Health Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland.
Health Research Board - Trials Methodology Research Network (HRB-TMRN), Galway, Ireland.
Trials. 2021 Feb 15;22(1):142. doi: 10.1186/s13063-021-05074-2.
The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants' survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process. For this reason, the Delphi method is popular as a consensus building approach in developing core outcome sets (COS), i.e. the minimum agreed set of standardised outcomes that should be measured and reported in studies on a specific health condition. In a COS setting, participants prioritise the importance of outcomes for inclusion in a COS. This usually involves participating in multiple rounds of a survey that can span several weeks or months. Challenges with participant retention have been highlighted in previous COS. We will compare a three-round with a Real-Time Delphi approach on prioritised outcomes. This trial is embedded within the COHESION study which is developing a COS for interventions treating neonatal encephalopathy.
One hundred and eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either the Multi-Round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects.
This trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods.
NCT04471103 . Registered on 14 July 2020.
德尔菲法在各种环境中被广泛用于就重要问题达成共识的方法。传统上，德尔菲法使用多轮调查，以便在轮次之间反馈其他参与者的调查回复。通过告知参与者其他人如何回答问题或对特定主题进行优先级排序，可以让不同的意见为共识过程提供信息。出于这个原因，德尔菲法在制定核心结局集（COS）方面很受欢迎，即应在特定健康状况的研究中测量和报告的标准化结局的最小商定集。在 COS 环境中，参与者对纳入 COS 的结局的重要性进行优先级排序。这通常涉及参与多轮调查，这些调查可能会持续数周或数月。以前的 COS 已经强调了参与者保留方面的挑战。我们将比较三轮和实时德尔菲法在优先结局方面的效果。这项试验嵌入在 COHESION 研究中，该研究正在制定治疗新生儿脑病的干预措施的 COS。
180 名利益相关者（新生儿脑病诊断和治疗的婴儿的父母/照顾者、医疗保健提供者和研究人员）将使用分层随机化方法随机分配到多轮或实时德尔菲组。利益相关者将在两个组中对同一组结局的重要性进行评分。我们将比较两次调查结束时的优先结局，以及其他参数，如反馈、初始条件和迭代效果。
这项试验将提供证据，为使用多轮与实时德尔菲调查方法做出决策提供信息。
NCT04471103。于 2020 年 7 月 14 日注册。
