Pharmacogenomic test that predicts response to inhaled corticosteroids in adults with asthma likely to be cost-saving.

AIM: To identify the clinical and economic circumstances under which a pharmacogenomic test that predicts response to inhaled corticosteroids might be a cost-effective option for individuals with asthma. MATERIALS & METHODS: We synthesized published data on clinical and economic outcomes to project 10-year costs, quality-adjusted life-years and cost-effectiveness of pharmacogenomic testing for inhaled corticosteroid response. We assumed the pharmacogenomic test cost was $500 with a sensitivity and specificity of 84 and 98%, respectively. These were varied in sensitivity analyses. RESULTS: Both strategies, pharmacogenomic testing for inhaled corticosteroid response and no testing conferred 7.1 quality-adjusted life-years. Compared with no testing, pharmacogenomic testing costs less. CONCLUSION: Pharmacogenomic testing for asthma is cost-saving and noninferior in improving health. Original submitted 19 November 2014; Revision submitted 23 February 2015.

Cost-effectiveness of strategies to prevent methicillin-resistant Staphylococcus aureus transmission and infection in an intensive care unit.

OBJECTIVE To create a national policy model to evaluate the projected cost-effectiveness of multiple hospital-based strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) transmission and infection. DESIGN Cost-effectiveness analysis using a Markov microsimulation model that simulates the natural history of MRSA acquisition and infection. PATIENTS AND SETTING Hypothetical cohort of 10,000 adult patients admitted to a US intensive care unit. METHODS We compared 7 strategies to standard precautions using a hospital perspective: (1) active surveillance cultures; (2) active surveillance cultures plus selective decolonization; (3) universal contact precautions (UCP); (4) universal chlorhexidine gluconate baths; (5) universal decolonization; (6) UCP + chlorhexidine gluconate baths; and (7) UCP+decolonization. For each strategy, both efficacy and compliance were considered. Outcomes of interest were: (1) MRSA colonization averted; (2) MRSA infection averted; (3) incremental cost per colonization averted; (4) incremental cost per infection averted. RESULTS A total of 1989 cases of colonization and 544 MRSA invasive infections occurred under standard precautions per 10,000 patients. Universal decolonization was the least expensive strategy and was more effective compared with all strategies except UCP+decolonization and UCP+chlorhexidine gluconate. UCP+decolonization was more effective than universal decolonization but would cost $2469 per colonization averted and $9007 per infection averted. If MRSA colonization prevalence decreases from 12% to 5%, active surveillance cultures plus selective decolonization becomes the least expensive strategy. CONCLUSIONS Universal decolonization is cost-saving, preventing 44% of cases of MRSA colonization and 45% of cases of MRSA infection. Our model provides useful guidance for decision makers choosing between multiple available hospital-based strategies to prevent MRSA transmission.

Pharmacogenomic test that predicts response to ß2-agonists in adults with asthma is cost effective.

BACKGROUND: Pharmacogenomic tests that predict which asthma patients are likely to respond to ß2-agonists hold promise to improve care for asthma. OBJECTIVE: To identify the clinical and economic circumstances under which a pharmacogenomic test that predicts response to ß2-agonists might or might not be an appropriate, cost-effective option. METHODS: We synthesized published data on clinical and economic outcomes in adults 18-35 to project 10-year costs, quality-adjusted life years and cost-effectiveness of pharmacogenomic testing for ß2-agonist response. RESULTS: Pharmacogenomic testing for ß2-agonist response conferred a cost-effectiveness ratio of $13,700 per quality-adjusted life year gained compared with no testing. CONCLUSION: Pharmacogenomic testing for ß2-agonist response in individuals with asthma is potentially cost effective and should be pursued by test developers.

Health care-associated infections among critically ill children in the US, 2007-2012.

BACKGROUND: Health care-associated infections (HAIs) are harmful and costly and can result in substantial morbidity for hospitalized children; however, little is known about national trends in HAIs in neonatal and pediatric populations. Our objective was to determine the incidence of HAIs among a large sample of hospitals in the United States caring for critically ill children from 2007 to 2012. METHODS: In this cohort study, we included NICUs and PICUs located in hospitals reporting data to the Centers for Disease Control and Prevention's National Healthcare Safety Network for central line-associated bloodstream infections (CLABSIs), ventilator-associated pneumonias, and catheter-associated urinary tract infections. We used a time-series design to evaluate changes in HAI rates. RESULTS: A total of 173 US hospitals provided data from NICUs, and 64 provided data from PICUs. From 2007 to 2012, rates of CLABSIs decreased in NICUs from 4.9 to 1.5 per 1000 central-line days (incidence rate ratio (IRR) per quarter = 0.96, 95% confidence interval 0.94-0.97) and in PICUs from 4.7 to 1.0 per 1000 central-line days (IRR per quarter = 0.96 [0.94-0.98]). Rates of ventilator-associated pneumonias decreased in NICUs from 1.6 to 0.6 per 1000 ventilator days (IRR per quarter = 0.97 [0.93-0.99]) and PICUs from 1.9 to 0.7 per 1000 ventilator-days (IRR per quarter = 0.95 [0.92-0.98]). Rates of catheter-associated urinary tract infections did not change significantly in PICUs. CONCLUSIONS: Between 2007 and 2012 there were substantial reductions in HAIs among hospitalized neonates and children.

Impact of Medicare's payment policy on mediastinitis following coronary artery bypass graft surgery in US hospitals.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) implemented a policy in October 2008 to eliminate additional Medicare payment for mediastinitis following coronary artery bypass graft (CABG) surgery. OBJECTIVE: To evaluate the impact of this policy on mediastinitis rates, using Medicare claims and National Healthcare Safety Network (NHSN) prospective surveillance data. METHODS: We used an interrupted time series design to compare mediastinitis rates before and after the policy, adjusted for secular trends. Billing rates came from Medicare inpatient claims following 638,761 CABG procedures in 1,234 US hospitals (January 2006-September 2010). Prospective surveillance rates came from 151 NHSN hospitals in 29 states performing 94,739 CABG procedures (January 2007-September 2010). Logistic regression mixed-effects models estimated trends for mediastinitis rates. RESULTS: We found a sudden drop in coding for index admission mediastinitis at the time of policy implementation (odds ratio, 0.36 [95% confidence interval (CI), 0.23-0.57]) and a decreasing trend in coding for index admission mediastinitis in the postintervention period compared with the preintervention period (ratio of slopes, 0.83 [95% CI, 0.74-0.95]). However, we saw no impact of the policy on infection rates as measured using NHSN data. Our results were not affected by changes in patient risk over time, heterogeneity in hospital demographics, or timing of hospital participation in NHSN. CONCLUSIONS: The CMS policy of withholding additional Medicare payment for mediastinitis on the basis of claims-based evidence of infection was associated with changes in coding for infections but not with changes in actual infection rates during the first 2 years after policy implementation.

Effect of nonpayment for preventable infections in U.S. hospitals.

BACKGROUND: In October 2008, the Centers for Medicare and Medicaid Services (CMS) discontinued additional payments for certain hospital-acquired conditions that were deemed preventable. The effect of this policy on rates of health care-associated infections is unknown. METHODS: Using a quasi-experimental design with interrupted time series with comparison series, we examined changes in trends of two health care-associated infections that were targeted by the CMS policy (central catheter-associated bloodstream infections and catheter-associated urinary tract infections) as compared with an outcome that was not targeted by the policy (ventilator-associated pneumonia). Hospitals participating in the National Healthcare Safety Network and reporting data on at least one health care-associated infection before the onset of the policy were eligible to participate. Data from January 2006 through March 2011 were included. We used regression models to measure the effect of the policy on changes in infection rates, adjusting for baseline trends. RESULTS: A total of 398 hospitals or health systems contributed 14,817 to 28,339 hospital unit-months, depending on the type of infection. We observed decreasing secular trends for both targeted and nontargeted infections long before the policy was implemented. There were no significant changes in quarterly rates of central catheter-associated bloodstream infections (incidence-rate ratio in the postimplementation vs. preimplementation period, 1.00; P=0.97), catheter-associated urinary tract infections (incidence-rate ratio, 1.03; P=0.08), or ventilator-associated pneumonia (incidence-rate ratio, 0.99; P=0.52) after the policy implementation. Our findings did not differ for hospitals in states without mandatory reporting, nor did it differ according to the quartile of percentage of Medicare admissions or hospital size, type of ownership, or teaching status. CONCLUSIONS: We found no evidence that the 2008 CMS policy to reduce payments for central catheter-associated bloodstream infections and catheter-associated urinary tract infections had any measurable effect on infection rates in U.S. hospitals. (Funded by the Agency for Healthcare Research and Quality.).

Delayed and forgone care for families with chronic conditions in high-deductible health plans.

BACKGROUND: High-deductible health plans (HDHPs) are an increasingly common strategy to contain health care costs. Individuals with chronic conditions are at particular risk for increased out-of-pocket costs in HDHPs and resulting cost-related underuse of essential health care. OBJECTIVE: To evaluate whether families with chronic conditions in HDHPs have higher rates of delayed or forgone care due to cost, compared with those in traditional health insurance plans. DESIGN: This mail and phone survey used multiple logistic regression to compare family-level rates of reporting delayed/forgone care in HDHPs vs. traditional plans. PARTICIPANTS: We selected families with children that had at least one member with a chronic condition. Families had employer-sponsored insurance in a Massachusetts health plan and >12 months of enrollment in an HDHP or a traditional plan. MAIN MEASURES: The primary outcome was report of any delayed or forgone care due to cost (acute care, emergency department visits, chronic care, checkups, or tests) for adults or children during the prior 12 months. RESULTS: Respondents included 208 families in HDHPs and 370 in traditional plans. Membership in an HDHP and lower income were each independently associated with higher probability of delayed/forgone care due to cost. For adult family members, the predicted probability of delayed/forgone care due to cost was higher in HDHPs than in traditional plans [40.0% vs 15.1% among families with incomes <400% of the federal poverty level (FPL) and 16.0% vs 4.8% among those with incomes ≥400% FPL]. Similar associations were observed for children. CONCLUSIONS: Among families with chronic conditions, reporting of delayed/forgone care due to cost is higher for both adults and children in HDHPs than in traditional plans. Families with lower incomes are also at higher risk for delayed/forgone care.

Nearly half of families in high-deductible health plans whose members have chronic conditions face substantial financial burden.

High-deductible health plans-typically with deductibles of at least $1,000 per individual and $2,000 per family-require greater enrollee cost sharing than traditional plans. But they also may provide more affordable premiums and may be the lowest-cost, or only, coverage option for many families with members who are chronically ill. We surveyed families with chronic conditions in high-deductible plans and families in traditional plans to compare health care-related financial burden-such as experiencing difficulty paying medical or basic bills or having to set up payment plans. Almost half (48 percent) of the families with chronic conditions in high-deductible plans reported health care-related financial burden, compared to 21 percent of families in traditional plans. Almost twice as many lower-income families in high-deductible plans spent more than 3 percent of income on health care expenses as lower-income families in traditional plans (53 percent versus 29 percent). As health reform efforts advance, policy makers must consider how to modify high-deductible plans to reduce the financial burden for families with chronic conditions.

Preferences for health outcomes associated with Group A Streptococcal disease and vaccination.

BACKGROUND: A 26-valent Group A Streptococcus (GAS) vaccine candidate has been developed that may provide protection against pharyngitis, invasive disease and rheumatic fever. However, recommendations for the use of a new vaccine must be informed by a range of considerations, including parents' preferences for different relevant health outcomes. Our objectives were to: (1) describe parent preferences for GAS disease and vaccination using willingness-to-pay (WTP) and time trade-off (TTO) methods; and (2) understand how parents' implied WTP for a quality-adjusted life year (QALY) gained might vary depending on the particular health outcome considered (e.g. averted GAS disease vs. vaccine adverse events). METHODS: Telephone interviews were conducted with parents of children diagnosed with GAS pharyngitis at 2 pediatric practice sites in the Boston metropolitan area. WTP and TTO (trading parental longevity for child's health) questions for 2 vaccine and 4 disease-associated health states were asked using a randomly selected opening bid, followed by a 2nd bid and a final open-ended question about the amount willing to pay or trade. Descriptive analyses included medians and interquartile ranges for WTP and TTO estimates. The Wilcoxon signed-rank test was used to assess differences in WTP/QALY values for vaccine adverse events vs. disease states. RESULTS: Of 119 respondents, 100 (84%) and 96 (81%) provided a complete set of responses for WTP and TTO questions, respectively. The median WTP and discounted (at 3% per year) TTO values to avoid each health state were as follows: local reaction, $30, 0.12 days; systemic reaction, $50, 0.22 days; impetigo, $75, 1.25 days; strep throat, $75, 2.5 days; septic arthritis, $1,000, 6.6 days; and toxic shock syndrome, $3,000, 31.0 days. The median WTP/QALY was significantly higher for vaccine adverse events (approximately $60,000/QALY) compared to disease states ($18,000 to $36,000/QALY). CONCLUSIONS: Parents strongly prefer to prevent GAS disease in children compared to vaccine adverse events. However, implied WTP/QALY ratios were higher for the prevention of vaccine adverse events. Regret for errors of commission vs. omission may differ and should be considered by vaccine policymakers.

Asthma care quality for children with minority-serving providers.

OBJECTIVE: To compare asthma care quality for children with and without minority-serving providers. DESIGN: Cross-sectional telephone survey of parents, linked with a mailed survey of their children's providers. SETTING: A Medicaid-predominant health plan and multispecialty provider group in Massachusetts. PARTICIPANTS: A total of 563 children with persistent asthma, identified by claims and encounter data. Main Exposure Whether the child's provider was minority serving (>25% of patients black or Latino). Outcomes Parent report of whether the child had (1) ever received inhaled steroids, (2) received influenza vaccination during the past season, and (3) received an asthma action plan in the past year. RESULTS: In unadjusted analyses, Latino children and those with minority-serving providers were more likely to have never received inhaled steroids. In adjusted models, the odds of never receiving inhaled steroids were not statistically significantly different for children with minority-serving providers (odds ratio [OR], 1.29; 95% confidence interval [CI], 0.63-2.64), or for Latino vs white children (OR, 1.76; 95% CI, 0.74-4.18); odds were increased for children receiving care in community health centers (OR, 4.88; 95% CI, 1.70-14.02) or hospital clinics (OR, 4.53; 95% CI, 1.09-18.92) vs multispecialty practices. Such differences were not seen for influenza vaccinations or action plans. CONCLUSIONS: Children with persistent asthma are less likely to receive inhaled steroids if they receive care in community health centers or hospital clinics. Practice setting mediated initially observed disparities in inhaled steroid use by Latino children and those with minority-serving providers. No differences by race/ethnicity or minority-serving provider were observed for influenza vaccinations or asthma action plans.

Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study.

BACKGROUND: Local reactions are the most commonly reported adverse events following tetanus and diphtheria toxoid (Td) vaccine and the risk of local reactions may increase with number of prior Td vaccinations. METHODS: To estimate the risk of medically attended local reactions following Td vaccination in adolescents and young adults we conducted a six-year retrospective cohort study assessing 436,828 Td vaccinations given to persons 9 through 25 years of age in the Vaccine Safety Datalink population from 1999 through 2004. RESULTS: Overall, the estimated risk of a medically attended local reaction was 3.6 events per 10,000 Td vaccinations. The lowest risk (2.8 events per 10,000 vaccinations) was found in the 11 to 15 year old age group. In comparison with that group, the event risks were significantly higher in both the 9 to 10 and 21 to 25 year old age groups. The risk of a local reaction was significantly higher in persons who had received another tetanus and diphtheria toxoid containing vaccine (TDCV) in the previous five years (incidence rate ratio, 2.9; 95% confidence interval, 1.2 to 7.2). Twenty-eight percent of persons with a local reaction to Td vaccine were prescribed antibiotics. CONCLUSION: Medically attended local reactions were uncommon following Td vaccination. The risk of those reactions varied by age and by prior receipt of TDCVs. These findings provide a point of reference for future evaluations of the safety profile of newer vaccines containing tetanus or diphtheria toxoid.

Asthma self-assessment in a Medicaid population.

BACKGROUND: Self-assessment of symptoms by patients with chronic conditions is an important element of disease management. A recent study in a commercially-insured population found that patients who received automated telephone calls for asthma self-assessment felt they benefitted from the calls. Few studies have evaluated the effectiveness of disease self-assessment in Medicaid populations. The goals of this study were to: (1) assess the feasibility of asthma self-assessment in a population predominantly insured by Medicaid, (2) study whether adding a gift card incentive increased completion of the self-assessment survey, and (3) evaluate how the self-assessment affected processes and outcomes of care. METHODS: We studied adults and children aged 4 years and older who were insured by a Medicaid-focused managed care organization (MCO) in a pre- and post-intervention study. During the pre-incentive period, patients with computerized utilization data that met specific criteria for problematic asthma control were mailed the Asthma Control Test (ACT), a self-assessment survey, and asked to return it to the MCO. During the intervention period, patients were offered a $20 gift card for returning the completed ACT to the MCO. To evaluate clinical outcomes, we used computerized claims data to assess the number of hospitalization visits and emergency department visits experienced in the 3 months after receiving the ACT. To evaluate whether the self-management intervention improved processes of care, we conducted telephone interviews with patients who returned or did not return the ACT by mail. RESULTS: During the pre-incentive period, 1183 patients were identified as having problems with asthma control; 25 (2.0%) of these returned the ACT to the MCO. In contrast, during the incentive period, 1612 patients were identified as having problems with asthma control and 87 (5.4%) of these returned the ACT to the MCO (p < 0.0001). Of all 95 ACTs that were returned, 87% had a score of 19 or less, which suggested poor asthma control.During the 3 months after they received the ACT, patients who completed it had similar numbers of outpatient visits, emergency department visits, and hospitalizations for asthma as patients who did not complete the ACT. We completed interviews with 95 patients, including 28 who had completed the ACT and 67 who had not. Based on an ACT administered at the time of the interview, patients who had previously returned the ACT to the MCO had asthma control similar to those who had not (mean scores of 14.2 vs. 14.6, p = 0.70). Patients had similar rates of contacting their providers within the past 2 months whether they had completed the mailed ACT or not (71% vs. 76%, p = 0.57). CONCLUSION: Mailing asthma self-assessment surveys to patients with poorly controlled asthma was not associated with better asthma-associated outcomes or processes of care in the Medicaid population studied. Adding a gift card incentive did not meaningfully increase response rates. Asthma disease management programs for Medicaid populations will most likely need to involve alternative strategies for engaging patients and their providers in managing their conditions.

Outcomes after periodic use of inhaled corticosteroids in children.

BACKGROUND: Many children with persistent asthma use inhaled corticosteroids on a periodic basis. Clinical trials in adults suggest that periodic use of inhaled corticosteroids may be effective for patients with mild persistent asthma. However, scant information exists on the clinical outcomes of children with asthma who are using inhaled corticosteroids on a periodic basis in real-world settings. OBJECTIVE: This prospective cohort study compared clinical outcomes during a 12-month follow-up period between children with persistent asthma whose parents believed that they were supposed to use inhaled steroids either (a) periodically or (b) daily year-round at the start of the period. The clinical outcomes studied were (1) asthma-related emergency department (ED) visits or hospitalizations, (2) uncontrolled asthma based on health care and medication use, and (3) outpatient visits for asthma. PATIENTS AND METHODS: The study population included children with persistent asthma from two health plans whose parents reported that they were using inhaled corticosteroids during a baseline telephone interview. The interviews collected information on whether the children's parents believed they were supposed to use inhaled corticosteroids on a periodic or daily basis, as well as baseline asthma symptom status, sociodemographic, and behavioral variables. We used computerized databases to identify clinical events for each child during the 12 months after their baseline interview. Uncontrolled asthma was defined as any asthma-related ED visit or hospitalization, two or more oral steroid prescription fills, or four or more beta-agonists canisters filled during the 12-month period. We compared these outcomes between the periodic versus daily users of inhaled corticosteroids using logistic regression analyses. We conducted both (1) a traditional logistic regression analysis in which we adjusted for selection bias by including covariates such as age, asthma physical status, sociodemographic and behavioral variables, and history of asthma-related health care use during the year before interview and (2) an analysis using propensity scores to more fully adjust for selection bias. RESULTS: Of a total of 476 children in the study, 55% of parents believed their children were supposed to be using inhaled corticosteroids on a periodic basis and 45% believed their children were supposed to be using them daily year-round based on the baseline parent interview. At baseline, periodic inhaled corticosteroid users had less severe asthma than daily users based on several measures including better asthma physical status scores on the Children's Health Survey for Asthma (mean 87 +/- 16.0 vs. 81 +/- 17.4, p = < 0.0001). During the year before the baseline interview, periodic users compared with daily users were less likely to have an ED visit or hospitalization (10% vs. 23%, p = 0.0001) and less likely to have had five or more albuterol prescription fills (13% vs. 31%, p < 0.0001). During the follow-up year, those who believed inhaled steroids were for periodic use were less likely than those who believed inhaled steroids were for daily use to have an ED visit or hospitalization for asthma (OR 0.36, 95% CI: 0.18-0.73), even after adjusting for baseline asthma status and other covariates. Similarly, those who believed inhaled steroids were for periodic use were less likely to have uncontrolled asthma, OR 0.38 (95% CI: 0.24-0.62). Analyses using propensity score adjustment yielded similar results to the logistic regression analyses. CONCLUSION: Children whose parents believed they were supposed to use inhaled corticosteroids on a periodic basis had less severe asthma at baseline than those whose parents believed they were supposed to be using them daily. Periodic users were less likely than daily users to have adverse asthma outcomes during 1-year follow-up. This suggests that clinicians may be applying appropriate selection criteria by choosing patients with less severe asthma for periodic inhaled corticosteroid regimens.

Periodic use of inhaled steroids in children with mild persistent asthma: what are pediatricians recommending?

Although asthma treatment guidelines recommend daily inhaled corticosteroid (ICS) use for all persistent asthma, pediatricians may recommend alternative treatment plans for children with mild persistent disease. The authors administered a survey of pediatricians to describe prescribing patterns for mild persistent asthma. More than 99% of providers agreed that periodic ICS could be effective for some asthma patients. Overall, 129/251 providers (51%) reported prescribing daily ICS to most patients with mild persistent asthma, whereas 78 (31%) reported recommending periodic ICS for most such patients. Providers with patient populations > or = 25% black were significantly less likely to report prescribing daily ICS (odds ratio, 0.3; 95% confidence interval, 0.2-0.6) for mild persistent asthma. Further research is needed on the effectiveness of periodic ICS use for children with mild persistent asthma and on underlying reasons for differing provider practice patterns.

Gaps in vaccine financing for underinsured children in the United States.

CONTEXT: The number of new vaccines recommended for children and adolescents has nearly doubled during the past 5 years, and the cost of fully vaccinating a child has increased dramatically in the past decade. Anecdotal reports from state policy makers and clinicians suggest that new gaps have arisen in financial coverage of vaccines for children who are underinsured (ie, have private insurance that does not cover all recommended vaccines). In 2000, approximately 14% of children were underinsured for vaccines in the United States. OBJECTIVES: To describe variation among states in the provision of new vaccines to underinsured children and to identify barriers to state purchase and distribution of new vaccines. DESIGN, SETTING, AND PARTICIPANTS: A 2-phase mixed-methods study of state immunization program managers in the United States. The first phase included 1-hour qualitative telephone interviews conducted from November to December 2005 with 9 program managers chosen to represent different state vaccine financing policies. The second phase incorporated findings from phase 1 to develop a national telephone and paper-based survey of state immunization program managers that was conducted from January to June 2006. MAIN OUTCOME MEASURES: Percentage of states in which underinsured children are unable to receive publicly purchased vaccines in the private or public sectors. RESULTS: Immunization program managers from 48 states (96%) participated in the study. Underinsured children were not eligible to receive publicly purchased meningococcal conjugate or pneumococcal conjugate vaccines in the private sector in 70% and 50% of states, respectively, or in the public sector in 40% and 17% of states, respectively. Due to limited financing for new vaccines, 10 states changed their policies for provision of publicly purchased vaccines between 2004 and early 2006 to restrict access to selected new vaccines for underinsured children. The most commonly cited barriers to implementation in underinsured children were lack of sufficient federal and state funding to purchase vaccines. CONCLUSIONS: The current vaccine financing system has resulted in gaps for underinsured children in the United States, many of whom are now unable to receive publicly purchased vaccines in either the private or public sectors. Additional strategies are needed to ensure financial coverage for all vaccines, particularly new vaccines, among this vulnerable population.