A single ALS center experience with clinical use of sodium phenylbutyrate-taurursodiol.

INTRODUCTION/AIMS: The aim of this study was to examine clinical utilization and discontinuation rates of sodium phenylbutyrate-taurursodiol (PB-TURSO) in a single Amyotrophic Lateral Sclerosis (ALS) center. PB-TURSO was approved by the United States Food and Drug Administration (FDA) in September 2022. Prior experience has been limited to clinical trials or expanded access protocols. In this manuscript, we discuss insurance approval rates, patient uptake, and discontinuation of PB-TURSO in a large academic center. METHODS: Records of patients seen for clinical visits between January 2022 and May 2023 were reviewed. Demographic and clinical characteristics of our clinic population and those initiating PB-TURSO were obtained from our clinical database. RESULTS: A total of 228 patients were seen during the observation period and 122 requested PB-TURSO prescriptions. 77% (94) were approved by insurance. 66% (65) of those who were approved or received free drug chose to start medication. 51% (34) of those who initiated PB-TURSO continued to take it through the end of the observation period. Four patients discontinued due to death during the observation period. Of the 29 patients who survived and discontinued, the main reasons for discontinuation were GI symptoms (17, 58.6%) and taste (8, 29.6%). DISCUSSION: PB-TURSO was approved by insurance for most patients. The discontinuation rate was high and was driven largely by GI side effects and taste. Future considerations would include deeper examination of demographic trends, patient costs, side effects, and potential benefits in clinical practice.

Intensity and type of physical activity predicts depression in older adults.

This study examined whether various levels of physical activity among older adults predicted levels of depression and whether there were racial differences in the levels and types of physical activities engaged in by adults aged 50 and older. METHOD: Data from the 2015-2016 National Health and Nutrition Examination Survey (NHANES) were analyzed for 2,474 adults aged 50 years and older. Variables of focus were demographics, physical activity and depression, assessed using the Physical Activity Questionnaire and the Mental Health - Depression Screener. RESULTS: There was a significant positive relationship between income and depression; individuals with higher income had lower levels of depression. Simple linear regression revealed income significantly predicted depression scores, b = -.20, F(1, 2296) = 96.35, p < .001, explaining 4% of the variance, R2 = .04. As age increased, all levels of physical activity declined, regardless of the category. Vigorous recreation-related activity and moderate recreation-related activity each made significant, unique contributions to depression scores. CONCLUSION: Findings from the current study suggest that physical activity interventions should be culturally appropriate and tailored to the needs and abilities of individual older adults to maximize benefits and minimize adverse events, particularly among community dwelling older adults.

Identifying Which Place Characteristics are Associated with the Odds of Recent HIV Testing in a Large Sample of People Who Inject Drugs in 19 US Metropolitan Areas.

This exploratory analysis investigates relationships of place characteristics to HIV testing among people who inject drugs (PWID). We used CDC's 2012 National HIV Behavioral Surveillance (NHBS) data among PWID from 19 US metropolitan statistical areas (MSAs); we restricted the analytic sample to PWID self-reporting being HIV negative (N = 7477). Administrative data were analyzed to describe the 1. Sociodemographic Composition; 2. Economic disadvantage; 3. Healthcare Service/Law enforcement; and 4. HIV burden of the ZIP codes, counties, and MSAs where PWID lived. Multilevel models tested associations of place characteristics with HIV testing. Fifty-eight percent of PWID reported past-year testing. MSA-level per capita correctional expenditures were positively associated with recent HIV testing among black PWID, but not white PWID. Higher MSA-level household income and imbalanced sex ratios (more women than men) in the MSA were associated with higher odds of testing. HIV screening for PWID is suboptimal (58%) and needs improvement. Identifying place characteristics associated with testing among PWID can strengthen service allocation and interventions in areas of need to increase access to HIV testing.

"If you understand you cope better with it": the role of education in building palliative care capacity in four First Nations communities in Canada.

BACKGROUND: In Canada, there is a growing need to develop community-based, culturally appropriate palliative care for Indigenous people living in First Nations communities. The public health approach to palliative care, which emphasizes community-based initiatives, is especially relevant in First Nations communities because care is grounded in their distinct social and cultural context. Central to the public health approach are educational strategies that strengthen communities' capacity to care for their vulnerable members as they die. This paper presents community-based research conducted with First Nations communities in Canada that aimed to assess and address local palliative care educational needs to improve community capacity in palliative care. METHODS: Participatory action research (PAR) was conducted with four First Nations communities in Canada over a six-year period (2010-2016). The research occurred in three phases. Phase 1: focus groups, interviews and surveys were employed to assess community specific needs and resources. Phase 2: recommendations were developed to guide the PAR process. Phase 3: educational resources were created to address the identified educational needs. These resources were implemented incrementally over 4 years. Ongoing process evaluation was employed, and revisions were made as required. RESULTS: Educational needs were identified for patients, families, community members and internal and external health care providers. A wide and comprehensive range of educational resources were created to address those needs. Those culturally appropriate educational resources are available in a very accessible and useable workbook format and are available for use by other Indigenous people and communities. CONCLUSIONS: This research provides an example of the public health approach and offers implementation strategies around palliative care education. This paper contributes to the international literature on the public health approach to palliative care by presenting a case study from Canada that includes: conducting a culturally appropriate assessment of educational needs, creating recommendations, facilitating development and implementation of educational resources in the community to improve community capacity in palliative care.

Consensus recommendations for trabecular meshwork cell isolation, characterization and culture.

Cultured trabecular meshwork (TM) cells are a valuable model system to study the cellular mechanisms involved in the regulation of conventional outflow resistance and thus intraocular pressure; and their dysfunction resulting in ocular hypertension. In this review, we describe the standard procedures used for the isolation of TM cells from several animal species including humans, and the methods used to validate their identity. Having a set of standard practices for TM cells will increase the scientific rigor when used as a model, and enable other researchers to replicate and build upon previous findings.

Response rate profiles for major depressive disorder: Characterizing early response and longitudinal nonresponse.

BACKGROUND: Definition of response is critical when seeking to establish valid predictors of treatment success. However, response at the end of study or endpoint only provides one view of the overall clinical picture that is relevant in testing for predictors. The current study employed a classification technique designed to group subjects based on their rate of change over time, while simultaneously addressing the issue of controlling for baseline severity. METHODS: A set of latent class trajectory analyses, incorporating baseline level of symptoms, were performed on a sample of 344 depressed patients from a clinical trial evaluating the efficacy of cognitive behavior therapy and two antidepressant medications (escitalopram and duloxetine) in patients with major depressive disorder. RESULTS: Although very few demographic and illness-related features were associated with response rate profiles, the aggregated effect of candidate genetic variants previously identified in large pharmacogenetic studies and meta-analyses showed a significant association with early remission as well as nonresponse. These same genetic scores showed a less compelling relationship with endpoint response categories. In addition, consistent nonresponse throughout the study treatment period was shown to occur in different subjects than endpoint nonresponse, which was verified by follow-up augmentation treatment outcomes. CONCLUSIONS: When defining groups based on the rate of change, controlling for baseline depression severity may help to identify the clinically relevant distinctions of early response on one end and consistent nonresponse on the other.

Wiisokotaatiwin: development and evaluation of a community-based palliative care program in Naotkamegwanning First Nation.

INTRODUCTION: Approximately 474 000 Indigenous people live in 617 First Nations communities across Canada; 125 of those communities are located in Ontario, primarily in rural and remote areas. Common rural health challenges, including for palliative care, involve quality and access. The need for culturally relevant palliative care programs in First Nations communities is urgent because the population is aging with a high burden of chronic and terminal disease. Because local palliative care is lacking, most First Nations people now leave their culture, family and community to receive care in distant hospitals or long-term care homes. Due to jurisdictional issues, a policy gap exists where neither federal nor provincial governments takes responsibility for funding palliative care in First Nations communities. Further, no Canadian program models existed for how different levels of government can collaborate to fund and deliver palliative care in First Nations communities. This article describes an innovative, community-based palliative care program (Wiisokotaatiwin) developed in rural Naotkamegwanning, and presents the results of a process evaluation of its pilot implementation. The evaluation aimed to (i) document the program's pilot implementation, (ii) assess progress toward intended program outcomes and (iii) assess the perceived value of the program. METHODS: The Wiisokotaatiwin Program was developed and implemented over 5 years using participatory action research (http://www.eolfn.lakeheadu.ca). A mixed-method evaluation approach was adopted. Descriptive data were extracted from program documents (eg client registration forms). Client tracking forms documented service provision data for a 4-month sample period. Quantitative and qualitative data were collected through client and family member questionnaires (n=7) and healthcare provider questionnaires (n=22). A focus group was conducted with the program leadership team responsible for program development. Quantitative data were summarized using descriptive statistics. An inductive approach was used to identify themes in the qualitative data related to the evaluation questions. RESULTS: The findings demonstrated the program was implemented as intended, and that there was a need for the program, with six clients on the 10-month pilot. The findings also indicated achievement of program-level outcomes and progress toward system-level outcomes. Clients/families and healthcare providers were satisfied with the program and perceived it to be meeting its objectives. The program model was also perceived to be transferrable to other First Nations communities. The results demonstrate how a rural First Nations community can build capacity and develop a palliative care program tailored to their unique culture and context that builds upon and is integrated into existing services. CONCLUSIONS: The Wiisokotaatiwin Program allowed community members to receive their palliative care at home, improved client experience and enhanced service integration. This article provides a First Nations specific model for a palliative care program that overcomes jurisdictional issues at the local level, and a methodology for developing and evaluating community-based palliative care programs in rural First Nations communities. The article demonstrates how local, federal and provincial healthcare providers and organizations collaborated to build capacity, fund and deliver community-based palliative care. The described process of developing the program has applicability in other First Nations (Indigenous) communities and for healthcare decisionmakers.

The role of unregulated care providers in managing heart failure patients in long-term care facilities.

AIMS AND OBJECTIVES: Heart failure is a complex syndrome in which abnormal heart function results in clinical symptoms and signs of low cardiac output and/or pulmonary or systemic congestion. Heart failure is common among long-term care residents, and is associated with significant morbidity and acute care utilisation. Heart failure guidelines endorse standard therapies, yet long-term care residents are less likely to receive recommended treatments. The objective of this study is to understand the perceptions and potential role of unregulated care providers in contributing to better heart failure management among long-term care residents. DESIGN: Focus group interviews. METHODS: This qualitative study employed focus groups to explore perceptions from 24 unregulated care providers in three Ontario, Canada long-term care homes, about barriers to the optimal management of heart failure. RESULTS: Three overarching concepts emerged characterising unregulated care providers' experiences in caring for residents with heart failure in long-term care: (1) the complexity of providing heart failure care in a long-term care setting, (2) striving for resident-centred decision making and (3) unregulated care providers role enactment nested within an interprofessional team in long-term care. These concepts reflect the complex interplay between individual unregulated care providers and residents, and heart failure-related, socio-cultural and organisational factors that influence heart failure care processes in the long-term care system. CONCLUSIONS: Optimising the management of heart failure in long-term care is contingent on greater engagement of unregulated care providers as active partners in the interprofessional care team. Interventions to improve heart failure management in long-term care must ensure that appropriate education is provided to all long-term care staff, including unregulated care providers, and in a manner that fosters greater and more effective interprofessional collaboration. RELEVANCE TO CLINICAL PRACTICE: Active and collaborative engagement unregulated care providers has the potential to improve the management of heart failure in long-term care residents.

Military Lesbian, Gay, Bisexual, and Transgender (LGBT) Awareness Training for Health Care Providers Within the Military Health System [Formula: see text].

BACKGROUND AND SIGNIFICANCE: Lesbian, gay, bisexual, and transgender (LGBT) individuals serving within the U.S. military and their beneficiaries have unique health care requirements. Department of Defense Directive 1304.26 "Don't Ask, Don't Tell" created a barrier for service members to speak candidly with their health care providers, which left specific health care needs unaddressed. There are no standardized cultural education programs to assist Military Health System (MHS) health care providers in delivering care to LGBT patients and their beneficiaries. PURPOSE: The purpose of this project was to develop, implement, and evaluate the effectiveness of an LGBT educational program for health care providers within the MHS to increase cultural awareness in caring for this special population. METHOD: This multisite educational program was conducted at Travis Air Force Base and Joint Base Lewis-McChord from November 15, 2014, to January 30, 2015. A 15-question multiple-choice questionnaire was developed based on the education program and was administered before and after the education program. A total of 51 individuals completed the program. RESULTS: Overall posttest scores improved compared to pretest scores. CONCLUSION: This program was designed to begin the process of educating health care providers about the unique health care issues of military LGBT Service Members and their beneficiaries. This program was the first to address the disparities in LGBT health care needs within the Department of Defense. It also provided a platform for facilitating open communication among providers regarding LGBT population health needs in the military.

Induced pluripotent stem cells restore function in a human cell loss model of open-angle glaucoma.

Normally, trabecular meshwork (TM) and Schlemm's canal inner wall endothelial cells within the aqueous humor outflow pathway maintain intraocular pressure within a narrow safe range. Elevation in intraocular pressure, because of the loss of homeostatic regulation by these outflow pathway cells, is the primary risk factor for vision loss due to glaucomatous optic neuropathy. A notable feature associated with glaucoma is outflow pathway cell loss. Using controlled cell loss in ex vivo perfused human outflow pathway organ culture, we developed compelling experimental evidence that this level of cell loss compromises intraocular pressure homeostatic function. This function was restored by repopulation of the model with fresh TM cells. We then differentiated induced pluripotent stem cells (iPSCs) and used them to repopulate this cell depletion model. These differentiated cells (TM-like iPSCs) became similar to TM cells in both morphology and expression patterns. When transplanted, they were able to fully restore intraocular pressure homeostatic function. This successful transplantation of TM-like iPSCs establishes the conceptual feasibility of using autologous stem cells to restore intraocular pressure regulatory function in open-angle glaucoma patients, providing a novel alternative treatment option.

Association between anger and mental stress-induced myocardial ischemia.

BACKGROUND: Mental stress-induced myocardial ischemia is associated with adverse prognosis in coronary artery disease patients. Anger is thought to be a trigger of acute coronary syndromes and is associated with increased cardiovascular risk; however, little direct evidence exists for a link between anger and myocardial ischemia. METHODS: [(99m)Tc]-sestamibi single-photon emission tomography was performed at rest, after mental stress (a social stressor with a speech task) and after exercise/pharmacologic stress. Summed scores of perfusion abnormalities were obtained by observer-independent software. A summed-difference score, the difference between stress and rest scores, was used to quantify myocardial ischemia under both stress conditions. The Spielberger's State-Trait Anger Expression Inventory was used to assess different anger dimensions. RESULTS: The mean age was 50 years, 50% were female, and 60% were non-white. After adjusting for demographic factors, smoking, coronary artery disease severity, depressive, and anxiety symptoms, each IQR increment in state-anger score was associated with 0.36 U-adjusted increase in ischemia as measured by the summed-difference score (95% CI 0.14-0.59); the corresponding association for trait anger was 0.95 (95% CI 0.21-1.69). Anger expression scales were not associated with ischemia. None of the anger dimensions was related to ischemia during exercise/pharmacologic stress. CONCLUSION: Anger, both as an emotional state and as a personality trait, is significantly associated with propensity to develop myocardial ischemia during mental stress but not during exercise/pharmacologic stress. Patients with this psychologic profile may be at increased risk for silent ischemia induced by emotional stress, and this may translate into worse prognosis.

Extracellular matrix in the trabecular meshwork: intraocular pressure regulation and dysregulation in glaucoma.

The trabecular meshwork (TM) is located in the anterior segment of the eye and is responsible for regulating the outflow of aqueous humor. Increased resistance to aqueous outflow causes intraocular pressure to increase, which is the primary risk factor for glaucoma. TM cells reside on a series of fenestrated beams and sheets through which the aqueous humor flows to exit the anterior chamber via Schlemm's canal. The outer trabecular cells are phagocytic and are thought to function as a pre-filter. However, most of the outflow resistance is thought to be from the extracellular matrix (ECM) of the juxtacanalicular region, the deepest portion of the TM, and from the inner wall basement membrane of Schlemm's canal. It is becoming increasingly evident that the extracellular milieu is important in maintaining the integrity of the TM. In glaucoma, not only have ultrastructural changes been observed in the ECM of the TM, and a significant number of mutations in ECM genes been noted, but the stiffness of glaucomatous TM appears to be greater than that of normal tissue. Additionally, TGFß2 has been found to be elevated in the aqueous humor of glaucoma patients and is assumed to be involved in ECM changes deep with the juxtacanalicular region of the TM. This review summarizes the current literature on trabecular ECM as well as the development and function of the TM. Animal models and organ culture models targeting specific ECM molecules to investigate the mechanisms of glaucoma are described. Finally, the growing number of mutations that have been identified in ECM genes and genes that modulate ECM in humans with glaucoma are documented.

HIV Infection Among People Who Inject Drugs in the United States: Geographically Explained Variance Across Racial and Ethnic Groups.

OBJECTIVES: We explored how variance in HIV infection is distributed across multiple geographical scales among people who inject drugs (PWID) in the United States, overall and within racial/ethnic groups. METHODS: People who inject drugs (n = 9077) were recruited via respondent-driven sampling from 19 metropolitan statistical areas (MSAs) for the Centers for Disease Control and Prevention's 2009 National HIV Behavioral Surveillance system. We used multilevel modeling to determine the percentage of variance in HIV infection explained by zip codes, counties, and MSAs where PWID lived, overall and for specific racial/ethnic groups. RESULTS: Collectively, zip codes, counties, and MSAs explained 29% of variance in HIV infection. Within specific racial/ethnic groups, all 3 scales explained variance in HIV infection among non-Hispanic/Latino White PWID (4.3%, 0.2%, and 7.5%, respectively), MSAs explained variance among Hispanic/Latino PWID (10.1%), and counties explained variance among non-Hispanic/Latino Black PWID (6.9%). CONCLUSIONS: Exposure to potential determinants of HIV infection at zip codes, counties, and MSAs may vary for different racial/ethnic groups of PWID, and may reveal opportunities to identify and ameliorate intraracial inequities in exposure to determinants of HIV infection at these geographical scales.

Changes in Exposure to Neighborhood Characteristics are Associated with Sexual Network Characteristics in a Cohort of Adults Relocating from Public Housing.

Ecologic and cross-sectional multilevel analyses suggest that characteristics of the places where people live influence their vulnerability to HIV and other sexually-transmitted infections (STIs). Using data from a predominately substance-misusing cohort of African-American adults relocating from US public housing complexes, this multilevel longitudinal study tested the hypothesis that participants who experienced greater post-relocation improvements in economic disadvantage, violent crime, and male:female sex ratios would experience greater reductions in perceived partner risk and in the odds of having a partner who had another partner (i.e., indirect concurrency). Baseline data were collected from 172 public housing residents before relocations occurred; three waves of post-relocation data were collected every 9 months. Participants who experienced greater improvements in community violence and in economic conditions experienced greater reductions in partner risk. Reduced community violence was associated with reduced indirect concurrency. Structural interventions that decrease exposure to violence and economic disadvantage may reduce vulnerability to HIV/STIs.

Preliminary Findings Supporting Insula Metabolic Activity as a Predictor of Outcome to Psychotherapy and Medication Treatments for Depression.

A putative right anterior insula metabolism biomarker predictive of treatment outcomes was retrospectively applied to 30 depressed psychotherapy--or escitalopram-treated nonremitters who entered combination treatment. Patients whose added treatment matched the biomarker-indicated treatment remitted more often than biomarker-mismatched patients.

Comfort Care Rounds: a staff capacity-building initiative in long-term care homes.

This article reports a pilot evaluation of Comfort Care Rounds (CCRs)--a strategy for addressing long-term care home staff's palliative and end-of-life care educational and support needs. Using a qualitative descriptive design, semistructured individual and focus group interviews were conducted to understand staff members' perspectives and feedback on the implementation and application of CCRs. Study participants identified that effective advertising, interest, and assigning staff to attend CCRs facilitated their participation. The key barriers to their attendance included difficulty in balancing heavy workloads and scheduling logistics. Interprofessional team member representation was sought but was not consistent. Study participants recognized the benefits of attending; however, they provided feedback on how the scheduling, content, and focus could be improved. Overall, study participants found CCRs to be beneficial to their palliative and end-of-life care knowledge, practice, and confidence. However, they identified barriers and recommendations, which warrant ongoing evaluation.

Hurricane Katrina: Maternal Depression Trajectories and Child Outcomes.

BACKGROUND: The authors examined depression trajectories over two years among mothers exposed to Hurricane Katrina. Risk and protective factors for depression trajectories, as well as associations with child outcomes were analyzed. METHOD: This study included 283 mothers (age at time 1, M = 39.20 years, SD = 7.21; 62% African American). Mothers were assessed at four time points over two years following Hurricane Katrina. Mothers reported posttraumatic stress symptoms, hurricane exposure, traumatic life events, and social support at time 1. Depressive symptoms were modeled at times 2, 3, and 4. Youth reported their distress symptoms (posttraumatic stress, depression, and anxiety) at time 4. RESULTS: Latent class growth analyses identified three maternal depression trajectories among mothers exposed to Hurricane Katrina: low (61%), resilient (29%), and chronic (10%). Social support was identified as a protective factor among mothers. CONCLUSIONS: Three main trajectories of maternal depression following Hurricane Katrina were identified. Social support was protective for mothers. Identified trajectories were not associated with children's distress outcomes. These results have implications for disaster responses, screening efforts, and interventions targeted towards families. Future studies warrant the investigation of additional risk and protective factors that can affect maternal and child outcomes.

Impact of public housing relocations: are changes in neighborhood conditions related to STIs among relocaters?

BACKGROUND: Cross-sectional and ecologic studies suggest that place characteristics influence sexual behaviors and sexually transmitted infections (STIs). Using data from a predominately substance-misusing cohort of African American adults relocating from US public housing complexes, this multilevel longitudinal study tested the hypothesis that participants who experienced greater postrelocation improvements in neighborhood conditions (i.e., socioeconomic disadvantage, social disorder, STI prevalence, and male/female sex ratios) would have reduced the odds of testing positive for an STI over time. METHODS: Baseline data were collected in 2009 from 172 public housing residents before relocations occurred; 3 waves of postrelocation data were collected every 9 months thereafter. Polymerase chain reaction methods were used to test participants' urine for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Individual-level characteristics were assessed via survey. Administrative data described the census tracts where participants lived at each wave (e.g., sex ratios, violent crime rates, and poverty rates). Hypotheses were tested using multilevel models. RESULTS: Participants experienced improvements in all tract-level conditions studied and reductions in STIs over time (baseline: 29% tested STI positive; wave 4: 16% tested positive). Analyses identified a borderline statistically significant relationship between moving to tracts with more equitable sex ratios and reduced odds of testing positive for an STI (odds ratio, 0.16; 95% confidence interval, 0.02-1.01). Changes in other neighborhood conditions were not associated with this outcome. DISCUSSION: Consonant with past research, our findings suggest that moving to areas with more equitable sex ratios reduces the risk of STI infection. Future research should study the extent to which this relationship is mediated by changes in sexual network dynamics.

Neuropsychological function before and after subcallosal cingulate deep brain stimulation in patients with treatment-resistant depression.

BACKGROUND: Treatment-resistant depression (TRD) is a pervasive and difficult to treat condition for which deep brain stimulation (DBS) of the subcallosal cingulate white matter (SCCwm) is an emerging therapeutic option. However, neuropsychological safety data for this novel treatment have only been published for a small number of subjects. Moreover, little is known regarding the neuropsychological profile present in TRD patients at baseline, prior to initiation of DBS therapy. This report describes the neuropsychological effects of TRD and acute and chronic DBS of the SCCwm in patients with unipolar and bipolar TRD. METHODS: Patients with TRD (N = 17) were compared to a healthy control group (N = 15) on subtests from the Cambridge Neuropsychological Test Automated Battery and the Stroop Task. Patients were then tested again at subsequent time points of 1 and 6 months following the initiation of chronic DBS of the SCCwm. RESULTS: Patients with TRD showed similar levels of performance to healthy controls on most neuropsychological measures, with the exception that the TRD group had slower processing speed. Patients with bipolar TRD, relative to those with unipolar TRD, obtained lower scores on measures of executive function and memory only at baseline. With acute and chronic SCCwm DBS, neuropsychological function improved in multiple domains including processing speed and executive function (planning, set shifting, response inhibition), and memory remained stable. CONCLUSIONS: Patients with TRD show slowed processing speed but otherwise largely preserved neuropsychological functioning. DBS of the SCCwm does not result in worsening of any aspect of neuropsychological function and may improve certain domains. Future research is warranted to better understand the effects of TRD and DBS on neuropsychological function.

Enhancing Hispanic participation in mental health clinical research: development of a Spanish-speaking depression research site.

BACKGROUND: Hispanics, particularly those with limited English proficiency, are underrepresented in psychiatric clinical research studies. We developed a bilingual and bicultural research clinic dedicated to the recruitment and treatment of Spanish-speaking subjects in the Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) study, a large clinical trial of treatment-naïve subjects with major depressive disorder (MDD). METHODS: Demographic and clinical data derived from screening evaluations of the first 1,174 subjects presenting for participation were compared between the Spanish-speaking site (N = 275) and the primary English-speaking site (N = 899). Reasons for ineligibility (N = 888) for the PReDICT study were tallied for each site. RESULTS: Compared to English speakers, Spanish speakers had a lower level of education and were more likely to be female, uninsured, and have uncontrolled medical conditions. Clinically, Spanish speakers demonstrated greater depression severity, with higher mean symptom severity scores, and a greater number of previous suicide attempts. Among the subjects who were not randomized into the PReDICT study, Spanish-speaking subjects were more likely to have an uncontrolled medical condition or refuse participation, whereas English-speaking subjects were more likely to have bipolar disorder or a non-MDD depressive disorder. CONCLUSION: Recruitment of Hispanic subjects with MDD is feasible and may enhance efforts at signal detection, given the higher severity of depression among Spanish-speaking participants presenting for clinical trials. Specific approaches for the recruitment and retention of Spanish-speaking participants are required.