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. 2025 Jan 15:80:103025.
doi: 10.1016/j.eclinm.2024.103025. eCollection 2025 Feb.

A core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS): a modified Delphi-based international consensus

Verónica Pingray  1 , Karen Klein  1 , Juan Pedro Alonso  2 , María Belizan  2 , Magdalena Babinska  3 , Jackeline Alger  4   5 , Hellen C Barsosio  6 , Kara Blackburn  7 , Olufunke Bolaji  8 , Courtney Carson  9 , Sofia Castiglioni  10 , Daniele De Luca  11   12 , Sangappa Dhaded  13 , Cyril Engmann  14   15 , María Fernanda Escobar Vidarte  16 , Ramón Escuriet  17 , Edna Kara  3 , Caron Rahn Kim  3 , Marian Knight  18 , Smaragda Lamprianou  19 , Maria Margarita Lota  20 , Silke Mader  21 , Lola Madrid  22 , Alessandra L Marcone  10 , Agustina Mazzoni  1 , Rangel Mirna Montenegro  23 , Rose Mukisa-Bisoborwa  24 , Flor M Munoz  25 , Uduak Okomo  26 , Pius Okong  27 , Vanesa Ortega  1 , Florencia A Salva  1 , David A Schwartz  28 , Tavitiya Sudjaritruk  29 , Laura Yates  30   31 , Manal Younus  32 , Noreen Zafar  33 , Olufemi T Oladapo  3 , Mabel Berrueta  1 , Mercedes Bonet  3
Affiliations

A core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS): a modified Delphi-based international consensus

Verónica Pingray et al. EClinicalMedicine. .

Abstract

Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: 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).

Keywords: Consensus; Core outcome set; Epidemics; Maternal health; Neonatal health.

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Conflict of interest statement

MK disclosed receiving grants from the National Institute for Health Research and the Healthcare Quality Improvement Programme, both awarded to their institution. SM disclosed serving as a member of the European Foundation for the Care of Newborn Infants (EFCNI), holding positions on both the Trustee Board and the Executive Board. These roles are unpaid. FM disclosed receiving a grant or contract from Pfizer for COVID-19 vaccine research (paid to her institution) and serving on a Data Safety Monitoring Board/Advisory Board for Pfizer and Moderna concerning RSV and other vaccines. LY disclosed receiving a five-year grant from IMI ConcePTION, which included part-time salary support to undertake project-related work as part of her job plan. Additionally, she provided consultancy services for Sanofi Genzyme South Africa on two occasions: one concerning genetic testing in Gaucher's Disease and the other involving a conference lecture on genetic testing in cardiac clinics. CE disclosed that their flight and per diem expenses for attending the in-person consensus meeting were covered by the project, while RE disclosed receiving payment for attending the consensus meeting. MBon and OTO disclosed receiving support for the present manuscript from the Bill & Melinda Gates Foundation through funding provided to their organization (WHO). All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the Modified-Delphi study process.
Fig. 2
Fig. 2
Geographical distribution of participants. Disclaimer: The boundaries and names shown and the designations used on this map do not imply official endorsement or acceptance by the World Health Organization. Note: The figure on the left represents the countries of residence of the participants from Delphi Round 1 (N = 150), grouped by WHO region. This geographic distribution was roughly maintained through Delphi Round 2 which had 141 participants (94% retention rate). Figure created with Datawrapper.
Fig. 3
Fig. 3
Flowchart of the outcomes selection process.
See this image and copyright information in PMC

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