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
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 acupun...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-06-01
|
| Series: | Integrative Medicine Research |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213422024000283 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850045664513228800 |
|---|---|
| author | Arya Nielsen Natalie L. Dyer Claudia Lechuga M. Diane McKee Jeffery A. Dusek |
| author_facet | Arya Nielsen Natalie L. Dyer Claudia Lechuga M. Diane McKee Jeffery A. Dusek |
| author_sort | Arya Nielsen |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-15a702e7d76241768a182cca8efebaaa |
| institution | DOAJ |
| issn | 2213-4220 |
| language | English |
| publishDate | 2024-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Integrative Medicine Research |
| spelling | doaj-art-15a702e7d76241768a182cca8efebaaa2025-08-20T02:54:39ZengElsevierIntegrative Medicine Research2213-42202024-06-0113210104810.1016/j.imr.2024.101048Fidelity 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 guidelinesArya Nielsen0Natalie L. Dyer1Claudia Lechuga2M. Diane McKee3Jeffery A. Dusek4Icahn School of Medicine at Mount Sinai, Department of Family Medicine and Community Health, New York, NY, USA; Corresponding author at: Icahn School of Medicine at Mount Sinai, Department of Family Medicine & Community Health, 1325 Madison Avenue, Suite L5-40, New York, NY 10029, USA.Susan Samueli Integrative Health Institute, University of California- Irvine, Irvine, CA, USADepartment of Family and Social Medicine, Albert Einstein College of Medicine, New York, NY, USADepartment of Family Medicine and Community Health, University of Massachusetts Chan Medical School, Worcester, MA, USASusan Samueli Integrative Health Institute, University of California- Irvine, Irvine, CA, USA; Department of Medicine, General Internal Medicine, University of California- Irvine, Irvine, CA, USABackground: 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.http://www.sciencedirect.com/science/article/pii/S2213422024000283Acupuncture therapyAcute painFidelity to intervention |
| spellingShingle | Arya Nielsen Natalie L. Dyer Claudia Lechuga M. Diane McKee Jeffery A. Dusek 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 Integrative Medicine Research Acupuncture therapy Acute pain Fidelity to intervention |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Acupuncture therapy Acute pain Fidelity to intervention |
| url | http://www.sciencedirect.com/science/article/pii/S2213422024000283 |
| work_keys_str_mv | AT aryanielsen fidelitytotheacupunctureinterventionprotocolintheacupunctureintheemergencydepartmentforpainmanagementacuitytrialexpandingthegoldstandardofstrictaandconsortguidelines AT natalieldyer fidelitytotheacupunctureinterventionprotocolintheacupunctureintheemergencydepartmentforpainmanagementacuitytrialexpandingthegoldstandardofstrictaandconsortguidelines AT claudialechuga fidelitytotheacupunctureinterventionprotocolintheacupunctureintheemergencydepartmentforpainmanagementacuitytrialexpandingthegoldstandardofstrictaandconsortguidelines AT mdianemckee fidelitytotheacupunctureinterventionprotocolintheacupunctureintheemergencydepartmentforpainmanagementacuitytrialexpandingthegoldstandardofstrictaandconsortguidelines AT jefferyadusek fidelitytotheacupunctureinterventionprotocolintheacupunctureintheemergencydepartmentforpainmanagementacuitytrialexpandingthegoldstandardofstrictaandconsortguidelines |