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Katsuyuki Fukutake,1,2 Kanae Togo,3 Linghua Xu,3 Leona E Markson,4 José Maria Jimenez Alvir,5 Ian Winburn,6 Toshiyuki Karumori3 1Laboratory Medicine, Tokyo Medical University, Shinjuku, Tokyo, Japan; 2Department of Blood Coagulation Diseases, Ogikubo Hospital, Suginami, Tokyo, Japan; 3Pfizer Japan Inc, Shibuya-ku, Tokyo, Japan; 4Pfizer Inc, Collegeville, PA, USA; 5Pfizer Inc, New York, NY, USA; 6Pfizer Ltd, Surrey, UKCorrespondence: Toshiyuki Karumori, Pfizer Japan Inc, Shinjuku Bunka Quint Bldg, 3-22-7, Yoyogi, Shibuya-ku, Tokyo, Japan, Tel +81-80-4152-4243, Email Toshiyuki.karumori@pfizer.comIntroduction: 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.Keywords: blood coagulation factors, drug labeling, factor IX, health care administrative claims, health care costs

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of a comprehensive migraine disease management program, as measured by humanistic outcomes measures, conducted in a managed care setting.Design: A prospective comparative study comprised of an intervention and a control group to evaluate the impact of the disease management initiative.Setting: Independent Practice Association (IPA)-type managed care organization.Study participants and main outcomes measures: Study participants resided in adjacent regions (intervention region included Minneapolis, MN, USA and the usual care region included St Paul, MN, USA and adjacent areas in MN, USA) separated by natural geographic barriers. Eligible patients were identified through a review of the Medica plan's administrative claims database and were asked to complete the Migraine Therapy Assessment Questionnaire (MTAQ), a tool to assess the presence of migraine management issues. Responders (patients completing the MTAQ) who reported >/= 2 migraine care risk indicators in the intervention region received the disease management intervention, while all responders in the control region received usual care. Responders in both regions with >/= 2 migraine care risk indicators were also asked to complete the Migraine Disability Assessment (MIDAS) questionnaire and the 12-item Short Form Health Survey (SF-12) at baseline. All participants were asked to complete the same instruments at the end of the program as they did at baseline.Interventions: Disease management intervention activities included patient and physician education, as well as a patient feedback report containing migraine care risk indicators, which was sent to the treating physicians. All patients were encouraged to contact their physicians if they reported two or more migraine management issues.Results: A total of 2232 patients with migraine were enrolled in the study (1373 from the intervention region and 859 in the control region). Compared with patients in the control region, patients in the intervention region reported, as measured by MTAQ, significant improvement in migraine symptom relief, more knowledge about potential migraine triggers, a decrease in economic burden, and more satisfaction with migraine treatment. In addition, the change in MIDAS scores from baseline showed a greater shift towards decreasing disability in the intervention group compared with the control group. However, no statistically significant improvement was detected in terms of health status as measured by SF-12. Of the participants in the intervention region who completed the program evaluation survey, 40% indicated that they called or visited their physicians regarding their migraine survey results if it was recommended. For those contacting their physicians, 76% had their medications changed and 75% noted an improvement in relief due to a change in medication.Conclusions: Considering the significant toll of migraine on patients, employers, and the healthcare system, healthcare plans should consider implementing migraine disease management programs to improve migraine care. [ABSTRACT FROM AUTHOR]

Context: Although current depression treatment guidelines recommend continuing antidepressant therapy for at least 4 to 9 months, many patients discontinue treatment prematurely, within 3 months.Objectives: To investigate the relationship between patient-physician communication and the continuation of treatment with antidepressants and to explore the demographics, adverse effects, therapeutic response, and frequency of follow-up visits.Design, Setting, and Patients: A total of 401 telephone interviews of depressed patients being treated with selective serotonin reuptake inhibitor (SSRI) therapy between December 15, 1999, and May 31, 2000, were conducted and 137 prescribing physicians completed written surveys from Northern California Kaiser Permanente health maintenance organization outpatient clinics.Main Outcome Measures: Patient-physician communication about therapy duration and about adverse effects; therapy discontinuation or medication switching within 3 months after start of SSRI therapy.Results: Ninety-nine physicians (72%) reported that they usually ask patients to continue using antidepressants for at least 6 months, but 137 patients (34%) reported that their physicians asked them to continue using antidepressants for this duration and 228 (56%) reported receiving no instructions. Patients who said they were told to take their medication for less than 6 months were 3 times more likely to discontinue therapy (odds ratio [OR], 3.12; 95% confidence interval [CI], 1.21-8.07) compared with patients who said they were told to continue therapy longer. Patients who discussed adverse effects with their physicians were less likely to discontinue therapy than patients who did not discuss them (OR, 0.49; 95% CI, 0.25-0.95). Patients who reported discussing adverse effects with their physicians were more likely to switch medications (OR, 5.60; 95% CI, 2.31-13.60). Fewer than 3 follow-up visits for depression, adverse effects, and lack of therapeutic response to medication were also associated with patients' discontinuing therapy.Conclusions: Discrepancies exist between instructions that physicians report they communicate to patients and what patients remember being told. Explicit instructions about expected duration of therapy and discussions about medication adverse effects throughout treatment may reduce discontinuation of SSRI use. Our finding that patients with 3 or more follow-up visits were more likely to continue using the initially prescribed antidepressant medication suggests that frequent patient-physician contact may increase the probability that patients will continue therapy. [ABSTRACT FROM AUTHOR]

Abstract 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.

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.

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 β-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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Asthma Therapy Assessment Questionnaire (ATAQ) for children and adolescents was developed to assist clinicians and health plans to identify children at risk for adverse outcomes of asthma. ATAQ is a brief, 20-item parent-completed questionnaire that generates indicators of potential care problems in several categories, including symptom control, behavior and attitude barriers, self-efficacy barriers, and communication gaps. This paper describes testing of the internal consistency and construct validity of the instrument. A cross-sectional mail survey with telephone follow-up was conducted with parents of 434 children aged 5-17 years being treated for asthma and enrolled in three managed care organizations in the Midwestern and Northeastern United States. ATAQ scales were evaluated using correlations with measures of health status, asthma impact, and healthcare utilization. ATAQ demonstrated good internal consistency and the hypothesized relationships to corresponding measures from existing instruments. Asthma control was significantly associated with measures of physical health, psychosocial health, resource use, and family impact. "Shared decision making," an indicator of patient-provider communication and involvement of the parent and child in developing asthma management plans, was significantly and positively associated with symptoms and parental satisfaction. Other ATAQ components showed similar associations. ATAQ appears to have satisfactory measurement properties and is ready for use to identify patients who might benefit from further disease management efforts or medical attention.

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.

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.

Pharmacologic treatment and goal attainment rates from published literature indicate that lipid management has generally improved for patients with coronary heart disease. The population implications of these changes in lipid management are examined, suggesting that the challenge of lipid management may be shifting from a problem of no treatment to one of undertreatment.

Introduction: Many patients treated with lipid-lowering medications in clinical practice do not achieve targeted National Cholesterol Education Program (NCEP) goals for low-density lipoprotein cholesterol (LDL-C), despite the proven efficacy of these medications. Understanding physician attitudes and beliefs about treating patients to goal may be useful in improving patient care and ensuring that all patients receive the benefits of treatments shown to be optimal in clinical trials., Objective: To develop a theoretically based, and statistically reliable and valid survey instrument for measuring the attitudes and beliefs of physicians toward hyperlipidemia and its treatment, including treatment of patients to goal. To determine whether the attitudes measured were associated with physician intentions to treat patients to LDL-C goal., Methods: We assessed the reliability of the instrument through an examination of the internal consistency and factor structure of the constructs. Validity was assessed through zero-order correlations among the constructs and the relationship between the constructs and an intent to treat to goal case study., Results: Internal consistency scores for the 8 constructs ranged from 0.48 to 0.75. Factor loadings indicated that the individual items belonged to their respective constructs, as hypothesized. The predictive validity of the instrument was demonstrated by significant relationships between 5 of the 8 attitudinal constructs and an intent to treat to goal case study., Conclusions: The HABIT physician survey is the first validated instrument covering a broad set of attitudes about the treatment of hyperlipidemia that are both theoretically and empirically linked to physician intent to treat to NCEP LDL-C goal.

We compared measures of treatment effectiveness when inhaled corticosteroids (ICSs) or leukotriene modifiers (LMs) were used as controller monotherapy for asthma. Asthma patients aged 6-55 years initiating ICS or LM monotherapy between July 1998 and June 1999 (index prescription) were identified using a managed care claims database. Asthma-related hospitalizations, emergency department (ED) visits, and use of short-acting beta-agonists and oral corticosteroids (OCSs) were assessed as proxies for treatment effectiveness. Propensity score was used to adjust for baseline differences between treatment cohorts. The change in the annual rate of claims from the preindex to postindex period for each measure was compared across treatment groups. Logistic regression models of the postindex composite events (hospitalization and/or ED) and OCS use were estimated. Nine hundred sixty patients were initiated on LMs (n = 153) and ICSs (n = 807). The mean annual rate of claims for OCSs increased in the ICS group (0.2) but was unchanged in the LM group (adjusted mean difference in change, 0.2; 95% CI, 0.05-0.4; p = 0.01). The mean annual rate of claims for short-acting beta-agonists increased in both the ICS and LM groups by 1.1 and 0.5, respectively (adjusted mean difference in change, 0.6; 95% CI, -0.06. 1.1; p = 0.08). Similar changes in annualized rates of claims for hospitalizations and ED visits were observed between treatment groups. In logistic regression models, greater odds of postindex OCS use was observed among the ICS group (odds ratio for ICS versus LM = 1.7; 95% CI, 1.04-2.8; p = 0.04). No association between treatment groups and postindex hospitalization and/or ED events was observed. In this managed care population, patients treated with ICSs or LMs had similar measures of treatment effectiveness, as measured by asthma-related health care resource use.

Objective: To assess asthma control and patient satisfaction among pediatric users of montelukast in a clinical practice setting., Study Design: A prospective study of 175 children with persistent asthma, 6 to 14 years of age, who initiated treatment with montelukast between Feb-1998 and Aug-1998, in primary care and pediatric offices across the United States. Data on asthma control and satisfaction with treatment was collected in physicians' offices after enrollment and by survey to the patients' homes at 1 month of treatment., Results: Across the study population, improvements in mean scores for asthma control and parent satisfaction were observed at the 1-month follow-up compared with baseline. At 1 month, 57.7% of patients had none offour issues indicative of poor asthma control, compared with 19.4% at baseline. Similarly, after 1 month of treatment with montelukast, 2.7 times as many parents reported being very satisfied with asthma therapy (using montelukast) compared with the previous controller therapy regimen at baseline. During the 1-month follow-up period, montelukast was used as the only controller medication by 18.3% of patients, and in combination with another controller medication by 81.7%., Conclusions: Observations from this study over one month suggest that a significant percentage of pediatric patients successfully managed their asthma with montelukast and their parents were satisfied with their medication, compared to baseline.

Objective: To observe the experience of 9 practice sites in implementing provider-defined disease management programs for coronary heart disease patients., Study Design: Observational study of provider-defined practice improvement programs., Methods: Practices chose from a variety of interventions that included provider- and patient-based disease management tools. Data were collected at baseline, 6, and 12 months., Results: Complete baseline, 6-month, and 12-month data were available for 586 patients (58% of the 1013 patients enrolled). Compared with baseline, 6-month data showed more patients whose total cholesterol was less than 200 mg/dL (56% to 76%; P < or = .001), whose low-density lipoprotein (LDL) cholesterol was less than 100 mg/dL (30% to 54%; P < or = .001), and whose high-density lipoprotein cholesterol was at least 35 mg/dL (75% to 81%; P < or = .001); who exercised rigorously for 30 minutes, 3 times a week (40% to 53%; P < or = .001); who used lipid medication (74% to 80%; P < or = .01); and who used aspirin (84% to 92%; P < or = .001). There were no significant improvements in triglyceride levels, blood pressure control, glycemic control among diabetes patients, smoking cessation, body mass index, and beta-blocker use. The 12-month results were similar to the 6-month results. Sites with a practice coordinator had the highest number of patients achieving their LDL goal (72% to 89%)., Conclusions: There may be an opportunity to improve patient care by applying disease management principles with a variety of interventions. Dedicated personnel to help coordinate disease management programs may be critical to the success of such programs.

Population-based disease management should be enhanced by good risk assessment models and instruments. We prospectively evaluated the ability of a simple measure of short-term asthma control (scored 0 to 4) to predict asthma 12-mo health care utilization (HCU). A total of 5,172 adult asthma patients completed a brief questionnaire in fall 1997 to assess current level of asthma control. We then evaluated HCU for calendar year 1998. Ninety-three percent had health plan eligibility in 1998 and were included in this analysis. Both acute and routine asthma utilization increased with increasing numbers of asthma control problems. Rates of acute care episodes were 3.5 (95% confidence interval [CI] = 2.9, 4.3) times more likely for those with 3 to 4 control problems versus those with no control problems. Lesser, but statistically significant, increases were seen for those with two (relative risk [RR] = 1.7, 95% CI = 1.4, 2.2) or one (RR = 1.4, 95% CI = 1.1, 1.8) control problems. These patterns were similar for men and women, and diminished with increasing age. The asthma control index contributed significantly to prospective prediction models even after adjusting for administrative data such as medication use and prior HCU. These data reinforce the usefulness of measures of short-term asthma control both for the individual clinician and for those interested in population-based asthma management.

Objective: To assess, in the setting of routine clinical practice, rizatriptan's effectiveness in treating acute migraine at its onset versus in a later phase of the attack., Background: Although the efficacy and tolerability of rizatriptan have been well documented in clinical trials, no information is available about the impact of the timing of medication use on clinical outcome., Methods: Migraineurs were enrolled in a prospective study and treated with rizatriptan 10 mg for two migraine attacks. Patients reported how they used the medication and treatment outcomes via an interactive voice response system. Outcome variables assessed included: time to onset of headache relief, headache severity 2 hours postdose and whether or not patients became largely symptoms-free (including associated symptoms), and when they were able to resume normal activities. Episodes in which patients took rizatriptan immediately after experiencing headache were designated "early use" and those in which patients delayed treatment until their headaches evolved to become moderate or severe were designated as "delayed use." Generalized estimating equations were used to assess the impact of early drug use and to control for age, gender, drug formulation, use of other migraine prescription medications before taking rizatriptan, attack sequence, migraine attack frequency, and recent migraine severity., Results: A total of 1919 migraineurs with 3450 migraine attack episodes were evaluated, of which 1369 episodes were early use and 2081 delayed use. Compared to delayed-use episodes, episodes wherein patients took rizatriptan early were 1.33 times more likely to be characterized by onset of headache relief within 30 minutes posttreatment (95% confidence interval [CI], 1.11 to 1.60), 1.32 times more likely to result in a largely symptom-free state (95% CI, 1.12 to 1.57), and 1.34 times more likely to be associated with a return to normal activities (95% CI, 1.13 to 1.58) within 1 hour posttreatment. No significant difference between early-use and delayed-use episodes was observed with respect to the likelihood of there being no or mild headache 2 hours posttreatment (odds ratio, 1.05; 95% CI, 0.90 to 1.24)., Conclusions: Whether taken at headache onset or later in the attack, rizatriptan was equally effective in relieving acute migraine headache by 2 hours postdose. Taking rizatriptan at the onset of headache was associated with more rapid relief of headache and reversal of functional disability.

Background: Measures of patient satisfaction or dissatisfaction with treatment are increasingly being used as indicators of quality of care. As these measures become more widely used, it is important to know if patient dissatisfaction is associated with important processes or outcomes of medical care., Methods: Survey of patient-reported asthma management issues using the Asthma Therapy Assessment Questionnaire in a large health maintenance organization in the Pacific Northwest. Associations between patient dissatisfaction with asthma treatment and patient-reported measures of asthma control, patient-provider communication, and belief in asthma medications (self-efficacy) were examined., Results: Of the 5181 adult members with asthma enrolled in the health maintenance organization, 30% indicated dissatisfaction with current treatment. Dissatisfaction was higher among patients with a higher number of asthma control problems, patient-provider communication problems, or belief in medication problems (eg, failure to believe their medications are useful and inability to take asthma medications as directed). The odds of dissatisfaction with treatment were 2.8 (95% confidence interval [CI], 2.4-3.3; P<.001) for asthma control problems, 2.0 (95% CI, 1.6-2.6; P<.001) for communication problems, and 8.0 (95% CI, 6.7-9.5; P<.001) for belief in medication problems compared with patients without these perceived problems., Conclusion: Patient dissatisfaction with treatment may be related to important asthma disease management issues.

Objective: To evaluate the consistency of pediatric asthma care with the National Asthma Education and Prevention Program Guidelines., Design: Cross-sectional survey at 2 managed care organizations in the United States (winter 1997-1998). The participants were parents of children (n = 318) age 5 to 17 years with asthma. There were no interventions. The outcome measures were indicators of care in 4 domains: (1) periodic physiologic assessment, (2) proper use of medications, (3) patient education, and (4) control of factors contributing to asthma severity., Results: Of 533 eligible patients with asthma, 318 (60%) parents responded; 59% of children were male, 76% were white, and 60% were aged 5 to 10 years. Deficiencies in care were identified in all care domains including, for patients with moderate and severe persistent symptoms, only 55% used long-term control medication daily, 49% had written instructions for handling asthma attacks, 44% had instructions for adjustment of medication before exposures, 56% had undergone allergy testing, and 54% had undergone pulmonary function testing., Conclusions: There are significant opportunities to improve the quality of care for children with asthma enrolled in managed care. A comprehensive approach to improving care may be necessary to address multiple aspects of care where opportunities exist.

Background: Highly active antiretroviral therapy (HAART) became standard for HIV in 1996. Studies at that time showed that most people infected with HIV had initiated HAART, but that members of minority groups and poor people had lower HAART use. It is not known whether high levels of HAART use have been sustained or whether socioeconomic and racial disparities have diminished over time., Objectives: To determine the proportion of patients who had received and were receiving HAART by January 1998, and to evaluate predictors of HAART receipt., Design and Participants: Prospective cohort study of a national probability sample of 2267 adults receiving HIV care who completed baseline, first follow-up, and second follow-up interviews from January 1996 to January 1998., Main Outcome Variables: Proportion currently using HAART at second follow-up (August 1997 to January 1998), contrasted with the cumulative proportions using HAART at any time before January 1998 and before December 1996., Analyses: Bivariate and multiple logistic regression analysis of population characteristics predicting current use of HAART at the time of the second follow-up interview., Results: The proportion of patients ever having received HAART increased from 37% in December 1996 to 71% by January 1998, but only 53% of people were receiving HAART at the time of the second follow-up interview. Differences between sociodemographic groups in ever using HAART narrowed after 1996. In bivariate analysis, several groups remained significantly less likely to be using HAART at the time of the second follow-up interview: blacks, male and female drug users, female heterosexuals, people with less education, those uninsured and insured by Medicaid, those in the Northeast, and those with CD4 counts of >/=500 cells/microl (all p <.05). Using multiple logistic regression analysis, low CD4 count (for CD4 <50 cells/microl: odds ratio [OR], 3.20; p <.001) remained a significant predictor of current HAART use at the time of the second follow-up interview, but lack of insurance (OR, 0.71; p <.05) predicted not receiving HAART., Conclusions: The proportion of persons under HIV care in the United States who had ever received HAART increased to over 70% of the affected population by January 1998 and the disparities in use between groups narrowed but did not disappear. However, nearly half of those eligible for HAART according to the U.S. Department of Health and Human Services guidelines were not actually receiving it nearly 2 years after these medications were first introduced. Strategies to promote the initiation and continuation of HAART are needed for those without contraindications and those who can tolerate it.

Objective: To determine costs of drug and nondrug treatment of HIV-infected patients during introduction of protease inhibitors and combination therapy., Study Design: Longitudinal, observational study of insurance claims data., Patients and Methods: Data from managed care organizations in Texas and California contracting with an HIV case management group were reviewed for all non-Medicaid/non-MediCal adults infected with HIV for costs of drugs and nondrug treatment per HIV-infected member per month from January 1995 to December 1997. Costs of care for patients with and without undetectable viral loads (< 400 copies/mL) were quantified., Results: Per HIV-infected member, average monthly drug costs increased, nondrug costs decreased, and total costs remained stable. Quarterly mortality rates decreased from 4.8% to 0.25%. From the first quarter of 1996 to the last quarter of 1997, the proportion of patients with undetectable viral loads increased from 6% to 56%. Increasing drug costs and decreasing nondrug costs were observed in patients with and without undetectable viral loads, but costs were higher for the latter: after the second quarter of 1996, drug costs were $67 to $277 higher for patients without undetectable viral loads, nondrug costs were $185 to $741 higher, and total costs were $333 to $808 higher., Conclusions: Reduced mortality rates and increased viral suppression to undetectable levels were observed during introduction of protease inhibitors and combination therapy in this MCO setting. Increased average monthly drug costs per HIV-infected patient were offset by decreased average monthly nondrug costs, and both costs were lower when patients achieved undetectable viral loads.

Objective: To describe and understand current care of simvastatin-treated patients with combined hyperlipidemia in routine clinical practice., Design: A 6-month prospective observational study. Demographics, simvastatin dosage, cardiac risk factors, and lipid profile were collected from August 1997 to December 1998 at 20 sites (230 patients) across the United States., Results: Overall mean percentage of reduction in total cholesterol levels was 27% (P<.001), low-density lipoprotein cholesterol (LDL-C) was 35% (P<.001), and triglyceride values was 28% (P<.001). Among those patients with low baseline high-density lipoprotein cholesterol (HDL-C) values (<0.91 mmol/L [<35 mg/dL]) (N = 49), there was a 17% increase in HDL-C (P< or =.001); 35% of these patients achieved National Cholesterol Education Program HDL-C goal (ie, < or =0.91 mmol/L [> or =35 mg/dL]). Coronary heart disease (CHD) patients were given significantly higher initial doses (mean, 15.1 mg) compared with non-CHD patients (mean, 11.5 mg) (P< or =.001). Overall, 74% of patients achieved LDL-C goal (52% on starting dose, 22% after 1 titration). Among those patients who were not at goal and had a follow-up lipid profile result available, only 1 patient (2%) was at the maximum dose (80 mg); 69% were receiving 20 mg or less. Approximately 63% of patients with CHD, 80% of patients with 2 or more risk factors, and 91% of patients with fewer than 2 risk factors achieved LDL-C goal., Conclusions: Multiple factors contribute to LDL-C goal achievement in a usual care setting. A significant opportunity exists to increase the number of patients who achieve LDL-C goal by appropriate dose titration and/or give patients a higher initial dose of simvastatin.

Objective: To compare ambulatory visit patterns, rates of medication use, and emergency department and hospital utilization for children with asthma covered under Medicaid and commercial payers within the same health maintenance organization (HMO)., Design: Retrospective cohort study., Setting: Eleven staff-model pediatric departments of an HMO., Patients: A total of 1928 Medicaid and 11007 non-Medicaid children aged 2 to 18 years with at least 1 encounter with a diagnosis of asthma between October 1, 1991, and September 30, 1996., Methods: We linked patient-level data from the HMO's automated medical record system for ambulatory encounters, a claims system for emergency department and hospital care, and an automated pharmacy dispensing database. Medicaid and non-Medicaid patients were compared for all encounter types and for prescribing and dispensing of beta-agonist and controller medications (inhaled corticosteroids and cromolyn sodium). Incidence rate ratios were calculated from Poisson regression models to control for age, sex, and, when appropriate, beta-agonist dispensing rate. The number of refills authorized on each prescription and the fraction of medications dispensed as refills compared with new prescriptions were compared for Medicaid and non-Medicaid patients., Results: Medicaid-insured children in the HMO were 1.4 times (95% confidence interval, 1.2-1.5) more likely to receive care in emergency departments and 1.3 times (95% confidence interval, 1.1-1.5) more likely to be hospitalized for their asthma compared with non-Medicaid members. Medicaid and non-Medicaid enrollees had similar yearly rates of nonurgent (1.32 vs 1.17) and urgent (0.38 vs 0.31) ambulatory visits. Beta-agonists were dispensed roughly equally to Medicaid and non-Medicaid members. Although Medicaid patients were less likely to have controller medications dispensed (relative risk, 0.72; 95% confidence interval, 0.69-0.74), they were equally likely to have them prescribed., Conclusions: Differences in ambulatory contact for Medicaid members do not explain the higher rates of emergency department visits and hospitalization in this population. Reasons for lower rates of dispensing of controller medications should continue to be investigated as one cause of increased morbidity for low-income children with asthma.

HIV-infected persons receiving methadone maintenance must often seek their medical care at a separate site. However, little data is available on the receipt of antiretroviral therapy (ART), beliefs about ART, and influences on the decision to initiate ART among those referred off-site. HIV-infected injection drug users (n = 72) were interviewed at three methadone maintenance programs; 83% with CD4 cell counts under 500 reported that they had received ART. Of these persons, 56% had used three drug combination therapy. Beliefs about the benefits of ART included: increased survival, 96%; decreased viral load 87%; decreased HIV-related infections 87%; could cure HIV, 29%. For those receiving ART, physician input, CD4 count, and possible side effects were more important than friends, family or mass media in deciding to start ART. We conclude that the model of referral for HIV care off-site does not appear to impede access to ART for HIV-infected IDUs in methadone maintenance.

Asthma severity and level of asthma control are two related, but conceptually distinct, concepts that are often confused in the literature. We report on an index of asthma control developed for use in population-based disease management. This index was measured on 5,181 adult members of a large health maintenance organization (HMO), as were various self-reported measures of health care utilization (HCU) and quality of life (QOL). A simple index of number of control problems, ranging from none through four, exhibited marked and highly significant cross-sectional associations with self- reported HCU and with both generic and disease-specific QOL instruments, suggesting that each of the four dimensions of asthma control represented by these problems correlates with clinically significant impairment. Qualitatively similar results were found for control problems assessed relative to the past month and relative to the past year. Asthma control is an important "vital sign" that may be useful both for population-based disease management as well as for the management of individual patients.

This study was undertaken to construct a health-related quality-of-life (QOL) questionnaire for hypertensive patients from preexisting instruments and to validate its use in full form and in a shortened version. Two hundred seventy hypertensive patients who were stable while taking antihypertensive medication (control group), changing medication because of side effects, or newly treated for hypertension were enrolled in a prospective, observational, longitudinal study. At baseline and at months 1, 2, and 3, patients completed a questionnaire covering 7 domains of QOL. The criteria for evaluating the scales were internal consistency, test-retest reliability, construct validity, and responsiveness to change. Data were analyzed for the full questionnaire and the shortened version. Internal consistency and test-retest correlation values were 0.69 to 0.95 for scales in the full questionnaire and 0.57 to 0.92 in the shortened version. Construct validity was supported by statistically significant, positive correlations with a global QOL item for all but 1 scale in both versions. Responsiveness to change was supported by increases in scores between baseline and month 3 for all scales in patients changing their medication because of side effects; scores remained unchanged (on all but 1 scale) in the stable (control) group. By uniformly applying standard validation criteria to a set of preexisting instruments, we created a new QOL questionnaire. Results were similar in both the full form and shortened version.

Specific features of ambulatory care, such as accessibility, may influence hospital use for patients with HIV infection. To identify clinic features associated with a lower risk of hospitalization, 6,280 New York state Medicaid enrollees diagnosed with AIDS in 1987-1992 and managed by one of 157 surveyed clinics were studied. The odds of hospitalization in the year before AIDS diagnosis were associated with five clinic features that facilitate the accessibility of care: (1) evening/weekend hours, (2) case manager, (3) appointments within 48 hours, (4) telephone consultation, and (5) whether the clinic handled urgent care. Hospitalization in the year before AIDS diagnosis occurred for 49 percent of patients. Three of the five accessibility features had unadjusted associations with lower hospitalization rates. The adjusted odds of hospitalization were lower for patients in clinics with extended hours (OR = 0.77, 95% CI = 0.63, 0.93) and for patients in clinics with four or more accessibility features compared with those in clinics with less than two features (OR = 0.67; 95% CI = 0.50, 0.89).

Background: Migraine is a common disabling disease but its economic burden has not been adequately quantified., Objective: To estimate the burden of migraine in the United States with respect to disability and economic costs., Methods: The following data sources were used: published data, the Baltimore County Migraine Study, MEDSTAT's MarketScan medical claims data set, and statistics from the Census Bureau and the Bureau of Labor Statistics. Disability was expressed as bedridden days. Charges for migraine-related treatment were used as direct cost inputs. The human capital approach was used in the estimation of indirect costs., Results: Migraineurs required 3.8 bed rest days for men and 5.6 days for women each year, resulting in a total of 112 million bedridden days. Migraine costs American employers about $13 billion a year because of missed workdays and impaired work function; close to $8 billion was directly due to missed workdays. Patients of both sexes aged 30 to 49 years incurred higher indirect costs compared with younger or older employed patients. Annual direct medical costs for migraine care were about $1 billion and about $100 was spent per diagnosed patient. Physician office visits accounted for about 60% of all costs; in contrast, emergency department visits contributed less than 1% of the direct costs., Conclusions: The economic burden of migraine predominantly falls on patients and their employers in the form of bedridden days and lost productivity. Various screening and treatment regimens should be evaluated to identify opportunities to reduce the disease burden.

Objective: Hospital and physician experience have been linked to improved outcomes for persons with HIV. Because many HIV-infected patients receive care in clinics, we studied clinic HIV experience and survival for women with AIDS., Design: Retrospective cohort study of women with AIDS whose dominant sources of care were clinics. Clinic HIV experience was estimated as the cumulative number of Medicaid enrollees with advanced HIV who used a particular clinic as their dominant provider up to the year of the patient's AIDS diagnosis: low experience (< 20 patients), medium (20-99 patients), high (> or = 100 patients). Proportional hazards models examined relationships between experience and survival., Setting: A total of 117 New York State clinics., Patients: A total of 887 New York State Medicaid-enrolled women diagnosed with AIDS in 1989-1992., Main Outcome Measure: Survival after AIDS diagnosis., Results: In later study years (1991-1992), patients in high experience clinics had an approximately 50% reduction in the relative hazard of death (0.53; 95% confidence interval, 0.35-0.82) compared with patients in low experience clinics. Adjusting for demographic and clinical variables, 71% of patients in high experience clinics were alive 21 months after diagnosis compared with 53% in low experience clinics. Experience and survival were not significantly associated in the early study years (1989-1990)., Conclusions: In more recent years, women with AIDS receiving care in high experience clinics survived longer after AIDS diagnosis than those in low experience clinics, providing further evidence of a relationship between provider HIV experience and outcomes.

Repeated emergency department (ED) visits by HIV-infected persons may signify poor access to care or treatment from inexperienced ambulatory providers. We examined features of 157 clinics following 6820 HIV-infected patients and associations with repeated (> or =2) ED visits by these patients in the year before their first AIDS diagnosis. Patient clinical and health care data came from 1987-1992 New York State (NYS) Medicaid files and clinic data came from interviews of clinic directors. The HIV/AIDS experience of each study patient's clinic was measured as the annual number of Medicaid enrollees newly diagnosed with AIDS who were contemporaneously followed by the patient's clinic. Repeated ED use was observed for 24%. The adjusted odds ratio (AOR) of repeated ED visits was reduced for patients in clinics with a physician on-call (0.77; 95% confidence interval [CI] = 0.65, 0.92), evening or weekend clinic hours (0.77; 95% CI = 0.64, 0.93), or >50 AIDS patients/year in 1987-1988 (0.56; 95% CI = 0.44, 0.71) versus fewer patients in those years. Patients in clinics with more than one feature promoting accessibility or HIV expertise had a greater reduction in their AOR of repeated ED use. HIV-infected patients in clinics with greater accessibility and HIV expertise rely less on the ED for care.

We investigated the association of cigarette smoking with maternal-child HIV transmission, adjusting for illicit drug use, maternal clinical status, and delivery factors. Vital statistics birth data were linked to the New York State Medicaid HIV/AIDS Research Database for HIV-infected women delivering a liveborn singleton from 1988 through 1990. Follow-up of these children was accomplished by Medicaid data > or = 2 years after birth, and their HIV status was ascertained by a clinically based classification. The adjusted relative risk or hazard (RH) of transmission for maternal factors was determined from Cox models. The overall transmission was 24.5% for the 901 maternal-child pairs. Smokers comprised 40% of women with data on smoking (n = 768); their transmission rate was 31% versus 22% for nonsmokers (p = 0.02). In the entire cohort, the adjusted RH of transmission for smokers was 1.45 (95% confidence interval [CI] 1.07-1.96); among women with advanced HIV, the adjusted RH was even higher (RH = 1.71; 95% CI 1.14-2.58). Users of cocaine (15% of the cohort) or of mixed or unspecified illicit drugs (28%) had higher transmission rates in unadjusted analysis (33%, p = 0.06 and 31%, p = 0.06 respectively); after adjustment for smoking and other maternal factors, neither cocaine (RH = 1.04 (95% CI 0.66-1.63)) nor mixed nor unspecified drug use (RH = 1.13 (95% CI = 0.75-1.70)) was significantly associated with transmission. Our data document an association of cigarette smoking during pregnancy with an increased risk of maternal-child HIV transmission that can be added to the growing list of complications caused by cigarette smoking.

Patients satisfaction with treatments is a growing area of research that has tremendous potential to provide outcome measures for clinical trials and disease management programs. It also has applications in marketing and product development, especially for the treatment of chronic diseases. The objective of this review is to demonstrate that treatment satisfaction is a distinct area of research that has produced some important initial results. We define treatment satisfaction and provide a conceptual framework that clarifies the role of treatment expectations, preferences, and satisfaction in the context of healthcare in general. Nineteen articles were selected from more than 1,400 abstracts and were reviewed for the following information: (1) topics covered; (2) method used to design the measure; (3) descriptive statistics; (4) assessment with respect to the attributes in the Instrument Review Criteria of the Medical Outcome Trust's Scientific Advisory Committee; and (5) covariates. We conclude that some important initial results about treatment satisfaction have been obtained, but that much work remains to be performed. We recommend that future research devote more attention to qualitative research with patients, assessment of the measures, and the covariates presented in the conceptual model. We also recommend that decision makers insist on measures that meet these criteria.