Device-specific Factors Research Articles

Problems Related to Endotracheal Intubation as an Input for the Design of a New Endotracheal Tube.

The purpose of the current review is to identify the main problems of endotracheal intubation, which will serve as a basis for the design requirements for a novel endotracheal tube. A PICO systematic search was conducted in PubMed up to December 2021 to identify issues related both to the endotracheal intubation procedure and device-specific factors. Two primary categories of problems were identified during endotracheal intubation: a) Issues related to laryngotracheal symptoms such as cough, hoarseness, aphonia, dysphonia, dysphagia, swallowing difficulties and the risk of stenosis with long-term intubation. The underlying pressure, abrasion and/or decubitus phenomena should be considered in a new design approach. b) Issues related to the cuff sealing and microaspirations, where the risk of ventilator-associated pneumonia (VAP) highlights the need to improve the design. This review has yielded valuable input for rethinking the design of endotracheal tubes to ensure an efficient and safe airway. This new design should focus on the protection of anatomical structures, avoid or reduce the phenomena of laryngotracheal symptoms, and even reduce the risk of ventilator-associated-pneumonia (VAP) and/or prevent the need for certain tracheostomies.

The Impact of Patient Factors on Objective Cochlear Implant Verification Using Acoustic Cortical Auditory-Evoked Potentials

Introduction: Hearing loss is a major global public health issue that negatively impacts quality of life, communication, cognition, social participation, and mental health. The cochlear implant (CI) is the most efficacious treatment for severe-to-profound sensorineural hearing loss. However, variability in outcomes remains high among CI users. Our previous research demonstrated that the existing subjective methodology of CI programming does not consistently produce optimal stimulation for speech perception, thereby limiting the potential for CI users to derive the maximum device benefit to achieve their peak potential. We demonstrated the benefit of utilising the objective method of measuring auditory-evoked cortical responses to speech stimuli as a reliable tool to guide and verify CI programming and, in turn, significantly improve speech perception performance. The present study was designed to investigate the impact of patient- and device-specific factors on the application of acoustically-evoked cortical auditory-evoked potential (aCAEP) measures as an objective clinical tool to verify CI mapping in adult CI users with bilateral deafness (BD). Methods: aCAEP responses were elicited using binaural peripheral auditory stimulation for four speech tokens (/m/, /g/, /t/, and /s/) and recorded by HEARLab™ software in adult BD CI users. Participants were classified into groups according to subjective or objective CI mapping procedures to elicit present aCAEP responses to all four speech tokens. The impact of patient- and device-specific factors on the presence of aCAEP responses and speech perception was investigated between participant groups. Results: Participants were categorised based on the presence or absence of the P1-N1-P2 aCAEP response to speech tokens. Out of the total cohort of adult CI users (n = 132), 63 participants demonstrated present responses pre-optimisation, 37 participants exhibited present responses post-optimisation, and the remaining 32 participants either showed an absent response for at least one speech token post-optimisation or did not accept the optimised CI map adjustments. Overall, no significant correlation was shown between patient and device-specific factors and the presence of aCAEP responses or speech perception scores. Conclusion: This study reinforces that aCAEP measures offer an objective, non-invasive approach to verify CI mapping, irrespective of patient or device factors. These findings further our understanding of the importance of personalised CI rehabilitation through CI mapping to minimise the degree of speech perception variation post-CI and allow all CI users to achieve maximum device benefit.

Conditionally helpful? The influence of person-, situation-, and device-specific factors on maternal smartphone use for stress coping and on coping effectiveness

Smartphones are omnipresent in the daily lives of parents and provide access to multiple resources in stressful situations. Thus, smartphones might be valuable coping tools. Previous research has mostly focused on the negative effects of parental phone use. In the present study, we investigated how mothers use smartphones for coping with stress and whether their phone use for coping is effective. We also explored factors on different levels (situation, person, device) which could influence phone use and coping effectiveness. Building on a one-week experience sampling study with over 200 mothers and multilevel models, we found that in stressful situations while being with children, mothers used their smartphones mostly for emotion-focused coping such as self-distraction and taking a break. Problem-focused coping was less prevalent. Mothers reporting increased cognitive phone salience used it more for coping with stress. Phone use for coping compared to no use related to lower stress decrease. No person-, situation-, or device-specific factors moderated the effects of phone use on coping effectiveness. Using positive phone content, however, was associated with increased perceived coping efficacy. Our results suggest that phone use is not generally successful for coping, but that momentary device-specific factors such as content characteristics might determine whether phones can be used for coping in an effective way.

Characterization of an In Vitro/Ex Vivo Mucoadhesiveness Measurement Method of PVA Films.

Transmucosal drug delivery systems can be an attractive alternative to conventional oral dosage forms such as tablets. There are numerous in vitro methods to estimate the behavior of mucoadhesive dosage forms in vivo. In this work, a tensile test system was used to measure the mucoadhesion of polyvinyl alcohol films. An in vitro screening of potential influencing variables was performed on biomimetic agar/mucin gels. Among the test device-specific factors, contact time and withdrawal speed were identified as influencing parameters. In addition, influencing factors such as the sample area, which showed a linear relationship in relation to the resulting work, and the liquid addition, which led to an abrupt decrease in adhesion, could be identified. The influence of tissue preparation was investigated in ex vivo experiments on porcine small intestinal tissue. It was found that lower values of Fmax and Wad were obtained on processed and fresh tissue than on processed and thawed tissue. Film adhesion on fresh, unprocessed tissue was lowest in most of the animals tested. Comparison of ex vivo measurements on porcine small intestinal tissue with in vitro measurements on agar/mucin gels illustrates the inter- and intra-individual variability of biological tissue.

Understanding health information literacy of mHealth app users from digital wellbeing perspective: Evidence from regression analysis and fsQCA

While past research suggests mHealth apps help cultivate users’ health information literacy (HIL), factors contributing to their HIL development have not been systematically studied. Applying digital wellbeing framework, an empirical investigation using a large-scale survey dataset was conducted. From regression analysis and fuzzy-set qualitative comparative analysis (fsQCA), two findings were yielded. First, six influential factors, including person-specific factors (i.e., gender, annual family income, Internet experience), device-specific factors (i.e., screen sizes of mobile phones), and context-specific factors (i.e., use frequency and perceived quality of mHealth apps), were identified. Second, gender, annual family income, internet experience, screen size of mobile phones, use frequency and perceived quality of mHealth apps had synergistic effects on HIL. By introducing fsQCA to library and information science community, the study not only extends literature by teasing out the combinations of different categories of factors contributing to HIL but informs health professionals and mHealth app developers.

Development of a Novel Web-based Standardised Workflow to Assist With Device Selection in Patients Undergoing Transcatheter Aortic Valve Implantation

Correct device selection for transcatheter aortic valve implantation is critical to achieving an optimal result, based on patient, anatomic, and device-specific factors. There is currently a wide variance in device choice, and despite accurate sizing from the CT, many manual calculations are required on the part of the clinician to determine risk profile and oversizing percentage. To partially automate this process, we have developed a web-based application incorporating sizing information for three common valves to assist with device selection.

AnaLysIs of Both sex and device specific factoRs on outcomes in pAtients with non-ischemic cardiomyopathy (BIO-LIBRA): Design and clinical protocol.

BackgroundOutcomes of patients with nonischemic cardiomyopathy and low ejection fraction implanted with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with a defibrillator (CRT-D), especially in contemporary, real-life cohorts, are not fully understood.ObjectiveWe aimed to better characterize outcomes of death and ventricular tachyarrhythmias in patients with nonischemic cardiomyopathy, implanted with an ICD or CRT-D, and specifically assess differences by sex.MethodsThe AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy (BIO-LIBRA) study was designed to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality events in nonischemic cardiomyopathy patients, indicated for an ICD or CRT-D implantation for the primary prevention of sudden cardiac death (SCD), with a specific focus on sex differences. We will enroll a total of 1000 subjects across 50 U.S. sites and follow patients for up to 3 years.ResultsThe primary objective of BIO-LIBRA is to evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by subject sex and by implanted device type. We will also assess all-cause mortality, VT or VF alone, cardiac death, and SCD in the total cohort, as well as by subject sex and by the implanted device type. In addition, the previously validated Seattle Proportional Risk Model (SPRM) will be used to compare the SPRM predicted incidence of SCD to the observed incidence.ConclusionsThe BIO-LIBRA study will provide novel and contemporary information regarding outcomes in patients with a NICM who receive a defibrillator.

Post-operative renal failure management in mechanical circulatory support patients.

Acute kidney injury (AKI) occurs commonly in patients requiring mechanical circulatory support (MCS) after cardiothoracic surgery. The prognostic implications of AKI in this patient group relate closely to the pathophysiology and risk factors associated with the underlying disease; pre-operative, intra-operative, and post-operative variables; hemodynamic factors; and type of support device used. General approaches to AKI management, including prevention strategies, medical management, and hemodynamic support, are also applicable in patients requiring MCS. Approaches to renal replacement therapy vary depend on patient factors, device-specific factors, and local preferences and experience. In this invited narrative review, we discuss the pathophysiology, risk factors, and prognostic implications of AKI in post-operative adult patients following institution of MCS. Management strategies for AKI are presented with a focus on those supported with either extracorporeal membrane oxygenation or a ventricular assist device.

Risk knowledge and concern as influences of purchase intention for internet of things devices

Consumer demand for Internet of Things (IoT) devices is projected to continue its lucrative acceleration despite growing cybersecurity concerns and incidents reported in the public press. We explore this apparent anomaly through a model, based on the relevant literature, casting consumers’ IoT Purchase Intention as driven by their pre-existing IoT Risk Knowledge, their level of IoT-related Security Concern, and their device-specific perceptions of Riskiness and Coolness. Based on this model, we collected survey data gauging Purchase Intention for four products varying in Riskiness and Coolness levels. Our analysis extends prior research by confirming the negative influence of IoT Risk Knowledge, implicating it as an emerging drag on IoT consumer demand growth. We further confirm the expected effects of Device Riskiness (negative) and Coolness (positive) as primary factors and we note the cognitive dissonance implied by the inherent IoT device trade-off: greater Coolness tends to come at the price of greater Riskiness. In this trade-off, Coolness mattered more for consumers with lower IoT Security Concern suggesting greater susceptibility to the “wow” factor as offsetting or even distracting from the associated risk. This work contributes to the literature by confirming antecedents and revealing subtleties in the interplay of general and device-specific factors affecting consumer IoT Purchase Intention, shedding light on the feature-attraction/risk-avoidance paradox and identifying implications for both research and practice as the marketplace and consumer perceptions co-evolve going forward.

Deleterious Musculoskeletal Conditions Secondary to Lower Limb Loss: Considerations for Prosthesis-Related Factors.

Significance: The intent of this work was to summarize the existing evidence of, and highlight knowledge gaps specific to, prosthetic devices/componentry and training regimes, particularly in the context of the human-device interaction and deleterious musculoskeletal conditions secondary to lower limb loss. Recent Advances: With the recent and evolving technological advancements in prostheses, there are numerous devices available to individuals with lower limb loss. Current literature demonstrates the importance of expanding the knowledge of all prosthetic device-specific factors and the significance of proper prescription, fit, and alignment, along with adequate device-/activity-specific training, to enhance human-device interaction, reduce gait abnormalities and compensatory motions, and as a result, mitigate risk for secondary musculoskeletal conditions. Critical Issues: Inadequate device prescription, fit, alignment, and training are evident owing to the lack of knowledge or awareness of the many device-specific properties and factors, leading to suboptimal use, as well as, biomechanical compensations, which collectively and adversely affect the function, activity level, and overall health of the prosthesis user. Future Directions: To maximize optimal outcomes after lower limb loss, it is essential to better appreciate the factors that affect both prosthesis use and satisfaction, particularly any modifiable factors that might be targeted in rehabilitation interventions such as device prescription, fit/alignment, and training regimes. A better understanding of such device-specific factors will help enhance the human-device interaction and resulting functional performance, thereby reducing secondary musculoskeletal conditions, allowing for the readiness of the fighting force (return-to-duty/redeployment) and/or improved reintegration into civilian society/work, and overall enhancing quality of life after lower limb loss.

Transcatheter Mitral Valve Replacement: Rationale and Current Status.

Mitral regurgitation (MR) is the most prevalent form of moderate or severe valve disease in the developed world. MR can result from impairment of any part of the mitral valve apparatus and is classified as primary (disease of the leaflets) or secondary (functional). The presence of at least moderate MR is associated with increased morbidity and mortality. With the goal of avoiding the risks of traditional surgery, transcatheter mitral valve therapies have been developed. The current transcatheter repair techniques are limited by therapeutic target and incomplete MR reduction, and thus transcatheter mitral valve replacement (TMVR) has been pursued. Several devices (both transapical and transseptal) are under development, with both early feasibility and pivotal trials under way. As this field develops, the decision to treat with TMVR will require a heart team approach that takes patient-, disease-, and device-specific factors into account.

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

Ischemic Cardiomyopathy is Associated with Increased Hemocompatibility Related Adverse Events Compared to Non-Ischemic Cardiomyopathy in LVAD Patients

Purpose Hemocompatibility Related Adverse Events (HRAE) remain a significant cause of morbidity and mortality in LVAD patients. The association between device specific factors and HRAE has been studied, however less is known about patient specific factors. The aim of this study was to investigate the influence of the etiology of heart failure on HRAE. Methods Retrospective single center chart review of all patients who underwent LVAD implantation from 3/2014 to 8/2018 was performed. The etiology of heart failure was classified as Ischemic Cardiomyopathy (ICM) or Non Ischemic Cardiomyopathy (NICM). An age matched cohort was analyzed using propensity score matching. Results 50 patients with ICM (age 61 yrs ± 11, 73% male) were compared to 49 patients with NICM (age 60 yrs ± 10, 76% male). There was no significant difference in heart failure free survival at 2 years(ICM= 50.2% vs NICM 58.3%,p=0.39) or all-cause mortality(ICM=25.8% vs NICM 27.7%,p=0.69) between the two groups. There was a statistically significant increase in HRAE -free survival in patients with NICM(61.9%) compared to ICM (25.5%) at 2 years(p=0.006) (Figure 1) Conclusion ICM is a risk factor for increased HRAE compared to NICM. Further studies are needed to ascertain whether these patients may benefit with different management strategies to avoid HRAE.

How does the failure of Absorb apply to the other bioresorbable scaffolds? An expert review of first-in-man and pivotal trials.

The Absorb bioresorbable scaffold (BRS), the most studied device among all BRS, suffered a major setback following the negative results of the ABSORB trials. However, approximately 34 BRSs from 22 companies are currently under development. The potential device-specific factors related to the increased event rate in Absorb were: 1) weak mechanical properties, 2) larger strut thickness (less embedment and larger protrusion) and width (larger footprint) predisposing to underexpansion/protrusion of struts, eventually resulting in increased thrombogenicity, and 3) longer bioresorption time combined with failure of encapsulation of struts before the dismantling process ensues. Given the diversity of bioresorbable materials (even amongst PLLA), and the different mechanical properties and bioresorption profiles of each new BRS, one could expect considerable difference in early and late clinical outcomes. As a matter of fact, data from first-in-man (FIM) and pivotal trials have demonstrated variable clinical results. Indeed, early clinical evidence from FIM trials does not support a class effect. However, the absence of a comparator precludes us from drawing definitive conclusions. Further clinical evidence should confirm the absence (or presence) of a class effect.

Development of custom calibration factors for respirable silica using standard methods compared to photometric monitoring data

The goal of this study was to investigate the relationship between particulate matter (PM) concentrations recorded by real-time monitors and respirable crystalline silica, in the form of quartz, (RCS) concentrations measured by the standard NIOSH 7500 method using an aluminum cyclone attached to a filter-cassette. Development of correction factors for real-time monitoring instruments would provide instant estimates of RCS concentrations in order to more immediately assess worker exposures and efficacy of controls implemented for worker health and safety. Sampling occurred in two environments: (a) during iron casting at a foundry in the Western United States and (b) in a controlled testing environment, using Arizona Test Dust (ATD) in a low-speed wind tunnel. Two DustTrak DRX 853 monitors were used to collect area samples of PM1, PM2.5, PM4, PM10 and PMtotal, and two SidePak AM510 monitors were used to collect personal samples of PM2.5. Calculated r-squared (R2) values analyzed how well paired data from real-time monitors and filter-based methods fit a line of regression, and how well real-time monitor measurements predicted RCS concentrations. Among the different PM size fractions recorded by the DRX monitors, the highest coefficient of determination was between RCS quantified by XRD and PM10 for DRX-1 and DRX-2 (both R2 = 0.80), however, their respective regression equations differed. The coefficients of determination calculated for each SidePak were 0.19 and 0.016 respectively, demonstrating a poor ability for these monitors to predict RCS concentrations. There was variability among the identical real-time monitors, especially among the regression equations. Results of this study indicate that it is reasonable to determine a calibration factor for DRX direct-read monitors, enabling them to estimate concentrations of RCS in real-time. Dust containing quartz percentages that are significantly different would require calculation of separate calibration factors. Successful development of silica-dust calibration factors from this study is not intended to replace either the OSHA or NIOSH standard silica sampling and analytical methods. Future work in this area should include using test material with a known, homogenous concentration of silica in a controlled environment to more accurately determine device-specific calibration factors.

Characterization of Wireless Multidevice Users

The number of wireless-enabled devices owned by a user has had huge growth over the past few years. Over one third of adults in the United States currently own three wireless devices: a smartphone, laptop, and tablet. This article provides a study of the network usage behavior of today’s multidevice users. Using data collected from a large university campus, we provide a detailed multidevice user (MDU) measurement study of more than 30,000 users. The major objective of this work is to study how the presence of multiple wireless devices affects the network usage behavior of users. Specifically, we characterize the usage pattern of the different device types in terms of total and intermittent usage, how the usage of different devices overlap over time, and uncarried device usage statistics. We also study user preferences of accessing sensitive content and device-specific factors that govern the choice of WiFi encryption type. The study reveals several interesting findings about MDUs. We see how the use of tablets and laptops are interchangeable and how the overall multidevice usage is additive instead of being shared among the devices. We also observe how current DHCP configurations are oblivious to multiple devices, which results in inefficient utilization of available IP address space. All findings about multidevice usage patterns have the potential to be utilized by different entities, such as app developers, network providers, security researchers, and analytics and advertisement systems, to provide more intelligent and informed services to users who have at least two devices among a smartphone, tablet, and laptop.

Recognizing Personal Locations From Egocentric Videos

Contextual awareness in wearable computing allows for construction of intelligent systems, which are able to interact with the user in a more natural way. In this paper, we study how personal locations arising from the user's daily activities can be recognized from egocentric videos. We assume that few training samples are available for learning purposes. Considering the diversity of the devices available on the market, we introduce a benchmark dataset containing egocentric videos of eight personal locations acquired by a user with four different wearable cameras. To make our analysis useful in real-world scenarios, we propose a method to reject negative locations, i.e., those not belonging to any of the categories of interest for the end-user. We assess the performances of the main state-of-the-art representations for scene and object classification on the considered task, as well as the influence of device-specific factors such as the field of view and the wearing modality. Concerning the different device-specific factors, experiments revealed that the best results are obtained using a head-mounted wide-angular device. Our analysis shows the effectiveness of using representations based on convolutional neural networks, employing basic transfer learning techniques and an entropy-based rejection algorithm.

Technique or technology? Evaluating leaks after gastric bypass

ObjectiveTo assess the relationship between technique and surgical devices on anastomotic and staple-line leaks after laparoscopic Roux-en-Y gastric bypass. BackgroundLeaks after bariatric surgery remain a major source of morbidity and mortality. The association of surgical technique and devices with leaks after gastric bypass is poorly understood. SettingMulti-centered study that included teaching and non-teaching hospitals that participate in a statewide consortium for quality improvement using a payer-funded outcome registry. MethodsWe analyzed data from the Michigan Bariatric Surgery Collaborative and performed a case-control study comparing patients who sustained a leak with those who did not after primary laparoscopic Roux-en-Y gastric bypass. A total of 71 (.44%) patients with leaks were identified between January 2007 and December 2011. The leak group was matched 1:2 to a control group (nonleak) based on procedure type, age, body mass index, sex, and the year in which the procedure was performed. Technique-specific case characteristics and device-specific factors were assessed by reviewing operative notes from all primary bariatric procedures in our study population. ResultsThe rate of leak decreased during the study period, and there was a significant downward trend (slope estimate: –.19961%, P = .0372). After performing multivariate analysis, the type of anastomosis (circular stapler, hand-sewn, or linear stapler) and stapler manufacturer were not associated with leaks. The use of buttressing material was associated with a higher rate of leaks (odds ratio: 8.79 [95% confidence interval: 2.49–31.01], P = .0007), whereas the use of fibrin sealant was associated with a lower rate of leaks (odds ratio .11 [95% confidence interval: .03–.41], P = .0013). These findings could not be explained by differences in measures of surgeon performance. ConclusionLeak rates after laparoscopic gastric bypass have fallen in Michigan despite variations in technique and device utilization. Although the type of anastomosis and stapler manufacturer do not appear to be significantly associated with leaks, it appears that the use of buttressing material was more common in cases in which leaks occurred, whereas the use of fibrin sealant was not. Given the complex interplay of multiple variables that affect surgical outcomes, future studies justifying the benefits of operative devices should be evaluated prospectively in the context of surgeon technique and skill.

The Economic Evaluation of Medical Devices

The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term 'medical devices' have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medical device manufacturer faces prior to market approval and the structure of the medical device industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medical devices.

Customizing Inhaled Therapy to Meet the Needs of COPD Patients

Chronic obstructive pulmonary disease (COPD) is a progressive disease characterized by airflow limitation resulting from emphysema and chronic bronchitis. Inhaled therapy is the major therapeutic approach for treating COPD. Multiple inhaler medications are available in the United States and are delivered by a variety of different devices: metered-dose inhalers, dry powdered inhalers, and nebulizers. Each inhaler device has unique requirements for use that must be correctly performed by the patient for successful drug delivery. Patients with COPD represent a medically diverse population, with each patient having distinct characteristics, such as lung function, comorbidities, cognitive functions, hand strength, and lifestyle. These characteristics impact the patient's ability to properly use specific inhaler devices and therefore affect adherence to therapy, therapeutic outcomes, and quality of life. It is estimated that between 28% to 68% of patients do not use metered-dose inhalers or dry powder inhalers correctly. Worsening symptoms or increased frequency of exacerbations may not always indicate disease progression but may indicate a patient's inability to use their inhaler device properly. This review discusses the patient- and device-specific factors to be considered when choosing an inhaled therapy, which will be concordant with the patient's medical needs, preferences, and lifestyle. The review also considers how the ideas underlying the patient-centered medical home model can be incorporated into the choice and use of inhaler device for a given patient with COPD to improve treatment outcomes.