Core Outcome Set and Reporting Checklist for Studies on Vasa Previa.
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IMPORTANCE: Vasa previa, although a rare condition affecting 0.46 per 1000 pregnancies, results in high rates of fetal and neonatal mortality and morbidity. Widespread use of a core outcome set and reporting checklist may enable data harmonization, enhance evidence synthesis, and ensure prioritization of patient-important outcomes in clinical practice, future research, and clinical practice guidelines. OBJECTIVE: To develop a core outcome set for studies on vasa previa that includes perinatal screening, diagnosis, and management of vasa previa. DESIGN, SETTING, AND PARTICIPANTS: This survey study involved a 2-round international and cross-disciplinary Delphi survey and virtual consensus meetings conducted between March 14, 2021, and October 4, 2022. Health care professionals (HCPs) and health service users (HSUs) were invited to participate in the development of the core outcome set. EXPOSURE: Perinatal screening, diagnosis, and management of vasa previa. MAIN OUTCOME AND MEASURES: Core outcomes and reporting checklist items for future studies on vasa previa were developed using Delphi surveys, small group discussions, and a consensus meeting. RESULTS: An international group of 204 participants, comprising 115 HSUs and 89 HCPs representing 27 countries, rated 67 outcomes identified through a systematic review and qualitative interviews in a 2-round online Delphi survey. Through virtual small group discussions and a consensus meeting, 13 core outcomes were identified: pregnancy outcome (live birth, fetal loss [miscarriage or stillbirth], or neonatal death), severe neonatal morbidity, fetal/neonatal blood loss, neonatal intensive care unit admission for >24 hours, gestational age at birth, third trimester confirmation of vasa previa diagnosis, neurocognitive and developmental outcomes, mode of birth, maternal death or severe morbidity, maternal quality of life, duration of antepartum admission, and antepartum or peripartum hemorrhage. A 22-item reporting checklist was simultaneously developed to include important items in studies on vasa previa when possible and/or relevant. CONCLUSIONS AND RELEVANCE: The core outcome set and reporting checklist for vasa previa are hoped to encourage researchers to incorporate patient-important outcomes in future studies to enable data harmonization, improve evidence synthesis, and facilitate the development of clinical practice guidelines for this rare and highly lethal condition for which timely diagnosis and management may prevent fetal and maternal morbidity and mortality.
