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Professor Jon Deeks at the University of Birmingham and Professor Hywel Williams at the University of Nottingham and their teams looked at the nine studies. They looked at the photos that the apps, as well as researchers, analyzed for the presence or absence of cancers. The images that the apps could not assess were excluded, and the other participants were analyzed for this new study.
Results showed that SkinScan in a study looked at 15 moles, and of these five had melanomas. The app has missed all five of them. SkinVision similarly was assessed in two studies. In one of the studies, the app had looked at 108 moles and of these, there were 35 moles that were either frankly cancerous or in a stage before actual cancer. The app had a sensitivity of 88 percent. This meant that it missed detecting 12 percent of cancerous or precancerous moles or false negatives. The app had a specificity of 79 percent, meaning 21 percent of the moles that were not cancerous would be flagged or false positives. The team analyzed the studies and wrote that if 1000 persons were screened using these apps, of which 3 percent or 30 had melanomas, SkinVision would miss 4 of the cases and tell 200 individuals falsely that their moles were cancerous or precancerous.
Lead researcher Dr. Jac Dinnes, of the Institute of Applied Health Research at the University of Birmingham, said, "This is a fast-moving field, and it's really disappointing that there is not better quality evidence available to judge the efficacy of these apps. It is vital that healthcare professionals are aware of the current limitations both in the technologies and in their evaluations." Hywel Williams, Professor of Dermatology at the University of Nottingham, one of the co-authors of the study, said that if there is a doubt, its best to get checked by a GP.
At present, these apps come under the purview of the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Starting this year, they may be regulated by the new Medical Device Regulations. Co-author Jon Deeks, Professor of Biostatistics in the Institute of Applied Health Research, said, "Regulators need to become alert to the potential harm that is poorly performing algorithm-based diagnostic or risk monitoring apps create. We rely on the CE mark as a sign of quality, but the current CE mark assessment processes are not fit for protecting the public against the risks that these apps present."
In a linked editorial in the same issue by researchers from the University of Oxford agreed that stricter measures need to be taken to ensure the safety and efficacy of these apps. Journal reference:
Algorithm based smartphone apps to assess risk of skin cancer in adults: systematic review of diagnostic accuracy studies BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m127 (Published 10 February 2020) BMJ 2020;368:m127
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