Evidence map›Paper›PMID 32184303›Full record

ArticleBMJ open2020

Outcome reporting bias in Cochrane systematic reviews: a cross-sectional analysis.

Kieran Shah, Gregory Egan, Lawrence Nichoe Huan, Jamie Kirkham, Emma Reid, Aaron M Tejani

Abstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Review
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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

6 authors.

Kieran ShahPharmacy, University of British Columbia, Vancouver, British Columbia, Canada Kieran.Shah@fraserhealth.ca.
Gregory EganLower Mainland Pharmacy Services, Vancouver General Hospital, Vancouver, British Columbia, Canada.
Lawrence Nichoe HuanLower Mainland Pharmacy Services, Vancouver General Hospital, Vancouver, British Columbia, Canada.
Jamie KirkhamDepartment of Biostatistics, University of Liverpool, Liverpool, UK.
Emma ReidPharmacy, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.
Aaron M TejaniTherapeutics Initiative, University of British Columbia, Vancouver, British Columbia, Canada.ORCID 0000-0001-5496-1470

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiscrepancies in outcome reporting (DOR) between protocol and published studies include inclusions of new outcomes, omission of prespecified outcomes, upgrade and downgrade of secondary and primary outcomes, and changes in definitions of prespecified outcomes. DOR can result in outcome reporting bias (ORB) when changes in outcomes occur after knowledge of results. This has potential to overestimate treatment effects and underestimate harms. This can also occur at the level of systematic reviews when changes in outcomes occur after knowledge of results of included studies. The prevalence of DOR and ORB in systematic reviews is unknown in systematic reviews published post-2007.

objectiveTo estimate the prevalence of DOR and risk of ORB in all Cochrane reviews between the years 2007 and 2014.

methodsA stratified random sampling approach was applied to collect a representative sample of Cochrane systematic reviews from each Cochrane review group. DOR was assessed by matching outcomes in each systematic review with their respective protocol. When DOR occurred, reviews were further assessed if there was a risk of ORB (unclear, low or high risk). We classified DOR as a high risk for ORB if the discrepancy occurred after knowledge of results in the systematic review.

results150 of 350 (43%) review and protocol pairings contained DOR. When reviews were further scrutinised, 23% (35 of 150) of reviews with DOR contained a high risk of ORB, with changes being made after knowledge of results from individual trials.

conclusionsIn our study, we identified just under a half of Cochrane reviews with at least one DOR. Of these, a fifth were at high risk of ORB. The presence of DOR and ORB in Cochrane reviews is of great concern; however, a solution is relatively simple. Authors are encouraged to be transparent where outcomes change and to describe the legitimacy of changing outcomes in order to prevent suspicion of bias.

Indexed as

BiasClinical Trials as TopicCross-Sectional StudiesHumansResearch DesignSystematic Reviews as Topicclinical trialsgeneral medicine (see internal medicine)statistics & research methods

Identifiers

PMID32184303
PMCPMC7076244

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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.