<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/NCT01679873</url>
  </required_header>
  <id_info>
    <org_study_id>CBV-001-HD</org_study_id>
    <nct_id>NCT01679873</nct_id>
  </id_info>
  <brief_title>Abstract' Content and GPs' Confidence in the Conclusion</brief_title>
  <acronym>ACOPI</acronym>
  <official_title>Impact of Reporting Funding Sources and Conflicts of Interest in RCTs' Abstracts on General Practitioners' Confidence: a 3-arms Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hotel Dieu Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hotel Dieu Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: The aim of this study is to assess the impact of reporting, in abstracts of&#xD;
      randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs)&#xD;
      of the authors on General Practitioners' confidence in the abstracts' conclusions.&#xD;
&#xD;
      Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP). They&#xD;
      will be recruited among residents from the Primary Care department of the Paris Descartes&#xD;
      University and among a GP network who agreed to participate to research studies.&#xD;
&#xD;
      The allocation of participants will be done by a computerized randomization list, the&#xD;
      sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants&#xD;
      will be blind of the hypothesis and of the randomization. Allocation concealment will be&#xD;
      provided because only the statistician will have access to the randomization list.&#xD;
&#xD;
      Methods: Three interventions will be assessed corresponding to three different types of&#xD;
      abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors, 2)&#xD;
      abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs of&#xD;
      authors.&#xD;
&#xD;
      A sample of abstracts will be selected from published randomized trials, testing superiority,&#xD;
      assessing pharmacological treatment, in the field of Primary Care and General Practice and&#xD;
      having a conclusion in favor of the beneficial effect of experimental treatment in terms of&#xD;
      tolerance and / or efficacy. They will then be standardized and modified to obtain three&#xD;
      types of abstracts: 1) with funding sources, 2) with funding sources and COIs and 3) without&#xD;
      either source of funding or COIs.&#xD;
&#xD;
      Participants will be asked to assess one abstract of their randomization arm. Outcome: The&#xD;
      primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be&#xD;
      the quality perception of the study and the interpretation of the benefit of experimental&#xD;
      treatment. Responses will be ranged by a 10-point numeric scale.&#xD;
&#xD;
      Potential interests: This study takes place in the field of Primary Care. We believe that&#xD;
      better understandings of impact of funding sources and conflicts of interests are necessary&#xD;
      to allow more transparency in medical research and in his translation into medical practice.&#xD;
&#xD;
      Sample size expected: 354 participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dissemination of knowledge and research results is an essential step in the practice of&#xD;
      Evidence-Based Medicine (EBM) (1).With the growing number of publications, a lack of&#xD;
      accessibility, and the need for timely messages among information resources larger and&#xD;
      larger, the General Practitioners (GP) often rely on abstracts of published trials (2).&#xD;
&#xD;
      Several methodological studies have shown an association between mode of financing, including&#xD;
      industry funding, and how the results and conclusions of published trials are reported&#xD;
      (3-14).&#xD;
&#xD;
      To improve transparency, the CONSORT recommends to report funding sources (15) in abstracts&#xD;
      of randomized trials, which is not always followed. Efforts are also made to report conflicts&#xD;
      of interest of authors (COIs). In its version in July 2010, the International Committee of&#xD;
      Medical Journal Editors Uniform Disclosure Form for Potential Conflicts of Interest (ICMJE)&#xD;
      recommends that editors ask to all authors who submit a manuscript, to complete the ICMJE&#xD;
      statement (16,17). Despite this, understanding the complexity and severity of conflicts of&#xD;
      interest is not yet fully taken into account by all the guidelines (18).&#xD;
&#xD;
      It was further demonstrated that the interpretation of results by physicians varies with&#xD;
      their mode of presentation (19-22).&#xD;
&#xD;
      The investigators do not know to what extent the knowledge of funding sources and COIs may&#xD;
      influence the interpretation of findings by the reader. The investigators are therefore&#xD;
      interested in the impact of the presence of these elements in abstracts of published trials&#xD;
      on GPs' confidence in the conclusions presented.&#xD;
&#xD;
      The aim of this study is to assess the impact of reporting, in abstracts of randomized&#xD;
      controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs) of the&#xD;
      authors on General Practitioners' confidence in the abstracts' conclusions.&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
      The investigators plan a 3 arms randomized parallel-group, conducted among GPs residents in&#xD;
      Primary care and planned according to the CONSORT 2010 guidelines (23).&#xD;
&#xD;
      For allocation of the participants, a computer-generated list of random numbers will be used.&#xD;
      Randomization sequence will be created by an independent statistician with R project with&#xD;
      1:1:1 ratio using random block sizes of 2, 4, and 6. The statistician will upload the&#xD;
      randomization list on a secure internet system to assure allocation concealment.&#xD;
&#xD;
      GPs will be invited by e-mail to participate to this study. They will log on a secure&#xD;
      internet system that will randomize the GP in 3 different arms: 1) abstracts not reporting&#xD;
      neither funding neither COIs, 2) abstract reporting funding source and 3) abstract with&#xD;
      funding and COIs.&#xD;
&#xD;
      Blinding participants is not possible in this study. To reduce the risk of bias, physicians&#xD;
      will not be informed of the objectives of the study (ie study of the impact of the&#xD;
      presentation of funding sources and COIS), or the existence of randomization. They will blind&#xD;
      of the working hypotheses of the study.&#xD;
&#xD;
      PARTICIPANTS&#xD;
&#xD;
      GPs will be recruited among a network of GPs in France: this network consists of GPs who&#xD;
      agreed to participate in research studies. It brings together members from the Collège&#xD;
      Nationale des Généralistes Enseignants (CNGE) and GPs recruited by regional relays&#xD;
      represented by 10 physicians members of primary Care departments.&#xD;
&#xD;
      INTERVENTION&#xD;
&#xD;
      Three interventions will be evaluated corresponding to 3 different types of abstracts: 1)&#xD;
      abstracts not reporting the sources of financing or the COIs, 2) abstracts reporting the&#xD;
      sources of funding as recommended by CONSORT for abstracts and 3) abstracts related funding&#xD;
      sources and COIs.&#xD;
&#xD;
      Abstracts identification:&#xD;
&#xD;
      To allow reproducibility and generalization of our results, abstracts will be selected from&#xD;
      randomized controlled trials (RCTs) published in field of Primary Care. The investigators&#xD;
      chose to select abstracts of RCTs because their contents are standardized because of the&#xD;
      CONSORT guidelines. The investigators also chose to retain only the positive trials&#xD;
      (conclusion in favor of the beneficial effect of experimental treatment in terms of tolerance&#xD;
      and / or efficacy) to have a uniform interpretation of the results.&#xD;
&#xD;
      To identify abstracts, the investigators will search in Medline via PubMed for all indexed&#xD;
      abstracts with using limits for randomized controlled trials, in English, published from the&#xD;
      1srt January 2010 to the 31 December 2010, in the Core Clinical Journal. The Core Clinical&#xD;
      Journal was chosen to ensure a good quality of trials. The investigators restricted the&#xD;
      search to the year 2010 to ensure that physicians do not remember the original abstract and&#xD;
      thus preserve the blinding.&#xD;
&#xD;
      The eligibility criteria will be: randomized controlled trials, testing superiority,&#xD;
      assessing pharmaceutical intervention (drugs) in the field of Primary Care (i.e. trials&#xD;
      assessing treatments that may be prescribed by a GP, and those assessing treatments being&#xD;
      prescribed in pathologies supported jointly between specialist and GP.), with a positive&#xD;
      conclusion and funded only by the pharmaceutical industry.&#xD;
&#xD;
      Exclusion criteria will be: the non-pharmaceutical interventions (eg medical devices, patient&#xD;
      education, etc..), equivalence or noninferiority trials, safety trials, trials assessing&#xD;
      different pharmacological procedures, abstracts reporting a negative conclusion, not&#xD;
      reporting or reporting the results in an ambiguous conclusion (successful trial but related&#xD;
      the need for other studies), intermediate publications.&#xD;
&#xD;
      Construction of the modified Abstracts:&#xD;
&#xD;
      Standardization:&#xD;
&#xD;
      All abstracts will be standardized: the journal, date and registration number of&#xD;
      ClinicalTrial.gov will be deleted. Authors' names will be replaced by generic names. A list&#xD;
      of author names will be determined by drawing 20 names among the 200 names most common in the&#xD;
      UK and will be identical for all abstracts.&#xD;
&#xD;
      The treatments will be referred to by &quot;experimental treatment A&quot; or &quot;treatment B&quot; in the&#xD;
      abstract and in the title. The names of studies as an acronym will be deleted.&#xD;
&#xD;
      Finally, abstracts will be translated into French.&#xD;
&#xD;
      Modifications:&#xD;
&#xD;
      The three types of abstracts will be presented as follows:&#xD;
&#xD;
        1. Abstracts not reporting funding or COIs If these items are reported in the original&#xD;
           abstract, they will be removed.&#xD;
&#xD;
        2. Abstracts reporting funding Funding sources will be searched in abstract reporting by&#xD;
           the editors and in the full text. If funding sources are not found, abstract won't be&#xD;
           retained. Original funding will be reported by the name of pharmaceutical industry, at&#xD;
           the end of the abstract, after conclusion, under the heading &quot;FUNDING&quot;.&#xD;
&#xD;
        3. Abstracts reporting funding and COIs Funding sources will be reported as presented&#xD;
           previously. COIs will be searched in abstract reporting by the editors and in the full&#xD;
           text. If they are not found, abstract won't be retained. The COIs will then be ranked&#xD;
           (1) no COIs, (2) authors employed by industry and (3) authors who have a financial&#xD;
           relationship with industry. Financial ties regroup together all COIs other than being&#xD;
           employed: fees, travel costs, as these are to be returned in a personal or institution&#xD;
           with which the author works, stock options, link with a family member employed by the&#xD;
           industry, etc.. For each abstract, the investigators will retain the number of authors&#xD;
           having a conflict. The COIs will be given in the modified abstract by taking the&#xD;
           initials of the authors and their type of COIs, presented in two categories: &quot;financial&#xD;
           or other relationship&quot; and &quot;being employee&quot; under the heading &quot;CONFLICT OF INTEREST&quot;.&#xD;
&#xD;
      Note that the investigators will consider in the same way &quot;no conflict of interest&quot; and the&#xD;
      authors who do not report their COIs. We won't report it in the abstract.&#xD;
&#xD;
      PROCEDURES&#xD;
&#xD;
      Participants will be invited to participate in a study evaluating the interpretation of&#xD;
      abstracts of RCTs by e-mail (with 3 reminders) or by an investigator during the national&#xD;
      annual medical congress for general practice. They will be informed that their participation&#xD;
      will take less than 5 minutes. After accepting, physicians will complete a questionnaire to&#xD;
      collect their characteristics: date of birth, sex, status (resident or GP). Then they will be&#xD;
      randomized and start immediately read the abstract and questionnaire. Participants will be&#xD;
      asked to evaluate only a abstract in his arm of randomization.&#xD;
&#xD;
      SAMPLE SIZE&#xD;
&#xD;
      The investigators estimate that 75 abstracts will be available to be assessed. Three main&#xD;
      comparisons will be made: a comparison with the placebo group related funding sources, the&#xD;
      comparison with the placebo group related funding sources and COIS and finally the comparison&#xD;
      group of related funding sources with the related funding sources and COIS. With a&#xD;
      significance level of 1.67% fixed for each of the three comparisons 2-2 (Bonferonni&#xD;
      correction to maintain an overall significance level of 5%), it is necessary to have about&#xD;
      118 quotations in each arm to demonstrate an effect size equal to 0.5 on the numeric scale&#xD;
      with a power of 90% for each comparison 2-2. As it is expected that each physician read a&#xD;
      single abstract, it is necessary to include 118 physicians per arm (354 in total, each&#xD;
      abstract is read 4.7 times on average (4 or 5 times in practice)).&#xD;
&#xD;
      STATISTICAL ANALYSIS&#xD;
&#xD;
      Data analysis will be done with the software R project, in intention to treat. A description&#xD;
      of the characteristics of physicians will be made initially. Qualitative variables will be&#xD;
      described by their numbers, percentage and missing data by mode of response and quantitative&#xD;
      variables by their rate, mean, standard deviation. In case of quantitative variables with&#xD;
      asymmetric behavior, they will be presented with their median and interquartile range (25th&#xD;
      percentile-75th percentile).&#xD;
&#xD;
      The primary analysis will be done on mean of GPs' confidence and the 3 possible comparisons&#xD;
      will be made. The primary endpoint is quantitative, the test used for comparisons 2to 2 will&#xD;
      be the non-parametric Mann Whitney 1.7% threshold. The same analysis is repeated for the&#xD;
      secondary endpoints quantitative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GPS' confidence on the conclusion of the abstract</measure>
    <time_frame>30 days</time_frame>
    <description>measure on a numeric scale frome 0 to 10 where 0 is &quot;no confidence&quot; and 10 is &quot;full confidence&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GPs' quality perception of the study</measure>
    <time_frame>30 days</time_frame>
    <description>measure on a numeric scale from 0 to 10 where 0 is &quot;poor quality&quot; and 10 is &quot;excellent quality&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GPs' interpretation of the benefit of experimental treatment</measure>
    <time_frame>30 days</time_frame>
    <description>measure on a numéric scale from 0 to 10 wher 0 is &quot;not beneficial&quot; and 10 is &quot;very beneficial&quot;</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">354</enrollment>
  <condition>The Study Will Focus on no Specific Conditions</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Assess abstract not reporting funding sources or conflicts of interest</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Funding sources</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assess one type of abstract in the randomized arm. Assess abstract reporting funding sources only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Funding sources/Conflicts of Interests</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assess one type of abstract in the randomized arm. Assess abstract reporting funding sources and conflicts of interest</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess one type of abstract in the randomized arm</intervention_name>
    <description>Participants will be asked to assess only one abstract in his arm of randomization. Three reminders will be made</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Funding sources</arm_group_label>
    <arm_group_label>Funding sources/Conflicts of Interests</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General practitioners&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no one&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celine Buffel du Vaure</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hotel Dieu Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>July 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>December 20, 2013</last_update_submitted>
  <last_update_submitted_qc>December 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hotel Dieu Hospital</investigator_affiliation>
    <investigator_full_name>Celine Buffel du Vaure</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>confidence</keyword>
  <keyword>funding sources</keyword>
  <keyword>conflicts of interests</keyword>
  <keyword>general practitioner</keyword>
  <!-- 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/NCT01679873
org study id: CBV-001-HD
nct id: NCT01679873
lead sponsor: 
has dmc: No
Objective: The aim of this study is to assess the impact of reporting, in abstracts of
      randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs)
      of the authors on General Practitioners' confidence in the abstracts' conclusions.

      Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP). They
      will be recruited among residents from the Primary Care department of the Paris Descartes
      University and among a GP network who agreed to participate to research studies.

      The allocation of participants will be done by a computerized randomization list, the
      sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants
      will be blind of the hypothesis and of the randomization. Allocation concealment will be
      provided because only the statistician will have access to the randomization list.

      Methods: Three interventions will be assessed corresponding to three different types of
      abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors, 2)
      abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs of
      authors.

      A sample of abstracts will be selected from published randomized trials, testing superiority,
      assessing pharmacological treatment, in the field of Primary Care and General Practice and
      having a conclusion in favor of the beneficial effect of experimental treatment in terms of
      tolerance and / or efficacy. They will then be standardized and modified to obtain three
      types of abstracts: 1) with funding sources, 2) with funding sources and COIs and 3) without
      either source of funding or COIs.

      Participants will be asked to assess one abstract of their randomization arm. Outcome: The
      primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be
      the quality perception of the study and the interpretation of the benefit of experimental
      treatment. Responses will be ranged by a 10-point numeric scale.

      Potential interests: This study takes place in the field of Primary Care. We believe that
      better understandings of impact of funding sources and conflicts of interests are necessary
      to allow more transparency in medical research and in his translation into medical practice.

      Sample size expected: 354 participants.
Dissemination of knowledge and research results is an essential step in the practice of
      Evidence-Based Medicine (EBM) (1).With the growing number of publications, a lack of
      accessibility, and the need for timely messages among information resources larger and
      larger, the General Practitioners (GP) often rely on abstracts of published trials (2).

      Several methodological studies have shown an association between mode of financing, including
      industry funding, and how the results and conclusions of published trials are reported
      (3-14).

      To improve transparency, the CONSORT recommends to report funding sources (15) in abstracts
      of randomized trials, which is not always followed. Efforts are also made to report conflicts
      of interest of authors (COIs). In its version in July 2010, the International Committee of
      Medical Journal Editors Uniform Disclosure Form for Potential Conflicts of Interest (ICMJE)
      recommends that editors ask to all authors who submit a manuscript, to complete the ICMJE
      statement (16,17). Despite this, understanding the complexity and severity of conflicts of
      interest is not yet fully taken into account by all the guidelines (18).

      It was further demonstrated that the interpretation of results by physicians varies with
      their mode of presentation (19-22).

      The investigators do not know to what extent the knowledge of funding sources and COIs may
      influence the interpretation of findings by the reader. The investigators are therefore
      interested in the impact of the presence of these elements in abstracts of published trials
      on GPs' confidence in the conclusions presented.

      The aim of this study is to assess the impact of reporting, in abstracts of randomized
      controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs) of the
      authors on General Practitioners' confidence in the abstracts' conclusions.

      STUDY DESIGN

      The investigators plan a 3 arms randomized parallel-group, conducted among GPs residents in
      Primary care and planned according to the CONSORT 2010 guidelines (23).

      For allocation of the participants, a computer-generated list of random numbers will be used.
      Randomization sequence will be created by an independent statistician with R project with
      1:1:1 ratio using random block sizes of 2, 4, and 6. The statistician will upload the
      randomization list on a secure internet system to assure allocation concealment.

      GPs will be invited by e-mail to participate to this study. They will log on a secure
      internet system that will randomize the GP in 3 different arms: 1) abstracts not reporting
      neither funding neither COIs, 2) abstract reporting funding source and 3) abstract with
      funding and COIs.

      Blinding participants is not possible in this study. To reduce the risk of bias, physicians
      will not be informed of the objectives of the study (ie study of the impact of the
      presentation of funding sources and COIS), or the existence of randomization. They will blind
      of the working hypotheses of the study.

      PARTICIPANTS

      GPs will be recruited among a network of GPs in France: this network consists of GPs who
      agreed to participate in research studies. It brings together members from the Collège
      Nationale des Généralistes Enseignants (CNGE) and GPs recruited by regional relays
      represented by 10 physicians members of primary Care departments.

      INTERVENTION

      Three interventions will be evaluated corresponding to 3 different types of abstracts: 1)
      abstracts not reporting the sources of financing or the COIs, 2) abstracts reporting the
      sources of funding as recommended by CONSORT for abstracts and 3) abstracts related funding
      sources and COIs.

      Abstracts identification:

      To allow reproducibility and generalization of our results, abstracts will be selected from
      randomized controlled trials (RCTs) published in field of Primary Care. The investigators
      chose to select abstracts of RCTs because their contents are standardized because of the
      CONSORT guidelines. The investigators also chose to retain only the positive trials
      (conclusion in favor of the beneficial effect of experimental treatment in terms of tolerance
      and / or efficacy) to have a uniform interpretation of the results.

      To identify abstracts, the investigators will search in Medline via PubMed for all indexed
      abstracts with using limits for randomized controlled trials, in English, published from the
      1srt January 2010 to the 31 December 2010, in the Core Clinical Journal. The Core Clinical
      Journal was chosen to ensure a good quality of trials. The investigators restricted the
      search to the year 2010 to ensure that physicians do not remember the original abstract and
      thus preserve the blinding.

      The eligibility criteria will be: randomized controlled trials, testing superiority,
      assessing pharmaceutical intervention (drugs) in the field of Primary Care (i.e. trials
      assessing treatments that may be prescribed by a GP, and those assessing treatments being
      prescribed in pathologies supported jointly between specialist and GP.), with a positive
      conclusion and funded only by the pharmaceutical industry.

      Exclusion criteria will be: the non-pharmaceutical interventions (eg medical devices, patient
      education, etc..), equivalence or noninferiority trials, safety trials, trials assessing
      different pharmacological procedures, abstracts reporting a negative conclusion, not
      reporting or reporting the results in an ambiguous conclusion (successful trial but related
      the need for other studies), intermediate publications.

      Construction of the modified Abstracts:

      Standardization:

      All abstracts will be standardized: the journal, date and registration number of
      ClinicalTrial.gov will be deleted. Authors' names will be replaced by generic names. A list
      of author names will be determined by drawing 20 names among the 200 names most common in the
      UK and will be identical for all abstracts.

      The treatments will be referred to by "experimental treatment A" or "treatment B" in the
      abstract and in the title. The names of studies as an acronym will be deleted.

      Finally, abstracts will be translated into French.

      Modifications:

      The three types of abstracts will be presented as follows:

        1. Abstracts not reporting funding or COIs If these items are reported in the original
           abstract, they will be removed.

        2. Abstracts reporting funding Funding sources will be searched in abstract reporting by
           the editors and in the full text. If funding sources are not found, abstract won't be
           retained. Original funding will be reported by the name of pharmaceutical industry, at
           the end of the abstract, after conclusion, under the heading "FUNDING".

        3. Abstracts reporting funding and COIs Funding sources will be reported as presented
           previously. COIs will be searched in abstract reporting by the editors and in the full
           text. If they are not found, abstract won't be retained. The COIs will then be ranked
           (1) no COIs, (2) authors employed by industry and (3) authors who have a financial
           relationship with industry. Financial ties regroup together all COIs other than being
           employed: fees, travel costs, as these are to be returned in a personal or institution
           with which the author works, stock options, link with a family member employed by the
           industry, etc.. For each abstract, the investigators will retain the number of authors
           having a conflict. The COIs will be given in the modified abstract by taking the
           initials of the authors and their type of COIs, presented in two categories: "financial
           or other relationship" and "being employee" under the heading "CONFLICT OF INTEREST".

      Note that the investigators will consider in the same way "no conflict of interest" and the
      authors who do not report their COIs. We won't report it in the abstract.

      PROCEDURES

      Participants will be invited to participate in a study evaluating the interpretation of
      abstracts of RCTs by e-mail (with 3 reminders) or by an investigator during the national
      annual medical congress for general practice. They will be informed that their participation
      will take less than 5 minutes. After accepting, physicians will complete a questionnaire to
      collect their characteristics: date of birth, sex, status (resident or GP). Then they will be
      randomized and start immediately read the abstract and questionnaire. Participants will be
      asked to evaluate only a abstract in his arm of randomization.

      SAMPLE SIZE

      The investigators estimate that 75 abstracts will be available to be assessed. Three main
      comparisons will be made: a comparison with the placebo group related funding sources, the
      comparison with the placebo group related funding sources and COIS and finally the comparison
      group of related funding sources with the related funding sources and COIS. With a
      significance level of 1.67% fixed for each of the three comparisons 2-2 (Bonferonni
      correction to maintain an overall significance level of 5%), it is necessary to have about
      118 quotations in each arm to demonstrate an effect size equal to 0.5 on the numeric scale
      with a power of 90% for each comparison 2-2. As it is expected that each physician read a
      single abstract, it is necessary to include 118 physicians per arm (354 in total, each
      abstract is read 4.7 times on average (4 or 5 times in practice)).

      STATISTICAL ANALYSIS

      Data analysis will be done with the software R project, in intention to treat. A description
      of the characteristics of physicians will be made initially. Qualitative variables will be
      described by their numbers, percentage and missing data by mode of response and quantitative
      variables by their rate, mean, standard deviation. In case of quantitative variables with
      asymmetric behavior, they will be presented with their median and interquartile range (25th
      percentile-75th percentile).

      The primary analysis will be done on mean of GPs' confidence and the 3 possible comparisons
      will be made. The primary endpoint is quantitative, the test used for comparisons 2to 2 will
      be the non-parametric Mann Whitney 1.7% threshold. The same analysis is repeated for the
      secondary endpoints quantitative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: GPS' confidence on the conclusion of the abstract
time frame: 30 days
description: measure on a numeric scale frome 0 to 10 where 0 is "no confidence" and 10 is "full confidence"
measure: GPs' quality perception of the study
time frame: 30 days
description: measure on a numeric scale from 0 to 10 where 0 is "poor quality" and 10 is "excellent quality"
measure: GPs' interpretation of the benefit of experimental treatment
time frame: 30 days
description: measure on a numéric scale from 0 to 10 wher 0 is "not beneficial" and 10 is "very beneficial"
arm group label: Control group
arm group type: Placebo Comparator
description: Assess abstract not reporting funding sources or conflicts of interest
arm group label: Funding sources
arm group type: Experimental
description: Assess one type of abstract in the randomized arm. Assess abstract reporting funding sources only.
arm group label: Funding sources/Conflicts of Interests
arm group type: Experimental
description: Assess one type of abstract in the randomized arm. Assess abstract reporting funding sources and conflicts of interest
intervention type: Other
intervention name: Assess one type of abstract in the randomized arm
description: Participants will be asked to assess only one abstract in his arm of randomization. Three reminders will be made
arm group label: Control group
arm group label: Funding sources
arm group label: Funding sources/Conflicts of Interests
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Celine Buffel du Vaure
role: Principal Investigator
affiliation: Hotel Dieu Hospital
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hotel Dieu Hospital
investigator full name: Celine Buffel du Vaure
investigator title: Resident