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

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.
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https://www.hal.inserm.fr/inserm-00857184
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Submitted on : Tuesday, September 3, 2013 - 6:06:24 AM
Last modification on : Thursday, May 14, 2020 - 2:48:10 PM
Long-term archiving on: : Wednesday, December 4, 2013 - 4:17:44 AM

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Sally Hopewell, Gary Collins, Allison Hirst, Shona Kirtley, Abdelouahid Tajar, et al.. Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review.. Trials, BioMed Central, 2013, 14 (1), pp.240. ⟨10.1186/1745-6215-14-240⟩. ⟨inserm-00857184⟩

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