Partial palivizumab prophylaxis and increased risk of hospitalization due to respiratory syncytial virus in a Medicaid population: a retrospective cohort analysis.

BACKGROUND: Infection with respiratory syncytial virus (RSV) is common among young children insured through Medicaid in the United States. Complete and timely dosing with palivizumab is associated with lower risk of RSV-related hospitalizations, but up to 60% of infants who receive palivizumab in Medicaid population do not receive full prophylaxis. The purpose of this study was to evaluate the association of partial palivizumab prophylaxis with the risk of RSV hospitalization among high-risk Medicaid-insured infants. METHODS: Claims data from 12 states during 6 RSV seasons (October 1st to April 30th in the first year of life in 2003-2009) were analyzed. Inclusion criteria were birth hospital discharge before October 1st, continuous insurance eligibility from birth through April 30th, ≥ one palivizumab administration from August 1st to end of season, and high-risk status (≤34 weeks gestational age or chronic lung disease of prematurity [CLDP] or hemodynamically significant congenital heart disease [CHD]). Fully prophylaxed infants received the first palivizumab dose by November 30th with no gaps >35 days up to the first RSV-related hospitalization or end of follow-up. All other infants were categorized as partially prophylaxed. RESULTS: Of the 8,443 high-risk infants evaluated, 67% (5,615) received partial prophylaxis. Partially prophylaxed infants were more likely to have RSV-related hospitalization than fully prophylaxed infants (11.7% versus 7.9%, p< 0.001). RSV-related hospitalization rates ranged from 8.5% to 24.8% in premature, CHD, and CLDP infants with partial prophylaxis. After adjusting for potential confounders, logistic regression showed that partially prophylaxed infants had a 21% greater odds of hospitalization compared with fully prophylaxed infants (odds ratio 1.21, 95% confidence interval 1.09-1.34). CONCLUSIONS: RSV-related hospitalization rates were significantly higher in high-risk Medicaid infants with partial palivizumab prophylaxis compared with fully prophylaxed infants. These findings suggest that reduced and/or delayed dosing is less effective.

Cost utility of palivizumab prophylaxis among pre-term infants in the United States: a national policy perspective.

OBJECTIVE: The cost-effectiveness of palivizumab has previously been reported among certain guideline-eligible, high-risk premature infants in Medicaid. Because guideline authorities base decisions on a national perspective, the economic model of palivizumab was adapted to include all infants, that is, public and privately insured patients (60% of palivizumab use is public, 40% is private). METHODS: This study examined four groups of premature infants without chronic lung disease of prematurity or congenital heart disease: (1) <32 weeks gestational age (wGA) and ≤ 6 months chronologic age (CA); (2) 32-34 wGA, ≤ 3 months CA, with 2009 American Academy of Pediatrics (AAP) risk factors (RFs); (3) 32-35 wGA, ≤ 6 months CA, with 2006 AAP RFs; and (4) 32-35 wGA, ≤ 6 months CA, with ≤ 1 RF. An average estimate was used between public and private payors for (1) background rates of respiratory syncytial virus hospitalization (RSV-H), (2) direct medical costs associated with RSV-H, and (3) cost of palivizumab. Incremental cost-effectiveness ratios (ICERs) are reported in cost per quality-adjusted life-year (QALY) gained. Sensitivity analyses were performed. RESULTS: Palivizumab saved costs and improved QALYs among infants <32 wGA. Palivizumab was cost-effective in infants 32-34 wGA with 2009 AAP RFs ($44,774 per QALY) and in infants 32-35 wGA with 2006 AAP RFs ($79,477 per QALY). The ICER for infants 32-35 wGA with ≤ 1 RF was $464,476 per QALY. Influential variables in the sensitivity analysis included background rate of RSV-H and cost and efficacy of palivizumab. LIMITATIONS: The results are not generalizable to populations outside of the US. The model did not examine all RFs. The wholesale acquisition cost was used as a payment benchmark; actual price paid by end providers varies. CONCLUSIONS: From a national policy perspective, palivizumab remained cost-effective for publically and commercially insured, guideline-eligible, high-risk premature infants. Palivizumab was not cost-effective in infants of 32-35 wGA with ≤ 1 RF.

Agreement between Internet-based self- and proxy-reported health care resource utilization and administrative health care claims.

OBJECTIVES: Although Internet-based surveys are becoming more common, little is known about agreement between administrative claims data and Internet-based survey self- and proxy-reported health care resource utilization (HCRU) data. This analysis evaluated the level of agreement between self- and proxy-reported HCRU data, as recorded through an Internet-based survey, and administrative claims-based HCRU data. METHODS: The Child and Household Influenza-Illness and Employee Function study collected self- and proxy-reported HCRU data monthly between November 2007 and May 2008. Data included the occurrence and number of visits to hospitals, emergency departments, urgent care centers, and outpatient offices for a respondent's and his or her household members' care. Administrative claims data from the MarketScan® Databases were assessed during the same time and evaluated relative to survey-based metrics. Only data for individuals with employer-sponsored health care coverage linkable to claims were included. The Kappa (κ) statistic was used to evaluate visit concordance, and the intraclass correlation coefficient was used to describe frequency consistency. RESULTS: Agreement for presence of a health care visit and the number of visits were similar for self- and proxy-reported HCRU data. There was moderate to substantial agreement related to health care visit occurrence between survey-based and claims-based HCRU data for inpatient, emergency department, and office visits (κ: 0.47-0.77). There was less agreement on health care visit frequencies, with intraclass correlation coefficient values ranging from 0.14 to 0.71. CONCLUSIONS: This study's agreement values suggest that Internet-based surveys are an effective method to collect self- and proxy-reported HCRU data. These results should increase confidence in the use of the Internet for evaluating disease burden.

Cost-effectiveness analysis of palivizumab among pre-term infant populations covered by Medicaid in the United States.

OBJECTIVE: Medicaid infants are at high risk of severe respiratory syncytial virus (RSV) disease. The study objective was to estimate the cost-effectiveness of palivizumab in a Medicaid population. METHODS: A societal cost-utility analysis was conducted of prophylaxis with palivizumab vs no prophylaxis among four groups of premature infants: (1) <32 weeks gestational age (wGA) and ≤ 6 months chronologic age (CA); (2) 32-34 wGA, ≤ 3 months CA with 2009 American Academy of Pediatrics (AAP) risk factors (RF); (3) 32-35 wGA, ≤ 6 months CA with 2006 AAP RF; and (4) 32-35 wGA, ≤ 6 months CA with ≤ 1 RF. Full dosing of palivizumab was assumed throughout the RSV season (consistent with the FDA-approved label). All costs were in 2010 US dollars. The societal public payer spend for palivizumab was estimated using Medicaid reimbursement methodologies for the top 10 palivizumab-using states in 2010 minus mandatory manufacturer rebates. This study reports the incremental cost-effectiveness ratios (ICERs) in cost per quality-adjusted life-year (QALY) gained. Sensitivity and probabilistic analyses were also conducted. RESULTS: Palivizumab saved costs and improved QALYs among infants <32 wGA. Palivizumab was cost-effective in infants 32-34 wGA with 2009 AAP RF ($16,037 per QALY) and in infants 32-35 wGA with 2006 AAP RF ($38,244 per QALY). The ICER for infants 32-35 wGA with ≤ 1 RF was $281,892 per QALY. Influential variables in the sensitivity analysis included the background rate of RSV hospitalization, the cost of palivizumab, and the efficacy of palivizumab. KEY LIMITATIONS: These results are not generalizable to commercially insured infants or infants outside of the US. CONCLUSIONS: This is the first cost-utility analysis of palivizumab in a Medicaid population. Palivizumab, when dosed consistent with the FDA-approved labeling, was either cost-saving or cost-effective among current guideline-eligible infants in the Medicaid population. Palivizumab did not demonstrate cost-effectiveness in 32-35 wGA infants with ≤ 1 RF.

Association of RSV lower respiratory tract infection and subsequent healthcare use and costs: a Medicaid claims analysis in early-preterm, late-preterm, and full-term infants.

OBJECTIVE: Healthcare use and costs within 1 year of a respiratory syncytial virus lower respiratory tract infection (RSV-LRI) among Medicaid early-preterm and late-preterm infants compared with full-term infants were evaluated. METHODS: Infants born during 2003-2005 were identified from the Thomson Reuters MarketScan Multi-State Medicaid Database. Infants <1 year of age were grouped based on RSV-LRI and unspecified bronchiolitis/pneumonia (UBP) diagnosis codes and stratified by inpatient or outpatient setting. Infants without RSV-LRI/UBP were selected for comparison. Economic and clinical outcomes were analyzed descriptively; the relationship between RSV-LRI/UBP and costs incurred within 1 year of infection were analyzed using logged ordinary least squares models. Results were stratified by gestational age. RESULTS: Most infants were diagnosed with RSV-LRI/UBP after 90 days of chronologic age. Early-preterm infants had the greatest mean number of inpatient, outpatient, and emergency department visits after an RSV-LRI/UBP episode. The marginal costs among infants with RSV-LRI compared with controls were $34,132 (p < 0.001) and $3869 (p = 0.115) among inpatients and outpatients, respectively. Among late-preterm infants, the marginal costs were $17,465 (p < 0.001) and $2158 (p < 0.001) among inpatients and outpatients, respectively. Full-term infants had the lowest marginal costs (inpatients, $9151 [p < 0.001]; outpatients, $1428 [p < 0.001]). Overall, inpatient infants with RSV-LRI/UBP had higher costs than outpatients, suggesting that increased downstream costs are associated with severity of RSV-LRI/UBP disease. LIMITATIONS: Infants with unknown etiology for bronchiolitis were assigned to the UBP group, which may underestimate the costs of the comparison group. CONCLUSIONS: The burden of RSV-LRI was substantial among early-preterm Medicaid infants. Costs were also higher among late-preterm relative to full-term infants.

Respiratory outcomes, utilization and costs 12 months following a respiratory syncytial virus diagnosis among commercially insured late-preterm infants.

OBJECTIVES: To determine, among a commercially-insured population of late-preterm infants, utilization of healthcare resources and costs during the 1 year following a diagnosis of respiratory syncytial virus lower respiratory infection (RSV LRI). METHODS: Administrative claims for non-capitated, commercially-insured infants <1 year old were used to identify infants diagnosed with RSV LRI and unspecified bronchiolitis/pneumonia (UBP). Infants were stratified by the setting of diagnosis. Infants without evidence of RSV LRI or UBP were selected as a comparison group. Economic and clinical outcomes were analyzed descriptively using propensity score weighting and logged ordinary least squares models were used to examine the relationship between RSV and costs (adjusted to 2006 USD) incurred within 1 year of RSV LRI. RESULTS: The majority of infants were 3 months or older at the time of RSV LRI or UBP diagnosis. The rate of wheezing was significantly greater for infants in the RSV LRI and UBP cohorts relative to the comparison group (p < 0.001). Infantile asthma rates were 6-9 times higher among RSV LRI and UBP infants than the comparison group. RSV LRI and UBP infants also had significantly more emergency department visits and outpatient visits than the comparison group. The marginal healthcare costs were significantly higher for RSV LRI inpatients ($24,027) and outpatients ($2703) infants than for the comparison group (all p < 0.001). CONCLUSION: Commercially insured late-preterm infants with RSV infection are at high risk for recurrent wheezing and infantile asthma during the 1-year period after the initial episode and impose a significant economic burden to the healthcare system.

Employees' willingness to pay to prevent influenza.

OBJECTIVES: To quantify employees' preferences, as measured by willingness to pay, to prevent influenza in themselves and in their child and adult household members and to examine factors associated with willingness to pay. STUDY DESIGN: Prospective observational cohort study of a convenience sample of employees from 3 large US employers. Participants had at least 1 child (< or = 17 years) living in their household for at least 4 days per week. METHODS: Each month from November 2007 to April 2008, employees completed Web-based surveys regarding acute respiratory illness in their household. In the final survey, employees were presented with descriptions of influenza and questions regarding their willingness to pay to prevent influenza. Factors associated with willingness to pay were examined using multivariate ordinary least squares regression analysis of the log of willingness to pay. RESULTS: Among 2006 employees, 31.3% were female, the mean age was 41.7 years, 85.3% were of white race/ethnicity, and the mean household size was 4.0. Employees' median (mean) willingness to pay to prevent influenza was $25 ($72) for themselves, $25 ($82) for their adult household members, and $50 ($142) (P <.01) for children. However, influenza vaccination rates were approximately equal for children (27.5%), employees (31.5%), and other adult household members (24.5%). This finding may be explained by barriers such as cost, dislike of vaccinations, and disagreement with national influenza vaccination recommendations, which were significantly associated with lower willingness to pay for prevention of influenza (P <.05). CONCLUSION: Employees expressed a stronger preference to prevent influenza in their children than in themselves or other household members; however, modifiable barriers depress vaccination rates.

Healthcare costs within a year of respiratory syncytial virus among Medicaid infants.

Limited research exists on the economic impact of respiratory syncytial virus lower respiratory infection (RSV LRI) among vulnerable infant populations. This study evaluated healthcare costs of full-term and late-preterm Medicaid infants with RSV LRI within 1 year of infection. Medicaid administrative claims were used to conduct a retrospective study of infants born 2003-2005. Full-term and late-preterm infants <1 year old were assigned to groups based on RSV LRI and unspecified bronchiolitis/pneumonia (UBP) diagnosis codes and stratified by setting of diagnosis. Infants without evidence of RSV LRI/UBP were selected as a comparison group. Economic and clinical outcomes were analyzed descriptively using propensity score weighting, and logged ordinary least squares models were used to examine relationship between RSV and costs incurred within 1 year of infection. RSV LRI and UBP infants, regardless of gestational age or healthcare setting, were more likely to experience respiratory diagnoses of wheezing and infantile asthma versus comparisons. Adjusted and weighted healthcare costs were significantly higher for all groups of RSV LRI and UBP infants relative to comparison infants (P < 0.001). Among late-preterm infants with inpatient and outpatient RSV, marginal costs compared with controls were $17,465 and $2,158, respectively. Costs for RSV LRI and UBP Medicaid infants are substantial. While much of the costs result from initial RSV episodes, higher post-episode costs and rates of respiratory events, procedures, and medications in RSV and UBP infants versus comparisons indicate long-term economic impact from infection and the impact is greater among late-preterm compared to full-term infants.

Effect of influenza-like illness and other wintertime respiratory illnesses on worker productivity: The child and household influenza-illness and employee function (CHIEF) study.

Acute respiratory illnesses (ARI), comprising influenza-like illness (ILI) and other wintertime respiratory illnesses (ORI), impose substantial health and economic burdens on the United States. Little is known about the impact of ILI among household members (HHM), particularly children, on employees' productivity. To quantify the impact of employee and HHM-ILI and ARI on employee productivity, a prospective, observational cohort study was conducted among employees from three large US companies. Employees who had at least one child living at home (N=2013) completed a monthly survey during the 2007-2008 influenza season, reporting the number of days missed from work and hours of presenteeism due to: (1) personal ILI, (2) HHM-ILI, and (3) personal and HHM-ARI. Employee ILI ranged from 4.8% (April) to 13.5% (February). Employees reporting ILI reported more absences than employees not reporting ILI (72% vs 30%, respectively; P<0.001). Overall, 61.2% of employees surveyed had at least one child with an ILI; these employees missed more days of work due to HHM illness than employees without an ARI-ill child (0.9 days vs 0.3 days, respectively; P<0.001). Employees with ILI were less productive, on average, for 4.8h each day that they worked while sick, 2.5h of which was attributable to ILI. HHM illnesses accounted for 17.7% (1389/7868 days) of employee absenteeism, over half of which was due to HHM-ARI. ILI causes a significant amount of employee absence. Household members, particularly children, comprise a sizable proportion of general illness and injury-related employee absences.

Comparative costs of hospitalisation among infants at high risk for respiratory syncytial virus lower respiratory tract infection during the first year of life.

OBJECTIVE: This retrospective cohort study compared the total cost of hospitalisation due to respiratory syncytial virus (RSV) lower respiratory tract infection (LRI) during the first year of life between late-preterm (33-36 weeks gestational age [wGA]) and term (≥ 37 wGA) infants. RESEARCH DESIGN AND METHODS: A large national claims database of commercially insured members was examined to identify hospital admissions associated with RSV between January 2003 and June 2007 among infants at high risk for RSV LRI, including late-preterm infants. Hospital use and costs were compared with those of a reference cohort of term infants with RSV. RESULTS: The cost of hospitalisation for RSV among late-preterm infants with at least one hospital admission associated with RSV (n=173) was twice that of term infants (n=1,983; $20,269 vs. 9,635; p< 0.001). The mean length of stay was also higher (5.3 vs. 3.4 days; p< 0.001). Approximately 21.9% of hospitalisations for late-preterm infants included an intensive care unit admission compared with 9.6% among term infants (p< 0.001). LIMITATIONS: Reliance on ICD-9 codes to identify potential cohort members may result in misclassification and underreporting the cohort size for conditions of interest. CONCLUSIONS: Hospitalisation costs and length of stay due to RSV LRI were significantly greater among late-preterm infants compared with term infants and higher than general estimates previously reported in the broader paediatric population.

A systematic review of compliance with palivizumab administration for RSV immunoprophylaxis.

BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children, accounting for approximately 75,000-125,000 hospitalizations per year. It is estimated that in 2000, RSV infection accounted for 1.7 million office visits, 402,000 emergency room visits, and 236,000 hospital outpatient visits per year for children younger than 5 years of age. Palivizumab, a humanized monoclonal antibody directed against RSV, is the only immunoprophylaxis therapy approved by the FDA for prevention of serious lower respiratory tract disease caused by RSV in infants (up to 2 years of age) who meet 1 or more of the following criteria for high risk: (a) gestational age up to 35 weeks;(b) diagnosis of chronic lung disease (CLD, formerly bronchopulmonary dysplasia [BPD]); or (c) diagnosis of cyanotic or complex congenital heart disease. The RSV season typically occurs between November and March but may vary by region. During the period of our review, depending on local duration of the RSV season, infants usually required 5 monthly (every 28-30 days) intramuscular injections of palivizumab. Infants born in the middle of the season received their palivizumab doses from the time of birth to the end of the season and, therefore, may have required less than 5 doses.It is unclear if compliance with monthly doses is a problem and whether noncompliance increases the risk of RSV hospitalizations in routine clinical practice. OBJECTIVES: To (a) identify and describe compliance rates and the factors that influence parental compliance with immunoprophylaxis regimens, (b)review intervention programs and describe those that have been associated with increased compliance, and (c) summarize the association of compliance with RSV hospitalization rates. METHODS: An electronic literature search was conducted using journal databases, including Ovid, Current Contents, Embase, Medline In-Process & Other Non-Indexed Citations; Ovid Medline, PubMed, and Web of Science;and an abstract database, Medical Intelligence Solution, for citations through April 2008. Specific search terms used were palivizumab with patient compliance, patient adherence, or patient persistence. RESULTS: Twenty-five articles and abstracts met the inclusion criteria. Available studies were mostly retrospective or observational prospective.Compliance, defined in various ways across the studies, varied between 25% and 100%, and 12 studies identified some of the factors related to noncompliance. Compliance generally was lower among Medicaid patients,African American patients, and other minorities. Ten studies (3 manuscripts and 7 abstracts) investigated the association of administration of prophylaxis through monthly home visits by a health professional with parental compliance with therapy. Most of the home-based programs were associated with higher compliance rates compared with clinic or office programs.Rates as high as 94% and 64% were achieved when Medicaid infants and infants of minority descent, respectively, received their doses through a home health program. When these infants received their doses at a clinic or office, depending on the definition of compliance, rates were 61%-100% for Medicaid infants and 44% for infants of minority descent. Reminder telephone calls to parents or caregivers, comprehensive multidisciplinary programs that included extensive counseling of parents, calendars with sticker reminders, and education in the language native to parents also were associated with increased compliance, although statistical significance was reported in only 1 study. Several studies recommended educating parents on the benefits of RSV prophylaxis, alleviating transportation and language difficulties, recognizing cultural differences and biases, and clarifying misperception of RSV illness severity. Home health programs had lower rates of RSV hospitalizations than office-based programs in 3 analyses conducted in 2 studies. In 4 other abstracts, the rates of RSV hospitalization for home health programs and office-based administration did not significantly differ. In a large, 4-season, prospective outcome study, compliant infants had lower RSV hospitalization rates than those who were not compliant under one definition of compliance (doses within 35-day intervals). RSV hospitalization rates were not significantly different using another definition of compliance (receipt of anticipated doses, expected vs. observed rates).In a large survey of 10,390 infants identified from pharmacy dispensing records, RSV hospitalization rates were 1.4% in the compliant group versus 3.1% in the noncompliant group (OR = 2.2, 95% CI = 1.4-3.5, P < 0.001).Adjustment for confounding was not reported in these studies. CONCLUSION: Medicaid and minority infants were less likely to receive scheduled palivizumab doses. Home-based programs for the administration of palivizumab have been investigated more than other interventions and are associated with improved compliance compared with office-based administration. Compliance with dosing, in general, was associated with lower RSV hospitalization rates. However, these strategies should be further investigated using well-designed studies.

Prevalence of respiratory syncytial virus (RSV) risk factors and cost implications of immunoprophylaxis to infants 32 to 35 weeks gestation for health plans in the United States.

BACKGROUND: During the period of this study, the American Academy of Pediatrics (AAP) 2006 guidelines recommended respiratory syncytial virus (RSV) prophylaxis for infants 32 to 35 weeks gestation age (wGA) with two or more of five risk factors (RFs). New recommendations have recently been published in 2009. The cost implications of expanding this list of RFs to include other evidence-based RFs like passive smoke exposure (PSE), crowded living conditions (CLCs), and young chronological age (YCA) are unclear. METHODS: We estimated the prevalence of RSV RFs in a US sample of infants 32 to 35 wGA referred for prophylaxis from nine specialty pharmacy providers during the 2007-2008 season. We estimated the percent eligible for RSV prophylaxis under various potential RF coverage policies. Using a budget impact model, we calculated the per-member-per-month (PMPM) cost for each policy in 2007 USD for a hypothetical one million member plan. RESULTS: Infants 32 to 35 wGA represented 0.08% of the plan. Approximately 20.2% of these infants met at least two or more of five AAP RFs. Expanding this list to include one additional RF of PSE, CLC, or YCA increased the percent of infants potentially prophylaxed to 29.9%, 23.9%, and 47%, respectively. Adding all three RFs to the list (two or more of eight) increased the percent of infants potentially prophylaxed to 55.6%, and increased payer costs by 9 cents PMPM. CONCLUSION: Expanding the AAP RF criteria to include PSE, CLC, and YCA would identify more 32 to 35 wGA infants at high risk for severe RSV disease at an acceptable budget impact.

Total healthcare costs in the US for preterm infants with respiratory syncytial virus lower respiratory infection in the first year of life requiring medical attention.

BACKGROUND: Respiratory syncytial virus (RSV) lower respiratory infection (LRI) is the most common cause of hospitalization among infants <1 year of age. The healthcare costs of preterm infants with RSV LRI were compared with those without RSV LRI in the first year of life. METHODS: This retrospective cohort study propensity-matched premature infants < or =36 weeks' gestational age (wGA) and/or < or =2499 g birth weight, born May 1, 2001 through April 30, 2006 (five RSV seasons) with RSV LRI to those without RSV LRI in a national United States health plan. The primary outcome was first-year healthcare costs and utilization excluding the birth hospitalization compared between the study cohorts. Subgroup analysis evaluated costs and healthcare resource utilization by GA (< or =32 wGA and 33-36 wGA) and hospitalization status (hospitalized and outpatient). RESULTS: A total of 2995 infants with RSV LRI were matched to 2995 controls. Infants with RSV LRI had $9115 higher healthcare costs (RSV LRI group: $19 559; control group: $10 444; p < 0.001) in the first year of life. Late preterm infants (33-36 wGA) with an RSV hospitalization incurred $21 977 higher costs (p < 0.001) and those with an outpatient RSV LRI incurred $3898 higher costs (p < 0.001) compared to corresponding controls. Similar results were found among infants < or =32 wGA with higher costs in the RSV LRI group. Rates of all-cause hospitalizations, emergency department visits, and ambulatory visits were significantly higher among infants with RSV LRI compared to controls. CONCLUSION: Development of RSV LRI among preterm and late preterm infants is associated with significantly higher healthcare costs in the first year of life. These findings must be considered in the context of potential study limitations that may have over- or underestimated costs, such as unconfirmed RSV infection, unintentional omission of fatal cases, and unobserved imbalances between groups.

Persistence of morbidity and cost differences between late-preterm and term infants during the first year of life.

BACKGROUND: Late-preterm infants are known to have greater morbidity and costs compared with term infants during the neonatal period, but less is known about whether these differences continue beyond this period. OBJECTIVE: The purpose of this study was to examine the most common causes and costs of rehospitalization and other health care use among late-preterm and term infants throughout the first year of life. METHODS: We conducted a retrospective cohort study of late-preterm (33-36 weeks' gestation) and term infants born in 2004 with > or =1 year of enrollment in a large national US database of commercially insured members. All of the reported health care services and costs were examined from the birth hospitalization through the first year of life. RESULTS: We evaluated 1683 late-preterm and 33 745 term infants. The average length of stay of the birth hospitalization for term infants was 2.2 days, and the average cost was $2061. Late-preterm infants had a substantially longer average stay of 8.8 days and average cost of $26 054. Total first-year costs after birth discharge were, on average, 3 times as high among late-preterm infants ($12 247) compared with term infants ($4069). Late-preterm infants were rehospitalized more often than term infants (15.2% vs 7.9%). A subset of late-preterm infants that were discharged late from their birth hospitalization had the highest rates of rehospitalization and total health care costs. Higher costs during rehospitalization of late-preterm infants, especially those with a late discharge, indicate their propensity to have more severe illness. CONCLUSIONS: Late-preterm infants have greater morbidity and total health care costs than term infants, and these differences persist throughout the first year of life. Management strategies and guidelines to reduce morbidity and costs in late-preterm infants should be investigated.

Cost-effectiveness of live attenuated influenza vaccine versus inactivated influenza vaccine among children aged 24-59 months in the United States.

BACKGROUND: The US Advisory Committee on Immunization Practices (ACIP) recently expanded the influenza vaccine recommendation to include children 24-59 months of age. In a large head-to-head randomized controlled trial, live attenuated influenza vaccine, trivalent (LAIV) demonstrated a 54% relative reduction in culture-confirmed influenza illness compared with trivalent inactivated influenza vaccine (TIV) among children aged 24-59 months. OBJECTIVE: To evaluate the relative cost and benefit between two influenza vaccines (LAIV and TIV) for healthy children 24-59 months of age. METHODS: Using patient-level data from the clinical trial supplemented with cost data from published literature, we modeled the cost-effectiveness of these two vaccines. Effectiveness was measured in quality-adjusted life years (QALY) and cases of influenza avoided. The analysis used the societal perspective. RESULTS: Due to its higher acquisition cost, LAIV increased vaccination costs by USD7.72 per child compared with TIV. However, compared with TIV, LAIV reduced the number of influenza illness cases and lowered the subsequent healthcare use of children and productivity losses of parents. The estimated offsets in direct and indirect costs saved USD15.80 and USD37.72 per vaccinated child, respectively. LAIV had a net total cost savings of USD45.80 per child relative to TIV. One-way and probabilistic sensitivity analyses indicated that the model was robust across a wide range of relative vaccine efficacy and cost estimates. CONCLUSIONS: Due to its increased relative vaccine efficacy over TIV, LAIV reduced the burden of influenza and lowered both direct health care and societal costs among children 24-59 months of age.

Benefits and costs of immunizing children against influenza at school: an economic analysis based on a large-cluster controlled clinical trial.

Current influenza vaccination recommendations focus on immunizing high-risk people; however, influenza mortality and morbidity remain elevated. U.S. policymakers are considering expansion of flu vaccination recommendations to include school-age children (ages 5-18). Children are at risk for flu and propagate epidemic spread. Immunizing children at school offers an efficient approach to covering this population. This study examines the cost consequences of a large multistate, school-based influenza immunization program. The results show that immunization reduces disease among children and adults and is cost-saving to society. An epidemiologically based influenza immunization policy might be an important supplement to the existing risk-based policy.

Cost-effectiveness of live-attenuated influenza vaccine, trivalent in preventing influenza in young children attending day-care centres.

Vaccinating children at day-care may be a cost-effective approach for improving influenza immunization rates in this high-risk group. This study uses influenza attack-rate data from a randomized, blinded, placebo-controlled clinical trial of live-attenuated influenza vaccine, trivalent in day-care centres from two consecutive influenza seasons, one with a moderate attack rate (H1N1 dominant) and one with a high attack rate (H3N2 dominant). Costs were measured in US dollars. In the moderate attack-rate season (vaccinated, 2.2%; placebo, 13.4%), vaccination saved US$ 5.47 per child in societal costs. In the high attack-rate season (vaccinated, 4.7%; placebo, 32.1%), vaccination led to a societal costs savings of US$ 144.44 per child.

Symptom burden among patients with renal cell carcinoma (RCC): content for a symptom index.

BACKGROUND: Renal cell carcinoma (RCC) has multiple symptoms stemming from disease and treatments. There are few validated scales for evaluating RCC symptoms. METHODS: A national cross-sectional study of adult RCC patients was conducted from October to December 2003 to define patient-reported RCC symptomology. Participants were asked open-ended questions regarding their signs and symptoms and completed an 86-item pilot questionnaire of physical and psychological symptoms. Patients were asked to rate the relevancy and clarity of each pilot question using a 5-point Likert scale. Subsequent open-ended caregiver interviews and a provider panel relevance ranking contributed additional information. RESULTS: The average age of the participants (n = 31) was 55 years; 55% of patients were male, 74% had attended college, and 97% were Caucasian. The five most frequent symptoms among localized-stage patients (n = 14) were irritability (79%), pain (71%), fatigue (71%), worry (71%), and sleep disturbance (64%). Among metastatic patients (n = 17), the five most frequent symptoms were fatigue (82%), weakness (65%), worry (65%), shortness of breath (53%), and irritability (53%). More than 50% of localized and metastatic-stage patients reported pain, weakness, fatigue, sleep disturbance, urinary frequency, worry, and mood disorders as being moderately to highly relevant. CONCLUSION: A brief, self-administered RCC Symptom Index was created that captures the relevant signs and symptoms of both localized and metastatic patients. Pending additional content validation, the Index can be used to assess the signs and symptoms of RCC and the clinical benefit resulting from RCC treatment.