<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/NCT03283592</url>
  </required_header>
  <id_info>
    <org_study_id>17-0107</org_study_id>
    <nct_id>NCT03283592</nct_id>
  </id_info>
  <brief_title>Review and Assessment of Network Meta-analyses for Knowledge Uptake Study</brief_title>
  <acronym>RANK</acronym>
  <official_title>Review and Assessment of Network Meta-analyses for Knowledge Uptake (RANK) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</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>
      This randomized controlled trial will assess the interpretability of the rank-heat plot for&#xD;
      presenting the results of network meta-analysis in comparison to SUCRA (surface under the&#xD;
      cumulative ranking) plots which are suggested to present one of the best ranking statistics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinicians are responsible for making decisions to improve health outcomes. When available,&#xD;
      clinicians should use the results of a knowledge synthesis, such as systematic reviews and&#xD;
      meta-analyses, to inform decision-making. Pairwise meta-analyses are limited, however, by the&#xD;
      availability of RCTs that directly compare interventions. This is troublesome for knowledge&#xD;
      users who require results from comparisons of multiple interventions to inform&#xD;
      decision-making. To address this concern, the use of network meta-analyses (NMAs) is&#xD;
      increasing in healthcare the literature. NMAs are a useful tool because they can summarize&#xD;
      results from numerous studies and interventions. It is unclear how NMA results should be&#xD;
      presented to increase the likelihood of clinicians understanding and using the results to&#xD;
      improve health outcomes. Thus, a randomized controlled trial of NMA plots will be conducted.&#xD;
      Participants will be randomized to either the rank-heat plot (intervention) or SUCRA plots&#xD;
      (control) that present the same NMA results of a study that explored the effectiveness of&#xD;
      quality improvement interventions for falls prevention. Outcomes will be ascertained via an&#xD;
      online survey. The RCT will take place in an online environment and will require each&#xD;
      participant to partake in a single session. This study will help guide best practices for the&#xD;
      presentation of reviews to improve the uptake and use of NMA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    did not receive funding to conduct study&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2019</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>2-arm, parallel assignment</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single blind (outcome assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants who appropriately define the clinical &quot;bottom line.&quot; Participants' answers will be independently evaluated by two investigators for agreement with an expert panel's recommendation.</measure>
    <time_frame>during experiment via single session, &lt;1 hour survey</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who accurately apply the evidence to the provided clinical scenario.</measure>
    <time_frame>during experiment via single session, &lt;1 hour survey</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completeness of survey data evaluated by two independent investigators</measure>
    <time_frame>Immediate post-experiment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken to complete survey</measure>
    <time_frame>Immediate post-experiment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Clinical Decision-making</condition>
  <arm_group>
    <arm_group_label>Rank-Heat Plot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive an online survey to evaluate their interpretation of the results from the NMA with a rank-heat plot including results from 2 outcomes that were selected by our knowledge users (#injurious falls, #fractures).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SUCRA (surface under the cumulative ranking) Plot</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive an online survey to evaluate their interpretation of the results from the NMA with the SUCRA plots including results from the same 2 outcomes that will be presented to the intervention group (i.e., #injurious falls, #fractures).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rank-Heat Plot</intervention_name>
    <description>provides a visual presentation of treatment hierarchy across multiple outcomes</description>
    <arm_group_label>Rank-Heat Plot</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SUCRA Plot</intervention_name>
    <description>provides a visual presentation of treatment ranking for a single outcome.</description>
    <arm_group_label>SUCRA (surface under the cumulative ranking) Plot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinicians must be accredited to practice in Canada and working (full- or part-time)&#xD;
             as a family physician or general internist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to read and understand English;&#xD;
&#xD;
          -  No access to the internet;&#xD;
&#xD;
          -  Read, co-authored or peer-reviewed the study: &quot;Quality Improvement strategies to&#xD;
             Prevent Falls in the Elderly: A systematic review and network meta-analysis&quot;&#xD;
             (manuscript in preparation).&#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>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03283592
org study id: 17-0107
nct id: NCT03283592
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial will assess the interpretability of the rank-heat plot for
      presenting the results of network meta-analysis in comparison to SUCRA (surface under the
      cumulative ranking) plots which are suggested to present one of the best ranking statistics.
Clinicians are responsible for making decisions to improve health outcomes. When available,
      clinicians should use the results of a knowledge synthesis, such as systematic reviews and
      meta-analyses, to inform decision-making. Pairwise meta-analyses are limited, however, by the
      availability of RCTs that directly compare interventions. This is troublesome for knowledge
      users who require results from comparisons of multiple interventions to inform
      decision-making. To address this concern, the use of network meta-analyses (NMAs) is
      increasing in healthcare the literature. NMAs are a useful tool because they can summarize
      results from numerous studies and interventions. It is unclear how NMA results should be
      presented to increase the likelihood of clinicians understanding and using the results to
      improve health outcomes. Thus, a randomized controlled trial of NMA plots will be conducted.
      Participants will be randomized to either the rank-heat plot (intervention) or SUCRA plots
      (control) that present the same NMA results of a study that explored the effectiveness of
      quality improvement interventions for falls prevention. Outcomes will be ascertained via an
      online survey. The RCT will take place in an online environment and will require each
      participant to partake in a single session. This study will help guide best practices for the
      presentation of reviews to improve the uptake and use of NMA.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2-arm, parallel assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Single blind (outcome assessor)
measure: Proportion of participants who appropriately define the clinical "bottom line." Participants' answers will be independently evaluated by two investigators for agreement with an expert panel's recommendation.
time frame: during experiment via single session, <1 hour survey
measure: Proportion of participants who accurately apply the evidence to the provided clinical scenario.
time frame: during experiment via single session, <1 hour survey
measure: Completeness of survey data evaluated by two independent investigators
time frame: Immediate post-experiment
measure: Time taken to complete survey
time frame: Immediate post-experiment
arm group label: Rank-Heat Plot
arm group type: Experimental
description: The intervention group will receive an online survey to evaluate their interpretation of the results from the NMA with a rank-heat plot including results from 2 outcomes that were selected by our knowledge users (#injurious falls, #fractures).
arm group label: SUCRA (surface under the cumulative ranking) Plot
arm group type: Active Comparator
description: The control group will receive an online survey to evaluate their interpretation of the results from the NMA with the SUCRA plots including results from the same 2 outcomes that will be presented to the intervention group (i.e., #injurious falls, #fractures).
intervention type: Other
intervention name: Rank-Heat Plot
description: provides a visual presentation of treatment hierarchy across multiple outcomes
arm group label: Rank-Heat Plot
intervention type: Other
intervention name: SUCRA Plot
description: provides a visual presentation of treatment ranking for a single outcome.
arm group label: SUCRA (surface under the cumulative ranking) Plot
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor