Clinical trial NCT04471103: Comparison of Multi-Round and Real-Time Delphi Survey Methods
Official title: Multi-round Compared to Real-Time Delphi for Consensus in Core Outcome Set (COS) Development: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Consensus Development
Keywords: Delphi
Real-Time Delphi
Multi-Round Delphi
Randomised Trial
Two-Group Parallel
Survey
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2020-07-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-group parallel randomised trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of outcomes prioritised within each survey arm
timeFrame: 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 outcomes:
measure: Feedback Effect
timeFrame: Through study completion, an average of 14 weeks.
measure: Initial Condition Effect
timeFrame: During the Real-Time Delphi intervention (5 weeks).
measure: Iteration Effect
timeFrame: Through study completion, an average of 14 weeks.
measure: Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
measure: Attrition rates
timeFrame: 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.
measure: Frequency of re-visiting the Real-Time Delphi arm
timeFrame: 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).
measure: Usefulness, Satisfaction and Ease of Use of each survey arm
timeFrame: 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)
Locations:
city: Galway
country: Ireland
facility: HRB-TMRN
Study officials:
affiliation: Health Research Board - Trials Methodology Research Network
name: Declan Devane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quirke FA, Healy P, Bhraonain EN, Daly M, Biesty L, Hurley T, Walker K, Meher S, Haas DM, Bloomfield FH, Kirkham JJ, Molloy EJ, Devane D. Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial. Trials. 2021 Feb 15;22(1):142. doi: 10.1186/s13063-021-05074-2.