<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/NCT02980107</url>
  </required_header>
  <id_info>
    <org_study_id>IP-2014-11-7672</org_study_id>
    <nct_id>NCT02980107</nct_id>
  </id_info>
  <brief_title>Presenting Summary Information From Cochrane Systematic Reviews: Protocol for Research of Infographics Presentation vs. Plain Language Summary</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of Split</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital of Split</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy of infographics, compared to standard&#xD;
      PLS format, in presenting information, in terms of understanding and remembering research&#xD;
      results by consumers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a randomized controlled trial (RCT) with two different formats&#xD;
      of the same systematic review summary (Infographics, PLS). The content of these two formats&#xD;
      is based on the same systematic review, but the ways of data presentation will differ: visual&#xD;
      presentation in plain language and plain language only. The interventions will be delivered&#xD;
      online in November 2016, with members of the consumers' groups for pregnancy and parenting -&#xD;
      RODA (&quot;Roditelji u akciji&quot;, engl.&quot;Parents in action&quot;), which gathers different types of&#xD;
      consumers: pregnant women, young mothers and parenting and pregnancy advisors; and the&#xD;
      members of the Association for Patients' Rights. The trial will be voluntary and anonymous.&#xD;
      The survey will consist of 5 parts, in the following order: 1) one format of the summary&#xD;
      (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the&#xD;
      information given in the summary, and 5) user friendliness of information and overall&#xD;
      satisfaction with the given summary assessed by survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Understanding of the Summary Content</measure>
    <time_frame>One month (30 days)</time_frame>
    <description>The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. There will be 10 open ended questions, which will be assessed by two assessors, and the total score will be the sum of correct answers (total score ranging from 0-10). Higher scores would represent greater understanding of the content.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reading Experience</measure>
    <time_frame>One month (30 days)</time_frame>
    <description>This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum 5, maximum 50). Greater scores indicate more positive reading experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Friendliness</measure>
    <time_frame>One month (30 days)</time_frame>
    <description>This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum 5, maximum 50). Higher scores indicate greater perception of the summary format as more user friendly.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health Numeracy</measure>
    <time_frame>One month (30 days)</time_frame>
    <description>This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">212</enrollment>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>PLS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infographics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infographics</intervention_name>
    <description>Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
    <arm_group_label>Infographics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PLS</intervention_name>
    <description>Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
    <arm_group_label>PLS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible participants will be members of RODA and Association for Patients' Rights&#xD;
             (women) .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male members of RODA and Association for Patient's Rights&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivan Buljan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Researcher</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Split</name>
      <address>
        <city>Split</city>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <link>
    <url>http://visuallycochrane.net</url>
    <description>Web page where new formats for presentation of Cochrane systematic reviews can be found.</description>
  </link>
  <reference>
    <citation>Osborn CY, Wallston KA, Shpigel A, Cavanaugh K, Kripalani S, Rothman RL. Development and validation of the General Health Numeracy Test (GHNT). Patient Educ Couns. 2013 Jun;91(3):350-6. doi: 10.1016/j.pec.2013.01.001. Epub 2013 Feb 21.</citation>
    <PMID>23433635</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>February 17, 2018</results_first_submitted>
  <results_first_submitted_qc>February 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 3, 2019</results_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of Split</investigator_affiliation>
    <investigator_full_name>Ivan Buljan</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Plain Language Summary</title>
          <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.&#xD;
PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
        </group>
        <group group_id="P2">
          <title>Infographics</title>
          <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.&#xD;
Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Plain Language Summary</title>
          <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.&#xD;
PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
        </group>
        <group group_id="B2">
          <title>Infographics</title>
          <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.&#xD;
Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="54"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="99"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39" lower_limit="32" upper_limit="40"/>
                    <measurement group_id="B2" value="37" lower_limit="32" upper_limit="42"/>
                    <measurement group_id="B3" value="38" lower_limit="32" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heard of Cochrane systematic reviews</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Used Cochrane library</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary source of health information</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Internet</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Family Members</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Family physician</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Library</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Understanding of the Summary Content</title>
        <description>The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. There will be 10 open ended questions, which will be assessed by two assessors, and the total score will be the sum of correct answers (total score ranging from 0-10). Higher scores would represent greater understanding of the content.</description>
        <time_frame>One month (30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plain Language Summary</title>
            <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.&#xD;
PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
          </group>
          <group group_id="O2">
            <title>Infographics</title>
            <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.&#xD;
Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Understanding of the Summary Content</title>
          <description>The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. There will be 10 open ended questions, which will be assessed by two assessors, and the total score will be the sum of correct answers (total score ranging from 0-10). Higher scores would represent greater understanding of the content.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="6.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="7.0" lower_limit="6.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reading Experience</title>
        <description>This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum 5, maximum 50). Greater scores indicate more positive reading experience.</description>
        <time_frame>One month (30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plain Language Summary</title>
            <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.&#xD;
PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
          </group>
          <group group_id="O2">
            <title>Infographics</title>
            <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.&#xD;
Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Reading Experience</title>
          <description>This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum 5, maximum 50). Greater scores indicate more positive reading experience.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" lower_limit="19.0" upper_limit="27.4"/>
                    <measurement group_id="O2" value="33.0" lower_limit="28.0" upper_limit="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>User Friendliness</title>
        <description>This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum 5, maximum 50). Higher scores indicate greater perception of the summary format as more user friendly.</description>
        <time_frame>One month (30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plain Language Summary</title>
            <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.&#xD;
PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
          </group>
          <group group_id="O2">
            <title>Infographics</title>
            <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.&#xD;
Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
          </group>
        </group_list>
        <measure>
          <title>User Friendliness</title>
          <description>This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum 5, maximum 50). Higher scores indicate greater perception of the summary format as more user friendly.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.0" lower_limit="19.0" upper_limit="25.0"/>
                    <measurement group_id="O2" value="30.0" lower_limit="25.5" upper_limit="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Health Numeracy</title>
        <description>This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.</description>
        <time_frame>One month (30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plain Language Summary</title>
            <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.&#xD;
PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
          </group>
          <group group_id="O2">
            <title>Infographics</title>
            <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.&#xD;
Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Numeracy</title>
          <description>This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>No adverse events were collected.</time_frame>
      <desc>0</desc>
      <group_list>
        <group group_id="E1">
          <title>Plain Language Summary</title>
          <description>The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.&#xD;
PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience.</description>
        </group>
        <group group_id="E2">
          <title>Infographics</title>
          <description>Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.&#xD;
Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor had no role in the research planning, its execution nor publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ivan Buljan</name_or_title>
      <organization>University of Split School of Medicine</organization>
      <phone>+385989027209</phone>
      <email>ibuljan@mefst.hr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02980107
org study id: IP-2014-11-7672
nct id: NCT02980107
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to evaluate the efficacy of infographics, compared to standard
      PLS format, in presenting information, in terms of understanding and remembering research
      results by consumers.
The investigators will conduct a randomized controlled trial (RCT) with two different formats
      of the same systematic review summary (Infographics, PLS). The content of these two formats
      is based on the same systematic review, but the ways of data presentation will differ: visual
      presentation in plain language and plain language only. The interventions will be delivered
      online in November 2016, with members of the consumers' groups for pregnancy and parenting -
      RODA ("Roditelji u akciji", engl."Parents in action"), which gathers different types of
      consumers: pregnant women, young mothers and parenting and pregnancy advisors; and the
      members of the Association for Patients' Rights. The trial will be voluntary and anonymous.
      The survey will consist of 5 parts, in the following order: 1) one format of the summary
      (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the
      information given in the summary, and 5) user friendliness of information and overall
      satisfaction with the given summary assessed by survey.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Understanding of the Summary Content
time frame: One month (30 days)
description: The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. There will be 10 open ended questions, which will be assessed by two assessors, and the total score will be the sum of correct answers (total score ranging from 0-10). Higher scores would represent greater understanding of the content.
measure: Reading Experience
time frame: One month (30 days)
description: This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum 5, maximum 50). Greater scores indicate more positive reading experience.
measure: User Friendliness
time frame: One month (30 days)
description: This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum 5, maximum 50). Higher scores indicate greater perception of the summary format as more user friendly.
measure: Health Numeracy
time frame: One month (30 days)
description: This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.
arm group label: PLS
arm group type: Active Comparator
description: The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.
arm group label: Infographics
arm group type: Experimental
description: Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.
intervention type: Other
intervention name: Infographics
description: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.
arm group label: Infographics
intervention type: Other
intervention name: PLS
description: Text format with simple explanation of the survey topic main findings and is intended for lay audience.
arm group label: PLS
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ivan Buljan
role: Principal Investigator
affiliation: Researcher
facility: 
country: Croatia
url: http://visuallycochrane.net
description: Web page where new formats for presentation of Cochrane systematic reviews can be found.
citation: Osborn CY, Wallston KA, Shpigel A, Cavanaugh K, Kripalani S, Rothman RL. Development and validation of the General Health Numeracy Test (GHNT). Patient Educ Couns. 2013 Jun;91(3):350-6. doi: 10.1016/j.pec.2013.01.001. Epub 2013 Feb 21.
PMID: 23433635
responsible party type: Principal Investigator
investigator affiliation: University Hospital of Split
investigator full name: Ivan Buljan
investigator title: Research Assistant
sharing ipd: Yes
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 