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Shared decision-making (SDM) for lung cancer screening (LCS) is recommended by multiple organizations, reflecting a larger movement toward patient-centered care. Yet SDM for LCS does not routinely occur owing to barriers at multiple levels. Moreover, how best to implement SDM into routine clinical practice remains unknown. There is a need for a novel approach to overcome multilevel barriers and ensure high-quality SDM for LCS is integrated into routine practice. We present the protocol for our U.S. Department of Veterans Affairs (VA)-funded study. Our protocol is designed to implement and evaluate a multilevel, tailored approach to SDM for LCS in routine clinical practice within the VA New England Health Care Network, comprising eight medical centers. In this prospective, pragmatic hybrid implementation-effectiveness study, we will first conduct a formative evaluation of barriers to SDM for LCS at each level of the socioecological model, which will inform our tailored implementation plan. We will then sequentially introduce components of our tailored, multilevel approach to implementing SDM for LCS across VA New England. Finally, using mixed methods, we will evaluate the implementation and its impact on effectiveness (primary outcome, defined as patient-centeredness of SDM), as well as implementation outcomes informed by the RE-AIM implementation science framework (i.e., reach to patients, adoption by providers, implementation fidelity). Tailored implementation will address identified challenges to achieving policy recommendations for SDM for LCS in VA New England, inform nationwide implementation of SDM for LCS, and address stakeholder interests in promoting more patient-centered interactions across the VA.

Objectives The aim of this study was to examine patterns of care and clinical outcomes among patients with heart failure with reduced ejection fraction (HFrEF) in the United States and Canada. Background In the GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment) trial, the use of N-terminal pro–B-type natriuretic peptide–guided titration of guideline-directed medical therapy (GDMT) was compared with usual care alone for patients with HFrEF in the United States and Canada. It remains unknown whether the country of enrollment had an impact on outcomes or GDMT use. Methods A total of 894 patients at 45 sites across the United States and Canada with HFrEF (ejection fraction ≤40%) were enrolled in the trial. Kaplan-Meier survival estimates stratified by country of enrollment were developed for the trial outcomes, and log-rank testing was compared between the groups. GDMT use and titration were also compared. Results U.S. patients were more likely to be younger, to be Black, to have higher body mass index, and to have histories of defibrillator placement or sleep apnea. Use of β-blockers was significantly higher in Canada at baseline (99.3% vs. 94.0%; p = 0.01) and 6 months (99.0% vs. 94.1%; p = 0.04), and use of mineralocorticoid receptor antagonists was higher in Canada at 6 months (68.3% vs. 55.1%; p = 0.01). Canadian patients were less likely to experience the primary study endpoint (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.45 to 0.93; p = 0.01) due to decreased rates of HF hospitalization (HR: 0.57; 95% CI: 0.38 to 0.86; p = 0.003). The differences in outcomes were driven by increased heart failure hospitalization among U.S. Black patients. Conclusions In GUIDE-IT, patients with HFrEF in Canada were significantly less likely to be hospitalized for heart failure. Differences in GDMT use, along with differences in sociodemographics and care delivery structures, may contribute to these differences, highlighting the importance of increasing diversity in clinical trials. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840 )

Objectives: Short-stay residents of nursing homes experience high rates of mental health (MH) distress compared to community dwelling counterparts, yet MH interventions are difficult to implement and sustain. We modified a music therapy framework to Effective Music in Psychotherapy. Using the modified model, we integrated music listening into MH group intervention and evaluated MH outcomes. This pilot study reports the development and evaluation of the Mental Health and Music Group for short-stay nursing homes residents.Method: The group was developed and refined to be non-sequential and non-cumulative, specific to the needs of short-stay nursing home residents. Pre-/post-session ratings examined affect, quality of life, and pain. Leaders monitored engagement across and between sessions. Qualitative interviews were conducted with a selection of attendees.Results: Findings indicated decreases in irritation and worry, and increases in mood, energy, and self-as-a-whole from pre- to post-session. There were no changes in pain, perception of physical health or life-as-a-whole, energetic, sad, or happy affect, or differences in engagement. Qualitative interviews demonstrated benefits of group modality and music to group cohesion and highlighted the relevance of music for mental health outcomes.Conclusion: The Mental Health and Music group was designed around a framework of Effective Music in Psychotherapy, for short-stay nursing home settings, and demonstrated promising results. Future research can solidify the interventions generalizeability to medical and rehabilitation settings addressing the specific population needs and preferences.Supplemental data for this article is available online at https://doi.org/10.1080/13607863.2021.1935463 .

OBJECTIVES Approximately 3.7% of patients experience adverse events in health care facilities, many of which are preventable. Patient safety requires effective training and an interprofessional culture of safety, but few studies compare the safety skills of different hospital professions. We sought to assess skills in safety hazards identification among staff from different health care disciplines with a pilot study. METHODS An exercise with a simulated room of an inpatient ward with a patient mannequin in a hospital bed with 34-intentionally planted safety hazards was set up. Health care staff members from various professions walked around the room and independently documented observed safety hazards. Identified hazards were separated based on staff disciplines, grouped into 5 categories (patient, medications, equipment, environment, care processes), and analyzed using analysis of variance. Because participants identified more hazards than the 34 intentionally planted hazards, these were analyzed separately. RESULTS The study included 111 staff: nurses (n = 68), nursing students (n = 5), medical students (n = 3), physicians (n = 11), social workers (n = 5), pharmacists (n = 6), certified nursing assistants (n = 9), and psychologists (n = 4). There were significant differences among professions in the following categories: medications, equipment, and total number of safety hazards (P < 0.05 for all). Nurses found more intended equipment hazards than did social workers (38.8% versus 4.4%, P < 0.001), pharmacists (38.8% versus 11.1%, P = 0.004), medical students (38.8% versus 7.4%, P = 0.021), and psychologists (38.8% versus 8.3%, P = 0.001) and more medication hazards than nursing students (20.3% versus 16.7%, P = 0.008), whereas certified nursing assistants also found more equipment hazards than did social workers (25.9% versus 4.4%, P = 0.016). CONCLUSIONS There were significant differences in patterns of safety hazards identified among health care professions, with nurses identifying more hazards than several other professions. This finding suggests that each health care profession's unique training and responsibilities result in varying ability to identify safety hazards and that interdisciplinary safety teams may be more effective than those from only a single profession. Our study provides a starting point to encourage diversification of hospital professions in simulation-based safety trainings, although further work is needed to validate these findings moving forward.

Tricuspid regurgitation (TR) is common in patients with end-stage heart failure receiving left ventricular assist devices (LVADs), but the benefit of concomitant tricuspid valve procedures (TVPs) remains uncertain. This study examined the impact of TVP at the time of LVAD implantation on clinical outcomes and quality of life (QOL) metrics.We included adult patients in the Interagency Registry for Mechanical Circulatory Support database with various degrees of TR who received continuous-flow LVADs from 2008 to 2017. Patients undergoing concomitant TVP were compared with those without the intervention in a stratified analysis. Descriptive analyses, survival analyses, and Andersen‒Gill hazard models were used as appropriate to examine associations with clinical and patient-centered QOL outcomes.Our analysis included 8,263 (53.1%) mild, 4,252 (33.3%) moderate, and 2,100 (13.5%) severe TR cases. TVP rate increased with severity: 8.6% of mild, 18.0% of moderate, and 43.9% of severe cases. TVP was not associated with survival benefit in cases of mild (adjusted hazard ratio [aHR]: 0.97, 95% CI: 0.79-1.19, p = 0.75), moderate (aHR: 1.03, 95% CI: 0.88-1.20, p = 0.72), or severe (aHR: 1.20, 95% CI: 0.98-1.48, p = 0.08) TR. For patients with combined moderate or severe TR, TVP was associated with increased mortality (log-rank p0.01, aHR: 1.13, 95% CI: 1.00-1.27, p = 0.04). After adjusting for TR severity, TVP was associated with increased risk of bleeding, arrhythmia, and stroke (p0.01 each) and no improvements in QOL (p0.05).TVP at the time of LVAD implantation was not associated with either improved survival or QOL, and there were associations with increased risk of adverse events among patients with moderate and severe TR.

This study sought to use INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) results to evaluate sex differences in the use and clinical outcomes of left ventricular assist devices (LVAD).Despite a similar incidence of heart failure in men and women, prior studies have highlighted potential underuse of LVADs in women, and studies of clinical outcomes have yielded conflicting results.Patients were enrolled from the INTERMACS study who underwent implantation of their first continuous-flow LVAD between 2008 and 2017, and survival analyses stratified by sex were conducted.Among the 18,868 patients, 3,984 (21.1%) were women. At 1 year, women were less likely to undergo heart transplantation than men (17.9% vs. 20.0%, respectively; p = 0.003). After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction. Although women younger than 50 years of age had an increased risk of death compared to men of the same age (HR: 1.34; 95% CI: 1.12 to 1.6), men and women 65 years of age and older had a similar risk of death (HR: 1.09; 95% CI: 0.95 to 1.24).This study found that women had a higher risk of mortality and adverse events after LVAD. Only 1 in 5 LVADs were implanted in women, and women were less likely to receive a heart transplant than men. Further investigation is needed to understand the causes of adverse events and potential underuse of advanced treatment options in women.

Psychiatric comorbidities play a key role in patient selection for left ventricular assist devices (LVADs), but their impact on clinical outcomes is unknown.The goal of this study was to examine the clinical impact of psychiatric illness on outcomes in patients receiving LVADs for end-stage heart failure (HF).The study identified adults in the Interagency Registry for Mechanically Assisted Circulatory Support with psychiatric comorbidities (history of alcohol abuse, drug use, narcotic dependence, depression, and other major psychiatric diagnoses) receiving continuous-flow LVADs from 2008 to 2017. Demographic characteristics, survival, adverse events, and quality of life scores were compared for patients with and without each psychiatric comorbidity.Over the study period, the prevalence of psychiatric comorbidities was low: alcohol abuse, n = 1,093 (5.5%); drug use, n = 1,077 (5.4%); narcotic dependence, n = 96 (0.5%); depression, n = 401 (2.0%); and other major psychiatric illnesses, n = 265 (1.4%). Narcotic dependence (adjusted hazard ratio: 1.9; 95% confidence interval: 1.2 to 3.0; p = 0.004) and other major psychiatric illnesses (adjusted hazard ratio: 1.4; 95% confidence interval: 1.0 to 1.9; p = 0.02) were associated with increased risk of mortality, whereas alcohol abuse, drug use, and depression were not. All comorbidities except narcotic dependence were associated with increased risk of rehospitalization and device-related infection (both p 0.05). Kansas City Cardiomyopathy Questionnaire scores were lower from 6 to 24 months' post-implantation among patients with psychiatric comorbidities (p 0.05).Despite a low prevalence of psychiatric comorbidities among LVAD recipients, these conditions were associated with mortality risk, adverse events, and poorer quality of life. Further study is needed to understand how specific psychiatric conditions affect outcomes and how to best manage this vulnerable patient population.

Objectives The purpose of this study was to examine outcomes after left ventricular assist device (LVAD) implantation in older adults (>75 years of age). Background An aging heart failure population together with improvements in mechanical circulatory support (MCS) technology have led to increasing LVAD implantations in older adults. However, data presenting age-specific outcomes are limited. Methods Adult patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) who required durable MCS between 2008 and 2017 were included. Patients were stratified by 4 age groups: 75 years of age. Kaplan-Meier survival estimates were used to assess post-LVAD outcomes, with log-rank testing used to compare groups. Univariate and multivariate cox proportional hazard regression models were used to determine predictors of survival and complications. Results A total of 20,939 individuals received an LVAD during the study period: 7,743 (37.0%) were Conclusions Despite careful selection of older adults for LVAD implantation, age remains a significant predictor of mortality. Higher bleeding and lower clotting risk in elderly patients with LVADs support the use of a less intense antithrombotic regimen in this unique population.

Current pharmacological therapies for heart failure with reduced ejection fraction are largely either repurposed anti-hypertensives that blunt overactivation of the neurohormonal system or diuretics that decrease congestion. However, they do not address the symptoms of heart failure that result from reductions in cardiac output and reserve. Over the last few decades, numerous attempts have been made to develop and test positive cardiac inotropes that improve cardiac haemodynamics. However, definitive clinical trials have failed to show a survival benefit. As a result, no positive inotrope is currently approved for long-term use in heart failure. The focus of this state-of-the-art review is to revisit prior clinical trials and to understand the causes for their findings. Using the learnings from those experiences, we propose a framework for future trials of such agents that maximizes their potential for success. This includes enriching the trials with patients who are most likely to derive benefit, using biomarkers and imaging in trial design and execution, evaluating efficacy based on a wider range of intermediate phenotypes, and collecting detailed data on functional status and quality of life. With a rapidly growing population of patients with advanced heart failure, the epidemiologic insignificance of heart transplantation as a therapeutic intervention, and both the cost and morbidity associated with ventricular assist devices, there is an enormous potential for positive inotropic therapies to impact the outcomes that matter most to patients.

Background Traditional statistical approaches to prediction of outcomes have drawbacks when applied to large clinical databases. It is hypothesized that machine learning methodologies might overcome these limitations by considering higher-dimensional and nonlinear relationships among patient variables. Methods and Results The Unified Network for Organ Sharing (UNOS) database was queried from 1987 to 2014 for adult patients undergoing cardiac transplantation. The dataset was divided into 3 time periods corresponding to major allocation adjustments and based on geographic regions. For our outcome of 1-year survival, we used the standard statistical methods logistic regression, ridge regression, and regressions with LASSO (least absolute shrinkage and selection operator) and compared them with the machine learning methodologies neural networks, naive-Bayes, tree-augmented naive-Bayes, support vector machines, random forest, and stochastic gradient boosting. Receiver operating characteristic curves and C-statistics were calculated for each model. C-Statistics were used for comparison of discriminatory capacity across models in the validation sample. After identifying 56,477 patients, the major univariate predictors of 1-year survival after heart transplantation were consistent with earlier reports and included age, renal function, body mass index, liver function tests, and hemodynamics. Advanced analytic models demonstrated similarly modest discrimination capabilities compared with traditional models (C-statistic ≤0.66, all). The neural network model demonstrated the highest C-statistic (0.66) but this was only slightly superior to the simple logistic regression, ridge regression, and regression with LASSO models (C-statistic = 0.65, all). Discrimination did not vary significantly across the 3 historically important time periods. Conclusions The use of advanced analytic algorithms did not improve prediction of 1-year survival from heart transplant compared with more traditional prediction models. The prognostic abilities of machine learning techniques may be limited by quality of the clinical dataset.

Background Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet, nursing home routines frequently disturb residents’ sleep through use of noise, light, or efforts to reduce incontinence. Nursing home residents with Alzheimer’s disease and or related dementias—almost two-thirds of long-stay nursing home residents—are likely to be particularly affected by sleep disturbance. Addressing these issues, this study protocol implements an evidence-based intervention to improve sleep: a nursing home frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Methods This study protocol outlines a NIH Stage III, real-world hybrid efficacy-effectiveness pragmatic trial of the LOCK sleep intervention. Over two phases, in a total of 27 non-VA nursing homes from 3 corporations, the study will (1) refine the LOCK program to focus on sleep for residents with dementia, (2) test the impact of the LOCK sleep intervention for nursing home residents with dementia, and (3) evaluate the intervention’s sustainability. Phase 1 (1 year; n = 3 nursing homes; 1 per corporation) will refine the intervention and train-the-trainer protocol and pilot-tests all study methods. Phase 2 (4 years; n = 24 nursing homes; 8 per corporation) will use the refined intervention to conduct a wedge-design randomized, controlled, clinical trial. Phase 2 results will measure the LOCK sleep intervention’s impact on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). Findings will point to inter-facility variation in the program’s implementation and sustainability. Discussion This is the first study to our knowledge that applies a dementia sleep intervention to systematically address known barriers to nursing home quality improvement efforts. This innovative study has future potential to address clinical issues beyond sleep (safety, infection control) and expand to other settings (assisted living, inpatient mental health). The study’s strong team, careful consideration of design challenges, and resulting rigorous, pragmatic approach will ensure success of this promising intervention for nursing home residents with dementia. Trial registration NCT04533815, ClinicalTrials.gov, August 20, 2020.

A downward trend in opioid prescribing between 2011 and 2018 has brought per-capita opioid prescriptions below the levels of 2006, the earliest year for which the Centers for Disease Control and Prevention has published data. That trend has affected roughly ten million patients who previously received long-term opioid therapy. Any effort to reduce or replace a prior health practice is termed de-implementation. We suggest that the evaluation of opioid prescribing de-implementation has been misdirected, within US policy and health research, resulting in detrimental impacts on patients, their families and clinicians. Policymakers and implementation scientists can address these deficiencies in how we study and how we perform opioid de-implementation by applying an implementation science framework: the Consolidated Framework for Implementation Research. The Consolidated Framework lays out relevant domains of activity (internal, external, etc.) that influence implementation processes and outcomes. It can deepen our understanding of how policies are chosen, communicated, and carried out. Policymakers and researchers who embrace this framework will need a better approach to measuring success and failure in health care where both pain and opioids are concerned. This would involve shifting from a reductive focus on opioid prescription counts toward measures that are more effective, holistic, and patient-centered.

Objective Vascular groin incision complications contribute significantly to patients' morbidity and rising health care costs. Negative pressure therapy over the closed incision decreases the infection rate in cardiac and orthopedic procedures. This study prospectively evaluated negative pressure therapy as a means to decrease wound complications and associated health care costs. Methods This was a randomized, prospective, single-institution study of 119 femoral incisions closed primarily after elective vascular surgery including both inflow (eg, aortofemoral) and outflow (eg, femoral-popliteal bypass) procedures. Incisions were categorized as high risk for wound complications on the basis of body mass index >30 kg/m2, pannus, reoperation, prosthetic graft, poor nutrition, immunosuppression, or hemoglobin A1c >8% and randomized 1:1 to standard gauze (n = 60) dressing vs negative pressure therapy (Prevena [Acelity, San Antonio, Tex], n = 59). Wound complication rate, length of stay (LOS), reoperation, readmission, and variable hospital costs were determined during 30 days. Statistical analysis was performed using χ2 test along with a two-sample unpaired t-test for continuous variables. Results There were no significant demographic differences (age, sex, risk factors for wound complication) between the two high-risk groups. In low-risk controls, the major wound complication rate was 4.8% (involving one infection in 21 incisions), resulting in a 3.8-day LOS, 4.8% reoperation, 4.8% readmission rate, and $17,599 in average variable cost. For high-risk controls, there was a significant increase in major wound complications to 25% (including all 12 infections in 60 incisions), LOS (10.6 days), reoperation (18.3%), readmission (16.7%), and costs ($36,537). Finally, negative pressure therapy significantly reduced major wound complications to 8.5% (including five of six infections in 59 incisions; P Conclusions This study suggests that negative pressure therapy significantly reduces the major wound complication, reoperation, and readmission rates for patients at high risk for groin wound complications. Furthermore, this therapy may lead to a reduction in hospital costs. Negative pressure therapy for all groin incisions considered at high risk for wound complications is recommended.

Clinical pharmacy specialists (CPS) were deployed nationally to improve care access and relieve provider burden in primary care.The aim of this study was to assess CPS integration in primary care and the Clinical Pharmacy Specialist Rural Veteran Access (CRVA) initiative's effectiveness in improving access.Concurrent embedded mixed-methods evaluation of participating CRVA CPS and their clinical team members (primary care providers, others).Health care providers on primary care teams in Veterans Health Administration (VHA).Perceived CPS integration in comprehensive medication management assessed using the MUPM and semi-structured interviews, and access measured with patient encounter data.There were 496,323 medical encounters with CPS in primary care over a 3-year period. One hundred twenty-four CPS and 1177 other clinical team members responded to a self-administered web-based questionnaire, with semi-structured interviews completed by 22 CPS and clinicians. Survey results indicated that all clinical provider groups rank CPS as making major contributions to CMM. CPS ranked themselves as contributing more to CMM than did their physician team members. CPS reported higher job satisfaction, less burn out, and better role fit; but CPS gave lower scores for communication and decision making as clinic organizational attributes. Themes in provider interviews focused on value of CPS in teams, relieving provider burden, facilitators to integration, and team communication issues.This evaluation indicates good integration of CPS on primary care teams as perceived by other team members despite some communication and role clarification challenges. CPS may play an important role in improving access to primary care.

Objective Venoarterial extracorporeal membrane oxygenation (ECMO) is a salvage therapy in patients with severe cardiopulmonary failure. Owing to the large size of the cannulas inserted via the femoral vessels (≤24-F) required for adequate oxygenation, this procedure could result in significant limb ischemic complications (10%-70%). This study evaluates the results of a distal limb perfusion arterial protocol designed to reduce associated complications. Methods We conducted a retrospective institutional review board-approved review of consecutive patients requiring ECMO via femoral cannulation (July 2010-January 2015). To prevent arterial ischemia, a distal perfusion catheter (DPC) was placed antegrade into the superficial femoral artery and connected to the ECMO circuit. Limb perfusion was monitored via near-infrared spectroscopy (NIRS) placed on both calves. Decannulation involved open repair, patch angioplasty, and femoral thrombectomy as needed. Results A total of 91 patients were placed on ECMO via femoral arterial cannula (16-F to 24-F) for a mean duration of 9 days (range, 1-40 days). A percutaneous DPC was inserted prophylactically at the time of cannulation in 55 of 91 patients, without subsequent ischemia. Of the remaining 36 patients without initial DPC placement, 12 (33% without DPC) developed ipsilateral limb ischemia related to arterial insufficiency, as detected by NIRS and clinical findings. In these patients, the placement of a DPC (n = 7) with or without a fasciotomy, or with a fasciotomy alone (n = 4), resulted in limb salvage; only one patient required subsequent amputation. After decannulation (n = 7), no patients had further evidence of limb ischemia. Risk factors for the development of limb ischemia identified by categorical analysis included lack of DPC at time of cannulation and ECMO cannula size of less than 20-Fr. There was a trend toward younger patient age. Overall ECMO survival rate was 42%, whereas survival in patients with limb ischemia was only 25%. Conclusions Limb ischemia complications from ECMO may be decreased by prophylactic placement of an antegrade DPC. Without DPC, continuous monitoring using NIRS may identify limb ischemia, which can be treated subsequently with DPC and or fasciotomy.

Purpose The clinical impact of mitral valve procedures (MVP) at time of left ventricular assist device (LVAD) is not well understood. We examined the association of MVP, according to severity of MR, with long term survival and quality of life metrics. Methods Continuous-flow LVAD recipients with MR from the 2008-2017 INTERMACS registry were included in the analysis. Patients with concomitant MVP were compared to those without intervention, stratified by severity of MR. Descriptive analyses, hazard modeling, and Kaplan-Meier analyses were used to examine associations between intervention and clinical outcomes. Results 6360 (40.0%) mild, 5592 (35.2%) moderate, and 3936 (24.8%) severe MR cases were included. MVP was not associated with improved survival for mild (median: 80.7 months for MVP vs. 55.0 months for non-MVP, P=0.49, HR 0.65 [95%:0.34-1.23]), moderate (58.8 vs. 49.3 months, P=0.31, HR 0.90 [0.57-1.42]), or severe MR (76.8 vs 49.7 months, P=0.15, HR 1.08 [0.73-1.59]). MVP was not associated with differential risk for device failure, bleeding, arrhythmia, thrombotic, right heart failure, or renal failure. There were no differences in Kansas City Cardiomyopathy Questionnaire with or without MVP for mild, moderate, or severe MR at 1- or 2-years after implantation. Conclusion Concomitant MVP with LVAD implantation was not associated with mortality, adverse events, or objective quality of life metrics. The role of concomitant MVP with LVAD implantation must be carefully considered.

BackgroundPatients with comorbid conditions have a higher risk of mortality with SARS-CoV-2 (COVID-19) infection, but the impact on heart failure patients living near a disease hotspot is unknown. Therefore, we sought to characterize the prevalence and outcomes of COVID-19 in a live registry of heart failure patients across an integrated health care system in Connecticut.MethodsIn this retrospective analysis, the Yale Heart Failure Registry (NCT04237701) that includes 26,703 patients with heart failure across a 6-hospital integrated health care system in Connecticut was queried on April 16th, 2020 for all patients tested for COVID-19. Sociodemographic and geospatial data as well as, clinical management, respiratory failure, and patient mortality were obtained via the real-time registry. Data on COVID-19 specific care was extracted by retrospective chart review.ResultsCOVID-19 testing was performed on 900 symptomatic patients, comprising 3.4% of the Yale Heart Failure Registry (N=26,703). Overall, 206 (23%) were COVID-19+. As compared to COVID-19-, these patients were more likely to be older, black, have hypertension, coronary artery disease, and were less likely to be on renin angiotensin blockers (P- patients tended to be more diffusely spread across the state whereas COVID-19+ were largely clustered around urban centers. 20% of COVID-19+ patients died, and age was associated with increased risk of death [OR 1.92 95% CI (1.33–2.78); P+ patients who were ≥85 years of age rates of hospitalization were 87%, rates of death 36%, and continuing hospitalization 62% at time of manuscript preparation.ConclusionsIn this real-world snapshot of COVID-19 infection among a large cohort of heart failure patients, we found that a small proportion had undergone testing. Patients found to be COVID-19+ tended to be black with multiple comorbidities and clustered around lower socioeconomic status communities. Elderly COVID-19+ patients were very likely to be admitted to the hospital and experience high rates of mortality.

Background: The impact of respiratory failure on patients undergoing left ventricular assist device (LVAD) implantation is not well understood, especially since these patients were excluded from landmark clinical trials. We sought to evaluate the associations between immediate preimplant and postimplant respiratory failure on outcomes in advanced heart failure patients undergoing LVAD implantation. Methods and Results: We included all patients in the Interagency Registry for Mechanically Assisted Circulatory Support who were implanted with continuous-flow LVADs from 2008 to 2016. Of the 16 362 patients who underwent continuous-flow LVAD placement, 906 (5.5%) required preimplant intubation within 48 hours before implantation, and 1001 (6.1%) patients developed respiratory failure within 1 week after implantation. A higher proportion of patients requiring preimplant intubation were Interagency Registry for Mechanically Assisted Circulatory Support profile 1, required mechanical circulatory support, and presented with cardiac arrest or myocardial infarction ( P P P =0.001). After multivariable analysis, both preimplant intubation (hazard ratio, 1.20 [95% CI, 1.03–1.41]; P =0.021) and respiratory failure within 1 week (hazard ratio, 2.54 [95% CI, 2.26–2.85]; P Conclusions: Respiratory failure both before and after LVAD implantation identifies an advanced heart failure population with significantly worse 1-year mortality. This data might be helpful in counseling patients and their families about expectations about life with an LVAD.

The purpose of this study was to examine outcomes after left ventricular assist device (LVAD) implantation in older adults (75 years of age).An aging heart failure population together with improvements in mechanical circulatory support (MCS) technology have led to increasing LVAD implantations in older adults. However, data presenting age-specific outcomes are limited.Adult patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) who required durable MCS between 2008 and 2017 were included. Patients were stratified by 4 age groups: 55 years of age, 55 to 64 years of age, and75 years of age. Kaplan-Meier survival estimates were used to assess post-LVAD outcomes, with log-rank testing used to compare groups. Univariate and multivariate cox proportional hazard regression models were used to determine predictors of survival and complications.A total of 20,939 individuals received an LVAD during the study period: 7,743 (37.0%) were 55 years of age, 6,755 (32.3%) were 55 to 64 years of age, 5,418 (25.9%) were 65 to 74 years of age, and 1,023 (4.9%) were ≥75 years of age or older. After multivariate adjustment, adults ≥75 years of age had increased mortality post-LVAD implantation. Elderly patients with LVADs had a higher incidence of gastrointestinal bleeding but lower rates of device thrombosis. Compared to 84.5% of patients 55 years of age who were discharged home, only 46.8% of adults ≥75 years of age were discharged home following implantation (p 0.001). Use of a RVAD, serum albumin level, and 6-min walk test distances were identified as predictors of outcomes in the oldest cohort.Despite careful selection of older adults for LVAD implantation, age remains a significant predictor of mortality. Higher bleeding and lower clotting risk in elderly patients with LVADs support the use of a less intense antithrombotic regimen in this unique population.

In 2008, the Veterans Health Administration published a groundbreaking policy on disclosing large-scale adverse events to patients in order to promote transparent communication in cases where harm may not be obvious or even certain. Without embedded research, the evidence on whether or not implementation of this policy was generating more harm than good among Veteran patients was unknown. Through an embedded research-operations partnership, we conducted four research projects that led to the development of an evidence-based large-scale disclosure toolkit and disclosure support program, and its implementation across VA healthcare. Guided by the Consolidated Framework for Implementation Research, we identified specific activities corresponding to planning, engaging, executing, reflecting and evaluating phases in the process of implementation. These activities included planning with operational leaders to establish a shared research agenda; engaging with stakeholders to discuss early results, establishing buy-in of our efforts and receiving feedback; joining existing operational teams to execute the toolkit implementation; partnering with clinical operations to evaluate the toolkit during real-time disclosures; and redesigning the toolkit to meet stakeholders' needs. Critical lessons learned for implementation success included a need for stakeholder collaboration and engagement, an organizational culture involving a strong belief in evidence, a willingness to embed researchers in clinical operation activities, allowing for testing and evaluation of innovative practices, and researchers open to constructive feedback. At the conclusion of the research, VA operations worked with the researchers to continue to support efforts to spread, scale-up and sustain toolkit use across the VA healthcare system, with the final goal to establish long-term sustainability.

Purpose Tricuspid regurgitation (TR) is common in end stage heart failure patients receiving left ventricular assist devices (LVADs), but the value of intervention is uncertain. This study examined the impact of tricuspid valve procedures (TVP) at time of LVAD implantation on clinical outcomes and quality of life metrics. Methods We included patients in the INTERMACS database with TR who received continuous-flow LVADs from the 2008 to 2017. TR was stratified by severity. Patients receiving concomitant TVP were compared to those without intervention in a stratified analysis. Survival analyses and Andersen-Gill hazard models were used to examine associations with clinical outcomes. Results Our analysis included 8263 (53.1%) mild, 4252 (33.3%) moderate, and 2100 (13.5%) severe TR cases. TVP rate increased with severity: 13.0% of mild cases underwent TVP versus 55.2% of severe cases. TVP was not associated with survival difference for mild (median 57.8 months for TVP vs. 55.6 months for non-TVP, P=0.69, HR 1.10 [95%: 0.87-1.50]), moderate (47.5 vs. 51.1 months, P=0.23, HR 1.20 [0.99-1.50]), or severe TR (43.3 vs 46.3 months, P=0.09, HR 1.30 [0.99-1.60]). TVP was associated with increased risk of bleeding, arrhythmia, stroke, renal failure, and respiratory failure (P Conclusion TVP at time of LVAD implantation was not associated with differences in survival or KCCQ scores. However, there were associations with increased risk of adverse events. Further studies are needed to understand appropriateness criteria for TVP with LVAD implantation.

Social support is considered a key factor that determines candidacy for LVADs. Few studies have examined its impact on clinical outcomes in a real-world population of patients receiving LVADs. We included INTERMACS patients who received an LVAD from 2008-2017 and excluded patients with missing data

The data regarding the risks of adverse outcomes in left ventricular assist device (LVAD) recipients with preoperative atrial arrhythmias (PAA) are inconclusive. The INTERMACS [Interagency Registry for Mechanically Assisted Circulatory Support] registry was used to assess the association between

Outcomes in heart failure clinical trials are generally better than those in the real-world. This may be due to stricter inclusion criteria. We compared patient characteristics and clinical outcomes in clinical trial patients and those in a real-world registry who received an axial flow left

Psychiatric comorbidities are increasingly prevalent in heart failure patients and may be associated with worse outcomes, including prolonged length of stay and increased rehospitalization rates. These relationships are unknown after left ventricular assist device (LVAD) implantation. Adult

Importance Left ventricular assist devices (LVADs) improve outcomes in patients with advanced heart failure, but little is known about the role of neurohormonal blockade (NHB) in treating these patients. Objective To analyze the association between NHB blockade and outcomes in patients with LVADs. Design, Setting, and Participants This retrospective cohort analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) included patients from more than 170 centers across the United States and Canada with continuous flow LVADs from 2008 to 2016 who were alive with the device in place at 6 months after implant. The data were analyzed between February and November 2019. Exposures Patients were stratified based on exposure to NHB and represented all permutations of the following drug classes: angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, and mineralocorticoid antagonists. Main Outcomes and Measures The outcomes of interest were survival at 4 years and quality of life at 2 years based on Kansas City Cardiomyopathy Questionnaire scores and a 6-minute walk test. Results A total of 12 144 patients in INTERMACS met inclusion criteria, of whom 2526 (20.8% ) were women, 8088 (66.6%) were white, 3024 (24.9%) were African American, and 753 (6.2%) were Hispanic; the mean (SD) age was 56.8 (12.9) years. Of these, 10 419 (85.8%) were receiving NHB. Those receiving any NHB medication at 6 months had a better survival rate at 4 years compared with patients not receiving NHB (56.0%; 95% CI, 54.5%-57.5% vs 43.9%; 95% CI, 40.5%-47.7%). After sensitivity analyses with an adjusted model, this trend persisted with patients receiving triple therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, β-blocker, and mineralocorticoid antagonist having the lowest hazard of death compared with patients in the other groups (hazard ratio, 0.34; 95% CI, 0.28-0.41). Compared with patients not receiving NHB, use of NHB was associated with a higher Kansas City Cardiomyopathy Questionnaire score (66.6; bootstrapped 95% CI, 65.8-67.3 vs 63.0; bootstrapped 95% CI, 60.1-65.8;P = .02) and a 6-minute walk test (1103 ft; bootstrapped 95% CI, 1084-1123 ft vs 987 ft; bootstrapped 95% CI, 913-1060 ft;P Conclusions and Relevance Among patients with LVADs who tolerated NHB therapy, continued treatment was associated with improved survival and quality of life. The optimal heart failure regimen for patients after LVAD implant may be the initiation and continuation of guideline-directed medical therapy.

Venous thromboembolism accounts for significant morbidity and mortality in patients with acute medical illnesses requiring hospital admission. American College of Chest Physicians guidelines recommend prophylaxis with heparins as first line and mechanical methods as second line. The risk of major bleeding with anticoagulants is less than 1% and not significantly different between agents. Although data support the use of all heparins, there is a trend toward superiority of low-molecular-weight heparins (LMWHs). Because acute illness and immobility do not end at hospital discharge, extended-duration therapy with LMWHs and direct oral anticoagulants remains under investigation.

An approach is proposed for modeling and simulating nonstationary earthquake ground motions that utilizes stationary wavelet and Hilbert transforms. The proposed model is based on the time-frequency representation of a process, which is essential for capturing the nonstationary characteristics of earthquake ground motions. Stationary wavelet transform is first utilized to decompose a sample of a multicomponent nonstationary random process into a set of monocomponent signals. These signals are subsequently transformed to analytic signals using the Hilbert transform, which yields the instantaneous amplitudes and frequencies. Without the customary assumption of piecewise stationarity or reliance on an assumed modulation function, this approach is able to simulate nonstationary random processes, such as earthquake ground motion, based on a sample realization of the process and its instantaneous features. The method is extended to the simulation of multivariate random processes utilizing the proper ort...

In comparison with atmospheric boundary-layer winds, which are generally regarded as stationary, windstorms such as hurricanes and thunderstorms/downbursts have strong nonstationary features characterized by rapid changes in wind speed and direction. The averaging interval associated with turbulent wind characteristics in boundary-layer winds is typically varied between 10 min and 1 h. A fixed averaging interval (FAI), which uses a constant mean to isolate the fluctuating wind component, has been effective in characterizing boundary-layer winds; however, the question remains as to whether the user-defined interval is appropriate for nonstationary winds. To address this concern, a variable averaging interval (VAI) scheme is proposed. For better understanding of the characteristics of nonstationary winds, traditional FAI methods are compared with alternative FAI approaches that use time-varying means and the proposed VAI approaches. In addition, the definitions for gust factor, turbulence intensity,...

Recognition of the significance of wind loading on low-rise buildings and transmission line structures during the passage of thunderstorm downbursts has prompted research aimed at modeling downburst wind fields and simulating wind flows. The non-uniformity and non-stationarity of thunderstorms in both time and space pose considerable challenges for effective simulation. In this paper, the evolutionary behavior of downburst winds is examined in the time–frequency domain using both stationary wavelet transform and Hilbert transform. Stationary wavelet transform first decomposes a sample of a multi-component non-stationary random process into a set of mono-component signals. These signals are subsequently transformed into analytic signals with the Hilbert transform, which yields the instantaneous amplitudes and frequencies. An efficient simulation approach is then proposed for thunderstorm downburst winds using the instantaneous properties as the basis. Simulation is performed based on a sample realization of the process without the customary assumptions of piecewise stationarity or parametric models. The method is extended to the simulation of multivariate random processes utilizing proper orthogonal decomposition. Analytical expressions for the statistical properties of the underlying random processes are formulated. Example simulations of measured full-scale downburst wind data are presented to demonstrate the efficacy of the proposed method.

Coastal structures are susceptible to a variety of natural hazards, such as wind, storm surge, waves, earthquakes, and tsunamis. These hazards must be fully studied and well understood in order to effectively and safely design and construct hazard-resilient structures. Knowledge of the damage mechanisms associated with coastal hazards helps reveal the anatomy of damage to constructed facilities during an event, which exposes vulnerabilities in current design practices. This paper focuses on damage to residential structures caused by hurricane winds, storm surge, and waves. After the different loading mechanisms associated with hurricanes are discussed, two case studies are introduced that examine structural damage during Hurricane Katrina (2005). On-site postdisaster field surveillance is complemented by the analysis of aerial photographs, satellite images, and data from wind and storm surge models in order to determine the structural damage timeline. The case studies demonstrate the importance of considering multiple hazards when designing and constructing coastal structures. A design and analysis framework that combines multi-hazard engineering strategies with performance-based design procedures is then introduced. The new approach seeks to significantly improve structural reliability in the most efficient and effective manner.

Traditional methods of using surrogate data to test for linearity of time-series data can be extended into the time-frequency domain to test for stationarity. Surrogates are time series that are created directly from the original dataset through manipulation and seek to replicate important properties of the original dataset. By comparing the original signal to the surrogates, additional structure in the original dataset not explained by the replicated properties may be revealed. The surrogates used for the purpose of testing stationarity are stationarized versions of an original signal that have the same Fourier amplitudes, but have randomized phases. Wavelet analysis is used in this method to transform the signals into the time-frequency domain and wavelet scalograms are used to quantitatively compare the original signal to the stationarized surrogate signals. Methods introduced in previous research compare the local and global spectral features of the surrogate signals with the local and global ...

Seroprevalence of antibodies to influenza A(H1N1)pdm09 virus among 193 emergency department health care personnel was similar among 147 non-health care personnel (odds ratio 1.4, 95% CI 0.8-2.4). Working in an acute care setting did not substantially increase risk for virus infection above risk conferred by community-based exposures.

A1 Introduction to the 8th Annual Conference on the Science of Dissemination and Implementation: Optimizing Personal and Population Health David Chambers1, Lisa Simpson2 1Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, Rockville, MD, 20850, USA; 2AcademyHealth, Washington, DC, 20036, USA For the second year in a row, we are pleased to be able to share the proceedings of the Annual Conference on the Science of Dissemination and Implementation in Health, a large meeting reflecting the expanding and evolving research field that seeks to optimize the use of evidence, interventions, and tools from health research within the myriad of settings where people receive health care, make health-related decisions, and increase knowledge of influences on the health of the population. We once again benefitted from a strong partnership, co-led by AcademyHealth and the National Institutes of Health (NIH), with co-sponsorship from the Agency for Healthcare Research and Quality (AHRQ), the Patient Centered Outcomes Research Institute (PCORI), the Robert Wood Johnson Foundation (RWJF), the US Department of Veterans Affairs (VA), and the WT Grant Foundation. In addition, we benefitted from the collaboration of staff from the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). NIH and AcademyHealth again co-led the program planning committee, which focused on the development of the plenary sessions, and convened a scientific advisory panel to suggest speakers and advise on the overall conference development. The planning committee identified four key areas around which to focus the plenary panels and keynote address. Dr. America Bracho, M.D., M.P.H., Executive Director of Latino Health Access in Orange County, California, spoke about the opportunities for implementation science to inform efforts to improve community health and engage underserved populations. The three plenary panels each focused on a significant future direction for dissemination and implementation (D & I) research: the interface between D&I science and population health, emerging opportunities for global implementation science, and the challenges around implementation of precision medicine. The plenary sessions were complemented by facilitated lunchtime discussions on the same three topics, which offered participants an opportunity to identify key research questions for each and brainstorm next steps. Synopses of the lunchtime discussions are included in this supplement. Given the overwhelming success of the 2014 conference and the large number of abstracts received in 2014 (660), the program planning committee identified eight program tracks for abstract submitters to respond to, and through which the concurrent sessions of the conference would be organized. These tracks—Behavioral Health, Big Data and Technology for Dissemination and Implementation Research, Clinical Care Settings, Global Dissemination and Implementation, Promoting Health Equity and Eliminating Disparities, Health Policy Dissemination and Implementation, Prevention and Public Health, and Models, Measures and Methods— were designed to enable conference participants to follow a consistent theme across the multiple sessions of the conference and form the structure of this supplement. The call for abstracts, including individual paper presentations, individual posters and panel presentations, resulted in 515 submissions, spread across the eight thematic tracks. Over one hundred reviewers devoted their time to ensuring a comprehensive and expert review, and reviews were conducted within each track and coordinated by the track leads. For the final program, 64 oral presentations, 12 panels, and 263 posters were presented over the two-day meeting. Slides for the oral presentations and panels (with the agreement of the authors) were posted on the conference website (http://diconference.academyhealth.org/archives/2015archives) and all abstracts were included on the conference webapp (https://academyhealth.confex.com/academyhealth/2015di/meetingapp.cgi). This supplement has compiled the abstracts for presented papers, panel sessions, and lunchtime discussions from the 8th Annual Meeting on the Science of Dissemination and Implementation in Health: Optimizing Personal and Population Health. We are pleased to have the abstracts from the conference together in one volume once again, and look forward to the 9th Annual meeting, scheduled for December in Washington, D.C.