<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/NCT03246945</url>
  </required_header>
  <id_info>
    <org_study_id>15-012463</org_study_id>
    <nct_id>NCT03246945</nct_id>
  </id_info>
  <brief_title>Photograph Quality Rating Scale Study (&quot;PQRS Study&quot;)</brief_title>
  <acronym>PQRS</acronym>
  <official_title>Assessing Parental Photographs of Skin Disease and the Concordance of a Virtual Diagnosis: Can 3 Simple Instructions Improve Photograph Quality?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</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>
      Advances in smart phone-based photography (both quality and image transmission) offer the&#xD;
      potential to greatly improve access to pediatric dermatologists. However, the accuracy of&#xD;
      diagnoses reliant on parent-provided photographs has been neither measured nor compared to&#xD;
      diagnoses based on in-person examinations. Therefore, the primary objective of this study was&#xD;
      to assess the concordance between diagnoses based on photographs taken by parents (or legal&#xD;
      guardians) and those based on in-person examinations. A secondary aim was to assess the&#xD;
      effect of photography instructions on improving this concordance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each patient/parent dyad will be randomized into one of two approximately equally sized&#xD;
      groups; half of the subjects will be provided with an instruction sheet on how best to take&#xD;
      photographs of skin conditions with their mobile devices (study group) and half will not be&#xD;
      provided this instruction sheet (control group). Photographs will be evaluated for image&#xD;
      quality and to provide a diagnosis (See attached forms including Photograph Quality Rating&#xD;
      Scale).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patient/parent dyads visiting a pediatric dermatology clinic were invited to participate. After consent, patient/parent dyads were randomly assigned to photography instruction versus no instruction. In both arms, parents photographed their child's skin condition (via smart phone) and provided medical history. Images were uploaded securely to the child's electronic health record for independent diagnosis by a dermatologist not involved in the patient's care.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <masking_description>Dermatologist providing remote diagnosis was blinded to whether parents were provided instructions, which phone they took and the diagnosis provided by the in-person dermatologist</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of photography instructions on average image quality, as evaluated using a photograph quality rating scale (PQRS)</measure>
    <time_frame>1 hour</time_frame>
    <description>The PQRS quantifies photograph quality based on five criteria: clarity, perspective, darkness, brightness, and color. Each criterion is rated on an integer scale from 0 to 2, yielding a total score ranging from 0 (lowest quality) to 10 (highest quality).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordance between photograph-based versus in-person-based diagnosis, as quantified using Cohen's kappa.</measure>
    <time_frame>1 hour</time_frame>
    <description>Cohen's kappa is a measure of inter-rater agreement that takes into account the possibility of agreement occurring by chance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Dermatology/Skin - Other</condition>
  <arm_group>
    <arm_group_label>Study Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient-Parent Dyad receiving photography instructions prior to taking photographs of skin conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient-Parent Dyad not receiving photography instructions prior to taking photographs of skin conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Instructions on taking photographs provided, see methods</intervention_name>
    <description>Parent-patient dyads were provided with written 3-step instructions on how best to take a photograph of skin conditions using a smart phone</description>
    <arm_group_label>Study Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be a new patient/parent dyad arrived at the main pediatric dermatology clinic&#xD;
&#xD;
          2. Patient must be under the age of 18.&#xD;
&#xD;
          3. Consenting parent or guardian must be present and able to speak English to&#xD;
             participate.&#xD;
&#xD;
          4. Patients are either already enrolled in MyCHOP (MyChart) or are willing to enroll&#xD;
             during the encounter.&#xD;
&#xD;
          5. Parent or legal guardian has a mobile phone with the capability to download the free&#xD;
             MyChart app.&#xD;
&#xD;
          6. Parents have a data plan that allows them to download the MyChart app (if not already&#xD;
             downloaded) and upload pictures, and are willing to accept any potential data charges&#xD;
             incurred with these activities.&#xD;
&#xD;
          7. Patient has active skin lesion or rash that can be photographed during the clinic&#xD;
             visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is over the age of 18.&#xD;
&#xD;
          2. Parent or guardian is not present or not able to speak English.&#xD;
&#xD;
          3. Parent or guardian is not able to enroll in MyCHOP (MyChart).&#xD;
&#xD;
          4. Parent or guardian does not have a mobile phone capable of downloading the MyChart&#xD;
             app.&#xD;
&#xD;
          5. Photographs are not able to be taken (phone battery dies, phone/app does not work,&#xD;
             patient is not cooperative, participant does not have time).&#xD;
&#xD;
          6. If there are no active skin lesions to photograph the patient/parent will not be&#xD;
             enrolled (e.g. hives that are inactive, hyperhidrosis [excessive sweating], itching&#xD;
             without a rash, resolved skin lesions [e.g. warts, molluscum]).&#xD;
&#xD;
          7. Patients presenting for a general full body skin exam will be excluded, as this would&#xD;
             require full body photography, which is too time consuming. (Note: this does not&#xD;
             include evaluation of one individual mole [nevus], which can be included in the&#xD;
             study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick McMahon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246945
org study id: 15-012463
nct id: NCT03246945
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Advances in smart phone-based photography (both quality and image transmission) offer the
      potential to greatly improve access to pediatric dermatologists. However, the accuracy of
      diagnoses reliant on parent-provided photographs has been neither measured nor compared to
      diagnoses based on in-person examinations. Therefore, the primary objective of this study was
      to assess the concordance between diagnoses based on photographs taken by parents (or legal
      guardians) and those based on in-person examinations. A secondary aim was to assess the
      effect of photography instructions on improving this concordance.
Each patient/parent dyad will be randomized into one of two approximately equally sized
      groups; half of the subjects will be provided with an instruction sheet on how best to take
      photographs of skin conditions with their mobile devices (study group) and half will not be
      provided this instruction sheet (control group). Photographs will be evaluated for image
      quality and to provide a diagnosis (See attached forms including Photograph Quality Rating
      Scale).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patient/parent dyads visiting a pediatric dermatology clinic were invited to participate. After consent, patient/parent dyads were randomly assigned to photography instruction versus no instruction. In both arms, parents photographed their child's skin condition (via smart phone) and provided medical history. Images were uploaded securely to the child's electronic health record for independent diagnosis by a dermatologist not involved in the patient's care.
primary purpose: Diagnostic
masking: Double (Care Provider, Investigator)
masking description: Dermatologist providing remote diagnosis was blinded to whether parents were provided instructions, which phone they took and the diagnosis provided by the in-person dermatologist
measure: The effect of photography instructions on average image quality, as evaluated using a photograph quality rating scale (PQRS)
time frame: 1 hour
description: The PQRS quantifies photograph quality based on five criteria: clarity, perspective, darkness, brightness, and color. Each criterion is rated on an integer scale from 0 to 2, yielding a total score ranging from 0 (lowest quality) to 10 (highest quality).
measure: Concordance between photograph-based versus in-person-based diagnosis, as quantified using Cohen's kappa.
time frame: 1 hour
description: Cohen's kappa is a measure of inter-rater agreement that takes into account the possibility of agreement occurring by chance.
arm group label: Study Arm
arm group type: Experimental
description: Patient-Parent Dyad receiving photography instructions prior to taking photographs of skin conditions
arm group label: Control Arm
arm group type: No Intervention
description: Patient-Parent Dyad not receiving photography instructions prior to taking photographs of skin conditions
intervention type: Behavioral
intervention name: Instructions on taking photographs provided, see methods
description: Parent-patient dyads were provided with written 3-step instructions on how best to take a photograph of skin conditions using a smart phone
arm group label: Study Arm
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick McMahon, MD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No