xml: <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/NCT05976061</url>
    </required_header>
    <id_info>
      <org_study_id>2020-2432</org_study_id>
      <nct_id>NCT05976061</nct_id>
    </id_info>
    <brief_title>High- and Low-risk Actinic Keratosis Referrals to Secondary Care</brief_title>
    <official_title>High- and Low-risk Actinic Keratosis Referrals to Secondary Care. Implementation of the General Practitioners Guidelines for Actinic Keratosis Patients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tergooi Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Maastricht University Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study evaluates the implementation of the General Practitioners guidelines 'Suspicious&#xD;
        Skin Lesions' and investigated whether their publication and implementation has led to a&#xD;
        reduction in the proportion of referrals of low-risk patients with actinic keratosis to&#xD;
        secondary care, after publication of the General Practitioners guidelines and implementation&#xD;
        activities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the Dutch healthcare system, patients are first examined by the general practitioner who&#xD;
        decides whether a referral to a dermatologist is indicated. Both general practitioners and&#xD;
        dermatologists can diagnose and treat patients with actinic keratosis. Therefore, it is&#xD;
        necessary to distinguish which patients the general practitioner should refer to a&#xD;
        dermatologist and which patients are suitable to be treated by the general practitioner.&#xD;
  &#xD;
        This retrospective data study evaluates the proportion of low risk actinic keratosis patients&#xD;
        in 2019 en 2018.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients.</measure>
      <time_frame>2018 compared to 2019 (2 years)</time_frame>
      <description>The change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients referred by the general practitioner to the dermatologist. The definition of low-risk actinic keratosis patients was based on the General Practitioners guidelines 'Suspicious skin lesions' (published in 2017). Patients were defined as low-risk when they were not immunocompromised, did not have a cutaneous malignancy in their medical history, did not have previous treatment or if they did not have extensive lesions.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">3379</enrollment>
    <condition>Actinic Keratoses</condition>
    <arm_group>
      <arm_group_label>Low risk patients</arm_group_label>
      <description>Low risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High risk patients</arm_group_label>
      <description>High risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Data from patients are collected retrospectively using the Electronic health records.&#xD;
          Patients were selected based on the diagnosis-treatment-combination (DTC) 17 (premalignant&#xD;
          lesion) and DTC 14 (cutaneous malignancy) that was registered from January 2018 to December&#xD;
          2019 by the dermatologist.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients of 18 years and older&#xD;
  &#xD;
            -  referred to dermatologist for suspicion of actinic keratosis and diagnosed as actinic&#xD;
               keratosis by the dermatologist&#xD;
  &#xD;
            -  treated at MaastrichtUMC+ or TergooiHospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  different diagnosis than actinic keratosis&#xD;
  &#xD;
            -  referred by a different specialist than the general practitioner&#xD;
  &#xD;
            -  referred with multiple problems&#xD;
  &#xD;
            -  referred for a second opinion&#xD;
  &#xD;
            -  if the patients was treated as different diagnosis than actinic keratosis by general&#xD;
               practitioner&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Klara Mosterd, prof.dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht UMC+</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Maud Jansen, dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht UMC+</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ellen Oyen</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <link>
      <url>https://richtlijnen.nhg.org/standaarden/verdachte-huidafwijkingen</url>
      <description>the Dutch College of General Practitioners guidelines 'Suspicious Skin lesions'. [updated 2020].</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>General Practitioners guidelines</keyword>
    <keyword>actinic keratosis</keyword>
    <keyword>general physician</keyword>
    <keyword>dermatology</keyword>
    <keyword>low-risk patients</keyword>
    <keyword>referrals</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Keratosis, Actinic</mesh_term>
      <mesh_term>Keratosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976061
  org study id: 2020-2432
  nct id: NCT05976061
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study evaluates the implementation of the General Practitioners guidelines 'Suspicious
        Skin Lesions' and investigated whether their publication and implementation has led to a
        reduction in the proportion of referrals of low-risk patients with actinic keratosis to
        secondary care, after publication of the General Practitioners guidelines and implementation
        activities.
  In the Dutch healthcare system, patients are first examined by the general practitioner who
        decides whether a referral to a dermatologist is indicated. Both general practitioners and
        dermatologists can diagnose and treat patients with actinic keratosis. Therefore, it is
        necessary to distinguish which patients the general practitioner should refer to a
        dermatologist and which patients are suitable to be treated by the general practitioner.
  
        This retrospective data study evaluates the proportion of low risk actinic keratosis patients
        in 2019 en 2018.
  observational model: Cohort
  time perspective: Retrospective
  measure: Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients.
  time frame: 2018 compared to 2019 (2 years)
  description: The change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients referred by the general practitioner to the dermatologist. The definition of low-risk actinic keratosis patients was based on the General Practitioners guidelines 'Suspicious skin lesions' (published in 2017). Patients were defined as low-risk when they were not immunocompromised, did not have a cutaneous malignancy in their medical history, did not have previous treatment or if they did not have extensive lesions.
  arm group label: Low risk patients
  description: Low risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.
  arm group label: High risk patients
  description: High risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Klara Mosterd, prof.dr.
  role: Principal Investigator
  affiliation: Maastricht UMC+
  last name: Maud Jansen, dr.
  role: Principal Investigator
  affiliation: Maastricht UMC+
  facility: 
  country: Netherlands
  url: https://richtlijnen.nhg.org/standaarden/verdachte-huidafwijkingen
  description: the Dutch College of General Practitioners guidelines 'Suspicious Skin lesions'. [updated 2020].
  responsible party type: Sponsor
  mesh term: Keratosis, Actinic
  mesh term: Keratosis