Longitudinal patient registries generate important evidence for advancing clinical care and the regulatory evaluation of health-care products. Most national registries rely on data collected as part of routine clinical encounters, an approach that does not capture real-world, patient-centred outcomes, such as physical activity, fatigue, ability to do daily tasks, and other indicators of quality of life. Digital health technologies that obtain such real-world data could greatly enhance patient registries but unresolved challenges have so far prevented their broad adoption.
View Article and Find Full Text PDF[This corrects the article DOI: 10.2196/55452.].
View Article and Find Full Text PDFBackground: Physical capacity and physical activity are important aspects of physical functioning and quality of life in people with a chronic disease such as Parkinson disease (PD) or chronic obstructive pulmonary disease (COPD). Both physical capacity and physical activity are currently measured in the clinic using standardized questionnaires and tests, such as the 6-minute walk test (6MWT) and the Timed Up and Go test (TUG). However, relying only on in-clinic tests is suboptimal since they offer limited information on how a person functions in daily life and how functioning fluctuates throughout the day.
View Article and Find Full Text PDFDiabetes mellitus is a widespread chronic metabolic disorder that requires regular blood glucose level surveillance. Current invasive techniques, such as finger-prick tests, often result in discomfort, leading to infrequent monitoring and potential health complications. The primary objective of this study was to design a novel, portable, non-invasive system for diabetes detection using breath samples, named DiabeticSense, an affordable digital health device for early detection, to encourage immediate intervention.
View Article and Find Full Text PDFBackground: Mobility is a meaningful aspect of an individual's health whose quantification can provide clinical insights. Wearable sensor technology can quantify walking behaviors (a key aspect of mobility) through continuous passive monitoring.
Objective: Our objective was to characterize the analytical performance (accuracy and reliability) of a suite of digital measures of walking behaviors as critical aspects in the practical implementation of digital measures into clinical studies.
Introduction: Few late-stage clinical trials in Parkinson's disease (PD) have produced evidence on the clinical validity of sensor-based digital measurements of daily life activities to detect responses to treatment. The objective of this study was to assess whether digital measures from patients with mild-to-moderate Lewy Body Dementia demonstrate treatment effects during a randomized Phase 2 trial.
Methods: Substudy within a 12-week trial of mevidalen (placebo vs 10, 30, or 75 mg), where 70/344 patients (comparable to the overall population) wore a wrist-worn multi-sensor device.
Sensor-based remote monitoring could help better track Parkinson's disease (PD) progression, and measure patients' response to putative disease-modifying therapeutic interventions. To be useful, the remotely-collected measurements should be valid, reliable, and sensitive to change, and people with PD must engage with the technology. We developed a smartwatch-based active assessment that enables unsupervised measurement of motor signs of PD.
View Article and Find Full Text PDFBackground/aims: The RNS® System utilizes a cranially implanted neurostimulator attached to leads placed at the seizure focus to provide brain responsive stimulation for the treatment of medically intractable partial onset epilepsy. Infection and erosion rates related to the cranial implant site were assessed overall and by neurostimulator procedure to determine whether rates increased with additional procedures.
Methods: Infection and erosion rates were calculated as (1) chance per neurostimulator procedure, (2) incidence per patient implant year, and (3) rates for initial and each subsequent neurostimulator implant (generalized estimating equation).
Objective: Evaluate the seizure-reduction response and safety of brain-responsive stimulation in adults with medically intractable partial-onset seizures of neocortical origin.
Methods: Patients with partial seizures of neocortical origin were identified from prospective clinical trials of a brain-responsive neurostimulator (RNS System, NeuroPace). The seizure reduction over years 2-6 postimplantation was calculated by assessing the seizure frequency compared to a preimplantation baseline.
Objective: Responsive neurostimulation decreases the frequency of disabling seizures when used as an adjunctive therapy in patients with medically refractory partial-onset seizures. The effect of long-term responsive neurostimulation on neuropsychological performance has not yet been established.
Methods: Neuropsychological data were collected from subjects participating in the open-label arm of a randomized controlled trial of responsive neurostimulation with the RNS(®) System.
Purpose: The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint.
Methods: The study was a multicenter randomized controlled double-blinded trial of responsive neurostimulation in 191 patients with medically resistant focal epilepsy.