Dermatology/Skin - OtherPQRSNCT03246945
Photograph Quality Rating Scale Study ("PQRS Study")
A study testing Instructions on taking photographs provided, see methods in people with Dermatology/Skin - Other, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatology/Skin - Other
- What is being tested?
- Instructions on taking photographs provided, see methods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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).
- Conditions
- Dermatology/Skin - Other
- Being tested
- Instructions on taking photographs provided, see methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructions on taking photographs provided, see methodsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Patient-Parent Dyad receiving photography instructions prior to taking photographs of skin conditions Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatology/Skin - OtherStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick McMahon, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246945
- Sponsor's protocol ID
- 15-012463
- Acronym
- PQRS
- Status last verified
- Sep 2017
- First submitted
- 25 Jul 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29141082
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Parental Photographs of Skin Disease and the Concordance of a Virtual Diagnosis: Can 3 Simple Instructions Improve Photograph Quality?
- ClinicalTrials.gov ID
- NCT03246945
- Acronym / sponsor ID
- PQRS / 15-012463
- Conditions
- Dermatology/Skin - Other
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Behavioral: Instructions on taking photographs provided, see methodsPatient-Parent Dyad receiving photography instructions prior to taking photographs of skin conditions |
| Control Arm | No intervention | –Patient-Parent Dyad not receiving photography instructions prior to taking photographs of skin conditions |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructions on taking photographs provided, see methodsParent-patient dyads were provided with written 3-step instructions on how best to take a photograph of skin conditions using a smart phone | Behavioural | Study Arm |
Primary outcome
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).
1 secondary outcome
Concordance between photograph-based versus in-person-based diagnosis, as quantified using Cohen's kappa.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 29141082O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick McMahon, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructions on taking photographs provided, see methods in people with Dermatology/Skin - Other, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of photography instructions on average image quality, as evaluated using a photograph quality rating scale (PQRS) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.