■针灸有望作为减少急诊科(ED)急性疼痛的有效非药物选择。遵循CONSORT和STRICTA准则,随机对照试验(RCT)通常报告干预细节和穴位选择,但是忠于针灸干预,对干预研究的可靠性至关重要,很少报道。
■ACUITY是由NCCIH资助的,3种ED针刺的多部位可行性RCT(克利夫兰,纳什维尔,和圣地亚哥)。ACUITY针灸师接受了研究设计培训,反应灵敏的针灸手册协议,通过为跟踪保真度而创建的REDCap表单,物流和实时记录会话详细信息。
■在3个招聘地点,79名参与者接受针灸治疗:51%的女性,43%黑人/非洲裔美国人,基线时异质性急性疼痛部位:32%腰背,22%四肢,20%腹部,10%的头。务实,参与者在ED公共区域接受治疗(52%),私人房间(39%),和半私人房间(9%)。客观跟踪发现98%坚持针灸手册协议的六个组成部分:分期,插入点的数量(M=13.2,范围2-22),针头保留时间(M=23.5分钟,范围4-52),会话长度(M=40.3分钟,范围20-66),是否提供了一般性建议,并填写了会议表格。
■据我们所知,这是第一个评估和报告针灸方案保真度的RCT.保真度监测将是ACUITY2的基础,这将是未来的决定性因素,多点RCT。此外,我们建议在未来的RCT中,将针灸干预的保真度添加到CONSORT和STRICTA报告指南中.
■本研究方案注册于clinicaltrials.gov:NCT04880733。
UNASSIGNED: Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA
guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported.
UNASSIGNED: ACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity.
UNASSIGNED: Across 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points (M = 13.2, range 2-22), needle retention time (M = 23.5 min, range 4-52), session length (M = 40.3 min, range 20-66), whether general recommendations were provided and completion of the session form.
UNASSIGNED: To the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting
guidelines in future RCTs.
UNASSIGNED: The protocol of this study is registered at clinicaltrials.gov: NCT04880733.