Melanoma surveillance photography (MSP) is a comprehensive surveillance method that comprises two- or three-dimensional total body photography with tagged digital dermoscopy, performed at prescribed ...intervals. It has the potential to reduce unnecessary biopsies and enhance early detection of melanoma, but it is not yet standard care for all high-risk patients in Australia. This protocol describes a randomised controlled trial (RCT) designed to evaluate the clinical impact and cost-effectiveness of using MSP for the surveillance of individuals at ultra-high or high risk of melanoma from a health system perspective.
This is a registry-based, unblinded, multi-site, parallel-arm RCT that will be conducted over 3 years. We aim to recruit 580 participants from three Australian states: Victoria, New South Wales and Queensland, via state cancer registries or direct referral from clinicians. Eligible participants within 24 months of a primary cutaneous melanoma diagnosis will be randomised 1:1 to receive either MSP in addition to their routine clinical surveillance (intervention group) or routine clinical surveillance without MSP (control group). Most participants will continue surveillance with their usual care provider, and the frequency of follow-up visits in both groups will depend on the stage of their primary melanoma and risk factors. The primary outcome measure of the study is the number of unnecessary biopsies (i.e. false positives, being cases where a lesion is biopsied due to suspected melanoma on clinical examination, either with or without MSP, but the resulting histopathology finding is negative for melanoma). Secondary outcomes include the evaluation of health economic outcomes, quality of life and patient acceptability. Two sub-studies will explore the benefit of MSP in high-risk patients prior to a melanoma diagnosis and the diagnostic performance of MSP in the teledermatology setting compared to the en face clinical setting.
This trial will determine the clinical efficacy, cost-effectiveness and affordability of MSP to facilitate policy decision-making at the national and local levels, across primary and specialist care.
ClinicalTrials.gov NCT04385732 . Registered on May 13, 2020.
Severe diarrhea from rotavirus remains an important cause of illness in infants. In this trial, investigators in Indonesia assessed the potential benefit of a neonatal rotavirus vaccine.
Background
A number of studies have shown promising performance of artificial intelligence (AI) algorithms for diagnosis of lesions in skin cancer. To date, none of these have assessed algorithm ...performance in the real-world setting.
Objective
The aim of this project is to evaluate practical issues of implementing a convolutional neural network developed by MoleMap Ltd and Monash University eResearch in the clinical setting.
Methods
Participants were recruited from the Alfred Hospital and Skin Health Institute, Melbourne, Australia, from November 1, 2019, to May 30, 2021. Any skin lesions of concern and at least two additional lesions were imaged using a proprietary dermoscopic camera. Images were uploaded directly to the study database by the research nurse via a custom interface installed on a clinic laptop. Doctors recorded their diagnosis and management plan for each lesion in real time. A pre-post study design was used. In the preintervention period, participating doctors were blinded to AI lesion assessment. An interim safety analysis for AI accuracy was then performed. In the postintervention period, the AI algorithm classified lesions as benign, malignant, or uncertain after the doctors’ initial assessment had been made. Doctors then had the opportunity to record an updated diagnosis and management plan. After discussing the AI diagnosis with the patient, a final management plan was agreed upon.
Results
Participants at both sites were high risk (for example, having a history of melanoma or being transplant recipients). 743 lesions were imaged in 214 participants. In total, 28 dermatology trainees and 17 consultant dermatologists provided diagnoses and management decisions, and 3 experienced teledermatologists provided remote assessments. A dedicated research nurse was essential to oversee study processes, maintain study documents, and assist with clinical workflow. In cases where AI algorithm and consultant dermatologist diagnoses were discordant, participant anxiety was an important factor in the final agreed management plan to biopsy or not.
Conclusions
Although AI algorithms are likely to be of most use in the primary care setting, higher event rates in specialist settings are important for the initial assessment of algorithm safety and accuracy. This study highlighted the importance of considering workflow issues and doctor-patient-AI interactions prior to larger-scale trials in community-based practices.
Acknowledgments
This research was supported by the Victorian Medical Research Acceleration Fund, with 1:1 contribution from MoleMap Ltd. VM is supported by the National Health and Medical Research Council Early Career Fellowship. CF is supported by the Monash University Research Training Program Scholarship.
Conflicts of Interest
SM is head of clinical research and regulatory affairs at Kahu.ai Ltd, a subsidiary of MoleMap Ltd. MH was the chief medical officer and a director of MoleMap Ltd, and holds shares in MoleMap Ltd.
Trial Registration
ClinicalTrials.gov NCT04040114; https://clinicaltrials.gov/ct2/show/NCT04040114
Acute limb ischemia (ALI) presents with significant pain that is often refractory to opioid pain management or is present in patients with relative contraindications to opioids. Here we present a ...case of ALI successfully managed with regional anesthesia using sciatic and saphenous nerve blocks. To our knowledge, this is the first case report of regional anesthesia for ALI performed in the Emergency Department (ED) by Emergency Medicine physicians.
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