Mindfulness based cognitive therapy versus treatment as usual in adults with attention deficit hyperactivity disorder (ADHD).

BACKGROUND: Adults with attention deficit hyperactivity disorder (ADHD) often present with a lifelong pattern of core symptoms that is associated with impairments of functioning in daily life. This has a substantial personal and economic impact. In clinical practice there is a high need for additional or alternative interventions for existing treatments, usually consisting of pharmacotherapy and/or psycho-education. Although previous studies show preliminary evidence for the effectiveness of mindfulness-based interventions in reducing ADHD symptoms and improving executive functioning, these studies have methodological limitations. This study will take account of these limitations and will examine the effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in further detail. METHODS/DESIGN: A multi-centre, parallel-group, randomised controlled trial will be conducted in N = 120 adults with ADHD. Patients will be randomised to MBCT in addition to treatment as usual (TAU) or TAU alone. Assessments will take place at baseline and at three, six and nine months after baseline. Primary outcome measure will be severity of ADHD symptoms rated by a blinded clinician. Secondary outcome measures will be self-reported ADHD symptoms, executive functioning, mindfulness skills, self-compassion, positive mental health and general functioning. In addition, a cost-effectiveness analysis will be conducted. DISCUSSION: This trial will offer valuable information about the clinical and cost-effectiveness of MBCT in addition to TAU compared to TAU alone in adults swith ADHD. TRIAL REGISTRATION: ClinicalTrials.gov NCT02463396. Registered 8 June 2015.

Neuropsychiatric symptoms and expenditure on complementary and alternative medicine.

OBJECTIVE: Neuropsychiatric symptoms affect 37% of US adults. These symptoms are often refractory to standard therapies, and patients may consequently opt for complementary and alternative medicine therapies (CAM). We sought to determine the demand for CAM by those with neuropsychiatric symptoms compared to those without neuropsychiatric symptoms as measured by out-of-pocket expenditure. METHOD: We compared CAM expenditure between US adults with and without neuropsychiatric symptoms (n = 23,393) using the 2007 National Health Interview Survey. Symptoms included depression, anxiety, insomnia, attention deficits, headaches, excessive sleepiness, and memory loss. CAM was defined per guidelines from the National Institutes of Health as mind-body therapies, biological therapies, manipulation therapies, or alternative medical systems. Expenditure on CAM by those without neuropsychiatric symptoms was compared to those with neuropsychiatric symptoms. RESULTS: Of the adults surveyed, 37% had ≥ 1 neuropsychiatric symptom and spent $14.8 billion out-of-pocket on CAM. Those with ≥ 1 neuropsychiatric symptom were more likely than those without neuropsychiatric symptoms to spend on CAM (27.4% vs 20.3%, P < .001). Likelihood to spend on CAM increased with number of symptoms (27.2% with ≥ 3 symptoms, P < .001). After adjustment was made for confounders using logistic regression, those with ≥ 1 neuropsychiatric symptom remained more likely to spend on CAM (odds ratio [OR] = 1.34; 95% CI, 1.22-1.48), and the likelihood increased to 1.55 (95% CI, 1.34-1.79) for ≥ 3 symptoms. Anxiety (OR = 1.40 [95% CI, 1.22-1.60]) and excessive sleepiness (OR = 1.36 [95% CI, 1.21-1.54]) were the most closely associated with CAM expenditure. CONCLUSIONS: Those with ≥ 1 neuropsychiatric symptom had disproportionately higher demand for CAM than those without symptoms. Research regarding safety, efficacy, and cost-effectiveness of CAM is limited; therefore, future research should evaluate these issues given the tremendous demand for these treatments.

Treatment patterns, resource use, and economic outcomes associated with atypical antipsychotic prescriptions in children and adolescents with attention-deficit hyperactivity disorder in quebec.

OBJECTIVE: To assess treatment patterns, health care resource utilization (HRU), and costs among previously stimulant-treated children and adolescents with attention-deficit hyperactivity disorder (ADHD) receiving atypical antipsychotic (AAP) prescriptions in Quebec. METHODS: Health care claims data extracted from Quebec's provincial health plan database between March 2007 and February 2012 were analyzed. Children and adolescents (6 to 17 years) with ADHD who were taking a stimulant and either switched to, or augmented with, an AAP (with the first AAP defined as the index AAP) without a documented diagnosis for which AAPs are Health Canada-approved were included. Discontinuation, augmentation, and switching of the index AAP during the 12-month, follow-up period were estimated using Kaplan-Meier survival analysis. HRU and costs for the 6 months before (baseline period) and after initiation of the index AAP were compared. RESULTS: A total of 453 children and adolescents with ADHD, mostly male (74.6%) and aged 6 to 12 years (73.7%), met the inclusion criteria. The 12-month discontinuation, augmentation, and switching rates were 45.5%, 68.2%, and 80.7%, respectively. Patients had, on average, more all-cause prescription fills (22.2, compared with 13.3) and incurred more all-cause pharmacy ($889, compared with $710), total medical ($1096, compared with $644), and total health care ($1985, compared with $1354) costs during the 6-month study period than during the 6-month baseline period (all P < 0.05). Similarly, ADHD-related total health care costs were higher during the study period ($1269, compared with $835; P < 0.05); all-cause and ADHD-related total health care costs increased by 46.6% and 52.0%, respectively. CONCLUSION: Use of an AAP among stimulant-treated children and adolescents with ADHD in Quebec was associated with high rates of therapy changes and increased HRU and costs.

Outpatient rehabilitation utilization and medical expenses in children aged 0-7 years with ADHD: analyses of population-based national health insurance data.

Medical costs of attention-deficit/hyperactivity disorder (ADHD) are substantial and have a large impact on the public health system. The present study presents information regarding outpatient rehabilitation care usage and medical expenditure for children with ADHD. A cross-sectional study was conducted by analyzing data from the Taiwan National Health Insurance claims database for the year 2009. A total of 6643 children aged 0-7 years with ADHD (ICD-9-CM codes 314.0x: attention deficit disorder, 314.00: attention deficit disorder without hyperactivity, or 314.01: attention-deficit disorder with hyperactivity) who had used outpatient rehabilitation care were included in the analyses. Results showed that the mean annual rehabilitation care was 22.24 visits. Among the care users, 76% of patients were male, and 24% were female. More than half of the children with ADHD had comorbid mental illnesses as well. A logistic regression analysis of outpatient rehabilitation expenditure (low vs. high) showed that of those children with ADHD, those aged 0-2 years tended to incur more medical costs than those aged 6-7 years. Other factors such as frequency of rehabilitation visits, hospital medical setting and ownership, location of medical care setting, and types of rehabilitation were also significantly correlated with medical expenditure. The results from this study suggest that health care systems should ensure accurate diagnosis and measurement of impairment to maintain appropriate and successful management of rehabilitation needs for children with ADHD.

Cost effectiveness of guanfacine extended-release versus atomoxetine for the treatment of attention-deficit/hyperactivity disorder: application of a matching-adjusted indirect comparison.

BACKGROUND: About 7% of children and adolescents are diagnosed with attention-deficit/hyperactivity disorder (ADHD) in the US. Patients with ADHD who are intolerant of or do not have an optimal response to stimulants often use non-stimulants as alternative therapies. Guanfacine extended-release (GXR) and atomoxetine (ATX) are the only non-stimulants approved by the US Food and Drug Administration for once-daily use in the treatment of children and adolescents with ADHD in the US. ATX has been on the market since 2002 while GXR was recently approved in 2009. To date, there is no comparative effectiveness or cost-effectiveness study comparing the two drugs. OBJECTIVES: The aim of this study was to assess the cost effectiveness of GXR versus ATX for the treatment of ADHD in children and adolescents, using the comparative efficacy results from a matching-adjusted indirect comparison (MAIC). METHODS: The MAIC method was used to compare the efficacy between GXR (target dose and lower doses) and ATX (target dose) in the absence of head-to-head clinical trials. Individual patients in the GXR trials were weighted such that the summary baseline characteristics and the efficacy of the placebo arm of the GXR trials matched exactly with those from published ATX trials. After weighting, the efficacy (i.e. change in the ADHD rating scale, fourth edition [ADHD-RS-IV] total score from baseline) was compared between each GXR dosing group and the ATX group. The results from the MAIC analyses were used to populate a 1-year Markov model that is used to compare the cost effectiveness of GXR versus ATX from a US third-party payer perspective. Effectiveness outcomes for each treatment group were estimated as the proportion of responders, defined as patients with ≥25% reduction in ADHD-RS-IV total score from baseline, and average quality-adjusted life years (QALYs). Utilities associated with response/non-response and disutilities due to adverse events were applied in the model. Costs included drug and medical service costs and were inflated to 2011 US dollars ($US). Incremental cost/QALY and incremental cost/responder were estimated. Univariate sensitivity analyses were conducted by varying all model parameters, including costs, utilities, and response rate. RESULTS: The target dose of GXR was 0.12 mg/kg/day. In match-adjusted populations with balanced baseline characteristics, patients receiving GXR at the dose of 0.09-0.12(p = 0.0016) [DOSAGE ERROR CORRECTED] and 0.075-0.09 mg/kg/day (p = 0.0248) had better efficacy, while those receiving GXR at the dose of 0.046-0.075 mg/kg/day had comparable efficacy (p = 0.0699), compared with patients receiving ATX at the target dose of 1.2 mg/kg/day. In the base case of the cost-effectiveness analysis (CEA), GXR had incremental cost-effectiveness ratios of $US10 637/QALY and $US853/responder, compared with ATX (incremental costs: $US74; incremental effectiveness: 0.007 QALYs and 86 responders per 1000 patients treated). Results of all univariate sensitivity analyses showed that the model results were robust to changes in model inputs. CONCLUSIONS: To our knowledge, this is the first application of the novel comparative efficacy method of MAIC to a CEA model. The MAIC results indicate that GXR (0.075-0.12 mg/kg/day) was more effective than ATX (1.2 mg/kg/day) in the trial population. The CEA results indicate that GXR is cost effective compared with ATX for the treatment of ADHD in children and adolescents.

An interagency service delivery model for autistic spectrum disorders and attention deficit hyperactivity disorder.

BACKGROUND: A multiplicity of government initiatives advocate increasing shared working between services to ensure that holistic and co-ordinated assessment of need and related shared intervention is available to children and families. Concurrently, there is an increasing demand upon services to provide a wide range of support for children with complex difficulties. METHODS: On the Isle of Wight, joint services have been developing shared practice. The inter-agency service was initiated in 2001 through a 3-year project funded jointly between all services on the Island and the government through the 'Invest to Save' initiative. The project initially focused upon developing a combined process of diagnosis of autistic spectrum disorders (ASD) and the co-ordination of intervention at schools, within families and in the child's community. Gradually, the service extended to include children with a much wider range of difficulties, including those of attention deficit hyperactivity disorder (ADHD), developmental co-ordination disorder and co-morbid diagnoses. RESULTS: There are 19 000 school-aged children on the Isle of Wight. A total of 1101 referrals have been accepted between June 2001 and May 2007. In total, 201 children have been given a diagnosis of ASD. Overall, 392 children have been given a diagnosis of ADHD or ADHD/Co-morbid. Seventy were co-morbid for ASD and ADHD. The current service is rated as 85% satisfactory by its users, in contrast to the high level of complaint which resulted in the bid for the project initially. CONCLUSION: Following the successful conclusion of the 3-year government-funded project Education Services, Social Care and The Health Authority shared the ongoing funding of the current service. This has been operating effectively for over 6 years and has highlighted a wide variety of issues around this style of service delivery.

Mothers of children diagnosed with attention-deficit/hyperactivity disorder: health conditions and medical care utilization in periods before and after birth of the child.

BACKGROUND: Analyzing health conditions and medical utilization of mothers of children with attention-deficit/hyperactivity disorder (ADHD) can shed light on biologic, environmental, and psychosocial factors relating to ADHD. OBJECTIVE: To examine health conditions, health care utilization, and costs of mothers of children with ADHD in periods before the child was diagnosed. METHODS: Using automated data from Northern California Kaiser Permanente we identified mothers of children with ADHD, mothers of children without ADHD, and mothers of children with asthma. Mothers' diagnostic clusters, health care utilization, and costs were compared. Mothers of children with ADHD were compared with mothers of children without ADHD and, separately, to mothers of children with asthma. RESULTS: Compared with mothers of children without ADHD, mothers of children with ADHD were more likely to be diagnosed with numerous medical and mental health problems in the 2 years after birth of their child, including depression [odds ratio (OR): 1.88], anxiety neuroses (OR: 1.64), obesity (OR: 1.70), and musculoskeletal symptoms (OR: 1.51). Results were similar for the year before delivery. Mothers of children with ADHD also had higher total health care costs per person in the year before ($1,003) and the 2 years after ($953) the birth of their child. Mothers of children with ADHD also were diagnosed with more health conditions and had higher health care costs than mothers of children with asthma. CONCLUSIONS: Our findings suggest that the likelihood of being diagnosed with ADHD is related to maternal conditions and use of health services that precede the child's diagnosis. Future studies are needed to clarify whether this is due to biologic, psychosocial, or environmental factors, or a combination.

Health care costs of adults treated for attention-deficit/hyperactivity disorder who received alternative drug therapies.

BACKGROUND: Many therapies exist for treating adult attention-deficit/hyperactivity disorder (ADHD), also referred to as attention-deficit disorder (ADD), but there is no research regarding cost differences associated with initiating alternative ADD/ADHD drug therapies in adults. OBJECTIVE: To compare from the perspective of a large self-insured employer the risk-adjusted direct health care costs associated with 3 alternative drug therapies for ADD in newly treated patients: extended-release methylphenidate (osmotic release oral system-MPH), mixed amphetamine salts extended release (MAS-XR), or atomoxetine. METHODS: We analyzed data from a US claims database of 5 million beneficiaries from 31 large self-insured employers (1999-2004). Analysis was restricted to adults aged 18 to 64 years with at least 1 diagnosis of ADD/ADHD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 314.0x--attention deficit disorder; 314.00--attention deficit disorder without hyperactivity; or 314.01--attention-deficit disorder with hyperactivity) and at least 1 pharmacy claim for OROS-MPH, MAS-XR, or atomoxetine identified using National Drug Codes. In preliminary analysis, we calculated the duration of index ADHD drug therapy as time from index therapy initiation to a minimum 60-day gap. Because the median duration of index ADHD drug therapy was found to be approximately 90 days, the primary measures were total direct medical plus drug costs and medical-only costs computed over 6 months following therapy initiation. Adults were required to have continuous eligibility 6 months before and 6 months after their latest drug therapy initiation and no ADHD therapy during the previous 6 months. Cost was measured as the payment amount made by the health plan to the provider rather than billed charges, and it excluded patient copayments and deductibles. Medical costs included costs incurred for all-cause inpatient and outpatient/other services. Costs were adjusted for inflation to 2004 U.S. dollars using the consumer price index for medical care. T tests were used for descriptive cost comparisons. Generalized linear models (GLMs) were used to compare costs of adults receiving alternative therapies, adjusting for demographic characteristics, substance abuse, depression, and the Charlson Comorbidity Index. RESULTS: Of the 4,569 patients who received 1 of these 3 drug therapies for ADHD, 31.8% received OROS-MPH for a median duration of 99 days of therapy, 34.0% received MAS-XR for a median 128 days, and 34.2% received atomoxetine for a median 86 days. In the 6-month follow-up period, the mean (standard deviation) total medical and drug costs were $2,008 ($3,231) for OROS-MPH, $2,169 ($4,828) for MAS-XR, and $2,540 ($4,269) for atomoxetine-treated adults. The GLM for patient characteristics suggested that 6-month, risk-adjusted mean medical costs, excluding drug costs, for adults treated with OROS-MPH were $142 less (10.4%, $1,220 vs. $1,362) compared with MAS-XR (P =0.022) and $132 less (9.8%, $1,220 vs. $1,352) compared with atomoxetine (P =0.033); risk-adjusted mean medical costs were not significantly different between MAS-XR and atomoxetine. The GLM comparison of risk-adjusted total direct costs, including drug cost, was on average $156 less (8.0%, $1,782 vs. $1,938) for OROS-MPH compared with MAS-XR (P = 0.017) and $226 less (11.3%, $1,782 vs. $2,008) compared with atomoxetine (P <0.001); the risk-adjusted total direct costs were not significantly different between MAS-XR and atomoxetine. Two high-cost outliers (greater than 99.96th percentile, 1 each for OROS-MPH and atomoxetine) accounted for $47 (30%) of the $156 cost difference between OROS-MPH and MAS-XR and $11 (5%) of the $226 cost difference between OROS-MPH and atomoxetine, and the medical diagnoses for the highest-cost claims for these 2 outlier patients were unrelated to ADHD. CONCLUSIONS: After adjusting for patient characteristics including substance abuse, depression, and the Charlson Comorbidity Index, adults treated with OROS-MPH had, on average, slightly lower medical and total medical and drug costs than those treated with MAS-XR or atomoxetine over the 6-month period after drug therapy initiation. Approximately 30% of the cost difference compared with MAS-XR was attributable to 1 high-cost outlier with medical diagnoses for the highest-cost claim that were unrelated to ADHD.

Attention-deficit/hyperactivity disorder in children: excess costs before and after initial diagnosis and treatment cost differences by ethnicity.

OBJECTIVES: To estimate the excess costs for children in the years surrounding initial diagnosis of attention-deficit/hyperactivity disorder (ADHD) and to estimate differences in treatment costs by ethnicity. DESIGN: We identified children diagnosed with ADHD and estimated their health service costs in the 2 years before and 2 years after initial diagnosis of ADHD. Costs were compared with those for children without ADHD. We adjusted for age, sex, ethnicity, pharmacy co-pay, estimated family income, coexisting mental health disorders, and chronic medical conditions. SETTING: Nonprofit, integrated health care delivery system in northern California from January 1, 1996, to December 31, 2004. PARTICIPANTS: Children aged 2 to 10 years with (n = 3122) and without (n = 15 899) ADHD. Main Exposure Attention-deficit/hyperactivity disorder. MAIN OUTCOME MEASURES: Health care costs and use in the years before and after initial ADHD diagnosis as well as costs of ADHD-related services. RESULTS: Compared with children without ADHD, children with ADHD had mean costs that were $488 more in the second year before their ADHD diagnosis, $678 more in the year before their diagnosis, $1328 more in the year after their diagnosis, and $1040 more in the second year after their diagnosis. Asian Americans diagnosed with ADHD had lower total ADHD-related mean costs per year than white Americans diagnosed with ADHD ($221 lower), and Asian Americans, African Americans, and Hispanic Americans all had lower ADHD-related pharmacy mean costs than white Americans ($95, $63, and $77 lower, respectively). CONCLUSIONS: Children with ADHD use significantly more health services before and after their diagnosis than children without ADHD. Among children diagnosed with ADHD, nonwhite Americans (especially Asian Americans) use fewer ADHD-related services than white Americans.