Photograph Quality Rating Scale Study ("PQRS Study")

NCT03246945 | Completed

• 1 other identifier: 15-012463
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatology/Skin - Other

Outcome Measures

Primary Outcomes (1)

• The effect of photography instructions on average image quality, as evaluated using a photograph quality rating scale (PQRS)

  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).

  1 hour

Secondary Outcomes (1)

• Concordance between photograph-based versus in-person-based diagnosis, as quantified using Cohen's kappa.

  1 hour

Study Arms (2)

Study Arm

EXPERIMENTAL

Patient-Parent Dyad receiving photography instructions prior to taking photographs of skin conditions

Behavioral: Instructions on taking photographs provided, see methods

Control Arm

NO INTERVENTION

Patient-Parent Dyad not receiving photography instructions prior to taking photographs of skin conditions

Interventions

Instructions on taking photographs provided, see methods BEHAVIORAL

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 Arm

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Must be a new patient/parent dyad arrived at the main pediatric dermatology clinic
• Patient must be under the age of 18.
• Consenting parent or guardian must be present and able to speak English to participate.
• Patients are either already enrolled in MyCHOP (MyChart) or are willing to enroll during the encounter.
• Parent or legal guardian has a mobile phone with the capability to download the free MyChart app.
• 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.
• Patient has active skin lesion or rash that can be photographed during the clinic visit.

You may not qualify if:

• Patient is over the age of 18.
• Parent or guardian is not present or not able to speak English.
• Parent or guardian is not able to enroll in MyCHOP (MyChart).
• Parent or guardian does not have a mobile phone capable of downloading the MyChart app.
• Photographs are not able to be taken (phone battery dies, phone/app does not work, patient is not cooperative, participant does not have time).
• 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 \[e.g. warts, molluscum\]).
• 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).

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 29141082 DERIVED

Study Officials

• Patrick McMahon, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 11, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)