Department of Obstetrics & Gynaecology, Division of Maternal-Fetal Medicine, Mount Sinai Hospital, University of Toronto, 3-908 - 700 University Avenue, Toronto, Ontario, M5G 1Z5, Canada.
Division of Cardiology, Schulich School of Medicine and Dentistry, Western University, London, Canada.
Trials. 2020 Mar 30;21(1):300. doi: 10.1186/s13063-020-04233-1.
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.
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.
研究心脏病女性及其婴儿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性，使得难以比较研究结果并得出有意义的结论。制定核心结局集（COS）——一个标准化的、必须在所有研究中收集和报告的最小结局集——是解决这一问题的实用方法。
方法/设计：我们将遵循五个步骤为患有心脏病的孕妇的研究制定 COS。首先，系统文献回顾将确定所有报告的结局（包括患者报告的结局）和定义。其次，对参与心脏病孕妇护理的利益相关者进行半结构化访谈，以确定他们的观点并增加他们认为重要的新结局。第三，国际电子 Delphi 调查将缩小前两步获得的结局，以试图达成共识。第四，面对面的共识会议将对 COS 进行审议以达成最终结论。最后，将通过一系列文献回顾和 Delphi 调查确定纳入结局的测量工具和定义。
本方案概述了制定心脏病孕妇研究中必须报告的 COS 所涉及的步骤，旨在协调结局报告，确保研究结果的有效性，不仅为临床实践和未来研究提供信息，还鼓励在其他医学领域制定 COS。COMET 核心结局集注册：http://www.comet initiative.org/studies/details/834。
