-
How Much Speech Data Is Needed for Tracking Language Change in Alzheimer's Disease? A Comparison of Random Length, 5-Min, and 1-Min Spontaneous Speech Samples. Digit Biomark. Pub Date : 2023-11-24 Ulla Petti,Simon Baker,Anna Korhonen,Jessica Robin
Introduction Changes in speech can act as biomarkers of cognitive decline in Alzheimer's disease (AD). While shorter speech samples would promote data collection and analysis, the minimum length of informative speech samples remains debated. This study aims to provide insight into the effect of sample length in analyzing longitudinal recordings of spontaneous speech in AD by comparing the original
-
Development of a Prototype Video Head Impulse Test System Using an iPhone for Screening of Peripheral Vestibular Dysfunction. Digit Biomark. Pub Date : 2023-11-02 Tatsuaki Kuroda,Kazuhiro Kuroda,Hiroaki Fushiki
Introduction Head impulse, nystagmus, and test of skew (HINTS) is more accurate for the early diagnosis of occipital fossa stroke than magnetic resonance imaging. However, the head impulse test (HIT) is relatively challenging to perform, as it is subjective. Herein, we developed a prototype video HIT (vHIT) system using an iPhone (Apple, Cupertino, CA, USA) that is compact, easy to operate, and analyzable
-
Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST. Digit Biomark. Pub Date : 2023-09-19 David Nobbs,Wojciech Piwko,Christopher Bull,Francesca Cormack,Teemu Ahmaniemi,Sebastian C Holst,Meenakshi Chatterjee,Walter Maetzler,Stefan Avey,Wan Fai Ng,
Background Innovative Medicines Initiative (IMI) consortium IDEA-FAST is developing novel digital measures of fatigue, sleep quality, and impact of sleep disturbances for neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the consortium met with the European Medicines Agency (EMA) to receive advice on its plans for regulatory qualification of the measures. This viewpoint
-
The Case for the Patient-Centric Development of Novel Digital Sleep Assessment Tools in Major Depressive Disorder. Digit Biomark. Pub Date : 2023-09-11 Nele Peerenboom,Suvekshya Aryal,Jennifer M Blankenship,Tracy Swibas,Yaya Zhai,Ieuan Clay,Kate Lyden
Background Depression imposes a major burden on public health as the leading cause of disability worldwide. Sleep disturbance is a core symptom of depression that affects the vast majority of patients. Nonetheless, it is frequently not resolved by depression treatment and may even be worsened through some pharmaceutical interventions. Disturbed sleep negatively impact patients' quality of life, and
-
Validation of an Automated Speech Analysis of Cognitive Tasks within a Semiautomated Phone Assessment. Digit Biomark. Pub Date : 2023-08-31 Daphne Ter Huurne,Nina Possemis,Leonie Banning,Angélique Gruters,Alexandra König,Nicklas Linz,Johannes Tröger,Kai Langel,Frans Verhey,Marjolein de Vugt,Inez Ramakers
Introduction We studied the accuracy of the automatic speech recognition (ASR) software by comparing ASR scores with manual scores from a verbal learning test (VLT) and a semantic verbal fluency (SVF) task in a semiautomated phone assessment in a memory clinic population. Furthermore, we examined the differentiating value of these tests between participants with subjective cognitive decline (SCD) and
-
Exploring the Potential of Apple SensorKit and Digital Phenotyping Data as New Digital Biomarkers for Mental Health Research. Digit Biomark. Pub Date : 2023-08-25 Carsten Langholm,Tobias Kowatsch,Sandra Bucci,Andrea Cipriani,John Torous
The use of digital phenotyping continues to expand across all fields of health. By collecting quantitative data in real-time using devices such as smartphones or smartwatches, researchers and clinicians can develop a profile of a wide range of conditions. Smartphones contain sensors that collect data, such as GPS or accelerometer data, which can inform secondary metrics such as time spent at home,
-
Automated Real-World Video Analysis of Sit-to-Stand Transitions Predicts Parkinson's Disease Severity. Digit Biomark. Pub Date : 2023-08-14 Catherine Morgan,Alessandro Masullo,Majid Mirmehdi,Hanna Kristiina Isotalus,Ferdian Jovan,Ryan McConville,Emma L Tonkin,Alan Whone,Ian Craddock
Introduction Technology holds the potential to track disease progression and response to neuroprotective therapies in Parkinson's disease (PD). The sit-to-stand (STS) transition is a frequently occurring event which is important to people with PD. The aim of this study was to demonstrate an automatic approach to quantify STS duration and speed using a real-world free-living dataset and look at clinical
-
Clinical Validation of Novel Digital Measures: Statistical Methods for Reliability Evaluation. Digit Biomark. Pub Date : 2023-08-09 Bohdana Ratitch,Andrew Trigg,Madhurima Majumder,Vanja Vlajnic,Nicole Rethemeier,Richard Nkulikiyinka
Background Assessment of reliability is one of the key components of the validation process designed to demonstrate that a novel clinical measure assessed by a digital health technology tool is fit-for-purpose in clinical research, care, and decision-making. Reliability assessment contributes to characterization of the signal-to-noise ratio and measurement error and is the first indicator of potential
-
Development and Assessment of an Artificial Intelligence-Based Tool for Ptosis Measurement in Adult Myasthenia Gravis Patients Using Selfie Video Clips Recorded on Smartphones. Digit Biomark. Pub Date : 2023-07-28 Meelis Lootus,Lulu Beatson,Lucas Atwood,Theo Bourdais,Sandra Steyaert,Chethan Sarabu,Zeenia Framroze,Harriet Dickinson,Jean-Christophe Steels,Emily Lewis,Nirav R Shah,Francesca Rinaldo
Introduction Myasthenia gravis (MG) is a rare autoimmune disease characterized by muscle weakness and fatigue. Ptosis (eyelid drooping) occurs due to fatigue of the muscles for eyelid elevation and is one symptom widely used by patients and healthcare providers to track progression of the disease. Margin reflex distance 1 (MRD1) is an accepted clinical measure of ptosis and is typically assessed using
-
Using Clinical Scales and Digital Measures to Explore Falls in Patients with Lewy Body Dementia. Digit Biomark. Pub Date : 2023-06-21 Chakib Battioui,Albert Man,Melissa Pugh,Jian Wang,Xiangnan Dang,Hui Zhang,Paul Ardayfio,Leanne Munsie,Ann Marie Hake,Kevin Biglan
Introduction PRESENCE was a phase 2 clinical trial assessing the efficacy of mevidalen, a D1 receptor positive allosteric modulator, for symptomatic treatment of Lewy body dementia (LBD). Mevidalen demonstrated improvements in motor and non-motor features of LBD, global functioning, and actigraphy-measured activity and daytime sleep. Adverse events (AEs) of fall were numerically increased in mevidalen-treated
-
How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints. Digit Biomark. Pub Date : 2023-06-08 Brian Perry,Lindsay Kehoe,Teresa Swezey,Quentin Le Masne,Jörg Goldhahn,Alicia Staley,Amy Corneli
Introduction Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited. Methods From November 2020 through March 2021, the Clinical Trials Transformation Initiative (CTTI) conducted a qualitative descriptive study using semi-structured
-
Reverse Engineering of Digital Measures: Inviting Patients to the Conversation. Digit Biomark. Pub Date : 2023-05-12 Ieuan Clay,Nele Peerenboom,Dana E Connors,Steven Bourke,Alison Keogh,Katarzyna Wac,Tova Gur-Arie,Justin Baker,Christopher Bull,Andrea Cereatti,Francesca Cormack,Damien Eggenspieler,Luca Foschini,Raluca Ganea,Peter M A Groenen,Nicole Gusset,Elena Izmailova,Christoph M Kanzler,Lada Leyens,Kate Lyden,Arne Mueller,Julian Nam,Wan-Fai Ng,David Nobbs,Foteini Orfaniotou,Thanneer Malai Perumal,Wojciech Piwko
Background Digital measures offer an unparalleled opportunity to create a more holistic picture of how people who are patients behave in their real-world environments, thereby establishing a better connection between patients, caregivers, and the clinical evidence used to drive drug development and disease management. Reaching this vision will require achieving a new level of co-creation between the
-
Pilot Study of a Wearable Hydration Monitor in Haemodialysis Patients: Haemodialysis Outcomes & Patient Empowerment Study 02. Digit Biomark. Pub Date : 2023-05-12 Vicki Sandys,Lavleen Bhat,Emer O'Hare,Anna Ninan,Kevin Doyle,Shane Kelly,Peter Conlon,Donal Sexton,Colin Edwards,Paul McAleese,Conall O'Seaghdha
Introduction We aimed to assess the validity and reproducibility of a wearable hydration device in a cohort of maintenance dialysis patients. Methods We conducted a prospective, single-arm observational study on 20 haemodialysis patients between January and June 2021 in a single centre. A prototype wearable infrared spectroscopy device, termed the Sixty device, was worn on the forearm during dialysis
-
Analytical Validation of a Webcam-Based Assessment of Speech Kinematics: Digital Biomarker Evaluation following the V3 Framework Digit Biomark. Pub Date : 2023-04-28 Leif Simmatis, Saeid Alavi Naeini, Deniz Jafari, Michael (Kai Yue) Xie, Chelsea Tanchip, Niyousha Taati, Scotia McKinlay, Rupinder Sran, Justin Truong, Diego L Guarin, Babak Taati, Yana Yunusova
Introduction: Kinematic analyses have recently revealed a strong potential to contribute to the assessment of neurological diseases. However, the validation of home-based kinematic assessments using consumer-grade video technology has yet to be performed. In line with best practices for digital biomarker development, we sought to validate webcam-based kinematic assessment against established, laboratory-based
-
Feasibility of Measuring Physiological Responses to Breakthrough Infections and COVID-19 Vaccine Using a Wearable Ring Sensor Digit Biomark. Pub Date : 2023-03-29 Gerald Norman Pho, Nina Thigpen, Shyamal Patel, Hal Tily
Continuous monitoring using commercial-grade wearable technology was used to quantify the physiological response to reported COVID-19 infections and vaccinations in five biometric measurements. Larger responses were observed following confirmed COVID-19 infection reported by unvaccinated versus vaccinated individuals. Responses following reported vaccination were smaller in both magnitude and duration
-
Remote Monitoring of Vital and Activity Parameters in Chronic Transfusion-Dependent Patients: A Feasibility Pilot Using Wearable Biosensors Digit Biomark. Pub Date : 2022-10-28 Rik Paulus Bernardus Tonino, Mackenzie Tweardy, Stephan Wegerich, Rolf Brouwer, Jaap Jan Zwaginga, Martin Roelof Schipperus
Introduction: Little is known if, and to what extent, outpatient red blood cell (RBC) transfusions benefit chronic transfusion-dependent patients. Costs, labour, and potential side effects of RBC transfusions cause a restrictive transfusion strategy to be the standard of care. However, effects on the actual performance and quality of life of patients who require RBCs on a regular basis are hardly studied
-
Remote Monitoring of Vital and Activity Parameters in Chronic Transfusion-Dependent Patients: A Feasibility Pilot Using Wearable Biosensors Digit Biomark. Pub Date : 2022-10-28
Introduction: Little is known if, and to what extent, outpatient red blood cell (RBC) transfusions benefit chronic transfusion-dependent patients. Costs, labour, and potential side effects of RBC transfusions cause a restrictive transfusion strategy to be the standard of care. However, effects on the actual performance and quality of life of patients who require RBCs on a regular basis are hardly studied
-
Validation of the Remote Automated ki:e Speech Biomarker for Cognition in Mild Cognitive Impairment: Verification and Validation following DiME V3 Framework Digit Biomark. Pub Date : 2022-09-30 Johannes Tröger, Ebru Baykara, Jian Zhao, Daphne ter Huurne, Nina Possemis, Elisa Mallick, Simona Schäfer, Louisa Schwed, Mario Mina, Nicklas Linz, Inez Ramakers, Craig Ritchie
Introduction: Progressive cognitive decline is the cardinal behavioral symptom in most dementia-causing diseases such as Alzheimer’s disease. While most well-established measures for cognition might not fit tomorrow’s decentralized remote clinical trials, digital cognitive assessments will gain importance. We present the evaluation of a novel digital speech biomarker for cognition (SB-C) following
-
Validation of the Remote Automated ki:e Speech Biomarker for Cognition in Mild Cognitive Impairment: Verification and Validation following DiME V3 Framework Digit Biomark. Pub Date : 2022-09-30
Introduction: Progressive cognitive decline is the cardinal behavioral symptom in most dementia-causing diseases such as Alzheimer’s disease. While most well-established measures for cognition might not fit tomorrow’s decentralized remote clinical trials, digital cognitive assessments will gain importance. We present the evaluation of a novel digital speech biomarker for cognition (SB-C) following
-
Usable Data Visualization for Digital Biomarkers: An Analysis of Usability, Data Sharing, and Clinician Contact Digit Biomark. Pub Date : 2022-09-12 Luke Scheuer, John Torous
Background: While digital phenotyping smartphone apps can collect vast amounts of information on participants, less is known about how these data can be shared back. Data visualization is critical to ensuring applications of digital signals and biomarkers are more informed, ethical, and impactful. But little is known about how sharing of these data, especially at different levels from raw data through
-
Usable Data Visualization for Digital Biomarkers: An Analysis of Usability, Data Sharing, and Clinician Contact Digit Biomark. Pub Date : 2022-09-12
Background: While digital phenotyping smartphone apps can collect vast amounts of information on participants, less is known about how these data can be shared back. Data visualization is critical to ensuring applications of digital signals and biomarkers are more informed, ethical, and impactful. But little is known about how sharing of these data, especially at different levels from raw data through
-
Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials Digit Biomark. Pub Date : 2022-08-29 Bohdana Ratitch, Isaac R. Rodriguez-Chavez, Abhishek Dabral, Adriano Fontanari, Julio Vega, Francesco Onorati, Benjamin Vandendriessche, Stuart Morton, Yasaman Damestani
Background: The proliferation and increasing maturity of biometric monitoring technologies allow clinical investigators to measure the health status of trial participants in a more holistic manner, especially outside of traditional clinical settings. This includes capturing meaningful aspects of health in daily living and a more granular and objective manner compared to traditional tools in clinical
-
Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials Digit Biomark. Pub Date : 2022-08-29
Background: The proliferation and increasing maturity of biometric monitoring technologies allow clinical investigators to measure the health status of trial participants in a more holistic manner, especially outside of traditional clinical settings. This includes capturing meaningful aspects of health in daily living and a more granular and objective manner compared to traditional tools in clinical
-
Reliability of Automatic Computer Vision-Based Assessment of Orofacial Kinematics for Telehealth Applications Digit Biomark. Pub Date : 2022-07-21 Leif Simmatis, Carolina Barnett, Reeman Marzouqah, Babak Taati, Mark Boulos, Yana Yunusova
Introduction: Telehealth/remote assessment using readily available 2D mobile cameras and deep learning-based analyses is rapidly becoming a viable option for detecting orofacial and speech impairments associated with neurological and neurodegenerative disease during telehealth practice. However, the psychometric properties (e.g., internal consistency and reliability) of kinematics obtained from these
-
Reliability of Automatic Computer Vision-Based Assessment of Orofacial Kinematics for Telehealth Applications Digit Biomark. Pub Date : 2022-07-21
Introduction: Telehealth/remote assessment using readily available 2D mobile cameras and deep learning-based analyses is rapidly becoming a viable option for detecting orofacial and speech impairments associated with neurological and neurodegenerative disease during telehealth practice. However, the psychometric properties (e.g., internal consistency and reliability) of kinematics obtained from these
-
Smartphone-Based Gait Cadence to Identify Older Adults with Decreased Functional Capacity Digit Biomark. Pub Date : 2022-07-14 Daniel S. Rubin, Sylvia L. Ranjeva, Jacek K. Urbanek, Marta Karas, Maria Lucia L. Madariaga, Megan Huisingh-Scheetz
Background: Functional capacity assessment is a critical step in the preoperative evaluation to identify patients at increased risk of cardiac complications and disability after major noncardiac surgery. Smartphones offer the potential to objectively measure functional capacity but are limited by inaccuracy in patients with poor functional capacity. Open-source methods exist to analyze accelerometer
-
Smartphone-Based Gait Cadence to Identify Older Adults with Decreased Functional Capacity Digit Biomark. Pub Date : 2022-07-14
Background: Functional capacity assessment is a critical step in the preoperative evaluation to identify patients at increased risk of cardiac complications and disability after major noncardiac surgery. Smartphones offer the potential to objectively measure functional capacity but are limited by inaccuracy in patients with poor functional capacity. Open-source methods exist to analyze accelerometer
-
Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies Digit Biomark. Pub Date : 2022-07-04 Charmaine Demanuele, Cynthia Lokker, Krishna Jhaveri, Pirinka Georgiev, Emre Sezgin, Cindy Geoghegan, Kelly H. Zou, Elena Izmailova, Marie McCarthy
Background: Digital health technologies are attracting attention as novel tools for data collection in clinical research. They present alternative methods compared to in-clinic data collection, which often yields snapshots of the participants’ physiology, behavior, and function that may be prone to biases and artifacts, e.g., white coat hypertension, and not representative of the data in free-living
-
Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies Digit Biomark. Pub Date : 2022-07-04
Background: Digital health technologies are attracting attention as novel tools for data collection in clinical research. They present alternative methods compared to in-clinic data collection, which often yields snapshots of the participants’ physiology, behavior, and function that may be prone to biases and artifacts, e.g., white coat hypertension, and not representative of the data in free-living
-
Quantifying the Benefits of Digital Biomarkers and Technology-Based Study Endpoints in Clinical Trials: Project Moneyball Digit Biomark. Pub Date : 2022-06-29 Hiromasa Mori, Stig Johan Wiklund, Jason Yuren Zhang
Introduction: Digital biomarkers have significant potential to transform drug development, but only a few have contributed meaningfully to bring new treatments to market. There are uncertainties in how they will generate quantifiable benefits in clinical trial performance and ultimately to the chances of phase 3 success. Here we have proposed a statistical framework and ran a proof-of-concept model
-
Quantifying the Benefits of Digital Biomarkers and Technology-Based Study Endpoints in Clinical Trials: Project Moneyball Digit Biomark. Pub Date : 2022-06-29
Introduction: Digital biomarkers have significant potential to transform drug development, but only a few have contributed meaningfully to bring new treatments to market. There are uncertainties in how they will generate quantifiable benefits in clinical trial performance and ultimately to the chances of phase 3 success. Here we have proposed a statistical framework and ran a proof-of-concept model
-
Dorsal Finger Fold Recognition by Convolutional Neural Networks for the Detection and Monitoring of Joint Swelling in Patients with Rheumatoid Arthritis Digit Biomark. Pub Date : 2022-06-08 Thomas Hügle, Leo Caratsch, Matteo Caorsi, Jules Maglione, Diana Dan, Alexandre Dumusc, Marc Blanchard, Gabriel Kalweit, Maria Kalweit
Digital biomarkers such as wearables are of increasing interest in monitoring rheumatic diseases, but they usually lack disease specificity. In this study, we apply convolutional neural networks (CNN) to real-world hand photographs in order to automatically detect, extract, and analyse dorsal finger fold lines as a correlate of proximal interphalangeal (PIP) joint swelling in patients with rheumatoid
-
Dorsal Finger Fold Recognition by Convolutional Neural Networks for the Detection and Monitoring of Joint Swelling in Patients with Rheumatoid Arthritis Digit Biomark. Pub Date : 2022-06-08
Digital biomarkers such as wearables are of increasing interest in monitoring rheumatic diseases, but they usually lack disease specificity. In this study, we apply convolutional neural networks (CNN) to real-world hand photographs in order to automatically detect, extract, and analyse dorsal finger fold lines as a correlate of proximal interphalangeal (PIP) joint swelling in patients with rheumatoid
-
Objective Home-Monitoring of Physical Activity, Cardiovascular Parameters, and Sleep in Pediatric Obesity Digit Biomark. Pub Date : 2022-03-31 Matthijs D. Kruizinga, Euphemia C.A.M. Houdijk, Daniëlle C.M. van der Kaay, Youri van Berkel, Luc Filippini, Frederik E. Stuurman, Adam F. Cohen, Gertjan J.A. Driessen, Matthijs D. Kruizinga
Introduction: Clinical research and treatment of childhood obesity is challenging, and objective biomarkers obtained in a home-setting are needed. The aim of this study was to determine the potential of novel digital endpoints gathered by a home-monitoring platform in pediatric obesity. Methods: In this prospective observational study, 28 children with obesity aged 6–16 years were included and monitored
-
Objective Home-Monitoring of Physical Activity, Cardiovascular Parameters, and Sleep in Pediatric Obesity Digit Biomark. Pub Date : 2022-03-31
Introduction: Clinical research and treatment of childhood obesity is challenging, and objective biomarkers obtained in a home-setting are needed. The aim of this study was to determine the potential of novel digital endpoints gathered by a home-monitoring platform in pediatric obesity. Methods: In this prospective observational study, 28 children with obesity aged 6–16 years were included and monitored
-
Video-Based Pose Estimation for Gait Analysis in Stroke Survivors during Clinical Assessments: A Proof-of-Concept Study Digit Biomark. Pub Date : 2022-01-13 Luca Lonini, Yaejin Moon, Kyle Embry, R. James Cotton, Kelly McKenzie, Sophia Jenz, Arun Jayaraman
Recent advancements in deep learning have produced significant progress in markerless human pose estimation, making it possible to estimate human kinematics from single camera videos without the need for reflective markers and specialized labs equipped with motion capture systems. Such algorithms have the potential to enable the quantification of clinical metrics from videos recorded with a handheld
-
A Smartphone Application as an Exploratory Endpoint in a Phase 3 Parkinson’s Disease Clinical Trial: A Pilot Study Digit Biomark. Pub Date : 2022-01-10 Alex Page, Norman Yung, Peggy Auinger, Charles Venuto, Alistair Glidden, Eric Macklin, Larsson Omberg, Michael A. Schwarzschild, E. Ray Dorsey
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. Objective: This study aimed to determine the feasibility of introducing a smartphone research application into a PD clinical trial and to evaluate the resulting measures. Methods: A smartphone application
-
-
-
Digital Endpoints: Definition, Benefits, and Current Barriers in Accelerating Development and Adoption Digit Biomark. Pub Date : 2021-09-13 Matthew Landers, Ray Dorsey, Suchi Saria
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 collected outside of a clinical setting such as in a patient’s free-living environment. Applicable sensors exist in an array of devices and can be applied in a diverse
-
Real-World Evidence for a Smartwatch-Based Parkinson’s Motor Assessment App for Patients Undergoing Therapy Changes Digit Biomark. Pub Date : 2021-09-08 Aaron J. Hadley, David E. Riley, Dustin A. Heldman
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 quantify symptoms such as tremor, dyskinesia, and bradykinesia. Commercially available smartwatches are equipped with accelerometers and gyroscopes that can measure motion for objective evaluation
-
Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations Digit Biomark. Pub Date : 2021-09-02 Michelle Crouthamel, Robert J. Mather, Suraj Ramachandran, Kai Bode, Godhuli Chatterjee, Luis Garcia-Gancedo, Joseph Kim, Rinol Alaj, Matthew F. Wipperman, Lada Leyens, Henrik Sillen, Tina Murphy, Michael Benecky, Brandon Maggio, Thomas Switzer
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 regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs
-
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 Digit Biomark. Pub Date : 2021-08-05 Laurent Servais, Eric Camino, Aude Clement, Craig M. McDonald, Jacek Lukawy, Linda P. Lowes, Damien Eggenspieler, Francesca Cerreta, Paul Strijbos
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 by the patient during hospital visits. These are prone to bias and may not reflect motor abilities in real-world settings. Digital tools, such as wearable devices and other remote
-
Beyond the Therapist’s Office: Merging Measurement-Based Care and Digital Medicine in the Real World Digit Biomark. Pub Date : 2021-07-29 Emil Chiauzzi, Paul Wicks
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 underutilization of digital measurement in psychiatry, and there is little discussion of the feedback and patient engagement process in digital medicine. Measurement-based
-
Advanced Machine Learning Tools to Monitor Biomarkers of Dysphagia: A Wearable Sensor Proof-of-Concept Study Digit Biomark. Pub Date : 2021-07-27 Megan K. O’Brien, Olivia K. Botonis, Elissa Larkin, Julia Carpenter, Bonnie Martin-Harris, Rachel Maronati, KunHyuck Lee, Leora R. Cherney, Brianna Hutchison, Shuai Xu, John A. Rogers, Arun Jayaraman
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 imaging procedures or subjective, qualitative bedside examinations. Wearable sensors are a promising alternative to noninvasively and objectively measure physiological signals relevant
-
Automatic Identification of Upper Extremity Rehabilitation Exercise Type and Dose Using Body-Worn Sensors and Machine Learning: A Pilot Study Digit Biomark. Pub Date : 2021-07-02 Noah Balestra, Gaurav Sharma, Linda M. Riek, Ania Busza
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 quantifying exercise activities over multiple days. Objectives: The objectives of this study were to assess the feasibility of using body-worn sensors to track rehabilitation exercises
-
The Real-World Data Challenges Radar: A Review on the Challenges and Risks regarding the Use of Real-World Data Digit Biomark. Pub Date : 2021-06-24 Frank Grimberg, Petra Maria Asprion, Bettina Schneider, Enkelejda Miho, Lmar Babrak, Ali Habbabeh
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 provide a summary overview of the challenges and risks regarding the use of RWD and its translation into real-world evidence and provide a classification and visualization of RWD challenges
-
EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration Digit Biomark. Pub Date : 2021-05-18 Christine Manta, Nikhil Mahadevan, Jessie Bakker, Simal Ozen Irmak, Elena Izmailova, Siyeon Park, Jiat-Ling Poon, Santosh Shevade, Sarah Valentine, Benjamin Vandendriessche, Courtney Webster, Jennifer C. Goldsack
The EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist was developed by a multidisciplinary group of content experts convened by the Digital Medicine Society, representing the clinical sciences, data management, technology development, and biostatistics. The aim of EVIDENCE is to promote high quality reporting in studies where the primary objective is an evaluation of a digital measurement
-
The Digital Neurologic Examination Digit Biomark. Pub Date : 2021-04-26 Adam B. Cohen, Brain V. Nahed
Digital health has been rapidly thrust into the forefront of care delivery. Poised to extend the clinician’s reach, a new set of examination tools will redefine neurologic and neurosurgical care, serving as the basis for the digital neurologic examination. We describe its components and review specific technologies, which move beyond traditional video-based telemedicine encounters and include separate
-
Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis Digit Biomark. Pub Date : 2021-04-22 Elena S. Izmailova, William A. Wood, Qi Liu, Vadim Zipunnikov, Daniel Bloomfield, Jason Homsy, Steven C. Hoffmann, John A. Wagner, Joseph P. Menetski
Clinical safety findings remain one of the reasons for attrition of drug candidates during clinical development. Cardiovascular liabilities are not consistently detected in early-stage clinical trials and often become apparent when drugs are administered chronically for extended periods of time. Vital sign data collection outside of the clinic offers an opportunity for deeper physiological characterization
-
Wearable Devices: Current Status and Opportunities in Pain Assessment and Management Digit Biomark. Pub Date : 2021-04-19 Andrew Leroux, Rachael Rzasa-Lynn, Ciprian Crainiceanu, Tushar Sharma
Introduction: We investigated the possibilities and opportunities for using wearable devices that measure physical activity and physiometric signals in conjunction with ecological momentary assessment (EMA) data to improve the assessment and treatment of pain. Methods: We considered studies with cross-sectional and longitudinal designs as well as interventional or observational studies correlating
-
The Future of Digital Health: Meeting Report Digit Biomark. Pub Date : 2021-04-16 Priya Kumar, Ieuan Clay
At the end of 2020, Karger’s Digital Biomarkers, together with Evidation Health, produced a special issue entitled “The Future of Digital Health.” This brief meeting report provides an overview of the expert panel and workshop that were held in early 2021 to explore key topics raised in the special issue. Digit Biomark 2021;5:74–77
-
Voice for Health: The Use of Vocal Biomarkers from Research to Clinical Practice Digit Biomark. Pub Date : 2021-04-16 Guy Fagherazzi, Aurélie Fischer, Muhannad Ismael, Vladimir Despotovic
Diseases can affect organs such as the heart, lungs, brain, muscles, or vocal folds, which can then alter an individual’s voice. Therefore, voice analysis using artificial intelligence opens new opportunities for healthcare. From using vocal biomarkers for diagnosis, risk prediction, and remote monitoring of various clinical outcomes and symptoms, we offer in this review an overview of the various
-
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint Digit Biomark. Pub Date : 2021-03-23 Jennifer C. Goldsack, Ariel V. Dowling, David Samuelson, Bray Patrick-Lake, Ieuan Clay
To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale
-
Concurrent Validity of Inertially Sensed Measures during Voluntary Body Sway in Silence and while Exposed to a Rhythmic Acoustic Stimulus: A Pilot Study Digit Biomark. Pub Date : 2021-03-23 Analina Emmanouil, Elissavet Rousanoglou, Anastasia Georgaki, Konstantinos Boudolos
Introduction: The effect of rhythmic acoustic stimuli on body sway is of increasing interest due to their positive contribution when training or restoring the control of movement. Inertial sensors show promise as a portable, easier, and more affordable method compared to the force plate “gold standard” concerning the evaluation of postural sway. This study examined the concurrent validity of inertially
-
Detecting Mild Cognitive Impairment via Digital Biomarkers of Cognitive Performance Found in Klondike Solitaire: A Machine-Learning Study Digit Biomark. Pub Date : 2021-02-19 Karsten Gielis, Marie-Elena Vanden Abeele, Katrien Verbert, Jos Tournoy, Maarten De Vos, Vero Vanden Abeele
Background: Mild cognitive impairment (MCI) is a condition that entails a slight yet noticeable decline in cognition that exceeds normal age-related changes. Older adults living with MCI have a higher chance of progressing to dementia, which warrants regular cognitive follow-up at memory clinics. However, due to time and resource constraints, this follow-up is conducted at separate moments in time
-
Real-Time Digital Biometric Monitoring during Elite Athletic Competition: System Feasibility with a Wearable Medical-Grade Sensor Digit Biomark. Pub Date : 2021-02-03 Mark A. Gorski, Stanley M. Mimoto, Vivek Khare, Viprali Bhatkar, Arthur H. Combs
Introduction: Real-time digital heart rate (HR) monitoring in sports can provide unique physiological insights into athletic performance. However, most HR monitoring of elite athletes is limited to non-real-time, non-competition settings while utilizing sensors that are cumbersome. The present study was undertaken to test the feasibility of using small, wearable medical-grade sensors, paired with a
-
Computer Vision-Based Assessment of Motor Functioning in Schizophrenia: Use of Smartphones for Remote Measurement of Schizophrenia Symptomatology Digit Biomark. Pub Date : 2021-01-21 Anzar Abbas, Vijay Yadav, Emma Smith, Elizabeth Ramjas, Sarah B. Rutter, Caridad Benavidez, Vidya Koesmahargyo, Li Zhang, Lei Guan, Paul Rosenfield, Mercedes Perez-Rodriguez, Isaac R. Galatzer-Levy
Introduction: Motor abnormalities have been shown to be a distinct component of schizophrenia symptomatology. However, objective and scalable methods for assessment of motor functioning in schizophrenia are lacking. Advancements in machine learning-based digital tools have allowed for automated and remote “digital phenotyping” of disease symptomatology. Here, we assess the performance of a computer
-
The Detection of Vancomycin in Sweat: A Next-Generation Digital Surrogate Marker for Antibiotic Tissue Penetration: A Pilot Study Digit Biomark. Pub Date : 2021-01-14 Noé Brasier, Andreas Widmer, Michael Osthoff, Markus Mutke, Fiorangelo De Ieso, Pascale Brasier-Lutz, Kitty Brown, Linxing Yao, Corey D. Broeckling, Jessica Prenni, Jens Eckstein
Background: Assuring adequate antibiotic tissue concentrations at the point of infection, especially in skin and soft tissue infections, is pivotal for an effective treatment and cure. Despite the global issue, a reliable AB monitoring test is missing. Inadequate antibiotic treatment leads to the development of antimicrobial resistances and toxic side effects. β-lactam antibiotics were already detected
-
Proof of Concept for an “eyePhone” App to Measure Video Head Impulses Digit Biomark. Pub Date : 2020-12-30 T. Maxwell Parker, Nathan Farrell, Jorge Otero-Millan, Amir Kheradmand, Ayodele McClenney, David E. Newman-Toker
Objective: Differentiating benign from dangerous causes of dizziness or vertigo presents a major diagnostic challenge for many clinicians. Bedside presentations of peripheral vestibular disorders and posterior fossa strokes are often indistinguishable other than by a few subtle vestibular eye movements. The most challenging of these to interpret is the head impulse test (HIT) of vestibulo-ocular reflex