BACKGROUND Secondary analysis of data from completed randomized controlled trials is a critical and efficient way to maximize the potential benefits from past research. De-identified primary data from completed randomized controlled trials have been increasingly available in recent years; however, the lack of standardized data products is a major barrier to further use of these valuable data. Pre-statistical harmonization of data structure, variables, and codebooks across randomized controlled trials would facilitate secondary data analysis, including meta-analyses and comparative effectiveness studies. We describe a pre-statistical data harmonization initiative to standardize de-identified primary data from substance use disorder treatment randomized controlled trials funded by the National Institute on Drug Abuse available on the National Institute on Drug Abuse Data Share website. METHODS Standardized datasets and codebooks with consistent data structures, variable names, labels, and definitions were developed for 36 completed randomized controlled trials. Common data domains were identified to bundle data files from individual randomized controlled trials according to relevant concepts. Variables were harmonized if at least two randomized controlled trials used the same instruments. The structures of the harmonized data were determined based on the feedback from clinical trialists and substance use disorder research experts. RESULTS We have created a harmonized database of variables across 36 randomized controlled trials with a build-in label and a brief definition for each variable. Data files from the randomized controlled trials have been consistently categorized into eight domains (enrollment, demographics, adherence, adverse events, physical health measures, mental-behavioral-cognitive health measures, self-reported substance use measures, and biologic substance use measures). Standardized codebooks and concordance tables have also been developed to help identify instruments and variables of interest more easily. CONCLUSION The harmonized data of randomized controlled trials of substance use disorder treatments can potentially promote future secondary data analysis of completed randomized controlled trials, allowing combining data from multiple randomized controlled trials and provide guidance for future randomized controlled trials in substance use disorder treatment research.

中文翻译：

---

物质使用障碍治疗研究中的数据管理：国家药物滥用研究所资助的随机对照试验数据协调的影响

背景 对已完成的随机对照试验的数据进行二次分析是从过去的研究中最大限度地发挥潜在益处的关键且有效的方法。近年来，来自已完成随机对照试验的去标识化原始数据越来越多；然而，标准化数据产品的缺乏是进一步利用这些有价值数据的主要障碍。随机对照试验中数据结构、变量和密码本的预统计协调将促进二级数据分析，包括荟萃分析和比较有效性研究。我们描述了一项统计前数据协调计划，以标准化来自国家药物滥用研究所资助的物质使用障碍治疗随机对照试验的去标识化原始数据，可在国家药物滥用研究所数据共享网站上找到。方法 为 36 项已完成的随机对照试验开发了具有一致数据结构、变量名称、标签和定义的标准化数据集和密码本。根据相关概念，确定了公共数据域以捆绑来自各个随机对照试验的数据文件。如果至少两个随机对照试验使用相同的工具，则变量被协调。协调数据的结构是根据临床试验人员和物质使用障碍研究专家的反馈确定的。结果 我们在 36 项随机对照试验中创建了一个统一的变量数据库，其中包含一个内置标签和每个变量的简要定义。来自随机对照试验的数据文件一直被分为八个领域（注册、人口统计、依从性、不良事件、身体健康测量、心理行为认知健康测量、自我报告的物质使用测量和生物物质使用测量）。还开发了标准化的码本和索引表，以帮助更轻松地识别感兴趣的工具和变量。结论 物质使用障碍治疗随机对照试验的统一数据有可能促进未来已完成随机对照试验的二次数据分析，