Abstract
BackgroundFor 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.MethodsWe 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.ResultsThe 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.ConclusionNon-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.
Highlights
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
Additional findings from a randomized trial are frequently reported in subsequent publications. We refer to these types of publication as non-primary publications and might include pre-specified or exploratory subgroup analyses, perhaps analyzing only a specific subgroup of patients from the randomized trial, secondary outcomes, health economic analyses, or the patient outcomes after an extended period of follow-up [1,3]
After screening the titles and abstracts of all retrieved citations, we reviewed 591 full text articles resulting in 85 reports of non-primary publications; 16 were excluded as they did not include a comparison group
Summary
The primary publication is usually the one which reports the results of the primary outcome and provides consolidated data from all study centers. Additional findings from a randomized trial (that is, non-primary results) are frequently reported in subsequent publications We refer to these types of publication as non-primary publications and might include pre-specified or exploratory subgroup analyses, perhaps analyzing only a specific subgroup of patients from the randomized trial, secondary outcomes, health economic analyses, or the patient outcomes after an extended period of follow-up [1,3]. Such publications are sometimes referred to as secondary publications; this term can be misleading as it can be used to refer to summaries of existing studies or publications in other languages [4]. We compared the trial information reported in non-primary publication with that reported in the full text of the corresponding primary publication
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
