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

Background: The national Omaolo digital social welfare and health care service of Finland provides a symptom checker, Omaolo, which is a medical device (based on Duodecim Clinical Decision Support EBMEDS software) with a CE marking (risk class IIa), manufactured by the government-owned DigiFinland Oy. Users of this service can perform their triage by using the questions in the symptom checker. By completing the symptom checker, the user receives a recommendation for action and a service assessment with appropriate guidance regarding their health problems on the basis of a selected specific symptom in the symptom checker. This allows users to be provided with appropriate health care services, regardless of time and place.

Objective: This study describes the protocol for the mixed methods validation process of the symptom checker available in Omaolo digital services.

Methods: This is a mixed methods study using quantitative and qualitative methods, which will be part of the clinical validation process that takes place in primary health care centers in Finland. Each organization provides a space where the study and the nurse triage can be done in order to include an unscreened target population of users. The primary health care units provide walk-in model services, where no prior phone call or contact is required. For the validation of the Omaolo symptom checker, case vignettes will be incorporated to supplement the triage accuracy of rare and acute cases that cannot be tested extensively in real-life settings. Vignettes are produced from a variety of clinical sources, and they test the symptom checker in different triage levels by using 1 standardized patient case example.

Results: This study plan underwent an ethics review by the regional permission, which was requested from each organization participating in the research, and an ethics committee statement was requested and granted from Pirkanmaa hospital district's ethics committee, which is in accordance with the University of Tampere's regulations. Of 964 clinical user-filled symptom checker assessments, 877 cases were fully completed with a triage result, and therefore, they met the requirements for clinical validation studies. The goal for sufficient data has been reached for most of the chief symptoms. Data collection was completed in September 2019, and the first feasibility and patient experience results were published by the end of 2020. Case vignettes have been identified and are to be completed before further testing the symptom checker. The analysis and reporting are estimated to be finalized in 2024.

Conclusions: The primary goals of this multimethod electronic symptom checker study are to assess safety and to provide crucial information regarding the accuracy and usability of the Omaolo electronic symptom checker. To our knowledge, this will be the first study to include real-life clinical cases along with case vignettes.

International Registered Report Identifier (irrid): DERR1-10.2196/41423.