the development of objective performance criteria and performance goals in single-arm trials

Single-arm trial (SAT) utilizing objective performance criterion (OPC) or performance goal (PG) has become a common approach for evaluating the effectiveness and safety of certain clinical interventions, particularly in the field of medical devices. In China, many researchers have attempted to apply SATs utilizing OPCs or PGs to the evaluation of traditional Chinese medicine (TCM). However, there is currently no widely recognized or accepted method for developing OPC or PG. Moreover, standardized reporting guideline for the development of OPC or PG is lacking. It is challenging to develop a robust OPC, and as a result, few validated OPCs are available. Researchers tend to develop their own new PGs for use as comparators in SATs, since it is generally less methodologically demanding than developing an OPC. PGs developed by researchers themselves may be subject to bias, and the methodological details involved are often inadequately reported. These limitations may undermine the credibility of the study results and affect the overall strength of the evidence. In this study, we aim to summarize the current methodologies for developing and reporting of OPCs or PGs in published SATs. We seek to synthesize the strengths and limitations of existing approaches and to formulate methodological and reporting recommendations. A particular focus will be placed on the application and future prospects of SAT utilizing OPC or PG in the field of TCM.