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find Author "LI Hongyi" 1 results
  • Evaluation method of "syndrome differentiation" of TCM based on adaptive interventions and sequential multiple assignment randomized trial

    The modern clinical research evaluation system has been increasingly emphasizing the evaluation of individual patients' clinical characteristics, diagnosis and treatment plans, and complex intervention measures. Traditional randomized controlled trial evaluated fixed interventions and non-adaptive treatment plans, which cannot meet the needs of evaluating adaptive interventions. This made researchers more inclined to explore an individualized and adaptive clinical trial design, then sequential multiple assignment randomized trial (SMART) emerged as the time needed. This article introduces the principles, key elements, and implementation points of SMART design, further explores the limitations of the mismatch between traditional Chinese medicine clinical trial design and syndrome differentiation treatment, and proposes that SMART design can meet the needs of traditional Chinese medicine clinical trials to inspire researchers in designing their plans.

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