Pingray Verónica, Klein Karen, Alonso Juan Pedro, Belizan María, Babinska Magdalena, Alger Jackeline, Barsosio Hellen C, Blackburn Kara, Bolaji Olufunke, Carson Courtney, Castiglioni Sofia, De Luca Daniele, Dhaded Sangappa, Engmann Cyril, Escobar Vidarte María Fernanda, Escuriet Ramón, Kara Edna, Kim Caron Rahn, Knight Marian, Lamprianou Smaragda, Lota Maria Margarita, Mader Silke, Madrid Lola, Marcone Alessandra L, Mazzoni Agustina, Montenegro Rangel Mirna, Mukisa-Bisoborwa Rose, Munoz Flor M, Okomo Uduak, Okong Pius, Ortega Vanesa, Salva Florencia A, Schwartz David A, Sudjaritruk Tavitiya, Yates Laura, Younus Manal, Zafar Noreen, Oladapo Olufemi T, Berrueta Mabel, Bonet Mercedes
Department of Maternal and Child Health, Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.
Unit of Qualitative Health Research, Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.
EClinicalMedicine. 2025 Jan 15;80:103025. doi: 10.1016/j.eclinm.2024.103025. eCollection 2025 Feb.
Disease outbreaks significantly affect maternal and neonatal health. Variability in reporting health outcomes hinder evidence generation. We aimed to develop a core outcome set (COS) for maternal and neonatal health research and surveillance during emerging and ongoing epidemic threats and to agree on outcomes' definitions.
We conducted a systematic review of observational and experimental studies related to epidemics to identify outcomes, and a four-stage modified-Delphi consensus. 150 international stakeholders participated in online surveys, and 24 representatives in consensus meetings. The panels were diverse, with balanced representation of professional background, gender, and geography, including civil society representatives. Outcome were included if ≥ 80% of participants scored them as critically important and ≤10% rated them as not important.
The final COS includes seven main maternal outcomes-pregnancy outcome, maternal death, suspected symptomatic infection, confirmed infection, severe disease, preterm delivery, mode of birth; seven complementary maternal outcomes-antepartum haemorrhage, postpartum haemorrhage, hypertensive disorders of pregnancy, maternal sepsis, admission to intensive care unit/special units, respiratory support, depression and anxiety; 11 main neonatal outcomes-neonatal death, neonatal suspected symptomatic infection, confirmed infection, severe disease, vertical transmission, low birth weight, prematurity, congenital disorder, respiratory support, skin-to-skin contact, breastfeeding; and, four complementary neonatal outcomes-admission to neonatal intensive care unit/special units, respiratory failure, birth asphyxia, sepsis.
This COS could contribute to standardize maternal and neonatal outcomes selection and reporting in observational and experimental studies, facilitating efficient data comparison and timely evidence-based decision-making in the context of ongoing and emerging epidemic threats.
Bill & Melinda Gates Foundation (grant INV-041181) and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (HQHRP2422779).
疾病暴发对孕产妇和新生儿健康有重大影响。健康结果报告的差异阻碍了证据的生成。我们旨在制定一套核心结局集（COS），用于在新出现和持续存在的疫情威胁期间进行孕产妇和新生儿健康研究及监测，并就结局的定义达成共识。
我们对与疫情相关的观察性和实验性研究进行了系统综述，以确定结局，并开展了一个四阶段的改良德尔菲共识法。150名国际利益相关者参与了在线调查，24名代表参加了共识会议。各小组人员构成多样，在专业背景、性别和地域方面有均衡的代表性，包括民间社会代表。如果≥80%的参与者将某个结局评为至关重要，且≤10%的参与者将其评为不重要，则该结局被纳入。
最终的核心结局集包括七个主要孕产妇结局——妊娠结局、孕产妇死亡、疑似有症状感染、确诊感染、重症疾病、早产、分娩方式；七个补充孕产妇结局——产前出血、产后出血、妊娠高血压疾病、孕产妇败血症、入住重症监护病房/特殊病房、呼吸支持、抑郁和焦虑；11个主要新生儿结局——新生儿死亡、新生儿疑似有症状感染、确诊感染、重症疾病、垂直传播、低出生体重、早产、先天性疾病、呼吸支持、皮肤接触、母乳喂养；以及四个补充新生儿结局——入住新生儿重症监护病房/特殊病房、呼吸衰竭、出生窒息、败血症。
这个核心结局集有助于在观察性和实验性研究中规范孕产妇和新生儿结局的选择及报告，便于在持续和新出现的疫情威胁背景下进行有效的数据比较和及时的循证决策。
比尔及梅琳达·盖茨基金会（资助编号INV-041181）以及联合国开发计划署/联合国人口基金/联合国儿童基金会/世界卫生组织/世界银行人类生殖特别研究、发展和研究培训计划（HRP），这是一个由世界卫生组织共同赞助执行的计划（HQHRP2422779）。
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