Introduction
Clinical trials suggest acupuncture significantly improves women’s health. However, findings are limited by small sample sizes, inconsistent methodologies, and varied outcome measures, hindering the ability to draw conclusions through systematic reviews and meta-analyses. By standardising Core Outcome Sets (COS), using the process developed by the COMET, COSs address this issue by providing a standardised set of outcomes to be consistently measured across trials. These core sets represent the minimum data that should be measured and reported in all clinical trials of a specific condition, and which are also suitable for clinical audit or research other than randomised controlled trials. Developed collaboratively with patients and practitioners, COSs enhance research quality, enable comparability, and reduce bias.
Aim
This study aims to develop a standardised Core Outcome Set (COS) to measure women’s health at key life stages (menstruation, pregnancy, labour, fertility and menopause). Standardised COSs strengthen the evidence base for clinical trials, supporting improved healthcare practice that meets research, clinical, and consumer needs.
Method/Description
Following the COMET initiative process, a three-stage process was used to develop the COS. These sets are arrived at by consultation, survey, voting and consensus – in this order.
- Stage I: A systematic review of the literature across three databases identified outcome measures from acupuncture trials in women’s health. Consultation with stakeholders via a roundtable discussion (SAR conference workshop 2023) occurred to refine these measures to develop a comprehensive survey for each of the five health conditions.
- Stage II: Five surveys were developed and distributed online to research, practice and consumer/patient networks, and SAR 2024 conference. 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 five surveys.
- Stage III: A final consensus meeting held at the SAR conference 2025, engaged stakeholders met to reach final consensus for the COS.
Results
The review identified 227 relevant papers across the five health 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. Final consensus was reached for 4-6 core outcomes for each domain for each health condition, with consensus for a separate safety and feasibility COS for acupuncture being reached.
Discussion
Core outcome sets represent the minimum data that should be measured and reported in all clinical trials of a specific condition, and which are also suitable for clinical audit or research other than randomised controlled trials. Having a standardised method for reaching consensus for trials from all stakeholders is important to maintain fidelity and consistency in clinical trial conduct and reporting, especially in areas where research standards are varied.
Consclusions
A COS for women’s acupuncture research will enable consistent, high-quality studies, improve meta-analyses, and guide clinical trials to reflect patient-centred outcomes. It will also support unified data collection for healthcare planning and resource allocation.
References
COMET Initiative: https://www.comet-initiative.org/