Data associated with: Study to Understand Fall Reduction and Vitamin D in You (STURDY) randomized clinical trial

This is the limited access database for the Study to Understand Fall Reduction and Vitamin D in You (STURDY) randomized response-adaptive clinical trial. The database includes baseline, treatment and post randomization data. This Database includes a set of files pertaining to the full study population (688 randomized participants plus screenees who were not randomized) and a set of files pertaining to the burn-in cohort (the 406 participants randomized prior to the first adjustment of the randomization probabilities). The Database also includes files that support the analyses included in the primary outcome paper published by the Annals of Internal Medicine (2021;174:(2):145-156). Each data file in the Database corresponds to a specific data collection form or type of data. This documentation notebook includes a SAS PROC CONTENTS listing for each SAS file and a copy of the relevant form if applicable. Each variable on each SAS data file has an associated SAS label. Several STURDY documents, including the final versions of the screening and trial consent statements, the Protocol, and the Manual of Procedures, are included with this documentation notebook to assist with understanding and navigation of STURDY data. Notes on analysis questions and issues are also included, as is a list of STURDY publications.

本数据集为「了解跌倒预防与维生素D应用研究（Study to Understand Fall Reduction and Vitamin D in You, STURDY）」的响应自适应随机对照临床试验受限访问数据库。该数据集包含基线数据、干预数据及随机化后数据。本数据集包含两类文件：一类对应全研究人群（共688名随机化受试者，加上未被随机化的筛查受试者），另一类对应预热队列（即首次调整随机概率前完成随机化的406名受试者）。本数据集还包含支撑《内科学年鉴》（Annals of Internal Medicine，2021；174(2)：145-156）发表的主要结局论文中所涉分析的文件。数据集内的每个数据文件均对应特定的数据采集表单或数据类型。本说明手册包含每个SAS数据文件的SAS PROC CONTENTS列表，若适用则附带相关表单的副本。每个SAS数据文件中的每个变量均配有对应的SAS标签。本说明手册还收录了多项STURDY相关文件，包括筛查与试验知情同意书的最终版本、试验方案以及操作手册，以辅助用户理解并浏览STURDY数据集。本手册还收录了分析相关问题与注意事项的说明，以及STURDY研究已发表论文列表。