Evidence map›Paper›PMID 26387520›Full record

ArticleBMJ (Clinical research ed.)2015

Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study.

Graham D Cole, Alexandra N Nowbar, Michael Mielewczik, Matthew J Shun-Shin, Darrel P Francis

Erratum issuedAbstract read
In one paragraph

Article in BMJ (Clinical research ed.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Graham D ColeInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London W2 1LA, UK g.cole@imperial.ac.uk.
Alexandra N NowbarInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London W2 1LA, UK.
Michael MielewczikInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London W2 1LA, UK.
Matthew J Shun-ShinInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London W2 1LA, UK.
Darrel P FrancisInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London W2 1LA, UK.

Funding

British Heart Foundation FS/10/038British Heart Foundation FS/10/38/28268British Heart Foundation FS/12/12/29294British Heart Foundation FS/14/27/30752
6 · The paper itself

Abstract

objectivesTo compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal.

designBlinded case-control study.

settingJournals in PubMed. POPULATION: 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis.

main outcome measureTotal number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report.

resultsOf 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); P<0.001). Papers with a discrepancy were significantly more likely to be retracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); P<0.001). In particular, three types of discrepancy arose significantly more frequently in retracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result.

conclusionsDiscrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist skill in the field, identify significantly more discrepancies in retracted than unretracted reports of clinical trials. Discrepancies could be an early and accessible signal of unreliability in clinical trial reports.

Indexed as

Journal Impact FactorPublication BiasCase-Control StudiesHumansOdds RatioPubMedRetrospective StudiesScientific Misconduct

Identifiers

PMID26387520
PMCPMC4575810

What OpenQuestion holds

Textmetadata
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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.