文章基本信息

标题：Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol
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作者：Rohan D’Souza ; Chelsea Hall ; Mathew Sermer 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2020
卷号：21
期号：1
页码：300-306
DOI：10.1186/s13063-020-04233-1
出版社：BioMed Central
摘要：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/834.
关键词：Cardiac disease;Core outcome set;Delphi Survey;Outcome reporting;Patient-reported outcomes;Pregnancy;Qualitative research