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What improvements do Cochrane systematic reviewers suggest for the design of trials?

ABSTRACT: Background: Many randomised trials have serious methodological flaws that fatally undermine their results, which makes the research wasteful. This is of concern for many, including those doing systematic reviews that include trials. Cochrane systematic reviews all have a section called ' Implications for research', which allows authors of the review to present their conclusions on how future research might be improved. Looking at these conclusions might highlight priority areas for improvement. Methods: We focused on the Cochrane Schizophrenia Review Group and the Multiple sclerosis and rare diseases of the central nervous system Review Group (the MS Review Group). Reviews with citations between 2009 and 2019 were identified and the recommendations given by review authors in ' Implications for research' were put into categories. Results: Between 2009 and 2019 we identified 162 reviews for the Schizophrenia Review Group and 43 reviews for the MS Review Group. We created 22 categories in total, of which 12 were common to both groups. The five most used categories were the same for both: better choice of outcomes; better choice of intervention/comparator; longer follow-up; larger sample size; use of validated scales. Better choice of outcomes and/or intervention/comparator was recommended in over 50% of reviews. Longer follow-up and larger sample size were recommended in over a third, with use of validated scales being suggested in around a fifth of reviews. There was no obvious pattern of improvement over time for trials included in systematic reviews published by both groups. Conclusions: We suggest that trialists working in these areas (and others too) ask themselves why they have chosen their particular outcomes, intervention and comparator, whether follow-up is long enough, if the sample size is big enough and whether the scales they choose to measure their outcomes are appropriate.

SUBMITTER: Pirosca S

PROVIDER: S-EPMC7194492 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Learning from Cochrane systematic reviews: what improvements do these suggest for the design of trials?

Pirosca Stefania S Clarke Mike M Treweek Shaun S

F1000Research 20200311

<b>Background: </b>Many randomised trials have serious methodological flaws that fatally undermine their results, which makes the research wasteful. This is of concern for many, including those doing systematic reviews that include trials. Cochrane systematic reviews have a section called ' <i>Implications for research</i>', which allows authors of the review to present their conclusions on how future research might be improved. Looking at these conclusions might highlight priority areas for im ...[more]

PMID: 32399204

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Project description:BackgroundPhysical identical and pharmacological inert are the basic requirements for placebo design, which are essential in clinical trials to evaluate the efficacy of an intervention. However, it is difficult to makeup a placebo of Chinese herbal medicine (CHM) because of special color, taste and smell, etc. Currently, there is no specific requirements and standards for the creation of a CHM-placebo. The purpose of this study is to review the characteristics of the CHM-placebo design and application in registered clinical trials with CHM interventions and identify the common problems, if any.MethodsThe World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) was systematically searched for CHM interventional trials with placebo-controlled design up to 31 December 2017. Registered information of each included trial was collected from specific registries involved in ICTRP through hyperlinks. Descriptive statistics were used to analyze the characteristics of placebo design in CHM trial registrations.ResultsA total of 889 CHM interventional trials were registered from 1999 to 2017, and 40.8% (363) of them included CHM-placebo control design. The common ways of their design were: placebo as sole control (191, 52.6%); placebo as add-on control with baseline treatment (84, 23.1%); and placebo as double-dummy control (57, 15.7%). Among 363 included trials, 46 (12.7%) reported the compositions of placebos, including CHM ingredients (17 trials), excipients and other agents (29 trials). 2 (0.6%) reported pharmacological inert testing, and 52 (14.3%) descripted their placebos to be physically identical with the CHMs. 14 (3.9%) reported quality control of placebos, and 2 (0.6%) provided blinding assessment of placebos.ConclusionsThe placebos included in most CHM trial registrations is not optimal in terms of placebo design, application, evaluation and reporting. Specific guidelines or standards of CHM-placebo design, including usage requirements, preparation specifications, quality assessments and reporting guidelines should be developed thus to improve their quality.

Project description:ObjectiveTo quantify the effect of strategies to improve retention in randomised trials.DesignSystematic review and meta-analysis.Data sourcesSources searched: MEDLINE, EMBASE, PsycINFO, DARE, CENTRAL, CINAHL, C2-SPECTR, ERIC, PreMEDLINE, Cochrane Methodology Register, Current Controlled Trials metaRegister, WHO trials platform, Society for Clinical Trials (SCT) conference proceedings and a survey of all UK clinical trial research units.Review methodsIncluded trials were randomised evaluations of strategies to improve retention embedded within host randomised trials. The primary outcome was retention of trial participants. Data from trials were pooled using the fixed-effect model. Subgroup analyses were used to explore the heterogeneity and to determine whether there were any differences in effect by the type of strategy.Results38 retention trials were identified. Six broad types of strategies were evaluated. Strategies that increased postal questionnaire responses were: adding, that is, giving a monetary incentive (RR 1.18; 95% CI 1.09 to 1.28) and higher valued incentives (RR 1.12; 95% CI 1.04 to 1.22). Offering a monetary incentive, that is, an incentive given on receipt of a completed questionnaire, also increased electronic questionnaire response (RR 1.25; 95% CI 1.14 to 1.38). The evidence for shorter questionnaires (RR 1.04; 95% CI 1.00 to 1.08) and questionnaires relevant to the disease/condition (RR 1.07; 95% CI 1.01 to 1.14) is less clear. On the basis of the results of single trials, the following strategies appeared effective at increasing questionnaire response: recorded delivery of questionnaires (RR 2.08; 95% CI 1.11 to 3.87); a 'package' of postal communication strategies (RR 1.43; 95% CI 1.22 to 1.67) and an open trial design (RR 1.37; 95% CI 1.16 to 1.63). There is no good evidence that the following strategies impact on trial response/retention: adding a non-monetary incentive (RR=1.00; 95% CI 0.98 to 1.02); offering a non-monetary incentive (RR=0.99; 95% CI 0.95 to 1.03); 'enhanced' letters (RR=1.01; 95% CI 0.97 to 1.05); monetary incentives compared with offering prize draw entry (RR=1.04; 95% CI 0.91 to 1.19); priority postal delivery (RR=1.02; 95% CI 0.95 to 1.09); behavioural motivational strategies (RR=1.08; 95% CI 0.93 to 1.24); additional reminders to participants (RR=1.03; 95% CI 0.99 to 1.06) and questionnaire question order (RR=1.00, 0.97 to 1.02). Also based on single trials, these strategies do not appear effective: a telephone survey compared with a monetary incentive plus questionnaire (RR=1.08; 95% CI 0.94 to 1.24); offering a charity donation (RR=1.02, 95% CI 0.78 to 1.32); sending sites reminders (RR=0.96; 95% CI 0.83 to 1.11); sending questionnaires early (RR=1.10; 95% CI 0.96 to 1.26); longer and clearer questionnaires (RR=1.01, 0.95 to 1.07) and participant case management by trial assistants (RR=1.00; 95% CI 0.97 to 1.04).ConclusionsMost of the trials evaluated questionnaire response rather than ways to improve participants return to site for follow-up. Monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Some strategies need further evaluation. Application of these results would depend on trial context and follow-up procedures.

Project description:This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review. To identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation. Systematic review. The Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied. Randomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility. 45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95% CI 1.09 to 1.36; two studies, 4833 participants). However, the effect of many other strategies is less clear, including the use of video to provide trial information and interventions aimed at recruiters. There are promising strategies for increasing recruitment to trials, but some methods, such as open-trial designs and opt-out strategies, must be considered carefully as their use may also present methodological or ethical challenges. Questions remain as to the applicability of results originating from hypothetical trials, including those relating to the use of monetary incentives, and there is a clear knowledge gap with regard to effective strategies aimed at recruiters.

Project description:BackgroundIndividuals and groups who write systematic reviews and meta-analyses in evidence-based medicine regularly carry out literature searches across multiple search engines linked to different bibliographic databases, and thus have an urgent need for a suitable metasearch engine to save time spent on repeated searches and to remove duplicate publications from initial consideration. Unlike general users who generally carry out searches to find a few highly relevant (or highly recent) articles, systematic reviewers seek to obtain a comprehensive set of articles on a given topic, satisfying specific criteria. This creates special requirements and challenges for metasearch engine design and implementation.MethodsWe created a federated search tool that is connected to five databases: PubMed, EMBASE, CINAHL, PsycINFO, and the Cochrane Central Register of Controlled Trials. Retrieved bibliographic records were shown online; optionally, results could be de-duplicated and exported in both BibTex and XML format.ResultsThe query interface was extensively modified in response to feedback from users within our team. Besides a general search track and one focused on human-related articles, we also added search tracks optimized to identify case reports and systematic reviews. Although users could modify preset search options, they were rarely if ever altered in practice. Up to several thousand retrieved records could be exported within a few minutes. De-duplication of records returned from multiple databases was carried out in a prioritized fashion that favored retaining citations returned from PubMed.ConclusionsSystematic reviewers are used to formulating complex queries using strategies and search tags that are specific for individual databases. Metta offers a different approach that may save substantial time but which requires modification of current search strategies and better indexing of randomized controlled trial articles. We envision Metta as one piece of a multi-tool pipeline that will assist systematic reviewers in retrieving, filtering and assessing publications. As such, Metta may find wide utility for anyone who is carrying out a comprehensive search of the biomedical literature.

Project description:OBJECTIVES:Assess the frequency and reasons for disagreements in risk of bias assessments for randomised controlled trials (RCTs) included in more than one Cochrane review. DESIGN:Research on research study, using cross-sectional design. DATA SOURCES:2796 Cochrane reviews published between March 2011 and September 2014. DATA SELECTION:RCTs included in more than one review. DATA EXTRACTION:Risk of bias assessment and support for judgement for five key risk of bias items. DATA SYNTHESIS:For each item, we compared risk of bias assessment made in each review and calculated proportion of agreement. Two reviewers independently analysed 50% of all disagreements by comparing support for each judgement with information from study report to evaluate whether disagreements were related to a difference in information (eg, contact the study author) or a difference in interpretation (same support for judgement but different interpretation). They also identified main reasons for different interpretation. RESULTS:1604 RCTs were included in more than one review. Proportion of agreement ranged from 57% (770/1348 trials) for incomplete outcome data to 81% for random sequence generation (1193/1466). Most common source of disagreement was difference in interpretation of the same information, ranging from 65% (88/136) for random sequence generation to 90% (56/62) for blinding of participants and personnel. Access to different information explained 32/136 (24%) disagreements for random sequence generation and 38/205 (19%) for allocation concealment. Disagreements related to difference in interpretation were frequently related to incomplete or unclear reporting in the study report (83% of disagreements related to different interpretation for random sequence generation). CONCLUSIONS:Risk of bias judgements of RCTs included in more than one Cochrane review differed substantially. Most disagreements were related to a difference in interpretation of an incomplete or unclear description in the study report. A clearer guidance on common causes of incomplete information may improve agreement.

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What improvements do Cochrane systematic reviewers suggest for the design of trials?

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Learning from Cochrane systematic reviews: what improvements do these suggest for the design of trials?

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