Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines

IF 2.8 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research Pub Date : 2024-06-01 DOI:10.1016/j.imr.2024.101048

Arya Nielsen , Natalie L. Dyer , Claudia Lechuga , M. Diane McKee , Jeffery A. Dusek

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引用次数: 0

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Protocol registration

The protocol of this study is registered at clinicaltrials.gov: NCT04880733.

查看原文本刊更多论文

ACUpuncture In The EmergencY Department for Pain Management (ACUITY) 试验中针灸干预方案的忠实性：扩展 STRICTA 和 CONSORT 指南的黄金标准。

背景针灸作为一种有效的非药物疗法，有望减轻急诊科（ED）的急性疼痛。根据 CONSORT 和 STRICTA 指南，随机对照试验（RCT）通常会报告干预细节和穴位选择，但对于干预研究可靠性至关重要的针灸干预的忠实性却很少报告。方法 ACUITY 是一项由 NCCIH 资助的多地点可行性 RCT，在 3 个急诊科（克利夫兰、纳什维尔和圣地亚哥）进行针灸治疗。ACUITY 针灸师在研究设计、响应性针灸手册协议、后勤以及通过 REDCap 表单实时记录疗程细节等方面接受了培训，以跟踪针灸的忠实性：女性占 51%，黑人/非裔美国人占 43%，基线急性疼痛部位各不相同：腰部 32%，四肢 22%，腹部 20%，头部 10%。根据实际情况，参与者在急诊室公共区域（52%）、私人病房（39%）和半私人病房（9%）接受治疗。客观追踪发现，98%的参与者遵守了针灸手册化方案的六项内容：分期、针刺点数量（M = 13.2，范围 2-22）、留针时间（M = 23.5 分钟，范围 4-52）、疗程长度（M = 40.3 分钟，范围 20-66）、是否提供一般性建议以及疗程表格的填写。忠实性监测对于 ACUITY2 将是至关重要的，ACUITY2 将是未来一项明确的多地点 RCT。此外，我们建议在未来的 RCT 中将针灸干预的忠实性加入 CONSORT 和 STRICTA 报告指南中：NCT04880733。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Integrative Medicine Research Medicine-Complementary and Alternative Medicine

CiteScore

6.50

自引率

2.90%

发文量

审稿时长

12 weeks

期刊介绍： Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.