Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, United States.
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, United States.
Curr Opin Psychol. 2019 Dec;30:35-41. doi: 10.1016/j.copsyc.2019.01.009. Epub 2019 Jan 28.
Treatment development and evaluation for substance use disorders are hindered when randomized controlled trials fail to show a treatment effect when one exists. This manuscript provides an overview of addressable methodological factors that may contribute to incorrect trial results. The collection of remote, naturalistic, real-time adherence and substance use data through ambulatory assessment methods in everyday life is presented as a partial solution. Other recommendations related to participant recruitment and selection, ensuring adequate consistency/fidelity and dose of treatment, and rigorously assessing clinical outcomes are discussed. With implementation of eligibility criteria verification, treatment adherence monitoring, and remote assessment of substance use and biomarkers, ambulatory assessment may help improve clinical trial success rates by improving precision, increasing reproducibility, and reducing the impact of methodological issues that may lead to inaccurate trial results.
当随机对照试验未能显示出治疗效果（即使存在效果）时，物质使用障碍的治疗开发和评估会受到阻碍。本文概述了可能导致试验结果不正确的可解决的方法学因素。通过日常生活中的动态评估方法收集远程、自然主义、实时的依从性和物质使用数据，被提出作为部分解决方案。还讨论了与参与者招募和选择、确保足够的一致性/保真度和治疗剂量以及严格评估临床结果相关的其他建议。通过实施资格标准验证、治疗依从性监测以及物质使用和生物标志物的远程评估，动态评估可以通过提高精度、增加可重复性和减少可能导致不准确试验结果的方法学问题的影响，帮助提高临床试验成功率。
