Delphi study for developing a checklist of adverse events associated with acupotomy  

作　　者：Hyungsun Jun Haebeom Lee Sang-Hoon Yoon Chan-Young Kwon Damin Jeon Jun-Hwan Lee Jungtae Leem 

机构地区：[1]Department of Diagnostics,College of Korean Medicine,Wonkwang University,Iksan 54538,Republic of Korea [2]7Days Inc.,Seoul 06247,Republic of Korea [3]Chung-Yeon Korean Medicine Clinic,Seoul 06224,Republic of Korea [4]Department of Oriental Neuropsychiatry,Dong-Eui University College of Korean Medicine,Busan 47227,Republic of Korea [5]Chonnam National University Hwasun Hospital,Hwasun 58128,Republic of Korea [6]KM Science Research Division,Korea Institute of Oriental Medicine,Daejeon 34054,Republic of Korea [7]Department of Korean Convergence Medical Science,KIOM School,University of Science&Technology(UST),Daejeon 34054,Republic of Korea [8]Department of Physical Medicine and Rehabilitation,Spaulding Rehabilitation Hospital,Harvard Medical School,Boston,MA 02115,USA [9]Research Center of Traditional Korean Medicine,College of Korean Medicine,Wonkwang University,Iksan 54538,Republic of Korea

出　　处：《Journal of Integrative Medicine》2024年第5期579-587,共9页结合医学学报（英文版）

基　　金：funded by the Establishment of Real World Data-based Clinical Evidence of Korean Medicine Health Technology(No.KSN1823211);Additionally,it received support from a National Research Foundation of Korea grant funded by the Korean government(No.NRF-2022R1C1C2008738).

摘　　要：Background Acupotomy,a more invasive procedure than acupuncture,involves the use of a thicker needle with an integrated knife at the tip,necessitating safety research.We aimed to define relevant adverse events(AEs)and create a standardized form of the ACUPOtomy-related AEs CHECKlist(ACUPOCHECK).Methods Before conducting the Delphi process,a systematic review and pilot prospective study were conducted to gather information on previously reported AEs.Using these data,pilot versions of the ACUPOCHECK and Delphi questionnaires were developed.The Delphi questionnaire involved selecting types of AE for inclusion,establishing separate criteria for acupotomy-related AEs,and achieving a consensus on AE assessment.Thirteen Korean doctors with experience in acupotomy or AE research were recruited to participate in each Delphi round.Consensus was considered to have been reached if the critical value for the content validity ratio met or exceeded 0.538.Results The final ACUPOCHECK was developed using four rounds of the Delphi method and one face-to-face consensus meeting.It included 12 local AEs(pain,hemorrhage,bruise,hematoma,edema,pruritus,rash,infection,nerve damage,dysesthesia,movement impairment,and pneumothorax)and 14 systemic AEs(disease aggravation,needle fatigue,sleepiness,procedural nausea,procedural vomiting,procedural headache,procedural dizziness,sweating,procedural shock,syncope,dyspnea,procedural pain,sleep disorder,and postprocedural infection).Separate criteria were established for pain,hemorrhage and bruising:pain was defined as pain that occurrs during daily activities and persists for longer than 72 h,hemorrhage as bleeding that continues for≥3 min despite pressure application,and bruising as having a bruise with a diameter of≥3 cm.Open-ended descriptions were allowed for AEs not covered by the checklist,and severity and causality were assessed using the Common Terminology Criteria for Adverse Events and modified World Health Organization-Uppsala Monitoring Center criteria.Conclusion ACUPOCHECK provide

关 键 词：ACUPOTOMY Delphi technique Patient safety Safety management Adverse event 

分 类 号：R246[医药卫生—针灸推拿学]