Complete and transparent reporting of primary end points of randomized trials in the dermatology literature: A comparison of registered and published primary end points - 12/10/21
Abstract |
Background |
Appropriate primary end points in randomized controlled trials (RCTs) improve the quality of the measurement and enable comparison of the findings with those of other trials.
Objective |
To assess the quality of reporting primary end points in RCTs recently published in dermatology journals.
Methods |
We identified 134 primary reports of RCTs among original articles in 4 dermatology journals published from January 2016 to December 2018. Details were extracted from articles, supplements, and trial registries. A multivariable logistic regression analysis was conducted to identify factors associated with adequate primary end point reporting.
Results |
Adequate primary end point reporting was conducted in 76 of 134 RCTs (56.7%). Nine missed the definition of primary end points, and 13 did not define the timing of primary end points in the publications. Among 113 RCTs reporting primary end points explicitly in the articles, 16 showed discrepancies between registration and publication, and 21 were not able to valuate prespecification of primary end points. Multicenter studies and sponsor-initiated trials were significantly associated with adequate reporting quality after adjusting for covariates.
Limitations |
Prespecification was evaluated based on a comparison of the article and registry.
Conclusions |
The quality of primary end point reporting, particularly in prespecification, has remained unsatisfactory in the recent dermatology literature.
Le texte complet de cet article est disponible en PDF.Key words : clinical trial, dermatology, guideline adherence, outcome assessment (health care), quality improvement, randomized controlled trial, research design
Abbreviations used : BJD, CONSORT, FDA, JAAD, JAMA Dermatol, JID, RCT, SIT
Plan
| Funding sources: This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF), funded by the Ministry of Science, ICT & Future Planning (NRF-2015R1C1A2A01053109). |
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| Conflicts of interest: None disclosed. |
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| IRB approval status: Not applicable. |
Vol 85 - N° 5
P. 1201-1208 - novembre 2021 Retour au numéro
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