Antidiabetic prescriptions and glycemic control in German patients with type 2 diabetes mellitus: a retrospective database study.

OBJECTIVES: This study examined patterns of antidiabetic treatment among individuals with type 2 diabetes in Germany and investigated potential differences in attainment of glycemic control associated with the use of specific antidiabetic regimens. METHODS: This was a retrospective database study. Data were obtained from the German IMS Disease Analyzer-MediPlus database. Patients aged >or=20 years who were identified as having type 2 diabetes and who underwent glycosylated hemoglobin (HbA(1c)) testing at least once between April 1, 2004, and December 31, 2004, were included in the analyses. Potential associations between age, sex, and diabetic complications and the use of specific antidiabetic medications were examined. Also examined were potential associations between attainment of the HbA(1c) target for glycemic control (56.5%), particular patient characteristics, and the use of specific antidiabetic medications. RESULTS: The study included data from 5135 patients with type 2 diabetes (mean age, 67 years; 2702 men, 2433 women; mean [SD] HbA(1c), 6.9% [1.2%]). The most commonly diagnosed comorbidities were hypertension (66.5%) and obesity (18.7%). There were no significant differences in mean age, sex, or comorbidities between patients categorized by HbA(1c) values 6.5%. The most commonly prescribed antidiabetic medications were metformin (20.4%), a sulfonylurea (11.7%), and oral combination therapy (10.9%). In the assessment of potential associations between selected patient characteristics and the receipt of specific antidiabetic medications, individuals were less likely to receive metformin monotherapy if they were aged >or=75 years (12.0%, compared with 21.4% of those aged 65-74 years and 24.7% of those aged <65 years; P < 0.001) or had a diagnosis of a diabetic complication (15.9%, compared with 21.2% in those without complications; P < 0.001). Among those who were more likely to receive insulin monotherapy were women (11.5%, compared with 9.6% of men; P = 0.025) and patients with diabetic complications (13.9%, compared with 9.8% of those without complications; P < 0.001). More than half (52.7%) of patients did not attain the HbA(1c) target. There were significant differences between patients attaining the HbA(1c) target and receipt of specific antidiabetic medications (P < 0.001). Patients treated with insulin monotherapy or oral plus insulin combination therapy were least likely to reach the HbA(1c) target (26.4% and 22.9%, respectively, attained glycemic control; both, P < 0.001). Only 179 (31.9%) of 562 patients treated with oral combination therapy achieved the HbA(1c) target (P < 0.001). CONCLUSIONS: Over half of these German patients with type 2 diabetes failed to attain the HbA(1c) target for glycemic control. Patients who were prescribed insulin monotherapy or combination therapy were least likely to achieve the target.

Patterns of blood glucose monitoring in relation to glycemic control among patients with type 2 diabetes in the UK.

AIMS: The objectives of this study were to compare patterns of blood glucose monitoring among patients with type 2 diabetes initiating therapy with insulin or oral medication and to examine the relationship between the quantity of prescribed monitoring strips and glycemic control. METHODS: Data were obtained from the UK General Practice Research Database. Patients were eligible if they were identified as having type 2 diabetes, initiated therapy with insulin or an oral agent, and had 12-month postinitiation data. Differences in patient characteristics and number of test strips prescribed between the insulin (n=347) and oral cohorts (n=2436) were examined. Multivariate regressions examined the relationship between quantity of monitoring and glycemic control for a subset of patients (insulin, n=245; oral, n=1795) with available glycosylated hemoglobin (HbA1c) data. RESULTS: During the 12-month postinitiation period, patients using insulin were prescribed approximately twice as many test strips compared with those patients using oral medication (149 vs. 78, P<.0001). Multivariate regressions revealed that individuals who initiated insulin therapy and were prescribed enough test strips to test at least once per day in the 6 months prior to the HbA1c test date had, on average, a 0.65% lower HbA1c value (P=.02) compared with individuals who were prescribed fewer test strips. CONCLUSIONS: Results indicate significant differences in the prescription of blood glucose monitoring strips, with patients initiated on insulin prescribed almost twice as many test strips compared with patients initiated on orals. The greater number of blood glucose test strips prescribed was associated with lower HbA1c values for insulin patients.

The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication.

OBJECTIVE: Despite growing interest in adult attention deficit hyperactivity disorder (ADHD), little is known about its prevalence or correlates. METHOD: A screen for adult ADHD was included in a probability subsample (N=3,199) of 18-44-year-old respondents in the National Comorbidity Survey Replication, a nationally representative household survey that used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. Blinded clinical follow-up interviews of adult ADHD were carried out with 154 respondents, oversampling those with positive screen results. Multiple imputation was used to estimate prevalence and correlates of clinician-assessed adult ADHD. RESULTS: The estimated prevalence of current adult ADHD was 4.4%. Significant correlates included being male, previously married, unemployed, and non-Hispanic white. Adult ADHD was highly comorbid with many other DSM-IV disorders assessed in the survey and was associated with substantial role impairment. The majority of cases were untreated, although many individuals had obtained treatment for other comorbid mental and substance-related disorders. CONCLUSIONS: Efforts are needed to increase the detection and treatment of adult ADHD. Research is needed to determine whether effective treatment would reduce the onset, persistence, and severity of disorders that co-occur with adult ADHD.

The association between diabetes related medical costs and glycemic control: a retrospective analysis.

BACKGROUND: The objective of this research is to quantify the association between direct medical costs attributable to type 2 diabetes and level of glycemic control. METHODS: A longitudinal analysis using a large health plan administrative database was performed. The index date was defined as the first date of diabetes diagnosis and individuals had to have at least two HbA1c values post index date in order to be included in the analyses. A total of 10,780 individuals were included in the analyses. Individuals were stratified into groups of good (N = 6,069), fair (N = 3,586), and poor (N = 1,125) glycemic control based upon mean HbA1c values across the study period. Differences between HbA1c groups were analyzed using a generalized linear model (GLM), with differences between groups tested by utilizing z-statistics. The analyses allowed a wide range of factors to affect costs. RESULTS: 42.1% of those treated only with oral agents, 66.1% of those treated with oral agents and insulin, and 57.2% of those treated with insulin alone were found to have suboptimal control (defined as fair or poor) throughout the study period (average duration of follow-up was 2.95 years). Results show that direct medical costs attributable to type 2 diabetes were 16% lower for individuals with good glycemic control than for those with fair control ($1,505 vs. $1,801, p < 0.05), and 20% lower for those with good glycemic control than for those with poor control ($1,505 vs. $1,871, p < 0.05). Prescription drug costs were also significantly lower for individuals with good glycemic control compared to those with fair ($377 vs. $465, p < 0.05) or poor control ($377 vs. $423, p < 0.05). CONCLUSION: Almost half (44%) of all patients diagnosed with type 2 diabetes are at sub-optimal glycemic control. Evidence from this analysis indicates that the direct medical costs of treating type 2 diabetes are significantly higher for individuals who have fair or poor glycemic control than for those who have good glycemic control. Patients under fair control account for a greater proportion of the cost burden associated with antidiabetic prescription drugs.

Utilization of diabetes medication and cost of testing supplies in Saskatchewan, 2001.

The purpose of this study was to describe the patterns of antidiabetic medication use and the cost of testing supplies in Canada using information collected by Saskatchewan's Drug Plan (DP) in 2001. The diabetes cohort (n = 41,630) included individuals who met the National Diabetes Surveillance System (NDSS) case definition. An algorithm was then used to identify subjects as having type 1 or type 2 diabetes. Among those identified as having type 2 diabetes (n = 37,625), 38% did not have records for antidiabetic medication in 2001. One-third of patients with type 2 diabetes received monotherapy. Metformin, alone or in combination with other medications, was the most commonly prescribed antidiabetic medication. Just over one-half of the all patients with diabetes had a DP records for diabetes testing supplies. For individuals (n = 4,005) with type 1 diabetes, 79% had a DP record for supplies, with an average annual cost of 472 +/- 560 dollars. For type 2 diabetes, 50% had records for testing supplies, with an average annual cost of 122 +/- 233 dollars. Those individuals with type 2 diabetes who used insulin had higher testing supply costs than those on oral antidiabetic medication alone (359 vs 131 dollars; p < 0.001).

Patterns and predictors of attention-deficit/hyperactivity disorder persistence into adulthood: results from the national comorbidity survey replication.

BACKGROUND: Despite growing interest in adult attention-deficit/hyperactivity disorder (ADHD), little is known about predictors of persistence of childhood cases into adulthood. METHODS: A retrospective assessment of childhood ADHD, childhood risk factors, and a screen for adult ADHD were included in a sample of 3197 18-44 year old respondents in the National Comorbidity Survey Replication (NCS-R). Blinded adult ADHD clinical reappraisal interviews were administered to a sub-sample of respondents. Multiple imputation (MI) was used to estimate adult persistence of childhood ADHD. Logistic regression was used to study retrospectively reported childhood predictors of persistence. Potential predictors included socio-demographics, childhood ADHD severity, childhood adversity, traumatic life experiences, and comorbid DSM-IV child-adolescent disorders (anxiety, mood, impulse-control, and substance disorders). RESULTS: Blinded clinical interviews classified 36.3% of respondents with retrospectively assessed childhood ADHD as meeting DSM-IV criteria for current ADHD. Childhood ADHD severity and childhood treatment significantly predicted persistence. Controlling for severity and excluding treatment, none of the other variables significantly predicted persistence even though they were significantly associated with childhood ADHD. CONCLUSIONS: No modifiable risk factors were found for adult persistence of ADHD. Further research, ideally based on prospective general population samples, is needed to search for modifiable determinants of adult persistence of ADHD.

Costs of attention deficit-hyperactivity disorder (ADHD) in the US: excess costs of persons with ADHD and their family members in 2000.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Review of the cost of diabetes complications in Australia, Canada, France, Germany, Italy and Spain.

OBJECTIVES: To provide a comprehensive source document on previously published cost data for diabetic complications in Australia, Canada, France, Germany, Italy and Spain for use in a peer-reviewed, validated diabetes model. METHODS: A search for published cost of diabetes complications data was performed in peer-reviewed journals listed in PubMed and health economic conference proceedings from 1994 to March 2005. Where country specific data were not available, we referred to government websites and local cost experts. All costs were inflated to 2003 Euros (E). Major complication costs are presented. RESULTS: First year costs of non-fatal myocardial infarction varied between E19277 in Spain and E12292 in Australia. In subsequent years of treatment, this range was E1226 (France) to E203 (Australia). Angina costs were similar across all four countries: E1716 in Australia; E2218 in Canada; E2613 in France; E3342 in Germany; E2297 in Italy; and E2207 in Spain. Event costs of non-fatal stroke were higher in Canada (E23173) than in other countries (Australia E13443; France E11754; Germany E19399; Italy E6583; Spain E4638). Event costs of end-stage renal disease varied depending on the type of dialysis: in Australia (E17188-27552); Canada (E33811-58159); France (E24608-56487); Germany (E46296-68175); Italy (E43075-56717); and Spain (E28370-32706). Lower extremity amputation costs were: E18547 (Australia); E17130 (Canada); E31998 (France); E22096 (Germany); E10177 (Italy); and E14787 (Spain). CONCLUSIONS: Overall, our search showed costs are well documented in Australia, Canada, France and Germany, but revealed a paucity of data for Spain and Italy. Spanish costs, collected by contacting local experts and from government reports, generally appeared to be lower for treating cardiovascular complications than in other countries. Italian costs reported in the literature were primarily hospitalization costs derived from diagnosis-related groups, and therefore likely to misrepresent the cost of specific complications. Additional research is required to document complication costs in Spain and Italy. Australian and German values were collected primarily by referring to diagnostic related group (DRG) tariffs and, as a result, there may be a need for future economic evaluations measuring the accuracy of the costs and resource utilization in the reported values. These cost data are essential to create models of diabetes that are able to accurately simulate the cumulative costs associated with the progression of the disease and its complications.

Comorbidities and costs of adult patients diagnosed with attention-deficit hyperactivity disorder.

INTRODUCTION: The purpose of this retrospective study was to examine the prevalence of comorbidities, resource use, direct medical costs, and the costs associated with missed work for adults diagnosed with attention-deficit hyperactivity disorder (ADHD). STUDY DESIGN: From a large claims database that captures inpatient, outpatient and prescription drug services, individuals diagnosed with ADHD between the years 1999 and 2001 were retrospectively identified. The ADHD cohort (n = 2252) were matched with a non-ADHD cohort (n = 2252) on a 1 : 1 ratio, based upon age, gender, metropolitan statistical area and type of insurance coverage. The ADHD cohort was compared with the non-ADHD cohort for differences in comorbidities and direct medical costs (inpatient, outpatient and prescription drug costs) using year 2001 prices. Using data from six Fortune 200 employers, time missed from work and costs associated with absenteeism, short-term disability and worker's compensation was examined for a subsample (n = 354) of the employees diagnosed with ADHD. Chi-square and t-statistics were used to compare the ADHD population with the control group with regards to comorbidites and service use. Analysis of covariance and multivariate regressions were used to examine differences in days missed from work, direct medical costs and costs associated with missed work. RESULTS: Adults diagnosed with ADHD were significantly more likely to have a comorbid diagnosis of asthma (p = 0.0014), anxiety (p < 0.0001), bipolar disorder (p < 0.0001), depression (p < 0.0001), drug or alcohol abuse (p < 0.0001), antisocial disorder (p = 0.0081) or oppositional disorder (p = 0.0022) compared with the control group. Controlling for the impact of comorbidities, adults diagnosed with ADHD had significantly higher outpatient costs (USD 3009 vs USD 1492; p < 0.0001), inpatient costs (USD 1259 vs USD 514; p < 0.0001), prescription drug costs (USD 1673 vs USD 1008; p < 0.0001), and total medical costs (USD 5651 vs USD 2771; p < 0.0001) compared with the non-ADHD cohort. Employees diagnosed with ADHD missed significantly more days due to 'unofficial' absences (4.33 days vs 1.13 days; p < 0.0001). CONCLUSIONS: The results demonstrate that adults diagnosed with ADHD have a higher prevalence of comorbidities, higher medical costs and more absences than matched individuals without ADHD. These findings suggest that there may be an opportunity for the effective treatment of ADHD to lead to cost-offsets.

Parent-proxy EQ-5D ratings of children with attention-deficit hyperactivity disorder in the US and the UK.

BACKGROUND: The symptoms of attention-deficit hyperactivity disorder (ADHD) are associated with impairment in multiple domains of health-related quality of life (HR-QOL). HR-QOL of children with ADHD has been assessed by relatively long multidimensional questionnaires. A review of the literature found no studies using the brief, well established EuroQoL Five-Dimension Questionnaire (EQ-5D) to estimate the HR-QOL of children with ADHD. The objective of this study was to assess the HR-QOL of children with ADHD using parents' responses to the proxy version of the EQ-5D. METHODS: Participants were recruited in the midwestern US and in the vicinity of London, England. All parents completed three questionnaires: the EQ-5D proxy version; a measure of ADHD symptoms based on Diagnostic and Statistical Manual of Mental Disorders (4th Edition) [DSM-IV] criteria (the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV - Parent Version [ADHD-RS]); and either the Child Health Questionnaire - Parent Form 50 (CHQ-PF50) or the Child Health and Illness Profile - Child Edition (CHIP-CE), which are both generic multidimensional paediatric HR-QOL questionnaires. RESULTS: A total of 126 parents of children with ADHD participated in the study: 43 in the US and 83 in the UK. On the EQ-5D, participants indicated that 78.6% of their children experienced some problems or extreme problems performing usual activities, while 64.8% believed their child demonstrated some or extreme anxiety or depression. The mean EQ-5D index score was 0.75 and the mean visual analogue scale (VAS) score was 73.9. The EQ-5D index and VAS scores were found to be significantly correlated (p < 0.05) with several domains of the CHQ-PF50 (e.g. Mental Health, Self-Esteem, Family Activities, Psychosocial Summary Score) and the CHIP-CE (e.g. Satisfaction, Comfort, Academic Performance, Peer Relations). The EQ-5D scales were also significantly correlated with the ADHD-RS scales (p < 0.001). CONCLUSION: The proxy version of the EQ-5D, completed by parents, was able to detect impairment in children diagnosed with ADHD in the US and the UK. Furthermore, the EQ-5D index and VAS scores demonstrated construct validity among this sample through significant correlations with an ADHD symptom measure and previously validated multidimensional QOL instruments. These results suggest that parent-proxy EQ-5D ratings are feasible and valid for use as part of an overall health outcomes assessment in clinical studies of childhood ADHD.

Health state utilities for childhood attention-deficit/hyperactivity disorder based on parent preferences in the United kingdom.

OBJECTIVES: The purpose of this study was to use standard gamble (SG) utility interviews to assess parent preferences for health states of childhood attention-deficit/hyperactivity disorder (ADHD). METHODS: The study was conducted in August 2003 in London, England. Parents (N=83) of children diagnosed with ADHD completed SG utility interviews, rating their child's current health and 14 hypothetical health states describing untreated ADHD and ADHD treated with a nonstimulant, immediate-release stimulant, or extended-release stimulant. Raw temporary utilities ranging from 0 (worst health) to 1 (best health) were adjusted to a chronic utility scale ranging from 0 (death) to 1 (best health) using a linear transformation. Parents rated the severity of their children's ADHD symptoms using the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS) and their children's health-related quality of life using the EuroQol EQ-5D. RESULTS: Raw and adjusted SG ratings of hypothetical health states ranged from 0.63-0.90 and 0.88-0.96, respectively. Parents' raw SG scores of their child's current health state (mean=0.72) were significantly correlated with inattentive, hyperactive, and overall ADHD symptoms (r=-0.25, -0.27, -0.27; P <0.05) and the EQ-5D visual analogue scale (r=0.26; P <0.05). CONCLUSION: This UK-based study suggests that parent SG interviews are a valid method for obtaining utilities for child ADHD-related health states. The utilities obtained in this study would be appropriate for use in a cost-utility analysis evaluating the costs and benefits of childhood ADHD treatments in the United Kingdom.

Relationship of glycemic control to total diabetes-related costs for managed care health plan members with type 2 diabetes.

OBJECTIVE: Glycosylated hemoglobin (A1c) is a well-established measure of glycemic control, and evidence suggests that maintaining an acceptable A1c level may be associated with lower treatment costs in adults with diabetes. Understanding the impact on total treatment costs of staying at the target A1c level is of great importance to managed care organizations. The goal of this study was to determine whether type 2 diabetes patients at or below the target A1c level of 7% had lower diabetes-related costs compared with patients above an A1c level of 7%. METHODS: This study was a retrospective database analysis using eligibility data, medical and pharmacy claims data, and laboratory data from a large U.S. health care organization. Patients were included in the study if they had 2 or more claims for type 2 diabetes (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 250.x0 or 250.x2) and at least 1 A1c value (first such date defined as the index date) during the 12-month period from January 1, 2002, through December 31, 2002. Patients with 2 or more medical claims for type 1 diabetes (ICD-9-CM codes 250.x1 or 250.x3) were excluded from the study. Study patients were divided into 2 groups, those at the target A1c level (7%) and those at the above-target A1c level (>7%), and were followed for a period of 1 year after their index date. Demographic, clinical, and cost variables were extracted from the administrative database. Multiple linear regression analysis was used to compare treatment costs between patients at the target A1c level and patients above target level. RESULTS: A total of 3,121 patients (46.0%) were identified as being at the target A1c level, and 3,659 patients (54%) were identified as being above the target A1c level during the study period. After controlling for confounding factors, the predicted total diabetes-related cost for the above-target group during the 1-year follow-up period was 1,540 US dollars per patient, 32% higher than the total diabetes-related cost (1,171 US dollars) for the at-target group (P <0.001). CONCLUSION: Results of this analysis suggest that managed care members with type 2 diabetes who stayed continuously at the target A1c level of 7% or less over a 1-year follow-up period incurred lower diabetes-related costs compared with managed care members with type 2 diabetes who were continuously over the target A1c level of 7%.

Attention-deficit/hyperactivity disorder: increased costs for patients and their families.

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.

Physician perceptions of the use of medications for attention deficit hyperactivity disorder.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a prevalent mental health condition, occurring in 3% to 5% of school-aged children. Although stimulant medications are a recommended treatment for this disorder, physicians. views of these medications have not been systematically evaluated. OBJECTIVE: This study examined physician-prescriber perceptions of using medications to treat ADHD symptoms in children or adolescents. METHODS: A survey was developed with 4 physicians expert in treating ADHD in children. The survey was pilot-tested with a sample of 10 practicing physicians. A sample of 1,000 physicians, with a history of prescribing stimulant medications to children or adolescents, was randomly selected and mailed a 30-item survey. Items were rated on a 7-point response scale (strongly agree, agree, slightly agree, undecided, slightly disagree, disagree, strongly disagree). RESULTS: A total of 365 physicians responded to the survey, for a 37% response rate. More than 92% of respondents strongly agreed or agreed that ADHD symptoms cause problems in pediatric patients and stimulants are effective in treating ADHD. The stimulant drug side effects of decreased appetite or weight loss, sleep disruption, and exacerbation of anxiety were a concern (strongly agree or agree response) for 32%, 50%, and 22% of physicians, respectively. Diversion of ADHD medication was a concern for 19% of respondents. Physicians reported that controlled medications for children or adolescents with ADHD are a burden for themselves (32% strongly agreed or agreed), for their staff (37% strongly agreed or agreed), and for parents (40% strongly agreed or agreed). Approximately 38% of physicians responded that they would prefer prescribing a nonstimulant medication with a U.S. Food and Drug Administration indication for treating children or adolescents instead of a stimulant medication, and 58% would prefer prescribing a noncontrolled medication that does not have evidence of abuse potential versus one that is controlled and has evidence of abuse potential. CONCLUSION: Although physicians overwhelmingly perceive stimulant medications as being effective for treating ADHD symptoms in children or adolescents, many would prefer a nonstimulant medication. While many physicians consider the side effects of the stimulants easily managed, others are concerned about prescribing stimulants because of their side effects, risk of diversion, and administrative burden. The majority of physicians would prefer to prescribe a noncontrolled medication without abuse potential instead of a controlled medication to treat children or adolescents with ADHD.

The link between health-related quality of life and clinical symptoms among children with attention-deficit hyperactivity disorder.

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.

Obesity and the use of insulin: a study of patients with type 2 diabetes in the UK.

OBJECTIVE: This analysis examines how obesity affects the prescribing of insulin for individuals with type 2 diabetes and poor glycemic control. METHODS: Data were obtained from the UK General Practice Research Database for the years 2000-2004. Patients were eligible if they had been identified as having type 2 diabetes and had undergone at least two valid glycosylated hemoglobin (HbA(1c)) tests. Additionally, patients had to have poor glycemic control on the index date (HbA(1c)>7.4), no use of insulin 6 months prior to the index date, and at least 30 months of data after the index date (N=6468). Descriptive statistics were used to examine unadjusted differences between obese and nonobese patients. A Cox proportional hazards model was applied to examine the relationship between obesity and the relative likelihood of initiation of insulin while controlling for differences in patient characteristics, medication use, and HbA(1c) levels. RESULTS: Obese individuals were significantly younger (P<.01), significantly more likely to be treated with two oral antidiabetic agents (P=.02), and significantly less likely to be treated with oral monotherapy (P=.02). Controlling for a wide range of factors that may impact receipt of insulin, results revealed that obese individuals had a "hazard" of initiation of insulin significantly lower than that of nonobese patients (hazard ratio=0.814, P=.01). CONCLUSIONS: Patient age, severity of illness, and prior medication use all affect whether the individual will be initially prescribed insulin. Moreover, the results of this study demonstrate that obesity is an additional critical factor in physicians' decision to begin treatment with insulin.

Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms.

BACKGROUND: The goal of this study was to validate the pilot Adult ADHD Self-Report Scale (pilot ASRS) versus standard clinician ratings on the ADHD Rating Scale (ADHD RS). METHOD: Sixty adult ADHD patients took the self-administered ADHD RS and then raters administered the standard ADHD RS. Internal consistency of symptom scores was assessed by Cronbach's alpha. Agreement of raters was established by intra-class correlation coefficients (ICCs) between scales. RESULTS: Internal consistency was high for both patient and rater-administered versions (Cronbach's alpha 0.88, 0.89, respectively). The ICC between scales for total scores was also high (0.84); ICCs for subset symptom scores were also high (both 0.83). There was acceptable agreement for individual items (% agreement: 43%-72%) and significant kappa coefficients for all items (p < 0.001). CONCLUSIONS: The pilot Adult ADHD Self-Report Scale symptom checklist is a reliable and valid scale for evaluating ADHD for adults and shows a high internal consistency and high concurrent validity with the rater-administered ADHD RS.

Quality of life assessment in adult patients with attention-deficit/hyperactivity disorder treated with atomoxetine.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) has its onset during childhood and is estimated to affect 3% to 7% of school-aged children. Unfortunately, the disorder frequently persists into adult life. The burden of this disorder is considerable and is often characterized by academic (or occupational) impairment and dysfunction within the family and society. Despite the existence of research demonstrating the effects of ADHD on certain aspects of life, the clinical trials of treatments for this disorder have focused primarily on efficacy and safety. METHODS: Atomoxetine was approved in the United States in November 2002 for the treatment of ADHD in children, adolescents, and adults. The present study uses data from a clinical trial of atomoxetine in adult patients with ADHD that incorporated a measure of health-related quality of life (the Medical Outcomes Study 36-item short-form health survey [SF-36]) as part of the overall assessment of the success of this relatively new treatment. The primary outcome measure for ADHD symptoms was the Conners Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS) ADHD total symptom score. RESULTS: In agreement with previous studies, adult patients with ADHD treated with atomoxetine at typical doses showed significant amelioration of ADHD symptoms, as measured on the CAARS. At baseline, the measures of overall mental health (one aspect of quality of life) of adult patients with ADHD were below the average level, as measured on the SF-36. Treatment with atomoxetine significantly improved the measures of mental health and ameliorated the ADHD symptoms. In addition, the 2 measures were correlated. CONCLUSIONS: These data suggest that pharmacological intervention with atomoxetine not only ameliorates ADHD symptoms in adult patients but also improves their perceived quality of life.

Psychometric validation of the child health questionnaire (CHQ) in a sample of children and adolescents with attention-deficit/hyperactivity disorder.

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.

Assessment of health state utilities for attention-deficit/hyperactivity disorder in children using parent proxy report.

This study used standard gamble (SG) utility interviews to assess parent preferences for health states of childhood attention-deficit/hyperactivity disorder (ADHD). Health state utilities are needed to calculate quality-adjusted life years (QALYs), a critical outcome measure in cost-effectiveness studies of new treatments. Parents (n = 43) of children diagnosed with ADHD completed SG utility interviews, rating their child's current health and 11 hypothetical health states describing untreated ADHD and ADHD treated with a stimulant or non-stimulant. Parents completed questionnaires on their children's symptoms and health-related quality of life (HRQL). Parents' SG rating of their child's current health state (mean of 0.74 on a utility scale ranging from 0 to 1) was significantly correlated with inattentive, hyperactive, and overall ADHD symptoms (r = 0.37, 0.36, and 0.40 respectively; p < 0.05) and psychosocial HRQL domains. Hypothetical health state utilities ranged from 0.48 (severe untreated ADHD) to 0.88 (effective and tolerable non-stimulant treatment). Comparisons between health states found expected differences between untreated mild, moderate, and severe ADHD health states. When both treatments were effective and tolerable, parents preferred the non-stimulant health state over the stimulant health state (p < 0.03). Results suggest that parent SG interviews are a feasible and useful method for obtaining utility scores that can be used in cost-effectiveness models of ADHD treatment.