Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Dermatology/Skin - Other Behavioral: Instructions on taking photographs provided, see methods Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: Assessing Parental Photographs of Skin Disease and the Concordance of a Virtual Diagnosis: Can 3 Simple Instructions Improve Photograph Quality?
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arm Intervention/treatment
Experimental: Study Arm
Patient-Parent Dyad receiving photography instructions prior to taking photographs of skin conditions
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

No Intervention: Control Arm
Patient-Parent Dyad not receiving photography instructions prior to taking photographs of skin conditions



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246945


Locations
Layout table for location information
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Layout table for investigator information
Principal Investigator: Patrick McMahon, MD Children's Hospital of Philadelphia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03246945     History of Changes
Other Study ID Numbers: 15-012463
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No