Allin Benjamin, Ross Andrew, Marven Sean, J Hall Nigel, Knight Marian
National Perinatal Epidemiology Unit, University of Oxford, Richard Doll Building, Old Road Campus, Oxford, OX3 7LF, England.
Oxford University Hospitals NHS Trust, Headley Way, Headington, Oxford, OX3 9DU, England.
Trials. 2016 Jul 27;17:360. doi: 10.1186/s13063-016-1453-7.
Gastroschisis research is limited in quality by the presence of significant heterogeneity in outcome measure reporting (PloS One 10(1):e0116908, 2015). Using core outcome sets in research is one proposed method for addressing this problem (Trials 13:103, 2012; Clin Rheumatol 33(9):1313-1322, 2014; Health Serv Res Policy 17(1):1-2, 2012). Ultimately, standardising outcome measure reporting will improve research quality and translate into improvements in patient care.
METHODS/DESIGN: Candidate outcome measures have been identified through systematic reviews. These outcome measures will form the starting point for an online, three-phase Delphi process that will be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel, panel 2 is a non-neonatal panel and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1-9 based on how important they think the measures are in determining the overall success of their/their child's/their patient's gastroschisis treatment. In round 2, experts will be presented with the same list of outcome measures and with graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. The results of the Delphi process will be discussed, and outcomes re-scored. Outcome measures where > 70 % of the participants at the meeting scored them as 7-9 and < 15 % scored them as 1-3 will form the core outcome set.
Development of a core outcome set will help to reduce the heterogeneity of the outcome measure reporting in gastroschisis. This will increase the quality of research taking place and ultimately improve care provided to infants with gastroschisis.
腹裂研究的质量受结局指标报告中显著异质性的限制（《公共科学图书馆·综合》10(1):e0116908, 2015）。在研究中使用核心结局指标集是解决这一问题的一种提议方法（《试验》13:103, 2012；《临床风湿病学》33(9):1313 - 1322, 2014；《卫生服务研究政策》17(1):1 - 2, 2012）。最终，使结局指标报告标准化将提高研究质量，并转化为患者护理的改善。
方法/设计：通过系统评价确定了候选结局指标。这些结局指标将作为一个在线的、分三个阶段的德尔菲法流程的起点，该流程将由三个专家小组并行开展。小组1是新生儿小组，小组2是非新生儿小组，小组3是外行小组。在第一轮中，将要求专家根据他们认为这些指标在确定其/其孩子/其患者腹裂治疗的总体成功方面的重要程度，对先前确定的结局指标从1到9进行评分。在第二轮中，将向专家展示相同的结局指标列表以及他们小组在第一轮中对该结局指标的评分的图形表示。将要求他们在考虑小组其他成员认为该指标的重要程度的情况下，对结局指标重新评分。在第三轮中，将再次要求专家对每个结局指标重新评分，但这次他们将收到来自所有三个小组的评分分布的图形表示，他们在重新评分时应予以考虑。在德尔菲法流程的第三轮之后，将邀请40位专家参加面对面的共识会议。将以有目的的方式邀请参与者，以在不同小组之间取得平衡。将讨论德尔菲法流程的结果，并对结局指标重新评分。在会议上，超过70%的参与者将其评为7 - 9分且低于15%的参与者将其评为1 - 3分的结局指标将构成核心结局指标集。
核心结局指标集的制定将有助于减少腹裂结局指标报告的异质性。这将提高正在进行的研究的质量，并最终改善为腹裂婴儿提供的护理。
