Background
Maternal and perinatal health is often directly and indirectly affected during infectious disease epidemics. Yet, a lack of evidence on epidemics' impact on women and their offspring delays informed decision-making for healthcare providers, pregnant women, women in the post-pregnancy period and policy-makers. To rapidly generate evidence in these circumstances, we aim to develop a Core Outcome Set (COS) for maternal and perinatal health research and surveillance in light of emerging and ongoing epidemic threats.
Methods
We will conduct a Systematic Review and a four-stage modified Delphi consensus. The systematic literature review will aim to inform experts on outcomes reported in maternal and perinatal research and surveillance during previous epidemics. The expert consensus will involve two individual, anonymous online surveys to rate outcomes' importance and suggest new outcomes, one virtual meeting to discuss disagreements, and one in-person meeting to agree on the final COS, outcomes definitions and measurement methods. Four panels will be established to participate in the modified Delphi with expertise in (a) maternal and perinatal health, (b) neonatal health, (c) public health and emergency response, and (d) representation of civil society. We will recruit at least 20 international experts for each stakeholder group, with diverse backgrounds and gender, professional, and geographic balance. Only highly-rated outcomes - with at least 80% of ratings being 7–9 on a 9-point Likert scale and no more than 10% of low ratings (1–3) - will be included in the final COS.
Discussion and conclusions
The focus of our COS encompasses maternal and perinatal health outcomes to be measured in research and surveillance in the context of emerging and ongoing epidemic threats. It will be suitable for epidemiological research, product development, and post-authorization surveillance, and it will propose outcomes related to disease burden, vertical transmission, and delivery of care.
Implementing this COS in future maternal and perinatal research and surveillance, in the context of emerging and ongoing epidemic threats, will facilitate the rapid and systematic generation of evidence. It will also enhance the ability of policy-makers, healthcare providers, pregnant women and women in the post-pregnancy period and their families to make well-informed choices in challenging circumstances.
Setting for intended use: The COS will be applicable to epidemiological, clinical, and post-authorization research and surveillance studies
Health area: Infectious diseases with the potential to develop into outbreaks, epidemics and / or pandemics
Target population: Pregnant women, women in the postpartum or post-pregnancy period (age 10-49), and their offspring (embryos, fetuses, neonates from 0 to 28 days after birth)
Principal investigator:
- Mercedes Bonet, World Health Organization (WHO), HRP (Human Reproduction Program)
Collaborators:
- Juan Pedro Alonso, Institute of clinical effectiveness and health policy (IECS: iecs.org.ar)
- Mabel Berrueta, IECS
- Magdalena Babinska, WHO
- María Belizán, IECS
- Agustín Ciapponi, IECS
- Karen Klein, IECS
- Agustina Mazzoni, IECS
- Vanesa Ortega, IECS
- Verónica Pingray, IECS
Disease Category: Infectious disease, Pregnancy & childbirth
Disease Name: N/A
Age Range: 10 - 49
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Device manufacturers
- Epidemiologists
- Ethicists
- Funders
- Governmental agencies
- Individuals with a known interest
- Methodologists
- Other
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service commissioners
- Service providers
- COS for clinical trials or clinical research
- COS (Other)
- Consensus meeting
- Delphi process
- Systematic review
- Literature review
- A systematic review to identify outcomes reported in maternal and perinatal research and surveillance during previous epidemics.
- A literature review on outcome definitions, measurement instruments and the feasibility to measure selected outcomes.
- A four-stage modified Delphi consensus: two individual, anonymous online surveys to rate outcomes' importance and suggest new ones, one virtual meeting to discuss disagreements, and one in-person meeting to agree on the final COS, outcomes definitions and measurement methods.