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Applied Ergonomics Sep 2023While the biomechanical effects of exoskeletons are well studied, research about potential side-effects and adverse events are limited. The aim of this systematic review... (Review)
Review
INTRODUCTION
While the biomechanical effects of exoskeletons are well studied, research about potential side-effects and adverse events are limited. The aim of this systematic review was to provide an overview of the side-effects and adverse events on shoulder- and back-support exoskeletons during work tasks.
METHODS
Four in-field studies and 32 laboratory studies were included in this review, reporting on n = 18 shoulder exoskeletons, n = 9 back exoskeletons, n = 1 full body with a supernumerary arm, and n = 1 combination of shoulder and back exoskeleton.
RESULTS
The most frequent side-effect reported is discomfort (n = 30), followed by a limited usability of the exoskeleton (n = 16). Other identified side-effects and adverse events were changes in muscle activity, mobility, task performance, balance and posture, neurovascular supply, gait parameters and precision. An incorrect fit of the exoskeleton and the decreased degrees of freedom are most often reported as causes of these side-effects. Two studies did not find any side-effects. This review also showed that there are differences in the occurrence of side-effects in gender, age, and physical fitness. Most studies (89%) were conducted in a laboratory setting. Most studies (97%) measured short-term effects only. Psychological and social side-effects or adverse events were not reported. Side-effects and adverse events for active exoskeletons were understudied (n = 4).
CONCLUSION
It was concluded that the evidence for side-effects and adverse events is limited. If available, it mainly consists of reports of mild discomfort and limited usability. Generalisation is limited because studies were conducted in lab settings and measured short term only, and most participants were young male workers.
Topics: Humans; Male; Shoulder; Exoskeleton Device; Upper Extremity; Posture; Task Performance and Analysis; Biomechanical Phenomena; Electromyography
PubMed: 37146320
DOI: 10.1016/j.apergo.2023.104042 -
JMIR MHealth and UHealth Nov 2023The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and...
BACKGROUND
The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app's effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses.
OBJECTIVE
This systematic review aims to address 2 critical questions regarding clinical trials of software as a medical device (SaMD) apps: How well do researchers report adherence and engagement metrics for studies of effectiveness and efficacy? and What efficacy analyses do researchers use to account for nonadherence and how appropriate are their methods?
METHODS
We searched the Food and Drug Administration's registration database for registrations of repeated-use, patient-facing SaMD therapeutics. For each such registration, we searched ClinicalTrials.gov, company websites, and MEDLINE for the corresponding clinical trial and study articles through March 2022. Adherence and engagement data were summarized for each of the 24 identified articles, corresponding to 10 SaMD therapeutics. Each article was analyzed with a framework developed using the Cochrane risk-of-bias questions to estimate the potential effects of imperfect adherence on SaMD effectiveness. This review, funded by the Richard King Mellon Foundation, is registered on the Open Science Framework.
RESULTS
We found that although most articles (23/24, 96%) reported collecting information about SaMD therapeutic engagement, of the 20 articles for apps with prescribed use, only 9 (45%) reported adherence information across all aspects of prescribed use: 15 (75%) reported metrics for the initiation of therapeutic use, 16 (80%) reported metrics reporting adherence between the initiation and discontinuation of the therapeutic (implementation), and 4 (20%) reported the discontinuation of the therapeutic (persistence). The articles varied in the reported metrics. For trials that reported adherence or engagement, there were 4 definitions of initiation, 8 definitions of implementation, and 4 definitions of persistence. All articles studying a therapeutic with a prescribed use reported effectiveness estimates that might have been affected by nonadherence; only a few (2/20, 10%) used methods appropriate to evaluate efficacy.
CONCLUSIONS
This review identifies 5 areas for improving future SaMD trials and studies: use consistent metrics for reporting adherence, use reliable adherence metrics, preregister analyses for observational studies, use less biased efficacy analysis methods, and fully report statistical methods and assumptions.
Topics: Mobile Applications; United States; Software; Equipment and Supplies; Clinical Trials as Topic
PubMed: 37966871
DOI: 10.2196/46237 -
Infection Apr 2024Cardiac implantable electronic devices (CIED) are increasingly used worldwide, and infection of these devices remains one of the most feared complications.CIED... (Review)
Review
Cardiac implantable electronic devices (CIED) are increasingly used worldwide, and infection of these devices remains one of the most feared complications.CIED infections (CDIs) represent a challenge for physicians and the healthcare system in general as they require prolonged hospitalization and antibiotic treatment and are burdened by high mortality and high costs, so management of CDIs must be multidisciplinary.The exact incidence of CDIs is difficult to define, considering that it is influenced by various factors mainly represented by the implanted device and the type of procedure. Risk factors for CDIs could be divided into three categories: device related, patient related, and procedural related and the etiology is mainly sustained by Gram-positive bacteria; however, other etiologies cannot be underestimated. As a matter of fact, the two cornerstones in the treatment of these infections are device removal and antimicrobial treatment. Finally, therapeutic drug monitoring and PK/PD correlations should be encouraged in all patients with CDIs receiving antibiotic therapy and may result in a better clinical outcome and a reduction in antibiotic resistance and economic costs.In this narrative review, we look at what is new in the management of these difficult-to-treat infections.
Topics: Humans; Pacemaker, Artificial; Defibrillators, Implantable; Device Removal; Anti-Bacterial Agents; Heart Diseases; Communicable Diseases; Prosthesis-Related Infections
PubMed: 37996646
DOI: 10.1007/s15010-023-02130-8 -
Biosensors Aug 2023Universal platforms to analyze biomolecules using sensor devices can address critical diagnostic challenges. Sensor devices like electrical-based field-effect...
Universal platforms to analyze biomolecules using sensor devices can address critical diagnostic challenges. Sensor devices like electrical-based field-effect transistors play an essential role in sensing biomolecules by charge probing. Graphene-based devices are more suitable for these applications. It has been previously reported that Graphene Field-Effect Transistor (GFET) devices detect DNA hybridization, pH sensors, and protein molecules. Graphene became a promising material for electrical-based field-effect transistor devices in sensing biomarkers, including biomolecules and proteins. In the last decade, FET devices have detected biomolecules such as DNA molecules, pH, glucose, and protein. These studies have suggested that the reference electrode is placed externally and measures the transfer characteristics. However, the external probing method damages the samples, requiring safety measurements and a substantial amount of time. To control this problem, the graphene field-effect transistor (GFET) device is fabricated with an inbuilt gate that acts as a reference electrode to measure the biomolecules. Herein, the monolayer graphene is exfoliated, and the GFET is designed with an in-built gate to detect the Interleukin-6 (IL-6) protein. IL-6 is a multifunctional cytokine which plays a significant role in immune regulation and metabolism. Additionally, IL-6 subsidizes a variability of disease states, including many types of cancer development, and metastasis, progression, and increased levels of IL-6 are associated with a higher risk of cancer and can also serve as a prognostic marker for cancer. Here, the protein is desiccated on the GFET device and measured, and Dirac point shifting in the transfer characteristics systematically evaluates the device's performance. Our work yielded a conductive and electrical response with the IL-6 protein. This graphene-based transducer with an inbuilt gate gives a promising platform to enable low-cost, compact, facile, real-time, and sensitive amperometric sensors to detect IL-6. Targeting this pathway may help develop treatments for several other symptoms, such as neuromyelitis optica, uveitis, and, more recently, COVID-19 pneumonia.
Topics: Humans; Interleukin-6; Graphite; Biosensing Techniques; Transistors, Electronic; COVID-19; DNA; Neoplasms
PubMed: 37754068
DOI: 10.3390/bios13090834 -
Annual Review of Medicine Jan 2024Wearable devices are integrated analytical units equipped with sensitive physical, chemical, and biological sensors capable of noninvasive and continuous monitoring of... (Review)
Review
Wearable devices are integrated analytical units equipped with sensitive physical, chemical, and biological sensors capable of noninvasive and continuous monitoring of vital physiological parameters. Recent advances in disciplines including electronics, computation, and material science have resulted in affordable and highly sensitive wearable devices that are routinely used for tracking and managing health and well-being. Combined with longitudinal monitoring of physiological parameters, wearables are poised to transform the early detection, diagnosis, and treatment/management of a range of clinical conditions. Smartwatches are the most commonly used wearable devices and have already demonstrated valuable biomedical potential in detecting clinical conditions such as arrhythmias, Lyme disease, inflammation, and, more recently, COVID-19 infection. Despite significant clinical promise shown in research settings, there remain major hurdles in translating the medical uses of wearables to the clinic. There is a clear need for more effective collaboration among stakeholders, including users, data scientists, clinicians, payers, and governments, to improve device security, user privacy, data standardization, regulatory approval, and clinical validity. This review examines the potential of wearables to offer affordable and reliable measures of physiological status that are on par with FDA-approved specialized medical devices. We briefly examine studies where wearables proved critical for the early detection of acute and chronic clinical conditions with a particular focus on cardiovascular disease, viral infections, and mental health. Finally, we discuss current obstacles to the clinical implementation of wearables and provide perspectives on their potential to deliver increasingly personalized proactive health care across a wide variety of conditions.
Topics: Humans; Precision Medicine; Wearable Electronic Devices; Delivery of Health Care; Arrhythmias, Cardiac
PubMed: 37983384
DOI: 10.1146/annurev-med-052422-020437 -
International Journal of Molecular... Jun 2023Organoids are an advanced cell model that hold the key to unlocking a deeper understanding of in vivo cellular processes. This model can be used in understanding organ... (Review)
Review
Organoids are an advanced cell model that hold the key to unlocking a deeper understanding of in vivo cellular processes. This model can be used in understanding organ development, disease progression, and treatment efficacy. As the scientific world embraces the model, it must also establish the best practices for cultivating organoids and utilizing them to the greatest potential in assays. Microfluidic devices are emerging as a solution to overcome the challenges of organoids and adapt assays. Unfortunately, the various applications of organoids often depend on specific features in a device. In this review, we discuss the options and considerations for features and materials depending on the application and development of the organoid.
Topics: Microfluidics; Organoids; Medical Oncology; Lab-On-A-Chip Devices; Developmental Biology
PubMed: 37446057
DOI: 10.3390/ijms241310882 -
Journal of the American Heart... Jan 2024Consumer wearable devices with health and wellness features are increasingly common and may enhance disease detection and management. Yet studies informing relationships...
BACKGROUND
Consumer wearable devices with health and wellness features are increasingly common and may enhance disease detection and management. Yet studies informing relationships between wearable device use, attitudes toward device data, and comprehensive clinical profiles are lacking.
METHODS AND RESULTS
WATCH-IT (Wearable Activity Tracking for Comprehensive Healthcare-Integrated Technology) studied adults receiving longitudinal primary or ambulatory cardiovascular care in the Mass General Brigham health care system from January 2010 to July 2021. Participants completed a 20-question electronic survey about perceptions and use of consumer wearable devices, with responses linked to electronic health records. Multivariable logistic regression was used to identify factors associated with device use. Among 214 992 individuals receiving longitudinal primary or cardiovascular care with an active electronic portal, 11 121 responded (5.2%). Most respondents (55.8%) currently used a wearable device, and most nonusers (95.3%) would use a wearable if provided at no cost. Although most users (70.2%) had not shared device data with their doctor previously, most believed it would be very (20.4%) or moderately (34.4%) important to share device-related health information with providers. In multivariable models, older age (odds ratio [OR], 0.80 per 10-year increase [95% CI, 0.77-0.82]), male sex (OR, 0.87 [95% CI, 0.80-0.95]), and heart failure (OR, 0.75 [95% CI, 0.63-0.89]) were associated with lower odds of wearable device use, whereas higher median income (OR, 1.08 per 1-quartile increase [95% CI, 1.04-1.12]) and care in a cardiovascular medicine clinic (OR, 1.17 [95% CI, 1.05-1.30]) were associated with greater odds of device use.
CONCLUSIONS
Among patients in primary and cardiovascular medicine clinics, consumer wearable device use is common, and most users perceive value in wearable health data.
Topics: Adult; Humans; Male; Wearable Electronic Devices; Surveys and Questionnaires; Electronic Health Records; Attitude; Delivery of Health Care
PubMed: 38156452
DOI: 10.1161/JAHA.123.032126 -
International Journal of Environmental... Jun 2023Wearable technologies, i.e., activity trackers and fitness watches, are extremely popular and have been increasingly integrated into medical research and clinical...
Wearable technologies, i.e., activity trackers and fitness watches, are extremely popular and have been increasingly integrated into medical research and clinical practice. To assist in optimizing health, wellness, or medical care, these devices require collaboration between researchers, healthcare providers, and wearable technology companies in order to clarify their clinical capabilities and educate consumers on the utilities and limitations of the wide-ranging wearable devices. Interestingly, activity trackers and fitness watches often track both health/wellness and medical information within the same device. In this commentary, we will focus our discussions regarding wearable technology on (1) defining and explaining the technical differences between tracking health, wellness, and medical information; (2) providing examples of health and wellness compared to medical tracking; (3) describing the potential medical benefits of wearable technology and its applications in clinical populations; and (4) elucidating the potential risks of wearable technology. We conclude that while wearable devices are powerful and informative tools, further research is needed to improve its clinical applications.
Topics: Wearable Electronic Devices; Fitness Trackers; Exercise; Biomedical Research; Technology
PubMed: 37444078
DOI: 10.3390/ijerph20136230 -
Journal of the Mechanical Behavior of... Dec 2023Medical adhesives are commonly used for securing wound dressings and medical devices used for diagnostic or therapeutic purposes. Mechanical irritation of skin due to...
BACKGROUND
Medical adhesives are commonly used for securing wound dressings and medical devices used for diagnostic or therapeutic purposes. Mechanical irritation of skin due to adhesive stripping and repeated application can lead to discomfort and device removal. This study aims to examine the peel strength and skin response to different medical adhesives in a cohort of healthy volunteers.
METHOD
Twelve healthy participants were recruited for peel strength testing of three candidate adhesive tapes, and evaluation of the skin response after adhesive removal. A modified ASTM D903 peel strength testing was performed at 180° peeling angle and a rate of 300 mm/min on the forehead, upper back and forearm skin. A longitudinal study was conducted on the forearm and back, with the adhesive samples left in-situ for up to 60 h for analysis of repeat application. The effects of two skin preparation approaches (water and alcohol cleaning) prior to adhesive application were also assessed. Skin biophysical properties were assessed at baseline and at various timepoints following adhesive removal using transepidermal water loss (TEWL), erythema and hydration.
RESULTS
Peel strength reduced uniformly with repeat application over prolonged periods for all the adhesive samples tested. Skin preparation with water and alcohol cleansing prior to adhesive application increased peel strength at both the back (1.1% and 2.9%), and forearm (21.3% and 20%) sites. There was statistically significant increase from baseline to post-tape application for TEWL, skin redness and hydration (p < 0.001). However, there were no statistically significant differences between adhesive types (TEWL: p = 0.38, SR: p = 0.53, HY: p = 0.46). TEWL increased the most post-adhesion across all test sites and adhesive samples with repeat application (p < 0.05). Two-way ANOVA tests revealed no statistically significant interactions between the effects of application duration and adhesive on skin redness or TEWL for both the back and forearm sites (p > 0.05), though a significant interaction was indicted for hydration at the back site (p = 0.01).
CONCLUSION
This study revealed that site and duration of adhesive application effected peel strength. The corresponding changes in skin properties identified that skin barrier function was disrupted with long-term application of adhesives. The back site was identified to be most reliable for adhesion testing and skin response assessment for future work.
Topics: Humans; Adhesives; Longitudinal Studies; Skin; Bandages; Water
PubMed: 37847959
DOI: 10.1016/j.jmbbm.2023.106168 -
BMC Health Services Research Dec 2023Medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other articles that are intended for use in the treatment or diagnosis...
BACKGROUND
Medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other articles that are intended for use in the treatment or diagnosis of disease or injury in humans. Concerning medical endoscope devices, which enable doctors to observe and manipulate the area under examination through a puncture hole in the body cavity or organ, hospitals predominantly consider the quality and cost of maintenance services when making their selection. The effective and efficient provision of maintenance services plays a crucial role in ensuring cost-effective and high-quality management of medical devices. In this study, we have developed an innovative decision tool that analyzed key factors impacting the choice of medical devices' maintenance service. This tool assists hospitals in evaluating and selecting appropriate maintenance services for medical device, specifically endoscopy devices. Moreover, it also serves as a valuable resource for manufacturers and suppliers to enhance their after-sales service offerings.
METHODS
A cross-sectional survey was undertaken in 50 Chinese hospitals, including primary and tertiary hospitals. Moreover, 56 medical staff and 65 medical engineers were recruited from 50 Chinese hospitals to participate the survey. A comprehensive set of factors were defined and investigated. Conjoint analysis and orthogonal design were used for survey design and statistical analysis.
RESULTS
Factors importance and utility values of decision-making factors were analyzed at the aggregate, occupation, and medical institution levels. (1) At the aggregate level, the most critical factor is "maintenance response" and the least important one is "maintenance efficiency". (2) At the occupation level, medical staff paid more attention to "maintenance response" while medical engineers paid more attention to "maintenance quality". (3) At the medical institution level, Primary hospitals paid more attention to "maintenance price", while tertiary hospitals paid more attention to "maintenance quality".
CONCLUSIONS
In general, this study provides a more scientific decision-making tool to both hospitals in choosing maintenance service for medical device such as endoscopy, and it also helps manufacturers and suppliers improve the after-sales service.
Topics: Humans; Cross-Sectional Studies; Endoscopy, Gastrointestinal; Endoscopes; Tertiary Care Centers
PubMed: 38102644
DOI: 10.1186/s12913-023-10458-y