Current practices and methodological challenges in establishing objective performance criteria for single-arm trials in traditional Chinese medicine: A scoping review

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Objective performance criteria (OPCs) are critical for evaluating efficacy in single-arm trials. This study aimed to examine current practices and methodological challenges in establishing OPCs in single-arm trials of traditional Chinese medicine (TCM). PubMed, Embase, the Cochrane Library, CNKI, Wanfang, and VIP were searched for TCM single-arm trials using OPCs published up to December 2025. Data on OPC sources, population comparability, uncertainty quantification, and primary outcome alignment were extracted and descriptively analysed. Twelve studies (13 publications; 1134 participants) conducted in China (2019-2025) evaluated Chinese herbal decoctions (n=9), proprietary Chinese medicines (n=2), or acupuncture plus rehabilitation (n=1) across kidney, neurological, gynaecological and other conditions. OPCs were derived from prior clinical studies (n=6), meta-analyses (n=5), or a synthesis of clinical experience and literature (n=1). Three studies reported 95% confidence intervals, and four justified population comparability. Ten studies exhibited limited comparability due to differences in disease duration, severity, or assessment timing. One study mentioned expert discussion but provided no details. Eleven studies reported a clear primary outcome, among which ten aligned their OPCs accordingly and one based its OPC on a secondary outcome. Only one study lacked an explicit primary outcome definition. Four studies based their OPCs on non-standardised composite outcomes such as remission rate. Current TCM single-arm trials face challenges in establishing OPCs, including incomplete reporting, poor population comparability, inadequate uncertainty quantification, and non-standardised endpoints. Future studies should adopt transparent and contextually appropriate OPC specification guidelines, ensuring methodological rigour in source selection, population comparability, and outcome definition.

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