Potential Facilitators and Barriers to Awareness of N-of-1 Trials for Physicians in Traditional Chinese Medicine

Min Dai, PhD; Long Ge, MS; Jiang Li, PhD, MD; Junquang Niu, MS; Hongcai Shang, PhD, MD; Jinhui Tian, PhD, MD; Xiaoqin Wang, MS; Dang Wei, MS; Min Yang, MS; Kehu Yang, PhD, MD; Wenzhen Yuan, PhD, MD; Jingbo Zhai, PhD

Context • N-of-1 trials are multiple crossover trials with randomized and blinded methods, conducted with a single participant to evaluate the effectiveness and safety of a therapy. They can be a helpful tool for enriching clinical research for traditional Chinese medicine (TCM), but the approach has gained little traction in TCM. Information is needed before supporters of the trials can pursue a change to that status.

Objective • The study intended to obtain data needed to support TCM clinicians' adoption of N-of-1 trials.

Methods • TCM clinicians were interviewed using a dedicated questionnaire between May 15, 2014, and July 31, 2014.

Setting • The study took place at 4 teaching hospitals (Lanzhou City, China).

Participants • Participants were TCM clinicians at the 4 hospitals.

Outcome Measures • The survey included questions to obtain information on (1) the various methods that the TCM physicians used to obtain information about how to develop and conduct clinical trials, (2) their knowledge and experience with traditional clinical trials, (3) their awareness of the concept and methodology of N-of-1 trials, and (4) their needs and willingness to receive training about such trials. Descriptive statistics were used.

Results • One-hundred-and-six clinicians, with a median age of 32 ± 9 y, participated in the survey. Most received information on research methods from a medical database (77%) or academic conferences (65%). Eighty-two percent of the clinicians had read papers about clinical trials, and 84% of the material read were medical articles in Mandarin. Of the participants, 57% had designed and carried out clinical trials during the 5 y before the survey, and among those participants, 26% had performed randomized controlled trials (RCTs), 28% had carried out retrospective studies, 16% had conducted observational studies, and 30% had completed case reports. For those studies, the results of 7% had been published in the Science Citation Index (SCI), 47% in the Chinese Science Citation Database (CSCD), and 31% in provincial journals; 15% were unpublished. Only 37% had heard of an N-of-1 trial, and only 5% understood what the term means. Most intermediate clinicians thought it is necessary to train different groups of clinicians using N-of-1 trials that included clinicians and patients.

Conclusions • The results highlight the possible interest of TCM clinicians in the methods of N-of-1 trials; meanwhile, the study's data stress the need for appropriate medical education and recommendations based on available evidence. Further efforts in the area should emphasize the benefits for patients and funders. The training is necessary in TCM clinical practice to improve the evidence quality of studies on TCM.

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