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

Not Applicable

• Conditions: Consensus Development
• Interventions: Other: Participation in a Delphi survey

• Registration Number: NCT04471103
• Lead Sponsor: National University of Ireland, Galway, Ireland

Brief Summary

A two-group parallel randomised trial of Delphi survey methods.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-15
• Study Start: 2021-08-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-Time Delphi Method	Participation in a Delphi survey	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.
Multi-round Delphi Method	Participation in a Delphi survey	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.

Primary Outcome Measures

Name	Time	Method
Comparison of outcomes prioritised within each survey arm	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)

Secondary Outcome Measures

Name	Time	Method
Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set	Through study completion, an average of 1 year.	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.
Iteration Effect	Through study completion, an average of 14 weeks.	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
Feedback Effect	Through study completion, an average of 14 weeks.	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)
Initial Condition Effect	During the Real-Time Delphi intervention (5 weeks).	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.

Trial Locations

Locations (1)

HRB-TMRN; 🇮🇪 Galway, Ireland