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Availability of Study Protocols for Randomized Trials Published in High-Impact Medical Journals: A Cross-Sectional Analysis
UMB Dataset

UID: 93

Author(s): Peter Doshi*, O'Mareen Spence, Kyungwan Hong, Richie Onwuchekwa Uba * Corresponding Author
Description
To improve reporting transparency and research integrity, some journals have begun publishing study protocols and statistical analysis plans alongside trial publications. To determine the overall availability and characteristics of protocols and statistical analysis plans this study reviewed all randomized clinical trials (RCT) published in 2016 in the following 5 general medicine journals: Annals of Internal Medicine, BMJ, JAMA, Lancet, and NEJM. Characteristics of RCTs were extracted from the publication and clinical trial registry. A detailed assessment of protocols and statistical analysis plans was conducted in a 20% random sample of trials. Dataset contains extraction sheets (as SAS data files), code to calculate the values in the tables in the manuscript, and a supplemental file with additional notes on methods used in the study.
Subject Domain
Keywords
Access via Zenodo

Extraction sheets, code to calculate values, and supplemental file with additional notes on methods used in the study

Access Restrictions
Free to All
Access Instructions
Available to download from the Zenodo site
Associated Publications
Data Type
Software Used
Microsoft Word
SAS
Study Type
Observational
Dataset Format(s)
Microsoft Word, SAS
Dataset Size
416.8 KB