Evidence map›Paper›PMID 34437948›Full record

SynthesisJournal of clinical epidemiology2021

Cochrane's risk of bias tool for non-randomized studies (ROBINS-I) is frequently misapplied: A methodological systematic review.

Erik Igelström, Mhairi Campbell, Peter Craig, Srinivasa Vittal Katikireddi

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of clinical epidemiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 107 papers, 39 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 39 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

107 citing papers in PubMed, 39 syntheses or guidelines pooled it.

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  16. Biological Consequences and Assessment Methods Analysis of Fixed Orthodontic Appliances on Oral Epithelial Cells: A Systematic Review.Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology · 2025
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47 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

4 authors.

Erik IgelströmMRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Berkeley Square 99 Berkeley Street, Glasgow, G3 7HR. Electronic address: e.igelstrom.1@research.gla.ac.uk.
Mhairi CampbellMRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Berkeley Square 99 Berkeley Street, Glasgow, G3 7HR.
Peter CraigMRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Berkeley Square 99 Berkeley Street, Glasgow, G3 7HR.
Srinivasa Vittal KatikireddiMRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Berkeley Square 99 Berkeley Street, Glasgow, G3 7HR.

Funding

Chief Scientist Office SCAF/15/02Chief Scientist Office SPHSU17Medical Research Council MC_UU_00022/2
6 · The paper itself

Abstract

objectivesWe aimed to review how 'Risk of Bias In Non-randomized Studies-of Interventions' (ROBINS-I), a Cochrane risk of bias assessment tool, has been used in recent systematic reviews. STUDY DESIGN AND

settingDatabase and citation searches were conducted in March 2020 to identify recently published reviews using ROBINS-I. Reported ROBINS-I assessments and data on how ROBINS-I was used were extracted from each review. Methodological quality of reviews was assessed using AMSTAR 2 ('A MeaSurement Tool to Assess systematic Reviews').

resultsOf 181 hits, 124 reviews were included. Risk of bias was serious/critical in 54% of assessments on average, most commonly due to confounding. Quality of reviews was mostly low, and modifications and incorrect use of ROBINS-I were common, with 20% reviews modifying the rating scale, 20% understating overall risk of bias, and 19% including critical-risk of bias studies in evidence synthesis. Poorly conducted reviews were more likely to report low/moderate risk of bias (predicted probability 57% [95% CI: 47-67] in critically low-quality reviews, 31% [19-46] in high/moderate-quality reviews).

conclusionLow-quality reviews frequently apply ROBINS-I incorrectly, and may thus inappropriately include or give too much weight to uncertain evidence. Readers should be aware that such problems can lead to incorrect conclusions in reviews.

Indexed as

BiasNon-Randomized Controlled Trials as TopicSystematic Reviews as TopicHumansRisk FactorsCochraneNon-randomized studiesObservational studiesRisk of biasSystematic review methods

Identifiers

PMID34437948
PMCPMC8809341

What OpenQuestion holds

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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.