Considerations of Left Ventricular Assist Device Therapy in the United States' Prison System.

Left ventricular assist device therapy for advanced heart failure is contraindicated if a patient lives in an unsafe environment and recent guidelines declare that "legal history is pertinent for determining personal constraints or financial responsibilities due to parole requirements, pending charges, and possible imprisonment," implying that incarceration would be a contraindication. International guidelines and precedent in the United States establish that medical care for incarcerated persons should match access in the community. We present a case example and practical considerations for advanced heart failure programs faced with the challenge of partnering with patients with heart failure who may be incarcerated and their correctional health systems in the care of their chronic condition. We encourage the heart failure community to not let incarceration be a contraindication to left ventricular assist device therapy.

Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol.

INTRODUCTION: Clostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for succeeding episodes. Preliminary in vitro and in vivo studies indicate that alanyl-glutamine (AQ) may be beneficial in treating CDI by its effect on restoring intestinal integrity in the epithelial barrier, ameliorating inflammation and decreasing relapse. METHODS AND ANALYSIS: This study is a randomised, placebo-controlled, double-blind, phase II clinical trial. The trial is designed to determine optimal dose and safety of oral AQ at 4, 24 and 44 g doses administered daily for 10 days concurrent with standard treatment of non-severe or severe uncomplicated CDI in persons age 18 and older. The primary outcome of interest is CDI recurrence during 60 days post-treatment follow-up, with the secondary outcome of mortality during 60 days post-treatment follow-up. Exploratory analysis will be done to determine the impact of AQ supplementation on intestinal and systemic inflammation, as well as intestinal microbial and metabolic profiles. ETHICS AND DISSEMINATION: The study has received University of Virginia Institutional Review Board approval (HSR200046, Protocol v9, April 2023). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04305769.

Human Immunodeficiency Virus (HIV) and Aging: Multimorbidity in Older People With HIV in One Nonurban Southeastern Ryan White HIV/AIDS Program Clinic.

BACKGROUND: Age-related chronic conditions are becoming more concerning for people with human immunodeficiency virus (PWH). We aimed to identify characteristics associated with multimorbidity and evaluate for association between multimorbidity and human immunodeficiency virus (HIV) outcomes. METHODS: Cohorts included PWH aged 45-89 with ≥1 medical visit at one Ryan White HIV/AIDS Program (RWHAP) Southeastern HIV clinic in 2006 (Cohort 1) or 2016 (Cohort 2). Multimorbidity was defined as ≥2 chronic diseases. We used multivariable logistic regression to assess for associations between characteristics and multimorbidity and between multimorbidity and HIV outcomes. RESULTS: Multimorbidity increased from Cohort 1 (n = 149) to Cohort 2 (n = 323) (18.8% vs 29.7%, P < .001). Private insurance was associated with less multimorbidity than Medicare (Cohort 1: adjusted odds ratio [aOR] = 0.15, 95% confidence interval [CI] = 0.02-0.63; Cohort 2: aOR = 0.53, 95% CI = 0.27-1.00). In Cohort 2, multimorbidity was associated with female gender (aOR, 2.57; 95% CI, 1.22-5.58). In Cohort 1, black participants were less likely to be engaged in care compared with non-black participants (aOR, 0.72; 95% CI, 0.61-0.87). In Cohort 2, participants with rural residences were more likely to be engaged in care compared with those with urban residences (aOR, 1.23; 95% CI, 1.10-1.38). Multimorbidity was not associated with differences in HIV outcomes. CONCLUSIONS: Although PWH have access to RWHAP HIV care, PWH with private insurance had lower rates of multimorbidity, which may reflect better access to preventative non-HIV care. In 2016, multimorbidity was higher for women. The RWHAP and RWHAP Part D could invest in addressing these disparities related to insurance and gender.

Validating Performance of a Hospital Discharge Planning Decision Tool in Community Hospitals.

PURPOSE OF STUDY: The Early Screen for Discharge Planning (ESDP) is a decision support tool developed in an urban academic medical center. High ESDP scores identify patients with nonroutine discharge plans who would benefit from early discharge planning intervention. We aimed to determine the predictive performance of the ESDP in a different practice setting. PRIMARY PRACTICE SETTING: Rural regional community hospital. METHODOLOGY AND SAMPLE: We designed a comparative, descriptive survey study and enrolled a convenience sample of 222 patients (identified at admission) who provided informed consent. Sample characteristics and ESDP scores were collected during enrollment. The Problems After Discharge Questionnaire, EuroQoL-5Dimensions quality-of-life measure, length of stay, and use of post-acute care services were recorded after discharge. We compared outcomes between patients with low and high ESDP scores. RESULTS: More than half of the sample (51.8%) had a high ESDP score. Patients with high ESDP scores reported more problems after discharge (p = .02), reported lower quality of life (p < .001), had longer length of stays (p = .04), and used post-acute care services (p = .006) more than patients with low ESDP scores. The difference in the average percentage of unmet needs was not statistically significant (p = .12), but patients with high ESDP scores reported more unmet needs than patients with low ESDP scores. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: The value of systematically proactive approaches to discharge planning is increasingly recognized, but establishing the performance capacity of support tools is critical for optimizing benefit. These study findings support use of the ESDP in regional community hospitals, making it a useful, open-source decision support tool for various health care delivery systems.

Exploring indicators of use of costly health services in community-dwelling adults with multiple chronic conditions.

UNLABELLED: Although experts recognize that including patient functional and social variables would improve models predicting risk of using costly health services, these self-reported variables are not widely used. PURPOSE OF STUDY: Explore differences in predisposing characteristics, enabling resources, patient-perceived need for care and professionally evaluated need for care variables between patients receiving primary care within a Health Care Home who did and did not use hospital, emergency department, or skilled nursing facility services in a 3-month period of time. PRIMARY PRACTICE SETTING(S): Primary care. METHODOLOGY AND SAMPLE: Guided by the Behavioral Model of Health Service Use, a secondary analysis was conducted on data from a study that included 57 community-dwelling older adults receiving primary care in a Health Care Home. Because of the exploratory nature of the study, group differences in the use of costly care services were compared at the 0.10 level of statistical significance. RESULTS: Seventeen patients (29.8%) experienced costly care services. The greatest number of differences in variables between groups was in the category of patient-perceived need for care (functional impairments, dependencies, difficulties). IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: Targeting case management services using evidence-based decision support tools such as prediction models enhances the opportunity to maximize outcomes and minimize waste of resources. Patient-perceived and clinician-evaluated need for care may need to be combined to fully describe the contextual needs that drive the use of health services. Difficulty with Activities with Daily Living and Instrumental Activities of Daily Living should be considered in future studies as candidate predictor variables for need for case management services in primary care settings.

Preemptive genotyping for personalized medicine: design of the right drug, right dose, right time-using genomic data to individualize treatment protocol.

OBJECTIVE: To report the design and implementation of the Right Drug, Right Dose, Right Time-Using Genomic Data to Individualize Treatment protocol that was developed to test the concept that prescribers can deliver genome-guided therapy at the point of care by using preemptive pharmacogenomics (PGx) data and clinical decision support (CDS) integrated into the electronic medical record (EMR). PATIENTS AND METHODS: We used a multivariate prediction model to identify patients with a high risk of initiating statin therapy within 3 years. The model was used to target a study cohort most likely to benefit from preemptive PGx testing among the Mayo Clinic Biobank participants, with a recruitment goal of 1000 patients. We used a Cox proportional hazards model with variables selected through the Lasso shrinkage method. An operational CDS model was adapted to implement PGx rules within the EMR. RESULTS: The prediction model included age, sex, race, and 6 chronic diseases categorized by the Clinical Classifications Software for International Classification of Diseases, Ninth Revision codes (dyslipidemia, diabetes, peripheral atherosclerosis, disease of the blood-forming organs, coronary atherosclerosis and other heart diseases, and hypertension). Of the 2000 Biobank participants invited, 1013 (51%) provided blood samples, 256 (13%) declined participation, 555 (28%) did not respond, and 176 (9%) consented but did not provide a blood sample within the recruitment window (October 4, 2012, through March 20, 2013). Preemptive PGx testing included CYP2D6 genotyping and targeted sequencing of 84 PGx genes. Synchronous real-time CDS was integrated into the EMR and flagged potential patient-specific drug-gene interactions and provided therapeutic guidance. CONCLUSION: This translational project provides an opportunity to begin to evaluate the impact of preemptive sequencing and EMR-driven genome-guided therapy. These interventions will improve understanding and implementation of genomic data in clinical practice.

Enhancing patient-centered care: pilot study results of a community care team intervention.

Health care reform focuses on primary care and development of Health Care Homes to improve patient-centered chronic illness care. This pilot study evaluated a community care team intervention that linked chronically ill older patients, support persons, and nurse care coordinators from a Health Care Home with community resources using an adaptation of the Wraparound process. A pragmatic clinical trial design was used. Patient-centered chronic illness care; physical, mental, and social health; service use; and study feasibility were evaluated. Differences between groups were compared using two-sample t, Wilcoxon rank sum, chi-square, or Fisher's exact tests. At 3 months, the intervention group reported higher patient-centered chronic illness care (mean total Patient Assessment of Chronic Illness Care change scores were 0.39 for the intervention group and -0.11 for the control group, p = .03). Results indicate that the integrated community care team intervention is a promising strategy to support patient-centered chronic illness care.

Increased adherence to prenatal group B streptococcal screening guidelines through a paired electronic reminder and education intervention.

The 2010 Centers for Disease Control and Prevention (CDC) update on perinatal group B streptococcal (GBS) prevention advises universal vaginal-rectal GBS screening of pregnant women in the 35th through 37th week of gestation. Because GBS colonization is transient, a test performed more than 5 weeks before delivery may not have sufficient negative predictive value to be clinically useful. Our objective was to increase rates of quality-improved, CDC-adherent GBS screening and decrease repeat screening. A reminder for maternal vaginal-rectal GBS testing was added to the physicians' electronic ordering screen, and family medicine physicians and residents were educated about screening guidelines through standardized, in-person presentations. Retrospective chart review was performed before and after these interventions. Univariate or bivariate analysis was performed for demographic factors, timing of first screen, rates of CDC-adherent screening (the newly defined quality-improved screen and the usual screen), and rates of repeat and unnecessary screens. Multivariate analysis was performed with quality-improved and usual screening as dependent variables. Bivariate analysis showed that post-intervention rates of quality-improved screening increased from 30 to 62 % (P < .001), usual screening increased from 69 to 84 % (P = .005), and repeat GBS screening decreased from 20 to 8 % (P = .007). Multivariate analysis showed increased post-intervention odds of quality-improved screening [odds ratio (OR) 3.59; 95 % CI 2.07-6.34] and usual screening (OR 2.67; 95 % CI 1.40-5.25). Low-cost, reproducible quality improvement interventions (electronic order reminder, educational sessions) have the potential to increase guideline adherence for GBS screening in pregnant women and decrease repeat screening.

Developing a community care team: lessons learned from the community connections program, a health care home-community care team partnership.

This article describes the development of the Community Connections Program (CCP), a community care team, within a health care home (HCH), as a short-term, intensive, team-based service planning and coordination program for older adults with multiple chronic health conditions. Three proven approaches were combined to support patient's self-management, nurse care coordination, the Wraparound process, and use of community services. Particzpants'responses to the CCP demonstrated the success of the community care team in connecting patients and nurse care coordinators (NCCs) with community service providers, thus supplying primary care providers with important information regarding the development of a community care team to support patient-centered care within a HCH.

Does the "office nurse" level of training matter in the family medicine office?

BACKGROUND: The "office nurse" or clinical associate (registered nurse [RN], licensed practical nurse[LPN], or medical assistant [MA]) is a key member of the family medicine care team, but little is known about the influence of their level of training on team performance. METHODS: The performance of the clinical dyad (clinician and associate) was studied in relation to the level of training of the nurse. The dyad's performance was measured by the performance indicators of diabetes scores, patient satisfaction, and productivity. RESULTS: Dyads with a RN scored higher in meeting all 5 of the diabetes quality indicators (27.8%) than those with a LPN (19.3%) or an MA (14.7%). For patient satisfaction, the RN dyads also scored higher than the other dyad groups (positive responses: RN, 96.8%; LPN, 95.5%; MA, 94.6%). Productivity was the same in all groups. Better diabetes performance was seen in those practices with fewer competing demands: nonrural versus rural (22.2% vs 15.1%, respectively), and those not doing obstetrics versus those doing obstetrics (20.3% vs 15.1%, respectively), and for physicians versus associate providers (18.8% vs 15.1%, respectively). Higher patient satisfaction was observed in those dyads who were nonrural verus rural (96.6 vs 94.1%), among those doing obstetrics (96.0% vs 94.9%), and in physicians verus associate providers (95.7% vs 93.2%). The number of years working with the same clinician was twice as high for RNs (6.63) and LPNs (6.57) than for MAs (3.29). CONCLUSIONS: A higher level of education of the clinical associate seems to confer skills that enhance the care team's management of chronic illness such as diabetes. This could potentially decrease the practice burden on other team members while facilitating the team's objectives in meeting quality indicators.

A cross-sectional survey of the relationship between walking, biking, and the built environment for adults aged over 70 years.

PURPOSE: Determine the relationship between walkability scores (using the Walk Score(®)) and activity levels (both bicycle and walking) in adults aged between 70 and 85 years in Rochester, Minnesota. PATIENTS AND METHODS: This was a self-reported cross-sectional survey in adults aged over 70 years living in Rochester, Minnesota. Analysis used t-tests or chi-square analysis as appropriate. The primary endpoint was bicycle use or walking. The predictor variables were the Walk Score(®) as determined by their address, Charlson index, Duke Activity Status Index (DASI), and a 12-item short-form survey (SF-12) scores. Secondary analysis used an outcome of functional status (using the DASI) and walkability scores. RESULTS: Fifty-three individuals completed the surveys (48% return rate). The average age in the overall cohort was 77.02 years. Eighty-nine percent of individuals could walk at least a block and 15.1% rode their bicycles. The Walk Scores(®) did not differ between those who walked (38.9 ± 27.4) and those that did not (40.0 ± 36.08; P = 0.93). In a similar fashion, the Walk Scores(®) were not different for those who biked (36.38 ± 27.68) and those that did not (39.44 ± 28.49; P = 0.78). There was no relationship between Walk Scores(®) and DASI; however, a decreased DASI score was associated with increased age and comorbid illness (Charlson Score). CONCLUSION: In this small pilot survey, there was no difference in Walk Scores(®) between those older adults who walked or biked, compared to those that did not. The Walk Scores(®) were low in both groups, which may indicate the lack of accessibility for all older adults living in Rochester, Minnesota. The functional status seemed to be more related to age or comorbid conditions than the built environment.

Effect of vascular burden as measured by vascular indexes upon vascular dementia: a matched case-control study.

BACKGROUND: Vascular dementia (VaD) is a challenging illness that affects the lives of older adults and caregivers. It is unclear how multiple vascular risk factor exposures (polyvascular disease) affect VaD. PURPOSE: To determine the relationship between multiple vascular risk exposures, as counted on an index in cases with VaD, compared with healthy age-/gender-matched controls. METHODS: This was a matched case-control study of subjects living in Olmsted County, MN with documented VaD. Controls were selected by gender and age within 3 years from those who did not have dementia. The exposures included a total index (eleven exposure factors) added together, along with indexes for cerebrovascular disease (two exposures), cardiovascular disease (four exposures), vascular disease (three exposures), and lifestyle (two exposures). Analysis used matched conditional univariable logistic regression for each index. RESULTS: A total of 1736 potential subjects were identified, and 205 subjects were diagnosed with VaD. There was a significant association of the total score index with an odds ratio of 1.45 (95% confidence interval 1.21-1.74). The cerebrovascular index was also associated with VaD with an odds ratio of 12.18 (95% confidence interval 6.29-23.61). The cardiovascular and vascular indexes were also associated with VaD status. The lifestyle index was not associated with VaD. CONCLUSION: The cumulative role of multiple vascular risk factors or diseases increased the risk of VaD, as noted by the total vascular index. The lifestyle index did not reveal any significant differences. Further work is required for evaluation of these indexes.

Effect of alcohol and tobacco use on vascular dementia: a matched case control study.

BACKGROUND: Vascular dementia is the second most common type of dementia in the United States. The underlying association of tobacco and alcohol with vascular dementia is not completely understood. PURPOSE: Determine the relationship of tobacco and alcohol use with the development of vascular dementia (VaD). METHODS: This was a matched case-control study of subjects living in Olmsted County, MN. Cases of VaD were identified through medical record abstraction using conventionally accepted definitions of VaD, using the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Ensignement en Neurosicences ( NINDS-AIRENS) criteria and were matched to controls by gender and age within 3 years among persons free of dementia on the index date. Exposure data for alcohol and tobacco use were abstracted by trained nurses, along with demographic, lifestyle, cerebrovascular, cardiovascular, and vascular comorbid disease characteristics. Matched conditional logistic regression for univariate and multivariate evaluation of the association of tobacco and alcohol use with VaD was utilized. RESULTS: Current alcohol exposure was associated with a decreased risk of VaD with an odds ratio of 0.48 (95% confidence interval: 0.31-0.74). This protective effect of alcohol was seen in men, women, and subjects under 80 years of age. Tobacco use was not associated with VaD in univariate and multivariate analysis, and stratified analysis did not reveal any subgroup-specific associations between tobacco use and VaD in the study population. CONCLUSION: Current alcohol use appears to have protective effects against the development of vascular dementia. The effects are more pronounced in subjects under age 80. This may reflect the direct vascular effects of alcohol on the vascular system or may represent a surrogate for better social or functional status. Previous alcohol use was not protective. Tobacco use was not a risk factor for VaD status, which was possibly an indication of survivorship bias in the cohort.

A retrospective cohort study of factors that affect healing in long-term care residents with chronic wounds.

Chronic ulcers such as pressure, ischemic, and venous ulcers are common in long-term care (LTC) and frequently do not heal. A retrospective medical records review of all LTC residents referred to a wound consultative service between April 1999 and January 2007 was conducted to assess predictors of 6-month healing outcome. Variables abstracted and analyzed included wound, resident demographic, and laboratory values at diagnosis and comorbid medical illnesses. The average age of study participants (n = 397) was 78.1 years (+/- 11), 47% were men, 48% had more than one wound, and the most common wound diagnosis was pressure ulcer (n = 163). After 6 months, 66% of ulcers were not healed. The odds ratio for nonhealing was significantly higher in residents who had more wounds, a larger wound area, diabetes mellitus, or peripheral vascular disease and lower in residents with increased age and hemoglobin values and/or a history of stroke, depression, dementia, degenerative arthritis, peripheral neuropathy, and falls. After adjustment in the multivariate model, only the number of wounds and hemoglobin level remained significant predictors of healing status. A higher number of chronic ulcers and lower hemoglobin counts increased the risk of nonhealing after 6 months of care. Including these variables in LTC resident assessments may help clinicians ascertain expected outcomes of care.

The association of transient ischemic attack symptoms with memory impairment among elderly participants of the Third US National Health and Nutrition Examination Survey.

BACKGROUND AND PURPOSE: Stroke is a well-known risk factor for vascular dementia. However, the association of transient ischemic attacks with cognitive impairment is less well-established. METHODS: Records from Third National Health and Nutrition Examination Survey were abstracted for demographic and medical information for participants with an age >or=60 years who reported being free of stroke. Five self-reported symptoms (weakness, numbness, loss of vision, inability to speak, and severe dizziness) were used as surrogates representing transient ischemic attacks. Information on conventional risk factors for vascular dementia was also obtained. Multivariable logistic regression was used to examine risk factors for memory impairment. RESULTS: 4617 participants were included with a sample-weighted prevalence of memory impairment of 6.6% (1417 participants). The final multivariable analysis revealed a significant association between transient weakness and memory impairment (odds ratio 1.52, 95% CI 1.11-2.07). The other 4 transient ischemic attacks symptoms were not significantly associated with memory impairment in the final model. Systolic blood pressure >140 was most strongly associated with prevalent memory impairment (odds ratio, 9.78, 95% CI 1.49-64.3). Other associated risk factors included non-white race, male gender, age, education

Nelfinavir monotherapy increases naïve T-cell numbers in HIV-negative healthy young adults.

Although patients treated with HIV protease inhibitor (PI) containing regimens manifest increases in naïve T cell number, it is unclear whether this is due to reduction in viral replication or a direct drug effect. We questioned whether Nelfinavir monotherapy directly impacted naïve T-cell number in HIV-negative individuals. HIV-negative volunteers received Nelfinavir, 1250 mg orally, BID for 3 weeks, and T-cell receptor recombination excision circles (TREC) content in peripheral blood were assessed. Whereas TREC copies did not change over 3 weeks in untreated controls, TREC copies/copies CCR5 increased following Nelfinavir monotherapy in 8 patients (p < 0.02), and did not change in 7 patients (p = NS). Those patients who responded were younger than those who did not with a median age of 55 years for responders and 71 years for non-responders (p < 0.03). The increase in TREC was most pronounced in those patients less than 40-years old (p < 0.01). Moreover, the patients who did not increase TREC levels were more likely to have suffered a medical illness previously shown to reduce thymic function. In HIV-negative patients, monotherapy with the HIV PI Nelfinavir for 21 days increases TREC-positive naïve T cell number, particularly in individuals who are healthy and young.

Pneumococcal vaccination in adults: recommendations, trends, and prospects.

The US Centers for Disease Control and Prevention recommends vaccination against Streptococcus pneumoniae for all people age 65 and older and also for younger people at high risk. However, experts continue to debate the efficacy of the vaccine; most observational studies found it beneficial, while clinical trials were inconclusive as a group. Although pneumococcal vaccination may or may not protect against pneumonia or death from any cause, it does significantly decrease the risk of invasive pneumococcal disease and is worthwhile for this reason.

Meta-analyses in vaccinology.

The use of meta-analysis as a method for systematic review of the literature has grown substantially since its appearance in 1988. We obtained and reviewed 134 meta-analyses cited in Current Contents, MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews reporting original meta-analyses in human subjects regarding vaccines directed against infectious diseases and their sequelae. More than a fifth of the meta-analyses concerned influenza vaccines and almost a sixth concerned pneumococcal vaccines. Nearly 80% principally evaluated efficacy, effectiveness, and immunogenicity. We review three prominent meta-analyses to illustrate features of the methods and make several observations. These concern electronic searches, the Cochrane Collaboration, individual study heterogeneity, and individual study quality as well as the utility of meta-analyses despite the limitations and the likelihood of its endurance as a methodologic technique in vaccinology.

Studies of twins in vaccinology.

In this survey, we review published investigations and trials of vaccines among twins. We identified 29 original studies, dating back to 1979. The studies include determinations of the role of genetics and environment in the variation in immune response to vaccination, the investigation of adverse events in which vaccination was the suspected etiologic agent, and the occurrence of vaccine preventable diseases or their complications. Specific methods include case reports, cross-sectional surveys, prospective surveys, and double-blind, randomized, placebo-controlled, cross-over studies. We examine three of these studies in detail to illustrate important opportunities and limitations of twins studies in vaccinology.

Avian and pandemic influenza: an overview.

Influenza A/H5N1 (avian influenza) has now caused 258 human infections (as of November 13, 2006), with an approximate 50% mortality rate. Because the virus is novel in terms of antigenic type and causes infection and illness, and because humans have no pre-existing immunity, the conditions for a possible pandemic exist. Additionally, wild migratory birds appear to be spreading the virus across ever larger geographic areas, and newer clade 2 influenza A/H5N1 viruses have begun to emerge. The US Congressional Budget Office has formally modeled the likely consequences of pandemic influenza and estimates that up to 2 million of the US population might die, with up to 40% of all workers ill for as long as 3 or more weeks. This brief overview will review basic virologic, immunologic and epidemiologic information relevant to understanding and preparing for this threat. In particular, the role of avian influenza vaccines will be reviewed.