Consensus Development
Conditions
Keywords
Delphi, Real-Time Delphi, Multi-Round Delphi, Randomised Trial, Two-Group Parallel, Survey
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.
Interventions
OTHERParticipation 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.
Sponsors
Health Research Board, Ireland
National University of Ireland, Galway, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A two-group parallel randomised trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usefulness, Satisfaction and Ease of Use of each survey arm | 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) | 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. |
| Frequency of re-visiting the Real-Time Delphi arm | 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). | Monitoring how often the Real-Time Delphi was re-visited by participants |
| Attrition rates | 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. | Comparison of attrition rates between multi-round and Real-Time Delphi arms. |
Countries
Ireland
Contacts
Primary ContactFiona A Quirke, BSc
Backup ContactDeclan Devane, PhD
Outcome results
None listed