Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, University of London, London, UK.
Ultrasound Obstet Gynecol. 2019 Aug;54(2):255-261. doi: 10.1002/uog.20183. Epub 2019 Jul 11.
To develop, using a Delphi procedure and a nominal group technique, a core outcome set (COS) for studies evaluating treatments for twin-twin transfusion syndrome (TTTS), which should assist in standardizing outcome selection, collection and reporting in future research studies.
An international steering group comprising healthcare professionals, researchers and patients with experience of TTTS guided the development of this COS. Potential core outcomes, identified through a comprehensive literature review and supplemented by outcomes suggested by the steering group, were entered into a three-round Delphi survey. Healthcare professionals, researchers, and patients or relatives of patients who had experienced TTTS were invited to participate. Consensus was defined a priori using the 15%/70% definition of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The modified nominal group technique was used to evaluate the consensus outcomes in a face-to-face consultation meeting and identify the final COS.
One hundred and three participants, from 29 countries, participated in the three-round Delphi survey. Of those, 88 completed all three rounds. Twenty-two consensus outcomes were identified through the Delphi procedure and entered into the modified nominal group technique. The consensus meeting was attended by 11 healthcare professionals, two researchers and three patients; 12 core outcomes were prioritized for inclusion in the COS. Fetal core outcomes included live birth, pregnancy loss (including miscarriage, stillbirth, termination of pregnancy and neonatal mortality), subsequent death of a cotwin following single-twin demise at the time of treatment, recurrence of TTTS, twin anemia-polycythemia sequence and amniotic band syndrome. Neonatal core outcomes included gestational age at delivery, birth weight, brain injury syndromes and ischemic limb injury. Maternal core outcomes included maternal mortality and admission to Level-2 or -3 care setting. One aspirational outcome, neurodevelopment at 18-24 months of age, was also prioritized.
Implementing the COS for TTTS within future research studies could make a substantial contribution to advancing the usefulness of research in TTTS. Standardized definitions and measurement instruments are now required for individual core outcomes. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.
采用德尔菲法和名义群体技术，为评估双胎输血综合征（TTTS）治疗方法的研究制定核心结局集（COS），以协助规范未来研究中结局的选择、采集和报告。
由具有 TTTS 诊治经验的医护人员、研究人员和患者组成的国际指导小组指导了本 COS 的制定。通过全面的文献回顾确定潜在的核心结局，并由指导小组补充建议的结局，将这些结局纳入三轮德尔菲调查。邀请医护人员、研究人员以及经历 TTTS 的患者或其亲属参与调查。采用核心结局测量有效性试验（COMET）倡议中预先设定的 15%/70%定义来确定共识。采用改良的名义群体技术在面对面的咨询会议上对共识结局进行评估，并确定最终的 COS。
共有来自 29 个国家的 103 名参与者参加了三轮德尔菲调查，其中 88 名完成了全部三轮调查。通过德尔菲法确定了 22 个共识结局，并将其纳入改良的名义群体技术。11 名医护人员、2 名研究人员和 3 名患者参加了共识会议，会议确定了 12 个核心结局纳入 COS。胎儿结局包括活产、妊娠丢失（包括流产、死胎、终止妊娠和新生儿死亡）、治疗时一胎死亡后另一胎的后续死亡、TTTS 复发、双胎贫血-红细胞增多序列和羊膜带综合征。新生儿结局包括分娩时的胎龄、出生体重、脑损伤综合征和缺血性肢体损伤。产妇结局包括产妇死亡率和入住 2 级或 3 级护理机构。同时还确定了一个期望结局，即 18-24 月龄时的神经发育。
在未来的研究中实施 TTTS 的 COS 将对提高 TTTS 研究的实用性做出重要贡献。现在需要为各个核心结局制定标准化的定义和测量工具。版权所有 © 2018 ISUOG。由约翰威立父子出版公司出版。
