What to Measure – and Why: COSCarP Brings Clarity to Cardio-Obstetrics Research
Research into cardiac disease in pregnancy has long been marked by inconsistency. Studies have defined outcomes differently, reported selectively, and often overlooked the very impacts patients care about most. The result: a fragmented evidence base that limits both understanding and application.
A newly published core outcome set, developed to address these gaps, offers a structured way forward.
Co-developed by the Outcome Reporting in Obstetric Studies (OROS) initiative, a part of the FLOURISH research group at McMaster University, COSCarP – the Core Outcome Set for Studies on Cardiac Disease in Pregnancy – identifies 12 core outcomes and 12 reporting checklist items, with flexibility to include additional measures relevant to specific conditions or patient concerns, in an attempt to incorporate patient-important outcomes in all future research on pregnancy and heart disease.
“Without consistency, we cannot compare studies. And without comparability, research struggles to inform care,” said Rohan D’Souza, senior author of the study and associate professor in the Departments of Obstetrics & Gynecology and Health Research Methods, Evidence, and Impact (HEI). “COSCarP is designed to bring clarity, coherence, and relevance to how cardio-obstetrics is studied.”
This work is the product of a two-year international consensus process involving 110 participants across 13 countries. Following best-practice guidance for core outcome set development, the team conducted a systematic review of 422 studies, followed by qualitative interviews, two Delphi survey rounds, and consensus meetings.
Crucially, people with lived experience of cardiac disease in pregnancy were embedded throughout the process – not as token voices, but as participants whose perspectives directly shaped the outcome set.
“Individuals shared concerns that are often absent from clinical trial design,” said Rizwana Ashraf, co-lead author and research coordinator with FLOURISH. “They spoke about long-term quality of life, the impact on their infants, side effects, fear of recurrence – outcomes that carry real weight in decision-making but are often excluded from reporting.”
Ashraf describes the project as an attempt to ensure cardio-obstetrics research reflects both clinical priorities and lived realities. “We wanted the final checklist to support better reporting, yes—but also to reflect the full scope of what matters. That meant asking researchers and patients to challenge assumptions about what should be measured.”
COSCarP is not a fixed requirement or prescriptive tool. It is a publicly available reference – developed through rigorous consensus – to support clearer outcome selection and reporting in future research.
“It is not meant to be static,” said Ashraf. “It offers a foundation that others can build on – practical, adaptable, and grounded in what both evidence and experience have shown to matter.”
A fillable version of the core outcome set and checklist can be accessed here.
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