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

Consensus Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04471103
• Other study ID #: NUIreland-COHESION
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: February 7, 2022

Study information

• Verified date: September 2021
• Source: National University of Ireland, Galway, Ireland
• Contact: Fiona A Quirke, BSc
• Phone: +353 91 495 481
• Email: f.quirke1[@]nuigalway.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 7, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consensus Development

Intervention

Other:
• Participation in a Delphi survey
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.

Locations

Country	Name	City	State
Ireland	HRB-TMRN	Galway

Sponsors (2)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Health Research Board, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attrition rates	Comparison of attrition rates between multi-round and Real-Time Delphi arms.	Attrition rates will be recorded at the end of round 1 (week 3) and round 2 (week 9) in the Multi-Round Delphi and at weeks 2 and 4 in the Real-Time Delphi arm.
Other	Frequency of re-visiting the Real-Time Delphi arm	Monitoring how often the Real-Time Delphi was re-visited by participants	This will be measured when a participant visits the Real-Time Delphi survey and rates the outcomes fully for a second time (between the start of week 1 and the end of week 5).
Other	Usefulness, Satisfaction and Ease of Use of each survey arm	Participants will be asked in a short questionnaire how they found answering each survey using a modified Usefulness, Satisfaction and Ease of use questionnaire on a 7-point Likert Scale where 1= Strongly Disagree and 7=Strongly Agree.	End of both surveys (i.e. when the Multi-Round Delphi round 3 (week 14) has finished and when the Real-Time Delphi has finished at the end of week 5)
Primary	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	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.
Secondary	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).
Secondary	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.
Secondary	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.