침구 치료 이상반응 설문지 개발과 타당도 평가

Objectives: To develop and validate a survey form for adverse events(AEs) associated with acupuncture and moxibustion treatment. Methods : The 1st version of a survey form consisting of 9 categories was developed and modified based on the analysis of questionnaires from previous studies on AEs. To evaluate content validity of the 1st version, a Delphi survey where experts in acupuncture and moxibustion, and research methodology were invited, was conducted alongside a separate content validity questionnaire. The content validity indices for each item and total scale were calculated as the proportion of the number of experts judging each item or scale valid to the number of total experts. Results : After the Delphi round 1, the content validity of 2 items and total scale was rated as inadequate. The 1st version was modified accordingly, and the 2nd version of the survey form was developed. The content validity of the 2nd version was assessed in the Delphi round 2 and the final version was completed after incorporating the expert comments. The final version consists of 13 questions regarding practitioner/patient information, condition/disease, intervention, treated body parts, safety issue and AE occurrence related with practitioner’s behavior or instruments, AEs associated with treatment and emergency actions taken if necessary, time to AE occurrence, outcomes, serious AEs or death, and time to AE disappearance. Conclusions : This newly developed and validated survey form will serve to collect AEs associated with acupuncture and moxibustion treatments in Korea and contribute to establishing the evidence on safety of Korean acupuncture treatment.