Comparison of Multi-Round and Real-Time Delphi Survey Methods

Study Overview
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Brief Summary
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A two-group parallel randomised trial of Delphi survey methods.

Detailed Description
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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.

Official Title
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Multi-round Compared to Real-Time Delphi for Consensus in Core Outcome Set (COS) Development: A Randomised Trial

Conditions
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Consensus Development

Intervention / Treatment
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* Other: Participation in a Delphi survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parents or caregivers of infants that have been diagnosed with and received treatment for neonatal encephalopathy healthcare providers including: neonatal nurse practitioners midwives 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. Exclusion Criteria: • participants not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two-group parallel randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-Time Delphi Method<br>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. | Other: Participation in a Delphi survey<br>* Participants will be asked to participate in an online Delphi survey (using one of two randomly allocated methods) to rate the importance of outcomes that should be measured to determine the effect of treatment for neonatal encephalopathy. Outcomes will be prioritised on their importance in a consensus-driven manner.<br>|
| Active Comparator: Multi-round Delphi Method<br>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. | Other: Participation in a Delphi survey<br>* Participants will be asked to participate in an online Delphi survey (using one of two randomly allocated methods) to rate the importance of outcomes that should be measured to determine the effect of treatment for neonatal encephalopathy. Outcomes will be prioritised on their importance in a consensus-driven manner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of outcomes prioritised within each survey arm | 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) | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feedback Effect | The feedback effect will tell if the feedback provided to participants resulted in them amending the rating they have to each outcome on the 9-point scale (higher scores= higher importance for inclusion in the COS) | Through study completion, an average of 14 weeks. | 
| Initial Condition Effect | The initial condition effect will capture if early participant's rating for each outcome on the 9-point scale ( higher scores= higher importance for inclusion in the COS) differs to rating given by later participants. | During the Real-Time Delphi intervention (5 weeks). | 
| Iteration Effect | The iteration effect will determine if there is a difference in how consensus is achieved on prioritising each outcome or not, between the Multi-Round and the Real-Time Delphi survey arms | Through study completion, an average of 14 weeks. | 
| Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set | Comparison of the of outcome headings prioritised at the end of both the Real-Time and Multi-Round Delphi processes with the outcome headings in the final Core Outcome Set. | Through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delphi, Real-Time Delphi, Multi-Round Delphi, Randomised Trial, Two-Group Parallel, Survey