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query-laysum
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8589
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is a updated version of our Cochrane Review published in Issue 6, 2012. Sexually-transmitted infections (STIs) continue to rise worldwide, imposing an enormous morbidity and mortality burden. Effective prevention strategies, including microbicides, are needed to achieve the goals of the World Heath Organization (WHO) global strategy for the prevention and control of these infections.\nObjectives\nTo determine the effectiveness and safety of topical microbicides for preventing acquisition of STIs, including HIV.\nSearch methods\nWe undertook a comprehensive search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, CLIB, Web of Science, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and reference lists of relevant articles up to August 2020. In addition, we contacted relevant organisations and experts.\nSelection criteria\nWe included randomised controlled trials of vaginal microbicides compared to placebo (except for nonoxynol-9 because it is covered in related Cochrane Reviews). Eligible participants were sexually-active non-pregnant, WSM and MSM, who had no laboratory confirmed STIs.\nData collection and analysis\nTwo review authors independently screened and selected studies, extracted data, and assessed risks of bias in duplicate, resolving differences by consensus. We conducted a fixed-effect meta-analysis, stratified by type of microbicide, and assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included eight trials from the earlier version of the review and four new trials, i.e. a total of 12 trials with 32,464 participants (all WSM). We did not find any eligible study that enrolled MSM or reported fungal STI as an outcome. We have no study awaiting assessment.\nAll 12 trials were conducted in sub-Saharan Africa, with one having a study site in the USA, and another having a site in India. Vaginal microbicides tested were BufferGel and PRO 2000 (1 trial, 3101 women), Carraguard (1 trial, 6202 women), cellulose sulphate (2 trials, 3069 women), dapivirine (2 trials, 4588 women), PRO 2000 (1 trial, 9385 women), C31G (SAVVY) (2 trials, 4295 women), and tenofovir (3 trials, 4958 women). All microbicides were compared to placebo and all trials had low risk of bias.\nDapivirine probably reduces the risk of acquiring HIV infection: risk ratio (RR) 0.71, (95% confidence interval (CI) 0.57 to 0.89, I2 = 0%, 2 trials, 4588 women; moderate-certainty evidence). The other microbicides may result in little to no difference in the risk of acquiring HIV (low-certainty evidence); including tenofovir (RR 0.83, 95% CI 0.68 to 1.02, cellulose sulphate (RR 1.20, 95% CI 0.74 to 1.95, BufferGel (RR 1.05, 95% CI 0.73 to 1.52), Carraguard (RR 0.89, 95% CI 0.71 to 1.11), PRO 2000 (RR 0.93, 95% CI 0.77 to 1.14), and SAVVY (RR 1.38, 95% CI 0.79 to 2.41).\nExisting evidence suggests that cellulose sulphate (RR 0.99, 95% CI 0.37 to 2.62, 1 trial, 1425 women), and PRO 2000 (RR 0.95, 95% CI 0.73 to 1.23) may result in little to no difference in the risk of getting herpes simplex virus type 2 infection (low-certainty evidence). Two studies reported data on tenofovir's effect on this virus. One suggested that tenofovir may reduce the risk (RR 0.55, 95% CI 0.36 to 0.82; 224 participants) while the other did not find evidence of an effect (RR 0.94, 95% CI 0.85 to 1.03; 1003 participants). We have not reported the pooled result because of substantial heterogeneity of effect between the two studies (l2 = 85%).\nThe evidence also suggests that dapivirine (RR 1.70, 95% CI 0.63 to 4.59), tenofovir (RR 1.27, 95% CI 0.58 to 2.78), cellulose sulphate (RR 0.69, 95% CI 0.26 to 1.81), and (Carraguard (RR 1.07, 95% CI 0.75 to 1.52) may have little or no effect on the risk of acquiring syphilis (low-certainty evidence).\nIn addition, dapivirine (RR 0.97, 95% CI 0.89 to 1.07), tenofovir (RR 0.90, 95% CI 0.71 to 1.13), cellulose sulphate (RR 0.70, 95% CI 0.49 to 0.99), BufferGel (RR 0.97, 95% CI 0.65 to 1.45), Carraguard (RR 0.96, 95% CI 0.83 to 1.12), and PRO 2000 (RR 1.01, 95% CI 0.84 to 1.22) may result in little to no difference in the risk of acquiring chlamydia infection (low-certainty evidence).\nThe evidence also suggests that current topical microbicides may not have an effect on the risk of acquiring gonorrhoea, condyloma acuminatum, trichomoniasis, or human papillomavirus infection (low-certainty evidence). Microbicide use in the 12 trials, compared to placebo, did not lead to any difference in adverse event rates.\nNo study reported on acceptability of the intervention.\nAuthors' conclusions\nCurrent evidence shows that vaginal dapivirine microbicide probably reduces HIV acquisition in women who have sex with men. Other types of vaginal microbicides have not shown evidence of an effect on acquisition of STIs, including HIV. Further research should continue on the development and testing of new microbicides.\n\nGiven the provided abstract, please respond to the following query: \"Trial characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cochrane researchers searched the available literature up to August 2020 and included 12 trials with 32,464 women who have sex with men. The trials included seven types of inserts (six vaginal gels and one vaginal ring) that were compared with placebo, all conducted among women aged over 16 years. All trials were conducted in sub-Saharan Africa, with one having a study site in India and another having a site in the USA. The Cochrane researchers did not find any studies that were conducted among men who have sex with men."
}
] |
query-laysum
|
8590
|
[
{
"role": "user",
"content": "Abstract: Background\nBreast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast.\nObjectives\nTo assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy.\nSearch methods\nWe searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations).\nData collection and analysis\nTwo review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.\nMain results\nFive RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.\nThe studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.\nTextured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.\nSilicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).\nPoly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).\nAnatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.\nVariable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).\nThere were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies.\nAuthors' conclusions\nDespite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.\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": "The evidence we found was limited: only a negligible, tiny fraction of women who undergo breast reconstruction have been studied in randomised controlled trials. The quality of evidence is very low, as the studies we identified suffered from major methodological limitations.\nDespite the fact that several million women have had their breasts reconstructed over the last 20 years, the small number of studies and the low numbers of women included in these studies does not allow us to draw any definitive conclusions about the which is the best type of breast implant. This lack of evidence should be discussed when informing women about the risks and complications of different implant-based breast reconstruction options. There is a need for further studies, which include a larger number of women and compare different types of implants, to free women from decisions made on the basis of surgical opinion alone."
}
] |
query-laysum
|
8591
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is the second update of a review originally published in 2017. Starting with one drug and with a combination of two drugs are strategies suggested in clinical guidelines as initial treatment for hypertension. The recommendations are not based on evidence about clinically relevant outcomes. Some antihypertensive combinations have been shown to be harmful. The actual harm-to-benefit balance of each strategy is unknown.\nObjectives\nTo determine if there are differences in clinical outcomes between monotherapy and combination therapy as initial treatment for primary hypertension.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to March 2021: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1946), and 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. We also contacted authors of relevant papers regarding further published and unpublished work. We used no language restrictions. We also searched clinical studies repositories of pharmaceutical companies, reviews of combination drugs on the US Food and Drug Administration and European Medicines Agency websites, and lists of references in reviews and clinical practice guidelines.\nSelection criteria\nWe included randomised, double-blind trials with at least 12 months' follow-up in adults with primary hypertension (systolic blood pressure/diastolic blood pressure 140/90 mmHg or higher, or 130/80 mmHg or higher if participants had diabetes), which compared a combination of two first-line antihypertensive drugs with monotherapy as initial treatment. Trials had to include at least 50 participants per group and report mortality, cardiovascular mortality, cardiovascular events, or serious adverse events.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, evaluated the risks of bias, and performed data entry. The primary outcomes were mortality, serious adverse events, cardiovascular events, and cardiovascular mortality. Secondary outcomes were withdrawals due to drug-related adverse effects, reaching blood pressure control (as defined in each trial), and blood pressure change from baseline. Analyses were based on the intention-to-treat principle. We summarised data on dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). We used GRADE to assess the quality of the evidence.\nMain results\nWe found no new trials for this update. The three original trials in the main comparison (monotherapy: 335 participants; combination therapy: 233 participants) included outpatients, mostly European and white people. Two trials only included people with type 2 diabetes; the remaining trial excluded people treated with diabetes, hypocholesterolaemia, or cardiovascular drugs. The follow-up was 12 months in two trials and 36 months in one trial. The following treatments were compared: perindopril + indapamide versus enalapril; perindopril + indapamide versus atenolol; and verapamil + trandolapril versus verapamil or trandolapril.\nOur 2019 update included one new study in which a subgroup of participants met our inclusion criteria. As none of the four included studies focused solely on people initiating antihypertensive treatment, we asked investigators for data for this subgroup. One study (PREVER-treatment 2016) used a combination of thiazide-type diuretic/potassium-sparing diuretic: chlorthalidone + amiloride compared to losartan. As the amiloride is not indicated in monotherapy, we analysed this study separately.\nIt is very uncertain whether combination therapy versus monotherapy reduces total mortality (RR 1.35, 95% CI 0.08 to 21.72), cardiovascular mortality (zero events reported), cardiovascular events (RR 0.98, 95% CI 0.22 to 4.41), serious adverse events (RR 0.77, 95% CI 0.31 to 1.92), or withdrawals due to adverse effects (RR 0.85, 95% CI 0.53 to 1.35); all outcomes had 568 participants, and we rated the evidence as of very low certainty due to serious imprecision and for using a subgroup that was not defined in advance. The confidence intervals were extremely wide for all important outcomes and included both appreciable harm and benefit.\nThe PREVER-treatment 2016 trial, which used a combination therapy with potassium-sparing diuretic (monotherapy: 84 participants; combination therapy: 116 participants), included outpatients. This trial was conducted in Brazil and had a follow-up of 18 months. The number of events was very low and confidence intervals very wide, with zero events reported for cardiovascular mortality and withdrawals due to adverse events. It is very uncertain if there are differences in clinical outcomes between monotherapy and combination therapy in this trial.\nAuthors' conclusions\nThe numbers of included participants, and hence the number of events, were too small to draw any conclusion about the relative efficacy of monotherapy versus combination therapy, as initial treatment for primary hypertension. There is a need for large clinical trials that address the review question and report clinically relevant endpoints.\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 that compared starting treatment of hypertension in adults with one medicine versus studies that started treatment with two medicines. Studies had to talk about results such as deaths or other events caused by diseases of the heart or the blood vessels, such as heart attack, stroke, or heart failure. Studies could also talk about other kinds of health-related side effects. We only chose studies with 50 or more people in each group and that lasted at least 12 months."
}
] |
query-laysum
|
8592
|
[
{
"role": "user",
"content": "Abstract: Background\nHealth insurance has the potential to improve access to health care and protect people from the financial risks of diseases. However, health insurance coverage is often low, particularly for people most in need of protection, including children and other vulnerable populations.\nObjectives\nTo assess the effectiveness of strategies for expanding health insurance coverage in vulnerable populations.\nSearch methods\nWe searched Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library. www.thecochranelibrary.com (searched 2 November 2012), PubMed (searched 1 November 2012), EMBASE (searched 6 July 2012), Global Health (searched 6 July 2012), IBSS (searched 6 July 2012), WHO Library Database (WHOLIS) (searched 1 November 2012), IDEAS (searched 1 November 2012), ISI-Proceedings (searched 1 November 2012),OpenGrey (changed from OpenSIGLE) (searched 1 November 2012), African Index Medicus (searched 1 November 2012), BLDS (searched 1 November 2012), Econlit (searched 1 November 2012), ELDIS (searched 1 November 2012), ERIC (searched 1 November 2012), HERDIN NeON Database (searched 1 November 2012), IndMED (searched 1 November 2012), JSTOR (searched 1 November 2012), LILACS(searched 1 November 2012), NTIS (searched 1 November 2012), PAIS (searched 6 July 2012), Popline (searched 1 November 2012), ProQuest Dissertation &Theses Database (searched 1 November 2012), PsycINFO (searched 6 July 2012), SSRN (searched 1 November 2012), Thai Index Medicus (searched 1 November 2012), World Bank (searched 2 November 2012), WanFang (searched 3 November 2012), China National Knowledge Infrastructure (CHKD-CNKI) (searched 2 November 2012).\nIn addition, we searched the reference lists of included studies and carried out a citation search for the included studies via Web of Science to find other potentially relevant studies.\nSelection criteria\nRandomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) studies and Interrupted time series (ITS) studies that evaluated the effects of strategies on increasing health insurance coverage for vulnerable populations. We defined strategies as measures to improve the enrolment of vulnerable populations into health insurance schemes. Two categories and six specified strategies were identified as the interventions.\nData collection and analysis\nAt least two review authors independently extracted data and assessed the risk of bias. We undertook a structured synthesis.\nMain results\nWe included two studies, both from the United States. People offered health insurance information and application support by community-based case managers were probably more likely to enrol their children into health insurance programmes (risk ratio (RR) 1.68, 95% confidence interval (CI) 1.44 to 1.96, moderate quality evidence) and were probably more likely to continue insuring their children (RR 2.59, 95% CI 1.95 to 3.44, moderate quality evidence). Of all the children that were insured, those in the intervention group may have been insured quicker (47.3 fewer days, 95% CI 20.6 to 74.0 fewer days, low quality evidence) and parents may have been more satisfied on average (satisfaction score average difference 1.07, 95% CI 0.72 to 1.42, low quality evidence).\nIn the second study applications were handed out in emergency departments at hospitals, compared to not handing out applications, and may have had an effect on enrolment (RR 1.5, 95% CI 1.03 to 2.18, low quality evidence).\nAuthors' conclusions\nCommunity-based case managers who provide health insurance information, application support, and negotiate with the insurer probably increase enrolment of children in health insurance schemes. However, the transferability of this intervention to other populations or other settings is uncertain. Handing out insurance application materials in hospital emergency departments may help increase the enrolment of children in health insurance schemes. Further studies evaluating the effectiveness of different strategies for expanding health insurance coverage in vulnerable population are needed in different settings, with careful attention given to study design.\n\nGiven the provided abstract, please respond to the following query: \"A summary of this review for policy-makers is available\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "here"
}
] |
query-laysum
|
8593
|
[
{
"role": "user",
"content": "Abstract: Background\nHereditary haemochromatosis is a genetic disorder related to proteins involved in iron transport, resulting in iron load and deposition of iron in various tissues of the body. This iron overload leads to complications including liver cirrhosis (and related complications such as liver failure and hepatocellular carcinoma), cardiac failure, cardiac arrhythmias, impotence, diabetes, arthritis, and skin pigmentation. Phlebotomy (venesection or 'blood letting') is the currently recommended treatment for hereditary haemochromatosis. The optimal treatment of hereditary haemochromatosis remains controversial.\nObjectives\nTo assess the comparative benefits and harms of different interventions in the treatment of hereditary haemochromatosis through a network meta-analysis and to generate rankings of the available treatments according to their safety and efficacy. However, we found only one comparison. Therefore, we did not perform the network meta-analysis and we assessed the comparative benefits and harms of different interventions using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and randomised clinical trials registers to March 2016 to identify randomised clinical trials on treatments for hereditary haemochromatosis.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or publication status) in participants with hereditary haemochromatosis. We excluded trials which included participants who had previously undergone liver transplantation. We considered any of the various interventions compared with each other or with inactive treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CI) using both fixed-effect and random-effects models with RevMan 5 based on available-participant analysis. We assessed risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.\nMain results\nThree trials with 146 participants met the inclusion criteria of this review. Two parallel group trials with 100 participants provided information on one or more outcomes. The remaining trial was a cross-over trial, with no usable data for analysis. All the trials were at high risk of bias. Overall, all the evidence was of very low quality. All three trials compared erythrocytapheresis (removal of red cells only, instead of whole blood) versus phlebotomy. Two of the trials shared the same first author. The mean or median age in the three trials ranged from 42 to 55 years. None of the trials reported whether the included participants were symptomatic or asymptomatic or a mixture of both. Two trials were conducted in people who were haemochromatosis treatment-naive. The trial that provided most data for this review excluded people with malignancy, heart failure, and serious cardiac arrhythmias. We found no trials assessing iron-chelating agents.\nOnly one of the trials with 38 participants reported no short-term mortality and no serious adverse events at the end of the short-term follow-up (eight months). Two trials reported the proportion of people with adverse events: 10/49 (20.4%) in the erythrocytapheresis group versus 11/51 (21.6%) in the phlebotomy group. One of these two trials provided data on adverse event rates (42.1 events per 100 participants with erythrocytapheresis versus 52.6 events per 100 participants with phlebotomy). There was no evidence of differences in the proportion of people with adverse events and the number of adverse events (serious and non-serious) between the groups (proportion of people with adverse events: OR 0.93, 95% CI 0.36 to 2.43; participants = 100; trials = 2; number of adverse events: rate ratio 0.80, 95% CI 0.32 to 2.03; participants = 38; trial = 1). There was no difference between the groups regarding short-term health-related quality of life (mean difference (MD) 1.00, 95% CI -10.80 to 12.80; participants = 38; trials = 1). This outcome was measured using EQ-VAS (range: 0 to 100 where a higher score indicates better health-related quality of life). None of the trials reported mortality beyond one year, health-related quality of life beyond one year, liver transplantation, decompensated liver disease, cirrhosis, hepatocellular carcinoma, diabetes, or cardiovascular complications during the long-term follow-up.\nThe two trials that provided data for this review were funded by parties with no vested interest in the results; the source of funding of the third trial was not reported.\nAuthors' conclusions\nThere is currently insufficient evidence to determine whether erythrocytapheresis is beneficial or harmful compared with phlebotomy. Phlebotomy has less equipment requirements and remains the treatment of choice in people with hereditary haemochromatosis who require blood letting in some form. However, it should be noted that there is no evidence from randomised clinical trials that blood letting in any form is beneficial in people with hereditary haemochromatosis. Having said this, a trial including no treatment is unlikely to be conducted. Future trials should compare different frequencies of phlebotomy and erythrocytapheresis versus phlebotomy with and without different iron-chelating agents compared with each other, and with placebo. Such trials should include long-term follow-up of participants (e.g. using national record linkage databases) to determine whether treatments are beneficial or harmful in terms of clinical outcomes such as deaths, health-related quality of life, liver damage and its consequences, heart damage and its consequences, and other outcomes that are of importance to people with hereditary haemochromatosis.\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 three trials. Two trials with 100 participants provided information on one or more outcomes (measures of how well the treatments worked). The trials compared phlebotomy (removal of blood or 'blood letting') versus erythrocytapheresis (removal of blood, separation of red cells (which carry oxygen in the blood), and return of the remaining parts of the blood). Two trials were conducted in people who had not undergone previous treatment for haemochromatosis. The trial that provided most data for this review excluded people with cancer, heart failure, and serious irregular heartbeats.\nSource of funding: the two trials that provided data for this review were funded by parties with no vested interest in the results; the source of funding of the third trial was not reported."
}
] |
query-laysum
|
8594
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic hepatitis B is associated with high morbidity and mortality. Chronic hepatitis B requires long-term management aiming at reduction of the risks of hepatocellular inflammatory necrosis, liver fibrosis, decompensated liver cirrhosis, liver failure, and liver cancer, and improving health-related quality of life. The Chinese herbal medicine formula Xiao Chai Hu Tang has been used to decrease discomfort and replication of the virus in people with chronic hepatitis B. However, the benefits and harms of Xiao Chai Hu Tang formula have never been established with rigorous review methodology.\nObjectives\nTo assess the benefits and harms of Xiao Chai Hu Tang formula versus placebo or no intervention in people with chronic hepatitis B.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, and seven other databases to 1 March 2019. We also searched the World Health Organization International Clinical Trials Registry Platform (www.who.int/ictrp), ClinicalTrials.gov (www.clinicaltrials.gov/), and the Chinese Clinical Trial Registry for ongoing or unpublished trials to 1 March 2019.\nSelection criteria\nWe included randomised clinical trials, irrespective of publication status, language, and blinding, comparing Xiao Chai Hu Tang formula versus no intervention or placebo in people with chronic hepatitis B. We included participants of any sex and age, diagnosed with chronic hepatitis B according to guidelines or as defined by the trialists. We allowed co-interventions when the co-interventions were administered equally to all the intervention groups.\nData collection and analysis\nReview authors independently retrieved data from reports and after correspondence with investigators. Our primary outcomes were all-cause mortality, serious adverse events, and health-related quality of life. Our secondary outcomes were hepatitis B-related mortality, hepatitis B-related morbidity, and adverse events considered 'not to be serious'. We presented the meta-analysed results as risk ratios (RR) with 95% confidence intervals (CI). We assessed the risks of bias using risk of bias domains with predefined definitions. We used GRADE methodology to evaluate our certainty in the evidence.\nMain results\nWe included 10 randomised clinical trials with 934 participants, but only five trials with 490 participants provided data for analysis. All the trials compared Xiao Chai Hu Tang formula with no intervention. All trials appeared to have been conducted and published only in China. The included trials assessed heterogeneous forms of Xiao Chai Hu Tang formula, administered for three to eight months. One trial included participants with hepatitis B and comorbid tuberculosis, and one trial included participants with hepatitis B and liver cirrhosis. The remaining trials included participants with hepatitis B only. All the trials were at high risk of bias, and the certainty of evidence for all outcomes that provided data for analyses was very low. We downgraded the evidence by one or two levels because of outcome risk of bias, inconsistency or heterogeneity of results (opposite direction of effect), indirectness of evidence (use of surrogate outcomes instead of clinically relevant outcomes), imprecision of results (the CIs were wide), and publication bias (small sample size of the trials). Additionally, 47 trials lacked the necessary methodological information needed to ensure the inclusion of these trials in our review.\nNone of the included trials aimed to assess clinically relevant outcomes such as all-cause mortality, serious adverse events, health-related quality of life, hepatitis B-related mortality, or hepatitis B-related morbidity. The effects of Xiao Chai Hu Tang formula on the proportion of participants with adverse events considered 'not to be serious' is uncertain (RR 0.43, 95% CI 0.02 to 11.98; I2 = 69%; very low-certainty evidence). Only three trials with 222 participants reported the proportion of people with detectable hepatitis B virus DNA (HBV-DNA), but the evidence that Xiao Chai Hu Tang formula reduces the presence of HBV-DNA in the blood (a surrogate outcome) is uncertain (RR 0.62, 95% CI 0.45 to 0.85; I2 = 0%; very low-certainty evidence). Only two trials with 160 participants reported the proportion of people with detectable hepatitis B virus e-antigen (HBeAg; a surrogate outcome) (RR 0.72, 95% CI 0.50 to 1.02; I2 = 38%; very low-certainty evidence) and the evidence is uncertain. The evidence is also uncertain for separately reported adverse events considered 'not to be serious'.\nFunding: two of the 10 included trials received academic funding from government or hospital. None of the remaining eight trials reported information on funding.\nAuthors' conclusions\nThe clinical effects of Xiao Chai Hu Tang formula for chronic hepatitis B remain unclear. The included trials were small and of low methodological quality. Despite the wide use of Xiao Chai Hu Tang formula, we lack data on all-cause mortality, serious adverse events, health-related quality of life, hepatitis B-related mortality, and hepatitis B-related morbidity. The evidence in this systematic review comes from data obtained from a maximum three trials. We graded the certainty of evidence as very low for adverse events considered not to be serious and the surrogate outcomes HBeAg and HBV-DNA. We found a large number of trials which lacked clear description of their design and conduct, and hence, these trials are not included in the present review. As all identified trials were conducted in China, there might be a concern about the applicability of this review outside China. Large-sized, high-quality randomised sham-controlled trials with homogeneous groups of participants and transparent funding are lacking.\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": "Chronic hepatitis B virus infection is a common liver disease, associated with high morbidity (illness) and death. It causes psychological stress and is a burden to people with chronic hepatitis B and their families. Xiao Chai Hu Tang formula has been used for treating people with chronic hepatitis B as it is believed that it decreases discomfort and prevents the replication of the virus in people with chronic hepatitis B. However, the benefits and harms of Xiao Chai Hu Tang formula have never been established in reviews with rigorous review methodology."
}
] |
query-laysum
|
8595
|
[
{
"role": "user",
"content": "Abstract: Background\n18F-flutemetamol uptake by brain tissue, measured by positron emission tomography (PET), is accepted by regulatory agencies like the Food and Drug Administration (FDA) and the European Medicine Agencies (EMA) for assessing amyloid load in people with dementia. Its added value is mainly demonstrated by excluding Alzheimer's pathology in an established dementia diagnosis. However, the National Institute on Aging and Alzheimer's Association (NIA-AA) revised the diagnostic criteria for Alzheimer's disease and the confidence in the diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease may be increased when using some amyloid biomarkers tests like 18F-flutemetamol. These tests, added to the MCI core clinical criteria, might increase the diagnostic test accuracy (DTA) of a testing strategy. However, the DTA of 18F-flutemetamol to predict the progression from MCI to Alzheimer’s disease dementia (ADD) or other dementias has not yet been systematically evaluated.\nObjectives\nTo determine the DTA of the 18F-flutemetamol PET scan for detecting people with MCI at time of performing the test who will clinically progress to ADD, other forms of dementia (non-ADD) or any form of dementia at follow-up.\nSearch methods\nThe most recent search for this review was performed in May 2017. We searched MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), BIOSIS Citation Index (Thomson Reuters Web of Science), Web of Science Core Collection, including the Science Citation Index (Thomson Reuters Web of Science) and the Conference Proceedings Citation Index (Thomson Reuters Web of Science), LILACS (BIREME), CINAHL (EBSCOhost), ClinicalTrials.gov (https://clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (http://www.who.int/ictrp/search/en/). We also searched ALOIS, the Cochrane Dementia & Cognitive Improvement Group’s specialised register of dementia studies (http://www.medicine.ox.ac.uk/alois/). We checked the reference lists of any relevant studies and systematic reviews, and performed citation tracking using the Science Citation Index to identify any additional relevant studies. No language or date restrictions were applied to the electronic searches.\nSelection criteria\nWe included studies that had prospectively defined cohorts with any accepted definition of MCI at time of performing the test and the use of 18F-flutemetamol scan to evaluate the DTA of the progression from MCI to ADD or other forms of dementia. In addition, we only selected studies that applied a reference standard for Alzheimer’s dementia diagnosis, for example, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) or Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria.\nData collection and analysis\nWe screened all titles and abstracts identified in electronic-database searches. Two review authors independently selected studies for inclusion and extracted data to create two-by-two tables, showing the binary test results cross-classified with the binary reference standard. We used these data to calculate sensitivities, specificities, and their 95% confidence intervals. Two independent assessors performed quality assessment using the QUADAS-2 tool plus some additional items to assess the methodological quality of the included studies.\nMain results\nProgression from MCI to ADD was evaluated in 243 participants from two studies. The studies reported data on 19 participants with two years of follow-up and on 224 participants with three years of follow-up. Nine (47.4%) participants converted at two years follow-up and 81 (36.2%) converted at three years of follow-up.\nThere were concerns about participant selection and sampling in both studies. The index test domain in one study was considered unclear and in the second study it was considered at low risk of bias. For the reference standard domain, one study was considered at low risk and the second study was considered to have an unclear risk of bias. Regarding the domains of flow and timing, both studies were considered at high risk of bias.\nMCI to ADD;\nProgression from MCI to ADD at two years of follow-up had a sensitivity of 89% (95% CI 52 to 100) and a specificity of 80% (95% CI 44 to 97) by quantitative assessment by SUVR (n = 19, 1 study).\nProgression from MCI to ADD at three years of follow-up had a sensitivity of 64% (95% CI 53 to 75) and a specificity of 69% (95% CI 60 to 76) by visual assessment (n = 224, 1 study).\nThere was no information regarding the other two objectives in this systematic review (SR): progression from MCI to other forms of dementia and progression to any form of dementia at follow-up.\nAuthors' conclusions\nDue to the varying sensitivity and specificity for predicting the progression from MCI to ADD and the limited data available, we cannot recommend routine use of 18F-flutemetamol in clinical practice. 18F-flutemetamol has high financial costs; therefore, clearly demonstrating its DTA and standardising the process of the 18F-flutemetamol modality is important prior to its wider use.\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 May 2017. We found two studies evaluating the progression from MCI to ADD. The studies included 252 MCI eligible participants, with 243 participants that had follow-up. Of these, 127 were women. The average age in one study with two years of follow-up was 72.7 + 7.09 years. In the other study with three years of follow-up, the average age was 71.1 + 8.62 years. The setting in one study was memory clinics.\nStudy funding sources: both studies were funded by the test manufacturer."
}
] |
query-laysum
|
8596
|
[
{
"role": "user",
"content": "Abstract: Background\nMild cognitive impairment (MCI) due to Alzheimer's disease is the symptomatic predementia phase of Alzheimer's disease dementia, characterised by cognitive and functional impairment not severe enough to fulfil the criteria for dementia. In clinical samples, people with amnestic MCI are at high risk of developing Alzheimer's disease dementia, with annual rates of progression from MCI to Alzheimer's disease estimated at approximately 10% to 15% compared with the base incidence rates of Alzheimer's disease dementia of 1% to 2% per year.\nObjectives\nTo assess the diagnostic accuracy of structural magnetic resonance imaging (MRI) for the early diagnosis of dementia due to Alzheimer's disease in people with MCI versus the clinical follow-up diagnosis of Alzheimer's disease dementia as a reference standard (delayed verification).\nTo investigate sources of heterogeneity in accuracy, such as the use of qualitative visual assessment or quantitative volumetric measurements, including manual or automatic (MRI) techniques, or the length of follow-up, and age of participants.\nMRI was evaluated as an add-on test in addition to clinical diagnosis of MCI to improve early diagnosis of dementia due to Alzheimer's disease in people with MCI.\nSearch methods\nOn 29 January 2019 we searched Cochrane Dementia and Cognitive Improvement's Specialised Register and the databases, MEDLINE, Embase, BIOSIS Previews, Science Citation Index, PsycINFO, and LILACS. We also searched the reference lists of all eligible studies identified by the electronic searches.\nSelection criteria\nWe considered cohort studies of any size that included prospectively recruited people of any age with a diagnosis of MCI. We included studies that compared the diagnostic test accuracy of baseline structural MRI versus the clinical follow-up diagnosis of Alzheimer's disease dementia (delayed verification). We did not exclude studies on the basis of length of follow-up. We included studies that used either qualitative visual assessment or quantitative volumetric measurements of MRI to detect atrophy in the whole brain or in specific brain regions, such as the hippocampus, medial temporal lobe, lateral ventricles, entorhinal cortex, medial temporal gyrus, lateral temporal lobe, amygdala, and cortical grey matter.\nData collection and analysis\nFour teams of two review authors each independently reviewed titles and abstracts of articles identified by the search strategy. Two teams of two review authors each independently assessed the selected full-text articles for eligibility, extracted data and solved disagreements by consensus. Two review authors independently assessed the quality of studies using the QUADAS-2 tool. We used the hierarchical summary receiver operating characteristic (HSROC) model to fit summary ROC curves and to obtain overall measures of relative accuracy in subgroup analyses. We also used these models to obtain pooled estimates of sensitivity and specificity when sufficient data sets were available.\nMain results\nWe included 33 studies, published from 1999 to 2019, with 3935 participants of whom 1341 (34%) progressed to Alzheimer's disease dementia and 2594 (66%) did not. Of the participants who did not progress to Alzheimer's disease dementia, 2561 (99%) remained stable MCI and 33 (1%) progressed to other types of dementia. The median proportion of women was 53% and the mean age of participants ranged from 63 to 87 years (median 73 years). The mean length of clinical follow-up ranged from 1 to 7.6 years (median 2 years). Most studies were of poor methodological quality due to risk of bias for participant selection or the index test, or both.\nMost of the included studies reported data on the volume of the total hippocampus (pooled mean sensitivity 0.73 (95% confidence interval (CI) 0.64 to 0.80); pooled mean specificity 0.71 (95% CI 0.65 to 0.77); 22 studies, 2209 participants). This evidence was of low certainty due to risk of bias and inconsistency.\nSeven studies reported data on the atrophy of the medial temporal lobe (mean sensitivity 0.64 (95% CI 0.53 to 0.73); mean specificity 0.65 (95% CI 0.51 to 0.76); 1077 participants) and five studies on the volume of the lateral ventricles (mean sensitivity 0.57 (95% CI 0.49 to 0.65); mean specificity 0.64 (95% CI 0.59 to 0.70); 1077 participants). This evidence was of moderate certainty due to risk of bias.\nFour studies with 529 participants analysed the volume of the total entorhinal cortex and four studies with 424 participants analysed the volume of the whole brain. We did not estimate pooled sensitivity and specificity for the volume of these two regions because available data were sparse and heterogeneous.\nWe could not statistically evaluate the volumes of the lateral temporal lobe, amygdala, medial temporal gyrus, or cortical grey matter assessed in small individual studies.\nWe found no evidence of a difference between studies in the accuracy of the total hippocampal volume with regards to duration of follow-up or age of participants, but the manual MRI technique was superior to automatic techniques in mixed (mostly indirect) comparisons. We did not assess the relative accuracy of the volumes of different brain regions measured by MRI because only indirect comparisons were available, studies were heterogeneous, and the overall accuracy of all regions was moderate.\nAuthors' conclusions\nThe volume of hippocampus or medial temporal lobe, the most studied brain regions, showed low sensitivity and specificity and did not qualify structural MRI as a stand-alone add-on test for an early diagnosis of dementia due to Alzheimer's disease in people with MCI. This is consistent with international guidelines, which recommend imaging to exclude non-degenerative or surgical causes of cognitive impairment and not to diagnose dementia due to Alzheimer's disease. In view of the low quality of most of the included studies, the findings of this review should be interpreted with caution. Future research should not focus on a single biomarker, but rather on combinations of biomarkers to improve an early diagnosis of Alzheimer's disease dementia.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The included studies diagnosed Alzheimer's disease dementia by assessing all participants with standard clinical criteria after two or three years' follow-up. We had some concerns about how the studies were conducted, since the participants were mainly selected from clinical registries and referral centres, and we also had concerns about how studies interpreted MRI. Moreover, the studies were conducted differently from each other, and they used different methods to select people with MCI and perform MRI."
}
] |
query-laysum
|
8597
|
[
{
"role": "user",
"content": "Abstract: Background\nTheoretically, autologous serum eye drops (AS) offer a potential advantage over traditional therapies on the assumption that AS not only serve as a lacrimal substitute to provide lubrication but contain other biochemical components that allow them to mimic natural tears more closely. Application of AS has gained popularity as second-line therapy for patients with dry eye. Published studies on this subject indicate that autologous serum could be an effective treatment for dry eye.\nObjectives\nWe conducted this review to evaluate the efficacy and safety of AS given alone or in combination with artificial tears as compared with artificial tears alone, saline, placebo, or no treatment for adults with dry eye.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2016), Embase (January 1980 to July 2016), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to July 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We also searched the Science Citation Index Expanded database (December 2016) and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 5 July 2016.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared AS versus artificial tears for treatment of adults with dry eye.\nData collection and analysis\nTwo review authors independently screened all titles and abstracts and assessed full-text reports of potentially eligible trials. Two review authors extracted data and assessed risk of bias and characteristics of included trials. We contacted investigators to ask for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals (CIs) for continuous outcomes. We did not perform meta-analysis owing to differences in outcome assessments across trials.\nMain results\nWe identified five eligible RCTs (92 participants) that compared AS versus artificial tears or saline in individuals with dry eye of various origins (Sjögren's syndrome-related dry eye, non-Sjögren's syndrome dry eye, and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)). We assessed the certainty of evidence as low or very low because of lack of reporting of quantitative data for most outcomes and unclear or high risk of bias among trials. We judged most risk of bias domains to have unclear risk in two trials owing to insufficient reporting of trial characteristics, and we considered one trial to have high risk of bias for most domains. We judged the remaining two trials to have low risk of bias; however, these trials used a cross-over design and did not report data in a way that could be used to compare outcomes between treatment groups appropriately. Incomplete outcome reporting and heterogeneity among outcomes and follow-up periods prevented inclusion of these trials in a summary meta-analysis.\nThree trials compared AS with artificial tears; however, only one trial reported quantitative data for analysis. Low-certainty evidence from one trial suggested that AS might provide some improvement in participant-reported symptoms compared with artificial tears after two weeks of treatment; the mean difference in mean change in symptom score measured on a visual analogue scale (range 0 to 100, with higher scores representing worse symptoms) was -12.0 (95% confidence interval (CI) -20.16 to -3.84; 20 participants). This same trial found mixed results with respect to ocular surface outcomes; the mean difference in mean change in scores between AS and artificial tears was -0.9 (95% CI -1.47 to -0.33; 20 participants; low-certainty evidence) for fluorescein staining and -2.2 (95% CI -2.73 to -1.67; 20 participants; low-certainty evidence) for Rose Bengal staining. Both staining scales range from 0 to 9, with higher scores indicating worse results. The mean change in tear film break-up time was 2.00 seconds longer (95% CI 0.99 to 3.01; 20 participants; low-certainty evidence) in the AS group than in the artificial tears group. Investigators reported no clinically meaningful differences in Schirmer’s test scores between groups (mean difference -0.40 mm, 95% CI -2.91 to 2.11; 20 participants; low-certainty evidence). None of these three trials reported tear hyperosmolarity and adverse events.\nTwo trials compared AS versus saline; however, only one trial reported quantitative data for analysis of only one outcome (Rose Bengal staining). Trial investigators of the two studies reported no differences in symptom scores, fluorescein staining scores, tear film break-up times, or Schirmer's test scores between groups at two to four weeks' follow-up. Very low-certainty evidence from one trial suggested that AS might provide some improvement in Rose Bengal staining scores compared with saline after four weeks of treatment; the mean difference in Rose Bengal staining score (range from 0 to 9, with higher scores showing worse results) was -0.60 (95% CI -1.11 to -0.09; 35 participants). Neither trial reported tear hyperosmolarity outcomes. One trial reported adverse events; two of 12 participants had signs of conjunctivitis with negative culture that did resolve.\nAuthors' conclusions\nOverall, investigators reported inconsistency in possible benefits of AS for improving participant-reported symptoms and other objective clinical measures. There might be some benefit in symptoms with AS compared with artificial tears in the short-term, but we found no evidence of an effect after two weeks of treatment. Well-planned, large, high-quality RCTs are warranted to examine participants with dry eye of different severities by using standardized questionnaires to measure participant-reported outcomes, as well as objective clinical tests and objective biomarkers to assess the benefit of AS therapy for dry eye.\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": "Dry eye is a common disorder of the tear film, which is a layer of tears covering the surface of the eye. Dry eye affects many adults older than 40 years of age. People with dry eye may feel discomfort in one or both eyes and have sensitivity to light. There are clinical tests that are used by healthcare professionals to measure the amount of tears the eye produces and how fast tears leave the eye. Sometimes these clinical measures do not match the symptoms; a person can have severe dry eye and normal clinical test results, or mild dry eye and abnormal clinical test results.\nOne common treatment for dry eye is artificial tears, which provide lubrication to the surface of the eye. However, artificial tears lack the biological nutrients found in natural tears that are critical to maintenance of the tear film. Eye drops made by separating liquid and cellular components of the patient’s blood, known as autologous serum eye drops, have been shown to possess many of the same biological nutrients found in natural tears. Because of this fact, autologous serum eye drops are believed to be a better tear substitute and have been proposed as treatment for dry eye."
}
] |
query-laysum
|
8598
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough in recent years the percentage of preterm infants who suffer intraventricular haemorrhage (IVH) has reduced, posthaemorrhagic hydrocephalus (PHH) remains a serious problem with a high rate of cerebral palsy and no evidence-based treatment. Survivors often have to undergo ventriculoperitoneal shunt (VPS) surgery, which makes the child permanently dependent on a valve and catheter system. This carries a significant risk of infection and the need for surgical revision of the shunt. Repeated removal of cerebrospinal fluid (CSF) by either lumbar puncture, ventricular puncture, or from a ventricular reservoir in preterm babies with IVH has been suggested as a treatment to reduce the risk of PHH development.\nObjectives\nTo determine the effect of repeated cerebrospinal fluid (CSF) removal (by lumbar/ventricular puncture or removal from a ventricular reservoir) compared to conservative management, where removal is limited to when there are signs of raised intracranial pressure (ICP), on reduction in the risk of permanent shunt dependence, neurodevelopmental disability, and death in neonates with or at risk of developing posthaemorrhagic hydrocephalus (PHH).\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 3), MEDLINE via PubMed (1966 to 24 March 2016), Embase (1980 to 24 March 2016), and CINAHL (1982 to 24 March 2016). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nRCTs and quasi-RCTs that compared serial removal of CSF (via lumbar puncture, ventricular puncture, or from a ventricular reservoir) with conservative management (removing CSF only when there were symptoms of raised ICP). Trials also had to report on at least one of the specified outcomes of death, disability, or shunt insertion.\nData collection and analysis\nWe extracted details of the participant selection, participant allocation and the interventions. We assessed the following outcomes: VPS, death, death or shunt, disability, multiple disability, death or disability, and CSF infection. We assessed the quality of the evidence using the GRADE approach.\nMain results\nFour trials (five articles) met the inclusion criteria of this review; three were RCTs and one was a quasi-RCT; and included a total of 280 participants treated in neonatal intensive care units in the UK. The trials were published between 1980 and 1990. The studies were sufficiently similar regarding the research question they asked and the interventions that we could combine the trials to assess the effect of the intervention.\nMeta-analysis showed that the intervention produced no significant difference when compared to conservative management for the outcomes of: placement of hydrocephalus shunt (typical risk ratio (RR) 0.96, 95% confidence interval (CI) 0.73 to 1.26; 3 trials, 233 infants; I² statistic = 0%; moderate quality evidence), death (RR 0.88, 95% CI 0.53 to 1.44; 4 trials, 280 infants; I² statistic = 0%; low quality evidence), major disability in survivors (RR 0.98, 95% CI 0.81 to 1.18; 2 trials, 141 infants; I² statistic = 11%; high quality evidence), multiple disability in survivors (RR 0.9, 95% CI 0.66 to 1.24; 2 trials, 141 infants; I² statistic = 0%; high quality evidence), death or disability (RR 0.99, 95% CI 0.86 to 1.14; 2 trials, 180 infants; I² statistic = 0%; high quality evidence), death or shunt (RR 0.91, 95% CI 0.75 to 1.11; 3 trials, 233 infants; I² statistic = 0%; moderate quality evidence), and infection of CSF presurgery (RR 1.73, 95% CI 0.53 to 5.67; 2 trials, 195 infants; low quality evidence).\nWe assessed the quality of the evidence as high for the outcomes of major disability, multiple disability, and disability or death. We rated the evidence for the outcomes of shunt insertion, and death or shunt insertion as of moderate quality as one included trial used an alternation method of randomisation. For the outcomes of death and infection of CSF presurgery, the quality of the evidence was low as one trial used an alternation method, the number of participants was too low to assess the objectives with sufficient precision, and there was inconsistency regarding the findings in the included trials regarding the outcome of infection of CSF presurgery.\nAuthors' conclusions\nThere was no evidence that repeated removal of CSF via lumbar puncture, ventricular puncture or from a ventricular reservoir produces any benefit over conservative management in neonates with or at risk for developing PHH in terms of reduction of disability, death, or need for placement of a permanent shunt.\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": "Cochrane researchers reviewed the evidence about the effect of removal of cerebrospinal fluid (CSF) via lumbar or ventricular puncture and draining CSF via a needle inserted into the base of the spine or into a fluid-filled cavity in the brain on improving rates of disability, death, and the need for a permanent surgical procedure in preterm infants who have had bleeding inside the cavities of the brain (intraventricular haemorrhage (IVH))."
}
] |
query-laysum
|
8599
|
[
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is a chronic joint disease that involves degeneration of articular cartilage. Pre-clinical data suggest that doxycycline might act as a disease-modifying agent for the treatment of osteoarthritis, with the potential to slow cartilage degeneration. This is an update of a Cochrane review first published in 2009.\nObjectives\nTo examine the effects of doxycycline compared with placebo or no intervention on pain and function in people with osteoarthritis of the hip or knee.\nSearch methods\nWe searched CENTRAL (The Cochrane Library 2008, issue 3), MEDLINE, EMBASE and CINAHL up to 28 July 2008, with an update performed at 16 March 2012. In addition, we checked conference proceedings, reference lists, and contacted authors.\nSelection criteria\nWe included studies if they were randomised or quasi-randomised controlled trials that compared doxycycline at any dosage and any formulation with placebo or no intervention in people with osteoarthritis of the knee or hip.\nData collection and analysis\nWe extracted data in duplicate. We contacted investigators to obtain missing outcome information. We calculated differences in means at follow-up between experimental and control groups for continuous outcomes and risk ratios (RR) for binary outcomes.\nMain results\nWe identified one additional trial (232 participants) and included two trials (663 participants) in this update. The methodological quality and the quality of reporting were considered moderate. At end of treatment, clinical outcomes were similar between the two treatment groups, with an effect size of -0.05 (95% confidence interval (CI) -0.22 to 0.13), corresponding to a difference in pain scores between doxycycline and control of -0.1 cm (95% CI -0.6 to 0.3 cm) on a 10-cm visual analogue scale, or 32% versus 29% improvement from baseline (difference 3%; 95% CI -5% to 10%). The effect size for function was -0.07 (95% CI -0.25 to 0.10), corresponding to a difference between doxycycline and control of -0.2 (95% CI -0.5 to 0.2) on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) disability subscale with a range of 0 to 10, or 24% versus 21% improvement (difference 3%; 95% CI -3% to 10%). The difference in changes in minimum joint space narrowing assessed in one trial was in favour of doxycycline (-0.15 mm; 95% CI -0.28 to -0.02 mm), which corresponds to a small effect size of -0.23 standard deviation units (95% CI -0.44 to -0.02). More participants withdrew from the doxycycline group compared with placebo due to adverse events (RR 2.28; 95% CI 1.06 to 4.90). There was no evidence that participants in the doxycycline group experienced more serious adverse events than those in the placebo group, but the estimate was imprecise (RR 1.07; 95% CI 0.68 to 1.68).\nAuthors' conclusions\nIn this update, the strength of evidence for effectiveness outcomes was improved from low to moderate and we confirmed that the symptomatic benefit of doxycycline is minimal to non-existent, while the small benefit in terms of joint space narrowing is of questionable clinical relevance and outweighed by safety problems. The CIs of the summary estimates now exclude any clinically relevant difference in improvement of symptoms and the small benefit in terms of joint space narrowing does not outweigh the harms.\n\nGiven the provided abstract, please respond to the following query: \"Side effects\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- 20 people out of 100 who took doxycycline experienced side effects of any type (20%).\n- 15 people out of 100 who took a placebo experienced side effects of any type (15%).\n- five more people who took doxycycline experienced side effects of any type (absolute difference of 5%)."
}
] |
query-laysum
|
8600
|
[
{
"role": "user",
"content": "Abstract: Background\nA dacryocystorhinostomy (DCR) procedure aims to restore drainage of tears by bypassing a blockage in the nasolacrimal duct, through the creation of a bony ostium that allows communication between the lacrimal sac and the nasal cavity. It can be performed using endonasal or external approaches. The comparative success rates of these two approaches have not yet been established and this review aims to evaluate the relevant up-to-date research.\nObjectives\nThe primary aim of this review is to compare the success rates of endonasal DCR with that of external DCR. The secondary aim is to compare the complication rates between the two procedures.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2016, Issue 8), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to 22 August 2016), Embase (January 1980 to 22 August 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to 22 August 2016), Web of Science Conference Proceedings Citation Index- Science (CPCI-S) (January 1990 to 22 August 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), 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 22 August 2016. We requested or examined relevant conference proceedings for appropriate trials.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing endonasal and external DCRs.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility and extracted data on reported outcomes. We attempted to contact investigators to clarify the methodological quality of the studies. We graded the certainty of the evidence using GRADE.\nMain results\nWe included two trials in this review. One trial from Finland compared laser-assisted endonasal DCR with external DCR, and one trial from India compared mechanical endonasal DCR (using punch forceps) with external DCR. The trials were poorly reported and it was difficult to judge the extent to which bias had been avoided.\nAnatomic success was defined as the demonstration of a patent lacrimal passage on syringing, or endoscopic visualisation of fluorescein dye at the nasal opening of the anastomoses after a period of at least six months following surgery. Subjective success was defined as the resolution of symptoms of watering following surgery after a period of at least six months. Both included trials used anatomic patency demonstrated by irrigation as a measure of anatomic success. Different effects were seen in these two trials (I2 = 76%). People receiving laser-assisted endonasal DCR were less likely to have a successful operation compared with external DCR (63% versus 91%; risk ratio (RR) 0.69, 95% confidence intervals (CI) 0.52 to 0.92; 64 participants). There was little or no difference in success comparing mechanical endonasal DCR and external DCR (90% in both groups; RR 1.00, CI 0.81 to 1.23; 40 participants). We judged this evidence on success to be very low-certainty, downgrading for risk of bias, imprecision and inconsistency. The trial from Finland also assessed subjective improvement in symptoms following surgery. Resolution of symptoms of watering in outdoor conditions was reported by 84% of the participants in the external DCR group and 59% of those in the laser-assisted endonasal DCR group (RR 0.70, CI 0.51 to 0.97; 64 participants, low-certainty evidence).\nThere were no cases of intraoperative bleeding in any participant in the trial that compared laser-assisted endonasal DCR to external DCR. This was in contrast to the trial comparing mechanical endonasal DCR to external DCR in which 45% of participants in both groups experienced intraoperative bleeding (RR 1.00, 95% CI 0.50 to 1.98; 40 participants). We judged this evidence on intraoperative bleeding to be very low-certainty, downgrading for risk of bias, imprecision and inconsistency.\nThere were only two cases of postoperative bleeding, both in the external DCR group (RR 0.33, 95% CI 0.04 to 3.10; participants = 104; studies = 2). There were only two cases of wound infection/gaping, again both in the external DCR group (RR 0.20, CI 0.01 to 3.92; participants = 40; studies = 1). We judged this evidence on complications to be very low-certainty, downgrading one level for risk of bias and two levels for imprecision due to the very low number of cases.\nAuthors' conclusions\nThere is uncertainty as to the relative effects of endonasal and external DCR. Differences in effect seen in the two trials included in this review may be due to variations in the endonasal technique, but may also be due to other differences between the trials. Future larger RCTs are required to further assess the success and complication rates of endonasal and external DCR. Different techniques of endonasal DCR should also be assessed, as the choice of endonasal technique can influence the outcome. Strict outcome criteria should be adopted to assess functional and anatomical outcomes with a minimal follow-up of six months.\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 Cochrane Review was to compare two different surgical techniques for treating blockage of the tear (nasolacrimal) duct. Cochrane researchers collected and analysed all relevant studies to answer this question and found two studies."
}
] |
query-laysum
|
8601
|
[
{
"role": "user",
"content": "Abstract: Background\nOncoplastic breast-conserving surgery (O-BCS) involves removing the tumour in the breast and using plastic surgery techniques to reconstruct the breast. The adequacy of published evidence on the safety and efficacy of O-BCS for the treatment of breast cancer compared to other surgical options for breast cancer is still debatable. It is estimated that the local recurrence rate is similar to standard breast-conserving surgery (S-BCS) and also mastectomy, but the aesthetic and patient-reported outcomes may be improved with oncoplastic techniques.\nObjectives\nOur primary objective was to assess oncological control outcomes following O-BCS compared with other surgical options for women with breast cancer. Our secondary objective was to assess surgical complications, recall rates, need for further surgery to achieve adequate oncological resection, patient satisfaction through patient-reported outcomes, and cosmetic outcomes through objective measures or clinician-reported outcomes.\nSearch methods\nWe searched the Cochrane Breast Cancer Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL),\nMEDLINE (via OVID), Embase (via OVID), the World Health Organization's International Clinical Trials Registry\nPlatform and ClinicalTrials.gov on 7 August 2020. We did not apply any language restrictions.\nSelection criteria\nWe selected randomised controlled trials (RCTs) and non-randomised comparative studies (cohort and case-control studies). Studies evaluated any O-BCS technique, including volume displacement techniques and partial breast volume replacement techniques compared to any other surgical treatment (partial resection or mastectomy) for the treatment of breast cancer.\nData collection and analysis\nFour review authors performed data extraction and resolved disagreements. We used ROBINS-I to assess the risk of bias by outcome. We performed descriptive data analysis and meta-analysis and evaluated the quality of the evidence using GRADE criteria. The outcomes included local recurrence, breast cancer-specific disease-free survival, re-excision rates, complications, recall rates, and patient-reported outcome measures.\nMain results\nWe included 78 non-randomised cohort studies evaluating 178,813 women. Overall, we assessed the risk of bias per outcome as being at serious risk of bias due to confounding; where studies adjusted for confounding, we deemed these at moderate risk.\nComparison 1: oncoplastic breast-conserving surgery (O-BCS) versus standard-BCS (S-BCS)\nThe evidence in the review found that O-BCS when compared to S-BCS, may make little or no difference to local recurrence; either when measured as local recurrence-free survival (hazard ratio (HR) 0.90, 95% confidence interval (CI) 0.61 to 1.34; 4 studies, 7600 participants; very low-certainty evidence) or local recurrence rate (HR 1.33, 95% CI 0.96 to 1.83; 4 studies, 2433 participants; low-certainty evidence), but the evidence is very uncertain due to most studies not controlling for confounding clinicopathological factors. O-BCS compared to S-BCS may make little to no difference to disease-free survival (HR 1.06, 95% CI 0.89 to 1.26; 7 studies, 5532 participants; low-certainty evidence). O-BCS may reduce the rate of re-excisions needed for oncological resection (risk ratio (RR) 0.76, 95% CI 0.69 to 0.85; 38 studies, 13,341 participants; very low-certainty evidence), but the evidence is very uncertain. O-BCS may increase the number of women who have at least one complication (RR 1.19, 95% CI 1.10 to 1.27; 20 studies, 118,005 participants; very low-certainty evidence) and increase the recall to biopsy rate (RR 2.39, 95% CI 1.67 to 3.42; 6 studies, 715 participants; low-certainty evidence). Meta-analysis was not possible when assessing patient-reported outcomes or cosmetic evaluation; in general, O-BCS reported a similar or more favourable result, however, the evidence is very uncertain due to risk of bias in the measurement methods.\nComparison 2: oncoplastic breast-conserving surgery (O-BCS) versus mastectomy alone\nO-BCS may increase local recurrence-free survival compared to mastectomy but the evidence is very uncertain (HR 0.55, 95% CI 0.34 to 0.91; 2 studies, 4713 participants; very low-certainty evidence). The evidence is very uncertain about the effect of O-BCS on disease-free survival as there were only data from one study. O-BCS may reduce complications compared to mastectomy, but the evidence is very uncertain due to high risk of bias mainly resulting from confounding (RR 0.75, 95% CI 0.67 to 0.83; 4 studies, 4839 participants; very low-certainty evidence). Data on patient-reported outcome measures came from single studies; it was not possible to meta-analyse the data.\nComparison 3: oncoplastic breast-conserving surgery (O-BCS) versus mastectomy with reconstruction\nO-BCS may make little or no difference to local recurrence-free survival (HR 1.37, 95% CI 0.72 to 2.62; 1 study, 3785 participants; very low-certainty evidence) or disease-free survival (HR 0.45, 95% CI 0.09 to 2.22; 1 study, 317 participants; very low-certainty evidence) when compared to mastectomy with reconstruction, but the evidence is very uncertain. O-BCS may reduce the complication rate compared to mastectomy with reconstruction (RR 0.49, 95% CI 0.45 to 0.54; 5 studies, 4973 participants; very low-certainty evidence) but the evidence is very uncertain due to high risk of bias from confounding and inconsistency of results. The evidence is very uncertain for patient-reported outcome measures and cosmetic evaluation.\nAuthors' conclusions\nThe evidence is very uncertain regarding oncological outcomes following O-BCS compared to S-BCS, though O-BCS has not been shown to be inferior. O-BCS may result in less need for a second re-excision surgery but may result in more complications and a greater recall rate than S-BCS. It seems that O-BCS may give better patient satisfaction and surgeon rating for the look of the breast, but the evidence for this is of poor quality, and due to lack of numerical data, it was not possible to pool the results of different studies. It seems O-BCS results in fewer complications compared with surgeries involving mastectomy.\nBased on this review, no certain conclusions can be made to help inform policymakers. The surgical decision for what operation to proceed with should be made jointly between clinician and patient after an appropriate discussion about the risks and benefits of O-BCS personalised to the patient, taking into account clinicopathological factors. This review highlighted the deficiency of well-conducted studies to evaluate efficacy, safety and patient-reported outcomes following O-BCS.\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": "Traditional surgery for early breast cancer is standard breast-conserving surgery (S-BCS) which aims to keep as much of the breast as possible. For women with large tumours compared to their breast size it can be difficult to conserve the breast whilst ensuring all the tumour is removed and may mean that mastectomy is needed. The most important part of surgical treatment for breast cancer is removing all cancer. In recent years, oncoplastic breast surgery techniques have been used to conserve the breast whilst removing breast cancer by applying the principles of plastic surgery, resulting in better cosmetic results. Oncoplastic breast-conserving surgery (O-BCS) may also result in better patient satisfaction and quality of life.\nTraditionally, surgeons have either preserved the breast tissue by removing the cancerous lump (S-BCS) or reconstructing immediately after mastectomy. O-BCS involves removing cancer and either moving/adjusting the remaining breast tissue around (volume displacement) or bringing in tissue from elsewhere to fill the defect after breast cancer removal (volume replacement). There are many techniques that fall under O-BCS that we have listed in full in other parts of the review; however, all are similar in their principle."
}
] |
query-laysum
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8602
|
[
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is one of the most common neurological disorders. Many people with epilepsy are drug-resistant and require add-on therapy, meaning that they concomitantly take multiple antiepileptic drugs. Carisbamate is a drug which is taken orally and inhibits voltage-gated sodium channels. Carisbamate may be useful for drug-resistant focal epilepsy.\nObjectives\nTo evaluate the efficacy and tolerability of carisbamate when used as an add-on therapy for drug-resistant focal epilepsy.\nSearch methods\nWe searched the following databases on 8 April 2021: Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid) 1946 to April 07, 2021. CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, WHO ICTRP, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane review groups including Epilepsy. We also searched ongoing trials registers, checked reference lists, and contacted authors of the included trials.\nSelection criteria\nDouble-blind randomised controlled trials (RCTs) comparing carisbamate versus placebo or another antiepileptic drug, as add-on therapy for drug-resistant focal epilepsy. Trials could have a parallel-group or cross-over design.\nData collection and analysis\nTwo review authors independently selected the trials for inclusion, assessed trial quality, and extracted data. The primary outcome was 50% or greater reduction in seizure frequency (responder rate). The secondary outcomes were: seizure freedom, treatment withdrawal (for any reason and due to adverse events); adverse events, and quality of life. We analysed data using the Mantel-Haenszel statistical method and according to the intention-to-treat population. We presented results as risk ratios (RRs) with 95% confidence intervals (CIs).\nMain results\nWe included four RCTs involving a total of 2211 participants. All four trials compared carisbamate with placebo for drug-resistant focal epilepsy. Participants in all trials were over 16 years of age and received at least one other antiepileptic drug concomitantly. We detected substantial risk of bias across the included trials. All four trials were at high risk of attrition bias due to the incomplete reporting of attrition and the high treatment withdrawal rates noted, especially with higher doses. All four trials also had unclear risk of detection bias, as they did not specify whether outcome assessors were blinded.\nMeta-analysis suggested that carisbamate produced a higher responder rate compared to placebo (RR 1.36, 95% CI 1.14 to 1.62; 4 studies; moderate-certainty evidence). More participants in the carsibamate group achieved seizure freedom (RR 2.43, 95% CI 0.84 to 7.03; 1 study); withdrew from treatment for any reason (RR 1.32, 95% CI 0.82 to 2.12; 4 studies); and withdrew from treatment due to adverse events (RR 1.80, 95% CI 0.78 to 4.17; 4 studies) than in the placebo group. However, the evidence for the three outcomes was very low-certainty. There was no difference between treatment groups for the proportion of participants experiencing at least one adverse event (RR 1.10, 95% CI 0.93 to 1.30; 2 studies; low-certainty evidence). More participants in the carisbamate group than in the placebo group developed dizziness (RR 2.06, 95% CI 1.23 to 3.44; 4 studies; very low-certainty evidence) and somnolence (RR 1.82, 95% CI 1.28 to 2.58; 4 studies; low-certainty evidence), but not fatigue (RR 1.11, 95% CI 0.73 to 1.68; 3 studies); headache (RR 1.13, 95% CI 0.92 to 1.38; 4 studies); or nausea (RR 1.19, 95% CI 0.81 to 1.75; 3 studies). None of the included trials reported quality of life.\nAuthors' conclusions\nThe results suggest that carisbamate may demonstrate efficacy and tolerability as an add-on therapy for drug-resistant focal epilepsy. Importantly, the evidence for all outcomes except responder rate was of low to very low certainty, therefore we are uncertain of the accuracy of the reported effects. The certainty of the evidence is limited by the significant risk of bias associated with the included studies, as well as the statistical heterogeneity detected for some outcomes. Consequently, it is difficult for these findings to inform clinical practice. The studies were all of short duration and only included adult study populations. There is a need for further RCTs with more clear methodology, long-term follow-up, more clinical outcomes, more seizure types, and a broader range of participants.\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": "We found four studies involving a total of 2211 participants, who were aged 16 years and above. A third more people experienced a 50% or greater reduction in seizure frequency when receiving add-on carisbamate compared to those who received add-on placebo (dummy pill).\nTwice as many people in the carisbamate group became free of all seizures compared to the placebo group. More people in the carisbamate group withdrew from treatment for any reason and withdrew due to side effects than in the placebo group. There was no difference in the number of people who experienced one of more adverse events between the carisbamate and placebo groups. Approximately twice as many people in the carisbamate group developed dizziness and drowsiness compared to the placebo group."
}
] |
query-laysum
|
8603
|
[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is a life-limiting inherited condition which affects one in 2500 newborns in the UK and 70,000 children and adults worldwide. The condition is multifaceted and affects many systems in the body. The respiratory system is particularly affected due to a build up of thickened secretions and a predisposition to infection. Inhaled bronchodilators are prescribed for 80% of people with cystic fibrosis in order to widen the airways and alleviate symptoms. Both short- and long-acting inhaled bronchodilators are used to improve respiratory symptoms. Short-acting inhaled bronchodilators take effect in minutes and typically last for four to eight hours (muscarinic antagonists). Long-acting inhaled bronchodilators also take effect within minutes but typically last for around 12 hours and sometimes longer. This review is one of two which are replacing a previously published review of both long- and short-acting inhaled bronchodilators. However, due to the lack of research in this area, we do not envisage undertaking any further updates of this long-acting inhaled bronchodilators review.\nObjectives\nThis review aims to evaluate long-acting inhaled bronchodilators in children and adults with cystic fibrosis in terms of clinical outcomes and safety. If possible, we aimed to assess the optimal drug and dosage regimen.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books.\nDate of last search: 10 October 2017.\nWe also carried out a separate search of Embase and the reference lists of included trials. We searched clinical trials registries for any ongoing trials and made contact with pharmaceutical companies for any further trials.\nDate of Embase search: 11 October 2017.\nSelection criteria\nRandomised or quasi-randomised parallel trials comparing long-acting inhaled bronchodilators (beta-2 agonists and muscarinic antagonists) with placebo, no treatment or a different long-acting inhaled bronchodilator in adults and children with cystic fibrosis.\nData collection and analysis\nBoth authors independently assessed trials for inclusion (based on title, abstract and full text). The authors independently assessed the included trials for quality and risk of bias and extracted data. Discrepancies were resolved by a third party.\nMain results\nThe searches identified 195 unique references, of which 155 were excluded on title and abstract. We assessed the full texts of the remaining references, excluded 16 trials (28 references) and included four trials (12 references) in the review with 1082 participants.\nOne trial (n = 16) measuring the effect of beta-2 agonists reported an improvement in forced expiratory volume at one second (FEV1) after treatment (at one month), but the trial was small with an unclear risk of bias so we judged the evidence to be very low quality. The trial did not report on participant-reported outcomes, quality of life or adverse events.\nThree trials (n = 1066) looked at the effects of the muscarinic antagonist tiotropium at doses of 2.5 µg and 5.0 µg in both the short term (up to 28 days) and the longer term (up to three months). Only one of the trials reported the change in FEV1 (L) after 28 days treatment and showed no significant difference between groups; with 2.5 µg tiotropium, mean difference (MD) -0.02 (95% confidence interval (CI) -0.13 to 0.09), or 5.0 µg tiotropium, MD 0.00 (95% CI -0.10 to 0.10) (moderate-quality evidence). All three trials of muscarinic antagonists provided data on adverse events which were found to differ little from placebo at doses of 2.5 µg, risk ratio (RR) 1.01 (95% CI 0.92 to 1.11) or 5.0 µg, RR 0.98 (95% CI 0.90 to 1.06). Very little participant-reported outcome data or quality of life data were available for analysis. Two of the trials were at low risk of bias overall whilst the remaining trial was at an unclear risk overall.\nAuthors' conclusions\nNeither long-acting beta-2 agonists nor long-acting muscarinic antagonist bronchodilators demonstrate improvement in our primary outcome of FEV1. No difference was observed between intervention and placebo in terms of quality of life or adverse events. The quality of evidence for the use of beta-2 agonists was very low. The use of a long-acting inhaled bronchodilator may help to reduce the burden of treatment for people with cystic fibrosis as it is taken less often than a short-acting inhaled bronchodilator, but future trials would benefit from looking at the effects on our primary outcomes (spirometric changes from baseline, quality of life and adverse effects) in the longer term.\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": "Cystic fibrosis affects many systems in the body, in particular how well the lungs work. There is a build-up of thickened, sticky mucus which makes breathing more difficult and makes people with cystic fibrosis more likely to get infections in their lungs. Short- and long-acting bronchodilators are prescribed for most people with cystic fibrosis to widen the airways and improve symptoms. This review partly replaces an earlier review of both short-acting and long-acting inhaled bronchodilators. However, due to the lack of research in this area, we do not plan to update this review of long-acting inhaled bronchodilators again."
}
] |
query-laysum
|
8604
|
[
{
"role": "user",
"content": "Abstract: Background\nTo limit long-term sick leave and associated consequences, insurers, healthcare providers and employers provide programmes to facilitate disabled people's return to work. These programmes include a variety of coordinated and individualised interventions. Despite the increasing popularity of such programmes, their benefits remain uncertain. We conducted a systematic review to determine the long-term effectiveness of return-to-work coordination programmes compared to usual practice in workers at risk for long-term disability.\nObjectives\nTo assess the effects of return-to-work coordination programmes versus usual practice for workers on sick leave or disability.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11), MEDLINE, Embase, CINAHL and PsycINFO up to 1 November 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) that enrolled workers absent from work for at least four weeks and randomly assigned them to return-to-work coordination programmes or usual practice.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full-text articles for study eligibility; extracted data; and assessed risk of bias from eligible trials. We contacted authors for additional data where required. We conducted random-effects meta-analyses and used the GRADE approach to rate the quality of the evidence.\nMain results\nWe identified 14 studies from nine countries that enrolled 12,568 workers. Eleven studies focused on musculoskeletal problems, two on mental health and one on both. Most studies (11 of 14) followed workers 12 months or longer. Risk of bias was low in 10 and high in 4 studies, but findings were not sensitive to their exclusion.\nWe found no benefits for return-to-work coordination programmes on return-to-work outcomes.\nFor short-term follow-up of six months, we found no effect on time to return to work (hazard ratio (HR) 1.32, 95% confidence interval (CI) 0.93 to 1.88, low-quality evidence), cumulative sickness absence (mean difference (MD) −16.18 work days per year, 95% CI −32.42 to 0.06, moderate-quality evidence), the proportion of participants at work at end of the follow-up (risk ratio (RR) 1.06, 95% CI 0.86 to 1.30, low-quality evidence) or on the proportion of participants who had ever returned to work, that is, regardless of whether they had remained at work until last follow-up (RR 0.87, 95% CI 0.63 to 1.19, very low-quality evidence).\nFor long-term follow-up of 12 months, we found no effect on time to return to work (HR 1.25, 95% CI 0.95 to 1.66, low-quality evidence), cumulative sickness absence (MD −14.84 work days per year, 95% CI −38.56 to 8.88, low-quality evidence), the proportion of participants at work at end of the follow-up (RR 1.06, 95% CI 0.99 to 1.15, low-quality evidence) or on the proportion of participants who had ever returned to work (RR 1.03, 95% CI 0.97 to 1.09, moderate-quality evidence).\nFor very long-term follow-up of longer than 12 months, we found no effect on time to return to work (HR 0.93, 95% CI 0.74 to 1.17, low-quality evidence), cumulative sickness absence (MD 7.00 work days per year, 95% CI −15.17 to 29.17, moderate-quality evidence), the proportion of participants at work at end of the follow-up (RR 0.94, 95% CI 0.82 to 1.07, low-quality evidence) or on the proportion of participants who had ever returned to work (RR 0.95, 95% CI 0.88 to 1.02, low-quality evidence).\nWe found only small benefits for return-to-work coordination programmes on patient-reported outcomes. All differences were below the minimal clinically important difference (MID).\nAuthors' conclusions\nOffering return-to-work coordination programmes for workers on sick leave for at least four weeks results in no benefits when compared to usual practice. We found no significant differences for the outcomes time to return to work, cumulative sickness absence, the proportion of participants at work at end of the follow-up or the proportion of participants who had ever returned to work at short-term, long-term or very long-term follow-up. For patient-reported outcomes, we found only marginal effects below the MID. The quality of the evidence ranged from very low to moderate across all outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 14 randomised controlled trials involving 12,568 workers with musculoskeletal or mental health problems. Workers had to be on sick leave for a minimum of four weeks.\nAt short-term follow-up of six months, return-to-work coordination programmes may make little or no difference to time to return to work (low-quality evidence), probably make little or no difference to cumulative sickness absence (moderate-quality evidence), may make little or no difference to the proportion of participants at work at end of the follow-up (low-quality evidence). Finally, we are uncertain whether the programmes improve the proportion of participants who had ever returned to work as the quality of the evidence has been assessed as very low.\nAt long-term follow-up of 12 months, return-to-work coordination programmes may make little or no difference to time to return to work, cumulative sickness absence or the proportion of participants at work at end of the follow-up (all low-quality evidence) and they probably make little or no difference to the proportion of participants who had ever returned to work (moderate-quality evidence).\nAt very long-term follow-up of longer than 12 months, return-to-work coordination programmes may make little or no difference to time to return to work (low-quality evidence), probably make little or no difference to cumulative sickness absence (moderate-quality evidence), and may make little or no difference to the proportion of participants at work at end of the follow-up and to the proportion of participants who had ever returned to work (both low-quality evidence).\nWe found only small benefits in patient-reported outcomes including pain, ability to function, depression and anxiety. All these effects were smaller than the so-called minimal clinically important difference.\nAs we found so much low- and very low-quality evidence it means that new research is likely to change the results."
}
] |
query-laysum
|
8605
|
[
{
"role": "user",
"content": "Abstract: Background\nGenital herpes is caused by herpes simplex virus 1 (HSV-1) or 2 (HSV-2). Some infected people experience outbreaks of genital herpes, typically, characterized by vesicular and erosive localized painful genital lesions.\nObjectives\nTo compare the effectiveness and safety of three oral antiviral drugs (acyclovir, famciclovir and valacyclovir) prescribed to suppress genital herpes outbreaks in non-pregnant patients.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the search portal of the World Health Organization International Clinical Trials Registry Platform and pharmaceutical company databases up to February 2014. We also searched US Food and Drug Administration databases and proceedings of seven congresses to a maximum of 10 years. We contacted trial authors and pharmaceutical companies.\nSelection criteria\nWe selected parallel-group and cross-over randomized controlled trials including patients with recurrent genital herpes caused by HSV, whatever the type (HSV-1, HSV-2, or undetermined), with at least four recurrences per year (trials concerning human immunodeficiency virus (HIV)-positive patients or pregnant women were not eligible) and comparing suppressive oral antiviral treatment with oral acyclovir, famciclovir, and valacyclovir versus placebo or another suppressive oral antiviral treatment.\nData collection and analysis\nTwo review authors independently selected eligible trials and extracted data. The Risk of bias tool was used to assess risk of bias. Treatment effect was measured by the risk ratio (RR) of having at least one genital herpes recurrence. Pooled RRs were derived by conventional pairwise meta-analyses. A network meta-analysis allowed for estimation of all possible two-by-two comparisons between antiviral drugs.\nMain results\nA total of 26 trials (among which six had a cross-over design) were included. Among the 6950 randomly assigned participants, 54% (range 0 to100%) were female, mean age was 35 years (range 26 to 45.1), and the mean number of recurrences per year was 11 (range 6.3 to 17.8). Duration of treatment was two to 12 months. Risk of bias was considered high for half of the studies and unclear for the other half. A total of 14 trials compared acyclovir versus placebo, four trials compared valacyclovir versus placebo and 2 trials compared valacyclovir versus no treatment. Three trials compared famciclovir versus placebo. Two trials compared valacyclovir versus famciclovir and one trial compared acyclovir versus valacyclovir versus placebo.\nWe analyzed data from 22 trials for the outcome: risk of having at least one clinical recurrence. We could not obtain the outcome data for four trials. In placebo-controlled trials, there was a low quality evidence that the risk of having at least one clinical recurrence was reduced with acyclovir (nine parallel-group trials, n = 2049; pooled RR 0.48, 95% confidence interval (CI) 0.39 to 0.58), valacyclovir (four trials, n = 1788; pooled RR 0.41, 95% CI 0.24 to 0.69), or famciclovir (two trials, n = 732; pooled RR 0.57, 95% CI 0.50 to 0.64). The six cross-over trials showed larger treatment effects on average than the parallel-group trials. We found evidence of a small-study effect for acyclovir placebo-controlled trials (adjusted pooled RR 0.61, 95% CI 0.49 to 0.75). In analyzing parallel-group trials by daily dose, no clear evidence was found of a dose-response relationship for any drug. In head-to-head trials, the risk of having at least one recurrence was increased with valacyclovir rather than acyclovir (one trial, n = 1345; RR 1.16, 95% CI 1.01 to 1.34) and was not significantly different from that seen with famciclovir as compared with valacyclovir (one trial, n = 320; RR 1.18, 95% CI 0.86 to 1.63).\nWe included 16 parallel-arm trials in a network meta-analysis and we were unable to determine which of the drugs was most effective in reducing the risk of at least one clinical recurrence (after adjustment for small-study effects, pooled RR 0.83, 95% CI 0.61 to 1.11 for valacyclovir vs acyclovir; pooled RR 1.04, 95% CI, 0.71 to 1.49 for famciclovir vs acyclovir; and pooled RR 1.26, 95% CI 0.89 to 1.75 for famciclovir vs valacyclovir). Safety data were sought but were reported as total numbers of adverse events.\nAuthors' conclusions\nOwing to risk of bias and inconsistency, there is low quality evidence that suppressive antiviral therapy with acyclovir, valacyclovir or famciclovir in pacients experiencing at least four recurrences of genital herpes per year decreases the number of pacients with at least one recurrence as compared with placebo. Network meta-analysis of the few direct comparisons and the indirect comparisons did not show superiority of one drug over another.\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": "Althought the three antiviral drugs showed better results compared with placebo, we are uncertain as to how much a difference there are likely to make, because of issues with the conduct and reporting of studies, and inconsistency of their results. The quality of the evidence is low and we think that the size of the effects is likely to change with more research. Because few studies compared the three drugs against one other, we are moderately confident in the fact that there is no difference between the three drugs in terms of effectiveness."
}
] |
query-laysum
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8606
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a previous Cochrane review published in Issue 1, 2010 and updated in Issue 9, 2015. The role of lymphadenectomy in surgical management of endometrial cancer remains controversial. Lymph node metastases can be found in approximately 10% of women who before surgery are thought to have cancer confined to the womb. Removal of all pelvic and para-aortic lymph nodes (lymphadenectomy) at initial surgery has been widely advocated, and pelvic and para-aortic lymphadenectomy remains part of the FIGO (International Federation of Gynaecology and Obstetrics) staging system for endometrial cancer. This recommendation is based on data from studies that suggested improvement in survival following pelvic and para-aortic lymphadenectomy. However, these studies were not randomised controlled trials (RCTs), and treatment of pelvic lymph nodes may not confer a direct therapeutic benefit, other than allocating women to poorer prognosis groups. Furthermore, the Cochrane review and meta-analysis of RCTs of routine adjuvant radiotherapy to treat possible lymph node metastases in women with early-stage endometrial cancer found no survival advantage. Surgical removal of pelvic and para-aortic lymph nodes has serious potential short-term and long-term sequelae. Therefore, it is important to investigate the clinical value of this treatment.\nObjectives\nTo evaluate the effectiveness and safety of lymphadenectomy for the management of endometrial cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase to June 2009 for the original review, updated the search to June 2015 for the last updated version and further extended the search to March 2017 for this version of the review. We also searched registers of clinical trials, abstracts of scientific meetings, and reference lists of included studies, and we contacted experts in the field.\nSelection criteria\nRCTs and quasi-RCTs that compared lymphadenectomy versus no lymphadenectomy in adult women diagnosed with endometrial cancer.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. Hazard ratios (HRs) for overall and progression-free survival and risk ratios (RRs) comparing adverse events in women who received lymphadenectomy versus those with no lymphadenectomy were pooled in random-effects meta-analyses. We assessed the quality of the evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.\nMain results\n978 unique references were identified via the search strategy. All but 50 were excluded by title and abstract screening. Three RCTs met the inclusion criteria; for one small RCT, data were insufficient for inclusion in the meta-analysis. The two RCTs included in the analysis randomly assigned 1945 women, reported HRs for survival adjusted for prognostic factors and based on 1851 women and had an overall low risk of bias, as they satisfied four of the assessment criteria. The third study had an overall unclear risk of bias, as information provided was not adequate concerning random sequence generation, allocation concealment, blinding, or completeness of outcome reporting.\nResults of the meta-analysis remained unchanged from the previous versions of this review and indicated no differences in overall and recurrence-free survival between women who underwent lymphadenectomy and those who did not undergo lymphadenectomy (pooled hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.81 to 1.43; HR 1.23, 95% CI 0.96 to 1.58 for overall and recurrence-free survival, respectively) (1851 participants, two studies; moderate-quality evidence).\nWe found no difference in risk of direct surgical morbidity between women who underwent lymphadenectomy and those who did not undergo lymphadenectomy. However, women who underwent lymphadenectomy had a significantly higher risk of surgery-related systemic morbidity and lymphoedema/lymphocyst formation than those who did not undergo lymphadenectomy (RR 3.72, 95% CI 1.04 to 13.27; RR 8.39, 95% CI 4.06 to 17.33 for risk of surgery-related systemic morbidity and lymphoedema/lymphocyst formation, respectively) (1922 participants, two studies; high-quality evidence).\nAuthors' conclusions\nThis review found no evidence that lymphadenectomy decreases risk of death or disease recurrence compared with no lymphadenectomy in women with presumed stage I disease. Evidence on serious adverse events suggests that women who undergo lymphadenectomy are more likely to experience surgery-related systemic morbidity or lymphoedema/lymphocyst formation. Currently, no RCT evidence shows the impact of lymphadenectomy in women with higher-stage disease and in those at high risk of disease recurrence.\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": "The overall quality of the evidence for lymphadenectomy versus standard surgery was moderate for survival outcomes and adverse events (other than evidence for presence or absence of lymphoedema or lymphocyst, which was of high quality). The quality of evidence for quality of life was very low, as this outcome was not reported."
}
] |
query-laysum
|
8607
|
[
{
"role": "user",
"content": "Abstract: Background\nGlaucoma is a leading cause of irreversible blindness. Subconjunctival draining minimally-invasive glaucoma devices such as the Xen gelatin implant and InnFocus stent have been introduced as a treatment to prevent glaucoma progressing.\nThese implants provide a channel to allow aqueous humour from the anterior chamber of the eye to drain into the subconjunctival space on the surface of the eye thus reducing intraocular pressure (IOP) and mimicking the mechanism of the most commonly undertaken glaucoma surgery, trabeculectomy.\nObjectives\nTo evaluate the efficacy and safety of subconjunctival draining minimally-invasive glaucoma devices in treating people with open angle glaucoma and ocular hypertension whose condition is inadequately controlled with drops.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2018, Issue 6); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 10 July 2018.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) of Xen gelatin implant or InnFocus MicroShunt to other surgical treatments (other minimally-invasive glaucoma device techniques, trabeculectomy), laser treatment or medical treatment. We also planned to include trials where these devices were combined with phacoemulsification compared to phacoemulsification alone.\nData collection and analysis\nWe planned to have two review authors independently extract data from reports of included studies using a data collection form and analyse data based on methods expected by Cochrane. Our primary outcome was mean change in IOP. Secondary outcomes included proportion of participants who were drop-free; proportion of participants who achieved an IOP of 21 mmHg or less, 17 mmHg or less or 14 mmHg or less; and proportion of participants experiencing intra- and postoperative complications. We planned to measure all outcomes in the short-term (six to 18 months), medium-term (18 to 36 months), and long-term (36 months onwards).\nMain results\nWe found no completed RCTs that met our inclusion criteria. We found one ongoing study (NCT01881425). The study compares InnFocus MicroShunt to trabeculectomy in people with primary open angle glaucoma. The primary outcome is greater than 20% IOP reduction from baseline to 12 months' follow-up. A total of 889 people aged between 40 and 85 years have been enrolled. The estimated study completion date is November 2019.\nAuthors' conclusions\nThere is currently no high-quality evidence for the effects of subconjunctival draining minimally-invasive glaucoma devices for medically uncontrolled open angle glaucoma. Properly designed RCTs are needed to assess the medium- and long-term efficacy and safety of this technique.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The Cochrane Review authors did not find any completed studies that could be included in this review."
}
] |
query-laysum
|
8608
|
[
{
"role": "user",
"content": "Abstract: Background\nThere are a limited number of treatment options for patients with ulcerative colitis (UC). An increased risk of thrombosis in UC coupled with an observation that UC patients being treated with anticoagulant therapy for thrombotic events had an improvement in their bowel symptoms led to trials examining the use of unfractionated heparin (UFH) and low molecular weight heparins (LMWH) in patients with active UC.\nObjectives\nTo review randomized trials examining the efficacy of unfractionated heparin (UFH) or low molecular weight heparins (LMWH) for remission induction in patients with ulcerative colitis.\nSearch methods\nWe searched MEDLINE, EMBASE, CENTRAL, and the Cochrane IBD/FBD group specialized trials register up to June 2014. We also searched review papers on ulcerative colitis and references from identified papers in an effort to identify additional randomized trials studying UFH or LMWH use in patients with ulcerative colitis. We searched abstracts from major gastroenterological meetings to identify research published in abstract form.\nSelection criteria\nRandomized controlled trials comparing UFH or LMWH to placebo or a control therapy for induction of remission in ulcerative colitis were included. Studies published in abstract form only were included if the authors could be contacted for further information.\nData collection and analysis\nA data extraction form was developed and used to extract data from included studies. Two authors independently extracted data. Any disagreements were resolved by consensus. The Cochrane Risk of Bias tool was used to assess study quality. Data were analyzed on an intention-to-treat basis. The primary outcome was induction of remission, as defined by the studies. Secondary outcomes measures included: endoscopic remission as defined by the authors; clinical, histological or endoscopic improvement as defined by the authors; the occurrence of adverse events; the occurrence of bleeding; and improvements in quality of life as measured by a validated instrument. We calculated the risk ratio (RR) and corresponding 95% confidence interval for dichotomous outcomes. Data were combined for analysis if they assessed the same treatments (UFH or LMWH versus placebo or other therapy). The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria.\nMain results\nFive studies were eligible for inclusion (329 patients). Three studies (270 patients) compared low molecular weight heparin to placebo, one study (34 patients) compared LMWH in addition to standard therapy, and one study (25 patients) compared UFH to corticosteroids. The study comparing UFH to corticosteroids was rated at high risk of bias due to a single-blind design. The study that compared the addition of LMWH to standard therapy to standard therapy alone was rated at high risk of bias due to open-label design. The other three studies were rated as low risk of bias. LMWH administered subcutaneously showed no benefit over placebo for any outcome, including clinical remission (very low quality of evidence), and clinical, endoscopic, or histological improvement. High dose LMWH administered via an extended colon-release tablet demonstrated benefit over placebo for clinical remission (RR 1.39; 95% CI 1.09 to 1.77 ; P = 0.008; very low quality of evidence), clinical improvement (RR 1.28; 95% CI 1.06 to 1.55; P = 0.01; very low quality of evidence), and endoscopic improvement (RR 1.21; 95% CI 1.00 to 1.47 ; P = 0.05) but not endoscopic remission or histologic improvement. LMWH was not beneficial when added to standard therapy for clinical remission, clinical improvement, endoscopic remission or endoscopic improvement. LMWH was well-tolerated but provided no significant benefit for quality of life. One study examining UFH versus corticosteroids for the treatment of severe UC demonstrated the inferiority of UFH for clinical improvement. More patients assigned to UFH had rectal hemorrhage as an adverse event.\nAuthors' conclusions\nThere is evidence to suggest that LMWH may be effective for the treatment of active UC. When administered by extended colon-release tablets, LMWH was more effective than placebo for treating outpatients with mild to moderate disease. This benefit needs to be confirmed by further randomized controlled studies. The same benefits were not seen when LMWH was administered subcutaneously at lower doses. There is no evidence to support the use of UFH for the treatment of active UC. A further trial of UFH in patients with mild disease may also be justified. Any benefit found would need to be weighed against a possible increased risk of rectal bleeding in patients with active UC.\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 researchers identified five studies that included a total of 329 patients. Three studies (270 patients) compared low molecular weight heparin to placebo (e.g. a sugar pill), one study (34 patients) compared low molecular weight heparin in addition to standard therapy, and one study (25 patients) compared unfractionated heparin to steroids. The study comparing unfractionated heparin to steroids and the study that compared the addition of low molecular weight heparin to standard therapy to standard therapy alone was judged to be of low quality. The three placebo-controlled studies were judged to be of high quality."
}
] |
query-laysum
|
8609
|
[
{
"role": "user",
"content": "Abstract: Background\nZinc deficiency is a global nutritional problem, particularly in children and women residing in settings where diets are cereal based and monotonous. It has several negative health consequences. Fortification of staple foods with zinc may be an effective strategy for preventing zinc deficiency and improving zinc-related health outcomes.\nObjectives\nTo evaluate the beneficial and adverse effects of fortification of staple foods with zinc on health-related outcomes and biomarkers of zinc status in the general population.\nSearch methods\nWe searched the following databases in April 2015: Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3 of 12, 2015, the Cochrane Library), MEDLINE & MEDLINE In Process (OVID) (1950 to 8 April 2015), EMBASE (OVID) (1974 to 8 April 2015), CINAHL (1982 to April 2015), Web of Science (1900 to 9 April 2015), BIOSIS (1969 to 9 April 2015), POPLINE (1970 to April 2015), AGRICOLA, OpenGrey, BiblioMap, and Trials Register of Promoting Health Interventions (TRoPHI), besides regional databases (April 2015) and theses. We also searched clinical trial registries (17 March 2015) and contacted relevant organisations (May 2014) in order to identify ongoing and unpublished studies.\nSelection criteria\nWe included randomised controlled trials, randomised either at the level of the individual or cluster. We also included non-randomised trials at the level of the individual if there was a concurrent comparison group. We included non-randomised cluster trials and controlled before-after studies only if there were at least two intervention sites and two control sites. Interventions included fortification (central/industrial) of staple foods (cereal flours, edible fats, sugar, condiments, seasonings, milk and beverages) with zinc for a minimum period of two weeks. Participants were members of the general population who were over two years of age (including pregnant and lactating women) from any country.\nData collection and analysis\nTwo review authors independently assessed the eligibility of studies for inclusion, extracted data from included studies, and assessed the risk of bias of the included studies.\nMain results\nWe included eight trials (709 participants); seven were from middle-income countries of Asia, Africa, Europe, and Latin America where zinc deficiency is likely to be a public health problem. Four trials compared the effect of zinc-fortified staple foods with unfortified foods (comparison 1), and four compared zinc-fortified staple foods in combination with other nutrients/factors with the same foods containing other nutrients or factors without zinc (comparison 2). The interventions lasted between one and nine months. We categorised most trials as having unclear or high risk of bias for randomisation, but low risk of bias for blinding and attrition. None of the studies in comparison 1 reported data on zinc deficiency.\nFoods fortified with zinc increased the serum or plasma zinc levels in comparison to foods without added zinc (mean difference (MD) 2.12 µmol/L, 95% confidence interval (CI) 1.25 to 3.00 µmol/L; 3 studies; 158 participants; low-quality evidence). Participants consuming foods fortified with zinc versus participants consuming the same food without zinc had similar risk of underweight (average risk ratio 3.10, 95% CI 0.52 to 18.38; 2 studies; 397 participants; low-quality evidence) and stunting (risk ratio (RR) 0.88, 95% CI 0.36 to 2.13; 2 studies; 397 participants; low-quality evidence). A single trial of addition of zinc to iron in wheat flour did not find a reduction in proportion of zinc deficiency (RR 0.17, 95% CI 0.01 to 3.94; very low-quality evidence). We did not find a difference in serum or plasma zinc levels in participants consuming foods fortified with zinc plus other micronutrients when compared with participants consuming the same foods with micronutrients but no added zinc (MD 0.03 µmol/L, 95% CI -0.67 to 0.72 µmol/L; 4 studies; 250 participants; low-quality evidence). No trial in comparison 2 provided information about underweight or stunting.\nThere was no reported adverse effect of fortification of foods with zinc on indicators of iron or copper status.\nAuthors' conclusions\nFortification of foods with zinc may improve the serum zinc status of populations if zinc is the only micronutrient used for fortification. If zinc is added to food in combination with other micronutrients, it may make little or no difference to the serum zinc status. Effects of fortification of foods with zinc on other outcomes including zinc deficiency, children’s growth, cognition, work capacity of adults, or on haematological indicators are unknown. Given the small number of trials and participants in each trial, further investigation of these outcomes is required.\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": "It is believed that zinc deficiency is widespread globally, particularly in children and women living in low- and middle-income countries. Cereal-based foods are rich in dietary fibre and phytates, which reduce absorption of zinc from the intestine. As people in low-income households eat a lot of cereal-based foods, they are more likely to develop zinc deficiency. Fortification of common staple foods with zinc alone or in combination with other vitamins and minerals has been proposed as an intervention to increase intake of zinc in populations who consume these foods."
}
] |
query-laysum
|
8610
|
[
{
"role": "user",
"content": "Abstract: Background\nPlatinum-based therapy, including cisplatin, carboplatin, oxaliplatin or a combination of these, is used to treat a variety of paediatric malignancies. One of the most significant adverse effects is the occurrence of hearing loss or ototoxicity. In an effort to prevent this ototoxicity, different otoprotective medical interventions have been studied. This review is the third update of a previously published Cochrane Review.\nObjectives\nTo assess the efficacy of medical interventions to prevent hearing loss and to determine possible effects of these interventions on antitumour efficacy, toxicities other than hearing loss and quality of life in children with cancer treated with platinum-based therapy as compared to placebo, no additional treatment or another protective medical intervention.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE (PubMed) and Embase (Ovid) to 8 January 2019. We handsearched reference lists of relevant articles and assessed the conference proceedings of the International Society for Paediatric Oncology (2006 up to and including 2018), the American Society of Pediatric Hematology/Oncology (2007 up to and including 2018) and the International Conference on Long-Term Complications of Treatment of Children and Adolescents for Cancer (2010 up to and including 2015). We scanned ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP; apps.who.int/trialsearch) for ongoing trials (on 2 January 2019).\nSelection criteria\nRandomized controlled trials (RCTs) or controlled clinical trials (CCTs) evaluating platinum-based therapy with an otoprotective medical intervention versus platinum-based therapy with placebo, no additional treatment or another protective medical intervention in children with cancer.\nData collection and analysis\nTwo review authors independently performed the study selection, data extraction, risk of bias assessment and GRADE assessment of included studies, including adverse effects. We performed analyses according to the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe identified two RCTs and one CCT (total number of participants 149) evaluating the use of amifostine versus no additional treatment in the original version of the review; the updates identified no additional studies. Two studies included children with osteosarcoma, and the other study included children with hepatoblastoma. Children received cisplatin only or a combination of cisplatin and carboplatin, either intra-arterially or intravenously. Pooling of results of the included studies was not possible. From individual studies the effect of amifostine on symptomatic ototoxicity only (i.e. National Cancer Institute Common Toxicity Criteria version 2 (NCICTCv2) or modified Brock grade 2 or higher) and combined asymptomatic and symptomatic ototoxicity (i.e. NCICTCv2 or modified Brock grade 1 or higher) were uncertain (low-certainty evidence). Only one study including children with osteosarcoma treated with intra-arterial cisplatin provided information on tumour response, defined as the number of participants with a good or partial remission. The available-data analysis (data were missing for one participant), best-case scenario analysis and worst-case scenario analysis showed a difference in favour of amifostine, although the certainty of evidence for this effect was low. There was no information on survival for any of the included studies. Only one study, including children with osteosarcoma treated with intra-arterial cisplatin, provided data on the number of participants with adverse effects other than ototoxicity grade 3 or higher (on NCICTCv2 scale). There was low-certainty evidence that grade 3 or 4 vomiting was higher with amifostine (risk ratio (RR) 9.04, 95% confidence interval (CI) 1.99 to 41.12). The effects on cardiotoxicity and renal toxicity grade 3 or 4 were uncertain (low-certainty evidence). None of the studies evaluated quality of life.\nIn the recent update, we also identified one RCT including 109 children with localized hepatoblastoma evaluating the use of sodium thiosulfate versus no additional treatment. Children received intravenous cisplatin only (one child also received carboplatin). There was moderate-certainty evidence that both symptomatic ototoxicity only (i.e. Brock criteria grade 2 or higher) and combined asymptomatic and symptomatic ototoxicity (i.e. Brock criteria grade 1 or higher) was lower with sodium thiosulfate (combined asymptomatic and symptomatic ototoxicity: RR 0.52, 95% CI 0.33 to 0.81; symptomatic ototoxicity only: RR 0.39, 95% CI 0.19 to 0.83). The effect of sodium thiosulfate on tumour response (defined as number of participants with a complete or partial response at the end of treatment), overall survival (calculated from time of randomization to death or last follow-up), event-free survival (calculated from time of randomization until disease progression, disease relapse, second primary cancer, death, or last follow-up, whichever came first) and adverse effects other than hearing loss and tinnitus grade 3 or higher (according to National Cancer Institute Common Toxicity Criteria Adverse Effects version 3 (NCICTCAEv3) criteria) was uncertain (low-certainty evidence for all these outcomes). Quality of life was not assessed.\nWe found no eligible studies for possible otoprotective medical interventions other than amifostine and sodium thiosulfate and for other types of malignancies.\nAuthors' conclusions\nAt the moment there is no evidence from individual studies in children with osteosarcoma or hepatoblastoma treated with different platinum analogues and dosage schedules that underscores the use of amifostine as an otoprotective intervention as compared to no additional treatment. Since pooling of results was not possible and the evidence was of low certainty, no definitive conclusions can be made. Since we found only one RCT evaluating the use of sodium thiosulfate in children with localized hepatoblastoma treated with cisplatin, no definitive conclusions on benefits and harms can be drawn. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. We identified no eligible studies for other possible otoprotective medical interventions and other types of malignancies, so no conclusions can be made about their efficacy in preventing ototoxicity in children treated with platinum-based therapy. More high-quality research is 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 of the effectiveness of any medical intervention to prevent hearing loss in children with cancer treated with platinum-based therapy (i.e. including the anticancer drugs cisplatin, carboplatin, oxaliplatin or a combination of these). We also looked at anticancer effectiveness, side effects other than hearing loss and quality of life."
}
] |
query-laysum
|
8611
|
[
{
"role": "user",
"content": "Abstract: Background\nAlveolar osteitis (dry socket) is a complication of dental extractions more often involving mandibular molar teeth. It is associated with severe pain developing 2 to 3 days postoperatively with or without halitosis, a socket that may be partially or totally devoid of a blood clot, and increased postoperative visits. This is an update of the Cochrane Review first published in 2012.\nObjectives\nTo assess the effects of local interventions used for the prevention and treatment of alveolar osteitis (dry socket) following tooth extraction.\nSearch methods\nAn Information Specialist searched four bibliographic databases up to 28 September 2021 and used additional search methods to identify published, unpublished, and ongoing studies.\nSelection criteria\nWe included randomised controlled trials of adults over 18 years of age who were having permanent teeth extracted or who had developed dry socket postextraction. We included studies with any type of local intervention used for the prevention or treatment of dry socket, compared to a different local intervention, placebo or no treatment. We excluded studies reporting on systemic use of antibiotics or the use of surgical techniques because these interventions are evaluated in separate Cochrane Reviews.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We followed Cochrane statistical guidelines and reported dichotomous outcomes as risk ratios (RR) and calculated 95% confidence intervals (CI) using random-effects models. For some of the split-mouth studies with sparse data, it was not possible to calculate RR so we calculated the exact odds ratio (OR) instead. We used GRADE to assess the certainty of the body of evidence.\nMain results\nWe included 49 trials with 6771 participants; 39 trials (with 6219 participants) investigated prevention of dry socket and 10 studies (with 552 participants) looked at the treatment of dry socket. 16 studies were at high risk of bias, 30 studies at unclear risk of bias, and 3 studies at low risk of bias.\nChlorhexidine in the prevention of dry socket\nWhen compared to placebo, rinsing with chlorhexidine mouthrinses (0.12% and 0.2% concentrations) both before and 24 hours after extraction(s) substantially reduced the risk of developing dry socket with an OR of 0.38 (95% CI 0.25 to 0.58; P < 0.00001; 6 trials, 1547 participants; moderate-certainty evidence). The prevalence of dry socket varies from 1% to 5% in routine dental extractions to upwards of 30% in surgically extracted third molars. The number of patients needed to be treated (NNT) with chlorhexidine rinse to prevent one patient having dry socket was 162 (95% CI 155 to 240), 33 (95% CI 27 to 49), and 7 (95% CI 5 to 10) for control prevalence of dry socket 0.01, 0.05, and 0.30 respectively.\nCompared to placebo, placing chlorhexidine gel intrasocket after extractions reduced the odds of developing a dry socket by 58% with an OR of 0.44 (95% CI 0.27 to 0.71; P = 0.0008; 7 trials, 753 participants; moderate-certainty evidence). The NNT with chlorhexidine gel (0.2%) to prevent one patient developing dry socket was 180 (95% CI 137 to 347), 37 (95% CI 28 to 72), and 7 (95% CI 5 to 15) for control prevalence of dry socket of 0.01, 0.05, and 0.30 respectively.\nCompared to chlorhexidine rinse (0.12%), placing chlorhexidine gel (0.2%) intrasocket after extractions was not superior in reducing the risk of dry socket (RR 0.74, 95% CI 0.46 to 1.20; P = 0.22; 2 trials, 383 participants; low-certainty evidence).\nThe present review found some evidence for the association of minor adverse reactions with use of 0.12%, 0.2% chlorhexidine mouthrinses (alteration in taste, staining of teeth, stomatitis) though most studies were not designed explicitly to detect the presence of hypersensitivity reactions to mouthwash as part of the study protocol. No adverse events were reported in relation to the use of 0.2% chlorhexidine gel placed directly into a socket.\nPlatelet rich plasma in the prevention of dry socket\nCompared to placebo, placing platelet rich plasma after extractions was not superior in reducing the risk of having a dry socket (RR 0.51, 95% CI 0.19 to 1.33; P = 0.17; 2 studies, 127 participants; very low-certainty evidence).\nA further 21 intrasocket interventions to prevent dry socket were each evaluated in single studies, and there is insufficient evidence to determine their effects.\nZinc oxide eugenol versus Alvogyl in the treatment of dry socket\nTwo studies, with 80 participants, showed that Alvogyl (old formulation) is more effective than zinc oxide eugenol at reducing pain at day 7 (mean difference (MD) -1.40, 95% CI -1.75 to -1.04; P < 0.00001; 2 studies, 80 participants; very low-certainty evidence)\nA further nine interventions for the treatment of dry socket were evaluated in single studies, providing insufficient evidence to determine their effects.\nAuthors' conclusions\nTooth extractions are generally undertaken by dentists for a variety of reasons, however, all but five studies included in the present review included participants undergoing extraction of third molars, most of which were undertaken by oral surgeons. There is moderate-certainty evidence that rinsing with chlorhexidine (0.12% and 0.2%) or placing chlorhexidine gel (0.2%) in the sockets of extracted teeth, probably results in a reduction in dry socket. There was insufficient evidence to determine the effects of the other 21 preventative interventions each evaluated in single studies. There was limited evidence of very low certainty that Alvogyl (old formulation) may reduce pain at day 7 in patients with dry socket when compared to zinc oxide eugenol.\n\nGiven the provided abstract, please respond to the following query: \"What is dry socket?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Dry socket is a painful condition that sometimes arises after a tooth has been extracted and is more likely to occur following extraction of wisdom teeth in the lower jaw."
}
] |
query-laysum
|
8612
|
[
{
"role": "user",
"content": "Abstract: Background\nThoracoabdominal aortic aneurysms (TAAAs) are a life-threatening condition which remain difficult to treat. Endovascular and open surgical repair (OSR) provide treatment options for patients, however, due to the lack of clinical trials comparing these, the optimum treatment option is unknown.\nObjectives\nTo assess the effectiveness and safety of endovascular repair versus conventional OSR for the treatment of TAAAs.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 26 April 2021. We also searched references of relevant articles retrieved from the electronic search for additional citations.\nSelection criteria\nWe considered all published and unpublished randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing endovascular repair to OSR for TAAAs for inclusion in the review. The main outcomes of interest were prevention of aneurysm rupture (participants without aneurysm rupture up to 5 years from intervention), aneurysm-related mortality (30 days and 12 months), all-cause mortality, spinal cord ischaemia (paraplegia, paraparesis), visceral arterial branch compromise causing mesenteric ischaemia or renal failure, and rate of reintervention.\nData collection and analysis\nTwo review authors independently screened all titles and abstracts identified from the searches to identify those that met the inclusion criteria. We planned to undertake data collection, risk of bias assessment, and analysis in accordance with Cochrane recommendations. We planned to assess the certainty of the evidence using GRADE.\nMain results\nNo RCTs or CCTs met the inclusion criteria for this review.\nAuthors' conclusions\nDue to the lack of RCTs or CCTs, we were unable to determine the safety and effectiveness of endovascular compared to OSR in patients with TAAAs and are unable to provide any evidence on the optimal surgical intervention for this cohort of patients. High-quality RCTs or CCTs addressing this objective are necessary, however conducting such studies will be logistically and ethically challenging for this life-threatening disease.\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 thoracoabdominal aortic aneurysm (TAAA) is a widening or swelling of a blood vessel 50% greater than the original vessel diameter, affecting the thoracic and abdominal aorta simultaneously. A TAAA greater than 6.0 cm to 6.5 cm in diameter (depending on the gender of the patient, or the presence of an underlying inherited weakness in the aortic wall), or a TAAA expanding faster than 1 cm per year, is regarded as a life-threatening condition if left untreated, and presents a complex challenge for surgeons in deciding on the best treatment path for each patient. The treatment options include open surgical repair which requires the surgical team to open both the chest and the abdomen to replace the diseased aorta with a material graft; endovascular repair which involves inserting a series of stents covered with material (endografts) within the aneurysm through small groin incisions using X-rays to guide the endografts into place; and non-interventional management which requires counselling patients and their family and, when necessary, prescribing patients medications to control risk factors. Significant complications including death exist after endovascular and open surgical repair. However, endovascular repair is conceptually less invasive, and for this reason, we aimed to determine if endovascular repair is a safer option for patients compared to open surgical repair."
}
] |
query-laysum
|
8613
|
[
{
"role": "user",
"content": "Abstract: Background\nFluid excess may place people undergoing surgery at risk for various complications. Hypertonic salt solution (HS) maintains intravascular volume with less intravenous fluid than isotonic salt (IS) solutions, but may increase serum sodium. This review was published in 2010 and updated in 2016.\nObjectives\nTo determine the benefits and harms of HS versus IS solutions administered for fluid resuscitation to people undergoing surgery.\nSearch methods\nIn this updated review we have searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4, 2016); MEDLINE (January 1966 to April 2016); EMBASE (January 1980 to April 2016); LILACS (January 1982 to April 2016) and CINAHL (January 1982 to April 2016) without language restrictions. We conducted the original search on April 30th, 2007, and reran it on April 8th, 2016.\nSelection criteria\nWe have included randomized clinical trials (RCTs) comparing HS to IS in people undergoing surgery, irrespective of blinding, language, and publication status.\nData collection and analysis\nTwo independent review authors read studies that met our selection criteria. We collected study information and data using a data collection sheet with predefined parameters. We have assessed the impact of HS administration on mortality, organ failure, fluid balance, serum sodium, serum osmolarity, diuresis and physiologic measures of cardiovascular function. We have pooled the data using the mean difference (MD) for continuous outcomes. We evaluated heterogeneity between studies by I² percentage. We consider studies with an I² of 0% to 30% to have no or little heterogeneity, 30% to 60% as having moderate heterogeneity, and more than 60% as having high heterogeneity. In studies with low heterogeneity we have used a fixed-effect model, and a random-effects model for studies with moderate to high heterogeneity.\nMain results\nWe have included 18 studies with 1087 participants of whom 545 received HS compared to 542 who received IS. All participants were over 18 years of age and all trials excluded high-risk patients (ASA IV). All trials assessed haematological parameters peri-operatively and up to three days post-operatively.\nThere were three (< 1%) deaths reported in the IS group and four (< 1%) in the HS group, as assessed at 90 days in one study. There were no reports of serious adverse events. Most participants were in a positive fluid balance postoperatively (4.4 L IS and 2.5 L HS), with the excess significantly less in HS participants (MD -1.92 L, 95% confidence interval (CI) -2.61 to -1.22 L; P < 0.00001). IS participants received a mean volume of 2.4 L and HS participants received 1.49 L, significantly less fluid than IS-treated participants (MD -0.91 L, 95% CI -1.24 to -0.59 L; P < 0.00001). The maximum average serum sodium ranged between 138.5 and 159 in HS groups compared to between 136 and 143 meq/L in the IS groups. The maximum serum sodium was significantly higher in HS participants (MD 7.73, 95% CI 5.84 to 9.62; P < 0.00001), although the level remained within normal limits (136 to 146 meq/L).\nA high degree of heterogeneity appeared to be related to considerable differences in the dose of HS between studies. The quality of the evidence for the outcomes reported ranged from high to very low. The risk of bias for many of the studies could not be determined for performance and detection bias, criteria that we assess as likely to impact the study outcomes.\nAuthors' conclusions\nHS reduces the volume of intravenous fluid required to maintain people undergoing surgery but transiently increases serum sodium. It is not known if HS affects survival and morbidity, but this should be examined in randomized controlled trials that are designed and powered to test these outcomes.\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 were seven deaths in total, three (less than 1%) from the IS group and four (less than 1%) from the HS group. The risk of death was very low in these studies. The studies did not report the occurrence of serious adverse events.\nThirteen studies reported the amount of fluid given. The IS group received a mean of 2.4 L and the HS group received 0.91 L less (1.49 L). The highest amount of sodium in the blood over the course of the study was reported by 16 studies. The IS group had a median of 139 meq/L and the HS group was 7.73 meq/L higher. The normal acceptable range is 136 to 146 meq/L."
}
] |
query-laysum
|
8614
|
[
{
"role": "user",
"content": "Abstract: Background\nGender dysphoria is described as a mismatch between an individual's experienced or expressed gender and their assigned gender, based on primary or secondary sexual characteristics. Gender dysphoria can be associated with clinically significant psychological distress and may result in a desire to change sexual characteristics. The process of adapting a person's sexual characteristics to their desired sex is called ‘transition.'\nCurrent guidelines suggest hormonal and, if needed, surgical intervention to aid transition in transgender women, i.e. persons who aim to transition from male to female. In adults, hormone therapy aims to reverse the body's male attributes and to support the development of female attributes. It usually includes estradiol, antiandrogens, or a combination of both. Many individuals first receive hormone therapy alone, without surgical interventions. However, this is not always sufficient to change such attributes as facial bone structure, breasts, and genitalia, as desired. For these transgender women, surgery may then be used to support transition.\nObjectives\nWe aimed to assess the efficacy and safety of hormone therapy with antiandrogens, estradiol, or both, compared to each other or placebo, in transgender women in transition.\nSearch methods\nWe searched MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase, Biosis Preview, PsycINFO, and PSYNDEX. We carried out our final searches on 19 December 2019.\nSelection criteria\nWe aimed to include randomised controlled trials (RCTs), quasi-RCTs, and cohort studies that enrolled transgender women, age 16 years and over, in transition from male to female. Eligible studies investigated antiandrogen and estradiol hormone therapies alone or in combination, in comparison to another form of the active intervention, or placebo control.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane to establish study eligibility.\nMain results\nOur database searches identified 1057 references, and after removing duplicates we screened 787 of these. We checked 13 studies for eligibility at the full text screening stage. We excluded 12 studies and identified one as an ongoing study. We did not identify any completed studies that met our inclusion criteria. The single ongoing study is an RCT conducted in Thailand, comparing estradiol valerate plus cyproterone treatment with estradiol valerate plus spironolactone treatment. The primary outcome will be testosterone level at three month follow-up.\nAuthors' conclusions\nWe found insufficient evidence to determine the efficacy or safety of hormonal treatment approaches for transgender women in transition. This lack of studies shows a gap between current clinical practice and clinical research. Robust RCTs and controlled cohort studies are needed to assess the benefits and harms of hormone therapy (used alone or in combination) for transgender women in transition. Studies should specifically focus on short-, medium-, and long-term adverse effects, quality of life, and participant satisfaction with the change in male to female body characteristics of antiandrogen and estradiol therapy alone, and in combination. They should also focus on the relative effects of these hormones when administered orally, transdermally, and intramuscularly. We will include non-controlled cohort studies in the next iteration of this review, as our review has shown that such studies provide the highest quality evidence currently available in the field. We will take into account methodological limitations when doing so.\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": "Transgender women may feel that they have been born in a body with the wrong sexual characteristics. This may result in significant psychological distress (gender dysphoria) and the desire to adapt their male physical and sexual characteristics to be more consistent with their experienced female gender. This is a process called transition. If measures to aid transition are not taken, this can result in greater psychological distress. One of the medical treatments given to help transgender women with male bodies to achieve transition is synthetic female hormones. These hormones can be taken by mouth, absorbed through the skin or injected into muscle."
}
] |
query-laysum
|
8615
|
[
{
"role": "user",
"content": "Abstract: Background\nMarfan syndrome is a hereditary disorder affecting the connective tissue and is caused by a mutation of the fibrillin-1 (FBN1) gene. It affects multiple systems of the body, most notably the cardiovascular, ocular, skeletal, dural and pulmonary systems. Aortic root dilatation is the most frequent cardiovascular manifestation and its complications, including aortic regurgitation, dissection and rupture are the main cause of morbidity and mortality.\nObjectives\nTo assess the long-term efficacy and safety of beta-blocker therapy as compared to placebo, no treatment or surveillance only in people with Marfan syndrome.\nSearch methods\nWe searched the following databases on 28 June 2017; CENTRAL, MEDLINE, Embase, Science Citation Index Expanded and the Conference Proceeding Citation Index - Science in the Web of Science Core Collection. We also searched the Online Metabolic and Molecular Bases of Inherited Disease (OMMBID), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 30 June 2017. We did not impose any restriction on language of publication.\nSelection criteria\nAll randomised controlled trials (RCTs) of at least one year in duration assessing the effects of beta-blocker monotherapy compared with placebo, no treatment or surveillance only, in people of all ages with a confirmed diagnosis of Marfan syndrome were eligible for inclusion.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for inclusion, extracted data and assessed trial quality. Trial authors were contacted to obtain missing data. Dichotomous outcomes will be reported as relative risk and continuous outcomes as mean differences with 95% confidence intervals. We assessed the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nOne open-label, randomised, single-centre trial including 70 participants with Marfan syndrome (aged 12 to 50 years old) met the inclusion criteria. Participants were randomly assigned to propranolol (N = 32) or no treatment (N = 38) for an average duration of 9.3 years in the control group and 10.7 years in the treatment group. The initial dose of propranolol was 10 mg four times daily and the optimal dose was reached when the heart rate remained below 100 beats per minute during exercise or the systolic time interval increased by 30%. The mean (± standard error (SE)) optimal dose of propranolol was 212 ± 68 mg given in four divided doses daily.\nBeta-blocker therapy did not reduce the incidence of all-cause mortality (RR 0.24, 95% CI 0.01 to 4.75; participants = 70; low-quality evidence). Mortality attributed to Marfan syndrome was not reported. Non-fatal serious adverse events were also not reported. However, study authors report on pre-defined, non-fatal clinical endpoints, which include aortic dissection, aortic regurgitation, cardiovascular surgery and congestive heart failure. Their analysis showed no difference between the treatment and control groups in these outcomes (RR 0.79, 95% CI 0.37 to 1.69; participants = 70; low-quality evidence).\nBeta-blocker therapy did not reduce the incidence of aortic dissection (RR 0.59, 95% CI 0.12 to 3.03), aortic regurgitation (RR 1.19, 95% CI 0.18 to 7.96), congestive heart failure (RR 1.19, 95% CI 0.18 to 7.96) or cardiovascular surgery, (RR 0.59, 95% CI 0.12 to 3.03); participants = 70; low-quality evidence.\nThe study reports a reduced rate of aortic dilatation measured by M-mode echocardiography in the treatment group (aortic ratio mean slope: 0.084 (control) vs 0.023 (treatment), P < 0.001). The change in systolic and diastolic blood pressure, total adverse events and withdrawal due to adverse events were not reported in the treatment or control group at study end point.\nWe judged this study to be at high risk of selection (allocation concealment) bias, performance bias, detection bias, attrition bias and selective reporting bias. The overall quality of evidence was low. We do not know whether a statistically significant reduced rate of aortic dilatation translates into clinical benefit in terms of aortic dissection or mortality.\nAuthors' conclusions\nBased on only one, low-quality RCT comparing long-term propranolol to no treatment in people with Marfan syndrome, we could draw no definitive conclusions for clinical practice. High-quality, randomised trials are needed to evaluate the long-term efficacy of beta-blocker treatment in people with Marfan syndrome. Future trials should report on all clinically relevant end points and adverse events to evaluate benefit versus harm of therapy.\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": "Marfan syndrome is a hereditary disorder affecting multiple systems in the body. Enlargement of the aorta (the largest blood vessel that carries blood out of the heart) is one of the most common and important features of this disease. It can lead to life-threatening problems, such as aortic dissection, which is a tear in the inner walls of the aorta causing blood to escape into the layers of the aortic wall, accumulate and potentially rupture.\nBeta-blockers, a group of drugs used to decrease blood pressure, have been recommended by guidelines as the first line medical treatment of Marfan syndrome. The exact mechanism of action of beta-blockers in Marfan syndrome is not known."
}
] |
query-laysum
|
8616
|
[
{
"role": "user",
"content": "Abstract: Background\nAngiostrongylus cantonensis (A. cantonensis) is the major cause of infectious eosinophilic meningitis. Dead larvae of this parasite cause inflammation and exacerbate symptoms of meningitis. Corticosteroids are drugs used to reduce the inflammation caused by this parasite.\nObjectives\nTo assess the efficacy and safety of corticosteroids for the treatment of eosinophilic meningitis.\nSearch methods\nWe searched CENTRAL (2014, Issue 11), MEDLINE (1950 to November Week 3, 2014), EMBASE (1974 to December 2014), Scopus (1960 to December 2014), Web of Science (1955 to December 2014), LILACS (1982 to December 2014) and CINAHL (1981 to December 2014).\nSelection criteria\nRandomised controlled trials (RCTs) of corticosteroids versus placebo for eosinophilic meningitis.\nData collection and analysis\nTwo review authors (SiT, SaT) independently collected and extracted study data. We graded the methodological quality of the RCTs. We identified and analysed outcomes and adverse effects.\nMain results\nWe did not identifiy any new trials for inclusion or exclusion in this 2014 update. One study involving 110 participants (55 participants in each group) met our inclusion criteria. The corticosteroid (prednisolone) showed a benefit in shortening the median time to resolution of headaches (five days in the treatment group versus 13 days in the control group, P value < 0.0001). Corticosteroids were also associated with smaller numbers of participants who still had headaches after a two-week course of treatment (9.1% versus 45.5%, P value < 0.0001). The number of patients who needed repeat lumbar puncture was also smaller in the treatment group (12.7% versus 40%, P value = 0.002). There was a reduction in the median time of analgesic use in participants receiving corticosteroids (10.5 versus 25.0, P value = 0.038). There were no reported adverse effects from prednisolone in the treatment group.\nAuthors' conclusions\nCorticosteroids significantly help relieve headache in patients with eosinophilic meningitis, who have a pain score of four or more on a visual analogue scale. However, there is only one RCT supporting this benefit and this trial did not clearly mention allocation concealment and stratification. Therefore, we agreed to grade our included study as a moderate quality trial. Future well-designed RCTs are necessary.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The included study showed that the median time to resolution of headaches was lower in the group treated with prednisolone (10.5 days versus 25 days) and the number of patients who still had headaches after 14 days was lower in the prednisolone group compared to the control (9.1% versus 45.5%). There were statistically significant differences, which favoured the treatment group, in other outcomes including the frequency of acetaminophen (paracetamol) use (median of number of times used) amongst those who still had headaches after 14 days of prednisolone treatment and the mean time until complete disappearance of headache. The number of patients who needed repeat lumbar puncture was also smaller in the treatment group. There were no reported adverse effects from prednisolone in the treatment group. Corticosteroids significantly help relieve headache in patients with eosinophilic meningitis, who have a pain score of four or more on a visual analogue scale."
}
] |
query-laysum
|
8617
|
[
{
"role": "user",
"content": "Abstract: Background\nOcrelizumab is a humanised anti-CD20 monoclonal antibody developed for the treatment of multiple sclerosis (MS). It was approved by the Food and Drug Administration (FDA) in March 2017 for using in adults with relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). Ocrelizumab is the only disease-modifying therapy (DMT) approved for PPMS. In November 2017, the European Medicines Agency (EMA) also approved ocrelizumab as the first drug for people with early PPMS. Therefore, it is important to evaluate the benefits, harms, and tolerability of ocrelizumab in people with MS.\nObjectives\nTo assess the benefits, harms, and tolerability of ocrelizumab in people with RRMS and PPMS.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL, and two trials registers on 8 October 2021. We screened reference lists, contacted experts, and contacted the main authors of studies.\nSelection criteria\nAll randomised controlled trials (RCTs) involving adults diagnosed with RRMS or PPMS according to the McDonald criteria, comparing ocrelizumab alone or associated with other medications, at the approved dose of 600 mg every 24 weeks for any duration, versus placebo or any other active drug therapy.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nFour RCTs met our selection criteria. The overall population included 2551 participants; 1370 treated with ocrelizumab 600 mg and 1181 controls. Among the controls, 298 participants received placebo and 883 received interferon beta-1a. The treatment duration was 24 weeks in one study, 96 weeks in two studies, and at least 120 weeks in one study. One study was at high risk of allocation concealment and blinding of participants and personnel; all four studies were at high risk of bias for incomplete outcome data.\nFor RRMS, compared with interferon beta-1a, ocrelizumab was associated with: 1. lower relapse rate (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.52 to 0.73; 2 studies, 1656 participants; moderate-certainty evidence); 2. a lower number of participants with disability progression (hazard ratio (HR) 0.60, 95% CI 0.43 to 0.84; 2 studies, 1656 participants; low-certainty evidence); 3. little to no difference in the number of participants with any adverse event (RR 1.00, 95% CI 0.96 to 1.04; 2 studies, 1651 participants; moderate-certainty evidence); 4. little to no difference in the number of participants with any serious adverse event (RR 0.79, 95% CI 0.57 to 1.11; 2 studies, 1651 participants; low-certainty evidence); 5. a lower number of participants experiencing treatment discontinuation caused by adverse events (RR 0.58, 95% CI 0.37 to 0.91; 2 studies, 1651 participants; low-certainty evidence); 6. a lower number of participants with gadolinium-enhancing T1 lesions on magnetic resonance imaging (MRI) (RR 0.27, 95% CI 0.22 to 0.35; 2 studies, 1656 participants; low-certainty evidence); 7. a lower number of participants with new or enlarging T2-hyperintense lesions on MRI (RR 0.63, 95% CI 0.57 to 0.69; 2 studies, 1656 participants; low-certainty evidence) at 96 weeks.\nFor PPMS, compared with placebo, ocrelizumab was associated with: 1. a lower number of participants with disability progression (HR 0.75, 95% CI 0.58 to 0.98; 1 study, 731 participants; low-certainty evidence); 2. a higher number of participants with any adverse events (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 725 participants; moderate-certainty evidence); 3. little to no difference in the number of participants with any serious adverse event (RR 0.92, 95% CI 0.68 to 1.23; 1 study, 725 participants; low-certainty evidence); 4. little to no difference in the number of participants experiencing treatment discontinuation caused by adverse events (RR 1.23, 95% CI 0.55 to 2.75; 1 study, 725 participants; low-certainty evidence) for at least 120 weeks. There were no data for number of participants with gadolinium-enhancing T1 lesions on MRI and number of participants with new or enlarging T2-hyperintense lesions on MRI.\nAuthors' conclusions\nFor people with RRMS, ocrelizumab probably results in a large reduction in relapse rate and little to no difference in adverse events when compared with interferon beta-1a at 96 weeks (moderate-certainty evidence). Ocrelizumab may result in a large reduction in disability progression, treatment discontinuation caused by adverse events, number of participants with gadolinium-enhancing T1 lesions on MRI, and number of participants with new or enlarging T2-hyperintense lesions on MRI, and may result in little to no difference in serious adverse events (low-certainty evidence).\nFor people with PPMS, ocrelizumab probably results in a higher rate of adverse events when compared with placebo for at least 120 weeks (moderate-certainty evidence). Ocrelizumab may result in a reduction in disability progression and little to no difference in serious adverse events and treatment discontinuation caused by adverse events (low-certainty evidence).\nOcrelizumab was well tolerated clinically; the most common adverse events were infusion-related reactions and nasopharyngitis, and urinary tract and upper respiratory tract infections.\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 that compared ocrelizumab against any other medicine or placebo for people with a confirmed diagnosis of relapsing-remitting MS or primary progressive MS. People in the studies could be any age or sex, could have mild or severe symptoms, and could have had MS for any length of time.\nWe compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
] |
query-laysum
|
8618
|
[
{
"role": "user",
"content": "Abstract: Background\nHepatocellular carcinoma (HCC) occurs mostly in people with chronic liver disease and ranks sixth in terms of global instances of cancer, and fourth in terms of cancer deaths for men. Despite that abdominal ultrasound (US) is used as an initial test to exclude the presence of focal liver lesions and serum alpha-foetoprotein (AFP) measurement may raise suspicion of HCC occurrence, further testing to confirm diagnosis as well as staging of HCC is required. Current guidelines recommend surveillance programme using US, with or without AFP, to detect HCC in high-risk populations despite the lack of clear benefits on overall survival. Assessing the diagnostic accuracy of US and AFP may clarify whether the absence of benefit in surveillance programmes could be related to under-diagnosis. Therefore, assessment of the accuracy of these two tests for diagnosing HCC in people with chronic liver disease, not included in surveillance programmes, is needed.\nObjectives\nPrimary: the diagnostic accuracy of US and AFP, alone or in combination, for the diagnosis of HCC of any size and at any stage in adults with chronic liver disease, either in a surveillance programme or in a clinical setting.\nSecondary: to assess the diagnostic accuracy of abdominal US and AFP, alone or in combination, for the diagnosis of resectable HCC; to compare the diagnostic accuracy of the individual tests versus the combination of both tests; to investigate sources of heterogeneity in the results.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Hepato-Biliary Group Diagnostic-Test-Accuracy Studies Register, Cochrane Library, MEDLINE, Embase, LILACS, Science Citation Index Expanded, until 5 June 2020. We applied no language or document-type restrictions.\nSelection criteria\nStudies assessing the diagnostic accuracy of US and AFP, independently or in combination, for the diagnosis of HCC in adults with chronic liver disease, with cross-sectional and case-control designs, using one of the acceptable reference standards, such as pathology of the explanted liver, histology of resected or biopsied focal liver lesion, or typical characteristics on computed tomography, or magnetic resonance imaging, all with a six-months follow-up.\nData collection and analysis\nWe independently screened studies, extracted data, and assessed the risk of bias and applicability concerns, using the QUADAS-2 checklist. We presented the results of sensitivity and specificity, using paired forest-plots, and tabulated the results. We used a hierarchical meta-analysis model where appropriate. We presented uncertainty of the accuracy estimates using 95% confidence intervals (CIs). We double-checked all data extractions and analyses.\nMain results\nWe included 373 studies. The index-test was AFP (326 studies, 144,570 participants); US (39 studies, 18,792 participants); and a combination of AFP and US (eight studies, 5454 participants).\nWe judged at high-risk of bias all but one study. Most studies used different reference standards, often inappropriate to exclude the presence of the target condition, and the time-interval between the index test and the reference standard was rarely defined. Most studies with AFP had a case-control design. We also had major concerns for the applicability due to the characteristics of the participants.\nAs the primary studies with AFP used different cut-offs, we performed a meta-analysis using the hierarchical-summary-receiver-operating-characteristic model, then we carried out two meta-analyses including only studies reporting the most used cut-offs: around 20 ng/mL or 200 ng/mL.\nAFP cut-off 20 ng/mL: for HCC (147 studies) sensitivity 60% (95% CI 58% to 62%), specificity 84% (95% CI 82% to 86%); for resectable HCC (six studies) sensitivity 65% (95% CI 62% to 68%), specificity 80% (95% CI 59% to 91%).\nAFP cut-off 200 ng/mL: for HCC (56 studies) sensitivity 36% (95% CI 31% to 41%), specificity 99% (95% CI 98% to 99%); for resectable HCC (two studies) one with sensitivity 4% (95% CI 0% to 19%), specificity 100% (95% CI 96% to 100%), and one with sensitivity 8% (95% CI 3% to 18%), specificity 100% (95% CI 97% to 100%).\nUS: for HCC (39 studies) sensitivity 72% (95% CI 63% to 79%), specificity 94% (95% CI 91% to 96%); for resectable HCC (seven studies) sensitivity 53% (95% CI 38% to 67%), specificity 96% (95% CI 94% to 97%).\nCombination of AFP (cut-off of 20 ng/mL) and US: for HCC (six studies) sensitivity 96% (95% CI 88% to 98%), specificity 85% (95% CI 73% to 93%); for resectable HCC (two studies) one with sensitivity 89% (95% CI 73% to 97%), specificity of 83% (95% CI 76% to 88%), and one with sensitivity 79% (95% CI 54% to 94%), specificity 87% (95% CI 79% to 94%).\nThe observed heterogeneity in the results remains mostly unexplained, and only in part referable to different cut-offs or settings (surveillance programme compared to clinical series). The sensitivity analyses, excluding studies published as abstracts, or with case-control design, showed no variation in the results.\nWe compared the accuracy obtained from studies with AFP (cut-off around 20 ng/mL) and US: a direct comparison in 11 studies (6674 participants) showed a higher sensitivity of US (81%, 95% CI 66% to 90%) versus AFP (64%, 95% CI 56% to 71%) with similar specificity: US 92% (95% CI 83% to 97%) versus AFP 89% (95% CI 79% to 94%). A direct comparison of six studies (5044 participants) showed a higher sensitivity (96%, 95% CI 88% to 98%) of the combination of AFP and US versus US (76%, 95% CI 56% to 89%) with similar specificity: AFP and US 85% (95% CI 73% to 92%) versus US 93% (95% CI 80% to 98%).\nAuthors' conclusions\nIn the clinical pathway for the diagnosis of HCC in adults, AFP and US, singularly or in combination, have the role of triage-tests. We found that using AFP, with 20 ng/mL as a cut-off, about 40% of HCC occurrences would be missed, and with US alone, more than a quarter. The combination of the two tests showed the highest sensitivity and less than 5% of HCC occurrences would be missed with about 15% of false-positive results. The uncertainty resulting from the poor study quality and the heterogeneity of included studies limit our ability to confidently draw conclusions based on our results.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "All but one study had issues with risk of bias, especially in participants selection and in the correct definition on presence of HCC. These problems could impair the correct estimates of the diagnostic ability of the three tests."
}
] |
query-laysum
|
8619
|
[
{
"role": "user",
"content": "Abstract: Background\nA consumer model of health supports that people undergoing elective surgery should be informed about the past operative performance of their surgeon before making two important decisions: 1. to consent to the proposed surgery, and 2. to have a particular doctor perform the surgery. This information arguably helps empower patients to participate in their care. While surgeons' performance data are available in some settings, there continues to be controversy over the provision of such data to patients, and the question of whether consumers should, or want to, be provided with this information.\nObjectives\nTo assess the effects of providing a surgeon's performance data to people considering elective surgery on patient-based and service utilisation outcomes.\nSearch methods\nFor the original review, we searched: the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2009, Issue 4); MEDLINE (Ovid) (1950 to 28 September 2009); EMBASE (Ovid) (1988 to 28 September 2009); PsycINFO (Ovid) (1806 to 28 September 2009); CINAHL (EBSCO) (1982 to 20 October 2009); Current Contents (Ovid) (1992 to 23 November 2009); and ProQuest Dissertations and Theses (1861 to 20 October 2009).\nFor this update, we searched: CENTRAL (2009 to 3 March 2014); MEDLINE (Ovid) (2009 to 3 March 2014); EMBASE (Ovid) (2009 to 3 March 2014); PsycINFO (Ovid) (2009 to 9 March 2014); CINAHL (EBSCO) (2009 to 9 March 2014), Current Contents (Web of Science) (November 2009 to 21 March 2014), and ProQuest Dissertations and Theses (2009 to 21 March 2014). We applied no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs), cluster RCTs, quasi-RCTs and controlled before and after studies (CBAs), in which an individual surgeon's performance data were provided to people considering elective surgery. We considered the CBAs for inclusion from 2009 onwards.\nData collection and analysis\nTwo review authors (AH, SH) independently assessed all titles, abstracts, or both of retrieved citations. We identified no studies for inclusion. Consequently, we conducted no data collection or analysis.\nMain results\nWe found no studies that met the inclusion criteria; therefore, there are no results to report on the effect of the provision of a surgeon's performance data for people considering elective surgery.\nAuthors' conclusions\nWe found no studies reporting the impact of the provision of a surgeon's performance data for people considering elective surgery. This is an important finding in itself. While the public reporting of a surgeon's performance is not a new concept, the efficacy of this data for individual patients has not been empirically tested. A review of qualitative studies or new primary qualitative research may be useful to determine what interventions are currently in use and explore the attitudes of consumers and professionals towards such interventions.\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": "Measuring the performance of surgeons is generally thought to be a good practice that will result in better surgical results. Providing information about the performance of individual surgeons is more controversial and it is not clear what effect giving consumers this information might have. We wanted to discover whether there was any evidence about the effect of making data about a surgeon's performance available to people who are thinking about having elective surgery, compared with people making similar decisions without this information."
}
] |
query-laysum
|
8620
|
[
{
"role": "user",
"content": "Abstract: Background\nDysvascularity accounts for 75% of all lower limb amputations in the UK. Around 37% of these procedures are done at the transfemoral level (mid-thigh), with most patients over the age of 60 and having existing comorbidities. A significant number of these amputees are prescribed a lower limb prosthesis for walking. However, many amputees do not achieve a high level of function following prosthetic rehabilitation. This is the third update of the review first published in 2005.\nObjectives\nTo identify and summarise the evidence evaluating prosthetic rehabilitation interventions for prosthetic ambulation following unilateral transfemoral or transgenicular amputation in older dysvascular people, whether community dwelling or institutionalised.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register and CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials registry to 14 June 2018. We performed additional searches by handsearching citations of studies identified by the electronic search. We applied no restrictions on language or publication status.\nSelection criteria\nRandomised and quasi-randomised controlled trials testing prosthetic rehabilitation interventions following a unilateral transfemoral or transgenicular amputation in older (aged 60 years or older) dysvascular people.\nData collection and analysis\nTwo review authors independently scanned the search results for potentially eligible studies and, on obtaining full reports of these, selected studies for inclusion and exclusion. Two review authors independently assessed the methodological quality of studies and extracted data. We used GRADE to assess the overall quality of evidence supporting the outcomes assessed in this review.\nMain results\nWe identified no new studies for inclusion in this update. In total we included one trial, excluded 18 trials, classed one trial as ongoing, and classed another as awaiting classification. The total number of participants in the included trial was 10, and the methodological quality of this trial was moderate because of high risk of bias in relation to two domains (random sequence generation and allocation concealment) but low risk of bias for the four remaining domains (blinding, incomplete outcome data, selective reporting, and any other bias). The included trial was a short-term cross-over randomised trial undertaken in Canada, which tested the effects of adding three seemingly identical prosthetic weights (150 g vs 770 g vs 1625 g) to the prostheses of a total of 10 participants with unilateral dysvascular transfemoral amputation. Eight participants were over 60 years of age. Trial authors found that four participants preferred the addition of the lightest weight (150 g), five preferred the middle weight (770 g), and one preferred the heaviest weight (1625 g). Researchers interpreted this as equating to user satisfaction (success) and reported no adverse effects.\nAuthors' conclusions\nThe limited evidence presented in this review is of very low quality and is insufficient to inform the choice of prosthetic rehabilitation, including the optimum weight of the prosthesis, after unilateral transfemoral amputation in older dysvascular people. A programme of research that includes randomised controlled trials to examine key interventions is urgently required in this area.\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": "Problems with inadequate circulation in the legs (dysvascularity), particularly in people over the age of 60 years, can be so severe that they need a leg amputated. This may occur as high as at or above the knee. Accompanying medical conditions (comorbidities) such as diabetes and cardiovascular or heart disease can affect a person's rehabilitation. When an above- or through-knee artificial limb (prosthesis) is fitted, it is hard for the person to regain mobility and function, and some people choose to use a wheelchair. Motivation, comfort, cosmetic appearance, functionality, reliability, ease of use, previous mobility, and the extra exertion needed to use an artificial leg are all important factors that can affect a person's independence and use of the prosthesis. Fear of falling, number of falls, social circumstances, and help and support from other people are also important influences. The review authors searched for trials comparing different types of rehabilitation that may benefit mobility or function in older people using an artificial limb."
}
] |
query-laysum
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8621
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic heart failure is one of the most common medical conditions, affecting more than 23 million people worldwide. Despite established guideline-based, multidrug pharmacotherapy, chronic heart failure is still the cause of frequent hospitalisation, and about 50% die within five years of diagnosis.\nObjectives\nTo assess the effectiveness and safety of ivabradine in individuals with chronic heart failure.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and CPCI-S Web of Science in March 2020. We also searched ClinicalTrials.gov and the WHO ICTRP. We checked reference lists of included studies. We did not apply any time or language restrictions.\nSelection criteria\nWe included randomised controlled trials in which adult participants diagnosed with chronic heart failure were randomly assigned to receive either ivabradine or placebo/usual care/no treatment. We distinguished between type of heart failure (heart failure with a reduced ejection fraction or heart failure with a preserved ejection fraction) as well as between duration of ivabradine treatment (short term (< 6 months) or long term (≥ 6 months)).\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted data, and checked data for accuracy. We calculated risk ratios (RR) using a random-effects model. We completed a comprehensive ’Risk of bias’ assessment for all studies. We contacted authors for missing data. Our primary endpoints were: mortality from cardiovascular causes; quality of life; time to first hospitalisation for heart failure during follow-up; and number of days spent in hospital due to heart failure during follow-up. Our secondary endpoints were: rate of serious adverse events; exercise capacity; and economic costs (narrative report). We assessed the certainty of the evidence applying the GRADE methodology.\nMain results\nWe included 19 studies (76 reports) involving a total of 19,628 participants (mean age 60.76 years, 69% male). However, few studies contributed data to meta-analyses due to inconsistency in trial design (type of heart failure) and outcome reporting and measurement. In general, risk of bias varied from low to high across the included studies, with insufficient detail provided to inform judgement in several cases.\nWe were able to perform two meta-analyses focusing on participants with heart failure with a reduced ejection fraction (HFrEF) and long-term ivabradine treatment. There was evidence of no difference between ivabradine and placebo/usual care/no treatment for mortality from cardiovascular causes (RR 0.99, 95% confidence interval (CI) 0.88 to 1.11; 3 studies; 17,676 participants; I2 = 33%; moderate-certainty evidence). Furthermore, we found evidence of no difference in rate of serious adverse events amongst HFrEF participants randomised to receive long-term ivabradine compared with those randomised to placebo, usual care, or no treatment (RR 0.96, 95% CI 0.92 to 1.00; 2 studies; 17,399 participants; I2 = 12%; moderate-certainty evidence). We were not able to perform meta-analysis for all other outcomes, and have low confidence in the findings based on the individual studies.\nAuthors' conclusions\nWe found evidence of no difference in cardiovascular mortality and serious adverse events between long-term treatment with ivabradine and placebo/usual care/no treatment in participants with heart failure with HFrEF. Nevertheless, due to indirectness (male predominance), the certainty of the available evidence is rated as moderate.\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": "We investigated the effects of ivabradine (either as short-term treatment (< 6 months) or long-term treatment (≥ 6 months) in people with heart failure and preserved (HFpEF, left ventricular ejection fraction is 50% or higher) or reduced ejection fraction (HFrEF, left ventricular ejection fraction is less than 40%)."
}
] |
query-laysum
|
8622
|
[
{
"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: \"Tofacitinib + MTX versus MTX\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "there was no difference in withdrawals due to adverse events between people on tofacitinib + MTX and people on MTX/DMARD, both with 5 participants out of 100, based on one study."
}
] |
query-laysum
|
8623
|
[
{
"role": "user",
"content": "Abstract: Background\nVascular cognitive impairment (VCI) describes a broad spectrum of cognitive impairments caused by cerebrovascular disease, ranging from mild cognitive impairment to dementia. There are currently no pharmacological treatments recommended for improving either cognition or function in people with VCI. Three cholinesterase inhibitors (donepezil, galantamine, and rivastigmine) are licenced for the treatment of dementia due to Alzheimer's disease. They are thought to work by compensating for reduced cholinergic neurotransmission, which is also a feature of VCI. Through pairwise comparisons with placebo and a network meta-analysis, we sought to determine whether these medications are effective in VCI and whether there are differences between them with regard to efficacy or adverse events.\nObjectives\n(1) To assess the efficacy and safety of cholinesterase inhibitors in the treatment of adults with vascular dementia and other VCI.\n(2) To compare the effects of different cholinesterase inhibitors on cognition and adverse events, using network meta-analysis.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 19 August 2020.\nSelection criteria\nWe included randomised controlled trials in which donepezil, galantamine, or rivastigmine was compared with placebo or in which the drugs were compared with each other in adults with vascular dementia or other VCI (excluding cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL)). We included all drug doses and routes of administration.\nData collection and analysis\nTwo review authors independently identified eligible trials, extracted data, assessed risk of bias, and applied the GRADE approach to assess the certainty of the evidence. The primary outcomes were cognition, clinical global impression, function (performance of activities of daily living), and adverse events. Secondary outcomes were serious adverse events, incidence of development of new dementia, behavioural disturbance, carer burden, institutionalisation, quality of life and death. For the pairwise analyses, we pooled outcome data at similar time points using random-effects methods. We also performed a network meta-analysis using Bayesian methods.\nMain results\nWe included eight trials (4373 participants) in the review. Three trials studied donepezil 5 mg or 10 mg daily (n= 2193); three trials studied rivastigmine at a maximum daily dose of 3 to 12 mg (n= 800); and two trials studied galantamine at a maximum daily dose of 16 to 24 mg (n= 1380). The trials included participants with possible or probable vascular dementia or cognitive impairment following stroke. Mean ages were between 72.2 and 73.9 years. All of the trials were at low or unclear risk of bias in all domains, and the evidence ranged from very low to high level of certainty.\nFor cognition, the results showed that donepezil 5 mg improves cognition slightly, although the size of the effect is unlikely to be clinically important (mean difference (MD) −0.92 Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) points (range 0 to 70), 95% confidence interval (CI) −1.44 to −0.40; high-certainty evidence). Donepezil 10 mg (MD −2.21 ADAS-Cog points, 95% CI −3.07 to −1.35; moderate-certainty evidence) and galantamine 16 to 24 mg (MD −2.01 ADAS-Cog point, 95%CI −3.18 to −0.85; moderate-certainty evidence) probably also improve cognition, although the larger effect estimates still may not be clinically important. With low certainty, there may be little to no effect of rivastigmine 3 to 12 mg daily on cognition (MD 0.03 ADAS-Cog points, 95% CI −3.04 to 3.10; low-certainty evidence).\nAdverse events reported in the studies included nausea and/or vomiting, diarrhoea, dizziness, headache, and hypertension. The results showed that there was probably little to no difference between donepezil 5 mg and placebo in the number of adverse events (odds ratio (OR) 1.22, 95% CI 0.94 to 1.58; moderate-certainty evidence), but there were slightly more adverse events with donepezil 10 mg than with placebo (OR 1.95, 95% CI 1.20 to 3.15; high-certainty evidence). The effect of rivastigmine 3 to 12 mg on adverse events was very uncertain (OR 3.21, 95% CI 0.36 to 28.88; very low-certainty evidence). Galantamine 16 to 24 mg is probably associated with a slight excess of adverse events over placebo (OR 1.57, 95% CI 1.02 to 2.43; moderate-certainty evidence).\nIn the network meta-analysis (NMA), we included cognition to represent benefit, and adverse events to represent harm. All drugs ranked above placebo for cognition and below placebo for adverse events. We found donepezil 10 mg to rank first in terms of benefit, but third in terms of harms, when considering the network estimates and quality of evidence. Galantamine was ranked second in terms of both benefit and harm. Rivastigmine had the lowest ranking of the cholinesterase inhibitors in both benefit and harm NMA estimates, but this may reflect possibly inadequate doses received by some trial participants and small trial sample sizes.\nAuthors' conclusions\nWe found moderate- to high-certainty evidence that donepezil 5 mg, donepezil 10 mg, and galantamine have a slight beneficial effect on cognition in people with VCI, although the size of the change is unlikely to be clinically important. Donepezil 10 mg and galantamine 16 to 24 mg are probably associated with more adverse events than placebo. The evidence for rivastigmine was less certain.\nThe data suggest that donepezil 10 mg has the greatest effect on cognition, but at the cost of adverse effects. The effect is modest, but in the absence of any other treatments, people living with VCI may still wish to consider the use of these agents. Further research into rivastigmine is needed, including the use of transdermal patches.\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": ""
}
] |
query-laysum
|
8624
|
[
{
"role": "user",
"content": "Abstract: Background\nMotion sickness is a syndrome that occurs as a result of passive body movement in response to actual motion, or the illusion of motion when exposed to virtual and moving visual environments. The most common symptoms are nausea and vomiting. Antihistamines have been used in the management of motion sickness for decades, however studies have shown conflicting results regarding their efficacy.\nObjectives\nTo assess the effectiveness of antihistamines in the prevention and treatment of motion sickness in adults and children.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 December 2021.\nSelection criteria\nRandomised controlled trials (RCTs) in susceptible adults and children in whom motion sickness was induced under natural conditions such as air, sea and land transportation. We also included studies in which motion sickness was induced under experimental conditions (analysed separately). Antihistamines were included regardless of class, route or dosage and compared to no treatment, placebo or any other pharmacological or non-pharmacological interventions.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1) the proportion of susceptible participants who did not experience any motion sickness symptoms; 2) the proportion of susceptible participants who experienced a reduction or resolution of existing symptoms. Secondary outcomes were 1) physiological measures (heart rate, core temperature and gastric tachyarrhythmia (electrogastrography)) and 2) adverse effects (sedation, impaired cognition, blurred vision). We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included nine RCTs (658 participants). Studies were conducted across seven countries, with an overall age range of 16 to 55 years. Motion sickness was induced naturally in six studies and experimentally in four studies (rotating chair). All the naturally induced studies only evaluated first-generation antihistamines (cinnarizine and dimenhydrinate). Risk of bias across the studies varied, with mostly low risk for random sequence generation and allocation concealment, and mostly high risk for selective reporting. Only the experimentally induced studies measured physiological parameters and only the naturally induced studies evaluated adverse effects. There were no studies that clearly assessed the paediatric population.\nAntihistamines versus placebo or no treatment\nAntihistamines are probably more effective than placebo at preventing motion sickness symptoms under natural conditions (symptoms prevented: 25% placebo; 40% antihistamines) (risk ratio (RR) 1.81, 95% confidence interval (CI) 1.23 to 2.66; 3 studies; 240 participants) (moderate-certainty). The evidence is very uncertain about the effect of antihistamines on preventing motion sickness under experimental conditions (standardised mean difference (SMD) 0.32, 95% CI -0.18 to 0.83; 2 studies; 62 participants) (very low-certainty). No studies reported results on the resolution of existing motion sickness symptoms.\nAntihistamines may result in little or no difference in gastric tachyarrhythmia under experimental conditions (mean difference (MD) -2.2, 95% CI -11.71 to 7.31; 1 study; 42 participants) (low-certainty). No studies reported results for any other physiological measures. When compared to placebo, antihistamines may be more likely to cause sedation (sedation: 44% placebo; 66% antihistamines) (RR 1.51, 95% CI 1.12 to 2.02; 2 studies; 190 participants) (low-certainty); they may result in little or no difference in blurred vision (blurred vision: 12.5% placebo; 14% antihistamines) (RR 1.14, 95% CI 0.53 to 2.48; 2 studies; 190 participants) (low-certainty); and they may result in little or no difference in terms of impaired cognition (impaired cognition: 33% placebo; 29% antihistamines) (RR 0.89, 95% CI 0.58 to 1.38; 2 studies; 190 participants) (low-certainty).\nAntihistamines versus scopolamine\nThe evidence is very uncertain about the effect of antihistamines on preventing motion sickness under natural conditions when compared to scopolamine (symptoms prevented: 81% scopolamine; 71% antihistamines) (RR 0.89, 95% CI 0.68 to 1.16; 2 studies; 71 participants) (very low-certainty). No studies were performed under experimental conditions. No studies reported results on the resolution of existing motion sickness symptoms.\nThe evidence is very uncertain about the effect of antihistamines on heart rate under natural conditions (narrative report, 1 study; 20 participants; \"No difference in pulse frequency\"; very low-certainty). No studies reported results for any other physiological measures. When compared to scopolamine, the evidence is very uncertain about the effect of antihistamines on sedation (sedation: 21% scopolamine; 30% antihistamines) (RR 0.82, 95% CI 0.07 to 9.25; 2 studies; 90 participants) (very low-certainty) and on blurred vision (narrative report: not a significant difference; 1 study; 51 participants; very low-certainty). No studies evaluated impaired cognition.\nAntihistamines versus antiemetics\nAntihistamines may result in little or no difference in the prevention of motion sickness under experimental conditions (MD -0.20, 95% CI -10.91 to 10.51; 1 study; 42 participants) (low-certainty). The evidence is of low certainty due to imprecision as the sample size is small and the confidence interval crosses the line of no effect. No studies assessed the effects of antihistamines versus antiemetics under natural conditions. No studies reported results on the resolution of existing motion sickness symptoms.\nAntihistamines may result in little or no difference in gastric tachyarrhythmia (MD 4.56, 95% CI -3.49 to 12.61; 1 study; 42 participants) (low-certainty). No studies reported results for any other physiological measures. No studies evaluated sedation, impaired cognition or blurred vision.\nOne study reported physiological data for this outcome, evaluating gastric tachyarrhythmia specifically. Antihistamines may result in little or no difference in gastric tachyarrhythmia (MD 4.56, 95% CI -3.49 to 12.61; 1 study; 42 participants; low-certainty evidence). This evidence is of low certainty due to imprecision as the sample size is small and the confidence interval crosses the line of no effect.\nAntihistamines versus acupuncture\nThe evidence is very uncertain about the effects of antihistamines on the prevention of motion sickness under experimental conditions when compared to acupuncture (RR 1.32, 95% CI 1.12 to 1.57; 1 study; 100 participants) (very low-certainty). This study did not assess the prevention of motion sickness under natural conditions, nor the resolution of existing motion sickness symptoms. There was no study performed under natural conditions.\nPhysiological measures and adverse effects were not reported.\nAuthors' conclusions\nThere is probably a reduction in the risk of developing motion sickness symptoms under naturally occurring conditions of motion when using first-generation antihistamines, in motion sickness-susceptible adults, compared to placebo. Antihistamines may be more likely to cause sedation when compared to placebo. No studies evaluated the treatment of existing motion sickness, and there are few data on the effect of antihistamines in children. The evidence for all other outcomes and comparisons (versus scopolamine, antiemetics and acupuncture) was of low or very low certainty and we are therefore uncertain about these effects of antihistamines.\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": "We looked at studies where people who are known to get motion sickness are given treatment with either an antihistamine or with a placebo (dummy treatment). We also looked at those that have been given an antihistamines compared with other medicines or other types of non-drug therapy."
}
] |
query-laysum
|
8625
|
[
{
"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: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Heavy menstrual bleeding and cramping are the most common reasons why women stop using an intrauterine device (IUD) for birth control. We reviewed studies to find out whether pain relief or other medicines, or other methods could reduce bleeding and pain related to IUD use."
}
] |
query-laysum
|
8626
|
[
{
"role": "user",
"content": "Abstract: Background\nSchool tobacco policies (STPs) might prove to be a promising strategy to prevent smoking initiation among adolescents, as there is evidence that the school environment can influence young people to smoke. STPs are cheap, relatively easy to implement and have a wide reach, but it is not clear whether this approach is effective in preventing smoking uptake.\nObjectives\nTo assess the effectiveness of policies aiming to prevent smoking initiation among students by regulating smoking in schools.\nSearch methods\nWe searched seven electronic bibliographic databases, including the Cochrane Tobacco Addiction Group specialized register, MEDLINE, EMBASE, PsycINFO and ERIC. We also searched the grey literature and ongoing trials resources. The most recent search was performed in May 2014.\nSelection criteria\nWe included cluster-randomised controlled trials (c-RCTs) in which primary and secondary schools were randomised to receive different levels of smoking policy or no intervention. Non-randomised controlled trials, interrupted time series and controlled before-after studies would also have been eligible. Cross-sectional studies were not formally included but we describe their findings and use them to generate hypotheses to inform future research.\nData collection and analysis\nWe independently assessed studies for inclusion in the review, and present a narrative synthesis, as the studies are too limited in quality to undertake a formal meta-analysis.\nMain results\nWe found only one study which was eligible for inclusion in the review. It was judged to be at high risk of bias. The study compared two 'middle schools' from two different regions in China. The experimental conditions included the introduction of a tobacco policy, environmental changes, and communication activities, while the control condition was no intervention. After a year's follow-up the study found no differences in smoking prevalence between intervention and control schools. We also described 24 observational studies, the results of which we considered for hypothesis generation. In these, policy exposure was mainly described using face-to-face interviews with school staff members, and the outcome evaluation was performed using self-administered questionnaires. Most studies reported no differences in students' smoking prevalence between schools with formal STPs when compared with schools without policies. In the majority of studies in schools with highly enforced policies, smoking bans extended to outdoor spaces, involving teachers and including sanctions for transgressions, with assistance to quit for smokers plus support by prevention programmes, there was no significant difference in smoking prevalence when compared to schools adopting weaker or no policies.\nAuthors' conclusions\nDespite a comprehensive literature search, and rigorous evaluation of studies, we found no evidence to support STPs. The absence of reliable evidence for the effectiveness of STPs is a concern in public health. We need well-designed randomised controlled trials or quasi-experimental studies to evaluate the effectiveness of school tobacco policies.\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": "We reviewed the evidence that School tobacco policies (STPs) might prevent smoking initiation among adolescents, as there may be some evidence that the school environment can influence young people to smoke. STP is intended to regulate whether and where pupils can smoke, adult smoking in school, and penalties for pupils caught smoking. We were also interested to know whether specific components of STPs might increase their impact. Components such as a smoking ban for students and/or teachers and their extent, levels of enforcement, monitoring strategies, sanctions for students or teachers found smoking, and the offer of tobacco cessation programmes."
}
] |
query-laysum
|
8627
|
[
{
"role": "user",
"content": "Abstract: Background\nIncidence of gestational diabetes mellitus (GDM) is increasing worldwide. Blood glucose monitoring plays a crucial part in maintaining glycaemic control in women with GDM and is generally recommended by healthcare professionals. There are several different methods for monitoring blood glucose which can be carried out in different settings (e.g. at home versus in hospital).\nObjectives\nThe objective of this review is to compare the effects of different methods and settings for glucose monitoring for women with GDM on maternal and fetal, neonatal, child and adult outcomes, and use and costs of health care.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 September 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-randomised controlled trials (qRCTs) comparing different methods (such as timings and frequencies) or settings, or both, for blood glucose monitoring for women with GDM.\nData collection and analysis\nTwo authors independently assessed study eligibility, risk of bias, and extracted data. Data were checked for accuracy.\nWe assessed the quality of the evidence for the main comparisons using GRADE, for:\n- primary outcomes for mothers: that is, hypertensive disorders of pregnancy; caesarean section; type 2 diabetes; and\n- primary outcomes for children: that is, large-for-gestational age; perinatal mortality; death or serious morbidity composite; childhood/adulthood neurosensory disability;\n- secondary outcomes for mothers: that is, induction of labour; perineal trauma; postnatal depression; postnatal weight retention or return to pre-pregnancy weight; and\n- secondary outcomes for children: that is, neonatal hypoglycaemia; childhood/adulthood adiposity; childhood/adulthood type 2 diabetes.\nMain results\nWe included 11 RCTs (10 RCTs; one qRCT) that randomised 1272 women with GDM in upper-middle or high-income countries; we considered these to be at a moderate to high risk of bias. We assessed the RCTs under five comparisons. For outcomes assessed using GRADE, we downgraded for study design limitations, imprecision and inconsistency. Three trials received some support from commercial partners who provided glucose meters or financial support, or both.\nMain comparisons\nTelemedicine versus standard care for glucose monitoring (five RCTs): we observed no clear differences between the telemedicine and standard care groups for the mother, for:\n- pre-eclampsia or pregnancy-induced hypertension (risk ratio (RR) 1.49, 95% confidence interval (CI) 0.69 to 3.20; 275 participants; four RCTs; very low quality evidence);\n- caesarean section (average RR 1.05, 95% CI 0.72 to 1.53; 478 participants; 5 RCTs; very low quality evidence); and\n- induction of labour (RR 1.06, 95% CI 0.63 to 1.77; 47 participants; 1 RCT; very low quality evidence);\nor for the child, for:\n- large-for-gestational age (RR 1.41, 95% CI 0.76 to 2.64; 228 participants; 3 RCTs; very low quality evidence);\n- death or serious morbidity composite (RR 1.06, 95% CI 0.68 to 1.66; 57 participants; 1 RCT; very low quality evidence); and\n- neonatal hypoglycaemia (RR 1.14, 95% CI 0.48 to 2.72; 198 participants; 3 RCTs; very low quality evidence).\nThere were no perinatal deaths in two RCTs (131 participants; very low quality evidence).\nSelf-monitoring versus periodic glucose monitoring (two RCTs): we observed no clear differences between the self-monitoring and periodic glucose monitoring groups for the mother, for:\n- pre-eclampsia (RR 0.17, 95% CI 0.01 to 3.49; 58 participants; 1 RCT; very low quality evidence); and\n- caesarean section (average RR 1.18, 95% CI 0.61 to 2.27; 400 participants; 2 RCTs; low quality evidence);\nor for the child, for:\n- perinatal mortality (RR 1.54, 95% CI 0.21 to 11.24; 400 participants; 2 RCTs; very low quality evidence);\n- large-for-gestational age (RR 0.82, 95% CI 0.50 to 1.37; 400 participants; 2 RCTs; low quality evidence); and\n- neonatal hypoglycaemia (RR 0.64, 95% CI 0.39 to 1.06; 391 participants; 2 RCTs; low quality evidence).\nContinuous glucose monitoring system (CGMS) versus self-monitoring of glucose (two RCTs): we observed no clear differences between the CGMS and self-monitoring groups for the mother, for:\n- caesarean section (RR 0.91, 95% CI 0.68 to 1.20; 179 participants; 2 RCTs; very low quality evidence);\nor for the child, for:\n- large-for-gestational age (RR 0.67, 95% CI 0.43 to 1.05; 106 participants; 1 RCT; very low quality evidence) and\n- neonatal hypoglycaemia (RR 0.79, 95% CI 0.35 to 1.78; 179 participants; 2 RCTs; very low quality evidence).\nThere were no perinatal deaths in the two RCTs (179 participants; very low quality evidence).\nOther comparisons\nModem versus telephone transmission for glucose monitoring (one RCT): none of the review's primary outcomes were reported in this trial\nPostprandial versus preprandial glucose monitoring (one RCT): we observed no clear differences between the postprandial and preprandial glucose monitoring groups for the mother, for:\n- pre-eclampsia (RR 1.00, 95% CI 0.15 to 6.68; 66 participants; 1 RCT);\n- caesarean section (RR 0.62, 95% CI 0.29 to 1.29; 66 participants; 1 RCT); and\n- perineal trauma (RR 0.38, 95% CI 0.11 to 1.29; 66 participants; 1 RCT);\nor for the child, for:\n- neonatal hypoglycaemia (RR 0.14, 95% CI 0.02 to 1.10; 66 participants; 1 RCT).\nThere were fewer large-for-gestational-age infants born to mothers in the postprandial compared with the preprandial glucose monitoring group (RR 0.29, 95% CI 0.11 to 0.78; 66 participants; 1 RCT).\nAuthors' conclusions\nEvidence from 11 RCTs assessing different methods or settings for glucose monitoring for GDM suggests no clear differences for the primary outcomes or other secondary outcomes assessed in this review.\nHowever, current evidence is limited by the small number of RCTs for the comparisons assessed, small sample sizes, and the variable methodological quality of the RCTs. More evidence is needed to assess the effects of different methods and settings for glucose monitoring for GDM on outcomes for mothers and their children, including use and costs of health care. Future RCTs may consider collecting and reporting on the standard outcomes suggested in this review.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Blood glucose monitoring is an important strategy for managing GDM, however it remains unclear what methods are best. Conclusive evidence from RCTs is not yet available to guide practice, although a range of methods has been investigated. Few RCTs have compared the same or similar interventions, RCTs have been small and have reported limited findings. Further large, well-designed, RCTs are required to assess the effects of different methods and settings for blood glucose monitoring for women with GDM in order to improve outcomes for women and their babies in the short and long term."
}
] |
query-laysum
|
8628
|
[
{
"role": "user",
"content": "Abstract: Background\nEndometriosis is a chronic inflammatory condition that occurs during the reproductive years. It is characterised by endometrium-like tissue developing outside the uterine cavity. This endometriotic tissue development is dependent on oestrogen produced primarily by the ovaries and partially by the endometriotic tissue itself, therefore traditional management has focused on ovarian suppression. In this review we considered the role of modulation of the immune system as an alternative approach. This is an update of a Cochrane Review previously published in 2012.\nObjectives\nTo determine the effectiveness and safety of pentoxifylline in the management of endometriosis.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, and AMED on 16 December 2020, together with reference checking and contact with study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing pentoxifylline with placebo or no treatment, other medical treatment, or surgery in women with endometriosis. The primary outcomes were live birth rate and overall pain (as measured by a visual analogue scale (VAS) of pain, other validated scales, or dichotomous outcomes) per woman randomised. Secondary outcomes included clinical pregnancy rate, miscarriage rate, rate of recurrence, and adverse events resulting from the pentoxifylline intervention.\nData collection and analysis\nTwo review authors independently assessed studies against the inclusion criteria, extracted data, and assessed risk of bias, consulting a third review author where required. We contacted study authors as needed. We analysed dichotomous outcomes using Mantel-Haenszel risk ratios (RRs), 95% confidence intervals (CIs), and a fixed-effect model. For small numbers of events, we used a Peto odds ratio (OR) with 95% CI instead. We analysed continuous outcomes using the mean difference (MD) between groups presented with 95% CIs. We used the I2 statistic to evaluate heterogeneity amongst studies. We employed the GRADE approach to assess the quality of the evidence.\nMain results\nWe included five parallel-design RCTs involving a total of 415 women. We included one additional RCT in this update. Three studies did not specify details relating to allocation concealment, and two studies were not blinded. There were also considerable loss to follow-up, with four studies not conducting intention-to-treat analysis. We judged the quality of the evidence as very low.\nPentoxifylline versus placebo\nNo trials reported on our primary outcomes of live birth rate and overall pain. We are uncertain as to whether pentoxifylline treatment affects clinical pregnancy rate when compared to placebo (RR 1.38, 95% CI 0.91 to 2.10; 3 RCTs, n = 285; I2 = 0%; very low-quality evidence). The evidence suggests that if the clinical pregnancy rate with placebo is estimated to be 20%, then the rate with pentoxifylline is estimated as between 18% and 43%. We are also uncertain as to whether pentoxifylline affects the recurrence rate of endometriosis (RR 0.84, 95% CI 0.30 to 2.36; 1 RCT, n = 121; very low-quality evidence) or miscarriage rate (Peto OR 1.99, 95% CI 0.20 to 19.37; 2 RCTs, n = 164; I2 = 0%; very low-quality evidence). No trials reported on the effect of pentoxifylline on improvement of endometriosis-related symptoms other than pain or adverse events.\nPentoxifylline versus no treatment\nNo trials reported on live birth rate. We are uncertain as to whether pentoxifylline treatment affects overall pain when compared to no treatment at one month (MD −0.36, 95% CI −2.12 to 1.40; 1 RCT, n = 34; very low-quality evidence), two months (MD −1.25, 95% CI −2.67 to 0.17; 1 RCT, n = 34; very low-quality evidence), or three months (MD −1.60, 95% CI −3.32 to 0.12; 1 RCT, n = 34; very low-quality evidence). No trials reported on adverse events caused by pentoxifylline or any of our other secondary outcomes.\nPentoxifylline versus other medical therapies\nOne study (n = 83) compared pentoxifylline to the combined oral contraceptive pill after laparoscopic surgery to treat endometriosis, but could not be included in the meta-analysis as it was unclear if the data were presented as +/- standard deviation and what the duration of treatment was. No trials reported on adverse events caused by pentoxifylline or any of our other secondary outcomes.\nPentoxifylline versus conservative surgical treatment\nNo study reported on this comparison.\nAuthors' conclusions\nNo studies reported on our primary outcome of live birth rate. Due to the very limited evidence, we are uncertain of the effects of pentoxifylline on clinical pregnancy rate, miscarriage rate, or overall pain.\nThere is currently insufficient evidence to support the use of pentoxifylline in the management of women with endometriosis with respect to subfertility and pain relief outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Endometriosis is a painful condition where endometrium-like tissue (tissue similar to the lining of the uterus) grows outside of the uterus, possibly affecting a woman's ability to conceive. Recent studies support the influence of the immune system on this disease. Pentoxifylline is an immunomodulator drug that also has anti-inflammatory (reducing inflammation) activity, which may relieve the symptoms of the disease without preventing ovulation."
}
] |
query-laysum
|
8630
|
[
{
"role": "user",
"content": "Abstract: Background\nMycoplasma pneumoniae (M. pneumoniae) is widely recognised as an important cause of community-acquired lower respiratory tract infection (LRTI) in children. Pulmonary manifestations are typically tracheobronchitis or pneumonia but M. pneumoniae is also implicated in wheezing episodes in both asthmatic and non-asthmatic individuals. Although antibiotics are used to treat LRTIs, a review of several major textbooks offers conflicting advice for using antibiotics in the management of M. pneumoniae LRTI in children.\nObjectives\nTo determine whether antibiotics are effective in the treatment of childhood LRTI secondary to M. pneumoniae infections acquired in the community.\nSearch methods\nWe searched CENTRAL (2014, Issue 3), MEDLINE (1966 to July week 4, 2014), EMBASE (1980 to July, 2014), and both WHO ICTRP and ClinicalTrials.gov (13 August 2014).\nSelection criteria\nRandomised controlled trials (RCTs) comparing antibiotics commonly used for treating M. pneumoniae (i.e. macrolide, tetracycline or quinolone classes) versus placebo, or antibiotics from any other class in the treatment of children under 18 years of age with community-acquired LRTI secondary to M. pneumoniae.\nData collection and analysis\nThe review authors independently selected trials for inclusion and assessed methodological quality. We extracted and analysed relevant data separately and resolved disagreements by consensus.\nMain results\nA total of 1912 children were enrolled from seven studies. Data interpretation was limited by the inability to extract data that referred to children with M. pneumoniae. In most studies, clinical response did not differ between children randomised to a macrolide antibiotic and children randomised to a non-macrolide antibiotic. In one controlled study (of children with recurrent respiratory infections, whose acute LRTI was associated with Mycoplasma, Chlamydia or both, by polymerase chain reaction and/or paired sera) 100% of children treated with azithromycin had clinical resolution of their illness compared to 77% not treated with azithromycin at one month.\nAuthors' conclusions\nThere is insufficient evidence to draw any specific conclusions about the efficacy of antibiotics for this condition in children (although one trial suggests macrolides may be efficacious in some children with LRTI secondary to Mycoplasma). The use of antibiotics has to be balanced with possible adverse events. There is still a need for high quality, double-blinded RCTs to assess the efficacy and safety of antibiotics for LRTI secondary to M. pneumoniae in children.\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": "Randomised controlled trials (RCTs) comparing either two types of antibiotic therapy or an antibiotic versus a placebo in children with pneumonia."
}
] |
query-laysum
|
8631
|
[
{
"role": "user",
"content": "Abstract: Background\nAmalgam is a common filling material for posterior teeth, as with any restoration amalgams have a finite life-span. Traditionally replacement was the ideal approach to treat defective amalgam restorations, however, repair offers an alternative more conservative approach where restorations are only partially defective. Repairing a restoration has the potential of taking less time and may sometimes be performed without the use of local anaesthesia hence it may be less distressing for a patient when compared with replacement. Repair of amalgam restorations is often more conservative of the tooth structure than replacement.\nObjectives\nTo evaluate the effects of replacing (with amalgam) versus repair (with amalgam) in the management of defective amalgam dental restorations in permanent molar and premolar teeth.\nSearch methods\nFor the identification of studies relevant to this review we searched the Cochrane Oral Health Group's Trials Register (to 5 August 2013); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 7); MEDLINE via OVID (1946 to 5 August 2013); EMBASE via OVID (1980 to 5 August 2013); BIOSIS via Web of Knowledge (1969 to 5 August 2013); Web of Science (1945 to 5 August 2013) and OpenGrey (to 5 August 2013). Researchers, experts and organisations known to be involved in this field were contacted in order to trace unpublished or ongoing studies. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nTrials were selected if they met the following criteria: randomised controlled trial (including split-mouth studies), involving replacement and repair of amalgam restorations in adults with a defective restoration in a molar or premolar tooth/teeth.\nData collection and analysis\nTwo review authors independently assessed titles and abstracts for each article identified by the searches in order to decide whether the article was likely to be relevant. Full papers were obtained for relevant articles and both review authors studied these. The Cochrane Collaboration statistical guidelines were to be followed for data synthesis.\nMain results\nThe search strategy retrieved 201 potentially eligible studies after de-duplication. After examination of the titles and abstracts, full texts of the relevant studies were retrieved but none of these met the inclusion criteria of the review.\nAuthors' conclusions\nThere are no published randomised controlled trials relevant to this review question. There is therefore a need for methodologically sound randomised controlled trials that are reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (www.consort-statement.org/). Further research also needs to explore qualitatively the views of patients on repairing versus replacement and investigate themes around pain, distress and anxiety, time and costs.\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": "This review of existing studies was carried out by the Cochrane Oral Health Group, and the evidence is current up to 5 August 2013."
}
] |
query-laysum
|
8632
|
[
{
"role": "user",
"content": "Abstract: Background\nLow back pain (LBP) is associated with enormous personal and societal burdens, especially when it reaches the chronic stage of the disorder (pain for a duration of more than three months). Indeed, individuals who reach the chronic stage tend to show a more persistent course, and they account for the majority of social and economic costs. As a result, there is increasing emphasis on the importance of intervening at the early stages of LBP.\nAccording to the biopsychosocial model, LBP is a condition best understood with reference to an interaction of physical, psychological, and social influences. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds.\nThis review is an update of a Cochrane Review on MBR for subacute LBP, which was published in 2003. It is part of a series of reviews on MBR for musculoskeletal pain published by the Cochrane Back and Neck Group and the Cochrane Musculoskeletal Group.\nObjectives\nTo examine the effectiveness of MBR for subacute LBP (pain for a duration of six to 12 weeks) among adults, with a focus on pain, back-specific disability, and work status.\nSearch methods\nWe searched for relevant trials in any language by a computer-aided search of CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and two trials registers. Our search is current to 13 July 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) of adults with subacute LBP. We included studies that investigated a MBR program compared to any type of control intervention. We defined MBR as an intervention that included a physical component (e.g. pharmacological, physical therapy) in combination with either a psychological, social, or occupational component (or any combination of these). We also required involvement of healthcare professionals from at least two different clinical backgrounds with appropriate training to deliver the component for which they were responsible.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. In particular, the data extraction and 'risk of bias' assessment were conducted by two people, independently. We used the Cochrane tool to assess risk of bias and the GRADE approach to assess the overall quality of the evidence for each outcome.\nMain results\nWe included a total of nine RCTs (981 participants) in this review. Five studies were conducted in Europe and four in North America. Sample sizes ranged from 33 to 351. The mean age across trials ranged between 32.0 and 43.7 years.\nAll included studies were judged as having high risk of performance bias and high risk of detection bias due to lack of blinding, and four of the nine studies suffered from at least one additional source of possible bias.\nIn MBR compared to usual care for subacute LBP, individuals receiving MBR had less pain (four studies with 336 participants; SMD -0.46, 95% CI -0.70 to -0.21, moderate-quality of evidence due to risk of bias) and less disability (three studies with 240 participants; SMD -0.44, 95% CI -0.87 to -0.01, low-quality of evidence due to risk of bias and inconsistency), as well as increased likelihood of return-to-work (three studies with 170 participants; OR 3.19, 95% CI 1.46 to 6.98, very low-quality of evidence due to serious risk of bias and imprecision) and fewer sick leave days (two studies with 210 participants; SMD -0.38 95% CI -0.66 to -0.10, low-quality of evidence due to risk of bias and imprecision) at 12-month follow-up. The effect sizes for pain and disability were low in terms of clinical meaningfulness, whereas effects for work-related outcomes were in the moderate range.\nHowever, when comparing MBR to other treatments (i.e. brief intervention with features from a light mobilization program and a graded activity program, functional restoration, brief clinical intervention including education and advice on exercise, and psychological counselling), we found no differences between the groups in terms of pain (two studies with 336 participants; SMD -0.14, 95% CI -0.36 to 0.07, low-quality evidence due to imprecision and risk of bias), functional disability (two studies with 345 participants; SMD -0.03, 95% CI -0.24 to 0.18, low-quality evidence due to imprecision and risk of bias), and time away from work (two studies with 158 participants; SMD -0.25 95% CI -0.98 to 0.47, very low-quality evidence due to serious imprecision, inconsistency and risk of bias). Return-to-work was not reported in any of the studies.\nAlthough we looked for adverse events in both comparisons, none of the included studies reported this outcome.\nAuthors' conclusions\nOn average, people with subacute LBP who receive MBR will do better than if they receive usual care, but it is not clear whether they do better than people who receive some other type of treatment. However, the available research provides mainly low to very low-quality evidence, thus additional high-quality trials are needed before we can describe the value of MBP for clinical practice.\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": "Low back pain (LBP) is a condition that causes a great deal of pain and suffering across the world and also accounts for large costs to society due to healthcare spending and missed work. Previous research has shown that people who have back pain for more than three months are less likely to recover. As a result, there is increasing emphasis on the importance of intervening at the early stages of LBP.\nThe purpose of this review was to discover whether multidisciplinary treatments were better or worse than other alternatives, such a usual care (i.e. current clinical practice) or other treatments (e.g. exercise therapy alone) for people experiencing low back pain for six to 12 weeks."
}
] |
query-laysum
|
8633
|
[
{
"role": "user",
"content": "Abstract: Background\nBrain metastases occur when cancer cells spread from their original site to the brain and are a frequent cause of morbidity and death in people with cancer. They occur in 20% to 40% of people during the course of their disease. Brain metastases are also the most frequent type of brain malignancy. Single and solitary brain metastasis is infrequent and choosing the most appropriate treatment is a clinical challenge. Surgery and stereotactic radiotherapy are two options. For surgery, tumour resection is performed using microsurgical techniques, while in stereotactic radiotherapy, external ionising radiation beams are precisely focused on the brain metastasis. Stereotactic radiotherapy may be given as a single dose, also known as single dose radiosurgery, or in a number of fractions, also known as fractionated stereotactic radiotherapy. There is uncertainty regarding which treatment (surgery or stereotactic radiotherapy) is more effective for people with single or solitary brain metastasis.\nObjectives\nTo assess the effectiveness and safety of surgery versus stereotactic radiotherapy for people with single or solitary brain metastasis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, March 2018), MEDLINE and Embase up to 25 March 2018 for relevant studies. We also searched trials databases, grey literature and handsearched relevant literature.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing surgery versus stereotactic radiotherapy, either a single fraction (stereotactic radiosurgery) or multiple fractions (fractionated stereotactic radiotherapy) for treatment of single or solitary brain metastasis.\nData collection and analysis\nTwo review authors screened all references, evaluated the quality of the included studies using the Cochrane tool for assessing risk of bias, and performed data extraction. The primary outcomes were overall survival and adverse events. Secondary outcomes included progression-free survival and quality of life . We analysed overall survival and progression-free survival as hazard ratios (HRs) with 95% confidence intervals (CIs), and analysed adverse events as risk ratios (RRs). For quality of life we used mean difference (MD).\nMain results\nTwo RCTs including 85 participants met our inclusion criteria. One study included people with single untreated brain metastasis (n = 64), and the other included people with solitary brain metastasis (22 consented to randomisation and 21 were analysed). We identified a third trial reported as completed and pending results this may be included in future updates of this review. The two included studies were prematurely closed due to poor participant accrual. One study compared surgery plus whole brain radiotherapy (WBRT) versus stereotactic radiosurgery alone, and the second study compared surgery plus WBRT versus stereotactic radiosurgery plus WBRT. Meta-analysis was not possible due to clinical heterogeneity between trial interventions. The overall certainty of evidence was low or very low for all outcomes due to high risk of bias and imprecision.\nWe found no difference in overall survival in either of the two comparisons. For the comparison of surgery plus WBRT versus stereotactic radiosurgery alone: HR 0.92, 95% CI 0.48 to 1.77; 64 participants, very low-certainty evidence. We downgraded the certainty of the evidence to very low due to risk of bias and imprecision. For the comparison of surgery plus WBRT versus stereotactic radiosurgery plus WBRT: HR 0.53, 95% CI 0.20 to 1.42; 21 participants, low-certainty evidence. We downgraded the certainty of the evidence to low due to imprecision. Adverse events were reported in both trial groups in the two studies, showing no differences for surgery plus WBRT versus stereotactic radiosurgery alone (RR 0.31, 95% CI 0.07 to 1.44; 64 participants) and for surgery plus WBRT versus stereotactic radiosurgery plus WBRT (RR 0.37, 95% CI 0.05 to 2.98; 21 participants). Most of the adverse events were related to radiation toxicities. We considered the certainty of the evidence from the two comparisons to be very low due to risk of bias and imprecision.\nThere was no difference in progression-free survival in the study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT (HR 0.55, 95% CI 0.22 to 1.38; 21 participants, low-certainty evidence). We downgraded the evidence to low certainty due to imprecision. This outcome was not clearly reported for the other comparison. In general, there were no differences in quality of life between the two studies. The study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT found no differences after two months using the QLQ-C30 global scale (MD -10.80, 95% CI -44.67 to 23.07; 14 participants, very low-certainty evidence). We downgraded the certainty of evidence to very low due to risk of bias and imprecision.\nAuthors' conclusions\nCurrently, there is no definitive evidence regarding the effectiveness and safety of surgery versus stereotactic radiotherapy on overall survival, adverse events, progression-free survival and quality of life in people with single or solitary brain metastasis, and benefits must be decided on a case-by-case basis until well powered and designed trials are available. Given the difficulties in participant accrual, an international multicentred approach should be considered for future studies.\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 relevant databases up to 25 March 2018. We found two clinical trials with a total of 85 participants with either single or solitary brain metastasis. One trial included 64 participants with a single brain metastasis, and the other included participants with a solitary brain metastasis (22 of these consented to randomisation and 21 were analysed). Both studies were prematurely closed due to difficulties in finding participants meeting the inclusion criteria or agreeing to participate. One trial compared surgery plus whole brain radiotherapy (WBRT) versus stereotactic radiosurgery alone, and the second trial compared surgery plus WBRT versus stereotactic radiosurgery plus WBRT."
}
] |
query-laysum
|
8634
|
[
{
"role": "user",
"content": "Abstract: Background\nManaged withdrawal is a necessary step prior to drug-free treatment or as the endpoint of substitution treatment.\nObjectives\nTo assess the effects of buprenorphine versus tapered doses of methadone, alpha2-adrenergic agonists, symptomatic medications or placebo, or different buprenorphine regimens for managing opioid withdrawal, in terms of the intensity of the withdrawal syndrome experienced, duration and completion of treatment, and adverse effects.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 11, 2016), MEDLINE (1946 to December week 1, 2016), Embase (to 22 December 2016), PsycINFO (1806 to December week 3, 2016), and the Web of Science (to 22 December 2016) and handsearched the reference lists of articles.\nSelection criteria\nRandomised controlled trials of interventions using buprenorphine to modify the signs and symptoms of withdrawal in participants who were primarily opioid dependent. Comparison interventions involved reducing doses of methadone, alpha2-adrenergic agonists (clonidine or lofexidine), symptomatic medications or placebo, and different buprenorphine-based regimens.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 27 studies involving 3048 participants. The main comparators were clonidine or lofexidine (14 studies). Six studies compared buprenorphine versus methadone, and seven compared different rates of buprenorphine dose reduction. We assessed 12 studies as being at high risk of bias in at least one of seven domains of methodological quality. Six of these studies compared buprenorphine with clonidine or lofexidine and two with methadone; the other four studies compared different rates of buprenorphine dose reduction.\nFor the comparison of buprenorphine and methadone in tapered doses, meta-analysis was not possible for the outcomes of intensity of withdrawal or adverse effects. However, information reported by the individual studies was suggestive of buprenorphine and methadone having similar capacity to ameliorate opioid withdrawal, without clinically significant adverse effects. The meta-analyses that were possible support a conclusion of no difference between buprenorphine and methadone in terms of average treatment duration (mean difference (MD) 1.30 days, 95% confidence interval (CI) −8.11 to 10.72; N = 82; studies = 2; low quality) or treatment completion rates (risk ratio (RR) 1.04, 95% CI 0.91 to 1.20; N = 457; studies = 5; moderate quality).\nRelative to clonidine or lofexidine, buprenorphine was associated with a lower average withdrawal score (indicating less severe withdrawal) during the treatment episode, with an effect size that is considered to be small to moderate (standardised mean difference (SMD) −0.43, 95% CI −0.58 to −0.28; N = 902; studies = 7; moderate quality). Patients receiving buprenorphine stayed in treatment for longer, with an effect size that is considered to be large (SMD 0.92, 95% CI 0.57 to 1.27; N = 558; studies = 5; moderate quality) and were more likely to complete withdrawal treatment (RR 1.59, 95% CI 1.23 to 2.06; N = 1264; studies = 12; moderate quality). At the same time there was no significant difference in the incidence of adverse effects, but dropout due to adverse effects may be more likely with clonidine (RR 0.20, 95% CI 0.04 to 1.15; N = 134; studies = 3; low quality). The difference in treatment completion rates translates to a number needed to treat for an additional beneficial outcome of 4 (95% CI 3 to 6), indicating that for every four people treated with buprenorphine, we can expect that one additional person will complete treatment than with clonidine or lofexidine.\nFor studies comparing different rates of reduction of the buprenorphine dose, meta-analysis was possible only for treatment completion, with separate analyses for inpatient and outpatient settings. The results were diverse, and we assessed the quality of evidence as being very low. It remains very uncertain what effect the rate of dose taper has on treatment outcome.\nAuthors' conclusions\nBuprenorphine is more effective than clonidine or lofexidine for managing opioid withdrawal in terms of severity of withdrawal, duration of withdrawal treatment, and the likelihood of treatment completion.\nBuprenorphine and methadone appear to be equally effective, but data are limited. It remains possible that the pattern of withdrawal experienced may differ and that withdrawal symptoms may resolve more quickly with buprenorphine.\nIt is not possible to draw any conclusions from the available evidence on the relative effectiveness of different rates of tapering the buprenorphine dose. The divergent findings of studies included in this review suggest that there may be multiple factors affecting the response to the rate of dose taper. One such factor could be whether or not the initial treatment plan includes a transition to subsequent relapse prevention treatment with naltrexone. Indeed, the use of buprenorphine to support transition to naltrexone treatment is an aspect worthy of further research.\nMost participants in the studies included in this review were male. None of the studies reported outcomes on the basis of sex, preventing any exploration of differences related to this variable. Consideration of sex as a factor influencing response to withdrawal treatment would be relevant research for selecting the most appropriate type of intervention for each individual.\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": "Managed withdrawal, or detoxification, is a required first step for long-term treatment of opioid dependence. The combination of uncomfortable symptoms and intense craving makes completion of opioid withdrawal difficult for most people. Buprenorphine is one of the medications used to manage withdrawal from opioid drugs. This review considered whether buprenorphine is more effective than methadone in tapered doses, or better than clonidine or lofexidine, which are other medications that have been commonly used for managing opioid withdrawal."
}
] |
query-laysum
|
8635
|
[
{
"role": "user",
"content": "Abstract: Background\nAlcohol-related liver disease is due to excessive alcohol consumption. It includes a spectrum of liver diseases such as alcohol-related fatty liver, alcoholic hepatitis, and alcoholic cirrhosis. Mortality associated with alcoholic hepatitis is high. The optimal pharmacological treatment of alcoholic hepatitis and other alcohol-related liver disease remains controversial.\nObjectives\nTo assess the comparative benefits and harms of different pharmacological interventions in the management of alcohol-related liver disease through a network meta-analysis and to generate rankings of the available pharmacological interventions according to their safety and efficacy in order to identify potential treatments. However, even in the subgroup of participants when the potential effect modifiers appeared reasonably similar across comparisons, there was evidence of inconsistency by one or more methods of assessment of inconsistency. Therefore, we did not report the results of the network meta-analysis and reported the comparative benefits and harms of different interventions using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform and randomised controlled trials registers until February 2017 to identify randomised clinical trials on pharmacological treatments for alcohol-related liver diseases.\nSelection criteria\nRandomised clinical trials (irrespective of language, blinding, or publication status) including participants with alcohol-related liver disease. We excluded trials that included participants who had previously undergone liver transplantation and those with co-existing chronic viral diseases. We considered any of the various pharmacological interventions compared with each other or with placebo or no intervention.\nData collection and analysis\nTwo review authors independently identified trials and independently extracted data. We calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CIs) using both fixed-effect and random-effects models based on available-participant analysis with Review Manager. We assessed risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.\nMain results\nWe identified a total of 81 randomised clinical trials. All the trials were at high risk of bias, and the overall quality of the evidence was low or very low for all outcomes.\nAlcoholic hepatitis\nFifty randomised clinical trials included 4484 participants with alcoholic hepatitis. The period of follow-up ranged from one to 12 months. Because of concerns about transitivity assumption, we did not perform the network meta-analysis. None of the active interventions showed any improvement in any of the clinical outcomes reported in the trials, which includes mortality (at various time points), cirrhosis, decompensated cirrhosis, liver transplantation. None of the trials reported health-related quality of life or incidence of hepatocellular carcinoma.\nSevere alcoholic hepatitis\nOf the trials on alcoholic hepatitis, 19 trials (2545 participants) included exclusively participants with severe alcoholic hepatitis (Maddrey Discriminat Function > 32). The period of follow-up ranged from one to 12 months. There was no alteration in the conclusions when only people with severe alcoholic hepatitis were included in the analysis.\nSource of funding: Eleven trials were funded by parties with vested interest in the results. Sixteen trials were funded by parties without vested interest in the results. The source of funding was not reported in 23 trials.\nOther alcohol-related liver diseases\nThirty-one randomised clinical trials included 3695 participants with other alcohol-related liver diseases (with a wide spectrum of alcohol-related liver diseases). The period of follow-up ranged from one to 48 months. The mortality at maximal follow-up was lower in the propylthiouracil group versus the no intervention group (OR 0.45, 95% CI 0.26 to 0.78; 423 participants; 2 trials; low-quality evidence). However, this result is based on two small trials at high risk of bias and further confirmation in larger trials of low risk of bias is necessary to recommend propylthiouracil routinely in people with other alcohol-related liver diseases. The mortality at maximal follow-up was higher in the ursodeoxycholic acid group versus the no intervention group (OR 2.09, 95% CI 1.12 to 3.90; 226 participants; 1 trial; low-quality evidence).\nSource of funding: Twelve trials were funded by parties with vested interest in the results. Three trials were funded by parties without vested interest in the results. The source of funding was not reported in 16 trials.\nAuthors' conclusions\nBecause of very low-quality evidence, there is uncertainty in the effectiveness of any pharmacological intervention versus no intervention in people with alcoholic hepatitis or severe alcoholic hepatitis. Based on low-quality evidence, propylthiouracil may decrease mortality in people with other alcohol-related liver diseases. However, these results must be confirmed by adequately powered trials with low risk of bias before propylthiouracil can be considered effective.\nFuture randomised clinical trials should be conducted with approximately 200 participants in each group and follow-up of one to two years in order to compare the benefits and harms of different treatments in people with alcoholic hepatitis. Randomised clinical trials should include health-related quality of life and report serious adverse events separately from adverse events. Future randomised clinical trials should have a low risk of bias and low risk of random errors.\n\nGiven the provided abstract, please respond to the following query: \"Source of funding\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eleven trials were funded by parties with vested interest in the results. Sixteen trials were funded by parties without vested interest in the results. The source of funding was not reported in 23 trials."
}
] |
query-laysum
|
8636
|
[
{
"role": "user",
"content": "Abstract: Background\nSeveral agents are used to clear secretions from the airways of people with cystic fibrosis. Mannitol increases mucociliary clearance, but its exact mechanism of action is unknown. The dry powder formulation of mannitol may be more convenient and easier to use compared with established agents which require delivery via a nebuliser. Phase III trials of inhaled dry powder mannitol for the treatment of cystic fibrosis have been completed and it is now available in Australia and some countries in Europe. This is an update of a previous review.\nObjectives\nTo assess whether inhaled dry powder mannitol is well tolerated, whether it improves the quality of life and respiratory function in people with cystic fibrosis and which adverse events are associated with the treatment.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic databases, handsearching relevant journals and abstracts from conferences.\nDate of last search: 12 December 2019.\nSelection criteria\nAll randomised controlled studies comparing mannitol with placebo, active inhaled comparators (for example, hypertonic saline or dornase alfa) or with no treatment.\nData collection and analysis\nAuthors independently assessed studies for inclusion, carried out data extraction and assessed the risk of bias in included studies. The quality of the evidence was assessed using GRADE.\nMain results\nSix studies (reported in 36 unique publications) were included with a total of 784 participants.\nDuration of treatment in the included studies ranged from 12 days to six months, with open-label treatment for an additional six months in two of the studies. Five studies compared mannitol with control (a very low dose of mannitol or non-respirable mannitol) and the final study compared mannitol to dornase alfa alone and to mannitol plus dornase alfa. Two large studies had a similar parallel design and provided data for 600 participants, which could be pooled where data for a particular outcome and time point were available. The remaining studies had much smaller sample sizes (ranging from 22 to 95) and data could not be pooled due to differences in design, interventions and population.\nPooled evidence from the two large parallel studies was judged to be of low to moderate quality and from the smaller studies was judged to be of low to very low quality. In all studies, there was an initial test to see if participants tolerated mannitol, with only those who could tolerate the drug being randomised; therefore, the study results are not applicable to the cystic fibrosis population as a whole.\nWhile the published papers did not provide all the data required for our analysis, additional unpublished data were provided by the drug's manufacturer and the author of one of the studies.\nPooling the large parallel studies comparing mannitol to control, up to and including six months, lung function (forced expiratory volume at one second) measured in both mL and % predicted was significantly improved in the mannitol group compared to the control group (moderate-quality evidence). Beneficial results were observed in these studies in adults and in both concomitant dornase alfa users and non-users in these studies. In the smaller studies, statistically significant improvements in lung function were also observed in the mannitol groups compared to the non-respirable mannitol groups; however, we judged this evidence to be of low to very low quality.\nFor the comparisons of mannitol and control, we found no consistent differences in health-related quality of life in any of the domains except for burden of treatment, which was less for mannitol up to four months in the two pooled studies of a similar design; this difference was not maintained at six months. It should be noted that the tool used to measure health-related quality of life was not designed to assess mucolytics and pooling of the age-appropriate tools (as done in some of the included studies) may not be valid so results were judged to be low to very low quality and should be interpreted with caution. Cough, haemoptysis, bronchospasm, pharyngolaryngeal pain and post-tussive vomiting were the most commonly reported side effects in both treatment groups. Where rates of adverse events could be compared, statistically no significant differences were found between mannitol and control groups; although some of these events may have clinical relevance for people with CF.\nFor the comparisons of mannitol to dornase alfa alone and to mannitol plus dornase alfa, very low-quality evidence from a 12-week cross-over study of 28 participants showed no statistically significant differences in the recorded domains of health-related quality of life or measures of lung function. Cough was the most common side effect in the mannitol alone arm but there was no occurrence of cough in the dornase alfa alone arm and the most commonly reported reason of withdrawal from the mannitol plus dornase alfa arm was pulmonary exacerbations.\nIn terms of secondary outcomes of the review (pulmonary exacerbations, hospitalisations, symptoms, sputum microbiology), evidence provided by the included studies was more limited. For all comparisons, no consistent statistically significant and clinically meaningful differences were observed between mannitol and control treatments (including dornase alfa).\nAuthors' conclusions\nThere is moderate-quality evidence to show that treatment with mannitol over a six-month period is associated with an improvement in some measures of lung function in people with cystic fibrosis compared to control. There is low to very low-quality evidence suggesting no difference in quality of life for participants taking mannitol compared to control. This review provides very low-quality evidence suggesting no difference in lung function or quality of life comparing mannitol to dornase alfa alone and to mannitol plus dornase alfa.\nThe clinical implications from this review suggest that mannitol could be considered as a treatment in cystic fibrosis; but further research is required in order to establish who may benefit most and whether this benefit is sustained in the longer term. Furthermore, studies comparing its efficacy against other (established) mucolytic therapies need to be undertaken before it can be considered for mainstream practice.\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": "It was difficult to combine evidence from the studies in this review due to differences in the designs of the studies, treatments examined and the settings (hospital or outpatients). Some additional information was obtained from the drug manufacturer and one study author to aid the review.\nThe review found low- to very low-quality evidence that there is no difference between mannitol and control treatments or mannitol given either with or without additional dornase alfa in terms of quality of life. There was moderate-quality evidence of improvements in some measures of lung function across the larger studies comparing mannitol to control. Beneficial effects were also seen in the subgroup of adults and in both those who were using dornase alfa and those who were not. Cough (including coughing up blood), contraction of the airways, pain in the pharynx or larynx and post-treatment vomiting were the most commonly reported side effects on both treatments, but there was no evidence to suggest that these side effects occurred more on mannitol than on control treatments or on dornase alfa.\nNone of the studies compared mannitol to nebulised hypertonic saline and so we can not comment on which agent is better for airway clearance. More research is needed to answer this question."
}
] |
query-laysum
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8637
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[
{
"role": "user",
"content": "Abstract: Background\nSudden cardiac death is a significant cause of mortality in both the US and globally. However, 5% to 15% of people with sudden cardiac death have no structural abnormalities, and most of these events are attributed to underlying cardiac ion channelopathies. Rates of cardiac ion channelopathy diagnosis are increasing. However, the optimal treatment for such people is poorly understood and current guidelines rely primarily on expert opinion.\nObjectives\nTo compare the effect of implantable cardioverter defibrillators (ICD) with antiarrhythmic drugs or usual care in reducing the risk of all-cause mortality, fatal and non-fatal cardiovascular events, and adverse events in people with cardiac ion channelopathies.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 6), EMBASE, MEDLINE, Conference Proceedings Citation Index - Science (CPCI-S), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) in July 2015. We applied no language restrictions.\nSelection criteria\nWe included all randomized controlled trials of people aged 18 years and older with ion channelopathies, including congenital long QT syndrome, congenital short QT syndrome, Brugada syndrome, or catecholaminergic polymorphic ventricular tachycardia. Participants must have been randomized to ICD implantation and compared to antiarrhythmic drug therapy or usual care.\nData collection and analysis\nTwo authors independently selected studies for inclusion and extracted the data. We included all-cause mortality, fatal and non-fatal cardiovascular events, and adverse events for our primary outcome analyses and non-fatal cardiovascular events, rates of inappropriate ICD firing, quality of life, and cost for our secondary outcome analyses. We calculated risk ratios (RR) and associated 95% confidence intervals (CIs) for dichotomous outcomes, both for independent and pooled study analyses.\nMain results\nFrom the 468 references identified after removing duplicates, we found two trials comprising 86 participants that met our inclusion criteria. Both trials included participants with Brugada syndrome who were randomized to ICD versus β-blocker therapy for secondary prevention for sudden cardiac death. Both studies were small, were performed by the same investigators, and exhibited a high risk of bias across multiple domains. In the group randomized to ICD therapy, there was a nine-fold lower risk of mortality compared with people randomized to medical therapy (0% with ICD versus 18% with medical therapy; RR 0.11, 95% CI 0.01 to 0.83; 2 trials, 86 participants). There was low quality evidence of a difference in the rates of combined fatal and non-fatal cardiovascular events, and the results were imprecise (26% with ICD versus 18% with medical therapy; RR 1.49, 95% CI 0.66 to 3.34; 2 trials, 86 participants). The rates of adverse events were higher in the ICD group, but these results were imprecise (28% with ICD versus 10% with medical therapy; RR 2.44, 95% CI 0.92 to 6.44; 2 trials, 86 participants). For secondary outcomes, the risk of non-fatal cardiovascular events was higher in the ICD group, but these results were imprecise and were driven entirely by appropriate ICD-termination of cardiac arrhythmias (26% with ICD versus 0% with medical therapy; RR 11.4, 95% CI 1.57 to 83.3; 2 trials, 86 participants). Approximately 25% of the ICD group experienced inappropriate ICD firing, all of which was corrected by device reprogramming. No data were available for quality of life or cost. We considered the quality of evidence low using the GRADE methodology, due to study limitations and imprecision of effects.\nAuthors' conclusions\nAmong people with Brugada syndrome who have survived a prior episode of sudden cardiac death, ICD therapy appeared to reduce mortality when compared to β-blocker therapy, but the true magnitude may be substantially different from the estimate of the effect because of study limitations and imprecision. Due to the large magnitude of effect, it is unlikely that there will be additional studies evaluating the role of ICDs for secondary prevention in this population. Further studies are necessary to determine the optimal treatment, if any, to prevent an initial episode of sudden cardiac death in people with cardiac ion channelopathies.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What is the evidence about potential benefits and harms of implantable cardioverter defibrillators compared to medical treatment for the prevention of sudden cardiac death in people with inherited heart rhythm abnormalities?"
}
] |
query-laysum
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8638
|
[
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is important to guide appropriate management, to reduce morbidity and to improve survival. Basal cell carcinoma (BCC) is almost always a localised skin cancer with potential to infiltrate and damage surrounding tissue, whereas a minority of cutaneous squamous cell carcinomas (cSCCs) and invasive melanomas are higher-risk skin cancers with the potential to metastasise and cause death. Dermoscopy has become an important tool to assist specialist clinicians in the diagnosis of melanoma, and is increasingly used in primary-care settings. Dermoscopy is a precision-built handheld illuminated magnifier that allows more detailed examination of the skin down to the level of the superficial dermis. Establishing the value of dermoscopy over and above visual inspection for the diagnosis of BCC or cSCC in primary- and secondary-care settings is critical to understanding its potential contribution to appropriate skin cancer triage, including referral of higher-risk cancers to secondary care, the identification of low-risk skin cancers that might be treated in primary care and to provide reassurance to those with benign skin lesions who can be safely discharged.\nObjectives\nTo determine the diagnostic accuracy of visual inspection and dermoscopy, alone or in combination, for the detection of (a) BCC and (b) cSCC, in adults. We separated studies according to whether the diagnosis was recorded face-to-face (in person) or based on remote (image-based) assessment.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.\nSelection criteria\nStudies of any design that evaluated visual inspection or dermoscopy or both in adults with lesions suspicious for skin cancer, compared with a reference standard of either histological confirmation or clinical follow-up.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic thresholds were missing. We estimated accuracy using hierarchical summary ROC methods. We undertook analysis of studies allowing direct comparison between tests. To facilitate interpretation of results, we computed values of sensitivity at the point on the SROC curve with 80% fixed specificity and values of specificity with 80% fixed sensitivity. We investigated the impact of in-person test interpretation; use of a purposely-developed algorithm to assist diagnosis; and observer expertise.\nMain results\nWe included 24 publications reporting on 24 study cohorts, providing 27 visual inspection datasets (8805 lesions; 2579 malignancies) and 33 dermoscopy datasets (6855 lesions; 1444 malignancies). The risk of bias was mainly low for the index test (for dermoscopy evaluations) and reference standard domains, particularly for in-person evaluations, and high or unclear for participant selection, application of the index test for visual inspection and for participant flow and timing. We scored concerns about the applicability of study findings as of ‘high’ or 'unclear' concern for almost all studies across all domains assessed. Selective participant recruitment, lack of reproducibility of diagnostic thresholds and lack of detail on observer expertise were particularly problematic.\nThe detection of BCC was reported in 28 datasets; 15 on an in-person basis and 13 image-based. Analysis of studies by prior testing of participants and according to observer expertise was not possible due to lack of data. Studies were primarily conducted in participants referred for specialist assessment of lesions with available histological classification. We found no clear differences in accuracy between dermoscopy studies undertaken in person and those which evaluated images. The lack of effect observed may be due to other sources of heterogeneity, including variations in the types of skin lesion studied, in dermatoscopes used, or in the use of algorithms and varying thresholds for deciding on a positive test result.\nMeta-analysis found in-person evaluations of dermoscopy (7 evaluations; 4683 lesions and 363 BCCs) to be more accurate than visual inspection alone for the detection of BCC (8 evaluations; 7017 lesions and 1586 BCCs), with a relative diagnostic odds ratio (RDOR) of 8.2 (95% confidence interval (CI) 3.5 to 19.3; P < 0.001). This corresponds to predicted differences in sensitivity of 14% (93% versus 79%) at a fixed specificity of 80% and predicted differences in specificity of 22% (99% versus 77%) at a fixed sensitivity of 80%. We observed very similar results for the image-based evaluations.\nWhen applied to a hypothetical population of 1000 lesions, of which 170 are BCC (based on median BCC prevalence across studies), an increased sensitivity of 14% from dermoscopy would lead to 24 fewer BCCs missed, assuming 166 false positive results from both tests. A 22% increase in specificity from dermoscopy with sensitivity fixed at 80% would result in 183 fewer unnecessary excisions, assuming 34 BCCs missed for both tests. There was not enough evidence to assess the use of algorithms or structured checklists for either visual inspection or dermoscopy.\nInsufficient data were available to draw conclusions on the accuracy of either test for the detection of cSCCs.\nAuthors' conclusions\nDermoscopy may be a valuable tool for the diagnosis of BCC as an adjunct to visual inspection of a suspicious skin lesion following a thorough history-taking including assessment of risk factors for keratinocyte cancer. The evidence primarily comes from secondary-care (referred) populations and populations with pigmented lesions or mixed lesion types. There is no clear evidence supporting the use of currently-available formal algorithms to assist dermoscopy diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out whether using a handheld illuminated microscope (dermatoscope or ‘dermoscopy’) is any better at diagnosing basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC) compared to just looking at the skin with the naked eye. We included 24 studies to answer this question."
}
] |
query-laysum
|
8639
|
[
{
"role": "user",
"content": "Abstract: Background\nEvidence from systematic reviews demonstrates that multi-disciplinary rehabilitation is effective in the stroke population, in which older adults predominate. However, the evidence base for the effectiveness of rehabilitation following acquired brain injury (ABI) in younger adults has not been established, perhaps because this scenario presents different methodological challenges in research.\nObjectives\nTo assess the effects of multi-disciplinary rehabilitation following ABI in adults 16 to 65 years of age.\nSearch methods\nWe ran the most recent search on 14 September 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic+Embase (OvidSP), Web of Science (ISI WOS) databases, clinical trials registers, and we screened reference lists.\nSelection criteria\nRandomised controlled trials (RCTs) comparing multi-disciplinary rehabilitation versus routinely available local services or lower levels of intervention; or trials comparing an intervention in different settings, of different intensities or of different timing of onset. Controlled clinical trials were included, provided they met pre-defined methodological criteria.\nData collection and analysis\nThree review authors independently selected trials and rated their methodological quality. A fourth review author would have arbitrated if consensus could not be reached by discussion, but in fact, this did not occur. As in previous versions of this review, we used the method described by Van Tulder 1997 to rate the quality of trials and to perform a 'best evidence' synthesis by attributing levels of evidence on the basis of methodological quality. Risk of bias assessments were performed in parallel using standard Cochrane methodology. However, the Van Tulder system provided a more discriminative evaluation of rehabilitation trials, so we have continued to use it for our primary synthesis of evidence. We subdivided trials in terms of severity of brain injury, setting and type and timing of rehabilitation offered.\nMain results\nWe identified a total of 19 studies involving 3480 people. Twelve studies were of good methodological quality and seven were of lower quality, according to the van Tulder scoring system. Within the subgroup of predominantly mild brain injury, 'strong evidence' suggested that most individuals made a good recovery when appropriate information was provided, without the need for additional specific interventions. For moderate to severe injury, 'strong evidence' showed benefit from formal intervention, and 'limited evidence' indicated that commencing rehabilitation early after injury results in better outcomes. For participants with moderate to severe ABI already in rehabilitation, 'strong evidence' revealed that more intensive programmes are associated with earlier functional gains, and 'moderate evidence' suggested that continued outpatient therapy could help to sustain gains made in early post-acute rehabilitation. The context of multi-disciplinary rehabilitation appears to influence outcomes. 'Strong evidence' supports the use of a milieu-oriented model for patients with severe brain injury, in which comprehensive cognitive rehabilitation takes place in a therapeutic environment and involves a peer group of patients. 'Limited evidence' shows that specialist in-patient rehabilitation and specialist multi-disciplinary community rehabilitation may provide additional functional gains, but studies serve to highlight the particular practical and ethical restraints imposed on randomisation of severely affected individuals for whom no realistic alternatives to specialist intervention are available.\nAuthors' conclusions\nProblems following ABI vary. Consequently, different interventions and combinations of interventions are required to meet the needs of patients with different problems. Patients who present acutely to hospital with mild brain injury benefit from follow-up and appropriate information and advice. Those with moderate to severe brain injury benefit from routine follow-up so their needs for rehabilitation can be assessed. Intensive intervention appears to lead to earlier gains, and earlier intervention whilst still in emergency and acute care has been supported by limited evidence. The balance between intensity and cost-effectiveness has yet to be determined. Patients discharged from in-patient rehabilitation benefit from access to out-patient or community-based services appropriate to their needs. Group-based rehabilitation in a therapeutic milieu (where patients undergo neuropsychological rehabilitation in a therapeutic environment with a peer group of individuals facing similar challenges) represents an effective approach for patients requiring neuropsychological rehabilitation following severe brain injury. Not all questions in rehabilitation can be addressed by randomised controlled trials or other experimental approaches. For example, trial-based literature does not tell us which treatments work best for which patients over the long term, and which models of service represent value for money in the context of life-long care. In the future, such questions will need to be considered alongside practice-based evidence gathered from large systematic longitudinal cohort studies conducted in the context of routine 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"
},
{
"role": "assistant",
"content": "Studies eligible for inclusion in this review were controlled trials, in which one group of people received treatment (such as MD rehabilitation) and was compared with a similar group that received a different treatment. We found 19 relevant studies, which involved a total of 3480 people."
}
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query-laysum
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8640
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[
{
"role": "user",
"content": "Abstract: Background\nCorneal abrasion is a common disorder frequently faced by ophthalmologists, emergency physicians, and primary care physicians. Ocular antibiotics are one of the management options for corneal abrasion. A comprehensive summary and synthesis of the evidence on antibiotic prophylaxis in traumatic corneal abrasion is thus far unavailable, therefore we conducted this review to evaluate the current evidence regarding this important issue.\nObjectives\nTo assess the safety and efficacy of topical antibiotic prophylaxis following corneal abrasion. Our objectives were 1) to investigate the incidence of infection with antibiotics versus placebo or alternative antibiotics in people with corneal abrasion; and 2) to investigate time to clinical cure, defined as complete healing (re-epithelialization) of the epithelium, with antibiotics versus placebo or alternative antibiotics in people with corneal abrasion.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 4), Ovid MEDLINE, Embase.com, PubMed, the Latin American and Caribbean Health Sciences Literature database (LILACS), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 25 April 2021.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing antibiotic with another antibiotic or placebo in children and adults with corneal abrasion due to any cause.\nData collection and analysis\nWe used standard Cochrane methodology and assessed the certainty of the body of evidence for the prespecified outcomes using the GRADE classification.\nMain results\nOur search of the electronic databases yielded 8661 records. We screened 7690 titles and abstracts after removal of duplicates. We retrieved 32 full-text reports for further review. We included two studies that randomized a total of 527 eyes of 527 participants in the review. One study was conducted in Denmark, and one was conducted in India.\nThe two studies did not examine most of our prespecified primary and secondary outcomes. The first study was a parallel-group RCT comparing chloramphenicol ocular ointment with fusidic acid ocular gels (frequency was not clearly reported). This study enrolled 153 participants older than 5 years of age with corneal abrasion in Denmark with a one-day follow-up duration. No participants had secondary infection in the fusidic acid group, whereas three (4.1%) participants in the chloramphenicol group had a slight reaction (risk ratio [RR] 0.15, 95% confidence interval [CI] 0.01 to 2.79; 144 participants; very low certainty evidence). Thirty-one (44.3%) participants in the fusidic acid arm and 34 (46.6%) participants in the chloramphenicol arm were cured (defined as the area of abrasion zero and no infection) at day 1 (RR 0.94, 95% CI 0.65 to 1.34; 144 participants; very low certainty evidence). Without providing specific data, the study reported that the degree of pain was not affected by the interventions received. The most common adverse events reported were itching and discomfort of the eye, which occurred in approximately one-third of participants in each group (low certainty evidence).\nA second multicenter, two-arm RCT conducted in India enrolled 374 participants older than 5 years of age with corneal abrasion who presented within 48 hours after injury. This study investigated the effect of a three-day course of either ocular ointment combinations of chloramphenicol-clotrimazole or chloramphenicol-placebo (all three times daily). At day 3, 169 (100%) participants in the chloramphenicol-clotrimazole arm and 203 (99%) out of 205 participants in the chloramphenicol-placebo arm were cured without any complication, defined as complete epithelialization of the cornea without evidence of infection (RR 1.01, 95% CI 0.99 to 1.03; 374 participants; very low certainty evidence). Four participants assigned to the chloramphenicol-placebo arm experienced mild adverse events: two participants (1%) had mild chemosis and irritation, and two (1%) had small single sterile corneal infiltrates (low certainty evidence).\nAuthors' conclusions\nGiven the low to very low certainty of the available evidence, any beneficial effects of antibiotic prophylaxis in preventing ocular infection or accelerating epithelial healing following a corneal abrasion remain unclear. Moreover, the current evidence is insufficient to support any antibiotic regimen being superior to another. There is a need for a well-designed RCT assessing the efficacy and safety of ocular antibiotics in the treatment of corneal abrasion with a particular focus on high-risk populations and formulation of interventions.\n\nGiven the provided abstract, please respond to the following query: \"How is corneal abrasion managed?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Corneal abrasion causes pain and irritation, so treating physicians prescribe painkillers to help ease the pain. Some physicians may also prescribe antibiotics to prevent eye infections."
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query-laysum
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8641
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[
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"role": "user",
"content": "Abstract: Background\nChronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss.\nTopical antiseptics, one of the possible treatments for CSOM, inhibit the micro-organisms that may be responsible for the infection. Antiseptics can be used alone or in addition to other treatments for CSOM, such as antibiotics or ear cleaning (aural toileting). Antiseptics or their application can cause irritation of the skin of the outer ear, manifesting as discomfort, pain or itching. Some antiseptics (such as alcohol) may have the potential to be toxic to the inner ear (ototoxicity), with a possible increased risk of causing sensorineural hearing loss, dizziness or tinnitus.\nObjectives\nTo assess the effects of topical antiseptics for people with chronic suppurative otitis media.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL; 2019, Issue 4, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) with at least a one-week follow-up involving patients (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks.\nThe interventions were any single, or combination of, topical antiseptic agent of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure.\nTwo main comparisons were topical antiseptics compared to: a) placebo or no intervention; and b) another topical antiseptic (e.g. topical antiseptic A versus topical antiseptic B).\nWithin each comparison we separated studies where both groups of patients had received topical antiseptics a) alone or with aural toileting and b) on top of antibiotic treatment.\nData collection and analysis\nWe used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome.\nOur primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.\nMain results\nFive studies were included. It was not possible to calculate the total number of participants as two studies only provided the number of ears included in the study.\nA. Topical antiseptic (boric acid) versus placebo or no treatment (all patients had aural toileting)\nThree studies compared topical antiseptics with no treatment, with one study reporting results we could use (254 children; cluster-RCT). This compared the instillation of boric acid in alcohol drops versus no ear drops for one month (both arms used daily dry mopping). We made adjustments to the data to account for the intra-cluster correlation. The very low certainty of the evidence means it is uncertain whether or not treatment with an antiseptic leads to an increase in resolution of ear discharge at both four weeks (risk ratio (RR) 1.94, 95% confidence interval (CI) 1.20 to 3.16; 174 participants) and at three to four months (RR 1.73, 95% CI 1.21 to 2.47; 180 participants). This study narratively described no differences in suspected ototoxicity or hearing outcomes between the arms (very low-certainty evidence). None of the studies reported results for health-related quality of life, adverse effects or serious complications.\nB. Topical antiseptic A versus topical antiseptic B\nTwo studies compared different antiseptics but only one (93 participants), comparing a single instillation of boric acid powder with daily acetic acid ear drops, provided any information for this comparison. The very low certainty of the evidence means that it is uncertain whether more patients had resolution of ear discharge with boric acid powder compared to acetic acid at four weeks (RR 2.61, 95% CI 1.51 to 4.53; 93 participants), or whether there was a difference between the arms with respect to ear discomfort due to the low number of reported events (RR 0.10, 95% CI 0.01 to 1.81; 93 participants). Narratively, the study reported no difference in hearing outcomes between the groups. None of the included studies reported any of the other primary or secondary outcomes.\nAuthors' conclusions\nDue to paucity of the evidence and the very low certainty of that which is available the effectiveness and safety profile of antiseptics in the treatment of CSOM is uncertain.\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": "Chronic suppurative otitis media is a long-term (chronic) swelling and infection of the middle ear, with ear discharge (otorrhoea) through a perforated tympanic membrane (eardrum). The main symptoms are ear discharge and hearing loss.\nTopical antiseptics (antiseptics put directly into the ear as ear drops or as a powder) are sometimes used as a treatment for CSOM. Topical antiseptics kill or stop the growth of the micro-organisms that may be responsible for the infection. Topical antiseptics can be used on their own or added to other treatments for CSOM, such as antibiotics or ear cleaning (aural toileting). Applying topical antiseptics can cause irritation of the skin within the outer ear, which may cause discomfort, pain or itching. Some antiseptics (such as alcohol) can be toxic to the inner ear (ototoxicity), which means they may cause irreparable hearing loss (sensorineural), dizziness or ringing in the ear (tinnitus)."
}
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query-laysum
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8642
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[
{
"role": "user",
"content": "Abstract: Background\nFollowing sexual abuse, children and young people may develop a range of psychological problems, including anxiety, depression, post-traumatic stress disorder (PTSD), and a range of behaviour problems. Those working with children and young people experiencing these problems may use one or more of a range of psychological approaches.\nObjectives\nTo assess the relative effectiveness of psychological interventions compared to other treatments or no treatment controls, to overcome psychological consequences of sexual abuse in children and young people up to 18 years of age.\nSecondary objectives\nTo rank psychotherapies according to their effectiveness.\nTo compare different ‘doses’ of the same intervention.\nSearch methods\nIn November 2022 we searched CENTRAL, MEDLINE, Embase, PsycINFO, 12 other databases and two trials registers. We reviewed the reference lists of included studies, alongside other work in the field, and communicated with the authors of included studies.\nSelection criteria\nWe included randomised controlled trials comparing psychological interventions for sexually abused children and young people up to 18 years old with other treatments or no treatments. Interventions included: cognitive behavioural therapy (CBT), psychodynamic therapy, family therapy, child centred therapy (CCT), and eye movement desensitisation and reprocessing (EMDR). We included both individual and group formats.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and assessed the risk of bias for our primary outcomes (psychological distress/mental health, behaviour, social functioning, relationships with family and others) and secondary outcomes (substance misuse, delinquency, resilience, carer distress and efficacy).\nWe considered the effects of the interventions on all outcomes at post-treatment, six months follow-up and 12 months follow-up. For each outcome and time point with sufficient data, we performed random-effects network and pairwise meta-analyses to determine an overall effect estimate for each possible pair of therapies. Where meta-analysis was not possible, we report the summaries from single studies. Due to the low number of studies in each network, we did not attempt to determine the probabilities of each treatment being the most effective relative to the others for each outcome at each time point.\nWe rated the certainty of evidence with GRADE for each outcome.\nMain results\nWe included 22 studies (1478 participants) in this review. Most of the participants were female (range: 52% to 100%), and were mainly white. Limited information was provided on socioeconomic status of participants. Seventeen studies were conducted in North America, with the remaining studies conducted in the UK (N = 2), Iran (N = 1), Australia (N = 1) and Democratic Republic of Congo (N = 1). CBT was explored in 14 studies and CCT in eight studies; psychodynamic therapy, family therapy and EMDR were each explored in two studies. Management as usual (MAU) was the comparator in three studies and a waiting list was the comparator in five studies. For all outcomes, comparisons were informed by low numbers of studies (one to three per comparison), sample sizes were small (median = 52, range 11 to 229) and networks were poorly connected. Our estimates were all imprecise and uncertain.\nPrimary outcomes\nAt post-treatment, network meta-analysis (NMA) was possible for measures of psychological distress and behaviour, but not for social functioning. Relative to MAU, there was very low certainty evidence that CCT involving parent and child reduced PTSD (standardised mean difference (SMD) -0.87, 95% confidence intervals (CI) -1.64 to -0.10), and CBT with only the child reduced PTSD symptoms (SMD -0.96, 95% CI -1.72 to -0.20). There was no clear evidence of an effect of any therapy relative to MAU for other primary outcomes or at any other time point.\nSecondary outcomes\nCompared to MAU, there was very low certainty evidence that, at post-treatment, CBT delivered to the child and the carer might reduce parents' emotional reactions (SMD -6.95, 95% CI -10.11 to -3.80), and that CCT might reduce parents' stress. However, there is high uncertainty in these effect estimates and both comparisons were informed only by one study. There was no evidence that the other therapies improved any other secondary outcome.\nWe attributed very low levels of confidence for all NMA and pairwise estimates for the following reasons. Reporting limitations resulted in judgements of 'unclear' to 'high' risk of bias in relation to selection, detection, performance, attrition and reporting bias; the effect estimates we derived were imprecise, and small or close to no change; our networks were underpowered due to the low number of studies informing them; and whilst studies were broadly comparable with regard to settings, the use of a manual, the training of the therapists, the duration of treatment and number of sessions offered, there was considerable variability in the age of participants and the format in which the interventions were delivered (individual or group).\nAuthors' conclusions\nThere was weak evidence that both CCT (delivered to child and carer) and CBT (delivered to the child) might reduce PTSD symptoms at post-treatment. However, the effect estimates are uncertain and imprecise. For the remaining outcomes examined, none of the estimates suggested that any of the interventions reduced symptoms compared to management as usual.\nWeaknesses in the evidence base include the dearth of evidence from low- and middle-income countries. Further, not all interventions have been evaluated to the same extent, and there is little evidence regarding the effectiveness of interventions for male participants or those from different ethnicities. In 18 studies, the age ranges of participants ranged from 4 to 16 years old or 5 to 17 years old. This may have influenced the way in which the interventions were delivered, received, and consequently influenced outcomes.\nMany of the included studies evaluated interventions that were developed by members of the research team. In others, developers were involved in monitoring the delivery of the treatment. It remains the case that evaluations conducted by independent research teams are needed to reduce the potential for investigator bias.\nStudies addressing these gaps would help to establish the relative effectiveness of interventions currently used with this vulnerable population.\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 which interventions were best for treating the range of problems that can occur following sexual abuse. We wanted to find out if we could rank them in order of how well they work. For example, we wanted to find out which intervention was the best at helping children who have PTSD, or children who are depressed. Which was second best? And so on."
}
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query-laysum
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8643
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[
{
"role": "user",
"content": "Abstract: Background\nPharmaceuticals make an important contribution to people's health. Medicines, however, are frequently not used appropriately. Improving the use of medicines can improve health outcomes and save resources. On the other hand, regulatory and educational policies may have unintended effects on health and costs.\nObjectives\nTo assess the effects of pharmaceutical educational and regulatory policies targeting prescribers on medicine use, healthcare utilisation, health outcomes and costs (expenditures).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trial registries in March 2018 and several other databases between 2014 and 2018. We reviewed the reference lists of included studies and other relevant reviews, contacted authors of relevant reviews and studies to identify additional studies, and did a citation search for all included studies using ISI Web of Science (searched 05 January 2016).\nSelection criteria\nRandomised trials, non-randomised trials, interrupted time series studies, repeated measures studies and controlled before‒after studies of policies regulating who can prescribe medicines and other policies targeted at prescribers. We included in this category monitoring and enforcement of restrictions, generic prescribing, programmes to implement treatment guidelines, system-wide policies regarding monitoring medicine safety, and legislated or mandatory continuing education or quality improvement specifically targeted at prescribing. We defined 'policies' in this review as laws, rules, financial and administrative orders made by governments, non-governmental organisations or private insurers. We excluded interventions applied at the level of a single facility. For us to include a study, it had to include an objective measure of at least one of the following outcomes: medicine use, healthcare utilization, health outcomes, or costs.\nData collection and analysis\nTwo review authors independently reviewed abstracts and reference lists of relevant reports, assessed full-text studies for inclusion, extracted data, and assessed risk of bias and certainty of the evidence (GRADE). For all the steps in the above process we resolved disagreements by discussion.\nMain results\nWe identified two studies that met our selection criteria: a controlled interrupted time series study evaluating a regulatory policy involving the monitoring of prescribing of benzodiazepines; and a controlled before‒after study of an educational policing involving mailed educational materials on prescribing for physicians and Health Maintenance Organization (HMO) members as well as an intervention to regulate drug reimbursement.\nWe are uncertain about the effects on medicine use of a regulatory policy involving the monitoring of prescribing with triplicate prescriptions, compared with no regulatory intervention (very low certainty evidence).\nWe are also uncertain about the effects on medicine use, assessed through doctors' prescribing, and costs of an educational policy involving mailed educational materials on prescribing for physicians and HMO members, compared to no educational intervention or an intervention to regulate drug reimbursement (very low certainty evidence).\nNeither of the included studies measured healthcare utilization, health outcomes, or additional costs, if any, to patients.\nAuthors' conclusions\nWe are uncertain of the effects of educational or regulatory policies targeting prescribers due to very limited evidence of very low certainty. The impacts of these policies therefore need to be evaluated rigorously using appropriate study designs. Evaluations are needed across a range of settings, including low- and middle-income countries, and across different types of prescribers and medicines.\n\nGiven the provided abstract, please respond to the following query: \"What are educational and regulatory policies?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Large amounts of health care funds are spent on medicines, and these amounts are increasing. And healthcare providers do not always prescribe the right medicines. Policy makers are therefore looking for ways to control the costs of medicines but still making sure that patients get the medicines they need. Governments, non-governmental organisations and health insurers sometimes try to do this through targeting the people who prescribe the medicines.\nOne way of doing this is to introduce educational policies. This can include laws, rules and regulations that require medicine prescribers to get certain types of information, education or feedback about their prescribing behaviour.\nAnother approach is to introduce regulatory policies. This can include laws, rules and regulations regarding who can prescribe medicines, what type of medicines they can prescribe and how much they can prescribe. Usually, prescribers are monitored to make sure they follow these policies."
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query-laysum
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8644
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[
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis, a common joint disorder, is one of the leading causes of disability. Chondroitin has emerged as a new treatment. Previous meta-analyses have shown contradictory results on the efficacy of chondroitin. This, in addition to the publication of more trials, necessitates a systematic review.\nObjectives\nTo evaluate the benefit and harm of oral chondroitin for treating osteoarthritis compared with placebo or a comparator oral medication including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, opioids, and glucosamine or other \"herbal\" medications.\nSearch methods\nWe searched seven databases up to November 2013, including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, CINAHL, EMBASE, Science Citation Index (Web of Science) and Current Controlled Trials. We searched the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) websites for adverse effects. Trial registers were not searched.\nSelection criteria\nAll randomized or quasi-randomized clinical trials lasting longer than two weeks, studying adults with osteoarthritis in any joint, and comparing chondroitin with placebo, an active control such as NSAIDs, or other \"herbal\" supplements such as glucosamine.\nData collection and analysis\nTwo review authors independently performed all title assessments, data extractions, and risk of bias assessments.\nMain results\nForty-three randomized controlled trials including 4,962 participants treated with chondroitin and 4,148 participants given placebo or another control were included. The majority of trials were in knee OA, with few in hip and hand OA. Trial duration varied from 1 month to 3 years. Participants treated with chondroitin achieved statistically significantly and clinically meaningful better pain scores (0-100) in studies less than 6 months than those given placebo with an absolute risk difference of 10% lower (95% confidence interval (CI), 15% to 6% lower; number needed to treat (NNT) = 5 (95% CI, 3 to 8; n = 8 trials) (level of evidence, low; risk of bias, high); but there was high heterogeneity between the trials (T2 = 0.07; I2 = 70%, which was not easily explained by differences in risk of bias or study sample size). In studies longer than 6 months, the absolute risk difference for pain was 9% lower (95% CI 18% lower to 0%); n = 6 trials; T2 = 0.18; I2 = 83% ), again with low level of evidence.\nFor the Western Ontario and McMaster Universities Osteoarthritis Index Minimal Clinically Important Improvement (WOMAC MCII Pain subscale) outcome, a reduction in knee pain by 20% was achieved by 53/100 in the chondroitin group versus 47/100 in the placebo group, an absolute risk difference of 6% (95% CI 1% to 11%), (RR 1.12, 95% CI 1.01 to 1.24; T2 = 0.00; I2 = 0%) (n = 2 trials, 1253 participants; level of evidence, high; risk of bias, low).\nDifferences in Lequesne's index (composite of pain,function and disability) statistically significantly favoured chondroitin as compared with placebo in studies under six months, with an absolute risk difference of 8% lower (95% CI 12% to 5% lower; T2= 0.78; n = 7 trials) (level of evidence, moderate; risk of bias, unclear), also clinically meaningful. Loss of minimum joint space width in the chondroitin group was statistically significantly less than in the placebo group, with a relative risk difference of 4.7% less (95% CI 1.6% to 7.8% less; n = 2 trials) (level of evidence, high; risk of bias, low). Chondroitin was associated with statistically significantly lower odds of serious adverse events compared with placebo with Peto odds ratio of 0.40 (95% CI 0.19 to 0.82; n = 6 trials) (level of evidence, moderate). Chondroitin did not result in statistically significant numbers of adverse events or withdrawals due to adverse events compared with placebo or another drug. Adverse events were reported in a limited fashion, with some studies providing data and others not.\nComparisons of chondroitin taken alone or in combination with glucosamine or another supplement showed a statistically significant reduction in pain (0-100) when compared with placebo or an active control, with an absolute risk difference of 10% lower (95% CI 14% to 5% lower); NNT = 4 (95% CI 3 to 6); T2 = 0.33; I2 = 91%; n = 17 trials) (level of evidence, low). For physical function, chondroitin in combination with glucosamine or another supplement showed no statistically significant difference from placebo or an active control, with an absolute risk difference of 1% lower (95% CI 6% lower to 3% higher with T2 = 0.04; n = 5 trials) (level of evidence, moderate). Differences in Lequesne's index statistically significantly favoured chondroitin as compared with placebo, with an absolute risk difference of 8% lower (95% CI, 12% to 4% lower; T2 = 0.12; n = 10 trials) (level of evidence, moderate). Chondroitin in combination with glucosamine did not result in statistically significant differences in the numbers of adverse events, withdrawals due to adverse events, or in the numbers of serious adverse events compared with placebo or with an active control.\nThe beneficial effects of chondroitin in pain and Lequesne's index persisted when evidence was limited to studies with adequate blinding or studies that used appropriate intention to treat (ITT) analyses. These beneficial effects were uncertain when we limited data to studies with appropriate allocation concealment or a large study sample (> 200) or to studies without pharmaceutical funding.\nAuthors' conclusions\nA review of randomized trials of mostly low quality reveals that chondroitin (alone or in combination with glucosamine) was better than placebo in improving pain in participants with osteoarthritis in short-term studies. The benefit was small to moderate with an 8 point greater improvement in pain (range 0 to 100) and a 2 point greater improvement in Lequesne's index (range 0 to 24), both likely clinically meaningful. These differences persisted in some sensitivity analyses and not others. Chondroitin had a lower risk of serious adverse events compared with control. More high-quality studies are needed to explore the role of chondroitin in the treatment of osteoarthritis. The combination of some efficacy and low risk associated with chondroitin may explain its popularity among patients as an over-the-counter supplement.\n\nGiven the provided abstract, please respond to the following query: \"1Western Ontario and McMaster Universities Osteoarthritis Index\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Western Ontario and McMaster Universities Osteoarthritis Index"
}
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8645
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[
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is important to guide appropriate management, to reduce morbidity and to improve survival. Basal cell carcinoma (BCC) is almost always a localised skin cancer with potential to infiltrate and damage surrounding tissue, whereas a minority of cutaneous squamous cell carcinomas (cSCCs) and invasive melanomas are higher-risk skin cancers with the potential to metastasise and cause death. Dermoscopy has become an important tool to assist specialist clinicians in the diagnosis of melanoma, and is increasingly used in primary-care settings. Dermoscopy is a precision-built handheld illuminated magnifier that allows more detailed examination of the skin down to the level of the superficial dermis. Establishing the value of dermoscopy over and above visual inspection for the diagnosis of BCC or cSCC in primary- and secondary-care settings is critical to understanding its potential contribution to appropriate skin cancer triage, including referral of higher-risk cancers to secondary care, the identification of low-risk skin cancers that might be treated in primary care and to provide reassurance to those with benign skin lesions who can be safely discharged.\nObjectives\nTo determine the diagnostic accuracy of visual inspection and dermoscopy, alone or in combination, for the detection of (a) BCC and (b) cSCC, in adults. We separated studies according to whether the diagnosis was recorded face-to-face (in person) or based on remote (image-based) assessment.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.\nSelection criteria\nStudies of any design that evaluated visual inspection or dermoscopy or both in adults with lesions suspicious for skin cancer, compared with a reference standard of either histological confirmation or clinical follow-up.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic thresholds were missing. We estimated accuracy using hierarchical summary ROC methods. We undertook analysis of studies allowing direct comparison between tests. To facilitate interpretation of results, we computed values of sensitivity at the point on the SROC curve with 80% fixed specificity and values of specificity with 80% fixed sensitivity. We investigated the impact of in-person test interpretation; use of a purposely-developed algorithm to assist diagnosis; and observer expertise.\nMain results\nWe included 24 publications reporting on 24 study cohorts, providing 27 visual inspection datasets (8805 lesions; 2579 malignancies) and 33 dermoscopy datasets (6855 lesions; 1444 malignancies). The risk of bias was mainly low for the index test (for dermoscopy evaluations) and reference standard domains, particularly for in-person evaluations, and high or unclear for participant selection, application of the index test for visual inspection and for participant flow and timing. We scored concerns about the applicability of study findings as of ‘high’ or 'unclear' concern for almost all studies across all domains assessed. Selective participant recruitment, lack of reproducibility of diagnostic thresholds and lack of detail on observer expertise were particularly problematic.\nThe detection of BCC was reported in 28 datasets; 15 on an in-person basis and 13 image-based. Analysis of studies by prior testing of participants and according to observer expertise was not possible due to lack of data. Studies were primarily conducted in participants referred for specialist assessment of lesions with available histological classification. We found no clear differences in accuracy between dermoscopy studies undertaken in person and those which evaluated images. The lack of effect observed may be due to other sources of heterogeneity, including variations in the types of skin lesion studied, in dermatoscopes used, or in the use of algorithms and varying thresholds for deciding on a positive test result.\nMeta-analysis found in-person evaluations of dermoscopy (7 evaluations; 4683 lesions and 363 BCCs) to be more accurate than visual inspection alone for the detection of BCC (8 evaluations; 7017 lesions and 1586 BCCs), with a relative diagnostic odds ratio (RDOR) of 8.2 (95% confidence interval (CI) 3.5 to 19.3; P < 0.001). This corresponds to predicted differences in sensitivity of 14% (93% versus 79%) at a fixed specificity of 80% and predicted differences in specificity of 22% (99% versus 77%) at a fixed sensitivity of 80%. We observed very similar results for the image-based evaluations.\nWhen applied to a hypothetical population of 1000 lesions, of which 170 are BCC (based on median BCC prevalence across studies), an increased sensitivity of 14% from dermoscopy would lead to 24 fewer BCCs missed, assuming 166 false positive results from both tests. A 22% increase in specificity from dermoscopy with sensitivity fixed at 80% would result in 183 fewer unnecessary excisions, assuming 34 BCCs missed for both tests. There was not enough evidence to assess the use of algorithms or structured checklists for either visual inspection or dermoscopy.\nInsufficient data were available to draw conclusions on the accuracy of either test for the detection of cSCCs.\nAuthors' conclusions\nDermoscopy may be a valuable tool for the diagnosis of BCC as an adjunct to visual inspection of a suspicious skin lesion following a thorough history-taking including assessment of risk factors for keratinocyte cancer. The evidence primarily comes from secondary-care (referred) populations and populations with pigmented lesions or mixed lesion types. There is no clear evidence supporting the use of currently-available formal algorithms to assist dermoscopy diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"Who do the results of this review apply to?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Eleven studies were done in Europe (46%), and the rest in North America (n = 3), Asia (n = 5), Oceania (n = 2), or multiple countries (n = 3). People included in the studies were on average between 30 and 74 years old. The percentage of people with BCC ranged between 1% and 61% for in-person studies and between 2% and 63% in studies using images. Almost all studies were done with people referred from primary care to specialist skin clinics. Over half of studies considered the ability of dermoscopy and visual inspection to diagnose any skin cancer, including melanoma and BCC, while 10 (42%) focused on just BCC. Variation in the expertise of doctors doing the examinations and differences in the definitions used to decide when a test was positive make it unclear how dermoscopy should be carried out and what level of training is needed in order to achieve the accuracy observed in studies."
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query-laysum
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8646
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[
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"role": "user",
"content": "Abstract: Background\nSelf-harm (SH; intentional self-poisoning or self-injury regardless of degree of suicidal intent or other types of motivation) is a growing problem in most countries, often repeated, and associated with suicide. Evidence assessing the effectiveness of interventions in the treatment of SH in children and adolescents is lacking, especially when compared with the evidence for psychosocial interventions in adults. This review therefore updates a previous Cochrane Review (last published in 2015) on the role of interventions for SH in children and adolescents.\nObjectives\nTo assess the effects of psychosocial interventions or pharmacological agents or natural products for SH compared to comparison types of care (e.g. treatment-as-usual, routine psychiatric care, enhanced usual care, active comparator, placebo, alternative pharmacological treatment, or a combination of these) for children and adolescents (up to 18 years of age) who engage in SH.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Specialized Register, the Cochrane Library (Central Register of Controlled Trials [CENTRAL] and Cochrane Database of Systematic Reviews [CDSR]), together with MEDLINE, Ovid Embase, and PsycINFO (to 4 July 2020).\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing specific psychosocial interventions or pharmacological agents or natural products with treatment-as-usual (TAU), routine psychiatric care, enhanced usual care (EUC), active comparator, placebo, alternative pharmacological treatment, or a combination of these, in children and adolescents with a recent (within six months of trial entry) episode of SH resulting in presentation to hospital or clinical services. The primary outcome was the occurrence of a repeated episode of SH over a maximum follow-up period of two years. Secondary outcomes included treatment adherence, depression, hopelessness, general functioning, social functioning, suicidal ideation, and suicide.\nData collection and analysis\nWe independently selected trials, extracted data, and appraised trial quality. For binary outcomes, we calculated odds ratios (ORs) and their 95% confidence internals (CIs). For continuous outcomes, we calculated the mean difference (MD) or standardised mean difference (SMD) and 95% CIs. The overall quality of evidence for the primary outcome (i.e. repetition of SH at post-intervention) was appraised for each intervention using the GRADE approach.\nMain results\nWe included data from 17 trials with a total of 2280 participants. Participants in these trials were predominately female (87.6%) with a mean age of 14.7 years (standard deviation (SD) 1.5 years). The trials included in this review investigated the effectiveness of various forms of psychosocial interventions. None of the included trials evaluated the effectiveness of pharmacological agents in this clinical population. There was a lower rate of SH repetition for DBT-A (30%) as compared to TAU, EUC, or alternative psychotherapy (43%) on repetition of SH at post-intervention in four trials (OR 0.46, 95% CI 0.26 to 0.82; N = 270; k = 4; high-certainty evidence). There may be no evidence of a difference for individual cognitive behavioural therapy (CBT)-based psychotherapy and TAU for repetition of SH at post-intervention (OR 0.93, 95% CI 0.12 to 7.24; N = 51; k = 2; low-certainty evidence). We are uncertain whether mentalisation based therapy for adolescents (MBT-A) reduces repetition of SH at post-intervention as compared to TAU (OR 0.70, 95% CI 0.06 to 8.46; N = 85; k = 2; very low-certainty evidence). Heterogeneity for this outcome was substantial ( I² = 68%). There is probably no evidence of a difference between family therapy and either TAU or EUC on repetition of SH at post-intervention (OR 1.00, 95% CI 0.49 to 2.07; N = 191; k = 2; moderate-certainty evidence). However, there was no evidence of a difference for compliance enhancement approaches on repetition of SH by the six-month follow-up assessment, for group-based psychotherapy at the six- or 12-month follow-up assessments, for a remote contact intervention (emergency cards) at the 12-month assessment, or for therapeutic assessment at the 12- or 24-month follow-up assessments.\nAuthors' conclusions\nGiven the moderate or very low quality of the available evidence, and the small number of trials identified, there is only uncertain evidence regarding a number of psychosocial interventions in children and adolescents who engage in SH. Further evaluation of DBT-A is warranted. Given the evidence for its benefit in adults who engage in SH, individual CBT-based psychotherapy should also be further developed and evaluated in children and adolescents.\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"
},
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"role": "assistant",
"content": "We recommend further trials of DBT-A. Given the evidence for its benefit for adults who engage in SH, individual CBT-based psychotherapy should also be further developed and evaluated in children and adolescents. Given the extent of SH in children and adolescents, greater attention should be paid to the development and evaluation of specific therapies for this population."
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8647
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[
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"role": "user",
"content": "Abstract: Background\nMinor oral surgery or dental extractions (oral or dental procedures) are widely performed and can be complicated by hazardous oral bleeding, especially in people with an inherited bleeding disorder such as haemophilia or Von Willebrand disease (VWD). The amount and severity of singular bleedings depend on disease-related factors, such as the severity of the haemophilia, both local and systemic patient factors (such as periodontal inflammation, vasculopathy or platelet dysfunction) and intervention-related factors (such as the type and number of teeth extracted or the dimension of the wound surface). Similar to local haemostatic measures and suturing, antifibrinolytic therapy is a cheap, safe and potentially effective treatment to prevent bleeding complications in individuals with bleeding disorders undergoing oral or dental procedures. However, a systematic review of trials reporting outcomes after oral surgery or a dental procedure in people with an inherited bleeding disorder, with or without, the use of antifibrinolytic agents has not been performed to date. This is an update of a previously published Cochrane Review.\nObjectives\nPrimarily, we aim to assess the efficacy of antifibrinolytic agents to prevent bleeding complications in people with haemophilia or VWD undergoing oral or dental procedures.\nSecondary objectives are to assess if antifibrinolytic agents can replace or reduce the need for clotting factor concentrate therapy in people with haemophilia or VWD and to establish the effects of these agents on bleeding in oral or dental procedures for each of these patient populations.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, compiled from electronic database searches of the Cochrane Central Register of Controlled Trials (CENTRAL), of MEDLINE and from handsearching of journals and conference abstract books. We additionally searched the reference lists of relevant articles and reviews. We searched PubMed, Embase, Cinahl and the Cochrane Library. Additional searches were performed in ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP).\nDate of last search of the Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register: 01 March 2019.\nSelection criteria\nRandomised and quasi-randomised controlled trials in people with haemophilia or VWD undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid or epsilon aminocaproic acid (EACA)) to prevent perioperative bleeding compared to no intervention or usual care with or without placebo.\nData collection and analysis\nTwo authors independently screened the titles and abstracts of all identified articles. Full texts were obtained for potentially relevant abstracts and two authors independently assessed these for inclusion based on the selection criteria. A third author verified trial eligibility. Two authors independently performed data extraction and risk of bias assessments using standardised forms.\nMain results\nWhile there were no eligible trials in people with VWD identified, two randomised, double-blind, placebo-controlled trials (total of 59 participants) in people with haemophilia undergoing dental extraction were included. One trial of tranexamic acid published in 1972 included 28 participants with mild, moderate or severe haemophilia A and B and one of EACA published in 1971 included 31 people with haemophilia with factor VIII or factor IX levels less than 15%. Overall, the two included trials showed a beneficial effect of tranexamic acid and EACA, administered systemically, in reducing the number of bleedings, the amount of blood loss and the need for therapeutic clotting factor concentrates. Regarding postoperative bleeding, the tranexamic acid trial showed a risk difference (RD) of -0.64 (95% confidence interval (CI) -0.93 to - 0.36) and the EACA trial a RD of -0.50 (95% CI 0.77 to -0.22). The combined RD of both trials was -0.57 (95% CI -0.76 to -0.37), with the quality of the evidence (GRADE) for this outcome is rated as moderate. Side effects occurred once and required stopping EACA (combined RD of -0.03 (95% CI -0.08 to 0.13). There was heterogeneity between the two trials regarding the proportion of people with severe haemophilia included, the concomitant standard therapy and fibrinolytic agent treatment regimens used. We cannot exclude that a selection bias has occurred in the EACA trial, but overall the risk of bias appeared to be low for both trials.\nAuthors' conclusions\nDespite the discovery of a beneficial effect of systemically administered tranexamic acid and EACA in preventing postoperative bleeding in people with haemophilia undergoing dental extraction, the limited number of randomised controlled trials identified, in combination with the small sample sizes and heterogeneity regarding standard therapy and treatment regimens between the two trials, do not allow us to conclude definite efficacy of antifibrinolytic therapy in oral or dental procedures in people with haemophilia. No trials were identified in people with VWD.\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": "Overall, the two included trials showed a reduction in the number of bleeds after dental extraction, in the amount of blood loss, and in the need for clotting factor concentrates in the people treated with tranexamic acid or epsilon aminocaproic acid tablets compared to those who received a placebo. When combining the results of both trials it appeared that antifibrinolytic medication roughly halves the bleeding rate after dental extraction and the trials reported. Side effects of the antifibrinolytic medicine rarely occurred and led to discontinuation of epsilon aminocaproic acid tablets in only one case."
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8648
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"role": "user",
"content": "Abstract: Background\nObservational studies of increasingly better quality and in different settings suggest that planned hospital birth in many places does not reduce mortality and morbidity but increases the frequency of interventions and complications. Euro-Peristat (part of the European Union's Health Monitoring Programme) has raised concerns about iatrogenic effects of obstetric interventions, and the World Health Organization (WHO) has raised concern that the increasing medicalisation of childbirth tends to undermine women’s own capability to give birth and negatively impacts their childbirth experience. This is an update of a Cochrane Review first published in 1998, and previously updated in 2012.\nObjectives\nTo compare the effects of planned hospital birth with planned home birth attended by a midwife or others with midwifery skills and backed up by a modern hospital system in case a transfer to hospital should turn out to be necessary. The primary focus is on women with an uncomplicated pregnancy and low risk of medical intervention during birth.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, WHO ICTRP, and conference proceedings), ClinicalTrials.gov (16 July 2021), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing planned hospital birth with planned home birth in low-risk women as described in the objectives. Cluster-randomised trials, quasi-randomised trials, and trials published only as an abstract were also eligible.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked the data for accuracy. We contacted study authors for additional information. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included one trial involving 11 participants. This was a small feasibility study to show that well-informed women - contrary to common beliefs - were prepared to be randomised. This update did not identify any additional studies for inclusion, but excluded one study that had been awaiting assessment. The included study was at high risk of bias for three out of seven risk of bias domains. The trial did not report on five of the seven primary outcomes, and reported zero events for one primary outcome (caesarean section), and non-zero events for the remaining primary outcome (baby not breastfed). Maternal mortality, perinatal mortality (non-malformed), Apgar < 7 at 5 minutes, transfer to neonatal intensive care unit, and maternal satisfaction were not reported. The overall certainty of the evidence for the two reported primary outcomes was very low according to our GRADE assessment (downgraded two levels for high overall risk of bias (due to high risk of bias arising from lack of blinding, high risk of selective reporting and lack of ability to check for publication bias) and two levels for very serious imprecision (single study with few events)).\nAuthors' conclusions\nThis review shows that for selected, low-risk pregnant women, the evidence from randomised trials to support that planned hospital birth reduces maternal or perinatal mortality, morbidity, or any other critical outcome is uncertain. As the quality of evidence in favour of home birth from observational studies seems to be steadily increasing, it might be just as important to prepare a regularly updated systematic review including observational studies as described in the Cochrane Handbook for Systematic Reviews of Interventions as to attempt to set up new RCTs. As women and healthcare practitioners may be aware of evidence from observational studies, and as the International Federation of Gynecology and Obstetrics and the International Confederation of Midwives collaboratively conclude that there is strong evidence that out-of-hospital birth supported by a registered midwife is safe, equipoise may no longer exist, and randomised trials may now thus be considered unethical or hardly feasible.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is not enough evidence from RCTs (considered the best form of evidence of effectiveness) to allow firm conclusions to be drawn. Also, further RCTs are not considered feasible, and they are no longer considered appropriate by many midwives, obstetricians, and parents. As the quality of evidence from observational studies is steadily increasing, it might be useful to include evidence from properly performed systematic reviews of observational studies in future updates of this review."
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8650
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[
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"role": "user",
"content": "Abstract: Background\nDevelopmental co-ordination disorder (DCD) is a common childhood disorder, which can persist into adolescence and adulthood. Children with DCD have difficulties in performing the essential motor tasks required for self-care, academic, social and recreational activities.\nObjectives\nTo assess the effectiveness of task-oriented interventions on movement performance, psychosocial functions, activity, and participation for children with DCD and to examine differential intervention effects as a factor of age, sex, severity of DCD, intervention intensity, and type of intervention.\nSearch methods\nIn March 2017, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, 13 other databases, and five trials registers. We also searched reference lists, and contacted members of the mailing list of the International Conference on DCD to identify additional studies.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs that compared the task-oriented intervention with either an inactive control intervention or an active control intervention in children and adolescents aged four to 18 years with a diagnosis of DCD.\nTypes of outcome measures included changes in motor function, as assessed by standardised performance outcome tests and questionnaires; adverse events; and measures of participation.\nData collection and analysis\nAll review authors participated in study selection, data extraction, and assessments of risk of bias and quality, and two review authors independently performed all tasks. Specifically, two review authors independently screened titles and abstracts to eliminate irrelevant studies, extracted data from the included studies, assessed risk of bias, and rated the quality of the evidence using the GRADE approach. In cases of ambiguity or information missing from the paper, one review author contacted trial authors.\nMain results\nThis review included 15 studies (eight RCTs and seven quasi-RCTs).\nStudy characteristics\nThe trials included 649 participants of both sexes, ranging in age from five to 12 years.\nThe participants were from Australia, Canada, China, Sweden, Taiwan, and the UK.\nTrials were conducted in hospital settings; at a university-based clinic, laboratory, or centre; in community centres; at home or school, or both at home and school.\nThe durations of task-oriented interventions were mostly short term (less than six months), with the total number of sessions ranging from five to 50. The length of each session ranged from 30 to 90 minutes, and the frequencies ranged from once to seven times per week.\nWe judged the risk of bias as moderate to high across the studies. Some elements were impossible to achieve (such as blinding of administering personnel or participants).\nKey results: primary outcomes\nA meta-analysis of two RCTs and four quasi-RCTs found in favour of task-oriented interventions for improved motor performance compared to no intervention (mean difference (MD) -3.63, 95% confidence interval (CI) -5.88 to -1.39; P = 0.002; I2 = 43%; 6 trials, 169 children; very low-quality evidence).\nA meta-analysis of two RCTs found no effect of task-oriented interventions for improved motor performance compared to no intervention (MD -2.34, 95% CI -7.50 to 2.83; P = 0.38; I2 = 42%; 2 trials, 51 children; low-quality evidence).\nTwo studies reported no adverse effects or events. Through personal correspondence, the authors of nine studies indicated that no injuries had occurred.\nKey results: secondary outcomes\nDue to the limited number of studies with complete and consistent data, we were unable to perform any meta-analyses on our secondary measures or any subgroup analysis on age, sex, severity of DCD, and intervention intensity.\nAuthors' conclusions\nWe have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. The conclusions drawn from previous reviews, which unanimously reported beneficial effects of intervention, are inconsistent with our conclusions. This review highlights the need for carefully designed and executed RCTs to investigate the effect of interventions for children with DCD.\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 for the effects of interventions that aim to practise real-life tasks on the movement skills of children with developmental co-ordination disorder (DCD)."
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query-laysum
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8651
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[
{
"role": "user",
"content": "Abstract: Background\nAge-related macular degeneration (AMD) is a common eye disease and leading cause of sight loss worldwide. Despite its high prevalence and increasing incidence as populations age, AMD remains incurable and there are no treatments for most patients. Mounting genetic and molecular evidence implicates complement system overactivity as a key driver of AMD development and progression. The last decade has seen the development of several novel therapeutics targeting complement in the eye for the treatment of AMD. This review update encompasses the results of the first randomised controlled trials in this field.\nObjectives\nTo assess the effects and safety of complement inhibitors in the prevention or treatment of AMD.\nSearch methods\nWe searched CENTRAL on the Cochrane Library, MEDLINE, Embase, LILACS, Web of Science, ISRCTN registry, ClinicalTrials.gov, and the WHO ICTRP to 29 June 2022 with no language restrictions. We also contacted companies running clinical trials for unpublished data.\nSelection criteria\nWe included randomised controlled trials (RCTs) with parallel groups and comparator arms that studied complement inhibition for advanced AMD prevention/treatment.\nData collection and analysis\nTwo authors independently assessed search results and resolved discrepancies through discussion. Outcome measures evaluated at one year included change in best-corrected visual acuity (BCVA), untransformed and square root-transformed geographic atrophy (GA) lesion size progression, development of macular neovascularisation (MNV) or exudative AMD, development of endophthalmitis, loss of ≥ 15 letters of BCVA, change in low luminance visual acuity, and change in quality of life. We assessed risk of bias and evidence certainty using Cochrane risk of bias and GRADE tools.\nMain results\nTen RCTs with 4052 participants and eyes with GA were included. Nine evaluated intravitreal (IVT) administrations against sham, and one investigated an intravenous agent against placebo. Seven studies excluded patients with prior MNV in the non-study eye, whereas the three pegcetacoplan studies did not. The risk of bias in the included studies was low overall. We also synthesised results of two intravitreal agents (lampalizumab, pegcetacoplan) at monthly and every-other-month (EOM) dosing intervals.\nEfficacy and safety of IVT lampalizumab versus sham for GA\nFor 1932 participants in three studies, lampalizumab did not meaningfully change BCVA given monthly (+1.03 letters, 95% confidence interval (CI) −0.19 to 2.25) or EOM (+0.22 letters, 95% CI −1.00 to 1.44) (high-certainty evidence). For 1920 participants, lampalizumab did not meaningfully change GA lesion growth given monthly (+0.07 mm², 95% CI −0.09 to 0.23; moderate-certainty due to imprecision) or EOM (+0.07 mm², 95% CI −0.05 to 0.19; high-certainty). For 2000 participants, lampalizumab may have also increased MNV risk given monthly (RR 1.77, 95% CI 0.73 to 4.30) and EOM (RR 1.70, 95% CI 0.67 to 4.28), based on low-certainty evidence. The incidence of endophthalmitis in patients treated with monthly and EOM lampalizumab was 4 per 1000 (0 to 87) and 3 per 1000 (0 to 62), respectively, based on moderate-certainty evidence.\nEfficacy and safety of IVT pegcetacoplan versus sham for GA\nFor 242 participants in one study, pegcetacoplan probably did not meaningfully change BCVA given monthly (+1.05 letters, 95% CI −2.71 to 4.81) or EOM (−1.42 letters, 95% CI −5.25 to 2.41), as supported by moderate-certainty evidence. In contrast, for 1208 participants across three studies, pegcetacoplan meaningfully reduced GA lesion growth when given monthly (−0.38 mm², 95% CI −0.57 to −0.19) and EOM (−0.29 mm², 95% CI −0.44 to −0.13), with high certainty. These reductions correspond to 19.2% and 14.8% versus sham, respectively. A post hoc analysis showed possibly greater benefits in 446 participants with extrafoveal GA given monthly (−0.67 mm², 95% CI −0.98 to −0.36) and EOM (−0.60 mm², 95% CI −0.91 to −0.30), representing 26.1% and 23.3% reductions, respectively. However, we did not have data on subfoveal GA growth to undertake a formal subgroup analysis. In 1502 participants, there is low-certainty evidence that pegcetacoplan may have increased MNV risk when given monthly (RR 4.47, 95% CI 0.41 to 48.98) or EOM (RR 2.29, 95% CI 0.46 to 11.35). The incidence of endophthalmitis in patients treated with monthly and EOM pegcetacoplan was 6 per 1000 (1 to 53) and 8 per 1000 (1 to 70) respectively, based on moderate-certainty evidence.\nEfficacy and safety of IVT avacincaptad pegol versus sham for GA\nIn a study of 260 participants with extrafoveal or juxtafoveal GA, monthly avacincaptad pegol probably did not result in a clinically meaningful change in BCVA at 2 mg (+1.39 letters, 95% CI −5.89 to 8.67) or 4 mg (−0.28 letters, 95% CI −8.74 to 8.18), based on moderate-certainty evidence. Despite this, the drug was still found to have probably reduced GA lesion growth, with estimates of 30.5% reduction at 2 mg (−0.70 mm², 95% CI −1.99 to 0.59) and 25.6% reduction at 4 mg (−0.71 mm², 95% CI −1.92 to 0.51), based on moderate-certainty evidence. Avacincaptad pegol may have also increased the risk of developing MNV (RR 3.13, 95% CI 0.93 to 10.55), although this evidence is of low certainty. There were no cases of endophthalmitis reported in this study.\nAuthors' conclusions\nDespite confirmation of the negative findings of intravitreal lampalizumab across all endpoints, local complement inhibition with intravitreal pegcetacoplan meaningfully reduces GA lesion growth relative to sham at one year. Inhibition of complement C5 with intravitreal avacincaptad pegol is also an emerging therapy with probable benefits on anatomical endpoints in the extrafoveal or juxtafoveal GA population. However, there is currently no evidence that complement inhibition with any agent improves functional endpoints in advanced AMD; further results from the phase 3 studies of pegcetacoplan and avacincaptad pegol are eagerly awaited. Progression to MNV or exudative AMD is a possible emergent adverse event of complement inhibition, requiring careful consideration should these agents be used clinically. Intravitreal administration of complement inhibitors is probably associated with a small risk of endophthalmitis, which may be higher than that of other intravitreal therapies. Further research is likely to have an important impact on our confidence in the estimates of adverse effects and may change these. The optimal dosing regimens, treatment duration, and cost-effectiveness of such therapies are yet to be established.\n\nGiven the provided abstract, please respond to the following query: \"How is age-related macular degeneration treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Currently, there is no cure for AMD, and while there are treatments available for the 'wet' type, no therapies are available for most of the 95% of patients with the 'dry' form. However, a new treatment option, pegcetacoplan, which blocks complement, has recently been approved in the US for treating severe 'dry' AMD."
}
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query-laysum
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8652
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[
{
"role": "user",
"content": "Abstract: Background\nPostoperative pain remains a significant problem following paediatric surgery. Premedication with a suitable agent may improve its management. Clonidine is an alpha-2 adrenergic agonist which has sedative, anxiolytic and analgesic properties. It may therefore be a useful premedication for reducing postoperative pain in children.\nObjectives\nTo evaluate the evidence for the effectiveness of clonidine, when given as a premedication, in reducing postoperative pain in children less than 18 years of age. We also sought evidence of any clinically significant side effects.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 12, 2012), Ovid MEDLINE (1966 to 21 December 2012) and Ovid EMBASE (1982 to 21 December 2012), as well as reference lists of other relevant articles and online trial registers.\nSelection criteria\nWe included all randomized (or quasi-randomized), controlled trials comparing clonidine premedication to placebo, a higher dose of clonidine, or another agent when used for surgical or other invasive procedures in children under the age of 18 years and where pain or a surrogate (principally the need for supplementary analgesia) was reported.\nData collection and analysis\nTwo authors independently performed the database search, decided on the inclusion eligibility of publications, ascertained study quality and extracted data. They then resolved any differences between their results by discussion. The data were entered into RevMan 5 for analyses and presentation. Sensitivity analyses were performed, as appropriate, to exclude studies with a high risk of bias.\nMain results\nWe identified 11 trials investigating a total of 742 children in treatment arms relevant to our study question. Risks of bias in the studies were mainly low or unclear, but two studies had aspects of their methodology that had a high risk of bias. Overall, the quality of the evidence from pooled studies was low or had unclear risk of bias. Four trials compared clonidine with a placebo or no treatment, six trials compared clonidine with midazolam, and one trial compared clonidine with fentanyl. There was substantial methodological heterogeneity between trials; the dose and route of clonidine administration varied as did the patient populations, the types of surgery and the outcomes measured. It was therefore difficult to combine the outcomes of some trials for meta-analysis.\nWhen clonidine was compared to placebo, pooling studies of low or unclear risk of bias, the need for additional analgesia was reduced when clonidine premedication was given orally at 4 µg/kg (risk ratio (RR) 0.24, 95% confidence interval (CI) 0.11 to 0.51). Only one small trial (15 patients per arm) compared clonidine to midazolam for the same outcome; this also found a reduction in the need for additional postoperative analgesia (RR 0.25, 95% CI 0.09 to 0.71) when clonidine premedication was given orally at 2 or 4 µg/kg compared to oral midazolam at 0.5 mg/kg. A trial comparing oral clonidine at 4 µg/kg with intravenous fentanyl at 3 µg/kg found no statistically significant difference in the need for rescue analgesia (RR 0.89, 95% CI 0.56 to 1.42). When clonidine 4 µg/kg was compared to clonidine 2 µg/kg, there was a statistically significant difference in the number of patients requiring additional analgesia, in favour of the higher dose, as reported by a single, higher-quality trial (RR 0.38, 95% CI 0.23 to 0.65).\nThe effect of clonidine on pain scores was hard to interpret due to differences in study methodology, the doses and route of drug administration, and the pain scale used. However, when given at a dose of 4 µg/kg, clonidine may have reduced analgesia requirements after surgery. There were no significant side effects of clonidine that were reported such as severe hypotension, bradycardia, or excessive sedation requiring intervention. However, several studies used atropine prophylactically with the aim of preventing such adverse effects.\nAuthors' conclusions\nThere were only 11 relevant trials studying 742 children having surgery where premedication with clonidine was compared to placebo or other drug treatment. Despite heterogeneity between trials, clonidine premedication in an adequate dosage (4 µg/kg) was likely to have a beneficial effect on postoperative pain in children. Side effects were minimal, but some of the studies used atropine prophylactically with the intention of preventing bradycardia and hypotension. Further research is required to determine under what conditions clonidine premedication is most effective in providing postoperative pain relief in children.\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": "We found evidence that when clonidine is given at an adequate dose (4 µg/kg) it is effective in reducing the need for pain relief after surgery for children (and probably reduces the children's pain) when compared to a placebo. The evidence is less clear when clonidine is compared to the sedative drug midazolam; this is likely to relate to differences in the design of the clinical trials. The side effects of clonidine did not seem to be a significant problem at the doses used, although in some of the studies the investigators took measures to prevent such side effects by the use of other medications."
}
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query-laysum
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8653
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[
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. Aminoglycosides are sometimes administered directly into the middle ear to treat this condition. The aim of this treatment is to partially or completely destroy the balance function of the affected ear. The efficacy of this intervention in preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of intratympanic aminoglycosides 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 a diagnosis of Ménière's disease comparing intratympanic aminoglycosides with either placebo 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 five RCTs with a total of 137 participants. All studies compared the use of gentamicin to either placebo or no treatment. Due to the very small numbers of participants in these trials, and concerns over the conduct and reporting of some studies, we considered all the evidence in this review to be very low-certainty.\nImprovement in vertigo\nThis outcome was assessed by only two studies, and they used different time periods for reporting. Improvement in vertigo was reported by more participants who received gentamicin at both 6 to ≤ 12 months (16/16 participants who received gentamicin, compared to 0/16 participants with no intervention; risk ratio (RR) 33.00, 95% confidence interval (CI) 2.15 to 507; 1 study; 32 participants; very low-certainty evidence) and at > 12 months follow-up (12/12 participants receiving gentamicin, compared to 6/10 participants receiving placebo; RR 1.63, 95% CI 0.98 to 2.69; 1 study; 22 participants; very low-certainty evidence). However, we were unable to conduct any meta-analysis for this outcome, the certainty of the evidence was very low and we cannot draw any meaningful conclusions from the results.\nChange in vertigo\nAgain, two studies assessed this outcome, but used different methods of measuring vertigo and assessed the outcome at different time points. We were therefore unable to carry out any meta-analysis or draw any meaningful conclusions from the results. Global scores of vertigo were lower for those who received gentamicin at both 6 to ≤ 12 months (mean difference (MD) -1 point, 95% CI -1.68 to -0.32; 1 study; 26 participants; very low-certainty evidence; four-point scale; minimally clinically important difference presumed to be one point) and at > 12 months (MD -1.8 points, 95% CI -2.49 to -1.11; 1 study; 26 participants; very low-certainty evidence). Vertigo frequency was also lower at > 12 months for those who received gentamicin (0 attacks per year in participants receiving gentamicin compared to 11 attacks per year for those receiving placebo; 1 study; 22 participants; very low-certainty evidence).\nSerious adverse events\nNone of the included studies provided information on the total number of participants who experienced a serious adverse event. It is unclear whether this is because no adverse events occurred, or because they were not assessed or reported.\nAuthors' conclusions\nThe evidence for the use of intratympanic gentamicin in the treatment of Ménière's disease is very uncertain. This is primarily due to the fact that there are few published RCTs in this area, and all the studies we identified enrolled a very small number of participants. As the studies assessed different outcomes, using different methods, and reported at different time points, we were not able to pool the results to obtain more reliable estimates of the efficacy of this treatment. More people may report an improvement in vertigo following gentamicin treatment, and scores of vertigo symptoms may also improve. However, the limitations of the evidence mean that we cannot be sure of these effects. Although there is the potential for intratympanic gentamicin to cause harm (for example, hearing loss) we did not find any information about the risks of treatment in this review.\nConsensus 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-analysis 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 did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found five studies, which included a total of 137 people. They lasted between six months and two years. All of the studies looked at the antibiotic gentamicin.\n- More people who received intratympanic gentamicin felt that their vertigo had improved, when compared to people who received no treatment (or a sham treatment). However, the studies were extremely small, so we cannot be sure that the treatment works to improve symptoms.\n- When people used a scoring system to rate their vertigo symptoms or the frequency of their vertigo, the ratings were better in those who received intratympanic gentamicin when compared to those who received no treatment (or sham treatment). Again, the studies were so small that we are very uncertain if the treatment is effective.\n- The studies included in this review did not provide any information on the risk of serious harms related to the treatment. Other types of studies have shown that this treatment might be associated with potential side effects (such as complete loss of hearing). However, we do not have any information from the studies included in this review on how common these problems are after treatment."
}
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query-laysum
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8654
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[
{
"role": "user",
"content": "Abstract: Background\nCritically ill newborn infants undergo a variety of painful procedures or experience a variety of painful conditions during their early life in the neonatal unit. In the critically ill paediatric and neonatal population, clonidine is prescribed as an adjunct to opioids or benzodiazepines aiming to reduce the doses of these drugs that are required for analgesia or sedation, or to facilitate weaning from mechanical ventilation. It has been shown that clonidine premedication might have a positive effect on postoperative pain in children.\nObjectives\nTo assess the benefit and harms of clonidine for the prevention or treatment of procedural pain; postoperative pain; or pain associated with clinical conditions in non-ventilated neonates.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the CENTRAL, MEDLINE via PubMed, Embase, and CINAHL to December 2018. We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We ran an updated search from 1 January 2018 to 11 March 2020 in CENTRAL via CRS Web, MEDLINE via Ovid, and CINAHL via EBSCOhost.\nSelection criteria\nRandomised controlled trials, quasi-randomised controlled trials, and cluster trials comparing clonidine to placebo or no treatment, opioids, paracetamol, dexmedetomidine, or non-pharmacological pain-reducing interventions for the management of procedural pain, postoperative pain, and pain associated with clinical conditions in preterm and term newborns.\nData collection and analysis\nTwo review authors independently planned to extract data (e.g. number of participants, birth weight, gestational age, modality of administration, and dose of clonidine) and assess the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). The primary outcome considered was pain: for procedural pain, the mean values of each analgesia scale assessed during the procedure and at one to two hours after the procedure; for postoperative pain and for pain associated with clinical conditions, the mean values of each analgesia scale assessed at 30 minutes, three hours, and 12 hours after the administration of the intervention. We planned to use the GRADE approach to assess the quality of evidence.\nMain results\nOur search strategy yielded 3383 references. Two review authors independently assessed all references for inclusion. We did not find any completed studies for inclusion. We excluded three trials where clonidine was administered for spinal anaesthesia.\nAuthors' conclusions\nWe did not find any studies that met our inclusion criteria and hence there is no evidence to recommend or refute the use of clonidine for the prevention or treatment of procedural or postoperative pain, or pain associated with clinical conditions in neonates.\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": "we found no studies for our review. Three studies were excluded because clonidine was given for spinal anaesthesia, whereas our review focuses on other indications."
}
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query-laysum
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8655
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[
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for individuals with fibromyalgia. This review is one of a series of reviews about exercise training for fibromyalgia that will replace the review titled \"Exercise for treating fibromyalgia syndrome\", which was first published in 2002.\nObjectives\nTo evaluate the benefits and harms of mixed exercise training protocols that include two or more types of exercise (aerobic, resistance, flexibility) for adults with fibromyalgia against control (treatment as usual, wait list control), non exercise (e.g. biofeedback), or other exercise (e.g. mixed versus flexibility) interventions.\nSpecific comparisons involving mixed exercise versus other exercises (e.g. resistance, aquatic, aerobic, flexibility, and whole body vibration exercises) were not assessed.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Thesis and Dissertations Abstracts, the Allied and Complementary Medicine Database (AMED), the Physiotherapy Evidence Databese (PEDro), Current Controlled Trials (to 2013), WHO ICTRP, and ClinicalTrials.gov up to December 2017, unrestricted by language, to identify all potentially relevant trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) in adults with a diagnosis of fibromyalgia that compared mixed exercise interventions with other or no exercise interventions. Major outcomes were health-related quality of life (HRQL), pain, stiffness, fatigue, physical function, withdrawals, and adverse events.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, and assessed risk of bias and the quality of evidence for major outcomes using the GRADE approach.\nMain results\nWe included 29 RCTs (2088 participants; 98% female; average age 51 years) that compared mixed exercise interventions (including at least two of the following: aerobic or cardiorespiratory, resistance or muscle strengthening exercise, and flexibility exercise) versus control (e.g. wait list), non-exercise (e.g. biofeedback), and other exercise interventions. Design flaws across studies led to selection, performance, detection, and selective reporting biases. We prioritised the findings of mixed exercise compared to control and present them fully here.\nTwenty-one trials (1253 participants) provided moderate-quality evidence for all major outcomes but stiffness (low quality). With the exception of withdrawals and adverse events, major outcome measures were self-reported and expressed on a 0 to 100 scale (lower values are best, negative mean differences (MDs) indicate improvement; we used a clinically important difference between groups of 15% relative difference). Results for mixed exercise versus control show that mean HRQL was 56 and 49 in the control and exercise groups, respectively (13 studies; 610 participants) with absolute improvement of 7% (3% better to 11% better) and relative improvement of 12% (6% better to 18% better). Mean pain was 58.6 and 53 in the control and exercise groups, respectively (15 studies; 832 participants) with absolute improvement of 5% (1% better to 9% better) and relative improvement of 9% (3% better to 15% better). Mean fatigue was 72 and 59 points in the control and exercise groups, respectively (1 study; 493 participants) with absolute improvement of 13% (8% better to 18% better) and relative improvement of 18% (11% better to 24% better). Mean stiffness was 68 and 61 in the control and exercise groups, respectively (5 studies; 261 participants) with absolute improvement of 7% (1% better to 12% better) and relative improvement of 9% (1% better to 17% better). Mean physical function was 49 and 38 in the control and exercise groups, respectively (9 studies; 477 participants) with absolute improvement of 11% (7% better to 15% better) and relative improvement of 22% (14% better to 30% better). Pooled analysis resulted in a moderate-quality risk ratio for all-cause withdrawals with similar rates across groups (11 per 100 and 12 per 100 in the control and intervention groups, respectively) (19 studies; 1065 participants; risk ratio (RR) 1.02, 95% confidence interval (CI) 0.69 to 1.51) with an absolute change of 1% (3% fewer to 5% more) and a relative change of 11% (28% fewer to 47% more). Across all 21 studies, no injuries or other adverse events were reported; however some participants experienced increased fibromyalgia symptoms (pain, soreness, or tiredness) during or after exercise. However due to low event rates, we are uncertain of the precise risks with exercise. Mixed exercise may improve HRQL and physical function and may decrease pain and fatigue; all-cause withdrawal was similar across groups, and mixed exercises may slightly reduce stiffness. For fatigue, physical function, HRQL, and stiffness, we cannot rule in or out a clinically relevant change, as the confidence intervals include both clinically important and unimportant effects.\nWe found very low-quality evidence on long-term effects. In eight trials, HRQL, fatigue, and physical function improvement persisted at 6 to 52 or more weeks post intervention but improvements in stiffness and pain did not persist. Withdrawals and adverse events were not measured.\nIt is uncertain whether mixed versus other non-exercise or other exercise interventions improve HRQL and physical function or decrease symptoms because the quality of evidence was very low. The interventions were heterogeneous, and results were often based on small single studies. Adverse events with these interventions were not measured, and thus uncertainty surrounds the risk of adverse events.\nAuthors' conclusions\nCompared to control, moderate-quality evidence indicates that mixed exercise probably improves HRQL, physical function, and fatigue, but this improvement may be small and clinically unimportant for some participants; physical function shows improvement in all participants. Withdrawal was similar across groups. Low-quality evidence suggests that mixed exercise may slightly improve stiffness. Very low-quality evidence indicates that we are 'uncertain' whether the long-term effects of mixed exercise are maintained for all outcomes; all-cause withdrawals and adverse events were not measured. Compared to other exercise or non-exercise interventions, we are uncertain about the effects of mixed exercise because we found only very low-quality evidence obtained from small, very heterogeneous trials. Although mixed exercise appears to be well tolerated (similar withdrawal rates across groups), evidence on adverse events is scarce, so we are uncertain about its safety. We downgraded the evidence from these trials due to imprecision (small trials), selection bias (e.g. allocation), blinding of participants and care providers or outcome assessors, and selective reporting.\n\nGiven the provided abstract, please respond to the following query: \"Ability to do daily activities (physical function)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "After 8 to 24 weeks, people who exercised were 11% better (7% to 15%) or improved by 11 points on a 100 point scale.\nPeople who exercised rated their physical function at 38 points.\nPeople in the control group rated their physical function at 49 points.\nHarms - Some participants experienced increased pain, soreness, or tiredness during or after exercise. Studies reported no injuries or other harms. However, reporting of harms was missing or incomplete in many studies. We are uncertain whether risk is increased with exercise.\nLeaving the study early – 11% of control participants left the study early compared with 12% of exercisers.\nLong-term effects - Analysis of long-term effects of HRQL showed maintenance of mixed exercise effects at 6 to 12 weeks and at 13 to 26 weeks but not at 27 to 52 weeks. Very low-quality evidence suggests that it is uncertain whether mixed exercises improve HRQL in the long term. Withdrawals and adverse events were not measured.\nOther - Reviewers found no evidence that the benefits and harms of mixed exercise were any different from education programmes, cognitive-behavioural training, biofeedback, medication, or other types of exercise."
}
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query-laysum
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8656
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[
{
"role": "user",
"content": "Abstract: Background\nEndophthalmitis refers to severe infection within the eye that involves the aqueous humor or vitreous humor, or both, and that threatens vision. Most cases of endophthalmitis are exogenous (i.e. due to inoculation of organisms from an outside source), and most exogenous endophthalmitis is acute and occurs after an intraocular procedure. The mainstay of treatment is emergent administration of broad-spectrum intravitreous antibiotics. Due to their anti-inflammatory effects, steroids in conjunction with antibiotics have been proposed as being beneficial in endophthalmitis management.\nObjectives\nTo assess the effects of antibiotics combined with steroids versus antibiotics alone for the treatment of acute endophthalmitis following intraocular surgery or intravitreous injection.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 8), MEDLINE Ovid (1946 to August 2021), Embase Ovid (1980 to August 2021), LILACS (Latin American and Caribbean Health Sciences Literature database) (1982 to August 2021), the ISRCTN registry; searched August 2021, ClinicalTrials.gov; searched August 2021, and the WHO International Clinical Trials Registry Platform; searched August 2021. We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing the effectiveness of adjunctive steroids with antibiotics alone in the management of acute, clinically diagnosed endophthalmitis following intraocular surgery or intravitreous injection. We excluded trials with participants with endogenous endophthalmitis unless outcomes were reported by source of infection. We imposed no restrictions on the method or order of administration, dose, frequency, or duration of antibiotics and steroids.\nData collection and analysis\nWe used standard Cochrane methodology, and graded the certainty of the body of evidence for six outcomes using the GRADE classification.\nMain results\nWe included four RCTs with a total of 264 eyes of 264 participants in this review update. The studies were conducted in South Africa, India, and the Netherlands. All studies used intravitreous dexamethasone for adjunctive steroid therapy and a combination of two intravitreous antibiotics that provided gram-positive and gram-negative coverage for the antibiotic therapy. We judged two trials to be at overall low risk of bias, and the other two studies to be at overall unclear risk of bias due to lack of reporting of study methods. Only one study was registered in a clinical trial register.\nWhile none of the included studies reported the primary outcome of complete resolution of endophthalmitis as defined in our protocol, one study reported combined anatomical and functional success (i.e. proportion of participants with intraocular pressure of at least 5 mmHg and visual acuity of at least 6/120). Very low certainty evidence suggested no difference in combined success when comparing adjunctive steroid to antibiotics alone (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.80 to 1.45; 32 participants). Low certainty evidence from two studies suggested that adjunctive dexamethasone may result in having a good visual outcome (Snellen visual acuity 6/6 to 6/18) at 3 months compared with antibiotics alone (RR 1.95, 95% CI 1.05 to 3.60; 60 participants); however, the evidence was less conclusive at 12 months (RR 1.12, 95% CI 0.92 to 1.37; 2 studies; 195 participants; low certainty evidence). Investigators of one study reported improvement in visual acuity, but we could not estimate the effect of adjunctive steroid therapy because the study investigators did not provide any estimates of precision. Only one study examined intraocular pressure (IOP). The evidence suggests that adjunctive dexamethasone may reduce IOP slightly after 12 months of interventions (mean difference −1.90, 95% CI −3.78 to 0.07; 1 study; 167 participants; low certainty evidence). Three studies reported adverse events (retinal detachment, hypotony, proliferative vitreoretinopathy, seclusion of pupil, floaters, and pucker). The total numbers of adverse events were 14 out of 111 (12.6%) for those who received dexamethasone versus 12 out of 116 (10.3%) for those who did not. We could only perform a pooled analysis for the occurrence of retinal detachment: any difference between the two treatment groups was uncertain (RR 1.41, 95% CI 0.53 to 3.74; 227 participants; low certainty evidence). No study reported cost-related outcomes.\nAuthors' conclusions\nThe currently available evidence on the effectiveness of adjunctive steroid therapy versus antibiotics alone in the management of acute endophthalmitis after intraocular surgery is inadequate. We found no studies that had enrolled cases of acute endophthalmitis following intravitreous injection. A combined analysis of two studies suggests that use of adjunctive steroids may provide a higher chance of having a good visual outcome at three months than not using adjunctive steroids. However, considering that most of the confidence intervals crossed the null, and that this review was limited in scope and applicability to clinical practice, it is not possible to conclude whether the use of adjunctive steroids is effective at this time. Any future trials should examine whether adjunctive steroids may be useful in certain clinical settings such as type of causative organism or etiology. These studies should include outcomes that take patients' symptoms and clinical examination into account; report outcomes in a uniform and consistent manner; and follow up at short- and long-term intervals.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found four studies from South Africa, India, and the Netherlands. Almost all study participants had endophthalmitis after cataract surgery. All four studies compared injecting dexamethasone (a steroid) plus two antibiotics into the eye versus injecting only antibiotics into the eye. Low certainty evidence showed that more participants in the group receiving dexamethasone had a good visual outcome 3 months after treatment than in the antibiotics-only group, but the evidence was uncertain at 12 months. The effects of using steroids on resolution of endophthalmitis and harms were also uncertain. Given the uncertainty of evidence for most outcomes, it is not clear whether doctors should use steroids with antibiotics to treat endophthalmitis after a procedure in the eye."
}
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query-laysum
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8657
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[
{
"role": "user",
"content": "Abstract: Background\nStroke results from an acute lack of blood supply to the brain and becomes a chronic health condition for millions of survivors around the world. Self management can offer stroke survivors a pathway to promote their recovery. Self management programmes for people with stroke can include specific education about the stroke and likely effects but essentially, also focusses on skills training to encourage people to take an active part in their management. Such skills training can include problem-solving, goal-setting, decision-making, and coping skills.\nObjectives\nTo assess the effects of self management interventions on the quality of life of adults with stroke who are living in the community, compared with inactive or active (usual care) control interventions.\nSearch methods\nWe searched the following databases from inception to April 2016: the Cochrane Stroke Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, SCOPUS, Web of Science, OTSeeker, OT Search, PEDro, REHABDATA, and DARE. We also searched the following trial registries: ClinicalTrials.gov, Stroke Trials Registry, Current Controlled Trials, World Health Organization, and Australian New Zealand Clinical Trials Registry.\nSelection criteria\nWe included randomised controlled trials of adults with stroke living in the community who received self management interventions. These interventions included more than one component of self management or targeted more than a single domain of change, or both. Interventions were compared with either an inactive control (waiting list or usual care) or active control (alternate intervention such as education only). Measured outcomes included changes in quality of life, self efficacy, activity or participation levels, impairments, health service usage, health behaviours (such as medication adherence or lifestyle behaviours), cost, participant satisfaction, or adverse events.\nData collection and analysis\nTwo review authors independently extracted prespecified data from all included studies and assessed trial quality and risk of bias. We performed meta-analyses where possible to pool results.\nMain results\nWe included 14 trials with 1863 participants. Evidence from six studies showed that self management programmes improved quality of life in people with stroke (standardised mean difference (SMD) random effects 0.20, 95% confidence interval (CI) 0.00 to 0.41, P = 0.05; low quality evidence) and improved self efficacy (SMD, random effects 0.33, 95% CI 0.04 to 0.61, P = 0.03; low quality evidence) compared with usual care. Individual studies reported benefits for health-related behaviours such as reduced use of health services, smoking, and alcohol intake, as well as improved diet and attitude. However, there was no superior effect for such programmes in the domains of locus of control, activities of daily living, medication adherence, participation, or mood. Statistical heterogeneity was mostly low; however, there was much variation in the types and delivery of programmes. Risk of bias was relatively low for complex intervention clinical trials where participants and personnel could not be blinded.\nAuthors' conclusions\nThe current evidence indicates that self management programmes may benefit people with stroke who are living in the community. The benefits of such programmes lie in improved quality of life and self efficacy. These are all well-recognised goals for people after stroke. There is evidence for many modes of delivery and examples of tailoring content to the target group. Leaders were usually professionals but peers (stroke survivors and carers) were also reported - the commonality is being trained and expert in stroke and its consequences. It would be beneficial for further research to be focused on identifying key features of effective self management programmes and assessing their cost-effectiveness.\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": "The majority of the studies were well conducted and represent credible evidence that self management programmes may benefit people with stroke who are living in the community."
}
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query-laysum
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8658
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[
{
"role": "user",
"content": "Abstract: Background\nIndividuals dying of coronavirus disease 2019 (COVID-19) may experience distressing symptoms such as breathlessness or delirium. Palliative symptom management can alleviate symptoms and improve the quality of life of patients. Various treatment options such as opioids or breathing techniques have been discussed for use in COVID-19 patients. However, guidance on symptom management of COVID-19 patients in palliative care has often been derived from clinical experiences and guidelines for the treatment of patients with other illnesses. An understanding of the effectiveness of pharmacological and non-pharmacological palliative interventions to manage specific symptoms of COVID-19 patients is required.\nObjectives\nTo assess the efficacy and safety of pharmacological and non-pharmacological interventions for palliative symptom control in individuals with COVID-19.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (including Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), Embase, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), medRxiv); Web of Science Core Collection (Science Citation Index Expanded, Emerging Sources); CINAHL; WHO COVID-19 Global literature on coronavirus disease; and COAP Living Evidence on COVID-19 to identify completed and ongoing studies without language restrictions until 23 March 2021.\nWe screened the reference lists of relevant review articles and current treatment guidelines for further literature.\nSelection criteria\nWe followed standard Cochrane methodology as outlined in the Cochrane Handbook for Systematic Reviews of Interventions.\nWe included studies evaluating palliative symptom management for individuals with a confirmed diagnosis of COVID-19 receiving interventions for palliative symptom control, with no restrictions regarding comorbidities, age, gender, or ethnicity. Interventions comprised pharmacological as well as non-pharmacological treatment (e.g. acupressure, physical therapy, relaxation, or breathing techniques). We searched for the following types of studies: randomized controlled trials (RCT), quasi-RCTs, controlled clinical trials, controlled before-after studies, interrupted time series (with comparison group), prospective cohort studies, retrospective cohort studies, (nested) case-control studies, and cross-sectional studies.\nWe searched for studies comparing pharmacological and non-pharmacological interventions for palliative symptom control with standard care.\nWe excluded studies evaluating palliative interventions for symptoms caused by other terminal illnesses. If studies enrolled populations with or exposed to multiple diseases, we would only include these if the authors provided subgroup data for individuals with COVID-19. We excluded studies investigating interventions for symptom control in a curative setting, for example patients receiving life-prolonging therapies such as invasive ventilation.\nData collection and analysis\nWe used a modified version of the Newcastle Ottawa Scale for non-randomized studies of interventions (NRSIs) to assess bias in the included studies. We included the following outcomes: symptom relief (primary outcome); quality of life; symptom burden; satisfaction of patients, caregivers, and relatives; serious adverse events; and grade 3 to 4 adverse events.\nWe rated the certainty of evidence using the GRADE approach.\nAs meta-analysis was not possible, we used tabulation to synthesize the studies and histograms to display the outcomes.\nMain results\nOverall, we identified four uncontrolled retrospective cohort studies investigating pharmacological interventions for palliative symptom control in hospitalized patients and patients in nursing homes. None of the studies included a comparator. We rated the risk of bias high across all studies. We rated the certainty of the evidence as very low for the primary outcome symptom relief, downgrading mainly for high risk of bias due to confounding and unblinded outcome assessors.\nPharmacological interventions for palliative symptom control\nWe identified four uncontrolled retrospective cohort studies (five references) investigating pharmacological interventions for palliative symptom control. Two references used the same register to form their cohorts, and study investigators confirmed a partial overlap of participants. We therefore do not know the exact number of participants, but individual reports included 61 to 2105 participants. Participants received multimodal pharmacological interventions: opioids, neuroleptics, anticholinergics, and benzodiazepines for relieving dyspnea (breathlessness), delirium, anxiety, pain, audible upper airway secretions, respiratory secretions, nausea, cough, and unspecified symptoms.\nPrimary outcome: symptom relief\nAll identified studies reported this outcome. For all symptoms (dyspnea, delirium, anxiety, pain, audible upper airway secretions, respiratory secretions, nausea, cough, and unspecified symptoms), a majority of interventions were rated as completely or partially effective by outcome assessors (treating clinicians or nursing staff). Interventions used in the studies were opioids, neuroleptics, anticholinergics, and benzodiazepines.\nWe are very uncertain about the effect of pharmacological interventions on symptom relief (very low-certainty evidence). The initial rating of the certainty of evidence was low since we only identified uncontrolled NRSIs. Our main reason for downgrading the certainty of evidence was high risk of bias due to confounding and unblinded outcome assessors. We therefore did not find evidence to confidently support or refute whether pharmacological interventions may be effective for palliative symptom relief in COVID-19 patients.\nSecondary outcomes\nWe planned to include the following outcomes: quality of life; symptom burden; satisfaction of patients, caregivers, and relatives; serious adverse events; and grade 3 to 4 adverse events.\nWe did not find any data for these outcomes, or any other information on the efficacy and safety of used interventions.\nNon-pharmacological interventions for palliative symptom control\nNone of the identified studies used non-pharmacological interventions for palliative symptom control.\nAuthors' conclusions\nWe found very low certainty evidence for the efficacy of pharmacological interventions for palliative symptom relief in COVID-19 patients. We found no evidence on the safety of pharmacological interventions or efficacy and safety of non-pharmacological interventions for palliative symptom control in COVID-19 patients. The evidence presented here has no specific implications for palliative symptom control in COVID-19 patients because we cannot draw any conclusions about the effectiveness or safety based on the identified evidence. More evidence is needed to guide clinicians, nursing staff, and caregivers when treating symptoms of COVID-19 patients at the end of life. Specifically, future studies ought to investigate palliative symptom control in prospectively registered studies, using an active-controlled setting, assess patient-reported outcomes, and clearly define interventions.\nThe publication of the results of ongoing studies will necessitate an update of this review. The conclusions of an updated review could differ from those of the present review and may allow for a better judgement regarding pharmacological and non-pharmacological interventions for palliative symptom control in COVID-19 patients.\n\nGiven the provided abstract, please respond to the following query: \"What type of studies did we search for?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched selected medical databases and trial registries until 23 March 2021. We included studies looking at how well different palliative treatments work to relieve COVID-19-associated symptoms at the end of life. We wanted to compare studies investigating different medicines or therapies, but we only found studies without a comparison group. Only one study reported the specific drugs used for individual symptoms."
}
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query-laysum
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8659
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[
{
"role": "user",
"content": "Abstract: Background\nExcessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally-focused counselling.\nThis is an update of a Cochrane Review published in 2007.\nObjectives\nTo assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption.\nMain results\nWe included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta-analysis included 34 studies (15,197 participants) and provided moderate-quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) -20 g/week, 95% confidence interval (CI) -28 to -12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention.\nWe found moderate-quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD -0.08, 95% CI -0.14 to -0.02; 15 studies, 6946 participants); drinking days per week (MD -0.13, 95% CI -0.23 to -0.04; 11 studies, 5469 participants); or drinking intensity (-0.2 g/drinking day, 95% CI -3.1 to 2.7; 10 studies, 3128 participants).\nWe found moderate-quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (-20 g/week, 95% CI -40 to 1; 6 studies, 1296 participants). There was little difference in binges per week (-0.08, 95% CI -0.28 to 0.12; 2 studies, 456 participants; moderate-quality evidence) or difference in days drinking per week (-0.45, 95% CI -0.81 to -0.09; 2 studies, 319 participants; moderate-quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI -26 to 9; 1 study, 158 participants; low-quality evidence).\nExtended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI -42 to 45; 3 studies, 552 participants; low-quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (-0.5, 95% CI -1.2 to 0.2; 147 participants; low-quality evidence). Results from this trial also suggested very little impact on drinking intensity (-1.7 g/drinking day, 95% CI -18.9 to 15.5; 147 participants; very low-quality evidence).\nOnly five studies reported adverse effects (very low-quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms.\nSources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment.\nAuthors' conclusions\nWe found moderate-quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness.\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": "One way to reduce heavy drinking may be for doctors and nurses to provide brief advice or brief counselling to targeted people who consult general practitioners or other primary health care providers. People seeking primary healthcare are routinely asked about their drinking behaviour because alcohol use can affect many health conditions.\nBrief interventions typically include feedback on alcohol use and health-related harms, identification of high risk situations for heavy drinking, simple advice about how to cut down drinking, strategies that can increase motivation to change drinking behaviour, and the development of a personal plan to reduce drinking. Brief interventions are designed to be delivered in regular consultations, which are often 5 to 15 minutes with doctors and around 20 to 30 minutes with nurses. Although short in duration, brief interventions can be delivered in one to five sessions. We did not include digital interventions in this review."
}
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query-laysum
|
8660
|
[
{
"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 is drug-resistant epilepsy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Epilepsy is one of the more common long-lasting neurological disorders; it affects 1% of the population worldwide. Up to 30% of people with epilepsy continue to have seizures (sudden bursts of electrical activity in the brain that change how it works for a short time) despite adequate therapy with antiepileptic medicines. These people are regarded as having drug-resistant epilepsy."
}
] |
query-laysum
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8661
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a disease that causes progressive or relapsing and remitting weakness and numbness. It is probably caused by an autoimmune process. Immunosuppressive or immunomodulatory drugs would be expected to be beneficial. This review was first published in 2003 and has been updated most recently in 2016.\nObjectives\nTo assess the effects of immunomodulatory and immunosuppressive agents other than corticosteroids, immunoglobulin, and plasma exchange in CIDP.\nSearch methods\nOn 24 May 2016, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4) in the Cochrane Library, MEDLINE, Embase, CINAHL, and LILACS for completed trials, and clinical trial registers for ongoing trials. We contacted the authors of the trials identified and other disease experts seeking other published and unpublished trials.\nSelection criteria\nWe sought randomised and quasi-randomised trials of all immunosuppressive agents, such as azathioprine, cyclophosphamide, methotrexate, ciclosporin, mycophenolate mofetil, and rituximab, and all immunomodulatory agents, such as interferon (IFN) alfa and IFN beta, in participants fulfilling standard diagnostic criteria for CIDP. We included all comparisons of these agents with placebo, another treatment, or no treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We wanted to measure the change in disability after one year as our primary outcome. Our secondary outcomes were change in disability after four or more weeks (from randomisation); change in impairment after at least one year; change in maximum motor nerve conduction velocity and compound muscle action potential amplitude after one year; and for participants who were receiving corticosteroids or intravenous immunoglobulin (IVIg), the amount of this medication given during at least one year after randomisation. Participants with one or more serious adverse events during the first year was also a secondary outcome.\nMain results\nFour trials fulfilled the selection criteria: one of azathioprine (27 participants), two of IFN beta-1a (77 participants in total) and one of methotrexate (60 participants). The risk of bias was considered low in the trials of IFN beta-1a and methotrexate but high in the trial of azathioprine. None of the trials showed significant benefit in any of the outcomes selected by their authors. The results of the outcomes which approximated most closely to the primary outcome for this review were as follows.\nIn the azathioprine trial there was a median improvement in the Neuropathy Impairment Scale (scale range 0 to 280) after nine months of 29 points (range 49 points worse to 84 points better) in the azathioprine and prednisone treated participants compared with 30 points worse (range 20 points worse to 104 points better) in the prednisone alone group. There were no reports of adverse events.\nIn a cross-over trial of IFN beta-1a with 20 participants, the treatment periods were 12 weeks. The median improvement in the Guy's Neurological Disability Scale (range 1 to 10) was 0.5 grades (interquartile range (IQR) 1.8 grades better to zero grade change) in the IFN beta-1a treatment period and 0.5 grades (IQR 1.8 grades better to 1.0 grade worse) in the placebo treatment period. There were no serious adverse events in either treatment period.\nIn a parallel group trial of IFN beta-1a with 67 participants, none of the outcomes for this review was available. The trial design involved withdrawal from ongoing IVIg treatment. The primary outcome used by the trial authors was total IVIg dose administered from week 16 to week 32 in the placebo group compared with the IFN beta-1a groups. This was slightly but not significantly lower in the combined IFN beta-1a groups (1.20 g/kg) compared with the placebo group (1.34 g/kg, P = 0.75). There were four participants in the IFN beta-1a group and none in the placebo group with one or more serious adverse events, risk ratio (RR) 4.50 (95% confidence interval (CI) 0.25 to 80.05).\nThe methotrexate trial had a similar design involving withdrawal from ongoing corticosteroid or IVIg treatment. At the end of the trial (approximately 40 weeks) there was no significant difference in the change in the Overall Neuropathy Limitations Scale, a disability scale (scale range 0 to 12), the median change being 0 (IQR −1 to 0) in the methotrexate group and 0 (IQR −0.75 to 0) in the placebo group. These changes in disability might have been confounded by the reduction in corticosteroid or IVIg dose required by the protocol. There were three participants in the methotrexate group and one in the placebo with one or more serious adverse events, RR 3.56 (95% CI 0.39 to 32.23).\nAuthors' conclusions\nLow-quality evidence from randomised trials does not show significant benefit from azathioprine or interferon beta-1a and moderate-quality evidence from one randomised trial does not show significant benefit from a relatively low dose of methotrexate for the treatment of CIDP. None of the trials was large enough to rule out small or moderate benefit. The evidence from observational studies is insufficient to avoid the need for randomised controlled trials to discover whether these drugs are beneficial. Future trials should have improved designs, more sensitive outcome measures relevant to people with CIDP, and longer treatment durations.\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 four trials. A trial with 27 participants compared the effects of azathioprine together with steroids to steroids alone for nine months. Azathioprine is a drug that is often used to treat autoimmune diseases because it suppresses the harmful immune cells. This trial had a parallel-group design, which means that the participants were divided into groups that each received only one of the treatments.\nA cross-over design trial with 10 participants compared the immune-regulating drug interferon (IFN) beta-1a with placebo (dummy treatment) for 12 weeks. The cross-over design means that all participants received both treatments in random order. A parallel-group trial with 67 participants also compared interferon beta-1a with placebo, but for 32 weeks. Another parallel-group trial with 60 participants compared the cytotoxic drug methotrexate with placebo for 40 weeks. The IFN beta-1a trials, but not the azathioprine or methotrexate trials, received pharmaceutical company support or sponsorship."
}
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query-laysum
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8662
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[
{
"role": "user",
"content": "Abstract: Background\nUnder-reporting of occupational diseases is an important issue worldwide. The collection of reliable data is essential for public health officials to plan intervention programmes to prevent occupational diseases. Little is known about the effects of interventions for increasing the reporting of occupational diseases.\nObjectives\nTo evaluate the effects of interventions aimed at increasing the reporting of occupational diseases by physicians.\nSearch methods\nWe searched the Cochrane Occupational Safety and Health Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE, OSH UPDATE, Database of Abstracts of Reviews of Effects (DARE), OpenSIGLE, and Health Evidence until January 2015.\nWe also checked reference lists of relevant articles and contacted study authors to identify additional published, unpublished, and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs (cRCTs), controlled before-after (CBA) studies, and interrupted time series (ITS) of the effects of increasing the reporting of occupational diseases by physicians. The primary outcome was the reporting of occupational diseases measured as the number of physicians reporting or as the rate of reporting occupational diseases.\nData collection and analysis\nPairs of authors independently assessed study eligibility and risk of bias and extracted data. We expressed intervention effects as risk ratios or rate ratios. We combined the results of similar studies in a meta-analysis. We assessed the overall quality of evidence for each combination of intervention and outcome using the GRADE approach.\nMain results\nWe included seven RCTs and five CBA studies. Six studies evaluated the effectiveness of educational materials alone, one study evaluated educational meetings, four studies evaluated a combination of the two, and one study evaluated a multifaceted educational campaign for increasing the reporting of occupational diseases by physicians. We judged all the included studies to have a high risk of bias.\nWe did not find any studies evaluating the effectiveness of Internet-based interventions or interventions on procedures or techniques of reporting, or the use of financial incentives. Moreover, we did not find any studies evaluating large-scale interventions like the introduction of new laws, existing or new specific disease registries, newly established occupational health services, or surveillance systems.\nEducational materials\nWe found moderate-quality evidence that the use of educational materials did not considerably increase the number of physicians reporting occupational diseases compared to no intervention (risk ratio of 1.11, 95% confidence interval (CI) 0.74 to 1.67). We also found moderate-quality evidence showing that sending a reminder message of a legal obligation to report increased the number of physicians reporting occupational diseases (risk ratio of 1.32, 95% CI 1.05 to 1.66) when compared to a reminder message about the benefits of reporting.\nWe found low-quality evidence that the use of educational materials did not considerably increase the rate of reporting when compared to no intervention.\nEducational materials plus meetings\nWe found moderate-quality evidence that the use of educational materials combined with meetings did not considerably increase the number of physicians reporting when compared to no intervention (risk ratio of 1.22, 95% CI 0.83 to 1.81).\nWe found low-quality evidence that educational materials plus meetings did not considerably increase the rate of reporting when compared to no intervention (rate ratio of 0.77, 95% CI 0.42 to 1.41).\nEducational meetings\nWe found very low-quality evidence showing that educational meetings increased the number of physicians reporting occupational diseases (risk ratio at baseline: 0.82, 95% CI 0.47 to 1.41 and at follow-up: 1.74, 95% CI 1.11 to 2.74) when compared to no intervention.\nWe found very low-quality evidence that educational meetings did not considerably increase the rate of reporting occupational diseases when compared to no intervention (rate ratio at baseline: 1.57, 95% CI 1.22 to 2.02 and at follow-up: 1.92, 95% CI 1.48 to 2.47).\nEducational campaign\nWe found very low-quality evidence showing that the use of an educational campaign increased the number of physicians reporting occupational diseases when compared to no intervention (risk ratio at baseline: 0.53, 95% CI 0.19 to 1.50 and at follow-up: 11.59, 95% CI 5.97 to 22.49).\nAuthors' conclusions\nWe found 12 studies to include in this review. They provide evidence ranging from very low to moderate quality showing that educational materials, educational meetings, or a combination of the two do not considerably increase the reporting of occupational diseases. The use of a reminder message on the legal obligation to report might provide some positive results. We need high-quality RCTs to corroborate these findings.\nFuture studies should investigate the effects of large-scale interventions like legislation, existing or new disease-specific registries, newly established occupational health services, or surveillance systems. When randomisation or the identification of a control group is impractical, these large-scale interventions should be evaluated using an interrupted time-series design.\nWe also need studies assessing online reporting and interventions aimed at simplifying procedures or techniques of reporting and the use of financial incentives.\n\nGiven the provided abstract, please respond to the following query: \"Further research\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We need high-quality studies to clarify the effectiveness of these interventions. This review was unable to determine the effectiveness of interventions other than education like the use of financial incentives, which could be an important form of motivation in changing physicians' behaviour. Such small-scale interventions could be investigated using larger randomised controlled trials, while the evaluation of large-scale interventions like legislation should use an interrupted time-series design."
}
] |
query-laysum
|
8663
|
[
{
"role": "user",
"content": "Abstract: Background\nFixed prosthodontic treatment (crowns, fixed dental prostheses (FDPs), complete arch prostheses) involves the use of several different materials to replace missing tooth structure. Traditionally full metal or metal frameworks veneered with ceramic (metal-ceramic (MC)) have been used. In recent years several different metal-free systems have become available to clinicians and patients. In general, metal-free restorations should allow practitioners to better reproduce natural tooth colour, avoiding shortcomings of MC restorations. The comparative in service clinical performance of fixed prosthodontic treatments of different materials is unclear.\nObjectives\nTo assess the effects of metal-free materials for prosthodontic restorations compared to metal-ceramic or other conventional all-metal materials.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (searched 3 May 2017), Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library (searched 3 May 2017), MEDLINE Ovid (1946 to 3 May 2017), and Embase Ovid (1980 to 3 May 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials (searched 3 May 2017). No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) in which the clinical performance of metal-free fixed prosthodontic restorations was compared with metal-ceramic (MC) or other conventional restorations in adult patients requiring prosthodontic treatment. RCTs in which the clinical performance of different kinds of metal-free systems were compared among themselves were also considered.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted independently and in duplicate. Trial authors were contacted for missing information. Available results for the outcomes of interest of the systematic review of the studies included were tabulated as they could not be included in a formal meta-analysis.\nMain results\nNine trials involving a total of 448 participants were included. We judged two trials to be at unclear risk of bias and seven to be at high risk of bias. The majority of items of risk of bias were evaluated to be at unclear or high risk level in more than 50% of the included trials. Each trial except two was addressing a different type of intervention. All evidence was rated as being of very low quality due to problems with risk of bias and imprecision of results, the latter being due to very small sample sizes, low event rates, 95% confidence intervals including the possibility of benefit for both the test and control groups, or combinations of these problems. This means that we are very uncertain about all of the results presented in this review.\nOne trial compared metal-free single crowns (full contour zirconia) to cast gold single crowns in 224 participants and found insufficient evidence of a difference in failure rate after one year, but after five years there was some evidence of a benefit for the gold crowns. There was insufficient evidence of a difference for crown complications at either time of assessment.\nOne trial compared three-unit metal-free FDPs (lithium disilicate) to three-unit metal-ceramic FDPs in 37 participants. There was insufficient evidence of a difference in bridge failure at one and six years, but some evidence of a benefit for the lithium disilicate group in terms of bridge complications at six years. One trial compared zirconia-ceramic FDPs to metal-ceramic FDPs in 34 participants but found insufficient evidence of a difference in bridge failures (i.e. no failures in either treatment group), bridge complications or patients' aesthetic evaluation at any time of assessment up to three years.\nOne trial compared metal-free cantilevered FDPs to metal-ceramic cantilevered FDPs in 21 participants. There was insufficient evidence of a difference for any primary outcome: bridge failures (i.e. no failures in either treatment group), bridge complications, or patients' aesthetic evaluation at any time of assessment up to three years.\nOne trial compared metal-free implant-supported screw retained single crowns (zirconia veneered with feldspathic ceramic) to metal-ceramic implant-supported screw-retained single crowns in 20 participants. There was insufficient evidence of a difference for any primary outcome: crown failures (i.e. no failures in either treatment group), crown complications, or satisfaction/aesthetic evaluation at any time of assessment up to two years.\nTwo trials compared metal-free implant abutments (zirconia) to metal implant abutments both supporting single crowns in 50 participants. There was insufficient evidence of a difference in abutment failure at one year.\nOne trial compared metal-free implant-supported FDPs made of two different types of zirconia ceramic in 18 participants. There was insufficient evidence of a difference in failures at any time of assessment up to 10 years (i.e. no failures in either treatment group). There was some evidence of a benefit for the zirconia-toughened alumina group in terms of complications (chipping).\nOne trial compared metal-free tooth-supported FDPs made with two different veneering techniques (pressed versus layered) in 40 participants. There was insufficient evidence of a difference for failures (i.e. no failures in either treatment group) or complications at any time of assessment up to three years.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the effectiveness of metal-free materials for fixed prosthodontic treatment over metal-ceramic or other type of standard restorations. The overall quality of existing evidence was very low, therefore great caution should be exercised when generalising the results of the included trials. Until more evidence becomes available clinicians should continue to base decisions on which material to use for fixed prosthodontic treatment on their own clinical experience, whilst taking into consideration the individual circumstances and preferences of their patients. There is urgent need of properly designed RCTs.\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": "Two trials were at unclear risk of bias and seven were at high risk of bias. The overall quality of evidence was very low, therefore caution should be exercised when generalising the results of the included trials. Future research should aim to provide more reliable information which can help clinicians to decide on appropriate materials for fixed prosthodontic treatment whilst taking into consideration the individual circumstances and preferences of their patients."
}
] |
query-laysum
|
8664
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[
{
"role": "user",
"content": "Abstract: Background\nChronic lung disease (CLD) occurs frequently in preterm infants. Bronchodilators have the potential effect of dilating small airways with muscle hypertrophy. Increased compliance and tidal volume and decreased pulmonary resistance have been documented with the use of bronchodilators in infants with CLD. Therefore, bronchodilators might have a role in the prevention and treatment of CLD.\nObjectives\nTo determine the effect of bronchodilators given as prophylaxis or as treatment for CLD on mortality and other complications of preterm birth in infants at risk for or identified as having CLD.\nSearch methods\nOn 2016 March 7, we used the standard strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (from 1966), Embase (from 1980) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; from 1982). We searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We applied no language restrictions.\nSelection criteria\nRandomised and quasi-randomised controlled trials involving preterm infants were eligible for inclusion. Initiation of bronchodilator therapy for prevention of CLD had to occur within two weeks of birth. Treatment of patients with CLD had to be initiated before discharge from the neonatal unit. The intervention had to include administration of a bronchodilator by nebulisation, by metered dose inhaler (with or without a spacer device) or by intravenous or oral administration versus placebo or no intervention. Eligible studies had to include at least one of the following predefined clinical outcomes: mortality, CLD, number of days on oxygen, number of days on ventilator, patent ductus arteriosus (PDA), pulmonary interstitial emphysema (PIE), pneumothorax, intraventricular haemorrhage (IVH) of any grade, necrotising enterocolitis (NEC), sepsis and adverse effects of bronchodilators.\nData collection and analysis\nWe used the standard method described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Two review authors extracted and assessed all data provided by each study. We reported risk ratio (RR), risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB) with 95% confidence interval (CI) for dichotomous outcomes and mean difference (MD) for continuous data. We assessed the quality of the evidence by using the GRADE approach.\nMain results\nFor this update, we identified one new randomised controlled trial investigating effects of bronchodilators in preterm infants. This study, which enrolled 73 infants but reported on 52 infants, examined prevention of CLD with the use of aminophylline. According to GRADE, the quality of the evidence was very low. One previously included study enrolled 173 infants to look at prevention of CLD with the use of salbutamol. According to GRADE, the quality of the evidence was moderate. We found no eligible trial that studied the use of bronchodilator therapy for treatment of individuals with CLD. Prophylaxis with salbutamol led to no statistically significant differences in mortality (RR 1.08, 95% CI 0.50 to 2.31; RD 0.01, 95% CI -0.09 to 0.11) nor in CLD (RR 1.03, 95% CI 0.78 to 1.37; RD 0.02, 95% CI -0.13 to 0.17). Results showed no statistically significant differences in other complications associated with CLD nor in preterm birth. Investigators in this study did not comment on side effects due to salbutamol. Prophylaxis with aminophylline led to a significant reduction in CLD at 28 days of life (RR 0.18, 95% CI 0.04 to 0.74; RD -0.35, 95% CI -0.56 to -0.13; NNTB 3, 95% CI 2 to 8) and no significant difference in mortality (RR 3.0, 95% CI 0.33 to 26.99; RD 0.08, 95% CI -0.07 to 0.22), along with a significantly shorter dependency on supplementary oxygen in the aminophylline group compared with the no treatment group (MD -17.75 days, 95% CI -27.56 to -7.94). Tests for heterogeneity were not applicable for any of the analyses, as each meta-analysis included only one study.\nAuthors' conclusions\nData are insufficient for reliable assessment of the use of salbutamol for prevention of CLD. One trial of poor quality reported a reduction in the incidence of CLD and shorter duration of supplementary oxygen with prophylactic aminophylline, but these results must be interpreted with caution. Additional clinical trials are necessary to assess the role of bronchodilator agents in prophylaxis or treatment of CLD. Researchers studying the effects of bronchodilators in preterm infants should include relevant clinical outcomes in addition to pulmonary mechanical outcomes. We identified no trials that studied the use of bronchodilator therapy for treatment of CLD.\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 randomised and quasi-randomised trials. We included in the analyses two studies that reported on 225 infants."
}
] |
query-laysum
|
8665
|
[
{
"role": "user",
"content": "Abstract: Background\nThe projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether metformin can prevent or delay T2DM and its complications in people with increased risk of developing T2DM is unknown.\nObjectives\nTo assess the effects of metformin for the prevention or delay of T2DM and its associated complications in persons at increased risk for the T2DM.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was March 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) with a duration of one year or more comparing metformin with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or standard care in people with impaired glucose tolerance, impaired fasting glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or combinations of these.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles and records, assessed risk of bias and extracted outcome data independently. We used a random-effects model to perform meta-analysis and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 20 RCTs randomising 6774 participants. One trial contributed 48% of all participants. The duration of intervention in the trials varied from one to five years. We judged none of the trials to be at low risk of bias in all 'Risk of bias' domains.\nOur main outcome measures were all-cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, non-fatal myocardial infarction or stroke, health-related quality of life and socioeconomic effects.The following comparisons mostly reported only a fraction of our main outcome set.\nFifteen RCTs compared metformin with diet and exercise with or without placebo: all-cause mortality was 7/1353 versus 7/1480 (RR 1.11, 95% CI 0.41 to 3.01; P = 0.83; 2833 participants, 5 trials; very low-quality evidence); incidence of T2DM was 324/1751 versus 529/1881 participants (RR 0.50, 95% CI 0.38 to 0.65; P < 0.001; 3632 participants, 12 trials; moderate-quality evidence); the reporting of SAEs was insufficient and diverse and meta-analysis could not be performed (reported numbers were 4/118 versus 2/191; 309 participants; 4 trials; very low-quality evidence); cardiovascular mortality was 1/1073 versus 4/1082 (2416 participants; 2 trials; very low-quality evidence). One trial reported no clear difference in health-related quality of life after 3.2 years of follow-up (very low-quality evidence). Two trials estimated the direct medical costs (DMC) per participant for metformin varying from $220 to $1177 versus $61 to $184 in the comparator group (2416 participants; 2 trials; low-quality evidence).\nEight RCTs compared metformin with intensive diet and exercise: all-cause mortality was 7/1278 versus 4/1272 (RR 1.61, 95% CI 0.50 to 5.23; P = 0.43; 2550 participants, 4 trials; very low-quality evidence); incidence of T2DM was 304/1455 versus 251/1505 (RR 0.80, 95% CI 0.47 to 1.37; P = 0.42; 2960 participants, 7 trials; moderate-quality evidence); the reporting of SAEs was sparse and meta-analysis could not be performed (one trial reported 1/44 in the metformin group versus 0/36 in the intensive exercise and diet group with SAEs). One trial reported that 1/1073 participants in the metformin group compared with 2/1079 participants in the comparator group died from cardiovascular causes. One trial reported that no participant died due to cardiovascular causes (very low-quality evidence). Two trials estimated the DMC per participant for metformin varying from $220 to $1177 versus $225 to $3628 in the comparator group (2400 participants; 2 trials; very low-quality evidence).\nThree RCTs compared metformin with acarbose: all-cause mortality was 1/44 versus 0/45 (89 participants; 1 trial; very low-quality evidence); incidence of T2DM was 12/147 versus 7/148 (RR 1.72, 95% CI 0.72 to 4.14; P = 0.22; 295 participants; 3 trials; low-quality evidence); SAEs were 1/51 versus 2/50 (101 participants; 1 trial; very low-quality evidence).\nThree RCTs compared metformin with thiazolidinediones: incidence of T2DM was 9/161 versus 9/159 (RR 0.99, 95% CI 0.41 to 2.40; P = 0.98; 320 participants; 3 trials; low-quality evidence). SAEs were 3/45 versus 0/41 (86 participants; 1 trial; very low-quality evidence).\nThree RCTs compared metformin plus intensive diet and exercise with identical intensive diet and exercise: all-cause mortality was 1/121 versus 1/120 participants (450 participants; 2 trials; very low-quality evidence); incidence of T2DM was 48/166 versus 53/166 (RR 0.55, 95% CI 0.10 to 2.92; P = 0.49; 332 participants; 2 trials; very low-quality evidence). One trial estimated the DMC of metformin plus intensive diet and exercise to be $270 per participant compared with $225 in the comparator group (94 participants; 1 trial; very-low quality evidence).\nOne trial in 45 participants compared metformin with a sulphonylurea. The trial reported no patient-important outcomes.\nFor all comparisons there were no data on non-fatal myocardial infarction, non-fatal stroke or microvascular complications.\nWe identified 11 ongoing trials which potentially could provide data of interest for this review. These trials will add a total of 17,853 participants in future updates of this review.\nAuthors' conclusions\nMetformin compared with placebo or diet and exercise reduced or delayed the risk of T2DM in people at increased risk for the development of T2DM (moderate-quality evidence). However, metformin compared to intensive diet and exercise did not reduce or delay the risk of T2DM (moderate-quality evidence). Likewise, the combination of metformin and intensive diet and exercise compared to intensive diet and exercise only neither showed an advantage or disadvantage regarding the development of T2DM (very low-quality evidence). Data on patient-important outcomes such as mortality, macrovascular and microvascular diabetic complications and health-related quality of life were sparse or missing.\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 the antidiabetic drug metformin able to prevent or delay the development of type 2 diabetes and its associated complications in people with moderately elevated blood sugar levels?"
}
] |
query-laysum
|
8666
|
[
{
"role": "user",
"content": "Abstract: Background\nAutism spectrum disorder is a neurodevelopmental disorder characterised by social communication difficulties, restricted interests and repetitive behaviours. The clinical pathway for children with a diagnosis of autism spectrum disorder is varied, and current research suggests some children may not continue to meet diagnostic criteria over time.\nObjectives\nThe primary objective of this review was to synthesise the available evidence on the proportion of preschool children who have a diagnosis of autism spectrum disorder at baseline (diagnosed before six years of age) who continue to meet diagnostic criteria at follow-up one or more years later (up to 19 years of age).\nSearch methods\nWe searched MEDLINE, Embase, PsycINFO, and eight other databases in October 2017 and ran top-up searches up to July 2021. We also searched reference lists of relevant systematic reviews.\nSelection criteria\nTwo review authors independently assessed prospective and retrospective follow-up studies that used the same measure and process within studies to diagnose autism spectrum disorder at baseline and follow-up. Studies were required to have at least one year of follow-up and contain at least 10 participants. Participants were all aged less than six years at baseline assessment and followed up before 19 years of age.\nData collection and analysis\nWe extracted data on study characteristics and the proportion of children diagnosed with autism spectrum disorder at baseline and follow-up. We also collected information on change in scores on measures that assess the dimensions of autism spectrum disorder (i.e. social communication and restricted interests and repetitive behaviours). Two review authors independently extracted data on study characteristics and assessed risk of bias using a modified quality in prognosis studies (QUIPS) tool. We conducted a random-effects meta-analysis or narrative synthesis, depending on the type of data available. We also conducted prognostic factor analyses to explore factors that may predict diagnostic outcome.\nMain results\nIn total, 49 studies met our inclusion criteria and 42 of these (11,740 participants) had data that could be extracted. Of the 42 studies, 25 (60%) were conducted in North America, 13 (31%) were conducted in Europe and the UK, and four (10%) in Asia. Most (52%) studies were published before 2014. The mean age of the participants was 3.19 years (range 1.13 to 5.0 years) at baseline and 6.12 years (range 3.0 to 12.14 years) at follow-up. The mean length of follow-up was 2.86 years (range 1.0 to 12.41 years). The majority of the children were boys (81%), and just over half (60%) of the studies primarily included participants with intellectual disability (intelligence quotient < 70). The mean sample size was 272 (range 10 to 8564). Sixty-nine per cent of studies used one diagnostic assessment tool, 24% used two tools and 7% used three or more tools. Diagnosis was decided by a multidisciplinary team in 41% of studies. No data were available for the outcomes of social communication and restricted and repetitive behaviours and interests.\nOf the 42 studies with available data, we were able to synthesise data from 34 studies (69% of all included studies; n = 11,129) in a meta-analysis. In summary, 92% (95% confidence interval 89% to 95%) of participants continued to meet diagnostic criteria for autism spectrum disorder from baseline to follow-up one or more years later; however, the quality of the evidence was judged as low due to study limitations and inconsistency. The majority of the included studies (95%) were rated at high risk of bias. We were unable to explore the outcomes of change in social communication and restricted and repetitive behaviour and interests between baseline and follow-up as none of the included studies provided separate domain scores at baseline and follow-up. Details on conflict of interest were reported in 24 studies. Funding support was reported by 30 studies, 12 studies omitted details on funding sources and two studies reported no funding support. Declared funding sources were categorised as government, university or non-government organisation or charity groups. We considered it unlikely funding sources would have significantly influenced the outcomes, given the nature of prognosis studies.\nAuthors' conclusions\nOverall, we found that nine out of 10 children who were diagnosed with autism spectrum disorder before six years of age continued to meet diagnostic criteria for autism spectrum disorder a year or more later, however the evidence was uncertain. Confidence in the evidence was rated low using GRADE, due to heterogeneity and risk of bias, and there were few studies that included children diagnosed using a current classification system, such as the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or the eleventh revision of the International Classification of Diseases (ICD-11). Future studies that are well-designed, prospective and specifically assess prognosis of autism spectrum disorder diagnoses are needed. These studies should also include contemporary diagnostic assessment methods across a broad range of participants and investigate a range of relevant prognostic factors.\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 preschool aged children diagnosed with autism. We then summarised the results, evaluated the evidence and rated our confidence in the evidence based on factors such as study methods and participation."
}
] |
query-laysum
|
8667
|
[
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease is a group of disorders characterized by deformation of erythrocytes. Renal damage is a frequent complication in sickle cell disease as a result of long-standing anemia and disturbed circulation through the renal medullary capillaries. Due to the improvement in life expectancy of people with sickle cell disease, there has been a corresponding significant increase in the incidence of renal complications. Microalbuminuria and proteinuria are noted to be a strong predictor of subsequent renal failure. There is extensive experience and evidence with angiotensin-converting enzyme (ACE) inhibitors over many years in a variety of clinical situations for patients who do not have sickle cell disease, but their effect in people with this disease is unknown. It is common practice to administer ACE inhibitors for sickle nephropathy due to their renoprotective properties; however, little is known about their effectiveness and safety in this setting. This is an update of a Cochrane Review first published in 2013 and 2015.\nObjectives\nTo determine the effectiveness of ACE inhibitor administration in people with sickle cell disease for decreasing intraglomerular pressure, microalbuminuria and proteinuria and to to assess the safety of ACE inhibitors as pertains to their adverse effects.\nSearch methods\nThe authors searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Hameoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of the most recent search: 18 October 2021.\nWe also searched clinical trial registries. Date of the most recent search: 22 August 2021.\nSelection criteria\nRandomized or quasi-randomized controlled trials of ACE inhibitors designed to reduce microalbuminuria and proteinuria in people with sickle cell disease compared to either placebo or standard treatment regimen.\nData collection and analysis\nThree authors independently applied the inclusion criteria in order to select studies for inclusion in the review. Two authors assessed the risk of bias of studies and extracted data and the third author verified these assessments.\nMain results\nSeven studies were identified through the searches. Six studies were excluded. The included study randomized 22 participants (7 males and 15 females) having proteinuria or microalbuminuria with sickle cell disease and treated the participants for six months (median length of follow up of three months) with captopril or placebo. Overall, the certainty of the evidence provided in this review was very low, since most risk of bias domains were judged to have either an unclear or a high risk of bias. Because of this, we are uncertain whether captopril makes any difference, in total urinary albumin excretion (at six months) as compared to the placebo group, although it yielded a mean difference of -49.00 (95% confidence interval (CI) -124.10 to 26.10) or in the absolute change score, although it yielded a mean difference of -63.00 (95% CI -93.78 to -32.22). At six months albumin excretion in the captopril group was noted to decrease from baseline by a mean (standard deviation) of 45 (23) mg/day and the placebo group was noted to increase by 18 (45) mg/day. Serum creatinine and potassium levels were reported constant throughout the study (very low-certainty evidence). The potential for inducing hypotension should be highlighted; the study reported a decrease of 8 mmHg in systolic pressure and 5 mmHg in diastolic and mean blood pressure (very low-certainty evidence).\nAuthors' conclusions\nOverall, we judged the certainty of the evidence to be very low. The included study selectively reported its results, was not powered to detect a group difference, should it exist, and otherwise did not offer enough information to allow us to judge the bias inherent in the study. Indirectness (in relation to the limited age and type of population included) and imprecision (wide confidence intervals around the effect estimate) were observed. More long-term studies involving multiple centers and larger cohorts using a randomized-controlled design are warranted, especially among the pediatric age group. Detailed reporting of each outcome measure is necessary to allow a clear cut interpretation in a systematic review. One of the difficulties encountered in this review was the lack of detailed data reported in the included study.\nOverall, we judged the certainty of this evidence to be very low.\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": "Sickle cell disease is a group of inherited conditions that often lead to kidney damage. High protein or albumin levels in urine is a strong predictor of future kidney failure. Angiotensin-converting enzyme (ACE) inhibitors are often given to reduce the level of protein or albumin in urine and to protect the kidneys from damage. However, we do not know very much about how effective and safe these are in people with sickle cell disease."
}
] |
query-laysum
|
8668
|
[
{
"role": "user",
"content": "Abstract: Background\nTopical analgesic drugs are used for a variety of painful conditions. Some are acute, typically strains or sprains, tendinopathy, or muscle aches. Others are chronic, typically osteoarthritis of hand or knee, or neuropathic pain.\nObjectives\nTo provide an overview of the analgesic efficacy and associated adverse events of topical analgesics (primarily nonsteroidal anti-inflammatory drugs (NSAIDs), salicylate rubefacients, capsaicin, and lidocaine) applied to intact skin for the treatment of acute and chronic pain in adults.\nMethods\nWe identified systematic reviews in acute and chronic pain published to February 2017 in the Cochrane Database of Systematic Reviews (the Cochrane Library). The primary outcome was at least 50% pain relief (participant-reported) at an appropriate duration. We extracted the number needed to treat for one additional beneficial outcome (NNT) for efficacy outcomes for each topical analgesic or formulation, and the number needed to treat for one additional harmful outcome (NNH) for adverse events. We also extracted information on withdrawals due to lack of efficacy or adverse events, systemic and local adverse events, and serious adverse events. We required information from at least 200 participants, in at least two studies. We judged that there was potential for publication bias if the addition of four studies of typical size (400 participants) with zero effect increased NNT compared with placebo to 10 (minimal clinical utility). We extracted GRADE assessment in the original papers, and made our own GRADE assessment.\nMain results\nThirteen Cochrane Reviews (206 studies with around 30,700 participants) assessed the efficacy and harms from a range of topical analgesics applied to intact skin in a number of acute and chronic painful conditions. Reviews were overseen by several Review Groups, and concentrated on evidence comparing topical analgesic with topical placebo; comparisons of topical and oral analgesics were rare.\nFor at least 50% pain relief, we considered evidence was moderate or high quality for several therapies, based on the underlying quality of studies and susceptibility to publication bias.\nIn acute musculoskeletal pain (strains and sprains) with assessment at about seven days, therapies were diclofenac Emulgel (78% Emulgel, 20% placebo; 2 studies, 314 participants, NNT 1.8 (95% confidence interval 1.5 to 2.1)), ketoprofen gel (72% ketoprofen, 33% placebo, 5 studies, 348 participants, NNT 2.5 (2.0 to 3.4)), piroxicam gel (70% piroxicam, 47% placebo, 3 studies, 522 participants, NNT 4.4 (3.2 to 6.9)), diclofenac Flector plaster (63% Flector, 41% placebo, 4 studies, 1030 participants, NNT 4.7 (3.7 to 6.5)), and diclofenac other plaster (88% diclofenac plaster, 57% placebo, 3 studies, 474 participants, NNT 3.2 (2.6 to 4.2)).\nIn chronic musculoskeletal pain (mainly hand and knee osteoarthritis) therapies were topical diclofenac preparations for less than six weeks (43% diclofenac, 23% placebo, 5 studies, 732 participants, NNT 5.0 (3.7 to 7.4)), ketoprofen over 6 to 12 weeks (63% ketoprofen, 48% placebo, 4 studies, 2573 participants, NNT 6.9 (5.4 to 9.3)), and topical diclofenac preparations over 6 to 12 weeks (60% diclofenac, 50% placebo, 4 studies, 2343 participants, NNT 9.8 (7.1 to 16)). In postherpetic neuralgia, topical high-concentration capsaicin had moderate-quality evidence of limited efficacy (33% capsaicin, 24% placebo, 2 studies, 571 participants, NNT 11 (6.1 to 62)).\nWe judged evidence of efficacy for other therapies as low or very low quality. Limited evidence of efficacy, potentially subject to publication bias, existed for topical preparations of ibuprofen gels and creams, unspecified diclofenac formulations and diclofenac gel other than Emulgel, indomethacin, and ketoprofen plaster in acute pain conditions, and for salicylate rubefacients for chronic pain conditions. Evidence for other interventions (other topical NSAIDs, topical salicylate in acute pain conditions, low concentration capsaicin, lidocaine, clonidine for neuropathic pain, and herbal remedies for any condition) was very low quality and typically limited to single studies or comparisons with sparse data.\nWe assessed the evidence on withdrawals as moderate or very low quality, because of small numbers of events. In chronic pain conditions lack of efficacy withdrawals were lower with topical diclofenac (6%) than placebo (9%) (11 studies, 3455 participants, number needed to treat to prevent (NNTp) 26, moderate-quality evidence), and topical salicylate (2% vs 7% for placebo) (5 studies, 501 participants, NNTp 21, very low-quality evidence). Adverse event withdrawals were higher with topical capsaicin low-concentration (15%) than placebo (3%) (4 studies, 477 participants, NNH 8, very low-quality evidence), topical salicylate (5% vs 1% for placebo) (7 studies, 735 participants, NNH 26, very low-quality evidence), and topical diclofenac (5% vs 4% for placebo) (12 studies, 3552 participants, NNH 51, very low-quality evidence).\nIn acute pain, systemic or local adverse event rates with topical NSAIDs (4.3%) were no greater than with topical placebo (4.6%) (42 studies, 6740 participants, high quality evidence). In chronic pain local adverse events with topical capsaicin low concentration (63%) were higher than topical placebo (5 studies, 557 participants, number needed to treat for harm (NNH) 2.6), high quality evidence. Moderate-quality evidence indicated more local adverse events than placebo in chronic pain conditions with topical diclofenac (NNH 16) and local pain with topical capsaicin high-concentration (NNH 16). There was moderate-quality evidence of no additional local adverse events with topical ketoprofen over topical placebo in chronic pain. Serious adverse events were rare (very low-quality evidence).\nGRADE assessments of moderate or low quality in some of the reviews were considered by us to be very low because of small numbers of participants and events.\nAuthors' conclusions\nThere is good evidence that some formulations of topical diclofenac and ketoprofen are useful in acute pain conditions such as sprains or strains, with low (good) NNT values. There is a strong message that the exact formulation used is critically important in acute conditions, and that might also apply to other pain conditions. In chronic musculoskeletal conditions with assessments over 6 to 12 weeks, topical diclofenac and ketoprofen had limited efficacy in hand and knee osteoarthritis, as did topical high-concentration capsaicin in postherpetic neuralgia. Though NNTs were higher, this still indicates that a small proportion of people had good pain relief.\nUse of GRADE in Cochrane Reviews with small numbers of participants and events requires attention.\n\nGiven the provided abstract, please respond to the following query: \"Bottom line\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Diclofenac Emulgel, ketoprofen gel, piroxicam gel, and diclofenac plaster work reasonably well for strains and sprains. For hand and knee osteoarthritis, the nonsteroidal anti-inflammatory drugs (NSAIDs) topical diclofenac and topical ketoprofen rubbed on the skin for at least 6 to 12 weeks help reduce pain by at least half in a modest number of people. For postherpetic neuralgia (pain following shingles), topical high-concentration capsaicin (derived from chili peppers) can reduce pain by at least half in a small number of people."
}
] |
query-laysum
|
8669
|
[
{
"role": "user",
"content": "Abstract: Background\nUnilateral ureteric-pelvic junction obstruction (UPJO) is the most common cause of obstructive uropathy and may lead to renal impairment and loss of renal function. The current diagnostic approach with renal imaging cannot reliably determine which newborns and infants less than two years of age have a significant obstruction and are at risk for permanent kidney damage. There is therefore no consensus on optimal therapeutic management of unilateral UPJO.\nObjectives\nTo assess the effects of surgical versus non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 6, 2016), MEDLINE/Ovid, and EMBASE/Ovid databases from their inception to 13 June 2016. We searched the reference lists of potentially relevant studies without using any language restriction. We also searched the following trial registers for relevant registered studies: www.clinicaltrials.gov/; ISRCTN registry (controlled-trials.com/); www.trialscentral.org/; apps.who.int/trialsearch/; www.drks.de/; and www.anzctr.org.au/trialSearch.aspx.\nSelection criteria\nWe selected randomised and quasi-randomised controlled trials comparing surgical with non-surgical interventions for the treatment of unilateral UPJO.\nData collection and analysis\nTwo review authors independently assessed study eligibility and risk of bias of included studies and extracted data. In case of disagreements we consulted a third review author. The data reported in the two included studies did not allow us to perform a meta-analysis.\nMain results\nWe found only two studies at high risk of bias that were eligible for inclusion in this review. The total sample size, including both trials, was small (n = 107 participants less than six months of age from the UK and USA), and not all prespecified outcome measures were assessed. Reported measures only accounted for the short-term follow-ups. The mean split renal function was not statistically different between the surgical and non-surgical group at the six-month or one-year time point (very low-quality evidence). The surgical group showed a significantly less obstructed drainage pattern and a lower urinary tract dilatation than the non-surgical group (very low-quality evidence). Transfer from the non-surgical group to the surgical group was reported for about one out of five participants. Split renal function after secondary surgical intervention was reported with variable results, but most of the participants reverted to pre-deteriorated values. The studies either provided no or insufficient data on the following outcome measures: postoperative complications, UPJO-associated clinical symptoms, costs of interventions, radiation exposure, quality of life, and adverse effects.\nAuthors' conclusions\nWe found limited evidence assessing the benefits and harms of surgical compared to non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO. The majority of participants in the non-surgical treatment group did not experience any significant deterioration of split renal function, and only about 20% of them underwent secondary surgical intervention, with minor risk of permanent deteriorated split renal function. The study follow-up period was too short to assess the long-term effects on split renal function in both treatment groups. We need further randomised controlled trials with sufficient statistical power and an adequate follow-up period to determine the optimal therapy for newborns and infants less than two years of age with unilateral UPJO.\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": "Do children with unilateral ureteric-pelvic junction obstruction do better with or without surgery?"
}
] |
query-laysum
|
8670
|
[
{
"role": "user",
"content": "Abstract: Background\nCardiogenic shock (CS) is a state of critical end-organ hypoperfusion due to a primary cardiac disorder. For people with refractory CS despite maximal vasopressors, inotropic support and intra-aortic balloon pump, mortality approaches 100%. Mechanical assist devices provide mechanical circulatory support (MCS) which has the ability to maintain vital organ perfusion, to unload the failing ventricle thus reduce intracardiac filling pressures which reduces pulmonary congestion, myocardial wall stress and myocardial oxygen consumption. This has been hypothesised to allow time for myocardial recovery (bridge to recovery) or allow time to come to a decision as to whether the person is a candidate for a longer-term ventricular assist device (VAD) either as a bridge to heart transplantation or as a destination therapy with a long-term VAD.\nObjectives\nTo assess whether mechanical assist devices improve survival in people with acute cardiogenic shock.\nSearch methods\nWe searched CENTRAL, MEDLINE (Ovid), Embase (Ovid) and Web of Science Core Collection in November 2019. In addition, we searched three trials registers in August 2019. We scanned reference lists and contacted experts in the field to obtain further information. There were no language restrictions.\nSelection criteria\nRandomised controlled trials on people with acute CS comparing mechanical assist devices with best current intensive care management, including intra-aortic balloon pump and inotropic support.\nData collection and analysis\nWe performed data collection and analysis according to the published protocol.\nPrimary outcomes were survival to discharge, 30 days, 1 year and secondary outcomes included, quality of life, major adverse cardiovascular events (30 days/end of follow-up), dialysis-dependent (30 days/end of follow-up), length of hospital stay and length of intensive care unit stay and major adverse events.\nWe used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of a body of evidence as it relates to the studies which contribute data to the meta-analyses for the prespecified outcomes\nSummary statistics for the primary endpoints were risk ratios (RR), hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs).\nMain results\nThe search identified five studies from 4534 original citations reviewed. Two studies included acute CS of all causes randomised to treatment using TandemHeart percutaneous VAD and three studies included people with CS secondary to acute myocardial infarction who were randomised to Impella CP or best medical management. Meta-analysis was performed only to assess the 30-day survival as there were insufficient data to perform any further meta-analyses. The results from the five studies with 162 participants showed mechanical assist devices may have little or no effect on 30-day survival (RR of 1.01 95% CI 0.76 to 1.35) but the evidence is very uncertain.\nComplications such as sepsis, thromboembolic phenomena, bleeding and major adverse cardiovascular events were not infrequent in both the MAD and control group across the studies, but these could not be pooled due to inconsistencies in adverse event definitions and reporting.\nWe identified four randomised control trials assessing mechanical assist devices in acute CS that are currently ongoing.\nAuthors' conclusions\nThere is no evidence from this review of a benefit from MCS in improving survival for people with acute CS. Further use of the technology, risk stratification and optimising the use protocols have been highlighted as potential reasons for lack of benefit and are being addressed in the current ongoing clinical trials.\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"
},
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"role": "assistant",
"content": "In conclusion, this review was unable to assess if mechanical assist devices help people with cardiogenic shock due to their heart failing. We await the results of the ongoing trials, which we anticipate will help clarify whether these devices will help people to survive with a full recovery or not."
}
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query-laysum
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8671
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[
{
"role": "user",
"content": "Abstract: Background\nNon-allergic rhinitis is defined as dysfunction and non-infectious inflammation of the nasal mucosa that is caused by provoking agents other than allergens or microbes. It is common, with an estimated prevalence of around 10% to 20%. Patients experience symptoms of nasal obstruction, anterior rhinorrhoea/post-nasal drip and sneezing. Several subgroups of non-allergic rhinitis can be distinguished, depending on the trigger responsible for symptoms; these include occupation, cigarette smoke, hormones, medication, food and age. On a cellular molecular level different disease mechanisms can also be identified. People with non-allergic rhinitis often lack an effective treatment as a result of poor understanding and lack of recognition of the underlying disease mechanism. Intranasal corticosteroids are one of the most common types of medication prescribed in patients with rhinitis or rhinosinusitis symptoms, including those with non-allergic rhinitis. However, it is unclear whether intranasal corticosteroids are truly effective in these patients.\nObjectives\nTo assess the effects of intranasal corticosteroids in the management of non-allergic rhinitis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 7); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 July 2019.\nSelection criteria\nRandomised controlled trials (RCTs) comparing intranasal corticosteroids, delivered by any means and in any volume, with (a) placebo/no intervention or (b) other active treatments in adults and children (aged ≥ 12 years).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. The primary outcomes were patient-reported disease severity and a\nsignificant adverse effect - epistaxis. Secondary outcomes were (disease-specific) health-related quality of life, objective measurements of airflow and other adverse events. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 34 studies (4452 participants); however, only 13 studies provided data for our main comparison, intranasal corticosteroids versus placebo. The participants were mainly defined as patients with perennial rhinitis symptoms and negative allergy tests. No distinction between different pheno- and endotypes could be made, although a few studies only included a specific phenotype such as pregnancy rhinitis, vasomotor rhinitis, rhinitis medicamentosa or senile rhinitis. Most studies were conducted in a secondary or tertiary healthcare setting. No studies reported outcomes beyond three months follow-up. Intranasal corticosteroid dosage in the review ranged from 50 µg to 2000 µg daily.\nIntranasal corticosteroids versus placebo\nThirteen studies (2045 participants) provided data for this comparison. These studies used different scoring systems for patient-reported disease severity, so we pooled the data in each analysis using the standardised mean difference (SMD). Intranasal corticosteroid treatment may improve patient-reported disease severity as measured by total nasal symptom score compared with placebo at up to four weeks (SMD -0.74, 95% confidence interval (CI) -1.15 to -0.33; 4 studies; 131 participants; I2 = 22%) (low-certainty evidence). However, between four weeks and three months the evidence is very uncertain (SMD -0.24, 95% CI -0.67 to 0.20; 3 studies; 85 participants; I2 = 0%) (very low-certainty evidence). Intranasal corticosteroid treatment may slightly improve patient-reported disease severity as measured by total nasal symptom score change from baseline when compared with placebo at up to four weeks (SMD -0.15, 95% CI -0.25 to -0.05; 4 studies; 1465 participants; I2 = 35%) (low-certainty evidence).\nAll four studies evaluating the risk of epistaxis showed that there is probably a higher risk in the intranasal corticosteroids group (65 per 1000) compared to placebo (31 per 1000) (risk ratio (RR) 2.10, 95% CI 1.24 to 3.57; 4 studies; 1174 participants; I2 = 0%) (moderate-certainty evidence). The absolute risk difference (RD) was 0.04 with a number needed to treat for an additional harmful outcome (NNTH) of 25 (95% CI 16.7 to 100).\nOnly one study reported numerical data for quality of life. It did report a higher quality of life score in the intranasal corticosteroids group (152.3 versus 145.6; SF-12v2 range 0 to 800); however, this disappeared at longer-term follow-up (148.4 versus 145.6) (low-certainty evidence).\nOnly two studies provided data for the outcome objective measurements of airflow. These data could not be pooled because they used different methods of outcome measurement. Neither found a significant difference between the intranasal corticosteroids and placebo group (rhinomanometry SMD -0.46, 95% CI -1.06 to 0.14; 44 participants; peak expiratory flow rate SMD 0.78, 95% CI -0.47 to 2.03; 11 participants) (very low-certainty evidence).\nIntranasal corticosteroids probably resulted in little or no difference in the risk of other adverse events compared to placebo (RR 0.99, 95% CI 0.87 to 1.12; 3 studies; 1130 participants; I2 = 0%) (moderate-certainty evidence).\nIntranasal corticosteroids versus other treatments\nOnly one or a few studies assessed each of the other comparisons (intranasal corticosteroids versus saline irrigation, intranasal antihistamine, capsaicin, cromoglycate sodium, ipratropium bromide, intranasal corticosteroids combined with intranasal antihistamine, intranasal corticosteroids combined with intranasal antihistamine and intranasal corticosteroids with saline compared to saline alone). It is therefore uncertain whether there are differences between intranasal corticosteroids and other active treatments for any of the outcomes reported.\nAuthors' conclusions\nOverall, the certainty of the evidence for most outcomes in this review was low or very low. It is unclear whether intranasal corticosteroids reduce patient-reported disease severity in non-allergic rhinitis patients compared with placebo when measured at up to three months. However, intranasal corticosteroids probably have a higher risk of the adverse effect epistaxis. There are very few studies comparing intranasal corticosteroids to other treatment modalities making it difficult to draw conclusions.\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": "Non-allergic rhinitis is a chronic disease of the nose, which is not caused by infection or allergies. People with non-allergic rhinitis experience symptoms that affect their quality of life, such as nasal obstruction, runny nose and sneezing. Non-allergic rhinitis patients can be divided into different subgroups who have different underlying causes for their disease. The underlying causes of non-allergic rhinitis are not fully understood, therefore treatment is often unsuccessful in these patients.\nTopical (intranasal) corticosteroids are used with the aim of reducing inflammation. They are the most commonly prescribed drug in other chronic diseases of the nose and sinuses, such as allergic rhinitis and chronic rhinosinusitis. Intranasal corticosteroid treatment can be delivered with sprays or drops and for different time periods."
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query-laysum
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8672
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[
{
"role": "user",
"content": "Abstract: Background\nEvery year, an estimated one million children and young adolescents become ill with tuberculosis, and around 226,000 of those children die. Xpert MTB/RIF Ultra (Xpert Ultra) is a molecular World Health Organization (WHO)-recommended rapid diagnostic test that simultaneously detects Mycobacterium tuberculosis complex and rifampicin resistance. We previously published a Cochrane Review 'Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for tuberculosis disease and rifampicin resistance in children'. The current review updates evidence on the diagnostic accuracy of Xpert Ultra in children presumed to have tuberculosis disease. Parts of this review update informed the 2022 WHO updated guidance on management of tuberculosis in children and adolescents.\nObjectives\nTo assess the diagnostic accuracy of Xpert Ultra for detecting: pulmonary tuberculosis, tuberculous meningitis, lymph node tuberculosis, and rifampicin resistance, in children with presumed tuberculosis.\nSecondary objectives\nTo investigate potential sources of heterogeneity in accuracy estimates. For detection of tuberculosis, we considered age, comorbidity (HIV, severe pneumonia, and severe malnutrition), and specimen type as potential sources.\nTo summarize the frequency of Xpert Ultra trace results.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, three other databases, and three trial registers without language restrictions to 9 March 2021.\nSelection criteria\nCross-sectional and cohort studies and randomized trials that evaluated Xpert Ultra in HIV-positive and HIV-negative children under 15 years of age. We included ongoing studies that helped us address the review objectives. We included studies evaluating sputum, gastric, stool, or nasopharyngeal specimens (pulmonary tuberculosis), cerebrospinal fluid (tuberculous meningitis), and fine needle aspirate or surgical biopsy tissue (lymph node tuberculosis). For detecting tuberculosis, reference standards were microbiological (culture) or composite reference standard; for stool, we also included Xpert Ultra performed on a routine respiratory specimen. For detecting rifampicin resistance, reference standards were drug susceptibility testing or MTBDRplus.\nData collection and analysis\nTwo review authors independently extracted data and, using QUADAS-2, assessed methodological quality judging risk of bias separately for each target condition and reference standard. For each target condition, we used the bivariate model to estimate summary sensitivity and specificity with 95% confidence intervals (CIs). We stratified all analyses by type of reference standard. We summarized the frequency of Xpert Ultra trace results; trace represents detection of a very low quantity of Mycobacterium tuberculosis DNA. We assessed certainty of evidence using GRADE.\nMain results\nWe identified 14 studies (11 new studies since the previous review). For detection of pulmonary tuberculosis, 335 data sets (25,937 participants) were available for analysis. We did not identify any studies that evaluated Xpert Ultra accuracy for tuberculous meningitis or lymph node tuberculosis. Three studies evaluated Xpert Ultra for detection of rifampicin resistance. Ten studies (71%) took place in countries with a high tuberculosis burden based on WHO classification. Overall, risk of bias was low.\nDetection of pulmonary tuberculosis\nSputum, 5 studies\nXpert Ultra summary sensitivity verified by culture was 75.3% (95% CI 64.3 to 83.8; 127 participants; high-certainty evidence), and specificity was 97.1% (95% CI 94.7 to 98.5; 1054 participants; high-certainty evidence).\nGastric aspirate, 7 studies\nXpert Ultra summary sensitivity verified by culture was 70.4% (95% CI 53.9 to 82.9; 120 participants; moderate-certainty evidence), and specificity was 94.1% (95% CI 84.8 to 97.8; 870 participants; moderate-certainty evidence).\nStool, 6 studies\nXpert Ultra summary sensitivity verified by culture was 56.1% (95% CI 39.1 to 71.7; 200 participants; moderate-certainty evidence), and specificity was 98.0% (95% CI 93.3 to 99.4; 1232 participants; high certainty-evidence).\nNasopharyngeal aspirate, 4 studies\nXpert Ultra summary sensitivity verified by culture was 43.7% (95% CI 26.7 to 62.2; 46 participants; very low-certainty evidence), and specificity was 97.5% (95% CI 93.6 to 99.0; 489 participants; high-certainty evidence).\nXpert Ultra sensitivity was lower against a composite than a culture reference standard for all specimen types other than nasopharyngeal aspirate, while specificity was similar against both reference standards.\nInterpretation of results\nIn theory, for a population of 1000 children:\n• where 100 have pulmonary tuberculosis in sputum (by culture):\n- 101 would be Xpert Ultra-positive, and of these, 26 (26%) would not have pulmonary tuberculosis (false positive); and\n- 899 would be Xpert Ultra-negative, and of these, 25 (3%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in gastric aspirate (by culture):\n- 123 would be Xpert Ultra-positive, and of these, 53 (43%) would not have pulmonary tuberculosis (false positive); and\n- 877 would be Xpert Ultra-negative, and of these, 30 (3%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in stool (by culture):\n- 74 would be Xpert Ultra-positive, and of these, 18 (24%) would not have pulmonary tuberculosis (false positive); and\n- 926 would be Xpert Ultra-negative, and of these, 44 (5%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in nasopharyngeal aspirate (by culture):\n- 66 would be Xpert Ultra-positive, and of these, 22 (33%) would not have pulmonary tuberculosis (false positive); and\n- 934 would be Xpert Ultra-negative, and of these, 56 (6%) would have tuberculosis (false negative).\nDetection of rifampicin resistance\nXpert Ultra sensitivity was 100% (3 studies, 3 participants; very low-certainty evidence), and specificity range was 97% to 100% (3 studies, 128 participants; low-certainty evidence).\nTrace results\nXpert Ultra trace results, regarded as positive in children by WHO standards, were common. Xpert Ultra specificity remained high in children, despite the frequency of trace results.\nAuthors' conclusions\nWe found Xpert Ultra sensitivity to vary by specimen type, with sputum having the highest sensitivity, followed by gastric aspirate and stool. Nasopharyngeal aspirate had the lowest sensitivity. Xpert Ultra specificity was high against both microbiological and composite reference standards. However, the evidence base is still limited, and findings may be imprecise and vary by study setting. Although we found Xpert Ultra accurate for detection of rifampicin resistance, results were based on a very small number of studies that included only three children with rifampicin resistance. Therefore, findings should be interpreted with caution. Our findings provide support for the use of Xpert Ultra as an initial rapid molecular diagnostic in children being evaluated for tuberculosis.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To determine the accuracy of Xpert Ultra in children with symptoms of tuberculosis for diagnosing pulmonary tuberculosis, tuberculous meningitis (affecting membranes that surround the brain and spinal cord), lymph node tuberculosis (a painful swelling of one or more lymph nodes, which are bean-shaped structures that help fight infection), and rifampicin resistance."
}
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query-laysum
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8673
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[
{
"role": "user",
"content": "Abstract: Background\nMedical treatment and detoxification from opiate disorders includes oral administration of opioid agonists. Dihydrocodeine (DHC) substitution treatment is typically low threshold and therefore has the capacity to reach wider groups of opiate users. Decisions to prescribe DHC to patients with less severe opiate disorders centre on its perceived safety, reduced toxicity, shorter half-life and more rapid onset of action, and potential retention of patients. This review set out to investigate the effects of DHC in comparison to other pharmaceutical opioids and placebos in the detoxification and substitution of individuals with opiate use disorders.\nObjectives\nTo investigate the effectiveness of DHC in reducing illicit opiate use and other health-related outcomes among adults compared to other drugs or placebos used for detoxification or substitution therapy.\nSearch methods\nIn February 2019 we searched Cochrane Drugs and Alcohol's Specialised Register, CENTRAL, PubMed, Embase and Web of Science. We also searched for ongoing and unpublished studies via ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and Trialsjournal.com. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and the included studies.\nSelection criteria\nWe included randomised controlled trials that evaluated the effect of DHC for detoxification and maintenance substitution therapy for adolescent (aged 15 years and older) and adult illicit opiate users.\nThe primary outcomes were abstinence from illicit opiate use following detoxification or maintenance therapy measured by self-report or urinalysis. The secondary outcomes were treatment retention and other health and behaviour outcomes.\nData collection and analysis\nWe followed the standard methodological procedures that are outlined by Cochrane. This includes the GRADE approach to appraise the quality of evidence.\nMain results\nWe included three trials (in five articles) with 385 opiate-using participants that measured outcomes at different follow-up periods in this review. Two studies with 150 individuals compared DHC with buprenorphine for detoxification, and one study with 235 participants compared DHC to methadone for maintenance substitution therapy. We downgraded the quality of evidence mainly due to risk of bias and imprecision.\nFor the two studies that compared DHC to buprenorphine, we found low-quality evidence of no significant difference between DHC and buprenorphine for detoxification at six-month follow-up (risk ratio (RR) 0.59, 95% confidence interval (CI) 0.25 to 1.39; P = 0.23) in the meta-analysis for the primary outcome of abstinence from illicit opiates. Similarly, low-quality evidence indicated no difference for treatment retention (RR 1.29, 95% CI 0.99 to 1.68; P = 0.06).\nIn the single trial that compared DHC to methadone for maintenance substitution therapy, the evidence was also of low quality, and there may be no difference in effects between DHC and methadone for reported abstinence from illicit opiates (mean difference (MD) −0.01, 95% CI −0.31 to 0.29). For treatment retention at six months' follow-up in this single trial, the RR calculated with an intention-to-treat analysis also indicated that there may be no difference between DHC and methadone (RR 1.04, 95% CI 0.94 to 1.16).\nThe studies that compared DHC to buprenorphine reported no serious adverse events, while the DHC versus methadone study reported one death due to methadone overdose.\nAuthors' conclusions\nWe found low-quality evidence that DHC may be no more effective than other commonly used pharmacological interventions in reducing illicit opiate use. It is therefore premature to make any conclusive statements about the effectiveness of DHC, and it is suggested that further high-quality studies are conducted, especially in low- to middle-income countries.\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": "For detoxification from illegal substances such as heroin, DHC may not work any better than buprenorphine in reducing substance use, keeping individuals in treatment and other behaviours. The pattern stayed the same for follow-up appointments.\nFor maintenance treatment, DHC also may not work better than methadone in reducing substance use or any of the secondary outcomes, but participants may be more likely to stay in treatment. This finding remained the same across longer follow-up periods as well.\nThe only adverse event reported was one death from a methadone overdose in the study that compared DHC with methadone as maintenance therapy.\nThe pattern of results indicates that individuals who received DHC generally may not do better in reducing their substance use, completing treatment or other measures of substance-related behaviours than those that received other types of medication. However it is premature to make definitive statements about the efficacy of DHC for reducing illegal substance use, due to the low quality of evidence."
}
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query-laysum
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8674
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[
{
"role": "user",
"content": "Abstract: Background\nIncreasing numbers of incidental pancreatic lesions are being detected each year. Accurate characterisation of pancreatic lesions into benign, precancerous, and cancer masses is crucial in deciding whether to use treatment or surveillance. Distinguishing benign lesions from precancerous and cancerous lesions can prevent patients from undergoing unnecessary major surgery. Despite the importance of accurately classifying pancreatic lesions, there is no clear algorithm for management of focal pancreatic lesions.\nObjectives\nTo determine and compare the diagnostic accuracy of various imaging modalities in detecting cancerous and precancerous lesions in people with focal pancreatic lesions.\nSearch methods\nWe searched the CENTRAL, MEDLINE, Embase, and Science Citation Index until 19 July 2016. We searched the references of included studies to identify further studies. We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively.\nSelection criteria\nWe planned to include studies reporting cross-sectional information on the index test (CT (computed tomography), MRI (magnetic resonance imaging), PET (positron emission tomography), EUS (endoscopic ultrasound), EUS elastography, and EUS-guided biopsy or FNA (fine-needle aspiration)) and reference standard (confirmation of the nature of the lesion was obtained by histopathological examination of the entire lesion by surgical excision, or histopathological examination for confirmation of precancer or cancer by biopsy and clinical follow-up of at least six months in people with negative index tests) in people with pancreatic lesions irrespective of language or publication status or whether the data were collected prospectively or retrospectively.\nData collection and analysis\nTwo review authors independently searched the references to identify relevant studies and extracted the data. We planned to use the bivariate analysis to calculate the summary sensitivity and specificity with their 95% confidence intervals and the hierarchical summary receiver operating characteristic (HSROC) to compare the tests and assess heterogeneity, but used simpler models (such as univariate random-effects model and univariate fixed-effect model) for combining studies when appropriate because of the sparse data. We were unable to compare the diagnostic performance of the tests using formal statistical methods because of sparse data.\nMain results\nWe included 54 studies involving a total of 3,196 participants evaluating the diagnostic accuracy of various index tests. In these 54 studies, eight different target conditions were identified with different final diagnoses constituting benign, precancerous, and cancerous lesions. None of the studies was of high methodological quality. None of the comparisons in which single studies were included was of sufficiently high methodological quality to warrant highlighting of the results. For differentiation of cancerous lesions from benign or precancerous lesions, we identified only one study per index test. The second analysis, of studies differentiating cancerous versus benign lesions, provided three tests in which meta-analysis could be performed. The sensitivities and specificities for diagnosing cancer were: EUS-FNA: sensitivity 0.79 (95% confidence interval (CI) 0.07 to 1.00), specificity 1.00 (95% CI 0.91 to 1.00); EUS: sensitivity 0.95 (95% CI 0.84 to 0.99), specificity 0.53 (95% CI 0.31 to 0.74); PET: sensitivity 0.92 (95% CI 0.80 to 0.97), specificity 0.65 (95% CI 0.39 to 0.84). The third analysis, of studies differentiating precancerous or cancerous lesions from benign lesions, only provided one test (EUS-FNA) in which meta-analysis was performed. EUS-FNA had moderate sensitivity for diagnosing precancerous or cancerous lesions (sensitivity 0.73 (95% CI 0.01 to 1.00) and high specificity 0.94 (95% CI 0.15 to 1.00), the extremely wide confidence intervals reflecting the heterogeneity between the studies). The fourth analysis, of studies differentiating cancerous (invasive carcinoma) from precancerous (dysplasia) provided three tests in which meta-analysis was performed. The sensitivities and specificities for diagnosing invasive carcinoma were: CT: sensitivity 0.72 (95% CI 0.50 to 0.87), specificity 0.92 (95% CI 0.81 to 0.97); EUS: sensitivity 0.78 (95% CI 0.44 to 0.94), specificity 0.91 (95% CI 0.61 to 0.98); EUS-FNA: sensitivity 0.66 (95% CI 0.03 to 0.99), specificity 0.92 (95% CI 0.73 to 0.98). The fifth analysis, of studies differentiating cancerous (high-grade dysplasia or invasive carcinoma) versus precancerous (low- or intermediate-grade dysplasia) provided six tests in which meta-analysis was performed. The sensitivities and specificities for diagnosing cancer (high-grade dysplasia or invasive carcinoma) were: CT: sensitivity 0.87 (95% CI 0.00 to 1.00), specificity 0.96 (95% CI 0.00 to 1.00); EUS: sensitivity 0.86 (95% CI 0.74 to 0.92), specificity 0.91 (95% CI 0.83 to 0.96); EUS-FNA: sensitivity 0.47 (95% CI 0.24 to 0.70), specificity 0.91 (95% CI 0.32 to 1.00); EUS-FNA carcinoembryonic antigen 200 ng/mL: sensitivity 0.58 (95% CI 0.28 to 0.83), specificity 0.51 (95% CI 0.19 to 0.81); MRI: sensitivity 0.69 (95% CI 0.44 to 0.86), specificity 0.93 (95% CI 0.43 to 1.00); PET: sensitivity 0.90 (95% CI 0.79 to 0.96), specificity 0.94 (95% CI 0.81 to 0.99). The sixth analysis, of studies differentiating cancerous (invasive carcinoma) from precancerous (low-grade dysplasia) provided no tests in which meta-analysis was performed. The seventh analysis, of studies differentiating precancerous or cancerous (intermediate- or high-grade dysplasia or invasive carcinoma) from precancerous (low-grade dysplasia) provided two tests in which meta-analysis was performed. The sensitivity and specificity for diagnosing cancer were: CT: sensitivity 0.83 (95% CI 0.68 to 0.92), specificity 0.83 (95% CI 0.64 to 0.93) and MRI: sensitivity 0.80 (95% CI 0.58 to 0.92), specificity 0.81 (95% CI 0.53 to 0.95), respectively. The eighth analysis, of studies differentiating precancerous or cancerous (intermediate- or high-grade dysplasia or invasive carcinoma) from precancerous (low-grade dysplasia) or benign lesions provided no test in which meta-analysis was performed.\nThere were no major alterations in the subgroup analysis of cystic pancreatic focal lesions (42 studies; 2086 participants). None of the included studies evaluated EUS elastography or sequential testing.\nAuthors' conclusions\nWe were unable to arrive at any firm conclusions because of the differences in the way that study authors classified focal pancreatic lesions into cancerous, precancerous, and benign lesions; the inclusion of few studies with wide confidence intervals for each comparison; poor methodological quality in the studies; and heterogeneity in the estimates within comparisons.\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 performed a thorough literature search for studies reporting the accuracy of different scans until 19 July 2016. We identified 54 studies reporting information on 3196 people with focal pancreatic lesions. These studies evaluated one or more of the above tests and compared these test results with the eventual diagnosis provided by surgical removal of the lesion and examination under microscope. There were no diagnostic test accuracy studies of EUS elastography or studies that looked at multiple scans rather than single scans."
}
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query-laysum
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8675
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[
{
"role": "user",
"content": "Abstract: Background\nAge-related cataract is the principal cause of blindness and visual impairment in the world. Phacoemulsification is the main surgical procedure used to treat cataract. The comparative effectiveness and safety of different-sized incisions for phacoemulsification has not been determined.\nObjectives\nThe aim of this systematic review was to assess the effectiveness and safety of smaller versus larger incisions for phacoemulsification in age-related cataract. The primary outcome of this review was surgically induced astigmatism at three months after surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 10), MEDLINE Ovid (1946 to 28 October 2016), Embase Ovid (1947 to 28 October 2016), PubMed (1948 to 28 October 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 28 October 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com; last searched 13 May 2013), ClinicalTrials.gov (www.clinicaltrials.gov; searched 28 October 2016), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp; searched 28 October 2016). We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing different-sized incisions in people with age-related cataract undergoing phacoemulsification.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 26 RCTs with a total of 2737 participants (3120 eyes). These trials were conducted in Bosnia and Herzegovina, China, France, India, Italy, Korea, Spain, Switzerland, and Turkey. Half of the 26 trials were conducted in China. We judged all trials as mostly at unclear to low risk of bias. The included RCTs compared four different-sized incisions:<= 1.5 mm, 1.8 mm, 2.2 mm, and approximately 3.0 mm. These incisions were performed using three different techniques: coaxial and biaxial microincision phacoemulsification (C-MICS and B-MICS) and standard phacoemulsification. Not all studies provided data in a form that could be included in this review. Five studies had three arms.\nFifteen trials compared C-MICS (2.2 mm) with standard phacoemulsification (about 3.0 mm). Very low-certainty evidence suggested less surgically induced astigmatism in the C-MICS group at three months compared with standard phacoemulsification (mean difference (MD) -0.19 diopters (D), 95% confidence interval (CI) -0.30 to -0.09; 996 eyes; 8 RCTs). There was low-certainty evidence that both groups achieved similar best-corrected visual acuity (MD 0.00 logMAR, 95% CI -0.02 to 0.02; 242 eyes; 3 RCTs). There was low-certainty evidence of little or no difference in endothelial cell loss and central corneal thickness comparing C-MICS with standard phacoemulsification (MD -7.23 cells/mm2, 95% CI -78.66 to 64.20; 596 eyes; 4 RCTs) and (MD -0.68 μm, 95% CI -3.26 to 1.90; 487 eyes; 5 RCTs).\nNine trials compared C-MICS (1.8 mm) with standard phacoemulsification (about 3.0 mm). Very low-certainty evidence suggested less astigmatism at three months in the C-MICS group compared with standard phacoemulsification group (MD -0.23 D, 95% CI -0.34 to -0.13; 561 eyes; 5 RCTs). Low-certainty evidence suggested little or no difference in best-corrected visual acuity, endothelial cell loss, and central corneal thickness in the two groups at three months (MD -0.02 logMAR, 95% CI -0.03 to -0.00; 192 eyes; 3 RCTs), (MD 7.56 cells/mm2, 95% CI -67.65 to 82.77; 380 eyes; 5 RCTs), and (MD -1.52 μm, 95% CI -6.29 to 3.25; 245 eyes; 3 RCTs).\nSix studies compared C-MICS (1.8 mm) with C-MICS (2.2 mm). There was low-certainty evidence that astigmatism, visual acuity, and central corneal thickness were similar in the two groups at three months (MD 0.04 D, 95% CI -0.09 to 0.16; 259 eyes; 3 RCTs), (MD 0.01 logMAR, 95% CI -0.01 to 0.04; 200 eyes; 3 RCTs), and (MD 0.45 μm, 95% CI -2.70 to 3.60; 100 eyes; 1 RCT). Very low-certainty evidence suggested higher endothelial cell loss in the 1.8 mm group (MD 213.00 cells/mm2, 95% CI 11.15 to 414.85; 70 eyes; 1 RCT).\nFour studies compared B-MICS (<= 1.5 mm) with standard phacoemulsification (about 3.0 mm). Astigmatism was similar in the two groups at three months (MD -0.01 D, 95% CI -0.03 to 0.01; 368 eyes; 2 RCTs; moderate-certainty evidence). There was low-certainty evidence on visual acuity, suggesting little or no difference between the two groups (MD -0.02 logMAR, 95% CI -0.04 to -0.00; 464 eyes; 3 RCTs). Low-certainty evidence on endothelial cell loss and central corneal thickness also suggested little or no difference between the two groups (MD 55.83 cells/mm2, 95% CI -34.93 to 146.59; 280 eyes; 1 RCT) and (MD 0.10 μm, 95% CI -14.04 to 14.24; 90 eyes; 1 RCT).\nNone of the trials reported on quality of life. One trial reported that no participants experienced endophthalmitis or posterior capsule rupture; they also reported little or no difference between incision groups regarding corneal edema (risk ratio 1.02, 95% CI 0.40 to 2.63; 362 eyes).\nAuthors' conclusions\nPhacoemulsification with smaller incisions was not consistently associated with less surgically induced astigmatism compared with phacoemulsification with larger incisions. Coaxial microincision phacoemulsification may be associated with less astigmatism than standard phacoemulsification, but the difference was small, in the order of 0.2 D, and the evidence was uncertain. Safety outcomes and quality of life were not adequately reported; these should be addressed in future studies.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to 28 October 2016."
}
] |
query-laysum
|
8676
|
[
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis (OA) is one of the most prevalent musculoskeletal diseases. There is currently no consensus on what is the best treatment to improve OA symptoms and slow disease progression. Diacerein is an anthraquinone synthesised in 1980 that interferes with interleukin-1, an inflammatory mediator. It has been proposed that diacerein acts as a slow-acting, symptom-modifying and perhaps disease-structure-modifying drug for OA. This is an update of a Cochrane review first published in 2006.\nObjectives\nTo assess the benefits and harms of diacerein for the treatment of adults with OA when compared with placebo and other pharmacologically active interventions (nonsteroidal anti-inflammatory drugs (NSAIDs) and other symptom-modifying, slow-acting drugs) for OA.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library, Issue 10, 2013, MEDLINE (1966 to 2013), EMBASE (1980 to 2013), LILACS (1982 to 2013), and ACP Journal Club, and we handsearched reference lists of published articles. We also searched the World Health Organization International Clinical Trials Platform ( http://www.who.int/trialsearch/Default.aspx) to identify ongoing trials and screened reference lists of retrieved review articles and trials to identify potentially relevant studies. All searches were up to date as of March 2013. Pharmaceutical companies and authors of published articles were contacted. We searched the websites of the regulatory agencies using the keyword ‘diacerein’ in November 2013. No language restrictions were applied.\nSelection criteria\nStudies were included if they were randomised or quasi-randomised controlled trials that compared diacerein with placebo or another active pharmacological intervention in participants with OA.\nData collection and analysis\nData abstraction and quality assessment were performed by two independent investigators, and their results were compared. The Cochrane risk of bias tool was used. The quality of evidence obtained was assessed using the GRADE approach.\nMain results\nWe identified three new trials (141 participants), and this updated review now includes 10 trials, totalling 2,210 participants. The most frequent risk of bias was incomplete outcome data, identified in approximately 80% of the studies. Allocation concealment and random sequence generation were unclear in 90% and 40% of the studies, respectively, because of poor reporting.\nLow-quality evidence from six trials (1,283 participants) indicates that diacerein has a small beneficial effect on overall pain (measured on a 100 mm visual analogue scale) at three to 36 months (mean difference (MD) -8.65, 95% confidence interval (CI) -15.62 to -1.68), which is equivalent to a 9% pain reduction in the diacerein group (95% CI -16% to -2%) compared with the placebo group. This benefit may not be clinically significant.\nNo statistically significant differences in physical function (4 studies, 1006 participants) were noted between the diacerein and placebo groups (Lequesne impairment index, 0 to 24 points) (MD -0.29, 95% CI -0.87 to 0.28).\nLow-quality evidence from two trials (616 participants) on slowing of joint space narrowing (a decrease greater than 0.50 mm) in the knee or hip favoured diacerein over placebo (risk ratio (RR) 0.85, 95% CI 0.72 to 0.99), with an absolute risk difference of -6% (95% CI -15% to 2%) and a number needed to treat for an additional beneficial outcome (NNTB) of 14 (95% CI 8 to 203). Analysis of the knee joint alone (1 study, 170 participants) did not reach statistical significance (RR 0.94, 95% CI 0.51 to 1.74).\nNone of the trials of diacerein versus placebo measured quality of life. According to one trial (161 participants), which compared diacerein versus non-steroidal anti-inflammatory drugs (NSAIDs), the quality of life of participants in the two groups (as assessed by the Short Form (SF)-36 health survey questionnaire (0 to 800 sum score)) did not differ significantly (MD -40.70, 95% CI -85.20 to 3.80).\nLow-quality evidence from seven trials showed significantly more adverse events in the diacerein group compared with the placebo group after two to 36 months, mainly diarrhoea (RR 3.52, 95% CI 2.42 to 5.11), with an absolute risk increase of 24% (95% CI 12% to 35%), and a number needed to treat for an additional harmful outcome (NNTH) of 4 (95% CI 3 to 7).\nNo statistically significant differences in participant withdrawal due to adverse events were seen at two to 36 months for diacerein compared with placebo (RR 1.29, 95% CI 0.83 to 2.01).\nA search of regulatory websites found a recommendation from the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) that the marketing authorization of diacerein should be suspended across Europe because of harms (particularly the risk of severe diarrhoea and potentially harmful effects on the liver) outweighing benefits. However, this guidance is not final as the PRAC recommendation will be re-examined.\nAuthors' conclusions\nIn this update, the strength of evidence for effectiveness outcomes was low to moderate. We confirmed that symptomatic benefit provided by diacerein in terms of pain reduction is minimal. The small benefit derived in terms of joint space narrowing is of questionable clinical relevance and was observed only for OA of the hip. With respect to adverse effects of diacerein, diarrhoea was most frequent. Given the recent guidance issued by the EMA recommending suspension of diacerein in Europe, the EMA website should be consulted for further recommendations regarding the use of diacerein.\n\nGiven the provided abstract, please respond to the following query: \"Radiographic progression - how the joint looks on an x-ray (reduction in joint space narrowing of at least 0.5 mm)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Seven more people who took placebo had radiographic progression (absolute difference of 7%).\n- 42 of every 100 people who took diacerein experienced reduction in joint space narrowing of at least 0.5 mm compared to 49 of every 100 people who took a fake pill."
}
] |
query-laysum
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8677
|
[
{
"role": "user",
"content": "Abstract: Background\nThe primary manifestation of coronavirus disease 2019 (COVID-19) is respiratory insufficiency that can also be related to diffuse pulmonary microthrombosis and thromboembolic events, such as pulmonary embolism, deep vein thrombosis, or arterial thrombosis. People with COVID-19 who develop thromboembolism have a worse prognosis.\nAnticoagulants such as heparinoids (heparins or pentasaccharides), vitamin K antagonists and direct anticoagulants are used for the prevention and treatment of venous or arterial thromboembolism. Besides their anticoagulant properties, heparinoids have an additional anti-inflammatory potential. However, the benefit of anticoagulants for people with COVID-19 is still under debate.\nObjectives\nTo assess the benefits and harms of anticoagulants versus active comparator, placebo or no intervention in people hospitalised with COVID-19.\nSearch methods\nWe searched the CENTRAL, MEDLINE, Embase, LILACS and IBECS databases, the Cochrane COVID-19 Study Register and medRxiv preprint database from their inception to 14 April 2021. We also checked the reference lists of any relevant systematic reviews identified, and contacted specialists in the field for additional references to trials.\nSelection criteria\nEligible studies were randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cohort studies that compared prophylactic anticoagulants versus active comparator, placebo or no intervention for the management of people hospitalised with COVID-19. We excluded studies without a comparator group and with a retrospective design (all previously included studies) as we were able to include better study designs. Primary outcomes were all-cause mortality and necessity for additional respiratory support. Secondary outcomes were mortality related to COVID-19, deep vein thrombosis, pulmonary embolism, major bleeding, adverse events, length of hospital stay and quality of life.\nData collection and analysis\nWe used standard Cochrane methodological procedures. We used Cochrane RoB 1 to assess the risk of bias for RCTs, ROBINS-I to assess risk of bias for non-randomised studies (NRS) and GRADE to assess the certainty of evidence. We meta-analysed data when appropriate.\nMain results\nWe included seven studies (16,185 participants) with participants hospitalised with COVID-19, in either intensive care units, hospital wards or emergency departments. Studies were from Brazil (2), Iran (1), Italy (1), and the USA (1), and two involved more than country. The mean age of participants was 55 to 68 years and the follow-up period ranged from 15 to 90 days. The studies assessed the effects of heparinoids, direct anticoagulants or vitamin K antagonists, and reported sparse data or did not report some of our outcomes of interest: necessity for additional respiratory support, mortality related to COVID-19, and quality of life.\nHigher-dose versus lower-dose anticoagulants (4 RCTs, 4647 participants)\nHigher-dose anticoagulants result in little or no difference in all-cause mortality (risk ratio (RR) 1.03, 95% CI 0.92 to 1.16, 4489 participants; 4 RCTs) and increase minor bleeding (RR 3.28, 95% CI 1.75 to 6.14, 1196 participants; 3 RCTs) compared to lower-dose anticoagulants up to 30 days (high-certainty evidence). Higher-dose anticoagulants probably reduce pulmonary embolism (RR 0.46, 95% CI 0.31 to 0.70, 4360 participants; 4 RCTs), and slightly increase major bleeding (RR 1.78, 95% CI 1.13 to 2.80, 4400 participants; 4 RCTs) compared to lower-dose anticoagulants up to 30 days (moderate-certainty evidence). Higher-dose anticoagulants may result in little or no difference in deep vein thrombosis (RR 1.08, 95% CI 0.57 to 2.03, 3422 participants; 4 RCTs), stroke (RR 0.91, 95% CI 0.40 to 2.03, 4349 participants; 3 RCTs), major adverse limb events (RR 0.33, 95% CI 0.01 to 7.99, 1176 participants; 2 RCTs), myocardial infarction (RR 0.86, 95% CI 0.48 to 1.55, 4349 participants; 3 RCTs), atrial fibrillation (RR 0.35, 95% CI 0.07 to 1.70, 562 participants; 1 study), or thrombocytopenia (RR 0.94, 95% CI 0.71 to 1.24, 2789 participants; 2 RCTs) compared to lower-dose anticoagulants up to 30 days (low-certainty evidence). It is unclear whether higher-dose anticoagulants have any effect on necessity for additional respiratory support, mortality related to COVID-19, and quality of life (very low-certainty evidence or no data).\nAnticoagulants versus no treatment (3 prospective NRS, 11,538 participants)\nAnticoagulants may reduce all-cause mortality but the evidence is very uncertain due to two study results being at critical and serious risk of bias (RR 0.64, 95% CI 0.55 to 0.74, 8395 participants; 3 NRS; very low-certainty evidence). It is uncertain if anticoagulants have any effect on necessity for additional respiratory support, mortality related to COVID-19, deep vein thrombosis, pulmonary embolism, major bleeding, stroke, myocardial infarction and quality of life (very low-certainty evidence or no data).\nOngoing studies\nWe found 62 ongoing studies in hospital settings (60 RCTs, 35,470 participants; 2 prospective NRS, 120 participants) in 20 different countries. Thirty-five ongoing studies plan to report mortality and 26 plan to report necessity for additional respiratory support. We expect 58 studies to be completed in December 2021, and four in July 2022. From 60 RCTs, 28 are comparing different doses of anticoagulants, 24 are comparing anticoagulants versus no anticoagulants, seven are comparing different types of anticoagulants, and one did not report detail of the comparator group.\nAuthors' conclusions\nWhen compared to a lower-dose regimen, higher-dose anticoagulants result in little to no difference in all-cause mortality and increase minor bleeding in people hospitalised with COVID-19 up to 30 days. Higher-dose anticoagulants possibly reduce pulmonary embolism, slightly increase major bleeding, may result in little to no difference in hospitalisation time, and may result in little to no difference in deep vein thrombosis, stroke, major adverse limb events, myocardial infarction, atrial fibrillation, or thrombocytopenia.\nCompared with no treatment, anticoagulants may reduce all-cause mortality but the evidence comes from non-randomised studies and is very uncertain. It is unclear whether anticoagulants have any effect on the remaining outcomes compared to no anticoagulants (very low-certainty evidence or no data).\nAlthough we are very confident that new RCTs will not change the effects of different doses of anticoagulants on mortality and minor bleeding, high-quality RCTs are still needed, mainly for the other primary outcome (necessity for additional respiratory support), the comparison with no anticoagulation, when comparing the types of anticoagulants and giving anticoagulants for a prolonged period of time.\n\nGiven the provided abstract, please respond to the following query: \"What are blood thinners?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Blood thinners are medicines that prevent harmful blood clots from forming (deep vein thrombosis). However, they can cause unwanted effects such as bleeding. Some guidelines recommend giving blood thinners when people are first admitted to hospital with COVID-19 to prevent blood clots from developing, rather than waiting to see whether blood clots develop and then treating them with blood thinners."
}
] |
query-laysum
|
8678
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with advanced ovarian or gastrointestinal cancer may develop malignant bowel obstruction (MBO). They are able to tolerate limited, if any, oral or enteral (via a tube directly into the gut) nutrition. Parenteral nutrition (PN) is the provision of macronutrients, micronutrients, electrolytes and fluid infused as an intravenous solution and provides a method for these people to receive nutrients. There are clinical and ethical arguments for and against the administration of PN to people receiving palliative care.\nObjectives\nTo assess the effectiveness of home parenteral nutrition (HPN) in improving survival and quality of life in people with inoperable MBO.\nSearch methods\nWe searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), MEDLINE (Ovid), Embase (Ovid), BNI, CINAHL, Web of Science and NHS Economic Evaluation and Health Technology Assessment up to January 2018, ClinicalTrials.gov (http://clinicaltrials.gov/) and in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal (http://apps.who.int/trialsearch/). In addition, we handsearched included studies and used the ‘Similar articles’ feature on PubMed for included articles.\nSelection criteria\nWe included any studies with more than five participants investigating HPN in people over 16 years of age with inoperable MBO.\nData collection and analysis\nWe extracted the data and assessed risk of bias for each study. We entered data into Review Manager 5 and used GRADEpro to assess the quality of the evidence.\nMain results\nWe included 13 studies with a total of 721 participants in the review. The studies were observational, 12 studies had only one relevant treatment arm and no control and for the one study with a control arm, very few details were given. The risk of bias was high and the certainty of evidence was graded as very low for all outcomes. Due to heterogeneity of data, meta-analysis was not performed and therefore the data were synthesised via a narrative summary.\nThe evidence for benefit derived from PN was very low for survival and quality of life. All the studies measured overall survival and 636 (88%) of participants were deceased at the end of the study. However there were varying definitions of overall survival that yielded median survival intervals between 15 to 155 days (range three to 1278 days). Three studies used validated measures of quality of life. The results from assessment of quality of life were equivocal; one study reported improvements up until three months and two studies reported approximately similar numbers of participants with improvements and deterioration. Different quality of life scales were used in each of the studies and quality of life was measured at different time points. Due to the very low certainty of the evidence, we are very uncertain about the adverse events related to PN use. Adverse events were measured by nine studies and data for individual participants could be extracted from eight studies. This revealed that 32 of 260 (12%) patients developed a central venous catheter infection or were hospitalised because of complications related to PN.\nAuthors' conclusions\nWe are very uncertain whether HPN improves survival or quality of life in people with MBO as the certainty of evidence was very low for both outcomes. As the evidence base is limited and at high risk of bias, further higher-quality prospective studies are required.\n\nGiven the provided abstract, please respond to the following query: \"This means\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Further research is needed to find out if PN is of benefit to people with an inoperable blockage of the bowel caused by advanced cancer."
}
] |
query-laysum
|
8679
|
[
{
"role": "user",
"content": "Abstract: Background\nThe detection and diagnosis of caries at the earliest opportunity is fundamental to the preservation of tooth tissue and maintenance of oral health. Radiographs have traditionally been used to supplement the conventional visual-tactile clinical examination. Accurate, timely detection and diagnosis of early signs of disease could afford patients the opportunity of less invasive treatment with less destruction of tooth tissue, reduce the need for treatment with aerosol-generating procedures, and potentially result in a reduced cost of care to the patient and to healthcare services.\nObjectives\nTo determine the diagnostic accuracy of different dental imaging methods to inform the detection and diagnosis of non-cavitated enamel only coronal dental caries.\nSearch methods\nCochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 31 December 2018); Embase Ovid (1980 to 31 December 2018); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 31 December 2018); and the World Health Organization International Clinical Trials Registry Platform (to 31 December 2018). We studied reference lists as well as published systematic review articles.\nSelection criteria\nWe included diagnostic accuracy study designs that compared a dental imaging method with a reference standard (histology, excavation, enhanced visual examination), studies that evaluated the diagnostic accuracy of single index tests, and studies that directly compared two or more index tests. Studies reporting at both the patient or tooth surface level were included. In vitro and in vivo studies were eligible for inclusion. Studies that explicitly recruited participants with more advanced lesions that were obviously into dentine or frankly cavitated were excluded. We also excluded studies that artificially created carious lesions and those that used an index test during the excavation of dental caries to ascertain the optimum depth of excavation.\nData collection and analysis\nTwo review authors extracted data independently and in duplicate using a standardised data extraction form and quality assessment based on QUADAS-2 specific to the clinical context. Estimates of diagnostic accuracy were determined using the bivariate hierarchical method to produce summary points of sensitivity and specificity with 95% confidence regions. Comparative accuracy of different radiograph methods was conducted based on indirect and direct comparisons between methods. Potential sources of heterogeneity were pre-specified and explored visually and more formally through meta-regression.\nMain results\nWe included 104 datasets from 77 studies reporting a total of 15,518 tooth sites or surfaces. The most frequently reported imaging methods were analogue radiographs (55 datasets from 51 studies) and digital radiographs (42 datasets from 40 studies) followed by cone beam computed tomography (CBCT) (7 datasets from 7 studies). Only 17 studies were of an in vivo study design, carried out in a clinical setting. No studies were considered to be at low risk of bias across all four domains but 16 studies were judged to have low concern for applicability across all domains. The patient selection domain had the largest number of studies judged to be at high risk of bias (43 studies); the index test, reference standard, and flow and timing domains were judged to be at high risk of bias in 30, 12, and 7 studies respectively.\nStudies were synthesised using a hierarchical bivariate method for meta-analysis. There was substantial variability in the results of the individual studies, with sensitivities that ranged from 0 to 0.96 and specificities from 0 to 1.00. For all imaging methods the estimated summary sensitivity and specificity point was 0.47 (95% confidence interval (CI) 0.40 to 0.53) and 0.88 (95% CI 0.84 to 0.92), respectively. In a cohort of 1000 tooth surfaces with a prevalence of enamel caries of 63%, this would result in 337 tooth surfaces being classified as disease free when enamel caries was truly present (false negatives), and 43 tooth surfaces being classified as diseased in the absence of enamel caries (false positives). Meta-regression indicated that measures of accuracy differed according to the imaging method (Chi2(4) = 32.44, P < 0.001), with the highest sensitivity observed for CBCT, and the highest specificity observed for analogue radiographs. None of the specified potential sources of heterogeneity were able to explain the variability in results. No studies included restored teeth in their sample or reported the inclusion of sealants.\nWe rated the certainty of the evidence as low for sensitivity and specificity and downgraded two levels in total for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the in vitro studies, and the observed inconsistency of the results.\nAuthors' conclusions\nThe design and conduct of studies to determine the diagnostic accuracy of methods to detect and diagnose caries in situ are particularly challenging. Low-certainty evidence suggests that imaging for the detection or diagnosis of early caries may have poor sensitivity but acceptable specificity, resulting in a relatively high number of false-negative results with the potential for early disease to progress. If left untreated, the opportunity to provide professional or self-care practices to arrest or reverse early caries lesions will be missed. The specificity of lesion detection is however relatively high, and one could argue that initiation of non-invasive management (such as the use of topical fluoride), is probably of low risk.\nCBCT showed superior sensitivity to analogue or digital radiographs but has very limited applicability to the general dental practitioner. However, given the high-radiation dose, and potential for caries-like artefacts from existing restorations, its use cannot be justified in routine caries detection. Nonetheless, if early incidental carious lesions are detected in CBCT scans taken for other purposes, these should be reported. CBCT has the potential to be used as a reference standard in diagnostic studies of this type.\nDespite the robust methodology applied in this comprehensive review, the results should be interpreted with some caution due to shortcomings in the design and execution of many of the included studies. Future research should evaluate the comparative accuracy of different methods, be undertaken in a clinical setting, and focus on minimising bias arising from the use of imperfect reference standards in clinical studies.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We only included studies that assessed healthy teeth or those that were thought to have early tooth decay. This is because teeth with deep tooth decay would be easier to identify. However, there were some problems with how the studies were conducted. This may result in these methods appearing more accurate than they are, increasing the number of correct results. We judged the certainty of the evidence to be low due to how the studies selected their participants and the large number of studies that were carried out in a laboratory setting on extracted teeth, and the variation in the results."
}
] |
query-laysum
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8680
|
[
{
"role": "user",
"content": "Abstract: Background\nPost-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) characterised by chronic complaints such as oedema and skin changes including; venous ectasia, varicose veins, redness, eczema, hyperpigmentation, and in severe cases fibrosis of the subcutaneous adipose in the affected limb. These chronic complaints are the effects of venous outflow restriction that can cause symptoms such as heaviness, itching, pain, cramps, and paraesthesia. Twenty to fifty percent of people with DVT develop post-thrombotic complications. Several non-pharmaceutical measures are used for prevention of PTS during the acute phase of DVT. These include elevation of the legs and compression therapy. There have been limited studies regarding the effectiveness of compression therapy for prevention or treatment of PTS. As a result, clinicians and guidelines differ in their assessment of compression therapy during treatment of DVT and in the treatment of PTS. This is an update of a review first published in 2003.\nObjectives\nTo assess the effectiveness of compression therapy for treatment of post-thrombotic syndrome, including elastic compression stockings and mechanical devices compared with no intervention, placebo and with each other.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries on 2 July 2018.\nSelection criteria\nWe included trials that evaluated compression therapy for the treatment of PTS. The primary outcomes were severity of PTS and adverse effects. There were no restrictions on date or language. Two review authors (SA, DNK) independently assessed whether potentially relevant studies met the inclusion criteria.\nData collection and analysis\nOne review author extracted and summarised data and one review author (DNK) verified them. We resolved disagreements by discussion. We assessed methodological study quality with the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of the evidence supporting the outcomes assessed in this review.\nMain results\nWe identified four trials, with 116 participants, investigating the effectiveness of compression therapy for treatment of PTS. The methodology used by each trial was too heterogeneous to perform a meta-analysis, so we reported our findings narratively.\nTwo trials studied the effect of graduated elastic compression stockings (GECS) on improvement of PTS symptoms. One study reported beneficial haemodynamic effects, while the other found no benefits on PTS severity compared to placebo (very low-certainty evidence). There was very limited evidence available for adverse effects and quality of life (QoL). The two studies did not report on compliance rates during the study period.\nTwo trials studied the effects of intermittent mechanical compression devices. Both reported improvement in PTS severity (low-certainty evidence). Improvement of the severity of PTS was defined by treatment 'success' or 'failure'. Only one study comparing compression devices evaluated adverse effects and QoL. Although 9% of the participants experienced adverse effects such as leg swelling, irritation, superficial bleeding, and skin itching (moderate-certainty evidence), QoL was improved (moderate-certainty evidence). Studies did not assess compliance using intermittent mechanical compression devices.\nNone of the studies evaluated patient satisfaction.\nAuthors' conclusions\nThere is very low-certainty evidence regarding the use of GECS for treatment of PTS as assessed by two small studies of short duration. One study reported beneficial haemodynamic effects, while one found no benefits on PTS severity compared to control/placebo stockings. There is very limited evidence for adverse effects, patient satisfaction, QoL, and compliance rates. There is low-certainty evidence favouring use of intermittent pneumatic compression devices compared to a control device for the treatment of severity owing to different measurements used by the studies reporting on this outcome and small studies of short duration. There is moderate-certainty evidence of improved QoL but possible increased adverse effects related to compression device use owing to small studies of short duration. High-certainty evidence to support the use of compression therapy in prevention of PTS is lacking and any conclusions drawn from current evidence should be interpreted with care. Further research is needed to assess whether compression can result in long-term reduction and relief of the symptoms caused by PTS, or prevent deterioration and leg ulceration.\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": "Deep vein thrombosis (DVT) occurs when a blood clot forms in a leg vein. The clot can break up and cause a potentially serious blockage in blood vessels. People who have had a DVT can develop post-thrombotic syndrome (PTS). This is characterised by problems such as leg pain, swelling ankles, and hardened discoloured skin. The symptoms are worsened with prolonged standing or sitting, and may limit lifestyle and day-to-day activities. In severe cases, venous ulcers, open sores that do not heal, also develop. Wearing compression bandages or graduated elastic compression stockings (GECS) after initial blood thinning (anticoagulant) treatment for DVT is used to reduce the likelihood of PTS and reduce symptoms. With severe swelling of the leg (oedema), a device or machine can be used to apply pressure to the leg to improve blood circulation (mechanical compression device or intermittent pneumatic compression device). There have been limited studies regarding the effectiveness of compression therapy for prevention or treatment of PTS. As a result, clinicians and guidelines differ in their assessment of the use of compression therapy during treatment of DVT and in the treatment of PTS."
}
] |
query-laysum
|
8681
|
[
{
"role": "user",
"content": "Abstract: Background\nVitamins and minerals are essential for growth and maintenance of a healthy body, and have a role in the functioning of almost every organ. Multiple interventions have been designed to improve micronutrient deficiency, and food fortification is one of them.\nObjectives\nTo assess the impact of food fortification with multiple micronutrients on health outcomes in the general population, including men, women and children.\nSearch methods\nWe searched electronic databases up to 29 August 2018, including the Cochrane Central Register of Controlled Trial (CENTRAL), the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register and Cochrane Public Health Specialised Register; MEDLINE; Embase, and 20 other databases, including clinical trial registries. There were no date or language restrictions. We checked reference lists of included studies and relevant systematic reviews for additional papers to be considered for inclusion.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs, quasi-randomised trials, controlled before-after (CBA) studies and interrupted time series (ITS) studies that assessed the impact of food fortification with multiple micronutrients (MMNs). Primary outcomes included anaemia, micronutrient deficiencies, anthropometric measures, morbidity, all-cause mortality and cause-specific mortality. Secondary outcomes included potential adverse outcomes, serum concentration of specific micronutrients, serum haemoglobin levels and neurodevelopmental and cognitive outcomes. We included food fortification studies from both high-income and low- and middle-income countries (LMICs).\nData collection and analysis\nTwo review authors independently screened, extracted and quality-appraised the data from eligible studies. We carried out statistical analysis using Review Manager 5 software. We used random-effects meta-analysis for combining data, as the characteristics of study participants and interventions differed significantly. We set out the main findings of the review in 'Summary of findings' tables, using the GRADE approach.\nMain results\nWe identified 127 studies as relevant through title/abstract screening, and included 43 studies (48 papers) with 19,585 participants (17,878 children) in the review. All the included studies except three compared MMN fortification with placebo/no intervention. Two studies compared MMN fortification versus iodised salt and one study compared MMN fortification versus calcium fortification alone. Thirty-six studies targeted children; 20 studies were conducted in LMICs. Food vehicles used included staple foods, such as rice and flour; dairy products, including milk and yogurt; non-dairy beverages; biscuits; spreads; and salt. Fourteen of the studies were fully commercially funded, 13 had partial-commercial funding, 14 had non-commercial funding and two studies did not specify the source of funding. We rated all the evidence as of low to very low quality due to study limitations, imprecision, high heterogeneity and small sample size.\nWhen compared with placebo/no intervention, MMN fortification may reduce anaemia by 32% (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.56 to 0.84; 11 studies, 3746 participants; low-quality evidence), iron deficiency anaemia by 72% (RR 0.28, 95% CI 0.19 to 0.39; 6 studies, 2189 participants; low-quality evidence), iron deficiency by 56% (RR 0.44, 95% CI 0.32 to 0.60; 11 studies, 3289 participants; low-quality evidence); vitamin A deficiency by 58% (RR 0.42, 95% CI 0.28 to 0.62; 6 studies, 1482 participants; low-quality evidence), vitamin B2 deficiency by 64% (RR 0.36, 95% CI 0.19 to 0.68; 1 study, 296 participants; low-quality evidence), vitamin B6 deficiency by 91% (RR 0.09, 95% CI 0.02 to 0.38; 2 studies, 301 participants; low-quality evidence), vitamin B12 deficiency by 58% (RR 0.42, 95% CI 0.25 to 0.71; 3 studies, 728 participants; low-quality evidence), weight-for-age z-scores (WAZ) (mean difference (MD) 0.1, 95% CI 0.02 to 0.17; 8 studies, 2889 participants; low-quality evidence) and weight-for-height/length z-score (WHZ/WLZ) (MD 0.1, 95% CI 0.02 to 0.18; 6 studies, 1758 participants; low-quality evidence). We are uncertain about the effect of MMN fortification on zinc deficiency (RR 0.84, 95% CI 0.65 to 1.08; 5 studies, 1490 participants; low-quality evidence) and height/length-for-age z-score (HAZ/LAZ) (MD 0.09, 95% CI 0.01 to 0.18; 8 studies, 2889 participants; low-quality evidence). Most of the studies in this comparison were conducted in children.\nSubgroup analyses of funding sources (commercial versus non-commercial) and duration of intervention did not demonstrate any difference in effects, although this was a relatively small number of studies and the possible association between commercial funding and increased effect estimates has been demonstrated in the wider health literature. We could not conduct subgroup analysis by food vehicle and funding; since there were too few studies in each subgroup to draw any meaningful conclusions.\nWhen we compared MMNs versus iodised salt, we are uncertain about the effect of MMN fortification on anaemia (R 0.86, 95% CI 0.37 to 2.01; 1 study, 88 participants; very low-quality evidence), iron deficiency anaemia (RR 0.40, 95% CI 0.09 to 1.83; 2 studies, 245 participants; very low-quality evidence), iron deficiency (RR 0.98, 95% CI 0.82 to 1.17; 1 study, 88 participants; very low-quality evidence) and vitamin A deficiency (RR 0.19, 95% CI 0.07 to 0.55; 2 studies, 363 participants; very low-quality evidence). Both of the studies were conducted in children.\nOnly one study conducted in children compared MMN fortification versus calcium fortification. None of the primary outcomes were reported in the study.\nNone of the included studies reported on morbidity, adverse events, all-cause or cause-specific mortality.\nAuthors' conclusions\nThe evidence from this review suggests that MMN fortification when compared to placebo/no intervention may reduce anaemia, iron deficiency anaemia and micronutrient deficiencies (iron, vitamin A, vitamin B2 and vitamin B6). We are uncertain of the effect of MMN fortification on anthropometric measures (HAZ/LAZ, WAZ and WHZ/WLZ). There are no data to suggest possible adverse effects of MMN fortification, and we could not draw reliable conclusions from various subgroup analyses due to a limited number of studies in each subgroup. We remain cautious about the level of commercial funding in this field, and the possibility that this may be associated with higher effect estimates, although subgroup analysis in this review did not demonstrate any impact of commercial funding. These findings are subject to study limitations, imprecision, high heterogeneity and small sample sizes, and we rated most of the evidence low to very low quality. and hence no concrete conclusions could be drawn from the findings of this review.\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 43 studies (48 papers) in 19,585 participants (17,878 children) in this review. The evidence is current to August 2018. Most of the included studies assessed the impact of food fortification with MMN compared to placebo or to no intervention; two studies compared food fortification with MMN to iodised salt and one study compared food fortification with MMN to food fortification with calcium alone. Most of the studies (36 out of 43) targeted children. Twenty studies were conducted in developing countries. Food used for fortification included staple foods, such as rice and flour; dairy products, including milk and yogurt; non-dairy beverages; biscuits; spreads; and salt. A high proportion of studies were funded by commercial sources (e.g. manufacturers of micronutrients), which can be associated with finding more beneficial effects than independently-funded studies."
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query-laysum
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8682
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[
{
"role": "user",
"content": "Abstract: Background\nMultiple myeloma is a malignant plasma cell disorder characterised by clonal plasma cells that cause end-organ damage such as renal failure, lytic bone lesions, hypercalcaemia and/or anaemia. People with multiple myeloma are treated with immunomodulatory agents including lenalidomide, pomalidomide, and thalidomide. Multiple myeloma is associated with an increased risk of thromboembolism, which appears to be further increased in people receiving immunomodulatory agents.\nObjectives\n(1) To systematically review the evidence for the relative efficacy and safety of aspirin, oral anticoagulants, or parenteral anticoagulants in ambulatory patients with multiple myeloma receiving immunomodulatory agents who otherwise have no standard therapeutic or prophylactic indication for anticoagulation.\n(2) To maintain this review as a living systematic review by continually running the searches and incorporating newly identified studies.\nSearch methods\nWe conducted a comprehensive literature search that included (1) a major electronic search (14 June 2021) of the following databases: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE via Ovid, and Embase via Ovid; (2) hand-searching of conference proceedings; (3) checking of reference lists of included studies; and (4) a search for ongoing studies in trial registries. As part of the living systematic review approach, we are running continual searches, and we will incorporate new evidence rapidly after it is identified.\nSelection criteria\nRandomised controlled trials (RCTs) assessing the benefits and harms of oral anticoagulants such as vitamin K antagonist (VKA) and direct oral anticoagulants (DOAC), anti-platelet agents such as aspirin (ASA), and parenteral anticoagulants such as low molecular weight heparin (LMWH)in ambulatory patients with multiple myeloma receiving immunomodulatory agents.\nData collection and analysis\nUsing a standardised form, we extracted data in duplicate on study design, participants, interventions, outcomes of interest, and risk of bias. Outcomes of interest included all-cause mortality, symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), major bleeding, and minor bleeding. For each outcome we calculated the risk ratio (RR) with its 95% confidence interval (CI) and the risk difference (RD) with its 95% CI. We then assessed the certainty of evidence at the outcome level following the GRADE approach (GRADE Handbook).\nMain results\nWe identified 1015 identified citations and included 11 articles reporting four RCTs that enrolled 1042 participants. The included studies made the following comparisons: ASA versus VKA (one study); ASA versus LMWH (two studies); VKA versus LMWH (one study); and ASA versus DOAC (two studies, one of which was an abstract).\nASA versus VKA\nOne RCT compared ASA to VKA at six months follow-up. The data did not confirm or exclude a beneficial or detrimental effect of ASA relative to VKA on all-cause mortality (RR 3.00, 95% CI 0.12 to 73.24; RD 2 more per 1000, 95% CI 1 fewer to 72 more; very low-certainty evidence); symptomatic DVT (RR 0.57, 95% CI 0.24 to 1.33; RD 27 fewer per 1000, 95% CI 48 fewer to 21 more; very low-certainty evidence); PE (RR 1.00, 95% CI 0.25 to 3.95; RD 0 fewer per 1000, 95% CI 14 fewer to 54 more; very low-certainty evidence); major bleeding (RR 7.00, 95% CI 0.36 to 134.72; RD 6 more per 1000, 95% CI 1 fewer to 134 more; very low-certainty evidence); and minor bleeding (RR 6.00, 95% CI 0.73 to 49.43; RD 23 more per 1000, 95% CI 1 fewer to 220 more; very low-certainty evidence).\nOne RCT compared ASA to VKA at two years follow-up. The data did not confirm or exclude a beneficial or detrimental effect of ASA relative to VKA on all-cause mortality (RR 0.50, 95% CI 0.05 to 5.47; RD 5 fewer per 1000, 95% CI 9 fewer to 41 more; very low-certainty evidence); symptomatic DVT (RR 0.71, 95% CI 0.35 to 1.44; RD 22 fewer per 1000, 95% CI 50 fewer to 34 more; very low-certainty evidence); and PE (RR 1.00, 95% CI 0.25 to 3.95; RD 0 fewer per 1000, 95% CI 14 fewer to 54 more; very low-certainty evidence).\nASA versus LMWH\nTwo RCTs compared ASA to LMWH at six months follow-up. The pooled data did not confirm or exclude a beneficial or detrimental effect of ASA relative to LMWH on all-cause mortality (RR 1.00, 95% CI 0.06 to 15.81; RD 0 fewer per 1000, 95% CI 2 fewer to 38 more; very low-certainty evidence); symptomatic DVT (RR 1.23, 95% CI 0.49 to 3.08; RD 5 more per 1000, 95% CI 11 fewer to 43 more; very low-certainty evidence); PE (RR 7.71, 95% CI 0.97 to 61.44; RD 7 more per 1000, 95% CI 0 fewer to 60 more; very low-certainty evidence); major bleeding (RR 6.97, 95% CI 0.36 to 134.11; RD 6 more per 1000, 95% CI 1 fewer to 133 more; very low-certainty evidence); and minor bleeding (RR 1.42, 95% CI 0.35 to 5.78; RD 4 more per 1000, 95% CI 7 fewer to 50 more; very low-certainty evidence).\nOne RCT compared ASA to LMWH at two years follow-up. The pooled data did not confirm or exclude a beneficial or detrimental effect of ASA relative to LMWH on all-cause mortality (RR 1.00, 95% CI 0.06 to 15.89; RD 0 fewer per 1000, 95% CI 4 fewer to 68 more; very low-certainty evidence); symptomatic DVT (RR 1.20, 95% CI 0.53 to 2.72; RD 9 more per 1000, 95% CI 21 fewer to 78 more; very low-certainty evidence); and PE (RR 9.00, 95% CI 0.49 to 166.17; RD 8 more per 1000, 95% CI 1 fewer to 165 more; very low-certainty evidence).\nVKA versus LMWH\nOne RCT compared VKA to LMWH at six months follow-up. The data did not confirm or exclude a beneficial or detrimental effect of VKA relative to LMWH on all-cause mortality (RR 0.33, 95% CI 0.01 to 8.10; RD 3 fewer per 1000, 95% CI 5 fewer to 32 more; very low-certainty evidence); symptomatic DVT (RR 2.32, 95% CI 0.91 to 5.93; RD 36 more per 1000, 95% CI 2 fewer to 135 more; very low-certainty evidence); PE (RR 8.96, 95% CI 0.49 to 165.42; RD 8 more per 1000, 95% CI 1 fewer to 164 more; very low-certainty evidence); and minor bleeding (RR 0.33, 95% CI 0.03 to 3.17; RD 9 fewer per 1000, 95% CI 13 fewer to 30 more; very low-certainty evidence). The study reported that no major bleeding occurred in either arm.\nOne RCT compared VKA to LMWH at two years follow-up. The data did not confirm or exclude a beneficial or detrimental effect of VKA relative to LMWH on all-cause mortality (RR 2.00, 95% CI 0.18 to 21.90; RD 5 more per 1000, 95% CI 4 fewer to 95 more; very low-certainty evidence); symptomatic DVT (RR 1.70, 95% CI 0.80 to 3.63; RD 32 more per 1000, 95% CI 9 fewer to 120 more; very low-certainty evidence); and PE (RR 9.00, 95% CI 0.49 to 166.17; RD 8 more per 1000, 95% CI 1 fewer to 165 more; very low-certainty evidence).\nASA versus DOAC\nOne RCT compared ASA to DOAC at six months follow-up. The data did not confirm or exclude a beneficial or detrimental effect of ASA relative to DOAC on DVT, PE, and major bleeding and minor bleeding (minor bleeding: RR 5.00, 95% CI 0.31 to 79.94; RD 4 more per 1000, 95% CI 1 fewer to 79 more; very low-certainty evidence). The study reported that no DVT, PE, or major bleeding events occurred in either arm. These results did not change in a meta-analysis including the study published as an abstract.\nAuthors' conclusions\nThe certainty of the available evidence for the comparative effects of ASA, VKA, LMWH, and DOAC on all-cause mortality, DVT, PE, or bleeding was either low or very low. People with multiple myeloma considering antithrombotic agents should balance the possible benefits of reduced thromboembolic complications with the possible harms and burden of anticoagulants.\nEditorial note: This is a living systematic review. Living systematic reviews offer a new approach to review updating in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.\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": "When comparing aspirin to VKA, aspirin to LMWH, or VKA to LMWH, the certainty of the evidence was very low for all studied outcomes (death, blood clots in the limbs or the lung, and bleeding). When comparing aspirin to direct oral anticoagulants, the certainty of the evidence was very low for all of the studied outcomes (death, blood clots in the limbs or the lung, and bleeding).\nEditorial note: This is a living systematic review. Living systematic reviews offer a new approach to review updating in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review."
}
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query-laysum
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8683
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[
{
"role": "user",
"content": "Abstract: Background\nMailuoning is widely used in the treatment of acute ischaemic stroke in China. Animal experimental studies and clinical pharmacological research indicate that mailuoning might improve blood circulation, prevent ischaemic injury, and protect heart and brain tissue. This review was last published in 2009. As new data have become available, it is necessary to reassess the evidence from randomised controlled trials.\nObjectives\nTo determine the effects and safety of mailuoning agents (injection or oral liquid) in the treatment of people with acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2014), the Cochrane Central Register of Controlled Trials (CENTRAL;2014, Issue 4), MEDLINE (1966 to May 2014), Embase (1980 to May 2014), AMED (1985 to May 2014), the Chinese Stroke Trials Register (June 2014), the China Biological Medicine Database (CBM-disc; 1979 to June 2014), China Science and Technology Journal database (CSTJ; 1979 to June 2014), Wanfang Data Chinese databases (1979 to June 2014), and the China National Knowledge Infrastructure (1979 to June 2014). We searched clinical trials and research registers, handsearched 10 Chinese journals including relevant conference proceedings, scanned reference lists, and contacted the pharmaceutical company that manufactures mailuoning. We also attempted to contact trial authors to obtain further data.\nSelection criteria\nRandomised controlled trials comparing mailuoning with placebo or mailuoning plus other treatment compared with that other treatment in people with acute ischaemic stroke.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, assessed trial quality, and extracted data.\nMain results\nWe included 21 trials, involving 1746 participants, in this update; six trials were new. The included trials did not report the numbers of dead and dependent participants at the end of at least three months' follow-up. Of the 12 trials that reported adverse events, five events occurred in two trials. There was no significant difference between the treatment group and the control group. We assessed 20 trials to be of a poor quality: When analysing these trials together, mailuoning was associated with a significant increase in the number of participants with an improved neurological deficit (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.23 to 0.42) and showed a significant improvement of neurological deficit with the European Stroke Scale (ESS) (mean difference (MD) (fixed) 8.29, 95% CI 3.44 to 13.15). One placebo-controlled trial, assessed to be of a better methodological quality, failed to show a significant improvement of neurological deficit at the end of three months' follow-up (MD (fixed) 2.49, 95% CI -1.45 to 6.43) or in quality of life. One trial, which reported cognitive function using the Montreal Cognitive Assessment as a continuous scale, showed a significant improvement of cognitive function (MD (fixed) 2.68, 95% CI 1.82 to 3.54). Two trials assessed activities of daily life: One trial showed a significant improvement, but the other did not.\nAuthors' conclusions\nThis review did not provide sufficient evidence to support the routine use of mailuoning for the treatment of people with acute ischaemic stroke. High-quality large-scale randomised controlled trials are needed to confirm the efficacy of mailuoning.\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 searched for trials up to June 2014 and included 21 randomised controlled trials, involving 1746 participants, of mailuoning for people with acute ischaemic stroke. Two trials followed up participants for three months after treatment ended, but the duration of the other trials was shorter, from 14 to 38 days. A government agency funded one of the 21 included trials."
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query-laysum
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8684
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[
{
"role": "user",
"content": "Abstract: Background\nInduction of general anaesthesia can be distressing for children. Non-pharmacological methods for reducing anxiety and improving co-operation may avoid the adverse effects of preoperative sedation.\nObjectives\nTo assess the effects of non-pharmacological interventions in assisting induction of anaesthesia in children by reducing their anxiety, distress or increasing their co-operation.\nSearch methods\nIn this updated review we searched CENTRAL (the Cochrane Library 2012, Issue 12) and searched the following databases from inception to 15 January 2013: MEDLINE, EMBASE, PsycINFO and Web of Science. We reran the search in August 2014. We will deal with the single study found to be of interest when we next update the review.\nSelection criteria\nWe included randomized controlled trials of a non-pharmacological intervention implemented on the day of surgery or anaesthesia.\nData collection and analysis\nAt least two review authors independently extracted data and assessed risk of bias in trials.\nMain results\nWe included 28 trials (2681 children) investigating 17 interventions of interest; all trials were conducted in high-income countries. Overall we judged the trials to be at high risk of bias. Except for parental acupuncture (graded low), all other GRADE assessments of the primary outcomes of comparisons were very low, indicating a high degree of uncertainty about the overall findings.\nParental presence: In five trials (557 children), parental presence at induction of anaesthesia did not reduce child anxiety compared with not having a parent present (standardized mean difference (SMD) 0.03, 95% confidence interval (CI) -0.14 to 0.20). In a further three trials (267 children) where we were unable to pool results, we found no clear differences in child anxiety, whether a parent was present or not. In a single trial, child anxiety showed no significant difference whether one or two parents were present, although parental anxiety was significantly reduced when both parents were present at the induction. Parental presence was significantly less effective than sedative premedication in reducing children's anxiety at induction in three trials with 254 children (we could not pool results).\nChild interventions (passive): When a video of the child's choice was played during induction, children were significantly less anxious than controls (median difference modified Yale Preoperative Anxiety Scale (mYPAS) 31.2, 95% CI 27.1 to 33.3) in a trial of 91 children. In another trial of 120 children, co-operation at induction did not differ significantly when a video fairytale was played before induction. Children exposed to low sensory stimulation were significantly less anxious than control children on introduction of the anaesthesia mask and more likely to be co-operative during induction in one trial of 70 children. Music therapy did not show a significant effect on children's anxiety in another trial of 51 children.\nChild interventions (mask introduction): We found no significant differences between a mask exposure intervention and control in a single trial of 103 children for child anxiety (risk ratio (RR) 0.59, 95% CI 0.31 to 1.11) although children did demonstrate significantly better co-operation in the mask exposure group (RR 1.27, 95% CI 1.06 to 1.51).\nChild interventions (interactive): In a three-arm trial of 168 children, preparation with interactive computer packages (in addition to parental presence) was more effective than verbal preparation, although differences between computer and cartoon preparation were not significant, and neither was cartoon preparation when compared with verbal preparation. Children given video games before induction were significantly less anxious at induction than those in the control group (mYPAS mean difference (MD) -9.80, 95% CI -19.42 to -0.18) and also when compared with children who were sedated with midazolam (mYPAS MD -12.20, 95% CI -21.82 to -2.58) in a trial of 112 children. When compared with parental presence only, clowns or clown doctors significantly lessened children's anxiety in the operating/induction room (mYPAS MD -24.41, 95% CI -38.43 to -10.48; random-effects, I² 75%) in three trials with a total of 133 children. However, we saw no significant differences in child anxiety in the operating room between clowns/clown doctors and sedative premedication (mYPAS MD -9.67, 95% CI -21.14 to 1.80, random-effects, I² 66%; 2 trials of 93 children). In a trial of hypnotherapy versus sedative premedication in 50 children, there were no significant differences in children's anxiety at induction (RR 0.59, 95% CI 0.33 to 1.04).\nParental interventions: Children of parents having acupuncture compared with parental sham acupuncture were less anxious during induction (mYPAS MD -17, 95% CI -30.51 to -3.49) and were more co-operative (RR 1.59, 95% CI 1.01 to 2.53) in a single trial of 67 children. Two trials with 191 parents assessed the effects of parental video viewing but did not report any of the review's prespecified primary outcomes.\nAuthors' conclusions\nThis review shows that the presence of parents during induction of general anaesthesia does not diminish their child's anxiety. Potentially promising non-pharmacological interventions such as parental acupuncture; clowns/clown doctors; playing videos of the child's choice during induction; low sensory stimulation; and hand-held video games need further investigation in larger 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"
},
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"role": "assistant",
"content": "The initial process of giving general anaesthesia (i.e. induction of anaesthesia) to children can be distressing for them and their parents. Children can be given a sedative medicine (premedication) to drink such as midazolam before anaesthesia is induced in order to help the child relax. However these drugs can have undesirable effects, such as possible airway obstruction before anaesthesia begins and during recovery. In addition behaviour changes may occur after the operation. Some non-drug alternatives have been tested to see if they could help children relax and co-operate at the beginning of their anaesthesia. This review aims to assess the effects of non-drug interventions such as hypnosis, acupuncture and video games in helping with the beginning of general anaesthesia in children"
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query-laysum
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8685
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[
{
"role": "user",
"content": "Abstract: Background\nEczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and has a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.\nObjectives\nTo assess the effects of moisturisers for eczema.\nSearch methods\nWe searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and GREAT. We searched five trials registers and checked references of included and excluded studies for further relevant trials.\nSelection criteria\nRandomised controlled trials in people with eczema.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 77 studies (mean duration: 6.7 weeks; 6603 participants, mean age: 18.6 years). Thirty-six studies were at high risk of bias, 34 at unclear risk, and seven at low risk. Twenty-four studies assessed our primary outcome of participant-assessed disease severity, 13 assessed satisfaction, and 41 assessed adverse events. Secondary outcomes included investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).\nSix studies evaluated moisturiser versus no moisturiser. Participant-assessed disease severity and satisfaction were not assessed. Moisturiser use yielded lower SCORing Atopic Dermatitis (SCORAD) scores than no moisturiser (3 studies, 276 participants; mean difference (MD) -2.42, 95% confidence interval (CI) -4.55 to -0.28), but the minimal important difference (MID) was unmet. Moisturiser use resulted in fewer flares (2 studies, 87 participants; RR 0.40, 95% CI 0.23 to 0.70), prolonged time to flare (median: 180 versus 30 days), and reduced use of topical corticosteroids (2 studies, 222 participants; MD -9.30 g, 95% CI -15.3 to -3.27). There was no clear difference in adverse events (1 study, 173 participants; risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.\nWith Atopiclair, 174/232 participants reported improvement in disease severity versus 27/158 using vehicle (3 studies; RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (4 studies, 396 participants; MD -2.65, 95% CI -4.21 to -1.09) and achieved more frequent satisfaction (2 studies, 248 participants; RR 2.14, 95% CI 1.58 to 2.89), fewer flares (3 studies, 397 participants; RR 0.18, 95% CI 0.11 to 0.31), and lower Eczema Area and Severity Index (EASI) scores (4 studies, 426 participants; MD -4.0, 95% CI -5.42 to -2.57), but the MID was unmet. The number of participants reporting adverse events was not statistically different (4 studies, 430 participants; RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.\nParticipants reported skin improvement more frequently with urea-containing cream than placebo (1 study, 129 participants; RR 1.28, 95% CI 1.06 to 1.53; low-quality evidence), with equal satisfaction between the two groups (1 study, 38 participants; low-quality evidence). Urea-containing cream improved dryness (investigator-assessed) (1 study, 128 participants; RR 1.40, 95% CI 1.14 to 1.71; moderate-quality evidence), and produced fewer flares (1 study, 44 participants; RR 0.47, 95% CI 0.24 to 0.92; low-quality evidence), but caused more adverse events (1 study, 129 participants; RR 1.65, 95% CI 1.16 to 2.34; moderate-quality evidence).\nThree studies assessed glycerol-containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (1 study, 134 participants; RR 1.22, 95% CI 1.01 to 1.48; moderate-quality evidence), which also included improved investigator-assessed SCORAD scores (1 study, 249 participants; MD -2.20, 95% CI -3.44 to -0.96; high-quality evidence), but the MID was unmet. Participant satisfaction was not addressed. The number of adverse events reported was not statistically significant (2 studies, 385 participants; RR 0.90, 95% CI 0.68 to 1.19; moderate-quality evidence).\nFour studies investigated oat-containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant-assessed disease severity (1 study, 50 participants; RR 1.11, 95% CI 0.84 to 1.46; low-quality evidence), satisfaction (1 study, 50 participants; RR 1.06, 95% CI 0.74 to 1.52; very low-quality evidence), or investigator-assessed disease severity (3 studies, 272 participants; standardised mean difference (SMD) -0.23, 95% CI -0.66 to 0.21; low-quality evidence). In the oat group, there were fewer flares (1 study, 43 participants; RR 0.31, 95% CI 0.12 to 0.7; low-quality evidence) and reduced use of topical corticosteroids (2 studies, 222 participants; MD -9.30g, 95% CI 15.3 to -3.27; low-quality evidence), but more adverse events (1 study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low-quality evidence).\nWe compared all moisturisers to placebo, vehicle, or no moisturiser. Participants considered moisturisers to be more effective for reducing eczema (5 studies, 572 participants; RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (7 studies, 749 participants; SMD -1.10, 95% CI -1.83 to -0.38) than control. Participants in both treatment arms reported comparable satisfaction (3 studies, 296 participants; RR 1.35, 95% CI 0.77 to 2.26; low-quality evidence). Moisturisers led to lower investigator-assessed disease severity scores (12 studies, 1281 participants; SMD -1.04, 95% CI -1.57 to -0.51; high-quality evidence) and fewer flares (6 studies, 607 participants; RR 0.33, 95% CI 0.17 to 0.62; moderate-quality evidence), without a difference in adverse events (10 studies, 1275 participants; RR 1.03, 95% CI 0.82 to 1.30; moderate-quality evidence).\nTopical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator-assessed disease severity scores (3 studies, 192 participants; SMD -0.87, 95% CI -1.17 to -0.57; moderate-quality evidence) and flares (1 study, 105 participants; RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low-quality evidence). There was no clear difference in number of adverse events (1 study, 125 participants; RR 0.39, 95% CI 0.13 to 1.19; very low-quality evidence). Participant-assessed disease severity was not addressed.\nAuthors' conclusions\nMost moisturisers showed some beneficial effects; prolonging time to flare, reducing the number of flares and the amount of topical corticosteroids needed to achieve similar reductions in eczema severity. Moisturisers combined with active treatment gave better results than active treatment alone. We did not find reliable evidence that one moisturiser is better than another.\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 medical literature up to December 2015, and identified 77 relevant studies with 6603 participants, with mainly mild to moderate eczema. Participant age ranged from four months to 84 years (mean: 18.6 years). Most studies lasted between two and six weeks; a few lasted six months.\nForty-six studies received funding from pharmaceutical companies."
}
] |
query-laysum
|
8686
|
[
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization recommends intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine for malaria for all women who live in moderate to high malaria transmission areas in Africa. However, parasite resistance to sulfadoxine-pyrimethamine has been increasing steadily in some areas of the region. Moreover, HIV-infected women on cotrimoxazole prophylaxis cannot receive sulfadoxine-pyrimethamine because of potential drug interactions. Thus, there is an urgent need to identify alternative drugs for prevention of malaria in pregnancy. One such candidate is mefloquine.\nObjectives\nTo assess the effects of mefloquine for preventing malaria in pregnant women, specifically, to evaluate:\n• the efficacy, safety, and tolerability of mefloquine for preventing malaria in pregnant women; and\n• the impact of HIV status, gravidity, and use of insecticide-treated nets on the effects of mefloquine.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, Latin American Caribbean Health Sciences Literature (LILACS), the Malaria in Pregnancy Library, and two trial registers up to 31 January 2018. In addition, we checked references and contacted study authors to identify additional studies, unpublished data, confidential reports, and raw data from published trials.\nSelection criteria\nRandomized and quasi-randomized controlled trials comparing mefloquine IPT or mefloquine prophylaxis against placebo, no treatment, or an alternative drug regimen.\nData collection and analysis\nTwo review authors independently screened all records identified by the search strategy, applied inclusion criteria, assessed risk of bias, and extracted data. We contacted trial authors to ask for additional information when required. Dichotomous outcomes were compared using risk ratios (RRs), count outcomes as incidence rate ratios (IRRs), and continuous outcomes using mean differences (MDs). We have presented all measures of effect with 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach for the following main outcomes of analysis: maternal peripheral parasitaemia at delivery, clinical malaria episodes during pregnancy, placental malaria, maternal anaemia at delivery, low birth weight, spontaneous abortions and stillbirths, dizziness, and vomiting.\nMain results\nSix trials conducted between 1987 and 2013 from Thailand (1), Benin (3), Gabon (1), Tanzania (1), Mozambique (2), and Kenya (1) that included 8192 pregnant women met our inclusion criteria.\nTwo trials (with 6350 HIV-uninfected pregnant women) compared two IPTp doses of mefloquine with two IPTp doses of sulfadoxine-pyrimethamine. Two other trials involving 1363 HIV-infected women compared three IPTp doses of mefloquine plus cotrimoxazole with cotrimoxazole. One trial in 140 HIV-infected women compared three doses of IPTp-mefloquine with cotrimoxazole. Finally, one trial enrolling 339 of unknown HIV status compared mefloquine prophylaxis with placebo.\nStudy participants included women of all gravidities and of all ages (four trials) or > 18 years (two trials). Gestational age at recruitment was > 20 weeks (one trial), between 16 and 28 weeks (three trials), or ≤ 28 weeks (two trials). Two of the six trials blinded participants and personnel, and only one had low risk of detection bias for safety outcomes.\nWhen compared with sulfadoxine-pyrimethamine, IPTp-mefloquine results in a 35% reduction in maternal peripheral parasitaemia at delivery (RR 0.65, 95% CI 0.48 to 0.86; 5455 participants, 2 studies; high-certainty evidence) but may have little or no effect on placental malaria infections (RR 1.04, 95% CI 0.58 to 1.86; 4668 participants, 2 studies; low-certainty evidence). Mefloquine results in little or no difference in the incidence of clinical malaria episodes during pregnancy (incidence rate ratio (IRR) 0.83, 95% CI 0.65 to 1.05, 2 studies; high-certainty evidence). Mefloquine decreased maternal anaemia at delivery (RR 0.84, 95% CI 0.76 to 0.94; 5469 participants, 2 studies; moderate-certainty evidence). Data show little or no difference in the proportions of low birth weight infants (RR 0.95, 95% CI 0.78 to 1.17; 5641 participants, 2 studies; high-certainty evidence) and in stillbirth and spontaneous abortion rates (RR 1.20, 95% CI 0.91 to 1.58; 6219 participants, 2 studies; I2 statistic = 0%; moderate-certainty evidence). IPTp-mefloquine increased drug-related vomiting (RR 4.76, 95% CI 4.13 to 5.49; 6272 participants, 2 studies; high-certainty evidence) and dizziness (RR 4.21, 95% CI 3.36 to 5.27; participants = 6272, 2 studies; moderate-certainty evidence).\nWhen compared with cotrimoxazole, IPTp-mefloquine plus cotrimoxazole probably results in a 48% reduction in maternal peripheral parasitaemia at delivery (RR 0.52, 95% CI 0.30 to 0.93; 989 participants, 2 studies; moderate-certainty evidence) and a 72% reduction in placental malaria (RR 0.28, 95% CI 0.14 to 0.57; 977 participants, 2 studies; moderate-certainty evidence) but has little or no effect on the incidence of clinical malaria episodes during pregnancy (IRR 0.76, 95% CI 0.33 to 1.76, 1 study; high-certainty evidence) and probably no effect on maternal anaemia at delivery (RR 0.94, 95% CI 0.73 to 1.20; 1197 participants, 2 studies; moderate-certainty evidence), low birth weight rates (RR 1.20, 95% CI 0.89 to 1.60; 1220 participants, 2 studies; moderate-certainty evidence), and rates of spontaneous abortion and stillbirth (RR 1.12, 95% CI 0.42 to 2.98; 1347 participants, 2 studies; very low-certainty evidence). Mefloquine was associated with higher risks of drug-related vomiting (RR 7.95, 95% CI 4.79 to 13.18; 1055 participants, one study; high-certainty evidence) and dizziness (RR 3.94, 95% CI 2.85 to 5.46; 1055 participants, 1 study; high-certainty evidence).\nAuthors' conclusions\nMefloquine was more efficacious than sulfadoxine-pyrimethamine in HIV-uninfected women or daily cotrimoxazole prophylaxis in HIV-infected pregnant women for prevention of malaria infection and was associated with lower risk of maternal anaemia, no adverse effects on pregnancy outcomes (such as stillbirths and abortions), and no effects on low birth weight and prematurity. However, the high proportion of mefloquine-related adverse events constitutes an important barrier to its effectiveness for malaria preventive treatment in pregnant women.\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 Cochrane Review was to find out whether the antimalarial drug mefloquine is efficacious and safe for prevention of malaria in pregnant women living in stable transmission areas. We found six relevant studies to help us answer this question."
}
] |
query-laysum
|
8687
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough conventional colonoscopy is the most accurate test available for the investigation of the colorectum for polyps, data exist that raise concerns about its sensitivity. Chromoscopy (spraying dye onto the surface of the colon to make polyps more visible) may be one way of enhancing the ability of colonoscopy to detect polyps, particularly diminutive flat lesions, which otherwise may be difficult to detect.\nObjectives\nTo determine whether the use of chromoscopy enhances the detection of polyps and neoplasia during endoscopic examination of the colon and rectum.\nSearch methods\nWe searched the following databases: Cochrane Colorectal Cancer Group Specialised Register (October 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library; Issue 10, 2015), MEDLINE (January 1950 to October 2015), EMBASE (January 1974 to October 2015), and ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (both November 2015). We also handsearched abstracts from relevant meetings from 1980 to 2015. Search terms included 'randomised trials' containing combinations of the following: 'chromoscopy' 'colonoscopy' 'dye-spray' 'chromo-endoscopy' 'indigo-carmine' 'magnifying endoscopy'.\nSelection criteria\nWe included all prospective randomised trials comparing chromoscopic with conventional endoscopic examination of the whole of the colon and rectum. We excluded studies of people with inflammatory bowel disease or polyposis syndromes and any studies that combined chromoscopy with additional interventions (cap assistance, water-perfused, etc.).\nData collection and analysis\nTwo review authors independently assessed the methodological quality of potentially eligible trials, and two review authors independently extracted data from the included trials. Outcome measures included the detection of polyps (neoplastic and non-neoplastic), the detection of diminutive lesions, the number of participants with multiple neoplastic lesions, and the extubation time.\nMain results\nWe included seven trials (2727 participants) in this update. Five trials were of sufficiently similar design to allow for pooled results. Two trials differed substantially in design and were included in a subgroup analysis. All the trials had some methodological drawbacks. However, combining the results showed a significant difference in favour of chromoscopy for all detection outcomes. In particular, chromoscopy was likely to yield significantly more people with at least one neoplastic lesion (odds ratio (OR) 1.53, 95% confidence interval (CI) 1.31 to 1.79; 7 trials; 2727 participants), and at least one diminutive neoplastic lesion (OR 1.51, 95% CI 1.19 to 1.92; 4 trials; 1757 participants). Significantly more people with three or more neoplastic lesions were also detected, but only when studies that used high-definition colonoscopy in the control group were excluded (OR 4.63, 95% CI 1.99 to 10.80; 2 trials; 519 participants). None of the included studies reported any adverse events related to the use of the contrast dye.\nAuthors' conclusions\nThere is strong evidence that chromoscopy enhances the detection of neoplasia in the colon and rectum. People with neoplastic polyps, particularly those with multiple polyps, are at increased risk of developing colorectal cancer. Such lesions, which presumably would be missed with conventional colonoscopy, could contribute to the interval cancer numbers on any surveillance programme.\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": "Colonoscopy is a diagnostic fibreoptic investigation that enables growths in the bowel (polyps) to be detected. Some of these polyps can develop into cancer. Although colonoscopy is the most accurate available test for the detection of these growths, some polyps, especially smaller ones, can be missed for a variety of reasons, including how well the polyp can be seen against the background of the normal lining of the large intestine (mucosa). It is important to identify even small polyps, which are often the precursors to cancer. Dye spraying (chromoscopy) is one of the simpler ways to make polyps stand out against the normal bowel mucosa, and hence be more easily seen."
}
] |
query-laysum
|
8688
|
[
{
"role": "user",
"content": "Abstract: Background\nHepatocellular carcinoma occurs mostly in people with chronic liver disease. Worldwide, it ranks sixth in terms of incidence of cancer, and fourth in terms of cancer-related deaths. Contrast-enhanced ultrasound (CEUS) is used as an add-on test to confirm the presence of focal liver lesions suspected as hepatocellular carcinoma after prior diagnostic tests such as abdominal ultrasound or measurement of alpha-foetoprotein, or both. According to guidelines, a single contrast-enhanced imaging investigation, with either computed tomography (CT) or magnetic resonance imaging (MRI), may show the typical hepatocellular carcinoma hallmarks in people with cirrhosis, which will be sufficient to diagnose hepatocellular carcinoma. However, a significant number of hepatocellular carcinomas show atypical imaging features, and therefore, are missed at imaging.\nDynamic CEUS images are obtained similarly to CT and MRI images. CEUS differentiates between arterial and portal venous phases, in which sonographic hepatocellular carcinoma hallmarks, such as arterial hyperenhancement and subsequent washout appearance, are investigated. The advantages of CEUS over CT and MRI include real-time imaging, use of contrast agents that do not contain iodine and are not nephrotoxic, and quick image acquisition. Despite the advantages, the use of CEUS in the diagnostic algorithm for HCC remains controversial, with disagreement on relevant guidelines.\nThere is no clear evidence of the benefit of surveillance programmes in terms of overall survival as the conflicting results can be a consequence of an inaccurate detection, ineffective treatment, or both. Therefore, assessing the diagnostic accuracy of CEUS may clarify whether the absence of benefit could be related to underdiagnosis. Furthermore, an assessment of the accuracy of CEUS for the diagnosis of hepatocellular carcinoma is needed for either diagnosing hepatocellular carcinoma or ruling it out in people with chronic liver disease who are not included in surveillance programmes.\nObjectives\n1. To assess the diagnostic accuracy of contrast-enhanced ultrasound (CEUS) for the diagnosis of hepatocellular carcinoma of any size and at any stage in adults with chronic liver disease, in a surveillance programme or in a clinical setting.\n2. To assess the diagnostic accuracy of CEUS for the diagnosis of resectable hepatocellular carcinoma in people with chronic liver disease and identify potential sources of heterogeneity in the results.\nSearch methods\nWe used standard, extensive Cochrane search methods. The last date of search was 5 November 2021.\nSelection criteria\nWe included studies assessing the diagnostic accuracy of CEUS for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease, with cross-sectional designs, using one of the acceptable reference standards, such as pathology of the explanted liver, and histology of resected or biopsied focal liver lesion with at least a six-month follow-up.\nData collection and analysis\nWe used standard Cochrane methods to screen studies, extract data, and assess the risk of bias and applicability concerns, using the QUADAS-2 checklist. We used the bivariate model and provided estimates of summary sensitivity and specificity. We assessed the certainty of the evidence using GRADE. We presented uncertainty-of-the-accuracy estimates using 95% confidence intervals (CIs).\nMain results\nWe included 23 studies with 6546 participants. Studies were published between 2001 and 2021. We judged all 23 studies at high-risk of bias in at least one domain, and 13/23 studies at high concern for applicability. Most studies used different reference standards to exclude the presence of the target condition. The time interval between the index test and the reference standard was rarely defined. We also had major concerns on their applicability due to the characteristics of the participants.\n– CEUS for hepatocellular carcinoma of any size and stage: sensitivity 77.8% (95% CI 69.4% to 84.4%) and specificity 93.8% (95% CI 89.1% to 96.6%) (23 studies, 6546 participants; very low-certainty evidence).\n– CEUS for resectable hepatocellular carcinoma: sensitivity 77.5% (95% CI 62.9% to 87.6%) and specificity 92.7% (95% CI 86.8% to 96.1%) (13 studies, 1257 participants; low-certainty evidence).\nThe observed heterogeneity in the results remains unexplained. The sensitivity analyses, including only studies with clearly prespecified positivity criteria and only studies in which the reference standard results were interpreted with no knowledge of the results about the index test, showed no differences in the results.\nAuthors' conclusions\nWe found that by using CEUS, as an add-on test following abdominal ultrasound, to diagnose hepatocellular carcinoma of any size and stage, 22% of people with hepatocellular carcinoma would be missed, and 6% of people without hepatocellular carcinoma would unnecessarily undergo further testing or inappropriate treatment. As to resectable hepatocellular carcinoma, we found that 23% of people with resectable hepatocellular carcinoma would incorrectly be unresected, while 8% of people without hepatocellular carcinoma would undergo further inappropriate testing or treatment. The uncertainty resulting from the high risk of bias of the included studies, heterogeneity, and imprecision of the results and concerns on their applicability limit our ability to draw confident conclusions.\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": "?\nOur confidence in the evidence is limited as the studies used different methods to select study participants and used different reference standards. This means that CEUS scans may be more or less accurate than what the evidence suggests."
}
] |
query-laysum
|
8689
|
[
{
"role": "user",
"content": "Abstract: Background\nLong-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICSs) are inhaled medications used to manage chronic obstructive pulmonary disease (COPD). When two classes of medications are required, a LAMA plus an ICS (LABA+ICS) were previously recommended within a single inhaler as the first-line treatment for managing stable COPD in people in high-risk categories. However, updated international guidance recommends a LAMA plus a LABA (LAMA+LABA). This systematic review is an update of a Cochrane Review first published in 2017.\nObjectives\nTo compare the benefits and harms of LAMA+LABA versus LABA+ICS for treatment of people with stable COPD.\nSearch methods\nWe performed an electronic search of the Cochrane Airways Group Specialised Register, ClinicalTrials.gov, and the World Health Organization Clinical Trials Search Portal, followed by handsearches. Two review authors screened the selected articles. The most recent search was run on 10 September 2022.\nSelection criteria\nWe included parallel or cross-over randomised controlled trials of at least one month's duration, comparing LAMA+LABA and LABA+ICS for stable COPD. We included studies conducted in an outpatient setting and irrespective of blinding.\nData collection and analysis\nTwo review authors independently extracted data and evaluated risk of bias. We resolved any discrepancies through discussion. We analysed dichotomous data as odds ratios (ORs), and continuous data as mean differences (MDs), with 95% confidence intervals (CIs) using Review Manager 5. Primary outcomes were: participants with one or more exacerbations of COPD; serious adverse events; quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score change from baseline; and trough forced expiratory volume in one second (FEV1). We used the GRADE framework to rate our certainty of the evidence in each meta-analysis as high, moderate, low or very low.\nMain results\nThis review updates the first version of the review, published in 2017, and increases the number of included studies from 11 to 19 (22,354 participants). The median number of participants per study was 700. In each study, between 54% and 91% (median 70%) of participants were males. Study participants had an average age of 64 years and percentage predicted FEV1 of 51.5% (medians of study means). Included studies had a generally low risk of selection, performance, detection, attrition, and reporting biases. All but two studies were sponsored by pharmaceutical companies, which had varying levels of involvement in study design, conduct, and data analysis.\nPrimary outcomes\nThe odds of having an exacerbation were similar for LAMA+LABA compared with LABA+ICS (OR 0.91, 95% CI 0.78 to 1.06; I2 = 61%; 13 studies, 20,960 participants; moderate-certainty evidence). The odds of having a serious adverse event were also similar (OR 1.02, 95% CI 0.91 to 1.15; I2 = 20%; 18 studies, 23,183 participants; high-certainty evidence). Participants receiving LAMA+LABA had a similar improvement in quality of life, as measured by the SGRQ, to those receiving LABA+ICS (MD -0.57, 95% CI -1.36 to 0.21; I2 = 78%; 9 studies, 14,437 participants; moderate-certainty evidence) but showed a greater improvement in trough FEV1 (MD 0.07, 95% CI 0.05 to 0.08; I2 = 73%; 12 studies, 14,681 participants; moderate-certainty evidence).\nSecondary outcomes\nLAMA+LABA decreased the odds of pneumonia compared with LABA+ICS from 5% to 3% (OR 0.61, 95% CI 0.52 to 0.72; I2 = 0%; 14 studies, 21,829 participants; high-certainty evidence) but increased the odds of all-cause death from 1% to 1.4% (OR 1.35, 95% CI 1.05 to 1.75; I2 = 0%; 15 studies, 21,510 participants; moderate-certainty evidence). The odds of achieving a minimal clinically important difference of four or more points on the SGRQ were similar between LAMA+LABA and LABA+ICS (OR 1.06, 95% CI 0.90 to 1.25; I2 = 77%; 4 studies, 13,614 participants; moderate-certainty evidence).\nAuthors' conclusions\nCombination LAMA+LABA therapy probably holds similar benefits to LABA+ICS for exacerbations and quality of life, as measured by the St George's Respiratory Questionnaire, for people with moderate to severe COPD, but offers a larger improvement in FEV1 and a slightly lower risk of pneumonia. There is little to no difference between LAMA+LABA and LAMA+ICS in the odds of having a serious adverse event. Whilst all-cause death may be lower with LABA+ICS, there was a very small number of events in the analysis, translating to a low absolute risk. Findings are based on moderate- to high-certainty evidence from heterogeneous trials with an observation period of less than one year. This review should be updated again in a few years.\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": "• Using an inhaler containing a long-acting muscarinic antagonist plus a long-acting beta-agonist (LAMA+LABA) for chronic obstructive pulmonary disease (COPD) probably improves respiratory function and reduces the risk of pneumonia compared to LABA plus an inhaled corticosteroid (LABA+ICS).\n• LAMA+LABA and LABA+ICS probably work as well as each other in reducing COPD exacerbations and improving quality of life.\n• The risk of death was slightly higher in people taking LAMA+LABA."
}
] |
query-laysum
|
8690
|
[
{
"role": "user",
"content": "Abstract: Background\nMidazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous system (CNS) with rapid onset of action and few adverse effects. The drug can be administered by several routes including oral, intravenous, intranasal and intramuscular.\nObjectives\nTo determine the evidence on the effectiveness of midazolam for sedation when administered before a procedure (diagnostic or therapeutic).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL to January 2016), MEDLINE in Ovid (1966 to January 2016) and Ovid EMBASE (1980 to January 2016). We imposed no language restrictions.\nSelection criteria\nRandomized controlled trials in which midazolam, administered to participants of any age, by any route, at any dose or any time before any procedure (apart from dental procedures), was compared with placebo or other medications including sedatives and analgesics.\nData collection and analysis\nTwo authors extracted data and assessed risk of bias for each included study. We performed a separate analysis for each different drug comparison.\nMain results\nWe included 30 trials (2319 participants) of midazolam for gastrointestinal endoscopy (16 trials), bronchoscopy (3), diagnostic imaging (5), cardioversion (1), minor plastic surgery (1), lumbar puncture (1), suturing (2) and Kirschner wire removal (1). Comparisons were: intravenous diazepam (14), placebo (5) etomidate (1) fentanyl (1), flunitrazepam (1) and propofol (1); oral chloral hydrate (4), diazepam (2), diazepam and clonidine (1); ketamine (1) and placebo (3); and intranasal placebo (2). There was a high risk of bias due to inadequate reporting about randomization (75% of trials). Effect estimates were imprecise due to small sample sizes. None of the trials reported on allergic or anaphylactoid reactions.\nIntravenous midazolam versus diazepam (14 trials; 1069 participants)\nThere was no difference in anxiety (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.39 to 1.62; 175 participants; 2 trials) or discomfort/pain (RR 0.60, 95% CI 0.24 to 1.49; 415 participants; 5 trials; I² = 67%). Midazolam produced greater anterograde amnesia (RR 0.45; 95% CI 0.30 to 0.66; 587 participants; 9 trials; low-quality evidence).\nIntravenous midazolam versus placebo (5 trials; 493 participants)\nOne trial reported that fewer participants who received midazolam were anxious (3/47 versus 15/35; low-quality evidence). There was no difference in discomfort/pain identified in a further trial (3/85 in midazolam group; 4/82 in placebo group; P = 0.876; very low-quality evidence).\nOral midazolam versus chloral hydrate (4 trials; 268 participants)\nMidazolam increased the risk of incomplete procedures (RR 4.01; 95% CI 1.92 to 8.40; moderate-quality evidence).\nOral midazolam versus placebo (3 trials; 176 participants)\nMidazolam reduced pain (midazolam mean 2.56 (standard deviation (SD) 0.49); placebo mean 4.62 (SD 1.49); P < 0.005) and anxiety (midazolam mean 1.52 (SD 0.3); placebo mean 3.97 (SD 0.44); P < 0.0001) in one trial with 99 participants. Two other trials did not find a difference in numerical rating of anxiety (mean 1.7 (SD 2.4) for 20 participants randomized to midazolam; mean 2.6 (SD 2.9) for 22 participants randomized to placebo; P = 0.216; mean Spielberger's Trait Anxiety Inventory score 47.56 (SD 11.68) in the midazolam group; mean 52.78 (SD 9.61) in placebo group; P > 0.05).\nIntranasal midazolam versus placebo (2 trials; 149 participants)\nMidazolam induced sedation (midazolam mean 3.15 (SD 0.36); placebo mean 2.56 (SD 0.64); P < 0.001) and reduced the numerical rating of anxiety in one trial with 54 participants (midazolam mean 17.3 (SD 18.58); placebo mean 49.3 (SD 29.46); P < 0.001). There was no difference in meta-analysis of results from both trials for risk of incomplete procedures (RR 0.14, 95% CI 0.02 to 1.12; downgraded to low-quality evidence).\nAuthors' conclusions\nWe found no high-quality evidence to determine if midazolam, when administered as the sole sedative agent prior to a procedure, produces more or less effective sedation than placebo or other medications. There is low-quality evidence that intravenous midazolam reduced anxiety when compared with placebo. There is inconsistent evidence that oral midazolam decreased anxiety during procedures compared with placebo. Intranasal midazolam did not reduce the risk of incomplete procedures, although anxiolysis and sedation were observed. There is moderate-quality evidence suggesting that oral midazolam produces less effective sedation than chloral hydrate for completion of procedures for children undergoing non-invasive diagnostic procedures.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the evidence, in the main, as being of low quality. Particularly concerning was that many trials did not explain how participants were randomized to either midazolam or to a different treatment, and that the results did not give us a very clearly defined answer."
}
] |
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