INTRO: Over a series of research conference meetings at the Society for Acupuncture Research (SAR) spanning three years, this study engaged conference attendees and online groups in the COMET process to establish the 'Acupuncture sets of trial reported core outcomes' (ASTRO) framework. Using this framework we developed core outcome sets (COSs), including for safety and feasibility of acupuncture trials in women’s health conditions across the lifespan (ASTRO-Safety and feasibility in women’s health).
PURPOSE: Using the COMET methodology and the ASTRO framework to develop a COS for safety and feasibility outcomes for clinical trials of acupuncture for women’s health.
METHODS: We used a multi-method design, including a four-stage consensus process involving practitioners, researchers and patients, to develop the ASTRO framework, and a specific COS for safety and feasibility outcomes for acupuncture trials in women’s health across the lifespan.
• Stage I: A systematic review of the literature across three databases identified all outcomes from acupuncture trials in women’s health, including safety and feasibility.
• Stage II: Consultation with stakeholders via a roundtable discussion (SAR conference workshop 2023) occurred to refine these measures to develop a set of five comprehensive surveys for outcomes in women’s health conditions.
• Stage III: The survey was distributed online to research practice and consumer/patient networks, and SAR 2024 conference attendees. Using a modified Delphi method, participants voted on each outcome’s importance on a Likert scale (1 = not important, 9 = critically important). Outcomes averaging =7 progressed to Round 2, where the process was repeated for the survey.
• Stage IV: A final consensus meeting held at the SAR conference 2025, where engaged stakeholders met to reach final consensus for the COS for safety and feasibility outcomes for acupuncture trials in women’s health using the ASTRO framework. A final core outcome set was proposed for five women’s health conditions, as well as safety and feasibility outcomes (ASTRO-Safety and feasibility in women’s health).
RESULTS: The process for developing a COS for safety and feasibility in women’s health explored the holistic nature of acupuncture trials to incorporate the intersection across life stages to establish common themes of pain, sleep, mood, cognition, safety (ASTRO framework). Using this framework, we developed specific safety and feasibility outcomes which can be included for all acupuncture trials for women’s health conditions (ASTRO-Safety and feasibility in women’s health). The two core safety outcomes included: Minor acupuncture related adverse events, and serious acupuncture related adverse events. The two core feasibility outcomes included: Acceptability of acupuncture treatment (acceptability, satisfaction with overall care) and cost of acupuncture treatment (individual treatment costs, cost of materials, patient expenses). A number of other outcomes were included as secondary outcomes for inclusion in trials, including PROMs for primary and secondary condition outcomes, changes in acupuncture and herbal medicine (AHM) diagnostic indices (pulse, tongue, abdomen etc), patient experience, demographics, and changes to mood/cognition, sleep, and pain. These outcomes are in addition to the previously developed outcomes covered in the STRICTA and NICMAN framework.
CONCLUSION: This model is highly relevant to inform future acupuncture research, commonly criticized for low data quality and heterogeneity of outcomes. Using international conference meetings to conduct studies using the COMET methodology offers a unique opportunity for researchers, practitioners and consumers/patients to come together for information gathering, data collection and analysis, and final consensus forums to establish the COSs with multidisciplinary input. This study used the COMET methodology and the ASTRO framework to develop a core outcome set for safety and feasibility of acupuncture trials for women’s health.
PI and supervisor: 1. Kate Levett, PhD, MPH, B.Ed (Hons I), Adv.Dip.App.Sci (Acup), School of Medicine, University of Notre Dame Australia
2. Valentina Buay, BSc (Medical Science, Hons I), School of Medicine, University of Notre Dame Australia
Supervisor 3. Claudia Citkovitz, PhD, MS, Lac, Director, Acupuncture Services, Research Assistant Professor, Department of Rehabilitation Medicine, NYU Medical School, ccitkovitz@gmail.com
4. Kathleen Lumiere, DAOM, Mac, LAc, Clinical Supervisor and Faculty, Bastyr University, klumiere@bastyr.edu
5. Rosa Schnyer, DAOM, IFMCP, LAc, School of Nursing, University of Texas, Austin rschnyer@utexas.edu
6. Debra Betts, PhD Debra Betts, PHD, LAc, Adjunct Research Fellow, NICM Health Research Institute, Western Sydney University debra.betts@rhizome.net.nz
7. Sandro Graca, MSc, Lic TCM, FABORM, Lecturer and Researcher, School of Health and Society, Faculty of Education, Health and Wellbeing, University of Wolverhampton
8. Wen Tu, BSN, MMSc, College of Nursing, University of Utah, u1412475@utah.edu
9. Belinda J. Anderson, PhD, LAc, College of Health Professions, Pace University and Albert Einstein College of Medicine
10. Lisa Conboy, MA, MS, ScD, Beth Israel Deaconess Medical Center, Harvard Medical School; Director of Academic Research, Maryland University of Integrative Health
P.I. and supervisor 11. Lisa Taylor-Swanson, PhD, MAcOM, LAc, College of Nursing, University of Utah
Disease Category: Gynaecology, Pregnancy & childbirth
Disease Name: Fertility, Menopause, Polycystic ovary syndrome , Pregnancy
Age Range: 15 - 120
Sex: Female
Nature of Intervention: Complementary and alternative medicine (CAM) therapy
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Researchers
- Service commissioners
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
- Survey
Multi-method design, including a four-stage consensus process involving practitioners, researchers and patients
• Stage I: A systematic review of the literature across three databases identified all outcomes from acupuncture trials in women’s health
• Stage II: Consultation with stakeholders via a meeting and roundtable discussion (conference workshop 2023) and development of surveys.
• Stage III: Survey distribution online to research practice and consumer/patient networks, and SAR 2024 conference attendees. Using a modified Delphi method, participants voted on each outcome’s importance on a Likert scale (1 = not important, 9 = critically important). Outcomes averaging =7 progressed to Round 2, where the process was repeated for the survey.
• Stage IV: A final consensus meeting held at the SAR conference 2025, where engaged stakeholders met to reach final consensus for the COS for safety and feasibility outcomes for acupuncture trials in women’s health using the ASTRO framework.