National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK.
Southampton Children's Hospital, Southampton, UK.
Arch Dis Child Fetal Neonatal Ed. 2019 Jan;104(1):F76-F82. doi: 10.1136/archdischild-2017-314560. Epub 2018 Mar 14.
Outcome reporting heterogeneity impedes identification of gold standard treatments for children born with gastroschisis. Use of core outcome sets (COSs) in research reduces outcome reporting heterogeneity and ensures that studies are relevant to patients. The aim of this study was to develop a gastroschisis COS.
Systematic reviews and stakeholder nomination were used to identify candidate outcomes that were subsequently prioritised by key stakeholders in a three-phase online Delphi process and face-to-face consensus meeting using a 9-point Likert scale. In phases two and three of the Delphi process, participants were shown graphical and numerical representations of their own, and all panels scores for each outcome respectively and asked to review their previous score in light of this information. Outcomes were carried forward to the consensus meeting if prioritised by two or three stakeholder panels in the third phase of the Delphi process. The COS was formed from outcomes where ≥70% of consensus meeting participants scored the outcome 7-9 and <15% of participants scored it 1-3.
71 participants (84%) completed all phases of the Delphi process, during which 87 outcomes were assessed. Eight outcomes, mortality, sepsis, growth, number of operations, severe gastrointestinal complication, time on parenteral nutrition, liver disease and quality of life for the child, met criteria for inclusion in the COS.
Eight outcomes have been included in the gastroschisis COS as a result of their importance to key stakeholders. Implementing use of the COS will increase the potential for identification of gold standard treatments for the management of children born with gastroschisis.
结局报告的异质性阻碍了识别先天性腹裂患儿的金标准治疗方法。核心结局集（COS）在研究中的应用减少了结局报告的异质性，并确保研究与患者相关。本研究旨在制定先天性腹裂的 COS。
系统评价和利益相关者提名用于确定候选结局，然后由关键利益相关者在三阶段在线 Delphi 过程和使用 9 分 Likert 量表的面对面共识会议中对这些结局进行优先排序。在 Delphi 过程的第二和第三阶段，参与者分别看到了他们自己和所有小组每个结局的图形和数值表示，并被要求根据这些信息重新审查他们之前的分数。如果在 Delphi 过程的第三阶段有两个或三个利益相关者小组对某个结局进行了优先排序，则该结局将进入共识会议。COS 由≥70%的共识会议参与者对结局的评分在 7-9 之间且<15%的参与者对结局的评分在 1-3 之间的结局组成。
71 名参与者（84%）完成了 Delphi 过程的所有阶段，在此期间评估了 87 个结局。8 个结局，即死亡率、败血症、生长、手术次数、严重胃肠道并发症、肠外营养时间、肝脏疾病和患儿的生活质量，符合纳入 COS 的标准。
由于对关键利益相关者的重要性，8 个结局被纳入先天性腹裂的 COS。实施 COS 的使用将增加识别治疗先天性腹裂患儿的金标准治疗方法的潜力。
