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Purpose: To examine and critique international clinical practice guidelines (CPGs) related to transgender and gender diverse children and youth and to assess the applicability of the guidelines to ...

The objective of this scoping review is to understand the extent and type of evidence in relation to barriers and facilitators experienced by transgender individuals in accessing hormone therapy. It will also explore experiences of primary care practitioners in prescribing hormone therapy in primary care.Providing care to transgender patients is a rapidly growing area of primary care. Despite the existence of clinical practice guidelines that support the prescription of gender-affirming hormone therapy in primary care, only a small number of primary care providers are providing this care. This review will seek to advance research on this topic by examining the barriers to and facilitators for hormone prescription for transgender people in primary care.This review will focus on research on primary care practitioners who prescribe hormone therapy to transgender adults. It will also focus on transgender adults who seek hormone therapy in primary care. Only studies that examine barriers and facilitators in primary care will be included. This review will include qualitative, quantitative, and mixed methods studies in addition to systematic reviews and meta-analyses written in English. No date limits will be applied to the search.The search will include MEDLINE, CINAHL, EmCare, and Nursing and Allied Health Premium. Articles will be reviewed and data extracted by 2 independent reviewers. The results of the extracted data will be presented in a narrative summary with accompanying tables.

Background Individuals of the LGBTQITS community face significant disparities when accessing healthcare, including stigma, oppression, and discrimination contributing to health inequities. Integrating cultural humility practice in nursing education is needed to navigate barriers. Method A mixed methods usability study evaluated a bilingual online educational toolkit including curated instructional videos, personal bias quiz, and virtual simulation games VSGs. A convenience sample of nursing faculty and students were invited to participate. Results Participants (N = 11) were observed playing the games, overall average time was 14 mins per game. Largely usability testers agreed or strongly agreed VSGs were easy and fun and helped them understand personal assumptions. Presimulation preparation was mostly viewed as relevant and engaging. Conclusions Results support the feasibility of educating nurses and students about cultural humility, sexual orientation, and gender identity (SOGI) using VSGs. The SOGI-Nursing toolkit was found to be functional and a valuable and engaging teaching and learning strategy.

Purpose: To examine and critique current international clinical practice guidelines (CPGs) related to providing primary care to transgender adults and to assess their applicability to practice. Methods: A review was conducted to obtain English language clinical guidelines. Guidelines included in this review were obtained from published journals and gray literature. Guidelines were critiqued using the AGREE II instrument. Results: Seventeen documents were included in the final review. Eleven were specifically designed for primary care practitioners, whereas the remaining six were deemed applicable to primary care. Overall, across the CPGs, the scope, purpose, and clarity of presentation were done well. However, the overall methodological rigor in guideline development was poor. Many CPGs included useful tools that could be helpful for the primary care practitioner. Conclusions: CPGs can be an important support for primary care providers' clinical practice with transgender people, particularly after having received limited formal education in transgender care. Improvements in transgender health CPG rigor and transparency are needed. Future CPGs would benefit from recommendations on the nuanced discussion of gender concepts and interpersonal communication that can create conflict in health care interactions.

To address a gap in nursing education regarding cultural humility and the health care needs of the LGBTQI2S an educational eLearning toolkit was created which incorporated virtual simulation games (VSG). The innovative VSGs depicted realistic clinical scenarios and featured actors from the LGBTQI2S community. This article shares our experiences, challenges and lessons learned in creating the VSGs. Additionally, the concept of psychological safety is addressed when using actors with lived experience in the creation of VSGs.

Antipsychotic medications may cause tardive dyskinesia (TD), an often-irreversible movement disorder characterized by involuntary movements that are typically stereotypic, choreiform, or dystonic and may impair quality of life. This study evaluated others' perceptions of abnormal TD movements in professional and social situations.This was an experimental, randomized, blinded, digital survey in a general population sample. Participants were randomized 1:1 into a test or control group to view a video of a professional actor simulating TD movements or no TD movements prior to completing surveys on employment, dating, and friendship domains. Assessments for mild-to-moderate and moderate-to-severe TD movements were conducted separately. Authenticity of abnormal movements and Abnormal Involuntary Movement Scale (AIMS) scores were evaluated by physician experts.Surveys were completed by 2,400 participants each for mild-to-moderate and moderate-to-severe TD. In all domains, participants responded significantly less favorably to persons with TD movements (both mild-to-moderate and moderate-to-severe) than those without TD movements. Fewer participants in the test versus control group for mild-to-moderate and moderate-to-severe TD, respectively, considered the candidate as a potential employee (29.2% and 22.7% fewer), found him/her attractive (20.5% and 18.7% fewer), and were interested in becoming friends with him/her (12.3% and 16.5% fewer).Professional actors simulating TD movements were perceived more negatively than those without TD movements in employment, dating, and friendship domains. To our knowledge, this is the first randomized study to quantify professional and social stigma associated with TD movements that may reduce opportunities for gainful employment, marital status, and an effective support system.

Aims: To evaluate the association of relapse and healthcare resource utilization in patients with schizophrenia (SZ), bipolar disorder (BD), or major depressive disorder (MDD) who switched antipsyc...

Purpose Tardive dyskinesia (TD) is a common but serious hyperkinetic movement disorder and side effect of antipsychotic medications used to treat bipolar disorder (BD), major depressive disorder (MDD), and schizophrenia (SZ). The purpose of this study was to evaluate health-related quality of life (HRQoL) in a population with diagnoses for BD, MDD, or SZ by comparing patients with TD (n = 197) with those without TD (n = 219). HRQoL in each group was also compared with HRQoL of the general population. Methods This study employed a cross-sectional web-based survey. HRQoL was assessed by four instruments: the SF-12 Health Survey, Version 2 (SF-12v2), the Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF), the Social Withdrawal subscale of the Internalized Stigma of Mental Illness Scale (SW-ISMI); and two questions on movement disorders. Results Patients with TD had significantly worse HRQoL and social withdrawal than those without. The differences were more pronounced for physical HRQoL domains than for mental health domains. Patients with more-severe TD, assessed through either self-rating or clinician rating, experienced significantly worse HRQoL than did those with less-severe TD. The impact of TD was substantially greater in patients with SZ than in those with BD or MDD. Compared with the general population, patients with BD, MDD, or SZ experienced significantly worse HRQoL regardless of TD status, although this deficit in HRQoL was greater among those with TD. Conclusions The presence of TD is associated with worse HRQoL and social withdrawal. The most severe impact of TD is on physical aspects of patients’ HRQoL.

Background The relative benefits and risks of long-term maintenance treatment with antipsychotics have not been well studied in patients with bipolar disorder and major depressive disorder. For example, while antipsychotic dose reduction has been recommended in the management of serious side effects associated with antipsychotics, there is limited evidence on the impact of lowering doses on the course of underlying mood disorders. Methods This retrospective cohort study analyzed the impact of antipsychotic dose reduction in patients with bipolar disorder or major depressive disorder. Medical claims from six US states over a 6-year period were analyzed for patients with ≥10% or ≥ 30% reductions in antipsychotic dose (cases) and compared using survival analyses with matched controls receiving a stable dosage. Outcomes included hospitalizations for disease-specific mood disorders, other psychiatric disorders and all-cause emergency room visits, and claims for tardive dyskinesia. Results A total of 23,992 patients with bipolar disorder and 17,766 with major depressive disorder had a ≥ 10% dose reduction, while 19,308 and 14,728, respectively, had a ≥ 30% dose reduction. In multivariate analyses, cases with a ≥ 10% dose reduction had a significantly increased risk of disease-specific admission (bipolar disorder: hazard ratio [95% confidence interval], 1.22 [1.15–1.31]; major depressive disorder: 1.22 [1.11–1.34]), other psychiatric admission (bipolar disorder: 1.19 [1.13–1.24]; major depressive disorder: 1.17 [1.11–1.23]), all-cause admission (bipolar disorder: 1.17 [1.12–1.23]; major depressive disorder: 1.11 [1.05–1.16]), and all-cause emergency room visits (bipolar disorder: 1.09 [1.05–1.13]; major depressive disorder: 1.07 [1.02–1.11]) (all P Conclusions Patients with mood disorders who had antipsychotic dose reductions showed small but statistically significant increases in all-cause and mental health-related hospitalizations, which may lead to increased healthcare costs. These results highlight the need for additional long-term studies of the necessity and safety of maintenance antipsychotic treatment in mood disorders.

Purpose There is an international drive to improve mental health services for young people. This study aims to investigate service user experience of a youth mental health service in Norfolk, UK. In addition to suggesting improvements to this service, recommendations are made for the development of youth mental health services in general. Design/methodology/approach A mixed-methods approach was used. Quantitative data from satisfaction questionnaires were analysed using descriptive statistics and compared between two time points. A semi-structured interview was used to generate qualitative data. Thematic analysis was used to identify themes in the interview transcripts and triangulation was used to synthesise quantitative and qualitative data. Findings Service users appeared satisfied with the service. Significant improvements in satisfaction were found between two time points. Qualitative analysis identified three main themes that were important to service users, including support, information and personhood. Practical implications Recommendations for the development of youth mental health services are provided. Although these are based on findings from the Norfolk youth service, they are likely to apply to other mental health services for young people. Originality/value Mental health care for young people requires significant improvement. The Norfolk youth service is one of the first services of its kind in the UK. The findings from this study might be helpful to consider in the development of youth mental health services across the world.

Background Data are limited on the benefits and risks of dose reduction in managing side effects associated with antipsychotic treatment. As an example, antipsychotic dose reduction has been recommended in the management of tardive dyskinesia (TD), yet the benefits of lowering doses are not well studied. However, stable maintenance treatment is essential to prevent deterioration and relapse in schizophrenia. Methods A retrospective cohort study was conducted to analyze the healthcare burden of antipsychotic dose reduction in patients with schizophrenia. Medical claims from six US states spanning a six-year period were analyzed for ≥10% or ≥ 30% antipsychotic dose reductions compared with those from patients receiving a stable dose. Outcomes measured were inpatient admissions and emergency room (ER) visits for schizophrenia, all psychiatric disorders, and all causes, and TD claims. Results A total of 19,556 patients were identified with ≥10% dose reduction and 15,239 patients with ≥30% dose reduction. Following a ≥ 10% dose reduction, the risk of an all-cause inpatient admission increased (hazard ratio [HR] 1.17; 95% confidence interval [CI] 1.11, 1.23; P

Study Objective:Evaluate the impact of orofacial tardive dyskinesia (TD) symptoms on the professional and social lives of patients with TD.Background:TD, a movement disorder affecting the face and extremities, may arise in patients taking antipsychotics. The impact of social stigma on the professional and social lives of patients with orofacial manifestations of TD has not been thoroughly examined.Methods:This study is an experimental, randomized digital survey of a general population sample. Three component surveys were developed, corresponding to employment, dating, and friendship domains. For each domain, participants were randomized 1:1 into either a test group (who viewed a video of a scripted interview with a standardized patient actor depicting TD movements) or a control group (who viewed the same actors but without TD movements), and asked about their impressions of the video subject. Actor simulations were validated by physicians familiar with TD and rehearsed to simulate a total Abnormal Involuntary Movement Scale score between 6 and 10. Statistical comparison was made using Wilcoxon sign-rank or chi-squared tests for continuous and categorical variables, respectively.Results:A total of 800 respondents completed each survey. In all domains, respondents had more-negative perceptions of actors portraying TD movements than of the same actors without movements. Regarding employment, 34.8% fewer respondents in the test group versus the control group agreed that the actor would be suitable for client-facing jobs (PConclusions:Actors simulating orofacial TD movements were perceived to be statistically significantly less likely to move forward in a job interview, be considered as a potential romantic partner, or be a new friend. This is the first study to quantify the stigma faced by people with TD in a variety of professional and social situations.Funding Acknowledgements:This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

Tardive dyskinesia (TD) is an often-irreversible movement disorder affecting any part of the body. Patients experience debilitating symptoms that lower quality of life and increase mortality. Prolonged exposure to dopamine antagonists, which are frequently prescribed for psychiatric disorders as neuroleptic (antipsychotic) drugs, is a common cause of TD. The estimated prevalence of TD is 20%-50% among patients on antipsychotics, and the reported incidence of TD ranges from1% to 42%, depending on the antipsychotics studied. However, there are few real-world studies examining health care utilization and the economic burden of TD.To assess health care utilization and costs in a sample of patients with TD from the commercially insured and Medicare supplemental U.S.A retrospective analysis was conducted using Truven MarketScan Commercial and Medicare administrative claims data. Patients were included in the TD group if they had the first TD diagnosis (index date) between January 1, 2008, and September 30, 2014, with ≥ 1 inpatient or ≥ 2 outpatient nondiagnostic claims for TD (ICD-9-CM code 333.85). Patients without TD were randomly assigned an index date. Further inclusion criteria for all patients were ≥ 12 months of pre- and post-index medical and pharmacy continuous enrollment and no evidence of TD claims during the pre-index period. Patients with TD were directly matched to patients without TD within subgroups for schizophrenia, major depressive disorder, bipolar disorder, and other psychiatric disorders and propensity matched on other demographic and clinical factors. Descriptive statistics on the incidence of resource utilization and costs of health care were reported.Of 3,397 patients with TD, 834 met the selection criteria and were matched to 834 non-TD controls. Patients with TD generally had significantly greater utilization during the 12 months after TD diagnosis than in the 12 months before TD diagnosis. Their rates for health care utilization and costs were also substantially higher than for those without TD. During the post-TD-diagnosis time, inpatient admissions (55.5% vs. 26.1%;Patients diagnosed with TD demonstrate significantly higher health care utilization and costs compared with non-TD patients.This study was funded by Teva Pharmaceuticals (Petach Tikva, Israel). Truven Health Analytics, an IBM Watson Health Company, received payment from Teva Pharmaceuticals for the analysis in this study. Carroll is employed by Teva Pharmaceuticals and Irwin is employed by Truven Health Analytics, an IBM Watson Health Company.

Objective: To assess the impact of developing tardive dyskinesia (TD), both with and without other pre-existing extrapyramidal symptoms (EPS), on healthcare resource utilization (HRU) among patient...

Study Objective:To Evaluate the impact of mild-to-moderate orofacial tardive dyskinesia (TD) symptoms on the people and social lives of people with TD.Background:TD, a movement disorder affecting the face and extremities, may arise in patients taking antipsychotics. The impact of stigma on the professional and social lives of people with moderate-to-severe TD was previously examined, but has not been investigated in those with mild-to-moderate TD.Methods:This study is an experimental, randomized digital survey of a general population sample. Three component surveys corresponding to employment, dating, and friendship domains were adopted from a prior study. For each domain, participants were randomized 1:1 into either a test group (who viewed a video of a scripted interview with an actor depicting mild-to-moderate TD movements) or a control group (who viewed the same actor but without TD movements) and asked about their impressions of the video subject. Actor simulations of the TD symptoms were validated by physicians familiar with TD and rehearsed to simulate orofacial movements with a total Abnormal Involuntary Movement Scale (AIMS) score of 3–6. Statistical comparison was made using Wilcoxon signed-rank or chi-squared tests for continuous and categorical variables.Results:A total of 800 respondents completed each survey. In all domains, respondents had more negative perceptions of actors portraying mild-to-moderate TD movements than of the same actors without movements. For employment, 41% fewer respondents in the test group versus the control group agreed that the actor would be suitable for client-facing jobs (PConclusions:This study addresses the stigma faced by those with mild-to-moderate TD in professional and social situations. Consistent with previous results for moderate-to-severe TD, actors simulating mild-to-moderate orofacial TD movements were perceived to be less likely to move forward in a job interview, be considered as a potential romantic partner, or be a new friend.Funding Acknowledgements:This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

Study Objective:To evaluate the risk of relapse for patients with schizophrenia (SZ), bipolar disorder (BP), and major depressive disorder (MDD) who switched antipsychotics compared with those who did not switch.Background:Antipsychotics are commonly used for maintenance treatment of SZ, BP, and MDD but can have significant side effects, such as extrapyramidal symptoms (EPS). Adherence to treatment is important for reducing the risk of relapse, but fear of side effects may prompt medication switching.Methods:Medicaid claims from 6 US states spanning 6 years were retrospectively analyzed for antipsychotic switching versus non-switching. For all patients with SZ, BD or MDD and for the subset of patients who also had ≥1 EPS diagnosis during the baseline period, times to the following outcomes, during a 2-year study period were analyzed: underlying disease relapse, psychiatric relapse, all-cause emergency room (ER) visit, all-cause inpatient (IP) admission and EPS diagnosis.Results:Switchers (N=10,548) had a shorter time to disease relapse, other psychiatric relapse, IP admissions, ER visits, and EPS diagnosis (all, log-rank PConclusions:These results show that disease and other psychiatric relapse, all-cause ER visits, IP admissions, and EPS diagnosis occurred earlier for switchers than for non-switchers, suggesting that switching is associated with an increased risk of relapse in patients with SZ, BP and MDD.Funding Acknowledgements:This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel.

BackgroundTardive dyskinesia (TD) is typically caused by exposure to antipsychotics, is often irreversible, and can be debilitating. TD symptoms can increase the social stigma of patients with comorbid psychiatric disorders, negatively impact quality of life, and potentially increase medical morbidity and mortality. An increased risk of developing TD has been associated with factors such as older age, female sex, underlying mental illness, and long-term use and higher doses of antipsychotics. The association of TD with the use of typical versus atypical antipsychotics has also been evaluated, with mixed results. To date, predictive models assessing the joint effect of clinical characteristics on TD risk have not been developed and validated in the US population.Study ObjectiveTo develop a prediction model to identify patient and treatment characteristics associated with the occurrence of TD among patients with psychiatric disorders taking antipsychotic medications, using a retrospective database analysis.MethodsAdult patients with schizophrenia, major depressive disorder, or bipolar disorder who were taking oral antipsychotics, and who had 6months of data prior to the index date were identified from Medicaid claims from six US states. The index date was defined as the date of the first claim for an antipsychotic drug after a claim for the underlying disorder but before TD diagnosis. A multivariate Cox prediction model was developed using a cross-validated version of the least absolute shrinkage and selection operator (LASSO) regression method to improve prediction accuracy and interpretability of the model. The predictive performance was assessed in a separate validation set via model discrimination (concordance) and calibration.ResultsA total of 189,415 patients were identified: 66,723 with bipolar disorder, 68,573 with depressive disorder, and 54,119 with schizophrenia. The selected prediction model had a clinically meaningful concordance of 70% and was well calibrated (P=0.46 for Hosmer–Leme show goodness-of-fit test). Patient’s age at index date (hazard ratio [HR]: 1.03), diagnosis of schizophrenia (HR: 1.73), dosage of antipsychotic at index date (up to 100mg/day chlorpromazine equivalent; HR: 1.40), and presence of bipolar and related disorders (HR: 1.16) were significantly associated with an increased risk of TD diagnosis. Use of atypical antipsychotics at index date was associated with a modest reduction in the risk of TD (HR=0.94).ConclusionsThis study identified a group of factors associated with the development of TD among patients with psychiatric disorders treated with antipsychotics. This may allow physicians to better monitor their patients receiving antipsychotics, allowing for the prompt identification and treatment of TD to help maintain quality of life.Presented at: American Psychiatric Association Annual Meeting; May 5–9, 2018, New York, New York, USAFunding Acknowledgements: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel.

Soybean, Glycine max (L.) Merr., is planted across a vast amount of land in the Mid-Southern U.S. (Arkansas, Louisiana, Mississippi, and Tennessee), and yield responses to defoliation can vary. Experiments were conducted during 2015-2017 evaluating how soybean yield responds to multiple and continuous defoliation, as well as planting date and plant population. Multiple defoliation events were evaluated by defoliating soybean at varying levels at V3, V6, and both growth stages. There was no interaction between defoliation occurring at V3 and V6 growth stages, indicating that the impact of each defoliation event was independent of the other. The effect of continuous defoliation was evaluated by defoliating soybean weekly, beginning at V2. Defoliation continued throughout the vegetative growth stages or throughout the entire growing season, and was compared to the same defoliation level occurring one time at R3. Continuous defoliation during vegetative growth stages only, did not reduce yield at any of the levels tested. Defoliation occurring throughout the growing season reduced yields more than a one-time defoliation event at R3, but only when defoliation levels exceeded the 20% defoliation threshold. This indicates that thresholds do not need to be modified to account for multiple or continuous defoliation. To evaluate the effect of planting date on yield loss from defoliation, soybean was planted at six planting dates beginning in early-April and continuing through mid-June. Each planting date included a defoliated treatment and an undefoliated control. It was determined that later planted soybean lose a greater amount of yield than earlier planted. Higher yielding soybean also lost more yield than lower yielding soybean at every planting date until Mid-June. It was concluded that late planted soybeans could benefit from a lower treatment threshold. The effect of plant population on yield loss from defoliation was evaluated by planting soybean at five populations r

Tardive dyskinesia (TD) occurs in patients receiving antipsychotic treatment with dopamine receptor antagonists. Despite the prevalence of TD and its negative impact on patients' lives, there has been a lack of approved treatments and limited evidence from controlled trials of pharmacological treatment. Areas covered: PubMed was searched for English-language papers published during 2007-2016 using terms 'tardive dyskinesia' or 'drug-induced movement disorder', and 'treatment'. Studies evaluating pharmacological agents for the treatment of TD were selected. A total of 26 studies (five meta-analyses, twelve randomized controlled trials, and nine open-label observational studies) are reviewed. Expert commentary: Treatment of TD necessitates a stepwise approach. Optimization of antipsychotic therapy should be considered before initiation of antidyskinetic therapies. Data from some recent studies indicate possible improvements in TD after switching antipsychotics or with the use of amantadine, levetiracetam, piracetam, zonisamide, propranolol, vitamin B

IntroductionExtrapyramidal symptoms (EPS), including tardive dyskinesia (TD), may result from exposure to antipsychotics. TD is often irreversible, may be debilitating, and cause additional burden to patients with underlying psychiatric conditions.ObjectiveTo assess the impact of developing TD, both with and without other EPS, on healthcare resource utilization (HRU).MethodsData on patients receiving antipsychotics who had schizophrenia, major depressive disorder, or bipolar disorder were extracted from a Medicaid claims database. Patients from the TD cohorts (TD+EPS and TD non-EPS) were matched to those in the non-TD/EPS cohort at ∼1:5 ratio. HRU outcomes associated with TD were assessed.ResultsTD+EPS (n=289) and TD non-EPS (n=394) cohorts were matched with 1398 and 1922 control patients, respectively. The percentage of patients with all-cause and mental disorder-related inpatient admissions increased from baseline to follow-up in the TD+EPS (12.8% and 12.5%, respectively) and TD non-EPS (16.0% and 13.5%) cohorts, in contrast with slight decreases (∼3%) in matched controls. A higher percentage of patients in the TD cohorts had medical admissions/visits and claims for drugs that might be used to address TD or EPS than their matched controls at baseline and follow-up. The within-cohort change from baseline to follow-up in the use of potential drugs for TD or EPS was similar between the TD cohorts and their matched controls; however, both TD cohorts exhibited a larger increase in crisis–non-specific psychotherapy services versus matched controls.ConclusionsResults demonstrated increased HRU in TD patients with or without other pre-existing EPS, compared with matched controls.Presented at: Psych Congress; September 16–19, 2017; New Orleans, Louisiana, USA.Funding AcknowledgementsThis study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.

IntroductionTardive dyskinesia (TD), an often-irreversible movement disorder, develops in patients treated withantipsychotics. Although antipsychotic dose reduction has been utilized in the management of TD, the benefits and risks of lowering doses have not been well studied and could cause additional burden to patients.ObjectiveTo analyze the healthcare burden of antipsychotic dose reduction in patients with schizophrenia.MethodsMedical claims from six US states spanning 6 years are retrospectively analyzed for ≥10% or ≥30% antipsychotic dosereductions and compared with those from patients receiving stable doses. Outcomes measured include inpatient admissions and emergency room (ER) visits for schizophrenia, all psychiatric disorders, and all causes.ResultsBaseline analysis revealed 17,984 patients with ≥10% and 14,029 patients with ≥30% dose reduction. Patients with≥10% dose reduction and matched controls were similar in age (mean 45.5 years), gender (51% male) and healthcare plan type. Preliminary analyses indicate that ≥10% dose reduction is associated with increased risk of admission or ER visit for schizophrenia (hazard ratio [HR] 1.26; 95% confidence interval [CI] 1.18, 1.35; PConclusionsPatients with antipsychotic dose reductions may be at risk for significant increases in hospital utilization rates. This suggests that dose reductions may increase overall healthcare burden in some schizophrenia patients, and highlights the need for alternative strategies in the management of TD.Presented at: Psych Congress; September 16–19, 2017; New Orleans, Louisiana, USA.Funding AcknowledgementsThis study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.

Vesicular monoamine transporter 2 (VMAT2) inhibitors can improve hyperkinetic movements, and are effective treatment options for chorea of Huntington disease (HD). Tetrabenazine was assessed for treating chorea in the TETRA-HD trial, and while efficacious, there are tolerability concerns possibly due to its pharmacokinetic properties. Deutetrabenazine is a novel VMAT2 inhibitor that contains deuterium, which extends active metabolite half-lives and minimizes drug concentration fluctuations. In the First-HD trial, deutetrabenazine was efficacious in treating chorea and was generally well tolerated. In the absence of a head-to-head trial, we performed an indirect treatment comparison (ITC) of the tolerability of deutetrabenazine and tetrabenazine for the treatment of HD-associated chorea, as observed in the First-HD and TETRA-HD trials, using well-established comparison methods. Data from the Phase III, 12-week, parallel-group, clinical trials First-HD (N = 90) and TETRA-HD (N = 84) were used to conduct an ITC of the tolerability of deutetrabenazine versus tetrabenazine using two anchor-based methods: Bucher comparison for unadjusted ITCs, and matching indirect comparison for adjusted ITCs. Overall adverse events (AEs; mild, moderate, and severe), serious AEs, specific AEs occurring in ≥10% of patients, and discontinuations (all-cause and AE-related) were included in the analysis. The risk differences of these outcomes for deutetrabenazine and tetrabenazine were estimated by subtracting the applicable placebo-adjusted risk in First-HD from that of TETRA-HD. Sensitivity analyses were performed to address differences between trials, and p-values were obtained from z-tests. Compared with tetrabenazine, deutetrabenazine was associated with a significantly lower risk of moderate to severe AEs and neuropsychiatric AEs including agitation, akathisia, depression, depression/agitated depression, drowsiness/somnolence, insomnia, and parkinsonism in both adjusted and unadjusted analyses (p

IntroductionTardive dyskinesia (TD), an often-irreversible movement disorder typically caused by exposure to antipsychotics, most commonly affects the face, mouth, and tongue and may be debilitatingObjectiveTo investigate TD burden on patients’ quality of life and functionalityMethodsAdults with clinician-confirmed schizophrenia, bipolar disorder, or major depressive disorder participated in an observational study. Approximately half (47%) ofparticipants had a clinician-confirmed TD diagnosis. Participants completed the SF-12v2 Health Survey® (SF-12v2), Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), social withdrawal subscale of the Internalized Stigma of Mental Illness scale (SW-ISMI), and rated the severity of their TD symptoms. Group differences in SF-12v2 physical and mental component summaries (PCS and MCS), Q-LES-Q-SF, and SW-ISMI scores were analyzed.ResultsTD (n=79) and non-TD (n=90) groups were similar in age, gender, and number of patients with schizophrenia, bipolar disorder, and major depressive disorder. TD patients reported significantly worse scores on PCS (P=0.003), Q-LES-Q-SF (PConclusionsAmong patients with psychiatric disorders, TD is associated with significant physical health burden and incremental mental health burden. TD severity is also associated with lower overall quality of life and greater social withdrawal.Presented at: Psych Congress; September 16–19, 2017; New Orleans, Louisiana, USA.Funding AcknowledgementsThis study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.

IntroductionTardive dyskinesia (TD) is an often-irreversible movement disorder that usually results from prolonged use of antipsychotics. Although the burden of TD on patients’ quality of life has been reported, there is limited evidence of its impact on the healthcare system.ObjectiveTo assess healthcare utilization and costs between TD and non-TD patients in a sample of patients from the commercially insured and Medicare Supplemental US populations.MethodsA retrospective cohort analysis was conducted using Truven MarketScan Commercial/Medicare claims data. For each patient included in the analysis, the index date was set as the first TD diagnosis between 1/1/2008 and 9/30/2014. Patients with TD were then matched to similar patients without TD to compare resource utilization andcosts. Descriptive statistics on the incidence of resource utilization and costs of healthcare were reported.ResultsA total of 1020 patients were included in this analysis. TD patients had significantly greater annual all-cause (TD: $54,656; non-TD: $28,777) and mental health-related (TD: $10,199; non-TD: $2,605) healthcare costs compared with non-TD patients (PConclusionsPatients identified as being diagnosed with TD demonstrate significantly higher healthcare utilization and costs in the 12 months after diagnosis than do similar patients without TD.Presented at: Psych Congress; September 16–19, 2017; New Orleans, Louisiana, USA.Funding AcknowledgementsThis study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.

A series of social and economic changes in American Samoa brought about by westernization from United States occupation has resulted in an interesting interaction between the fishery and coral reef fish populations. Analysis of data from an extensive database and review of technical reports rarely accessed by the public yield a unique temporal pattern showing a significant decline in shoreline fishing effort and a non-significant decrease in boat-based effort, resulting in constant catch landings and catch-per-unit effort. Concurrent with the decline in fishing effort and constant catch landing was an increase in fish abundance and biomass for the targeted families. This fishing pressure release and recovery of the fish stock occurs in a period of rapid population growth, indicating non-dependence of the general population on fishing, reflecting the change in the social and economic dynamics within the territory. On a historical context, Samoans had relied and utilized marine resources for thousands of ye...

Background: Biopharmaceutical companies face multiple external pressures. Shareholders demand a profitable company while governments, nongovernmental third parties, and the public at large expect a commitment to improving health in developed and, in particular, emerging economies. Current industry commercial models are inadequate for assessing opportunities in emerging economies where disease and market data are highly limited. Objective: The purpose of this article was to define a conceptual framework and build an analytic decision-making tool to assess and enhance a company’s global portfolio while balancing its business needs with broader social expectations. Methods: Through a case-study methodology, we explore the relationship between business and social parameters associated with pharmaceutical innovation in three distinct disease areas. The global burden of disease–based theoretical framework using disability-adjusted life-years provides an overview of the burden associated with particular diseases. The social return on investment is expressed as disability-adjusted life-years averted as a result of the particular pharmaceutical innovation. Simultaneously, the business return on investment captures the research and development costs and projects revenues in terms of a profitability index. Conclusions: The proposed framework can assist companies as they strive to meet the medical needs of populations around the world for decades to come.

Background DTB was efficacious and well tolerated in patients with Huntington’s disease (HD) chorea (First-HD). In the absence of a head-to-head trial with TBZ, we compared safety and tolerability outcomes of TBZ versus DTB using an indirect treatment comparison method and an NNH metric. Methods Safety data from First-HD and TETRA-HD were used to calculate the NNH, where serious adverse events (SAEs), discontinuation (all cause- and adverse event [AE]-related), and specific AEs (in > 10% of patients) were defined as undesirable outcomes. The difference between the proportions of undesirable outcomes was estimated by subtracting the applicable placebo-adjusted risk from both studies (TETRA-HD minus First-HD). NNH estimates, defined as the number of patients to be treated with TBZ instead of DTB for an average of one additional patient to experience an AE, were calculated as the inverses of the risk differences. P-values were obtained from z-tests, which approximate normal distribution. Results First-HD (N = 90) and TETRA-HD (N = 84) cohorts were of similar age (53.7 years vs 49.2 years) and gender (proportion of females 44% vs 62%), and baseline chorea scores were 12.7 vs 14.9. TBZ demonstrated a significant NNH vs DTB of 3 (95% CI: 1, 8; P Conclusions In this NNH analysis, DTB demonstrated significantly better outcomes than TBZ on several safety measures. Further analysis adjusting for demographic differences between trials should be conducted to confirm these findings.

The kinetics of the early stages of pyrolysis of several disaccharides have been examined thermogravimetrically. Cleavage of the glycosidic bond has been postulated as the rate-determining step for these thermal reactions. This step is followed primarily by the formation of anhydrohexopyranoses with the elimination of water. The kinetic parameters for these disaccharides have been compared with the literature values for aqueous acid hydrolyses of these same compounds.

A novel and convenient method for the determination of the activation energy from isothermal kinetic runs has been proposed recently. A significant limitation of this method is discussed and is illustrated with an experimental example. A modification of the proposed method is suggested to circumvent this limitation.

The hydrogen isotope effect in the activation energy for the dehydration of calcium oxalate monohydrate has been investigated as a function of the progress of the reaction using thermogravimetry. Although the activation energy appears to decrease during the course of the reaction, contrary to the data in the literature no significant isotope effect is apparent when the activation energy for the protonated and deuterated hydrates are compared at the same degree of conversion. Theoretical considerations rule out an isotope effect greater than one kilocalorie, a value which is well within the experimental error for non-isothermal kinetics.

The ratio of two intensities has been used to determine the optical activity of highly scattering solutions. A modified Brice light-scattering photometer was used for this purpose. The difficulty introduced by the presence of the depolarized scattered radiation was eliminated by the imposing of a measurable rotation on the system. The imposed rotation was achieved by the incorporation of an adjustable polarizer between the analyzer and the phototransducer linked to an angular scale. The optical rotation of scattering systems having a transmission of less than 10% have been determined with an accuracy of a few hundredths of a degree, the precision being limited by the improvised angular scale.

Thermogravimetric procedures are used to obtain the kinetic parameters for the intermolecular condensation of the anomers of D-glucose, D-mannose, and D-galactose. The condensation rates in the temperature range 176–220°C are found sufficiently rapid compared to the rates of mutarotation that significant differences between anomers can be observed.

Photometric observations of the region of the counterglow (Gegenschein) made from OSO-6 are examined. The observations were made during the September to October 1970 period when the counterglow was between the Milky Way arms at a relatively high (negative) galactic latitude. The lines of sight included a slice across the antisun region at an inclination of 48 degrees to the ecliptic. A comparison is made between the photometric gradients as measured from the spacecraft and similar gradients deduced from ground-based observations.

During the past decade a large number of methods have been suggested for the kinetic treatment of data obtained from the thermal traces of differential thermal analysis (DTA), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA), in addition to a variety of other thermal methods1. The temperature of the sample in these systems is usually advanced at a constant linear rate. This paper attempts to describe the treatment of experimental data under non-isothermal conditions in order to obtain the kinetic parameters of chemical reactions.

The interaction between crystal violet, a cationic dye, and native and denatured forms of bovine serum albumin has been investigated using spectrophotometry and equilibrium dialysis. Changes in the extent of binding as a function of pH indicate that the sites of binding of crystal violet by bovine serum albumin may be the carboxylate groups. The complex formation was used to characterize the proteins through thermodynamic quantities derived from an analysis of binding data, and by the unique spectral properties of the dye bound to the different substrates.

An example of photometric variability of a counterglow region in the antisolar direction is discussed. A speculative interpretation of its significance leads to the suggestion that the weakened radiance of the counterglow may in this case be due to a dust cloud of scattering material in the general region of the earth-moon system.