Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review
| Autor: | Sally Hopewell, Douglas G. Altman, Abdelouahid Tajar, Stephen Gerry, Gary S. Collins, Allison Hirst, Shona Kirtley |
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| Přispěvatelé: | BMC, Ed., Centre for Statistics in Medicine, University of Oxford, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), This study was carried out as part of a larger study funded by a grant from the UK Medical Research Council., University of Oxford [Oxford], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7) |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Research design
medicine.medical_specialty Cross-sectional study Secondary outcomes Trial protocol Specialty Medicine (miscellaneous) 030204 cardiovascular system & hematology law.invention Access to Information 03 medical and health sciences 0302 clinical medicine Primary outcome Randomized controlled trial law Internal medicine Medicine Humans Multicenter Studies as Topic Pharmacology (medical) 030212 general & internal medicine Trial registration Randomized Controlled Trials as Topic business.industry Information Dissemination Research Reproducibility of Results 3. Good health Access to information Cross-Sectional Studies [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie Subgroup analyses Bibliometrics Research Design Family medicine [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie Periodicals as Topic business Non-primary publication |
| Zdroj: | Trials Trials, 2013, 14 (1), pp.240. ⟨10.1186/1745-6215-14-240⟩ Trials, BioMed Central, 2013, 14 (1), pp.240. ⟨10.1186/1745-6215-14-240⟩ |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/1745-6215-14-240⟩ |
| Popis: | International audience; 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. |
| Databáze: | OpenAIRE |
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