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.
ContributorsPrincipal 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.