Background Wearable devices and sensor technology provide objective, unbiased range of motion measurements that help health care professionals overcome the hindrances of protractor-based goniometry. This review aims to analyze the accuracy of existing wearable sensor technologies for hand range of motion measurement and identify the most accurate one. Methods We performed a systematic review by searching PubMed, CINAHL, and Embase for studies evaluating wearable sensor technology in hand range of motion assessment. Keywords used for the inquiry were related to wearable devices and hand goniometry. Results Of the 71 studies, 11 met the inclusion criteria. Ten studies evaluated gloves and 1 evaluated a wristband. The most common types of sensors used were bend sensors, followed by inertial sensors, Hall effect sensors, and magnetometers. Most studies compared wearable devices with manual goniometry, achieving optimal accuracy. Although most of the devices reached adequate levels of measurement error, accuracy evaluation in the reviewed studies might be subject to bias owing to the use of poorly reliable measurement techniques for comparison of the devices. Conclusion Gloves using inertial sensors were the most accurate. Future studies should use different comparison techniques, such as infrared camera–based goniometry or virtual motion tracking, to evaluate the performance of wearable devices.
Remote TELEmonitoring and Health Coaching for patients with acute heart failure: results of the TELE-HC randomized trial
Abstract Introduction Patients discharged after acute decompensated heart failure (ADHF) have elevated risk for readmission due to multiple factors including suboptimal behavioral and social support. Telemonitoring interventions have shown inconsistent effectiveness in reducing HF readmissions. Patient-centered health coaching, when combined with telemonitoring, may be a viable model to engage patients in self-care behaviors and enhance patient experiences following acute hospitalization. Purpose This multicenter randomized trial evaluates whether remote telemonitoring combined with health coaching decreases 60 day readmission rates for patients with ADHF when compared to standard of care. Methods Patients with primary or secondary diagnosis of ADHF were consented and randomized prior to hospital discharge to either standard care or intervention of remote telemonitoring and health coaching. Within 2 days of hospital dismissal, intervention patients were onboarded to the remote monitoring platform, which links personal health sensors which collect on-body physiologic measures (ECG, heart rate, respiration rate, and activity via 3-axis accelerometer) with providers through secure mobile communication. A registered nurse was designated as the primary health coach focusing on disease management - including symptom recognition, adherence to treatment strategies, care coordination, medication matters, and problem solving. A social worker and nutritionist were also assigned. The primary outcome was all-cause mortality or readmission within 60 days of hospital dismissal. Statistical analysis included stratified log-rank tests and stratified Cochran-Mantel-Haenszel Chi-square test to account for site-stratified randomization. Results The study was halted due to low rate of subject accrual. Of planned 304 subjects, 143 were randomized between 2015 and 2019 at 6 sites in the United States. Dropout and withdrawal after randomization of 32 subjects (22%) left 112 analyzable for the primary endpoint. Many subject withdrawals after unblinded disclosure of arm allocation were related to treatment assignment. Immediate withdrawal without follow up in these subjects precluded an intention-to-treat analysis. Mean age was 69 years and subjects were more often male (56%) and non-Hispanic white (70%). In per-protocol analysis, using subjects adherent to protocol specified visits (n=112), we observe no difference in the primary outcome (26% among intervention vs 28% among standard care, Figure, p=0.77). There were also no differences among secondary outcomes of overall mortality (2% vs 7%, p=0.20) or composite emergency department visit, hospital admission, or death (35% vs 34%, p=0.85). Conclusions Among patients with heart failure, an intervention of remote telemonitoring and health coaching did not reduce all-cause readmission or mortality. Significant withdrawal rates suggest future studies may need to improve screening and study retention. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health, National Institute on Aging
The senescence-associated secretome as an indicator of age and medical risk
Produced by senescent cells, the senescence-associated secretory phenotype (SASP) is a potential driver of age-related dysfunction. We tested whether circulating concentrations of SASP proteins reflect age and medical risk in humans. We first screened senescent endothelial cells, fibroblasts, preadipocytes, epithelial cells, and myoblasts to identify candidates for human profiling. We then tested associations between circulating SASP proteins and clinical data from individuals throughout the life span and older adults undergoing surgery for prevalent but distinct age-related diseases. A community-based sample of people aged 20–90 years (retrospective cross-sectional) was studied to test associations between circulating SASP factors and chronological age. A subset of this cohort aged 60–90 years and separate cohorts of older adults undergoing surgery for severe aortic stenosis (prospective longitudinal) or ovarian cancer (prospective case-control) were studied to assess relationships between circulating concentrations of SASP proteins and biological age (determined by the accumulation of age-related health deficits) and/or postsurgical outcomes. We showed that SASP proteins were positively associated with age, frailty, and adverse postsurgery outcomes. A panel of 7 SASP factors composed of growth differentiation factor 15 (GDF15), TNF receptor superfamily member 6 (FAS), osteopontin (OPN), TNF receptor 1 (TNFR1), ACTIVIN A, chemokine (C-C motif) ligand 3 (CCL3), and IL-15 predicted adverse events markedly better than a single SASP protein or age. Our findings suggest that the circulating SASP may serve as a clinically useful candidate biomarker of age-related health and a powerful tool for interventional human studies.
A Randomized, Controlled Pilot Trial Comparing Platelet-Rich Plasma to Topical Minoxidil Foam for Treatment of Androgenic Alopecia in Women
BACKGROUNDAndrogenic alopecia (AGA) is a common hair loss disorder. Studies have demonstrated successful treatment with platelet-rich plasma (PRP) in men, but studies in women are few.OBJECTIVETo evaluate PRP in the treatment of AGA in women, compared with topical minoxidil.MATERIALS AND METHODSTwenty women with AGA received topical minoxidil for 12 weeks and injectable PRP for 12 weeks in a randomized crossover design with an 8-week washout between treatments. Standardized TrichoScan analysis and quality-of-life questionnaires were assessed at baseline and 12-week follow-up for each treatment.RESULTSAfter PRP, significant increases from baseline to Week 12 in TrichoScan analysis hair count (p= .002) and vellus hair density (p= .009) occurred. However, minoxidil resulted in significant increases in hair count (p< .001), vellus hair density (p= .03), terminal hair density (p= .004), and cumulative thickness (p= .004). Several quality of life responses improved from baseline to Week 12 after PRP treatment, whereas no improvements were noted after minoxidil.CONCLUSIONPlatelet-rich plasma is an effective treatment for hair regrowth in female AGA, although not as effective as minoxidil. However, the improved quality of life responses after PRP, but not minoxidil, suggest a potential overall greater degree of satisfaction with PRP.LEVELS OF EVIDENCEI.CLINICAL TRIAL REGISTRATIONNCT03488108.
“The Balloon Plug Concept” for Tricuspid Valve Repair Ex Vivo Proof of Concept
The time required to get a device to market is critical to a successful design, development, and manufacturing process [1]. Achieving status of the first device to market is often a priority for manufacturers and developers. Upon market introduction, it is well known that device performance must meet at least minimum standards in order to provide consumer satisfaction and be a successful product to prevent competitive devices from taking over the market [1]. However, if a design only meets minimum expectations, it may struggle to maintain market control. This demonstrates the tradeoffs of speed-to-market and performance, for which optimization has not been clearly defined [2]. Product performance and usability can be designed in, evaluated and enhanced in order to avoid user errors and achieve optimal profitability. For medical devices, clinical trials are a key step in preparing to take a device to market. Clinical trials can allow for analyses of the effectiveness of the device in the patient care process. For wearable medical devices, patient usability is crucial to patient adherence and safety since the device will be operated by non-medically trained individuals [3,4]. Without adequate usability, adherence and continuity of care are greatly reduced which will reduce the overall effectiveness of the device [5,6]. Human factors principles can best be incorporated in the design process to improve the usability of medical devices and patient safety [5,6,7], specifically for those used in telemedicine [4] and cardiovascular treatment [3]. The objective of this project was to evaluate a telemedicine heart rate monitoring device for patient usability in order to improve the next device’s performance and lead to greater patient adherence for the current version via an improved user manual.
Iterative Implementation of a Remote Cardiac Patient Monitoring Device using Qualitative Analysis and Human Factors Engineering
Remote monitoring has the potential to improve patient care and satisfaction while reducing the cost of care and burden on the healthcare system for Congestive Heart Failure (CHF) and Atrial Fibrillation (AF) patients. However, the device must be convenient and easy for the population to use correctly. In this study, human factors and qualitative researchers evaluated the use of a remote cardiac monitoring device during a clinical trial with 74 CHF and AF patients. Human factors usability concerns centered on device use and the information presented in the manual. The key themes identified during the qualitative analysis were related to patient education. These findings were incorporated into device design, user manual, or education material updates. This study illustrates how these methods can infuse patient experience into device design to inform continued quality improvement and usability refinement specifically in devices to aid CHF and AF patients without added burden.
The Impact of Frailty on Patient-Centered Outcomes Following Aortic Valve Replacement
BackgroundAutomated external defibrillators can provide life‐saving therapies to treat ventricular fibrillation. We developed a prototype unit that can deliver a unique shock waveform produced by four independent capacitors that is delivered through two shock vectors, with the rationale of providing more robust shock pathways during emergent defibrillation. We describe the initial testing and feasibility of this unique defibrillation unit, features of which may enable downsizing of current defibrillator devices.MethodsWe tested our defibrillation unit in four large animal models (two canine and two swine) under general anesthesia. Experimental defibrillation thresholds (DFT) were obtained by delivery of a unique waveform shock pulse via a dual‐vector pathway with four defibrillation pads (placed across the chest). DFTs were measured and compared with those of a commercially available biphasic defibrillator (Zoll M series, Zoll Medical, Chelmsford, MA, USA) tested in two different vectors. Shocks were delivered after 10 seconds of stable ventricular fibrillation and the output characteristics and shock outcome recorded. Each defibrillation series used a step‐down to failure protocol to define the defibrillation threshold.ResultsA total of 96 shocks were delivered during ventricular fibrillation in four large animals. In comparison to the Zoll M series, which delivered a single‐vector, biphasic shock, the energy required for successful defibrillation using the unique dual‐vector biphasic waveform did not differ significantly (P = 0.65).ConclusionsOur early findings support the feasibility of a unique external defibrillation unit using a dual‐vector biphasic waveform approach. This warrants further study to leverage this unique concept and work toward a miniaturized, portable shock delivery system.