Evidence map›Paper›PMID 30940766›Full record

ArticleBMJ open2019

Disagreements in risk of bias assessment for randomised controlled trials included in more than one Cochrane systematic reviews: a research on research study using cross-sectional design.

Lorenzo Bertizzolo, Patrick Bossuyt, Ignacio Atal, Philippe Ravaud, Agnes Dechartres

Abstract read
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 7 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

13 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. The effectiveness of personalised surveillance and aftercare in breast cancer follow-up: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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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

5 authors.

Lorenzo BertizzoloU1153, Epidemiology and Biostatistics Sorbonne Paris Cite Research Center (CRESS), Methods of therapeutic evaluation of chronic diseases team (METHODS), INSERM, Paris, Île-de-France, France.ORCID 0000-0002-1666-2450
Patrick BossuytDepartmentof Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Ignacio AtalU1153, Epidemiology and Biostatistics Sorbonne Paris Cite Research Center (CRESS), Methods of therapeutic evaluation of chronic diseases team (METHODS), INSERM, Paris, Île-de-France, France.
Philippe RavaudU1153, Epidemiology and Biostatistics Sorbonne Paris Cite Research Center (CRESS), Methods of therapeutic evaluation of chronic diseases team (METHODS), INSERM, Paris, Île-de-France, France.
Agnes DechartresSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, Département Biostatistique Santé Publique et Information Médicale, F75013, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesAssess the frequency and reasons for disagreements in risk of bias assessments for randomised controlled trials (RCTs) included in more than one Cochrane review.

designResearch on research study, using cross-sectional design. DATA SOURCES: 2796 Cochrane reviews published between March 2011 and September 2014. DATA SELECTION: RCTs included in more than one review. DATA EXTRACTION: Risk of bias assessment and support for judgement for five key risk of bias items. DATA SYNTHESIS: For each item, we compared risk of bias assessment made in each review and calculated proportion of agreement. Two reviewers independently analysed 50% of all disagreements by comparing support for each judgement with information from study report to evaluate whether disagreements were related to a difference in information (eg, contact the study author) or a difference in interpretation (same support for judgement but different interpretation). They also identified main reasons for different interpretation.

results1604 RCTs were included in more than one review. Proportion of agreement ranged from 57% (770/1348 trials) for incomplete outcome data to 81% for random sequence generation (1193/1466). Most common source of disagreement was difference in interpretation of the same information, ranging from 65% (88/136) for random sequence generation to 90% (56/62) for blinding of participants and personnel. Access to different information explained 32/136 (24%) disagreements for random sequence generation and 38/205 (19%) for allocation concealment. Disagreements related to difference in interpretation were frequently related to incomplete or unclear reporting in the study report (83% of disagreements related to different interpretation for random sequence generation).

conclusionsRisk of bias judgements of RCTs included in more than one Cochrane review differed substantially. Most disagreements were related to a difference in interpretation of an incomplete or unclear description in the study report. A clearer guidance on common causes of incomplete information may improve agreement.

Indexed as

BiasSystematic Reviews as TopicCross-Sectional StudiesHumansRandomized Controlled Trials as Topiccochraneinterrater agreementpublic healthreproducibilityrisk of biassystematic reviews

Identifiers

PMID30940766
PMCPMC6500379

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.