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Patterns and predictors of off-label prescription of psychiatric drugs

Vijay, Aishwarya; Becker, Jessica E; Ross, Joseph S
Off-label prescribing of psychiatric drugs is common, despite lacking strong scientific evidence of efficacy and potentially increasing risk for adverse events. The goal of this study was to characterize prevalence of off-label prescriptions of psychiatric drugs and examine patient and clinician predictors of off-label use. This manuscript presents a retrospective, cross-sectional study using data from the 2012 and 2013 National Ambulatory Medical Care Surveys (NAMCS). The study examined all adult outpatient visits to psychiatric practices for chronic care management with a single listed visit diagnosis in which at least one psychiatric drug was prescribed. The main outcome measure was off-label prescribing of at least one psychiatric drug, defined as prescription for a condition for which it has not been approved for use by the FDA. Among our sample representative of 1.85 billion outpatient visits, 18.5 million (1.3%) visits were to psychiatrists for chronic care management in which at least one psychiatric drug was prescribed. Overall, the rate of off-label use was 12.9% (95% CI: 12.2-15.7). The most common off-label uses were for manic-depressive psychosis treated with citalopram and primary insomnia treated with trazodone. Several patient and clinician characteristics were positively associated with off-label prescribing, including seeing a psychiatrist (OR: 1.06, 95% CI, 1.01-1.12; p = 0.03) instead of another type of clinician, the office visit taking place in the Western region of the country (OR: 1.09, 95% CI, 1.01-1.17; p = 0.02), and the patient having 3 or more chronic conditions (OR: 1.12, 95% CI, 1.02-1.14; p = 0.003). In contrast, having Medicare coverage (OR: 0.93, 95% CI, 0.84-0.97; p = 0.04) and receiving payment assistance from a medical charity (OR: 0.91, 95% CI, 0.88-0.96; p = 0.03) instead of private insurance were negatively associated with off-label prescribing. These results suggest that certain classes of psychiatric medications are being commonly prescribed to treat conditions for which they have not been determined by the FDA to be clinically efficacious and/or safe.
PMCID:6053129
PMID: 30024873
ISSN: 1932-6203
CID: 5297462

An open resource for transdiagnostic research in pediatric mental health and learning disorders

Alexander, Lindsay M; Escalera, Jasmine; Ai, Lei; Andreotti, Charissa; Febre, Karina; Mangone, Alexander; Vega-Potler, Natan; Langer, Nicolas; Alexander, Alexis; Kovacs, Meagan; Litke, Shannon; O'Hagan, Bridget; Andersen, Jennifer; Bronstein, Batya; Bui, Anastasia; Bushey, Marijayne; Butler, Henry; Castagna, Victoria; Camacho, Nicolas; Chan, Elisha; Citera, Danielle; Clucas, Jon; Cohen, Samantha; Dufek, Sarah; Eaves, Megan; Fradera, Brian; Gardner, Judith; Grant-Villegas, Natalie; Green, Gabriella; Gregory, Camille; Hart, Emily; Harris, Shana; Horton, Megan; Kahn, Danielle; Kabotyanski, Katherine; Karmel, Bernard; Kelly, Simon P; Kleinman, Kayla; Koo, Bonhwang; Kramer, Eliza; Lennon, Elizabeth; Lord, Catherine; Mantello, Ginny; Margolis, Amy; Merikangas, Kathleen R; Milham, Judith; Minniti, Giuseppe; Neuhaus, Rebecca; Levine, Alexandra; Osman, Yael; Parra, Lucas C; Pugh, Ken R; Racanello, Amy; Restrepo, Anita; Saltzman, Tian; Septimus, Batya; Tobe, Russell; Waltz, Rachel; Williams, Anna; Yeo, Anna; Castellanos, Francisco X; Klein, Arno; Paus, Tomas; Leventhal, Bennett L; Craddock, R Cameron; Koplewicz, Harold S; Milham, Michael P
Technological and methodological innovations are equipping researchers with unprecedented capabilities for detecting and characterizing pathologic processes in the developing human brain. As a result, ambitions to achieve clinically useful tools to assist in the diagnosis and management of mental health and learning disorders are gaining momentum. To this end, it is critical to accrue large-scale multimodal datasets that capture a broad range of commonly encountered clinical psychopathology. The Child Mind Institute has launched the Healthy Brain Network (HBN), an ongoing initiative focused on creating and sharing a biobank of data from 10,000 New York area participants (ages 5-21). The HBN Biobank houses data about psychiatric, behavioral, cognitive, and lifestyle phenotypes, as well as multimodal brain imaging (resting and naturalistic viewing fMRI, diffusion MRI, morphometric MRI), electroencephalography, eye-tracking, voice and video recordings, genetics and actigraphy. Here, we present the rationale, design and implementation of HBN protocols. We describe the first data release (n=664) and the potential of the biobank to advance related areas (e.g., biophysical modeling, voice analysis).
PMCID:5735921
PMID: 29257126
ISSN: 2052-4463
CID: 2892562

Effects of early trauma on psychosis development in clinical high-risk individuals and stability of trauma assessment across studies: a review

Redman, Samantha L; Corcoran, Cheryl M; Kimhy, David; Malaspina, Dolores
Early trauma (ET), though broadly and inconsistently defined, has been repeatedly linked to numerous psychological disturbances, including various developmental stages of psychotic disorders. The prodromal phase of psychosis highlights a unique and relevant population that provides insight into the critical periods of psychosis development. As such, a relatively recent research focus on individuals at clinical high risk (CHR) for psychosis reveals robust associations of early life trauma exposures with prodromal symptoms and function in these cohorts. While prevalence rates of ET in CHR cohorts remain consistently high, methodological measures of traumatic experiences vary across studies, presenting potential problems for reliability and validity of results. This review aims to 1) highlight the existing evidence identifying associations of ET, of multiple forms, with both symptom severity and transition rates to psychosis in CHR individuals, 2) present data on the variability among trauma assessments and its implications for conclusions about its relationship with clinical variables, 3) describe cognitive deficits common in CHR cohorts, including perceptual and neurocognitive impairments, and their neural correlates, that may modify the relationship of ET to symptoms, and 4) propose future directions for standardization of trauma assessment in CHR cohorts to better understand its clinical and cognitive correlates.
PMCID:5791764
PMID: 29400347
ISSN: 2573-7902
CID: 3060672

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial

Acri, Mary; Hamovitch, Emily; Mini, Maria; Garay, Elene; Connolly, Claire; McKay, Mary
BACKGROUND:Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. METHODS/DESIGN/METHODS:This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. DISCUSSION/CONCLUSIONS:The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.
PMCID:5716003
PMID: 29202867
ISSN: 1745-6215
CID: 3034862

Adolescent and caregiver perspectives on provider-patient interactions in Type 2 diabetes.

Amirniroumand, Roya; Valenzuela, Jessica M.; Smith, Laura B.; Nicholl, Meg C.; Dolan, Lawrence M.; Powers, Scott W.
This study aimed to describe the experience of adolescents with Type 2 diabetes and their caregivers during medical encounters, in an effort to improve clinical care and outcomes in this population. Twenty-eight families were recruited from a Midwestern diabetes clinic. Adolescents (13-18 years old) identified as Black (50%), Caucasian (43%), and Hispanic (7%), with variable levels of glycemic control (glycosylated hemoglobin A1c = 5.1-12.9%). Participants completed demographic and disease-related (adherence) questionnaires. Six adolescent and six caregiver focus groups were conducted and transcribed, coded, and systematically analyzed using principles of thematic analysis. Participants reported moderate to high rates of nonadherence. Qualitative themes indicated multiple factors influencing perceptions of the quality of provider-patient interactions. Participants' experiences of these interactions was affected by provider characteristics (e.g., gender, age), provider approach and communication style, systemic issues (e.g., long wait times), and caregivers assuming primary roles in medical encounters (e.g., more caregiver participation and caregiver disclosure of nonadherence). Focus group discussions provided rich information about the experiences of adolescents with Type 2 diabetes and implicate barriers in provider-patient interactions, including challenges in triadic interactions and communication around nonadherence, suggesting these areas should be considered in efforts to improve provider-patient interactions within this population.
SCOPUS:85037836711
ISSN: 2169-4826
CID: 5415572

Psychometric properties of the ces-d among black adolescents in public housing

Lu, Wenhua; Lindsey, Michael A.; Irsheid, Sireen; Nebbitt, Von Eugene
Objective: The Center for Epidemiologic Studies Depression Scale (CES-D) has not been fully validated as a depression screening scale among Black adolescents. This study examines the psychometric properties of the CES-D as applied to Black adolescents, seeking to understand the unique way in which Black adolescents express their depression symptoms. Method: We hypothesized that the expression and factor structure of depressive symptoms measured by CES-D would be different when applied to Black adolescents. Black adolescents (N = 782) ages 11"“21 were recruited from 9 urban public housing developments in 4 large U.S. cities. Confirmatory factor analysis and exploratory structural equation modeling (ESEM) were used to compare the fit of competing models. Convergent validity of the CES-D was examined via associations with gender, age, and suicidal ideation in the ESEM model. Results: Instead of the original 4-factor structure of the CES-D, a 2-factor ESEM model demonstrated satisfactory fit to our data (CFI = 0.95, TLI = 0.93, RMSEA = 0.04). Compared with females, Black males were less likely to endorse positive affect items of the CES-D (r = -0.13, p < 0.01). Conclusions: Conceptualizations of depression among Black adolescents may differ from any other populations previously studied. Clinicians should assess the unique expression of depression among Black youth when developing treatment plans.
SCOPUS:85044084478
ISSN: 2334-2315
CID: 3929112

THE MAKING OF SOCIAL EXPERIENCE FROM THE SOUNDS IN NAMES

Maglio, Sam J.; Feder, Michael A.
People use names to infer meaning about the objects to which those names refer. Objects whose names include vowels produced toward the front of the mouth (Siri), relative to those with vowels produced toward the back of the mouth (Google), are expected to have certain physical features (e.g., smallness, sharpness, and quickness). Do these expectations map onto social experience? The present investigation examines this question through the lens of social closeness. Participants simulating an interaction with another person whose name included a front (versus a back) vowel sound saw that person as more socially connected to themselves (Study 1), which could facilitate the interaction (better tips for servers, Study 2) or undermine it (exacerbate negative emotionality, Study 3). Theoretical and practical implications note how the sounds in names not only create expectations but also sow the seeds for self-fulfilling prophecies to be borne out in experience.
ISI:000419071900004
ISSN: 0278-016x
CID: 3259682

Parental Responses to Temper Outbursts in Children With ADHD: The Role of Psychological Factors

Godovich, Sheina A; Adelsberg, Samantha; Roy, Amy Krain
OBJECTIVE:Children with ADHD frequently exhibit temper outbursts (TO). One related factor may be parental responses, such as harsh discipline and accommodation. This study tests the hypotheses that these responses will be associated with greater TO, and parental characteristics of higher anger and lower sense of competence, in children with ADHD. METHOD/METHODS:Participants included 79 5- to 9-year-old children with ADHD (77.22% boys). Regressions were used to determine the association between parental psychological factors and responses to TO while covarying for TO frequency, severity, and duration. RESULTS:Parental anger and sense of competence were not significantly related to any discipline responses after covarying for TO characteristics, although sense of competence predicted spanking at trend-level significance. Both parental anger and sense of competence significantly predicted accommodation over and above TO characteristics. CONCLUSION/CONCLUSIONS:Results underscore the importance of parental anger and sense of competency in predicting parental behavior, specifically parental accommodation.
PMID: 29224417
ISSN: 1557-1246
CID: 2844692

Which Clinical and Patient Factors Influence the National Economic Burden of Hospital Readmissions After Total Joint Arthroplasty?

Kurtz, Steven M; Lau, Edmund C; Ong, Kevin L; Adler, Edward M; Kolisek, Frank R; Manley, Michael T
BACKGROUND:The Affordable Care Act of 2010 advanced the economic model of bundled payments for total joint arthroplasty (TJA), in which hospitals will be financially responsible for readmissions, typically at 90 days after surgery. However, little is known about the financial burden of readmissions and what patient, clinical, and hospital factors drive readmission costs. QUESTIONS/PURPOSES/OBJECTIVE:(1) What is the incidence, payer mix, and demographics of THA and TKA readmissions in the United States? (2) What patient, clinical, and hospital factors are associated with the cost of 30- and 90-day readmissions after primary THA and TKA? (3) Are there any differences in the economic burden of THA and TKA readmissions between payers? (4) What types of THA and TKA readmissions are most costly to the US hospital system? METHODS:The recently developed Nationwide Readmissions Database from the Healthcare Cost and Utilization Project (2006 hospitals from 21 states) was used to identify 719,394 primary TJAs and 62,493 90-day readmissions in the first 9 months of 2013 based on International Classification of Diseases, 9th Revision, Clinical Modification codes. We classified the reasons for readmissions as either procedure- or medical-related. Cost-to-charge ratios supplied with the Nationwide Readmissions Database were used to compute the individual per-patient cost of 90-day readmissions as a continuous variable in separate general linear models for THA and TKA. Payer, patient, clinical, and hospital factors were treated as covariates. We estimated the national burden of readmissions by payer and by the reason for readmission. RESULTS:The national rates of 30- and 90-day readmissions after THA were 4% (95% confidence interval [CI], 4.2%-4.5%) and 8% (95% CI, 7.5%-8.1%), respectively. The national rates of 30- and 90-day readmissions after primary TKA were 4% (95% CI, 3.8%-4.0%) and 7% (95% CI, 6.8%-7.2%), respectively. The five most important variables responsible for the cost of 90-day THA readmissions (in rank order, based on the Type III F-statistic, p < 0.001) were length of stay (LOS), all patient-refined diagnosis-related group (APR DRG) severity, type of readmission (that is, medical- versus procedure-related), hospital ownership, and age. Likewise, the five most important variables responsible for the cost of 90-day TKA readmissions were LOS, APR DRG severity, gender, hospital procedure volume, and hospital ownership. After adjusting for covariates, mean 90-day readmission costs reimbursed by private insurance were, on average, USD 1324 and USD 1372 greater than Medicare (p < 0.001) for THA and TKA, respectively. In the 90 days after TJA, two-thirds of the total annual readmission costs were covered by Medicare. In 90 days after THA, more readmissions were still associated with procedure-related complications, including infections, dislocations, and periprosthetic fractures, which in aggregate account for 59% (95% CI, 59.1%-59.6%) of the total readmission costs to the US healthcare system. For TKA, 49% of the total readmission cost (95% CI, 48.8%-49.6%) in 90 days for the United States was associated with procedure issues, most notably including infections. CONCLUSIONS:Hospital readmissions up to 90 days after TJA represent a massive economic burden on the US healthcare system. Approximately half of the total annual economic burden for readmissions in the United States is medical and unrelated to the joint replacement procedure and half is related to procedural complications. CLINICAL RELEVANCE/CONCLUSIONS:This national study underscores LOS during readmission as a primary cost driver, suggesting that hospitals and doctors further optimize, to the extent possible, the clinical pathways for the hospitalization of readmitted patients. Because patients readmitted as a result of infection, dislocation, and periprosthetic fractures are the most costly types of readmissions, efforts to reduce the LOS for these types of readmissions will have the greatest impact on their economic burden. Additional clinical research is needed to determine the extent to which, if any, the LOS during readmissions can be reduced without sacrificing quality or access of care.
PMID: 28108823
ISSN: 1528-1132
CID: 3732352

Persistent Post-9/11 Hearing Problems Among World Trade Center Health Registry Rescue and Recovery Workers, 2001 to 2007

Stein, Cheryl R; Lee, David J; Flamme, Gregory A; Cone, James E
OBJECTIVE:To examine the association between 9/11-related exposures and self-reported hearing problems among 16,579 rescue/recovery workers in the World Trade Center (WTC) Health Registry. METHODS:Using Registry Waves 1 (2003 to 2004) and 2 (2006 to 2007), we modeled the association between two metrics of 9/11-related exposures and hearing difficulties. RESULTS:The prevalence of incident, persistent hearing problems was 4.4%. In a fully adjusted model, workers with higher environmental hazards scores were twice as likely (interquartile range OR 2.1; 95% confidence interval [CI] 1.8, 2.5) to report hearing problems. Based on the same fully adjusted model, workers unable to hear in the dust cloud were 2.3 (95% CI 1.8, 3.0) times more likely to report hearing problems as compared with workers not in the dust cloud. CONCLUSIONS:We observed a consistent association between WTC-related exposures and self-reported hearing problems among rescue/recovery workers.
PMID: 28953072
ISSN: 1536-5948
CID: 3066772