WANG Handong 1 , CHAI Qianyun 1 , FENG Yuting 1 , LUO Minjing 1 , CAO Rui 1 , TAO Liyuan 2 , FEI Yutong 1
  • 1. Center for Evidence-Based Medicine, Beijing University of Traditional Chinese Medicine, Beijing 100029, P. R. China;
  • 2. Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, P. R. China;
FEI Yutong, Email: feiyt@bucm.edu.cn
Single arm trial; Qualitative interview; Methodology; Objective performance criteria; Traditional Chinese medicine
10.7507/1672-2531.202404038
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Objective  To understand the feasibility of application of objective performance criteria single arm trial in clinical efficacy evaluation of traditional Chinese medicine, and put forward theoretical countermeasures for the difficulties in application, so as to provide references for promoting the application of objective performance criteria single arm trial in clinical efficacy evaluation of traditional Chinese medicine in the future. Methods  Semi-structured qualitative interviews were conducted among clinical experts and methodologists who were involved in objective performance criteria single arm trials using purposive sampling combined with snowball sampling and a preset interview outline. To explore the application situations, influencing factors and difficulties in the application process of objective performance criteria single arm trial in the clinical efficacy evaluation of traditional Chinese medicine, and put forward theoretical countermeasures. Results  A total of 12 respondents were interviewed, including 7 clinical experts and 5 methodologists. The interview content was summarized and formed into 216 codes. After category analysis, 5 categories were formed, including the applicable situations, advantages, limitations, difficulties in the application process and theoretical countermeasures. The respondents believed that objective performance criteria single arm trial could be used as an alternative plan when controlled trials could not be carried out, or as a preliminary exploration or evidence supplement. It had the advantages of reducing sample size, good patient compliance, saving resource input, and relatively rigorous design. However, its application was limited due to low awareness and unclear level of evidence. The application difficulties included the setting of objective performance criteria, sample size calculation, quality control and statistical analysis. It was suggested to form a standard to promote its application in the efficacy evaluation of traditional Chinese medicine. Conclusion  The design of objective performance criteria single arm trial is consistent with the characteristics of clinical research of traditional Chinese medicine. However, because there is no control group, the validity of objective performance criteria single arm trial is challenged, which hinders its further application in the clinical efficacy evaluation of traditional Chinese medicine. By standardizing the selection of objective performance criteria, calculation of sample size, statistical analysis methods and research implementation steps, the strength of its demonstration and the recognition can be improved to a certain extent, but attention should be paid to avoid its misuse. In the future, the objective performance criteria single arm trial may be used as a basis to further explore the new direction of scientific research methods for clinical efficacy evaluation of traditional Chinese medicine.