Evidence map›Paper›PMID 24731537›Full record

ArticleSystematic reviews2014

Evaluation of the Cochrane Collaboration's tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation.

Jelena Savović, Laura Weeks, Jonathan A C Sterne, Lucy Turner, Douglas G Altman, David Moher, Julian P T Higgins

Abstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Systematic reviews, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 167 papers, 77 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
167citing papers in PubMed, 77 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

167 citing papers in PubMed, 77 syntheses or guidelines pooled it.

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  16. Impact of psilocybin on cognitive function: A systematic review.Psychiatry and clinical neurosciences · 2024
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107 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jelena SavovićSchool of Social and Community Medicine, University of Bristol, Bristol, UK. j.savovic@bristol.ac.uk.
Laura Weeks
Jonathan A C Sterne
Lucy Turner
Douglas G Altman
David Moher
Julian P T Higgins

Funding

Cancer Research UK 16895Cancer Research UK C-5592CIHRMedical Research Council G0701659Medical Research Council G0701659/1Medical Research Council MR/K025643/1Medical Research Council U105285807
6 · The paper itself

Abstract

backgroundIn 2008, the Cochrane Collaboration introduced a tool for assessing the risk of bias in clinical trials included in Cochrane reviews. The risk of bias (RoB) tool is based on narrative descriptions of evidence-based methodological features known to increase the risk of bias in trials.

methodsTo assess the usability of this tool, we conducted an evaluation by means of focus groups, online surveys and a face-to-face meeting. We obtained feedback from a range of stakeholders within The Cochrane Collaboration regarding their experiences with, and perceptions of, the RoB tool and associated guidance materials. We then assessed this feedback in a face-to-face meeting of experts and stakeholders and made recommendations for improvements and further developments of the RoB tool.

resultsThe survey attracted 380 responses. Respondents reported taking an average of between 10 and 60 minutes per study to complete their RoB assessments, which 83% deemed acceptable. Most respondents (87% of authors and 95% of editorial staff) thought RoB assessments were an improvement over past approaches to trial quality assessment. Most authors liked the standardized approach (81%) and the ability to provide quotes to support judgements (74%). A third of participants disliked the increased workload and found the wording describing RoB judgements confusing. The RoB domains reported to be the most difficult to assess were incomplete outcome data and selective reporting of outcomes. Authors expressed the need for more guidance on how to incorporate RoB assessments into meta-analyses and review conclusions. Based on this evaluation, recommendations were made for improvements to the RoB tool and the associated guidance. The implementation of these recommendations is currently underway.

conclusionsOverall, respondents identified positive experiences and perceptions of the RoB tool. Revisions of the tool and associated guidance made in response to this evaluation, and improved provision of training, may improve implementation.

Indexed as

BiasData CollectionEvidence-Based MedicineFocus GroupsHumansRandomized Controlled Trials as TopicRisk Assessment

Identifiers

PMID24731537
PMCPMC4022341

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.