Real-World Amount of Clotting Factor Concentrates Dispensed and Annual Medical Expenditures for Japanese Patients with Hemophilia B.

Introduction: Until extended half-life (EHL) factor IX (FIX) concentrates became available in Japan in 2010, patients with hemophilia B received intravenous FIX replacement therapy with standard half-life (SHL) FIX concentrates. Purpose: To investigate the amount of factor dispensed and the associated medical expenditures for the treatment of hemophilia B in the real-world clinical setting in Japan. Methods: This retrospective study comprised patients with hemophilia B (N=197) who had filled prescriptions for FIX concentrates reported in Japan's Medical Data Vision database from 2015 to 2019. Patients were included if they had 2 or more prescriptions for the same FIX concentrates within the first 6 months of the study period and the interval between prescriptions was at least 2 weeks. Results: Since 2015, there was a decrease in the proportion of patients using SHL FIX concentrates and a corresponding increase in international units of dispensed EHL FIX concentrates. Median annualized dispensed dosages (IU/kg body weight) of EHL FIX concentrates were lower than for SHL concentrates for outpatient use only. Annual total health care expenditures per patient and annual expenditures for prescribed FIX concentrates increased each year during the study period. Following a switch from an SHL to an EHL concentrate, the median amount of prescribed FIX concentrate decreased slightly, although median total health care expenditures and FIX concentrate expenditures increased. Conclusion: In the real-world setting in Japan, medical expenditures and the proportion of patients prescribed EHL FIX concentrates for the treatment of hemophilia B have increased.

Variation in adherence to medications across the healthcare system in two comparative effectiveness research cohorts.

AIM: To assess heterogeneity in adherence to medications in two example comparative effectiveness research studies. PATIENTS & METHODS: We analyzed data from commercially insured patients initiating a statin or anticoagulant during 2005-2012. We calculated the cross-validated R2 from a series of hierarchical linear models to assess variation in 1-year adherence. RESULTS: There was less heterogeneity in adherence in the statin cohort compared with the anticoagulant cohort, where patient characteristics explained 7.2% of variation in adherence, and adding therapy and provider characteristics increased the proportion of variation explained to 8.0 and 8.5%, cumulatively. Random effects provided essentially no explanatory power, even in the statin cohort with large numbers of patients clustered within each pharmacy, prescriber and provider. CONCLUSION: The dependence of adherence on the healthcare system was stronger when the healthcare system influenced treatment choice and patient access to medication and when indications for treatment were strong.

Projecting the effectiveness of RotaTeq® against rotavirus-related hospitalisations in Brazil.

RotaTeq® (Merck & Company, Inc, Whitehouse Station, NJ, USA) is an oral pentavalent rotavirus vaccine (RV5) that has shown high and consistent efficacy in preventing rotavirus gastroenteritis (RGE) in randomised clinical trials previously conducted in industrialised countries with high medical care resources. To date, the efficacy and effectiveness data for RV5 are available in some Latin American countries, but not Brazil. In this analysis, we projected the effectiveness of RV5 in terms of the percentage reduction in RGE-related hospitalisations among children less than five years of age in four regions of Brazil, using a previously validated mathematical model. The model inputs included hospital-based rotavirus surveillance data from Goiânia, Porto Alegre, Salvador and São Paulo from 2005-2006, which provided the proportions of rotavirus attributable to serotypes G1, G2, G3, G4 and G9, and published rotavirus serotype-specific efficacy from the Rotavirus Efficacy and Safety Trial. The model projected an overall percentage reduction of 93% in RGE-related hospitalisations, with an estimated annual reduction in RGE-related hospitalisations between 42,991-77,383 in the four combined regions of Brazil. These results suggest that RV5 could substantially prevent RGE-related hospitalisations in Brazil.

Projecting the effectiveness of RotaTeq® against rotavirus-related hospitalisations in Brazil

RotaTeq® (Merck & Company, Inc, Whitehouse Station, NJ, USA) is an oral pentavalent rotavirus vaccine (RV5) that has shown high and consistent efficacy in preventing rotavirus gastroenteritis (RGE) in randomised clinical trials previously conducted in industrialised countries with high medical care resources. To date, the efficacy and effectiveness data for RV5 are available in some Latin American countries, but not Brazil. In this analysis, we projected the effectiveness of RV5 in terms of the percentage reduction in RGE-related hospitalisations among children less than five years of age in four regions of Brazil, using a previously validated mathematical model. The model inputs included hospital-based rotavirus surveillance data from Goiânia, Porto Alegre, Salvador and São Paulo from 2005-2006, which provided the proportions of rotavirus attributable to serotypes G1, G2, G3, G4 and G9, and published rotavirus serotype-specific efficacy from the Rotavirus Efficacy and Safety Trial. The model projected an overall percentage reduction of 93 percent in RGE-related hospitalisations, with an estimated annual reduction in RGE-related hospitalisations between 42,991-77,383 in the four combined regions of Brazil. These results suggest that RV5 could substantially prevent RGE-related hospitalisations in Brazil.

Projecting the effectiveness of RotaTeq® against rotavirus-related hospitalizations and deaths in six Asian countries.

RotaTeq is an oral pentavalent rotavirus vaccine (RV5) that has shown high and consistent efficacy in preventing rotavirus gastroenteritis (RGE) in randomized clinical trials conducted mostly in industrialized countries. We projected the effectiveness of RV5 against RGE-related hospitalizations and deaths in 6 Asian countries by using a simple mathematical model. Model inputs included rotavirus surveillance data collected 2006-2007 in China, 2001-2002 in Hong Kong, 2005-2007 in India, 2005-2007 in South Korea, 2005-2007 in Taiwan, and 2001-2003 in Thailand; the numbers of rotavirus-related deaths in each country; and published rotavirus serotype-specific efficacy of RV5. The model projected an overall effectiveness in the region of 82% to 89% against RGE-related hospitalizations and a substantial reduction in RGE-related deaths, suggesting that RV5 could substantially reduce the burden of rotavirus disease in Asia.

Asthma Severity in patients initiating controller monotherapy versus combination therapy.

BACKGROUND: Asthma treatment guidelines recommend medications based on the level of asthma control. OBJECTIVE: To evaluate differences in asthma control between patients who initiated asthma controller monotherapy versus combination therapy. PATIENTS AND METHODS: Children (5-16 years; n = 488) and adults (17-80 years; n = 530) with asthma and no controller therapy in the prior 6 months were included. Telephone surveys were conducted within 5 days of filling a new asthma controller prescription with either the caregiver of children or the adult patient. Demographics, asthma control before therapy, and asthma-related resource use were assessed for patients initiating monotherapy (filling one asthma controller prescription) and combination therapy (filling more than one controller medication or a fixed-dose combination). RESULTS: Mean pediatric age was 10 years; 53% were male. Mean adult age was 47 years; 25% were male. There were no significant differences in asthma control score between patients receiving monotherapy and combination therapy. Children on combination therapy did not have more nighttime awakening or short-acting ß-agonist use but were more likely to have been hospitalized due to asthma attack (p = .05) and have more unscheduled (p = .0374) and scheduled (p = .009) physician visits. Adults on combination therapy were more likely to have been hospitalized due to asthma attack (p < .05) and have regular doctor visits for asthma (p < .01). CONCLUSIONS: Assessment of asthma control scores in the 4 weeks before index medication suggests that asthma severity during a treatment-free period did not differ significantly for patients initiating controller monotherapy versus combination therapy. From these findings, it appears that although physicians may not focus on asthma control when choosing the intensity of initial controller therapy, the intensity of health-care encounters may be an influence.

Perception and management of fever in infants up to six months of age: a survey of US pediatricans.

BACKGROUND: A fever is an increase in the body's temperature above normal. This study examined how US pediatricians perceive and manage fever generally versus fever occurring after vaccination in infants up to six months of age. METHODS: A web-based survey of 400 US pediatricians subscribing to the Physician Desk Reference was conducted in December 2008. Data were collected on the respondents' socio-demographics, number of years in practice, type of practice, their definition of fever severity in infants, and their recommendations for managing fever. Generalized Estimating Equations were used to estimate the odds of a pediatrician recommending an emergency room visit (ER) or a hospital admission, office visits, or other treatment option, as a function of infant's age, temperature, whether the infant has recently received a vaccine, and whether the fever was reported during or after office hours, adjusting for practice type and socio-demographic variables. RESULTS: On average, the 400 responding pediatricians' (64% were female, average age of 49 years, years in practice = 20 years) threshold for extremely serious fever was ≥39.5°C and ≥ 40.0°C for infants 0-2 month and >2-6 month of age respectively. Infants were more likely to be referred to an ER or hospital admission if they were ≤ 2 months of age (Odds Ratio [OR], 29.13; 95% Confidence interval [95% CI], 23.69-35.82) or >2-4 months old (OR 3.37; 95% CI 2.99-3.81) versus > 4 to 6 months old or if they had a temperature ≥ 40.0°C (OR 21.06; 95% CI 17.20-25.79) versus a temperature of 38.0-38.5°C. Fever after vaccination (OR 0.29; 95% CI 0.25-0.33) or reported during office hours (OR 0.17; 95% CI 0.15-0.20) were less likely to result in referral to ER or hospital admission. CONCLUSION: Within this sample of US pediatricians, perception of the severity of fever in infants, as well as the response to infant fever are likely to depend on the infant's age. Recommendations for the management of fever in infants are likely to depend on fever severity level, the infant age, timing in relation to recent vaccination, and the time of day fever is reported. Our results indicate that US pediatricians are more concerned about general fever than fever following vaccination.

Using the pediatric asthma therapy assessment questionnaire to measure asthma control and healthcare utilization in children.

BACKGROUND: : The usefulness of questionnaires to assess asthma control in clinical practice is recognized in recent international guidelines. While several questionnaires have been developed to measure asthma control in adults, there has been little study of the performance of such instruments in children. OBJECTIVE: : To determine whether there is an association between asthma-related healthcare use and poor asthma control, as determined by categorical score on the control domain of the Asthma Therapy Assessment Questionnaire for children and adolescents (the pediatric ATAQ). METHODS: : An analysis of a 1998 mailed survey of parents or caregivers of children aged 5-17 years with asthma enrolled in three large managed-care organizations in the Northeast and Midwest US was conducted. Pediatric ATAQ control domain score (reported for the past 4 weeks) was the main outcome measure. The pediatric ATAQ control domain was scored from 0 to 7, with 0 indicating no asthma control problems as measured by the questionnaire, and higher scores indicating increasing asthma problems. The hypothesis of an association between pediatric ATAQ control domain score and asthma-related healthcare use (hospitalizations, ER or urgent care facility visits, and doctor visits for worsening asthma in the past 12 months) was examined. RESULTS: : 406 completed surveys were received. Asthma-related hospitalizations, ER/urgent care visits, and doctor visits were reported for 38, 173, and 319 children, respectively. Of the three control score categories (0, 1-3, and 4-7), children with a control score of 4-7 were more likely to have been hospitalized (p = 0.01), to have visited the ER or urgent care facility (p < 0.0001), or to have visited a doctor (p = 0.0001) because of asthma managed care.In multivariate models including demographic variables and a measure of general health status, higher odds of ER/urgent care visits (odds ratio [OR] 3.47, 95% CI 1.92, 6.26) and doctor visits (OR 7.14; 95% CI 2.40, 21.2) was observed for children with an asthma control score of 4-7 than for children with no identified asthma control problems (score of 0). An asthma control score of 4-7 was significantly associated with hospitalization in a multivariate model including only demographic variables (OR 3.06; 95% CI 1.28, 7.33) but not in a model that included general health status (OR 2.44; 95% CI 0.96, 6.16). Relative to an excellent health status, a fair or poor health status was significantly associated with asthma-related hospitalization (OR 7.03; 95% CI 1.71, 28.87). Compared with White race, Black race was significantly associated with hospitalization (OR 2.30; 95% CI 1.05, 5.04) and ER/urgent care visits (OR 2.89; 95% CI 1.67, 5.01). CONCLUSIONS: : Children identified as having poor asthma control using the pediatric ATAQ instrument had significantly higher rates of asthma-related hospitalizations, ER or urgent care visits, and doctor visits than those with good control. This asthma control measure may be useful in identifying children in need of more intensive asthma management.

Factors influencing the acceptance of changes in antiretroviral therapy among HIV-1-infected patients.

Physicians routinely consider modifying antiretroviral therapy (ART) regimen for their patients with HIV. Little is known about the factors associated with patients' willingness to accept providers' recommended ART changes. This multicenter prospective observational study examined factors associated with willingness to accept ART changes recommended by their providers among HIV-infected adults from six urban outpatient HIV clinics. Patients were surveyed using the Patient Attitudes about Altering Antiretroviral Therapy Survey questionnaire (PAAARTS). Factors associated with willingness to accept ART changes were assessed using a multivariate generalized estimating equation (GEE) model to account for correlated responses. The Classification and Regression Trees (CART) analysis was also performed to determine subgroups of patients with higher acceptance of change. 216 of 289 patients (75%) definitely accepted recommended changes. Odds for acceptance were 3.2, 2.3, and 2.8 times higher for patients with higher attitudes and beliefs about ART (p < 0.01; 95% confidence interval [CI] = 1.59, 6.52), patients who rated their provider's care as excellent (p < 0.05; 95% CI = 1.07, 4.78), and non-Hispanic patients (p < 0.05; 95% CI 1.03, 7.57), respectively. CART analysis showed similar results and identified that when patients had less positive attitude about ART, acceptance rates were higher for non-Hispanic patients with higher assessments of their patient-provider communication. While most patients accepted providers' recommendation for ART changes, this willingness was influenced by both patients' attitudes and beliefs about ART and their assessment of either the effectiveness of patient-provider communication or their rating of providers' care. ART acceptance rates among Hispanic patients were lower.

Assessment of asthma severity and asthma control in children.

National and international guidelines for asthma recommend the assessment and documentation of severity as the basis for patient management. However, studies show that there are problems with application of the severity assessment to children in clinical practice. More recently, asthma control has been introduced as a method to assess the adequacy of current treatment and inform asthma management. In this article we review the application and limitations of the severity assessment and the asthma-control tools that have been tested for use in children. A system of using asthma severity for disease assessment in the absence of treatment and using asthma-control assessment to guide management decisions while a child is receiving treatment appears to be a promising approach to tailor treatment to improve care and outcomes for children with asthma.

Patterns of asthma-related health care resource use in children treated with montelukast or fluticasone.

OBJECTIVE: To examine the impact of controller monotherapy with montelukast or fluticasone on asthma-related health care resource use among children aged 2-14 years old. DESIGN AND METHODS: A retrospective claims-based analysis of asthmatic children, 2-14 years old, receiving a prescription (index) for montelukast or fluticasone between January 1, 1999 and June 30, 2000 was conducted. Children were matched by age and propensity score to obtain comparable treatment groups. The propensity score was derived using patient demographics, pre-existing respiratory conditions, and asthma-related pharmacy and health service utilization (i.e. ambulatory visits, emergency department visits and hospitalizations). Claims for asthma-related emergent care and medication use were examined for the 12-month periods before and after the index prescription. Treatment group comparisons of asthma-related resource use were conducted for the total pediatric population and separately for children 2-5 years and 6-14 years. Persistent controller medication use was assessed at 6 and 12 months post-index. RESULTS: A total of 2034 children were matched (1017 in each treatment group). Post-index rates of asthma-related resource use were similar among children treated with montelukast or fluticasone. Among children 2-5 years old, fewer emergency department visits were observed with montelukast versus fluticasone (relative risk = 0.52, 95% confidence interval [CI]: 0.28-0.96); no significant difference was observed among children 6-14 years old. No significant differences between montelukast and fluticasone cohorts in hospitalizations or rescue medication fills were noted in either age group. Evidence of at least one medication refill was significantly greater with montelukast at both 6 and 12 months post-index. CONCLUSIONS: Similar levels of resource use were achieved by children 2-14 years initiating montelukast or fluticasone, as indicated by use of asthma-related emergent care and rescue/acute medications. Subgroup analyses suggest a differential effect of age on the relationship between treatment and asthma-related resource use, with children 2-5 years observed to have less resource use while on montelukast.

Administrative claims analysis of asthma-related health care utilization for patients who received inhaled corticosteroids with either montelukast or salmeterol as combination therapy.

OBJECTIVE: To compare asthma-related health care resource utilization among a matched cohort of asthma patients using inhaled corticosteroids (ICSs) plus either montelukast (MON) or salmeterol (SAL) as combination therapy for asthma, during a time prior to the availability of fixed-dose combinations of ICS/SAL. METHODS: A retrospective analysis using the PHARMetrics patient-centric claims database was conducted for the period preceding the market introduction of combination fluticasone-SAL in September 2000. Patients had to meet the following criteria for inclusion in the study: they had to be between the ages of 4 and 55 years; they had to have been continuously enrolled for 2 years; they had to have initiated ICS/MON or ICS/SAL therapy between July 1, 1998, and June 30, 1999; and they had to have had either (a) a diagnosis of asthma (based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes of 493.xx) for 2 outpatient visits, 1 or more emergency department (ED) visits, or 1 or more hospitalizations within 1 year or (b) pharmacy claim records that contained a National Drug Code for an antiasthma medication (betaagonist, theophylline, ICS, cromolyn, or leukotriene) 2 or more times within 1 year. ICS/MON and ICS/SAL patients were matched 1 to 1 on age and propensity score. Outcomes included asthma-related hopitalizations and ED visits with ICD-9-CM codes of 493.xx, and oral corticosteroid (OCS) fills and short-acting beta-agonist (SABA) fills. Multivariate regression analyses were performed. Subgroup analyses based on sequential or concurrent initiation of combination therapy were also conducted. RESULTS: A total of 1,216 patients were matched (ICS/MON = 608; ICS/SAL= 608). Decreased odds of ED visits and/or hospitalizations were observed with ICS/MON (adjusted odds ratio [OR] = 0.58; 95% confidence interval [CI], 0.35- 0.98) versus ICS/SAL. The odds of postindex OCS fills were not different for ICS/MON and ICS/SAL patients (adjusted OR = 1.04; 95% CI, 0.79-1.38). Postindex pharmacy claims for SABAs were significantly higher among ICS/MON patients versus ICS/SAL patients (adjusted relative risk [RR] = 1.33; 95% CI, 1.17-1.52), and this difference remained regardless of prior use or no prior use of ICSs. In subgroup analyses, mean change in SABA fills varied by how combination therapy was initiated, with sequential addition of asthma controllers leading to a reduction in SABA fills in both groups. For patients with concurrent initiation of combination therapy, the odds of ED visits/hospitalizations were significantly lower in patients initiating ICS/MON (adjusted OR = 0.25; 95% CI, 0.08-0.79). CONCLUSION: In this matched cohort, use of ICS/MON compared with ICS/SAL resulted in similar odds of OCS fills, decreased odds of ED visits and asthmarelated hospitalizations, but higher utilization of SABA.

Impact of recent fracture on health-related quality of life in postmenopausal women.

UNLABELLED: The effect of fractures other than hip and spine on HRQoL in younger and older women has not been extensively studied. In a cohort of 86,128 postmenopausal women, we found the impact of recent osteoporosis-related fractures on HRQoL to be similar between women < 65 compared with those > or = 65 years of age. The impact of spine, hip, or rib fractures was greater than that of wrist fractures in both age groups. INTRODUCTION: Health-related quality of life (HRQoL) after vertebral and hip fractures has been well studied. Less is known about HRQoL after fractures at other sites. We studied the effect of recent clinical fractures on HRQoL, using Short Form-12 (SF-12). MATERIALS AND METHODS: This study included 86,128 postmenopausal participants in the National Osteoporosis Risk Assessment (NORA) who responded to two follow-up surveys during a 2-year interval. At each survey, they completed the SF-12 HRQoL questionnaire and reported new fractures of the hip, spine, wrist, and rib. The effect of recent fracture on HRQoL was assessed by comparing Physical Component Score (PCS) and Mental Component Score (MCS) means for women with and without new fractures at the second survey. Analyses were by fracture type and by age group (50-64 and 65-99) and were adjusted for PCS and MCS at the first survey. RESULTS: New fractures (320 hip, 445 vertebral, 657 rib, 835 wrist) occurring during the interval between the first and second follow-up surveys were reported by 2257 women. The PCS was poorer in both older and younger women who had fractured the hip, spine, or rib (p < or = 0.001). Wrist fractures had an impact on PCS in women < or = 65 years of age (p < 0.001), but not older women (p > 0.10). These differences in PCS by fracture status were similar to those reported for other chronic diseases such as asthma, chronic obstructive pulmonary disease (COPD), and osteoarthritis. MCS was less consistently changed by fracture status, but younger and older women with vertebral fracture (p < 0.004), older women with hip fracture (p < 0.004), and younger women with rib fracture (p < 0.004) had poorer MCS compared with those who did not fracture within their age cohort. CONCLUSIONS: Recent osteoporosis-related fractures have significant impact on HRQoL as measured by SF-12. The impact of recent fracture on HRQoL was similar for older and younger postmenopausal women. Fracture prevention and postfracture interventions that target the subsequent symptoms are needed for postmenopausal women of any age.

Using an asthma control questionnaire and administrative data to predict health-care utilization.

OBJECTIVE: To examine the merits of the Asthma Therapy Assessment Questionnaire (ATAQ) control index together with prior asthma health-care utilization from administrative data in predicting future acute asthma health-care utilization. DESIGN: Prospective cohort study. POPULATION: A total of 4,788 adult asthma patients aged 17 to 93 years who completed a baseline evaluation and had at least 6 months of follow-up data. STATISTICAL METHODS: Classification and regression tree methodology to predict future risk of acute health-care utilization events. RESULTS: These results show that the ATAQ control index and administrative data are jointly useful for predicting future health-care utilization. The utility of the ATAQ control index in the presence of information about prior health-care utilization is to further stratify risk among the subset of younger individuals who did not have any prior acute health-care utilization. While administrative health-care utilization data served as the strongest predictor of future health-care utilization, the ATAQ control index helped to identify 1% of individuals without recent acute care that had approximately a sixfold elevated risk (95% confidence interval, 4.2 to 8.4) of future acute health-care utilization. This is an important result since only a small fraction of individuals with acute events in a given year will have had acute events in the previous year. CONCLUSION: These findings should assist the practicing clinician and organizations interested in population-based asthma disease management.

Asthma-related health care resource use among patients starting fluticasone or montelukast therapy.

STUDY OBJECTIVES: To compare patterns of asthma-related health care resource use among patients prescribed fluticasone or montelukast as singlecontroller therapy for asthma, and to confirm patterns previously observed in retrospective analyses examining outcomes among patients receiving fluticasone or montelukast for asthma. DESIGN: Retrospective cohort study. DATA SOURCE: Administrative claims data drawn from United States health insurers in 35 states, covering 17 million privately insured patients. PATIENTS; A total of 4758 patients aged 2-55 years with asthma who were prescribed either fluticasone or montelukast from July 1, 1998-June 30, 1999, were continuously enrolled for at least 24 months, had no evidence of controller therapy for 6 months before the start of drug therapy, and had no evidence of chronic obstructive pulmonary disease or other respiratory illness. MEASUREMENTS AND MAIN RESULTS: Patients were identified using an algorithm based on medical and pharmacy insurance claims. Patients were matched between groups based on a propensity score of clinical characteristics and age; this resulted in 1512 patients/treatment group. Asthma-related health care claims incurred for 12 months before and after the start of controller therapy were analyzed. After adjustment, the fluticasone-treated group had greater risk than the montelukast-treated group of requiring therapy with a short-acting beta-agonist in the follow-up period (relative risk 1.12, 95% confidence interval [CI] 1.03-1.20). Odds were similar across treatment groups for needing an emergency department visit and/or hospitalization (odds ratio 1.08, 95% CI 0.74-1.58) and for needing therapy with an oral corticosteroid (odds ratio 1.02, 95% CI 0.84-1.26). CONCLUSION: The start of therapy with either fluticasone or montelukast as a single-controller for asthma was associated with similar asthma-related health care resource use in this matched population.

Sensitization to common allergens in adults with asthma.

PURPOSE: To estimate the prevalence of atopy (ie, allergen sensitization) in a sample of adult asthma outpatients. METHODS: Population consisted of a total of 218 patients, 18 to 55 years of age, who were currently receiving care for asthma; and 13 physicians, whose specialties were Family Practice, Allergy, or Pulmonology and who were providing care to at least 10 to 15 asthma patients weekly. Patients provided a blood sample for quantification of total and allergen-specific IgE. Outcomes were the proportion of patients with atopy and the proportions of patients with elevated serum IgE specific to each of 8 specific common allergens. RESULTS: The patients' mean age was 42 years, and 74% were women; 68% of patients met the study definition of atopy. Total serum IgE > or = 114 kU/L was observed in 48% of patients, and 59% had elevated levels of IgE specific to one or more of 8 common allergens. CONCLUSIONS: The majority of adult asthma outpatients had evidence of atopy and most were sensitive to a specific identifiable allergen. Awareness of the high prevalence of atopy among asthma patients might improve patient management.

The Hyperlipidemia: Attitudes and Beliefs in Treatment (HABIT) survey for patients: results of a validation study.

Patient adherence with cholesterol-lowering medications is a crucial component in helping patients achieve lipid goals. Understanding patient attitudes and beliefs about hyperlipidemia and its pharmacological treatments may be useful in improving patient adherence with their treatment plan. The objectives of this study were to develop a theoretically based, statistically reliable, and valid survey instrument for measuring the attitudes and beliefs of patients towards hyperlipidemia and its treatments, and to determine whether the attitudes measured were associated with patient-reported medication adherence. We assessed the reliability of the instrument through an examination of the internal consistency and factor structure of 8 attitude constructs including attitudes about the effectiveness of medications and the quality of doctor-patient communication. Validity was assessed through correlations among the attitudes and the relationship between the attitudes and the number of medication adherence problems the patient experienced in the past month. Internal consistency scores for the 8 constructs ranged from .46 to .82. Factor loadings indicated that the individual items belonged to their respective constructs, as hypothesized. The validity of the instrument was demonstrated by significant relationships between 4 of the attitudinal constructs and self-reported medication adherence problems. This study provides preliminary evidence of the reliability and validity of the HABIT (Hyperlipidemia: Attitudes and Beliefs in Treatment) patient survey of attitudes about the treatment of hyperlipidemia.

Observational study of the effects of using montelukast vs fluticasone in patients matched at baseline.

BACKGROUND: The relative effectiveness of inhaled corticosteroids and leukotriene receptor antagonists in asthma therapy continues to be the subject of clinical studies. Recent studies have examined the impact of these therapies using a retrospective design. Retrospective studies require special attention to nonrandom assignment of participants to treatment groups and, consequently, to the need to appropriately account for baseline differences. OBJECTIVE: To examine the relative effectiveness of montelukast sodium vs fluticasone propionate as controller monotherapy in patients with asthma. METHODS: A retrospective cohort analysis of claims data from 6,160 individuals continuously enrolled in 1 of 20 US managed care plans. Patients using fluticasone were matched to those treated with montelukast using propensity scores and age (2-55 years). Health care use was determined for the 12-month periods before and after the initial controller prescription. Outcomes included asthma-related hospitalizations and emergency department visits, along with use of oral corticosteroids and short-acting beta-agonists. Logistic regression analyses were also performed. RESULTS: Overall, controller therapy significantly reduced the odds of postindex asthma-related hospitalizations (odds ratio, 0.56; 95% confidence interval, 0.38-0.79); no significant difference was observed with asthma-related emergency department visits (odds ratio, 0.89; 95% confidence interval, 0.76-1.04). Differences in the relative effect in the montelukast and fluticasone groups were not observed. Similarly, increases in the postindex rate of short-acting beta-agonist use and increases in oral corticosteroid use for both montelukast and fluticasone patients were noted. CONCLUSIONS: Similar outcomes were observed in montelukast and fluticasone users in this matched cohort analysis.

Incidence and duration of side effects and those rated as bothersome with selective serotonin reuptake inhibitor treatment for depression: patient report versus physician estimate.

BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) are widely used as the first-line treatment for depression. Information regarding their side effects is mostly based on controlled clinical trials. METHOD: Patients who received an SSRI for a new or recurrent case of depression (ICD-9 code 296.2 or 311) between December 15, 1999, and May 31, 2000 were interviewed by telephone 75 to 105 days after initiation of SSRI therapy. Using closed-ended questions, investigators asked patients if they experienced any of 17 side effects commonly associated with SSRIs, how bothersome they were, and what their duration was. Prescribing physicians completed a written survey providing their estimates about frequency of side effects associated with SSRIs and how bothersome those side effects are. RESULTS: Of 401 patients who completed the phone interview, 344 patients (86%) reported at least 1 side effect, and 219 patients (55%) experienced 1 or more bothersome side effect(s). The most common bothersome side effects were sexual dysfunction and drowsiness (17% each). While most side effects first occurred within the first 2 weeks of treatment, the majority of patients were still experiencing the same side effects at the time of interview, most notably blurred vision (85%) and sexual dysfunction (83%). Overall, physicians (N = 137) significantly underestimated the occurrence of the 17 side effects explored, and they tended to underrate how bothersome those side effects were to their patients. CONCLUSION: Side effects associated with SSRIs are common and bothersome to patients. Treatment-emergent side effects tend to persist during the first 3 months of treatment.