Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

Abstract

Introduction Increasingly more pregnant women are living with pre-existing multimorbidity (≥2 long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a COS for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings. Methods and analysis We propose a four stage study design: 1) systematic literature search, 2) focus groups, 3) Delphi surveys, and 4) consensus group meeting. The study will be conducted from June 2021 – August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted amongst 1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners), and 2) their health/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include 1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, 2) health/social care professionals involved in their care, and 3) researchers in this field. Ethics and dissemination This study has been approved by the University of Birmingham’s Ethical Review Committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders.