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We performed Thyroseq v2 molecular testing on indeterminate thyroid nodules and evaluated whether they underwent a management change from the standard of thyroid lobectomy.We conducted a retrospective analysis of all indeterminate thyroid nodules that underwent Thyroseq v2 molecular testing from 2014 to 2019 at a large academic center. Pathology was reviewed by thyroid cytopathologists. Thyroseq results were reported benign (malignancy probability less than 10%) or suspicious (malignancy probability greater than 30%). The primary endpoint was a management change from a diagnostic lobectomy.A total of 142 nodules were included: 113 (80%) Bethesda III and 29 (20%) Bethesda IV. Seventy-three nodules underwent surgical management and 69 did not. We noted a change in management in 64% (91/142) of nodules. Patients who underwent a change in management to no surgery had a significantly higher rate of benign Thyroseq result than those without a change (75.8% vs. 49.0%, p = 0.001). On logistic regression analysis, a benign Thyroseq result was a positive independent predictor of a change to no surgery (OR 3.87, 95% CI 1.69-8.89). Nodule size, multiple nodules, compressive symptoms, and history of hypothyroidism were not significant. Of the 91 patients who underwent a management change, 71% (65/91) did not undergo surgery. On follow-up (average 985 ± 615 days), 12% (8/65) of those nodules were growing or developed suspicious features requiring surgery.Molecular testing helped avoid surgery in almost half our population with indeterminate thyroid nodules, and benign results may help avoid surgery in asymptomatic patients with indeterminate thyroid nodules.

Objectives Some managed care companies are testing rideshare services as an approach to providing transportation to health care for Medicaid enrollees. The objective of this study was to assess whether more rideshare transportation to health care was associated with improved self-reported ride experiences and fewer late/failed passenger pickups for Medicaid enrollees. Study design We surveyed a random sample of Medicaid enrollees in a northwestern US state on their experiences with nonemergency medical transportation (NEMT) in the past year. We linked survey responses to administrative data on NEMT utilization from the state's transportation broker to obtain an objective measure of rideshare utilization. Methods We used bivariate tests and multivariable logistic regressions to examine associations between enrollee perspectives on the quality of and access to health care and rideshare use, defined as none, some, or many NEMT trips through rideshare services. Results More than 35% of respondents received NEMT from rideshare services at least once. Perceptions of the ride experience, driver, and vehicle did not differ based on the proportion of rideshare trips received. Having more rideshare trips was associated with reporting late and failed pickups. In multivariable regression, the statistical significance held for failed pickups. Sensitivity analyses showed similar results. Conclusions This study suggests that rideshare to health care programs can meet similar goals of quality compared with traditional NEMT services but may have implications for health care access for Medicaid enrollees. Future evaluations need to include the perspectives of enrollees and explore potential differences among different Medicaid subpopulations.

This paper explores the impact of family-informed care on Medicaid enrollees with disabilities’ unmet needs for medical services and long-term services and supports (LTSS) and family member...

We studied the use of surgeon-performed office ultrasound (OU) and preincision ultrasound (PIU) in preoperatively localizing parathyroid adenomas in primary hyperparathyroidism (PHPT).A retrospective chart review was performed for patients with PHPT who underwent parathyroidectomy between 2013 and 2015. The results of OU and PIU were recorded and compared with the final surgical pathology.Of 348 patients with PHPT, 285 (81.9%) had single-lesion disease, 49 (14.1%) had double-lesion disease, and 14 (4.0%) had multigland disease with 3 or more lesions. For single-lesion disease, the overall sensitivity and specificity of OU to correctly lateralize the lesion were 64.2% and 91.2%, while those of PIU were 89.4% and 93.6%, respectively. The sensitivity and specificity of PIU were comparable to those of 4-dimensional computed tomography (87.1% and 90.7%, respectively) andSurgeon-performed OU and PIU are valuable tools in preoperatively localizing the parathyroid adenoma in single-lesion disease, while their utility may be limited for double-lesion or multigland disease. PIU in particular yields high accuracy in detecting parathyroid lesions in combination with other imaging modalities.

The objective of this study was to determine whether seniors and disabled adults in Illinois’s Medicaid managed care (MMC) were more likely to see, maintain longitudinal relationships with, and have continuity of care with a primary care provider (PCP) compared with fee-for-service (FFS) Medicaid enrollees. Medicaid PCP service claims for 13,221 MMC and 54,625 FFS enrollees were analyzed using an inverse propensity score weighted difference-in-differences design to match the groups by demographic characteristics and historical Medicaid utilization. All data came from Medicaid claims data and corresponding administrative records. Regression analyses showed that enrollment in MMC was significantly related to each of the three outcomes; MMC enrollees were more likely than the FFS group to see a PCP during the 1-year post-period and have high levels of continuity of care with a single PCP. However, FFS enrollees were more likely to maintain a relationship with their PCP providers from the pre-period through the post-period. Therefore, while more people in MMC than FFS visit a PCP each year, for people in MMC, it is often a new provider relationship, which can be problematic for people with disabilities. Additional training for PCPs, to prepare them for working with people with disabilities, and additional efforts to expand the MMC network of providers are needed.

For women with disabilities in particular, there is a need for information about both contraception and planning for a baby and preventing sexually transmitted infections (STIs). The study purpose was to determine which variables were associated with whether health care providers discussed birth control or planning for a baby and what enrollees can do to prevent STIs among a sample of female Medicaid enrollees with disabilities. A cross-sectional survey design was used in this study of 584 female Medicaid enrollees in a Midwestern state. Independent variables included demographics, community participation, experiences with primary care providers and care coordinators, whether the survey was completed by the enrollee, the level of activities of daily living help needed, and whether or not they could see the same doctors after transition to Medicaid managed care. Outcome variables were whether or not women with disabilities had conversations with their health care providers about preventing STIs and also birth control/planning for a baby. Results indicate that women’s likelihood of having conversations about sexual health with their health care provider varied significantly between participants of different age, ethnic, and racial groups, as well as between women with varying levels of independence. Further research should explore why particular groups of female Medicaid enrollees with disabilities are more or less likely to have these conversations with their providers.

Objective: To longitudinally examine the impact of public family support on appraisals of caregiving burden, satisfaction, and self-efficacy among families of adults with disabilities. Background: Little research exists on family support and the family experience within Medicaid managed care across disabilities and longitudinally. Method: Illinois Medicaid managed care enrollees with disabilities and their family members completed surveys over 2 years. Only families and enrollees who lived together were included (N = 182 pairs). Results: Family members with more unmet family support needs had increased caregiving burden and decreased satisfaction and self-efficacy. Family members providing more unpaid care reported higher burden. Black family members had significantly lower burden, and parents had significantly lower satisfaction and self-efficacy. Family members of enrollees with intellectual and developmental disabilities had higher self-efficacy. Conclusion: Family support is important to caregiving appraisals. Implications: There is a need for including family needs for services within assessments for services and within policy.Implications for rehabilitationFamilies provide a substantial amount of care for their family members with disabilities.More family support for family caregivers of people with disabilities is related to better caregiving appraisals within Medicaid managed care.Family caregiver support needs should be taken into account within policy and service assessments. Families provide a substantial amount of care for their family members with disabilities. More family support for family caregivers of people with disabilities is related to better caregiving appraisals within Medicaid managed care. Family caregiver support needs should be taken into account within policy and service assessments.

OBJECTIVES: This study assessed the impact of the Integrated Care Program (ICP), a new Medicaid managed care model in Illinois, on health services utilization and costs for adults with behavioral health conditions. METHODS: Data sources included Medicaid claims, encounter records, and state payment data for 28,127 persons with a behavioral health diagnosis. Difference-in-differences models, in conjunction with propensity score weighting, were used to compare utilization and costs between ICP enrollees and a fee-for-service (FFS) comparison group. The model considered the impact of the SMART Act, which restricted access to care for the comparison group. RESULTS: Before the SMART Act, ICP was associated with 2.8 fewer all-cause primary care visits, 34.6 fewer behavioral health-specific outpatient visits, and 2.5 fewer all-cause inpatient admissions per 100 persons per month, and $228 lower total costs per member per month relative to the FFS group. After the SMART Act, ICP enrollees had increased outpatient and dental services utilization without significantly higher costs. The relative increase in utilization was due primarily to decreased utilization in the restricted FFS group after the SMART Act. By the end of the study period, the ICP group had 13.3 more all-cause primary care visits, 1.5 more emergency department visits, and 1.4 more dental visits per 100 persons per month relative to the FFS program. CONCLUSIONS: A fully-capitated, integrated managed care program has the potential to reduce overall Medicaid costs for people with behavioral health conditions without negative effects on service utilization.

States have increasingly transitioned Medicaid enrollees with disabilities from fee-for-service (FFS) to Medicaid Managed Care (MMC), intending to reduce state Medicaid spending and to provide better access to health services. Yet, previous studies on the impact of MMC are limited and findings are inconsistent. We analyzed the impact of MMC on costs by tracking Illinois's Medicaid acute health services expenditures for adults with intellectual and developmental disabilities (IDD) living in the community (n = 1,216) before and after their transition to MMC. Results of the difference-in-differences (DID) regression analysis using an inverse propensity score weight (IPW) matched comparison group (n = 1,134) design suggest that there were no significant state Medicaid cost savings in transitioning people with IDD from FFS to MMC.

Pimavanserin is a selective 5-HTWe did a phase 2, randomised, double-blind, placebo-controlled, single-centre (with multiple affiliated nursing home sites across the UK) study. We included participants of either sex who were aged 50 years or older with possible or probable Alzheimer's disease and psychotic symptoms including visual or auditory hallucinations, delusions, or both. Participants were randomly assigned (1:1) to 12 weeks of oral treatment with either pimavanserin (two 17 mg tablets daily) or placebo, with use of permuted block sizes of four and stratified by baseline Mini-Mental State Examination (MMSE) total score (6 or ≥6) and Neuropsychiatric Inventory-Nursing Home version (NPI-NH) psychosis score (12 or ≥12). Participants, caregivers, the study sponsor, and study personnel at the clinic site were masked to treatment assignment. The primary endpoint was mean change from baseline to week 6 in the NPI-NH psychosis score for pimavanserin versus placebo in the modified intention-to-treat population. Sustained benefit and safety of pimavanserin were assessed through week 12. This study is registered at ClinicalTrials.gov, number NCT02035553.Between Jan 16, 2014, and Oct 27, 2016, 345 participants across 133 nursing homes were screened, of whom 181 were randomly assigned treatment (n=90 pimavanserin and n=91 placebo). 178 participants were included in the modified intention-to-treat population. Mean total baseline NPI-NH psychosis scores were 9·5 (SD 4·8) for the pimavanserin group and 10·0 (5·6) for the placebo group. Mean change in the NPI-NH psychosis score at week 6 was -3·76 points (SE 0·65) for pimavanserin and -1·93 points (0·63) for placebo (mean difference -1·84 [95% CI -3·64 to -0·04], Cohen's d=-0·32; p=0·045). By week 12, no significant advantage for pimavanserin versus placebo was observed for the overall study population (treatment difference -0·51 [95% CI -2·23 to 1·21]; p=0·561). Common adverse events were falls (21 [23%] of 90 participants in the pimavanserin group vs 21 [23%] of 91 in the placebo group), urinary tract infections (20 [22%] vs 25 [28%]), and agitation (19 [21%] vs 13 [14%]). Eight (9%) participants on pimavanserin and 11 (12%) on placebo discontinued treatment because of adverse events. No detrimental effect was observed on cognition or motor function in either group.Pimavanserin showed efficacy in patients with Alzheimer's disease psychosis at the primary endpoint (week 6) with an acceptable tolerability profile and without negative effect on cognition. Further follow-up to week 12 did not show significant advantage for pimavanserin versus placebo.ACADIA Pharmaceuticals.

This qualitative analysis of survey data explores service and care experiences reported by Medicaid enrollees with disabilities newly transitioned to managed care. Consumer surveys were distributed to a random sample of adult program enrollees with disabilities in an independent evaluation of one state's Medicaid managed care (MMC) rollout. Researchers performed conventional content analysis to code comments submitted by enrollee participants (N=402) in response to two open-ended survey items. Six key themes were observed in the data: (1) unmet medical, long-term services and supports (LTSS), and informational needs; (2) ineffective care coordination; (3) barriers in accessing providers; (4) limitations in benefit coverage; (5) unreliable transportation; and (6) variable provider care experiences. The results revealed salient managed care performance issues for the disabled Medicaid population. Enrollee experiences can inform recommendations for service access, provision capacity, and the integrated care of people with disabilities in the state MMC program.

People with intellectual and developmental disabilities (IDD) are frequent users of health services. We examined how their service utilization of emergency department (ED), inpatient hospitalization, and primary care physicians changed as they transitioned from fee-for-service to Medicaid managed care (MMC). Our results showed that MMC reduced the utilization of all of these services. A substantial decrease in ED visits was associated with the reduction in visits due to mental/behavioral health conditions and conditions that could be nonemergent and manageable with the community-based health services. These findings suggest that health service utilization of people with IDD is related not only to their health needs, but also to the delivery model that provides their health services.

To understand the impact of experience and contacts with care coordinators on Medicaid Managed Care (MMC) enrollees with disabilities.Primary data was collected from a random sample of 6000 out of the 100,000 people with disabilities enrolled in one state's mandatory MMC program. Surveys were conducted through the mail, telephone, and Internet; 1041 surveys were completed. The sample used for analysis included 442 MMC enrollees who received care coordination. Regression analyses were conducted with the outcomes of number of unmet health care needs and enrollee appraisal of the health services they received. Race, age, gender, and disability variables controlled for demographic differences, and the independent variables included enrollee experience with a care coordinator (coordinator knowledge of enrollee medical history and whether the coordinator took into account enrollee wishes and input) and frequency of contact with a care coordinator.Positive enrollee experiences with care coordinators significantly related to more positive enrollee health service appraisals and fewer unmet health care needs; frequency of contact did not have any significant impacts. People with mental health disabilities and intellectual/developmental disabilities had significantly lower health service appraisals. People with mental health disabilities had significantly more unmet needs.Quality of care coordination, but not frequency of contact alone, is associated with better health outcomes for MMC enrollees. Implications for rehabilitation Care coordination is a core component of managed care and facilitates effective healthcare management for people with complex chronic conditions and disabilities. Better experiences with care coordinators is related to fewer unmet healthcare needs and more positive health care service appraisals for Medicaid managed care enrollees. The continuous development of person-centered care coordination strategies and training programs emphasizing quality relationships between coordinators and consumers should be prioritized.

Background Many states are transitioning fee-for-service (FFS) Medicaid into Medicaid Managed Care (MMC) for people with disabilities. Objective This study examined managed care's impact on health services appraisal (HSA) and unmet medical needs of individuals with disabilities receiving Medicaid. Key questions included 1) Do participant demographics and enrollment in MMC impact unmet medical needs and HSA? 2) Within MMC, do demographics and continuity of care relate to unmet medical needs? 3) Within MMC, do demographics, unmet medical needs and continuity of care relate to HSA? Methods We collected cross-sectional survey data ( n = 1615) from people with disabilities in MMC operated by for-profit insurance companies ( n = 849) and a similar group remaining in FFS ( n = 766) in one state. Regression analyses were conducted across these groups and within MMC only. Results Across Medicaid groups, MMC enrollment was not related to either HSA or unmet needs; health status, having a mental health disability and unmet transportation needs related to HSA and health status, unmet transportation needs and having a mental health or physical disability related to higher unmet medical needs. Within MMC, in addition to better health and fewer unmet medical needs, less continuity of care significantly decreased HSA. Higher unmet transportation needs, poorer health status, having a physical or mental health disability, and less continuity of care significantly decreased unmet medical needs. Conclusions This research points to the importance of meeting unmet needs of individuals in MMC and the need for increased continuity of care as people transition from FFS.

Objective: We evaluated the impact of Medicaid managed care (MMC) on health service use and state costs among adults with early-acquired physical disabilities. Method: Using claims data, we tracked utilization of the emergency department (ED), inpatient admissions, outpatient physician visits, and state expenditures on enrollees who transitioned to MMC ( n = 881). The inverse propensity score weight and a difference-in-differences regression model were used to estimate the impact of MMC using their counterparts who remained in fee-for-service ( n = 1,552) as the comparison group. Results: MMC reduced ED use by 3.2% points/month ( p < .001). Relative to younger enrollees (age ⩽45 years), MMC reduced inpatient admissions of older enrollees (age ⩾46 years) by 3.3% points/month ( p < .001), and state expenditures by US$839/month ( p < .01). Discussion: MMC could reduce the hospital service use of and state spending on enrollees with early-acquired physical disabilities. This impact may vary depending on the enrollees’ age.

People with intellectual and developmental disabilities (IDD) often rely on long-term services and supports (LTSS) to live and work in the community or with their families. As policy reforms continue, it is important that we have research goals to guide the field. In August 2015, an expert panel met to discuss the future of LTSS for people with IDD and reached consensus that future work should ensure adequate funding and quality standards are in place, especially with the growth of managed long-term services and supports (MLTSS) programs, the increasing variety of Medicaid funding authorities used to finance supports for people with IDD, the changes in public policy regarding LTSS, and the application of behavioral supports, particularly positive behavior support (PBS).

This study examines health services appraisal (HSA) and unmet health-care needs for adults (age 50 and over) with physical disabilities in Medicaid managed care (MMC) versus Medicaid fee for service (FFS). Surveys from 309 individuals in MMC and 349 in FFS 2 years after MMC implementation included demographics, MMC processes, HSA, and unmet health-care needs. Regression analyses with HSA and unmet health-care needs as outcomes included demographics and group status (MMC or FFS) for the entire sample, and demographics and MMC processes (continuity of care, experience with care coordinators and primary care physicians) as independent variables for only MMC enrollees. Group status was not associated with HSA or unmet needs. Among MMC enrollees, better health and more positive MMC processes related to higher HSA and lower unmet needs. It is important to consider the perspectives of people aging with disabilities in MMC to better serve their needs.

BACKGROUND: Policymakers in the United States continue to face challenges in implementing effective strategies to encourage people with disabilities receiving disability benefits to participate in the labor market. Ticket to Work is one such strategy that has undergone considerable scrutiny. However, the experience of people with disabilities within welfare reform is an area that has been under-researched. OBJECTIVE: To explore how this contentious issue affects the provision of Vocational Rehabilitation services. Following the implementation of Ticket to Work, does workfare policy allow people with disabilities to pursue full and equal participation in the labor market, and do they have equality of opportunity to achieve employment? METHODS: This research takes a qualitative approach to social policy, using empirical data from focus groups with people with disabilities and interviews with policymakers, employment service providers and employers. RESULTS: Three themes emerged from an analysis of data framed within the United Nations Convention on the Rights of Persons with Disabilities in relation to disability rights and workfare policy: the rights of people with disabilities; the expectations of people with disabilities; and the practices associated with policy reform. The findings suggest that a collaboration of government actors, community organizations and the business community is necessary in order to achieve human rights.

This study examined perceptions of health and healthcare of people with intellectual and developmental disabilities (IDD) receiving Medicaid Managed Care. Exploratory, semistructured interviews were conducted with 23 participants. Findings indicate that participants generally expressed being in good health and defined good health as (a) absence of pain, disease, and symptoms; (b) adherence to or not requiring treatment; (c) physical self-care; (d) mental or spiritual self-care; and (e) ability to perform the activities one wants to do. Participants conceptualized healthcare as (a) ensuring needs are met through access to services, (b) obtaining quality services, (c) navigating the healthcare system successfully, and (d) receiving humanizing healthcare. This study has implications for improving healthcare and communications between people with IDD and healthcare providers.

In an ongoing open-label extension (OV-1004), patients with Lennox-Gastaut syndrome who had completed 1 of 2 randomized controlled trials (OV-1002 [Phase II] or OV-1012 [Phase III]) are receiving clobazam at dosages ≤2.0 mg/kg/day (≤80 mg/day). Of 306 eligible patients from OV-1002 or OV-1012, 267 entered the open-label extension. As of the interim date, July 1, 2010, 213 patients (79.8%) had remained in the trial, and 189 had received clobazam for ≥12 months, 128 for ≥18 months, and 94 for ≥24 months. Median percentage decreases in average weekly rates of drop seizures were 71.1% and 91.6% at Months 3 and 24. Mean modal and mean maximum daily dosages were 0.94 mg/kg and 1.22 mg/kg for those who had received clobazam for ≥1 year. The 4 most common adverse events were upper respiratory tract infection (18.4%), fall (14.2%), pneumonia (13.9%), and somnolence (12.7%). Clobazam's adverse event profile was consistent with its profile in controlled trials.

Governments continue to face challenges in implementing effective strategies to increase social and economic participation of people with disabilities. In a recent OECD high-level policy forum on Sickness, Disability and Work, the main policy message was the need for a culture of inclusion; with a dual focus on short-term active policy interventions and long-term structural reform. This paper examines policies in liberal welfare states that encourage people receiving disability benefits to participate in the labor market. Examples from the United States, the United Kingdom and Australia of active labor market programs aimed at moving people with disabilities from workfare are analyzed in the context of international disability rights and neoliberal discourse. The paper explores the extent to which new approaches to activation policies are facilitating parity of participation and factors that impact the effectiveness of these policies.

Background This study followed manic or mixed bipolar I subjects for an additional 40 weeks after initial randomization to 12 weeks of lithium versus aripiprazole monotherapy. This is the only long-term, double-blind study comparing lithium and aripiprazole. Methods Patients continued receiving either aripiprazole 15 or 30 mg/day, or lithium 900, 1200 or 1500 mg/day in a double-blind fashion for 40 weeks after completing a 12-week double-blind study (52 weeks total treatment). Efficacy endpoints included adjusted mean change from baseline to Week 52 in Young Mania Rating Scale (YMRS) total score and Montgomery–Asberg Depression Rating Scale (MADRS) total scores (observed cases). Remission was defined as YMRS total score ≤ 12. Safety and tolerability were also assessed. Results Of the 66 patients who entered the extension phase, only 20 patients (30.3%) completed the entire phase (aripiprazole n = 7; lithium n = 13). The significant improvement that occurred over the first 12 weeks was maintained over the 40 weeks of blinded continuation (from Week 12 through Week 52). The most common treatment-emergent adverse events in the extension phase for aripiprazole were akathisia, headache, somnolence, anxiety and nasopharyngitis (all 8%), and for lithium were insomnia (15.8%), headache (13.2%), diarrhea (13.2%) and vomiting (10.5%). Mean weight change was + 2.71 kg for lithium and + 5.66 kg for aripiprazole (p = 0.46). Limitations This trial was not powered to statistically compare active treatments, and long-term completion rates were low in both groups. Conclusions Aripiprazole monotherapy appears to be equivalently useful to lithium for the extended treatment of mixed or manic bipolar disorder patients.

This study evaluated the long-term tolerability and effectiveness of aripiprazole adjunctive to lithium or valproate in partial responders with bipolar mania.Completers of a 6-week double-blind comparison of adjunctive aripiprazole versus placebo in bipolar mania partially responsive to lithium or valproate monotherapy could enter a 46-week extension treatment with open-label adjunctive aripiprazole plus lithium (ARI + LI) or valproate (ARI + VAL). Safety, efficacy and functioning were assessed.CN138-134LT: Study of Aripiprazole in Patients With Bipolar I Disorder; ID number: NCT00257972; registry: www.clinicaltrials.gov.In total, 283 (ARI + LI n = 108; ARI + VAL n = 175) patients entered and 146 (ARI + LI n = 55; ARI + VAL n = 91) completed the 46-week, open-label extension. Frequently reported adverse events (AEs) that occurred with ARI + LI vs. ARI + VAL were: tremor (17.0% vs. 12.1%), akathisia (6.6% vs. 8.6%), headache (6.6% vs. 4.0%), insomnia (9.4% vs. 10.3%), depression (7.5% vs. 9.2%) and weight increase (11.3% vs. 8.6%). Extrapyramidal symptom-related AEs occurred in 24 (22.6%) ARI + LI- and 38 (21.8%) ARI + VAL-treated patients, with eight discontinuations. The majority of new-onset events of akathisia and insomnia occurred early. Mean (SE) weight change from double-blind endpoint to Week 46 (LOCF) was 2.3 (0.6) kg with ARI + LI and 2.0 (0.4) kg with ARI + VAL. Significant improvements from baseline over the 52 weeks (LOCF) occurred with ARI + LI and ARI + VAL on mean (95%CI) YMRS total score (-16.5 [-18.1; -14.8] and -17.6 [-18.9; -16.3], both p0.001 vs. baseline) and MADRS total score (-1.7 [-3.3; -0.1], p0.05 vs. baseline vs. -2.7 [-4.0; -1.4], p0.001 vs. baseline). Over the 46-week extension, continued aripiprazole provided continued YMRS improvement with ARI + LI (-2.9) and ARI + VAL (-3.3), while mean MADRS total changes were +1.1 and +1.0, respectively, and LIFE-RIFT changes were 0.2 and -0.5, respectively.Long-term aripiprazole adjunctive to lithium/valproate in bipolar mania was safe and well tolerated. Improvements in manic symptoms and functioning were maintained. Aripiprazole, adjunctive to either lithium or valproate, appeared to be equally safe and effective combinations for the treatment of bipolar disorder.As an open-label extension study with a low completion rate, a conservative interpretation of the findings is warranted. Additionally, the study population was not randomly selected but chosen at the discretion of the investigator, and patients did not maintain therapeutic levels of their mood stabiliser consistently.

OBJECTIVE: The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these. METHODS: This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6–17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression–Improvement score (CGI-I). Safety and tolerability were also assessed. RESULTS: Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8. CONCLUSIONS: Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated.

To evaluate the short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder.Two hundred eighteen children and adolescents (aged 6-17 years) with a diagnosis of autistic disorder, and with behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these symptoms, were randomized 1:1:1:1 to aripiprazole (5, 10, or 15 mg/day) or placebo in this 8-week double-blind, randomized, placebo-controlled, parallel-group study. Efficacy was evaluated using the caregiver-rated Aberrant Behavior Checklist Irritability subscale (primary efficacy measure) and the clinician-rated Clinical Global Impressions-Improvement score. Safety and tolerability were also assessed.At week 8, all aripiprazole doses produced significantly greater improvement than placebo in mean Aberrant Behavior Checklist Irritability subscale scores (5 mg/day, -12.4; 10 mg/day, -13.2; 15 mg/day, -14.4; versus placebo, -8.4; all p.05). All aripiprazole doses demonstrated significantly greater improvements in mean Clinical Global Impressions-Improvement score than placebo at week 8. Discontinuation rates due to adverse events were as follows: placebo 7.7%, aripiprazole 5 mg/day 9.4%, 10 mg/day 13.6%, and 15 mg/day 7.4%. The most common adverse event leading to discontinuation was sedation. There were two serious adverse events: presyncope (5 mg/day) and aggression (10 mg/day). At week 8, mean weight change (last observation carried forward) was as follows: placebo +0.3 kg, aripiprazole 5 mg/day +1.3 kg, 10 mg/day +1.3 kg, and 15 mg/day +1.5 kg; all p.05 versus placebo.Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adolescents with irritability associated with autistic disorder.

The authors evaluated the efficacy and safety of adjunctive aripiprazole in bipolar I patients with mania partially nonresponsive to lithium/valproate monotherapy.This multicenter, randomized, placebo-controlled study included outpatients experiencing a manic or mixed episode (with or without psychotic features). Patients with partial nonresponse to lithium/valproate monotherapy (defined as a Young Mania Rating Scale total score/=16 at the end of phases 1 and 2, with a decrease of/=25% between phases) with target serum concentrations of lithium (0.6-1.0 mmol/liter) or valproate (50-125 mug/ml) were randomly assigned in a 2:1 ratio to adjunctive aripiprazole (N=253; 15 or 30 mg/day) or placebo (N=131) for 6 weeks.Mean improvement from baseline in Young Mania Rating Scale total score at week 6 (primary endpoint) was significantly greater with aripiprazole (-13.3) than with placebo (-10.7). Significant improvements in Young Mania Rating Scale total score with aripiprazole versus placebo occurred from week 1 onward. In addition, the mean improvement in Clinical Global Impression Bipolar Version (CGI-BP) severity of illness (mania) score from baseline to week 6 was significantly greater with aripiprazole (-1.9) than with placebo (-1.6). Discontinuation rates due to adverse events were higher with aripiprazole than with placebo (9% versus 5%, respectively). Akathisia was the most frequently reported extrapyramidal symptom-related adverse event and occurred significantly more frequently among those receiving aripiprazole (18.6%) than among those receiving placebo (5.4%). There were no significant differences between treatments in weight change from baseline to week 6 (+0.55 kg and +0.23 kg for aripiprazole and placebo, respectively; last observation carried forward).Adjunctive aripiprazole therapy showed significant improvements in mania symptoms as early as week 1 and demonstrated a tolerability profile similar to that of monotherapy studies.

Although most treatment research on bipolar disorder has focused on mania, depressive episodes occur more frequently among patients with bipolar disorder. Here, we report the results of 2 identically designed, 8-week, multicenter, randomized, double-blind, placebo-controlled studies (CN138-096 and CN138-146) to evaluate the efficacy and safety of aripiprazole monotherapy in outpatients with bipolar I disorder experiencing a major depressive episode without psychotic features. Patients were randomized to placebo or aripiprazole (initiated at 10 mg/d, then flexibly dosed at 5-30 mg/d based on clinical effect and tolerability). The primary end point was mean change from baseline to Week 8 (last observation carried forward) in the Montgomery-Asberg Depression Rating Scale total score. In Studies 1 and 2, respectively, 186 and 187 patients were randomized to aripiprazole, and 188 and 188 to placebo. Although statistically significant differences were observed during Weeks 1 to 6, aripiprazole did not achieve statistical significance versus placebo at Week 8 in either study in the change in Montgomery-Asberg Depression Rating Scale total (primary end point). In addition, despite early statistical separation on the Clinical Global Impressions Bipolar Version Severity of Illness-Depression score (key secondary end point), aripiprazole was not superior to placebo at end point. Aripiprazole was associated with a higher incidence of akathisia, insomnia, nausea, fatigue, restlessness, and dry mouth versus placebo. More patients discontinued with aripiprazole versus placebo in Study 1 (46.8% vs 35.1%) and Study 2 (41.2% vs 29.8%). Aripiprazole monotherapy-as dosed in this study design-was not significantly more effective than placebo in the treatment of bipolar depression at end point (Week 8).

Recent policy approaches in Australia, influenced by neoliberalism, have constrained the implementation of international disability rights at the national level. Within the neoliberal and human rights approaches to social policy, what is the lived experience of people with disabilities? In focus groups with people with disabilities and interviews with disability stakeholders in Australia, participants were asked about their experiences and perspectives of welfare to work programs. We analyzed the data by drawing on the United Nations Convention on the Rights of Persons with Disabilities as a framework. The analysis revealed tensions between the rights and responsibilities of citizens and the government, and a disconnection between policy discourse and policy practice. The results suggest that disability rights are jeopardized unless governments take responsibility to create the policy environment for rights-based policy to be implemented; including the equalization of opportunities, providing accessible information and communication about employment, and addressing the administration and process practices that employment service providers follow.

Objective This review critically evaluates recent information on the cytochrome P450 system, with an emphasis on drug interactions involving antidepressant medications, particularly venlafaxine, nefazodone, and mirtazapine. Methods: International literature on the cytochrome P450 system and related drug interactions from 1995–1997 were critically examined. Results: Venlafaxine, nefazodone, and mirtazapine have different effects on the cytochrome P450 system. In vitro, venlafaxine is a weaker CYP2D6 inhibitor than most of the selective serotonin reuptake inhibitors (SSRIs) by a factor of 1–3 orders of magnitude. In vivo drug interaction studies generally confirm in vitro results. However, some exceptions exist. The clinical significance of such interactions remains unknown. Venlafaxine had minimal or no demonstratable inhibition of CYP1A2, CYP3A4, or CYP2C. Nefazodone is a potent inhibitor of CYP3A4 and is therefore absolutely contraindicated with concurrent administration of terfenadine, astemizole, and cisapride. It is a weak inhibitor of CYP1A2, 3A4, and 2D6. A metabolite of nefazodone, mCPP, is a weak and probably clinically insignificant inhibitor of CYP2D6. Mirtazapine has minimal inhibitory effects on CYP1A2, CYP3A4, and CYP2D6 in vitro. Little is known about its interactions with other drugs. Conclusions: With the addition of the latest antidepressant medications, the clinician may now choose antidepressants with little liability for drug–drug interactions. Venlafaxine and mirtazapine are associated with a lower risk of clinically significant drug interactions than SSRIs. Nefazodone is a potent inhibitor of CYP3A4 and therefore may not be suitable for all patient populations. It is, however, a much weaker CYP2D6 inhibitor than the SSRIs. More studies are needed to assess more accurately and precisely the risk of such untoward drug–drug interactions with these novel antidepressants, particularly in more diverse ethnic patient populations. Depression and Anxiety, Volume 7, Supplement 1:24–32, 1998. © 1998 Wiley-Liss, Inc.

Since the postwar period, conceptions of disability have shifted from a status involving isolation and segregation to one that recognizes equal rights and participation. An integral factor in participation, the right to work, is recognized as a fundamental human right by the United Nations Convention on the Rights of Persons with Disabilities (CRPD 2006). However, people with disabilities continue to be impeded by a disabling society embedded in structural and attitudinal barriers. People with disabilities are denied equal citizenship, which has been exacerbated in recent years as governments continue to face challenges in increasing the social and economic participation of people with disabilities. Particularly in liberal welfare states, contemporary disability employment policy embraces a neoliberal discourse and focuses on the development of workfare programs that encourage labor force participation as the principle means of achieving equality. This has resulted in a limited policy focus that fails to account for all the economic and cultural steps needed to ensure parity of participation of people with disabilities. This chapter uses examples from the United States, United Kingdom, and Australia of active labor market programs aimed at moving people with disabilities from welfare to work.

There are limited published data on the impact of treatment on the health-related quality of life (HRQOL) in individuals with autistic disorder.The aim of this study was to evaluate the impact of aripiprazole on HRQOL in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder.This post hoc analysis assessed data from two 8-week, double-blind, randomized, placebo-controlled studies that compared the efficacy of aripiprazole (fixed-dose study, 5, 10, and 15 mg/d; flexible-dose study, 2-15 mg/d) with placebo in the treatment of irritability associated with autistic disorder. HRQOL was assessed at baseline and week 8 using 3 Pediatric Quality of Life Inventory (PedsQL™) scales. Clinically relevant improvement in HRQOL was determined using an accepted distribution-based criterion-1 standard error of measurement.In total, 316 patients were randomly assigned to receive treatment with aripiprazole (fixed-dose study, 166; flexible-dose study, 47) or placebo (fixed-dose study, 52; flexible-dose study, 51). Aripiprazole was associated with significantly greater improvement than placebo in PedsQL combined-scales total score (difference, 7.8; 95% CI, 3.8-11.8; P0.001) and in 3 PedsQL scale scores (differences [95% CI]: Emotional Functioning, 7.8 [3.4-12.2]; Social Functioning, 6.2 [0.7-11.8]; Cognitive Functioning, 9.3 [3.8-14.9]; all, P0.05). Patients who received aripiprazole were significantly more likely than those who received placebo to have a clinically meaningful improvement on the combined-scales total score (odds ratio [OR] = 1.9; 95% CI, 1.0-3.3; P0.05), Emotional Functioning scale (OR = 2.2; 95% CI, 1.2-4.0; P0.05) and Social Functioning scale (OR = 2.2; 95% CI, 1.2-4.1; P0.05), and were significantly less likely to experience deterioration (OR: 0.3, 95% CI: 0.1-0.8; P0.05) when "Stable" was used as the reference group.The findings from the present post hoc analysis suggest that aripiprazole was associated with improved HRQOL, as assessed using 3 PedsQL scales, in pediatric patients with irritability associated with autistic disorder.