Evidence map›Paper›PMID 29126260›Full record

ArticleAmerican journal of epidemiology2018

Association Between Risk-of-Bias Assessments and Results of Randomized Trials in Cochrane Reviews: The ROBES Meta-Epidemiologic Study.

Jelena Savovic, Rebecca M Turner, David Mawdsley, Hayley E Jones, Rebecca Beynon, Julian P T Higgins, Jonathan A C Sterne

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in American journal of epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 190 papers, 108 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
190citing papers in PubMed, 108 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

190 citing papers in PubMed, 108 syntheses or guidelines pooled it.

  1. Albumin for people with liver cirrhosis and bacterial infections.The Cochrane database of systematic reviews · 2026
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  3. Liver support systems for adults with acute liver failure.The Cochrane database of systematic reviews · 2026
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  19. Tamoxifen for adults with hepatocellular carcinoma.The Cochrane database of systematic reviews · 2024
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130 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 SavovicPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Rebecca M TurnerMedical Research Council.
David MawdsleyPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Hayley E JonesPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Rebecca BeynonPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Julian P T HigginsPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Jonathan A C SternePopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.

Funding

Medical Research Council G0701659Medical Research Council MC_EX_MR/K014587/1Medical Research Council MC_EX_UU_G0800814Medical Research Council MC_U105260558Medical Research Council MC_UU_12023/21Medical Research Council MC_UU_12023/24Medical Research Council MR/K025643/1Medical Research Council MR/M014533/1Medical Research Council MR/M025209/1
6 · The paper itself

Abstract

Flaws in the design of randomized trials may bias intervention effect estimates and increase between-trial heterogeneity. Empirical evidence suggests that these problems are greatest for subjectively assessed outcomes. For the Risk of Bias in Evidence Synthesis (ROBES) Study, we extracted risk-of-bias judgements (for sequence generation, allocation concealment, blinding, and incomplete data) from a large collection of meta-analyses published in the Cochrane Library (issue 4; April 2011). We categorized outcome measures as mortality, other objective outcome, or subjective outcome, and we estimated associations of bias judgements with intervention effect estimates using Bayesian hierarchical models. Among 2,443 randomized trials in 228 meta-analyses, intervention effect estimates were, on average, exaggerated in trials with high or unclear (versus low) risk-of-bias judgements for sequence generation (ratio of odds ratios (ROR) = 0.91, 95% credible interval (CrI): 0.86, 0.98), allocation concealment (ROR = 0.92, 95% CrI: 0.86, 0.98), and blinding (ROR = 0.87, 95% CrI: 0.80, 0.93). In contrast to previous work, we did not observe consistently different bias for subjective outcomes compared with mortality. However, we found an increase in between-trial heterogeneity associated with lack of blinding in meta-analyses with subjective outcomes. Inconsistency in criteria for risk-of-bias judgements applied by individual reviewers is a likely limitation of routinely collected bias assessments. Inadequate randomization and lack of blinding may lead to exaggeration of intervention effect estimates in randomized trials.

Indexed as

BiasBayes TheoremEpidemiologic StudiesHumansMeta-Analysis as TopicOdds RatioOutcome Assessment, Health CareRandomized Controlled Trials as Topic

Identifiers

PMID29126260
PMCPMC5928453

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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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.