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

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 provides a standardization framework that can help research on traditional practices as well as new tools and techniques that are more invasive and may cause more severe AEs.Subsequent studies will use ACUPOCHECK to develop rational safety guidelines for acupotomy techniques.

Safety of acupotomy in a real-world setting:A prospective pilot and feasibility study

Objective:Acupotomy is a modern acupuncture method that includes modern surgical methods.Since acupotomy is relatively more invasive than filiform acupuncture treatment,it is important to establish the safety profile of this practice.To justify further large-scale prospective observational studies,this preliminary study was performed to assess the feasibility of the approach and investigate the safety profile and factors potentially associated with adverse events(AEs).Methods:This was a prospective pilot study that assessed the feasibility of a large-scale forthcoming safety study on acupotomy treatment in a real-world setting.The feasibility(call response rate,dropout rate,response rate for each variable and recruitment per month)and safety profile(incidence,type,severity and causality of AEs,and factors potentially associated with AEs)were measured.Results:A total of 28 participants joined the study from January to May 2018.A follow-up assessment was achieved in 258(1185 treatment points)out of 261 sessions(1214 treatment points).The response rate via telephone on the day after treatment was 87.3%.There were 8 systemic AEs in all the sessions(8/258;3.11%)and 27 local AEs on the total points treated(27/1185;2.28%).Severe AEs did not occur.Total AE and local AE occurrence were associated with blade width and the number of needle stimulations per treatment point.Conclusion:The findings suggest that it could be feasible to analyze the safety of acupotomy in a realworld setting.Moreover,the primary data on some relevant AEs could be determined.We are planning large-scale prospective studies based on these findings.Trial registration:Clinical Research Information Service(CRIS)KCT0002849(https://cris.nih.go.kr/cris/search/detailSearch.do/11487).