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

Assessing Parental Photographs of Skin Disease and the Concordance of a Virtual Diagnosis: Can 3 Simple Instructions Improve Photograph Quality?

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.

Study Overview

• Status: Completed
• Conditions: Dermatology/Skin - Other
• Intervention / Treatment: Behavioral: Instructions on taking photographs provided, see methods

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between photograph-based versus in-person-based diagnosis, as quantified using Cohen's kappa.	Cohen's kappa is a measure of inter-rater agreement that takes into account the possibility of agreement occurring by chance.	1 hour

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Patrick McMahon, MD, Children's Hospital of Philadelphia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 15-012463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No