Core outcome sets for acupuncture trials in women’s health across the lifespan
Valentina Buay, Belinda Anderson, Debra Betts, Claudia Citkovitz, Lisa Conboy, Sandro Graca, Kathleen Lumiere, Rosa Schnyer, Lisa Taylor-Swanson, Kate Levett
Introduction:
Acupuncture shows promise in improving women’s health, but clinical trial findings are often limited by small sample sizes, inconsistent methodologies, and varied outcome measures. These inconsistencies hinder inclusion in systematic reviews and meta-analyses. The development of Core Outcome Sets (COS), as outlined by the COMET Initiative, addresses this by standardising outcomes across trials. COSs represent the minimum outcomes that should be measured and reported in all clinical trials for a specific condition. Developed collaboratively with patients and practitioners, COSs enhance research quality, comparability, and reduce bias.
Aim/Purpose:
To develop a standardised Core Outcome Set (COS) to measure women’s health at key life stages: menstruation, pregnancy, labour, fertility and menopause.
Methods:
A three-stage COMET initiative process was used to develop the COS through consultation, survey, voting and consensus.
• Stage I: A systematic review of three databases identified outcomes from acupuncture trials in women’s health. A stakeholder roundtable at the SAR 2023 conference refined these into surveys for each of the five conditions.
• Stage II: Five surveys were distributed online and at SAR 2024. Using a modified Delphi method, participants rated outcomes on a Likert scale (1 = not important, 9 = critically important). Outcomes scoring ≥7 moved to Round 2, where the process was repeated.
• Stage III: A final consensus meeting at SAR 2025 engaged stakeholders to finalise the COS.
Findings:
The review identified 227 relevant papers across the five conditions. Outcomes were grouped into the domains of Pain, Sleep, Mood/Cognition, Patient Experience and Safety. Over 100 stakeholders from 10 countries participated. Round 1 produced 442 outcomes scoring ≥7; Round 2 refined this to 396. Consensus was reached for 4-6 core outcomes per domain for each condition, along with a separate COS for acupuncture safety and feasibility.
Conclusion:
Standardised stakeholder-driven consensus is vital for consistency in clinical trial design and reporting, especially in fields with varied research practices. This COS will improve the quality and consistency of acupuncture research in women’s health, enhance meta-analyses, and ensure trials reflect patient-centred outcomes. It will also support coordinated data collection for healthcare planning.
References:
COMET Initiative: https://www.comet-initiative.org/