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]
  • Use of Mobile Devices to Measure Outcomes in Clinical Research,
           2010–2016: A Systematic Literature Review

    • Abstract: Background: The use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future use of mobile devices in interventional clinical research to measure primary outcomes, we conducted a systematic review of the use of and clinical outcomes measured by mobile devices (mobile outcomes) in observational and interventional clinical research. Method: We conducted a PubMed search using a range of search terms to retrieve peer-reviewed articles on clinical research published between January 2010 and May 2016 in which mobile devices were used to measure study outcomes. We screened each publication for specific inclusion and exclusion criteria. We then identified and qualitatively summarized the use of mobile outcome assessments in clinical research, including the type and design of the study, therapeutic focus, type of mobile device(s) used, and specific mobile outcomes reported. Results: The search retrieved 2,530 potential articles of interest. After screening, 88 publications remained. Twenty-five percent of the publications (n = 22) described mobile outcomes used in interventional research, and the rest (n = 66) described observational clinical research. Thirteen therapeutic areas were represented. Five categories of mobile devices were identified: (1) inertial sensors, (2) biosensors, (3) pressure sensors and walkways, (4) medication adherence monitors, and (5) location monitors; inertial sensors/accelerometers were most common (reported in 86% of the publications). Among the variety of mobile outcomes, various assessments of physical activity were most common (reported in 74% of the publications). Other mobile outcomes included assessments of sleep, mobility, and pill adherence, as well as biomarkers assessed using a mobile device, including cardiac measures, glucose, gastric reflux, respiratory measures, and intensity of head-related injury. Conclusion: Mobile devices are being widely used in clinical research to assess outcomes, although their use in interventional research to assess therapeutic effectiveness is limited. For mobile devices to be used more frequently in pivotal interventional research – such as trials informing regulatory decision-making – more focus should be placed on: (1) consolidating the evidence supporting the clinical meaningfulness of specific mobile outcomes, and (2) standardizing the use of mobile devices in clinical research to measure specific mobile outcomes (e.g., data capture frequencies, placement of device). To that aim, this manuscript offers a broad overview of the various mobile outcome assessments currently used in observational and interventional research, and categorizes and consolidates this information for researchers interested in using mobile devices to assess outcomes in interventional research.
      Digit Biomark 2018;2:11–30
       
  • Assessment of Postural Sway in Individuals with Multiple Sclerosis Using a
           Novel Wearable Inertial Sensor

    • Abstract: Balance impairment is common in individuals with multiple sclerosis (MS). However, objective assessment of balance usually requires clinical expertise and/or the use of expensive and obtrusive measuring equipment. These barriers to the objective assessment of balance may be overcome with the development of a lightweight inertial sensor system. In this study, we examined the concurrent validity of a novel wireless, skin-mounted inertial sensor system (BioStamp®, MC10 Inc.) to measure postural sway in individuals with MS by comparing measurement agreement between this novel sensor and gold standard measurement tools (force plate and externally validated inertial sensor). A total of 39 individuals with MS and 15 healthy controls participated in the study. Participants with MS were divided into groups based on the amount of impairment (MSMild: EDSS 2–4, n = 19; MSSevere: EDSS ≥6, n = 20). The balance assessment consisted of two 30-s quiet standing trials in each of three conditions: eyes open/firm surface, eyes closed/firm surface, and eyes open/foam surface. For each trial, postural sway was recorded with a force plate (Bertec) and simultaneously using two accelerometers (BioStamp and Xsens) mounted on the participant’s posterior trunk at L5. Sway metrics (sway area, sway path length, root mean square amplitude, mean velocity, JERK, and total power) were derived to compare the measurement agreement among the measurement devices. Excellent agreement (intraclass correlation coefficients #x3e;0.9) between sway metrics derived from the BioStamp and the MTx sensors were observed across all conditions and groups. Good to excellent correlations (r #x3e;0.7) between devices were observed in all sway metrics and conditions. Additionally, the acceleration sway metrics were nearly as effective as the force plate sway metrics in differentiating individuals with poor balance from healthy controls. Overall, the BioStamp sensor is a valid and objective measurement tool for postural sway assessment. This novel, lightweight and portable sensor may offer unique advantages in tracking patient’s postural performance.
      Digit Biomark 2018;2:1–10
       
  • A Pilot Study Evaluating the Physiological Parameters of
           Performance-Induced Stress in Undergraduate Music Students

    • Abstract: Music performance anxiety (MPA) is a specific condition for musicians. Although it can have a negative influence on their music careers, little attention is paid to this phenomenon both in the professional environment and in stress research. In the current pilot study, insight was gained into the physiology of the autonomic stress response related to anxiety in musicians when performing on stage by using a wearable biosensor patch for registration of a range of physiological parameters. Also, the validity of two different psychometric questionnaires in objectifying the stress response on stage to predict the individual stress response was explored. The autonomic physiological parameters (heart rate, respiratory rate, skin temperature) of 11 violists and violinists were collected while performing on stage and in resting state using the VitalConnect HealthPatch®. In addition, scores on validated questionnaires in research on MPA (State Anxiety Inventory, Kenny Music Performance Anxiety Inventory, Short Form Health Survey) were collected in order to try to objectify the magnitude of the subjective level of both MPA and experienced stress. The registration of the autonomic parameters showed a significant increase in heart rate, respiratory rate, and stress level from resting state measurements during stage performance. Analysis of heart rate variability showed a shift from indices of parasympathetic nervous system activity during baseline measurements towards indices of sympathetic nervous system activity during stress measurements. Surprisingly, none of the questionnaires was correlated to the physiological stress parameters on stage. In conclusion, the wearable biosensor patch proved to be an adequate tool to assess physiological stress parameters on stage. The different questionnaires did not contribute to the prediction of its occurrence in a group of musicians.
      Digit Biomark 2017;1:118–125
       
  • Inertial Sensor Technology Can Capture Changes in Dynamic Balance Control
           during the Y Balance Test

    • Abstract: Introduction: The Y Balance Test (YBT) is one of the most commonly utilised clinical dynamic balance assessments. Research has demonstrated the utility of the YBT in identifying balance deficits in individuals following lower limb injury. However, quantifying dynamic balance based on reach distances alone fails to provide potentially important information related to the quality of movement control and choice of movement strategy during the reaching action. The addition of an inertial sensor to capture more detailed motion data may allow for the inexpensive, accessible quantification of dynamic balance control during the YBT reach excursions. As such, the aim of this study was to compare baseline and fatigued dynamic balance control, using reach distances and 95EV (95% ellipsoid volume), and evaluate the ability of 95EV to capture alterations in dynamic balance control, which are not detected by YBT reach distances. Methods: As part of this descriptive laboratory study, 15 healthy participants completed repeated YBTs at 20, 10, and 0 min prior to and following a modified 60-s Wingate test that was used to introduce a short-term reduction in dynamic balance capability. Dynamic balance was assessed using the standard normalised reach distance method, while dynamic balance control during the reach attempts was simultaneously measured by means of the 95EV derived from an inertial sensor, worn at the level of the 4th lumbar vertebra. Results: Intraclass correlation coefficients for the inertial sensor-derived measures ranged from 0.76 to 0.92, demonstrating strong intrasession test-retest reliability. Statistically significant alterations (p #x3c; 0.05) in both reach distance and the inertial sensor-derived 95EV measure were observed immediately post-fatigue. However, reach distance deficits returned to baseline levels within 10 min, while 95EV remained significantly increased (p #x3c; 0.05) beyond 20 min for all 3 reach distances. Conclusion: These findings demonstrate the ability of an inertial sensor-derived measure to quantify alterations in dynamic balance control, which are not captured by traditional reach distances alone. This suggests that the addition of an inertial sensor to the YBT may provide clinicians and researchers with an accessible means to capture subtle alterations in motor function in the clinical setting.
      Digit Biomark 2017;1:106–117
       
  • Tablet-Based Application for Objective Measurement of Motor Fluctuations
           in Parkinson Disease

    • Abstract: Background: The motor subscale of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS-III) has limited applicability for the assessment of motor fluctuations in the home setting. Methods: To assess whether a self-administered, tablet-based application can reliably quantify differences in motor performance using two-target finger tapping and forearm pronation-supination tasks in the ON (maximal dopaminergic medication efficacy) and OFF (reemergence of parkinsonian deficits) medication states, we recruited 11 Parkinson disease (PD) patients (age, 60.6 ± 9.0 years; disease duration, 12.8 ± 4.1 years) and 11 healthy age-matched controls (age, 62.5 ± 10.5 years). The total number of taps, tap interval, tap duration, and tap accuracy were algorithmically calculated by the application, using the more affected side in patients and the dominant hand in healthy controls. Results: Compared to the OFF state, PD patients showed a higher number of taps (84.2 ± 20.3 vs. 54.9 ± 26.9 taps; p = 0.0036) and a shorter tap interval (375.3 ± 97.2 vs. 708.2 ± 412.8 ms; p = 0.0146) but poorer tap accuracy (2,008.4 ± 995.7 vs. 1,111.8 ± 901.3 pixels; p = 0.0055) for the two-target task in the ON state, unaffected by the magnitude of coexistent dyskinesia. Overall, test-retest reliability was high (r #x3e;0.75) and the discriminatory ability between OFF and ON states was good (0.60 ≤ AUC ≤ 0.82). The correlations between tapping data and MDS-UPDRS-III scores were only moderate (–0.55 to 0.55). Conclusions: A self-administered, tablet-based application can reliably distinguish between OFF and ON states in fluctuating PD patients and may be sensitive to additional motor phenomena, such as accuracy, not captured by the MDS-UPDRS-III.
      Digit Biomark 2017;1:126–135
       
  • 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
           Califf

    • 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
       
 
 
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