Duffy James M N, Cairns Alexandra E, Magee Laura A, von Dadelszen Peter, van 't Hooft Janneke, Gale Chris, Brown Mark, Chappell Lucy C, Grobman William A, Fitzpatrick Ray, Karumanchi S Ananth, Lucas D Nuala, Mol Ben, Stark Michael, Thangaratinam Shakila, Wilson Mathew J, Williamson Paula R, Ziebland Sue, McManus Richard J
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom; Institute for Women's Health, University College London, London, United Kingdom.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
Pregnancy Hypertens. 2020 Jul;21:208-217. doi: 10.1016/j.preghy.2020.06.005. Epub 2020 Jun 20.
To develop consensus definitions for the core outcome set for pre-eclampsia.
Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group.
Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring.
Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0.
制定子痫前期核心结局集的共识定义。
在四项正式定义制定倡议、九项国家和国际指南、十二项Cochrane系统评价以及79项随机试验中确定了各个核心结局的潜在定义。86个定义被纳入共识制定会议。十名医疗保健专业人员和三名研究人员参与了共识制定过程，其中包括六名在低收入和中等收入国家有研究经验的参与者。最终的核心结局集由一个国际指导小组批准。
为所有核心结局制定了共识定义。在考虑中风、肺水肿、急性肾损伤、肝酶升高、血小板减少、出生体重和新生儿惊厥时，由于包括计算机断层扫描、胸部X光、实验室检查、设备和脑电图监测在内的诊断干预措施在低收入和中等收入国家的可及性有限，因此专门为这些国家制定了共识定义。
子痫前期核心结局集测量方法的共识将有助于确保未来随机试验和系统评价的一致性。这种标准化应使研究证据更容易获取，并促进研究成果转化为临床实践。视频摘要可在以下网址获取：www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0 。
