Acupuncture sets of trial reported core outcomes (ASTRO) for women’s health across the lifespan
Year: 2025
Type: preprint
Abstract: Introduction Clinical trials of acupuncture are difficult to meaningfully aggregate due to small sample sizes, and reductionist, heterogenous outcome measures. To improve the quality of evidence, standardized reporting of minimum data that reflects whole-person health, essential to East Asian Medicine (EAM), is needed. The Core Outcome Measures in Effectiveness Trials (COMET) initiative (1) offers a methodology for developing core outcome sets (COS) through collaborative group consensus, including consumers. This study presents the ‘Acupuncture Sets of Trial Reported Outcomes’ (ASTRO) for women’s health. Using domains of pain, sleep, mood/cognition, and safety, the ASTRO framework captures EAM complexity as well as standardizing reporting outcomes. Purpose To develop a COS for acupuncture trials in women’s health, reflecting whole-person health outcomes across the lifespan. Methods Following COMET guidelines, we used a three-stage consensus process involving practitioners, researchers, patients, and policymakers to develop a COS for reporting minimum data for acupuncture trials in women’s health. This process involved a systematic review, roundtable discussion, two-round Delphi survey, and a consensus meeting. We examined the conditions of menstrual health, PCOS, fertility, pregnancy, and menopause to develop an outcome set for safety, feasibility and EAM specific outcomes. Results From 320 studies, 579 outcomes were identified. A final COS of 12 outcomes was agreed upon: Safety (n=2): Serious adverse events (SAEs) and minor adverse events (AEs); EAM (n=8): Changes to primary and secondary patient reported outcome measures (PROMs), change in EAM diagnostic indices, patient experience/satisfaction, demographics, mood/cognition, sleep, and pain; Feasibility (n=2): Acceptability and cost. Definitions for S/AEs follow Witt et al. (2) and Bäumler et al. (3), and outcomes are to be used in conjunction with those specified in the STRICTA guidelines (4). Conclusion The ASTRO Women’s Health COS enables consistent, whole-person outcome reporting, to improve the quality and comparability of acupuncture research. Summary box Definitions of terms
Source: medRxiv
Institutions: University of Technology Sydney, Western Sydney University, The University of Notre Dame Australia, Massachusetts College of Pharmacy and Health Sciences, New England School of Acupuncture, The University of Texas at Austin, University of Wolverhampton, Northern College of Acupuncture, University of Utah, Pace University, Albert Einstein College of Medicine, Beth Israel Deaconess Medical Center, Harvard University
Language: English
Topic: Delphi Technique in Research
Subfield: Sociology and Political Science
Field: Social Sciences
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W4414119453