Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
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Development and Validation of a Survey Form for Adverse Events Associated with Acupuncture and Moxibustion

침구 치료 이상반응 설문지 개발과 타당도 평가

  • Kim, Seoyeon (Department of Korean Medical Science, Graduate School, College of Korean Medicine, Kyung Hee University) ;
  • Lee, Jun-Hwan (Clinical Research Division, Korea Institute of Oriental Medicine) ;
  • Yook, Tae Han (Department of Acupuncture & Moxibustion, College of Korean Medicine, Woosuk University) ;
  • Park, Jimin (Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University) ;
  • Leem, Jungtae (Department of Clinical Research of Korean Medicine, Graduate School, College of Korean Medicine, Kyung Hee University) ;
  • Lee, Hyangsook (Department of Korean Medical Science, Graduate School, College of Korean Medicine, Kyung Hee University)
  • 김서연 (경희대학교 한의과대학 대학원 기초한의과학과) ;
  • 이준환 (한국한의학연구원 임상연구부) ;
  • 육태한 (우석대학교 한의과대학 침구의학과) ;
  • 박지민 (경희대학교 한의과대학 침구의학과) ;
  • 임정태 (경희대학교 한의과대학 대학원 임상한의학과) ;
  • 이향숙 (경희대학교 한의과대학 대학원 기초한의과학과)
  • Received : 2015.12.07
  • Accepted : 2015.12.16
  • Published : 2015.12.27
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Abstract

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.

Keywords

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