The ethics of unilateral implantable cardioverter defibrillators and cardiac resynchronization therapy with defibrillator deactivation: patient perspectives.

AIMS: Decisions about deactivation of implantable cardioverter defibrillators (ICDs) are complicated. Unilateral do-not-resuscitate (DNR) orders (against patient/family wishes) have been ethically justified in cases of medical futility. Unilateral deactivation of ICDs may be seen as a logical extension of a unilateral DNR order. However, the ethical implications of unilateral ICD deactivation have not been explored. METHODS AND RESULTS: Sixty patients who had an ICD or cardiac resynchronization therapy with defibrillator (CRT-D) were interviewed at a quaternary medical centre outpatient electrophysiology practice. Survey questions addressed whether deactivation of defibrillator function was included in advanced directives, whether deactivation constitutes physician-assisted suicide, and whether unilateral deactivation can be ethically justified. Responses were elicited to scenarios in which defibrillation function was deactivated in different contexts (including patient request to deactivate, existing DNR, and unilateral deactivation). Only 15% of respondents had thought about device deactivation if they were to develop a serious illness from which they were not expected to recover. A majority (53%) had advance directives, but only one mentioned what to do with the device. However, a majority (78%) did not consider deactivation of an ICD shocking function against patients' wishes to be ethical or moral. CONCLUSION: Management of ICDs and CRT-Ds as patients near the end of their lives creates ethical dilemmas. Few patients consider device deactivation at end-of-life, although a large majority believes that unilateral deactivation is not ethical/moral, even in the setting of medical futility. Advance care planning for these patients should address device deactivation.

Defibrillator Deactivation against a Patient's Wishes: Perspectives of Electrophysiology Practitioners.

BACKGROUND: Unilateral do-not-resuscitate (DNR) orders (against patient/family wishes) have been ethically justified in cases of medical futility. We investigated whether electrophysiology practitioners believe medical futility justifies unilateral implantable cardioverter defibrillator (ICD) deactivation. METHODS AND RESULTS: Email invitations to take an online survey were sent to 1,894 electrophysiology practitioners. A total of 384 responses were collected (response rate 20.6%). Though the sample included respondents from Europe, Asia, Australia, South America, and Africa, the majority were from North America (78%), were academically affiliated (64%), and practiced in an urban setting (67.8%). Deactivation of ICD shock function in agreement with patient wishes and a preexisting DNR were not considered physician-assisted suicide (93.2%, 358/384). However, a majority of the sample responded that it was not ethical/moral for doctors to deactivate ICDs against patients' wishes (77.1%, 296/384) or against family/surrogates' wishes (72.4%, 278/384), even in the context of medical futility. A majority indicated that deactivating ICD shock function is not ethically/morally different than withholding cardiopulmonary resuscitation or external defibrillation in a code (72.7%, 277/381), but was different than deactivating pacing in a pacemaker-dependent patient (82.8%, 318/384). In the classification of interventions, a plurality (43.0%, 165/383) regarded ICDs to be unlike any other intervention. Concerning pacemakers, 50% (191/382) considered them to be like dialysis (a therapy that keeps patients alive). CONCLUSIONS: This international sample of electrophysiology practitioners considered ICD and pacemaker deactivation to be ethically distinct. While ICD deactivation was considered appropriate in the setting of patient/family agreement, unilateral deactivation was not.

Recruitment for Remote Decentralized Studies in Parkinson's Disease.

BACKGROUND: Traditional in-person Parkinson's disease (PD) research studies are often slow to recruit and place unnecessary burden on participants. The ongoing COVID-19 pandemic has added new impetus to the development of new research models. OBJECTIVE: To compare recruitment processes and outcomes of three remote decentralized observational PD studies with video visits. METHODS: We examined the number of participants recruited, speed of recruitment, geographic distribution of participants, and strategies used to enhance recruitment in FIVE, a cross-sectional study of Fox Insight participants with and without PD (n = 203); VALOR-PD, a longitudinal study of 23andMe, Inc. research participants carrying the LRRK2 G2019S variant with and without PD (n = 277); and AT-HOME PD, a longitudinal study of former phase III clinical trial participants with PD (n = 226). RESULTS: Across the three studies, 706 participants from 45 U.S. states and Canada enrolled at a mean per study rate of 4.9 participants per week over an average of 51 weeks. The cohorts were demographically homogenous with regard to race (over 95%white) and level of education (over 90%with more than a high school education). The number of participants living in primary care Health Professional Shortage Areas in each study ranged from 30.3-42.9%. Participants reported interest in future observational (98.5-99.6%) and interventional (76.1-87.6%) research studies with remote video visits. CONCLUSION: Recruitment of large, geographically dispersed remote cohorts from a single location is feasible. Interest in participation in future remote decentralized PD studies is high. More work is needed to identify best practices for recruitment, particularly of diverse participants.

Use of Figurative Language by People With Parkinson Disease to Describe "Off" Periods: Clear as Mud.

OBJECTIVE: "Off" periods are characterized by the reemergence of motor and nonmotor symptoms in individuals with Parkinson disease (PD) and often negatively affect daily functioning. Individuals' experiences are diverse and may be difficult to articulate; figurative language is often used by patients to describe such experiences. Our objective was to understand how individuals with PD use figurative language to explain off periods and how experts interpret such expressions. METHODS: Individuals with self-reported PD participating in the online Fox Insight study were invited to participate in a survey about off periods. Those endorsing off periods were asked to describe their experiences with open-ended free-text responses. Instances where any type of figurative language was used were identified and classified into themes. Three movement disorder neurologists reviewed each phrase and specified what symptoms they felt were likely represented. RESULTS: A total of 109 instances of figurative language phrases were identified across descriptions from 86 patients. Allusions to viscous materials (e.g., mud and cement) and effects of chemicals (e.g., drunkenness) were common (18.35% and 17.43% of phrases, respectively). Most phrases were interpreted by the neurologists as representing motor symptoms, but neurologists agreed on what specific symptom was being referred to for only 42 (38.5%) phrases. CONCLUSIONS: To describe off periods, individuals with PD use various forms of figurative language, but this language is not uniformly interpreted and understood by specialists. Given the subjective interpretation of figurative language, exploring what patients are trying to convey when they use such language is important and could improve patient-physician communication.

Triggers and alleviating factors for fatigue in Parkinson's disease.

BACKGROUND: Fatigue is common in Parkinson's Disease, but few effective treatments are available for it. Exploring triggers and alleviating factors, including effects of exercise, could inform development of management strategies for Parkinson's Disease fatigue. OBJECTIVES: To examine triggers and alleviating factors for fatigue reported by individuals with Parkinson's Disease, including perceived effect of exercise. METHODS: A sample of individuals with self-reported Parkinson's Disease participating in the study Fox Insight were administered an online survey. The survey included the Parkinson's Fatigue Scale, the Physical Activity Scale for the Elderly, and multiple-choice questions about triggers and alleviating factors for fatigue. RESULTS: Among the sample of 1,029 individuals with Parkinson's disease, mean (standard deviation (SD)) age was 67.4 (9.3) years, 44.0% were female. Parkinson's Fatigue Scale score ranged from 16-80, mean (SD) 48.8 (16.2). Poor sleep (62.1%) and physical exertion (45.1%) were frequently reported triggers for fatigue. Coping strategies including sitting quietly (58.1%), laying down with or without napping, and exercise (20%). Physical Activity Scale for the Elderly scores were higher in those who reported that exercise alleviated their fatigue (49.7%) compared to those who reported it worsened their fatigue (18.9%) (mean (SD) score 158.5 (88.8) vs 119.8 (66.6) respectively; p<0.001). CONCLUSIONS: Several behavioral and environmental triggers and alleviating strategies for fatigue are reported by individuals with Parkinson's disease. Many feel that exercise alleviates fatigue, though the relationship between exercise and fatigue in Parkinson's Disease appears complex. This exploratory study may inform future development of treatments or coping strategies for Parkinson's disease fatigue.

The Experience of OFF Periods in Parkinson's Disease: Descriptions, Triggers, and Alleviating Factors.

PURPOSE: Wearing off of Parkinson's disease medication is common, but triggers and coping strategies for this transient phenomenon are poorly understood. We aimed to assess the lived experience of OFF periods for people with Parkinson's disease. METHODS: Participants in the longitudinal Fox Insight study who endorsed OFF periods were invited to complete a survey consisting of both multiple-choice and free-text responses. Descriptive statistics were used to summarize multiple-choice responses, and free-text responses were classified into themes through iterative discussion by 3 movement disorders specialists. RESULTS: A total of 2110 participants (52.4% male) completed the survey. Tremor was the most common description of OFF periods (n=1038, 49.2%), followed by gait changes (n=535, 25.4%) and rigidity (n=430, 20.4%). Of 1498 specific triggers for OFF symptoms, the most common was stress (n=920, 61.4%), followed by anxiety/depression (n=476, 31.8%) and tiredness/fatigue (n=351, 23.4%). Common coping strategies (n=1416 responses) included exercise (n=678, 47.9%), taking a break (n=504, 35.6%), and meditation (n=276, 19.5%). CONCLUSIONS: Although OFF periods are common, the individual experiences of OFF vary. This knowledge could be used to develop new counseling strategies for OFF periods in people with Parkinson's disease.

Knowledge, Responsibilities, and Peer Advice From Care Partners of Patients With Parkinson Disease Psychosis.

Introduction: Care partners (CPs) of individuals with Parkinson disease psychosis (PDP) experience increased strain and rely on informal support networks. The objective of this study was to characterize CP responsibilities, sources of support, and peer advice. Methods: This was a mixed-methods cross-sectional study. The sample was recruited from the online Fox Insight study cohort. CPs who indicated their care recipient suffered hallucinations and/or delusions were administered a questionnaire regarding their caregiving experience to person with PDP. A free-text question asked CPs to give advice to a hypothetical peer CP. Responses to multiple-choice questions were tabulated; responses to the free-text question were grouped into advice categories. Results: 145 CP of individuals with PDP were included in this analysis, mean age (standard deviation, SD) 66.4 (9.4) years; 110 (75.9%) were women. Most (115, 79.3%) provided caregiving on a daily basis, with a range of responsibilities. Only 16 (11%) learned about PDP from a physician; communication challenges included perceived embarrassment or having to prioritize other issues in a limited appointment time. The most common peer advice was to alert the care recipient's neurologist (n = 38, 30.4%); only 8 (6.4%) suggested medication changes. Conclusion: CPs face challenges with clinician communication and learn about psychosis from a variety of informal sources. Few CPs advocate for medications to control PDP, instead preferring non-pharmacological management strategies. Peer advice favored alerting the care recipient's physician, suggesting that CPs do desire more information from the medical team.

The experience of care partners of patients with Parkinson's disease psychosis.

BACKGROUND: Parkinson's disease psychosis (PDP) has a major impact on quality of life and care partner burden; however, little is known about the lived experiences of care partners in managing PDP. OBJECTIVE: To understand how care partners of individuals with PDP experience their role and articulate their needs related to psychosis. METHODS: This was a qualitative study of semi-structured telephone interviews. Recruitment was conducted online via the clinical study matching tool, Fox Trial Finder; study activities took place remotely via telephone interviews. Transcripts of the phone interviews were analyzed by grounded theory methods, and a codebook of key themes that emerged from the analysis was developed. RESULTS: Nine care partners (all female) were interviewed. Discussion topics in the codebook included (1) care partner burden and guilt; (2) communication with medical professionals; (3) coping strategies; (4) emotional reactions of the care partner to psychosis; (5) sources of knowledge about PD psychosis; (6) attitudes towards medications for PDP; (7) strategies to care for loved ones with psychosis; (8) psychosis triggers. CONCLUSIONS: This qualitative analysis uncovers important aspects of the care partner experience, including challenges in navigating the medical system and communicating with professionals. Providers treating patients with PDP should be aware of these constraints and provide added support for strained care partners.

Video-based Parkinson's disease assessments in a nationwide cohort of Fox Insight participants.

INTRODUCTION: Parkinson's disease (PD) research is hampered by slow, inefficient recruitment and burdensome in-person assessments that may be challenging to conduct in a world affected by COVID-19. Fox Insight is an ongoing prospective clinical research study that enables individuals to participate in clinical research from their own homes by completing online questionnaires. To date, over 45,000 participants with and without PD have enrolled. We sought to validate self-reported PD diagnosis in the Fox Insight cohort, assess the validity of other self-reported health information, and evaluate the willingness of participants to participate in video-based research studies. METHODS: Individuals with and without self-reported PD enrolled in Fox Insight were invited to participate in this virtual research study. Participants completed online questionnaires and two virtual visits, during which we conducted standard cognitive and motor assessments. A movement disorder expert determined the most likely diagnosis, which was compared to self-reported diagnosis. RESULTS: A total of 203 participants from 40 U.S. states, 159 with remote clinician-determined PD and 44 without, completed the study (59% male, mean (SD) age 65.7 (9.8)). Level of agreement between self-reported PD diagnosis in Fox Insight and clinician-determined diagnosis was very good ((kappa = 0.85, 95% CI 0.76-0.94). Overall, 97.9% of participants were satisfied with the study, 98.5% were willing to participate in a future observational study with virtual visits, and 76.1% were willing to participate in an interventional trial with virtual visits. CONCLUSION: Among the Fox Insight cohort, self-reported diagnosis is accurate and interest in virtual research studies is high.

Accelerometer data collected with a minimum set of wearable sensors from subjects with Parkinson's disease.

Parkinson's disease (PD) is a neurodegenerative disorder associated with motor and non-motor symptoms. Current treatments primarily focus on managing motor symptom severity such as tremor, bradykinesia, and rigidity. However, as the disease progresses, treatment side-effects can emerge such as on/off periods and dyskinesia. The objective of the Levodopa Response Study was to identify whether wearable sensor data can be used to objectively quantify symptom severity in individuals with PD exhibiting motor fluctuations. Thirty-one subjects with PD were recruited from 2 sites to participate in a 4-day study. Data was collected using 2 wrist-worn accelerometers and a waist-worn smartphone. During Days 1 and 4, a portion of the data was collected in the laboratory while subjects performed a battery of motor tasks as clinicians rated symptom severity. The remaining of the recordings were performed in the home and community settings. To our knowledge, this is the first dataset collected using wearable accelerometers with specific focus on individuals with PD experiencing motor fluctuations that is made available via an open data repository.

Limb and trunk accelerometer data collected with wearable sensors from subjects with Parkinson's disease.

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor and non-motor symptoms. Dyskinesia and motor fluctuations are complications of PD medications. An objective measure of on/off time with/without dyskinesia has been sought for some time because it would facilitate the titration of medications. The objective of the dataset herein presented is to assess if wearable sensor data can be used to generate accurate estimates of limb-specific symptom severity. Nineteen subjects with PD experiencing motor fluctuations were asked to wear a total of five wearable sensors on both forearms and shanks, as well as on the lower back. Accelerometer data was collected for four days, including two laboratory visits lasting 3 to 4 hours each while the remainder of the time was spent at home and in the community. During the laboratory visits, subjects performed a battery of motor tasks while clinicians rated limb-specific symptom severity. At home, subjects were instructed to use a smartphone app that guided the periodic performance of a set of motor tasks.

Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD).

OBJECTIVE: The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site-centric therapeutic trials in Parkinson's disease and generate novel insights. The value of this approach has never been more evident than during the current COVID-19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow-up of clinical trial participants, (2) compare changes in smartphone-based assessments, online patient-reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson's disease disability and progression. METHODS: Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease trials (AT-HOME PD), a two-year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone-based assessments of motor function and socialization, and patient-reported outcomes online. RESULTS: From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study's smartphone application and 161 (71%) have completed patient-reported outcomes on the online platform. INTERPRETATION: It is feasible to conduct a large-scale, international virtual observational study following the completion of participation in brick-and-mortar clinical trials in Parkinson's disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow-up of clinical trial participants and design of future clinical trials.

The Most Bothersome Aspects of Off Periods Reported by Individuals with Parkinson's Disease.

INTRODUCTION: The off periods in Parkinson's disease have a significantly negative impact on quality of life. What the most bothersome aspects of off periods are from the patient's perspective are not well studied, nor is the degree to which screening tools for wearing off such as the Wearing Off Questionnaires (WOQs) capture what bothers patients most. METHODS: A questionnaire was deployed to eligible participants of Fox Insight, an online study of individuals with self-reported Parkinson's disease. Inclusion criteria were the use of ≥1 dopaminergic medications and an affirmative response to a question on experiencing off periods. Participants provided free-text responses regarding the top 3 most bothersome symptoms they experience when off. A determination was made regarding whether each response would have been captured by the 32-item, 19-item, and 9-item WOQs. RESULTS: The final sample had 2106 participants, a mean age of 66.6 years, 52.3% were men, and had a disease duration of 4.9 years. The WOQ-32 items covered all of the most bothersome symptoms for 53.2% of respondents. Among bothersome aspects of off not captured by the WOQs, 597 (66.2%) were specific symptoms, with freezing of gait, apathy, and memory problems being the most common. The functional consequences of off periods were most bothersome to 232 (25.7%), with walking problems being the most common. The emotional response to off periods was the most bothersome aspect to 169 respondents (18.7%). DISCUSSION: This study emphasizes the value of narrative data in understanding patient experiences, and what bothers patients most about off periods. The WOQs, although of established utility in the screening for wearing off, may not capture those symptoms most bothersome to patients.

Fox Insight collects online, longitudinal patient-reported outcomes and genetic data on Parkinson's disease.

Fox Insight is an online, longitudinal health study of people with and without Parkinson's disease with targeted enrollment set to at least 125,000 individuals. Fox Insight data is a rich data set facilitating discovery, validation, and reproducibility in Parkinson's disease research. The dataset is generated through routine longitudinal assessments (health and medical questionnaires evaluated at regular cycles), one-time questionnaires about environmental exposure and healthcare preferences, and genetic data collection. Qualified Researchers can explore, analyze, and download patient-reported outcomes (PROs) data and Parkinson's disease- related genetic variants at https://foxden.michaeljfox.org. The full Fox Insight genetic data set, including approximately 600,000 single nucleotide polymorphisms (SNPs), can be requested separately with institutional review and are described outside of this data descriptor.

Understanding the Lexicon of Fatigue in Parkinson's Disease.

BACKGROUND: Fatigue in Parkinson's disease (PD) is multifaceted and associated with reduced quality of life. In turn, the language used by people with PD to describe fatigue is variable and poorly understood. We sought to elucidate the lexicon of fatigue using a qualitative grounded theory approach. OBJECTIVE: The objective of this study was to understand how patients with PD describe fatigue. METHODS: A pre-study phase of online journaling (Phase 1) provided information regarding topics of importance to patients. Following this, two independent samples of fatigued subjects were studied. Individuals with PD participated in a telephone interview (Phase 2); interview transcripts were analyzed to develop a detailed codebook. To ensure trustworthiness of the findings, an online survey (Phase 3) was administered to individuals with self-reported PD participating in the online study Fox Insight. The survey included the following question: "How do you define fatigue? Please provide your definition in the space below." The codebook developed from Phase 2 was applied to the Phase 3 responses. RESULTS: Fifteen individuals participated in Phase 2 and 413 individuals completed Phase 3. Fatigue was subdivided into three domains: cognitive, emotional, and physical. Nearly all individuals experienced more than one domain of fatigue. The most common themes included tiredness, lack of energy, and negative motivation. CONCLUSION: Fatigue in PD is multidimensional. Questionnaires that only assess the physical impact of fatigue may not be adequate to capture the broad range of experiences of fatigue among people with PD.

Feasibility and utility of a clinician dashboard from wearable and mobile application Parkinson's disease data.

Mobile and wearable device-captured data have the potential to inform Parkinson's disease (PD) care. The objective of the Clinician Input Study was to assess the feasibility and clinical utility of data obtained using a mobile health technology from PD patients. In this observational, exploratory study, PD participants wore a smartwatch and used the Fox Wearable Companion mobile phone app to stream movement data and report symptom severity and medication intake for 6 months. Data were analyzed using the Intel® Pharma Analytics Platform. Clinicians reviewed participants' data in a dashboard during in-office visits at 2 weeks, 1, 3, and 6 months. Clinicians provided feedback in focus groups leading to dashboard updates. Between June and August 2017, 51 PD patients were recruited at four US sites, and 39 (76%) completed the 6-month study. Patients streamed 83,432 h of movement data from their smartwatches (91% of expected). Reporting of symptoms and medication intake using the app was lower than expected, 44% and 60%, respectively, but did not differ according to baseline characteristics. Clinicians' feedback resulted in ten updates to the dashboard during the study period. Clinicians reported that medications and patient reported outcomes were generally discernable in the dashboard and complementary to clinical assessments. Movement, symptoms, and medication intake data were feasibly translated from the app into a clinician dashboard but there was substantial attrition rate over 6 months. Further enhancements are needed to ensure long-term patient adherence to portable technologies and optimal digital data transfer to clinicians caring for PD patients.

Wearable sensors for Parkinson's disease: which data are worth collecting for training symptom detection models.

Machine learning algorithms that use data streams captured from soft wearable sensors have the potential to automatically detect PD symptoms and inform clinicians about the progression of disease. However, these algorithms must be trained with annotated data from clinical experts who can recognize symptoms, and collecting such data are costly. Understanding how many sensors and how much labeled data are required is key to successfully deploying these models outside of the clinic. Here we recorded movement data using 6 flexible wearable sensors in 20 individuals with PD over the course of multiple clinical assessments conducted on 1 day and repeated 2 weeks later. Participants performed 13 common tasks, such as walking or typing, and a clinician rated the severity of symptoms (bradykinesia and tremor). We then trained convolutional neural networks and statistical ensembles to detect whether a segment of movement showed signs of bradykinesia or tremor based on data from tasks performed by other individuals. Our results show that a single wearable sensor on the back of the hand is sufficient for detecting bradykinesia and tremor in the upper extremities, whereas using sensors on both sides does not improve performance. Increasing the amount of training data by adding other individuals can lead to improved performance, but repeating assessments with the same individuals-even at different medication states-does not substantially improve detection across days. Our results suggest that PD symptoms can be detected during a variety of activities and are best modeled by a dataset incorporating many individuals.

Impact of motor fluctuations on real-life gait in Parkinson's patients.

BACKGROUND: People with PD (PWP) have an increased risk of becoming inactive. Wearable sensors can provide insights into daily physical activity and walking patterns. RESEARCH QUESTIONS: (1) Is the severity of motor fluctuations associated with sensor-derived average daily walking quantity? (2) Is the severity of motor fluctuations associated with the amount of change in sensor-derived walking quantity after levodopa intake? METHODS: 304 Dutch PWP from the Parkinson@Home study were included. At baseline, all participants received a clinical examination. During the follow-up period (median: 97 days; 25-Interquartile range-IQR: 91 days, 75-IQR: 188 days), participants used the Fox Wearable Companion app and streamed smartwatch accelerometer data to a cloud platform. The first research question was assessed by linear regression on the sensor-derived mean time spent walking/day with the severity of fluctuations (MDS-UPDRS item 4.4) as independent variable, controlled for age and MDS-UPDRS part-III score. The second research question was assessed by linear regression on the sensor-derived mean post-levodopa walking quantity, with the sensor-derived mean pre-levodopa walking quantity and severity of fluctuations as independent variables, controlled for mean time spent walking per day, age and MDS-UPDRS part-III score. RESULTS: PWP spent most time walking between 8am and 1pm, summing up to 72 ±â€¯39 (mean ±â€¯standard deviation) minutes of walking/day. The severity of motor fluctuations did not influence the mean time spent walking (B = 2.4 ±â€¯1.9, p = 0.20), but higher age (B = -1.3 ±â€¯0.3, p = < 0.001) and greater severity of motor symptoms (B = -0.6 ±â€¯0.2, p < 0.001) was associated with less time spent walking (F(3216) = 14.6, p < .001, R2 = .17). The severity of fluctuations was not associated with the amount of change in time spent walking in relation to levodopa intake in any part of the day. SIGNIFICANCE: Analysis of sensor-derived gait quantity suggests that the severity of motor fluctuations is not associated with changes in real-life walking patterns in mildly to moderate affected PWP.

Feasibility of large-scale deployment of multiple wearable sensors in Parkinson's disease.

Wearable devices can capture objective day-to-day data about Parkinson's Disease (PD). This study aims to assess the feasibility of implementing wearable technology to collect data from multiple sensors during the daily lives of PD patients. The Parkinson@home study is an observational, two-cohort (North America, NAM; The Netherlands, NL) study. To recruit participants, different strategies were used between sites. Main enrolment criteria were self-reported diagnosis of PD, possession of a smartphone and age≥18 years. Participants used the Fox Wearable Companion app on a smartwatch and smartphone for a minimum of 6 weeks (NAM) or 13 weeks (NL). Sensor-derived measures estimated information about movement. Additionally, medication intake and symptoms were collected via self-reports in the app. A total of 953 participants were included (NL: 304, NAM: 649). Enrolment rate was 88% in the NL (n = 304) and 51% (n = 649) in NAM. Overall, 84% (n = 805) of participants contributed sensor data. Participants were compliant for 68% (16.3 hours/participant/day) of the study period in NL and for 62% (14.8 hours/participant/day) in NAM. Daily accelerometer data collection decreased 23% in the NL after 13 weeks, and 27% in NAM after 6 weeks. Data contribution was not affected by demographics, clinical characteristics or attitude towards technology, but was by the platform usability score in the NL (χ2 (2) = 32.014, p<0.001), and self-reported depression in NAM (χ2(2) = 6.397, p = .04). The Parkinson@home study shows that it is feasible to collect objective data using multiple wearable sensors in PD during daily life in a large cohort.