A Review of Direct Oral Anticoagulants in Patients With Stage 5 or End-Stage Kidney Disease.

OBJECTIVE: To evaluate the role of oral anticoagulation in patients with stage 5 chronic kidney disease (CKD-5) or end-stage kidney disease (ESKD). DATA SOURCES: A literature search of PubMed (January 2000 to July 1, 2021), the Cochrane Library, and Google Scholar databases (through April 1, 2021) was performed with keywords DOAC (direct-acting oral anticoagulant) OR NOAC or dabigatran OR rivaroxaban OR apixaban OR edoxaban AND end-stage kidney disease combined with atrial fibrillation (AF) or venous thromboembolism (VTE) OR pulmonary embolism OR deep-vein thrombosis. STUDY SELECTION AND DATA EXTRACTION: Case-control, cohort, and randomized controlled trials comparing DOACs to an active control for AF or VTE in patients with CKD-5 or ESKD and reporting outcomes of stroke, recurrent thromboembolism, or major bleeding were included. DATA SYNTHESIS: Nine studies were included. Efficacy data supporting routine use of warfarin or DOACs in CKD-5 or ESKD are limited. Rivaroxaban and apixaban may provide enhanced safety compared to warfarin in patients with AF. Data for VTE are limited to 1 retrospective study. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Because of the paucity of rigorous, prospective studies in CKD-5 or ESKD, OACs should not be broadly used in this population. It is clear that data regarding efficacy of DOACs cannot be reliably and safely extrapolated from the non-ESKD population. Therefore, use of OACs in this population should be individualized. CONCLUSIONS: If OACs for stroke prevention with AF are deemed necessary, apixaban or rivaroxaban can be considered. DOACs cannot currently be recommended over warfarin in patients with CKD-5 or ESKD and VTE.

High-Resolution Hyperspectral Imaging Using Low-Cost Components: Application within Environmental Monitoring Scenarios.

High-resolution hyperspectral imaging is becoming indispensable, enabling the precise detection of spectral variations across complex, spatially intricate targets. However, despite these significant benefits, currently available high-resolution set-ups are typically prohibitively expensive, significantly limiting their user base and accessibility. These limitations can have wider implications, limiting data collection opportunities, and therefore our knowledge, across a wide range of environments. In this article we introduce a low-cost alternative to the currently available instrumentation. This instrument provides hyperspectral datasets capable of resolving spectral variations in mm-scale targets, that cannot typically be resolved with many existing low-cost hyperspectral imaging alternatives. Instrument metrology is provided, and its efficacy is demonstrated within a mineralogy-based environmental monitoring application highlighting it as a valuable addition to the field of low-cost hyperspectral imaging.

Efficacy and Safety of Nonvitamin K Oral Anticoagulants following Cardiac Valve Replacement.

OBJECTIVE: To compare the efficacy and safety of nonvitamin K oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) following bioprosthetic cardiac valve replacement. METHODS: This was a retrospective analysis conducted at a community teaching hospital in the southeastern United States between August 2015 and August 2018. Patients 18 years of age and older who underwent cardiac valve replacement and were prescribed oral anticoagulation were screened for inclusion. Patients were excluded if they had a mechanical valve replacement, experienced a venous thromboembolism, cerebrovascular accident, or acute coronary syndrome within 1 month before valve replacement, changed oral anticoagulation during the study period, were lost to follow-up, or declined to participate in the follow-up survey. The primary outcome was a composite of thromboembolic events within 90 days following bioprosthetic cardiac valve replacement. The safety outcome was major bleeding within 180 days of bioprosthetic cardiac valve replacement. RESULTS: The primary outcome of a composite of thromboembolic events within 90 days following bioprosthetic cardiac valve replacement occurred in 1 patient (4.3%) in the VKA group and 4 patients (7.4%) in the NOAC group. Major bleeding occurred in 2 patients (8.7%) in the VKA group and 0 patients in the NOAC group. CONCLUSION: Our study is the first to report the efficacy and safety of NOACs compared with VKA therapy following bioprosthetic cardiac valve replacement irrespective of an atrial fibrillation diagnosis. Notably, two of the thromboembolic events in the NOAC group occurred while therapy was held or inappropriately dosed; when these events are removed, the rate of thromboembolism is 3.8%. This rate is consistent with the VKA group. Our study adds to a small pool of literature regarding the use of NOACs following bioprosthetic cardiac valve replacement and suggests that NOACs may have similar efficacy and improved safety as compared with VKA therapy. Large randomized controlled trials are warranted to confirm our observations.

Low-Cost Hyperspectral Imaging System: Design and Testing for Laboratory-Based Environmental Applications.

The recent surge in the development of low-cost, miniaturised technologies provides a significant opportunity to develop miniaturised hyperspectral imagers at a fraction of the cost of currently available commercial set-ups. This article introduces a low-cost laboratory-based hyperspectral imager developed using commercially available components. The imager is capable of quantitative and qualitative hyperspectral measurements, and it was tested in a variety of laboratory-based environmental applications where it demonstrated its ability to collect data that correlates well with existing datasets. In its current format, the imager is an accurate laboratory measurement tool, with significant potential for ongoing future developments. It represents an initial development in accessible hyperspectral technologies, providing a robust basis for future improvements.

Hyperspectral Imaging in Environmental Monitoring: A Review of Recent Developments and Technological Advances in Compact Field Deployable Systems.

The development and uptake of field deployable hyperspectral imaging systems within environmental monitoring represents an exciting and innovative development that could revolutionize a number of sensing applications in the coming decades. In this article we focus on the successful miniaturization and improved portability of hyperspectral sensors, covering their application both from aerial and ground-based platforms in a number of environmental application areas, highlighting in particular the recent implementation of low-cost consumer technology in this context. At present, these devices largely complement existing monitoring approaches, however, as technology continues to improve, these units are moving towards reaching a standard suitable for stand-alone monitoring in the not too distant future. As these low-cost and light-weight devices are already producing scientific grade results, they now have the potential to significantly improve accessibility to hyperspectral monitoring technology, as well as vastly proliferating acquisition of such datasets.

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial.

BACKGROUND: Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy. METHODS: In this phase 3, randomised, double-blind trial, we recruited eligible patients with histologically confirmed oestrogen receptor-positive or progesterone receptor-positive, or both, locally advanced or metastatic breast cancer from 113 academic hospitals and community centres in 20 countries. Eligible patients were endocrine therapy-naive, with WHO performance status 0-2, and at least one measurable or non-measurable lesion. Patients were randomly assigned (1:1) to fulvestrant (500 mg intramuscular injection; on days 0, 14, 28, then every 28 days thereafter) or anastrozole (1 mg orally daily) using a computer-generated randomisation scheme. The primary endpoint was progression-free survival, determined by Response Evaluation Criteria in Solid Tumors version 1·1, intervention by surgery or radiotherapy because of disease deterioration, or death from any cause, assessed in the intention-to-treat population. Safety outcomes were assessed in all patients who received at least one dose of randomised treatment (including placebo). This trial is registered with ClinicalTrials.gov, number NCT01602380. FINDINGS: Between Oct 17, 2012, and July 11, 2014, 524 patients were enrolled to this study. Of these, 462 patients were randomised (230 to receive fulvestrant and 232 to receive anastrozole). Progression-free survival was significantly longer in the fulvestrant group than in the anastrozole group (hazard ratio [HR] 0·797, 95% CI 0·637-0·999, p=0·0486). Median progression-free survival was 16·6 months (95% CI 13·83-20·99) in the fulvestrant group versus 13·8 months (11·99-16·59) in the anastrozole group. The most common adverse events were arthralgia (38 [17%] in the fulvestrant group vs 24 [10%] in the anastrozole group) and hot flushes (26 [11%] in the fulvestrant group vs 24 [10%] in the anastrozole group). 16 (7%) of 228 patients in in the fulvestrant group and 11 (5%) of 232 patients in the anastrozole group discontinued because of adverse events. INTERPRETATION: Fulvestrant has superior efficacy and is a preferred treatment option for patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not received previous endocrine therapy compared with a third-generation aromatase inhibitor, a standard of care for first-line treatment of these patients. FUNDING: AstraZeneca.

Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naïve advanced breast cancer.

PURPOSE: AZD8931 is an orally bioavailable, reversible tyrosine kinase inhibitor of EGFR, HER2, and HER3 signaling. The Phase II MINT study (ClinicalTrials.gov NCT01151215) investigated whether adding AZD8931 to endocrine therapy would delay development of endocrine resistance in patients with hormone-sensitive advanced breast cancer. METHODS: Patients were randomized 1:1:1 to receive daily anastrozole (1 mg) in combination with AZD8931 20 mg twice daily (bid), AZD8931 40 mg bid, or placebo. The primary objective was evaluation of progression-free survival (PFS) in patients treated with combination AZD8931 and anastrozole versus anastrozole alone. Secondary objectives included assessment of safety and tolerability, objective response rate, and overall survival. RESULTS: At the interim analysis, 359 patients were randomized and received anastrozole in combination with AZD8931 20 mg (n = 118), 40 mg (n = 120), or placebo (n = 121); 39 % of patients (n = 141) had a progression event. Median PFS (HR; 95 % CI vs placebo) in the AZD8931 20, 40 mg, and placebo arms was 10.9 (1.37; 0.91-2.06, P = 0.135), 13.8 (1.16; 0.77-1.75, P = 0.485), and 14.0 months, respectively. No indication of clinical benefit was observed following treatment with AZD8931 for the secondary endpoints. Safety findings showed a greater incidence of diarrhea (40, 51, and 12 % for AZD8931 20, 40 mg, and placebo, respectively), rash (32, 48, and 12 %), dry skin (19, 25, and 2 %), and acneiform dermatitis (16, 28, and 2 %) in patients treated with AZD8931 versus placebo. CONCLUSIONS: AZD8931, in combination with endocrine therapy, does not appear to enhance endocrine responsiveness and is associated with greater skin and gastrointestinal toxicity.

Robotic surgery: financial impact of surgical trays optimization in bariatric and thoracic surgery.

The incorporation of new technologies in the surgical field, such as the robotic da Vinci System, has made it possible to offer a series of advantages to the patient and the surgeon, with important benefits for both. However, cost continues to be a limiting factor to the adoption of this technology. The development of strategies to maximize the measures that can lead to reduced expenses is a key factor to improve cost-benefit ratio. According to some studies, more than 50% of the costs of a surgical procedure are related to materials and medical supplies, which is why any measure aimed at optimizing their use is pertinent. Our institution, the Orlando Regional Medical Center (ORMC), created a working group whose main purpose is to optimize the Robotic OR process. Their first step was to optimize the surgical trays, and this was carried out in four stages: observation, modification, trial period, and cost analysis. The specialties involved in this initiative were Bariatric and Thoracic Surgeries. Once the optimization process ended, the number of laparoscopic/thoracoscopy instruments in the trays decreased by 63 and 87% for bariatric and thoracic surgery, respectively; and the number of conventional surgery instruments was also reduced by 47 and 64%, for the same specialties, respectively. The financial analysis concluded that implementing this measure will lead to an estimated six-figure savings per year.

New knowledge, innovations, and improvement in a Magnet® Children's Hospital Cardiac Center.

Bedside nurses involved in research and evidence-based practice (EBP) have the ability to change policies, patient care, and outcomes. This article describes the journey of a research committee using the Magnet® component of new knowledge, innovation, and improvements. Using several tools, the unit-based committee developed skills in meeting management, nursing research methods, and EBP. Focusing to improve family and nurse communication about the plan of care, the committee recommended changes in the existing Plan of Care tool, including family input and recommendations for families to view and add to the sheet and participate in daily rounds, which was not the standard practice. Since this intervention was implemented, patient satisfaction has increased, as well as nurse engagement and intent to stay. This project exemplifies how nurse-driven innovations and family partnership led to new knowledge, innovations in learning about research, applying it to practice, and improving practice.

Low-Cost Hyperspectral Imaging with A Smartphone.

Recent advances in smartphone technologies have opened the door to the development of accessible, highly portable sensing tools capable of accurate and reliable data collection in a range of environmental settings. In this article, we introduce a low-cost smartphone-based hyperspectral imaging system that can convert a standard smartphone camera into a visible wavelength hyperspectral sensor for ca. £100. To the best of our knowledge, this represents the first smartphone capable of hyperspectral data collection without the need for extensive post processing. The Hyperspectral Smartphone's abilities are tested in a variety of environmental applications and its capabilities directly compared to the laboratory-based analogue from our previous research, as well as the wider existing literature. The Hyperspectral Smartphone is capable of accurate, laboratory- and field-based hyperspectral data collection, demonstrating the significant promise of both this device and smartphone-based hyperspectral imaging as a whole.

Community-based adaptive physical activity program for chronic stroke: feasibility, safety, and efficacy of the Empoli model.

OBJECTIVE: To determine whether Adaptive Physical Activity (APA-stroke), a community-based exercise program for participants with hemiparetic stroke, improves function in the community. METHODS: Nonrandomized controlled study in Tuscany, Italy, of participants with mild to moderate hemiparesis at least 9 months after stroke. Forty-nine participants in a geographic health authority (Empoli) were offered APA-stroke (40 completed the study). Forty-four control participants in neighboring health authorities (Florence and Pisa) received usual care (38 completed the study). The APA intervention was a community-based progressive group exercise regimen that included walking, strength, and balance training for 1 hour, thrice a week, in local gyms, supervised by gym instructors. No serious adverse clinical events occurred during the exercise intervention. Outcome measures included the following: 6-month change in gait velocity (6-Minute Timed Walk), Short Physical Performance Battery (SPPB), Berg Balance Scale, Stroke Impact Scale (SIS), Barthel Index, Hamilton Rating Scale for Depression, and Index of Caregivers Strain. RESULTS: After 6 months, the intervention group improved whereas controls declined in gait velocity, balance, SPPB, and SIS social participation domains. These between-group comparisons were statistically significant at P<.00015. Individuals with depressive symptoms at baseline improved whereas controls were unchanged (P<.003). Oral glucose tolerance tests were performed on a subset of participants in the intervention group. For these individuals, insulin secretion declined 29% after 6 months (P=.01). CONCLUSION: APA-stroke appears to be safe, feasible, and efficacious in a community setting.

Community exercise: a vital component to healthy aging.

Exercise plays a critical role in promoting healthy aging and in the management of chronic illness. In this paper, we provide an overview of the leading research regarding exercise and chronic illness, and the variables influencing exercise participation among persons with a chronic illness. We then examine the Empoli Adaptive Physical Activity (APA) program as a model program that has overcome many of the obstacles to exercise adherence. Piloted by Local Health Authority 11 in Tuscany, Italy, APA has over 2,000 participants, and it provides tailored exercise opportunities for persons with stroke, back pain, Parkinson's disease or multiple sclerosis, among others illnesses. The Empoli APA program serves as a model community exercise program and is now being replicated throughout Tuscany and in the United States.

Adaptive Physical Activity for Stroke: An Early-Stage Randomized Controlled Trial in the United States.

Background. As stroke survival improves, there is an increasing need for effective, low-cost programs to reduce deconditioning and improve mobility. Objective. To conduct a phase II trial examining whether the community-based Italian Adaptive Physical Activity exercise program for stroke survivors (APA-Stroke) is safe, effective, and feasible in the United States. Methods. In this single-blind, randomized controlled trial, 76 stroke survivors with mild to moderate hemiparesis >6 months were randomized to either APA-Stroke (N = 43) or Sittercise (N = 33). APA-Stroke is a progressive group exercise regimen tailored to hemiparesis that includes walking, strength, and balance training. Sittercise, a seated, nonprogressive aerobic upper body general exercise program, served as the control. Both interventions were 1 hour, 3 times weekly, in 5 community locations, supervised by exercise instructors. Results. A total of 76 participants aged 63.9 ± 1.2 years, mean months poststroke 61.8 ± 9.3, were included. There were no serious adverse events; completion rates were 58% for APA-Stroke, 70% for Sittercise. APA-Stroke participants improved significantly in walking speed. Sample size was inadequate to demonstrate significant between-group differences. Financial and logistical feasibility of the program has been demonstrated. Ongoing APA classes have been offered to >200 participants in county Senior Centers since study completion. Conclusion. APA-Stroke shows great promise as a low-cost, feasible intervention. It significantly increased walking speed. Safety and feasibility in the US context are demonstrated. A pivotal clinical trial is required to determine whether APA-Stroke should be considered standard of care.

Stroke survivors with severe mental illness: Are they at-risk for increased non-psychiatric hospitalizations?

BACKGROUND: This study examined outcomes for two groups of stroke survivors treated in Veteran Health Administration (VHA) hospitals, those with a severe mental illness (SMI) and those without prior psychiatric diagnoses, to examine risk of non-psychiatric medical hospitalizations over five years after initial stroke. METHODS: This retrospective cohort study included 523 veterans who survived an initial stroke hospitalization in a VHA medical center during fiscal year 2003. The survivors were followed using administrative data documenting inpatient stroke treatment, patient demographics, disease comorbidities, and VHA hospital admissions. Multivariate Poisson regression was used to examine the relationship between patients with and without SMI diagnosis preceding the stroke and their experience with non-psychiatric medical hospitalizations after the stroke. RESULTS: The study included 100 patients with SMI and 423 without SMI. Unadjusted means for pre-stroke non-psychiatric hospitalizations were higher (p = 0.0004) among SMI patients (1.47 ± 0.51) compared to those without SMI (1.00 ± 1.33), a difference which persisted through the first year post-stroke (SMI: 2.33 ± 2.46; No SMI: 1.74 ± 1.86; p = 0.0004). Number of non-psychiatric hospitalizations were not significantly different between the two groups after adjustment for patient sociodemographic, comorbidity, length of stay and inpatient stroke treatment characteristics. Antithrombotic medications significantly lowered risk (OR = 0.61; 95% CI: 0.49-0.73) for stroke-related readmission within 30 days of discharge. CONCLUSIONS: No significant differences in medical hospitalizations were present after adjusting for comorbid and sociodemographic characteristics between SMI and non-SMI stroke patients in the five-year follow-up. However, unadjusted results continue to draw attention to disparities, with SMI patients experiencing more non-psychiatric hospitalizations both prior to and up to one year after their initial stroke. Additionally, stroke survivors discharged on antithrombotic medications were at lower risk of re-admission within 30 days suggesting the VHA should continue to focus on effective stroke management irrespective of SMI.

A single nutrition counseling session with a registered dietitian improves short-term clinical outcomes for rural Kentucky patients with chronic diseases.

Relying on data derived from medical records of past visits to a physician, patients' charts were examined to evaluate the effectiveness of a single nutrition counseling session provided by the same registered dietitian in improving outcome measures for patients with type 2 diabetes mellitus or cardiovascular disease. This was a retrospective study of 175 patients' charts from which laboratory data were extracted before and at 3 months after seeing the dietitian. Records were categorized into two groups based on whether the patient had attended or not attended a single nutrition counseling session. At 3 months, the group that received the nutrition counseling had statistically significant improvements in blood values and body mass index compared with the group that did not receive nutrition counseling. This study further confirms the value of a single nutrition counseling session as an effective approach to treating type 2 diabetes and cardiovascular disease.

Effectiveness of adaptive physical activity combined with therapeutic patient education in stroke survivors at twelve months: a non-randomized parallel group study.

BACKGROUND: Adaptive physical activity (APA) is a community-based exercise program for chronic stroke survivors that proved to be effective in improving physical functioning and psychological well-being in the short term. AIM: The aim of the present paper is to determine the effectiveness at twelve months of an intervention of APA combined with therapeutic patient education (TPE) in stroke survivors. DESIGN: This study is a non-randomized parallel group study comparing APA-TPE intervention with treatment as usual (TAU). SETTING: Patients were recruited after discharge from two Physical Medicine and Rehabilitation Units, 3 to 18 months after the stroke event. The APA-TPE intervention was conducted in local gymnasiums. POPULATION: The study population includes consecutive adult stroke survivors with mild to moderate hemiparesis who were able to walk 25 m independently and had no need of physical therapy. METHODS: The experimental group (N.=126) underwent 16 biweekly sessions of APA and 3 TPE sessions and controls (N.=103) underwent TAU. Twelve-month outcomes included the Modified Barthel Index, the Caregiver Strain Index, SF-12 health-related quality of life, medical complications and health services use. RESULTS: At twelve months, the ability to perform daily living activities, assessed using Modified Barthel Index, was decreased in the TAU group and improved in the APA-TPE group. The physical and mental components of quality of life were significantly improved in both groups. The risk of fractures (OR=0.09, 95% CI 0.01-0.79) and recourse to rehabilitation treatments (OR=0.24, 95% CI 0.08-0.77) were lower in the APA-TPE compared with the TAU group. No difference was found between groups concerning the caregiver burden. CONCLUSION: APA-TPE is an effective intervention to maintain and improve activities of daily living, reduce falls and recourse to rehabilitation treatments at twelve months. CLINICAL REHABILITATION IMPACT: Structured physical activity programs that can be performed also at home, when combined with therapeutic education focused on benefits of physical activity, will encourage stroke survivors to continue exercising. Therefore, it fulfills an essential requirement to the maintenance of lasting health benefits and the prevention of physical and psychological deterioration.

Rules for rehabilitation: an agenda for research.

Rehabilitation services have grown tremendously in the United States over the past 2 decades. Rules originally designed to guide Medicare reimbursement policies have had substantial effects in shaping the design of clinical services. This article traces the development of the most significant federal rules regarding rehabilitation, outlines the existing empirical evidence to support these rules, and discusses an agenda for research to improve the evidence for future policy development.

Stroke rehabilitation in Switzerland versus the United States: a preliminary comparison.

This article compares the structure and process of rehabilitation for stroke patients at 2 internationally recognized rehabilitation hospitals, Klinik Valens ("Valens") in Switzerland and the William Donald Schaeffer Rehabilitation Hospital at Kernan ("Kernan") in the United States. Although the patient mix, structure, and process of rehabilitation were similar in many regards, there were some important differences. Most notably, on average, patients at the U.S. hospital were discharged from rehabilitation at approximately the same day poststroke that rehabilitation began in Switzerland. Patients remained in an inpatient setting an average of 40 days longer in Switzerland (for the combination of acute care and rehabilitation) and had significantly higher levels of functioning at discharge when compared to their U.S. counterparts. The authors' findings suggest that Europe may offer opportunities for rehabilitation research that would be difficult to duplicate in the United States and highlight policy-relevant questions for future studies aimed at developing efficient managed care systems for stroke survivors.

Integrated health system for chronic disease management: lessons learned from France.

Rated number one in overall health system performance by the World Health Organization, the French spend less than half the amount on annual health care per capita that the United States spends. One contributing factor may be the attention given to chronic care. Since the mid-1900s, the French have developed regional community-based specialty systems for patients with chronic respiratory insufficiency or failure. COPD is the major cause of respiratory failure, the fourth leading cause of death in the United States, and its prevalence is increasing. Despite the clinical success of home mechanical ventilation and the potential for cost savings, providing such services in the United States remains a challenge. Lessons from France can inform the development of cost-effective chronic care models in the United States In this article, we review the French experience in the context of the United States Supreme Court's Olmstead decision, mandating that people in "more restrictive settings" such as nursing homes be offered community-based supports. We suggest that regional demonstration projects for patients with chronic respiratory failure or insufficiency can provide an important step in the development of effective chronic care systems in the United States