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Journal Cover Digital Biomarkers
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  This is an Open Access Journal Open Access journal
   ISSN (Online) 2504-110X
   Published by Karger Homepage  [120 journals]
  • Digital Footprints in Drug Development: A Perspective from within the FDA

    • Abstract:
      Digit Biomark 2017;1:101–105
  • Multiple Wearable Sensors in Parkinson and Huntington Disease Individuals:
           A Pilot Study in Clinic and at Home

    • Abstract: Background: Clinician rating scales and patient-reported outcomes are the principal means of assessing motor symptoms in Parkinson disease and Huntington disease. However, these assessments are subjective and generally limited to episodic in-person visits. Wearable sensors can objectively and continuously measure motor features and could be valuable in clinical research and care. Methods: We recruited participants with Parkinson disease, Huntington disease, and prodromal Huntington disease (individuals who carry the genetic marker but do not yet exhibit symptoms of the disease), and controls to wear 5 accelerometer-based sensors on their chest and limbs for standardized in-clinic assessments and for 2 days at home. The study’s aims were to assess the feasibility of use of wearable sensors, to determine the activity (lying, sitting, standing, walking) of participants, and to survey participants on their experience. Results: Fifty-six individuals (16 with Parkinson disease, 15 with Huntington disease, 5 with prodromal Huntington disease, and 20 controls) were enrolled in the study. Data were successfully obtained from 99.3% (278/280) of sensors dispatched. On average, individuals with Huntington disease spent over 50% of the total time lying down, substantially more than individuals with prodromal Huntington disease (33%, p = 0.003), Parkinson disease (38%, p = 0.01), and controls (34%; p #x3c; 0.001). Most (86%) participants were “willing” or “very willing” to wear the sensors again. Conclusions: Among individuals with movement disorders, the use of wearable sensors in clinic and at home was feasible and well-received. These sensors can identify statistically significant differences in activity profiles between individuals with movement disorders and those without. In addition, continuous, objective monitoring can reveal disease characteristics not observed in clinic.
      Digit Biomark 2017;1:52–63
  • The Future of Computing in Health Care: An Interview with Dr. Robert

    • Abstract:
      Digit Biomark 2017;1:92–95
  • Need for Digital Biomarkers in Musculoskeletal Trials

    • Abstract: Pain and loss of function – both problems cause patients to visit a musculoskeletal specialist. Therefore, both lead symptoms should serve as a benchmark for new therapeutic approaches. New technologies generating digital biomarkers have the potential to significantly change musculoskeletal trials. However, more work is needed to agree upon data and variable standards, to improve user friendliness, and to ensure data integrity along the whole processing way. Therefore, rigorous and systematic testing of new technological approaches is required to establish new outcome variables suitable for musculoskeletal trials. Consortia of researchers working on similar technologies and outcome variables should collaborate from the beginning to enable comparing and pooling data. Early interaction with health authorities and regulatory bodies are necessary to pave the way for a widespread use of a new technology.
      Digit Biomark 2017;1:82–86
  • Pharmaceutical Perspective: How Digital Biomarkers and Contextual Data
           Will Enable Therapeutic Environments

    • Abstract: Digital biomarkers are helping to reshape the understanding of health and disease, which will have an impact in how an individual’s relationship to the environment is assessed, how research is conducted, and how treatment effectiveness is determined. In particular, this article highlights key activities by the pharmaceutical industry as they explore the utility and relevance of digital biomarkers across the value chain. Lastly, this paper will discuss how digital biomarkers, in conjunction with digital environmental markers, will pave the way for the creation of healthy spaces that more directly improve patient outcomes.
      Digit Biomark 2017;1:73–81
  • The Inaugural Issue

    • Abstract:
      Digit Biomark 2017;1:4–5
  • The Broken Health Information Technology Innovation Pipeline: A
           Perspective from the NODE Health Consortium

    • Abstract: Background: The Network of Digital Evidence (NODE) was formed to further advance the field of health information technology (HIT) and evidence-based digital medicine at different healthcare institutions nationwide. As the NODE network reviewed the state of the field, it was noted that despite substantial financial and human capital investments, the processes and results of HIT innovation seem chaotic and subpar, especially in comparison to the more well-established drug and device industries. During the course of this white paper, we will explore the causes for this observed phenomenon as well as propose possible solutions to improve the state of HIT. Methods: We compared the entire process of discovery, proof of concept, Food and Drug Administration (FDA) review, and postmarket monitoring and distribution/implementation of HIT innovations to the equivalent processes for drugs and devices. Whereas drug and device innovations are subject to a standardized pipeline of production, HIT innovations are not held to equivalent standards. Conclusions: As a result, HIT lags behind the more mature drug and device industries in producing effective and reliable products. This leads to an inefficient use of already scarce healthcare resources. The authors believe that the HIT industry must adopt many of the mechanisms implemented by the drug and device industries as dictated by their innovation pipelines of discovery, proof of concept, FDA review, and postmarket monitoring and distribution/implementation. We propose an eight-point plan to fundamentally evolve the HIT lifecycle, including reforms for institutions such as neutral government agencies, new health system boards and management systems, modified incentive structures, improved relationships with financial investors and start-ups, patient engagement, and enhanced mechanisms to improve HIT adoption.
      Digit Biomark 2017;1:64–72
  • Verily and Its Approach to Digital Biomarkers

    • Abstract:
      Digit Biomark 2017;1:96–99
  • The First Frontier: Digital Biomarkers for Neurodegenerative Disorders

    • Abstract: Current measures of neurodegenerative diseases are highly subjective and based on episodic visits. Consequently, drug development decisions rely on sparse, subjective data, which have led to the conduct of large-scale phase 3 trials of drugs that are likely not effective. Such failures are costly, deter future investment, and hinder the development of treatments. Given the lack of reliable physiological biomarkers, digital biomarkers may help to address current shortcomings. Objective, high-frequency data can guide critical decision-making in therapeutic development and allow for a more efficient evaluation of therapies of increasingly common disorders.
      Digit Biomark 2017;1:6–13
  • Physical Activity Monitoring in Patients with Neurological Disorders: A
           Review of Novel Body-Worn Devices

    • Abstract: Aim: The aim was to conduct a systematic review to examine the literature reporting the validity and reliability of wearable physical activity monitoring in individuals with neurological disorders. Method: A systematic search of the literature was performed using a specific search strategy in PubMed and CINAHL. A search constraint of articles published in English, including human participants, published between January 2008 and March 2017 was applied. Peer-reviewed studies which enrolled adult participants with any neurological disorder were included. For the studies which sought to explore the validity of activity monitors, the outcomes measured using the monitor were compared to a criterion measure of physical activity. The studies’ methodological quality was assessed using an adapted version of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) framework. Data extracted from each study included the following: characteristics of the study participants, study setting, devices used, study protocol/methods, outcomes measured, and the validity/reliability of measurement produced. Results: Twenty-three studies examining the validity and reliability of 16 different monitors were included. The identified studies comprised participants with a range of different disorders of neurological origin. The available evidence suggests that biaxial or triaxial accelerometer devices positioned around the ankle produce the most accurate step count measurements in patients with neurological disorders. The findings regarding the reliability and validity of activity counts and energy expenditure are largely inconclusive in this population. Discussion: Ankle-worn biaxial or triaxial accelerometer-type devices provide the most accurate measurement of physical activity. However, further work is required in this field before wearable activity monitoring can be more widely implemented clinically. Standardised activity monitoring protocols are required for implementing these devices in clinical trials and clinical practice, and consensus is required as to the reporting and interpretation of derived variables.
      Digit Biomark 2017;1:14–42
School of Mathematical and Computer Sciences
Heriot-Watt University
Edinburgh, EH14 4AS, UK
Tel: +00 44 (0)131 4513762
Fax: +00 44 (0)131 4513327
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