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Photograph Quality Rating Scale Study ("PQRS Study")

NCT ID: NCT03246945

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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).

Conditions

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Dermatology/Skin - Other

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Investigators
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

Study Groups

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Study Arm

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

Group Type EXPERIMENTAL

Instructions on taking photographs provided, see methods

Intervention Type 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

Control Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick McMahon, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29141082 (View on PubMed)

Other Identifiers

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15-012463

Identifier Type: -

Identifier Source: org_study_id