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Photograph Quality Rating Scale Study ("PQRS Study") (PQRS)

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ClinicalTrials.gov Identifier: NCT03246945
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE July 25, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date October 2, 2017
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
The effect of photography instructions on average image quality, as evaluated using a photograph quality rating scale (PQRS) [ Time Frame: 1 hour ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03246945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Concordance between photograph-based versus in-person-based diagnosis, as quantified using Cohen's kappa. [ Time Frame: 1 hour ]
Cohen's kappa is a measure of inter-rater agreement that takes into account the possibility of agreement occurring by chance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photograph Quality Rating Scale Study ("PQRS Study")
Official Title  ICMJE Assessing Parental Photographs of Skin Disease and the Concordance of a Virtual Diagnosis: Can 3 Simple Instructions Improve Photograph Quality?
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
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
Primary Purpose: Diagnostic
Condition  ICMJE Dermatology/Skin - Other
Intervention  ICMJE Behavioral: Instructions on taking photographs provided, see methods
Parent-patient dyads were provided with written 3-step instructions on how best to take a photograph of skin conditions using a smart phone
Study Arms  ICMJE
  • Experimental: Study Arm
    Patient-Parent Dyad receiving photography instructions prior to taking photographs of skin conditions
    Intervention: Behavioral: Instructions on taking photographs provided, see methods
  • No Intervention: Control Arm
    Patient-Parent Dyad not receiving photography instructions prior to taking photographs of skin conditions
Publications * O'Connor DM, Jew OS, Perman MJ, Castelo-Soccio LA, Winston FK, McMahon PJ. Diagnostic Accuracy of Pediatric Teledermatology Using Parent-Submitted Photographs: A Randomized Clinical Trial. JAMA Dermatol. 2017 Dec 1;153(12):1243-1248. doi: 10.1001/jamadermatol.2017.4280.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Must be a new patient/parent dyad arrived at the main pediatric dermatology clinic
  2. Patient must be under the age of 18.
  3. Consenting parent or guardian must be present and able to speak English to participate.
  4. Patients are either already enrolled in MyCHOP (MyChart) or are willing to enroll during the encounter.
  5. Parent or legal guardian has a mobile phone with the capability to download the free MyChart app.
  6. Parents have a data plan that allows them to download the MyChart app (if not already downloaded) and upload pictures, and are willing to accept any potential data charges incurred with these activities.
  7. Patient has active skin lesion or rash that can be photographed during the clinic visit.

Exclusion Criteria:

  1. Patient is over the age of 18.
  2. Parent or guardian is not present or not able to speak English.
  3. Parent or guardian is not able to enroll in MyCHOP (MyChart).
  4. Parent or guardian does not have a mobile phone capable of downloading the MyChart app.
  5. Photographs are not able to be taken (phone battery dies, phone/app does not work, patient is not cooperative, participant does not have time).
  6. If there are no active skin lesions to photograph the patient/parent will not be enrolled (e.g. hives that are inactive, hyperhidrosis [excessive sweating], itching without a rash, resolved skin lesions [e.g. warts, molluscum]).
  7. Patients presenting for a general full body skin exam will be excluded, as this would require full body photography, which is too time consuming. (Note: this does not include evaluation of one individual mole [nevus], which can be included in the study).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03246945
Other Study ID Numbers  ICMJE 15-012463
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick McMahon, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP