BACKGROUND:
Outcome reporting in cardio-obstetrics studies is inconsistent. The objective of the COSCarP (Core Outcome Set on Cardiac Diseases in Pregnancy) study was to develop a core outcome set through international consensus and harmonize outcome reporting in cardio-obstetrics studies.
METHODS:
We conducted a multimethod study between February 2021 and April 2023 that included an online 2-round Delphi survey, 3 small group discussions and a consensus meeting with health service users (people with lived experience of pregnancy and heart disease) and health care professionals.
RESULTS:
A total of 110 participants (22 health service users and 88 health care professionals) from 13 countries in Africa, Asia, Europe, and North America scored 71 candidate items obtained through literature reviews and qualitative interviews. Participants identified 12 core outcomes and 12 core reporting checklist items (which may not always represent outcomes) for inclusion in all cardio-obstetrics studies. Core outcomes included: maternal mortality, cardiac arrest, cerebrovascular events, heart failure, arrhythmias requiring treatment or change in treatment, thromboembolism, syncope, maternal intensive care unit admission, cardiovascular interventions, fetal/neonatal loss (miscarriage, stillbirth, neonatal death), severe neonatal morbidity, and prolonged neonatal intensive care unit admission. Reporting checklist items included: hypertensive disorders, major bleeding, anesthetic complications, adverse reactions, labor and birth details, maternal hospitalization and re-admissions, treatment compliance, fetal growth restriction, congenital malformations, gestational age at birth, and nonsevere neonatal morbidity. Participants also identified 7 condition-specific outcomes and 7 other patient-important outcomes, which may be challenging to measure in all studies and should be reported when feasible and relevant.
CONCLUSIONS:
The COSCarP study has identified core outcomes, reporting checklist items, and patient-important outcomes, which researchers are encouraged to measure and report in future cardio-obstetrics studies. Widespread use of the COSCarP checklists could support data harmonization, enable meaningful comparisons between studies, facilitate meta-analyses, and ensure that future guidelines incorporate patient-important outcomes while making clinical practice recommendations.
Increasing number of women with cardiac disease are undergoing pregnancy as a result of diagnostic and treatment advances during childhood and adolescence. The profound cardiovascular changes during pregnancy pose unique challenges to women with pre-existing cardiac disease and result in significant maternal and offspring morbidity and mortality. Trials and cohort studies evaluating therapeutic interventions in women with cardiac disease report many different outcomes resulting in significant outcome reporting bias and an inability to compare results across studies. The development and use of core outcome sets would help to address these issues.
ContributorsRizwana Ashraf, Yun Zhi He, Candice K Silversides, Samuel C Siu, Mathew Sermer, Anish Keepanasseril, Meron Seyoum, Isabelle Malhamé, Rohan D'Souza
Principal Investigator:
Rohan D’Souza
Assistant Professor, Division of Maternal and Fetal Medicine, Department of Obstetrics & Gynaecology, Mount Sinai Hospital, University of Toronto, Toronto, Canada
Collaborators:
Candice Silversides (Supervisor and cardiology content expert)
Head, Obstetric Medicine Program, Division of Cardiology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, Canada
Mathew Sermer (Supervisor and obstetric content expert)
Professor, Division of Maternal and Fetal Medicine, Department of Obstetrics & Gynaecology, Mount Sinai Hospital, University of Toronto, Toronto, Canada
James Duffy (Supervisor and methodological content expert)
NIHR Doctoral Fellow, Balliol College, Oxford, UK
Samuel Siu (Collaborator)
Professor of Medicine, Cardiologist, Schulich School of Medicine & Dentistry, Western University, London, Canada
Catriona Bhagra (Collaborator)
Clinical Fellow in Adult Congenital Heart Disease in pregnancy, Division of Cardiology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, Canada
Robin Thurman (Collaborator)
Maternal Fetal Medicine Fellow, Division of Maternal and Fetal Medicine, Department of Obstetrics & Gynaecology, Mount Sinai Hospital, University of Toronto, Toronto, Canada
Paula Williamson (collaborator)
MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom
Disease Category: Heart & circulation, Pregnancy & childbirth
Disease Name: Cardiovascular Disease
Age Range: 18 - 55
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Guideline developers
- Journal editors
- Researchers
- Service providers
- Statisticians
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
Step-I- Systematic Review: A systematic literature review will be undertaken to explore all reported outcomes in studies involving pregnant women with cardiac disease, and will generate a preliminary list of outcomes that are deemed important and hence reported by researchers. Three bibliographic databases - Medline, Embase and Web of Science will be searched from inception.
Step-II- Stakeholder Interviews: In addition to identifying outcomes reported by researchers, we will invite four subgroups of individuals to participate in either semi-structured focus group interviews or individual one-on-one interviews to identify clinical health outcomes that they consider important. Subgroups include 1) patients and patient advocates, 2) healthcare providers, 3) researchers, epidemiologists and methodologists and 4) other stakeholders directly or indirectly involved in the care of pregnant women.
Step-III: Delphi Methodology: The long-list of outcomes generated by Steps I and II will be reviewed to create a shorter list of outcomes for the online Delphi Survey. The Delphi Survey will be disseminated to all stakeholder groups in an attempt to arrive at a consensus. There will be two rounds of the Delphi Survey.
Step-IV: Consensus Group Meeting: The Delphi Survey will be followed by a face-to-face consensus meeting to resolve outstanding outcomes, and establish final core outcome set.