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Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion. Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis. Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician’s Global Assessment of “clear” or “almost clear,” [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated. Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.

Dear Editor, Thank you for the opportunity to respond to Dr. Glick and colleagues regarding their Letter to the Editor and for allowing us to provide clarity on aspects of the methodology in our re...

Benign prostatic hyperplasia (BPH) is a common disease in men that is characterized by lower urinary tract symptoms. Pharmacologic treatment with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) is recommended to alleviate symptoms, prevent disease progression that can lead to complications, and reduce health care costs.To compare clinical, economic, and health care resource utilization outcomes among BPH patients treated with early continuous combination AB and 5ARI therapy (dutasteride vs. finasteride) using administrative claims data from the United States.A retrospective analysis of administrative claims data from 2003-2013 was conducted to compare outcomes between patients with claims for early combination therapy with dutasteride + AB and patients with claims for early finasteride + AB. The study population included males aged older than 50 years with at least 1 medical claim with a diagnosis of BPH and pharmacy dispensing for AB and 5ARI therapies. Outcomes included acute urinary retention (AUR), prostate-related surgery, clinical progression, medical and pharmacy costs, and health care resource utilization. Inverse probability of treatment (IPT) weighted Cox proportional hazards, linear, and Poisson regression models were used to assess the association between outcomes and early combination therapy as appropriate.A total of 2,778 patients were included in the early finasteride + AB treatment cohort, and 4,125 patients were included in the early dutasteride + AB cohort. Dutasteride users were younger than finasteride users (mean age: 64.8 vs. 67.5 years, P0.001) and had a greater mean number of urologist visits (10.7 vs. 7.9, P0.001) during baseline. After adjusting for confounding using IPT weighting, no statistically significant difference was observed between dutasteride and finasteride for AUR (hazard ratio [HR] = 0.845, 95% CI = 0.660-1.070, P = 0.1643), prostate-related surgery (HR = 0.806, 95% CI = 0.568-1.171, P = 0.2525), and clinical progression (HR = 0.834, 95% CI = 0.663-1.043, P = 0.1122). While dutasteride was associated with higher pharmacy costs per month (adjusted monthly cost difference = $79, 95% CI = $45-$105), total all-cause medical costs were not significantly different between the 2 cohorts (adjusted monthly cost difference = -$44, 95% CI = -$110-$22).Clinical and economic outcomes were similar between the early dutasteride + AB and early finasteride + AB cohorts, with no statistically significant differences detected.Funding for this study was provided by GlaxoSmithKline (HO-14-15325 and AVO110072). Bell and Swensen are employees of GlaxoSmithKline. DerSarkissian, Xiao, Duh, and Lefebvre are employed by Analysis Group, a consulting company that received research grants from GlaxoSmithKline to conduct this study. Study concept and design were contributed by Bell, Swensen, Lefebvre, and Duh. Bell and Duh acquired the data. DerSarkissian and Xiao performed the statistical analysis and interpreted the data along with Lefebvre, Duh, and Bell. DerSarkissian and Bell drafted the manuscript. All authors contributed equally to critically revising the manuscript and providing final approval of the submitted manuscript.

not available. Disclosures: Study sponsored by LEO Pharma. Copyright 2018 SKIN

Background Longer survival of patients with cystic fibrosis (CF) has been linked to initiation of national newborn screening, new therapies that prevent and treat pulmonary exacerbations, and closer monitoring of health outcomes. However, few studies have examined the economic impact of these medical advances on costs, and none have examined these costs longitudinally. Methods We used a nationwide database of the healthcare claims of privately insured individuals with CF between 2001 and 2007. Study subjects had at least two claims with diagnoses of CF (ICD-277.xx). We extracted inpatient admissions, outpatient visits, prescribed therapies, and screening procedures and then calculated all-cause medical utilization and annual medical costs, adjusted for inflation. We adjusted for comorbidity burden and tested longitudinal time trends using regression models. Results We identified 3,273 individuals with CF. Overall, the costs of prescription drugs, outpatient visits, and durable medical equipment increased by 59% during the 7-year period ($18,715 in 2001 vs. $29,718 in 2007, P 30; $20,536 in 2001 to $56,116 in 2007, P

Summary Background Medication adherence is important in managing COPD. This study analyzed real-world use of inhaled medications for COPD to characterize relationships between daily dosing frequency, adherence, healthcare resource utilization, and cost. Methods This retrospective study used a large administrative claims database covering 8 million insured lives in the US from 1999 to 2006. Patients were stratified based on the recommended daily dosing frequency of their first COPD drug claim following COPD diagnosis. Adherence was measured using proportion of days covered (PDC) over 12 months following treatment initiation. Healthcare resource use included inpatient, outpatient, and emergency room visits. A multivariate regression model assessed the relationship between adherence and one-year healthcare resource use, controlling for demographics, comorbidities, and baseline resource use. Unit healthcare costs were obtained from the 2005 Medical Expenditure Panel Survey, adjusted to 2008 dollars. Results Based on a sample of 55,076 COPD patients, adherence was strongly correlated with dosing frequency. PDC was 43.3%, 37.0%, 30.2% and 23.0% for QD, BID, TID, and QID patient cohorts, respectively. Regression analysis showed that one-year adherence was correlated with healthcare resource utilization. For 1000 COPD patients, a 5% point increase in PDC reduced the annual number of inpatient visits (−2.5%) and emergency room visits (−1.8%) and slightly increased outpatient visits (+.2%); the net reduction in annual cost was approximately $300,000. Conclusion COPD patients who initiated treatment with once-daily dosing had significantly higher adherence than other daily dosing frequencies. Better treatment adherence was found to yield reductions in healthcare resource utilization and cost.

Chronic obstructive pulmonary disease (COPD) poses a significant economic burden on society, and a substantial portion is related to exacerbations of COPD. A literature review of the direct and indirect costs of COPD exacerbations was performed. A systematic search of the MEDLINE database from 1998-2008 was conducted and supplemented with searches of conference abstracts and article bibliographies. Articles that contained cost data related to COPD exacerbations were selected for in-depth review. Eleven studies examining healthcare costs associated with COPD exacerbations were identified. The estimated costs of exacerbations vary widely across studies: $88 to $7,757 per exacerbation (2007 US dollars). The largest component of the total costs of COPD exacerbations was typically hospitalization. Costs were highly correlated with exacerbation severity. Indirect costs have rarely been measured. The wide variability in the cost estimates reflected cross-study differences in geographic locations, treatment patterns, and patient populations. Important methodological differences also existed across studies. Researchers have used different definitions of exacerbation (e.g., symptom- versus event-based definitions), different tools to identify and measure exacerbations, and different classification systems to define exacerbation severity. Unreported exacerbations are common and may influence the long-term costs of exacerbations. Measurement of indirect costs will provide a more comprehensive picture of the burden of exacerbations. Evaluation of pharmacoeconomic analyses would be aided by the use of more consistent and comprehensive approaches to defining and measuring COPD exacerbations.

Background There are few comprehensive estimates of the cost of psoriasis in the United States. Objective We sought to quantify the incremental direct medical and indirect work loss costs associated with psoriasis. Methods A de-identified claims database from 31 self-insured employers during the period 1998 to 2005 was used. Patients with at least two psoriasis diagnosis claims (N = 12,280) were compared with 3 control subjects (matched on year of birth and sex) without psoriasis. Multivariate two-part regression analysis was used to isolate the incremental cost of psoriasis by controlling for comorbidities and other confounding factors. Results After multivariate adjustment, the incremental direct and indirect costs of psoriasis were approximately $900 and $600 ( P Limitations The database used in this study does not contain information on patient out-of-pocket costs or loss of productivity costs at work. Conclusion The incremental cost of psoriasis is approximately $1500 per patient per year, with work loss costs accounting for 40% of the cost burden.

Chronic obstructive pulmonary disease (COPD) is associated with important chronic comorbid diseases, including cardiovascular disease, diabetes and hypertension. The present study analysed data from 20,296 subjects aged > or =45 yrs at baseline in the Atherosclerosis Risk in Communities Study (ARIC) and the Cardiovascular Health Study (CHS). The sample was stratified based on baseline lung function data, according to modified Global Initiative for Obstructive Lung Disease (GOLD) criteria. Comorbid disease at baseline and death and hospitalisations over a 5-yr follow-up were then searched for. Lung function impairment was found to be associated with more comorbid disease. In logistic regression models adjusting for age, sex, race, smoking, body mass index and education, subjects with GOLD stage 3 or 4 COPD had a higher prevalence of diabetes (odds ratio (OR) 1.5, 95% confidence interval (CI) 1.1-1.9), hypertension (OR 1.6, 95% CI 1.3-1.9) and cardiovascular disease (OR 2.4, 95% CI 1.9-3.0). Comorbid disease was associated with a higher risk of hospitalisation and mortality that was worse in people with impaired lung function. Lung function impairment is associated with a higher risk of comorbid disease, which contributes to a higher risk of adverse outcomes of mortality and hospitalisations.

The objective of this study is to provide a comprehensive estimate of the cost of ADHD by consider ing the healthcare and work loss costs of persons with ADHD, as well as those costs imposed on their family members.Excess per capita healthcare (medical and prescription drug) and work loss (disability and work absence) costs of treated ADHD patients (ages 7 years-44 years) and their family members (under 65 years of age) were calculated using administrative claims data from a single large company; work loss costs are from disability data or imputed for medically related work loss days. Excess costs are the additional costs of patients and their family members over and above those of comparable control individuals. The excess costs of untreated individuals with ADHD and their family members were also estimated. All per capita costs were extrapolated using published prevalence and treatment rates and population data; the prevalence of persons with ADHD was based upon the literature.The total excess cost of ADHD in the US in 2000 was $31.6 billion. Of this total, $1.6 billion was for the ADHD treatment of patients, $12.1 billion was for all other healthcare costs of persons with ADHD, $14.2 billion was for all other healthcare costs of family members of persons with ADHD, and $3.7 billion was for the work loss cost of adults with ADHD and adult family members of persons with ADHD.The annual cost of ADHD in the US is substantial. Both treated and untreated persons with ADHD, as well as their family members, impose consider able economic burdens on the healthcare system as a result of this condition. While these first estimates of the cost of ADHD to the nation are suggestive of its substantial economic burden, future research needs to refine and build on this analysis, particularly in the context of a model to control for related co-morbidities. Similarly, since these results are based on data from a single company for the period 1996-1998, the analysis should be validated with more representative, current data.

Clinical research on attention-deficit hyperactivity disorder (ADHD) has begun to integrate measures of health-related quality of life (HRQL) as part of the overall assessment of treatment outcomes. This study examines the association between HRQL and measures of clinical symptoms of ADHD. Data were gathered from 297 children and adolescents in an 8-week, randomized, double-blind, placebo-controlled, clinical trial of atomoxetine treatment for ADHD. HRQL was assessed with the Child Health Questionnaire 50-item Parent Form. ADHD symptoms were assessed with the ADHD Rating Scale-IV; Parent Version and Clinical Global Impressions-ADHD-Severity. Associations between HRQL and clinical symptoms were assessed with correlations, analyses of variance with post hoc comparisons, and t tests. The Child Health Questionnaire 50-item Parent Form scales assessing psychosocial domains of HRQL were significantly negatively correlated with clinical measures. Improvement in clinical symptoms was associated with corresponding improvement in psychosocial aspects of HRQL. The findings suggest that HRQL instruments can add important information to efficacy measures in clinical trials of ADHD treatment.

Objective To evaluate nutrient intake from dietary sources for 95 pregnant women enrolled in the Special Supplemental Program for Women, Infants, and Children (WIC). Subjects/Setting Women were recruited from Minneapolis and St Paul area WIC clinics between January and June 1999. Based on estimates from the WIC clinics, the study was described to 159 (63%) of the 251 potentially eligible women. Of these 159 women, 107 (67%) completed the in-person interview. Ninety-five (89%) were included in the nutrition analysis. Methods Each woman completed a 1-hour in-person interview that included a questionnaire, anthropometric measurements, and a venous blood sample. A shortened Block 98 food frequency questionnaire was used to assess dietary intake. Serum ferritin was measured for 86 women. Means, medians, and standard deviations of dietary intake were explored as well as body mass index distributions. Additionally, the percentage of women consuming less than two thirds of the recommended dietary allowance (RDA) for certain nutrients was calculated. Results Overall, the women reported consuming only 85% of the RDA for energy. The average percentage of energy from fat was higher than recommended (37% vs 30%). The most notable nutrient shortfall was iron; 90% of the women reported consuming less than 2/3 of the RDA. Additionally, serum ferritin analysis classified 22% of the women with iron-deficiency anemia ( Conclusions Interventions should be designed to decrease fat consumption and increase iron intake among pregnant WIC participants to meet dietary recommendations. J Am Diet Assoc. 2001:101:903-908.

SummaryBackground Chronic plaque psoriasis has a profound impact on a patient's daily life. To understand the effects of psoriasis treatments, it is essential to assess the patient's experience of symptoms and how they impact their daily life. The goal of this study was to develop and establish the content validity of a new patient reported outcome (PRO) psoriasis measure. Methods The Psoriasis Symptom Diary was developed by (i) identifying key plaque psoriasis-related symptoms and impacts through qualitative patient interviews (n = 29); (ii) developing an initial set of items that captured the key patient experiences; and (iii) conducting cognitive interviews to test patient understanding of items selected for inclusion in the new psoriasis symptom measure (n = 16). Results Patients noted a variety of symptoms, with plaque-related pain (including related concepts of burning and stinging), changes in skin appearance, and itching reported by all patients. Patients also expressed notable embarrassment and avoidance of social situations, due to the appearance of plaques, and limited mobility. The Psoriasis Symptom Diary assesses the severity and impact of symptoms using a 24-hour recall period to reduce recall bias and error. Conclusions The Psoriasis Symptom Diary was developed to assess important symptoms and disease-related impacts in a manner consistent with guidelines for establishing the content validity of new PRO instruments. Following quantitative psychometric testing, the Psoriasis Symptom Diary may support efficacy endpoints in clinical trials.

Several adverse birth outcomes are associated with cigarette smoking. It is important to determine the prevalence of cigarette smoking among pregnant low-income women and to evaluate their smoking cessation patterns in order to target appropriate interventions. Ethnically diverse pregnant women aged 15-45 years were recruited from Minneapolis or Saint Paul Women, Infants, and Children (WIC) clinics before their third trimester. Serum cotinine levels were assayed for 98 women and compared with self-report. The women were unaware that their smoking status would be validated. Twenty-one (21%) women had a positive serum cotinine value (> or =3 ng/mL); 16 (76%) admitted smoking within the previous 24 h before interview and five denied smoking. Of the five, four had cotinine levels that could suggest passive smoke exposure. Thirty-seven women (38%) admitted cigarette smoking during the pregnancy but before knowing that they were pregnant; 18 (49%) of these denied current smoking at the interview and also presented with negative cotinine levels. These data suggest that some participants in WIC make a concerted effort to quit smoking when they find out they are pregnant, and are generally truthful when reporting their smoking habits during pregnancy.

Omalizumab (Xolair®) is a monoclonal antibody indicated for moderate to severe persistent allergic asthma patients with symptoms that are inadequately controlled with inhaled corticosteroids (ICS).This study describes concomitant asthma medication use in patients treated with omalizumab.An analysis of health insurance claims from MarketScan (2002-2009), Medicaid (2002-2009), and the HealthCore Integrated Research Database (HIRD™) (2002-2010) was conducted. Medical charts were also extracted for a subset of HIRD patients. Patients aged ≥12 years and newly initiated on omalizumab with 12 months of continuous insurance coverage prior to the first omalizumab dispensing (baseline period) and ≥2 asthma claims were included. Concomitant asthma medication use was summarized in eight medication classes.A total of 6038 patients were identified (Medicaid: 731; MarketScan: 3521; HIRD: 1786). A high proportion of new omalizumab users had an asthma-related emergency room visit (Medicaid: 34%; MarketScan: 17%; HIRD: 16%) or hospitalization (Medicaid: 36%; MarketScan: 14%; HIRD: 21%) within 12 months prior to initiating omalizumab. Most patients (Medicaid: 96%; MarketScan: 89%; HIRD: 86%) received three concomitant asthma medication classes or more during the baseline period. Concomitant ICS use was observed in 95%, 89%, and 86% of Medicaid, MarketScan, and HIRD patients, respectively. In HIRD patients without evidence of receiving other asthma medication prior to omalizumab, 17 out of 20 patients had a documented baseline history of asthma-related medication use in their medical charts.This large observational study using health insurance claims from three databases and confirming results from medical charts provides evidence that nearly all omalizumab users had received other asthma medications prior to initiating omalizumab.

Objectives: For more than three decades there has been speculation regarding a possible role of zoonotic diseases in the development of human leukemia. This study investigated the potential relationship between exposure to pets and the development of childhood leukemia. Methods: Data from 2359 cases of acute leukemia from two large case–control studies were analyzed. Cases were individually matched to population controls on telephone exchange, age, and race. Conditional logistic regression was used to estimate odds ratios (OR) associated with pet ownership. Results: Overall, there was no association between pet ownership (either “any pet”, dog, or cat) and childhood acute leukemia (ORany pet:=1.01, 95% CI 0.89–1.2). Additionally, no relationship was found between exposure to an ill pet and childhood leukemia. Conclusion: The results of this analysis suggest that pet ownership (healthy or sick) is unrelated to an increased risk of childhood leukemia.

Measuring health-related quality of life (HRQL) in children with attention-deficit/hyperactivity disorder (ADHD) in clinical trials can complement efficacy measures, offering a complete picture of the impact of disease and treatment on overall well-being. The purpose of the current study was to psychometrically validate a multidimensional, generic HRQL instrument completed by parents of children with ADHD. A total of 921 children and adolescents with ADHD participated in a clinical study of atomoxetine. Subjects' parents completed the 50-item Child Health Questionnaire-Parent Version (CHQ-PF50) at baseline and week 10. ADHD symptoms and behavioral problems were assessed using parent and clinician rating scales. Internal consistency reliability at baseline was 0.88 for the CHQ-PF50 Psychosocial Summary Score, ranging from 0.53 to 0.91 for subscale scores. Construct validity was supported by statistically significant correlations between CHQ-PF50 psychosocial scores and parent and clinician symptom ratings. Several methods were used to determine clinically meaningful differences in patient outcomes: inter- and intra-patient mean CHQ-PF50 change scores were tested and standard error of measurement (SEM) and effect sizes were calculated. Study results indicate the CHQ-PF50 is reliable, valid, and responsive to change in ADHD symptoms, suggesting it may provide a means of assessing HRQL outcomes associated with treatments for ADHD.

OBJECTIVE: To identify newly treated cases of attention-deficit/hyperactivity disorder (ADHD), assess the presence of comorbid psychiatric conditions, identify pharmacological treatment patterns, and examine treatment compliance rates among children and adults with newly diagnosed and pharmacologically treated ADHD in a managed care population. METHODS: Children (aged 18 years or younger) and adults having newly treated ADHD were identified from medical and pharmacy claims in an administrative claims database from 6 health plans. Claims data for services or products provided between April 1, 1997, and September 30, 1999, was analyzed for the managed care population (604,538 children and 1,542,304 adults). Data on compliance, persistence, and pharmacological treatment patterns were collected for the 6 months prior to and the 18 months following each patient’s initial ADHD pharmacological treatment. A medication possession ratio (MPR) was calculated by dividing the number of days supplied in a prescription by the number of days until the next prescription was filled. Compliance was defined as an MPR >0.8 and persistence as an MPR >0.3. RESULTS: The prevalence of diagnosed ADHD in this population was 0.7% (11,962 [2%] of children and 2,636 [0.2%] of adults) and incidence of ADHD was 0.04% (735 [0.1%] of children and 162 [0.01%] of adults). The most common comorbid psychiatric condition for incident cases was depression (31.6% of children and 63% of adults). Few children and adults switched their initial ADHD treatment agent, 11% and 12%, respectively. Dose titration occurred in 67% of children and 54% of adults. On average, changes in treatment (switching, titrating) took place after 2 to 3 months of treatment. Although patients, on average, obtained more than 6 refills for a total 200 days supply, the majority of patients (84% of children and 88% of adults) were compliant for less than 2 months over the period they were refilling prescriptions. CONCLUSION: Although the majority of patients had dosage changes, these changes typically occurred after several months of treatment. Results suggest that, even though patients continued their ADHD medication for several months, they did not consistently take medication for more than 2 months. Given these treatment patterns, pharmacologic treatment in newly treated ADHD patients may be suboptimal and may impact outcomes, including the effectiveness and cost of treatment.

Recently, the FDA has encouraged testing of medications among pediatric patients during drug development. Pharmaceutical companies have responded by conducting more clinical trials among children, and researchers are becoming aware of the unique challenges of assessing pediatric health outcomes, including health-related quality of life (HRQL). Like adults, children experience effects of illness and treatment beyond physiologic outcomes. Further pediatric HRQL research is necessary to examine these broader psychosocial outcomes and provide a thorough understanding of the effects of treatment on children's health status. The purpose of the current review is to discuss key regulatory and methodologic developments and provide guidance for future research on pediatric HRQL. This review of pediatric HRQL assessment includes five sections: 1) recent pediatric regulatory developments in the United States; 2) issues in defining and conceptualizing pediatric HRQL, including the importance of contextual variables such as family and peer systems; 3) methodologic issues (e.g., the proxy question, developmental differences, response sets) with recommendations for addressing these issues in clinical trials; 4) validated generic and condition-specific pediatric HRQL measures; and 5) a recommendation for additional research on the HRQL impact of childhood psychiatric disorders. It is advocated that assessment of HRQL among children should be conducted regularly as an integral part of drug development.

Objective To estimate the direct (medical and prescription drug) and indirect (work loss) costs of children treated for attention-deficit/hyperactivity disorder (ADHD) and their family members. Method The data source was an administrative database from a national, Fortune 100 manufacturer that included all medical, pharmaceutical, and disability claims for beneficiaries (n > 100,000). The analysis involved four samples. The ADHD patient sample included individuals age 18 or younger with at least one ADHD claim during the study period (1996–1998). Resource utilization of ADHD patients was contrasted with a matched control sample of patients who did not have claims for ADHD. The ADHD and non-ADHD family samples included non-ADHD family members of ADHD patients and their matched controls. Results The annual average expenditure (direct cost) per ADHD patient was $1,574, compared to $541 among matched controls. The annual average payment (direct plus indirect cost) per family member was $2,728 for non-ADHD family members of ADHD patients versus $1,440 for family members of matched controls. Both patient and family cost differences were significant at the 95% confidence level. Conclusions ADHD imposes a significant financial burden regarding the cost of medical care and work loss for patients and family members.

With the exception of a small percentage of cases attributable to hereditary cancer syndromes (eg, familial retinoblastoma) or genetic syndromes (Down syndrome), the etiology of most childhood cancers is unknown. Recent epidemiologic studies have focused on the prenatal period and have investigated potential associations with parental age, cigarette smoking, birth weight of the child, parental occupational exposures, and specific environmental exposures. The following challenges lie ahead for future epidemiologic studies of childhood cancer: 1) improvement of diagnostic classification; 2) improved methods for exposure assessment; 3) evaluation of data from molecular biology to generate biologically derived hypotheses; and 4) incorporation of markers of genetic susceptibility when feasible.

Purpose The purpose is to analyze the incidence and costs of accidents among Attention-Deficit/Hyperactivity Disorder (ADHD) patients. Methods The analysis relied on administrative medical, pharmaceutical, and disability claims for a national manufacturer's employees, spouses, dependents, and retirees (n > 100,000). Accidental injuries were identified using ICD-9 codes for injuries or poisoning treatment. ADHD sample consists of individuals with at least one claim for ADHD during 1996–98 (N ADHD = 1308), which was compared with a matched control sample. In addition to descriptive statistics, multivariate analysis involving logistic regression was used to model the probability of having an accident claim in 1998. This probability was estimated for the whole population, for adults alone, for children (under age 12 years), and for adolescents (age 12–18 years). We also estimated a generalized estimation equation (GEE) model to account for the possibility of multiple accident claims for a single patient. Results ADHD patients had a greater probability of having at least one accident claim than their controls for children (28% vs. 18%), adolescents (32% vs. 23%), and adults (38% vs. 18%). Although ADHD patients' costs were greater than their controls for adults ($483 vs. $146), there was no difference for children or adolescents. However, among patients with accident claims, the average number of accident claims was similar for both groups (3.6 vs. 3.5) and costs were not statistically different. The multivariate analysis confirms this utilization pattern: the odds of having an accident for ADHD patients were 1.7 times greater than for controls. Conclusions ADHD was a significant predictor of having an accident claim. However, for people with an accident claim, ADHD patients and controls had a similar number of accident claims and costs.