Summary: | OBJECTIVE
To examine the validity and findings of studies that
examine the accuracy of algorithm based smartphone
applications (“apps”) to assess risk of skin cancer in
suspicious skin lesions.
DESIGN
Systematic review of diagnostic accuracy studies.
DATA SOURCES
Cochrane Central Register of Controlled Trials,
MEDLINE, Embase, CINAHL, CPCI, Zetoc, Science
Citation Index, and online trial registers (from
database inception to 10 April 2019).
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Studies of any design that evaluated algorithm based
smartphone apps to assess images of skin lesions
suspicious for skin cancer. Reference standards
included histological diagnosis or follow-up, and
expert recommendation for further investigation or
intervention. Two authors independently extracted
data and assessed validity using QUADAS-2 (Quality
Assessment of Diagnostic Accuracy Studies 2 tool).
Estimates of sensitivity and specificity were reported
for each app.
RESULTS
Nine studies that evaluated six different identifiable
smartphone apps were included. Six verified
results by using histology or follow-up (n=725
lesions), and three verified results by using expert
recommendations (n=407 lesions). Studies were
small and of poor methodological quality, with
selective recruitment, high rates of unevaluable
images, and differential verification. Lesion
selection and image acquisition were performed
by clinicians rather than smartphone users. Two CE
(Conformit Europenne) marked apps are available
for download. No published peer reviewed study
was found evaluating the TeleSkin skinScan app.
SkinVision was evaluated in three studies (n=267, 66
malignant or premalignant lesions) and achieved
a sensitivity of 80% (95% confidence interval 63%
to 92%) and a specificity of 78% (67% to 87%) for
the detection of malignant or premalignant lesions.
Accuracy of the SkinVision app verified against expert
recommendations was poor (three studies).
CONCLUSIONS
Current algorithm based smartphone apps cannot
be relied on to detect all cases of melanoma or other
skin cancers. Test performance is likely to be poorer
than reported here when used in clinically relevant
populations and by the intended users of the apps.
The current regulatory process for awarding the CE
marking for algorithm based apps does not provide
adequate protection to the public.
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