DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III includes 33 items to assess severity of motor symptoms, scoring per each item goes from 0= normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Total score ranges from 0 to 132.

To develop and test machine learning model's performance outcome in predicting the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor symptoms scores.The specific outcome metrics and the respective units used to evaluate the models cannot be defined in advance, as they will depend on the nature of the data and the method of analysis as described by Giannakopoulou,et al. 2022 (Internet of Things Technologies and Machine Learning Methods for Parkinson's Disease Diagnosis, Monitoring and Management: A Systematic Review. Sensors, 22(5), 1799)

"Change in Patient-Reported Motor Symptoms" focuses on assessing changes in motor symptoms reported by patients using an electronic symptoms diary, from baseline to the 6-month follow-up visit. Patients self-report their motor symptoms through the electronic diary, which allows them to record their symptoms and their severity, duration, and frequency.

To develop and test machine learning model's performance outcome in predicting patient-reported symptom scores. The specific outcome metrics and the respective units used to evaluate the models cannot be defined in advance, as they will depend on the nature of the data and the method of analysis as described by Giannakopoulou,et al. 2022 (Internet of Things Technologies and Machine Learning Methods for Parkinson's Disease Diagnosis, Monitoring and Management: A Systematic Review. Sensors, 22(5), 1799)

The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive assessment tool for Parkinson's disease. The MDS-UPDRS total scale, ranging from 0 to 199, measures the overall severity of motor and non-motor symptoms, with higher scores indicating worse outcomes. The subscales include Part I for non-motor aspects, Part II for motor aspects of daily living, Part III for motor examination, and Part IV for motor complications. Higher scores in all subscales suggest a worse outcome, reflecting the severity of symptoms in different domains.

The Parkinson's Disease Questionnaire-39 (PDQ-39) is a validated tool used to measure health-related quality of life in individuals with Parkinson's disease. With scores ranging from 0 to 100, higher scores on the PDQ-39 indicate a worse outcome. It assesses various domains, including mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. Higher scores reflect greater impairment and a lower quality of life, while lower scores indicate better overall well-being and functioning.

"Change in Levodopa and Dopamine-Agonist Equivalent Daily Dosages (LEDD, DAEDD)" focuses on assessing the changes in the daily dosages of levodopa and dopamine agonists. Levodopa and dopamine agonists are common medications used in the treatment of Parkinson's disease. The dosages of these medications are calculated using standardized conversion factors to obtain Levodopa Equivalent Daily Dosage (LEDD) and Dopamine-Agonist Equivalent Daily Dosage (DAEDD), (expressed in mg/day). This outcome aims to measure any changes in the daily dosages of these medications over the course of the study or intervention.

"Change in Levodopa Medication Plan: Medication Dose Strength" focuses on assessing changes in the dose strength of levodopa medication per single intake event, measured in milligrams (mg).

"Change in Levodopa Medication Plan: Units" focuses on assessing changes in the units of levodopa medication per single intake event. The units refer to the quantity of medication taken, which can be measured in whole pills, fractions of pills, or other specified units.

"Change in Medication Levodopa Plan: Frequency of Intakes" focuses on assessing changes in the frequency of intakes for a specified levodopa medication. The frequency refers to the total number of times the medication is taken in a day. Levodopa is a commonly prescribed medication for managing Parkinson's disease symptoms. This outcome aims to capture any modifications made to the frequency of intakes during the study or intervention period.

"Change in Motor Symptoms Digital Biomarkers: duration" refers to the measure of time spent with specific motor symptoms. The duration is typically measured in minutes or seconds, representing the length of time an individual experiences the motor symptom being monitored. This outcome aims to capture any changes or fluctuations in the duration of motor symptoms over the course of the study or intervention.

"Change in Motor Symptoms Digital Biomarkers: frequency" focuses on measuring the frequency of motor symptoms experienced by individuals. The frequency is typically recorded as the number of occurrences within a specific time period, such as per hour or per day.

"Change in Motor Symptoms Digital Biomarkers: severity" involves assessing the severity of motor symptoms using digital biomarkers on a scale ranging from 0 to 4.

"Change in Digital Biomarker: Activity" measures the time spent on specific motor activities, such as walking, standing, active not moving, running, and climbing stairs, using digital biomarkers. The duration is measured in minutes and captures changes in activity time throughout the study or intervention.

"Change in ePROMs: Symptoms Frequency" uses the Soturi mobile app to collect electronic Patient-Reported Outcome Measures (ePROMs) regarding the frequency of symptoms. Participants report the frequency of specific symptoms they experience over time using the app.

"Change in ePROMs: Symptoms Severity" utilizes the Soturi mobile app to collect electronic Patient-Reported Outcome Measures (ePROMs) regarding the severity of symptoms. Participants rate the severity of specific symptoms they experience on a scale ranging from 0 (absent) to 4 (severe) using the app.

"Change in ePROMs: Symptoms Duration" involves using the symptom tracking function within the Soturi mobile app to collect electronic Patient-Reported Outcome Measures (ePROMs) regarding the duration of symptoms. Participants are asked to record the start time and end time of specific symptoms they experience using the app's symptom tracking feature.

"Usability of Soturi Mobile App: System Usability Scale (SUS)" assesses the usability of the Soturi mobile app using the System Usability Scale (SUS). The SUS is a validated questionnaire consisting of several statements related to app usability. Participants rate their agreement on a scale of 0 to 100, with higher scores indicating better usability. This outcome provides insights into the user-friendliness and effectiveness of the Soturi app. Higher scores on the SUS indicate a better outcome, suggesting that the app is more intuitive, easy to use, and meets user expectations. It helps evaluate and enhance the app's usability, resulting in improved user experiences and satisfaction

"Usability of Soturi Mobile App: Session Duration" focuses on assessing the usability of the Soturi mobile app by analyzing session durations. Session duration refers to the length of time that users spend actively engaging with the app during a single session. By examining session durations, study will obtain insights into how long users typically interact with the app, indicating the level of engagement and usability. Longer session durations suggest that users find the app engaging and easy to navigate, indicating a positive usability outcome.

"Usability of Soturi Mobile App: Frequency of App Interactions" assesses the usability of the Soturi mobile app by analyzing the frequency of user interactions. This outcome involves measuring how often users interact with different features and functions within the app. By analyzing the frequency of app interactions, study will determine the level of user engagement and the ease of navigating various app functionalities. A higher frequency of app interactions suggests that users find the app intuitive, engaging, and user-friendly, indicating a positive usability outcome.