None listed
Conditions
Brief summary
"One Million Skin Checks: A Feasibility Study of Teledermatology and Artificial Intelligence in General Practice For Skin Checks in Adults” is a research study looking at using teledermatology and artificial intelligence to help diagnose skin cancers. The primary aim of the study is to assess the feasibility of using these technologies in general practice to support skin cancer diagnosis and management. The secondary aim is to evaluate GPs’ experience of using the teledermatology and artificial intelligence diagnosis tools and the online training modules for these tools. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have a skin lesion where the GP is concerned about possible skin cancer and the lesion is suitable for imaging and biopsy. Study details All participants who choose to enrol in this study will have their skin lesion assessed by the GP using both standard care methods, and the newly developed artificial intelligence (AI) diagnosis tools. All participants will have a biopsy of the lesion taken and sent for further cellular analysis to determine next treatment steps. Please note that the use of the AI tools will not impact upon the care you receive. The GP will continue to treat all participants as they would without the AI tools, but they will then assess their treatment decisions against those provided by the AI tools at a later time. In order to assess the lesion using the AI diagnosis tools, the GP will attach a specialised microscope fitting to their smartphone and use this to take photos of the lesion. These photos will then be uploaded to a new app (DermEngine) which will connect the GP to a consultant dermatologist for further review of the lesion. The app also has an AI algorithm built into it which will assess the lesion photos, make a diagnosis, and tells the clinician how likely it is to be cancer. The AI result and the teledermatology opinion from the consultant dermatologist will be made available to your GP a day or two after your consultation. As all of the images in the study are anonymised before leaving the GP practice, the AI and teledermatology results will not be communicated directly to patients, but may be available from your GP upon request. It is hoped this research will demonstrate that use of these AI diagnostic tools for skin cancer checks is practical and acceptable to GPs. If this study does find that using the AI diagnostic tools is beneficial, a larger study enrolling more participants may be undertaken to determine the efficacy of the diagnostic tools compared to standard care for skin cancer checks.
Interventions
The study involves 3 interventions made directly to GP's. All GP's will have access to all 3 interventions. The interventions will not affect patient care.
Intervention 1: Provision of a 2 hour online education module for GP's, produced by MetaOptima, to teach GP's how to use the DermEngine software to obtain dermoscopic images of suspicious skin lesions using a smartphone and dermatoscope, and to interpret the artificial intelligence report. Each GP will access the education module via the
The study involves 3 interventions made directly to GP's. All GP's will have access to all 3 interventions. The interventions will not affect patient care. Intervention 1: Provision of a 2 hour online education module for GP's, produced by MetaOptima, to teach GP's how to use the DermEngine software to obtain dermoscopic images of suspicious skin lesions using a smartphone and dermatoscope, and to interpret the artificial intelligence report. Each GP will access the education module via the DermEngine Academy online training website on one occasion, at the start of the trial. The module involves text and images demonstrating correct and incorrect ways to use the DermEngine software, take dermoscopic images as well as labelled images of appropriate lesions and a selection of images of examples of conditions which would not be suitable for imaging (eg inflammatory skin disorders). There is an evaluation quiz at the end of the module. Immediately after successful completion of the training module, GP's will be able to begin enrolling sequential patients and accessing interventions 2 and 3, as below. Access to the DermEngine app and cloud based web portal will be granted automatically by the software on successful completion of the training module. The study team (Drs Anderson and Koutsis) will check that the information has been entered and accessed on DermEngine on a weekly basis and contact GP's where there are significant delays. Intervention 2: Provision of a teledermatology opinion by an Australian Consultant Dermatologist to the GP's on skin lesions from patients that they have enrolled into the study and imaged, after they have finalised standard care clinical management plan. The Consultant Dermatologist will log in to a dedicated clinical trial version of the secure online (cloud based) DermEngine site and view trial images and enter their diagnosis. The teledermatology opinion is generated for every patient and will be accessed within the DermEngine or website by the GP. Teledermatology opinions will be delayed by at least 24hrs to ensure that they do not affect patient care. The DermEngine app and site are already in common use in clinical care in dermatology services across Australia and meet relevant IT data security/governance requirements. Intervention 3: Provision of an artificial intelligence (AI) assessment to the GP's on skin lesions from patients that they have enrolled into the study and imaged, after they have finalised standard care clinical management plan for patients. The AI opinion is generated for every patient and provided within the cloud based DermEngine site. AI results will be delayed by at least 24 hrs to ensure that they do not affect patient care. DermEngine is a commercial product produced by MetaOptima Technology Australia Pty Ltd Sydney, NSW. It consists of a smartphone app and a cloudbased platform, accessed from any web browser. The product has been modified for this trial to incorporate produce a bespoke study version. Modifications include identifying patients only by their study ID (ie DermEngine is anonymised for trial patients) and the inclusion of teledermatology and AI opinions. which will only be available to those engaged in this clinical trial.
Sponsors
Melanoma Institute Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
STUDY PARTICIPANTS: Patients with a skin lesion where the GP is concerned about possible skin cancer Lesions: • For surgical biopsy and submission for histopathological assessment • Suspicious for one of the three target cutaneous malignancies of DermDx o Melanoma o Basal Cell Carcinoma o Squamous Cell Carcinoma or Actinic Keratosis (Intraepithelial SCC/Bowen’s Disease) • Amenable for imaging with a dermatoscope (or dermoscopic attachment) and digital imaging device (E.g.: digital camera or smartphone) • Amenable for contact or non-contact dermoscopy • Size: entire lesion must fit within field of view of the dermatoscope Biopsy type: • All types of surgical biopsy or excision suitable for histological assessment. These include partial biopsy or complete excision, shave, punch, curettage. Patients: • Types 1 to 3 Fitzpatrick skin phototype • Aged 18 years or older • ability to consent to digital image acquisition, analysis of the image by teledermatologist and artificial intelligence image algorithm and surgical biopsy/excision. If they are unable to consent an authorised person may provide consent on their behalf (As outlined in the Health Privacy Act 1988). GP'S • GPs must have general, unrestricted medical practitioner registration with AHPRA • They must work and recruit patients in a primary care environment (mixed general practice, GP skin cancer practice)
Exclusion criteria
Lesions • Previously biopsied • Sites: mucosal, acral, ocular, umbilicus Clinical scenarios • Emergency or Life-Threatening conditions, e.g.: Steven-Johnson Syndrome, Toxic-Epidermal Necrolysis • Infections, e.g.: folliculitis • Infestations, e.g.: scabies • Inflammatory conditions, e.g.: eczema, psoriasis • Blistering disorders, e.g.: pemphigus vulgaris • Hair loss, e.g.: alopecia areata • Traumatic injuries Patient • Pregnant women (due to known physiological changes that occur in naevi during pregnancy) • Unable to tolerate dermoscopy (e.g.: sitting still, hypersensitivity to any contact materials) GP Practitioners • Other primary care clinicians who do not hold medical registration with AHPRA. E.g.: nurse practitioners • Practitioners working in a specialist practice or environment. E.g.: GPs working within a surgical oncology or dermatology practice
Outcome results
None listed