"以证统病"随机对照试验研究设计、评价与报告方法学问题探讨OA

This study explores methodological issues in the design,evaluation,and reporting of randomized controlled trials(RCTs)under the concept of"syndrome dominating disease".The discussion focuses on key aspects including the adaptability of trial design,the screening of research participants,the standardization of syndrome differ-entiation,the balance between intervention individualization and standardization,the integration of multi-dimensional outcome measures,and the limitations of existing evaluation and reporting tools when applied to this type of research,along with corresponding recommendations and future perspectives.Regarding research design,it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs,in order to innovate the design format of RCTs.Meanwhile,criteria for participant screening,TCM syndrome differentiation,and disease classification should be standardized.The balance should be appropriately achieved between intervention individualization and standardization,and a multidimensional assessment system encom-passing TCM syndromes,disease-specific outcomes,and patient-reported outcomes should be established.For risk of bias assessment and research reporting,it is recommended,to develop specialized assessment and reporting tools based on existing instruments,in order to standardize the assessment and reporting of study findings.Future research may further explore the potential applications of artificial intelligence in the study design,risk-of-bias assessment,and reporting quality assessment of RCTs based on the"syndrome dominating disease"model,with a particular focus on methodological optimization,data integration,and enhancement of research quality.