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Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses.

ABSTRACT: Objective To evaluate the impact of searching clinical trial registries in systematic reviews.Design Methodological systematic review and reanalyses of meta-analyses.Data sources Medline was searched to identify systematic reviews of randomised controlled trials (RCTs) assessing pharmaceutical treatments published between June 2014 and January 2015. For all systematic reviews that did not report a trial registry search but reported the information to perform it, the World Health Organization International Trials Registry Platform (WHO ICTRP search portal) was searched for completed or terminated RCTs not originally included in the systematic review.Data extraction For each systematic review, two researchers independently extracted the outcomes analysed, the number of patients included, and the treatment effect estimated. For each RCT identified, two researchers independently determined whether the results were available (ie, posted, published, or available on the sponsor website) and extracted the data. When additional data were retrieved, we reanalysed meta-analyses and calculated the weight of the additional RCTs and the change in summary statistics by comparison with the original meta-analysis.Results Among 223 selected systematic reviews, 116 (52%) did not report a search of trial registries; 21 of these did not report the information to perform the search (key words, search date). A search was performed for 95 systematic reviews; for 54 (57%), no additional RCTs were found and for 41 (43%) 122 additional RCTs were identified. The search allowed for increasing the number of patients by more than 10% in 19 systematic reviews, 20% in 10, 30% in seven, and 50% in four. Moreover, 63 RCTs had results available; the results for 45 could be included in a meta-analysis. 14 systematic reviews including 45 RCTs were reanalysed. The weight of the additional RCTs in the recalculated meta-analyses ranged from 0% to 58% and was greater than 10% in five of 14 systematic reviews, 20% in three, and 50% in one. The change in summary statistics ranged from 0% to 29% and was greater than 10% for five of 14 systematic reviews and greater than 20% for two. However, none of the changes to summary effect estimates led to a qualitative change in the interpretation of the results once the new trials were added.Conclusions Trial registries are an important source for identifying additional RCTs. The additional number of RCTs and patients included if a search were performed varied across systematic reviews.

SUBMITTER: Baudard M

PROVIDER: S-EPMC5421496 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses.

Baudard Marie M Yavchitz Amélie A Ravaud Philippe P Perrodeau Elodie E Boutron Isabelle I

BMJ (Clinical research ed.) 20170217

Objective To evaluate the impact of searching clinical trial registries in systematic reviews.Design Methodological systematic review and reanalyses of meta-analyses.Data sources Medline was searched to identify systematic reviews of randomised controlled trials (RCTs) assessing pharmaceutical treatments published between June 2014 and January 2015. For all systematic reviews that did not report a trial registry search but reported the information to perform it, the World He ...[more]

PMID: 28213479

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Project description:Qualitative systematic reviews or qualitative evidence syntheses (QES) are increasingly recognised as a way to enhance the value of systematic reviews (SRs) of clinical trials. They can explain the mechanisms by which interventions, evaluated within trials, might achieve their effect. They can investigate differences in effects between different population groups. They can identify which outcomes are most important to patients, carers, health professionals and other stakeholders. QES can explore the impact of acceptance, feasibility, meaningfulness and implementation-related factors within a real world setting and thus contribute to the design and further refinement of future interventions. To produce valid, reliable and meaningful QES requires systematic identification of relevant qualitative evidence. Although the methodologies of QES, including methods for information retrieval, are well-documented, little empirical evidence exists to inform their conduct and reporting.This structured methodological overview examines papers on searching for qualitative research identified from the Cochrane Qualitative and Implementation Methods Group Methodology Register and from citation searches of 15 key papers.A single reviewer reviewed 1299 references. Papers reporting methodological guidance, use of innovative methodologies or empirical studies of retrieval methods were categorised under eight topical headings: overviews and methodological guidance, sampling, sources, structured questions, search procedures, search strategies and filters, supplementary strategies and standards.This structured overview presents a contemporaneous view of information retrieval for qualitative research and identifies a future research agenda. This review concludes that poor empirical evidence underpins current information practice in information retrieval of qualitative research. A trend towards improved transparency of search methods and further evaluation of key search procedures offers the prospect of rapid development of search methods.

Project description:ObjectiveTo examine whether network meta-analyses, increasingly used to assess comparative effectiveness of healthcare interventions, follow the key methodological recommendations for reporting and conduct of systematic reviews.DesignMethodological systematic review of reports of network meta-analyses.Data sourcesCochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Medline, and Embase, searched from inception to 12 July 2012.Review methodsAll network meta-analyses comparing clinical efficacy of three or more interventions based on randomised controlled trials, excluding meta-analyses with an open loop network of three interventions. We assessed the reporting of general characteristics and key methodological components of the systematic review process using two composite outcomes. For some components, if reporting was adequate, we assessed their conduct quality.ResultsOf 121 network meta-analyses covering a wide range of medical areas, 100 (83%) assessed pharmacological interventions and 11 (9%) non-pharmacological interventions; 56 (46%) were published in journals with a high impact factor. The electronic search strategy for each database was not reported in 88 (73%) network meta-analyses; for 36 (30%), the primary outcome was not clearly identified. Overall, 61 (50%) network meta-analyses did not report any information regarding the assessment of risk of bias of individual studies, and 103 (85%) did not report any methods to assess the likelihood of publication bias. Overall, 87 (72%) network meta-analyses did not report the literature search, searched only one database, did not search other sources, or did not report an assessment of risk of bias of individual studies. These methodological components did not differ by publication in a general or specialty journal or by public or private funding.ConclusionsEssential methodological components of the systematic review process-conducting a literature search and assessing risk of bias of individual studies-are frequently lacking in reports of network meta-analyses, even when published in journals with high impact factors.

Project description:BackgroundClinical trial results registries may contain relevant unpublished information. Our main aim was to investigate the potential impact of the inclusion of reports from industry results registries on systematic reviews (SRs).MethodsWe identified a sample of 150 eligible SRs in PubMed via backward selection. Eligible SRs investigated randomized controlled trials of drugs and included at least 2 bibliographic databases (original search date: 11/2009). We checked whether results registries of manufacturers and/or industry associations had also been searched. If not, we searched these registries for additional trials not considered in the SRs, as well as for additional data on trials already considered. We reanalysed the primary outcome and harm outcomes reported in the SRs and determined whether results had changed. A "change" was defined as either a new relevant result or a change in the statistical significance of an existing result. We performed a search update in 8/2013 and identified a sample of 20 eligible SRs to determine whether mandatory results registration from 9/2008 onwards in the public trial and results registry ClinicalTrials.gov had led to its inclusion as a standard information source in SRs, and whether the inclusion rate of industry results registries had changed.Results133 of the 150 SRs (89%) in the original analysis did not search industry results registries. For 23 (17%) of these SRs we found 25 additional trials and additional data on 31 trials already included in the SRs. This additional information was found for more than twice as many SRs of drugs approved from 2000 as approved beforehand. The inclusion of the additional trials and data yielded changes in existing results or the addition of new results for 6 of the 23 SRs. Of the 20 SRs retrieved in the search update, 8 considered ClinicalTrials.gov or a meta-registry linking to ClinicalTrials.gov, and 1 considered an industry results registry.ConclusionThe inclusion of industry and public results registries as an information source in SRs is still insufficient and may result in publication and outcome reporting bias. In addition to an essential search in ClinicalTrials.gov, authors of SRs should consider searching industry results registries.

Project description:Rationale, aims, and objectivesCOVID-19 has caused an ongoing public health crisis. Many systematic reviews and meta-analyses have been performed to synthesize evidence for better understanding this new disease. However, some concerns have been raised about rapid COVID-19 research. This meta-epidemiological study aims to methodologically assess the current systematic reviews and meta-analyses on COVID-19.MethodsWe searched in various databases for systematic reviews with meta-analyses published between 1 January 2020 and 31 October 2020. We extracted their basic characteristics, data analyses, evidence appraisal, and assessment of publication bias and heterogeneity.ResultsWe identified 295 systematic reviews on COVID-19. The median time from submission to acceptance was 33 days. Among these systematic reviews, 73.9% evaluated clinical manifestations or comorbidities of COVID-19. Stata was the most used software programme (43.39%). The odds ratio was the most used effect measure (34.24%). Moreover, 28.14% of the systematic reviews did not present evidence appraisal. Among those reporting the risk of bias results, 14.64% of studies had a high risk of bias. Egger's test was the most used method for assessing publication bias (38.31%), while 38.66% of the systematic reviews did not assess publication bias. The I2 statistic was widely used for assessing heterogeneity (92.20%); many meta-analyses had high values of I2 . Among the meta-analyses using the random-effects model, 75.82% did not report the methods for model implementation; among those meta-analyses reporting implementation methods, the DerSimonian-Laird method was the most used one.ConclusionsThe current systematic reviews and meta-analyses on COVID-19 might suffer from low transparency, high heterogeneity, and suboptimal statistical methods. It is recommended that future systematic reviews on COVID-19 strictly follow well-developed guidelines. Sensitivity analyses may be performed to examine how the synthesized evidence might depend on different methods for appraising evidence, assessing publication bias, and implementing meta-analysis models.

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Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses.

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Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses.

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