Aiming at the problems of uneven reporting quality and lack of unified standards in SMART in the context of personalized medicine, this paper analyzes the application and reporting status of SMART, and summarizes the key problems of current research reporting. These include unclear description of core design elements, missing information on randomization and blinding, insufficient reporting of phase transition rules, opaque sample size estimation and multiple comparisons, and lack of detailed description of data processing procedures. Based on the CONSORT standard, this paper proposed to expand the reporting specifications for SMART design methodology. By adding and elaborating items, the standardized description of multi-stage randomization process, decision nodes, embedded dynamic treatment regimes comparison framework and dedicated flow chart are emphasized to enhance the transparency, reproducibility and reliability of the results of SMART study. This study aims to provide structured and standardized reporting recommendations for SMART trials, and promote the output of high-quality evidence and clinical transformation of dynamic treatment strategies.
Citation： PAN Zhiyu, SUN Xin, LIU Jianping, TANG Jianyuan, ZHANG Junhua, GAO Rui, JING Zhiwei. Recommendations for reporting sequential multiple assignment randomized trials. Chinese Journal of Evidence-Based Medicine, 2026, 26(5): 553-558. doi: 10.7507/1672-2531.202510105 Copy
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