BACKGROUND
National Omaolo digital social welfare and health care services include a symptom checker in Finland. Omaolo is a medical device (based on Duodecim Clinical Decision Support EBMEDS) with a CE marking (risk class: IIa), manufactured by government owned DigiFinland Oy. Users of these services can do their triage with the help of questions from the symptom checker. As a result of completing the symptom checker, the user receives a recommendation of action and a service assessment with appropriate guidance regarding their health problems to a specific symptom. This allows users to be provided with healthcare 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. Study will be part of the clinical validation process that takes place in primary healthcare 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 healthcare units included in this study provide walk-in model services, where no mandatory prior phone call or contact is required.
Finally, the use of case vignettes will be incorporated to supplement the triage accuracy of some areas of the Omaolo symptom checker. Vignettes are produced from a variety of clinical sources, including material used in the exams of medical students. These vignettes test the symptom checker, in different triage levels, using one standardized patient case example.
RESULTS
A total of 964 clinical user filled symptom checker assessments were available, of which, 877 cases were fully completed with a triage result and therefore meet the requirements for clinical validation studies. The goal for sufficient data has been reached for most of the chief symptoms. Data collection was completed at the end of December 2020, and the first feasibility and user experience results were published at the end of 2020. Case vignettes have been identified and are to be completed before further testing the symptom checker.
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 the best of our knowledge this will be the first study to include real-life setting clinical cases along with case vignettes.
CLINICALTRIAL
Regional Ethics Committee of the Expert Responsibility area of Tampere University Hospital