Evidence assessing the diagnostic performance of medical smartphone apps: a systematic review and exploratory meta-analysis.

Objective: The number of mobile applications addressing health topics is increasing. Whether these apps underwent scientific evaluation is unclear. We comprehensively assessed papers investigating the diagnostic value of available diagnostic health applications using inbuilt smartphone sensors.

Methods: Systematic Review-MEDLINE, Scopus, Web of Science inclusive Medical Informatics and Business Source Premier (by citation of reference) were searched from inception until 15 December 2016. Checking of reference lists of review articles and of included articles complemented electronic searches. We included all studies investigating a health application that used inbuilt sensors of a smartphone for diagnosis of disease. The methodological quality of 11 studies used in an exploratory meta-analysis was assessed with the Quality Assessment of Diagnostic Accuracy Studies 2 tool and the reporting quality with the 'STAndards for the Reporting of Diagnostic accuracy studies' (STARD) statement. Sensitivity and specificity of studies reporting two-by-two tables were calculated and summarised.

Results: We screened 3296 references for eligibility. Eleven studies, most of them assessing melanoma screening apps, reported 17 two-by-two tables. Quality assessment revealed high risk of bias in all studies. Included papers studied 1048 subjects (758 with the target conditions and 290 healthy volunteers). Overall, the summary estimate for sensitivity was 0.82 (95 % CI 0.56 to 0.94) and 0.89 (95 %CI 0.70 to 0.97) for specificity.

Conclusions: The diagnostic evidence of available health apps on Apple's and Google's app stores is scarce. Consumers and healthcare professionals should be aware of this when using or recommending them.

Prospero Registration Number: 42016033049.