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

Restrictions: Unrestricted access
Instructions: Available to download from the Zenodo site; Access via Zenodo
Extraction sheets, code to calculate values, and supplemental file with additional notes on methods used in the study

Associated Publications

Data Type

Software Used

Microsoft Word

SAS

Study Type

Observational

Dataset Format(s)

Microsoft Word, SAS

Dataset Size

416.8 KB

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