Evidence map›Paper›PMID 31501094›Full record

ArticleBMJ open2019

Reporting and interpretation of results from clinical trials that did not claim a treatment difference: survey of four general medical journals.

Simon Gates, Elizabeth Ealing

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 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–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

15 citing papers in PubMed.

  1. Trial
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  11. One Year of the COVID-19 Pandemic in Galicia: A Global View of Age-Group Statistics during Three Waves.International journal of environmental research and public health · 2021
    Article
  12. Biostatistics: essential concepts for the clinician.Dental press journal of orthodontics · 2021
    Article
  13. Article
  14. Article
  15. Review
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

2 authors.

Simon GatesCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK S.Gates@bham.ac.uk.
Elizabeth EalingWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.

Funding

Cancer Research UK 15958Cancer Research UK 25354
6 · The paper itself

Abstract

objectivesTo describe and summarise how the results of randomised controlled trials (RCTs) that did not find a significant treatment effect are reported, and to estimate how commonly trial reports make unwarranted claims.

designWe performed a retrospective survey of published RCTs, published in four high impact factor general medical journals between June 2016 and June 2017.

settingTrials conducted in all settings were included.

participants94 reports of RCTs that did not find a difference in their main comparison or comparisons were included.

interventionsAll interventions. PRIMARY AND SECONDARY OUTCOMES: We recorded the way the results of each trial for its primary outcome or outcomes were described in Results and Conclusions sections of the Abstract, using a 10-category classification. Other outcomes were whether confidence intervals (CIs) and p values were presented for the main treatment comparisons, and whether the results and conclusions referred to measures of uncertainty. We estimated the proportion of papers that made claims that were not justified by the results, or were open to multiple interpretations.

results94 trial reports (120 treatment comparisons) were included. In Results sections, for 58/120 comparisons (48.3%) the results of the study were re-stated, without interpretation, and 38/120 (31.7%) stated that there was no statistically significant difference. In Conclusions, 65/120 treatment comparisons (54.2%) stated that there was no treatment benefit, 14/120 (11.7%) that there was no significant benefit and 16/120 (13.3%) that there was no significant difference. CIs and p values were both presented by 84% of studies (79/94), but only 3/94 studies referred to uncertainty when drawing conclusions.

conclusionsThe majority of trials (54.2%) inappropriately interpreted a result that was not statistically significant as indicating no treatment benefit. Very few studies interpreted the result as indicating a lack of evidence against the null hypothesis of zero difference between the trial arms.

Indexed as

Evidence-Based MedicineHumansOutcome Assessment, Health CarePeriodicals as TopicRandomized Controlled Trials as TopicResearch DesignRetrospective StudiesSelection Biasclinical trialsreportingstatistics & research methods

Identifiers

PMID31501094
PMCPMC6738699

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.