Drug Shortage Impacts Patient Receipt of Induction Treatment.

OBJECTIVE: Examine the impact of the 2011 shortage of the drug cytarabine on patient receipt and timeliness of induction treatment for Acute Myeloid Leukemia (AML). STUDY DESIGN: A retrospective cohort was utilized to examine odds of receipt of inpatient induction chemotherapy and time to first dose across major (N = 105) and moderate (N = 316) shortage time periods as compared to a nonshortage baseline (N = 1,147). DATA COLLECTION/EXTRACTION METHODS: De-identified patient data from 2008 to 2011 Surveillance, Epidemiology, and End Results (SEER) were linked to 2007-2013 Medicare claims and 2007-2013 Hospital Characteristics. PRINCIPAL FINDINGS: Compared to prior nonshortage time period, patients diagnosed during a major drug shortage were 47 percent less likely (p < .05) to receive inpatient chemotherapy within 14 days of diagnosis. Patients who were younger, had a lower Charlson Comorbidity score, and for whom AML was a first primary cancer were prioritized across all periods. CONCLUSIONS: Period of major shortage of a generic oncolytic, without an equivalent therapeutic substitute, reduced timely receipt of induction chemotherapy treatment. More favorable economic and regulatory policies for generic drug suppliers might result in greater availability of essential, older generic drug products that face prolonged or chronic shortage.

The California Competitive Model: How Has It Fared, And What's Next?

California became very successful in controlling rising health care costs by promoting price competition through market-based, managed care policies. However, recent data reveal that the state has not been able sustain its initial success in controlling growth in hospital prices. Two powerful trends emerged in California that eroded the conditions needed to sustain price competition. To ensure timely access to emergency hospital services, government regulators enacted regulations that had the unintended effect of giving hospitals tremendous leverage when contracting with health plans. Also, antitrust authorities allowed hospitals to consolidate into multihospital systems by adding members that were not direct competitors in local markets. The combined effect of these policies and consolidation trends was a substantial reduction in the competitiveness of provider markets in California, which reduced health plans' ability to leverage competitive provider markets and negotiate lower prices and other benefits for their members. Policy makers can and should act to restore competitive conditions.

Prognostic Value of Serum Proteomic Test and Comorbidity Index in Diversified Population with Lung Cancer.

BACKGROUND: The usefulness of serum proteomic test (VeriStrat) in African-Americans with non-small cell lung cancer (NSCLC) as well as the relationship between comorbidity and test performance have not been studied. MATERIALS AND METHODS: We reviewed records of patients with NSCLC in our practice for whom VeriStrat was performed to assist with the selection of therapy. We correlated survival with VeriStrat test classification, race, and comorbidity index using SAS software 9.4. RESULTS: We identified 49 qualified patients; 33 with VeriStrat Good (VSG), 16 with VeriStrat Poor (VSP). When stratified by VSG vs. VSP, overall survival (OS) did not differ between African-Americans and Whites [hazard ratio (HR)test (VSG/VSP)=0.78, 95% confidence interval (CI)=0.38-1.61; p=0.51]. OS adjusted for mean Charlson Comorbidity Index (CCI) was not different between erlotinib- and chemotherapy-treated groups in patients with non-squamous NSCLC (adjusted HR=0.91, 95% CI= 0.37-2.23; p=0.84), but was inferior in patients with squamous NSCLC treated with erlotinib (adjusted HR=10.6, 95% CI=1.28-87.8; p=0.029). Cox proportional hazard model for OS effect of VeriStrat test was estimated after adjusting for CCI. In both the VSG and VSP groups, a higher CCI value was associated with lower survival, and at any CCI value, the VSG group had better survival than the VSP group. CONCLUSION: Our study corroborates that race does not influence prognostic and predictive values of VeriStrat; however, comorbidities have a significant impact on survival in each proteomic stratum.

Mentoring in Clinical-Translational Research: A Study of Participants in Master's Degree Programs.

Research projects in translational science are increasingly complex and require interdisciplinary collaborations. In the context of training translational researchers, this suggests that multiple mentors may be needed in different content areas. This study explored mentoring structure as it relates to perceived mentoring effectiveness and other characteristics of master's-level trainees in clinical-translational research training programs. A cross-sectional online survey of recent graduates of clinical research master's program was conducted. Of 73 surveys distributed, 56.2% (n = 41) complete responses were analyzed. Trainees were overwhelmingly positive about participation in their master's programs and the impact it had on their professional development. Overall the majority (≥75%) of trainees perceived they had effective mentoring in terms of developing skills needed for conducting clinical-translational research. Fewer trainees perceived effective mentoring in career development and work-life balance. In all 15 areas of mentoring effectiveness assessed, higher rates of perceived mentor effectiveness was seen among trainees with ≥2 mentors compared to those with solo mentoring (SM). In addition, trainees with ≥2 mentors perceived having effective mentoring in more mentoring aspects (median: 14.0; IQR: 12.0-15.0) than trainees with SM (median: 10.5; IQR: 8.0-14.5). Results from this survey suggest having ≥2 mentors may be beneficial in fulfilling trainee expectations for mentoring in clinical-translational training.

A decade of investment in infection prevention: a cost-effectiveness analysis.

BACKGROUND: Health care-associated infection (HAI) rates have fallen with the development of multifaceted infection prevention programs. These programs require ongoing investments, however. Our objective was to examine the cost-effectiveness of hospitals' ongoing investments in HAI prevention in intensive care units (ICUs). METHODS: Five years of Medicare data were combined with HAI rates and cost and quality of life estimates drawn from the literature. Life-years (LYs), quality-adjusted LYs (QALYs), and health care expenditures with and without central line-associated bloodstream infection (CLABSI) and/or ventilator-associated pneumonia (VAP), as well as incremental cost-effectiveness ratios (ICERs) of multifaceted HAI prevention programs, were modeled. RESULTS: Total LYs and QALYs gained per ICU due to infection prevention programs were 15.55 LY and 9.61 QALY for CLABSI and 10.84 LY and 6.55 QALY for VAP. Reductions in index admission ICU costs were $174,713.09 for CLABSI and $163,090.54 for VAP. The ICERs were $14,250.74 per LY gained and $23,277.86 per QALY gained. CONCLUSIONS: Multifaceted HAI prevention programs are cost-effective. Our results underscore the importance of maintaining ongoing investments in HAI prevention. The welfare benefits implied by the advantageous ICERs would be lost if the investments were suspended.

School and Behavioral Outcomes Among Inner City Children: Five-Year Follow-Up.

Educational achievement is a key determinant of future life chances, but children growing up in poverty tend to do worse by many academic measures. Family, school, and neighborhood contextual characteristics may affect academic outcomes. In an attempt to explore neighborhood and individual level factors, we performed multilevel analyses to explain child's behavioral problems, repeat grade, average math and reading scores. Outcome measures were associated with specific neighborhood characteristics, above and beyond the effect of student/family level factors. The findings warrant further consideration of ecological interventions aiming to improve academic and behavioral outcomes of children living in poverty.

Long-term survival and healthcare utilization outcomes attributable to sepsis and pneumonia.

BACKGROUND: Hospital associated infections are major problems, which are increasing in incidence and very costly. However, most research has focused only on measuring consequences associated with the initial hospitalization. We explored the long-term consequences of infections in elderly Medicare patients admitted to an intensive care unit (ICU) and discharged alive, focusing on: sepsis, pneumonia, central-line-associated bloodstream infections (CLABSI), and ventilator-associated pneumonia (VAP); the relationships between the infections and long-term survival and resource utilization; and how resource utilization was related to impending death during the follow up period. METHODS: Clinical data and one year pre- and five years post-index hospitalization Medicare records were examined. Hazard ratios (HR) and healthcare utilization incidence ratios (IR) were estimated from state of the art econometric models. Patient demographics (i.e., age, gender, race and health status) and Medicaid status (i.e., dual eligibility) were controlled for in these models. RESULTS: In 17,537 patients, there were 1,062 sepsis, 1,802 pneumonia, 42 CLABSI and 52 VAP cases. These subjects accounted for 62,554 person-years post discharge. The sepsis and CLABSI cohorts were similar as were the pneumonia and VAP cohorts. Infection was associated with increased mortality (sepsis HR = 1.39, P < 0.01; and pneumonia HR = 1.58, P < 0.01) and the risk persisted throughout the follow-up period. Persons with sepsis and pneumonia experienced higher utilization than controls (e.g., IR for long-term care utilization for those with sepsis ranged from 2.67 to 1.93 in years 1 through 5); and, utilization was partially related to impending death. CONCLUSIONS: The infections had significant and lasting adverse consequences among the elderly. Yet, many of these infections may be preventable. Investments in infection prevention interventions are needed in both community and hospitals settings.

Strong government influence over the Israeli health care system has led to low rates of spending growth.

Israel reformed its health care system in 1995. In contrast to many other developed nations, it has since experienced relatively low rates of growth in health spending, even as health outcomes have continued to improve. This paper describes characteristics of the Israeli system that have helped control rising costs. We describe how the national government exerts direct operational control over a large proportion of total health care expenditures (39.1 percent in 2007) through a range of mechanisms, including caps on hospital revenue and national contracts with salaried physicians. The Ministry of Finance has been able to persuade the national government to agree to relatively small increases in the health care budget because the system has performed well, with a very high level of public satisfaction. It is unclear whether this success in health expenditure control can be sustained because of growing signs of strain within the system, the rapid increase in nongovernment financing for health care services, and the growing prosperity of Israeli society.

The relationship between safety net activities and hospital financial performance.

BACKGROUND: During the 1990's hospitals in the U.S were faced with cost containment charges, which may have disproportionately impacted hospitals that serve poor patients. The purposes of this paper are to study the impact of safety net activities on total profit margins and operating expenditures, and to trace these relationships over the 1990s for all U.S urban hospitals, controlling for hospital and market characteristics. METHODS: The primary data source used for this analysis is the Annual Survey of Hospitals from the American Hospital Association and Medicare Hospital Cost Reports for years 1990-1999. Ordinary least square, hospital fixed effects, and two-stage least square analyses were performed for years 1990-1999. Logged total profit margin and operating expenditure were the dependent variables. The safety net activities are the socioeconomic status of the population in the hospital serving area, and Medicaid intensity. In some specifications, we also included uncompensated care burden. RESULTS: We found little evidence of negative effects of safety net activities on total margin. However, hospitals serving a low socioeconomic population had lower expenditure raising concerns for the quality of the services provided. CONCLUSIONS: Despite potentially negative policy and market changes during the 1990s, safety net activities do not appear to have imperiled the survival of hospitals. There may, however, be concerns about the long-term quality of the services for hospitals serving low socioeconomic population.

Safety-net hospitals.

Vulnerable populations, who have difficulty accessing the health care system, primarily receive their medical care from hospitals. Policy makers have struggled to ensure the survival of "safety-net hospitals," hospitals that provide a disproportionate share of care to these patient populations. The objective of this article is to develop measures to guide analysis and policy for urban safety-net hospitals. The authors developed three safety-net measures: the socioeconomic status of hospital service area, Medicaid intensity, and uncompensated care burden and its market share. Cluster analysis was used to identify break points that distinguish a safety-net hospital from a non-safety-net hospital. The measures developed were stable and independent, but a data-driven binary assignment of hospitals to a "safety-net" category was not supported. These analyses call into question the empirical basis for distinguishing a specific group of hospitals as safety-net hospitals.

Is the impact of managed care on hospital prices decreasing?

Prior studies find that the growth of managed care through the early 1990s introduced a strong positive relationship between price and concentration in hospital markets. We hypothesize that the relaxation of constraints on consumer choice in response to a "managed care backlash" has diminished the price sensitivity of demand facing hospitals, reducing or possibly reversing the price-concentration relationship. We test this hypothesis by studying the price/concentration relationship for hospitals in California and Florida for selected years between 1990 and 2003, while addressing the potential endogeneity of concentration. We find an increasingly positive price/concentration in the 1990s with a peak occurring by 2001. Between 2001 and 2003, the growth in this relationship halts and possibly reverses.

Nurse working conditions and patient safety outcomes.

BACKGROUND: System approaches, such as improving working conditions, have been advocated to improve patient safety. However, the independent effect of many working condition variables on patient outcomes is unknown. OBJECTIVE: To examine effects of a comprehensive set of working conditions on elderly patient safety outcomes in intensive care units. DESIGN: Observational study, with patient outcome data collected using the National Nosocomial Infection Surveillance system protocols and Medicare files. Several measures of health status and fixed setting characteristics were used to capture distinct dimensions of patient severity of illness and risk for disease. Working condition variables included organizational climate measured by nurse survey; objective measures of staffing, overtime, and wages (derived from payroll data); and hospital profitability and magnet accreditation. SETTING AND PATIENTS: The sample comprised 15,846 patients in 51 adult intensive care units in 31 hospitals depending on the outcome analyzed; 1095 nurses were surveyed. MAIN OUTCOME MEASURES: Central line associated bloodstream infections (CLBSI), ventilator-associated pneumonia, catheter-associated urinary tract infections, 30-day mortality, and decubiti. RESULTS: Units with higher staffing had lower incidence of CLBSI, ventilator-associated pneumonia, 30-day mortality, and decubiti (P

Nurse working conditions, organizational climate, and intent to leave in ICUs: an instrumental variable approach.

OBJECTIVE: To investigate causes of nurse intention to leave (ITL) while simultaneously considering organizational climate (OC) in intensive care units (ICUs) and identify policy implications. DATA SOURCES/STUDY SETTING: Data were obtained from multiple sources including nurse surveys, hospital administrative data, public use, and Medicare files. Survey responses were analyzed from 837 nurses employed in 39 adult ICUs from 23 hospitals located in 20 separate metropolitan statistical areas. STUDY DESIGN: We used an instrumental variable technique to assess simultaneously the relationship between OC and ITL. We estimated ordinary least squares and reduced form regressions to determine the extent of simultaneity bias as well as the sensitivity of our results to the instrumental variable model specification. PRINCIPAL FINDINGS: Fifteen percent of the nurses indicated their ITL in the coming year. Based on the structural model, we found that nurses' ITL contributed little if anything directly to OC, but that OC and the tightness of the labor market had significant roles in determining ITL (p values <.05). Furthermore, OC was affected by the average regionally adjusted ICU wages, hospital profitability, teaching, and Magnet status (p values <.05). CONCLUSIONS: OC is an important determinant of ITL among ICU nurses. Because higher wages do not reduce ITL, increased pay alone without attention to OC is likely insufficient to reduce nurse turnover. Implementing interventions aimed at creating a positive OC, as found in Magnet hospitals, may be a more effective strategy.

Health-related quality of life consequences of implantable cardioverter defibrillators: results from MADIT II.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) improve survival and extend lives of patients with severe heart disease. OBJECTIVE: We sought to evaluate the impact of ICDs on health-related quality of life (HRQOL) during the first 3 years after implantation. SUBJECTS: A total of 1089 patients from the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) were randomized to an ICD or medical treatment only. MEASURES: Health Utility Index (HUI3) at baseline, 3, 12, 24, and 36 months following randomization; survival data. RESEARCH DESIGN: We constructed mean profiles of HRQOL for living patients, estimated overall quality-adjusted life years (QALYs), separately by treatment arm, and calculated cumulative QALY gains/losses as the difference between the areas under the treatment specific HRQOL profiles. Multivariate fixed effect regression models were developed to impute the missing HRQOL data using baseline patient characteristics (age, gender, treatment, HUI3 score, diabetes, diuretics use, and NYHA class). Bootstrapped standard errors were calculated for the estimated differences in HRQOL gains/losses between treatment arms. Similarly, we performed subgroup analyses (by gender, age, and baseline NYHA class, blood urine nitrogen, ejection fraction, and QRS). RESULTS: There were no differences in QALYs loss for living patients by treatment group (-0.037, P = 0.64) or in overall QALYs loss by treatment group (0.043, P = 0.37) over 3 years. In subgroup analysis, female subjects demonstrated a trend towards greater survival benefit (0.298, P = 0.07) and overall QALYs (0.261, P = 0.14). CONCLUSIONS: Adverse effects of the ICD on HRQOL together with lower HRQOL among survivors may offset the 3-year survival benefits of ICDs.

Safety-net activities and hospital contracting with managed care organizations.

This article studies factors of safety-net hospitals that affect contracting with managed-care organizations. Web-based data were used to identify the hospital networks of managed-care plans in 71 metropolitan statistical areas. We collected lists of hospitals from a national sample of managed-care plans. After combining these data with hospital, managed-care, and area characteristics, multivariate logistic regressions with random effects were estimated to determine hospital characteristics that influence the probability of a contract between the plan and hospital. Hospital characteristics included size, ownership, whether it was part of a system, teaching status, and safety-net activities. Managed-care plan characteristics included type of plan and ownership. Certain safety-net hospital measures and a cluster of related hospital characteristics are associated with a lower probability of contract. Hospitals accounting for a disproportionate share of safety-net activities are less likely to belong to managed-care networks, which may place them at a competitive disadvantage.

The cost effectiveness of implantable cardioverter-defibrillators: results from the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II.

OBJECTIVES: We sought to evaluate the cost implications of the implantable cardioverter-defibrillator (ICD), using utilization, cost, and survival data from the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II. BACKGROUND: This trial showed that prophylactic implantation of a defibrillator reduces the rate of mortality in patients who experienced a previous myocardial infarction and low left ventricular ejection fraction. Given the size of the eligible population, the cost effectiveness of the ICD has substantial implications. METHODS: Our research comprises the cost-effectiveness component of the randomized controlled trial, MADIT-II, based on utilization, cost, and survival information from 1,095 U.S. patients who were assigned randomly to receive an ICD or conventional medical care. Utilization data were converted to costs using a variety of national and hospital-specific data. The incremental cost-effectiveness ratio (iCER) was calculated as the difference in discounted costs divided by the difference in discounted life expectancy within 3.5 years. Secondary analyses included projections of survival (using three alternative assumptions), corresponding cost assumptions, and the resulting cost-effectiveness ratios until 12 years after randomization. RESULTS: During the 3.5-year period of the study, the average survival gain for the defibrillator arm was 0.167 years (2 months), the additional costs were 39,200 dollars, and the iCER was 235,000 dollars per year-of-life saved. In three alternative projections to 12 years, this ratio ranged from 78,600 dollars to 114,000 dollars. CONCLUSIONS: The estimated cost per life-year saved by the ICD in the MADIT-II study is relatively high at 3.5 years but is projected to be substantially lower over the course of longer time horizons.

Improved asthma care after enrollment in the State Children's Health Insurance Program in New York.

BACKGROUND: Uninsured children with asthma are known to face barriers to asthma care, but little is known about the impact of health insurance on asthma care. OBJECTIVES: We sought to assess the impact of New York's State Children's Health Insurance Program (SCHIP) on health care for children with asthma. DESIGN: Parents of a stratified random sample of new enrollees in New York's SCHIP were interviewed by telephone shortly after enrollment (baseline, n = 2644 [74% of eligible children]) and 1 year later (follow-up, n = 2310 [87%]). Asthma was defined by parent report using questions based on National Heart, Lung, and Blood Institute criteria. A comparison group (n = 401) who enrolled in SCHIP 1 year later was interviewed as a test for secular trends. MAIN OUTCOME MEASURES: Access (having a usual source of care [USC], unmet health needs, problems receiving acute asthma care), asthma-related medical visits, quality (continuity of care at the USC, problems receiving chronic asthma care, use of antiinflammatory medications), and asthma outcomes (change in asthma care or severity) were the main outcome measures used. Bivariate and multivariate analyses compared measures at baseline (year before SCHIP) versus follow-up (year during SCHIP). RESULTS: Three-hundred eighty-three children (14%) had asthma at baseline, and 364 had asthma at follow-up (16%). No secular trends were detected between the baseline study group and the comparison group. After enrollment in SCHIP, improvements were noted in access: lacking a USC (decrease from 5% to 1%), unmet health needs (48% to 21%), and problems getting to the USC for asthma (13 to 4%). Children had fewer asthma-related attacks and medical visits after SCHIP (mean number of attacks: 9.5 to 3.8: mean number of asthma visits: 3.0 to 1.5; hospitalizations: 11% to 3%). Quality of asthma care improved for general measures (most/all visits to USC: 53% to 94%; mean rating of provider: 7.9 to 8.8 of 10) and asthma-specific measures (problems getting to the USC for asthma care when child was well: 13% to 1%). More than two thirds of the parents at follow-up reported that both quality of asthma care and asthma severity were "better or much better" than at baseline, generally because of insurance coverage or lower costs of medications and medical care. CONCLUSIONS: Enrollment in New York's SCHIP was associated with improvements in access to asthma care, quality of asthma care, and asthma-specific outcomes. These findings suggest that health insurance improves the health of children with asthma.

Evidence of cost shifting in California hospitals.

We used 1993-2001 data from private hospitals in California to investigate whether decreases in Medicare and Medicaid prices were associated with increases in prices paid for privately insured patients. We found that a 1 percent relative decrease in the average Medicare price is associated with a 0.17 percent increase in the corresponding price paid by privately insured patients; similarly, a 1 percent relative reduction in the average Medicaid price is associated with a 0.04 percent increase. These relationships imply that cost shifting from Medicare and Medicaid to private payers accounted for 12.3 percent of the total increase in private payers' prices from 1997 to 2001.

Has price competition changed hospital revenues and expenses in New York?

This study analyzes the factors that influenced hospital expenses and revenues prior to and following the enactment of the New York State Health Care Reform Act of 1996 (HCRA)-the period from 1994-1999. HCRA was expected to encourage price competition which in turn was anticipated to lower hospital revenues and expenses. We measured the differential effects on hospital revenues and expenses in markets with varying degrees of competition. We also measured the relationship between hospital revenues and expenses and the increased concentration resulting from the formation of local hospital systems. We found that revenues and expenses both grew more slowly for hospitals located in more competitive markets; hospital systems that increased concentration tended to have higher revenues. In the short run at least, price competition induced by HCRA did constrain both hospital expense and revenue growth, although the increase in hospital mergers countered this trend.