Trends in the Use of Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Heart Transplant Patients in Virginia.

OBJECTIVES: To explore trends in intraoperative procoagulant factor concentrate use in patients undergoing heart transplantation (HTx) in Virginia. Secondarily, to evaluate their association with postoperative thrombosis. DESIGN: Patients who underwent HTx were identified using a statewide database. Trends in off-label recombinant activated factor VII (rFVIIa) use and on-label and off-label prothrombin complex concentrate (PCC) use were tested using the Mantel-Haenszel test. Multivariate logistic regression was used to test for an association between procoagulant factor concentrate administration and thrombosis. SETTING: Virginia hospitals performing HTx. PARTICIPANTS: Adults undergoing HTx between 2012 and 2022. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 899 patients who required HTx, 100 (11.1%) received off-label rFVIIa, 69 (7.7%) received on-label PCC, and 80 (8.9%) received off-label PCC. There was a downward trend in the use of rFVIIa over the 10-year period (p = 0.04). There was no trend in on-label PCC use (p = 0.12); however, there was an increase in off-label PCC use (p < 0.001). Patients who received rFVIIa were transfused more and had longer cardiopulmonary bypass time (p < 0.001). Receipt of rFVIIa was associated with increased thrombotic risk (odds ratio [OR] 1.92; 95% CI 1.12-3.29; p = 0.02), whereas on-label and off-label PCC use had no association with thrombosis (OR 0.98, 95% CI 0.49-1.96, p = 0.96 for on-label use; and OR 0.61, 95% CI 0.29-1.30, p = 0.20 for off-label use). CONCLUSIONS: Use of rFVIIa in HTx decreased over the past decade, whereas off-label PCC use increased. Receipt of rFVIIa was associated with thrombosis; however, patients who received rFVIIa were more severely ill, and risk adjustment may have been incomplete.

A Pilot Replication Study of Implementing an Equine-Assisted Services Program Within a VA Residential Substance Use Disorder Treatment Program.

INTRODUCTION: Veterans have high rates of substance use disorders and other mental health conditions including post-traumatic stress disorder. Effective treatments for these conditions exist; however, high attrition rates and residual symptoms after completing treatment are common. Complementary treatment approaches could enhance treatment engagement and/or response among this population. We previously reported a study of one such intervention, an equine-assisted learning, and psychotherapy incorporating horses intervention provided to veterans admitted to a Veterans Health Care Administration residential substance abuse treatment program. The first aim of this study was to replicate the previous study assessing the safety, feasibility, and preliminary outcomes of this intervention. The second aim was to examine the effect of participants attending multiple intervention sessions. MATERIALS AND METHODS: Participants were 94 veterans who participated in one to six sessions of a 3-4-hour program consisting of both equine-assisted learning and psychotherapy incorporating horses. Pre- and post-session administration of the Positive and Negative Affect Scale, State-Trait Anxiety Inventory, and Craving Experience Questionnaire was utilized to assess changes in affect, anxiety, and craving. Wilcoxon signed-rank or paired two-tailed t-tests were utilized for pre- to post-session comparisons of the outcome measures for sessions 1-4. Generalized linear mixed-effects (GLME) models were constructed to determine the impact of dosage. GLME models were constructed to determine the impact of dosage. RESULTS: As with our previous study, the intervention was safe and feasible to utilize for this population. There were statistically significant pre- to post-session improvements, with medium-to-large effect sizes, for sessions 1-3 for negative affect and sessions 1 and 2 for positive affect, anxiety, and craving. The GLME models revealed no statistical significance for any of the predictors. CONCLUSIONS: Taken together, this study and our previous investigation of this equine-assisted services intervention suggest that it is safe and feasible to utilize for veterans admitted to a residential substance abuse treatment program and we have now found short-term benefits in two separate studies. Thus, a randomized controlled trial of this intervention is warranted to demonstrate cause and effect and determine whether longer-term benefits are associated with the intervention. The finding that there was no additional benefit from attendance at more than two intervention sessions suggests that dose-response relationship studies of equine-assisted services interventions for veterans are needed.

Reimagining the NICU: a human-centered design approach to healthcare innovation.

Design charettes have been utilized in architectural and design practice to generate innovative ideas. The Reimagining Workshop is a version that combines practical and blue-sky thinking to improve healthcare facility design. The workshop engages diverse stakeholders who follow a human-centered design framework. The Reimagining the Neonatal Intensive Care Unit workshop sought to generate ideas for the future, optimal NICU without specific site or client constraints. Key themes include family-centered care, technology-enabled care, neighborhood and village design and investing in the care team. Recommendations include a supportive physical environment, celebrating milestones, complementary and alternative medicine, enhancing the transition of care, aiding the transition period, and leveraging technology. The workshop showcased the potential for transformative change in NICU design and provided a roadmap for future advancements. These findings can inform regulatory standards for NICU design and drive improvements in family-centered care, patient experiences, and outcomes within the NICU environment.

Career Satisfaction and Advancement Related to Mentorship Experiences of Underrepresented Nursing Faculty.

AIM: This study aimed to describe the perceived impact of mentorship on career satisfaction and advancement for underrepresented nursing faculty. BACKGROUND: Mentoring contributes to career development through a continuous learning process and support for role development. METHOD: Fifteen underrepresented nurse faculty in academia comprised the sample for this qualitative phenomenological study. RESULTS: Themes of career advancement and satisfaction related to mentorship included personal and professional growth, retention, lost opportunities, isolation, and multilayered mentoring. CONCLUSION: Results of this study may be used to support the development of multilayered mentorship programs to meet the unique needs of underrepresented nurse faculty and improve diversity in nursing education.

Investigating Dog Welfare When Interacting with Autistic Children within Canine-Assisted Occupational Therapy Sessions: A Single Case Study.

Human-animal bond is defined as the mutually beneficial relationship between humans and animals. Recent years have seen increasing research regarding the benefits of interaction with animals for autistic children. However, there continue to be limited studies exploring the impact of this interaction on the welfare of therapy dogs. As part of a pilot randomised control trial assessing the efficacy of canine-assisted occupational therapy with autistic children, this project assessed welfare markers of the therapy dog involved. A total of twenty-one saliva samples were taken from the therapy dog to assess cortisol, alpha amylase, and oxytocin concentrations at home and throughout the treatment days. Additionally, six hours of therapy session videos were analysed for stress indicators of canine behaviour. No significant differences were found between days spent at home and treatment days for any of the biomarkers or stress indicators. Results suggest that the therapy dog involved did not experience increased stress resulting from interaction with the autistic children throughout the therapy sessions. This study supports the need for further research regarding therapy dog welfare when interacting with autistic children including an increased sample size of therapy dogs and therapists.

A pilot observational study of horsemanship skills training for veterans with posttraumatic stress disorder.

OBJECTIVES: Pilot assessment of an equine-assisted services intervention for Veterans with posttraumatic stress disorder. DESIGN: Prospective cohort. SETTING: A large Veterans Administration healthcare system. INTERVENTION: Two sessions of instruction in horsemanship skills and two sessions of trail rides. MAIN OUTCOME MEASURES: Safety and feasibility of recruitment, retention, providing the intervention, and measuring outcomes, as well as acceptability of the intervention to the population studied were the main outcome measures. RESULTS: There were no injuries among the 18 participants, 6 staff, or 11 equines over the 3 months of the study. Eleven of 12 (92 %) planned intervention sessions were provided, with one being canceled due to weather. Out of approximately 1800 potential subjects, 21 were enrolled within three months and three dropped out before the first session. The mean number of sessions attended was 3 % and 52 % of participants completed all sessions. The mean PACES score for all sessions together was 109 (SD = 12), with a range of 50-126. Pre- to one-month post-intervention exploratory results indicated increased psychological flexibility (p = 0.008) and positive affect (p = 0.008) as measured by the Acceptance and Action Questionnaire II and the Positive and Negative Affect Scale, respectively as well as decreased PTSD (p = 0.001) and depressive symptoms (p = 0.017) as measured by the PTSD Checklist for DSM 5 and the Beck Depression Inventory, respectively. CONCLUSIONS: Results suggest the intervention can be conducted with minimal risk. Further, it was feasible to recruit participants as well as provide the intervention and measure exploratory outcomes. Session attendance and PACES scores indicate acceptability to the Veteran population. The exploratory results will provide sample size estimates for future randomized controlled studies of this intervention Future studies should plan for missed sessions due to weather and consider compensating subjects to enhance retention. Finally, this work provides preliminary evidence that this intervention, without a mental health treatment component, might benefit the mental health of Veterans with PTSD.

Reimagining Workshops.

Design charettes have been a mainstay in architectural and design practice. Although they are relatively common, research studies on their effectiveness and methods are rare. Recently, an approach has been introduced in the format of Reimagining Workshops (RWs), a charette characterized by both practical and blue-sky thinking, training in empathy, and multi-stakeholder input. In spring of 2021, two RWs were held to explore ideal neonatal intensive care environments. The RWs were born out of a desire to provide a source of information for the Facility Guidelines Institute Guidelines. To date, there have been four RWs: Reimagining the ED, Reimagining Childbirth Facilities, Reimagining Critical Care, and Reimagining the NICU (virtual). This experience enables participants to operate outside of their comfort zone, an important step toward achieving innovation. They are unique in the following ways: (1) the assignments are broad, (2) participants are encouraged to think radically, (3) there are no constraints, (4) participants receive empathy training, and (5) multiple facilities and stakeholders are brought together rather than focusing on a single facility. This article describes the history of design charettes, the history of the RWs, the methodology associated with RWs, and the specific findings from the NICU and the other workshop events.

A Pilot Observational Study of Implementing an Equine-A ssisted Services Program Within a VA Medical Center Residential Substance Use Disorder Treatment Program.

INTRODUCTION: The aim of this observational pilot study was to assess the safety, feasibility, preliminary outcomes, and predictors of participant response as a result of implementing an equine-assisted intervention within a residential substance abuse treatment program at a large Veterans Administration medical center. A secondary aim was to evaluate psychological instruments for use in future, more rigorous studies. The overarching goal was to complete the necessary work to prepare for a large randomized controlled trial of this intervention for Veterans with addictive disorders. MATERIALS AND METHODS: Participants were 33 Veterans, 29 males and 4 females, who participated in one 4-hour session of combined equine-assisted learning and equine-assisted psychotherapy during an admission to a residential substance abuse treatment program. Preintervention and postintervention instruments were utilized to assess changes in affect, anxiety, and craving. Demographic and diagnostic variables were evaluated for the potential to predict outcomes. RESULTS: The intervention was safe and feasible to utilize as there were no adverse outcomes to patients, staff, or equines. The State-Trait Anxiety Inventory, Craving Experience Questionnaire, and Positive and Negative Affect Scale revealed preliminary findings of significant preintervention to postintervention decreases in anxiety, negative affect, and craving, as well as increased positive affect. Lastly, the presence or absence of a history of suicide attempts and/or suicidal ideation were predictive of some postintervention scores. CONCLUSION: While more rigorous studies are needed, these results indicate that the intervention evaluated in this study is safe and feasible to utilize for Veterans admitted to a residential substance abuse treatment program. Furthermore, preliminary outcomes suggest that this intervention, and perhaps other equine-assisted interventions, has the potential to be beneficial to Veterans with addictive disorders as well as those at risk of suicide. The psychological instruments used in this intervention appear to be appropriate for use in future investigations. Additionally, more rigorous studies are warranted, and this work provides the necessary first steps needed to proceed with those investigations.

Consumer engagement in health care policy, research and services: A systematic review and meta-analysis of methods and effects.

To assess the effects of consumer engagement in health care policy, research and services. We updated a review published in 2006 and 2009 and revised the previous search strategies for key databases (The Cochrane Central Register of Controlled Trials; MEDLINE; EMBASE; PsycINFO; CINAHL; Web of Science) up to February 2020. Selection criteria included randomised controlled trials assessing consumer engagement in developing health care policy, research, or health services. The International Association for Public Participation, Spectrum of Public Participation was used to identify, describe, compare and analyse consumer engagement. Outcome measures were effects on people; effects on the policy/research/health care services; or process outcomes. We included 23 randomised controlled trials with a moderate or high risk of bias, involving 136,265 participants. Most consumer engagement strategies adopted a consultative approach during the development phase of interventions, targeted to health services. Based on four large cluster-randomised controlled trials, there is evidence that consumer engagement in the development and delivery of health services to enhance the care of pregnant women results in a reduction in neonatal, but not maternal, mortality. From other trials, there is evidence that involving consumers in developing patient information material results in material that is more relevant, readable and understandable for patients, and can improve knowledge. Mixed effects are reported of consumer-engagement on the development and/or implementation of health professional training. There is some evidence that using consumer interviewers instead of staff in satisfaction surveys can have a small influence on the results. There is some evidence that consumers may have a role in identifying a broader range of health care priorities that are complementary to those from professionals. There is some evidence that consumer engagement in monitoring and evaluating health services may impact perceptions of patient safety or quality of life. There is growing evidence from randomised controlled trials of the effects of consumer engagement on the relevance and positive outcomes of health policy, research and services. Health care consumers, providers, researchers and funders should continue to employ evidence-informed consumer engagement in their jurisdictions, with embedded evaluation. Systematic review registration: PROSPERO CRD42018102595.

Household Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 in the United States: Living Density, Viral Load, and Disproportionate Impact on Communities of Color.

BACKGROUND: Households are hot spots for severe acute respiratory syndrome coronavirus 2 transmission. METHODS: This prospective study enrolled 100 coronavirus disease 2019 (COVID-19) cases and 208 of their household members in North Carolina though October 2020, including 44% who identified as Hispanic or non-White. Households were enrolled a median of 6 days from symptom onset in the index case. Incident secondary cases within the household were detected using quantitative polymerase chain reaction of weekly nasal swabs (days 7, 14, 21) or by seroconversion at day 28. RESULTS: Excluding 73 household contacts who were PCR-positive at baseline, the secondary attack rate (SAR) among household contacts was 32% (33 of 103; 95% confidence interval [CI], 22%-44%). The majority of cases occurred by day 7, with later cases confirmed as household-acquired by viral sequencing. Infected persons in the same household had similar nasopharyngeal viral loads (intraclass correlation coefficient = 0.45; 95% CI, .23-.62). Households with secondary transmission had index cases with a median viral load that was 1.4 log10 higher than those without transmission (P = .03), as well as higher living density (more than 3 persons occupying fewer than 6 rooms; odds ratio, 3.3; 95% CI, 1.02-10.9). Minority households were more likely to experience high living density and had a higher risk of incident infection than did White households (SAR, 51% vs 19%; P = .01). CONCLUSIONS: Household crowding in the context of high-inoculum infections may amplify the spread of COVID-19, potentially contributing to disproportionate impact on communities of color.

Assessment of the Field Utility of a Rapid Point-of-Care Test for SARS-CoV-2 Antibodies in a Household Cohort.

Point-of-care (POC) tests to detect SARS-CoV-2 antibodies offer quick assessment of serostatus after natural infection or vaccination. We compared the field performance of the BioMedomics COVID-19 IgM/IgG Rapid Antibody Test against an ELISA in 303 participants enrolled in a SARS-CoV-2 household cohort study. The rapid antibody test was easily implemented with consistent interpretation across 14 users in a variety of field settings. Compared with ELISA, detection of seroconversion lagged by 5 to 10 days. However, it retained a sensitivity of 90% (160/177, 95% confidence interval [CI] 85-94%) and specificity of 100% (43/43, 95% CI 92-100%) for those tested 3 to 5 weeks after symptom onset. Sensitivity was diminished among those with asymptomatic infection (74% [14/19], 95% CI 49-91%) and early in infection (45% [29/64], 95% CI 33-58%). When used appropriately, rapid antibody tests offer a convenient way to detect symptomatic infections during convalescence.

High household transmission of SARS-CoV-2 in the United States: living density, viral load, and disproportionate impact on communities of color.

Background: Few prospective studies of SARS-CoV-2 transmission within households have been reported from the United States, where COVID-19 cases are the highest in the world and the pandemic has had disproportionate impact on communities of color. Methods and Findings: This is a prospective observational study. Between April-October 2020, the UNC CO-HOST study enrolled 102 COVID-positive persons and 213 of their household members across the Piedmont region of North Carolina, including 45% who identified as Hispanic/Latinx or non-white. Households were enrolled a median of 6 days from onset of symptoms in the index case. Secondary cases within the household were detected either by PCR of a nasopharyngeal (NP) swab on study day 1 and weekly nasal swabs (days 7, 14, 21) thereafter, or based on seroconversion by day 28. After excluding household contacts exposed at the same time as the index case, the secondary attack rate (SAR) among susceptible household contacts was 60% (106/176, 95% CI 53%-67%). The majority of secondary cases were already infected at study enrollment (73/106), while 33 were observed during study follow-up. Despite the potential for continuous exposure and sequential transmission over time, 93% (84/90, 95% CI 86%-97%) of PCR-positive secondary cases were detected within 14 days of symptom onset in the index case, while 83% were detected within 10 days. Index cases with high NP viral load (>10^6 viral copies/ul) at enrollment were more likely to transmit virus to household contacts during the study (OR 4.9, 95% CI 1.3-18 p=0.02). Furthermore, NP viral load was correlated within families (ICC=0.44, 95% CI 0.26-0.60), meaning persons in the same household were more likely to have similar viral loads, suggesting an inoculum effect. High household living density was associated with a higher risk of secondary household transmission (OR 5.8, 95% CI 1.3-55) for households with >3 persons occupying <6 rooms (SAR=91%, 95% CI 71-98%). Index cases who self-identified as Hispanic/Latinx or non-white were more likely to experience a high living density and transmit virus to a household member, translating into an SAR in minority households of 70%, versus 52% in white households (p=0.05). Conclusions: SARS-CoV-2 transmits early and often among household members. Risk for spread and subsequent disease is elevated in high-inoculum households with limited living space. Very high infection rates due to household crowding likely contribute to the increased incidence of SARS-CoV-2 infection and morbidity observed among racial and ethnic minorities in the US. Quarantine for 14 days from symptom onset of the first case in the household is appropriate to prevent onward transmission from the household. Ultimately, primary prevention through equitable distribution of effective vaccines is of paramount importance.

Equine-Assisted Activities and Therapies for Veterans With Posttraumatic Stress Disorder: Current State, Challenges and Future Directions.

Posttraumatic stress disorder is common among military Veterans. While effective treatments exist, many Veterans either do not engage in treatment or fail to achieve full remission. Thus, there is a need to develop adjunctive complementary interventions to enhance treatment engagement and/or response. Equine-assisted activities and therapies (EAAT) are one category of animal assisted interventions that might serve this function. The aim of this article is to review the current state and challenges regarding the use of EAAT for Veterans with PTSD and provide a roadmap to move the field forward. EAAT hold promise as adjunctive complementary interventions for symptom reduction among Veterans with PTSD. Additionally, there is evidence that these approaches may enhance wellbeing in this population. At this time, many gaps in the literature exist and rigorous randomized controlled trials are needed before definitive conclusions can be drawn. The authors of this work provide recommendations as a roadmap to move the field forward. These include standardizing the EAAT nomenclature, focusing mechanism of action studies on the human-horse bond using biological metrics and using a standardized intervention model across studies.

Building Health Systems Science Education from the Core Domain of Interprofessional Education at Virginia Tech Carilion School of Medicine.

The Virginia Tech Carilion School of Medicine (VTCSOM) is a 4-year allopathic medical school in Roanoke, VA. The curriculum is organized into four learning domains: basic science, clinical science, research, and interprofessionalism (IPE). A recent curriculum renewal effort allowed the school to embark upon a redesign of the IPE learning domain to incorporate new core content from health systems science (HSS). We describe how our unique approach to IPE is being preserved as we innovate to produce graduates who are future thought leaders and "systems citizens," prepared to deliver patient care with an expanded knowledge of the health systems in which they will eventually practice.

Towards an architecture of flexibility.

OBJECTIVE: Our objective was to explore the case for adoption of flexibility as a core value in the design process for Neonatal Intensive Care Units (NICUs). METHODS: Guidelines for NICU design and care of NICU patients and families were examined to identify opportunities for building flexibility into NICU design to optimize function and experience. RESULTS: Benefits of building flexibility into NICU design included the ability for units to adapt quickly and economically to unpredictable events and demographic changes. Further, by centering family presence as a design necessity, NICUs may better protect families from experiencing additional harm due to separation and interruption of restorative activities. We were able to highlight several examples of current NICUs, which have successfully adopted flexible design and operational models to provide optimal levels of clinical and family-centered care. CONCLUSION: By intentionally incorporating flexibility into the design of an NICU, infants, families, and healthcare providers can be provided with an environment that can adapt to shifting needs to optimally support unit function and clinical outcomes.

Canine Assisted Occupational Therapy for Children on the Autism Spectrum: A Pilot Randomised Control Trial.

Children on the autism spectrum frequently display difficulties engaging with people and with functional tasks. A pilot, randomised control trial was completed to explore the impact of canine assisted occupational therapy on the on-task behaviours and goal attainment of autistic children when compared to occupational therapy sessions as usual. Twenty-two children between the ages of 4, and 6 years and 11 months, were randomly placed in either the treatment group (n-11) or waitlist control group (n = 11). Results showed that although there was a positive trend for on-task behaviour and goal attainment within the treatment group, results were not statistically significant. These results support the need for further research in the area of canine assisted occupational therapy for autistic children.

Cost-Effectiveness of Negative Pressure Incision Management System in Cardiac Surgery.

BACKGROUND: Sternal wound infections (SWIs) can be a devastating long-term complication with significant morbidity and health care cost. The purpose of this analysis was to evaluate the cost-effectiveness of negative pressure incision management systems (NPIMS) in cardiac surgery. MATERIALS AND METHODS: All cardiac surgery cases at an academic hospital with risk scores available (2009-2017) were extracted from an institutional database (n = 4455). Patients were stratified by utilization of NPIMS, and high risk was defined as above the median. Costs included infection-related readmissions and were adjusted for inflation. Multivariable regression models assessed the risk-adjusted cost of SWI and efficacy of NPIMS use. Cost-effectiveness was modeled using TreeAge Pro using institutional results. RESULTS: The rate of deep SWI was 0.9% with an estimated cost of $111,175 (P < 0.0001). The rate of superficial SWI was 0.8% at a cost of $7981 (P = 0.08). Risk-adjusted NPIMS use was not significantly associated with reduced SWI (OR 1.2, P = 0.62) and thus not cost-effective. However, in the high-risk cohort with an OR 0.84 (P = 0.72) and SWI rate of 2.3%, NPIMS use cost $205 per patient with an incremental cost-effectiveness ratio of $179,092. Therefore, NPIMS is estimated to be cost-effective with a deep SWI rate over 1.3% or improved efficacy (OR < 0.83). CONCLUSIONS: SWIs are extremely expensive complications with estimates of $111,175 for deep yet only $7981 for superficial. Although NPIMS was not cost-effective for SWI prevention as currently utilized, a protocol for use on patients with a higher risk of sternal infection could be cost-effective.

Clinical management practices of life-threatening asthma: an audit of practices in intensive care.

OBJECTIVE: Lack of management guidelines for lifethreatening asthma (LTA) risks practice variation. This study aims to elucidate management practices of LTA in the intensive care unit (ICU). DESIGN: A retrospective cohort study. SETTING: Thirteen participating ICUs in Australia between July 2010 and June 2013. PARTICIPANTS: Patients with the principal diagnosis of LTA. MAIN OUTCOME MEASURES: Clinical history, ICU management, patient outcomes, ward education and discharge plans. RESULTS: Of the 270 (267 patients) ICU admissions, 69% were female, with a median age of 39 years (interquartile range [IQR], 26-53 years); 119 (44%) were current smokers; 89 patients (33%) previously required ICU admission, of whom 23 (25%) were intubated. The median ICU stay was 2 days (IQR, 2-4 days). Three patients (1%) died. Seventy-nine patients (29%) received non-invasive ventilation, with 11 (14%) needing subsequent invasive ventilation. Sixty-eight patients (25%) were intubated, with the majority of patients receiving volume cycled synchronised intermittent mechanical ventilation (n = 63; 93%). Drugs used included ß2-agonist by intravenous infusion (n = 69; 26%), inhaled adrenaline (n = 15; 6%) or an adrenaline intravenous infusion (n = 23; 9%), inhaled anticholinergics (n = 238; 90%), systemic corticosteroids (n = 232; 88%), antibiotics (n = 126; 48%) and antivirals (n = 22; 8%). When suitable, 105 patients (n = 200; 53%) had an asthma management plan and 122 (n = 202; 60%) had asthma education upon hospital discharge. Myopathy was associated with hyperglycaemia requiring treatment (odds ratio [OR], 31.6; 95% CI, 2.1-474). Asthma education was more common under specialist thoracic medicine care (OR, 3.0; 95% CI, 1.61-5.54). CONCLUSION: In LTA, practice variation is common, with opportunities to improve discharge management plans and asthma education.

Phase 2 trial of bortezomib in combination with rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with bortezomib, rituximab, methotrexate, and cytarabine for untreated mantle cell lymphoma.

BACKGROUND: Although the outcomes of patients with mantle cell lymphoma (MCL) have improved, there is still no cure. Bortezomib has a 33% response rate in relapsed/refractory MCL and has shown additive and/or synergistic effects in preclinical trials with known effective agents. METHODS: This is a report of a prospective phase 2 trial of bortezomib added to rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (BzR-hyperCVAD)/rituximab, high-dose methotrexate, and high-dose cytarabine (BzR-MA) for 95 patients with newly diagnosed MCL. RESULTS: The overall and complete response rates were 100% and 82%, respectively. Hematologic toxicity was high but expected and did not lead to an increased incidence of neutropenic fever or dose reductions in comparison with a similar reported regimen without bortezomib. After a median follow-up of 44 months, the median overall survival had not been reached, and the time to treatment failure (TTF) was 55 months, which is not different from that of historical controls. CONCLUSIONS: BzR-hyperCVAD/BzR-MA at the dose and schedule studied produced high rates of response and a TTF similar to that of historical reports without bortezomib. Cancer 2018;124:2561-9. © 2018 American Cancer Society.

Amiodarone Protocol Provides Cost-Effective Reduction in Postoperative Atrial Fibrillation.

BACKGROUND: Postoperative atrial fibrillation (POAF) after cardiac operations results in a significant increase in morbidity, mortality, and health care costs. Prophylactic amiodarone has been shown to reduce the incidence of POAF; however, the cost-effectiveness of a protocol-driven approach remains unknown. METHODS: All patients with a Society of Thoracic Surgeons risk score enrolled in a prophylactic amiodarone protocol (n = 153) were propensity score matched 1:3 with patients before protocol implementation (n = 3,574). Multivariate logistic and linear regressions assessed the relative risks (POAF reduction and adverse medication effects) in the matched cohort of amiodarone therapy and costs, respectively. TreeAge cost-effectiveness software (TreeAge Software, Inc, Williamstown, MA) modeled the effects of prophylactic amiodarone costs, complication rates, and quality of life. RESULTS: Of patients eligible for the prophylactic amiodarone protocol, 94.3% (281 of 298) were enrolled. Prophylactic amiodarone significantly reduced the rate of POAF (25.7% vs 16.8%, p < 0.0001). A total of 600 matched patients demonstrate no baseline differences in demographics, comorbidities, disease state, or operative factors, with a significant reduction in POAF without an increase in other associated complications. With the use these adjusted estimates, the prophylactic amiodarone protocol demonstrated a cost savings of $458 per patient. Sensitivity analysis confirmed the protocol is cost-effective for all protocol-related POAF risk reductions below an odds ratio of 0.726. CONCLUSIONS: Implementation of a prophylactic amiodarone protocol significantly reduced risk-adjusted rates of POAF, with a cost savings of $458 per patient. This analysis demonstrates how rigorous quantitative analysis can evaluate the benefits of quality improvement projects.