheal intubation) respiratory support may, however, be administered to reduce respiratory distress during TTN. In addition, non-invasive respiratory support might improve clearance of lung liquid thus reducing the effort required to breathe, improving respiratory distress and potentially reducing the duration of tachypnea.\nObjectives\nTo assess benefits and harms of non-invasive respiratory support for the management of transient tachypnea of the newborn.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 2), MEDLINE (1996 to 19 February 2019), Embase (1980 to 19 February 2019) and CINAHL (1982 to 19 February 2019). We applied no language restrictions. We searched clinical trial registries for ongoing studies.\nSelection criteria\nRandomized controlled trials, quasi-randomized controlled trials and cluster trials on non-invasive respiratory support provided to infants born at 34 weeks' gestational age or more and less than three days of age with transient tachypnea of the newborn.\nData collection and analysis\nFor each of the included trials, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy, need for continuous positive airway pressure [CPAP] and need for mechanical ventilation, duration of mechanical ventilation, etc.) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcomes considered in this review were need for mechanical ventilation and pneumothorax. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included three trials (150 infants) comparing either CPAP to free-flow oxygen, nasal intermittent mandatory ventilation to nasal CPAP, or nasal high-frequency percussive ventilation versus nasal CPAP. Due to these different comparisons and to high clinical heterogeneity in the baseline clinical characteristics, we did not pool the three studies. The use of CPAP versus free oxygen did not improve the primary outcomes of this review: need for mechanical ventilation (risk ratio [RR] 0.30, 95% confidence interval [CI] 0.01 to 6.99; 1 study, 64 participants); and pneumothorax (not estimable, no cases occurred). Among secondary outcomes, CPAP reduced the duration of tachypnea as compared to free oxygen (mean difference [MD] −21.10 hours, 95% CI −22.92 to −19.28; 1 study, 64 participants). Nasal intermittent ventilation did not reduce the need for mechanical ventilation as compared with CPAP (RR 4.00, 95% CI 0.49 to 32.72; 1 study, 40 participants) or the incidence of pneumothorax (RR 1.00, 95% CI 0.07 to 14.90; 1 study, 40 participants); duration of tachypnea did not differ (MD 4.30, 95% CI −19.14 to 27.74; 1 study, 40 participants). In the study comparing nasal high-frequency ventilation to CPAP, no cases of mechanical ventilation of pneumothorax occurred (not estimable; 1 study, 46 participants); duration of tachypnea was reduced in the nasal high-frequency ventilation group (MD −4.53, 95% CI −5.64 to −3.42; 1 study, 46 participants). The quality of the evidence was very low due to the imprecision of the estimates and unclear risk of bias for detection bias and high risk of bias for reporting bias. Tests for heterogeneity were not applicable for any of the analyses as no studies were pooled. Two trials are ongoing.\nAuthors' conclusions\nThere is insufficient evidence to establish the benefit and harms of non-invasive respiratory support in the management of transient tachypnea of the newborn. Though two of the included trials showed a shorter duration of tachypnea, clinically relevant outcomes did not differ amongst the groups. Given the limited and low quality of the evidence available, it was impossible to determine whether non-invasive respiratory support was safe or effective for the treatment of transient tachypnea of the newborn.\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 identified and included three studies (150 newborns in total) comparing the use of non-invasive respiratory support with oxygen (one study), or different types of non-invasive respiratory support (two studies). We found two ongoing studies. Evidence is up to date as of February 2019."
}
]
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query-laysum | 5400 | [
{
"role": "user",
"content": "Abstract: Background\nDelayed recovery of urinary continence is a major adverse effect of robotic-assisted laparoscopic prostatectomy (RALP) in men undergoing prostate cancer treatment. To address this issue, a number of surgical techniques have been designed to reconstruct the posterior aspect of the rhabdosphincter, which is responsible for urinary continence after removal of the prostate; however, it is unclear how well they work.\nObjectives\nTo assess the effects of posterior musculofascial reconstruction RALP compared to no posterior reconstruction during RALP for the treatment of clinically localized prostate cancer.\nSearch methods\nWe performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings, up to 12 March 2021. We applied no restrictions on publication language or status.\nSelection criteria\nWe included randomized controlled trials (RCTs) in which participants were randomized to undergo variations of posterior musculofascial reconstruction RALP versus no posterior reconstruction during RALP for clinically localized prostate cancer.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. Primary outcomes were: urinary continence recovery within one week after catheter removal, at three months after surgery, and serious adverse events. Secondary outcomes were: urinary continence recovery at six and twelve months after surgery, potency recovery twelve months after surgery, positive surgical margins (PSM), and biochemical recurrence-free survival (BCRFS). We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach.\nMain results\nOur search identified 13 records of eight unique RCTs, of which six were published studies and two were abstract proceedings. We included 1085 randomized participants, of whom 963 completed the trials (88.8%). All participants had either cT1c or cT2 or cT3a disease, with a mean prostate-specific antigen level of 8.15 ng/mL.\nPrimary outcomes\nPosterior reconstruction RALP (PR-RALP) may improve urinary continence one week after catheter removal compared to no posterior reconstruction during RALP (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.90 to 1.73; I2 = 42%; studies = 5, participants = 498; low CoE) although the CI also includes the possibility of no effect. Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 84 more men per 1000 (33 fewer to 244 more) reporting urinary continence recovery.\nPosterior reconstruction may have little to no effect on urinary continence three months after surgery compared to no posterior reconstruction during RALP (RR 0.98, 95% CI 0.84 to 1.14; I2 = 67%; studies = 6, participants = 842; low CoE). Assuming 701 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 14 fewer men per 1000 (112 fewer to 98 more) reporting urinary continence after three months.\nPR-RALP probably results in little to no difference in serious adverse events compared to no posterior reconstruction during RALP (RR 0.75, 95% CI 0.29 to 1.92; I2 = 0%; studies = 6, participants = 835; moderate CoE). Assuming 25 per 1000 men undergoing standard RALP experience a serious adverse event at this time point, this corresponds to six fewer men per 1000 (17 fewer to 23 more) reporting serious adverse events.\nSecondary outcomes\nPR-RALP may result in little to no difference in recovery of continence 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.98 to 1.07; I2 = 25%; studies = 3, participants = 602; low CoE). Assuming 918 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 18 more men per 1000 (18 fewer to 64 more) reporting urinary continence recovery.\nWe are very uncertain about the effects of PR-RALP on recovery of potency 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.82 to 1.26; I2 = 3%; studies = 2, participants = 308; very low CoE). Assuming 433 per 1000 men undergoing standard RALP are potent at this time point, this corresponds to nine more men per 1000 (78 fewer to 113 more) reporting potency recovery.\nPR-RALP may result in little to no difference in positive surgical margins compared to no posterior reconstruction during RALP (RR 1.24, 95% CI 0.65 to 2.33; I2 = 50%; studies = 3, participants = 517; low CoE). Assuming 130 per 1000 men undergoing standard RALP have a positive surgical margin, this corresponds to 31 more men per 1000 (46 fewer to 173 more) reporting positive surgical margins.\nPR-RALP may result in little to no difference in biochemical recurrence compared to no posterior reconstruction during RALP (RR 1.36, 95% CI 0.74 to 2.52; I2 = 0%; studies = 2, participants = 468; low CoE). Assuming 70 per 1000 men undergoing standard RALP have experienced biochemical recurrence at this time point, this corresponds to 25 more men per 1000 (18 fewer to 107 more) reporting biochemical recurrence.\nAuthors' conclusions\nThis review found evidence that PR-RALP may improve early continence one week after catheter removal but not thereafter. Meanwhile, adverse event rates are probably not impacted and surgical margins rates are likely similar. This review was unable to determine if or how these findings may be impacted by the person's age, nerve-sparing status, or clinical stage. Study limitations, imprecision, and inconsistency lowered the certainty of evidence for the outcomes assessed.\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": "In men with prostate cancer who are having their prostate removed using surgery assisted by a robotic device (called robotic-assisted laparoscopic prostatectomy, or RALP), how does connecting the tissue behind the urethra (so-called posterior reconstruction) compare to surgery where these connections are not made (standard RALP)?"
}
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query-laysum | 5401 | [
{
"role": "user",
"content": "Abstract: Background\nThe prognosis of people with metastatic cutaneous melanoma, a skin cancer, is generally poor. Recently, new classes of drugs (e.g. immune checkpoint inhibitors and small-molecule targeted drugs) have significantly improved patient prognosis, which has drastically changed the landscape of melanoma therapeutic management. This is an update of a Cochrane Review published in 2000.\nObjectives\nTo assess the beneficial and harmful effects of systemic treatments for metastatic cutaneous melanoma.\nSearch methods\nWe searched the following databases up to October 2017: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials registers and the ASCO database in February 2017, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nWe considered RCTs of systemic therapies for people with unresectable lymph node metastasis and distant metastatic cutaneous melanoma compared to any other treatment. We checked the reference lists of selected articles to identify further references to relevant trials.\nData collection and analysis\nTwo review authors extracted data, and a third review author independently verified extracted data. We implemented a network meta-analysis approach to make indirect comparisons and rank treatments according to their effectiveness (as measured by the impact on survival) and harm (as measured by occurrence of high-grade toxicity). The same two review authors independently assessed the risk of bias of eligible studies according to Cochrane standards and assessed evidence quality based on the GRADE criteria.\nMain results\nWe included 122 RCTs (28,561 participants). Of these, 83 RCTs, encompassing 21 different comparisons, were included in meta-analyses. Included participants were men and women with a mean age of 57.5 years who were recruited from hospital settings. Twenty-nine studies included people whose cancer had spread to their brains. Interventions were categorised into five groups: conventional chemotherapy (including single agent and polychemotherapy), biochemotherapy (combining chemotherapy with cytokines such as interleukin-2 and interferon-alpha), immune checkpoint inhibitors (such as anti-CTLA4 and anti-PD1 monoclonal antibodies), small-molecule targeted drugs used for melanomas with specific gene changes (such as BRAF inhibitors and MEK inhibitors), and other agents (such as anti-angiogenic drugs). Most interventions were compared with chemotherapy. In many cases, trials were sponsored by pharmaceutical companies producing the tested drug: this was especially true for new classes of drugs, such as immune checkpoint inhibitors and small-molecule targeted drugs.\nWhen compared to single agent chemotherapy, the combination of multiple chemotherapeutic agents (polychemotherapy) did not translate into significantly better survival (overall survival: HR 0.99, 95% CI 0.85 to 1.16, 6 studies, 594 participants; high-quality evidence; progression-free survival: HR 1.07, 95% CI 0.91 to 1.25, 5 studies, 398 participants; high-quality evidence. Those who received combined treatment are probably burdened by higher toxicity rates (RR 1.97, 95% CI 1.44 to 2.71, 3 studies, 390 participants; moderate-quality evidence). (We defined toxicity as the occurrence of grade 3 (G3) or higher adverse events according to the World Health Organization scale.)\nCompared to chemotherapy, biochemotherapy (chemotherapy combined with both interferon-alpha and interleukin-2) improved progression-free survival (HR 0.90, 95% CI 0.83 to 0.99, 6 studies, 964 participants; high-quality evidence), but did not significantly improve overall survival (HR 0.94, 95% CI 0.84 to 1.06, 7 studies, 1317 participants; high-quality evidence). Biochemotherapy had higher toxicity rates (RR 1.35, 95% CI 1.14 to 1.61, 2 studies, 631 participants; high-quality evidence).\nWith regard to immune checkpoint inhibitors, anti-CTLA4 monoclonal antibodies plus chemotherapy probably increased the chance of progression-free survival compared to chemotherapy alone (HR 0.76, 95% CI 0.63 to 0.92, 1 study, 502 participants; moderate-quality evidence), but may not significantly improve overall survival (HR 0.81, 95% CI 0.65 to 1.01, 2 studies, 1157 participants; low-quality evidence). Compared to chemotherapy alone, anti-CTLA4 monoclonal antibodies is likely to be associated with higher toxicity rates (RR 1.69, 95% CI 1.19 to 2.42, 2 studies, 1142 participants; moderate-quality evidence).\nCompared to chemotherapy, anti-PD1 monoclonal antibodies (immune checkpoint inhibitors) improved overall survival (HR 0.42, 95% CI 0.37 to 0.48, 1 study, 418 participants; high-quality evidence) and probably improved progression-free survival (HR 0.49, 95% CI 0.39 to 0.61, 2 studies, 957 participants; moderate-quality evidence). Anti-PD1 monoclonal antibodies may also result in less toxicity than chemotherapy (RR 0.55, 95% CI 0.31 to 0.97, 3 studies, 1360 participants; low-quality evidence).\nAnti-PD1 monoclonal antibodies performed better than anti-CTLA4 monoclonal antibodies in terms of overall survival (HR 0.63, 95% CI 0.60 to 0.66, 1 study, 764 participants; high-quality evidence) and progression-free survival (HR 0.54, 95% CI 0.50 to 0.60, 2 studies, 1465 participants; high-quality evidence). Anti-PD1 monoclonal antibodies may result in better toxicity outcomes than anti-CTLA4 monoclonal antibodies (RR 0.70, 95% CI 0.54 to 0.91, 2 studies, 1465 participants; low-quality evidence).\nCompared to anti-CTLA4 monoclonal antibodies alone, the combination of anti-CTLA4 plus anti-PD1 monoclonal antibodies was associated with better progression-free survival (HR 0.40, 95% CI 0.35 to 0.46, 2 studies, 738 participants; high-quality evidence). There may be no significant difference in toxicity outcomes (RR 1.57, 95% CI 0.85 to 2.92, 2 studies, 764 participants; low-quality evidence) (no data for overall survival were available).\nThe class of small-molecule targeted drugs, BRAF inhibitors (which are active exclusively against BRAF-mutated melanoma), performed better than chemotherapy in terms of overall survival (HR 0.40, 95% CI 0.28 to 0.57, 2 studies, 925 participants; high-quality evidence) and progression-free survival (HR 0.27, 95% CI 0.21 to 0.34, 2 studies, 925 participants; high-quality evidence), and there may be no significant difference in toxicity (RR 1.27, 95% CI 0.48 to 3.33, 2 studies, 408 participants; low-quality evidence).\nCompared to chemotherapy, MEK inhibitors (which are active exclusively against BRAF-mutated melanoma) may not significantly improve overall survival (HR 0.85, 95% CI 0.58 to 1.25, 3 studies, 496 participants; low-quality evidence), but they probably lead to better progression-free survival (HR 0.58, 95% CI 0.42 to 0.80, 3 studies, 496 participants; moderate-quality evidence). However, MEK inhibitors probably have higher toxicity rates (RR 1.61, 95% CI 1.08 to 2.41, 1 study, 91 participants; moderate-quality evidence).\nCompared to BRAF inhibitors, the combination of BRAF plus MEK inhibitors was associated with better overall survival (HR 0.70, 95% CI 0.59 to 0.82, 4 studies, 1784 participants; high-quality evidence). BRAF plus MEK inhibitors was also probably better in terms of progression-free survival (HR 0.56, 95% CI 0.44 to 0.71, 4 studies, 1784 participants; moderate-quality evidence), and there appears likely to be no significant difference in toxicity (RR 1.01, 95% CI 0.85 to 1.20, 4 studies, 1774 participants; moderate-quality evidence).\nCompared to chemotherapy, the combination of chemotherapy plus anti-angiogenic drugs was probably associated with better overall survival (HR 0.60, 95% CI 0.45 to 0.81; moderate-quality evidence) and progression-free survival (HR 0.69, 95% CI 0.52 to 0.92; moderate-quality evidence). There may be no difference in terms of toxicity (RR 0.68, 95% CI 0.09 to 5.32; low-quality evidence). All results for this comparison were based on 324 participants from 2 studies.\nNetwork meta-analysis focused on chemotherapy as the common comparator and currently approved treatments for which high- to moderate-quality evidence of efficacy (as represented by treatment effect on progression-free survival) was available (based on the above results) for: biochemotherapy (with both interferon-alpha and interleukin-2); anti-CTLA4 monoclonal antibodies; anti-PD1 monoclonal antibodies; anti-CTLA4 plus anti-PD1 monoclonal antibodies; BRAF inhibitors; MEK inhibitors, and BRAF plus MEK inhibitors. Analysis (which included 19 RCTs and 7632 participants) generated 21 indirect comparisons.\nThe best evidence (moderate-quality evidence) for progression-free survival was found for the following indirect comparisons:\n• both combinations of immune checkpoint inhibitors (HR 0.30, 95% CI 0.17 to 0.51) and small-molecule targeted drugs (HR 0.17, 95% CI 0.11 to 0.26) probably improved progression-free survival compared to chemotherapy;\n• both BRAF inhibitors (HR 0.40, 95% CI 0.23 to 0.68) and combinations of small-molecule targeted drugs (HR 0.22, 95% CI 0.12 to 0.39) were probably associated with better progression-free survival compared to anti-CTLA4 monoclonal antibodies;\n• biochemotherapy (HR 2.81, 95% CI 1.76 to 4.51) probably lead to worse progression-free survival compared to BRAF inhibitors;\n• the combination of small-molecule targeted drugs probably improved progression-free survival (HR 0.38, 95% CI 0.21 to 0.68) compared to anti-PD1 monoclonal antibodies;\n• both biochemotherapy (HR 5.05, 95% CI 3.01 to 8.45) and MEK inhibitors (HR 3.16, 95% CI 1.77 to 5.65) were probably associated with worse progression-free survival compared to the combination of small-molecule targeted drugs; and\n• biochemotherapy was probably associated with worse progression-free survival (HR 2.81, 95% CI 1.54 to 5.11) compared to the combination of immune checkpoint inhibitors.\nThe best evidence (moderate-quality evidence) for toxicity was found for the following indirect comparisons:\n• combination of immune checkpoint inhibitors (RR 3.49, 95% CI 2.12 to 5.77) probably increased toxicity compared to chemotherapy;\n• combination of immune checkpoint inhibitors probably increased toxicity (RR 2.50, 95% CI 1.20 to 5.20) compared to BRAF inhibitors;\n• the combination of immune checkpoint inhibitors probably increased toxicity (RR 3.83, 95% CI 2.59 to 5.68) compared to anti-PD1 monoclonal antibodies; and\n• biochemotherapy was probably associated with lower toxicity (RR 0.41, 95% CI 0.24 to 0.71) compared to the combination of immune checkpoint inhibitors.\nNetwork meta-analysis-based ranking suggested that the combination of BRAF plus MEK inhibitors is the most effective strategy in terms of progression-free survival, whereas anti-PD1 monoclonal antibodies are associated with the lowest toxicity.\nOverall, the risk of bias of the included trials can be considered as limited. When considering the 122 trials included in this review and the seven types of bias we assessed, we performed 854 evaluations only seven of which (< 1%) assigned high risk to six trials.\nAuthors' conclusions\nWe found high-quality evidence that many treatments offer better efficacy than chemotherapy, especially recently implemented treatments, such as small-molecule targeted drugs, which are used to treat melanoma with specific gene mutations. Compared with chemotherapy, biochemotherapy (in this case, chemotherapy combined with both interferon-alpha and interleukin-2) and BRAF inhibitors improved progression-free survival; BRAF inhibitors (for BRAF-mutated melanoma) and anti-PD1 monoclonal antibodies improved overall survival. However, there was no difference between polychemotherapy and monochemotherapy in terms of achieving progression-free survival and overall survival. Biochemotherapy did not significantly improve overall survival and has higher toxicity rates compared with chemotherapy.\nThere was some evidence that combined treatments worked better than single treatments: anti-PD1 monoclonal antibodies, alone or with anti-CTLA4, improved progression-free survival compared with anti-CTLA4 monoclonal antibodies alone. Anti-PD1 monoclonal antibodies performed better than anti-CTLA4 monoclonal antibodies in terms of overall survival, and a combination of BRAF plus MEK inhibitors was associated with better overall survival for BRAF-mutated melanoma, compared to BRAF inhibitors alone.\nThe combination of BRAF plus MEK inhibitors (which can only be administered to people with BRAF-mutated melanoma) appeared to be the most effective treatment (based on results for progression-free survival), whereas anti-PD1 monoclonal antibodies appeared to be the least toxic, and most acceptable, treatment.\nEvidence quality was reduced due to imprecision, between-study heterogeneity, and substandard reporting of trials. Future research should ensure that those diminishing influences are addressed. Clinical areas of future investigation should include the longer-term effect of new therapeutic agents (i.e. immune checkpoint inhibitors and targeted therapies) on overall survival, as well as the combination of drugs used in melanoma treatment; research should also investigate the potential influence of biomarkers.\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": "All 122 studies were randomised controlled trials that enrolled participants with metastatic cutaneous melanoma and compared different systemic treatments (28,561 participants). Study participants were adults of either sex, with a mean age of 57.5 years. There were 29 studies that included people whose cancer had spread to the brain, which is important because the detection and treatment of brain metastases often present unique challenges. Most treatments were compared with chemotherapy, and all studies were set in hospitals. Frequently, the pharmaceutical company who produced a tested drug also sponsored the study in which it was assessed, especially in the case of new classes of drugs, such as immune checkpoint inhibitors and small-molecule targeted drugs."
}
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query-laysum | 5402 | [
{
"role": "user",
"content": "Abstract: Background\nScrub typhus, an important cause of acute fever in Asia, is caused by Orientia tsutsugamushi, an obligate intracellular bacterium. Antibiotics currently used to treat scrub typhus include tetracyclines, chloramphenicol, macrolides, and rifampicin.\nObjectives\nTo assess and compare the effects of different antibiotic regimens for treatment of scrub typhus.\nSearch methods\nWe searched the following databases up to 8 January 2018: the Cochrane Infectious Diseases Group specialized trials register; CENTRAL, in the Cochrane Library (2018, Issue 1); MEDLINE; Embase; LILACS; and the metaRegister of Controlled Trials (mRCT). We checked references and contacted study authors for additional data. We applied no language or date restrictions.\nSelection criteria\nRandomized controlled trials (RCTs) or quasi-RCTs comparing antibiotic regimens in people with the diagnosis of scrub typhus based on clinical symptoms and compatible laboratory tests (excluding the Weil-Felix test).\nData collection and analysis\nFor this update, two review authors re-extracted all data and assessed the certainty of evidence. We meta-analysed data to calculate risk ratios (RRs) for dichotomous outcomes when appropriate, and elsewhere tabulated data to facilitate narrative analysis.\nMain results\nWe included six RCTs and one quasi-RCT with 548 participants; they took place in the Asia-Pacific region: Korea (three trials), Malaysia (one trial), and Thailand (three trials). Only one trial included children younger than 15 years (N = 57). We judged five trials to be at high risk of performance and detection bias owing to inadequate blinding. Trials were heterogenous in terms of dosing of interventions and outcome measures. Across trials, treatment failure rates were low.\nTwo trials compared doxycycline to tetracycline. For treatment failure, the difference between doxycycline and tetracycline is uncertain (very low-certainty evidence). Doxycycline compared to tetracycline may make little or no difference in resolution of fever within 48 hours (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.90 to 1.44, 55 participants; one trial; low-certainty evidence) and in time to defervescence (116 participants; one trial; low-certainty evidence). We were unable to extract data for other outcomes.\nThree trials compared doxycycline versus macrolides. For most outcomes, including treatment failure, resolution of fever within 48 hours, time to defervescence, and serious adverse events, we are uncertain whether study results show a difference between doxycycline and macrolides (very low-certainty evidence). Macrolides compared to doxycycline may make little or no difference in the proportion of patients with resolution of fever within five days (RR 1.05, 95% CI 0.99 to 1.10; 185 participants; two trials; low-certainty evidence). Another trial compared azithromycin versus doxycycline or chloramphenicol in children, but we were not able to disaggregate date for the doxycycline/chloramphenicol group.\nOne trial compared doxycycline versus rifampicin. For all outcomes, we are uncertain whether study results show a difference between doxycycline and rifampicin (very low-certainty evidence). Of note, this trial deviated from the protocol after three out of eight patients who had received doxycycline and rifampicin combination therapy experienced treatment failure.\nAcross trials, mild gastrointestinal side effects appeared to be more common with doxycycline than with comparator drugs.\nAuthors' conclusions\nTetracycline, doxycycline, azithromycin, and rifampicin are effective treatment options for scrub typhus and have resulted in few treatment failures. Chloramphenicol also remains a treatment option, but we could not include this among direct comparisons in this review.\nMost available evidence is of low or very low certainty. For specific outcomes, some low-certainty evidence suggests there may be little or no difference between tetracycline, doxycycline, and azithromycin as treatment options. Given very low-certainty evidence for rifampicin and the risk of inducing resistance in undiagnosed tuberculosis, clinicians should not regard this as a first-line treatment option. Clinicians could consider rifampicin as a second-line treatment option after exclusion of active tuberculosis.\nFurther research should consist of additional adequately powered trials of doxycycline versus azithromycin or other macrolides, trials of other candidate antibiotics including rifampicin, and trials of treatments for severe scrub typhus. Researchers should standardize diagnostic techniques and reporting of clinical outcomes to allow robust comparisons.\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": "Scrub typhus is an important cause of fever in Asia. We studied people with scrub typhus diagnosed by health professionals and confirmed by laboratory tests. We compared different antibiotic treatments. We looked at whether choice of antibiotic made a difference in the number of people who experienced failed treatment, and we determined the proportions who had resolution of fever at 48 hours."
}
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query-laysum | 5403 | [
{
"role": "user",
"content": "Abstract: Background\nThe surgical stress response plays an important role on the pathogenesis of perioperative cardiac complications. Alpha-2 adrenergic agonists attenuate this response and may help prevent postoperative cardiac complications.\nObjectives\nTo determine the efficacy and safety of α-2 adrenergic agonists for reducing mortality and cardiac complications in adults undergoing cardiac surgery and non-cardiac surgery.\nSearch methods\nWe searched CENTRAL (2017, Issue 4), MEDLINE (1950 to April Week 4, 2017), Embase (1980 to May 2017), the Science Citation Index, clinical trial registries, and reference lists of included articles.\nSelection criteria\nWe included randomized controlled trials that compared α-2 adrenergic agonists (i.e. clonidine, dexmedetomidine or mivazerol) against placebo or non-α-2 adrenergic agonists. Included trials had to evaluate the efficacy and safety of α-2 adrenergic agonists for preventing perioperative mortality or cardiac complications (or both), or measure one or more relevant outcomes (i.e. death, myocardial infarction, heart failure, acute stroke, supraventricular tachyarrhythmia and myocardial ischaemia).\nData collection and analysis\nTwo authors independently assessed trial quality, extracted data and independently performed computer entry of abstracted data. We contacted study authors for additional information. Adverse event data were gathered from the trials. We evaluated included studies using the Cochrane 'Risk of bias' tool, and the quality of the evidence underlying pooled treatment effects using GRADE methodology. Given the clinical heterogeneity between cardiac and non-cardiac surgery, we analysed these subgroups separately. We expressed treatment effects as pooled risk ratios (RR) with 95% confidence intervals (CI).\nMain results\nWe included 47 trials with 17,039 participants. Of these studies, 24 trials only included participants undergoing cardiac surgery, 23 only included participants undergoing non-cardiac surgery and eight only included participants undergoing vascular surgery. The α-2 adrenergic agonist studied was clonidine in 21 trials, dexmedetomidine in 24 trials and mivazerol in two trials.\nIn non-cardiac surgery, there was high quality evidence that α-2 adrenergic agonists led to a similar risk of all-cause mortality compared with control groups (1.3% with α-2 adrenergic agonists versus 1.7% with control; RR 0.80, 95% CI 0.61 to 1.04; participants = 14,081; studies = 16). Additionally, the risk of cardiac mortality was similar between treatment groups (0.8% with α-2 adrenergic agonists versus 1.0% with control; RR 0.86, 95% CI 0.60 to 1.23; participants = 12,525; studies = 5, high quality evidence). The risk of myocardial infarction was probably similar between treatment groups (RR 0.94, 95% CI 0.69 to 1.27; participants = 13,907; studies = 12, moderate quality evidence). There was no associated effect on the risk of stroke (RR 0.93, 95% CI 0.55 to 1.56; participants = 11,542; studies = 7; high quality evidence). Conversely, α-2 adrenergic agonists probably increase the risks of clinically significant bradycardia (RR 1.59, 95% CI 1.18 to 2.13; participants = 14,035; studies = 16) and hypotension (RR 1.24, 95% CI 1.03 to 1.48; participants = 13,738; studies = 15), based on moderate quality evidence.\nThere was insufficient evidence to determine the effect of α-2 adrenergic agonists on all-cause mortality in cardiac surgery (RR 0.52, 95% CI 0.26 to 1.04; participants = 1947; studies = 16) and myocardial infarction (RR 1.01, 95% CI 0.43 to 2.40; participants = 782; studies = 8), based on moderate quality evidence. There was one cardiac death in the clonidine arm of a study of 22 participants. Based on very limited data, α-2 adrenergic agonists may have reduced the risk of stroke (RR 0.37, 95% CI 0.15 to 0.93; participants = 1175; studies = 7; outcome events = 18; low quality evidence). Conversely, α-2 adrenergic agonists increased the risk of bradycardia from 6.4% to 12.0% (RR 1.88, 95% CI 1.35 to 2.62; participants = 1477; studies = 10; moderate quality evidence), but their effect on hypotension was uncertain (RR 1.19, 95% CI 0.87 to 1.64; participants = 1413; studies = 9; low quality evidence).\nThese results were qualitatively unchanged in subgroup analyses and sensitivity analyses.\nAuthors' conclusions\nOur review concludes that prophylactic α-2 adrenergic agonists generally do not prevent perioperative death or major cardiac complications. For non-cardiac surgery, there is moderate-to-high quality evidence that these agents do not prevent death, myocardial infarction or stroke. Conversely, there is moderate quality evidence that these agents have important adverse effects, namely increased risks of hypotension and bradycardia. For cardiac surgery, there is moderate quality evidence that α-2 adrenergic agonists have no effect on the risk of mortality or myocardial infarction, and that they increase the risk of bradycardia. The quality of evidence was inadequate to draw conclusions regarding the effects of alpha-2 agonists on stroke or hypotension during cardiac surgery.\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 found 47 studies that were published up to May 2017. These studies involved 17,039 adults who had major surgery. Twenty-four studies involved 2672 adults having heart surgery. Twenty-three studies involved 14,367 adults undergoing major operations other than heart surgery. Forty studies compared alpha-2 adrenergic agonists to dummy treatment (placebo). The other seven studies compared them to other medicines. Twenty-one studies tested an alpha-2 adrenergic agonist medicine called clonidine, 24 studied another medicine called dexmedetomidine and two studied another medicine called mivazerol. The duration of alpha-2 adrenergic agonist medicine studied varied from one dose before surgery to three days of treatment. Most people who took part in these studies were men, and their average age was 60 to 70 years old. Fourteen studies reported receiving money from the company that manufactured the medicine being tested in the same study. Another 15 studies did not report where they received the money needed to fund the study. The number of people who took part in each study varied between 20 participants to as many as 10,000 participants. Nineteen studies included more than 100 participants."
}
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query-laysum | 5404 | [
{
"role": "user",
"content": "Abstract: Background\nThe main complications of elevated systemic blood pressure (BP), coronary heart disease, ischaemic stroke, and peripheral vascular disease, are related to thrombosis rather than haemorrhage. Therefore, it is important to investigate if antithrombotic therapy may be useful in preventing thrombosis-related complications in patients with elevated BP.\nObjectives\nTo conduct a systematic review of the role of antiplatelet therapy and anticoagulation in patients with elevated BP, including elevations in systolic or diastolic BP alone or together.\nTo assess the effects of antiplatelet agents on total deaths or major thrombotic events or both in these patients versus placebo or other active treatment.\nTo assess the effects of oral anticoagulants on total deaths or major thromboembolic events or both in these patients versus placebo or other active treatment.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials (RCTs) up to January 2021: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 12), Ovid MEDLINE (from 1946), and Ovid Embase (from 1974). The World Health Organization International Clinical Trials Registry Platform and the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) were searched for ongoing trials.\nSelection criteria\nRCTs in patients with elevated BP were included if they were ≥ 3 months in duration and compared antithrombotic therapy with control or other active treatment.\nData collection and analysis\nTwo review authors independently extracted data for inclusion criteria, our prespecified outcomes, and sources of bias. They assessed the risks and benefits of antiplatelet agents and anticoagulants by calculating odds ratios (OR), accompanied by the 95% confidence intervals (CI). They assessed risks of bias and applied GRADE criteria.\nMain results\nSix trials (61,015 patients) met the inclusion criteria and were included in this review.\nFour trials were primary prevention (41,695 patients; HOT, JPAD, JPPP, and TPT), and two secondary prevention (19,320 patients, CAPRIE and Huynh). Four trials (HOT, JPAD, JPPP, and TPT) were placebo-controlled and two studies (CAPRIE and Huynh) included active comparators.\nFour studies compared acetylsalicylic acid (ASA) versus placebo and found no evidence of a difference for all-cause mortality (OR 0.97, 95% CI 0.87 to 1.08; 3 studies, 35,794 participants; low-certainty evidence). We found no evidence of a difference for cardiovascular mortality (OR 0.98, 95% CI 0.82 to 1.17; 3 studies, 35,794 participants; low-certainty evidence). ASA reduced the risk of all non-fatal cardiovascular events (OR 0.63, 95% CI 0.45 to 0.87; 1 study (missing data in 3 studies), 2540 participants; low-certainty evidence) and the risk of all cardiovascular events (OR 0.86, 95% CI 0.77 to 0.96; 3 studies, 35,794 participants; low-certainty evidence). ASA increased the risk of major bleeding events (OR 1.77, 95% CI 1.34 to 2.32; 2 studies, 21,330 participants; high-certainty evidence).\nOne study (CAPRIE; ASA versus clopidogrel) included patients diagnosed with hypertension (mean age 62.5 years, 72% males, 95% Caucasians, mean follow-up: 1.91 years). It showed no evidence of a difference for all-cause mortality (OR 1.02, 95% CI 0.91 to 1.15; 1 study, 19,143 participants; high-certainty evidence) and for cardiovascular mortality (OR 1.08, 95% CI 0.94 to 1.26; 1 study, 19,143 participants; high-certainty evidence). ASA probably reduced the risk of non-fatal cardiovascular events (OR 1.10, 95% CI 1.00 to 1.22; 1 study, 19,143 participants; high-certainty evidence) and the risk of all cardiovascular events (OR 1.08, 95% CI 1.00 to 1.17; 1 study, 19,143 participants; high-certainty evidence) when compared to clopidogrel. Clopidogrel increased the risk of major bleeding events when compared to ASA (OR 1.35, 95% CI 1.14 to 1.61; 1 study, 19,143 participants; high-certainty evidence).\nIn one study (Huynh; ASA verus warfarin) patients with unstable angina or non–ST-segment elevation myocardial infarction, with prior coronary artery bypass grafting (CABG) were included (mean age 68 years, 79.8% males, mean follow-up: 1.1 year). There was no evidence of a difference for all-cause mortality (OR 0.98, 95% CI 0.06 to 16.12; 1 study, 91 participants; low-certainty evidence). Cardiovascular mortality, non-fatal cardiovascular events, and all cardiovascular events were not available. There was no evidence of a difference for major bleeding events (OR 0.13, 95% CI 0.01 to 2.60; 1 study, 91 participants; low-certainty evidence).\nAuthors' conclusions\nThere is no evidence that antiplatelet therapy modifies mortality in patients with elevated BP for primary prevention. ASA reduced the risk of cardiovascular events and increased the risk of major bleeding events.\nAntiplatelet therapy with ASA probably reduces the risk of non-fatal and all cardiovascular events when compared to clopidogrel. Clopidogrel increases the risk of major bleeding events compared to ASA in patients with elevated BP for secondary prevention.\nThere is no evidence that warfarin modifies mortality in patients with elevated BP for secondary prevention.\nThe benefits and harms of the newer drugs glycoprotein IIb/IIIa inhibitors, clopidogrel, prasugrel, ticagrelor, and non-vitamin K antagonist oral anticoagulants for patients with high BP have not been studied in clinical trials.\nFurther RCTs of antithrombotic therapy including newer agents and complete documentation of all benefits and harms are required in patients with elevated BP.\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": "Antiplatelet therapy with acetylsalicylic acid (ASA), also known as aspirin, for primary prevention in patients with elevated BP did not modify mortality and increased the risk of major bleedings.\nAntiplatelet therapy with aspirin probably reduces the risk of non-fatal and all cardiovascular events when compared to clopidogrel. Clopidogrel increases the risk of major bleeding events when compared to aspirin in patients with elevated BP for secondary prevention.\nThere is no evidence that oral anticoagulation with warfarin modifies mortality in patients with elevated BP for secondary prevention.\nTiclopidine, clopidogrel, and newer antiplatelet agents, such as prasugrel and ticagrelor have not been sufficiently evaluated in patients with elevated BP. Newer antithrombotic oral drugs (dabigatran, rivaroxaban, apixaban, and edoxaban) are yet to be tested in patients with high BP."
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query-laysum | 5405 | [
{
"role": "user",
"content": "Abstract: Background\nAmong people with a diagnosis of borderline personality disorder (BPD) who are engaged in clinical care, prescription rates of psychotropic medications are high, despite the fact that medication use is off-label as a treatment for BPD. Nevertheless, people with BPD often receive several psychotropic drugs at a time for sustained periods.\nObjectives\nTo assess the effects of pharmacological treatment for people with BPD.\nSearch methods\nFor this update, we searched CENTRAL, MEDLINE, Embase, 14 other databases and four trials registers up to February 2022. We contacted researchers working in the field to ask for additional data from published and unpublished trials, and handsearched relevant journals. We did not restrict the search by year of publication, language or type of publication.\nSelection criteria\nRandomised controlled trials comparing pharmacological treatment to placebo, other pharmacologic treatments or a combination of pharmacologic treatments in people of all ages with a formal diagnosis of BPD. The primary outcomes were BPD symptom severity, self-harm, suicide-related outcomes, and psychosocial functioning. Secondary outcomes were individual BPD symptoms, depression, attrition and adverse events.\nData collection and analysis\nAt least two review authors independently selected trials, extracted data, assessed risk of bias using Cochrane's risk of bias tool and assessed the certainty of the evidence using the GRADE approach. We performed data analysis using Review Manager 5 and quantified the statistical reliability of the data using Trial Sequential Analysis.\nMain results\nWe included 46 randomised controlled trials (2769 participants) in this review, 45 of which were eligible for quantitative analysis and comprised 2752 participants with BPD in total. This is 18 more trials than the 2010 review on this topic. Participants were predominantly female except for one trial that included men only. The mean age ranged from 16.2 to 39.7 years across the included trials. Twenty-nine different types of medications compared to placebo or other medications were included in the analyses. Seventeen trials were funded or partially funded by the pharmaceutical industry, 10 were funded by universities or research foundations, eight received no funding, and 11 had unclear funding.\nFor all reported effect sizes, negative effect estimates indicate beneficial effects by active medication. Compared with placebo, no difference in effects were observed on any of the primary outcomes at the end of treatment for any medication.\nCompared with placebo, medication may have little to no effect on BPD symptom severity, although the evidence is of very low certainty (antipsychotics: SMD -0.18, 95% confidence interval (CI) -0.45 to 0.08; 8 trials, 951 participants; antidepressants: SMD −0.27, 95% CI −0.65 to 1.18; 2 trials, 87 participants; mood stabilisers: SMD −0.07, 95% CI −0.43 to 0.57; 4 trials, 265 participants).\nThe evidence is very uncertain about the effect of medication compared with placebo on self-harm, indicating little to no effect (antipsychotics: RR 0.66, 95% CI 0.15 to 2.84; 2 trials, 76 participants; antidepressants: MD 0.45 points on the Overt Aggression Scale-Modified-Self-Injury item (0-5 points), 95% CI −10.55 to 11.45; 1 trial, 20 participants; mood stabilisers: RR 1.08, 95% CI 0.79 to 1.48; 1 trial, 276 participants).\nThe evidence is also very uncertain about the effect of medication compared with placebo on suicide-related outcomes, with little to no effect (antipsychotics: SMD 0.05, 95 % CI −0.18 to 0.29; 7 trials, 854 participants; antidepressants: SMD −0.26, 95% CI −1.62 to 1.09; 2 trials, 45 participants; mood stabilisers: SMD −0.36, 95% CI −1.96 to 1.25; 2 trials, 44 participants).\nVery low-certainty evidence shows little to no difference between medication and placebo on psychosocial functioning (antipsychotics: SMD −0.16, 95% CI −0.33 to 0.00; 7 trials, 904 participants; antidepressants: SMD −0.25, 95% CI -0.57 to 0.06; 4 trials, 161 participants; mood stabilisers: SMD −0.01, 95% CI -0.28 to 0.26; 2 trials, 214 participants).\nLow-certainty evidence suggests that antipsychotics may slightly reduce interpersonal problems (SMD −0.21, 95% CI −0.34 to -0.08; 8 trials, 907 participants), and that mood stabilisers may result in a reduction in this outcome (SMD −0.58, 95% CI -1.14 to -0.02; 4 trials, 300 participants). Antidepressants may have little to no effect on interpersonal problems, but the corresponding evidence is very uncertain (SMD −0.07, 95% CI -0.69 to 0.55; 2 trials, 119 participants).\nThe evidence is very uncertain about dropout rates compared with placebo by antipsychotics (RR 1.11, 95% CI 0.89 to 1.38; 13 trials, 1216 participants). Low-certainty evidence suggests there may be no difference in dropout rates between antidepressants (RR 1.07, 95% CI 0.65 to 1.76; 6 trials, 289 participants) and mood stabilisers (RR 0.89, 95% CI 0.69 to 1.15; 9 trials, 530 participants), compared to placebo.\nReporting on adverse events was poor and mostly non-standardised. The available evidence on non-serious adverse events was of very low certainty for antipsychotics (RR 1.07, 95% CI 0.90 to 1.29; 5 trials, 814 participants) and mood stabilisers (RR 0.84, 95% CI 0.70 to 1.01; 1 trial, 276 participants). For antidepressants, no data on adverse events were identified.\nAuthors' conclusions\nThis review included 18 more trials than the 2010 version, so larger meta-analyses with more statistical power were feasible. We found mostly very low-certainty evidence that medication may result in no difference in any primary outcome. The rest of the secondary outcomes were inconclusive. Very limited data were available for serious adverse events. The review supports the continued understanding that no pharmacological therapy seems effective in specifically treating BPD pathology. More research is needed to understand the underlying pathophysiologic mechanisms of BPD better. Also, more trials including comorbidities such as trauma-related disorders, major depression, substance use disorders, or eating disorders are needed. Additionally, more focus should be put on male and adolescent samples.\n\nGiven the provided abstract, please respond to the following query: \"Intense but unstable relationships\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "People with BPD may find it difficult to keep stable relationships (e.g. they may feel very worried about being abandoned and might constantly text or call, or make threats to harm or kill themselves if the person leaves them).\nA person only needs to experience five out of nine criteria across these categories to be given a diagnosis of BPD."
}
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query-laysum | 5406 | [
{
"role": "user",
"content": "Abstract: Background\nCaring for someone with dementia can be emotionally and physically demanding. Respite care is any intervention designed to give rest or relief to caregivers. It is not clear what positive and negative effects such care may have on them, or on people with dementia.\nObjectives\nTo assess the benefits and harms of respite care for people with dementia and their caregivers, in particular the effect of respite care on rates of institutionalisation.\nSearch methods\nThe trials were identified from a search of ALOIS, the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group, using the terms respite* OR daycare OR caregiver* relief. ALOIS contains up-to-date records from all major healthcare databases and many ongoing trial databases.\nSelection criteria\nRandomised controlled trials comparing respite care with a control intervention for people with dementia.\nData collection and analysis\nTwo review authors carried out study selection independently and reached a consensus through discussion. Data were extracted by a single review author. The review authors contacted all investigators for methodological details not reported in the text and for additional data for three studies included in the previous version of the review.\nMain results\nFour trials are now included in the review, with 753 participants. They were different in many ways including the intervention, duration, outcomes and control group so pooling of data was not possible. Overall, the quality of the evidence was rated as very low. Re-analysis of outcomes using data from the published studies found no significant effects of respite care compared to no respite care on any caregiver variable. When respite care was compared to polarity therapy a significant effect was found in favour of polarity therapy for caregiver perceived stress (n = 38, MD 5.80, 95% CI 1.43 to 10.17), but not for other measures of psychological health and other caregiver outcomes. No studies reported evaluable data on outcomes related to the people with dementia.\nAuthors' conclusions\nCurrent evidence does not demonstrate any benefits or adverse effects from the use of respite care for people with dementia or their caregivers. These results should be treated with caution, however, as they may reflect the lack of high quality research in this area rather than an actual lack of benefit. Given the frequency with which respite care is advocated and provided, well-designed trials are needed in this area.\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": "Four studies with 753 participants were included in this review. Three compared respite care to no respite care and one compared respite care to polarity therapy, a type of touch therapy. All studies included people with dementia and their caregivers. We were not able to pool the results of the studies as there were so few studies and they measured the outcomes in different ways. All the studies reported outcomes for the caregiver, but only one reported outcomes for the person with dementia."
}
]
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query-laysum | 5407 | [
{
"role": "user",
"content": "Abstract: Background\nVaccines are effective in preventing severe COVID-19, a disease for which few treatments are available and which can lead to disability or death. Widespread vaccination against COVID-19 may help protect those not yet able to get vaccinated. In addition, new and vaccine-resistant mutations of SARS-CoV-2 may be less likely to develop if the spread of COVID-19 is limited. Different vaccines are now widely available in many settings. However, vaccine hesitancy is a serious threat to the goal of nationwide vaccination in many countries and poses a substantial threat to population health. This scoping review maps interventions aimed at increasing COVID-19 vaccine uptake and decreasing COVID-19 vaccine hesitancy.\nObjectives\nTo scope the existing research landscape on interventions to enhance the willingness of different populations to be vaccinated against COVID-19, increase COVID-19 vaccine uptake, or decrease COVID-19 vaccine hesitancy, and to map the evidence according to addressed populations and intervention categories.\nSearch methods\nWe searched Cochrane COVID-19 Study Register, Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index), WHO COVID-19 Global literature on coronavirus disease, PsycINFO, and CINAHL to 11 October 2021.\nSelection criteria\nWe included studies that assess the impact of interventions implemented to enhance the willingness of different populations to be vaccinated against COVID-19, increase vaccine uptake, or decrease COVID-19 vaccine hesitancy. We included randomised controlled trials (RCTs), non-randomised studies of intervention (NRSIs), observational studies and case studies with more than 100 participants. Furthermore, we included systematic reviews and meta-analyses. We did not limit the scope of the review to a specific population or to specific outcomes assessed. We excluded interventions addressing hesitancy towards vaccines for diseases other than COVID-19.\nData collection and analysis\nData were analysed according to a protocol uploaded to the Open Science Framework. We used an interactive scoping map to visualise the results of our scoping review. We mapped the identified interventions according to pre-specified intervention categories, that were adapted to better fit the evidence. The intervention categories were: communication interventions, policy interventions, educational interventions, incentives (both financial and non-financial), interventions to improve access, and multidimensional interventions. The study outcomes were also included in the mapping. Furthermore, we mapped the country in which the study was conducted, the addressed population, and whether the design was randomised-controlled or not.\nMain results\nWe included 96 studies in the scoping review, 35 of which are ongoing and 61 studies with published results. We did not identify any relevant systematic reviews. For an overview, please see the interactive scoping map (https://tinyurl.com/2p9jmx24).\nStudies with published results\nOf the 61 studies with published results, 46 studies were RCTs and 15 NRSIs. The interventions investigated in the studies were heterogeneous with most studies testing communication strategies to enhance COVID-19 vaccine uptake. Most studies assessed the willingness to get vaccinated as an outcome. The majority of studies were conducted in English-speaking high-income countries. Moreover, most studies investigated digital interventions in an online setting. Populations that were addressed were diverse. For example, studies targeted healthcare workers, ethnic minorities in the USA, students, soldiers, at-risk patients, or the general population.\nOngoing studies\nOf the 35 ongoing studies, 29 studies are RCTs and six NRSIs. Educational and communication interventions were the most used types of interventions. The majority of ongoing studies plan to assess vaccine uptake as an outcome. Again, the majority of studies are being conducted in English-speaking high-income countries. In contrast to the studies with published results, most ongoing studies will not be conducted online. Addressed populations range from minority populations in the USA to healthcare workers or students. Eleven ongoing studies have estimated completion dates in 2022.\nAuthors' conclusions\nWe were able to identify and map a variety of heterogeneous interventions for increasing COVID-19 vaccine uptake or decreasing vaccine hesitancy. Our results demonstrate that this is an active field of research with 61 published studies and 35 studies still ongoing. This review gives a comprehensive overview of interventions to increase COVID-19 vaccine uptake and can be the foundation for subsequent systematic reviews on the effectiveness of interventions to increase COVID-19 vaccine uptake.\nA research gap was shown for studies conducted in low and middle-income countries and studies investigating policy interventions and improved access, as well as for interventions addressing children and adolescents. As COVID-19 vaccines become more widely available, these populations and interventions should not be neglected in research.\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"
},
{
"role": "assistant",
"content": "We identified a large number of studies that investigate how COVID-19 vaccine uptake might be increased. However, more studies are needed focusing on lower-middle-income countries and on children. Future research should compare the effectiveness of different interventions to improve COVID-19 vaccine uptake."
}
]
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query-laysum | 5408 | [
{
"role": "user",
"content": "Abstract: Background\nCohort studies have suggested that nasal continuous positive airway pressure (CPAP) starting in the immediate postnatal period before the onset of respiratory disease (prophylactic CPAP) may be beneficial in reducing the need for intubation and intermittent positive pressure ventilation (IPPV), and in preventing bronchopulmonary dysplasia (BPD), in preterm or low birth weight infants.\nObjectives\nTo determine if prophylactic nasal CPAP (started within the first 15 minutes) or very early nasal CPAP regardless of respiratory status (started within the first hour of life), reduces the use of mechanical ventilation and the incidence of bronchopulmonary dysplasia without any adverse effects in preterm infants.\nSearch methods\nA comprehensive search was run on 6 November 2020 in the Cochrane Central Register of Controlled Trials (CENTRAL via CRS Web) and MEDLINE via Ovid. We also searched the reference lists of retrieved studies.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs in preterm infants (under 37 weeks of gestation). We included trials if they compared prophylactic nasal CPAP (started within the first 15 minutes) or very early nasal CPAP (started within the first hour of life) in infants with minimal signs of respiratory distress with 'supportive care', such as supplemental oxygen therapy, standard nasal cannula, or mechanical ventilation. We excluded studies where prophylactic CPAP was compared with CPAP along with co-interventions.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal, including independent study selection, assessment of trial quality, and extraction of data by two review authors.\nMain results\nWe included eight trials (seven from the previous version of the review and one new study), recruiting 3201 babies, in the meta-analysis. Four trials, involving 765 babies, compared CPAP with supportive care, and three trials (2364 babies) compared CPAP with mechanical ventilation. One trial (72 babies) compared prophylactic CPAP with very early CPAP. Apart from a lack of blinding of the intervention, we judged seven studies to have a low risk of bias. However, one study had a high risk of selection bias.\nProphylactic or very early CPAP compared to supportive care\nThere may be a reduction in failed treatment (risk ratio (RR) 0.6, 95% confidence interval (CI) 0.49 to 0.74; risk difference (RD) -0.16, 95% CI -0.34 to 0.02; 4 studies, 765 infants; very low certainty evidence). CPAP possibly reduces BPD at 36 weeks (RR 0.76, 95% CI 0.51 to 1.14; 3 studies, 683 infants, moderate certainty evidence); there may be little or no difference in death (RR 1.04, 95% CI 0.56 to 1.93; 4 studies, 765 infants; moderate certainty evidence). Prophylactic CPAP may reduce the composite outcome of death or BPD (RR 0.69, 95% CI 0.40 to 1.19; 1 study, 256 infants; low certainty evidence). There may be no difference in pulmonary air leak (pneumothorax) (RR 0.75, 95% CI 0.35 to 1.16; 3 studies, 568 infants; low certainty evidence), or intraventricular haemorrhage (IVH) Grade 3 or 4 (RR 0.96, 95% CI 0.39 to 2.37; 2 studies, 486 infants; moderate certainty evidence). Neurodevelopmental impairment was not reported in any of the studies.\nProphylactic or very early CPAP compared to mechanical ventilation\nThere was probably a reduction in the incidence of BPD at 36 weeks (RR 0.89, 95% CI 0.8 to 0.99; RD -0.04, 95% CI -0.08 to 0.00; 3 studies, 2150 infants; moderate certainty evidence); and death or BPD (RR 0.89, 95% CI 0.81 to 0.97; RD -0.05, 95% CI -0.09 to 0.01; 3 studies, 2358 infants; moderate certainty evidence). There was also probably a reduction in the need for mechanical ventilation (failed treatment) (RR 0.49, 95% CI 0.45 to 0.54; RD -0.50, 95% CI -0.54 to -0.45; 2 studies, 1042 infants; moderate certainty evidence). There was probably a reduction in the incidence of death (RR 0.82, 95% CI 0.66 to 1.03; 3 studies, 2358 infants; moderate certainty evidence); pulmonary air leak (pneumothorax) (RR 1.24, 95% CI 0.91 to 1.69; 3 studies, 2357 infants; low certainty evidence); and IVH Grade 3 or 4 (RR 1.09, 95% CI 0.86 to 1.39; 3 studies, 2301 infants; moderate certainty evidence). One study in this comparison reported that there was probably little or no difference between the groups in the incidence of neurodevelopmental impairment at 18 to 22 months (RR 0.91, 95% CI 0.62 to 1.32; 976 infants; moderate certainty evidence).\nProphylactic CPAP compared with very early CPAP\nThere was one study in this comparison. We are very uncertain whether there is any difference in the incidence of BPD (RR 0.5, 95% CI 0.05 to 5.27; very low certainty evidence). The combined outcome of death and BPD was not reported, and failed treatment was reported but without data. There may have been little to no effect on death (RR 0.75, 95% CI 0.29 to1.94; 1 study, 72 infants; very low certainty evidence). Intraventricular haemorrhage Grade 3 or 4 and neurodevelopmental outcomes were not reported in this study. Pulmonary air leak (pneumothorax) was reported in this study, but there were no events in either group.\nAuthors' conclusions\nFor preterm and very preterm infants, there is insufficient evidence to evaluate prophylactic CPAP compared to oxygen therapy and other supportive care. When compared to mechanical ventilation, prophylactic nasal CPAP in very preterm infants reduces the incidence of BPD, the combined outcome of death and BPD, and mechanical ventilation. There is probably no difference in neurodevelopmental impairment at 18 to 22 months of age.\nWhen prophylactic CPAP is compared to early CPAP, we are very uncertain about whether there is any difference between prophylactic and very early CPAP.\nThere is no information about the effect of prophylactic or very early CPAP in late preterm infants.\nThere is one study awaiting classification.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to know if preventive CPAP and very early CPAP are effective in preventing RDS in premature babies. We were interested in:\n- how many babies had BPD;\n- whether CPAP successfully supported babies’ breathing, or if they needed to be put on a ventilator;\n- how many babies died; and\n- the combined number of babies who died or developed BPD."
}
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query-laysum | 5409 | [
{
"role": "user",
"content": "Abstract: Background\nFunctional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date.\nObjectives\nTo evaluate the efficacy and safety of probiotics for the management of chronic constipation without a physical explanation in children.\nSearch methods\nOn 28 June 2021, we searched CENTRAL, MEDLINE, Embase, CINAHL, AMED, WHO ICTR, and ClinicalTrials.gov, with no language, date, publication status, or document type limitations.\nSelection criteria\nWe included randomised controlled trials (RCTs) that assessed probiotic preparations (including synbiotics) compared to placebo, no treatment or any other interventional preparation in people aged between 0 and 18 years old with a diagnosis of functional constipation according to consensus criteria (such as Rome IV).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 14 studies (1127 randomised participants): 12 studies assessed probiotics in the treatment of functional constipation, whilst two studies investigated synbiotic preparations.\nThree studies compared probiotics to placebo in relation to the frequency of defecation at study end, but we did not pool them as there was very significant unexplained heterogeneity. Four studies compared probiotics to placebo in relation to treatment success. There may be no difference in global improvement/treatment success (RR 1.29, 95% CI 0.73 to 2.26; 313 participants; low-certainty evidence). Five studies compared probiotics to placebo in relation to withdrawals due to adverse events, with the pooled effect suggesting there may be no difference (RR 0.64, 95% CI 0.21 to 1.95; 357 participants; low-certainty evidence).\nThe pooled estimate from three studies that compared probiotics plus an osmotic laxative to osmotic laxative alone found there may be no difference in frequency of defecation (MD -0.01, 95% CI -0.57 to 0.56; 268 participants; low-certainty evidence). Two studies compared probiotics plus an osmotic laxative to osmotic laxative alone in relation to global improvement/treatment success, and found there may be no difference between the treatments (RR 0.95, 95% CI 0.79 to 1.15; 139 participants; low-certainty evidence). Three studies compared probiotics plus osmotic laxative to osmotic laxative alone in relation to withdrawals due to adverse events, but it is unclear if there is a difference between them (RR 2.86, 95% CI 0.12 to 68.35; 268 participants; very low-certainty evidence).\nTwo studies compared probiotics versus magnesium oxide. It is unclear if there is a difference in frequency of defecation (MD 0.28, 95% CI -0.58 to 1.14; 36 participants), treatment success (RR 1.08, 95% CI 0.74 to 1.57; 36 participants) or withdrawals due to adverse events (RR 0.50, 95% CI 0.05 to 5.04; 77 participants). The certainty of the evidence is very low for these outcomes.\nOne study assessed the role of a synbiotic preparation in comparison to placebo. There may be higher treatment success in favour of synbiotics compared to placebo (RR 2.32, 95% CI 1.54 to 3.47; 155 participants; low-certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.\nOne study assessed a synbiotic plus paraffin compared to paraffin alone. It is uncertain if there is a difference in frequency of defecation (MD 0.74, 95% CI -0.96, 2.44; 66 participants; very low-certainty evidence), or treatment success (RR 0.91, 95% CI 0.71 to 1.17; 66 participants; very low-certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.\nOne study compared a synbiotic preparation to paraffin. It is uncertain if there is a difference in frequency of defecation (MD -1.53, 95% CI -3.00, -0.06; 60 participants; very low-certainty evidence) or in treatment success (RR 0.86, 95% CI 0.65, 1.13; 60 participants; very low-certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.\nAll secondary outcomes were either not reported or reported in a way that did not allow for analysis.\nAuthors' conclusions\nThere is insufficient evidence to conclude whether probiotics are efficacious in successfully treating chronic constipation without a physical explanation in children or changing the frequency of defecation, or whether there is a difference in withdrawals due to adverse events when compared with placebo. There is limited evidence from one study to suggest a synbiotic preparation may be more likely than placebo to lead to treatment success, with no difference in withdrawals due to adverse events.\nThere is insufficient evidence to draw efficacy or safety conclusions about the use of probiotics in combination with or in comparison to any of the other interventions reported. The majority of the studies that presented data on serious adverse events reported that no events occurred. Two studies did not report this outcome.\nFuture studies are needed to confirm efficacy, but the research community requires guidance on the best context for probiotics in such studies, considering where they should be best considered in a potential treatment hierarchy and should align with core outcome sets to support future interpretation of findings.\n\nGiven the provided abstract, please respond to the following query: \"What next?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Future studies are needed to find out how helpful probiotics are for childhood constipation. Researchers need to agree whether probiotics should be a first option therapy, an add-on to other therapies, a second option after other therapies have failed, or a combination of all the above.\nFuture research should measure the same items (known as a core outcome set) to ensure these results can support future reviews."
}
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query-laysum | 5410 | [
{
"role": "user",
"content": "Abstract: Background\nCustom foot orthoses are commonly recommended for the treatment of foot pain.\nObjectives\nTo evaluate the effectiveness of custom foot orthoses for different types of foot pain.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2), MEDLINE (from January 1966), EMBASE (from January 1980), CINAHL (from January 1982) and the Physiotherapy Evidence Database (PEDro) (to June 2007). We also contacted authors of included trials and known researchers in the field and checked the reference lists of included trials to identify trials. No language or publication restrictions were applied.\nSelection criteria\nRandomised controlled trials and controlled clinical trials evaluating custom-made foot orthoses for any type of foot pain. Outcomes included quantifiable levels of foot pain, function, disability, health-related quality of life, participant satisfaction, adverse effects and compliance.\nData collection and analysis\nTwo authors independently selected trials, rated methodological quality and cross checked data extraction. Data were analysed separately for different diagnoses of foot pain and follow-up time points.\nMain results\nEleven trials involving 1332 participants were included: five trials evaluated custom-made foot orthoses for plantar fasciitis (691 participants); three for foot pain in rheumatoid arthritis (231 participants); and one each for foot pain in pes cavus (154 participants), hallux valgus (209 participants) and juvenile idiopathic arthritis (JIA) (47 participants). Comparisons to custom-made foot orthoses included sham orthoses; no intervention; standardised interventions given to all participants; non-custom (prefabricated) foot orthoses; combined manipulation, mobilisation or stretching; night splints; and surgery. Follow up ranged from one week to three years. Custom-made foot orthoses were effective for painful pes cavus (NNTB:5), rearfoot pain in rheumatoid arthritis (NNTB:4), foot pain in JIA (NNTB:3) and painful hallux valgus (NNTB:6); however, surgery was even more effective for hallux valgus and non-custom foot orthoses appeared just as effective for JIA but the analysis may have lacked sufficient power to detect a difference in effect. It is unclear if custom-made foot orthoses were effective for plantar fasciitis or metatarsophalangeal joint pain in rheumatoid arthritis. Custom-made foot orthoses were a safe intervention in all studies.\nAuthors' conclusions\nThere is limited evidence on which to base clinical decisions regarding the prescription of custom-made foot orthoses for the treatment of foot pain. Currently, there is gold level evidence for painful pes cavus and silver level evidence for foot pain in JIA, rheumatoid arthritis, plantar fasciitis and hallux valgus.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to people with RA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes or doing nothing\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "After 3 months, custom-made foot orthoses improve foot pain by 14 more points on a scale of 0 to 100 (possibly as many as 23 points or as few as 5 points).\nAfter 2 and a half years, custom-made foot orthoses improve foot pain."
}
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query-laysum | 5412 | [
{
"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: \"Review aim\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review, first published in 2007, was to summarise research on immunising healthy children up to the age of 16 with influenza vaccines during influenza seasons. We used randomised trials comparing either one of two types of vaccines with dummy vaccines or nothing. One type of vaccine is based on live but weakened influenza viruses (live attenuated influenza vaccines) and is given via the nose. The other is prepared by killing the influenza viruses with a chemical (inactivated virus) and is given by injection through the skin. We analysed the number of children with confirmed influenza and those who had influenza-like illness (ILI) (headache, high temperature, cough, and muscle pain) and harms from vaccination. Future updates of this review will be made only when new trials or vaccines become available. Data from 33 observational studies included in previous versions of the review have been retained for historical reasons but have not been updated due to their lack of influence on the review conclusions."
}
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query-laysum | 5413 | [
{
"role": "user",
"content": "Abstract: Background\nLumbar spinal stenosis with neurogenic claudication is one of the most commonly diagnosed and treated pathological spinal conditions. It frequently afflicts the elderly population.\nObjectives\nTo systematically review the evidence for the effectiveness of nonoperative treatment of lumbar spinal stenosis with neurogenic claudication.\nSearch methods\nCENTRAL, MEDLINE, CINAHL, and Index to Chiropractic Literature (ICL) databases were searched up to June 2012.\nSelection criteria\nRandomized controlled trials published in English, in which at least one arm provided data on nonoperative treatments\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration. Risk of bias in each study was independently assessed by two review authors using the 12 criteria recommended by the Cochrane Back Review Group (Furlan 2009). Dichotomous outcomes were expressed as relative risk, continuous outcomes as mean difference or standardized mean difference; uncertainty was expressed with 95% confidence intervals. If possible a meta-analysis was performed, otherwise results were described qualitatively. GRADE was used to assess the quality of the evidence.\nMain results\nFrom the 8635 citations screened, 56 full-text articles were assessed and 21 trials (1851 participants) were included. There was very low-quality evidence from six trials that calcitonin is no better than placebo or paracetamol, regardless of mode of administration or outcome assessed. From single small trials, there was low-quality evidence for prostaglandins, and very low-quality evidence for gabapentin or methylcobalamin that they improved walking distance. There was very low-quality evidence from a single trial that epidural steroid injections improved pain, function, and quality of life, up to two weeks, compared with home exercise or inpatient physical therapy. There was low-quality evidence from a single trial that exercise is of short-term benefit for leg pain and function compared with no treatment. There was low and very low-quality evidence from six trials that multimodal nonoperative treatment is less effective than indirect or direct surgical decompression with or without fusion. A meta-analysis of two trials comparing direct decompression with or without fusion to multimodal nonoperative care found no significant difference in function at six months (mean difference (MD) -3.66, 95% CI -10.12 to 2.80) and one year (MD -6.18, 95% CI -15.03 to 2.66), but at 24 months a significant difference was found favouring decompression (MD -4.43, 95% CI -7.91 to -0.96).\nAuthors' conclusions\nModerate and high-quality evidence for nonoperative treatment is lacking and thus prohibits recommendations for guiding clinical practice. Given the expected exponential rise in the prevalence of lumbar spinal stenosis with neurogenic claudication, large high-quality trials are urgently needed.\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 on the effectiveness of non-surgical treatments for people with leg pain caused by pressure on the nerves in the spine."
}
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query-laysum | 5414 | [
{
"role": "user",
"content": "Abstract: Background\nAxillary surgery is an established part of the management of primary breast cancer. It provides staging information to guide adjuvant therapy and potentially local control of axillary disease. Several alternative approaches to axillary surgery are available, most of which aim to spare a proportion of women the morbidity of complete axillary dissection.\nObjectives\nTo assess the benefits and harms of alternative approaches to axillary surgery (including omitting such surgery altogether) in terms of overall survival; local, regional and distant recurrences; and adverse events.\nSearch methods\nWe searched the Cochrane Breast Cancer Group Specialised Register, MEDLINE, Pre-MEDLINE, Embase, CENTRAL, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov on 12 March 2015 without language restrictions. We also contacted study authors and checked reference lists.\nSelection criteria\nRandomised controlled trials (RCTs) including women with clinically defined operable primary breast cancer conducted to compare axillary lymph node dissection (ALND) with no axillary surgery, axillary sampling or sentinel lymph node biopsy (SLNB); RCTs comparing axillary sampling with SLNB or no axillary surgery; RCTs comparing SLNB with no axillary surgery; and RCTs comparing ALND with or without radiotherapy (RT) versus RT alone.\nData collection and analysis\nTwo review authors independently assessed each potentially relevant trial for inclusion. We independently extracted outcome data, risk of bias information and study characteristics from all included trials. We pooled data according to trial interventions, and we used hazard ratios (HRs) for time-to-event outcomes and odds ratios (OR) for binary outcomes.\nMain results\nWe included 26 RCTs in this review. Studies were at low or unclear risk of selection bias. Blinding was not done, but this was only considered a source of bias for outcomes with potential for subjectivity in measurements. We found no RCTs of axillary sampling versus SLNB, axillary sampling versus no axillary surgery or SLNB versus no axillary surgery.\nNo axillary surgery versus ALND \nTen trials involving 3849 participants compared no axillary surgery versus ALND. Moderate quality evidence showed no important differences between overall survival of women in the two groups (HR 1.06, 95% confidence interval (CI) 0.96 to 1.17; 3849 participants; 10 studies) although no axillary surgery increased the risk of locoregional recurrence (HR ranging from 1.10 to 3.06; 20,863 person-years of follow-up; four studies). It was uncertain whether no surgery increased the risk of distant metastasis compared with ALND (HR 1.06, 95% CI 0.87 to 1.30; 946 participants; two studies). Low-quality evidence indicated no axillary surgery decreased the risk of lymphoedema compared with ALND (OR 0.31, 95% CI 0.23 to 0.43; 1714 participants; four studies).\nAxillary sampling versus ALND \nSix trials involving 1559 participants compared axillary sampling versus ALND. Low-quality evidence indicated similar effectiveness of axillary sampling compared with ALND in terms of overall survival (HR 0.94, 95% CI 0.73 to 1.21; 967 participants; three studies) but it was unclear whether axillary sampling led to increased risk of local recurrence compared with ALND (HR 1.41, 95% CI 0.94 to 2.12; 1404 participants; three studies). The relative effectiveness of axillary sampling and ALND for locoregional recurrence (HR 0.74, 95% CI 0.46 to 1.20; 406 participants; one study) and distant metastasis was uncertain (HR 1.05, 95% CI 0.74 to 1.49; 406 participants; one study). Lymphoedema was less likely after axillary sampling than after ALND (OR 0.32, 95% CI 0.13 to 0.81; 80 participants; one study).\nSLNB versus ALND \nSeven trials involving 9426 participants compared SLNB with ALND. Moderate-quality evidence showed similar overall survival following SLNB compared with ALND (HR 1.05, 95% CI 0.89 to 1.25; 6352 participants; three studies; moderate-quality evidence). Differences in local recurrence (HR 0.94, 95% CI 0.24 to 3.77; 516 participants; one study), locoregional recurrence (HR 0.96, 95% CI 0.74 to 1.24; 5611 participants; one study) and distant metastasis (HR 0.80, 95% CI 0.42 to 1.53; 516 participants; one study) were uncertain. However, studies showed little absolute difference in the aforementioned outcomes. Lymphoedema was less likely after SLNB than ALND (OR ranged from 0.04 to 0.60; three studies; 1965 participants; low-quality evidence). Three studies including 1755 participants reported quality of life: Investigators in two studies found quality of life better after SLNB than ALND, and in the other study observed no difference.\nRT versus ALND \nFour trials involving 2585 participants compared RT alone with ALND (with or without RT). High-quality evidence indicated that overall survival was reduced among women treated with radiotherapy alone compared with those treated with ALND (HR 1.10, 95% CI 1.00 to 1.21; 2469 participants; four studies), and local recurrence was less likely in women treated with radiotherapy than in those treated with ALND (HR 0.80, 95% CI 0.64 to 0.99; 22,256 person-years of follow-up; four studies). Risk of distant metastasis was similar for radiotherapy alone as for ALND (HR 1.07, 95% CI 0.93 to 1.25; 1313 participants; one study), and whether lymphoedema was less likely after RT alone than ALND remained uncertain (OR 0.47, 95% CI 0.16 to 1.44; 200 participants; one study).\nLess surgery versus ALND \nWhen combining results from all trials, treatment involving less surgery was associated with reduced overall survival compared with ALND (HR 1.08, 95% CI 1.01 to 1.16; 12,864 participants; 19 studies). Whether local recurrence was reduced with less axillary surgery when compared with ALND was uncertain (HR 0.90, 95% CI 0.75 to 1.09; 24,176 participant-years of follow up; eight studies). Locoregional recurrence was more likely with less surgery than with ALND (HR 1.53, 95% CI 1.31 to 1.78; 26,880 participant-years of follow-up; seven studies). Whether risk of distant metastasis was increased after less axillary surgery compared with ALND was uncertain (HR 1.07, 95% CI 0.95 to 1.20; 2665 participants; five studies). Lymphoedema was less likely after less axillary surgery than with ALND (OR 0.37, 95% CI 0.29 to 0.46; 3964 participants; nine studies).\nNo studies reported on disease control in the axilla.\nAuthors' conclusions\nThis review confirms the benefit of SLNB and axillary sampling as alternatives to ALND for axillary staging, supporting the view that ALND of the clinically and radiologically uninvolved axilla is no longer acceptable practice in people with breast cancer.\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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"role": "assistant",
"content": "Moderate-quality evidence suggests that patients treated with approaches involving lesser axillary surgery (such as axillary sampling or SLNB) do not have a reduced chance of survival compared with those treated with ALND. Moderate-quality evidence indicates that overall survival is slightly reduced in patients who receive radiotherapy (but no axillary surgery) when compared with ALND. If survival is assumed to be 81% five years after surgery with ALND, then the evidence suggests it would be between 77% and 81% after treatment with radiotherapy alone.\nModerate-quality evidence suggests that patients who have no axillary lymph nodes removed at all are at increased risk of locoregional recurrence (regrowth of cancer, in the breast, mastectomy scar area or underarm glands). If it is assumed that 86% of patients receiving ALND are free of locoregional recurrence five years after surgery, evidence suggests that the corresponding figure for patients who have no lymph nodes removed at all would be between 66% and 76%. For patients treated with axillary sampling, low-quality evidence suggests that between 73% and 87% would be free of locoregional recurrence at five years.\nAxillary recurrence rates were reported only in SLNB versus ALND trials, and researchers remain uncertain about the best treatment for this outcome because rates were very low (occurring in less than 1% of patients).\nLow-quality evidence suggests that patients treated with ALND are at increased risk of lymphoedema compared with those treated with SLNB or no axillary surgery. On the basis of this evidence, we would expect that out of every 1000 patients receiving ALND, 132 would experience lymphoedema at one year after surgery, compared with between 22 and 115 of those receiving SLNB. Other long-term harms such as pain, impaired arm movement and numbness were also more likely with ALND than with SLNB."
}
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query-laysum | 5415 | [
{
"role": "user",
"content": "Abstract: Background\nRegional anaesthesia may reduce the rate of persistent postoperative pain (PPP), a frequent and debilitating condition. This review was originally published in 2012 and updated in 2017.\nObjectives\nTo compare local anaesthetics and regional anaesthesia versus conventional analgesia for the prevention of PPP beyond three months in adults and children undergoing elective surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase to December 2016 without any language restriction. We used a combination of free text search and controlled vocabulary search. We limited results to randomized controlled trials (RCTs). We updated this search in December 2017, but these results have not yet been incorporated in the review. We conducted a handsearch in reference lists of included studies, review articles and conference abstracts. We searched the PROSPERO systematic review registry for related systematic reviews.\nSelection criteria\nWe included RCTs comparing local or regional anaesthesia versus conventional analgesia with a pain outcome beyond three months after elective, non-orthopaedic surgery.\nData collection and analysis\nAt least two review authors independently assessed trial quality and extracted data and adverse events. We contacted study authors for additional information. We presented outcomes as pooled odds ratios (OR) with 95% confidence intervals (95% CI), based on random-effects models (inverse variance method). We analysed studies separately by surgical intervention, but pooled outcomes reported at different follow-up intervals. We compared our results to Bayesian and classical (frequentist) models. We investigated heterogeneity. We assessed the quality of evidence with GRADE.\nMain results\nIn this updated review, we identified 40 new RCTs and seven ongoing studies. In total, we included 63 RCTs in the review, but we were only able to synthesize data on regional anaesthesia for the prevention of PPP beyond three months after surgery from 39 studies, enrolling a total of 3027 participants in our inclusive analysis.\nEvidence synthesis of seven RCTs favoured epidural anaesthesia for thoracotomy, suggesting the odds of having PPP three to 18 months following an epidural for thoracotomy were 0.52 compared to not having an epidural (OR 0.52 (95% CI 0.32 to 0.84, 499 participants, moderate-quality evidence). Simlarly, evidence synthesis of 18 RCTs favoured regional anaesthesia for the prevention of persistent pain three to 12 months after breast cancer surgery with an OR of 0.43 (95% CI 0.28 to 0.68, 1297 participants, low-quality evidence). Pooling data at three to 8 months after surgery from four RCTs favoured regional anaesthesia after caesarean section with an OR of 0.46, (95% CI 0.28 to 0.78; 551 participants, moderate-quality evidence). Evidence synthesis of three RCTs investigating continuous infusion with local anaesthetic for the prevention of PPP three to 55 months after iliac crest bone graft harvesting (ICBG) was inconclusive (OR 0.20, 95% CI 0.04 to 1.09; 123 participants, low-quality evidence). However, evidence synthesis of two RCTs also favoured the infusion of intravenous local anaesthetics for the prevention of PPP three to six months after breast cancer surgery with an OR of 0.24 (95% CI 0.08 to 0.69, 97 participants, moderate-quality evidence).\nWe did not synthesize evidence for the surgical subgroups of limb amputation, hernia repair, cardiac surgery and laparotomy. We could not pool evidence for adverse effects because the included studies did not examine them systematically, and reported them sparsely. Clinical heterogeneity, attrition and sparse outcome data hampered evidence synthesis. High risk of bias from missing data and lack of blinding across a number of included studies reduced our confidence in the findings. Thus results must be interpreted with caution.\nAuthors' conclusions\nWe conclude that there is moderate-quality evidence that regional anaesthesia may reduce the risk of developing PPP after three to 18 months after thoracotomy and three to 12 months after caesarean section. There is low-quality evidence that regional anaesthesia may reduce the risk of developing PPP three to 12 months after breast cancer surgery. There is moderate evidence that intravenous infusion of local anaesthetics may reduce the risk of developing PPP three to six months after breast cancer surgery.\nOur conclusions are considerably weakened by the small size and number of studies, by performance bias, null bias, attrition and missing data. Larger, high-quality studies, including children, are needed. We caution that except for breast surgery, our evidence synthesis is based on only a few small studies. On a cautionary note, we cannot extend our conclusions to other surgical interventions or regional anaesthesia techniques, for example we cannot conclude that paravertebral block reduces the risk of PPP after thoracotomy. There are seven ongoing studies and 12 studies awaiting classification that may change the conclusions of the current review once they are published and incorporated.\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 set out to determine if the use of local anaesthetics (numbing medicine) at the time of surgery reduces the risk of having pain that persists for three months and more after surgery. The comparison was with pain killers alone, such as opioids and non-steroidal anti-inflammatory drugs."
}
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query-laysum | 5416 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Beds, overlays or mattresses are widely used with the aim of treating pressure ulcers.\nObjectives\nTo assess the effects of beds, overlays and mattresses on pressure ulcer healing in people with pressure ulcers of any stage, in any setting.\nSearch methods\nIn November 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\nWe included randomised controlled trials that allocated participants of any age to pressure-redistributing beds, overlays or mattresses. Comparators were any beds, overlays or mattresses that were applied for treating pressure ulcers.\nData collection and analysis\nAt least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology.\nMain results\nWe included 13 studies (972 participants) in the review. Most studies were small (median study sample size: 72 participants). The average age of participants ranged from 64.0 to 86.5 years (median: 82.7 years) and all studies recruited people with existing pressure ulcers (the baseline ulcer area size ranging from 4.2 to 18.6 cm2,median 6.6 cm2). Participants were recruited from acute care settings (six studies) and community and long-term care settings (seven studies). Of the 13 studies, three (224 participants) involved surfaces that were not well described and therefore could not be classified. Additionally, six (46.2%) of the 13 studies presented findings which were considered at high overall risk of bias. We synthesised data for four comparisons in the review: alternating pressure (active) air surfaces versus foam surfaces; reactive air surfaces versus foam surfaces; reactive water surfaces versus foam surfaces, and a comparison between two types of alternating pressure (active) air surfaces. We summarise key findings for these four comparisons below.\n(1) Alternating pressure (active) air surfaces versus foam surfaces: we are uncertain if there is a difference between alternating pressure (active) air surfaces and foam surfaces in the proportion of participants whose pressure ulcers completely healed (two studies with 132 participants; the reported risk ratio (RR) in one study was 0.97, 95% confidence interval (CI) 0.26 to 3.58). There is also uncertainty for the outcomes of patient comfort (one study with 83 participants) and adverse events (one study with 49 participants). These outcomes have very low-certainty evidence. Included studies did not report time to complete ulcer healing, health-related quality of life, or cost effectiveness.\n(2) Reactive air surfaces versus foam surfaces: it is uncertain if there is a difference in the proportion of participants with completely healed pressure ulcers between reactive air surfaces and foam surfaces (RR 1.32, 95% CI 0.96 to 1.80; I2 = 0%; 2 studies, 156 participants; low-certainty evidence). When time to complete pressure ulcer healing is considered using a hazard ratio, data from one small study (84 participants) suggests a greater hazard for complete ulcer healing on reactive air surfaces (hazard ratio 2.66, 95% CI 1.34 to 5.17; low-certainty evidence). These results are sensitive to the choice of outcome measure so should be interpreted as uncertain. We are also uncertain whether there is any difference between these surfaces in patient comfort responses (1 study, 72 participants; very low-certainty evidence) and in adverse events (2 studies, 156 participants; low-certainty evidence). There is low-certainty evidence that reactive air surfaces may cost an extra 26 US dollars for every ulcer-free day in the first year of use (1 study, 87 participants). Included studies did not report health-related quality of life.\n(3) Reactive water surfaces versus foam surfaces: it is uncertain if there is a difference between reactive water surfaces and foam surfaces in the proportion of participants with healed pressure ulcers (RR 1.07, 95% CI 0.70 to 1.63; 1 study, 101 participants) and in adverse events (1 study, 120 participants). All these have very low-certainty evidence. Included studies did not report time to complete ulcer healing, patient comfort, health-related quality of life, or cost effectiveness.\n(4) Comparison between two types of alternating pressure (active) air surfaces: it is uncertain if there is a difference between Nimbus and Pegasus alternating pressure (active) air surfaces in the proportion of participants with healed pressure ulcers, in patient comfort responses and in adverse events: each of these outcomes had four studies (256 participants) but very low-certainty evidence. Included studies did not report time to complete ulcer healing, health-related quality of life, or cost effectiveness.\nAuthors' conclusions\nWe are uncertain about the relative effects of most different pressure-redistributing surfaces for pressure ulcer healing (types directly compared are alternating pressure air surfaces versus foam surfaces, reactive air surfaces versus foam surfaces, reactive water surfaces versus foam surfaces, and Nimbus versus Pegasus alternating pressure (active) air surfaces). There is also uncertainty regarding the effects of these different surfaces on the outcomes of comfort and adverse events. However, people using reactive air surfaces may be more likely to have pressure ulcers completely healed than those using foam surfaces over 37.5 days' follow-up, and reactive air surfaces may cost more for each ulcer-free day than foam surfaces.\nFuture research in this area could consider the evaluation of alternating pressure air surfaces versus foam surfaces as a high priority. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Further review using network meta-analysis adds to the findings reported here.\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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"role": "assistant",
"content": "We found 13 studies (972 people, average age: 83 years) that lasted between seven days and 18 months (average: 37.5 days).\nIn general, the studies did not provide sufficiently robust evidence for us to determine the effects of active and reactive surfaces.\nEvidence from two studies suggests that, when compared with mattresses and mattress toppers made of foam, beds with a reactive air-filled surface may:\n- improve chances of pressure ulcers healing if the data on the time needed to completely heal an ulcer is looked at (1 study, 84 people);\n- cost an extra 26 US dollars per person for every ulcer-free day in the first year of use (1 study, 87 people).\nThe other benefits and risks of these and other surfaces are unclear."
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query-laysum | 5417 | [
{
"role": "user",
"content": "Abstract: Background\nAntenatal care (ANC) is a core component of maternity care. However, both quality of care provision and rates of attendance vary widely between and within countries. Qualitative research can assess factors underlying variation, including acceptability, feasibility, and the values and beliefs that frame provision and uptake of ANC programmes.\nThis synthesis links to the Cochrane Reviews of the effectiveness of different antenatal models of care. It was designed to inform the World Health Organization guidelines for a positive pregnancy experience and to provide insights for the design and implementation of improved antenatal care in the future.\nObjectives\nTo identify, appraise, and synthesise qualitative studies exploring:\n· Women’s views and experiences of attending ANC; and factors influencing the uptake of ANC arising from women’s accounts;\n· Healthcare providers’ views and experiences of providing ANC; and factors influencing the provision of ANC arising from the accounts of healthcare providers.\nSearch methods\nTo find primary studies we searched MEDLINE, Ovid; Embase, Ovid; CINAHL, EbscoHost; PsycINFO, EbscoHost; AMED, EbscoHost; LILACS, VHL; and African Journals Online (AJOL) from January 2000 to February 2019. We handsearched reference lists of included papers and checked the contents pages of 50 relevant journals through Zetoc alerts received during the searching phase.\nSelection criteria\nWe included studies that used qualitative methodology and that met our quality threshold; that explored the views and experiences of routine ANC among healthy, pregnant and postnatal women or among healthcare providers offering this care, including doctors, midwives, nurses, lay health workers and traditional birth attendants; and that took place in any setting where ANC was provided.\nWe excluded studies of ANC programmes designed for women with specific complications. We also excluded studies of programmes that focused solely on antenatal education.\nData collection and analysis\nTwo authors undertook data extraction, logged study characteristics, and assessed study quality. We used meta-ethnographic and Framework techniques to code and categorise study data. We developed findings from the data and presented these in a 'Summary of Qualitative Findings' (SoQF) table. We assessed confidence in each finding using GRADE-CERQual. We used these findings to generate higher-level explanatory thematic domains. We then developed two lines of argument syntheses, one from service user data, and one from healthcare provider data. In addition, we mapped the findings to relevant Cochrane effectiveness reviews to assess how far review authors had taken account of behavioural and organisational factors in the design and implementation of the interventions they tested. We also translated the findings into logic models to explain full, partial and no uptake of ANC, using the theory of planned behaviour.\nMain results\nWe include 85 studies in our synthesis. Forty-six studies explored the views and experiences of healthy pregnant or postnatal women, 17 studies explored the views and experiences of healthcare providers and 22 studies incorporated the views of both women and healthcare providers. The studies took place in 41 countries, including eight high-income countries, 18 middle-income countries and 15 low-income countries, in rural, urban and semi-urban locations. We developed 52 findings in total and organised these into three thematic domains: socio-cultural context (11 findings, five moderate- or high-confidence); service design and provision (24 findings, 15 moderate- or high-confidence); and what matters to women and staff (17 findings, 11 moderate- or high-confidence) The third domain was sub-divided into two conceptual areas; personalised supportive care, and information and safety. We also developed two lines of argument, using high- or moderate-confidence findings:\nFor women, initial or continued use of ANC depends on a perception that doing so will be a positive experience. This is a result of the provision of good-quality local services that are not dependent on the payment of informal fees and that include continuity of care that is authentically personalised, kind, caring, supportive, culturally sensitive, flexible, and respectful of women’s need for privacy, and that allow staff to take the time needed to provide relevant support, information and clinical safety for the woman and the baby, as and when they need it. Women’s perceptions of the value of ANC depend on their general beliefs about pregnancy as a healthy or a risky state, and on their reaction to being pregnant, as well as on local socio-cultural norms relating to the advantages or otherwise of antenatal care for healthy pregnancies, and for those with complications. Whether they continue to use ANC or not depends on their experience of ANC design and provision when they access it for the first time.\nThe capacity of healthcare providers to deliver the kind of high-quality, relationship-based, locally accessible ANC that is likely to facilitate access by women depends on the provision of sufficient resources and staffing as well as the time to provide flexible personalised, private appointments that are not overloaded with organisational tasks. Such provision also depends on organisational norms and values that overtly value kind, caring staff who make effective, culturally-appropriate links with local communities, who respect women’s belief that pregnancy is usually a normal life event, but who can recognise and respond to complications when they arise. Healthcare providers also require sufficient training and education to do their job well, as well as an adequate salary, so that they do not need to demand extra informal funds from women and families, to supplement their income, or to fund essential supplies.\nAuthors' conclusions\nThis review has identified key barriers and facilitators to the uptake (or not) of ANC services by pregnant women, and in the provision (or not) of good-quality ANC by healthcare providers. It complements existing effectiveness reviews of models of ANC provision and adds essential insights into why a particular type of ANC provided in specific local contexts may or may not be acceptable, accessible, or valued by some pregnant women and their families/communities. Those providing and funding services should consider the three thematic domains identified by the review as a basis for service development and improvement. Such developments should include pregnant and postnatal women, community members and other relevant stakeholders.\n\nGiven the provided abstract, please respond to the following query: \"What are the main findings of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We include 85 studies in our synthesis. Forty-six studies explored the views and experiences of women who were pregnant or who had recently given birth. 17 studies explored the views and experiences of healthcare providers, including lay or community health workers, and 22 studies included the views of both women and healthcare providers. The studies took place in eight high-income countries, 18 middle-income countries and 12 low-income countries, in rural and urban locations.\nOur findings suggest that women use antenatal care if they find it is a positive experience that fits with their beliefs and values, is easy for them to access, affordable, and treats them as an individual. They want care that helps them to feel that they and their baby are safe, and that is provided by kind, caring, culturally sensitive, flexible, and respectful staff that have time to give them support and reassurance about the health and well-being of them and their babies. They also value tests and treatments that are offered when they need them, and information and advice that is relevant to them.\nOur findings also suggest that healthcare staff want to be able to offer this kind of care. They would like to work in antenatal services that are properly funded, and that give them proper support, pay, training and education. They believe this will help them to have enough time to treat each pregnant woman as an individual, and to have the knowledge, skills resources and equipment to do their job well."
}
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query-laysum | 5418 | [
{
"role": "user",
"content": "Abstract: Background\nBreast milk provides optimal nutrition for term and preterm infants, and the ideal way for infants to receive breast milk is through suckling at the breast. Unfortunately, this may not always be possible for medical or physiological reasons such as being born sick or preterm and as a result requiring supplemental feeding. Currently, there are various ways in which infants can receive supplemental feeds. Traditionally in neonatal and maternity units, bottles and nasogastric tubes have been used; however, cup feeding is becoming increasingly popular as a means of offering supplemental feeds in an attempt to improve breastfeeding rates. There is no consistency to guide the choice of method for supplemental feeding.\nObjectives\nTo determine the effects of cup feeding versus other forms of supplemental enteral feeding on weight gain and achievement of successful breastfeeding in term and preterm infants who are unable to fully breastfeed.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 1), MEDLINE via PubMed (1966 to 31 January 2016), Embase (1980 to 31 January 2016), and CINAHL (1982 to 31 January 2016). We also searched clinical trials' databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised or quasi-randomised controlled trials comparing cup feeding to other forms of enteral feeding for the supplementation of term and preterm infants.\nData collection and analysis\nData collection and analysis was performed in accordance with the methods of Cochrane Neonatal. We used the GRADE approach to assess the quality of evidence.\nThe review authors independently conducted quality assessments and data extraction for included trials. Outcomes reported from these studies were: weight gain; proportion not breastfeeding at hospital discharge; proportion not feeding at three months of age; proportion not feeding at six months of age; proportion not fully feeding at hospital discharge; proportion not fully breastfeeding at three months of age; proportion not fully breastfeeding at six months of age; average time per feed (minutes); length of stay; and physiological events of instability such as bradycardia, apnoea, and low oxygen saturation. For continuous variables such as weight gain, mean differences and 95% confidence intervals (CIs) were reported. For categorical outcomes such as mortality, the relative risks (RR) and 95% CIs were reported.\nMain results\nThe experimental intervention was cup feeding and the control intervention was bottle feeding in all five studies included in this review. One study reported weight gain as g/kg/day and there was no statistically significant difference between the two groups (MD −0.60, 95% CI −3.21 to 2.01); while a second study reported weight gain in the first seven days as grams/day and also showed no statistically significant difference between the two groups (MD −0.10, 95% CI −0.36 to 0.16). There was substantial variation in results for the majority of breastfeeding outcomes, except for not breastfeeding at three months (three studies) (typical RR 0.83, 95% CI 0.71 to 0.97) which favoured cup feeding. Where there was moderate heterogeneity meta-analysis was performed: not breastfeeding at six months (two studies) (typical RR 0.83, 95% CI 0.72 to 0.95); not fully breastfeeding at hospital discharge (four studies) (typical RR 0.61, 95% CI 0.52 to 0.71).\nTwo studies reported average time to feed which showed no difference between the two groups. Two studies assessed length of hospital stay and there was considerable variation in results and in the direction of effect. Only one study has reported gestational age at discharge, which showed no difference between the two groups (MD −0.10, 95% CI −0.54 to 0.34).\nAuthors' conclusions\nAs the majority of infants in the included studies are preterm infants, no recommendations can be made for cup feeding term infants due to the lack of evidence in this population.\nFrom the studies of preterm infants, cup feeding may have some benefits for late preterm infants and on breastfeeding rates up to six months of age. Self-reported breastfeeding status and compliance to supplemental interventions may over-report exclusivity and compliance, as societal expectations of breastfeeding and not wishing to disappoint healthcare professionals may influence responses at interview and on questionnaires.\nThe results for length of stay are mixed, with the study involving lower gestational age preterm infants finding that those fed by cup spent approximately 10 days longer in hospital, whereas the study involving preterm infants at a higher gestational age, who did not commence cup feeding until 35 weeks' gestation, did not have a longer length of stay, with both groups staying on average 26 days. This finding may have been influenced by gestational age at birth and gestational age at commencement of cup feeding, and their mothers' visits; (a large number of mothers of these late preterm infants lived regionally from the hospital and could visit at least twice per week).\nCompliance to the intervention of cup feeding remains a challenge. The two largest studies have both reported non-compliance, with one study analysing data by intention to treat and the other excluding those infants from the analysis. This may have influenced the findings of the trial. Non-compliance issues need consideration before further large randomised controlled trials are undertaken as this influences power of the study and therefore the statistical results. In addition larger studies with better-quality (especially blinded) outcome assessment with 100% follow-up are needed.\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": "Our search for eligible studies conducted on 31 January 2016 revealed five studies, all comparing cup and bottle feeding in newborn infants, which we were able to include in this review. These studies were conducted in neonatal and maternity units in hospitals in Australia, the United Kingdom, Brazil and Turkey. The mean gestational age of the infants in most of the studies were similar at the time of entry into the study. In four of the studies the intervention (cup or bottle) commenced from the time of enrolment into the study, when the infants first needed a supplemental feed and were as young as 30 weeks' gestation. In the study conducted in Turkey, supplemental feeding was not commenced on enrolment into the study and at the time of first supplemental feed but delayed until infants were at least 35 weeks of age."
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query-laysum | 5419 | [
{
"role": "user",
"content": "Abstract: Background\nUrinary incontinence in women is associated with poor quality of life and difficulties in social, psychological and sexual functioning. The condition may affect up to 15% of middle-aged or older women in the general population. Conservative treatments such as lifestyle interventions, bladder training and pelvic floor muscle training (used either alone or in combination with other interventions) are the initial approaches to the management of urinary incontinence. Many women are interested in additional treatments such as yoga, a system of philosophy, lifestyle and physical practice that originated in ancient India.\nObjectives\nTo assess the effects of yoga for treating urinary incontinence in women.\nSearch methods\nWe searched the Cochrane Incontinence and Cochrane Complementary Medicine Specialised Registers. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov to identify any ongoing or unpublished studies. We handsearched Proceedings of the International Congress on Complementary Medicine Research and the European Congress for Integrative Medicine. We searched the NHS Economic Evaluation Database for economic studies, and supplemented this search with searches for economics studies in MEDLINE and Embase from 2015 onwards. Database searches are up-to-date as of 21 June 2018.\nSelection criteria\nRandomised controlled trials in women diagnosed with urinary incontinence in which one group was allocated to treatment with yoga.\nData collection and analysis\nTwo review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias and evaluated the certainty of the evidence for each reported outcome. Any disagreements were resolved by consensus. We planned to combine clinically comparable studies in Review Manager 5 using random-effects meta-analysis and to carry out sensitivity and subgroup analyses. We planned to create a table listing economic studies on yoga for incontinence but not carry out any analyses on these studies.\nMain results\nWe included two studies (involving a total of 49 women). Each study compared yoga to a different comparator, therefore we were unable to combine the data in a meta-analysis. A third study that has been completed but not yet fully reported is awaiting assessment.\nOne included study was a six-week study comparing yoga to a waiting list in 19 women with either urgency urinary incontinence or stress urinary incontinence. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, detection bias, and imprecision. The number of women reporting cure was not reported. We are uncertain whether yoga results in satisfaction with cure or improvement of incontinence (risk ratio (RR) 6.33, 95% confidence interval (CI) 1.44 to 27.88; an increase of 592 from 111 per 1000, 95% CI 160 to 1000). We are uncertain whether there is a difference between yoga and waiting list in condition-specific quality of life as measured on the Incontinence Impact Questionnaire Short Form (mean difference (MD) 1.74, 95% CI -33.02 to 36.50); the number of micturitions (MD -0.77, 95% CI -2.13 to 0.59); the number of incontinence episodes (MD -1.57, 95% CI -2.83 to -0.31); or the bothersomeness of incontinence as measured on the Urogenital Distress Inventory 6 (MD -0.90, 95% CI -1.46 to -0.34). There was no evidence of a difference in the number of women who experienced at least one adverse event (risk difference 0%, 95% CI -38% to 38%; no difference from 222 per 1000, 95% CI 380 fewer to 380 more).\nThe second included study was an eight-week study in 30 women with urgency urinary incontinence that compared mindfulness-based stress reduction (MBSR) to an active control intervention of yoga classes. The study was unblinded, and there was high attrition from both study arms for all outcome assessments. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, attrition bias, imprecision and indirectness. The number of women reporting cure was not reported. We are uncertain whether women in the yoga group were less likely to report improvement in incontinence at eight weeks compared to women in the MBSR group (RR 0.09, 95% CI 0.01 to 1.43; a decrease of 419 from 461 per 1000, 95% CI 5 to 660). We are uncertain about the effect of MBSR compared to yoga on reports of cure or improvement in incontinence, improvement in condition-specific quality of life measured on the Overactive Bladder Health-Related Quality of Life Scale, reduction in incontinence episodes or reduction in bothersomeness of incontinence as measured on the Overactive Bladder Symptom and Quality of Life-Short Form at eight weeks. The study did not report on adverse effects.\nAuthors' conclusions\nWe identified few trials on yoga for incontinence, and the existing trials were small and at high risk of bias. In addition, we did not find any studies of economic outcomes related to yoga for urinary incontinence. Due to the lack of evidence to answer the review question, we are uncertain whether yoga is useful for women with urinary incontinence. Additional, well-conducted trials with larger sample sizes are needed.\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": "Up to 15% of women who are middle-aged or older may have urinary incontinence. Incontinence can be categorised as urgency urinary incontinence, defined as an involuntary loss of urine associated with a sudden strong desire to urinate, or stress urinary incontinence, where an activity such as sneezing triggers an involuntary leak of urine. Both types can negatively affect quality of life and social, psychological and sexual functioning. Treating incontinence usually begins with advice on lifestyle changes such as lowering caffeine use, behavioural interventions such as bladder training or exercises for the pelvic floor muscles. However, many women are interested in additional treatments such as yoga, a system of philosophy, lifestyle and physical practice that originated in ancient India."
}
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query-laysum | 5420 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants have fewer nutrient reserves at birth than full-term infants and often receive artificial formula feeds in the absence of expressed breast milk. Although it is generally agreed that feeding must be initiated slowly and advanced with much greater deliberation than in a healthy, full-term infant, the way in which feeds are introduced and advanced in preterm infants varies widely. This review focuses on whether dilute or full-strength formula is the preferable mode of introducing feeds in preterm infants for whom expressed breast milk is unavailable.\nObjectives\nTo assess the effects of dilute versus full-strength formula on the incidence of necrotising enterocolitis, feeding intolerance, weight gain, length of stay in hospital and time to achieve full calorie intake in exclusively formula-fed preterm or low birth weight infants. A secondary objective was to assess the effects of different dilution strategies.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to update the search in the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 9), MEDLINE via PubMed (1966 to 1 October 2018), Embase (1980 to 1 October 2018), and CINAHL (1982 to 1 October 2018).\nWe searched clinical trials' registries for ongoing or recently completed trials (clinicaltrials.gov; the World Health Organization’s International Trials Registry and Platform; and the ISRCTN Registry).\nSelection criteria\nRandomised or quasi-randomised trials comparing strengths of formula milk in exclusively formula-fed preterm or low birth weight infants. We excluded studies if infants received formula as a supplement to breast milk.\nData collection and analysis\nWe independently assessed studies for inclusion. We collected data using the standard methods of Cochrane Neonatal, with independent assessment of risk of bias and data extraction. We synthesised mean differences using a fixed-effect meta-analysis model. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included three studies involving 102 preterm or low birth weight infants in the review. The studies compared dilute (double-volume, half-strength) formula with full-strength (20 kcal/oz (~ 68 to 70 kcal/100 mL)) formula. We assessed all three studies as having unclear risk of bias due to the likely absence of blinding of study personnel and the potential for selection bias in the largest trial. Data for the primary outcome of necrotising enterocolitis were not reported in any of the studies. We could combine two of the studies (88 infants) in the meta-analysis. The evidence suggests that dilute formula with double-volume (half-strength) may lead to fewer episodes of gastric residuals per day (one study; mean difference (MD) −1.20, 95% confidence interval (CI) −2.20 to −0.20; low-certainty evidence), fewer episodes of gastric residuals per baby until attaining 100 kcal/kg (one study; MD −0.80, 95% CI −1.32 to −0.28; low-certainty evidence), fewer episodes of vomiting per day (one study; MD −0.04, 95% CI −0.07 to −0.01; low-certainty evidence) and fewer occurrences of abdominal distension greater than 2 cm (two studies; MD −0.16, 95% CI −0.19 to −0.13; low-certainty evidence). For the secondary outcomes, data suggest that infants in the dilute formula with double-volume (half-strength) group may have attained an adequate energy intake earlier than infants in the full-strength group (two studies; MD −2.26, 95% CI −2.85 to −1.67; low-certainty evidence). There was no evidence of a difference between groups for weight gain one week after commencement of intragastric feeds (one study; MD 0.05 kg, 95% CI −0.06 to 0.15; low-certainty evidence). Data were not reported for length of hospital stay.\nAuthors' conclusions\nThere is low-certainty evidence from three small, old trials that use of dilute formula in preterm or low birth weight formula-fed infants may lead to an important reduction in the time taken for preterm infants to attain an adequate energy intake.\nHowever, our confidence in this result is limited due to uncertainty over risk of bias and sparsity of available data. Dilute formula may reduce incidence of feeding intolerance, but the clinical significance of the reduction is uncertain. The impact on serious gastrointestinal problems, including necrotising enterocolitis, was not reported in any of the trials. Further randomised trials are needed to confirm these results.\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": "Babies born preterm (at less than 37 weeks' gestation) or with a low birth weight (less than 2500 grams) have special feeding requirements. Expressed breast milk is preferred, but preterm babies are often fed with formula milk because breast milk is not always available. The provision of artificial feeds varies considerably in preterm babies and there is concern that introducing full-strength formulas too early may lead to the retention of feed in the stomach, which is associated with feeding intolerance and necrotising enterocolitis, a severe bowel disorder."
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query-laysum | 5421 | [
{
"role": "user",
"content": "Abstract: Background\nUpper gastrointestinal (GI) bleeding due to stress ulcers contributes to increased morbidity and mortality in people admitted to intensive care units (ICUs). Stress ulceration refers to GI mucosal injury related to the stress of being critically ill. ICU patients with major bleeding as a result of stress ulceration might have mortality rates approaching 48.5% to 65%. However, the incidence of stress-induced GI bleeding in ICUs has decreased, and not all critically ill patients need prophylaxis. Stress ulcer prophylaxis can result in adverse events such as ventilator-associated pneumonia; therefore, it is necessary to evaluate strategies that safely decrease the incidence of GI bleeding.\nObjectives\nTo assess the effect and risk-benefit profile of interventions for preventing upper GI bleeding in people admitted to ICUs.\nSearch methods\nWe searched the following databases up to 23 August 2017, using relevant search terms: MEDLINE; Embase; the Cochrane Central Register of Controlled Trials; Latin American Caribbean Health Sciences Literature; and the Cochrane Upper Gastrointestinal and Pancreatic Disease Group Specialised Register, as published in the Cochrane Library (2017, Issue 8). We searched the reference lists of all included studies and those from relevant systematic reviews and meta-analyses to identify additional studies. We also searched the World Health Organization International Clinical Trials Registry Platform search portal and contacted individual researchers working in this field, as well as organisations and pharmaceutical companies, to identify unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs with participants of any age and gender admitted to ICUs for longer than 48 hours. We excluded studies in which participants were admitted to ICUs primarily for the management of GI bleeding and studies that compared different doses, routes, and regimens of one drug in the same class because we were not interested in intraclass effects of drugs.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane.\nMain results\nWe identified 2292 unique records.We included 129 records reporting on 121 studies, including 12 ongoing studies and two studies awaiting classification.\nWe judged the overall risk of bias of two studies as low. Selection bias was the most relevant risk of bias domain across the included studies, with 78 studies not clearly reporting the method used for random sequence generation. Reporting bias was the domain with least risk of bias, with 12 studies not reporting all outcomes that researchers intended to investigate.\nAny intervention versus placebo or no prophylaxis\nIn comparison with placebo, any intervention seems to have a beneficial effect on the occurrence of upper GI bleeding (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.39 to 0.57; moderate certainty of evidence). The use of any intervention reduced the risk of upper GI bleeding by 10% (95% CI -12.0% to -7%). The effect estimate of any intervention versus placebo or no prophylaxis with respect to the occurrence of nosocomial pneumonia, all-cause mortality in the ICU, duration of ICU stay, duration of intubation (all with low certainty of evidence), the number of participants requiring blood transfusions (moderate certainty of evidence), and the units of blood transfused was consistent with benefits and harms. None of the included studies explicitly reported on serious adverse events.\nIndividual interventions versus placebo or no prophylaxis\nIn comparison with placebo or no prophylaxis, antacids, H2 receptor antagonists, and sucralfate were effective in preventing upper GI bleeding in ICU patients. Researchers found that with H2 receptor antagonists compared with placebo or no prophylaxis, 11% less developed upper GI bleeding (95% CI -0.16 to -0.06; RR 0.50, 95% CI 0.36 to 0.70; 24 studies; 2149 participants; moderate certainty of evidence). Of ICU patients taking antacids versus placebo or no prophylaxis, 9% less developed upper GI bleeding (95% CI -0.17 to -0.00; RR 0.49, 95% CI 0.25 to 0.99; eight studies; 774 participants; low certainty of evidence). Among ICU patients taking sucralfate versus placebo or no prophylaxis, 5% less had upper GI bleeding (95% CI -0.10 to -0.01; RR 0.53, 95% CI 0.32 to 0.88; seven studies; 598 participants; moderate certainty of evidence). The remaining interventions including proton pump inhibitors did not show a significant effect in preventing upper GI bleeding in ICU patients when compared with placebo or no prophylaxis.\nRegarding the occurrence of nosocomial pneumonia, the effects of H2 receptor antagonists (RR 1.12, 95% CI 0.85 to 1.48; eight studies; 945 participants; low certainty of evidence) and of sucralfate (RR 1.33, 95% CI 0.86 to 2.04; four studies; 450 participants; low certainty of evidence) were consistent with benefits and harms when compared with placebo or no prophylaxis. None of the studies comparing antacids versus placebo or no prophylaxis provided data regarding nosocomial pneumonia.\nH2 receptor antagonists versus proton pump inhibitors\nH2 receptor antagonists and proton pump inhibitors are most commonly used in practice to prevent upper GI bleeding in ICU patients. Proton pump inhibitors significantly more often prevented upper GI bleeding in ICU patients compared with H2 receptor antagonists (RR 2.90, 95% CI 1.83 to 4.58; 18 studies; 1636 participants; low certainty of evidence). When taking H2 receptor antagonists, 4.8% more patients might experience upper GI bleeding (95% CI 2.1% to 9%). Nosocomial pneumonia occurred in similar proportions of participants taking H2 receptor antagonists and participants taking proton pump inhibitors (RR 1.02, 95% CI 0.77 to 1.35; 10 studies; 1256 participants; low certainty of evidence).\nAuthors' conclusions\nThis review shows that antacids, sucralfate, and H2 receptor antagonists might be more effective in preventing upper GI bleeding in ICU patients compared with placebo or no prophylaxis. The effect estimates of any treatment versus no prophylaxis on nosocomial pneumonia were consistent with benefits and harms. Evidence of low certainty suggests that proton pump inhibitors might be more effective than H2 receptor antagonists. Therefore, patient-relevant benefits and especially harms of H2 receptor antagonists compared with proton pump inhibitors need to be assessed by larger, high-quality RCTs to confirm the results of previously conducted, smaller, and older studies.\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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"role": "assistant",
"content": "Relevant effects were found for the following drugs: H2 receptor antagonists, antacids, sucralfate, and proton pump inhibitors.\nH2 receptor antagonists inhibit gastric acid secretion by blocking histamine receptors but can cause a small number of blood platelets (thrombocytopaenia), inflammation of the kidney (interstitial nephritis), and confusion. Antacids neutralise stomach acid but may cause diarrhoea or constipation. Proton pump inhibitors inhibit the final stage of gastric acid production, and it has been found that they may be associated with increased risk of Clostridium difficile diarrhoea. Ulcer protective agents, such as sucralfate, create a barrier between the gastric acid and the gastric mucosa by coating it. They may, however, cause constipation and interfere with the absorption of certain antibacterial agents.\nIn comparison with placebo or no preventive treatment, H2 receptor antagonists, antacids, and sucralfate might be effective in preventing clinically important upper GI bleeding in ICU patients. Hospital-acquired pneumonia was most likely to occur in ICU patients taking either H2 receptor antagonists or sucralfate when compared with patients given placebo or no preventive treatment.\nEvidence of low certainty suggests that proton pump inhibitors were more effective than H2 receptor antagonists in preventing upper GI bleeding in ICU patients. With proton pump inhibitors, 25 of 1000 people were likely to develop upper GI bleeding, and with H2 receptor antagonists, 73 of 1000 people (95% confidence interval 46 to 115 people) were likely to develop upper GI bleeding. The effect of H2 receptor antagonists versus proton pump inhibitors with respect to the risk for developing hospital-acquired pneumonia was consistent with benefits and harms."
}
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query-laysum | 5422 | [
{
"role": "user",
"content": "Abstract: Background\nAdvances in embryo culture media have led to a shift in in vitro fertilisation (IVF) practice from cleavage-stage embryo transfer to blastocyst-stage embryo transfer. The rationale for blastocyst-stage transfer is to improve both uterine and embryonic synchronicity and enable self selection of viable embryos, thus resulting in better live birth rates.\nObjectives\nTo determine whether blastocyst-stage (day 5 to 6) embryo transfer improves the live birth rate (LBR) per fresh transfer, and other associated outcomes, compared with cleavage-stage (day 2 to 3) embryo transfer.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL, from inception to October 2021. We also searched registers of ongoing trials and the reference lists of studies retrieved.\nSelection criteria\nWe included randomised controlled trials (RCTs) which compared the effectiveness of IVF with blastocyst-stage embryo transfer versus IVF with cleavage-stage embryo transfer.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Our primary outcomes were LBR per fresh transfer and cumulative clinical pregnancy rates (cCPR). Secondary outcomes were clinical pregnancy rate (CPR), multiple pregnancy, high-order multiple pregnancy, miscarriage (all following first embryo transfer), failure to transfer embryos, and whether supernumerary embryos were frozen for transfer at a later date (frozen-thawed embryo transfer). We assessed the overall quality of the evidence for the main comparisons using GRADE methods.\nMain results\nWe included 32 RCTs (5821 couples or women).\nThe live birth rate following fresh transfer was higher in the blastocyst-stage transfer group (odds ratio (OR) 1.27, 95% confidence interval (CI) 1.06 to 1.51; I2 = 53%; 15 studies, 2219 women; low-quality evidence). This suggests that if 31% of women achieve live birth after fresh cleavage-stage transfer, between 32% and 41% would do so after fresh blastocyst-stage transfer.\nWe are uncertain whether blastocyst-stage transfer improves the cCPR. A post hoc analysis showed that vitrification could increase the cCPR. This is an interesting finding that warrants further investigation when more studies using vitrification are published.\nThe CPR was also higher in the blastocyst-stage transfer group, following fresh transfer (OR 1.25, 95% CI 1.12 to 1.39; I2 = 51%; 32 studies, 5821 women; moderate-quality evidence). This suggests that if 39% of women achieve a clinical pregnancy after fresh cleavage-stage transfer, between 42% and 47% will probably do so after fresh blastocyst-stage transfer.\nWe are uncertain whether blastocyst-stage transfer increases multiple pregnancy (OR 1.05, 95% CI 0.83 to 1.33; I2 = 30%; 19 studies, 3019 women; low-quality evidence) or miscarriage rates (OR 1.12, 95% CI 0.90 to 1.38; I2 = 24%; 22 studies, 4208 women; low-quality evidence). This suggests that if 9% of women have a multiple pregnancy after fresh cleavage-stage transfer, between 8% and 12% would do so after fresh blastocyst-stage transfer. However, a sensitivity analysis restricted only to studies with low or 'some concerns' for risk of bias, in the subgroup of equal number of embryos transferred, showed that blastocyst transfer probably increases the multiple pregnancy rate.\nEmbryo freezing rates (when there are frozen supernumerary embryos for transfer at a later date) were lower in the blastocyst-stage transfer group (OR 0.48, 95% CI 0.40 to 0.57; I2 = 84%; 14 studies, 2292 women; low-quality evidence). This suggests that if 60% of women have embryos frozen after cleavage-stage transfer, between 37% and 46% would do so after blastocyst-stage transfer.\nFailure to transfer any embryos was higher in the blastocyst transfer group (OR 2.50, 95% CI 1.76 to 3.55; I2 = 36%; 17 studies, 2577 women; moderate-quality evidence). This suggests that if 1% of women have no embryos transferred in planned fresh cleavage-stage transfer, between 2% and 4% probably have no embryos transferred in planned fresh blastocyst-stage transfer.\nThe evidence was of low quality for most outcomes. The main limitations were serious imprecision and serious risk of bias, associated with failure to describe acceptable methods of randomisation.\nAuthors' conclusions\nThere is low-quality evidence for live birth and moderate-quality evidence for clinical pregnancy that fresh blastocyst-stage transfer is associated with higher rates of both than fresh cleavage-stage transfer. We are uncertain whether blastocyst-stage transfer improves the cCPR derived from fresh and frozen-thawed cycles following a single oocyte retrieval. Although there is a benefit favouring blastocyst-stage transfer in fresh cycles, more evidence is needed to know whether the stage of transfer impacts on cumulative live birth and pregnancy rates. Future RCTs should report rates of live birth, cumulative live birth, and miscarriage. They should also evaluate women with a poor prognosis to enable those undergoing assisted reproductive technology (ART) and service providers to make well-informed decisions on the best treatment option available.\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": "Many women and couples are unlikely to get pregnant and have a baby without medical treatment, due to infertility. Doctors have developed a variety of assisted reproductive technologies (ARTs), such as in vitro fertilisation (IVF), which involve the manipulation of eggs and sperm outside a woman's body, to try to increase her chances of getting pregnant.\nTypically, in assisted conception, doctors collect eggs from a woman and fertilise them in a laboratory, leading to the formation of embryos. An embryo is the early stage of human development. Doctors commonly transfer one or several embryos into a woman’s womb (uterus) at one of two stages of embryo development: either the cleavage stage, which is 2 or 3 days after egg collection when an embryo typically consists of between 2 and 128 cells; or the blastocyst stage, which is 5 or 6 days after egg collection when an embryo consists of between 70 and 100 cells.\nUntil recently, doctors usually transferred embryos at the earlier, cleavage, stage. However, there has been a trend to transferring embryos at the later, blastocyst, stage. Researchers believe that only those embryos capable of surviving make it to the blastocyst stage; in other words, viable embryos will self-select. So, it is thought that transferring embryos at the later stage may improve a woman's chances of becoming pregnant and having a healthy baby."
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query-laysum | 5423 | [
{
"role": "user",
"content": "Abstract: Background\nDay surgery involves admission of selected patients to hospital for a planned surgical procedure with the patients returning home on the same day. An anaesthetic regimen usually involves a combination of an anxiolytic, an induction agent, a maintenance agent, a method of maintaining the airway (laryngeal mask versus endotracheal intubation), and a muscle relaxant. The effect of anaesthesia may continue after the completion of surgery and can delay discharge. Various regimens of anaesthesia have been suggested for day-procedure laparoscopic cholecystectomy.\nObjectives\nTo compare the benefits and harms of different anaesthetic regimens (risks of mortality and morbidity, measures of recovery after surgery) in patients undergoing day-procedure laparoscopic cholecystectomy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 10, 2013), MEDLINE (PubMed) (1987 to November 2013), EMBASE (OvidSP) (1987 to November 2013), Science Citation Index Expanded (ISI Web of Knowledge) (1987 to November 2013), LILACS (Virtual Health Library) (1987 to November 2013), metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) (November 2013), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal (November 2013), and ClinicalTrials.gov (November 2013).\nSelection criteria\nWe included randomized clinical trials comparing different anaesthetic regimens during elective day-procedure laparoscopic cholecystectomy (irrespective of language or publication status).\nData collection and analysis\nTwo authors independently assessed trials for inclusion and independently extracted the data. We calculated the risk ratio, rate ratio or mean difference with 95% confidence intervals based on intention-to-treat or available data analysis.\nMain results\nWe included 11 trials involving 1069 participants at low anaesthetic risk. The sample size varied from 40 to 300 participants. We included 23 comparisons. All trials were at a high risk of bias. We were unable to perform a meta-analysis because there were no two trials involving the same comparison. Primary outcomes included perioperative mortality, serious morbidity and proportion of patients who were discharged on the same day. There were no perioperative deaths or serious adverse events in either group in the only trial that reported this information (0/60). There was no clear evidence of a difference in the proportion of patients who were discharged on the same day between any of the comparisons. Overall, 472/554 patients (85%) included in this review were discharged as day-procedure laparoscopic cholecystectomy patients. Secondary outcomes included hospital readmissions, health-related quality of life, pain, return to activity and return to work. There was no clear evidence of a difference in hospital readmissions within 30 days in the only comparison in which this outcome was reported. One readmission was reported in the 60 patients (2%) in whom this outcome was assessed. Quality of life was not reported in any of the trials. There was no clear evidence of a difference in the pain intensity, measured by a visual analogue scale, between comparators in the only trial which reported the pain intensity at between four and eight hours after surgery. Times to return to activity and return to work were not reported in any of the trials.\nAuthors' conclusions\nThere is currently insufficient evidence to conclude that one anaesthetic regimen for day-procedure laparoscopic cholecystectomy is to be preferred over another. However, the data are sparse (that is, there were few trials under each comparison and the trials had few participants) and further well designed randomized trials at low risk of bias and which are powered to measure differences in clinically important outcomes are necessary to determine the optimal anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "All the trials had elements that tended to reduce our trust in the accuracy of the results. Few patients were included in each comparison resulting in a considerable chance of arriving at erroneous conclusions."
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query-laysum | 5424 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is an inherited life-limiting disorder. Over time persistent infection and inflammation within the lungs contribute to severe airway damage and loss of respiratory function. Chest physiotherapy, or airway clearance techniques (ACTs), are integral in removing airway secretions and initiated shortly after CF diagnosis. Conventional chest physiotherapy (CCPT) generally requires assistance, while alternative ACTs can be self-administered, facilitating independence and flexibility. This is an updated review.\nObjectives\nTo evaluate the effectiveness (in terms of respiratory function, respiratory exacerbations, exercise capacity) and acceptability (in terms of individual preference, adherence, quality of life) of CCPT for people with CF compared to alternative ACTs.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was 26 June 2022.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials (including cross-over design) lasting at least seven days and comparing CCPT with alternative ACTs in people with CF.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. pulmonary function tests and 2. number of respiratory exacerbations per year. Our secondary outcomes were 3. quality of life, 4. adherence to therapy, 5. cost–benefit analysis, 6. objective change in exercise capacity, 7. additional lung function tests, 8. ventilation scanning, 9. blood oxygen levels, 10. nutritional status, 11. mortality, 12. mucus transport rate and 13. mucus wet or dry weight.\nWe reported outcomes as short-term (seven to 20 days), medium-term (more than 20 days to up to one year) and long-term (over one year).\nMain results\nWe included 21 studies (778 participants) comprising seven short-term, eight medium-term and six long-term studies. Studies were conducted in the USA (10), Canada (five), Australia (two), the UK (two), Denmark (one) and Italy (one) with a median of 23 participants per study (range 13 to 166). Participant ages ranged from newborns to 45 years; most studies only recruited children and young people. Sixteen studies reported the sex of participants (375 males; 296 females).\nMost studies compared modifications of CCPT with a single comparator, but two studies compared three interventions and another compared four interventions. The interventions varied in the duration of treatments, times per day and periods of comparison making meta-analysis challenging. All evidence was very low certainty.\nNineteen studies reported the primary outcomes forced expiratory volume in one second (FEV1)and forced vital capacity (FVC), and found no difference in change from baseline in FEV1 % predicted or rate of decline between groups for either measure. Most studies suggested equivalence between CCPT and alternative ACTs, including positive expiratory pressure (PEP), extrapulmonary mechanical percussion, active cycle of breathing technique (ACBT), oscillating PEP devices (O-PEP), autogenic drainage (AD) and exercise. Where single studies suggested superiority of one ACT, these findings were not corroborated in similar studies; pooled data generally concluded that effects of CCPT were comparable to those of alternative ACTs.\nCCPT versus PEP\nWe are uncertain whether CCPT improves lung function or has an impact on the number of respiratory exacerbations per year compared with PEP (both very low-certainty evidence). There were no analysable data for our secondary outcomes, but many studies provided favourable narrative reports on the independence achieved with PEP mask therapy.\nCCPT versus extrapulmonary mechanical percussion\nWe are uncertain whether CCPT improves lung function compared with extrapulmonary mechanical percussions (very low-certainty evidence). The annual rate of decline in average forced expiratory flow between 25% and 75% of FVC (FEF25–75) was greater with high-frequency chest compression compared to CCPT in medium- to long-term studies, but there was no difference in any other outcome.\nCCPT versus ACBT\nWe are uncertain whether CCPT improves lung function compared to ACBT (very low-certainty evidence). Annual decline in FEF25–75 was worse in participants using the FET component of ACBT only (mean difference (MD) 6.00, 95% confidence interval (CI) 0.55 to 11.45; 1 study, 63 participants; very low-certainty evidence). One short-term study reported that directed coughing was as effective as CCPT for all lung function outcomes, but with no analysable data. One study found no difference in hospital admissions and days in hospital for exacerbations.\nCCPT versus O-PEP\nWe are uncertain whether CCPT improves lung function compared to O-PEP devices (Flutter device and intrapulmonary percussive ventilation); however, only one study provided analysable data (very low-certainty evidence). No study reported data for number of exacerbations. There was no difference in results for number of days in hospital for an exacerbation, number of hospital admissions and number of days of intravenous antibiotics; this was also true for other secondary outcomes.\nCCPT versus AD\nWe are uncertain whether CCPT improves lung function compared to AD (very low-certainty evidence). No studies reported the number of exacerbations per year; however, one study reported more hospital admissions for exacerbations in the CCPT group (MD 0.24, 95% CI 0.06 to 0.42; 33 participants). One study provided a narrative report of a preference for AD.\nCCPT versus exercise\nWe are uncertain whether CCPT improves lung function compared to exercise (very low-certainty evidence). Analysis of original data from one study demonstrated a higher FEV1 % predicted (MD 7.05, 95% CI 3.15 to 10.95; P = 0.0004), FVC (MD 7.83, 95% CI 2.48 to 13.18; P = 0.004) and FEF25–75 (MD 7.05, 95% CI 3.15 to 10.95; P = 0.0004) in the CCPT group; however, the study reported no difference between groups (likely because the original analysis accounted for baseline differences).\nAuthors' conclusions\nWe are uncertain whether CCPT has a more positive impact on respiratory function, respiratory exacerbations, individual preference, adherence, quality of life, exercise capacity and other outcomes when compared to alternative ACTs as the certainty of the evidence is very low.\nThere was no advantage in respiratory function of CCPT over alternative ACTs, but this may reflect insufficient evidence rather than real equivalence. Narrative reports indicated that participants prefer self-administered ACTs. This review is limited by a paucity of well-designed, adequately powered, long-term studies. This review cannot yet recommend any single ACT above others; physiotherapists and people with CF may wish to try different ACTs until they find an ACT that suits them best.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to compare how different ACTs affect lung function (how well the lungs work), respiratory exacerbations (flare-ups of lung disease), a person's preference, adherence (how well the person follows their doctor's advice), quality of life and impact on fitness levels."
}
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query-laysum | 5425 | [
{
"role": "user",
"content": "Abstract: Background\nHealthy sleep is an important component of childhood development. Changes in sleep architecture, including sleep stage composition, quantity, and quality from infancy to adolescence are a reflection of neurologic maturation. Hospital admission for acute illness introduces modifiable risk factors for sleep disruption that may negatively affect active brain development during a period of illness and recovery. Thus, it is important to examine non-pharmacologic interventions for sleep promotion in the pediatric inpatient setting.\nObjectives\nTo evaluate the effect of non-pharmacological sleep promotion interventions in hospitalized children and adolescents on sleep quality and sleep duration, child or parent satisfaction, cost-effectiveness, delirium incidence, length of mechanical ventilation, length of stay, and mortality.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, three other databases, and three trials registers to December 2021. We searched Google Scholar, and two websites, handsearched conference abstracts, and checked reference lists of included studies.\nSelection criteria\nRandomized controlled trials (RCTs) or quasi-RCTs, including cross-over trials, investigating the effects of any non-pharmacological sleep promotion intervention on the sleep quality or sleep duration (or both) of children aged 1 month to 18 years in the pediatric inpatient setting (intensive care unit [ICU] or general ward setting).\nData collection and analysis\nTwo review authors independently assessed trial eligibility, evaluated risk of bias, extracted and synthesized data, and used the GRADE approach to assess certainty of evidence. The primary outcomes were changes in both objective and subjective validated measures of sleep in children; secondary outcomes were child and parent satisfaction, cost-effectiveness ratios, delirium incidence or delirium-free days at time of hospital discharge, duration of mechanical ventilation, length of hospital stay, and mortality.\nMain results\nWe included 10 trials (528 participants; aged 3 to 22 years) in inpatient pediatric settings. Seven studies were conducted in the USA, two in Canada, and one in Brazil. Eight studies were funded by government, charity, or foundation grants. Two provided no information on funding.\nEight studies investigated behavioral interventions (massage, touch therapy, and bedtime stories); two investigated physical activity interventions. Duration and timing of interventions varied widely. All studies were at high risk of performance bias due to the nature of the intervention, as participants, parents, and staff could not be masked to group assignment.\nWe were unable to perform a quantitative synthesis due to substantial clinical heterogeneity.\nBehavioral interventions versus usual care\nFive studies (145 participants) provided low-certainty evidence of no clear difference between multicomponent relaxation interventions and usual care on objective sleep measures. Overall, evidence from single studies found no clear differences in daytime or nighttime sleep measures (33 participants); any sleep parameter (48 participants); or daytime or nighttime sleep or nighttime arousals (20 participants). One study (34 participants) reported no effect of massage on nighttime sleep, sleep efficiency (SE), wake after sleep onset (WASO), or total sleep time (TST) in adolescents with cancer. Evidence from a cross-over study in 10 children with burns suggested touch therapy may increase TST (391 minutes, interquartile range [IQR] 251 to 467 versus 331 minutes, IQR 268 to 373; P = 0.02); SE (76, IQR 53 to 90 versus 66, IQR 55 to 78; P = 0.04); and the number of rapid eye movement (REM) periods (4.5, IQR 2 to 5 versus 3.5, IQR 2 to 4; P = 0.03); but not WASO, sleep latency (SL), total duration of REM, or per cent of slow wave sleep.\nFour studies (232 participants) provided very low-certainty evidence on subjective measures of sleep. Evidence from single studies found that sleep efficiency may increase, and the percentage of nighttime wakefulness may decrease more over a five-day period following a massage than usual care (72 participants). One study (48 participants) reported an improvement in Children's Sleep Habits Questionnaire scores after discharge in children who received a multicomponent relaxation intervention compared to usual care. In another study, mean sleep duration per sleep episode was longer (23 minutes versus 15 minutes), and time to fall asleep was shorter (22 minutes versus 27 minutes) following a bedtime story versus no story (18 participants); and children listening to a parent-recorded story had longer SL than when a parent was present (mean 57.5 versus 43.5 minutes); both groups reported longer SL than groups who had a stranger-recorded story, and those who had no story and absent parents (94 participants; P < 0.001).\nIn one study (34 participants), 87% (13/15) of participants felt they slept better following massage, with most parents (92%; 11/12) reporting they wanted their child to receive a massage again. Another study (20 participants) reported that parents thought the music, touch, and reading components of the intervention were acceptable, feasible, and had positive effects on their children (very low-certainty evidence).\nPhysical activity interventions versus usual care\nOne study (29 participants) found that an enhanced physical activity intervention may result in little or no improvement in TST or SE compared to usual care (low-certainty evidence). Another study (139 participants), comparing play versus no play found inconsistent results on subjective measures of sleep across different ages (TST was 49% higher for the no play groups in 4- to 7-year olds, 10% higher in 7- to 11-year olds, and 22% higher in 11- to 14-year olds). This study also found inconsistent results between boys and girls (girls in the first two age groups in the play group slept more than the no play group).\nNo study evaluated child or parent satisfaction for behavioral interventions, or cost-effectiveness, delirium incidence or delirium-free days at hospital discharge, length of mechanical ventilation, length of hospital stay, or mortality for either behavioral or physical activity intervention.\nAuthors' conclusions\nThe included studies were heterogeneous, so we could not quantitatively synthesize the results. Our narrative summary found inconsistent, low to very low-certainty evidence. Therefore, we are unable to determine how non-pharmacologic sleep promotion interventions affect sleep quality or sleep duration compared with usual care or other interventions.\nThe evidence base should be strengthened through design and conduct of randomized trials, which use validated and highly reliable sleep assessment tools, including objective measures, such as polysomnography and actigraphy.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out whether non-medicinal ways of trying to improve sleep work better than usual care or other methods in hospitalized children.\nWe wanted to look at how well these different methods worked on:\n- the quality and quantity of sleep in the children;\n- child and parent satisfaction;\n- length of time for which breathing was supported by a ventilator (ventilator support);\n- delirium;\n- cost-effectiveness;\n- length of hospital stay; and\n- mortality.\nWe also wanted to find out if non-medicinal methods were associated with any unwanted effects."
}
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query-laysum | 5426 | [
{
"role": "user",
"content": "Abstract: Background\nSelf-management interventions help people with chronic obstructive pulmonary disease (COPD) to acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable them to control their disease. Since the 2014 update of this review, several studies have been published.\nObjectives\nPrimary objectives\nTo evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of health-related quality of life (HRQoL) and respiratory-related hospital admissions.\nTo evaluate the safety of COPD self-management interventions compared to usual care in terms of respiratory-related mortality and all-cause mortality.\nSecondary objectives\nTo evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of other health outcomes and healthcare utilisation.\nTo evaluate effective characteristics of COPD self-management interventions.\nSearch methods\nWe searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, EMBASE, trials registries and the reference lists of included studies up until January 2020.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-randomised trials (CRTs) published since 1995. To be eligible for inclusion, self-management interventions had to include at least two intervention components and include an iterative process between participant and healthcare provider(s) in which goals were formulated and feedback was given on self-management actions by the participant.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. We contacted study authors to obtain additional information and missing outcome data where possible. Primary outcomes were health-related quality of life (HRQoL), number of respiratory-related hospital admissions, respiratory-related mortality, and all-cause mortality. When appropriate, we pooled study results using random-effects modelling meta-analyses.\nMain results\nWe included 27 studies involving 6008 participants with COPD. The follow-up time ranged from two-and-a-half to 24 months and the content of the interventions was diverse. Participants' mean age ranged from 57 to 74 years, and the proportion of male participants ranged from 33% to 98%. The post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of participants ranged from 33.6% to 57.0%. The FEV1/FVC ratio is a measure used to diagnose COPD and to determine the severity of the disease. Studies were conducted on four different continents (Europe (n = 15), North America (n = 8), Asia (n = 1), and Oceania (n = 4); with one study conducted in both Europe and Oceania).\nSelf-management interventions likely improve HRQoL, as measured by the St. George’s Respiratory Questionnaire (SGRQ) total score (lower score represents better HRQoL) with a mean difference (MD) from usual care of -2.86 points (95% confidence interval (CI) -4.87 to -0.85; 14 studies, 2778 participants; low-quality evidence). The pooled MD of -2.86 did not reach the SGRQ minimal clinically important difference (MCID) of four points. Self-management intervention participants were also at a slightly lower risk for at least one respiratory-related hospital admission (odds ratio (OR) 0.75, 95% CI 0.57 to 0.98; 15 studies, 3263 participants; very low-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over a mean of 9.75 months' follow-up was 15 (95% CI 8 to 399) for participants with high baseline risk and 26 (95% CI 15 to 677) for participants with low baseline risk. No differences were observed in respiratory-related mortality (risk difference (RD) 0.01, 95% CI -0.02 to 0.04; 8 studies, 1572 participants ; low-quality evidence) and all-cause mortality (RD -0.01, 95% CI -0.03 to 0.01; 24 studies, 5719 participants; low-quality evidence).\nWe graded the evidence to be of ‘moderate’ to ‘very low’ quality according to GRADE. All studies had a substantial risk of bias, because of lack of blinding of participants and personnel to the interventions, which is inherently impossible in a self-management intervention. In addition, risk of bias was noticeably increased because of insufficient information regarding a) non-protocol interventions, and b) analyses to estimate the effect of adhering to interventions. Consequently, the highest GRADE evidence score that could be obtained by studies was ‘moderate’.\nAuthors' conclusions\nSelf-management interventions for people with COPD are associated with improvements in HRQoL, as measured with the SGRQ, and a lower probability of respiratory-related hospital admissions. No excess respiratory-related and all-cause mortality risks were observed, which strengthens the view that COPD self-management interventions are unlikely to cause harm. By using stricter inclusion criteria, we decreased heterogeneity in studies, but also reduced the number of included studies and therefore our capacity to conduct subgroup analyses. Data were therefore still insufficient to reach clear conclusions about effective (intervention) characteristics of COPD self-management interventions. As tailoring of COPD self-management interventions to individuals is desirable, heterogeneity is and will likely remain present in self-management interventions.\nFor future studies, we would urge using only COPD self-management interventions that include iterative interactions between participants and healthcare professionals who are competent using behavioural change techniques (BCTs) to elicit participants' motivation, confidence and competence to positively adapt their health behaviour(s) and develop skills to better manage their disease. In addition, to inform further subgroup and meta-regression analyses and to provide stronger conclusions regarding effective COPD self-management interventions, there is a need for more homogeneity in outcome measures. More attention should be paid to behavioural outcome measures and to providing more detailed, uniform and transparently reported data on self-management intervention components and BCTs. Assessment of outcomes over the long term is also recommended to capture changes in people's behaviour. Finally, information regarding non-protocol interventions as well as analyses to estimate the effect of adhering to interventions should be included to increase the quality of evidence.\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 for studies up until January 2020."
}
]
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query-laysum | 5427 | [
{
"role": "user",
"content": "Abstract: Background\nPhacoemulsification cataract surgery is usually performed in adults under local anaesthesia. Topical anaesthesia, which involves instilling anaesthetic drops to the ocular surface prior to and during surgery, has found large acceptance internationally. It is safe and allows for rapid patient turnover and visual recovery. Some surgeons have supplemented topical anaesthesia with intracameral lidocaine, reasoning that this may further reduce intraoperative pain, particularly during surgical stages involving manipulation of intraocular structures and rapid changes in fluid dynamics. This review, originally published in 2006 and updated in 2020, explores the efficacy and safety of using supplementary intracameral lidocaine in phacoemulsification cataract surgery.\nObjectives\nTo assess whether supplementing topical anaesthesia with intracameral lidocaine for phacoemulsification cataract surgery in adults reduces intraoperative and postoperative pain, and to assess differences in participant satisfaction, need for additional intraoperative anaesthesia, surgeon satisfaction, measures of intraocular toxicity, and adverse effects attributable to choice of anaesthesia.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, LILACS BIREME iAH, and six trial registries on 4 February 2020. We also searched the reference lists of identified studies. There were no language restrictions.\nSelection criteria\nWe included only randomized controlled trials (RCTs) where participants underwent phacoemulsification for age-related cataract under topical anaesthesia with or without intracameral lidocaine either in two eyes of the same participant, or in different participants. We also included studies that used oral or intravenous sedation in addition to local anaesthesia.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial methodological quality using standard Cochrane procedures.\nMain results\nWe identified five new RCTs in this updated review. We included a total of 13 trials in the review, conducted in the UK, the USA, Australia, Italy, Canada, Taiwan, Singapore, India, and Pakistan, and comprising 2388 eyes of 2355 participants (one study was a paired-eye study with each participant acting as their own control). The age range of participants was 34 to 95 years. We excluded studies that only included low-risk participants and excluded more difficult operative cases, for example hard lens nuclei or small pupils. We excluded studies assessing only participants with Fuchs' endothelial dystrophy.\nWe judged one study as at high risk for selection bias. We assessed five studies as having an unclear risk of bias for random sequence generation and seven studies an unclear risk of bias for allocation concealment. We judged three studies as at high risk of performance bias, as the surgeon was not blinded, and two studies as at unclear risk of bias for this domain. No studies were judged as at high risk for detection bias, but five studies were judged to have an unclear risk of bias for this domain. We judged all 13 included studies to have a low risk of attrition bias and an unclear risk of reporting bias.\nData from eight RCTs favoured topical anaesthesia plus intracameral lidocaine 0.5% to 1% over topical anaesthesia alone for reducing intraoperative pain when measured using a 10-point visual analogue scale, analysed as a continuous outcome. Mean pain score was 0.26 lower in the supplemental intracameral lidocaine group (95% confidence interval (CI) −0.39 to −0.13, 1692 eyes, moderate-quality evidence). Data from seven RCTs favoured supplemental intracameral lidocaine for reducing intraoperative pain when measured as a dichotomous outcome. The odds ratio of experiencing any pain was 0.40 versus the topical anaesthesia-only group (95% CI 0.29 to 0.57, 1268 eyes, moderate-quality evidence). Data from four RCTs did not show any additional benefit on postoperative pain when measured using a 10-point visual analogue scale (mean difference 0.12 points, 95% CI −0.29 to 0.05, 751 eyes, moderate-quality evidence).\nThe impact on participant satisfaction was uncertain as only one small study investigated this outcome. The study suggested no difference between groups (mean difference 0.1 points, 95% CI −0.47 to 0.27, 60 eyes, low-quality evidence).\nData from seven RCTs did not demonstrate a difference between groups in the need for additional intraoperative anaesthesia (odds ratio 0.88, 95% CI 0.56 to 1.39, 1194 eyes of 1161 participants; low-quality evidence), although this result is uncertain.\nA variety of measures were reported relating to possible intraocular toxicity. Data from four RCTs did not demonstrate a difference between groups in mean percentage corneal endothelial cell count change from pre- to postoperatively (mean difference 0.89%, 95% CI −1.12% to 2.9%, 254 eyes of 221 participants, moderate-quality evidence).\nSynthesis of the evidence from eight RCTs identified no difference in intraoperative adverse events between groups (odds ratio 1.00, 95% CI 0.32 to 3.16, 1726 eyes, low-quality evidence). This result should be interpreted with caution, mainly due to a lack of clear definitions of adverse events, low numbers of events, heterogeneity between studies, and large confidence intervals. Large observational studies may have been more appropriate for looking at this outcome.\nAuthors' conclusions\nThere is moderate-quality evidence that supplementation of topical anaesthesia with intracameral lidocaine 0.5% to 1% for phacoemulsification cataract surgery in adults reduces participant perception of intraoperative pain. The odds of experiencing any pain (as opposed to no pain) were 60% less for the topical anaesthesia plus intracameral lidocaine group versus the topical anaesthesia-only group. However, the numerical amplitude of the effect may not be of great clinical significance on the continuous pain score scale. Generally, the pain scores were consistently low for both techniques. We found moderate-quality evidence that there is no additional benefit of intracameral lidocaine on postoperative pain. There is insufficient evidence to determine the impact on participant satisfaction and need for additional intraoperative anaesthesia due to low-quality evidence. There is moderate-quality evidence that intracameral lidocaine supplementation does not increase measures of intraocular toxicity, specifically loss of corneal endothelial cells. There is low-quality evidence that the incidence of intraoperative adverse events is unchanged with intracameral lidocaine supplementation, but as RCTs are not the optimum medium for looking at this, this result should be interpreted with caution.\nFurther research specifically investigating the adverse effects of intracameral anaesthesia might help to better determine its safety profile. Economic evaluations would also be useful for detailing cost implications.\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": "Lidocaine injection plus anaesthetic eye drops probably reduced the level of pain during a cataract operation more than using anaesthetic eye drops alone, and led to fewer people reporting pain during the operation. However, pain ratings for this operation were generally low both with and without a lidocaine injection, so this difference may not be clinically important.\nLidocaine injection plus anaesthetic eye drops did not reduce the level of pain people said they felt after their operation. Although lidocaine injection did not cause additional eye damage, we are uncertain whether its use causes more unwanted effects than eye drops alone."
}
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query-laysum | 5428 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants who are fed breast milk in comparison to infant formula have decreased morbidity such as necrotizing enterocolitis. Multi-nutrient fortifiers used to increase the nutritional content of the breast milk are commonly derived from bovine milk. Human milk-derived multi-nutrient fortifier is now available, but it is not clear if it improves outcomes in preterm infants fed with breast milk.\nObjectives\nTo determine whether the fortification of breast milk feeds with human milk-derived fortifier in preterm infants reduces mortality, morbidity, and promotes growth and development compared to bovine milk-derived fortifier.\nSearch methods\nWe searched the following databases for relevant trials in September 2018.\nCochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 9), electronic journal reference databases including MEDLINE (1980 to 20 September 2018), PREMEDLINE, Embase (1974 to 20 September 2018), CINAHL (1982 to 20 September 2018), biological abstracts in the database BIOSIS and conference abstracts from 'Proceedings First' (from 1992 to 2011). We also included the following clinical trials registries for ongoing or recently completed trials: ClinicalTrials.gov (ClinicalTrials.gov), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP; www.whoint/ictrp/search/en/) and the ISRCTN Registry (www.isrctn.com/), and abstracts of conferences: proceedings of Pediatric Academic Societies (American Pediatric Society, Society for Pediatric Research and European Society for Paediatric Research) from 1990 in the 'Pediatric Research' journal and 'Abstracts online' (2000 to 2017).\nSelection criteria\nWe included randomized and quasi-randomized controlled trials that compared preterm infants fed breast milk fortified with human milk-derived fortifier versus those fed with breast milk fortified with bovine milk-derived fortifier.\nData collection and analysis\nThe data were collected using the standard methods of Cochrane Neonatal. Two authors evaluated trial quality of the studies and extracted data. We reported dichotomous data using risk ratios (RRs), risk differences (RDs), number needed to treat (NNT) where applicable, and continuous data using mean differences (MDs). We assessed the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nOne randomized trial with 127 infants met the eligibility criteria and had low risk of bias. Human milk-based fortifier did not decrease the risk of necrotizing enterocolitis in exclusively breast milk-fed preterm infants (RR 0.95, 95% CI 0.2 to 4.54; 1 study, 125 infants, low certainty of evidence). Human milk-derived fortifiers did not improve growth, decrease feeding intolerance, late-onset sepsis, or death.\nAuthors' conclusions\nThere is insufficient evidence evaluating human milk-derived fortifier with bovine milk-derived fortifier in exclusively breast milk-fed preterm infants. Low-certainty evidence from one study suggests that in exclusively breast milk-fed preterm infants human milk-derived fortifiers in comparison with bovine milk-derived fortifier may not change the risk of necrotizing enterocolitis, mortality, feeding intolerance, infection, or improve growth. Well-designed randomized controlled trials are needed to evaluate short-term and long-term outcomes.\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": "Nutrients made from human milk (multi-nutrient fortifier), when compared with nutrients made from cow's milk, may not change the occurrence of illnesses or improve the growth in preterm infants fed only with breast milk. This evidence is insufficient to conclude whether nutrient made from human milk (multi-nutrient fortifier) when provided to preterm infants fed only with breast milk is beneficial or not. More studies are needed to address this important question."
}
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query-laysum | 5429 | [
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia (FM) is a clinically well-defined chronic condition of unknown aetiology characterized by chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction and fatigue. Patients often report high disability levels and negative mood. Psychotherapies focus on reducing key symptoms, improving daily functioning, mood and sense of personal control over pain.\nObjectives\nTo assess the benefits and harms of cognitive behavioural therapies (CBTs) for treating FM at end of treatment and at long-term (at least six months) follow-up.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE (1966 to 28 August 2013), PsycINFO (1966 to 28 August 2013) and SCOPUS (1980 to 28 August 2013). We searched http://www.clinicaltrials.gov (web site of the US National Institutes of Health) and the World Health Organization Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/) for ongoing trials (last search 28 August,2013), and the reference lists of reviewed articles.\nSelection criteria\nWe selected randomised controlled trials of CBTs with children, adolescents and adults diagnosed with FM.\nData collection and analysis\nThe data of all included studies were extracted and the risks of bias of the studies were assessed independently by two review authors. Discrepancies were resolved by discussion.\nMain results\nTwenty-three studies with 24 study arms with CBTs were included. A total of 2031 patients were included; 1073 patients in CBT groups and 958 patients in control groups. Only two studies were without any risk of bias. The GRADE quality of evidence of the studies was low. CBTs were superior to controls in reducing pain at end of treatment by 0.5 points on a scale of 0 to 10 (standardised mean difference (SMD) - 0.29; 95% confidence interval (CI) -0.49 to -0.17) and by 0.6 points at long-term follow-up (median 6 months) (SMD -0.40; 95% CI -0.62 to -0.17); in reducing negative mood at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.33; 95% CI -0.49 to -0.17) and by 1.3 points at long-term follow-up (median 6 months) (SMD -0.43; 95% CI -0.75 to -0.11); and in reducing disability at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.30; 95% CI -0.51 to -0.08) and at long-term follow-up (median 6 months) by 1.2 points (SMD -0.52; 95% CI -0.86 to -0.18). There was no statistically significant difference in dropout rates for any reasons between CBTs and controls (risk ratio (RR) 0.94; 95% CI 0.65 to 1.35).\nAuthors' conclusions\nCBTs provided a small incremental benefit over control interventions in reducing pain, negative mood and disability at the end of treatment and at long-term follow-up. The dropout rates due to any reason did not differ between CBTs and controls.\n\nGiven the provided abstract, please respond to the following query: \"Negative mood\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "(higher scores mean worse or more severe negative mood):\n- People who used CBTs rated their depressed mood to be 0.7 points lower at the end of treatment (10.2% absolute improvement) and to be 1.3 points lower six months after the end of treatment on a scale of 0 to 10 (2.7% absolute improvement).\n- People who used CBTs rated their negative mood to be 6.1 points on a scale of 0 to 10.\n- People who had a control treatment rated their negative mood to be 6.8 points on a scale of 0 to 10."
}
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query-laysum | 5430 | [
{
"role": "user",
"content": "Abstract: Background\nHair has traditionally been removed from the surgical site before surgery; however, some studies claim that this increases surgical site infections (SSIs) and should be avoided. This is the second update of a review published in 2006 and first updated in 2011.\nObjectives\nTo determine whether routine preoperative hair removal (compared with no removal) and the method, timing, or setting of hair removal effect SSI rates.\nSearch methods\nIn November 2019, for this second update we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase; and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies, and scanned the reference lists of included studies plus reviews to identify additional studies. We applied no date or language restrictions.\nSelection criteria\nWe included randomised controlled trials or quasi-randomised trials that compared:\n· hair removal with no hair removal;\n· different methods of hair removal; and\n· hair removal at different times before surgery.\nData collection and analysis\nTwo review authors independently assessed the relevance of each study. Data were extracted independently by both review authors and cross-checked. We carried out 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool and assessed the certainty of evidence according to GRADE. Sensitivity analyses excluding studies at high risk of bias were conducted.\nMain results\nWe included 11 new studies in this update resulting in a total of 19 randomised and 6 quasi-randomised trials (8919 participants).\nClipping compared with no hair removal\nLow certainty evidence suggests there may be little difference in risk of SSI when no hair removal is compared with hair removal using clippers (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.65 to 1.39; three studies with 1733 participants).\nShaving with a razor compared with no hair removal\nModerate certainty evidence suggests the risk of SSI is probably increased in participants who have hair removal with a razor compared with no removal (RR 1.82, 95% CI 1.05 to 3.14; seven studies with 1706 participants). In terms of absolute risk this represents 17 more SSIs per 1000 in the razor group compared with the no hair removal group (95% CI 1 more to 45 more SSI in the razor group).\nBased on low-certainty evidence, it is unclear whether there is a difference in stitch abscesses between hair removal with a razor and no hair removal (1 trial with 80 participants; RR 1.00, 95% CI 0.21 to 4.66).\nBased on narrative data from one trial with 136 participants, there may be little difference in length of hospital stay between participants having hair removed with a razor compared with those having no hair removal (low-certainty evidence).\nBased on narrative data from one trial with 278 participants, it is uncertain whether there is a difference in cost between participants having hair removed by shaving with a razor compared with no hair removal (very low certainty evidence).\nDepilatory cream compared with no hair removal\nLow certainty evidence suggests there may be little difference in SSI risk between depilatory cream or no hair removal, although there are were wide confidence intervals around the point estimate that included benefit and harm (RR 1.02, 95% CI 0.45 to 2.31; low-certainty evidence; 1 trial with 267 participants).\nBased on narrative data from one trial with 267 participants, it is uncertain whether there is a difference in cost between participants having hair removed with depilatory cream compared with no hair removal (very low certainty evidence).\nShaving with a razor compared with clipping\nModerate-certainty evidence from 7 studies with 3723 participants suggests the risk of SSI is probably increased by shaving with a razor compared with clipping (RR 1.64, 95% CI 1.16 to 2.33).\nModerate-certainty evidence suggests the risk of skin injury is probably increased in people who have hair removal with a razor rather than clipping (3 trials with 1333 participants; RR 1.74, CI 95% 1.12 to 2.71).\nShaving with a razor compared with depilatory cream\nModerate-certainty evidence from 9 studies with 1593 participants suggests there is probably more SSI risk when razors are used compared with depilatory cream (RR 2.28, 95% CI 1.12 to 4.65).\nLow-certainty evidence suggests the risk of skin injury may be increased when using a razor rather than depilatory cream for hair removal (RR 6.95, CI 95% 3.45 to 13.98; 5 trials with 937 participants).\nBased on narrative data from three trials with 402 participants, it is uncertain whether depilatory cream is more expensive than shaving (very low certainty evidence).\nHair removal on the day of surgery compared with one-day preoperatively\nLow-certainty evidence suggests that there may be a small reduction in SSI risk when hair is removed on the day of surgery compared with the day before surgery although there are were wide confidence intervals around the point estimate that included benefit and harm (one trial, 977 participants; RR 0.83, 95% CI 0.54 to 1.30).\nAuthors' conclusions\nCompared with no hair removal, there may be little difference in risk of SSI when clippers or depilatory cream are used (low-certainty evidence). However, there are probably fewer SSIs when hair is not removed compared with shaving with a razor (moderate-certainty evidence). If hair has to be removed, moderate-certainty evidence suggests using clippers or depilatory cream probably results in fewer SSIs and other complications compared with shaving using a razor. There may be a small reduction in SSIs when hair is removed on the day of, rather than the day before, surgery.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence show?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hair removal compared to no hair removal\n· Hair removal with clippers and cream may make little to no difference to the number of surgical site infections.\n· Hair removal with a razor probably risks more infections than no hair removal.\nWhether hair is removed with a razor or not removed may make little to no difference for length of hospital stay (1 study).\nComparisons of different hair removal methods\n· Clippers probably cause fewer infections and skin injuries than razors.\n· Cream probably causes fewer infections, and may cause fewer skin injuries, than razors.\nTime of hair removal\nWhether hair is removed on the day of surgery or the day before surgery may slightly reduce infection numbers (1 study)."
}
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query-laysum | 5431 | [
{
"role": "user",
"content": "Abstract: Background\nPanic disorder is common and deleterious to mental well-being. Psychological therapies and pharmacological interventions are both used as treatments for panic disorder with and without agoraphobia. However, there are no up-to-date reviews on the comparative efficacy and acceptability of the two treatment modalities, and such a review is necessary for improved treatment planning for this disorder.\nObjectives\nTo assess the efficacy and acceptability of psychological therapies versus pharmacological interventions for panic disorder, with or without agoraphobia, in adults.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Group Specialised Register on 11 September 2015. This register contains reports of relevant randomised controlled trials from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1950 to present), Embase (1974 to present), and PsycINFO (1967 to present). We cross-checked reference lists of relevant papers and systematic reviews. We did not apply any restrictions on date, language, or publication status.\nSelection criteria\nWe included all randomised controlled trials comparing psychological therapies with pharmacological interventions for panic disorder with or without agoraphobia as diagnosed by operationalised criteria in adults.\nData collection and analysis\nTwo review authors independently extracted data and resolved any disagreements in consultation with a third review author. For dichotomous data, we calculated risk ratios (RR) with 95% confidence intervals (CI). We analysed continuous data using standardised mean differences (with 95% CI). We used the random-effects model throughout.\nMain results\nWe included 16 studies with a total of 966 participants in the present review. Eight of the studies were conducted in Europe, four in the USA, two in the Middle East, and one in Southeast Asia.\nNone of the studies reported long-term remission/response (long term being six months or longer from treatment commencement).\nThere was no evidence of a difference between psychological therapies and selective serotonin reuptake inhibitors (SSRIs) in terms of short-term remission (RR 0.85, 95% CI 0.62 to 1.17; 6 studies; 334 participants) or short-term response (RR 0.97, 95% CI 0.51 to 1.86; 5 studies; 277 participants) (very low-quality evidence), and no evidence of a difference between psychological therapies and SSRIs in treatment acceptability as measured using dropouts for any reason (RR 1.33, 95% CI 0.80 to 2.22; 6 studies; 334 participants; low-quality evidence).\nThere was no evidence of a difference between psychological therapies and tricyclic antidepressants in terms of short-term remission (RR 0.82, 95% CI 0.62 to 1.09; 3 studies; 229 participants), short-term response (RR 0.75, 95% CI 0.51 to 1.10; 4 studies; 270 participants), or dropouts for any reason (RR 0.83, 95% CI 0.53 to 1.30; 5 studies; 430 participants) (low-quality evidence).\nThere was no evidence of a difference between psychological therapies and other antidepressants in terms of short-term remission (RR 0.90, 95% CI 0.48 to 1.67; 3 studies; 135 participants; very low-quality evidence) and evidence that psychological therapies did not significantly increase or decrease the short-term response over other antidepressants (RR 0.96, 95% CI 0.67 to 1.37; 3 studies; 128 participants) or dropouts for any reason (RR 1.55, 95% CI 0.91 to 2.65; 3 studies; 180 participants) (low-quality evidence).\nThere was no evidence of a difference between psychological therapies and benzodiazepines in terms of short-term remission (RR 1.08, 95% CI 0.70 to 1.65; 3 studies; 95 participants), short-term response (RR 1.58, 95% CI 0.70 to 3.58; 2 studies; 69 participants), or dropouts for any reason (RR 1.12, 95% CI 0.54 to 2.36; 3 studies; 116 participants) (very low-quality evidence).\nThere was no evidence of a difference between psychological therapies and either antidepressant alone or antidepressants plus benzodiazepines in terms of short-term remission (RR 0.86, 95% CI 0.71 to 1.05; 11 studies; 663 participants) and short-term response (RR 0.95, 95% CI 0.76 to 1.18; 12 studies; 800 participants) (low-quality evidence), and there was no evidence of a difference between psychological therapies and either antidepressants alone or antidepressants plus benzodiazepines in terms of treatment acceptability as measured by dropouts for any reason (RR 1.08, 95% CI 0.77 to 1.51; 13 studies; 909 participants; very low-quality evidence). The risk of selection bias and reporting bias was largely unclear. Preplanned subgroup and sensitivity analyses limited to trials with longer-term, quality-controlled, or individual psychological therapies suggested that antidepressants might be more effective than psychological therapies for some outcomes.\nThere were no data to contribute to a comparison between psychological therapies and serotonin–norepinephrine reuptake inhibitors (SNRIs) and subsequent adverse effects.\nAuthors' conclusions\nThe evidence in this review was often imprecise. The superiority of either therapy over the other is uncertain due to the low and very low quality of the evidence with regard to short-term efficacy and treatment acceptability, and no data were available regarding adverse effects.\nThe sensitivity analysis and investigation of the sources of heterogeneity indicated three possible influential factors: quality control of psychological therapies, the length of intervention, and the individual modality of psychological therapies.\nFuture studies should examine the long-term effects after intervention or treatment continuation and should provide information on risk of bias, especially with regard to selection and reporting biases.\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": "The review authors recommend that future research should use less biased psychological therapies, evaluate long-term outcomes, and report information related to the risk of study bias."
}
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query-laysum | 5432 | [
{
"role": "user",
"content": "Abstract: Background\nFaecal incontinence (FI) and constipation are both socially-embarrassing and physically-disabling conditions that impair quality of life. For both, surgery may be required in a minority of people when more conservative measures fail. However, the invasiveness and irreversible nature of direct surgery on bowel and sphincter muscles, poor long-term outcomes and well-established compIications makes such procedures unappealing for these benign conditions. A less-invasive surgical option to treat faecal incontinence and constipation is direct, low-voltage stimulation of the sacral nerve roots, termed sacral nerve stimulation (SNS). SNS has become the first line surgical treatment for FI in people failing conservative therapies. Its value in the treatment of constipation is less clear.\nObjectives\nTo assess the effects of sacral nerve stimulation using implanted electrodes for the treatment of faecal incontinence and constipation in adults.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, ClinicalTrials.gov, the World Health Organization (WHO) ICTRP and handsearched journals and conference proceedings (searched 5 February 2015), EMBASE (1 January 1947 to 2015 Week 5), and the reference lists of retrieved relevant articles.\nSelection criteria\nAll randomised or quasi-randomised trials assessing the effects of SNS for faecal incontinence or constipation in adults.\nData collection and analysis\nTwo review authors independently screened the search results, assessed the methodological quality of the included trials, and undertook data extraction.\nMain results\nSix crossover trials and two parallel group trials were included.\nSix trials assessed the effects of SNS for FI. In the parallel group trial conducted by Tjandra, 53 participants with severe FI in the SNS group experienced fewer episodes of faecal incontinence compared to the control group who received optimal medical therapy (mean difference (MD) −5.20, 95% confidence interval (CI) −9.15 to −1.25 at 3 months; MD −6.30, 95% CI −10.34 to −2.26 at 12 months). Adverse events were reported in a proportion of participants: pain at implant site (6%), seroma (2%) and excessive tingling in the vaginal region (9%).\nIn the parallel group trial carried out by Thin, 15 participants with FI in the SNS group experienced fewer episodes of FI compared with the percutaneous tibial nerve stimulation (PTNS) group (MD −3.00, 95% CI −6.61 to 0.61 at 3 months; MD −3.20, 95% CI −7.14 to 0.74 at 12 months). Adverse events were reported in three participants: mild ipsilateral leg pain during temporary testing (n = 1); and stimulator-site pain following insertion of neurostimulator (n = 2).\nIn the crossover trial by Leroi 7 of 34 recruited participants were excluded from the crossover due mainly to complications or immediate device failure. Twenty-four of the remaining 27 participants while still blinded chose the period of stimulation they had preferred. Outcomes were reported separately for 19 participants who preferred the 'on' and five who preferred the 'off' period. For the group of 19, the median (range) episodes of faecal incontinence per week fell from 1.7 (0 to 9) during the 'off' period to 0.7 (0 to 5) during the 'on' period; for the group of five, however, the median (range) rose from 1.7 (0 to 11) during the 'off' period compared with 3.7 (0 to 11) during the 'on' period. Four of 27 participants experienced an adverse event resulting in removal of the stimulator.\nIn the crossover trial by Sørensen and colleagues, participants did not experience any FI episodes in either the one-week ‘on’ or ‘off’ periods.\nIn the crossover trial by Vaizey, participants reported an average of six, and one, episodes of faecal incontinence per week during the 'off' and 'on' periods respectively in two participants with FI. Neither study reported adverse events.\nIn the crossover trial by Kahlke, 14 participants with FI experienced significantly lower episodes of FI per week during the stimulator 'on' (1 (SD, 1.7)) compared with the 'off' period (8.4 (SD, 8.7)). Adverse events reported include: haematoma formation (n = 3); misplacement of tined lead (1); and pain at stimulator site (n = 1).\nTwo trials assessed SNS for constipation. In the Kenefick trial, the two participants experienced an average of two bowel movements per week during the 'off' crossover period, compared with five during the 'on' period. Abdominal pain and bloating occurred 79% of the time during the 'off' period compared with 33% during the 'on' period. No adverse events occurred. In contrast, in the trial by Dinning with 59 participants, SNS did not improve frequency of bowel movements and 73 adverse events were reported, which included pain at site of the implanted pulse generator (32), wound infection (12), and urological (17) events.\nAuthors' conclusions\nThe limited evidence from the included trials suggests that SNS can improve continence in a proportion of patients with faecal incontinence. However, SNS did not improve symptoms in patients with constipation. In addition, adverse events occurred in some patients where these were reported. Rigorous high quality randomised trials are needed to allow the effects of SNS for these conditions to be assessed with more certainty.\n\nGiven the provided abstract, please respond to the following query: \"Importance of the review/Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Faecal incontinence occurs when a person passes stools without the usual control. Constipation is harder to define but generally describes a situation in which a person feels that their bowel opening is unsatisfactory (usually a combination of difficulty or infrequency of passing stools). Both conditions can severely affect people's quality of life. There are many non-surgical treatments for both conditions but occasionally surgery is required when other options fail. Sacral nerve stimulation (SNS) is a relatively new treatment for these conditions. It involves implanting a battery-powered stimulator unit in the buttock. This is connected to electrodes which rest on the nerves in the lower spine. The stimulator then continuously sends impulses to the nerves and muscles that control the bowel and anus. Initially, a temporary electrode lead is connected to a portable battery unit outside the body. If symptoms are improved enough, this is replaced by the implanted battery."
}
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query-laysum | 5433 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants may accumulate nutrient deficits leading to extrauterine growth restriction. Feeding preterm infants with nutrient-enriched rather than standard formula might increase nutrient accretion and growth rates and might improve neurodevelopmental outcomes.\nObjectives\nTo compare the effects of feeding with nutrient-enriched formula versus standard formula on growth and development of preterm infants.\nSearch methods\nWe used the Cochrane Neonatal standard search strategy. This included electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 11), MEDLINE, Embase, and the Cumulative Index to Nursing and Allied Health Literature (until November 2018), as well as conference proceedings, previous reviews, and clinical trials databases.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared feeding preterm infants with nutrient-enriched formula (protein and energy plus minerals, vitamins, or other nutrients) versus standard formula.\nData collection and analysis\nWe extracted data using the Cochrane Neonatal standard methods. Two review authors separately evaluated trial quality and extracted and synthesised data using risk ratios (RRs), risk differences, and mean differences (MDs). We assessed certainty of evidence at the outcome level using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods.\nMain results\nWe identified seven trials in which a total of 590 preterm infants participated. Most participants were clinically stable preterm infants of birth weight less than 1850 g. Few participants were extremely preterm, extremely low birth weight, or growth restricted at birth. Trials were conducted more than 30 years ago, were formula industry funded, and were small with methodological weaknesses (including lack of masking) that might bias effect estimates. Meta-analyses of in-hospital growth parameters were limited by statistical heterogeneity. There is no evidence of an effect on time to regain birth weight (MD -1.48 days, 95% confidence interval (CI) -4.73 to 1.77) and low-certainty evidence suggests that feeding with nutrient-enriched formula increases in-hospital rates of weight gain (MD 2.43 g/kg/d, 95% CI 1.60 to 3.26) and head circumference growth (MD 1.04 mm/week, 95% CI 0.18 to 1.89). Meta-analysis did not show an effect on the average rate of length gain (MD 0.22 mm/week, 95% CI -0.70 to 1.13). Fewer data are available for growth and developmental outcomes assessed beyond infancy, and these do not show consistent effects of nutrient-enriched formula feeding. Data from two trials did not show an effect on Bayley Mental Development Index scores at 18 months post term (MD 2.87, 95% CI -1.38 to 7.12; moderate-certainty evidence). Infants who received nutrient-enriched formula had higher Bayley Psychomotor Development Index scores at 18 months post term (MD 6.56. 95% CI 2.87 to 10.26; low-certainty evidence), but no evidence suggested an effect on cerebral palsy (typical RR 0.79, 95% CI 0.30 to 2.07; 2 studies, 377 infants). Available data did not indicate any other benefits or harms and provided low-certainty evidence about the effect of nutrient-enriched formula feeding on the risk of necrotising enterocolitis in preterm infants (typical RR 0.72, 95% CI 0.41 to 1.25; 3 studies, 489 infants).\nAuthors' conclusions\nAvailable trial data show that feeding preterm infants nutrient-enriched (compared with standard) formulas has only modest effects on growth rates during their initial hospital admission. No evidence suggests effects on long-term growth or development. The GRADE assessment indicates that the certainty of this evidence is low, and that these findings should be interpreted and applied with caution. Further randomised trials would be needed to resolve this uncertainty.\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": "Although available trial data show that nutrient-enriched formulas increase growth rates of preterm infants during their initial hospital admission, they do not provide evidence of effects on longer-term growth or development. Further randomised trials would be needed to resolve this uncertainty."
}
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query-laysum | 5434 | [
{
"role": "user",
"content": "Abstract: Background\nBiologic disease-modifying anti-rheumatic drugs (DMARDs: referred to as biologics) are effective in treating rheumatoid arthritis (RA), however there are few head-to-head comparison studies. Our systematic review, standard meta-analysis and network meta-analysis (NMA) updates the 2009 Cochrane overview, 'Biologics for rheumatoid arthritis (RA)' and adds new data. This review is focused on biologic or tofacitinib therapy in people with RA who had previously been treated unsuccessfully with biologics.\nObjectives\nTo compare the benefits and harms of biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib versus comparator (placebo or methotrexate (MTX)/other DMARDs) in people with RA, previously unsuccessfully treated with biologics.\nMethods\nOn 22 June 2015 we searched for randomized controlled trials (RCTs) in CENTRAL, MEDLINE, and Embase; and trials registries (WHO trials register, Clinicaltrials.gov). We carried out article selection, data extraction, and risk of bias and GRADE assessments in duplicate. We calculated direct estimates with 95% confidence intervals (CI) using standard meta-analysis. We used a Bayesian mixed treatment comparison (MTC) approach for NMA estimates with 95% credible intervals (CrI). We converted odds ratios (OR) to risk ratios (RR) for ease of understanding. We have also presented results in absolute measures as risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB). Outcomes measured included four benefits (ACR50, function measured by Health Assessment Questionnaire (HAQ) score, remission defined as DAS < 1.6 or DAS28 < 2.6, slowing of radiographic progression) and three harms (withdrawals due to adverse events, serious adverse events, and cancer).\nMain results\nThis update includes nine new RCTs for a total of 12 RCTs that included 3364 participants. The comparator was placebo only in three RCTs (548 participants), MTX or other traditional DMARD in six RCTs (2468 participants), and another biologic in three RCTs (348 participants). Data were available for four tumor necrosis factor (TNF)-biologics: (certolizumab pegol (1 study; 37 participants), etanercept (3 studies; 348 participants), golimumab (1 study; 461 participants), infliximab (1 study; 27 participants)), three non-TNF biologics (abatacept (3 studies; 632 participants), rituximab (2 studies; 1019 participants), and tocilizumab (2 studies; 589 participants)); there was only one study for tofacitinib (399 participants). The majority of the trials (10/12) lasted less than 12 months.\nWe judged 33% of the studies at low risk of bias for allocation sequence generation, allocation concealment and blinding, 25% had low risk of bias for attrition, 92% were at unclear risk for selective reporting; and 92% had low risk of bias for major baseline imbalance. We downgraded the quality of the evidence for most outcomes to moderate or low due to study limitations, heterogeneity, or rarity of direct comparator trials.\nBiologic monotherapy versus placebo\nCompared to placebo, biologics were associated with clinically meaningful and statistically significant improvement in RA as demonstrated by higher ACR50 and RA remission rates. RR was 4.10 for ACR50 (95% CI 1.97 to 8.55; moderate-quality evidence); absolute benefit RD 14% (95% CI 6% to 21%); and NNTB = 8 (95% CI 4 to 23). RR for RA remission was 13.51 (95% CI 1.85 to 98.45, one study available; moderate-quality evidence); absolute benefit RD 9% (95% CI 5% to 13%); and NNTB = 11 (95% CI 3 to 136). Results for withdrawals due to adverse events and serious adverse events did not show any statistically significant or clinically meaningful differences. There were no studies available for analysis for function measured by HAQ, radiographic progression, or cancer outcomes. There were not enough data for any of the outcomes to look at subgroups.\nBiologic + MTX versus active comparator (MTX/other traditional DMARDs)\nCompared to MTX/other traditional DMARDs, biologic + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50, function measured by HAQ, and RA remission rates in direct comparisons. RR for ACR50 was 4.07 (95% CI 2.76 to 5.99; high-quality evidence); absolute benefit RD 16% (10% to 21%); NNTB = 7 (95% CI 5 to 11). HAQ scores showed an improvement with a mean difference (MD) of 0.29 (95% CI 0.21 to 0.36; high-quality evidence); absolute benefit RD 9.7% improvement (95% CI 7% to 12%); and NNTB = 5 (95% CI 4 to 7). Remission rates showed an improved RR of 20.73 (95% CI 4.13 to 104.16; moderate-quality evidence); absolute benefit RD 10% (95% CI 8% to 13%); and NNTB = 17 (95% CI 4 to 96), among the biologic + MTX group compared to MTX/other DMARDs. There were no studies for radiographic progression. Results were not clinically meaningful or statistically significantly different for withdrawals due to adverse events or serious adverse events, and were inconclusive for cancer.\nTofacitinib monotherapy versus placebo\nThere were no published data.\nTofacitinib + MTX versus active comparator (MTX)\nIn one study, compared to MTX, tofacitinib + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50 (RR 3.24; 95% CI 1.78 to 5.89; absolute benefit RD 19% (95% CI 12% to 26%); NNTB = 6 (95% CI 3 to 14); moderate-quality evidence), and function measured by HAQ, MD 0.27 improvement (95% CI 0.14 to 0.39); absolute benefit RD 9% (95% CI 4.7% to 13%), NNTB = 5 (95% CI 4 to 10); high-quality evidence). RA remission rates were not statistically significantly different but the observed difference may be clinically meaningful (RR 15.44 (95% CI 0.93 to 256.1; high-quality evidence); absolute benefit RD 6% (95% CI 3% to 9%); NNTB could not be calculated. There were no studies for radiographic progression. There were no statistically significant or clinically meaningful differences for withdrawals due to adverse events and serious adverse events, and results were inconclusive for cancer.\nAuthors' conclusions\nBiologic (with or without MTX) or tofacitinib (with MTX) use was associated with clinically meaningful and statistically significant benefits (ACR50, HAQ, remission) compared to placebo or an active comparator (MTX/other traditional DMARDs) among people with RA previously unsuccessfully treated with biologics.\nNo studies examined radiographic progression. Results were not clinically meaningful or statistically significant for withdrawals due to adverse events and serious adverse events, and were inconclusive for cancer.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to people with RA when taking biologics or tofacitinib\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": ""
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query-laysum | 5435 | [
{
"role": "user",
"content": "Abstract: Background\nCardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated. This is an update of a review previously published in 2009, 2013, and 2015.\nObjectives\nTo determine whether homocysteine-lowering interventions, provided to patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events, as well as reducing all-cause mortality, and to evaluate their safety.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 5), MEDLINE (1946 to 1 June 2017), Embase (1980 to 2017 week 22) and LILACS (1986 to 1 June 2017). We also searched Web of Science (1970 to 1 June 2017). We handsearched the reference lists of included papers. We also contacted researchers in the field. There was no language restriction in the search.\nSelection criteria\nWe included randomised controlled trials assessing the effects of homocysteine-lowering interventions for preventing cardiovascular events with a follow-up period of one year or longer. We considered myocardial infarction and stroke as the primary outcomes. We excluded studies in patients with end-stage renal disease.\nData collection and analysis\nWe performed study selection, 'Risk of bias' assessment and data extraction in duplicate. We estimated risk ratios (RR) for dichotomous outcomes. We calculated the number needed to treat for an additional beneficial outcome (NNTB). We measured statistical heterogeneity using the I2 statistic. We used a random-effects model. We conducted trial sequential analyses, Bayes factor, and fragility indices where appropriate.\nMain results\nIn this third update, we identified three new randomised controlled trials, for a total of 15 randomised controlled trials involving 71,422 participants. Nine trials (60%) had low risk of bias, length of follow-up ranged from one to 7.3 years. Compared with placebo, there were no differences in effects of homocysteine-lowering interventions on myocardial infarction (homocysteine-lowering = 7.1% versus placebo = 6.0%; RR 1.02, 95% confidence interval (CI) 0.95 to 1.10, I2 = 0%, 12 trials; N = 46,699; Bayes factor 1.04, high-quality evidence), death from any cause (homocysteine-lowering = 11.7% versus placebo = 12.3%, RR 1.01, 95% CI 0.96 to 1.06, I2 = 0%, 11 trials, N = 44,817; Bayes factor = 1.05, high-quality evidence), or serious adverse events (homocysteine-lowering = 8.3% versus comparator = 8.5%, RR 1.07, 95% CI 1.00 to 1.14, I2 = 0%, eight trials, N = 35,788; high-quality evidence). Compared with placebo, homocysteine-lowering interventions were associated with reduced stroke outcome (homocysteine-lowering = 4.3% versus comparator = 5.1%, RR 0.90, 95% CI 0.82 to 0.99, I2 = 8%, 10 trials, N = 44,224; high-quality evidence). Compared with low doses, there were uncertain effects of high doses of homocysteine-lowering interventions on stroke (high = 10.8% versus low = 11.2%, RR 0.90, 95% CI 0.66 to 1.22, I2 = 72%, two trials, N = 3929; very low-quality evidence).\nWe found no evidence of publication bias.\nAuthors' conclusions\nIn this third update of the Cochrane review, there were no differences in effects of homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo on myocardial infarction, death from any cause or adverse events. In terms of stroke, this review found a small difference in effect favouring to homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo.\nThere were uncertain effects of enalapril plus folic acid compared with enalapril on stroke; approximately 143 (95% CI 85 to 428) people would need to be treated for 5.4 years to prevent 1 stroke, this evidence emerged from one mega-trial.\nTrial sequential analyses showed that additional trials are unlikely to increase the certainty about the findings of this issue regarding homocysteine-lowering interventions versus placebo. There is a need for additional trials comparing homocysteine-lowering interventions combined with antihypertensive medication versus antihypertensive medication, and homocysteine-lowering interventions at high doses versus homocysteine-lowering interventions at low doses. Potential trials should be large and co-operative.\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 June 2017. We included 15 studies involving 71,422 participants living in countries with or without mandatory supplementation of foods with vitamins. These studies compared different regimens of B vitamins (cyanocobalamin (B12), folic acid (B9) and pyridoxine (B6)) with a control or any other comparison group. The studies were published between 2002 and 2015."
}
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query-laysum | 5436 | [
{
"role": "user",
"content": "Abstract: Background\nDressings are part of the routine postoperative management of people after transtibial amputation. Two types of dressings are commonly used; soft dressings (e.g. elastic bandages, crepe bandages) and rigid dressings (e.g. non-removable rigid dressings, removable rigid dressings, immediate postoperative protheses). Soft dressings are the conventional dressing choice as they are cheap and easy to apply, while rigid dressings are costly, more time consuming to apply and require skilled personnel to apply the dressings. However, rigid dressings have been suggested to result in faster wound healing due to the hard exterior providing a greater degree of compression to the stump.\nObjectives\nTo assess the benefits and harms of rigid dressings versus soft dressings for treating transtibial amputations.\nSearch methods\nIn December 2018 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, EBSCO CINAHL Plus, Ovid AMED and PEDro to identify relevant trials. To identify further published, unpublished and ongoing studies, we also searched clinical trial registries, the grey literature, the reference lists of relevant studies and reviews identified in prior searches. We used the Cited Reference Search facility on ThomsonReuters Web of Science and contacted relevant individuals and organisations. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that enrolled people with transtibial amputations. There were no restrictions on the age of participants and reasons for amputation. Trials that compared the effectiveness of rigid dressings with soft dressings were the main focus of this review.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full-text publications for eligible studies. Two review authors also independently extracted data on study characteristics and outcomes, and performed risk of bias and GRADE assessments.\nMain results\nWe included nine RCTs and quasi-RCTs involving 436 participants (441 limbs). All studies recruited participants from acute and/or rehabilitation hospitals from seven different countries (the USA, Australia, Indonesia, Thailand, Canada, France and the UK). In all but one study, it was clearly stated that amputations were secondary to vascular conditions.\nPrimary outcomes\nWound healing\nWe are uncertain whether rigid dressings decrease the time to wound healing compared with soft dressings (MD -25.60 days; 95% CI -49.08 to -2.12; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. It is not clear whether rigid dressings increase the proportion of wounds healed compared with soft dressings (RR 1.14; 95% CI 0.74 to 1.76; one study, 51 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision.\nAdverse events\nIt is not clear whether rigid dressings increase the proportion of skin-related adverse events compared with soft dressings (RR 0.65; 95% CI 0.32 to 1.32; I2 = 0%; six studies, 336 participants (340 limbs)); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision.\nIt is not clear whether rigid dressings increase the proportion of non skin-related adverse events compared with soft dressings (RR 1.09; 95% CI 0.60 to 1.99; I2 = 0%; six studies, 342 participants (346 limbs)); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. In addition, we are uncertain whether rigid dressings decrease the time to no pain compared with soft dressings (MD -0.35 weeks; 95% CI -2.11 to 1.41; one study of 23 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision.\nSecondary outcomes\nWe are uncertain whether rigid dressings decrease the time to walking compared with soft dressings (MD -3 days; 95% CI -9.96 to 3.96; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision. We are also uncertain whether rigid dressings decrease the length of hospital stay compared with soft dressings (MD -30.10 days; 95% CI -49.82 to -10.38; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. It is also not clear whether rigid dressings decrease the time to readiness for prosthetic prescription and swelling compared with soft dressings, as results are based on very low-certainty evidence, downgraded twice for very high risk of bias and once/twice for serious/very serious imprecision. None of the studies reported outcomes on patient comfort, quality of life and cost.\nAuthors' conclusions\nWe are uncertain of the benefits and harms of rigid dressings compared with soft dressings for people undergoing transtibial amputation due to limited and very low-certainty evidence. It is not clear if rigid dressings are superior to soft dressings for improving outcomes related to wound healing, adverse events, prosthetic prescription, walking function, length of hospital stay and swelling. Clinicians should exercise clinical judgement as to which type of dressing they use, and consider the pros and cons of each for patients (e.g. patients with high risk of falling may benefit from the protection offered by a rigid dressing, and patients with poor skin integrity may have less risk of skin breakdown from a soft dressing).\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 determine whether rigid dressings are more effective than soft dressings in helping the wound to heal following transtibial (below the knee) amputations. Researchers from Cochrane searched for all relevant studies (randomised controlled trials (RCTs) and quasi-randomised controlled trials) to answer this question and found nine relevant studies."
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query-laysum | 5437 | [
{
"role": "user",
"content": "Abstract: Background\nHelicobacter pylori (H pylori) infection has been implicated in a number of malignancies and non-malignant conditions including peptic ulcers, non-ulcer dyspepsia, recurrent peptic ulcer bleeding, unexplained iron deficiency anaemia, idiopathic thrombocytopaenia purpura, and colorectal adenomas. The confirmatory diagnosis of H pylori is by endoscopic biopsy, followed by histopathological examination using haemotoxylin and eosin (H & E) stain or special stains such as Giemsa stain and Warthin-Starry stain. Special stains are more accurate than H & E stain. There is significant uncertainty about the diagnostic accuracy of non-invasive tests for diagnosis of H pylori.\nObjectives\nTo compare the diagnostic accuracy of urea breath test, serology, and stool antigen test, used alone or in combination, for diagnosis of H pylori infection in symptomatic and asymptomatic people, so that eradication therapy for H pylori can be started.\nSearch methods\nWe searched MEDLINE, Embase, the Science Citation Index and the National Institute for Health Research Health Technology Assessment Database on 4 March 2016. We screened references in the included studies to identify additional studies. We also conducted citation searches of relevant studies, most recently on 4 December 2016. We did not restrict studies by language or publication status, or whether data were collected prospectively or retrospectively.\nSelection criteria\nWe included diagnostic accuracy studies that evaluated at least one of the index tests (urea breath test using isotopes such as 13C or 14C, serology and stool antigen test) against the reference standard (histopathological examination using H & E stain, special stains or immunohistochemical stain) in people suspected of having H pylori infection.\nData collection and analysis\nTwo review authors independently screened the references to identify relevant studies and independently extracted data. We assessed the methodological quality of studies using the QUADAS-2 tool. We performed meta-analysis by using the hierarchical summary receiver operating characteristic (HSROC) model to estimate and compare SROC curves. Where appropriate, we used bivariate or univariate logistic regression models to estimate summary sensitivities and specificities.\nMain results\nWe included 101 studies involving 11,003 participants, of which 5839 participants (53.1%) had H pylori infection. The prevalence of H pylori infection in the studies ranged from 15.2% to 94.7%, with a median prevalence of 53.7% (interquartile range 42.0% to 66.5%). Most of the studies (57%) included participants with dyspepsia and 53 studies excluded participants who recently had proton pump inhibitors or antibiotics.There was at least an unclear risk of bias or unclear applicability concern for each study.\nOf the 101 studies, 15 compared the accuracy of two index tests and two studies compared the accuracy of three index tests. Thirty-four studies (4242 participants) evaluated serology; 29 studies (2988 participants) evaluated stool antigen test; 34 studies (3139 participants) evaluated urea breath test-13C; 21 studies (1810 participants) evaluated urea breath test-14C; and two studies (127 participants) evaluated urea breath test but did not report the isotope used. The thresholds used to define test positivity and the staining techniques used for histopathological examination (reference standard) varied between studies. Due to sparse data for each threshold reported, it was not possible to identify the best threshold for each test.\nUsing data from 99 studies in an indirect test comparison, there was statistical evidence of a difference in diagnostic accuracy between urea breath test-13C, urea breath test-14C, serology and stool antigen test (P = 0.024). The diagnostic odds ratios for urea breath test-13C, urea breath test-14C, serology, and stool antigen test were 153 (95% confidence interval (CI) 73.7 to 316), 105 (95% CI 74.0 to 150), 47.4 (95% CI 25.5 to 88.1) and 45.1 (95% CI 24.2 to 84.1). The sensitivity (95% CI) estimated at a fixed specificity of 0.90 (median from studies across the four tests), was 0.94 (95% CI 0.89 to 0.97) for urea breath test-13C, 0.92 (95% CI 0.89 to 0.94) for urea breath test-14C, 0.84 (95% CI 0.74 to 0.91) for serology, and 0.83 (95% CI 0.73 to 0.90) for stool antigen test. This implies that on average, given a specificity of 0.90 and prevalence of 53.7% (median specificity and prevalence in the studies), out of 1000 people tested for H pylori infection, there will be 46 false positives (people without H pylori infection who will be diagnosed as having H pylori infection). In this hypothetical cohort, urea breath test-13C, urea breath test-14C, serology, and stool antigen test will give 30 (95% CI 15 to 58), 42 (95% CI 30 to 58), 86 (95% CI 50 to 140), and 89 (95% CI 52 to 146) false negatives respectively (people with H pylori infection for whom the diagnosis of H pylori will be missed).\nDirect comparisons were based on few head-to-head studies. The ratios of diagnostic odds ratios (DORs) were 0.68 (95% CI 0.12 to 3.70; P = 0.56) for urea breath test-13C versus serology (seven studies), and 0.88 (95% CI 0.14 to 5.56; P = 0.84) for urea breath test-13C versus stool antigen test (seven studies). The 95% CIs of these estimates overlap with those of the ratios of DORs from the indirect comparison. Data were limited or unavailable for meta-analysis of other direct comparisons.\nAuthors' conclusions\nIn people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.\nWe need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There are two types of urea breath test which use two different forms of carbon known as 13C and 14C, as well as multiple versions of serology and stool tests."
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query-laysum | 5438 | [
{
"role": "user",
"content": "Abstract: Background\nWomen with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013.\nObjectives\nTo assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy.\nMain results\nEight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns.\nVaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported.\nVaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported.\nFoley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.\nDouble-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported.\nOral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported.\nVaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.\n80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.\nVaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.\nAuthors' conclusions\nRCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.\nHigh-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.\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 studies on 31 August 2016. Eight small randomised controlled trials are included in this updated review, with data from 707 women and babies. The studies compared different methods of inducing labour, so results could not be combined.\nThere were design problems in all of the trials: women and health professionals knew which induction method was being used in seven out of eight trials, which may have affected clinical decisions. Women were left out of the analysis in some trials, and trials often did not report important outcomes (vaginal birth not achieved within 24 hours of induction, overstimulation of the uterus with changes to the baby's heart rate, caesarean section, serious illness or death of the baby, serious illness or death of the mother).\nThe trials were too small to show clear differences. The quality of the evidence was very low, low, or moderate, because the trials were small and had high risk of bias. We cannot be certain about the results, and future research may show something different."
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query-laysum | 5439 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is a common life-shortening genetic condition caused by a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A class II CFTR variant F508del (found in up to 90% of people with CF (pwCF)) is the commonest CF-causing variant. The faulty protein is degraded before reaching the cell membrane, where it needs to be to effect transepithelial salt transport. The F508del variant lacks meaningful CFTR function and corrective therapy could benefit many pwCF. Therapies in this review include single correctors and any combination of correctors and potentiators.\nObjectives\nTo evaluate the effects of CFTR correctors (with or without potentiators) on clinically important benefits and harms in pwCF of any age with class II CFTR mutations (most commonly F508del).\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Cystic Fibrosis Trials Register, reference lists of relevant articles and online trials registries. Most recent search: 14 October 2020.\nSelection criteria\nRandomised controlled trials (RCTs) (parallel design) comparing CFTR correctors to control in pwCF with class II mutations.\nData collection and analysis\nTwo authors independently extracted data, assessed risk of bias and evidence quality (GRADE); we contacted investigators for additional data.\nMain results\nWe included 19 RCTs (2959 participants), lasting between 1 day and 24 weeks; an extension of two lumacaftor-ivacaftor studies provided additional 96-week safety data (1029 participants). We assessed eight monotherapy RCTs (344 participants) (4PBA, CPX, lumacaftor, cavosonstat and FDL169), six dual-therapy RCTs (1840 participants) (lumacaftor-ivacaftor or tezacaftor-ivacaftor) and five triple-therapy RCTs (775 participants) (elexacaftor-tezacaftor-ivacaftor or VX-659-tezacaftor-ivacaftor); below we report only the data from elexacaftor-tezacaftor-ivacaftor combination which proceeded to Phase 3 trials. In 14 RCTs participants had F508del/F508del genotypes, in three RCTs F508del/minimal function (MF) genotypes and in two RCTs both genotypes.\nRisk of bias judgements varied across different comparisons. Results from 11 RCTs may not be applicable to all pwCF due to age limits (e.g. adults only) or non-standard design (converting from monotherapy to combination therapy).\nMonotherapy\nInvestigators reported no deaths or clinically-relevant improvements in quality of life (QoL). There was insufficient evidence to determine any important effects on lung function.\nNo placebo-controlled monotherapy RCT demonstrated differences in mild, moderate or severe adverse effects (AEs); the clinical relevance of these events is difficult to assess with their variety and small number of participants (all F508del/F508del).\nDual therapy\nInvestigators reported no deaths (moderate- to high-quality evidence). QoL scores (respiratory domain) favoured both lumacaftor-ivacaftor and tezacaftor-ivacaftor therapy compared to placebo at all time points. At six months lumacaftor 600 mg or 400 mg (both once daily) plus ivacaftor improved Cystic Fibrosis Questionnaire (CFQ) scores slightly compared with placebo (mean difference (MD) 2.62 points (95% confidence interval (CI) 0.64 to 4.59); 1061 participants; high-quality evidence). A similar effect was observed for twice-daily lumacaftor (200 mg) plus ivacaftor (250 mg), but with low-quality evidence (MD 2.50 points (95% CI 0.10 to 5.10)). The mean increase in CFQ scores with twice-daily tezacaftor (100 mg) and ivacaftor (150 mg) was approximately five points (95% CI 3.20 to 7.00; 504 participants; moderate-quality evidence). At six months, the relative change in forced expiratory volume in one second (FEV1) % predicted improved with combination therapies compared to placebo by: 5.21% with once-daily lumacaftor-ivacaftor (95% CI 3.61% to 6.80%; 504 participants; high-quality evidence); 2.40% with twice-daily lumacaftor-ivacaftor (95% CI 0.40% to 4.40%; 204 participants; low-quality evidence); and 6.80% with tezacaftor-ivacaftor (95% CI 5.30 to 8.30%; 520 participants; moderate-quality evidence).\nMore pwCF reported early transient breathlessness with lumacaftor-ivacaftor, odds ratio 2.05 (99% CI 1.10 to 3.83; 739 participants; high-quality evidence). Over 120 weeks (initial study period and follow-up) systolic blood pressure rose by 5.1 mmHg and diastolic blood pressure by 4.1 mmHg with twice-daily 400 mg lumacaftor-ivacaftor (80 participants; high-quality evidence). The tezacaftor-ivacaftor RCTs did not report these adverse effects.\nPulmonary exacerbation rates decreased in pwCF receiving additional therapies to ivacaftor compared to placebo: lumacaftor 600 mg hazard ratio (HR) 0.70 (95% CI 0.57 to 0.87; 739 participants); lumacaftor 400 mg, HR 0.61 (95% CI 0.49 to 0.76; 740 participants); and tezacaftor, HR 0.64 (95% CI, 0.46 to 0.89; 506 participants) (moderate-quality evidence).\nTriple therapy\nThree RCTs of elexacaftor to tezacaftor-ivacaftor in pwCF (aged 12 years and older with either one or two F508del variants) reported no deaths (high-quality evidence). All other evidence was graded as moderate quality. In 403 participants with F508del/minimal function (MF) elexacaftor-tezacaftor-ivacaftor improved QoL respiratory scores (MD 20.2 points (95% CI 16.2 to 24.2)) and absolute change in FEV1 (MD 14.3% predicted (95% CI 12.7 to 15.8)) compared to placebo at 24 weeks. At four weeks in 107 F508del/F508del participants, elexacaftor-tezacaftor-ivacaftor improved QoL respiratory scores (17.4 points (95% CI 11.9 to 22.9)) and absolute change in FEV1 (MD 10.0% predicted (95% CI 7.5 to 12.5)) compared to tezacaftor-ivacaftor. There was probably little or no difference in the number or severity of AEs between elexacaftor-tezacaftor-ivacaftor and placebo or control (moderate-quality evidence). In 403 F508del/F508del participants, there was a longer time to protocol-defined pulmonary exacerbation with elexacaftor-tezacaftor-ivacaftor over 24 weeks (moderate-quality evidence).\nAuthors' conclusions\nThere is insufficient evidence that corrector monotherapy has clinically important effects in pwCF with F508del/F508del.\nBoth dual therapies (lumacaftor-ivacaftor, tezacaftor-ivacaftor) result in similar improvements in QoL and respiratory function with lower pulmonary exacerbation rates. Lumacaftor-ivacaftor was associated with an increase in early transient shortness of breath and longer-term increases in blood pressure (not observed for tezacaftor-ivacaftor). Tezacaftor-ivacaftor has a better safety profile, although data are lacking in children under 12 years. In this population, lumacaftor-ivacaftor had an important impact on respiratory function with no apparent immediate safety concerns; but this should be balanced against the blood pressure increase and shortness of breath seen in longer-term adult data when considering lumacaftor-ivacaftor.\nThere is high-quality evidence of clinical efficacy with probably little or no difference in AEs for triple (elexacaftor-tezacaftor-ivacaftor) therapy in pwCF with one or two F508del variants aged 12 years or older. Further RCTs are required in children (under 12 years) and those with more severe respiratory function.\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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"role": "assistant",
"content": "Monotherapy versus control\nThese studies did not report any deaths or clinically relevant improvements in QoL scores. There was insufficient evidence to show an effect on lung function. All studies reported side effects, but it is difficult to assess their relevance due to the range of effects and the small number of participants in the studies.\nDual therapy versus control\nNeither the lumacaftor-ivacaftor or tezacaftor-ivacaftor studies in people with two copies of F508del reported any deaths and there were improvements in QoL and lung function. Pulmonary exacerbation (a flare-up of symptoms) rates were also lower. Neither combination therapy was linked to severe side effects, although people starting treatment with lumacaftor-ivacaftor experienced shortness of breath for one to two weeks, this usually stopped without further treatment. More concerningly, in longer studies some people taking lumacaftor-ivacaftor experienced a rise in blood pressure; two people (out of over 500) even stopped lumacaftor-ivacaftor treatment because of high blood pressure. These side effects were not reported for tezacaftor-ivacaftor. Tezacaftor-ivacaftor therapy has not yet been assessed in children with CF under 12 years old.\nTriple therapy versus control.\nThe three studies reported no deaths. Triple therapies improved QoL scores and lung function, with no difference in the number or severity of side effects; there was a longer time until the next pulmonary exacerbation. There is high-quality evidence that elexacaftor-tezacaftor-ivacaftor therapy is clinically effective with few side effects for pwCF with one or two F508del variants aged 12 years or older. Further RCTs are required in children (under 12 years) and those with more severe respiratory function. The side effect profile of elexacaftor-tezacaftor-ivacaftor therapy seems to be similar to tezacaftor-ivacaftor, but we need to collect information over the longer term."
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query-laysum | 5440 | [
{
"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: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The available evidence suggests that topical corticosteroids may be effective for treating painful oral lichen planus, but our confidence in these findings is limited as there were only a small number of studies and participants. There is some evidence that tacrolimus may be more effective than a corticosteroid, but evidence on negative side effects is inconclusive."
}
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query-laysum | 5441 | [
{
"role": "user",
"content": "Abstract: Background\nDressings are part of the routine postoperative management of people after transtibial amputation. Two types of dressings are commonly used; soft dressings (e.g. elastic bandages, crepe bandages) and rigid dressings (e.g. non-removable rigid dressings, removable rigid dressings, immediate postoperative protheses). Soft dressings are the conventional dressing choice as they are cheap and easy to apply, while rigid dressings are costly, more time consuming to apply and require skilled personnel to apply the dressings. However, rigid dressings have been suggested to result in faster wound healing due to the hard exterior providing a greater degree of compression to the stump.\nObjectives\nTo assess the benefits and harms of rigid dressings versus soft dressings for treating transtibial amputations.\nSearch methods\nIn December 2018 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, EBSCO CINAHL Plus, Ovid AMED and PEDro to identify relevant trials. To identify further published, unpublished and ongoing studies, we also searched clinical trial registries, the grey literature, the reference lists of relevant studies and reviews identified in prior searches. We used the Cited Reference Search facility on ThomsonReuters Web of Science and contacted relevant individuals and organisations. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that enrolled people with transtibial amputations. There were no restrictions on the age of participants and reasons for amputation. Trials that compared the effectiveness of rigid dressings with soft dressings were the main focus of this review.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full-text publications for eligible studies. Two review authors also independently extracted data on study characteristics and outcomes, and performed risk of bias and GRADE assessments.\nMain results\nWe included nine RCTs and quasi-RCTs involving 436 participants (441 limbs). All studies recruited participants from acute and/or rehabilitation hospitals from seven different countries (the USA, Australia, Indonesia, Thailand, Canada, France and the UK). In all but one study, it was clearly stated that amputations were secondary to vascular conditions.\nPrimary outcomes\nWound healing\nWe are uncertain whether rigid dressings decrease the time to wound healing compared with soft dressings (MD -25.60 days; 95% CI -49.08 to -2.12; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. It is not clear whether rigid dressings increase the proportion of wounds healed compared with soft dressings (RR 1.14; 95% CI 0.74 to 1.76; one study, 51 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision.\nAdverse events\nIt is not clear whether rigid dressings increase the proportion of skin-related adverse events compared with soft dressings (RR 0.65; 95% CI 0.32 to 1.32; I2 = 0%; six studies, 336 participants (340 limbs)); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision.\nIt is not clear whether rigid dressings increase the proportion of non skin-related adverse events compared with soft dressings (RR 1.09; 95% CI 0.60 to 1.99; I2 = 0%; six studies, 342 participants (346 limbs)); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. In addition, we are uncertain whether rigid dressings decrease the time to no pain compared with soft dressings (MD -0.35 weeks; 95% CI -2.11 to 1.41; one study of 23 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision.\nSecondary outcomes\nWe are uncertain whether rigid dressings decrease the time to walking compared with soft dressings (MD -3 days; 95% CI -9.96 to 3.96; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and twice for very serious imprecision. We are also uncertain whether rigid dressings decrease the length of hospital stay compared with soft dressings (MD -30.10 days; 95% CI -49.82 to -10.38; one study, 56 participants); very low-certainty evidence, downgraded twice for very high risk of bias and once for serious imprecision. It is also not clear whether rigid dressings decrease the time to readiness for prosthetic prescription and swelling compared with soft dressings, as results are based on very low-certainty evidence, downgraded twice for very high risk of bias and once/twice for serious/very serious imprecision. None of the studies reported outcomes on patient comfort, quality of life and cost.\nAuthors' conclusions\nWe are uncertain of the benefits and harms of rigid dressings compared with soft dressings for people undergoing transtibial amputation due to limited and very low-certainty evidence. It is not clear if rigid dressings are superior to soft dressings for improving outcomes related to wound healing, adverse events, prosthetic prescription, walking function, length of hospital stay and swelling. Clinicians should exercise clinical judgement as to which type of dressing they use, and consider the pros and cons of each for patients (e.g. patients with high risk of falling may benefit from the protection offered by a rigid dressing, and patients with poor skin integrity may have less risk of skin breakdown from a soft dressing).\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": "The certainty of evidence for all outcomes was very low because the results could not rule in or rule out important benefits or harms, and because the design and reporting of the studies was not of a high standard. Therefore, we cannot be certain if the use of rigid dressings leads to better or worse patient outcomes compared with soft dressings."
}
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query-laysum | 5442 | [
{
"role": "user",
"content": "Abstract: Background\nExercise programmes are a relatively inexpensive, low-risk option compared with other, more invasive therapies for treatment of leg pain on walking (intermittent claudication (IC)). This is the fourth update of a review first published in 1998.\nObjectives\nOur goal was to determine whether an exercise programme was effective in alleviating symptoms and increasing walking treadmill distances and walking times in people with intermittent claudication. Secondary objectives were to determine whether exercise was effective in preventing deterioration of underlying disease, reducing cardiovascular events, and improving quality of life.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Specialised Register (last searched 15 November 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 10) via the Cochrane Register of Studies Online, along with trials registries.\nSelection criteria\nRandomised controlled trials of an exercise regimen versus control or versus medical therapy for people with IC due to peripheral arterial disease (PAD). We included any exercise programme or regimen used for treatment of IC, such as walking, skipping, and running. Inclusion of trials was not affected by duration, frequency, or intensity of the exercise programme. Outcome measures collected included treadmill walking distance (time to onset of pain or pain-free walking distance and maximum walking time or maximum walking distance), ankle brachial index (ABI), quality of life, morbidity, or amputation; if none of these was reported, we did not include the trial in this review.\nData collection and analysis\nFor this update (2017), RAL and AH selected trials and extracted data independently. We assessed study quality by using the Cochrane 'Risk of bias' tool. We analysed continuous data by determining mean differences (MDs) and 95% confidence intervals (CIs), and dichotomous data by determining risk ratios (RRs) and 95% CIs. We pooled data using a fixed-effect model unless we identified significant heterogeneity, in which case we used a random-effects model. We used the GRADE approach to assess the overall quality of evidence supporting the outcomes assessed in this review.\nMain results\nWe included two new studies in this update and identified additional publications for previously included studies, bringing the total number of studies meeting the inclusion criteria to 32, and involving a total of 1835 participants with stable leg pain. The follow-up period ranged from two weeks to two years. Types of exercise varied from strength training to polestriding and upper or lower limb exercises; supervised sessions were generally held at least twice a week. Most trials used a treadmill walking test for one of the primary outcome measures. The methodological quality of included trials was moderate, mainly owing to absence of relevant information. Most trials were small and included 20 to 49 participants. Twenty-seven trials compared exercise versus usual care or placebo, and the five remaining trials compared exercise versus medication (pentoxifylline, iloprost, antiplatelet agents, and vitamin E) or pneumatic calf compression; we generally excluded people with various medical conditions or other pre-existing limitations to their exercise capacity.\nMeta-analysis from nine studies with 391 participants showed overall improvement in pain-free walking distance in the exercise group compared with the no exercise group (MD 82.11 m, 95% CI 71.73 to 92.48, P < 0.00001, high-quality evidence). Data also showed benefit from exercise in improved maximum walking distance (MD 120.36 m, 95% CI 50.79 to 189.92, P < 0.0007, high-quality evidence), as revealed by pooling data from 10 studies with 500 participants. Improvements were seen for up to two years.\nExercise did not improve the ABI (MD 0.04, 95% CI 0.00 to 0.08, 13 trials, 570 participants, moderate-quality evidence). Limited data were available for the outcomes of mortality and amputation; trials provided no evidence of an effect of exercise, when compared with placebo or usual care, on mortality (RR 0.92, 95% CI 0.39 to 2.17, 5 trials, 540 participants, moderate-quality evidence) or amputation (RR 0.20, 95% CI 0.01 to 4.15, 1 trial, 177 participants, low-quality evidence).\nResearchers measured quality of life using Short Form (SF)-36 at three and six months. At three months, the domains 'physical function', 'vitality', and 'role physical' improved with exercise; however this was a limited finding, as it was reported by only two trials. At six months, meta-analysis showed improvement in 'physical summary score' (MD 2.15, 95% CI 1.26 to 3.04, P = 0.02, 5 trials, 429 participants, moderate-quality evidence) and in 'mental summary score' (MD 3.76, 95% CI 2.70 to 4.82, P < 0.01, 4 trials, 343 participants, moderate-quality evidence) secondary to exercise. Two trials reported the remaining domains of the SF-36. Data showed improvements secondary to exercise in 'physical function' and 'general health'. The other domains - 'role physical', 'bodily pain', 'vitality', 'social', 'role emotional', and 'mental health' - did not show improvement at six months.\nEvidence was generally limited in trials comparing exercise versus antiplatelet therapy, pentoxifylline, iloprost, vitamin E, and pneumatic foot and calf compression owing to small numbers of trials and participants.\nReview authors used GRADE to assess the evidence presented in this review and determined that quality was moderate to high. Although results showed significant heterogeneity between trials, populations and outcomes were comparable overall, with findings relevant to the claudicant population. Results were pooled for large sample sizes - over 300 participants for most outcomes - using reproducible methods.\nAuthors' conclusions\nHigh-quality evidence shows that exercise programmes provided important benefit compared with placebo or usual care in improving both pain-free and maximum walking distance in people with leg pain from IC who were considered to be fit for exercise intervention. Exercise did not improve ABI, and we found no evidence of an effect of exercise on amputation or mortality. Exercise may improve quality of life when compared with placebo or usual care. As time has progressed, the trials undertaken have begun to include exercise versus exercise or other modalities; therefore we can include fewer of the new trials in this update.\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": "Intermittent claudication is a cramping leg pain that develops when walking and is relieved with rest. It is caused by inadequate blood flow to the leg muscles caused by atherosclerosis (fatty deposits restricting blood flow through the arteries). People with mild to moderate claudication are advised to keep walking, stop smoking, and reduce cardiovascular risk factors. Other treatments include antiplatelet therapy, pentoxifylline or cilostazol, angioplasty (inserting a balloon into the artery to open it up), and bypass surgery."
}
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query-laysum | 5443 | [
{
"role": "user",
"content": "Abstract: Background\nRepetitive peripheral magnetic stimulation (rPMS) is a non-invasive treatment method that can penetrate to deeper structures with painless stimulation to improve motor function in people with physical impairment due to brain or nerve disorders. rPMS for people after stroke has proved to be a feasible approach to improving activities of daily living and functional ability. However, the effectiveness and safety of this intervention for people after stroke remain uncertain. This is an update of the review published in 2019.\nObjectives\nTo assess the effects of rPMS for improving activities of daily living and functional ability in people after stroke.\nSearch methods\nWe searched the Cochrane Stroke Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); PsycINFO; the Allied and Complementary Medicine Database (AMED); OTseeker: Occupational Therapy Systematic Evaluation of Evidence; the Physiotherapy Evidence Database (PEDro); Ichushi-Web; and six ongoing trial registries on 5 October 2021. We screened reference lists and contacted experts in the field. We placed no restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (RCTs) conducted to assess the therapeutic effect of rPMS for people after stroke. The following comparisons were eligible for inclusion: 1) active rPMS only compared with 'sham' rPMS (a very weak form of stimulation or a sound only); 2) active rPMS only compared with no intervention; 3) active rPMS plus rehabilitation compared with sham rPMS plus rehabilitation; and 4) active rPMS plus rehabilitation compared with rehabilitation only.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion in the review. The same review authors assessed methods and risk of bias, undertook data extraction, and evaluated the certainty of the evidence using the GRADE approach. We contacted trial authors to request unpublished information if necessary. Any disagreements were resolved through discussion.\nMain results\nWe included four trials (three parallel-group RCTs and one cross-over trial) involving a total of 139 participants. This result was unchanged from the review published in 2019. Blinding of participants and physicians was well reported in three trials, with no information on whether personnel were blinded in one trial. We judged the overall risk of bias across trials as low. Only two trials (with 63 and 18 participants, respectively) provided sufficient information to be included in the meta-analysis. We found no clear effect of rPMS on activities of daily living at the end of treatment (mean difference (MD) −3.00, 95% confidence interval (CI) −16.35 to 10.35; P = 0.66; 1 trial; 63 participants; low-certainty evidence) and at the end of follow-up (MD −2.00, 95% CI −14.86 to 10.86; P = 0.76; 1 trial; 63 participants; low-certainty evidence) when comparing rPMS plus rehabilitation versus sham rPMS plus rehabilitation. We found no statistical difference in improvement of upper limb function at the end of treatment (MD 2.00, 95% CI −4.91 to 8.91; P = 0.57; 1 trial; 63 participants; low-certainty evidence) and at the end of follow-up (MD 4.00, 95% CI −2.92 to 10.92; P = 0.26; 1 trial; 63 participants; low-certainty evidence) when comparing rPMS plus rehabilitation versus sham rPMS plus rehabilitation. We observed a decrease in spasticity of the elbow at the end of follow-up (MD −0.41, 95% CI −0.89 to 0.07; 1 trial; 63 participants; low-certainty evidence) when comparing rPMS plus rehabilitation versus sham rPMS plus rehabilitation. In terms of muscle strength, rPMS treatment was not associated with improved muscle strength of the ankle dorsiflexors at the end of treatment (MD 3.00, 95% CI −2.44 to 8.44; P = 0.28; 1 trial; 18 participants; low-certainty evidence) when compared with sham rPMS. No studies provided information on lower limb function or adverse events, including death. Based on the GRADE approach, we judged the certainty of evidence related to the primary outcome as low, owing to the small sample size of the studies.\nAuthors' conclusions\nThere is insufficient evidence to permit the drawing of any conclusions about routine use of rPMS for people after stroke. Additional trials with large sample sizes are needed to provide robust evidence for rPMS after stroke.\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": "Is repetitive peripheral magnetic stimulation (rPMS) effective for improving daily activities in people after stroke?"
}
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query-laysum | 5444 | [
{
"role": "user",
"content": "Abstract: Background\nPelvic adhesions can form secondary to inflammation, endometriosis, or surgical trauma. Strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene, and fibrin or collagen sheets between pelvic structures.\nObjectives\nTo evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth, and postoperative adhesions in women of reproductive age.\nSearch methods\nWe searched the following databases in August 2019: the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Epistemonikos, and trial registries. We searched reference lists of relevant papers, conference proceedings, and grey literature sources. We contacted pharmaceutical companies for information and handsearched relevant journals and conference abstracts.\nSelection criteria\nRandomised controlled trials (RCTs) on the use of barrier agents compared with other barrier agents, placebo, or no treatment for prevention of adhesions in women undergoing gynaecological surgery.\nData collection and analysis\nThree review authors independently assessed trials for eligibility and risk of bias and extracted data. We calculated odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) using a fixed-effect model. We assessed the overall quality of the evidence using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods.\nMain results\nWe included 19 RCTs (1316 women). Seven RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (11 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (seven RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT), and mixed gynaecological surgery (one RCT). The sole indication for surgery in three of the RCTs was infertility. Thirteen RCTs reported commercial funding; the rest did not state their source of funding.\nNo studies reported our primary outcomes of pelvic pain and live birth rate.\nOxidised regenerated cellulose versus no treatment at laparoscopy or laparotomy (13 RCTs)\nAt second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose at laparoscopy reduced the incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, 3 RCTs, 360 participants; I² = 75%; very low-quality evidence) or of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, 3 RCTs, 100 participants; I² = 36%; very low-quality evidence).\nAt second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose affected the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, 1 RCT, 271 participants; very low-quality evidence). However, the incidence of re-formed adhesions may have been reduced in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, 6 RCTs, 554 participants; I² = 41%; low-quality evidence).\nNo studies reported results on pelvic pain, live birth rate, adhesion score, or clinical pregnancy rate.\nExpanded polytetrafluoroethylene versus oxidised regenerated cellulose at gynaecological surgery (two RCTs)\nWe are uncertain whether expanded polytetrafluoroethylene reduced the incidence of de novo adhesions at second-look laparoscopy (OR 0.93, 95% CI 0.26 to 3.41, 38 participants; very low-quality evidence). We are also uncertain whether expanded polytetrafluoroethylene resulted in a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants; very low-quality evidence) or a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants; very low-quality evidence) when compared with oxidised regenerated cellulose.\nNo studies reported results regarding pelvic pain, live birth rate, or clinical pregnancy rate.\nCollagen membrane with polyethylene glycol and glycerol versus no treatment at gynaecological surgery (one RCT)\nEvidence suggests that collagen membrane with polyethylene glycol and glycerol may reduce the incidence of adhesions at second-look laparoscopy (OR 0.04, 95% CI 0.00 to 0.77, 47 participants; low-quality evidence). We are uncertain whether collagen membrane with polyethylene glycol and glycerol improved clinical pregnancy rate (OR 5.69, 95% CI 1.38 to 23.48, 39 participants; very low-quality evidence).\nOne study reported adhesion scores but reported them as median scores rather than mean scores (median score 0.8 in the treatment group vs median score 1.2 in the control group) and therefore could not be included in the meta-analysis. The reported P value was 0.230, and no evidence suggests a difference between treatment and control groups.\nNo studies reported results regarding pelvic pain or live birth rate.\nIn total, 15 of the 19 RCTs included in this review reported adverse events. No events directly attributed to adhesion agents were reported.\nAuthors' conclusions\nWe found no evidence on the effects of barrier agents used during pelvic surgery on pelvic pain or live birth rate in women of reproductive age because no trial reported these outcomes.\nIt is difficult to draw credible conclusions due to lack of evidence and the low quality of included studies. Given this caveat, low-quality evidence suggests that collagen membrane with polyethylene glycol plus glycerol may be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. Low-quality evidence also shows that oxidised regenerated cellulose may reduce the incidence of re-formation of adhesions when compared with no treatment at laparotomy. It is not possible to draw conclusions on the relative effectiveness of these interventions due to lack of evidence.\nNo adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. Common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out.\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": "A common problem following pelvic surgery is the occurrence of adhesions, where the surfaces of two separate pelvic structures (e.g. inner lining of pelvic wall or pelvic organs such as uterus, ovaries, bladder, or bowel) stick together. During pelvic surgery, strategies to reduce pelvic adhesion formation include placing a synthetic physical barrier between pelvic structures."
}
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query-laysum | 5445 | [
{
"role": "user",
"content": "Abstract: Background\nEmbryo incubation and assessment is a vital step in assisted reproductive technology (ART). Traditionally, embryo assessment has been achieved by removing embryos from a conventional incubator daily for quality assessment by an embryologist, under a microscope. In recent years time-lapse systems (TLS) have been developed which can take digital images of embryos at frequent time intervals. This allows embryologists, with or without the assistance of embryo selection software, to assess the quality of the embryos without physically removing them from the incubator.\nThe potential advantages of a TLS include the ability to maintain a stable culture environment, therefore limiting the exposure of embryos to changes in gas composition, temperature, and movement. A TLS has the potential advantage of improving embryo selection for ART treatment by utilising additional information gained through continuously monitoring embryo development. Use of a TLS often adds significant extra cost to ART treatment.\nObjectives\nTo determine the effect of a TLS compared to conventional embryo incubation and assessment on clinical outcomes in couples undergoing ART.\nSearch methods\nWe used standard methodology recommended by Cochrane. We searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, and two trials registers on 7 January 2019 and checked references of appropriate papers.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing TLS, with or without embryo selection software, versus conventional incubation with morphological assessment; and TLS with embryo selection software versus TLS without embryo selection software among couples undergoing ART.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth or ongoing pregnancy, miscarriage and stillbirth, and cumulative live birth or ongoing pregnancy rate. The secondary outcomes were clinical pregnancy and cumulative clinical pregnancy. We assessed the quality of the evidence using GRADE methodology. We made the following comparisons.\nTLS with conventional morphological assessment of still TLS images versus conventional incubation and assessment\nTLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images\nTLS utilising embryo selection software versus conventional incubation and assessment\nMain results\nWe included nine RCTs (N = 2955 infertile couples). The quality of the evidence ranged from very low to low. The main limitations were high risk of bias in the included studies, imprecision, indirectness, and inconsistency. There were no data on cumulative live birth or ongoing pregnancy rate or cumulative clinical pregnancy rate.\nTLS with conventional morphological assessment of still TLS images versus conventional incubation and assessment\nIt is unclear whether there is any difference between interventions in rates of live birth or ongoing pregnancy (odds ratio (OR) 0.91, 95% confidence interval (CI) 0.67 to 1.23, 3 RCTs, N = 826, I2 = 33%, low-quality evidence) or in miscarriage rates (OR 1.90, 95% CI 0.99 to 3.61, 3 RCTs, N = 826, I2 = 0%, low-quality evidence). The evidence suggests that if the rate of live birth or ongoing pregnancy associated with conventional incubation and assessment is 35%, the rate with the use of TLS with conventional morphological assessment of still TLS images would be between 27% and 40%, and if the miscarriage rate with conventional incubation is 4%, the rate associated with conventional morphological assessment of still TLS images would be between 4% and 14%. It is unclear whether there is a difference between the interventions in rates of stillbirth (OR 1.00, 95% CI 0.13 to 7.49, 1 RCT, N = 76, low-quality evidence) or clinical pregnancy (OR 1.06, 95% CI 0.79 to 1.41, 4 RCTs, N = 875, I2 = 0%, low-quality evidence).\nTLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images\nAll findings for this comparison were very uncertain due to the very low-quality of the evidence. No data were available on live birth, but one RCT reported ongoing pregnancy. It is unclear whether there is any difference between the interventions in rates of ongoing pregnancy (OR 0.61, 95% CI 0.32 to 1.20, 1 RCT, N = 163); miscarriage (OR 1.39, 95% CI 0.64 to 3.01, 2 RCTs, N = 463, I2 = 0%); or clinical pregnancy (OR 0.97, 95% CI 0.67 to 1.42, 2 RCTs, N = 463, I2 = 0%). The evidence suggests that if the rate of ongoing pregnancy associated with TLS with conventional morphological assessment of still TLS images is 47%, the rate associated with TLS utilising embryo selection software would be between 22% and 52%, and if the miscarriage rate associated with conventional morphological assessment of still TLS images is 5%, the rate associated with TLS utilising embryo selection software would be between 4% and 15%. No studies reported stillbirth.\nTLS utilising embryo selection software versus conventional incubation and assessment\nThe findings for this comparison were also very uncertain due to the very low quality of the evidence. It is unclear whether there is any difference between the interventions in rates of live birth (OR 1.12, 95% CI 0.92 to 1.36, 3 RCTs, N = 1617, I2 = 84%). There was very low-quality evidence that TLS might reduce miscarriage rates (OR 0.63, 95% CI 0.45 to 0.89, 3 RCTs, N = 1617, I2 = 0%). It is unclear whether there is any difference between the interventions in rates of clinical pregnancy (OR 0.95, 95% CI 0.78 to 1.16, 3 RCTs, N = 1617, I2 = 89%). The evidence suggests that if the rate of live birth associated with conventional incubation and assessment is 48%, the rate with TLS utilising embryo selection software would be between 46% and 55%, and if the miscarriage rate with conventional incubation and assessment is 11%, the rate associated with TLS would be between 5% and 10%. No stillbirths occurred in the only study reporting this outcome.\nAuthors' conclusions\nThere is insufficient good-quality evidence of differences in live birth or ongoing pregnancy, miscarriage and stillbirth, or clinical pregnancy to choose between TLS, with or without embryo selection software, and conventional incubation. As the evidence is of low or very low-quality, our findings should be interpreted with caution.\n\nGiven the provided abstract, please respond to the following query: \"What the review found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "TLS with conventional assessment of still TLS images versus conventional incubation and assessment\nAll the evidence for this comparison was low-quality. It is unclear whether there is any difference between the interventions in rates of livebirth or ongoing pregnancy or miscarriage. The evidence suggests that if the rate of livebirth or ongoing pregnancy associated with conventional incubation and assessment is 35%, the rate with use of TLS with conventional morphological assessment of still TLS images would be between 27% and 40%, and if the miscarriage rate with conventional incubation is 4%, the rate associated with conventional morphological assessment of still TLS images would be between 4% and 14%. It is unclear whether there is a difference between interventions in rates of stillbirth or clinical pregnancy.\nTLS utilising embryo selection software versus TLS with conventional assessment of still TLS images\nAll findings for this comparison were very uncertain due to very low-quality evidence. No data were available on livebirth, but one study reported ongoing pregnancy. It is unclear whether there is any difference between interventions in rates of ongoing pregnancy, miscarriage, or clinical pregnancy. The evidence suggests that if the rate of ongoing pregnancy associated with TLS with conventional morphological assessment of still TLS images is 47%, the rate associated with TLS utilising embryo selection software would be between 22% and 52%, and if the miscarriage rate associated with conventional morphological assessment of still TLS images is 5%, the rate associated with TLS utilising embryo selection software would be between 4% and 15%. No studies reported stillbirth.\nTLS utilising embryo selection software versus conventional incubation and assessment\nAll findings for this comparison were very uncertain due to the very low-quality of the evidence. It is unclear whether there is any difference between interventions with respect to rates of livebirth or clinical pregnancy. The evidence suggests lower rates of miscarriage in the TLS group for the outcome of miscarriage. The evidence suggests that if the livebirth rate associated with conventional incubation is 48%, the rate with the use of TLS would be between 46% and 55%, and if the miscarriage rate with conventional incubation is 11%, the rate associated with TLS would be between 5% and 10%."
}
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query-laysum | 5446 | [
{
"role": "user",
"content": "Abstract: Background\nTriple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer associated with shorter survival and a higher likelihood of the cancer returning. In early TNBC, platinum-based chemotherapy has been shown to improve pathological complete response (pCR); however, its effect on long-term survival outcomes has not been fully elucidated and recommendations to include platinum chemotherapy are not consistent in international guidelines.\nObjectives\nTo evaluate the benefits and harms of platinum-based chemotherapy as adjuvant and neoadjuvant treatment in people with early triple-negative breast cancer.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 4 April 2022.\nSelection criteria\nWe included randomised controlled trials examining neoadjuvant or adjuvant platinum chemotherapy for early TNBC.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were disease-free survival (DFS) and overall survival (OS). Our secondary outcomes were pCR, treatment adherence, grade III or IV toxicity related to chemotherapy, and quality of life. Prespecified subgroups included BRCA mutation status, homologous recombination deficiency (HRD) status, frequency of chemotherapy, type of platinum agent used, and the presence or absence of anthracycline chemotherapy. We assessed risk of bias using Cochrane's RoB 1 tool and certainty of evidence using the GRADE approach.\nMain results\nFrom 3972 records, we included 20 published studies involving 21 treatment comparisons, and 25 ongoing studies. For most domains, risk of bias was low across studies. There were 16 neoadjuvant chemotherapy studies (one of which combined neoadjuvant and adjuvant therapy) and four adjuvant chemotherapy trials. Most studies used carboplatin (17 studies) followed by cisplatin (two), and lobaplatin (one). Eight studies had an anthracycline-free intervention arm, five of which had a carboplatin-taxane intervention compared to an anthracycline-taxane control.\nAll studies reporting DFS and OS used carboplatin. Inclusion of platinum chemotherapy improved DFS in neoadjuvant and adjuvant settings (neoadjuvant: hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.53 to 0.75; 7 studies, 8 treatment comparisons, 1966 participants; high-certainty evidence; adjuvant: HR 0.69, 95% CI 0.54 to 0.88; 4 studies, 1256 participants; high-certainty evidence). Platinum chemotherapy in the regimen improved OS (neoadjuvant: HR 0.69, 95% CI 0.55 to 0.86; 7 studies, 8 treatment comparisons, 1973 participants; high-certainty evidence; adjuvant: 0.70, 95% CI 0.50 to 0.96; 4 studies, 1256 participants; high-certainty evidence). Median follow-up for survival outcomes ranged from 36 to 97.6 months.\nOur analysis confirmed platinum chemotherapy increased pCR rates (risk ratio (RR) 1.44, 95% CI 1.31 to 1.59; 15 studies, 16 treatment comparisons, 3083 participants; high-certainty evidence). Subgroup analyses showed no evidence of differences in DFS according to BRCA mutation status, HRD status, lymph node status, or whether the intervention arm contained anthracycline chemotherapy or not.\nPlatinum chemotherapy was associated with reduced dose intensity, with participants more likely to require chemotherapy delays (RR 2.23, 95% CI 1.70 to 2.94; 4 studies, 5 treatment comparisons, 1053 participants; moderate-certainty evidence), dose reductions (RR 1.77, 95% CI 1.56 to 2.02; 7 studies, 8 treatment comparisons, 2055 participants; moderate-certainty evidence) and early cessation of treatment (RR 1.20, 95% CI 1.04 to 1.38; 16 studies, 17 treatment comparisons, 4178 participants; moderate-certainty evidence). Increased haematological toxicity occurred in the platinum group who were more likely to experience grade III/IV neutropenia (RR 1.53, 95% CI 1.43 to 1.63; 19 studies, 20 treatment comparisons, 4849 participants; moderate-certainty evidence), anaemia (RR 8.20, 95% CI 5.66 to 11.89; 18 studies, 19 treatment comparisons, 4757 participants; moderate-certainty evidence) and thrombocytopenia (RR 7.59, 95% CI 5.10 to 11.29; 18 studies, 19 treatment comparisons, 4731 participants; moderate-certainty evidence). There was no evidence of a difference between chemotherapy groups in febrile neutropenia (RR 1.16, 95% CI 0.89 to 1.49; 11 studies, 3771 participants; moderate-certainty evidence). Renal impairment was very rare (0.4%, 2 events in 463 participants; note 3 studies reported 0 events in both arms; 4 studies; high-certainty evidence). Treatment-related death was very rare (0.2%, 7 events in 3176 participants and similar across treatment groups; RR 0.58, 95% 0.14 to 2.33; 10 studies, 11 treatment comparisons; note 8 studies reported treatment-related deaths but recorded 0 events in both groups. Thus, the RR and CIs were calculated from 3 studies rather than 11; 3176 participants; high-certainty evidence). Five studies collected quality of life data but did not report them.\nAuthors' conclusions\nPlatinum-based chemotherapy using carboplatin in the adjuvant or neoadjuvant setting improves long-term outcomes of DFS and OS in early TNBC, with no evidence of differences by subgroup. This was at the cost of more frequent chemotherapy delays and dose reductions, and greater haematological toxicity, though serious adverse events including neuropathy, febrile neutropenia or treatment-related death were not increased.\nThese findings support the use of platinum-based chemotherapy for people with early TNBC. The optimal dose and regimen are not defined by this analysis, but there is a suggestion that similar relative benefits result from the addition of carboplatin to either anthracycline-free regimens or those containing anthracycline agents.\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 searched for studies looking at chemotherapy for early triple-negative breast cancer that compared regimens containing platinum chemotherapy to regimens without platinum chemotherapy.\nWe compared and summarised the results of the studies, and rated our confidence in the evidence based on factors such as study methods and size."
}
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query-laysum | 5447 | [
{
"role": "user",
"content": "Abstract: Background\nThe perimenopausal and postmenopausal periods are associated with many symptoms, including sexual complaints. This review is an update of a review first published in 2013.\nObjectives\nWe aimed to assess the effect of hormone therapy on sexual function in perimenopausal and postmenopausal women.\nSearch methods\nOn 19 December 2022 we searched the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Science, two trials registries, and OpenGrey, together with reference checking and contact with experts in the field for any additional studies.\nSelection criteria\nWe included randomized controlled trials that compared hormone therapy to either placebo or no intervention (control) using any validated assessment tool to evaluate sexual function. We considered hormone therapy: estrogen alone; estrogen in combination with progestogens; synthetic steroids, for example, tibolone; selective estrogen receptor modulators (SERMs), for example, raloxifene, bazedoxifene; and SERMs in combination with estrogen.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. We analyzed data using mean differences (MDs) and standardized mean differences (SMDs). The primary outcome was the sexual function score. Secondary outcomes were the domains of sexual response: desire; arousal; lubrication; orgasm; satisfaction; and pain. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 36 studies (23,299 women; 12,225 intervention group; 11,074 control group), of which 35 evaluated postmenopausal women; only one study evaluated perimenopausal women. The 'symptomatic or early postmenopausal women' subgroup included 10 studies, which included women experiencing menopausal symptoms (symptoms such as hot flushes, night sweats, sleep disturbance, vaginal atrophy, and dyspareunia) or early postmenopausal women (within five years after menopause). The 'unselected postmenopausal women’ subgroup included 26 studies, which included women regardless of menopausal symptoms and women whose last menstrual period was more than five years earlier. No study included only women with sexual dysfunction and only seven studies evaluated sexual function as a primary outcome. We deemed 20 studies at high risk of bias, two studies at low risk, and the other 14 studies at unclear risk of bias. Nineteen studies received commercial funding.\nEstrogen alone versus control probably slightly improves the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.50, 95% confidence interval (CI) (0.04 to 0.96; I² = 88%; 3 studies, 699 women; moderate-quality evidence), and probably makes little or no difference to the sexual function composite score in unselected postmenopausal women (SMD 0.64, 95% CI −0.12 to 1.41; I² = 94%; 6 studies, 608 women; moderate-quality evidence). The pooled result suggests that estrogen alone versus placebo or no intervention probably slightly improves sexual function composite score (SMD 0.60, 95% CI 0.16 to 1.04; I² = 92%; 9 studies, 1307 women, moderate-quality evidence).\nWe are uncertain of the effect of estrogen combined with progestogens versus placebo or no intervention on the sexual function composite score in unselected postmenopausal women (MD 0.08 95% CI −1.52 to 1.68; 1 study, 104 women; very low-quality evidence).\nWe are uncertain of the effect of synthetic steroids versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 1.32, 95% CI 1.18 to 1.47; 1 study, 883 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 0.46, 95% CI 0.07 to 0.85; 1 study, 105 women; very low-quality evidence).\nWe are uncertain of the effect of SERMs versus control on the sexual function composite score in symptomatic or early postmenopausal women (MD −1.00, 95% CI −2.00 to -0.00; 1 study, 215 women; very low-quality evidence) and of their effect in unselected postmenopausal women (MD 2.24, 95% 1.37 to 3.11 2 studies, 1525 women, I² = 1%, low-quality evidence).\nWe are uncertain of the effect of SERMs combined with estrogen versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.22, 95% CI 0.00 to 0.43; 1 study, 542 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 2.79, 95% CI 2.41 to 3.18; 1 study, 272 women; very low-quality evidence).\nThe observed heterogeneity in many analyses may be caused by variations in the interventions and doses used, and by different tools used for assessment.\nAuthors' conclusions\nHormone therapy treatment with estrogen alone probably slightly improves the sexual function composite score in women with menopausal symptoms or in early postmenopause (within five years of amenorrhoea), and in unselected postmenopausal women, especially in the lubrication, pain, and satisfaction domains. We are uncertain whether estrogen combined with progestogens improves the sexual function composite score in unselected postmenopausal women. Evidence regarding other hormone therapies (synthetic steroids and SERMs) is of very low quality and we are uncertain of their effect on sexual function. The current evidence does not suggest the beneficial effects of synthetic steroids (for example tibolone) or SERMs alone or combined with estrogen on sexual function. More studies that evaluate the effect of estrogen combined with progestogens, synthetic steroids, SERMs, and SERMs combined with estrogen would improve the quality of the evidence for the effect of these treatments on sexual function in perimenopausal and postmenopausal women.\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 to December 2022."
}
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query-laysum | 5448 | [
{
"role": "user",
"content": "Abstract: Background\nThis systematic review update summarizes the current evidence on the use of natalizumab for induction of remission in Crohn's disease (CD).\nObjectives\nTo determine the efficacy and safety of natalizumab for induction of remission in CD.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Trials Register, and clinicaltrials.gov from inception to 10 May 2018.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing natalizumab to a placebo or control therapy for induction of remission in CD.\nData collection and analysis\nTwo authors independently screened studies, extracted data and assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was failure to enter clinical remission. Secondary outcomes included clinical response, mean change in Crohn's Disease Activity Index (CDAI), adverse events (AEs), withdrawal due to AEs and serious AEs. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (95% CI). For continuous outcomes we calculated the mean difference (MD) and 95% CI. Data were pooled for meta-analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). We used GRADE to assess the overall quality of the evidence.\nMain results\nA total of five RCTs (1771 participants) were included. Four studies (1692 participants) compared one, two or three infusions of natalizumab (300 mg or 3 mg/kg or 6mg/kg) to placebo. One study (79 participants) compared three infusions of natalizumab (300 mg) and infliximab (5 mg/kg) to infliximab and placebo. Four studies were rated as low risk of bias. One study was rated as unclear risk of bias for selective reporting.\nOne, two and three infusions of natalizumab were superior to placebo for induction of remission and clinical response. Infusions were administered at weeks zero, four and eight. After one infusion, 76% (849/1117) of natalizumab participants failed to enter remission at 4 weeks compared to 83% (411/494) of placebo participants (RR 0.91, 95% CI 0.86 to 0.96, 3 studies, GRADE high quality). At 4 weeks, the RR for clinical response was 0.78 (95% CI 0.66 to 0.92, 3 studies, 1611 participants, GRADE moderate quality). After two infusions, after 8 weeks, 66% (693/1049) of natalizumab participants failed to enter remission compared to 77% (382/494) of placebo participants (RR 0.85, 95% CI 0.76 to 0.95; 3 studies, GRADE moderate quality). At 8 weeks, the RR for clinical response was 0.73 (95% CI 0.58 to 0.91, 3 studies, 1543 participants, GRADE low quality). After three infusions, at 12 weeks, 61% (596/983) of natalizumab participants failed to enter remission compared to 73% (313/431) of placebo participants (RR 0.85, 95% CI 0.78 to 0.92, 2 studies, GRADE high quality). At 12 weeks, the RR for clinical response was 0.76 (95% CI 0.67 to 0.86, 2 studies, 1414 participants, GRADE high quality). One study (507 participants) reported on change in CADI from baseline. Natalizumab participants had a larger drop in mean CDAI scores than placebo participants at 4, 8 and 12 weeks.\nThe rates of AEs, withdrawals due to AEs and serious AEs were similar across groups at 4, 8 and 12 weeks. After one infusion, 74% (50/68) of natalizumab participants experienced an AE compared to 81% (51/63) of placebo participants (RR 0.91, 95% CI 0.75 to 1.09, GRADE moderate quality). Withdrawal due to an AE occurred in 1% (1/68) of natalizumab participants and 3% of placebo participants (RR 0.46, 95% CI 0.04 to 4.98, GRADE low quality). SAEs occurred in 10% (7/68) of natalizumab participants compared to 11% (7/63) of placebo participants (RR 0.93, 95% CI 0.34 to 2.49, GRADE low quality). After two infusions, 86% (57/66) of natalizumab participants experienced an AE compared to 81% (51/63) of placebo participants (RR 1.07, 95% CI 0.92 to 1.24, GRADE moderate quality). Withdrawal due to an AE occurred in 3% (2/66) natalizumab participants compared to 3% (2/63) placebo participants (RR 0.95, 95% CI 0.14 to 6.57, GRADE low quality). SAEs occurred in 9% (6/66) of natalizumab participants and 11% (7/63) of placebo participants (RR 0.82, 95% CI 0.29 to 2.30, GRADE low quality). After three infusions, 86% (848/984) of natalizumab participants experienced an AE compared to 83% (359/431) placebo participants (RR 1.03, 95% CI 0.98 to 1.08, GRADE high quality). Withdrawals due to AEs occurred in 8% (82/984) of natalizumab participants compared to 10% (45/431) of placebo participants (RR 0.86, 95% CI 0.59 to 1.26, GRADE moderate quality). SAEs occurred in 7% (65/983) of natalizumab participants and 8% (36/431) of placebo participants (RR 0.76. 95% CI 0.37 to 1.56, GRADE low quality). Adverse events included headache, nausea, nasopharyngitis, abdominal pain, fatigue, vomiting, and exacerbation of CD.\nThe study comparing combination therapy with natalizumab and infliximab to infliximab and placebo demonstrated similar remission rates at 10 weeks. Sixty-four per cent (33/52) of participants assigned to natalizumab and infliximab failed to achieve remission compared to 70% (19/27) assigned to placebo and infliximab (RR 0.90, 95% CI 0.65 to 1.24, GRADE moderate quality). The rates of AEs (moderate quality evidence), withdrawals due to AEs (low quality evidence) and serious AEs (low quality evidence) were similar across groups at 10 weeks. Adverse events included headache, exacerbation of CD, nausea, and nasopharyngitis.\nNatalizumab is associated with the development of progressive multifocal leukoencephalopathy (PML) resulting in some patient deaths. There are currently no tests which can reliably predict those at risk of developing PML.\nAuthors' conclusions\nHigh quality data suggest that natalizumab is effective for induction of clinical remission and response in some patients with moderately to severely active CD. However, none of the included studies had the power to detect rare but serious adverse events such as PML. Due to the association with PML, and the availability of alternative agents that are not associated with PML, natalizumab is not likely to be used in patients who fail currently available medical therapy. The use of natalizumab in select patients (e.g. patients allergic to different biologics) needs to be carefully considered against the potential risk of developing PML. Futher studies of natalizumab are not likely to be done.\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 (CD) is a chronic inflammatory disease of the intestines. CD frequently occurs in the lower part of the small intestine, called the ileum, but it can affect any part of the digestive tract. Common symptoms include abdominal pain, often in the lower right area, and diarrhea. When people with CD are experiencing symptoms, the disease is called 'active'. When the symptoms stop, it is called 'remission'. Natalizumab and infliximab are biologic medications. These medications are directly infused into a vein (intravenous). Biologics suppress the immune system and reduce the inflammation associated with CD. Biologics are often given to people with moderate to severe CD who are unable to achieve remission despite treatment with standard drugs."
}
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query-laysum | 5449 | [
{
"role": "user",
"content": "Abstract: Background\nMagnesium sulphate is the drug of choice for the prevention and treatment of women with eclampsia. Regimens for administration of this drug have evolved over the years, but there is no clarity on the comparative benefits or harm of alternative regimens. This is an update of a review first published in 2010.\nObjectives\nTo assess if one magnesium sulphate regimen is better than another when used for the care of women with pre-eclampsia or eclampsia, or both, to reduce the risk of severe morbidity and mortality for the woman and her baby.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (29 April 2022), and reference lists of retrieved studies.\nSelection criteria\nWe included randomised trials and cluster-randomised trials comparing different regimens for administration of magnesium sulphate used in women with pre-eclampsia or eclampsia, or both. Comparisons included different dose regimens, intramuscular versus intravenous route for maintenance therapy, and different durations of therapy. We excluded studies with quasi-random or cross-over designs. We included abstracts of conference proceedings if compliant with the trustworthiness assessment.\nData collection and analysis\nFor this update, two review authors assessed trials for inclusion, performed risk of bias assessment, and extracted data. We checked data for accuracy. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nFor this update, a total of 16 trials (3020 women) met our inclusion criteria: four trials (409 women) compared regimens for women with eclampsia, and 12 trials (2611 women) compared regimens for women with pre-eclampsia. Most of the included trials had small sample sizes and were conducted in low- and middle-income countries. Eleven trials reported adequate randomisation and allocation concealment. Blinding of participants and clinicians was not possible in most trials. The included studies were for the most part at low risk of attrition and reporting bias.\nTreatment of women with eclampsia (four comparisons)\nOne trial compared a loading dose-alone regimen with a loading dose plus maintenance dose regimen (80 women). It is uncertain whether either regimen has an effect on the risk of recurrence of convulsions or maternal death (very low-certainty evidence).\nOne trial compared a lower-dose regimen with standard-dose regimen over 24 hours (72 women). It is uncertain whether either regimen has an effect on the risk of recurrence of convulsion, severe morbidity, perinatal death, or maternal death (very low-certainty evidence).\nOne trial (137 women) compared intravenous (IV) versus standard intramuscular (IM) maintenance regimen. It is uncertain whether either route has an effect on recurrence of convulsions, death of the baby before discharge (stillbirth and neonatal death), or maternal death (very low-certainty evidence).\nOne trial (120 women) compared a short maintenance regimen with a standard (24 hours after birth) maintenance regimen. It is uncertain whether the duration of the maintenance regimen has an effect on recurrence of convulsions, severe morbidity, or side effects such as nausea and respiratory failure. A short maintenance regimen may reduce the risk of flushing when compared to a standard 24 hours maintenance regimen (risk ratio (RR) 0.27, 95% confidence interval (CI) 0.08 to 0.93; 1 trial, 120 women; low-certainty evidence).\nMany of our prespecified critical outcomes were not reported in the included trials.\nPrevention of eclampsia for women with pre-eclampsia (five comparisons)\nTwo trials (462 women) compared loading dose alone with loading dose plus maintenance therapy. Low-certainty evidence suggests an uncertain effect with either regimen on the risk of eclampsia (RR 2.00, 95% CI 0.61 to 6.54; 2 trials, 462 women) or perinatal death (RR 0.50, 95% CI 0.19 to 1.36; 2 trials, 462 women).\nOne small trial (17 women) compared an IV versus IM maintenance regimen for 24 hours. It is uncertain whether IV or IM maintenance regimen has an effect on eclampsia or stillbirth (very low-certainty evidence).\nFour trials (1713 women) compared short postpartum maintenance regimens with continuing for 24 hours after birth. Low-certainty evidence suggests there may be a wide range of benefit or harm between groups regarding eclampsia (RR 1.99, 95% CI 0.18 to 21.87; 4 trials, 1713 women). Low-certainty evidence suggests there may be little or no effect on severe morbidity (RR 0.96, 95% CI 0.71 to 1.29; 2 trials, 1233 women) or side effects such as respiratory depression (RR 0.80, 95% CI 0.25 to 2.61; 2 trials, 1424 women).\nThree trials (185 women) compared a higher-dose maintenance regimen versus a lower-dose maintenance regimen. It is uncertain whether either regimen has an effect on eclampsia (very low-certainty evidence). Low-certainty evidence suggests that a higher-dose maintenance regimen has little or no effect on side effects when compared to a lower-dose regimen (RR 0.79, 95% CI 0.61 to 1.01; 1 trial 62 women).\nOne trial (200 women) compared a maintenance regimen by continuous infusion versus a serial IV bolus regimen. It is uncertain whether the duration of the maintenance regimen has an effect on eclampsia, side effects, perinatal death, maternal death, or other neonatal morbidity (very low-certainty evidence).\nMany of our prespecified critical outcomes were not reported in the included trials.\nAuthors' conclusions\nDespite the number of trials evaluating various magnesium sulphate regimens for eclampsia prophylaxis and treatment, there is still no compelling evidence that one particular regimen is more effective than another. Well-designed randomised controlled trials are needed to answer this question.\n\nGiven the provided abstract, please respond to the following query: \"Why is this is important for women with pre-eclampsia and eclampsia?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Magnesium sulphate is effective in preventing eclampsia in women who have pre-eclampsia and in treating women who experience an eclamptic convulsion to avoid severe maternal/infant illnesses and death. However, magnesium sulphate may cause undesirable effects (difficulties in breathing; a reduction in the amount of urine, which could damage the kidneys) in high doses and may need to be administered by experienced personnel."
}
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query-laysum | 5450 | [
{
"role": "user",
"content": "Abstract: Background\nCervical artery dissection (CeAD) is a pathological bleed or tear, or both, in the wall of the carotid or vertebral arteries as they course through the neck, and is a leading cause of stroke in young people.\nObjectives\nTo assess the effectiveness of surgical and radiological interventions versus best medical treatment alone for treating symptomatic cervical artery dissection.\nSearch methods\nWe performed comprehensive searches of the Cochrane Stroke Group Trials Register (last searched March 2020), the Cochrane Central Register of Controlled Trials (CENTRAL), 2020, Issue 4, in the Cochrane Library (searched March 2020), MEDLINE (1946 to March 2020) and Embase (1974 to March 2020). We searched relevant ongoing trials and research registers (searched March 2020), checked references in all relevant papers for additional eligible studies, and contacted authors and researchers in the field.\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) of either surgical or endovascular intervention for the management of symptomatic CeAD were eligible for inclusion. Only studies with anticoagulants or antiplatelet treatment as the control group were included. Two review authors planned to independently extract data.\nData collection and analysis\nPrimary outcomes were ipsilateral stroke and disability. Secondary outcomes were death, any stroke, or transient ischaemic attack, residual stenosis (> 50%), recurrence of cervical dissection, expanding pseudoaneurysm, or major bleeding. We analysed the studies according to the first choice of treatment. We planned to assess for risk of bias and apply GRADE criteria for any included studies.\nMain results\nWe did not find any completed RCTs or CCTs undertaken in this area of research.\nAuthors' conclusions\nNo RCTs or CCTs compared either surgery or endovascular therapy with control. Thus, there is no available evidence to support their use for the treatment of extracranial cervical artery dissection in addition to antithrombotic therapy in people who continue to have neurological symptoms when treated with antithrombotic therapy alone.\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 looked for trials which were conducted in an objective way and designed specifically to compare either surgery or radiological intervention to medical therapy alone."
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query-laysum | 5451 | [
{
"role": "user",
"content": "Abstract: Background\nRapid and accurate detection of stroke by paramedics or other emergency clinicians at the time of first contact is crucial for timely initiation of appropriate treatment. Several stroke recognition scales have been developed to support the initial triage. However, their accuracy remains uncertain and there is no agreement which of the scales perform better.\nObjectives\nTo systematically identify and review the evidence pertaining to the test accuracy of validated stroke recognition scales, as used in a prehospital or emergency room (ER) setting to screen people suspected of having stroke.\nSearch methods\nWe searched CENTRAL, MEDLINE (Ovid), Embase (Ovid) and the Science Citation Index to 30 January 2018. We handsearched the reference lists of all included studies and other relevant publications and contacted experts in the field to identify additional studies or unpublished data.\nSelection criteria\nWe included studies evaluating the accuracy of stroke recognition scales used in a prehospital or ER setting to identify stroke and transient Ischemic attack (TIA) in people suspected of stroke. The scales had to be applied to actual people and the results compared to a final diagnosis of stroke or TIA. We excluded studies that applied scales to patient records; enrolled only screen-positive participants and without complete 2 × 2 data.\nData collection and analysis\nTwo review authors independently conducted a two-stage screening of all publications identified by the searches, extracted data and assessed the methodologic quality of the included studies using a tailored version of QUADAS-2. A third review author acted as an arbiter. We recalculated study-level sensitivity and specificity with 95% confidence intervals (CI), and presented them in forest plots and in the receiver operating characteristics (ROC) space. When a sufficient number of studies reported the accuracy of the test in the same setting (prehospital or ER) and the level of heterogeneity was relatively low, we pooled the results using the bivariate random-effects model. We plotted the results in the summary ROC (SROC) space presenting an estimate point (mean sensitivity and specificity) with 95% CI and prediction regions. Because of the small number of studies, we did not conduct meta-regression to investigate between-study heterogeneity and the relative accuracy of the scales. Instead, we summarized the results in tables and diagrams, and presented our findings narratively.\nMain results\nWe selected 23 studies for inclusion (22 journal articles and one conference abstract). We evaluated the following scales: Cincinnati Prehospital Stroke Scale (CPSS; 11 studies), Recognition of Stroke in the Emergency Room (ROSIER; eight studies), Face Arm Speech Time (FAST; five studies), Los Angeles Prehospital Stroke Scale (LAPSS; five studies), Melbourne Ambulance Stroke Scale (MASS; three studies), Ontario Prehospital Stroke Screening Tool (OPSST; one study), Medic Prehospital Assessment for Code Stroke (MedPACS; one study) and PreHospital Ambulance Stroke Test (PreHAST; one study). Nine studies compared the accuracy of two or more scales. We considered 12 studies at high risk of bias and one with applicability concerns in the patient selection domain; 14 at unclear risk of bias and one with applicability concerns in the reference standard domain; and the risk of bias in the flow and timing domain was high in one study and unclear in another 16.\nWe pooled the results from five studies evaluating ROSIER in the ER and five studies evaluating LAPSS in a prehospital setting. The studies included in the meta-analysis of ROSIER were of relatively good methodologic quality and produced a summary sensitivity of 0.88 (95% CI 0.84 to 0.91), with the prediction interval ranging from approximately 0.75 to 0.95. This means that the test will miss on average 12% of people with stroke/TIA which, depending on the circumstances, could range from 5% to 25%. We could not obtain a reliable summary estimate of specificity due to extreme heterogeneity in study-level results. The summary sensitivity of LAPSS was 0.83 (95% CI 0.75 to 0.89) and summary specificity 0.93 (95% CI 0.88 to 0.96). However, we were uncertain in the validity of these results as four of the studies were at high and one at uncertain risk of bias. We did not report summary estimates for the rest of the scales, as the number of studies per test per setting was small, the risk of bias was high or uncertain, the results were highly heterogenous, or a combination of these.\nStudies comparing two or more scales in the same participants reported that ROSIER and FAST had similar accuracy when used in the ER. In the field, CPSS was more sensitive than MedPACS and LAPSS, but had similar sensitivity to that of MASS; and MASS was more sensitive than LAPSS. In contrast, MASS, ROSIER and MedPACS were more specific than CPSS; and the difference in the specificities of MASS and LAPSS was not statistically significant.\nAuthors' conclusions\nIn the field, CPSS had consistently the highest sensitivity and, therefore, should be preferred to other scales. Further evidence is needed to determine its absolute accuracy and whether alternatives scales, such as MASS and ROSIER, which might have comparable sensitivity but higher specificity, should be used instead, to achieve better overall accuracy. In the ER, ROSIER should be the test of choice, as it was evaluated in more studies than FAST and showed consistently high sensitivity. In a cohort of 100 people of whom 62 have stroke/TIA, the test will miss on average seven people with stroke/TIA (ranging from three to 16). We were unable to obtain an estimate of its summary specificity. Because of the small number of studies per test per setting, high risk of bias, substantial differences in study characteristics and large between-study heterogeneity, these findings should be treated as provisional hypotheses that need further verification in better-designed studies.\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": "Stroke is a life-threatening medical condition in which brain tissue is damaged. This could be caused by a clot blocking the blood supply to part of the brain or bleeding in the brain. If symptoms resolve within 24 hours without lasting consequences, the condition is called TIA (mini stroke). Effective treatment depends on early identification of stroke and any delays may result in brain damage or death.\nEmergency medical services are the first point of contact for people experiencing symptoms suggestive of stroke. Medical responders could identify people with stroke more accurately if they use checklists called stroke recognition scales. Such scales include symptoms and other readily-available information. A positive result on the scale indicates high risk of stroke and the need of urgent specialist assessment. The scales do not differentiate between stroke and TIA; this is done in hospital by a neurologist or stroke physician.\nOur objective was to review the research evidence on how accurately stroke recognition scales can detect stroke or TIA when used by paramedics or other prehospital clinicians, who are the first point of contact for people suspected of stroke."
}
]
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query-laysum | 5452 | [
{
"role": "user",
"content": "Abstract: Background\nAcute psychotic illness, especially when associated with agitated or violent behaviour, can require urgent pharmacological tranquillisation or sedation. In several countries, clinicians often use benzodiazepines (either alone or in combination with antipsychotics) for this outcome.\nObjectives\nTo examine whether benzodiazepines, alone or in combination with other pharmacological agents, is an effective treatment for psychosis-induced aggression or agitation when compared with placebo, other pharmacological agents (alone or in combination) or non-pharmacological approaches.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's register (January 2012, 20 August 2015 and 3 August 2016), inspected reference lists of included and excluded studies, and contacted authors of relevant studies.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing benzodiazepines alone or in combination with any antipsychotics, versus antipsychotics alone or in combination with any other antipsychotics, benzodiazepines or antihistamines, for people who were aggressive or agitated due to psychosis.\nData collection and analysis\nWe reliably selected studies, quality assessed them and extracted data. For binary outcomes, we calculated standard estimates of risk ratio (RR) and their 95% confidence intervals (CI) using a fixed-effect model. For continuous outcomes, we calculated the mean difference (MD) between groups. If there was heterogeneity, this was explored using a random-effects model. We assessed risk of bias and created a 'Summary of findings' table using GRADE.\nMain results\nTwenty trials including 695 participants are now included in the review. The trials compared benzodiazepines or benzodiazepines plus an antipsychotic with placebo, antipsychotics, antihistamines, or a combination of these. The quality of evidence for the main outcomes was low or very low due to very small sample size of included studies and serious risk of bias (randomisation, allocation concealment and blinding were not well conducted in the included trials, 30% of trials (six out of 20) were supported by pharmaceutical institutes). There was no clear effect for most outcomes.\nBenzodiazepines versus placebo\nOne trial compared benzodiazepines with placebo. There was no difference in the number of participants sedated at 24 hours (very low quality evidence). However, for the outcome of global state, clearly more people receiving placebo showed no improvement in the medium term (one to 48 hours) (n = 102, 1 RCT, RR 0.62, 95% CI 0.40 to 0.97, very low quality evidence).\nBenzodiazepines versus antipsychotics\nFor the outcome of sedation by 16 hours, there was no difference between haloperidol and benzodiazepine (n = 434, 8 RCTs, RR 1.13, 95% CI 0.83 to 1.54, low quality evidence). There was no difference in the number of participants who had not improved in the medium term (n = 188, 5 RCTs, RR 0.89, 95% CI 0.71 to 1.11, low quality evidence). However, one small study found fewer participants improved when receiving benzodiazepines compared with olanzapine (n = 150, 1 RCT, RR 1.84, 95% CI 1.06 to 3.18, very low quality evidence). People receiving benzodiazepines were less likely to experience extrapyramidal effects in the medium term compared to people receiving haloperidol (n = 233, 6 RCTs, RR 0.13, 95% CI 0.04 to 0.41, low quality evidence).\nBenzodiazepines versus combined antipsychotics/antihistamines\nWhen benzodiazepine was compared with combined antipsychotics/antihistamines (haloperidol plus promethazine), there was a higher risk of no improvement in people receiving benzodiazepines in the medium term (n = 200, 1 RCT, RR 2.17, 95% CI 1.16 to 4.05, low quality evidence). However, for sedation, the results were controversial between two groups: lorazepam may lead to lower risk of sedation than combined antipsychotics/antihistamines (n = 200, 1 RCT, RR 0.91, 95% CI 0.84 to 0.98, low quality evidence); while, midazolam may lead to higher risk of sedation than combined antipsychotics/antihistamines (n = 200, 1 RCT, RR 1.13, 95% CI 1.04 to 1.23, low quality evidence).\nOther combinations\nData comparing benzodiazepines plus antipsychotics versus benzodiazepines alone did not yield any results with clear differences; all were very low quality evidence. When comparing combined benzodiazepines/antipsychotics (all studies compared haloperidol) with the same antipsychotics alone (haloperidol), there was no difference between groups in improvement in the medium term (n = 185, 4 RCTs, RR 1.17, 95% CI 0.93 to 1.46, low quality evidence), but sedation was more likely in people who received the combination therapy (n = 172, 3 RCTs, RR 1.75, 95% CI 1.14 to 2.67, very low quality evidence). Only one study compared combined benzodiazepine/antipsychotics with antipsychotics; however, this study did not report our primary outcomes. One small study compared combined benzodiazepines/antipsychotics with combined antihistamines/antipsychotics. Results showed a higher risk of no clinical improvement (n = 60, 1 RCT, RR 25.00, 95% CI 1.55 to 403.99, very low quality evidence) and sedation status (n = 60, 1 RCT, RR 12.00, 95% CI 1.66 to 86.59, very low quality evidence) in the combined benzodiazepines/antipsychotics group.\nAuthors' conclusions\nThe evidence from RCTs for the use of benzodiazepines alone is not good. There were relatively few good data. Most trials were too small to highlight differences in either positive or negative effects. Adding a benzodiazepine to other drugs does not seem to confer clear advantage and has potential for adding unnecessary adverse effects. Sole use of older antipsychotics unaccompanied by anticholinergic drugs seems difficult to justify. Much more high-quality research is still needed in this area.\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": "The aim of this review was to compare the tranquillising (calming) or sedative (sleepiness) effects of benzodiazepines, given alone or combined with other drugs compared with the effect of placebo (a pretend treatment), other drugs or non-drug treatments for people who are aggressive or agitated because they are experiencing psychoses."
}
]
|
query-laysum | 5453 | [
{
"role": "user",
"content": "Abstract: Background\nUndifferentiated acute respiratory infections (ARIs) are a large and heterogeneous group of infections not clearly restricted to one specific part of the upper respiratory tract, which last for up to seven days. They are more common in pre-school children in low-income countries and are responsible for 75% of the total amount of prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications.\nObjectives\nTo assess the effectiveness and safety of antibiotics in preventing bacterial complications in children aged two months to 59 months with undifferentiated ARIs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1950 to August week 1, 2015) and EMBASE (1974 to August 2015).\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs comparing antibiotic prescriptions with placebo or no treatment in children aged two months to 59 months with an undifferentiated ARI for up to seven days.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted and analysed data using the standard Cochrane methodological procedures.\nMain results\nWe identified four trials involving 1314 children. Three trials investigated the use of amoxicillin/clavulanic acid to prevent otitis and one investigated ampicillin to prevent pneumonia.\nThe use of amoxicillin/clavulanic acid compared to placebo to prevent otitis showed a risk ratio (RR) of 0.70 (95% confidence interval (CI) 0.45 to 1.11, three trials, 414 selected children, moderate-quality evidence). Methods of random sequence generation and allocation concealment were not clearly stated in two trials. Performance, detection and reporting bias could not be ruled out in three trials.\nAmpicillin compared to supportive care (continuation of breastfeeding, clearing of the nose and paracetamol for fever control) to prevent pneumonia showed a RR of 1.05 (95% CI 0.74 to 1.49, one trial, 889 selected children, moderate-quality evidence). The trial was non-blinded. Random sequence generation and allocation concealment methods were not clearly stated, so the possibility of reporting bias could not be ruled out.\nHarm outcomes could not be analysed as they were expressed only in percentages.\nWe found no studies assessing mastoiditis, quinsy, abscess, meningitis, hospital admission or death.\nAuthors' conclusions\nThere is insufficient evidence for antibiotic use as a means of reducing the risk of otitis or pneumonia in children up to five years of age with undifferentiated ARIs. Further high-quality research is needed to provide more definitive evidence of the effectiveness of antibiotics in this population.\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": "Common upper ARIs are a large and varied groups of infections. They occur in any part of the upper respiratory system, last for up to seven days and have a wide variety of causes. They may lead to complications such as ear, throat and sinus infections. More common in pre-school children, they are the most frequent reason for parents to seek medical assistance. Furthermore, they are responsible for 75% of the total prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications."
}
]
|
query-laysum | 5454 | [
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory distress syndrome (ARDS) represents the most severe course of COVID-19 (caused by the SARS-CoV-2 virus), usually resulting in a prolonged stay in an intensive care unit (ICU) and high mortality rates. Despite the fact that most affected individuals need invasive mechanical ventilation (IMV), evidence on specific ventilation strategies for ARDS caused by COVID-19 is scarce. Spontaneous breathing during IMV is part of a therapeutic concept comprising light levels of sedation and the avoidance of neuromuscular blocking agents (NMBA). This approach is potentially associated with both advantages (e.g. a preserved diaphragmatic motility and an optimised ventilation-perfusion ratio of the ventilated lung), as well as risks (e.g. a higher rate of ventilator-induced lung injury or a worsening of pulmonary oedema due to increases in transpulmonary pressure). As a consequence, spontaneous breathing in people with COVID-19-ARDS who are receiving IMV is subject to an ongoing debate amongst intensivists.\nObjectives\nTo assess the benefits and harms of early spontaneous breathing activity in invasively ventilated people with COVID-19 with ARDS compared to ventilation strategies that avoid spontaneous breathing.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (which includes CENTRAL, PubMed, Embase, Clinical Trials.gov WHO ICTRP, and medRxiv) and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies from their inception to 2 March 2022.\nSelection criteria\nEligible study designs comprised randomised controlled trials (RCTs) that evaluated spontaneous breathing in participants with COVID-19-related ARDS compared to ventilation strategies that avoided spontaneous breathing (e.g. using NMBA or deep sedation levels). Additionally, we considered controlled before-after studies, interrupted time series with comparison group, prospective cohort studies and retrospective cohort studies. For these non-RCT studies, we considered a minimum total number of 50 participants to be compared as necessary for inclusion. Prioritised outcomes were all-cause mortality, clinical improvement or worsening, quality of life, rate of (serious) adverse events and rate of pneumothorax. Additional outcomes were need for tracheostomy, duration of ICU length of stay and duration of hospitalisation.\nData collection and analysis\nWe followed the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions.\nTwo review authors independently screened all studies at the title/abstract and full-text screening stage. We also planned to conduct data extraction and risk of bias assessment in duplicate. We planned to conduct meta-analysis for each prioritised outcome, as well as subgroup analyses of mortality regarding severity of oxygenation impairment and duration of ARDS. In addition, we planned to perform sensitivity analyses for studies at high risk of bias, studies using NMBA in addition to deep sedation level to avoid spontaneous breathing and a comparison of preprints versus peer-reviewed articles. We planned to assess the certainty of evidence using the GRADE approach.\nMain results\nWe identified no eligible studies for this review.\nAuthors' conclusions\nWe found no direct evidence on whether early spontaneous breathing in SARS-CoV-2-induced ARDS is beneficial or detrimental to this particular group of patients. RCTs comparing early spontaneous breathing with ventilatory strategies not allowing for spontaneous breathing in SARS-CoV-2-induced ARDS are necessary to determine its value within the treatment of severely ill people with COVID-19. Additionally, studies should aim to clarify whether treatment effects differ between people with SARS-CoV-2-induced ARDS and people with non-SARS-CoV-2-induced ARDS.\n\nGiven the provided abstract, please respond to the following query: \"What are the advantages of early spontaneous breathing in ARDS?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The advantage of spontaneous breathing during mechanical ventilation is the preserved movement of the diaphragm (the major muscle for breathing located under the lungs). It leads to better distribution of the inhaled air, especially in the pulmonary alveoli (small air sacs within the lungs) close to the diaphragm. In general, ventilation procedures with possible spontaneous breathing require lower doses of sedatives (which slow down brain activity). Since these can cause low blood pressure, it can additionally reduce the administration of cardiovascular medicines."
}
]
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query-laysum | 5455 | [
{
"role": "user",
"content": "Abstract: Background\nDamage caused by lung overdistension (volutrauma) has been implicated in the development of bronchopulmonary dysplasia (BPD). Modern neonatal ventilation modes can target a set tidal volume as an alternative to traditional pressure-limited ventilation (PLV) using a fixed inflation pressure. Volume-targeted ventilation (VTV) aims to produce a more stable tidal volume in order to reduce lung damage and stabilise the partial pressure of carbon dioxide (pCO2).\nObjectives\nTo determine whether VTV compared with PLV leads to reduced rates of death and death or BPD in newborn infants and to determine whether use of VTV affected outcomes including air leak, cranial ultrasound findings and neurodevelopment.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 12), MEDLINE via PubMed (1966 to 13 January 2017), Embase (1980 to 13 January 2017) and CINAHL (1982 to 13 January 2017). We also searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We contacted the principal investigators of studies to obtain supplementary information.\nSelection criteria\nRandomised and quasi-randomised trials comparing VTV versus PLV in infants of less than 44 weeks' postmenstrual age and reporting clinically relevant outcomes.\nData collection and analysis\nWe assessed risk of bias for each trial using Cochrane methodology. We evaluated quality of evidence for each outcome using GRADE criteria. We tabulated mortality, rates of BPD, short-term clinical outcomes and long-term developmental outcomes.\nStatistics: for categorical outcomes, we calculated typical estimates for risk ratios (RR), risk differences (RD) and number needed to treat for an additional beneficial outcome (NNTB). For continuous variables, we calculated typical estimates for mean differences (MD). We used 95% confidence intervals (CI) and assumed a fixed-effect model for meta-analysis.\nMain results\nTwenty randomised trials met our inclusion criteria; 16 parallel trials (977 infants) and four cross-over trials (88 infants). No studies were blinded and the quality of evidence for outcomes assessed varied from moderate to low.\nWe found no difference in the primary outcome, death before hospital discharge, between VTV modes versus PLV modes (typical RR 0.75, 95% CI 0.53 to 1.07; low quality evidence). However, there was moderate quality evidence that the use of VTV modes resulted in a reduction in the primary outcome, death or BPD at 36 weeks' gestation (typical RR 0.73, 95% CI 0.59 to 0.89; typical NNTB 8, 95% CI 5 to 20) and the following secondary outcomes: rates of pneumothorax (typical RR 0.52, 95% CI 0.31 to 0.87; typical NNTB 20, 95% CI 11 to 100), mean days of mechanical ventilation (MD -1.35 days, 95% CI -1.83 to -0.86), rates of hypocarbia (typical RR 0.49, 95% CI 0.33 to 0.72; typical NNTB 3, 95% CI 2 to 5), rates of grade 3 or 4 intraventricular haemorrhage (typical RR 0.53, 95% CI 0.37 to 0.77; typical NNTB 11, 95% CI 7 to 25) and the combined outcome of periventricular leukomalacia with or without grade 3 or 4 intraventricular haemorrhage (typical RR 0.47, 95% CI 0.27 to 0.80; typical NNTB 11, 95% CI 7 to 33). VTV modes were not associated with any increased adverse outcomes.\nAuthors' conclusions\nInfants ventilated using VTV modes had reduced rates of death or BPD, pneumothoraces, hypocarbia, severe cranial ultrasound pathologies and duration of ventilation compared with infants ventilated using PLV modes. Further studies are needed to identify whether VTV modes improve neurodevelopmental outcomes and to compare and refine VTV strategies.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Low to moderate quality as none of the studies were blinded and there were issues with study design in some of the studies."
}
]
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