Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Institute for Women's Health, University College London, London, UK.
BJOG. 2020 Nov;127(12):1516-1526. doi: 10.1111/1471-0528.16319. Epub 2020 Jun 21.
To develop a core outcome set for pre-eclampsia.
Consensus development study.
International.
Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated.
Modified Delphi method and Modified Nominal Group Technique.
A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support.
The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies.
281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.].
制定子痫前期的核心结局集。
共识发展研究。
国际。
281 名医疗保健专业人员、41 名研究人员和 110 名患者代表 56 个国家参与了研究。
改良 Delphi 法和改良名义群体技术。
通过合并 79 项子痫前期试验报告的结局以及对 30 名有子痫前期经历的女性深入访谈的主题分析，制定了一份 116 项潜在核心结局的长清单。在 Delphi 过程中确定了 47 项共识结局，之后在共识发展会议上达成了 14 项母亲和 8 项后代核心结局。母亲核心结局：死亡、子痫、中风、皮质盲、视网膜脱离、肺水肿、急性肾损伤、肝血肿或破裂、胎盘早剥、产后出血、肝酶升高、血小板减少症、需要入住重症监护室、气管插管和通气。后代核心结局：死胎、分娩时的胎龄、出生体重、小于胎龄儿、新生儿死亡率、癫痫发作、需要入住新生儿病房和呼吸支持。
子痫前期的核心结局集应成为未来随机试验和系统评价的基础。这种实施应该确保未来的研究具有必要的范围和相关性，以告知临床实践，增强妇女的护理，并改善孕妇及其婴儿的结局。
281 名医疗保健专业人员、41 名研究人员和 110 名女性制定了#子痫前期核心结局 @HOPEoutcomes @jamesmnduffy。[2020 年 6 月 29 日在线更正：更正了顺序。]。
