Consensus DevelopmentNCT04471103
Comparison of Multi-Round and Real-Time Delphi Survey Methods
A study testing Participation in a Delphi survey in people with Consensus Development, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
A two-group parallel randomised trial of Delphi survey methods. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Consensus Development
- What is being tested?
- Participation in a Delphi survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIreland
- Study dates
- 13 Aug 2021to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- neonatal/paediatric neurologists
- general practitioners who provide long-term care for children with neonatal encephalopathy
- policymakers
- researchers/ academics with expertise in neonatal encephalopathy treatment.
Who cannot join
- participants not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
HRB-TMRN
Galway, H91 W6P8
Declan M Devane, PhD, 091 49 5828, declan.devane@nuigalway.ie
Sandra Galvin, PhD, 091 494493, sandra.galvin@nuigalway.ie
About this study
Official title: Multi-round Compared to Real-Time Delphi for Consensus in Core Outcome Set (COS) Development: A Randomised Trial
A two-group parallel randomised trial of Delphi survey methods.
Read the 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.
- Conditions
- Consensus Development
- Being tested
- Participation in a Delphi survey
- Keywords
- Delphi, Real-Time Delphi, Multi-Round Delphi, Randomised Trial, Two-Group Parallel, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in a Delphi surveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Delphi Method | Experimental | 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. Receives: Other: Participation in a Delphi survey |
| Multi-round Delphi Method | Active comparator | 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. Receives: Other: Participation in a Delphi survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (4)
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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start13 Aug 2021
- Primary completion7 Feb 2022 (estimated)
- Study completion7 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Consensus DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-group parallel randomised trial
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Prof. Declan Devane, Health Research Board - Trials Methodology Research Network
- Investigators
- Declan Devane, PhD, Principal investigator, Health Research Board - Trials Methodology Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471103
- Sponsor's protocol ID
- NUIreland-COHESION
- Status last verified
- Sep 2021
- First submitted
- 2 Jul 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quirke FA, Battin MR, Bernard C, Biesty L, Bloomfield FH, Daly M, Finucane E, Haas DM, Healy P, Hurley T, Koskei S, Meher S, Molloy EJ, Niaz M, Bhraonain EN, Okaronon CO, Tabassum F, Walker K, Webbe JRH, Parkes MJ, Kirkham JJ, Devane D. Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial. Trials. 2023 Jul 19;24(1):461. doi: 10.1186/s13063-023-07388-9.
PubMed 37468987Quirke 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.
PubMed 33588938
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-round Compared to Real-Time Delphi for Consensus in Core Outcome Set (COS) Development: A Randomised Trial
- ClinicalTrials.gov ID
- NCT04471103
- Acronym / sponsor ID
- NUIreland-COHESION
- Conditions
- Consensus Development
- Keywords
- Delphi, Real-Time Delphi, Multi-Round Delphi, Randomised Trial, Two-Group Parallel, Survey
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 7 Feb 2022 (estimated)
- Study completion
- 7 Feb 2022 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-group parallel randomised trial
| Arm | Type | Receives |
|---|---|---|
| Real-Time Delphi Method | Experimental | Other: Participation in a Delphi surveyThe 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 | Active comparator | Other: Participation in a Delphi surveyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- parents or caregivers of infants that have been diagnosed with and received treatment for neonatal encephalopathy
- healthcare providers including:
- researchers/ academics with expertise in neonatal encephalopathy treatment.
Key exclusion criteria (1 listed)
- participants not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in a Delphi surveyParticipants 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. | Other | Multi-round Delphi Method, Real-Time Delphi Method |
Primary outcome
Comparison of outcomes prioritised within each survey arm
Time frame: 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)
4 secondary outcomes
Feedback Effect
Time frame: Through study completion, an average of 14 weeks.
Initial Condition Effect
Time frame: During the Real-Time Delphi intervention (5 weeks).
Iteration Effect
Time frame: Through study completion, an average of 14 weeks.
Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 37468987Quirke FA, Battin MR, Bernard C, Biesty L, Bloomfield FH, Daly M, Finucane E, Haas DM, Healy P, Hurley T, Koskei S, Meher S, Molloy EJ, Niaz M, Bhraonain EN, Okaronon CO, Tabassum F, Walker K, Webbe JRH, Parkes MJ, Kirkham JJ, Devane D. Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial. Trials. 2023 Jul 19;24(1):461. doi: 10.1186/s13063-023-07388-9.
- Derived from this study: PubMed 33588938Quirke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Declan Devane, PhD principal investigator
Health Research Board - Trials Methodology Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in a Delphi survey in people with Consensus Development, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona A Quirke, BSc (+353 91 495 481, f.quirke1@nuigalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of outcomes prioritised within each survey arm (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471103, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.