Multi-round Compared to Real-Time Delphi for Consensus in Core Outcome Set (COS) Development: A Randomised Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Comparison of outcomes prioritised within each survey arm
研究概览
简要总结
A two-group parallel randomised trial of Delphi survey methods.
详细描述
Aim:
The aim of this trial is to compare a multi-round Delphi survey method with a Real-Time Delphi method on prioritised outcomes included in a core outcome set (COS). This trial is embedded within the COHESION study which is developing a COS for interventions for the treatment of neonatal encephalopathy.
Methods:
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 a 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •parents or caregivers of infants that have been diagnosed with and received treatment for neonatal encephalopathy
- •healthcare providers including:
- •neonatal nurse practitioners
- •obstetricians
- •neonatologists/paediatricians
- •neonatal/paediatric neurologists
- •general practitioners who provide long-term care for children with neonatal encephalopathy
- •policymakers
- •researchers/ academics with expertise in neonatal encephalopathy treatment.
排除标准
- •participants not meeting the inclusion criteria
研究组 & 干预措施
Real-Time Delphi Method
The Real-Time Delphi Method involves a single-round Delphi survey rating the importance of outcomes for neonatal encephalopathy. Feedback on each outcome (participant's own rating score, rating of the outcome by stakeholder group and overall consensus results for that outcome) will be provided to the participant once they have rated an outcome. They can then modify how they rated the outcome based on this feedback if they wish. Participants can also re-visit and re-rate outcomes as many times as they wish when the survey is live. Duration will span approximately 5 weeks.
干预措施: Participation in a Delphi survey (Other)
Multi-round Delphi Method
The Multi-Round Delphi Method involves a three-round Delphi survey rating the importance of outcomes for neonatal encephalopathy. Feedback on each outcome (participant's own rating score, rating of the outcome by stakeholder group and overall consensus results for that outcome) will be provided to the participant at the end of Round 1 and the end of Round 2. Participants can then modify how they rated the outcome based on feedback, in Rounds 2 and 3, if they wish. Each survey Round will run for 3 weeks approximately. In between survey Rounds, there will be a downtime of approximately 10 days before providing feedback and a further 7 days before starting the next round. Duration will span approximately 14 weeks.
干预措施: Participation in a Delphi survey (Other)
结局指标
主要结局
Comparison of outcomes prioritised within each survey arm
时间窗: End of both surveys (i.e. when the Multi-Round Delphi round 3 has finished and when the Real-Time Delphi has finished at the end of week 5).
Comparison of outcomes prioritised by respondents at the end of (i) the Real-time and (ii) multi-round Delphi processes. An outcome is judged 'prioritised' based on the proportion of respondents rating the outcome a 7-9 (inclusive) on a 9-point Likert scale (higher scores = higher importance for inclusion in the COS)
次要结局
- Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set(Through study completion, an average of 1 year.)
- Iteration Effect(Through study completion, an average of 14 weeks.)
- Feedback Effect(Through study completion, an average of 14 weeks.)
- Initial Condition Effect(During the Real-Time Delphi intervention (5 weeks).)
研究者
Prof. Declan Devane
Scientific Director
Health Research Board - Trials Methodology Research Network