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. 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. 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. http://www.comet initiative.org/studies/details/834

中文翻译：

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妊娠心脏疾病研究核心结果集（COSCarP）的开发：研究方案

旨在优化心脏疾病妇女及其婴儿的妊娠和长期结局的干预措施的临床研究在报告临床结局方面存在不一致之处，因此难以比较各个研究的结果并得出有意义的结论。核心结果集（COS）（在所有研究中必须收集和报告的标准化，最小结果集）的开发是解决此问题的切实可行的方法。我们将按照五个步骤开发用于研究心脏病孕妇的COS。首先，系统的文献综述将确定所有报告的结果（包括患者报告的结果）和定义。第二，与参与心脏病孕妇治疗的利益相关者进行的半结构式访谈将确定他们的观点，并增加他们认为重要的新结果。第三，Delphi国际电子调查将缩小通过前两个步骤获得的结果，以期达成共识。第四，将举行一次面对面的共识会议以最终确定COS，最后，将通过一系列文献综述和Delphi调查确定包括结果的测量工具和定义。该协议概述了开发COS所涉及的步骤，在涉及心脏病的孕妇的研究中必须报告这些步骤，试图统一结果报告并确保研究结果的有效性，这不仅可以为临床实践和未来研究提供信息，还可以鼓励在其他医学领域发展COS。http：//www.comet Initiative.org/studies/details/834