Acupuncture sets of trial reported core outcomes (ASTRO) for women's health across the lifespan.

IntroductionClinical 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 womens health. Using domains of pain, sleep, mood/cognition, and safety, the ASTRO framework captures EAM complexity as well as standardizing reporting outcomes. PurposeTo develop a COS for acupuncture trials in womens health, reflecting whole-person health outcomes across the lifespan. MethodsFollowing 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 womens 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. ResultsFrom 320 studies, 579 outcomes were identified. A final COS of 12 outcomes was agreed upon: O_LISafety (n=2): Serious adverse events (SAEs) and minor adverse events (AEs); C_LIO_LIEAM (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; C_LIO_LIFeasibility (n=2): Acceptability and cost. C_LI Definitions for S/AEs follow Witt et al. (2) and Baumler et al. (3), and outcomes are to be used in conjunction with those specified in the STRICTA guidelines (4). ConclusionThe ASTRO Womens Health COS enables consistent, whole-person outcome reporting, to improve the quality and comparability of acupuncture research. Summary box O_TBL View this table: org.highwire.dtl.DTLVardef@e2a846org.highwire.dtl.DTLVardef@959a7aorg.highwire.dtl.DTLVardef@1d0f32dorg.highwire.dtl.DTLVardef@10d1c98org.highwire.dtl.DTLVardef@1d072fc_HPS_FORMAT_FIGEXP M_TBL C_TBL Definitions of terms O_TBL View this table: org.highwire.dtl.DTLVardef@2d1f1forg.highwire.dtl.DTLVardef@56337eorg.highwire.dtl.DTLVardef@14eb00aorg.highwire.dtl.DTLVardef@1076445org.highwire.dtl.DTLVardef@480e56_HPS_FORMAT_FIGEXP M_TBL C_TBL