Device Compliance Research Articles

173 Electrical Stimulation Used as an Adjunct to Cervical Spine Fusion in Patients at Risk for Pseudarthrosis

INTRODUCTION: Prior studies show that pulsed electromagnetic field (PEMF) stimulation promotes bone healing and can be a valuable tool to help overcome biological deficiencies in patients at risk. The current study further evaluates the adjunct effect of PEMF in subjects undergoing cervical spinal surgery presenting with risk factors for pseudarthrosis. METHODS: A prospective multicenter clinical trial (NCT 03177473) was conducted at eleven clinical sites. Subjects undergoing cervical spinal fusion surgery with one or more risk factors for pseudarthrosis were identified for enrollment. Risk factors for pseudarthrosis included multilevel fusion, prior failed cervical spine fusion, diabetes, osteoporosis, or smoking. Subjects undergoing cervical spinal fusion were required to wear the PEMF device for 4 hours/day for 6 months post-op. Fusion status was determined at the 12-month visit using anterior/posterior, lateral, and flexion/extension radiographs and computed tomography (without contrast). NDI, EQ-5D, SF-36, and VAS for neck and arm pain were collected as secondary outcome measures. RESULTS: Out of 160 subjects, 144 (90.0%) were graded as fused (all levels) at the 12-month visit. Fusion success was 91.7% (n = 55/60), 89.0% (n = 89/100), and 90.9% (n = 20/22) for subjects with 1, 2+, or 3+ risk factors, respectively. Significant improvements in NDI, SF-36, EQ-5D, VAS-arm and VAS-neck were observed compared to baseline (p < 0.001). A device compliance rate of 85.0% was observed at 3-months and 78.3% at 6-months in subjects who had successful cervical fusion. CONCLUSIONS: The PEMF bone growth stimulator device is a valuable tool to aid in fusion healing, especially in challenging populations. Subjects in this study experienced favorable fusion rates of 90% and significant improvement in patient reported outcomes despite having elevated comorbidity and/or complex surgeries.

Head Protection Device for Individuals at Risk for Head Injury due to Ground-Level Falls: Single Trauma Center User Experience Investigation.

Falls represent a large percentage of hospitalized patients with trauma as they may result in head injuries. Brain injury from ground-level falls (GLFs) in patients is common and has substantial mortality. As fall prevention initiatives have been inconclusive, we changed our strategy to injury prevention. We identified a head protection device (HPD) with impact-resistant technology, which meets head impact criteria sustained in a GLF. HPDs such as helmets are ubiquitous in preventing head injuries in sports and industrial activities; yet, they have not been studied for daily activities. We investigated the usability of a novel HPD on patients with head injury in acute care and home contexts to predict future compliance. A total of 26 individuals who sustained head injuries, wore an HPD in the hospital, while ambulatory and were evaluated at baseline and 2 months post discharge. Clinical and demographic data were collected; a usability survey captured HPD domains. This user experience design revealed patient perceptions, satisfaction, and compliance. Nonparametric tests were used for intragroup comparisons (Wilcoxon signed rank test). Differences between categorical variables including sex, race, and age (age group 1: 55-77 years; age group 2: 78+ years) and compliance were tested using the chi-square test. Of the 26 patients enrolled, 12 (46%) were female, 18 (69%) were on anticoagulants, and 25 (96%) were admitted with a head injury due to a GLF. The median age was 77 (IQR 55-92) years. After 2 months, 22 (85%) wore the device with 0 falls and no GLF hospital readmissions. Usability assessment with 26 patients revealed positive scores for the HPD post discharge regarding satisfaction (mean 4.8, SD 0.89), usability (mean 4.23, SD 0.86), effectiveness (mean 4.69, SD 0.54), and relevance (mean 4.12, SD 1.10). Nonparametric tests showed positive results with no significant differences between 2 observations. One issue emerged in the domain of aesthetics; post discharge, 8 (30%) patients had a concern about device weight. Analysis showed differences in patient compliance regarding age (χ12=4.27; P=.04) but not sex (χ12=1.58; P=.23) or race (χ12=0.75; P=.60). Age group 1 was more likely to wear the device for normal daily activities. Patients most often wore the device ambulating, and protection was identified as the primary benefit. The HPD intervention is likely to have reasonably high compliance in a population at risk for GLFs as it was considered usable, protective, and relevant. The feasibility and wearability of the device in patients who are at risk for GLFs will inform future directions, which includes a multicenter study to evaluate device compliance and effectiveness. Our work will guide other institutions in pursuing technologies and interventions that are effective in mitigating injury in the event of a fall in this high-risk population.

Impact of a pharmacy technician on an interprofessional antithrombotic stewardship program at an academic medical center.

The need for monitoring and standardization of anticoagulation management has garnered the attention of national organizations, driving the implementation of antithrombotic stewardship programs (ASPs). Established ASPs have highlighted interdisciplinary collaboration between physicians, nurses, and pharmacists and demonstrated financial benefits and positive patient care outcomes. While pharmacy technicians are key members of the pharmacy profession, they are rarely utilized to expand clinical programs. The aim of this report is to describe the impact of adding a pharmacy technician to an ASP at an academic medical center. The departments of pharmacy and quality at West Virginia University Hospitals (WVUH) developed a business plan and financially justified an ASP. The ASP was implemented in January 2022 and consisted of 2 full-time clinical pharmacist specialists, 1 full-time clinical pharmacy technician, 2 full-time clinical nurse specialists, and 1 part-time physician medical director. The clinical pharmacy technician's primary role was to review patients' sequential compression device (SCD) compliance and newly started oral anticoagulants prior to discharge. The clinical nurse specialists educated patients newly started on oral anticoagulants within 24 hours of discharge and triaged any postdischarge medication access issues. The medical director provided high-level program oversight and acted as a clinical consultant on complex patient cases. In the first 6 months after the program's implementation, the clinical pharmacy technician made 174 recommendations to the clinical pharmacist specialists regarding discharge transitions of care and assessed SCD compliance in 246 patients. Of the 246 patients assessed, 217 patients (88%) were deemed to be noncompliant. The pharmacy department at WVUH successfully justified and implemented an interprofessional ASP at an academic medical center, which is the first ASP to date to incorporate a clinical pharmacy technician.

Sequential Compression Device Compliance for Venous Thromboembolism in High-Risk Trauma: A Quality Improvement Study.

Hospital-acquired, perioperative venous thromboembolism is a recognized patient safety indicator in the adult trauma patient population. Mechanical prophylaxis has been identified as a standard intervention to reduce the incidence of venous thromboembolism when prescribed along with anticoagulation or if anticoagulation is contraindicated in the surgical population. Adherence to consistent mechanical prophylaxis remains a nursing issue impacted by numerous factors in patient care. The purpose of this quality improvement project was to improve the compliance of sequential compression device utilization to decrease the hospital-acquired, perioperative venous thromboembolism rate in the adult hospitalized trauma patient population. A pre- and postintervention quality improvement approach utilized a nurse-led strategy to engage multidisciplinary team members to increase the consistency of sequential compression device utilization on patients within trauma units. The patient safety indicator rate per 1,000 for hospital-acquired, perioperative venous thromboembolism was monitored for improvement. The patient safety indicator rate per 1,000 for hospital-acquired, perioperative venous thromboembolism demonstrated a decline from 10.60 to 4.95 rate per 1,000 over 12 months. In the trauma units, sequential compression device compliance increased from an initial direct observation audit of only 12% to an average of 65% compliance rate during the last 16-week audits. We found that a multidisciplinary, nurse-driven approach in the trauma units was effective in improving the compliance of sequential compression device utilization and impacted the hospital acquired, perioperative venous thromboembolism rate in the adult trauma patient population.

Plantar Kinetics During Wheeled Knee Walker Use Compared to Different Assistive Walking Devices in Persons With Type 2 Diabetes Mellitus.

Diabetic patients with foot ulcers are commonly prescribed assistive walking devices to unload the affected foot and promote tissue healing. However, the effect on shear loads to the contralateral foot is unknown. This study investigated the effect of a wheeled knee walker (WKW), compared to common devices, on compressive and shear plantar forces carried by the propulsive foot during walking in patients with type 2 diabetes mellitus. A secondary objective investigated plantar forces' correlations with body weight unloaded (BWU). Participants walked a maximum of 200 m per condition during normal walking or when using crutches, a standard walker, and a WKW in randomized order. Plantar forces were measured with force plates, and wireless force-sensitive pads measured BWU through the hands. The WKW was instrumented to measure BWU onto the seat and handlebars. Three-dimensional motion capture confirmed gait events. The WKW produced the lowest vertical, braking, propulsive, and medial shear forces but the highest lateral shear force among all conditions. Using crutches or a walker had negligible medial and lateral shear (mean = -6.69 N and -7.80 N), with normal walking producing the highest medial shear. There was a poor relationship between BWU and assistive walking devices and shear force values. A WKW could be the preferred assistive device for unloading a diabetic foot ulcer. The magnitude of lateral force would need further investigation to determine ulceration risk, given patient susceptibility and neuropathy. Understanding shear forces on the propulsive foot is important for minimizing contralateral limb tissue damage risk while treating an ulcer. Different assistive walking devices change walking patterns and affect shear forces on the plantar surface of the foot. Although the WKW minimizes several loading metrics, a clinical trial investigating assistive walking device compliance and wound healing in diabetic foot ulcer patients across devices is needed.

Impact of text reminders on pneumatic compression device (PCD) compliance in patients with breast cancer-related lymphedema

PurposeDo cell phone text reminders impact the rate of compliance with pneumatic compression device (PCD) therapy among women with breast cancer-related lymphedema (BCRL)?MethodsA prospective, randomized, 2-group feasibility study conducted at 2 centers. Participants were adult females (≥18 years old) with unilateral BCRL who had the capability of receiving reminder text messages. All participants underwent PCD therapy. Participants were randomized 1:1 to control (no text messages) or test group (received text message reminders if the PCD had not been used for 2 consecutive days). The rate of compliance between treatment groups was the main outcome measure. Secondary outcome measures were changes in arm girth, quality of life (QOL), and symptom severity.ResultsTwenty-nine participants were enrolled and randomized, 25 were available for follow-up at 60 days (14 test, 11 control). Overall, 52.2% (12/23) of all participants were completely compliant, an additional 43.5% (10/23) were partially compliant, and 1 patient (4.3%) was noncompliant. The test and control groups did not differ in device compliance. In the pooled population, weight, BMI, and arm girth were improved. Overall disease-specific QOL and symptom severity were improved. Regression analysis showed benefits were greater among participants with higher rates of compliance.ConclusionsAutomated text reminders did not improve compliance in patients with BCRL as compliance rates were already high in this patient population. Improvements in weight, BMI, arm girth, disease-specific quality of life, and symptom severity measures were observed regardless of the treatment assignment. Full compliance resulted in greater functional and QOL benefits.Trial registrationThe study was registered at www.clinicaltrials.gov (NCT04432727) on June 16, 2020.

Validated Wearable Device Shows Acute Postoperative Changes in Sleep Patterns Consistent With Patient-Reported Outcomes and Progressive Decreases in Device Compliance After Shoulder Surgery

To assess the utility of a validated wearable device (VWD) in examining preoperative and postoperative sleep patterns and how these data compare to patient-reported outcomes (PROs) after rotator cuff repair (RCR) or total shoulder arthroplasty (TSA). Male and female adult patients undergoing either RCR or TSA were followed up from 34 days preoperatively to 6 weeks postoperatively. Sleep metrics were collected using a VWD in an unsupervised setting. PROs were assessed using the following validated outcome measures: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire; American Shoulder and Elbow Surgeons self-evaluation questionnaire; visual analog scale assessing pain; and Disabilities of the Arm, Shoulder and Hand questionnaire. Data were analyzed preoperatively and at 2-week intervals postoperatively with χ2 analysis to evaluate device compliance. Sleep metrics and PROs were evaluated at each interval relative to preoperative values within each surgery type with an analysis of variance repeated on time point. The relation between sleep metrics and PROs was assessed with correlation analysis. A total of 57 patients were included, 37 in the RCR group and 20 in the TSA group. The rate of device compliance in the RCR group decreased from 84% at surgery to 46% by 6 weeks postoperatively (P < .001). Similarly, the rate of device compliance in the TSA group decreased from 81% to 52% (P < .001). Deep sleep decreased in RCR patients at 2 to 4 weeks (decrease by 10.99 ± 3.96 minutes, P= .021) and 4 to 6 weeks postoperatively (decrease by 13.37 ± 4.08 minutes, P= .008). TSA patients showed decreased deep sleep at 0 to 2 weeks postoperatively (decrease by 12.91 ± 5.62 minutes, P= .045) and increased rapid eye movement sleep at 2 to 4 weeks postoperatively (increase by 26.91 ± 10.70 minutes, P= .031). Rapid eye movement sleep in the RCR group and total sleep in the TSA group were positively correlated with more favorable PROs (P < .05). VWDs allow for monitoring components of sleep that offer insight into potential targets for improving postoperative fatigue, pain, and overall recovery after shoulder surgery. However, population demographic factors and ease of device use are barriers to optimized patient compliance during data collection. Level IV, diagnostic case series.

Stenting of a patient with long coronary artery lesion under the control of optical coherence tomography (clinical case)

One of the topical issues in percutaneous coronary interventions (PCI) is the stenting of extended lesions. Currently, there are two main approaches: stenting with a single long stent (SLS) and stenting with two or more overlapping stents (OS). However, due to the conical geometry of the vessel, stenting of the SLS with a large difference between the proximal and distal reference diameters of the artery may lead to worse results than stenting of the OS, due to lower device compliance to the vessel. The article presents a clinical case illustrating our proposed algorithm for making a decision in favor of SLS or OS based on data obtained using optical coherence tomography.

Feasibility of using wearable technology to monitor agitation and sleep in patients with Alzheimer’s dementia: Lessons learned

AbstractBackgroundIndividuals with Alzheimer’s dementia (AD) often go through a period of significant behavioral and psychological symptoms including agitation. This can lead to impaired daily functioning, prolongation of hospitalization, early institutionalization, and higher mortality. The integration of biomedical data acquisition systems and information technology enables continuous real‐time monitoring of physiological data in daily life.MethodThis feasibility study is part of a clinical trial that examines the effects of THC‐free CBD oil on agitation in patients with AD (NCT04436081), involves caregiver/care‐recipient dyads and the use of technology to capture agitation during a 14‐week period. Participants are given 2 Fitbit versa 2 (each includes a 3‐axis accelerometer and an optical heart rate monitor), a smartphone, a tablet, and a digital timer. Participants’ Fitbit are paired with their smartphone, while the caregivers’ FitBit is paired with their tablet. Participants include males/females over 50 years old, with the diagnosis of AD, a MMSE score ≤28 &amp; ≥4, and agitation measured with an NPI agitation/aggression subscore &gt;3. Each dyad completes 24 forms/questionnaires throughout the study electronically via provided apps. Caregivers are instructed to send a real time electronic alert when agitation episodes happen.ResultSo far, we have enrolled 26 dyads. For this report we have collected data on 22 participants with 140 million data points for limb movement and heart rate, and 969 nights of sleep data records. Overall compliance with wearable use was 77% of the time, with 82% in 11 participants, 65% in 8 participants and 32% in 3 participants. Compliance with electronic form/questionnaire completion was 87%. Electronic alert for agitation episodes were recorded by the caregivers only 50% of time.ConclusionThis study explores the feasibility and acceptability of using technology (wearables, electronic form data completion and submission, sleep, and real time agitation episode collection) for a 16‐week period in AD patients with agitation and their caregivers. We found high acceptability of wearing the Fitbit by AD patients with agitation. The primary issues interfering with data collection and device compliance were device battery life and memory, remembering to wear the device after charging, and technical fault in capturing the data.

Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial

BackgroundThe influence of body position in obstructive sleep apnoea patients is well known. A positional therapy device placed at the forehead has proven to be effective in reducing the severity...

Hearing outcomes in children with single sided deafness: Our experience at a tertiary paediatric otorhinolaryngology unit.

Hearing rehabilitation options for single sided deafness (SSD) include contralateral routing of sound (CROS) aids and bone conduction devices (BCDs). This study aimed to review the management of children with SSD at our tertiary paediatric otolaryngology unit over the last 15 years. A retrospective cohort study was performed. Primary hearing outcomes were measured using the Children's Home Inventory for Listening Difficulties (CHILD) questionnaire score and secondary hearing outcomes were measured using hearing thresholds for speech in noise. Outcomes were measured pre and post bone conduction device (BCD) trial. 49 patients with SSD were identified. 20 children had trial of a BCD. 16 patients had pre- and post- BCD trial CHILD scores available for analysis. There was a statistically significant improvement in CHILD scores and speech in noise testing at +5dB and +0dB following amplification with a BCD. The mean use of BCD was 1.3h per day. We have described the management of children with SSD in our unit. This study demonstrated a statistically significant benefit of BCD use on hearing outcomes. However, device compliance is low suggesting hearing advice choice in the population is complex and further research is warranted.

High-frequency ultrasound point-of-care device to quantify myopia-induced microstructural changes in the anterior sclera.

To develop a point-of-care (POC) device using high-frequency ultrasound (US) for evaluating microstructural changes in the anterior sclera associated with myopia. The proposed POC device must satisfy four primary requirements for effective clinical use: the measurement component is handheld; the software must be simple and provide real-time feedback; patient safety and health data security requirements set forth by relevant governing bodies must be satisfied and the measurement data must have sufficient signal-to-noise ratio (SNR) and repeatability. Radiofrequency (RF) echo data acquired by the POC device will be processed using our quantitative US methods to characterise tissue microstructure and biomechanical properties. All stated requirements have been met in the developed POC device. The high-frequency transducer is housed in a custom, 3D-printed, pen-like holder that allows for easy measurements of the anterior sclera. Custom software provides a simple interface for data acquisition, real-time data display and secure data storage. Exposimetry measurements of the US pressure field indicate device compliance with United States Food and Drug Administration limits for ophthalmic US. In vivo measurements on a volunteer suggest the RF data SNR and acquisition consistency are suitable for quantitative analysis. A fully functioning POC device using high-frequency US has been created for evaluating the microstructure of the anterior sclera. Planned studies using the POC device to scan the eyes of myopia patients will help clarify how the anterior sclera microstructure may be affected by myopia. If effective, this portable, inexpensive and user-friendly system could be an important part of routine eye examinations.

Comparison of Two Generations of Thoracic Aortic Stent Grafts and Their Impact on Aortic Stiffness in an Ex Vivo Porcine Model

Little is known about the cardiovascular changes after TEVAR and regarding the impact on aortic stiffness for different stent graft generations specifically, following changes in device design. The present study evaluated the stent graft induced aortic stiffening of two generations of the Valiant thoracic aortic stent graft. This was an exvivo porcine investigation using an experimental mock circulatory loop. Thoracic aortas of young healthy pigs were harvested and connected to the mock circulatory loop. At a 60 bpm heart rate and stable mean arterial pressure, baseline aortic characteristics were obtained. Pulse wave velocity (PWV) was calculated before and after stent graft deployment. Paired and independent sample t tests or their non-parametric alternatives were performed to test for differences where appropriate. Twenty porcine thoracic aortas were divided into two equal subgroups, in which a Valiant Captivia or a Valiant Navion stent graft was deployed. Both stent grafts were similar in diameter and length. Baseline aortic characteristics did not differ between the subgroups. Mean arterial pressure values did not change after either stent graft, while pulse pressures increased statistically significantly after Captivia (mean 44±10mmHg to 51±13mmHg, p=.002) but not after Navion. Mean baseline PWV increased after both Captivia (4.4±0.6 m/s to 4.8±0.7 m/s, p=.007) and Navion (4.6±0.7 m/s to 4.9±0.7m/s, p=.002). There was no statistically significant difference in the mean percentage increase in PWV for either subgroup (8±4% vs. 6±4%, p=.25). These experimental findings showed no statistically significant difference in the percentage increase of aortic PWV after either stent graft generation and confirm that TEVAR increases aortic PWV. As a surrogate for aortic stiffness, this calls for further improvements in future thoracic aortic stent graft designs regarding device compliance.

Children with Conductive Hearing Loss Fitted with Hearing Aids: Outcomes and Caregiver Experiences in South Africa.

Introduction Hearing aids are a frequent management option for children with conductive hearing loss (CHL) and it is necessary to determine the efficacy of outcomes. Limited information regarding caregivers' perceptions and experiences are available to examine outcomes in this population. Objectives To describe hearing aid outcomes and caregivers' experiences for children with CHL who wear behind-the-ear (BTE) hearing aids. Methods Retrospective review of clinical data from 19 children between 0 and 13 years of age with CHL, who were fitted with BTE hearing aids between January 2017 and March 2020. Hearing aid outcomes were documented at one month post-hearing aid fitting, via average daily use and caregiver and teacher reports obtained through the Parents' Evaluation of Aural/oral performance of Children (PEACH) and the Teachers' Evaluation of Aural/oral performance of Children (TEACH). Telephonic surveys were conducted with 13 caregivers to explore their experiences. Qualitative data from open-ended questions were analyzed thematically. Results The average hearing aid use was 6.5 hours/day (2.0 standard deviation, SD; range 4.1-10.3) for bilateral hearing aid users. Questionnaire results indicated that most children (PEACH - 83.3% and TEACH - 92.3%) used their hearing aids more than 75% of the time. Participants performed better in quiet environments with limited sensitivity to loud sounds at home and at school. Reported challenges included stigma and device compliance. Conclusions Children with CHL used their hearing aids for comparable hours (5-8 hours/day), as reported for children with sensorineural hearing loss, but less than the recommended 10 hours/day required for adequate language development. Caregivers reported benefits equivalent to expectations, with challenges similar to those reported in high-income countries.

Patients' Perception of the Use of the EasyPod™ Growth Hormone Injector Device and Impact on Injection Adherence: A Multi-Center Regional Study

ObjectiveThis study aimed to assess patient perceptions of the use of the EasyPod™ growth hormone delivery device and its association with compliance.MethodsThis cross-sectional, multicenter study was conducted in six centers from three countries (United Arab Emirates, Oman, and Saudi Arabia,) between March 2020 and June 2020. Children and adolescents aged 3–18 years, diagnosed with growth disorders and receiving rhGH through the EasyPod™ device were enrolled. Patients and caregivers were given a pre-set questionnaire that evaluated patient satisfaction, preference for technical and personalized features, and device drawbacks. The results were analyzed using independent measures of analysis of variance to evaluate the association of higher satisfaction with device features and better compliance.ResultsA total of 186 patients were enrolled in the study. Of these, 45.7% had GH deficiency. The mean age (±SD) of patients was 11.8 (±2.76) years; 117 (62.90%) were males. Average compliance was 87%. One hundred patients (53.76%) had injection compliance of ≥90%. Amongst these patients, 74%, 68%, and 77% top-scored (5/5) the technical features of hidden needle, skin sensor, and pre-set dosing, respectively, compared to top scores by 39%, 34%, and 51% patients in the <90% compliance group (p-value <0.05). Similarly, a statistically significant difference was observed between the groups (p-value <0.05) in the perception of the usefulness of the tracking features such as display of history of injected doses (78% vs. 47.7%), a reminder for medicine remaining (46% vs. 23.3%) and battery power indicator (48% vs. 20.9%). Personal screen messages were associated with higher compliance while the requirement to keep the device in the fridge was reported as the most inconvenient feature by 56% of patients in the higher compliance group as against 39.5% in the lower compliance group (p-value <0.05). There was no statistically significant difference in the intensity of pain reported in the two compliance groups.ConclusionOur study showed that there is a statistically significant association between better perception of device features and higher compliance.

A Randomized Trial of Photobiomodulation Therapy for Center-Involved Diabetic Macular Edema with Good Visual Acuity (Protocol AE)

To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness (CST) than placebo in eyes with center-involved diabetic macular edema (CI-DME) and good vision. Phase 2 randomized clinical trial. Participants had CI-DME and visual acuity (VA) 20/25 or better in the study eye and were recruited from 23 clinical sites in the United States. One eye of each participant was randomly assigned 1:1 to a 670-nm light-emitting PBM eye patch or an identical device emitting broad-spectrum white light at low power. Treatment was applied for 90 seconds twice daily for 4 months. Change in CST on spectral-domain OCT at 4 months. From April 2019 to February 2020, 135 adults were randomly assigned to either PBM (n= 69) or placebo (n= 66); median age was 62 years, 37% were women, and 82% were White. The median device compliance was 92% with PBM and 95% with placebo. OCT CST increased from baseline to 4 months by a mean (SD) of 13 (53) μm in PBM eyes and 15 (57) μm in placebo eyes, with the mean difference (95% confidence interval [CI]) being-2 (-20 to 16) μm (P= 0.84). CI-DME, based on DRCR Retina Network sex- and machine-based thresholds, was present in 61 (90%) PBM eyes and 57 (86%) placebo eyes at 4 months (adjusted odds ratio [95% CI]= 1.30 (0.44-3.83); P= 0.63). VA decreased by a mean (SD) of-0.2 (5.5) letters and-0.6 (4.6) letters in the PBM and placebo groups, respectively (difference [95% CI]= 0.4 (-1.3 to 2.0) letters; P= 0.64). There were 8 adverse events possibly related to the PBM device and 2 adverse events possibly related to the placebo device. None were serious. PBM as given in this study, although safe and well-tolerated, was not found to be effective for the treatment of CI-DME in eyes with good vision.

Factors affecting compliance with positive airway pressure therapy in obstructive sleep apnea.

To investigate the factors affecting compliance with positive airway pressure (PAP) therapy and establish the relationship between compliance and pulmonary function tests (PFT) in patients with OSA. In this prospective study, patients with OSAusing PAP devices were questioned about the complaints related to the device. Depression and anxiety scales along with PFT parameters werealso assessed. Of 98 participants, 63% were men. The mean age was 52.0 ± 9.6years. Sixty-seven percent of the patients were compliant with their devices. A significant difference was observed between the proportion of the participants compliant or non-compliant with the device, based on OSA severity (p < 0.05). Beck depression inventory (BDI) and Beck anxiety inventory (BAI) scores of the compliant patients were significantly lower than those of the non-compliant patients (p < 0.001, p = 0.044, respectively). No statistically significant difference was detected between the groups regarding individual pulmonary function tests (p > 0.05). The rates of nasal mask use, not having difficulty in tolerating CPAP, falling asleep, absence of abdominal distension, no facial sores, no air leakage, patients benefiting from the device, reduction in daytime sleepiness, and the belief that they are receiving appropriate therapy in participants compliant with the device were higher than those in non-compliant participants (p < 0.05). The rates of claustrophobia and discomfort due to pressure were significantly lower in patients compliant with the device than in the non-compliant patients (p < 0.05). While no relationship was detected between PFT parameters and PAP therapy compliance, significant factors affecting the device compliance were detected.

A quality improvement initiative to reduce venous thromboembolism on a gynecologic oncology service

ObjectiveTo describe and evaluate the effects of implementation of a venous thromboembolism (VTE) prophylaxis quality improvement (QI) initiative on a gynecologic oncology service at a single institution. MethodsPrior to 2018, no consensus gynecologic oncology VTE prophylaxis protocol existed at the authors' academic institution. Published, evidence-based guidelines were reviewed to create a standardized VTE risk stratification algorithm. Interventions to improve perioperative heparin administration and sequential compression device (SCD) compliance as well as provider/patient education efforts were introduced in January 2018. Initial efforts included nursing and patient SCD education, internal dissemination of VTE prophylaxis guidelines, and creation of a VTE ‘dashboard’ to track performance. During a second phase, VTE prophylaxis guidelines were reviewed and further refined, non-compliant operative cases reviewed weekly, and guidelines incorporated into the electronic medical record. Performance was measured using Tableau data software (www.tableau.com) and by separately evaluating adherence to the developed guidelines in three retrospective cancer-enriched surgical cohorts (2016–2017, 2018, 2019). ResultsCompared to the baseline period, we observed a reduction in VTE rate during the 2018–2019 VTE QI implementation period from 2.1% (19/905) to 1.0% (20/2015, p = 0.02) among gynecologic oncology inpatients. In the retrospective cancer-enriched cohorts, adherence to evidence based guidelines improved: 31.0% in 2016–2017, 69.1% in 2018, and 82.4% in 2019 (p < 0.001). There were no significant differences in rates of peri-operative blood transfusion, surgical site infections, hematomas, or vaginal cuff dehiscences. ConclusionsImplementation of a robust VTE prophylaxis QI initiative has resulted in improved VTE prophylaxis guideline adherence and higher rates of pre-operative heparin administration.

SenSARS: A Low-Cost Portable Electrochemical System for Ultra-Sensitive, Near Real-Time, Diagnostics of SARS-CoV-2 Infections.

A critical path to solving the SARS-CoV-2 pandemic, without further socioeconomic impact, is to stop its spread. For this to happen, pre- or asymptomatic individuals infected with the virus need to be detected and isolated opportunely. Unfortunately, there are no current ubiquitous (i.e., ultra-sensitive, cheap, and widely available) rapid testing tools capable of early detection of SARS-CoV-2 infections. In this article, we introduce an accurate, portable, and low-cost medical device and bio-nanosensing electrode dubbed SenSARS and its experimental validation. SenSARS’ device measures the electrochemical impedance spectra of a disposable bio-modified screen-printed carbon-based working electrode (SPCE) to the changes in the concentration of SARS-CoV-2 antigen molecules (“S” spike proteins) contained within a sub-microliter fluid sample deposited on its surface. SenSARS offers real-time diagnostics and viral load tracking capabilities. Positive and negative control tests were performed in phosphate-buffered saline (PBS) at different concentrations (between 1 and 50 fg/mL) of SARS-CoV-2(S), Epstein–Barr virus (EBV) glycoprotein gp350, and Influenza H1N1 M1 recombinant viral proteins. We demonstrate that SenSARS is easy to use, with a portable and lightweight (< 200 g) instrument and disposable test electrodes (<U.S. n}{} n5), capable of fast diagnosis (~10 min), with high analytical sensitivity (low limits of detection, LOD = 1.065 fg/mL, and quantitation, LOQ = 3.6 fg/mL) and selectivity to SARS-CoV-2(S) antigens, even in the presence of structural proteins from the other pathogens tested. SenSARS provides a potential path to pervasive rapid diagnostics of SARS-CoV-2 in clinical, point-of-care, and home-care settings, and to breaking the transmission chain of this virus. Medical device compliance testing of SenSARS to EIC-60601 technical standards is underway.

Bone conduction hearing device adherence in relationship to age in pediatric unilateral congenital aural atresia

ObjectiveTo characterize the adherence of bone conduction hearing devices (BCHDs) for hearing management in children with unilateral congenital aural atresia (UCAA) in relation to the age of offer and fitting. BCHD Soft Bands help predict amplification benefits before surgery can be performed beginning around five years when both hearing and parental compliance reach stability. We hypothesized device compliance might decrease with age of fitting from lack of early acclimatization. MethodsRetrospective case series of patients less than five years old at a tertiary pediatric center's microtia clinic database, born between 2014 and 2018 with UCAA. Adherence was assessed through electronic health record note documentation at less than 1 year, 1–2 years, and greater than 2 years from fitting. The ages at offer and fitting, along with the time from offer to fitting, were recorded. ResultsOne hundred and eight patients with UCAA were identified, including 46 patients fit with a BCHD used for further analysis. Adherence rates at 1 year, 1–2 years, and greater than 2 years were 47.8%, 30%, and 43.5%, respectively. However, there was no significant association between age offered, age fit, or time from offer to fit and adherence at all time points. Also, there was no significant difference between ages at the time of BCHD offer for those who chose not to proceed with fitting (20.9 months) compared to the age of offer in patients that were subsequently fit (13.9 months). ConclusionBCHD adherence in patients less than five years old may not be affected by the age offered or fit. The time between offer and fitting was also not associated with usage. BCHDs should be offered to UCAA patients regardless of age. Further investigation in this younger age group would help expand these findings.