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: Unrestricted access
Access Instructions: Available to download from the Zenodo site
Associated Publications: Spence O'M, Hong K, Onwuchekwa Uba R, Doshi P. (2019). Availability of Study Protocols for Randomized Trials as Published in High-Impact Medical Journals: A Cross-Sectional Analysis. Clinical Trials. https://doi.org/10.1177/1740774519868310
Data Type: Statistical
Software Used: Microsoft Word
Word processing software

SAS
Analytics software
Study Type: Observational
Dataset Format(s): Microsoft Word, SAS
Dataset Size: 416.8 KB

UMB Data Catalog

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