Economic and Humanistic Burden Associated with Depression and Anxiety Among Adults with Non-Communicable Chronic Diseases (NCCDs) in the United States.

INTRODUCTION: Patients with both major depressive disorder (MDD) and generalized anxiety disorder (GAD) in addition to one or multiple comorbid non-communicable chronic diseases (NCCDs) face unique challenges. However, few studies have characterized how the burden of co-occurring MDD and GAD differs from that of only MDD or only GAD among patients with NCCDs. METHODS: In this study, we used Medical Expenditures Panel Survey data from 2010-2017 to understand how the economic and humanistic burden of co-occurring MDD and GAD differs from that of MDD or GAD alone among patients with NCCDs. We used generalized linear models to investigate this relationship and controlled for patient sociodemographics and clinical characteristics. RESULTS: Co-occurring MDD and GAD was associated with increases in mean annual per patient inpatient visits, office visits, emergency department visits, annual drug costs, and total medical costs. Among patients with 3+ NCCDs, MDD or GAD only was associated with lower odds ratios (ORs) of limitations in activities of daily living (ADLs; 0.532 and 0.508, respectively) and social (0.503, 0.526) and physical limitations (0.613, 0.613) compared to co-occurring MDD and GAD. Compared to patients with co-occurring MDD and GAD, having MDD only or GAD only was associated with significantly lower odds of cognitive limitations (0.659 and 0.461, respectively) in patients with 1-2 NCCDs and patients with 3+ NCCDs (0.511, 0.416). DISCUSSION: Comorbid MDD and GAD was associated with higher economic burden, lower quality of life, and greater limitations in daily living compared to MDD or GAD alone. Health-related economic and humanistic burden increased with number of NCCDs.

Economic and humanistic burden associated with noncommunicable diseases among adults with depression and anxiety in the United States.

Aims: This study estimated the economic and humanistic burden associated with chronic non-communicable diseases (NCCDs) among adults with comorbid major depressive and/or any anxiety disorders (MDD and/or AAD).Materials and methods: A retrospective analysis was conducted using the Medical Expenditure Panel Survey data (2010-2015). The analytic cohort included adults (≥18 years) with MDD only (C1), AAD only (C2), or both (C3). The presence of either of 6 NCCDs (cardiovascular diseases [CVD], pulmonary disorders [PD], pain, high cholesterol, diabetes, and obesity) were assessed. Study outcomes included healthcare costs, activity limitations, and quality of life. Multivariate regressions were conducted in each of the 3 cohorts to evaluate the association between the presence of NCCDs and outcomes.Results: The analytic sample included 9,160,465 patients: C1 (4,391,738), C2 (3,648,436), C3 (1,120,292). Pain (59%) was the most common condition, followed by CVD (55%), high cholesterol (50%), obesity (42%), PD (17%), and diabetes (14%). Mean annual healthcare costs were the greatest for C3 ($14,317), followed by C1 ($10,490) and C2 ($7,906). For C1, CVD was associated with the highest increment in annual costs ($3,966) followed by pain ($3,617). For C2, diabetes was associated with the highest incremental annual costs ($4,281) followed by PD ($2,997). For C3, cost trends were similar to those seen in C2. NCCDs resulted in a significant decrease in physical quality of life across all cohorts. Pain was associated with a significantly higher likelihood of self-reported physical, social, cognitive, and activity limitations compared to those without pain.Conclusions: 60% of patients with MDD and/or AAD had at least one additional NCCD, which significantly increased the economic and humanistic burden. These findings are important for payers and clinicians in making treatment decisions. These results underscore the need for development of multi-pronged interventions which aim to improve quality of life and reduce activity limitations among patients with mental health disorders and NCCDs.

Economic burden associated with inadequate antidepressant medication management among patients with depression and known cardiovascular diseases: insights from a United States-based retrospective claims database analysis.

Aims: The current study examined the association between insufficient major depressive disorder (MDD) care and healthcare resource use (HCRU) and costs among patients with prior myocardial infarction (MI) or stroke.Methods: This was a retrospective study conducted using the MarketScan Claims Database (2010-2015). The date of the first MI/stroke diagnosis was defined as the cardiovascular disease (CVD) index date and the first date of a subsequent MDD diagnosis was the index MDD date. Adequacy of MDD care was assessed during the 90 days following the index MDD date (profiling period) using 2 measures: dosage adequacy (average fluoxetine equivalent dose of ≥20 mg/day for nonelderly and ≥10 mg/day for elderly patients) and duration adequacy (measured as the proportion of days covered of 80% or higher for all MDD drugs). Study outcomes included all-cause and CVD-related HCRU and costs which were determined from the end of the profiling period until the end of study follow-up. Propensity-score adjusted generalized linear models (GLMs) were used to compare patients receiving adequate versus inadequate MDD care in terms of study outcomes.Results: Of 1,568 CVD patients who were treated for MDD, 937 (59.8%) were categorized as receiving inadequate MDD care. Results from the GLMs suggested that patients receiving inadequate MDD care had 14% more all-cause hospitalizations, 4% more all-cause outpatient visits, 17% more CVD-related outpatient visits, 13% more CVD-related emergency room (ER) visits, higher per patient per year CVD-related hospitalization costs ($21,485 vs. $17,756), higher all-cause outpatient costs ($2,820 vs. $2,055), and higher CVD-related outpatient costs ($520 vs. $434) compared to patients receiving adequate MDD care.Limitations: Clinical information such as depression severity and frailty, which are potential predictors of adverse CVD outcomes, could not be ascertained using administrative claims data.Conclusions: Among post-MI and post-stroke patients, inadequate MDD care was associated with a significantly higher economic burden.

Healthcare resource use and cost associated with timing of pharmacological treatment for major depressive disorder in the United States: a real-world study.

Background: Guidelines recommend selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitors (SNRI) as first-line treatments for major depressive disorder (MDD) and emphasize the importance of early pharmacological treatment as key factors to treatment success.Objectives: To compare the MDD-related healthcare resource utilization (HCRU) and cost among patients (1) with early vs late pharmacological treatment initiation and (2) achieving minimum therapeutic dose (MTD) early vs late.Methods: The MarketScan database (2010-2015) was used. Adults who were newly-treated with SSRI/SNRI within 12 months after the initial MDD diagnosis (index) were included. Patients who initiated SSRI/SNRI within 2 weeks of the index date were defined as early initiators; those who reached MTD within 4 weeks of index date were defined as early MTD achievers. MDD-related HCRU and costs per year after the index date were compared between early and late initiators and between early and late achievers using propensity score matching and generalized linear models.Results: Of the 55,539 patients, 60% were early initiators and 61% were early MTD achievers. The mean number of MDD-related outpatient visits per year were significantly higher for late initiator (6.7 vs 4.2, p < .001) and late MTD achievers (6.5 vs 4.5, p < .001) vs their early counterparts. Mean annual MDD-related outpatient, drug, and total cost were significantly higher for late initiators and MTD achievers vs the early groups.Conclusions: There is an opportunity to improve outcomes by treating MDD patients with SSRI/SNRI within 2 weeks and at or above the MTD within 4 weeks of diagnosis or less.

Changes in weight, plasma lipids, and glucose in adults treated with ziprasidone: a comprehensive analysis of pfizer-initiated clinical trials.

BACKGROUND: Elevated cardiometabolic morbidity and mortality in patients with schizophrenia and bipolar disorder have been attributed to multiple sources, including antipsychotic treatment, which may adversely affect cardiometabolic risk factors. We therefore present here a comprehensive set of analyses of changes in metabolic parameters from ziprasidone clinical trials. METHOD: The comprehensive set of analyses of metabolic changes conducted here was considered post hoc and exploratory. Changes in weight, fasting lipids, and fasting glucose from baseline to study end (last observation carried forward [LOCF]) for adult subjects in Pfizer-sponsored oral monotherapy randomized placebo-controlled ziprasidone clinical trials were analyzed by using an analysis of covariance model. In addition, available weight, fasting lipids, and fasting glucose data from all ziprasidone-treated subjects from all controlled and uncontrolled oral monotherapy studies of ziprasidone (102 studies; N = 12,599) conducted from 1992 to 2009 were analyzed similarly. RESULTS: In short-term randomized controlled trials (RCTs) (duration ≤ 12 weeks), least squares mean ± SD change from baseline to end of study (LOCF) in weight was 0.64 ± 0.12 kg in ziprasidone-treated subjects (n = 1,386) versus -0.02 ± 0.14 kg in placebo-treated subjects (n = 747) (P < .0001); in long-term RCTs (duration > 12 weeks), the corresponding values were -0.96 ± 0.68 kg for ziprasidone (n = 363) and -1.68 ± 0.80 kg for placebo (n = 142) (P = .24). Mean ± SD weight change in ziprasidone-treated subjects from all controlled and uncontrolled studies ranged from 0.2 ± 5.6 kg at 6 weeks (n = 3,156) to 1.7 ± 10.1 kg at 36 months (n = 178). There were no significant differences between the ziprasidone and placebo groups in fasting triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, or glucose in the controlled studies, and there were minimal changes in ziprasidone-treated subjects in all controlled and uncontrolled studies. CONCLUSIONS: This comprehensive analysis of data from the ziprasidone clinical trial database demonstrates limited evidence of any clinically significant adverse effects of ziprasidone on weight and consistent evidence of a neutral effect on fasting plasma lipids and glucose.

Treatment of maladaptive aggression in youth: CERT guidelines I. Engagement, assessment, and management.

OBJECTIVE: To develop guidelines for management and treatment of maladaptive aggression in the areas of family engagement, assessment and diagnosis, and initial management, appropriate for use by primary care clinicians and mental health providers. Maladaptive aggression in youth is increasingly treated with psychotropic medications, particularly second-generation antipsychotic agents. Multiple treatment modalities are available, but guidance for clinicians' assessment and treatment strategies has been inadequately developed. To address this need, the Center for Education and Research on Mental Health Therapeutics and the REACH Institute convened a steering group of national experts to develop evidence-based treatment recommendations for maladaptive aggression in youth. METHODS: Evidence was assembled and evaluated in a multistep process that included a systematic review of published literature; a survey of experts on recommended treatment practices; a consensus conference that brought together clinical experts along with researchers, policy makers, and family advocates; and subsequent review and discussion by the steering committee of successive drafts of the recommendations. The Center for Education and Research on Mental Health Therapeutics Treatment of Maladaptive Aggression in Youth (T-MAY) guidelines reflect a synthesis of the available evidence, based on this multistep process. RESULTS: The current article describes 9 recommendations for family engagement, assessment, and diagnosis as key prerequisites for treatment selection and initiation. CONCLUSIONS: Recognizing the family and social context in which aggressive symptoms arise, and understanding the underlying psychiatric conditions that may be associated with aggression, are essential to treatment planning.

Impact of geographical and cultural factors on clinical trials in acute mania: lessons from a ziprasidone and haloperidol placebo-controlled study.

Clinical trials today are conducted in multiple countries to enhance patient recruitment and improve efficiency of trials. However, the demographic and cultural diversity may contribute to variations in study outcomes. Here we conducted post-hoc analyses for a placebo-controlled study with ziprasidone and haloperidol for the treatment of acute mania to address the demographic, dosing, and outcome disparities in India, Russia and the USA. We compared the baseline characteristics, outcomes and discontinuations in patients and explored the relationship between the outcome measures across these countries. We found substantial differences in baseline characteristics of subjects, administered dosage and disease severity in India compared to the USA and Russia. Conversely, US subjects had a higher placebo response compared to subjects in Russia and India. These results are probably due to demographic differences in patient populations and psychiatric clinical practice across countries. While we offer initial ideas to address the disparities identified in this analysis, it is clear that further research to improve our understanding of geographical differences is essential to ensure globally applicable results for clinical trials in psychiatry.

Applying theory-driven approaches to understanding and modifying clinicians' behavior: what do we know?

OBJECTIVE: Despite major recent research advances, large gaps exist between accepted mental health knowledge and clinicians' real-world practices. Although hundreds of studies have successfully utilized basic behavioral science theories to understand, predict, and change patients' health behaviors, the extent to which these theories-most notably the theory of reasoned action (TRA) and its extension, the theory of planned behavior (TPB)-have been applied to understand and change clinician behavior is unclear. This article reviews the application of theory-driven approaches to understanding and changing clinician behaviors. METHODS: MEDLINE and PsycINFO databases were searched, along with bibliographies, textbooks on health behavior or public health, and references from experts, to find article titles that describe theory-driven approaches (TRA or TPB) to understanding and modifying health professionals' behavior. RESULTS: A total of 19 articles that detailed 20 studies described the use of TRA or TPB and clinicians' behavior. Eight articles describe the use of TRA or TPB with physicians, four relate to nurses, three relate to pharmacists, and two relate to health workers. Only two articles applied TRA or TPB to mental health clinicians. The body of work shows that different constructs of TRA or TPB predict intentions and behavior among different groups of clinicians and for different behaviors and guidelines. CONCLUSIONS: The number of studies on this topic is extremely limited, but they offer a rationale and a direction for future research as well as a theoretical basis for increasing the specificity and efficiency of clinician-targeted interventions.