Cumulative All-Cause Mortality in Diverse Hispanic/Latino Adults : A Prospective, Multicenter Cohort Study.

BACKGROUND: All-cause mortality among diverse Hispanic/Latino groups in the United States and factors underlying mortality differences have not been examined prospectively. OBJECTIVE: To describe cumulative all-cause mortality (and factors underlying differences) by Hispanic/Latino background, before and during the COVID-19 pandemic. DESIGN: Prospective, multicenter cohort study. SETTING: Hispanic Community Health Study/Study of Latinos. PARTICIPANTS: 15 568 adults aged 18 to 74 years at baseline (2008 to 2011) of Central American, Cuban, Dominican, Mexican, Puerto Rican, South American, and other backgrounds from the Bronx, New York; Chicago, Illinois; Miami, Florida; and San Diego, California. MEASUREMENTS: Sociodemographic, acculturation-related, lifestyle, and clinical factors were assessed at baseline, and vital status was ascertained through December 2021 (969 deaths; 173 444 person-years of follow-up). Marginally adjusted cumulative all-cause mortality risks (11-year before the pandemic and 2-year during the pandemic) were examined using progressively adjusted Cox regression. RESULTS: Before the pandemic, 11-year cumulative mortality risks adjusted for age and sex were higher in the Puerto Rican and Cuban groups (6.3% [95% CI, 5.2% to 7.6%] and 5.7% [CI, 5.0% to 6.6%], respectively) and lowest in the South American group (2.4% [CI, 1.7% to 3.5%]). Differences were attenuated with adjustment for lifestyle and clinical factors. During the pandemic, 2-year cumulative mortality risks adjusted for age and sex ranged from 1.1% (CI, 0.6% to 2.0%; South American) to 2.0% (CI, 1.4% to 3.0%; Central American); CIs overlapped across groups. With adjustment for lifestyle factors, 2-year cumulative mortality risks were highest in persons of Central American and Mexican backgrounds and lowest among those of Puerto Rican and Cuban backgrounds. LIMITATION: Lack of data on race and baseline citizenship status; correlation between Hispanic/Latino background and site. CONCLUSION: Differences in prepandemic mortality risks across Hispanic/Latino groups were explained by lifestyle and clinical factors. Mortality patterns changed during the pandemic, with higher risks in persons of Central American and Mexican backgrounds than in those of Puerto Rican and Cuban backgrounds. PRIMARY FUNDING SOURCE: National Institutes of Health.

Economic and Psychosocial Impact of COVID-19 in the Hispanic Community Health Study/Study of Latinos.

Objectives: To examine the prevalence and correlates of economic hardship and psychosocial distress experienced during the initial phase of the coronavirus disease 2019 (COVID-19) pandemic in a large cohort of Hispanic/Latino adults. Methods: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), an ongoing multicenter study of Hispanic/Latino adults, collected information about COVID-19 illness and psychosocial and economic distress that occurred during the pandemic (N=11,283). We estimated the prevalence of these experiences during the initial phase of the pandemic (May 2020 to May 2021) and examined the prepandemic factors associated with pandemic-related economic hardship and emotional distress using multivariable log linear models with binomial distributions to estimate prevalence ratios. Results: Almost half of the households reported job losses and a third reported economic hardship during the first year of the pandemic. Pandemic-related household job losses and economic hardship were more pronounced among noncitizens who are likely to be undocumented. Pandemic-related economic hardship and psychosocial distress varied by age group and sex. Contrary to the economic hardship findings, noncitizens were less likely to report pandemic-related psychosocial distress. Prepandemic social resources were inversely related to psychosocial distress. Conclusions: The study findings underscore the economic vulnerability that the pandemic has brought to ethnic minoritized and immigrant populations in the United States, in particular noncitizens. The study also highlights the need to incorporate documentation status as a social determinant of health. Characterizing the initial economic and mental health impact of the pandemic is important for understanding the pandemic consequences on future health. Clinical Trial Registration Number: NCT02060344.

Evolving Science on Cardiovascular Disease Among Hispanic/Latino Adults: JACC International.

The landmark, multicenter HCHS/SOL (Hispanic Community Health Study/Study of Latinos) is the largest, most comprehensive, longitudinal community-based cohort study to date of diverse Hispanic/Latino persons in the United States. The HCHS/SOL aimed to address the dearth of comprehensive data on risk factors for cardiovascular disease (CVD) and other chronic diseases in this population and has expanded considerably in scope since its inception. This paper describes the aims/objectives and data collection of the HCHS/SOL and its ancillary studies to date and highlights the critical and sizable contributions made by the study to understanding the prevalence of and changes in CVD risk/protective factors and the burden of CVD and related chronic conditions among adults of diverse Hispanic/Latino backgrounds. The continued follow-up of this cohort will allow in-depth investigations on cardiovascular and pulmonary outcomes in this population, and data from the ongoing ancillary studies will facilitate generation of new hypotheses and study questions.

Doubled-Up Households, Self-Management Behaviors, Diabetes Preventive Care Services, and Hospital Use in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) 2015-2020.

OBJECTIVE: We investigated associations of living in a doubled-up household (i.e., adults living with adult children, other related adults, or other unrelated adults) with diabetes self-management behaviors, occurrence of diabetes preventive care services, and hospital use by Hispanic/Latino adults with diabetes. RESEARCH DESIGN AND METHODS: We analyzed data from the second clinical visit (2014-2017) through subsequent annual follow-up interviews completed through January 2020 of all participants with diabetes in the Hispanic Community Health Study/Study of Latinos. Multivariable regression was used to test associations between doubled-up status with diabetes self-management behaviors (i.e., checking blood glucose level, checking feet for sores), diabetes preventive care services done by a doctor (i.e., dilated-eye examination, feet checked, hemoglobin A1c measured, urine analysis for kidney function), and hospital use (i.e., emergency department [ED] visits and hospitalizations). RESULTS: Hispanic/Latino adults living doubled up were less likely to have their urine checked by a doctor for kidney disease compared with adults not in doubled-up households. Doubled-up status was not associated with diabetes self-management behaviors. Adults living doubled up in a household with other related adults had a 33% increased risk of ED visits compared with adults living doubled up in a household with adult children. CONCLUSIONS: Health care settings where Hispanic/Latino adults with diabetes receive trusted care should add housing characteristics such as doubled-up status to social-needs screening to identify residents in need of connecting with housing or social services and more targeted diabetes management services.

Subjective cognitive decline and objective cognition among diverse U.S. Hispanics/Latinos: Results from the Study of Latinos-Investigation of Neurocognitive Aging (SOL-INCA).

INTRODUCTION: Despite increased risk of cognitive decline in Hispanics/Latinos, research on early risk markers of Alzheimer's disease in this group is lacking. Subjective cognitive decline (SCD) may be an early risk marker of pathological aging. We investigated associations of SCD with objective cognition among a diverse sample of Hispanics/Latinos living in the United States. METHODS: SCD was measured with the Everyday Cognition Short Form (ECog-12) and cognitive performance with a standardized battery in 6125 adults aged ≥ 50 years without mild cognitive impairment or dementia (x̄age  = 63.2 years, 54.5% women). Regression models interrogated associations of SCD with objective global, memory, and executive function scores. RESULTS: Higher SCD was associated with lower objective global (B = -0.16, SE = 0.01), memory (B = -0.13, SE = 0.02), and executive (B = -0.13, SE = 0.02, p's < .001) function composite scores in fully adjusted models. DISCUSSION: Self-reported SCD, using the ECog-12, may be an indicator of concurrent objective cognition in diverse middle-aged and older community-dwelling Hispanics/Latinos.

Periodontal Disease and Incident CKD in US Hispanics/Latinos: The Hispanic Community Health Study/Study of Latinos.

RATIONALE & OBJECTIVE: Recent studies suggest that periodontal disease may be associated with incident chronic kidney disease (CKD). However, studies have focused on older populations, and US Hispanics/Latinos were not well represented. STUDY DESIGN: Observational cohort. SETTING & PARTICIPANTS: We analyzed data from the Hispanic Community Health Study/Study of Latinos who completed a baseline visit with a periodontal examination and a follow-up visit, and did not have CKD at baseline. PREDICTORS: Predictors included ≥30% of sites with clinical attachment loss ≥3 mm, ≥30% of sites with probing depth ≥4 mm, percentage of sites with bleeding on probing, and absence of functional dentition (<21 permanent teeth present). OUTCOMES: Outcomes were incident low estimated glomerular filtration rate (eGFR) (eGFR <60 mL/min/1.73 m2 and decline in eGFR ≥1 mL/min/year); incident albuminuria (urine albumin:creatinine ratio [ACR] ≥30 mg/g); and change in eGFR and ACR. ANALYTIC APPROACH: Poisson and linear regression. RESULTS: For the sample (n = 7.732), baseline mean age was 41.5 years, 45.2% were male, 11.7% had ≥30% of sites with clinical attachment loss ≥3 mm, 5.1% had ≥30% of sites with probing depth ≥4 mm, 30.7% had ≥50% of sites with bleeding on probing, and 16.2% had absent functional dentition. During a median follow-up of 5.9 years, 149 patients developed low eGFR and 415 patients developed albuminuria. On multivariable analysis, presence versus absence of ≥30% of sites with probing depth ≥4 mm and absence of functional dentition were each associated with increased risk for incident low eGFR (incident density ratio, 2.31; 95% CI, 1.14-4.65 and 1.65, 95% CI, 1.01-2.70, respectively). None of the other predictors were associated with outcomes. LIMITATIONS: Only a single kidney function follow-up measure. CONCLUSIONS: In this cohort of US Hispanics/Latinos, we found that select measures of periodontal disease were associated with incident low eGFR. Future work is needed to assess whether the treatment of periodontal disease may prevent CKD.

Retaining Hispanics: Lessons From the Hispanic Community Health Study/Study of Latinos.

We aimed to examine the retention of Hispanics/Latinos participating in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a prospective cohort study of 16,415 adults in 4 US cities who were enrolled between 2008 and 2011. We summarized retention strategies and examined contact, response, and participation rates over 5 years of annual follow-up interviews. We then evaluated motivations for participation and satisfaction with retention efforts among participants who completed a second in-person interview approximately 6 years after their baseline interview. Finally, we conducted logistic regression analyses estimating associations of demographic, health, and interview characteristics at study visit 1 (baseline) with participation, high motivation, and high satisfaction at visit 2. Across 5 years, the HCHS/SOL maintained contact, response, and participation rates over 80%. The most difficult Hispanic/Latino populations to retain included young, single, US-born males with less than a high school education. At visit 2, we found high rates of motivation and satisfaction. HCHS/SOL participants primarily sought to help their community and learn more about their health. High rates of retention of Hispanics/Latinos can be facilitated through the employment of bilingual/bicultural staff and the development of culturally tailored retention materials.

Cultural factors and oral health-related quality of life among dentate adults: Hispanic community health study/study of Latinos.

Objective: Research on the relationships between acculturation, ethnic identity, and oral health-related quality of life (OHRQOL) among the U.S. Hispanic/Latino population is sparse. The aim of this study is to examine the association between acculturation, ethnic identity, and OHRQOL among 13,172 adults in the 2008-2011 Hispanic Community Health Study/Study of Latinos (HCHS/SOL).Design: Participants self-reported their acculturation (immigrant generation, birthplace, residence in the U.S., language, and social acculturation), ethnic identity (sense of belonging and pride), and four OHRQOL measures. Key socio-demographic, behavioral, and oral health outcomes were tested as potential confounders.Results: Overall, 57% of individuals experienced poor OHRQOL in at least one of the domains examined. In multivariable analyses, some elements of higher acculturation were associated with greater food restriction and difficulty doing usual jobs/attending school, but not associated with pain or difficulty chewing, tasting, or swallowing. While sense of belonging to one's ethnic group was not associated with poor OHRQOL, low sense of pride was associated with food restriction. Socio-behavioral characteristics were significant effect modifiers.Conclusion: This study contributes to the understanding of the role of Hispanic/Latino's cultural factors in OHRQOL perception and can inform targeted strategies to improve OHRQOL in this diverse population.

Alcohol use, acculturation and socioeconomic status among Hispanic/Latino men and women: The Hispanic Community Health Study/Study of Latinos.

The objective of this study was to examine the prevalence and patterns of alcohol use among U.S. Hispanic/Latino adults of diverse backgrounds. The population-based Hispanic Community Health Study/ Study of Latinos (HCHS/SOL) enrolled a cohort of Hispanic/Latino adults (N = 16,415) ages 18-74 years at time of recruitment, from four US metropolitan areas between 2008-11. Drinking patterns and socio-demographics questionnaires were administered as part of the baseline examination. The relationship between age, sex, socio-demographics, acculturation, current alcohol use, and alcohol risk disorder, defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [no risk (i.e., never drinker), low risk (i.e., women<7 drinks/week; men<14 drinks/week), and at-risk (i.e., women>7 drinks/week; men>14 drinks/week)] were assessed in unadjusted and adjusted multinomial logistic regression analyses. Men reported a higher prevalence than women of at-risk drinking. For women, increased odds of at-risk alcohol use was associated with: a younger age, greater education, full-time employment, and acculturation after adjustment. For men, having a lower income (vs. higher income) or a higher income (vs. not reported) and being employed fulltime (vs. retired) was associated with at-risk alcohol use. For both men and women, there were variations in odds of at-risk drinking across Hispanic/Latino heritage backgrounds, after adjustment. Exact values, odds ratios and p-values are reported within the text. Common factors across sex associated with at-risk drinking included being of Mexican background and being employed full-time. Intervention strategies should consider diversity within the Hispanic/Latino community when designing alcohol abuse prevention programs.

Unfair Treatment and Periodontitis Among Adults in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL).

This study investigates how perceived unfair treatment, towards self and observed towards others due to ethnicity, is associated with periodontitis among diverse Hispanic/Latino adults, accounting for sociodemographic, health behavior, and acculturation factors. Baseline (2008-2011) dental and survey data from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a multicenter epidemiologic study, were analyzed (N = 12,750). Crude and adjusted prevalence ratios and confidence limits were estimated. Half (49%) reported never being treated unfairly, while 41% reported they were sometimes, and 10% reported it often/always. One third (32%) never saw others treated unfairly, while 42% reported it sometimes, and 26% reported it often/always. In the final fully adjusted model, the prevalence of periodontitis was higher among adults who were as follows: non-Dominican, older, male, had a past year dental visit, current and former smokers, and among those who observed unfair treatment towards others. Lower prevalence was associated with higher income, higher educational attainment, less than full-time employment, reporting experiencing unfair treatment, higher acculturation scores, and having health insurance. Perceived unfair treatment towards self was negatively associated with periodontitis prevalence, while observed unfair treatment towards others was positively associated with the outcome among diverse Hispanics/Latinos. The associations between unfair treatment and periodontitis warrant further exploration.

Validation of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being-Expanded (FACIT-Sp-Ex) Across English and Spanish-Speaking Hispanics/Latinos: Results From the Hispanic Community Health Study/Study of Latinos Sociocultural Ancillary Study.

The validity of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) has been examined in primarily non-Hispanics/Latinos with chronic illness. This study assessed the psychometric properties of the non-illness, expanded FACIT-Sp (FACIT-Sp-Ex) in 5,163 U.S. Hispanic/Latino adults. Measures were interviewer-administered in English or Spanish. Confirmatory factor analyses indicated four factors: Meaning, Peace, Faith, and Relational. The scale demonstrated measurement invariance across English and Spanish. Subscales displayed adequate internal and test-retest reliability. Scores were positively associated with Duke Religion Index (DUREL) subscales. When all subscales were entered in a single model, Meaning and Peace were inversely associated with depressive symptoms and positively associated with HRQOL. Faith was positively associated with depressive symptoms and inversely associated with HRQOL. Relational was not associated with any outcome. FACIT-Sp-Ex subscales were generally more strongly associated than DUREL subscales with well-being. The FACIT-Sp-Ex appears to be a valid measure of spiritual well-being in U.S. Hispanics/Latinos.

Analytical and biological variability in biomarker measurement in the Hispanic Community Health Study/Study of Latinos.

BACKGROUND: Biomarker variability, which includes within-individual variability (CVI), between-individual variability (CVG) and methodological variability (CVP+A) is an important determinant of our ability to detect biomarker-disease associations. Estimates of CVI and CVG may be population specific and little data exists on biomarker variability in diverse Hispanic populations. Hence, we evaluated all 3 components of biomarker variability in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) using repeat blood collections (n=58) and duplicate blood measurements (n=761-929 depending on the biomarker). METHODS: We estimated the index of individuality (II) ((CVI+CVP+A)/CVG) for 41 analytes and evaluated differences in the II across sexes and age groups. RESULTS: Biomarkers such as fasting glucose, triglycerides and ferritin had substantially higher inter-individual variability and lower II in HCHS/SOL as compared to the published literature. We also found significant sex-specific differences in the II for neutrophil count, platelet count, hemoglobin, % eosinophils and fasting glucose. The II for fasting insulin, post oral glucose tolerance test glucose and cystatin C was significantly higher among the 18-44y age group as compared to the 45+y age group. CONCLUSIONS: The implications of these findings for determining biomarker-disease associations in Hispanic populations need to be evaluated in future studies.

Association of Impaired Glucose Regulation and Insulin Resistance With Cardiac Structure and Function: Results From ECHO-SOL (Echocardiographic Study of Latinos).

BACKGROUND: We examined the relationship between glucose homeostasis and comprehensive measures of cardiac structure and function among a representative sample of US Hispanics. METHODS AND RESULTS: ECHO-SOL (Echocardiographic Study of Latinos), an echocardiographic ancillary study of the HCHS/SOL (Hispanic Community Health Study/Study of Latinos), enrolled 1818 Hispanic/Latino men (43%) and women (57%) aged ≥45 years (mean=56). Glucose intolerance was defined as follows: (1) prediabetes: hemoglobin (HbA1c) ≥5.7 and <6.5% and (2) diabetes mellitus: fasting plasma glucose ≥126 mg/dL, 2-hour postload glucose ≥200 mg/dL, HbA1c ≥6.5%, or hypoglycemic agent use. Uncontrolled diabetes mellitus was defined as HbA1c ≥7.0%. Insulin resistance was defined using the homeostatic model assessment for insulin resistance. Echocardiography examinations assessed left ventricular structure and systolic/diastolic function. Multivariable linear and logistic regression models were used. Prediabetes prevalence was 42%, and diabetes mellitus prevalence was 28% (47% uncontrolled). Glucose intolerance was associated with increased left ventricular posterior wall and interventricular septal and relative wall thicknesses (all P<0.05), reduced ejection fraction (P<0.01), reduced stroke and end-diastolic volumes (both P<0.001), decreased peak E' velocity (lateral and septal P<0.001), and increased E/E' ratio (lateral and septal P<0.01). The odds ratios (95% confidence intervals) for diastolic dysfunction among individuals with prediabetes and diabetes mellitus (versus diabetes mellitus free) were 1.36 (0.96-1.9) and 1.90 (1.3-2.8), respectively(P=0.006). Results were consistent for uncontrolled diabetes mellitus versus diabetes mellitus. Homeostatic model assessment for insulin resistance was associated with increased E/E' (P<0.001), and greater relative wall thickness and septal thickness (both P<0.05); lower stroke volume (P<0.0001); and lower peak lateral and septal E' velocities (both P<0.01). CONCLUSIONS: Glucose intolerance and insulin resistance are associated with unfavorable cardiac structure and function, particularly worsened measures of diastolic function, even before the development of diabetes mellitus.

Factors Associated With Ocular Health Care Utilization Among Hispanics/Latinos: Results From an Ancillary Study to the Hispanic Community Health Study/Study of Latinos (HCHS/SOL).

IMPORTANCE: Regular ocular care is critical to early detection and prevention of eye disease and associated morbidity and mortality; however, there have been relatively few studies of ocular health care utilization among Hispanics/Latinos of diverse backgrounds. OBJECTIVE: To examine factors associated with ocular health care utilization among Cuban, Central American, and South American Hispanics/Latinos in a cohort study. DESIGN, SETTING, AND PARTICIPANTS: An ancillary study to the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) evaluating ocular health, knowledge, risk factors, and health care use was conducted with 1235 HCHS/SOL participants (aged ≥40 years) at the Miami, Florida, study site. Data were collected from October 17, 2011, to September 30, 2013, and analyses were conducted from May 28, 2014, to March 18, 2015. Descriptive and multivariable logistic regression analyses were performed for 3 ocular health care outcomes. Regression models were built sequentially with variables conceptually grouped according to Andersen's Behavioral Model of Health Services Use. MAIN OUTCOMES AND MEASURES: Ever having an eye examination, having an eye examination performed within the past 2 years, and difficulty obtaining needed eye care in the past year. RESULTS: Of the 1235 participants, 478 were men and 757 were women, and they had a mean (SD) age of 53.6 (8.1) years. Those who never had insurance were less likely to have had an eye examination (with data reported as odds ratios [95% CIs]) ever, 0.19 (0.07-0.53) and in the past 2 years, 0.22 (0.15-0.33) and were more likely to have had difficulty obtaining needed eye care in the past year (3.72 [1.75-7.93]). Those with less than excellent or good self-rated eyesight were less likely to ever have had an eye examination (0.26 [0.12-0.56]) and more likely to have had difficulty obtaining care (3.00 [1.48-6.11]). Men were less likely to ever have had an eye examination (0.31 [0.18-0.53]). Older (55-64 years) Hispanics/Latinos (3.04 [1.47-6.31]) and those with a high school degree or general educational development certification (2.06 [1.02-4.13]) or higher levels of education (4.20 [2.12-8.30]) were more likely to ever have had an eye examination. Finally, those living in the United States for more than 15 years (0.42 [0.21-0.82]) were less likely to have had difficulty obtaining care. CONCLUSIONS AND RELEVANCE: Our findings suggest that increasing insurance coverage, decreasing the costs of care, and increasing the availability of care for Hispanics/Latinos with poor self-rated eyesight are relevant issues to address to improve ocular health care use among Hispanics/Latinos of diverse backgrounds.

Prevalence of suspected nonalcoholic fatty liver disease in Hispanic/Latino individuals differs by heritage.

BACKGROUND & AIMS: Nonalcoholic fatty liver disease (NAFLD) was shown to disproportionally affect Hispanic persons. We examined the prevalence of suspected NAFLD in Hispanic/Latino persons with diverse backgrounds. METHODS: We studied the prevalence of suspected NAFLD among 12,133 persons included in the Hispanic Community Health Study/Study of Latinos. We collected data on levels of aminotransferase, metabolic syndrome (defined by National Cholesterol Education Program-Adult Treatment Panel III guidelines), demographics, and health behaviors. Suspected NAFLD was defined on the basis of increased level of aminotransferase in the absence of serologic evidence for common causes of liver disease or excessive alcohol consumption. In multivariate analyses, data were adjusted for metabolic syndrome, age, acculturation, diet, physical activity, sleep, and levels of education and income. RESULTS: In multivariate analysis, compared with persons of Mexican heritage, persons of Cuban (odds ratio [OR], 0.69; 95% confidence interval [CI], 0.57-0.85), Puerto Rican (OR, 0.67; 95% CI, 0.52-0.87), and Dominican backgrounds (OR, 0.71; 95% CI, 0.54-0.93) had lower rates of suspected NAFLD. Persons of Central American and South American heritage had a similar prevalence of suspected NAFLD compared with persons of Mexican heritage. NAFLD was less common in women than in men (OR, 0.49; 95% CI, 0.40-0.60). Suspected NAFLD associated with metabolic syndrome and all 5 of its components. CONCLUSIONS: On the basis of an analysis of a large database of health in Latino populations, we found the prevalence of suspected NAFLD among Hispanic/Latino individuals to vary by region of heritage.

Smoking among U.S. Hispanic/Latino adults: the Hispanic community health study/study of Latinos.

BACKGROUND: Prior national surveys capture smoking behaviors of the aggregated U.S. Hispanic/Latino population, possibly obscuring subgroup variation. PURPOSE: To describe cigarette use among Hispanic/Latino adults across subgroups of age, gender, national background, SES, birthplace, and degree of acculturation to the dominant U.S. culture. METHODS: A cross-sectional survey of 16,322 participants in the Hispanic Community Health Study/Study of Latinos aged 18-74 years, recruited in Bronx NY, Chicago IL, Miami FL, and San Diego CA, was conducted during 2008-2011. RESULTS: Prevalence of current smoking was highest among Puerto Ricans (men, 35.0%; women, 32.6%) and Cubans (men, 31.3%; women, 21.9%), with particularly high smoking intensity noted among Cubans as measured by pack-years and cigarettes/day. Dominicans had the lowest smoking prevalence (men, 11.0%; women, 11.7%). Individuals of other national backgrounds had a smoking prevalence that was intermediate between these groups, and typically higher among men than women. Non-daily smoking was common, particularly although not exclusively among young men of Mexican background. Persons of low SES were more likely to smoke, less likely to have quit smoking, and less frequently used over-the-counter quit aids compared to those with higher income and education levels. Smoking was more common among individuals who were born in the U.S. and had a higher level of acculturation to the dominant U.S. culture, particularly among women. CONCLUSIONS: Smoking behaviors vary widely across Hispanic/Latino groups in the U.S., with a high prevalence of smoking among population subgroups with specific, readily identifiable characteristics.

The Hispanic Community Health Study/Study of Latinos Sociocultural Ancillary Study: sample, design, and procedures.

OBJECTIVES: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL) Sociocultural Ancillary Study aims to examine associations between sociocultural and psychosocial factors and cardiovascular disease (CVD) and metabolic syndrome prevalence in Hispanics/Latinos. The conceptual framework is based on the Reserve Capacity and Lifespan Biopsychosocial Models, which emphasize multiple risk and protective pathways underlying socioeconomic and ethnic influences in health. This study describes the rationale, participants, and procedures for the HCHS/SOL Sociocultural Ancillary Study. DESIGN AND SETTING: The Sociocultural Ancillary Study to the HCHS/SOL is a cross-sectional cohort study with future opportunities for prospective investigation. PARTICIPANTS: Participants were 5,313 adults, aged 18-74 years, of self-identified Hispanic/Latino descent and representing multiple Hispanic/Latino background groups, recruited from the Bronx, N.Y., Chicago, Ill., Miami, Fla., and San Diego, Calif. INTERVENTION: Participants completed an interview-administered sociocultural assessment battery within 9 months of their HCHS/SOL clinical baseline exam. OUTCOME MEASURES: The primary outcomes are CVD and metabolic syndrome and its component risk factors. RESULTS: The Sociocultural Ancillary Study sample is broadly representative of the HCHS/SOL cohort. Weighted demographics are: 55% male, 56% 18-44 years, 44% > or =45 years, and 37% Mexican, 20% Cuban, 16% Puerto Rican, 12% Dominican, 8% Central American, and 5% South American descent. CONCLUSIONS: By testing theoretically driven hypotheses concerning sociocultural and psychosocial factors in CVD, the Sociocultural Ancillary Study seeks to inform future prevention and intervention efforts for US Hispanic/Latinos.

Predictors of treatment response for depression and inadequate social support--the ENRICHD randomized clinical trial.

OBJECTIVE: To determine whether the 'dose' of treatment exposure, delivery of specific components of cognitive behavior therapy (CBT), patient adherence and/or use of antidepressants predict favorable depression and social support outcomes after 6 months of cognitive behavioral treatment. METHODS: Secondary analyses of the intervention arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial involving persons with acute myocardial infarction (MI): n = 641 for the depression outcomes and n = 523 for the social support outcomes. The outcome measures were, for depression: the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HAM-D); for social support: the ENRICHD Social Support Instrument (ESSI) and Perceived Social Support Scale (PSSS). RESULTS: Better depression outcomes (measured by the BDI) were receiving a high number of depression-specific intervention components, p < 0.01, and completing a high proportion of homework assignments, p < 0.02. Better depression outcomes (measured by the HAM-D) were receiving a high number of the social communication and assertiveness components of the intervention, p < 0.01, and completing a high proportion of homework assignments, p < 0.01. Better social support outcomes (measured by the ESSI and PSSS) were predicted by membership in a racial or ethnic minority group, p < 0.02 and p < 0.01, respectively; and by completing a higher number of homework assignments, p < 0.01 and p < 0.05, respectively. Delivery of the social communication and assertiveness components of the intervention was an independent predictor of a worse social support outcome, p < 0.01 (measured by the PSSS). CONCLUSIONS: The standard components of CBT for depression are useful in treating comorbid depression in post-MI patients. Working on communication skills may help to improve depression but not necessarily social support outcomes in this patient population, while adherence to cognitive-behavioral homework assignments is important for both outcomes. Other components of the ENRICHD intervention that were designed to improve social support had no discernible effects on outcomes. Intervention refinements may be needed in order to achieve better results in future post-MI clinical trials. A greater emphasis on CBT homework adherence could improve both depression and social support outcomes.

Coordinating and monitoring multisite clinical trials that combine pharmacological and behavioral treatments.

OBJECTIVE: Coordination of a large, multicenter Phase 3 clinical trial is critical to the success of the trial. The focus of this article is to describe the special challenges involved in the coordination of the 11 clinical centers conducting the COMBINE clinical trial and to discuss the challenges of monitoring the information collected on the 1,383 participants enrolled in this trial. METHOD: The role of the coordinating center in working with the clinical sites is to ensure both high data quality and that the intervention protocol is conducted with appropriate attention paid to patient safety and consistency across sites. To satisfy those goals, a research committee of investigators and coordinating center staff was formed. The committee monitored adverse event reporting, participant safety, recruitment, delivery of the interventions, collection of assessments and completeness and timeliness of transfer of data to the coordinating center. Objective measures of performance were determined for each criterion to provide the principal investigators, study sponsor and Data and Safety Monitoring Board with feedback on conduct of the trial. Site performance as defined by these criteria was evaluated periodically, with both detailed written and verbal feedback provided to each investigator and study coordinator. RESULTS: The system was successful in detecting sites with performance issues, providing feedback to site personnel and measuring improvement. Study leadership, clinical center staff and coordinating center staff felt that the procedures for identifying and solving performance issues worked well and improved overall performance. CONCLUSIONS: Establishing an organizational structure that provided (1) leadership, (2) a venue for communication, (3) performance criteria and (4) a process for monitoring performance goals and providing feedback has enabled COMBINE to achieve success in reaching these markers of clinical trial practice.

Effects of antidepressant medication on morbidity and mortality in depressed patients after myocardial infarction.

BACKGROUND: Depression after myocardial infarction (MI) is associated with higher morbidity and mortality. Although antidepressants are effective in reducing depression, their use in patients with cardiovascular disease remains controversial. OBJECTIVE: To undertake a secondary analysis to determine the effects of using antidepressants on morbidity and mortality in post-MI patients who participated in the Enhancing Recovery in Coronary Heart Disease study. DESIGN: Observational secondary analysis. SETTING: Eight academic sites. PATIENTS: The Enhancing Recovery in Coronary Heart Disease clinical trial randomized 2481 depressed and/or socially isolated patients from October 1, 1996, to October 31, 1999. Depression was diagnosed using a structured clinical interview. This analysis was conducted on the 1834 patients enrolled with depression (849 women and 985 men). INTERVENTION: Use of antidepressant medication. MAIN OUTCOME MEASURES: Event-free survival was defined as the absence of death or recurrent MI. All-cause mortality was also examined. To relate exposure to antidepressants to subsequent morbidity and mortality, the data were analyzed using a time-dependent covariate model. RESULTS: During a mean follow-up of 29 months, 457 fatal and nonfatal cardiovascular events occurred. The risk of death or recurrent MI was significantly lower in patients taking selective serotonin reuptake inhibitors (adjusted hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.38-0.84), as were the risk of all-cause mortality (adjusted HR, 0.59; 95% CI, 0.37-0.96) and recurrent MI (adjusted HR, 0.53; 95% CI, 0.32-0.90), compared with patients who did not use selective serotonin reuptake inhibitors. For patients taking non-selective serotonin reuptake inhibitor antidepressants, the comparable HRs (95% CIs) were 0.72 (0.44-1.18), 0.64 (0.34-1.22), and 0.73 (0.38-1.38) for risk of death or recurrent MI, all-cause mortality, or recurrent MI, respectively, compared with nonusers. CONCLUSIONS: Use of selective serotonin reuptake inhibitors in depressed patients who experience an acute MI might reduce subsequent cardiovascular morbidity and mortality. A controlled trial is needed to examine this important issue.