Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications
Trials ,
Nov 2013
Kerry Dwan , Paula R Williamson , Carrol Gamble , Julian Higgins , Jonathan Sterne , Douglas G Altman , Mike Clarke , Jamie J Kirkham
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Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications
Dwan et al. Trials
Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications
Kerry Dwan 2
Paula R Williamson 2
Carrol Gamble 2
Julian Higgins 1
Jonathan Sterne 1
Douglas G Altman 0
Mike Clarke 3
Jamie J Kirkham 2
0 The University of Oxford , Oxford , UK
1 The University of Bristol , Bristol , UK
2 The University of Liverpool , Liverpool , UK
3 Queen's University , Belfast , UK
-
From 2nd Clinical Trials Methodology Conference: Methodology Matters
Edinburgh, UK. 18-19 November 2013
Background
Many aspects of a trial may be incompletely reported,
including the outcomes collected and the full set of
analyses undertaken. Selective reporting bias occurs when
the inclusion of outcomes or analyses in the report is
based on the results. We review and summarise the
empirical evidence from studies that have assessed the
selective reporting of outcomes and analyses and
provide guidance to trialists to help reduce this problem.
Methods
Two systematic reviews of studies that have examined
randomised trials for i) evidence for publication bias or
selective reporting of outcomes and ii) evidence for
selective reporting of analyses. An international collaboration
of experts will be brought together in July to discuss the
available evidence alongside current reporting guidance
for trials. Recommendations are being produced with
regards to raising the awareness and safeguarding trial
publications against selective reporting.
Results
From twenty studies, of which four were newly
identified, the evidence in the first systematic review
demonstrated an association between statistically significant
results and publication. Statistically significant outcomes
had a higher odds of being fully reported compared to
non-significant outcomes (range of odds ratios: 2.2
to 4.7). A further seventeen studies consider aspects of
selective reporting such as statistical analyses; subgroup
analyses and composite outcomes.
1The University of Liverpool, Liverpool, UK
Full list of author information is available at the end of the article
Conclusions
This work highlights the evidence of selective reporting
and demonstrates the importance of pre-specifying
outcomes, analyses and reporting strategies during the
planning and design of a clinical trial, for the purposes
of minimising bias when findings are reported.
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Kerry Dwan, Paula R Williamson, Carrol Gamble, Julian Higgins, Jonathan Sterne, Douglas G Altman, Mike Clarke, Jamie J Kirkham.
Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications ,
Trials,
2013, pp. O91, 14,