Nephrolithiasis and renal failure among patients exposed to atazanavir, other PIs and PI-free regimens.

INTRODUCTION: Recent single-site studies and case reports have linked atazanavir (ATV) with the occurrence of nephrolithiasis. The purpose of this study was to estimate and compare the incidence rate of nephrolithiasis and to characterize the occurrence of subsequent renal failure among patients on ATV, other protease inhibitors (PIs) and PI-free regimens using real world data. MATERIALS AND METHODS: This was a retrospective cohort analysis using claims data from a US commercial and a US public health insurance database (Medicaid) spanning 2003-2011 and 2006-2011, respectively. We identified adult HIV patients who were prescribed ATV, other PIs or PI-free regimens with at least 6 months of continuous enrolment prior to the index claim. Nephrolithiasis was defined as an inpatient or outpatient ICD-9 diagnosis code for nephrolithiasis or an associated condition, plus an imaging/corrective procedure code. Renal failure was also identified using diagnosis codes among patients experiencing nephrolithiasis. Hazard ratios were estimated using propensity score (PS) adjusted Cox regression, crude and adjusted for demographics, baseline comorbidities and comedications. RESULTS: A total of 14,477 patients (ATV: 4,150; other PIs: 4,153; PI-free: 6,174) were identified in the commercial database: 83% male and 20% age ≥50 years. In the Medicaid database, 9,104 patients (ATV: 3,460; other PIs: 3,117; PI-free: 2,527) were identified: 53% male and 25% age ≥50 years. There were significant baseline differences in demographics, comorbidities and concomitant medications among the three cohorts. In adjusted analyses, ATV use was not significantly associated with nephrolithiasis when compared to other PIs. When ATV was compared to PI-free regimens, a positive association was observed in the commercial insurance but not the Medicaid database. In both databases, previous history of nephrolithiasis was the strongest predictor of nephrolithiasis in the ATV/PI-free regimens contrast, but not the ATV/other PIs contrast. For the renal failure outcomes, there were insufficient cases across all cohorts to conduct crude or adjusted analyses (see Table 1). CONCLUSIONS: In this analysis of two large real world databases, we did not find evidence of an increased risk of nephrolithiasis among patients on ATV compared to other PIs. However, when ATV was compared to PI-free regimens, the results differed across the two databases, requiring further study. Additionally, renal failure following nephrolithiasis was infrequent and not significantly different across the three cohorts.

The risk of long-term morbidity and mortality in patients with chronic hepatitis C: results from an analysis of data from a Department of Veterans Affairs Clinical Registry.

IMPORTANCE: The impact of viral load suppression, genotype, race, and other factors on the risk of late-stage liver-related events in patients with hepatitis C (HCV) has been assessed previously using data from small observational cohorts or clinical trials. Data from large real-world practice samples are needed to improve risk factor estimates for late-stage liver events and death in HCV. OBJECTIVE: To describe the natural history of HCV in real-world clinical practice. DESIGN, SETTING, AND PARTICIPANTS: Observational cohort study. Patients with a detectable viral load (>25 IU/mL) and a recorded baseline genotype were selected from the Veterans Affairs (VA) HCV clinical registry (CCR), which compiles electronic medical records data from 1999 to present. EXPOSURES: Risk factors included genotype, race, age, sex, and time to achieving an observed undetected viral load. MAIN OUTCOMES AND MEASURES: The primary outcomes were time to death and time to a composite of liver-related clinical events. Secondary outcomes included the components of the composite clinical outcome. Outcomes were measured using a time-to-event format and were analyzed using Cox proportional hazards models. RESULTS A total of 28,769 of 360,857 unique HCV CCR patients met all study criteria. Only 24.3% of patients received treatment, and 16.4% of treated patients (4.0% of all patients) achieved an undetectable viral load. The unadjusted death rates were 6.8 (95% CI, 6.0-7.7) per 1000 person-years for patients who achieved viral load suppression vs 21.8 (95% CI, 21.5-22.2) deaths per 1000 person-years in patients who did not achieve this goal. Cox model results found that achieving viral suppression reduced risk of the composite clinical end point by 27% (hazard ratio [HR], 0.73 [95% CI, 0.66-0.82]) and the risk of death by 45% (HR, 0.55 [95% CI, 0.47-0.64]). Genotype 2 patients were at significantly lower risk, and genotype 3 patients were at higher risk for all study outcomes relative to genotype 1. Black patients were at lower risk for all liver events than white patients. CONCLUSION AND RELEVANCE: Achieving an undetectable viral load was associated with decreased hepatic morbidity and mortality. It remains to be determined whether newer treatment regimens can offer higher response rates with fewer adverse effects in real-world settings.

Medicaid reform: are you ready?

Hospitals and health systems should follow a four-step process to evaluate their state's Medicaid initiatives and to develop new care models to better manage the Medicaid patient populations they serve: Perform an initial assessment. Identify opportunities and risks. Develop a business plan. Implement the plan.

Designing the role of the embedded care manager.

PURPOSE/OBJECTIVES: : The role of the professional case manager is changing rapidly. Health reform has called upon the industry to ensure that care is delivered in an efficient, effective, and high-quality and low cost manner. As a means to achieve this objective, health plans and health systems are moving the care manager out of a centralized location within their organizations to "embedding" them into physician offices. This move enables the care manager to work alongside the primary care physicians and their high-risk patients. This article discusses the framework for designing and implementing an embedded care manager role into a physician practice. Key elements of the program are discussed. IMPLICATIONS FOR CARE MANAGEMENT:: Historically care management has played a foundational role in improving the quality of care for individuals and populations via the efficient and effective use of resources. Now with the goals of health care reform, a successful transition from a volume-based to value-based reimbursement system requires primary care physicians to welcome care managers into their practices to improve patient care, quality, and costs through care coordination across health care settings and populations. PRIMARY PRACTICE SETTING(S): : As patient-centered medical homes and integrated delivery systems formulate their plans for population health management, their efforts have included embedding a care manager in the primary practice setting. Having care managers embedded at the physician offices increases their ability to collaborate with the physician and their staff in the implementation and monitoring care plans for their patients. FINDINGS/CONCLUSIONS: : Implementing an embedded care manager into an existing physician's practice requires the following:Although the embedded care manager is a highly evolving role, physician groups are beginning to realize the benefits from their care management collaborations. Examples cited include improved outreach and coordination, patient adherence to care plans, and improved quality of life.

Leadership development and succession planning in case management.

PURPOSE/OBJECTIVES: The director of case management is one of health care's leadership positions most frequently in demand. The lack of qualified and effective case management leaders will continue to be an issue for organizations for years to come, influenced by increasing pressures on health care reimbursement and the aging case management workforce. Organizations have an opportunity to create a program to develop future case management leaders from their internal talent. PRIMARY PRACTICE SETTING(S): The proposed strategies are designed for the acute care hospital but also have applicability in other health care settings where there are case managers and a need for case management leadership. FINDINGS/CONCLUSIONS: The business community offers leadership research and leadership development models with relevance to case management. Identifying and developing internal talent for leadership roles has been proven to be effective in preparation for advanced responsibilities, has a positive effect on staff morale, and minimizes the impact of vacant leadership positions during recruitment and onboarding activities. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: Creating a case management leadership development program for an organization can be an alternative to the process of external recruitment for case management department leaders. Such a program can be undertaken even in today's budget conscious environment by accessing existing resources in an organization in a creative and organized manner. The authors outline an approach for case management leaders to accept responsibility for succession planning and for case managers to accept responsibility for promoting their own career development through creation of a leadership development program.

Proposed severity and response criteria for Routine Assessment of Patient Index Data (RAPID3): results for categories of disease activity and response criteria in abatacept clinical trials.

BACKGROUND: An index is needed to assess the status of patients with rheumatoid arthritis (RA), as none of the existing measures are applicable to all individual patients. The 28-joint Disease Activity Score (DAS28) is the most specific and widely used index. Routine Assessment of Patient Index Data (RAPID3) is an index containing only the 3 patient self-report core dataset measures, without a laboratory test or formal joint count, and with simple scoring. RAPID3 is correlated significantly with DAS28, but calculated in 5-10 seconds on a Multidimensional Health Assessment Questionnaire (MDHAQ), compared to 114 seconds for DAS28. METHODS: DAS28 (0-10 scale) categories for high, moderate, and low activity, and remission (≤ 2.6, 2.6-3.2, 3.21-5.1, and > 5.1, respectively) and proposed RAPID3 (0-30 scale) categories for severity (0 ≤ 3, 3.1-6, 6.1-12, and > 12) were compared in patients taking abatacept and control-treated patients at the endpoint of the Abatacept in Inadequate Response to Methotrexate (AIM) and the Abatacept Trial in Treatment of Anti-TNF INadequate Responders (ATTAIN) clinical trials, using cross-tabulations and kappa statistics. RESULTS: Overall, 92%-99% of patients classified as having high DAS28 activity had high or moderate RAPID3 severity, while 64%-83% in DAS28 remission had RAPID3 low severity or remission; 50%-82% of patients with good or poor EULAR responses had good or poor RAPID3 responses. Kappa values ranged from 0.25 to 0.48, and weighted kappas from 0.32 to 0.52, indicating fair to moderate agreement for the 2 indices. CONCLUSION: Proposed RAPID3 severity and response categories yield comparable results to DAS28 and EULAR criteria in AIM and ATTAIN. DAS28 is more specific for clinical trials. RAPID3 does not preclude also scoring DAS28, and may be informative in the infrastructure of routine care.

Preventing heart failure readmissions: is your organization prepared?

Many hospitals and health care systems are focusing on improving performance and patient outcomes in cardiovascular services, with a particular emphasis on how the management of heart failure can prevent readmissions, decrease the cost per case, and improve the quality and satisfaction for this particular patient population. Quality outcomes and optimal lifestyle management of chronic care diseases, such as heart failure (HF), will be deciding factors in patient choice about health care providers and systems. Implementing heart failure programs or heart failure readmission reduction strategies are undertakings that require significant analysis, planning, preparation, and execution. Given the significant volumes of HF readmissions, as well as numerous potential policy changes focused on reducing costs, properly aligning incentives, and improving quality, HF may be an ideal place to start to begin initiatives around readmission reduction. For an organization to identify and execute appropriate strategies, a structured approach to assessment and implementation can ensure the highest likelihood of success.

The changing reimbursement landscape: nurses' role in quality and operational excellence.

Operational excellence, care quality, and financial performance are increasingly linked as key drivers of hospital performance. This environment may be seen as a challenge, but it is also an excellent opportunity for nursing services to further demonstrate their value in patient care outcomes and support financial performance. Nursing contributions toward reduced complications, reductions in length of stay, and lower costs per case should be measured, rewarded, and made transparent to the public. Staff nurses should not view quality as simply another task on which to focus their attention, but rather a continuous process that requires critical thinking about how care is delivered and its effect on the entire care progression of a patient. Nursing management must focus on continually educating their staff on appropriate care, as well as developing and supporting a culture of safety and accountability. Nursing leadership must improve nurse retention and recruiting efforts, encourage interdisciplinary collaboration and, most importantly, demonstrate to the rest of the organization the value nursing brings to the organization through consistently tracking quality and financial indicators and tying them to nursing initiatives.

Changing patterns of tumor necrosis factor inhibitor use in 9074 patients with rheumatoid arthritis.

OBJECTIVE: Patients with rheumatoid arthritis (RA) commonly switch between tumor necrosis factor (TNF) inhibitors after failing to control disease activity. Much of the clinical data that support switching to a second TNF agent when one agent fails to work has come from small, short-term studies. We utilized a US insurance claims database to determine patterns of use such as dose escalation, time to discontinuation, and switching between TNF inhibitors in patients with RA. METHODS: A retrospective analysis was performed using an insurance claims database in the US from 2000 to 2005. TNF inhibitor use, time to switch, dose escalation, and continuation times were analyzed in patients with RA. RESULTS: Nine thousand seventy-four patients with RA started TNF inhibitors during the period 2000 to 2005. Etanercept was the most commonly used TNF inhibitor; infliximab had the highest duration of continuation, about 50% at 2 years. In addition, infliximab showed higher rates of dose escalation compared to etanercept and adalimumab. For all TNF inhibitors, time to switching decreased from 2000 to 2005. CONCLUSION: TNF inhibitor use patterns changed from 2000 to 2005, with more frequent changes among the different TNF inhibitors and a shorter duration of treatment before the change. Only about 50% of TNF inhibitors are still continued at 2 years, reflecting the difference between randomized clinical trials and real-world experience.

Hyperlipidemia following treatment with antipsychotic medications.

OBJECTIVE: This study attempted to estimate the relative risk of developing hyperlipidemia after treatment with antipsychotics in relation to no antipsychotic treatment. METHOD: A matched case-control analysis was performed with pharmacy and claims data from California Medicaid (Medi-Cal). Patients were excluded if they were treated for medical disorders or prescribed medications known to increase their risk of hyperlipidemia. Cases were ages 18 to 64 years with schizophrenia, major depression, bipolar disorder, or other affective psychoses and incident hyperlipidemia. Cases were matched to up to six control subjects by age, sex, race, and psychiatric diagnosis. Both groups were prescribed either no antipsychotic medication or had two or more prescriptions for one and only one antipsychotic medication during the 60 days prior to the first indication of hyperlipidemia (cases) or matched index date (controls) in the billing record. Conditional logistic regressions were used to derive odds ratios and 95% confidence intervals (95% CIs) of each antipsychotic medication in relation to no antipsychotic medication. RESULTS: A total of 13,133 incident cases of hyperlipidemia were matched to 72,140 control subjects. As compared with no antipsychotic medication, treatment with clozapine (odds ratio: 1.82, 95% CI: 1.61-2.05), risperidone (odds ratio: 1.53, 95% CI: 1.43-1.64), quetiapine (odds ratio: 1.52, 95% CI: 1.40-1.65), olanzapine (odds ratio: 1.56, 95% CI: 1.47-1.67), ziprasidone (odds ratio: 1.40, 95% CI: 1.19-1.65), and first-generation antipsychotics (odds ratio: 1.26, 95% CI: 1.14-1.39), but not aripiprazole (odds ratio: 1.19, 95% CI: 0.94-1.52) was associated with a significant increase in risk of incident hyperlipidemia. CONCLUSIONS: These findings suggest that most commonly prescribed antipsychotic medications increase the risk of developing hyperlipidemia in patients with schizophrenia or mood disorders.

The effects of congenital heart disease on cognitive development, illness causality concepts, and vulnerability.

This study suggests that childhood cardiac illness has a depressive impact on the attainment of conservation tasks, but does not affect illness causality conceptualization. The group of twelve ill children studied appeared to feel somewhat more vulnerable to illness in general, especially when projecting to adult health status, than did a matched group of healthy children.

The role of cognitive level and sibling illness in children's conceptualizations of illness.

Levels of illness conceptualization were studied among children with diabetic siblings. Results revealed a significant association between pretested Piagetian level of cognitive development and illness conceptualization. Children with ill siblings, especially those at the formal operational level, demonstrated lower conceptualization levels than did children with healthy siblings.