<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/NCT03002610</url>
  </required_header>
  <id_info>
    <org_study_id>IP-2014-12-7672</org_study_id>
    <nct_id>NCT03002610</nct_id>
  </id_info>
  <brief_title>Presenting Summary Information From Cochrane Systematic Reviews to Physicians</brief_title>
  <official_title>Presenting Summary Information From Cochrane Systematic Reviews to Physicians: Protocol for Research of Infographics Presentation vs. Plain Language Summary</official_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 and scientific abstract format, in presenting information, in terms of understanding and&#xD;
      remembering research results by physicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a randomized controlled trial (RCT) with three different&#xD;
      formats of the same systematic review summary (Infographics, PLS, scientific abstract). The&#xD;
      content of these three formats is based on the same systematic review, but the ways of data&#xD;
      presentation will differ: visual presentation in plain language, plain language only, and&#xD;
      text with scientific abbreviations. The interventions will be delivered online in January&#xD;
      2016, with physicians who are currently working at Clinical Hospital Split. The trial will be&#xD;
      preformed online, and it will be voluntary and anonymous. The survey will consist of 5 parts,&#xD;
      in the following order: 1) one format of the summary (randomly assigned), 2) health numeracy,&#xD;
      3) demographic data 4) comprehension test of the information given in the summary, and 5)&#xD;
      user friendliness of information and overall satisfaction with the given summary assessed by&#xD;
      survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Understanding of the Content of Summary Format</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. In total, there will be 10 open ended questions, and the total score will be the sum of the correct answers (minimum 0, maximum 10). Higher scores would indicate higher understanding.</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). Higher scores would indicate higher, or 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 would indicate greater, or more positive user friendliness, meaning that participants consider that format as easier to find relevant information.</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>3</number_of_arms>
  <enrollment type="Actual">108</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>
  <arm_group>
    <arm_group_label>Scientific abstract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.</description>
  </arm_group>
  <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>
  <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>Scientific abstract</intervention_name>
    <description>Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</description>
    <arm_group_label>Scientific abstract</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  physicians who are working at Clinical Hospital Split&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</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>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>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03002610/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <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 group_id="P3">
          <title>Scientific Abstract</title>
          <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.&#xD;
Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="13"/>
              </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>Scientific Abstract</title>
          <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.&#xD;
Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</description>
        </group>
        <group group_id="B4">
          <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="18"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="21"/>
            <count group_id="B4" value="64"/>
          </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="21"/>
                    <count group_id="B4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.0" lower_limit="29.0" upper_limit="54.5"/>
                    <measurement group_id="B2" value="36.0" lower_limit="30.0" upper_limit="48.5"/>
                    <measurement group_id="B3" value="38.0" lower_limit="29.0" upper_limit="48.5"/>
                    <measurement group_id="B4" value="37.0" lower_limit="30.0" upper_limit="50.0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="21"/>
                    <count group_id="B4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Croatia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="21"/>
                    <count group_id="B4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Specialization obtained</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="21"/>
                    <count group_id="B4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PhD degree</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="21"/>
                    <count group_id="B4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heard of Cochrane systematic reviews before</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="21"/>
                    <count group_id="B4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="61"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="21"/>
                    <count group_id="B4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Understanding of the Content of Summary Format</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. In total, there will be 10 open ended questions, and the total score will be the sum of the correct answers (minimum 0, maximum 10). Higher scores would indicate higher understanding.</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 group_id="O3">
            <title>Scientific Abstract</title>
            <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.&#xD;
Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</description>
          </group>
        </group_list>
        <measure>
          <title>Understanding of the Content of Summary Format</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. In total, there will be 10 open ended questions, and the total score will be the sum of the correct answers (minimum 0, maximum 10). Higher scores would indicate higher understanding.</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="18"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="7.0" upper_limit="9.0"/>
                    <measurement group_id="O2" value="8.0" lower_limit="6.0" upper_limit="8.0"/>
                    <measurement group_id="O3" value="8.0" lower_limit="5.9" upper_limit="9.0"/>
                  </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). Higher scores would indicate higher, or 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 group_id="O3">
            <title>Scientific Abstract</title>
            <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.&#xD;
Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</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). Higher scores would indicate higher, or 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="18"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" lower_limit="30.0" upper_limit="39.9"/>
                    <measurement group_id="O2" value="37.0" lower_limit="26.8" upper_limit="41.3"/>
                    <measurement group_id="O3" value="24.0" lower_limit="21.3" upper_limit="31.8"/>
                  </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 would indicate greater, or more positive user friendliness, meaning that participants consider that format as easier to find relevant information.</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 group_id="O3">
            <title>Scientific Abstract</title>
            <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.&#xD;
Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</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 would indicate greater, or more positive user friendliness, meaning that participants consider that format as easier to find relevant information.</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="18"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" lower_limit="26.8" upper_limit="36.2"/>
                    <measurement group_id="O2" value="36.0" lower_limit="30.9" upper_limit="40.0"/>
                    <measurement group_id="O3" value="25.0" lower_limit="23.5" upper_limit="27.2"/>
                  </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 group_id="O3">
            <title>Scientific Abstract</title>
            <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.&#xD;
Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</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="18"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.0" upper_limit="6.0"/>
                    <measurement group_id="O3" value="5.0" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were not 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 group_id="E3">
          <title>Scientific Abstract</title>
          <description>Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.&#xD;
Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.</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"/>
                <counts group_id="E3" 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"/>
                <counts group_id="E3" 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"/>
                <counts group_id="E3" 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>Sponsor had no role in planning of research, its execution or 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/NCT03002610
org study id: IP-2014-12-7672
nct id: NCT03002610
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to evaluate the efficacy of infographics, compared to standard
      PLS and scientific abstract format, in presenting information, in terms of understanding and
      remembering research results by physicians.
The investigators will conduct a randomized controlled trial (RCT) with three different
      formats of the same systematic review summary (Infographics, PLS, scientific abstract). The
      content of these three formats is based on the same systematic review, but the ways of data
      presentation will differ: visual presentation in plain language, plain language only, and
      text with scientific abbreviations. The interventions will be delivered online in January
      2016, with physicians who are currently working at Clinical Hospital Split. The trial will be
      preformed online, and it 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: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Understanding of the Content of Summary Format
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. In total, there will be 10 open ended questions, and the total score will be the sum of the correct answers (minimum 0, maximum 10). Higher scores would indicate higher understanding.
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). Higher scores would indicate higher, or 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 would indicate greater, or more positive user friendliness, meaning that participants consider that format as easier to find relevant information.
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.
arm group label: Scientific abstract
arm group type: Active Comparator
description: Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.
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
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: Scientific abstract
description: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.
arm group label: Scientific abstract
criteria: 
gender: All
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: 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
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 