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Background Knowledge of real‐world antihypertensive use is limited to prevalent hypertension, limiting our understanding of how treatment evolves and its contribution to persistently poor blood pressure control. We sought to characterize antihypertensive initiation among new users. Methods and Results Using Medicaid and Medicare data from the OneFlorida+ Clinical Research Consortium, we identified new users of ≥1 first‐line antihypertensives (angiotensin‐converting enzyme inhibitor, calcium channel blocker, angiotensin receptor blocker, thiazide diuretic, or β‐blocker) between 2013 and 2021 among adults with diagnosed hypertension, and no antihypertensive fill during the prior 12 months. We evaluated initial antihypertensive regimens by class and drug overall and across study years and examined variation in antihypertensive initiation across demographics (sex, race, and ethnicity) and comorbidity (chronic kidney disease, diabetes, and atherosclerotic cardiovascular disease). We identified 143 054 patients initiating 188 995 antihypertensives (75% monotherapy; 25% combination therapy), with mean age 59 years and 57% of whom were women. The most commonly initiated antihypertensive class overall was angiotensin‐converting enzyme inhibitors (39%) followed by β‐blockers (31%), calcium channel blockers (24%), thiazides (19%), and angiotensin receptor blockers (11%). With the exception of β‐blockers, a single drug accounted for ≥75% of use of each class. β‐blocker use decreased (35%–26%), and calcium channel blocker use increased (24%–28%) over the study period, while initiation of most other classes remained relatively stable. We also observed significant differences in antihypertensive selection across demographic and comorbidity strata. Conclusions These findings indicate that substantial variation exists in initial antihypertensive prescribing, and there remain significant gaps between current guideline recommendations and real‐world implementation in early hypertension care.

STUDY OBJECTIVE To assess the association between tenofovir diphosphate (TFV-DP) in dried blood spots (DBS), a measure of cumulative tenofovir-based antiretroviral (ART) adherence, with medication regimen complexity in persons with human immunodeficiency virus (PWH). DESIGN Prospective clinical cohort (up to three visits over 48 weeks). SETTING Academic-based HIV clinic. PATIENTS PWH receiving tenofovir disoproxil fumarate (TDF)-based ART. MEASUREMENTS DBS for TFV-DP were collected at every study visit. Baseline patient-level medication regimen complexity index (pMRCI) scores were calculated and categorized into three sub-scores (disease-specific [ART], non-ART, and over-the-counter [OTC]). The pMRCI scores were evaluated to assess the association with TFV-DP in DBS

As the nation seeks to recruit and retain physician-scientists, gaps remain in understanding and addressing mitigatable challenges to the success of faculty from underrepresented minority (URM) backgrounds. The Doris Duke Charitable Foundation Fund to Retain Clinical Scientists program, implemented in 2015 at 10 academic medical centers in the United States, seeks to retain physician-scientists at risk of leaving science because of periods of extraordinary family caregiving needs, hardships that URM faculty-especially those who identify as female-are more likely to experience. At the annual Fund to Retain Clinical Scientists program directors conference in 2018, program directors-21% of whom identify as URM individuals and 13% as male-addressed issues that affect URM physician-scientists in particular. Key issues that threaten the retention of URM physician-scientists were identified through focused literature reviews; institutional environmental scans; and structured small- and large-group discussions with program directors, staff, and participants. These issues include bias and discrimination, personal wealth differential, the minority tax (i.e., service burdens placed on URM faculty who represent URM perspectives on committees and at conferences), lack of mentorship training, intersectionality and isolation, concerns about confirming stereotypes, and institutional-level factors. The authors present recommendations for how to create an environment in which URM physician-scientists can expect equitable opportunities to thrive, as institutions demonstrate proactive allyship and remove structural barriers to success. Recommendations include providing universal training to reduce interpersonal bias and discrimination, addressing the consequences of the personal wealth gap through financial counseling and benefits, measuring the service faculty members provide to the institution as advocates for URM faculty issues and compensating them appropriately, supporting URM faculty who wish to engage in national leadership programs, and sustaining institutional policies that address structural and interpersonal barriers to inclusive excellence.

Background: Research is needed to improve understanding of work-life integration issues in academic medicine and to guide the implementation of the Doris Duke Charitable Foundation's Fund to Retain Clinical Scientists (FRCS), a national initiative offering financial support to physician-scientists facing caregiving challenges. Materials and Methods: In 2018, as part of a prospective program evaluation, the authors conducted a qualitative study to examine FRCS program participants' initial impressions, solicit descriptions of their career and caregiving experiences, and inquire how such factors might influence their professional advancement. The authors invited all 33 awardees who had been granted FRCS funding in the first year of the program to participate in the study, of whom 28 agreed to complete an interview. Analysts evaluated de-identified transcripts and explicated the data using a thematic analysis approach. Results: While participants described aspects of a culture that harbor stigma against caregivers and impede satisfactory work-life integration, they also perceived an optimistic cultural shift taking place as a result of programs like the FRCS. Their comments indicated that the FRCS has the potential to influence culture if institutional leadership simultaneously fosters a community that validates individuals both as caregivers and as scientists. Conclusions: Insights garnered from this qualitative study suggest that there is a pressing need for institutional leaders to implement programs that can foster awareness and normalization of caregiving challenges. In addition to providing funding and other tangible resources, interventions should strive to reinforce a broader culture that affirms the presence of work-life integration challenges and openly embraces solutions.

The Colorado Mentoring Training program (CO-Mentor) was developed at the University of Colorado Anschutz Medical Campus in 2010, supported by the Colorado Clinical and Translational Sciences Institute. CO-Mentor represents a different paradigm in mentorship training by focusing equally on the development of mentees, who are valued as essential to institutional capacity for effective mentorship. The training model is unique among Clinical and Translational Science Award sites in that it engages mentors and mentees in an established relationship. Dyads participate in 4 day-long sessions I scheduled throughout the academic year. Each session features workshops that combine didactic and experiential components. The latter provide structured opportunities to develop mentorship-related skills, including self-knowledge and goal setting, communication skills (including negotiation), “managing up,” and the purposeful development of a mentorship support network. Mentors and mentees in 3 recent cohorts reported significant growth in confidence with respect to all mentorship-related skills assessed using a pre–post evaluation survey (P = .001). Mentors reported the most growth in relation to networking to engage social and professional support to realize goals as well as sharing insights regarding paths to success. Mentees reported the most growth with respect to connecting with potential/future mentors, knowing characteristics to look for in current/future mentors, and managing the work environment (e.g., prioritizing work most fruitful to advancing research/career objectives). CO-Mentor represents a novel approach to enhancing mentorship capacity by investing equally in the development of salient skills among mentees and mentors and in the mentorship relationship as an essential resource for professional development, persistence, and scholarly achievement.

Background: Insufficient support for balancing career and family responsibilities hinders retention of physician-scientists. Programs to improve retention of this important group of faculty are crucial. Understanding the experiences of program implementers is key to refining and improving program offerings. Methods: We conducted an interpretive, descriptive, and qualitative study as part of an ongoing evaluation of the Doris Duke Charitable Foundation's Fund to Retain Clinical Scientists (FRCS) awards. We conducted telephone interviews with 12 program directors representing all 10 US medical schools who received the Doris Duke funding in 2016. Results: Of the 12 participants, 10 were women (83.3%). Participating program directors perceived the FRCS award as capable of producing paradigmatic changes regarding how responsibilities at home and work in academic medicine are viewed and integrated by early-career faculty members. The main qualitative themes that captured directors' experiences implementing the program were as follows: (1) championing a new paradigm of support, (2) lessons learned while implementing the new paradigm, (3) results of the new paradigm, and (4) sustaining the paradigm. Conclusions: These findings may help to inform development of similar programs to retain and support the career progress of physician-scientists with extraprofessional caregiving responsibilities. The interviews illuminate ways in which the Doris Duke FRCS award has driven institutional culture change by normalizing discussion and prompted reassessment of extraprofessional challenges and how best to aid early-career faculty members in overcoming these challenges.

Background: This study was a national scan of education resources on integrating sex and gender considerations into research. The purpose was to assess capacity for educating researchers and to identify gaps, with implications for implementation of guidelines or mandates to consider sex and gender differences in research. Information sources were U.S. training programs in women's health and sex/gender difference research, Building Interdisciplinary Research Careers in Women's Health (BIRCWH), and published peer-reviewed biomedical literature. Materials and Methods: This descriptive study used multiple methods: a national survey and a comprehensive literature review. BIRCWH leaders responded to a survey regarding education on sex/gender difference research for BIRCWH scholars (response rate 100%, 20 of 20). A comprehensive literature review was conducted for 1993-2018. Results: Nearly half (45%) of BIRCWH institutions offered education on integrating sex or gender differences in clinical translational research; of those, roughly half (54%) offered in-person training and one-third (31%) offered content within existing for-credit courses. Respondents preferred online training (84%) to in-person offerings or reference materials (47% and 42% respectively). Published indexed literature on sex or gender differences has quadrupled since 1993, although growth in these publications remained flat in the most recent six years. Conclusions: Published resources to educate researchers on integrating sex and gender differences into medical research have increased, and BIRCWH programs connect scholars to national resources. Educational gaps remain due to limited access to curricula on applied research approaches, design, and methods for sex/gender difference research. BIRCWH programs desire curricula that are easily accessible online and asynchronously; sanctioned and supported by national thought leaders; linked to required training such as rigor and reproducibility; foster collaboration; and offer practical applications. Evidence-based, high-quality educational curricula and a dissemination plan are needed to enhance the adoption and integration of sex and gender into scientific endeavors.

The fifth in a 5-part series on the clinical and translational sciences educational pipeline, this paper focuses on strategies for developing leadership capacity among senior faculty and administrators responsible for clinical and translational science (CTS) research. Although progression in academic rank recognizes scientific excellence in research or scholarship, neither disciplinary training nor experience alone prepare senior faculty for the leadership challenges they inevitably face. Yet these faculty are increasingly responsible for multidisciplinary teams working within complex organizations with unclear or conflicting incentives that demand innovation. In academic health centers with Clinical and Translational Science Awards (CTSAs), investing in leadership often includes career development support in the CTSA education and training pillar programs. Only a few CTSAs have taken an intentional approach to developing senior leadership capacity, however, and still fewer have focused specifically on building such capacity for current CTS leaders within the context of a growing emphasis on team science. This manuscript explains the need for senior leadership training and describes an established example of such a program, the year-long Leadership for Innovative Team Science program for senior CTS researchers at the University of Colorado. The development of the program over time, topical elements, and participant perspectives are provided.

PurposeTo enhance understanding of challenges related to work-life integration in academic medicine and to inform the ongoing implementation of an existing program and the development of other interventions to promote success of physician-scientists.MethodThis study is part of a prospective analysis of the effects of the Fund to Retain Clinical Scientists (FRCS), a national program launched by the Doris Duke Charitable Foundation at 10 U.S. institutions, which provides financial support to physician-scientists facing caregiving challenges. In early 2018, 28 of 33 program awardees participated in semistructured interviews. Questions were about challenges faced by physician-scientists as caregivers and their early perceptions of the FRCS. Multiple analysts reviewed deidentified transcripts, iteratively revised the coding scheme, and interpreted the data using qualitative thematic analysis.ResultsParticipants' rich descriptions illuminated 5 interconnected themes: (1) Time is a critical and limited resource, (2) timing is key, (3) limited time resources and timing conflicts may have a particularly adverse effect on women's careers, (4) flexible funds enable reclamation and repurposing of time resources, and (5) FRCS leaders should be cognizant of time and timing conflicts when developing program-related offerings.ConclusionsPrograms such as the FRCS are instrumental in supporting individuals to delegate time-consuming tasks and to control how they spend their valuable time. Qualitative analysis suggests that access to and command of valuable time resources are crucial to career advancement, research productivity, and work-life flexibility, especially during critical time points along the physician-scientist trajectory.

Background: Medication regimen complexity describes multiple characteristics of a patient’s prescribed drug regimen. Heart transplant recipients must comply with a lifelong regimen that consists of numerous medications. However, a systematic assessment of medication regimen complexity over time has not been conducted in this, or any other, transplant population. Objective: The objective of this study was to quantify patient-level medication regimen complexity over time following primary heart transplantation and heart retransplantation, using the validated patient-level Medication Regimen Complexity Index (pMRCI) tool. Methods: Medication lists were reviewed at transplant discharge and years 1, 3, and 5 post–primary heart transplant, and at transplant discharge and years 1 and 3 post–heart retransplantation. Medications were categorized as transplant-specific, other prescription, and over-the-counter (OTC). Results: In primary heart transplant recipients (n = 60), mean total medication count was 14.3 ± 3.4 at transplant discharge and did not change significantly over time ( P = 0.64). Transplant-specific medication count decreased significantly from discharge (2.9 ± 0.4) to year 5 (2.3 ± 0.6); P = 0.02. However, 32% of patients were taking 16 or more total medications at year 5 posttransplant. More than 70% of the pMRCI score was attributed to other prescription and OTC medications, which was largely driven by dosing frequency in this cohort. Medication complexity did not differ significantly between heart retransplant recipients (n = 11) and matched primary heart transplant controls (n = 22). Conclusion: Together, these data highlight the substantial medication burden after heart transplantation and reveal opportunities to address medication regimen complexity in this, and other, transplant populations.

BackgroundPlacebo-controlled clinical trials have led to concern over possible increased risk of suicide-related events in some populations exposed to antidepressants.AimsTo evaluate the risk of suicide attempts by antidepressant drug class and the presence or absence of depression.MethodA retrospective propensity-matched new-user cohort study was used to compare participants with incident depression classified by antidepressant treatment with each other and with the general population.ResultsAmong the treated group, the suicide attempt rate peaked in the month prior to diagnosis then decreased steadily over the next 6 months. Among the pharmacologically untreated group, the highest rate was seen in the second month after diagnosis. Cohorts with depression had significantly higher suicide attempt risk than the general population, but the treated group did not differ significantly from the untreated group.ConclusionsPatients on antidepressants did not have significantly higher risk compared with untreated patients. No significant differences were observed for patients treated with individual serotonin–noradrenaline reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) or by class (SSRI v. SNRI cohorts).

Author(s): Jagsi, Reshma; Jones, Rochelle D; Griffith, Kent A; Brady, Kathleen T; Brown, Ann J; Davis, Randal D; Drake, Amelia F; Ford, Daniel; Fraser, Victoria J; Hartmann, Katherine E; Hochman, Judith S; Girdler, Susan; Libby, Anne M; Mangurian, Christina; Regensteiner, Judith G; Yonkers, Kimberly; Escobar-Alvarez, Sindy; Myers, Elizabeth R

Grant writing starts with crafting an effective Specific Aims page. This page should be a succinct combination of sales pitch and science. The Specific Aims page demonstrates a problem, a gap in current knowledge, and suggests a solution. It proposes aims that work toward a defended solution and reveal the impact of the proposal on the problem, the field, and future research. The language must be efficient and persuasive; the presentation must drive a reviewer to support the proposal. Here we present a refined recipe for an effective Specific Aims page.

Introduction: Patients at risk for suicide often come into contact with primary care providers, many of whom use electronic health records (EHRs) for charting. It is not known, however, how often suicide ideation or attempts are documented in EHRs. Methods: We used retrospective analyses of de-identified EHR data from a distributed health network of primary care organizations to estimate the frequency of using diagnostic codes to record suicidal ideation and attempts. Data came from 3 sources: a clinician notes field processed using natural language processing; a suicidal ideation item on a patient-reported depression severity instrument (9-item Patient Health Questionnaire [PHQ-9]); and diagnostic codes from the EHR. Results: Only 3% of patients with an indication of suicidal ideation in the notes field had a corresponding International Classification of Diseases, 9th Revision (ICD-9), code (κ = 0.036). Agreement between an indication of suicidal ideation from item 9 of the PHQ-9 and an ICD-9 code was slightly higher (κ = 0.068). Suicide attempt indicated in the notes field was more likely to be recorded using an ICD-9 code (19%; κ = 0.18). Conclusions: Few cases of suicidal ideation and attempt were documented in patients9 EHRs using diagnostic codes. Increased documentation of suicidal ideation and behaviors in patients9 EHRs may improve their monitoring in the health care system.

This study evaluated a videoconference-based psychiatric emergency consultation program (telepsychiatry) at geographically dispersed emergency department (ED) sites that are part of the network of care of an academic children's hospital system. The study compared program outcomes with those of usual care involving ambulance transport to the hospital for in-person psychiatric emergency consultation prior to disposition to inpatient care or discharge home.This study compared process outcomes in a cross-sectional, pre-post design at five network-of-care sites before and after systemwide implementation of telepsychiatry consultation in 2015. Clinical records on 494 pediatric psychiatric emergencies included ED length of stay, disposition/discharge, and hospital system charges. Satisfaction surveys regarding telepsychiatry consultations were completed by providers and parents or guardians.Compared with children who received usual care, children who received telepsychiatry consultations had significantly shorter median ED lengths of stay (5.5 hours and 8.3 hours, respectively, p.001) and lower total patient charges ($3,493 and $8,611, p.001). Providers and patient caregivers reported high satisfaction with overall acceptability, effectiveness, and efficiency of telepsychiatry. No safety concerns were indicated based on readmissions within 72 hours in either treatment condition.Measured by charges and time, telepsychiatry consultations for pediatric psychiatric emergencies were cost-efficient from a hospital system perspective compared with usual care consisting of ambulance transport for in-person consultation at a children's hospital main campus. Telepsychiatry also improved clinical and operational efficiency and patient and family experience, and it showed promise for increasing access to other specialized health care needs.

OBJECTIVEAneurysmal subarachnoid hemorrhage (aSAH) has devastating consequences. The association between higher institutional volumes and improved outcomes for aSAH patients has been studied extensively. However, the literature exploring patterns of transfer in this context is sparse. Expansion of the endovascular workforce has raised concerns about the decentralization of care, reduced institutional volumes, and worsened patient outcomes. In this paper, the authors explored various patient and hospital factors associated with the transfer of aSAH patients by using a nationally representative database.METHODSThe 2013 and 2014 years of the National Inpatient Sample (NIS) were used to define an observational cohort of patients with ruptured brain aneurysms. The initial search identified patients with SAH (ICD-9-CM 430). Those with concomitant codes suggesting trauma or other intracranial vascular abnormalities were excluded. Finally, the patients who had not undergone a subsequent procedure to repair an intracranial aneurysm were excluded. These criteria yielded a cohort of 4373 patients, 1379 of whom had undergone microsurgical clip ligation and 2994 of whom had undergone endovascular repair. The outcome of interest was transfer status, and the NIS data element TRAN_IN was used to define this state. Multiple explanatory variables were identified, including age, sex, primary payer, median household income by zip code, race, hospital size, hospital control, hospital teaching status, and hospital location. These variables were evaluated using descriptive statistics, bivariate correlation analysis, and multivariable logistic regression modeling to determine their relationship with transfer status.RESULTSPatients with aSAH who were treated in an urban teaching hospital had higher odds of being a transfer (OR 2.15, 95% CI 1.71–2.72) than the patients in urban nonteaching hospitals. White patients were more likely to be transfer patients than were any of the other racial groups (p < 0.0001). Moreover, patients who lived in the highest-income zip codes were less likely to be transferred than the patients in the lowest income quartile (OR 0.78, 95% CI 0.64–0.95). Repair type (clip vs coil) and primary payer were not associated with transfer status.CONCLUSIONSA relatively high percentage of patients with aSAH are transferred between acute care hospitals. Race and income were associated with transfer status. White patients are more likely to be transferred than other races. Patients from zip codes with the highest income transferred at lower rates than those from the lowest income quartile. Transfer patients were preferentially sent to urban teaching hospitals. The modality of aneurysm treatment was not associated with transfer status.

Little is known about adult patients' attitudes toward vaccination and preferences for reminder/recall. The objective of this study was to determine patient perspectives on adult vaccines generally; attitudes about Tdap, pneumococcal polysaccharide (PPSV-23), and seasonal influenza vaccines specifically; and preferences for adult reminder/recall delivery. Twelve focus groups were conducted with 68 patients in a safety net health system. The sample was stratified by preferred language (English or Spanish), age (18-64 or 65+), and health status (with or without chronic conditions). Participants expressed positive attitudes toward vaccines generally, but had little knowledge of specific vaccines other than influenza, about which they expressed concerns. Although none reported previous experience receiving reminder/recall notices for adult vaccines, all were in favor of receiving them. These results suggest potential patient interest in greater adoption of evidence-based methods to improve immunization rates, and highlight the need for improved communication between providers and patients about adult vaccines.

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222ABSTRACT A goal of comparative effectiveness research is to help stakeholders reach consensus about the benefits and harms of medical interventions, at both the individual and population levels. The Institute of Medicine and others have recognized that to advance comparative effectiveness research, it will be necessary to use evidence from data sources otherthan randomized-controlled clinical trials. Different sources of evidence, such as randomized trials, observational studies, and meta-analyses, however, have strengths and weaknesses. Therefore, to help stakeholders reach consensus about the effectiveness of medical interventions, we argue it will be necessary not only to generate, but also to synthesize and weigh evidence from multiple data sources. In this chapter, we illustrate and refine an approach for using information from multiple data sources called crossdesign synthesis. Cross-design synthesis is a way of thinking about and framing comparative effectiveness questions such that multiple data sources can be used together to help answer those questions. We briefly review the strengths and weaknesses of evidence generated from different study designs, introduce cross-design synthesis, and illustrate the use of crossdesign synthesis with a case study investigating whether the initiation of the use of antidepressants increases the risk of suicidal behavior in depressed children and adolescents.

Objectives. To compare model input influence on incremental net monetary benefit (INMB) across 3 uncertainty methods: 1) 1-way sensitivity analysis; 2) probabilistic analysis of covariance (ANCOVA); and 3) expected value of partial perfect information (EVPPI). Methods. In a preliminary model, we used a published cost-effectiveness model and assumed £20,000 per quality-adjusted life-year (QALY) willingness-to-pay (Case 1: lower decision uncertainty) and £8000/QALY willingness-to-pay (Case 2: higher decision uncertainty). We conducted 1-way sensitivity, ANCOVA (10,000 Monte Carlo draws), and EVPPI for each model input (1000 inner and 1000 outer draws). We ranked inputs based on influence of INMB and compared input ranks across methods within case using Spearman’s rank correlation. We replicated this approach in 3 follow-up models: an additional linear model, a less linear model with uncorrelated inputs, and a less linear model with correlated inputs. Results. In the preliminary model, lower and higher decision uncertainty cases had the same top 3 influential parameters across uncertainty methods. The 2 most influential inputs contributed 78% and 49% of variation in outcome based on ANCOVA for lower decision uncertainty and higher decision uncertainty cases, respectively. In the follow-up models, input rank order correlations were higher across uncertainty methods in the linear model compared with both of the less linear models. Conclusions. Evidence across models suggests influential input rank agreement between 1-way and more advanced uncertainty analyses for relatively linear models with uncorrelated parameters but less agreement for less linear models. Although each method provides unique information, the additional resources needed to generate and communicate advanced analyses should be weighed, especially when outcome decision uncertainty is low. For less linear models or those with correlated inputs, performing and reporting deterministic and probabilistic uncertainty analyses appear prudent and conservative.

Purpose Medicaid programs are concerned about inappropriate, potentially hazardous, and costly off-label use of second-generation antipsychotics (SGAs). Several states are exploring policies aimed at managing low-dose quetiapine, commonly prescribed for off-label conditions. This study aimed to characterize longitudinal trends and patient characteristics associated with low-dose quetiapine in two state Medicaid programs. We further aimed to quantify changes in the use of quetiapine associated with a legal settlement that curtailed offlabel promotion of this product. Methods Using administrative data from two state Medicaid programs, Oregon and Colorado, we identified SGA initiators and determined patient level factors associated with receipt of low-dose SGAs. We evaluated changes in low-dose quetiapine initiation during and after a period in which quetiapine was being promoted illegally for off-label purposes. Results We identified 14763 new SGA starts during the study period. Low-dose (versus therapeutic dose) SGA use was common in both states, representing 53% to 56% of initiators. Quetiapine was the most commonly used SGA in both states and both dose ranges. Diagnoses of schizophrenia, bipolar disorder, posttraumatic stress disorder, anxiety disorder, and use of newer sedative hypnotics were associated with lower likelihood of initiating low-dose quetiapine. Initiation of low-dose quetiapine as a proportion of all SGA initiation and of all quetiapine initiation significantly declined in Oregon following suspension of off-label promotional activities. Conclusions Low-dose SGA and specifically low-dose quetiapine use remains common. Medicaid programs must set policies carefully to maximize the net safety of prescription use while optimizing disease management considering the potential for substitution effects. Copyright © 2013 John Wiley & Sons, Ltd. key words—Medicaid; drug utilization; antipsychotics; pharmacoepidemiology Received 31 May 2013; Revised 19 September 2013; Accepted 24 September 2013

Background Evidence is missing on showcasing current practices of degree programs specific to the field of pharmaceutical outcomes research. Objectives To measure current practices of pharmacoeconomics and outcomes research PhD programs in the United States and synthesize recommendations for improving the success of programs and prospective students. Methods A 23-question online survey instrument was created and distributed to 32 program directors identified in the International Society for Pharmacoeconomics and Outcomes Research educational directory. Descriptive statistics summarized both the program characteristics (including observed and desired number of faculty and students) and training recommendations (traits of program and student success). Results Of 30 eligible programs that conferred a PhD in pharmacoeconomics, pharmaceutical outcomes research, or a related field, 16 respondents (53%) completed the survey. Seventy-five percent of respondents were located in a school of pharmacy. The average observed number of faculty (7.5) and students (11.5) was lower than the average desired numbers (8.1) and (14.7), respectively. Reputation of faculty research and a collaborative environment with other disciplines were rated highest for a program’s success. Faculty’s mentoring experience and reputation and student funding opportunities were rated highest for prospective students’ success. Conclusions Existing and emerging programs as well as prospective students can use these findings to further their chances of success.

It has long been known that mentoring is critical to the success of junior faculty researchers. The controlled intervention study by Libby et al published in this issue of Academic Medicine demonstrates that institutional investment in a mentored research career development program for early-career faculty investigators provided significant long-term gains in grant productivity. Academic institutions hoping to replicate this program's success by launching similar mentoring programs for their junior faculty investigators will, however, find that the Achilles' heel lies in the scarcity of skilled research mentors and the relative lack of attention to and recognition of the importance of a supportive institutional climate for mentoring. It is essential, therefore, to begin by developing programs to "train the trainer" as well as programs and policies to support mentors. As a recent trial at 16 Clinical and Translational Science Award institutions demonstrated, competency-based, structured research mentor training can improve mentors' skills.In this Commentary, the authors offer a comprehensive two-pronged framework for mentor development with elements that address both individual mentoring competencies and the institutional climate for mentoring. The framework depicts the gaps, activities, and outcomes that a mentor development program can address. Activities directed at changing the institutional climate related to mentor development should complement training activities for individual mentors. The authors propose that employing this framework's approach to mentor development will lead to the desired impact: to increase the competence, productivity, and retention of a diverse clinical and translational research workforce.

Background: Depression is a leading cause of morbidity worldwide. The majority of treatment for depression occurs in primary care, but effective care remains elusive. Clinical decision making and comparative studies of real-world antidepressant effectiveness are limited by the absence of clinical measures of severity of illness and suicidality. Methods: The Distributed Ambulatory Research in Therapeutics Network (DARTNet) was engaged to systematically collect data using the 9-item Patient Health Questionnaire (PHQ-9) at the point of care. We used electronic health records (EHRs) and the PHQ-9 to capture, describe, and compare data on both baseline severity of illness and suicidality and response and suicidality after diagnosis for depressed patients in participating DARTNet practices. Results: EHR data were obtained for 81,028 episodes of depression (61,464 patients) from 14 clinical organizations. Over 9 months, data for 4900 PHQ-9s were collected from 2969 patients in DARTNet practices (this included 1892 PHQ-9s for 1019 adults and adolescents who had at least one depression diagnosis). Only 8.3% of episodes identified in our depression cohort had severity of illness information available in the EHR. For these episodes, considerable variation existed in both severity of illness (32.05% with no depression, 26.89% with minimal, 19.54% with mild, 12.04% with moderate, and 9.47% with severe depression) and suicidality (69.43% with a score of 0, 22.58% with a score of 1, 4.97% with a score of 2, and 3.02% with a score of 3 on item 9 of the PHQ-9). Patients with an EHR diagnosis of depression and a PHQ-9 (n = 1019) had similar severity but slightly higher suicidality levels compared with all patients for which PHQ-9 data were available. The PHQ-9 showed higher sensitivity for identifying depression response and emergent (after diagnosis) severity and suicidality; 25% to 30% of subjects had some degree of suicidal thought at some point in time according to the PHQ-9. Conclusions: This study demonstrated the value of adding PHQ-9 data and prescription fulfillment data to EHRs to improve diagnosis and management of depression in primary care and to enable more robust comparative effectiveness research on antidepressants.

After the Patient Protection and Affordable Care Act is fully implemented, Medicaid will be the largest single health care payer in the United States. Each U.S. state controls the size and scope of the medicine benefit beyond the federally mandated minimum; however, regulations that require balanced budgets and prohibit deficit spending limit each state's control. In a recessionary environment with reduced revenue, state Medicaid programs operate under a fixed or shrinking budget. Thus, the state Medicaid experience of providing high-quality care under explicit financial limits can inform Medicare and private payers of measures that control per-capita costs without adversely affecting health outcomes. The academic medicine community must play an expanded role in filling evidence gaps in order to continuously improve health policy making among U.S. states. The Drug Effectiveness Review Project and the Medicaid Evidence-based Decisions Project are two multistate Medicaid collaborations that leverage academic health center researchers' comparative effectiveness research (CER) projects to answer policy-relevant research questions. The authors of this article highlight how academic medicine can support states' health policies through CER and how CER-driven benefit-design choices can help states meet their cost and quality needs.

ACADEMIC EMERGENCY MEDICINE 2011; 18:158–166 © 2011 by the Society for Academic Emergency Medicine Abstract Objectives: The objective was to describe the emergency department (ED) resource burden of the spring 2009 H1N1 influenza pandemic at U.S. children’s hospitals by quantifying observed-to-expected utilization. Methods: The authors performed an ecologic analysis for April through July 2009 using data from 23 EDs in the Pediatric Health Information System (PHIS), an administrative database of widely distributed U.S. children’s hospitals. All ED visits during the study period were included, and data from the 5 prior years were used for establishing expected values. Primary outcome measures included observed-to-expected ratios for ED visits for all reasons and for influenza-related illness (IRI). Results: Overall, 390,983 visits, and 88,885 visits for IRI, were included for Calendar Weeks 16 through 29, when 2009 H1N1 influenza was circulating. The subset of 106,330 visits and 31,703 IRI visits made to the 14 hospitals experiencing the authors’ definition of ED surge during Weeks 16 to 29 was also studied. During surge weeks, the 14 EDs experienced 29% more total visits and 51% more IRI visits than expected (p

The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health record (EHR) data, designed as a platform for next-generation comparative effectiveness research in real-world settings. DARTNet links information from nonintegrated primary care clinics that use EHRs to deliver ambulatory care to overcome limitations with traditional observational research.Test the ability to conduct a remote, electronic point of care study in DARTNet practices by prompting clinic staff to obtain specific information during a patient encounter.Prospective survey of patients identified through queries of clinical data repositories in federated network organizations. On patient visit, survey is triggered and data are relinked to the EHR, de-identified, and copied for evaluation.Adult patients diagnosed with diabetes mellitus that scheduled a clinic visit for any reason in a 2-week period in DARTNet primary care practices.Survey on hypoglycemic events (past month) and over-the-counter and herbal supplement use.DARTNet facilitated point of care data collection triggered by an electronic prompt for additional information at a patient visit. More than one-third of respondents (33% response rate) reported either mild (45%) or severe hypoglycemic events (5%) in the month before the survey; only 3 of those were also coded using the ICD-9 (a significant difference in detection rates 37% vs. 1%). Nearly one-quarter of patients reported taking an OTC/herbal, 4% specifically for the treatment of symptoms of diabetes.Prospective data collection is feasible in DARTNet and can enable comparative effectiveness and safety research.

OBJECTIVE: Prior efforts to assess the impact of antidepressant use on risk of suicide attempt focused on antidepressant initiation or duration of use. Gaps remain in understanding risks associated with antidepressant discontinuation in the context of the drug regimen. We assessed the effects of antidepressant discontinuation on the risk of suicide attempt. METHOD: We report a nested case-control study of suicide attempt with at least 12 months of prior observation. A retrospective cohort of 2.4 million patients with depression (ICD-9 codes 296.2, 296.3, 300.4, and 311), aged 5-89 years, was created using standard Healthcare Effectiveness Data and Information Set (HEDIS) criteria; from this cohort, cases (n = 10,456) and controls (n = 41,815) were selected for study. Data were from a large, national, longitudinal, integrated claims database of managed care enrollees in the United States from calendar years 1999 through 2006. RESULTS: Compared to controls, cases were more likely to have used antidepressants, to have had multiple antidepressants, and to have had prior depressive episodes and inpatient stays that involved depression. After adjusting for confounding due to depression severity, comorbidities, and other medications, antidepressant use showed a protective effect for suicide attempt (OR = 0.62, P < .001). Compared to prior therapy, antidepressant discontinuation had a significant risk for suicide attempt (OR = 1.61, P < .05). Antidepressant initiation had the highest risk for suicide attempt (OR = 3.42, P < .05), followed by titration (titration up, OR = 2.62; down, OR = 2.19; P < .05). CONCLUSIONS: Substantial confounding exists in examining the link between antidepressant use and suicide attempt, specifically regarding those factors associated with characteristics of depression. Antidepressant discontinuation showed a significant risk for suicide attempt, as did the period of an abbreviated trial, that is, stopping before a therapeutic regimen of 56 days had been reached. The highest risk was associated with initiation, a finding consistent with other studies, closely followed by periods of dosing changes and discontinuation. Patients should be closely monitored during these periods.

Purpose Estimate separate and combined prevalence of depression and frequent substance use (FSU), evaluate gender differences, and compare the severity of depression and substance use across groups in a sample of youth in the U.S. child welfare system. Methods Data on youth aged 11 to 15 years from the National Survey on Child and Adolescent Well-Being were used (N = 1179). Depression was assessed using the Children's Depression Inventory. Substances assessed included tobacco, alcohol, marijuana, inhalants, hard drugs, and use of prescription medication for non-medical purposes. Descriptive statistics and chi-square tests were used to estimate and compare prevalence rates. Multinomial logistic regression was used to estimate the age-adjusted effect of gender on depression/FSU. Results Depression was more than twice as common in girls as boys (17% versus 7%, p Conclusions Although the prevalence of depression was significantly higher among girls than boys, there were no gender differences in FSU prevalence. Boys with comorbid depression and FSU had more severe depressive symptoms as those with depression only.

OBJECTIVES: To evaluate the performance of a patient recall intervention that relies on an outreach coordinator with a bachelor's degree to prompt women by mail and telephone about their eligibility for bone densitometry (dual-energy X-ray absorptiometry (DXA)) screening and allow them to schedule an examination without a medical provider visit ahead of time. DESIGN: Observational. SETTING: Academic general internal medicine practice. INTERVENTION: Mail- and telephone-based patient recall for DXA. PARTICIPANTS: Five hundred sixty-four women aged 65 to 79 at average risk for osteoporosis without a history of DXA. MEASUREMENTS: Rates of DXA completion and the change in proportion of screened women during a 7-month intervention period, case finding for clinically significant bone loss, frequency of appropriate clinical follow-up, DXA no-show rates compared with usual care, and clinician satisfaction. RESULTS: Through patient recall, rates of DXA screening rose significantly (P

The Food and Drug Administration (FDA) issued a public health advisory in October 2003 on the risk of suicide in pediatric patients taking antidepressants and advised maintaining "close supervision" of such patients. In this study, the authors compared trends in the frequency of provider contacts for patients with depression before and after the advisory was issued.Retrospective cohorts of children (N=27,370) and adults (N=193,151) with new episodes of depression treated with antidepressants were created from a national claims database of managed care plans (1998-2005). Two standards were used in measuring patient monitoring: the Health Plan Employer Data and Information Set (HEDIS) quality-of-care criterion calling for three contacts in 3 months and the FDA-recommended contact schedule totaling seven visits in 3 months. Time-series models compared postadvisory trends to the expected trend based on preadvisory measures.Less than 5% of all patients met FDA contact recommendations before the advisory, and the rate did not change after the advisory. A greater proportion of patients met the HEDIS contact criterion before the advisory (60% for children and 40% for adults), and the rate did not change after the advisory. A greater proportion of pediatric patients seen by a psychiatrist (80%) met the HEDIS criterion than those seen by a pediatrician (60%) or a non-pediatrician primary care physician (54%), and than adults seen by a psychiatrist (65%) or a primary care physician (37%). The proportions of pediatric patients who met the FDA recommendations did not differ by specialty.Contrary to expectations, the frequency of visits by patients with new episodes of depression treated with antidepressants did not increase after the October 2003 FDA advisory was issued.

Objectives. We examined rates and intensity of crisis services use by race/ethnicity for 351174 children younger than 18 years who received specialty mental health care from California’s 57 county public mental health systems between July 1998 and June 2001. Methods. We used fixed-effects regression for a controlled assessment of racial/ethnic disparities in children’s use of hospital-based services for the most serious mental health crises (crisis stabilization services) and community-based services for other crises (crisis intervention services). Results. African American children were more likely than were White children to use both kinds of crisis care and made more visits to hospital-based crisis stabilization services after initial use. Asian American/Pacific Islander and American Indian/Alaska Native children were more likely than were White children to use hospital-based crisis stabilization services but, along with Latino children, made fewer hospital-based crisis stabilization visits after an initial visit. Conclusions. African American children used both kinds of crisis services more than did White children, and Asian Americans/Pacific Islander and American Indians/Alaska Native children visited only when they experienced the most disruptive and troubling kind of crises, and made nonrecurring visits.

Little is known about the impact of treatment-resistant hypertension (TRH) on health-related quality of life (HrQoL). We aimed to compare HrQoL measures in adults with apparent TRH (aTRH) and non-resistant hypertension among nationally representative US Medical Expenditure Panel Survey data pooled from 2000 to 2011. Cohorts compared were adults with aTRH (⩾2 unique fills from ⩾4 antihypertensive classes during a year) versus non-resistant hypertension (those with hypertension not meeting the aTRH definition). Key outcomes were cohort differences in SF-12v2 physical component summary (PCS) and mental component summary (MCS) scores and disease-state utility using the SF-6D. Of 57 150 adults with hypertension, 2501 (4.4%) met criteria for aTRH. Persons with aTRH, compared with non-resistant hypertension, were older (mean, 68 vs 61 years), had a higher BMI (30.9 vs 29.7 kg m(-)(2)) and were more likely to be Black (20% vs 14%), but less likely to be female (46% vs 54%). Persons with aTRH, compared with non-resistant hypertension, had lower mean PCS scores (35.8 vs 43.2; P0.0001), and utility (0.68 vs 0.74; P0.0001), but similar MCS scores (49.1 vs 50.4). In multivariable-adjusted analyses, aTRH was associated with a 2.37 (95% CI 1.71 to 3.02) lower PCS score and 0.02 (95% CI 0.01 to 0.03) lower utility, compared with non-resistant hypertension. In conclusion, aTRH was associated with substantially lower HrQoL in physical functioning and health utility, but not in mental functioning, compared with non-resistant hypertension. The multivariable-adjusted reduction in physical functioning was similar in magnitude to previous observations comparing hypertension with no hypertension.

This study presented national data on financing policies and practices for health and mental health care among children in child welfare settings, including those who are not placed out of the home. Our three objectives were to: examine variation in the provision of health insurance with a specific focus on placement status; describe mechanisms for assuring timing of coverage; and compare Medicaid expansionary practices to innovations in financing and organization of services for youth. Expansionary Medicaid practices were associated with managed care and innovations in the financing and organization of mental health services such as carve-outs.

We analyzed the effects of the Colorado Medicaid Capitation Program on the duration and services of over 21,000 outpatient mental health episodes for young children. The study spanned a three year period before and after capitation was implemented, and compared episodes of outpatient care for children from 14 capitated Community Mental Health Centers (CMHCs) with those from three CMHCs that remained fee-for-service. Proportional hazards regressions revealed that capitation resulted in an increase in outpatient episode duration, over and above similar effects for the comparison fee-for-service episodes. The hypothesis that there were longer capitated episodes for children who were hospitalized was not supported. Children with behavioral and anxiety disorders had longer capitated episodes. Service intensity decreased over time in the managed care sites. Changes in case mix may have had an impact on changes in episode duration and service intensity. That outpatient episode duration increased over time while costs were lowered in the capitated agencies indicates some effects of capitation in changing patterns of care.

This study investigated the impact of Colorado's Medicaid mental health managed care program on patterns of antipsychotic medication treatment among persons with a diagnosis of schizophrenia. These patterns were compared with patterns of psychosocial treatment and a measure of symptom change.Changes in study measures over time in two areas of the state where the policy intervention was implemented were compared with changes in measures in areas where it was not implemented. The study sample consisted of 235 consumers. Measures of antipsychotic medication treatment included any use in a given period, months in which a prescription was filled, and use of second-generation antipsychotics. Psychosocial treatment was measured by any use and expenditures per user. The schizophrenia subscale of the Brief Psychiatric Rating Scale was used to measure consumer outcomes.Probabilities of antipsychotic use in the managed care areas were stable or increased compared with the other areas. The average number of months with filled prescriptions was unchanged. Consumers served under managed care were less likely to use psychosocial treatment, and additional decreases in treatment costs were noted in one area. Difference scores for the schizophrenia subscale showed no change or positive effects for the managed care areas.Within the Colorado managed care program, antipsychotic medication therapy was not impaired, despite significant decreases in the continuity or intensity of psychosocial treatment, and no reduction in symptom levels was noted. Mental health managed care does not inherently impair medication therapy. Patterns of medication use appeared to be better indicators of program success than psychosocial treatment patterns and were more consistent with outcomes.

This study utilized data on a treatment cohort from a randomized clinical trial that recruited adolescents with co-occurring major depression and substance use disorder (N=126). The purpose of this study was to compare adolescents for whom the onset of depression was first versus those for whom the onset of substance use disorder was first or in the same year as depression. Intake clinical evaluations were abstracted to yield common stressors that included childhood abuse, early loss or death, exposure to violence, and attachment problems. Tobacco, alcohol, and cannabis initiation and dependence were compared for the depression first and substance use disorder first groups, and within those groups by gender. Among the substances studied, only cannabis dependence was significantly more prevalent among those with depression first. Comparisons suggest some differences in the developmental path toward comorbid depression and substance use disorders, but remarkable similarity in measures of dependence and severity. Although small samples limited statistical significance, observed differences suggest possible avenues for prevention or intervention.

Residential Treatment Centres (RTCs) provide 24-hour care and mental health services to young people, many of whom are referred from county departments that oversee services to young people involved with child welfare services, mental health services and corrections. While RTCs are required to provide mental health services to young people, the regulations governing these programmes have few specific requirements about the process, content or duration of treatment. Therefore, many questions have arisen about what a typical RTC day looks like and whether it differs among providers or differs based on the severity or type of the young person's mental-health related behaviours and symptoms. This study conducted interviews with RTC providers in the State of Colorado on this topic. Most RTC services were relatively uniform across case types within each RTC. It appears that with a few exceptions, a similar set of services is provided to all young people, regardless of their problems.

Objective: The purpose of this study was to examine the relationship of childhood physical and sexual abuse to subsequent life- time alcohol or drug use disorders among American Indians (AIs) by using cross-sectional and retrospective data collected from a structured epidemiological interview. Method: A sample of 3,084 AIs from two tribal populations—Southwest and Northern Plains—participated in a large-scale, community-based study. Participants were asked about trau- matic events and family history and were administered standard diag- nostic measures of substance use disorders. Results: Prevalence of childhood physical abuse was approximately 7% for both tribes, and childhood sexual abuse was 4%-5%, much higher for females. The Northern Plains tribe had higher prevalences of substance use disorders. Childhood physical abuse had a significant main effect in bivariate mod- els of substance dependence, but remained significant only in the mul- tivariate models of substance dependence for the Northern Plains tribe. Correlates of disorder were psychiatric and medical comorbidity, paren- tal alcohol problems and adult experience of physical attacks. Conclu- sions: Childhood physical abuse had a stronger effect than childhood sexual abuse on lifetime substance dependence. Childhood sexual abuse, on the other hand, was more associated with lifetime substance abuse. Females more commonly experienced childhood abuse but were less likely than males to develop substance use disorders. Although additional covariates reduced the main effect on disorder, results provide clinical guidance to constellations of risk factors and expand the population at risk to include males. (J. Stud. Alcohol 65: 74-83, 2004)

Context: The US FDA has issued an advisory warning of a possible link between antidepressant treatment for paediatric patients with major depressive disorder (MDD) and an increased risk of suicidal behaviour. A large database of paid health insurance claims for adolescents with MDD provided the opportunity to examine this possible relationship. Objective: To examine the potential empirical link between antidepressant treatment and suicide attempts among adolescents aged 12–18 years using a community sample of managed care enrollees across the US. Design: A retrospective longitudinal cohort using paid insurance claims for all healthcare and prescription fills for adolescents who were newly diagnosed with MDD and had at least 6 months of follow-up data. A multivariate Cox proportional hazards regression analysis was used to test the hypothesis that antidepressant use increased the risk of suicide attempt, adjusting for propensity for allocation to each treatment group and for demographic and clinical characteristics. Setting: Managed care plans including both commercial and Medicaid plans in the east, midwest, south and western regions of the US from January 1997 to March 2003. Participants: All adolescent insurance members aged 12–18 years at first diagnosis of MDD. Main outcome measures: Suicide attempts as indicated by medical utilisation with International Classification of Diseases (9th edition) [ICD-9] or 10th edition (ICD-10) codes in any healthcare setting or by any covered provider. Results: 24 119 adolescents met inclusion criteria (63% female). Crude suicide attempt rates ranged from 0.0-2.3% by index treatment group. Treatment with SSRIs (hazard ratio) [HR] = 1.59; CI 0.89, 2.82), other antidepressants (HR = 1.03; CI 0.43, 2.44), or multiple antidepressants (HR = 1.43; CI 0.70, 2.89) after index MDD diagnosis resulted in no statistically increased risk of suicide attempt. Treatment with antidepressant medication for at least 180 days (6 months) reduced the likelihood of suicide attempt compared with antidepressant treatment for