A cross-sectional evaluation of the validity of a smartphone otoscopy device in screening for ear disease in Nepal.

OBJECTIVES: Hearing loss is a neglected international health problem. The greatest burden of ear disease is in low-income countries where there is also a lack of resources. In this context, screening for otological disease may be worthwhile. Cupris© has developed an otoscopy device that offers the possibility of low-cost mass screening in remote communities. We evaluated the validity of this device in diagnosing ear disease and in determining whether referral to an ENT centre is warranted.

DESIGN: Cross-sectional study.

SETTING: Outpatient clinic, Nepal.

PARTICIPANTS: All adults and children were invited to take part over a 2-day period. The Cupris© device was used to record participants otological history and examination. Stored history and images were assessed in the United Kingdom by a Consultant-grade ENT Surgeon, who provided a diagnosis and decided whether referral to an ENT centre was warranted. After screening with the Cupris© device, participants were immediately assessed by a UK trained ENT Consultant Surgeon using a standard otoscope ("standard assessment"). A diagnosis was recorded for each participant and a decision was made as to whether referral to an ENT centre was warranted.

OUTCOMES: Concordance in primary diagnosis (analysed per ear) and concordance in the decision to refer (analysed per patient). Cohen's kappa coefficient for inter-rater agreement in diagnosis.

RESULTS: Fifty-six patients agreed to participate. In four patients, the quality of video recorded precluded a diagnosis or management plan. These patients were excluded from subsequent analysis, leaving 52 patients for analysis. The same diagnosis was reached for 99 of 104 ears when comparing the Cupris© device to standard assessment (95% concordance), with Cohen's kappa coefficient of 0.89. The decision as to whether a patient should be referred to an ENT centre for further assessment was the same for all 52 participants when comparing the Cupris© device to standard assessment.

CONCLUSIONS: When compared to standard assessment, the Cupris© device is a valid tool for the diagnosis of ear disease and decision for onward referral. It shows considerable promise for use by trained non-medical workers, as a low-cost and portable tool to screen for ear disease in remote settings, particularly in low- and middle-income countries.