Primary care in Northern Ontario for transgender people in the context of the COVID-19 pandemic: A qualitative secondary analysis.

PURPOSE: To examine changes to primary care practice for transgender clients resulting from government mandated public health measures in response to COVID-19 in Northern Ontario. DESIGN: Secondary analysis of qualitative data using interview transcripts from a dataset that included 15 interviews conducted between October 2020 and April 2021. METHODS: The dataset came from a convergent mixed method study exploring the delivery of primary care services to transgender individuals in Northern Ontario. Qualitative interviews with primary care practitioners including nurse practitioners, nurses, physicians, social workers, psychotherapists, and pharmacists providing care for transgender people in Northern Ontario were included in the secondary analysis. RESULTS: Fifteen primary care practitioner providing care to transgender individuals in Northern Ontario participated in the parent study. Practitioners described their understanding of the effect of the early stages of the COVID-19 pandemic changes on their practice and the care experience for their transgender patients. Two themes were identified and described by participants: (1) a change in the delivery of care; and (2) barriers and facilitators to care. CONCLUSIONS: Practitioners' primary care experiences in the early waves of COVID suggest the integral use of telehealth in Northern Ontario transgender care. Nurses working in advance practice and nurse practitioners are essential in providing continuity of care for their transgender clients. CLINICAL RELEVANCE/SIGNIFICANCE: Identification of initial practice changes for the primary care of trans people will illuminate avenues for further research. The urban, rural, and remote practice settings in Northern Ontario provide an opportunity for increasing access for gender diverse people in these areas and for developing increased understanding of uptake of telemedicine practice. Nurses are integral to primary care for transgender patients in Northern Ontario.

Hospital utilization rates following antipsychotic dose reduction in mood disorders: implications for treatment of tardive dyskinesia.

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 <  0.01). Similar results were observed following an ≥30% dose reduction. Dose reduction was not associated with decreased claims for tardive dyskinesia. 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.

Risk assessment and prediction of TD incidence in psychiatric patients taking concomitant antipsychotics: a retrospective data analysis.

BACKGROUND: Tardive dyskinesia (TD) is a serious, often irreversible movement disorder caused by prolonged exposure to antipsychotics; identifying patients at risk for TD is critical to preventing it. Predictive models for the occurrence of TD can improve patient monitoring and inform implementation of counteractive interventions. This study aims to identify risk factors associated with TD and to develop a model using a retrospective data analysis to predict the incidence of TD among patients taking antipsychotic medications. METHODS: Adult patients with schizophrenia, major depressive disorder, or bipolar disorder taking oral antipsychotics were identified in a Medicaid claims database (covering six US states from 1997 to 2016) and divided into cohorts based on whether they developed TD within 1 year after the first observed claim for antipsychotics. Patient characteristics between cohorts were compared, and univariate Cox analyses were used to identify potential TD risk factors. A cross-validated version of the least absolute shrinkage and selection operator regression method was used to develop a parsimonious multivariable Cox proportional hazards model to predict diagnosis of TD. RESULTS: A total of 189,415 eligible patients were identified. Potential TD risk factors were identified based on the cohort analysis within a sample of 151,280 patients with at least 1 year of continuous eligibility. The prediction model had a clinically meaningful concordance of 70% and was well calibrated (P = 0.32 for Hosmer-Lemeshow goodness-of-fit test). Age (hazard ratio [HR] = 1.04, P < 0.001), diagnosis of schizophrenia (HR = 1.99, P < 0.001), antipsychotic dosage (up to 100 mg/day chlorpromazine equivalent; HR = 1.65, P < 0.01), and comorbid bipolar and related disorders (HR = 1.39, P < 0.01) were significantly associated with an increased risk of TD. Other potential risk factors included history of extrapyramidal symptoms (HR = 1.35), other movement disorders (parkinsonism, HR = 1.43; bradykinesia, HR = 1.44; tremors, HR = 2.12, and myoclonus, HR = 2.33), and diabetes (HR = 1.13). A modest reduction in the risk of TD was associated with the use of second-generation antipsychotics (HR = 0.85) versus first-generation drugs. CONCLUSIONS: This study identified factors associated with development of TD among patients taking antipsychotics. The prediction model described herein can enable physicians to better monitor patients at high risk for TD and recommend appropriate treatment plans to help maintain quality of life.

Effect of tardive dyskinesia on quality of life in patients with bipolar disorder, major depressive disorder, and schizophrenia.

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.

Hospital utilization rates following antipsychotic dose reductions: implications for tardive dyskinesia.

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 < 0.001), and the risk of an all-cause ER visit increased (HR 1.09; 95% CI 1.05, 1.14; P < 0.001) compared with controls. Patients with a ≥ 10% dose reduction had an increased risk of admission or ER visit for schizophrenia (HR 1.27; 95% CI 1.19, 1.36; P < 0.001) and for all psychiatric disorders (HR 1.16; 95% CI 1.10, 1.23; P < 0.001) compared with controls. A dose reduction of ≥30% also led to an increased risk of admission for all causes (HR 1.23; 95% CI 1.17, 1.31; P < 0.001), and for admission or ER visit for schizophrenia (HR 1.31; 95% CI 1.21, 1.41; P < 0.001) or for all psychiatric disorders (HR 1.21; 95% CI 1.14, 1.29; P < 0.001) compared with controls. Dose reductions had no significant effect on claims for TD. CONCLUSION: Patients with antipsychotic dose reductions showed significant increases in both all-cause and mental health-related hospitalizations, suggesting that antipsychotic dose reductions may lead to increased overall healthcare burden in some schizophrenia patients. This highlights the need for alternative strategies for the management of side effects, including TD, in schizophrenia patients that allow for maintaining effective antipsychotic treatment.

Pharmaceutical portfolio management: global disease burden and corporate performance metrics.

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.

Barriers and facilitators for accessing and prescribing hormone therapy in primary care for transgender adults: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to understand the extent and type of evidence in relation to barriers and facilitators experienced by transgender adults in accessing hormone therapy. It will also explore the experiences of primary care practitioners in prescribing hormone therapy in primary care. INTRODUCTION: 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 offering this care. This review will seek to advance research on this topic by examining the barriers and facilitators of hormone prescription for transgender adults in primary care. INCLUSION CRITERIA: This review will consider 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. The review will include qualitative, quantitative, and mixed methods studies, in addition to systematic reviews and meta-analyses. METHODS: The search will include MEDLINE, CINAHL, EmCare, and Nursing and Allied Health Premium. No date limits will be applied to the search. Only articles written in English will be eligible for inclusion. 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.

A Critical Review of Clinical Practice Guidelines for Care of Transgender and Gender Diverse Children and Youth for Use by Primary Care Practitioners.

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 ethical and affirming primary care practice. Methods: A review was conducted to obtain English language clinical guidelines. Guidelines were obtained from electronic databases, medical associations, government agencies, and community organizations. Guidelines were critiqued by all authors using the AGREE II instrument. Results: Nine documents were reviewed. Overall, there was agreement among reviewers that the scope, purpose, and clarity of presentation of the guidelines was carried out well. Areas identified for improvement in all guidelines included clarity/rigor of methodologic development, inclusion of community stakeholders, and transparency of editorial independence. The Endocrine Society Clinical Practice Guideline scored highest overall. Despite lower overall scores, other guidelines were identified as having strengths of practical utility within primary care and/or in the discussion of specific social, ethical, and cultural considerations of transgender care in differing contexts worldwide. Conclusion: The use of specific, high-quality CPGs can support primary care practitioners to provide gender-affirming care to children and youth. Methodologic improvement in the development of these CPGs is needed to ensure the best possible quality of care is being outlined.

An Experimental Study to Assess the Professional and Social Consequences of Tardive Dyskinesia.

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

Review and Analysis of International Transgender Adult Primary Care Guidelines.

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.

Development of an online educational toolkit for sexual orientation and gender identity minority nursing care.

OBJECTIVE: to develop and implement an online education resources to address a gap in nursing education regarding the concept of cultural humility and its application to healthcare encounters with persons who identify as lesbian, gay, bisexual, transgender, queer, intersex (LGBTQI) or Two-Spirit. Improved understanding of LGBTQI and Two-Spirit community health issues is essential to reducing the healthcare access barriers they currently face. METHOD: an online educational toolkit was developed that included virtual simulation games and curated resources. The development process included community involvement, a team-building meeting, development of learning outcomes, decision-point maps and scriptwriting for filming. A website and learning management system was designed to present learning objectives, curated resources, and the virtual games. RESULTS: the Sexual Orientation and Gender Identity Nursing Toolkit was created to advance cultural humility in nursing practice. The learning toolkit focuses on encounters using cultural humility to meet the unique needs of LGBTQI and Two-Spirit communities. CONCLUSION: our innovative online educational toolkit can be used to provide professional development of nurses and other healthcare practitioners to care for LGBTQI and Two-Spirit individuals.

Coronavirus Disease 2019 and Pituitary Apoplexy: A Single-Center Case Series and Review of the Literature.

BACKGROUND: Pituitary apoplexy (PA) is a rare, but life-threatening, condition characterized by pituitary infarction and hemorrhage, most often in the setting of a preexisting adenoma. The risk factors and mechanisms associated with PA are poorly understood. Although neurovascular manifestations of coronavirus disease 2019 (COVID-19) infection have been documented, its association with PA has not yet been determined. METHODS: From a prospectively collected database of patients treated at a tertiary care center for pituitary adenoma, we conducted a retrospective medical record review of PA cases during the COVID-19 pandemic from March 2020 to December 2020. We also conducted a literature review to identify other reported cases. RESULTS: We identified 3 consecutive cases of PA and concomitant COVID-19 infection. The most common symptoms at presentation were headache and vision changes. The included patients were successfully treated with surgical decompression and medical management of the associated endocrinopathy, ultimately experiencing improvement in their visual symptoms at the latest follow-up examination. COVID-19 infection in the perioperative period was corroborated by polymerase chain reaction test results in all the patients. CONCLUSIONS: With the addition of our series to the literature, 10 cases of PA in the setting of COVID-19 infection have been confirmed. The present series was limited in its ability to draw conclusions about the relationship between these 2 entities. However, COVID-19 infection might represent a risk factor for the development of PA. Further studies are required.

Design Thinking in Nursing Education to Improve Care for Lesbian, Gay, Bisexual, Transgender, Queer, Intersex and Two-Spirit People.

Design thinking methodology is a collaborative strategy with the potential to create innovations. Design thinking is being used increasingly in health care. Design jams are interdisciplinary events that bring together experts and community members to collaborate on creative solutions to health-care problems. This article describes the design thinking process and includes reflection on the authors' participation in a design jam event aimed to address the knowledge-to-action gap that exists in health care for (LGBTQI2S) people.

Association of antipsychotic treatment switching in patients with schizophrenia, bipolar, and major depressive disorders.

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 antipsychotic medication versus those who did not.Materials and methods: Medicaid claims from six US states spanning six 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 extrapyramidal symptoms (EPS) diagnosis at baseline, times to the following outcomes were analyzed: underlying disease relapse, other 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 p < .001) than non-switchers (N = 31,644). Switchers reached the median for IP admission (21.50 months) vs non-switchers (not reached) and for ER visits (switchers, 9.07 months; non-switchers, 13.35 months). For disease relapse, other psychiatric relapse, and EPS diagnosis, <50% of patients had an event during the two-year study period. Subgroup analysis of those with ≥1 EPS diagnosis revealed similar associations.Limitations: Only association, not causation, may be inferred, and there may be differences between the patient groups in parameters not evaluated.Conclusions: These results show that disease and other psychiatric relapse, all-cause ER visits, IP admissions, and EPS diagnosis occurred earlier for patients who switched antipsychotics than for those who did not, suggesting that switching is associated with an increased risk of relapse in patients with SZ, BD, and MDD. This may be attributed to more-severely ill patients being less responsive than those with less-severe illness, which, in turn, may require more episodes of switching.

Developing a Sexual Orientation and Gender Identity Nursing Education Toolkit.

BACKGROUND: Current education lacks lesbian, gay, bisexual, transgender, questioning, intersex, and two-spirit (LGBTQI2S) content for health care providers (HCPs). Providing HCPs with understanding of LGBTQI2S health issues would reduce barriers. The Innovative Thinking to Support LGBTQI2S Health and Wellness trainee award supported the development of a website with virtual simulation games (VSGs) about providing culturally humble care to LGBTQI2S individuals to address this need. METHOD: An online educational toolbox was developed that included VSGs and resources. Development processes included a visioning meeting, development of learning objectives, and using a decision-point map for script writing. Bilingual VSGs were filmed, and the website was developed. RESULTS: The Sexual Orientation and Gender Identity Nursing Toolkit was created to advance cultural humility in practice. Learning modules focus on encounters using cultural humility to meet the unique needs of the LGBTQI2S community. CONCLUSION: Our innovative educational toolkit can be used to provide professional development of nurses and other HCPs to care for LGBTQI2S individuals. [J Contin Educ Nurs. 2020;51(9):412-419.].

Health Care Resource Utilization and Costs for Patients with Tardive Dyskinesia.

BACKGROUND: 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 from < 1% to 42%, depending on the antipsychotics studied. However, there are few real-world studies examining health care utilization and the economic burden of TD. OBJECTIVE: To assess health care utilization and costs in a sample of patients with TD from the commercially insured and Medicare supplemental U.S. METHODS: 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. RESULTS: 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%; P < 0.001) and emergency room visits (61.5% vs. 50.6%; P < 0.001) occurred more for patients with TD than for patients without TD. Total health care costs were significantly greater for patients with TD than for those without TD ($54,656 vs. $28,777; P < 0.001). CONCLUSIONS: Patients diagnosed with TD demonstrate significantly higher health care utilization and costs compared with non-TD patients. DISCLOSURES: 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.

Deutetrabenazine for tardive dyskinesia and chorea associated with Huntington's disease: a review of clinical trial data.

Introduction: Huntington's disease (HD)-associated chorea and tardive dyskinesia (TD) are hyperkinetic movement disorders that can have deleterious effects on patients' quality of life (QoL). Deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, was approved by the US Food and Drug Administration (FDA) for the treatment of HD-associated chorea and TD. It is structurally similar to tetrabenazine, an FDA-approved compound for treatment of chorea that is widely used off-label for treatment of TD, but has deuterium modifications that improve its pharmacokinetic profile.Areas covered: Herein, the authors cover the key clinical trials with deutetrabenazine in patients with HD-associated chorea (First-HD and ARC-HD) and in patients with TD (ARM-TD, AIM-TD, and RIM-TD).Expert opinion: Deutetrabenazine demonstrates consistent efficacy across patient types regardless of underlying psychiatric illness, or through use of dopamine-receptor antagonists (DRAs), which are the primary cause of TD. The safety profile of deutetrabenazine in clinical trials is similar to that of placebo. Long-term extension studies in both HD-associated chorea and TD show consistent efficacy and safety. Deutetrabenazine will likely be an integral part of the treatment strategy for HD-associated chorea and TD. Meanwhile, its potential to treat other hyperkinetic movement disorders is still under investigation.

Tardive dyskinesia among patients using antipsychotic medications in customary clinical care in the United States.

BACKGROUND: Tardive dyskinesia (TD) is a movement disorder resulting from treatment with typical and atypical antipsychotics. An estimated 16-50% of patients treated with antipsychotics have TD, but this number may be underestimated. The objectives of this study were to build an algorithm for use in electronic health records (EHRs) for the detection and characterization of TD patients, and to estimate the prevalence of TD in a population of patients exposed to antipsychotic medications. METHODS: This retrospective observational study included patients identified in the Optum EHR Database who received a new or refill prescription for an antipsychotic medication between January 2011 and December 2015 (follow-up through June 2016). TD mentions were identified in the natural language-processed clinical notes, and an algorithm was built to classify the likelihood that the mention represented documentation of a TD diagnosis as probable, possible, unlikely, or negative. The final TD population comprised a subgroup identified using this algorithm, with ≥1 probable TD mention (highly likely TD). RESULTS: 164,417 patients were identified for the antipsychotic population, with1,314 comprising the final TD population. Conservatively, the estimated average annual prevalence of TD in patients receiving antipsychotics was 0.8% of the antipsychotic user population. The average annual prevalence may be as high as 1.9% per antipsychotic user per year, allowing for a more-inclusive algorithm using both probable and possible TD. Most TD patients were prescribed atypical antipsychotics (1049/1314, 79.8%). Schizophrenia (601/1314, 45.7%), and paranoid and schizophrenia-like disorders (277/1314, 21.1%) were more prevalent in the TD population compared with the entire antipsychotic drug cohort (13,308/164,417; 8.1% and 19,359/164,417; 11.8%, respectively). CONCLUSIONS: Despite a lower TD prevalence than previously estimated and the predominant use of atypical antipsychotics, identified TD patients appear to have a substantial comorbidity burden that requires special treatment and management consideration.

The burden of tardive dyskinesia secondary to antipsychotic medication use among patients with mental disorders.

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 patients with mental disorders receiving antipsychotic medications. Methods: Data on patients receiving antipsychotics who had schizophrenia, major depressive disorder or bipolar disorder were extracted from a Medicaid claims database. Separate cohorts of TD patients with and without other EPS ("TD + EPS" and "TD non-EPS") were constructed and matched to patients in a non-TD/EPS control cohort at a ∼1:5 ratio. HRU outcomes were assessed using descriptive statistics and difference-in-differences techniques over baseline and follow-up periods defined as the 6 months before and after TD development, respectively. Results: The TD + 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; by contrast, slight decreases (∼3%) in these outcomes were observed in the matched controls. Difference-in-differences analyses demonstrated that development of TD was associated with a statistically significant increase of ∼15-19% in the percentage of patients with all-cause and mental-disorder-related inpatient admissions/visits. 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. Conclusions: This study demonstrates a significant economic burden associated with developing TD, as captured by increased HRU including inpatient admissions and ER visits.

Pharmacological treatment of tardive dyskinesia: recent developments.

INTRODUCTION: 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 B6, or certain unregulated herbal medicines; although significance of these improvements is unclear and require further investigation in randomized controlled trials. By contrast, recent evidence from Phase III trials of novel vesicular monoamine transporter-2 inhibitors demonstrates they could have a significant effect on TD symptom severity and suggests these agents may have the potential to transform treatment of TD in coming years.