Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol
Open Access
- 30 March 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 21 (1), 1-7
- https://doi.org/10.1186/s13063-020-04233-1
Abstract
Background Clinical studies looking at interventions to optimize pregnancy and long-term outcomes for women with cardiac disease and their babies are inconsistent in their reporting of clinical outcomes, making it difficult to compare results across studies and draw meaningful conclusions. The development of a core outcome set (COS)—a standardized, minimum set of outcomes that must be collected and reported in all studies—is a practical solution to this problem. Methods/design We will follow a five-step process in developing a COS for studies on pregnant women with cardiac disease. First, a systematic literature review will identify all reported outcomes (including patient-reported outcomes) and definitions. Second, semi-structured interviews with stakeholders involved in the care of pregnant women with cardiac disease will determine their perspective and add new outcomes that they consider important. Third, an international electronic Delphi survey will narrow outcomes obtained through the first two steps, in an attempt to arrive at a consensus. Fourth, a face-to-face consensus meeting will deliberate to finalize the COS. Finally, measurement tools and definitions for included outcomes will be determined through a series of literature reviews and Delphi surveys. Discussion This protocol provides an overview of the steps involved in the development of a COS that must be reported in studies involving pregnant women with cardiac disease, in an attempt to harmonize outcome reporting and ensure the validity of study results that will not only inform clinical practice and future research but also encourage the development of COS in other areas of medicine. COMET core outcome set registration http://www.comet initiative.org/studies/details/834Funding Information
- Tolnai Grant (410010150)
This publication has 22 references indexed in Scilit:
- High-Risk Cardiac Disease in PregnancyJournal of the American College of Cardiology, 2016
- High-Risk Cardiac Disease in PregnancyJournal of the American College of Cardiology, 2016
- Medical disease as a cause of maternal mortality: the pre-imminence of cardiovascular pathologyCardioVascular Journal of Africa, 2016
- Pregnancy-Related Mortality in the United States, 2006–2010Obstetrics & Gynecology, 2015
- MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi surveyTrials, 2013
- Developing core outcome sets for clinical trials: issues to considerTrials, 2012
- GRADE guidelines 6. Rating the quality of evidence—imprecisionJournal of Clinical Epidemiology, 2011
- GRADE guidelines: 2. Framing the question and deciding on important outcomesJournal of Clinical Epidemiology, 2011
- Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing StudiesPLoS Medicine, 2011
- The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi studyQuality of Life Research, 2010