A Smartphone Application as an Exploratory Endpoint in a Phase 3 Parkinson's Disease Clinical Trial: A Pilot Study [0.03%]
帕金森病三期临床试验中手机应用程序的探索性研究终点:一项试点研究
Alex Page,Norman Yung,Peggy Auinger et al.
Alex Page et al.
Background: Smartphones can generate objective measures of Parkinson's disease (PD) and supplement traditional in-person rating scales. However, smartphone use in clinical trials has been limited. ...
[This corrects the article DOI: 10.1159/000512500.]. Copyright © 2021 by S. Karger AG, Basel.
Published Erratum
Digital biomarkers. 2021 Nov 25;5(3):224. DOI:10.1159/000520738 2021
First Regulatory Qualification of a Novel Digital Endpoint in Duchenne Muscular Dystrophy: A Multi-Stakeholder Perspective on the Impact for Patients and for Drug Development in Neuromuscular Diseases [0.03%]
杜兴氏肌肉营养不良新型数字终点首次监管认定:多利益相关方视角对神经肌肉疾病患者及药物研发的影响
Laurent Servais,Eric Camino,Aude Clement et al.
Laurent Servais et al.
Background: Functional outcome measures used to assess efficacy in clinical trials of investigational treatments for rare neuromuscular diseases like Duchenne muscular dystrophy (DMD) are performance-based tasks completed...
Beyond the Therapist's Office: Merging Measurement-Based Care and Digital Medicine in the Real World [0.03%]
超越治疗室:在现实世界中结合基于测量的护理和数字医疗
Emil Chiauzzi,Paul Wicks
Emil Chiauzzi
This viewpoint focuses on the ways in which digital medicine and measurement-based care can be utilized in tandem to promote better assessment, patient engagement, and an improved quality of psychiatric care. To date, there has been an unde...
Advanced Machine Learning Tools to Monitor Biomarkers of Dysphagia: A Wearable Sensor Proof-of-Concept Study [0.03%]
高级机器学习工具监测吞咽障碍生物标志物:可穿戴传感器的概念验证研究
Megan K OBrien,Olivia K Botonis,Elissa Larkin et al.
Megan K OBrien et al.
Introduction: Difficulty swallowing (dysphagia) occurs frequently in patients with neurological disorders and can lead to aspiration, choking, and malnutrition. Dysphagia is typically diagnosed using costly, invasive imag...
Digital Endpoints: Definition, Benefits, and Current Barriers in Accelerating Development and Adoption [0.03%]
数字终点:定义、益处及目前在加速发展和采纳方面遇到的障碍
Matthew Landers,Ray Dorsey,Suchi Saria
Matthew Landers
The assessment of health and disease requires a set of criteria to define health status and progression. These health measures are referred to as "endpoints." A "digital endpoint" is defined by its use of sensor-generated data often collect...
Real-World Evidence for a Smartwatch-Based Parkinson's Motor Assessment App for Patients Undergoing Therapy Changes [0.03%]
基于智能手表的帕金森病运动评估应用程序在治疗改变时的现实世界证据
Aaron J Hadley,David E Riley,Dustin A Heldman
Aaron J Hadley
Introduction: Parkinson's disease (PD) is poorly quantified by patients outside the clinic, and paper diaries have problems with subjective descriptions and bias. Wearable sensor platforms; however, can accurately quantif...
Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations [0.03%]
在类风湿关节炎中开发一种新型睡眠测量方法的研究提案:研究方法和考虑因素
Michelle Crouthamel,Robert J Mather,Suraj Ramachandran et al.
Michelle Crouthamel et al.
The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulato...
Automatic Identification of Upper Extremity Rehabilitation Exercise Type and Dose Using Body-Worn Sensors and Machine Learning: A Pilot Study [0.03%]
基于身体穿戴传感器和机器学习的上肢康复运动类型和剂量自动识别:一项初步研究
Noah Balestra,Gaurav Sharma,Linda M Riek et al.
Noah Balestra et al.
Background: Prior studies suggest that participation in rehabilitation exercises improves motor function poststroke; however, studies on optimal exercise dose and timing have been limited by the technical challenge of qua...
The Real-World Data Challenges Radar: A Review on the Challenges and Risks regarding the Use of Real-World Data [0.03%]
真实世界数据挑战雷达:关于使用真实世界数据的挑战和风险的回顾性研究
Frank Grimberg,Petra Maria Asprion,Bettina Schneider et al.
Frank Grimberg et al.
Background: The life science industry has a strong interest in real-world data (RWD), a term that is currently being used in many ways and with varying definitions depending on the source. In this review article, we provi...