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Open Access Research

Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review

Sally Hopewell12*, Gary S Collins1, Allison Hirst1, Shona Kirtley1, Abdelouahid Tajar1, Stephen Gerry1 and Douglas G Altman1

Author Affiliations

1 Centre for Statistics in Medicine, University of Oxford, Botnar Recpsearch Building, Windmill Road, Oxford, UK

2 INSERM U738 Paris, France; Centre d'Épidémiologie Clinique, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Paris, France

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Trials 2013, 14:240  doi:10.1186/1745-6215-14-240

Published: 31 July 2013

Abstract

Background

For a randomized trial, the primary publication is usually the one which reports the results of the primary outcome and provides consolidated data from all study centers. Other aspects of a randomized trial’s findings (that is, non-primary results) are often reported in subsequent publications.

Methods

We carried out a cross-sectional review of the characteristics and type of information reported in non-primary reports (n = 69) of randomized trials (indexed in PubMed core clinical journals in 2009) and whether they report pre-specified or exploratory analyses. We also compared consistency of information in non-primary publications with that reported in the primary publication.

Results

The majority (n = 56; 81%) of non-primary publications were large, multicenter trials, published in specialty journals. Most reported subgroup analyses (n = 27; 39%), analyzing a specific subgroup of patients from the randomized trial, or reported on secondary outcomes (n = 29; 42%); 19% (n = 13) reported extended follow-up. Less than half reported details of trial registration (n = 30; 43%) or the trial protocol (n = 27; 39%) and in 41% (n = 28) it was unclear from reading the abstract that the report was not the primary publication for the trial. Non-primary publications often analyzed and reported multiple different outcomes (16% reported >20 outcomes) and in 10% (n = 7) it was unclear how many outcomes had actually been assessed; in 42% (n = 29) it was unclear whether the analyses reported were pre-specified or exploratory. Only 39% (n = 27) of non-primary publications described the primary outcome of the randomized trial, 6% (n = 4) reported its numerical results and 9% (n = 6) details of how participants were randomized.

Conclusion

Non-primary publications often lack important information about the randomized trial and the type of analyses conducted and whether these were pre-specified or exploratory to enable readers to accurately identify and assess the validity and reliably of the study findings. We provide recommendations for what information authors should include in non-primary reports of randomized trials.

Keywords:
Randomized controlled trial; Non-primary publication; Subgroup analyses; Secondary outcomes