Lee Ye-Seul, Lee Yoon Jae, Ha In-Hyuk
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Korea.
Integr Med Res. 2023 Dec;12(4):101000. doi: 10.1016/j.imr.2023.101000. Epub 2023 Oct 20.
Real world data (RWD) is increasingly used to investigate health outcomes and treatment efficacy in the field of integrative medicine. Due to the fact that the majority of RWDs are not intended for research, their secondary use in research necessitates complex study designs to account for bias and confounding. To conduct a robust analysis of RWD in integrative medicine, a comprehensive study design process that reflects the characteristics of integrative therapies is necessary. In this paper, we present a guide for designing comparative effectiveness RWE research in integrative medicine. We discuss key factors to consider when selecting RWDs for research on integrative medicine. We provide practical steps for developing a research question, formulating the PICOT objectives (population, intervention, comparator, outcome, and time horizon), and selecting and defining covariates with a summary table. Specific study designs are depicted with corresponding diagrams. Finally, data analysis procedures are introduced. We hope this article clarifies the importance of RWE research design and related processes in order to improve the rigor of RWD studies in the field of integrative medicine research.
真实世界数据（RWD）在整合医学领域越来越多地用于研究健康结局和治疗效果。由于大多数真实世界数据并非用于研究目的，因此在研究中对其进行二次利用需要复杂的研究设计来应对偏倚和混杂因素。为了对整合医学中的真实世界数据进行有力分析，需要一个反映整合疗法特点的全面研究设计过程。在本文中，我们提出了一个在整合医学中设计比较有效性真实世界证据（RWE）研究的指南。我们讨论了在选择用于整合医学研究的真实世界数据时需要考虑的关键因素。我们提供了制定研究问题、制定PICOT目标（人群、干预措施、对照、结局和时间范围）以及通过汇总表选择和定义协变量的实际步骤。具体的研究设计用相应的图表进行了描述。最后，介绍了数据分析程序。我们希望本文能够阐明真实世界证据研究设计及相关过程的重要性，以提高整合医学研究领域中真实世界数据研究的严谨性。
