<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471103</url>
  </required_header>
  <id_info>
    <org_study_id>NUIreland-COHESION</org_study_id>
    <nct_id>NCT04471103</nct_id>
  </id_info>
  <brief_title>Comparison of Multi-Round and Real-Time Delphi Survey Methods</brief_title>
  <official_title>Multi-round Compared to Real-Time Delphi for Consensus in Core Outcome Set (COS) Development: A Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Ireland, Galway, Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Research Board, Ireland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University of Ireland, Galway, Ireland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A two-group parallel randomised trial of Delphi survey methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim:&#xD;
&#xD;
      The aim of this trial is to compare a multi-round Delphi survey method with a Real-Time&#xD;
      Delphi method on prioritised outcomes included in a core outcome set (COS). This trial is&#xD;
      embedded within the COHESION study which is developing a COS for interventions for the&#xD;
      treatment of neonatal encephalopathy.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Stakeholders (parents/ caregivers of infants diagnosed and treated with neonatal&#xD;
      encephalopathy, healthcare providers and researchers) will be randomised using stratified&#xD;
      randomisation to take part in either a multi-round or Real-Time Delphi. Stakeholders will&#xD;
      rate the importance of the same set of outcomes in both arms. We will compare the prioritised&#xD;
      outcomes at the end of both surveys as well as other parameters such as feedback, initial&#xD;
      condition and iteration effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 13, 2021</start_date>
  <completion_date type="Anticipated">February 7, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 7, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A two-group parallel randomised trial</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of outcomes prioritised within each survey arm</measure>
    <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).</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feedback Effect</measure>
    <time_frame>Through study completion, an average of 14 weeks.</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initial Condition Effect</measure>
    <time_frame>During the Real-Time Delphi intervention (5 weeks).</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iteration Effect</measure>
    <time_frame>Through study completion, an average of 14 weeks.</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Attrition rates</measure>
    <time_frame>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.</time_frame>
    <description>Comparison of attrition rates between multi-round and Real-Time Delphi arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of re-visiting the Real-Time Delphi arm</measure>
    <time_frame>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).</time_frame>
    <description>Monitoring how often the Real-Time Delphi was re-visited by participants</description>
  </other_outcome>
  <other_outcome>
    <measure>Usefulness, Satisfaction and Ease of Use of each survey arm</measure>
    <time_frame>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)</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Consensus Development</condition>
  <arm_group>
    <arm_group_label>Real-Time Delphi Method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multi-round Delphi Method</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Participation in a Delphi survey</intervention_name>
    <description>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.</description>
    <arm_group_label>Multi-round Delphi Method</arm_group_label>
    <arm_group_label>Real-Time Delphi Method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parents or caregivers of infants that have been diagnosed with and received treatment&#xD;
             for neonatal encephalopathy&#xD;
&#xD;
          -  healthcare providers including:&#xD;
&#xD;
               -  neonatal nurse practitioners&#xD;
&#xD;
               -  midwives&#xD;
&#xD;
               -  obstetricians&#xD;
&#xD;
               -  neonatologists/paediatricians&#xD;
&#xD;
               -  neonatal/paediatric neurologists&#xD;
&#xD;
               -  general practitioners who provide long-term care for children with neonatal&#xD;
                  encephalopathy&#xD;
&#xD;
               -  policymakers&#xD;
&#xD;
          -  researchers/ academics with expertise in neonatal encephalopathy treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • participants not meeting the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Declan Devane, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Health Research Board - Trials Methodology Research Network</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fiona A Quirke, BSc</last_name>
    <phone>+353 91 495 481</phone>
    <email>f.quirke1@nuigalway.ie</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Declan Devane, PhD</last_name>
    <phone>+353 91 495 828</phone>
    <email>declan.devane@nuigalway.ie</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HRB-TMRN</name>
      <address>
        <city>Galway</city>
        <zip>H91 W6P8</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Declan M Devane, PhD</last_name>
      <phone>091 49 5828</phone>
      <email>declan.devane@nuigalway.ie</email>
    </contact>
    <contact_backup>
      <last_name>Sandra Galvin, PhD</last_name>
      <phone>091 494493</phone>
      <email>sandra.galvin@nuigalway.ie</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Health Research Board - Trials Methodology Research Network</investigator_affiliation>
    <investigator_full_name>Prof. Declan Devane</investigator_full_name>
    <investigator_title>Scientific Director</investigator_title>
  </responsible_party>
  <keyword>Delphi</keyword>
  <keyword>Real-Time Delphi</keyword>
  <keyword>Multi-Round Delphi</keyword>
  <keyword>Randomised Trial</keyword>
  <keyword>Two-Group Parallel</keyword>
  <keyword>Survey</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471103
org study id: NUIreland-COHESION
nct id: NCT04471103
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A two-group parallel randomised trial of Delphi survey methods.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A two-group parallel randomised trial
primary purpose: Health Services Research
masking: None (Open Label)
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).
description: 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)
measure: Feedback Effect
time frame: Through study completion, an average of 14 weeks.
description: 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)
measure: Initial Condition Effect
time frame: During the Real-Time Delphi intervention (5 weeks).
description: 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.
measure: Iteration Effect
time frame: Through study completion, an average of 14 weeks.
description: 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
measure: Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Attrition rates
time frame: 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.
description: Comparison of attrition rates between multi-round and Real-Time Delphi arms.
measure: Frequency of re-visiting the Real-Time Delphi arm
time frame: 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).
description: Monitoring how often the Real-Time Delphi was re-visited by participants
measure: Usefulness, Satisfaction and Ease of Use of each survey arm
time frame: 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)
description: 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.
arm group label: Real-Time Delphi Method
arm group type: Experimental
description: 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.
arm group label: Multi-round Delphi Method
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Participation in a Delphi survey
description: 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.
arm group label: Multi-round Delphi Method
arm group label: Real-Time Delphi Method
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Declan Devane, PhD
role: Principal Investigator
affiliation: Health Research Board - Trials Methodology Research Network
last name: Fiona A Quirke, BSc
phone: +353 91 495 481
email: f.quirke1@nuigalway.ie
last name: Declan Devane, PhD
phone: +353 91 495 828
email: declan.devane@nuigalway.ie
facility: 
status: Recruiting
contact: 
contact backup: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: Health Research Board - Trials Methodology Research Network
investigator full name: Prof. Declan Devane
investigator title: Scientific Director
sharing ipd: No