Advances in Sequential Multiple Assignment Randomized Trial Methodology and Considerations for Its Application in Traditional Chinese Medicine
- VernacularTitle:序列多重分配随机试验方法学进展及其在中医学领域应用的思考
- Author:
Wenxin MA
1
;
Xuehui WANG
;
Yuyi WANG
;
Yuan SUN
;
Yike SONG
;
Zhijun BU
;
Zeyang SHI
;
Jianping LIU
;
Zhaolan LIU
Author Information
- Publication Type:Journal Article
- Keywords: Sequential multiple assignment randomized trial; Adaptive interventions; Traditional Chinese medicine clinical research; Dynamic treatment regimens; Methodological progress
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1530-1539
- CountryChina
- Language:Chinese
- Abstract: Traditional Chinese Medicine(TCM)emphasizes syndrome differentiation and treatment,characterized by"maintaining the prescription if effective"and"changing the prescription if ineffective".Traditional randomized controlled trials(RCTs)are inadequate for evaluating the efficacy of dynamic treatment adjustments.The Sequential Multiple Assignment Randomized Trial(SMART)is an emerging adaptive research design that incorporates randomization at multiple stages,allowing for adjustments in subsequent interventions based on treatment responses.This approach is suitable for evaluating dynamic treatment regimens while retaining the low bias risk of traditional RCTs,making it highly promising for clinical research in TCM.This paper summarizes recent methodological advancements in SMART design,including different sample size estimation and statistical analysis methods for primary effect objectives,embedded adaptive intervention objectives,and optimization objectives,along with providing corresponding operational software.Additionally,it offers considerations for applying SMART design in TCM research,such as the selection of disease types,interventions,decision points,tailoring variables,sample size calculation,statistical methods,the importance of pilot trials,ethical considerations,and limitations.The aim is to promote the exploration and practice of this method in the field of TCM,thereby contributing to the generation of high-quality evidence-based evidence for TCM.
