User-Initiated Symptom Assessment With an Electronic Symptom Checker: Protocol for a Mixed Methods Validation Study

Area of Science:

• Digital health
• Medical device validation
• Clinical decision support systems

Background:

• The Omaolo service in Finland offers a CE-marked medical device (risk class IIa) symptom checker for public use.
• This digital tool, based on Duodecim Clinical Decision Support EBMEDS software, enables users to perform self-triage and receive health guidance.
• It aims to provide accessible healthcare services irrespective of time and location.

Purpose of the Study:

• To describe the protocol for a mixed methods validation of the Omaolo electronic symptom checker.
• To assess the safety, accuracy, and usability of the Omaolo symptom checker in real-world clinical settings.

Main Methods:

• A mixed methods approach combining quantitative and qualitative data collection.
• Validation conducted in primary health care centers in Finland, including walk-in services.
• Inclusion of case vignettes to test triage accuracy for rare and acute conditions.

Main Results:

• Ethics approval obtained from Pirkanmaa hospital district's ethics committee.
• 877 out of 964 user-filled assessments met requirements for clinical validation.
• Data collection completed September 2019; initial feasibility and patient experience results published by end of 2020.

Conclusions:

• The study aims to provide crucial safety and accuracy information for the Omaolo electronic symptom checker.
• This research is the first to combine real-life clinical cases with standardized case vignettes for validation.
• Results will inform the ongoing development and deployment of digital health tools.