Evidence map›Paper›PMID 27160280›Full record

ReviewSystematic reviews2016

Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials: overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews.

Lars Jørgensen, Asger S Paludan-Müller, David R T Laursen, Jelena Savović, Isabelle Boutron, Jonathan A C Sterne, Julian P T Higgins, Asbjørn Hróbjartsson

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Systematic reviews, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 168 papers, 86 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
168citing papers in PubMed, 86 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

168 citing papers in PubMed, 86 syntheses or guidelines pooled it.

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  5. The effect of kinesiology tape on respiratory function in adults: A systematic review and meta-analysis.Canadian journal of respiratory therapy : CJRT = Revue canadienne de la therapie respiratoire : RCTR · 2026
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  11. Micronutrient status of patients with diabetic foot: A systematic review.Asia Pacific journal of clinical nutrition · 2025
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108 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

8 authors.

Lars JørgensenThe Nordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark. lj@cochrane.dk.
Asger S Paludan-MüllerThe Nordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark.
David R T LaursenThe Nordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Jelena SavovićSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Isabelle BoutronMethods of Therapeutic Evaluation of Chronic Diseases Team, Epidemiology and Biostatistics, Sorbonne Paris Cité Research Centre, L'Institut National de la Santé et de la Recherche Médicale, Unite Mixte de Recherche 1153, Paris, France.
Jonathan A C SterneSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Julian P T HigginsSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Asbjørn HróbjartssonThe Nordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Funding

Medical Research Council G0701659Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

backgroundThe Cochrane risk of bias tool for randomized clinical trials was introduced in 2008 and has frequently been commented on and used in systematic reviews. We wanted to evaluate the tool by reviewing published comments on its strengths and challenges and by describing and analysing how the tool is applied to both Cochrane and non-Cochrane systematic reviews.

methodsA review of published comments (searches in PubMed, The Cochrane Methodology Register and Google Scholar) and an observational study (100 Cochrane and 100 non-Cochrane reviews from 2014).

resultsOur review included 68 comments, 15 of which were categorised as major. The main strengths of the tool were considered to be its aim (to assess trial conduct and not reporting), its developmental basis (wide consultation, empirical and theoretical evidence) and its transparent procedures. The challenges of the tool were mainly considered to be its choice of core bias domains (e.g. not involving funding/conflicts of interest) and issues to do with implementation (i.e. modest inter-rater agreement) and terminology. Our observational study found that the tool was used in all Cochrane reviews (100/100) and was the preferred tool in non-Cochrane reviews (31/100). Both types of reviews frequently implemented the tool in non-recommended ways. Most Cochrane reviews planned to use risk of bias assessments as basis for sensitivity analyses (70 %), but only a minority conducted such analyses (19 %) because, in many cases, few trials were assessed as having "low" risk of bias for all standard domains (6 %). The judgement of at least one risk of bias domain as "unclear" was found in 89 % of included randomized clinical trials (1103/1242).

conclusionsThe Cochrane tool has become the standard approach to assess risk of bias in randomized clinical trials but is frequently implemented in a non-recommended way. Based on published comments and how it is applied in practice in systematic reviews, the tool may be further improved by a revised structure and more focused guidance.

Indexed as

BiasRandomized Controlled Trials as TopicRisk AssessmentHumansSystematic Reviews as TopicBiasCochraneCommentRandomized clinical trialSystematic reviewToolUser practice

Identifiers

PMID27160280
PMCPMC4862216

What OpenQuestion holds

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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.