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

NCT ID: NCT04471103

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2022-02-07

Brief Summary

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

Detailed Description

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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

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Consensus Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A two-group parallel randomised trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Real-Time Delphi Method

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.

Group Type EXPERIMENTAL

Participation in a Delphi survey

Intervention Type OTHER

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.

Multi-round Delphi Method

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.

Group Type ACTIVE_COMPARATOR

Participation in a Delphi survey

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Research Board, Ireland

OTHER

Sponsor Role collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Prof. Declan Devane

Scientific Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Declan Devane, PhD

Role: PRINCIPAL_INVESTIGATOR

Health Research Board - Trials Methodology Research Network

Locations

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HRB-TMRN

Galway, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Fiona A Quirke, BSc

Role: CONTACT

+353 91 495 481

Declan Devane, PhD

Role: CONTACT

+353 91 495 828

Facility Contacts

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Declan M Devane, PhD

Role: primary

091 49 5828

Sandra Galvin, PhD

Role: backup

091 494493

References

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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.

Reference Type DERIVED
PMID: 37468987 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33588938 (View on PubMed)

Other Identifiers

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NUIreland-COHESION

Identifier Type: -

Identifier Source: org_study_id

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