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침구 치료 이상반응 설문지 개발과 타당도 평가

Development and Validation of a Survey Form for Adverse Events Associated with Acupuncture and Moxibustion

  • 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)
  • 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)
  • 투고 : 2015.12.07
  • 심사 : 2015.12.16
  • 발행 : 2015.12.27

초록

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.

키워드

참고문헌

  1. Wonderling D, Vickers AJ, Grieve R, McCarney R. Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care. BMJ. 2004 ; 328(7442) : 747-9. https://doi.org/10.1136/bmj.38033.896505.EB
  2. Streng A, Wagenpfeil S, Linde K, Weidenhammer W, Melchart D, Hoppe A, et al. Acupuncture for Patients With Migraine: A Randomized Controlled Trial. JAMA. 2005 ; 293(17) : 2118-25. https://doi.org/10.1001/jama.293.17.2118
  3. Cherkin D, Sherman K, Avins A, Erro J, Ichikawa L, Barlow W, et al. A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain. Arch Intern Med. 2009 ; 169(9) : 858-66. https://doi.org/10.1001/archinternmed.2009.65
  4. Boer d, M.R., Kuijpers T, Verhagen AP, Middelkoop v, M., Tulder v, M.W., Rubinstein SM, et al. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain. Eur Spine J. 2010 ; 19(8) : 1213-28. https://doi.org/10.1007/s00586-010-1356-3
  5. Vickers A, Wilson P, Kleijnen J. Acupuncture. Qual Saf Health Care. 2002 ; 11(1) : 92-7. https://doi.org/10.1136/qhc.11.1.92
  6. Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. National health statistics reports. 2015 ; (79) : 1.
  7. Woo PCY, Li JHC, Tang W, Yuen K. Acupuncture Mycobacteriosis. N Engl J Med. 2001 ; 345(11) : 842-3. https://doi.org/10.1056/NEJM200109133451119
  8. Studd RC, Stewart PJ. Images in clinical medicine. Intraabdominal abscess after acupuncture. N Engl J Med. 2004 ; 350(17) : 1763. https://doi.org/10.1056/NEJMicm010431
  9. Saifeldeen K, Evans M. Acupuncture associated pneumothorax. Emerg Med J. 2004 ; 21(3) : 398. https://doi.org/10.1136/emj.2003.006049
  10. Vucicevic Z, Sharma M, Miklic S, Ferencic Z. Multiloculated Pleural Empyema following Acupuncture. Infection. 2005 ; 33(4) : 297-8. https://doi.org/10.1007/s15010-005-4135-z
  11. Park J, Shin HJ, Choo SJ, Song JK, Kim J. Successful removal of migrated acupuncture needles in a patient with cardiac tamponade by means of intraoperative transesophageal echocardiographic assistance. J Thorac Cardiovasc Surg. 2005 ; 130(1) : 210-2. https://doi.org/10.1016/j.jtcvs.2004.11.046
  12. Ernst E, White A. Life-threatening adverse reactions after acupuncture? A systematic review. Pain. 1997 ; 71(2) : 123-6. https://doi.org/10.1016/S0304-3959(97)03368-X
  13. Lao L, Hamilton G, Fu J, Berman B. Is acupuncture safe? A systematic review of case reports. Altern Ther Health Med. 2003 ; 9(1) : 72-83.
  14. Ernst E, White AR. Prospective studies of the safety of acupuncture: a systematic review. Am J Med. 2001 ; 110(6) : 481-5. https://doi.org/10.1016/S0002-9343(01)00651-9
  15. Yamashita H, Tsukayama H, Tanno Y, Nishijo K. Adverse events in acupuncture and moxibustion treatment: a six-year survey at a national clinic in Japan. J Altern Complement Med. 1999 ; 5(3) : 229-36. https://doi.org/10.1089/acm.1999.5.229
  16. MacPherson H, Thomas K, Walters S, Fitter M. The York Acupuncture Safety Study: Prospective Survey Of 34 000 Treatments By Traditional Acupuncturists. BMJ. 2001 ; 323(7311) : 486-7. https://doi.org/10.1136/bmj.323.7311.486
  17. White A, Hayhoe S, Hart A, Ernst E. Adverse Events Following Acupuncture: Prospective Survey Of 32 000 Consultations With Doctors And Physiotherapists. BMJ. 2001 ; 323(7311) : 485-6. https://doi.org/10.1136/bmj.323.7311.485
  18. Melchart D, Weidenhammer W, Streng A, Reitmayr S, Hoppe A, Ernst E, et al. Prospective investigation of adverse effects of acupuncture in 97 733 patients. Arch Intern Med. 2004 ; 164(1) : 104. https://doi.org/10.1001/archinte.164.1.104
  19. Witt CM, Brinkhaus B, Jena S, Selim D, Straub C, Willich SN. Wirksamkeit, Sicherheit und Wirtschaftlichkeit der Akupunktur- Ein Modellvorhaben mit der Techniker Krankenkasse. Dtsch Arztebl International. 2006 : A-196.
  20. Park J, Sohn Y, White A, Lee H. The safety of acupuncture during pregnancy: a systematic review. Acupunct Med. 2014 ; 32(3) : 257-66. https://doi.org/10.1136/acupmed-2013-010480
  21. Park J, Lee MS, Choi J, Kim B, Choi S. Adverse events associated with acupuncture: a prospective survey. J Altern Complement Med. 2010 ; 16(9) : 959-63. https://doi.org/10.1089/acm.2009.0415
  22. Park S, Ko C, Bae H, Jung W, Moon S, Cho K, et al. Short-term reactions to acupuncture treatment and adverse events following acupuncture: a cross-sectional survey of patient reports in Korea. J Altern Complement Med. 2009 ; 15(12) : 1275-83. https://doi.org/10.1089/acm.2009.0181
  23. Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, et al. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forschende Komplementärmedizin. 2009 ; 16(2) : 91-7. https://doi.org/10.1159/000209315
  24. Yamashita H, Tsukayama H, Hori N, Kimura T, Tanno Y. Incidence of adverse reactions associated with acupuncture. J Altern Complement Med. 2000 ; 6(4) : 345-50. https://doi.org/10.1089/10755530050120718
  25. Park J, Oh D, Choi J, Jung S, Kim A, Koo C et al. Review of adverse events in acupuncture treatment. Korea J Oriental Med. 2007 ; 13(3) : 79-85.
  26. Jung H, Choi J, Park J, Kim K, Choi S, Oh D. Causality assessment of adverse events on acupuncture. Korean J Acupunct. 2008 ; 25(2) : 95-105.
  27. White A, Hayhoe S, Hart A, Ernst E, BMAS and AACP. British Medical Acupuncture Society and Acupuncture Association of Chartered Physiotherapists. Survey of adverse events following acupuncture (SAFA): a prospective study of 32,000 consultations. Acupunct Med. 2001 ; 19(2) : 84-92. https://doi.org/10.1136/aim.19.2.84
  28. White A. A cumulative review of the range and incidence of significant adverse events associated with acupuncture. Acupunct Med. 2004 ; 22(3) : 122-33. https://doi.org/10.1136/aim.22.3.122
  29. White A. The safety of acupuncture - evidence from the UK. Acupunct Med. 2006; 24(Suppl) : S53-7. https://doi.org/10.1136/aim.24.Suppl.53
  30. Regulations for Management of Safety Information on Medical Devices including Adverse Event, etc. KFDA Notification No.2014-197 (Amended on December 16, 2014). Available from:URL:http://www.mfds.go.kr/index.do?x=0&searchkey= title:contents&mid=1013&searchword=%C0%C7%B7% E1%B1%E2%B1%E2&y=0&division=&pageNo=1&seq= 8650&cmd=v
  31. Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 ; 35(6) : 382-5.
  32. Polit D, Beck C. The content validity index: Are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006 ; 29(5) : 489-97. https://doi.org/10.1002/nur.20147
  33. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996 ; 312(7023) : 71-2. https://doi.org/10.1136/bmj.312.7023.71
  34. Witt CM, Witt CM, Lao L, MacPherson H. Evidence on acupuncture safety needs to be based on large-scale prospective surveys, not single case reports. Pain. 2011 ; 152(9) : 2180. https://doi.org/10.1016/j.pain.2011.04.010
  35. Linstone HA, Turoff M. The Delphi method: Techniques and applications. Addison-Wesley Reading. 1975.
  36. Lee J. Delphi method. 1st ed. Seoul : Gyoyukgwahaksa. 2001 : 7.
  37. Dalkey N, Helmer O. An Experimental Application of the DELPHI Method to the Use of Experts. Manage Sci. 1963 ; 9(3) : 458-67. https://doi.org/10.1287/mnsc.9.3.458
  38. McKenna H, Hasson F, Keeney S. The Delphi technique in nursing and health research. John Wiley & Sons, Inc. 2010.
  39. Zamanzadeh V, Ghahramanian A, Rassouli M, Abbaszadeh A, Alavi-Majd H, Nikanfar A. Design and Implementation Content Validity Study: Development of an instrument for measuring Patient-Centered Communication. J Caring Sci. 2015 ; 4(2) : 165-78. https://doi.org/10.15171/jcs.2015.017
  40. Tinsley HE, Weiss DJ. Interrater reliability and agreement of subjective judgments. J Couns Psychol. 1975 ; 22(4) : 358-76. https://doi.org/10.1037/h0076640
  41. Wynd CA, Schmidt B, Schaefer MA. Two Quantitative Approaches for Estimating Content Validity. West J Nurs Res. 2003 ; 25(5) : 508-18. https://doi.org/10.1177/0193945903252998

피인용 문헌

  1. Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles vol.97, pp.41, 2018, https://doi.org/10.1097/MD.0000000000012736