Comparison of Imputation Strategies for Incomplete Longitudinal Data in Life-Course Epidemiology.

Incomplete longitudinal data are common in life-course epidemiology and may induce bias leading to incorrect inference. Multiple imputation (MI) is increasingly preferred for handling missing data, but few studies explore MI-method performance and feasibility in real-data settings. We compared 3 MI methods using real data under 9 missing-data scenarios, representing combinations of 10%, 20%, and 30% missingness and missing completely at random, at random, and not at random. Using data from Health and Retirement Study (HRS) participants, we introduced record-level missingness to a sample of participants with complete data on depressive symptoms (1998-2008), mortality (2008-2018), and relevant covariates. We then imputed missing data using 3 MI methods (normal linear regression, predictive mean matching, variable-tailored specification), and fitted Cox proportional hazards models to estimate effects of 4 operationalizations of longitudinal depressive symptoms on mortality. We compared bias in hazard ratios, root mean square error, and computation time for each method. Bias was similar across MI methods, and results were consistent across operationalizations of the longitudinal exposure variable. However, our results suggest that predictive mean matching may be an appealing strategy for imputing life-course exposure data, given consistently low root mean square error, competitive computation times, and few implementation challenges.

Randomized Comparative Effectiveness Trial of 2 Federally Recommended Strategies to Reduce Excess Body Fat in Overweight, Low-Income Patients: MyPlate.gov vs Calorie Counting.

PURPOSE: Since 2011, US authorities have supported the following 2 approaches to healthier body fat composition: the Centers for Disease Control and Prevention National Diabetes Prevention Program's calorie counting (CC) approach and the US Department of Agriculture's MyPlate (adherence to federal nutrition guidelines). The purpose of this study was to compare the effect of CC vs MyPlate approaches on satiety/satiation and on achieving healthier body fat composition among primary care patients. METHODS: We conducted a randomized controlled trial comparing the CC and MyPlate approaches from 2015 to 2017. The adult participants were overweight, of low income, and were mostly Latine (n = 261). For both approaches, community health workers conducted 2 home education visits, 2 group education sessions, and 7 telephone coaching calls over a period of 6 months. Satiation and satiety were the primary patient-centered outcome measures. Waist circumference and body weight were the primary anthropometric measures. Measures were assessed at baseline, 6 months, and 12 months. RESULTS: Satiation and satiety scores increased for both groups. Waist circumference was significantly decreased in both groups. MyPlate, but not CC, resulted in lower systolic blood pressure at 6 months but not at 12 months. Participants for both MyPlate and CC reported greater quality of life and emotional well-being and high satisfaction with their assigned weight-loss program. The most acculturated participants showed the greatest decreases in waist circumference. CONCLUSIONS: A MyPlate-based intervention might be a practical alternative to the more traditional CC approach to promoting satiety and facilitating decreases in central adiposity among low-income, mostly Latine primary care patients.

Intimate Partner Violence and Food Insecurity Predict Early Behavior Problems Among South African Children over 5-years Post-Birth.

Households experiencing intimate partner violence (IPV) and food insecurity are at high risk of lifelong physical and behavioral difficulties. Longitudinal data from a perinatal home-visiting cluster-randomized controlled intervention trial in South Africa townships were used to examine the relationships between household settings and mothers' histories of risk and children's behavior problems at 3 and 5 years of age. IPV, food insecurity, maternal depressed mood, and geriatric pregnancy (at age of 35 or older) were consistently associated with children's internalizing and externalizing behavior problems. Aggressive behavior was more prevalent among 3- and 5-year olds boys, and was associated with maternal alcohol use. The effects of these factors on child behavior were more prominent than maternal HIV status. There is a continuing need to reduce IPV and household food insecurity, as well as supporting older, depressed, alcohol using mothers in order to address children's behavioral needs.

Comparative effectiveness trial comparing MyPlate to calorie counting for mostly low-income Latino primary care patients of a federally qualified community health center: study design, baseline characteristics.

BACKGROUND: Primary care-based behavior change obesity treatment has long featured the Calorie restriction (CC), portion control approach. By contrast, the MyPlate-based obesity treatment approach encourages eating more high-satiety/high-satiation foods and requires no calorie-counting. This report describes study methods of a comparative effectiveness trial of CC versus MyPlate. It also describes baseline findings involving demographic characteristics and their associations with primary outcome measures and covariates, including satiety/satiation, dietary quality and acculturation. METHODS: A comparative effectiveness trial was designed to compare the CC approach (n = 130) versus a MyPlate-based approach (n = 131) to treating patient overweight. Intervenors were trained community health workers. The 11 intervention sessions included two in-home health education sessions, two group education sessions, and seven telephone coaching sessions. Questionnaire and anthropometric assessments occurred at baseline, 6- and 12 months; food frequency questionnaires were administered at baseline and 12 months. Participants were overweight adult primary care patients of a federally qualified health center in Long Beach, California. Two measures of satiety/satiation and one measure of post-meal hunger comprised the primary outcome measures. Secondary outcomes included weight, waist circumference, blood pressure, dietary quality, sugary beverage intake, water intake, fruit and vegetable fiber intake, mental health and health-related quality of life. Covariates included age, gender, nativity status (U.S.-born, not U.S.-born), race/ethnicity, education, and acculturation. ANALYSIS: Baseline characteristics were compared using chi square tests. Associations between covariates and outcome measures were evaluated using multiple regression and logistic regression. RESULTS: Two thousand eighty-six adult patients were screened, yielding 261 enrollees who were 86% Latino, 8% African American, 4% White and 2% Other. Women predominated (95%). Mean age was 42 years. Most (82%) were foreign-born; 74% chose the Spanish language option. Mean BMI was 33.3 kg/m2; mean weight was 82 kg; mean waist circumference was 102 cm. Mean blood pressure was 122/77 mm. Study arms on key baseline measures did not differ except on dietary quality and sugary beverage intake. Nativity status was significantly associated with dietary quality. CONCLUSIONS: The two treatment arms were well-balanced demographically at baseline. Nativity status is inversely related to dietary quality. TRIAL REGISTRATION: NCT02514889 , posted on 8/4/2015.

Methamphetamine use and oral health-related quality of life.

PURPOSE: Methamphetamine (MA) is associated with adverse health effects, including the rampant tooth decay condition called "Meth Mouth." However, the impact of MA use on oral health-related quality of life (OHRQOL) is unknown. This study assessed the relationship between MA use and self-reported OHRQOL. METHODS: This cross-sectional study uses information from 545 MA-using participants recruited from Los Angeles County, California. Dental examinations were performed by three calibrated dentists using National Health and Nutrition Examination Survey (NHANES) protocols. Data on socio-demographic, behavioral, and drug-use history were recorded using questionnaires. Participants were categorized as 'light' or 'moderate/heavy' users based on reported frequency of MA use in the past 30 days. Route of MA administration was categorized as 'smoking' or 'other.' Self-reported OHRQOL was based on the Oral Health Impact Profile scale. RESULTS: Majority of the participants were male (80.9%). Median age was 45.0 years (IQR-13.0). Median number of days of MA use was 10.0 (IQR-12.0). Smoking was the preferred route of MA use (70.2%). Root caries in ≥ 3 teeth were reported in 78% of MA users. More than half of the participants reported having painful aching in mouth, avoidance of particular food items, feeling embarrassed, and discomfort while eating in the last 12 months. In unadjusted logistic models, moderate/heavy MA users were more likely to report an affected sense of taste [OR = 1.58, 95% CI (1.10-2.27)] and avoidance of particular foods [OR = 1.45, 95% CI (1.02-2.01)] than light users. Among individuals preferring other MA administration routes, moderate/heavy MA users were 3.09 times as likely to report an affected sense of taste than light users [OR = 3.09, 95% CI (1.52-6.27)]. CONCLUSION: Oral health and OHRQOL appear to be worse among Methamphetamine users than in the US general population.

Maintaining Internal Validity in Community Partnered Participatory Research: Experience from the Community Partners in Care Study.

Objective: With internal validity being a central goal of designed experiments, we seek to elucidate how community partnered participatory research (CPPR) impacts the internal validity of public health comparative-effectiveness research. Methods: Community Partners in Care (CPIC), a study comparing a community-coalition intervention to direct technical assistance for disseminating depression care to vulnerable populations, is used to illustrate design choices developed with attention to core CPPR principles. The study-design process is reviewed retrospectively and evaluated based on the resulting covariate balance across intervention arms and on broader peer-review assessments. Contributions of the CPIC Council and the study's design committee are highlighted. Results: CPPR principles contributed to building consensus around the use of randomization, creating a sampling frame, specifying geographic boundaries delimiting the scope of the investigation, grouping similar programs into pairs or other small blocks of units, collaboratively choosing random-number-generator seeds to determine randomized intervention assignments, and addressing logistical constraints in field operations. Study protocols yielded samples that were well-balanced on background characteristics across intervention arms. CPIC has been recognized for scientific merit, has drawn attention from policymakers, and has fueled ongoing research collaborations. Conclusions: Creative and collaborative fulfillment of CPPR principles reinforced the internal validity of CPIC, strengthening the study's scientific rigor by engaging complementary areas of knowledge and expertise among members of the investigative team.

Comparative Effectiveness of Coalitions Versus Technical Assistance for Depression Quality Improvement in Persons with Multiple Chronic Conditions.

Significance: Prior research suggests that Community Engagement and Planning (CEP) for coalition support compared with Resources for Services (RS) for program technical assistance to implement depression quality improvement programs improves 6- and 12-month client mental-health related quality of life (MHRQL); however, effects for clients with multiple chronic medical conditions (MCC) are unknown. Objective: To explore effectiveness of CEP vs RS in MCC and non-MCC subgroups. Design: Secondary analyses of a cluster-randomized trial. Setting: 93 health care and community-based programs in two neighborhoods. Participants: Of 4,440 clients screened, 1,322 depressed (Patient Health Questionnaire, PHQ8) provided contact information, 1,246 enrolled and 1,018 (548 with ≥3 MCC) completed baseline, 6- or 12-month surveys. Intervention: CEP or RS for implementing depression quality improvement programs. Outcomes and Analyses: Primary: depression (PHQ9 <10), poor MHRQL (Short Form Health Survey, SF-12<40); Secondary: mental wellness, good physical health, behavioral health hospitalization, chronic homelessness risk, work/workloss days, services use at 6 and 12 months. End-point regressions were used to estimate intervention effects on outcomes for subgroups with ≥3 MCC, non-MCC, and intervention-by-MCC interactions (exploratory). Results: Among MCC clients at 6 months, CEP vs RS lowered likelihoods of depression and poor MHRQL; increased likelihood of mental wellness; reduced work-loss days among employed and likelihoods of ≥4 behavioral-health hospitalization nights and chronic homelessness risk, while increasing faith-based and park community center depression services; and at 12 months, likelihood of good physical health and park community center depression services use (each P<.05). There were no significant interactions or primary outcome effects for non-MCC. Conclusions: CEP was more effective than RS in improving 6-month primary outcomes among depressed MCC clients, without significant interactions.

A corner store intervention to improve access to fruits and vegetables in two Latino communities.

OBJECTIVE: Investments have been made to alter the food environment of neighbourhoods that have a disproportionate number of unhealthy food venues. Corner store conversions are one strategy to increase access to fruits and vegetables (F&V). Although the literature shows modest success, the effectiveness of these interventions remains equivocal. The present paper reports on the evaluation of Proyecto MercadoFRESCO, a corner store conversion intervention in two Latino communities. DESIGN: A repeated cross-sectional design was employed. Data were stratified by intervention arm and bivariate tests assessed changes over time. Logistic and multiple regression models with intervention arm, time and the interaction of intervention and time were conducted. Supplementary analyses account for clustering of patrons within stores and staggering of store conversions. SETTING: Three stores were converted and five stores served as comparisons in East Los Angeles and Boyle Heights, California, USA. SUBJECTS: Store patrons were interviewed before (n550) and after (n407) the intervention. RESULTS: Relative to patrons of comparison stores, patrons of intervention stores demonstrated more favourable perceptions of corner stores and increased purchasing of F&V during that store visit. Changes were not detected in store patronage, percentage of weekly dollars spent on food for F&V or daily consumption of F&V. CONCLUSIONS: Consistent with some extant food environment literature, findings demonstrate limited effects. Investments should be made in multilevel, comprehensive interventions that target a variety retail food outlets rather than focusing on corner stores exclusively. Complementary policies limiting the availability, affordability and marketing of energy-dense, nutrient-poor foods should also be pursued.

Training the Next Generation of Latino Health Researchers: A Multilevel, Transdisciplinary, Community-Engaged Approach.

Reducing health disparities is a national public health priority. Latinos represent the largest racial/ethnic minority group in the United States and suffer disproportionately from poor health outcomes, including cardiovascular disease risk. Academic training programs are an opportunity for reducing health disparities, in part by increasing the diversity of the public health workforce and by incorporating training designed to develop a skill set to address health disparities. This article describes the Training and Career Development Program at the UCLA Center for Population Health and Health Disparities: a multilevel, transdisciplinary training program that uses a community-engaged approach to reduce cardiovascular disease risk in two urban Mexican American communities. Results suggest that this program is effective in enhancing the skill sets of traditionally underrepresented students to become health disparities researchers and practitioners.

Long-Term Effects of Pre-Placement Risk Factors on Children's Psychological Symptoms and Parenting Stress Among Families Adopting Children From Foster Care.

This exploratory longitudinal study examined behavioral outcomes and parenting stress among families with children adopted from foster care, taking into account environmental and biological risk factors. Child internalizing and externalizing problems and parenting stress were assessed in 82 adopted children and their families at 2 months post-placement, 12 months post-placement, and then yearly until 5 years post-placement. A history of abuse/neglect predicted significantly higher externalizing and internalizing problems at a borderline level of statistical significance. In the initial stages after placement, externalizing problems were significantly higher among children who were 4 years or older at placement versus those who were younger than 4, although differences were no longer significant 5 years post-placement. Statistical trends in parenting stress reflected reduced stress in the first 12 months followed by a plateau for parents who adopted older children and greater stress for parents who adopted younger children. Familiar limitations for observational cohort data apply. Nonetheless, the availability of longitudinal follow-up on a sizable sample of children adopted from foster care adds insight to the psychological dynamics for adoptive families and suggests that families of children adopted from the foster care system may have unique needs for ongoing support around behavioral issues.

Substantial improvements not seen in health behaviors following corner store conversions in two Latino food swamps.

BACKGROUND: The effectiveness of food retail interventions is largely undetermined, yet substantial investments have been made to improve access to healthy foods in food deserts and swamps via grocery and corner store interventions. This study evaluated the effects of corner store conversions in East Los Angeles and Boyle Heights, California on perceived accessibility of healthy foods, perceptions of corner stores, store patronage, food purchasing, and eating behaviors. METHODS: Household data (n = 1686) were collected at baseline and 12- to 24-months post-intervention among residents surrounding eight stores, three of which implemented a multi-faceted intervention and five of which were comparisons. Bivariate analyses and logistic and linear regressions were employed to assess differences in time, treatment, and the interaction between time and treatment to determine the effectiveness of this intervention. RESULTS: Improvements were found in perceived healthy food accessibility and perceptions of corner stores. No changes were found, however, in store patronage, purchasing, or consumption of fruits and vegetables. CONCLUSIONS: Results suggest limited effectiveness of food retail interventions on improving health behaviors. Future research should focus on other strategies to reduce community-level obesity.

Sampling and Recruiting Community-Based Programs Using Community-Partnered Participation Research.

The inclusion of community partners in participatory leadership roles around statistical design issues like sampling and randomization has raised concerns about scientific integrity. This article presents a case study of a community-partnered, participatory research (CPPR) cluster-randomized, comparative effectiveness trial to examine implications for study validity and community relevance. Using study administrative data, we describe a CPPR-based design and implementation process for agency/program sampling, recruitment, and randomization for depression interventions. We calculated participation rates and used cross-tabulation to examine balance by intervention status on service sector, location, and program size and assessed differences in potential populations served. We achieved 51.5% agency and 89.6% program participation rates. Programs in different intervention arms were not significantly different on service sector, location, or program size. Participating programs were not significantly different from eligible, nonparticipating programs on community characteristics. We reject claims that including community members in research design decisions compromises scientific integrity. This case study suggests that a CPPR process can improve implementation of a community-grounded, rigorous randomized comparative effectiveness trial.

Evaluating model-based imputation methods for missing covariates in regression models with interactions.

Imputation strategies are widely used in settings that involve inference with incomplete data. However, implementation of a particular approach always rests on assumptions, and subtle distinctions between methods can have an impact on subsequent analyses. In this research article, we are concerned with regression models in which the true underlying relationship includes interaction terms. We focus in particular on a linear model with one fully observed continuous predictor, a second partially observed continuous predictor, and their interaction. We derive the conditional distribution of the missing covariate and interaction term given the observed covariate and the outcome variable, and examine the performance of a multiple imputation procedure based on this distribution. We also investigate several alternative procedures that can be implemented by adapting multivariate normal multiple imputation software in ways that might be expected to perform well despite incompatibilities between model assumptions and true underlying relationships among the variables. The methods are compared in terms of bias, coverage, and CI width. As expected, the procedure based on the correct conditional distribution performs well across all scenarios. Just as importantly for general practitioners, several of the approaches based on multivariate normality perform comparably with the correct conditional distribution in a number of circumstances, although interestingly, procedures that seek to preserve the multiplicative relationship between the interaction term and the main-effects are found to be substantially less reliable. For illustration, the various procedures are applied to an analysis of post-traumatic stress disorder symptoms in a study of childhood trauma.

12-month outcomes of community engagement versus technical assistance to implement depression collaborative care: a partnered, cluster, randomized, comparative effectiveness trial.

BACKGROUND: Depression collaborative care implementation using community engagement and planning (CEP) across programs improves 6-month client outcomes in minority communities, compared with technical assistance to individual programs (resources for services [RS]). However, 12-month outcomes are unknown. OBJECTIVE: To compare effects of CEP and RS on mental health-related quality of life (MHRQL) and use of services among depressed clients at 12 months. DESIGN: Matched health and community programs (n = 93) in 2 communities randomly assigned to receive CEP or RS. (ClinicalTrials.gov: NCT01699789). MEASUREMENTS: Self-reported MHRQL and services use at baseline, 6 months, and 12 months. SETTING: Los Angeles, California. PATIENTS: 1018 adults with depressive symptoms (8-item Patient Health Questionnaire score ≥10), 88% of whom were an ethnic minority. INTERVENTION: CEP and RS to implement depression collaborative care. MEASUREMENTS: The primary outcome was poor MHRQL (12-item mental health composite score ≤40) at baseline, 6 months, and 12 months; the secondary outcome was use of services at 12 months. RESULTS: At 6 months, the finding that CEP outperformed RS to reduce poor MHRQL was significant but sensitive to underlying statistical assumptions. At 12 months, some analyses suggested that CEP was advantageous to MHRQL, whereas others did not confirm a significant difference favoring CEP. The finding that CEP reduced behavioral health hospitalizations at 6 months was less evident at 12 months and was sensitive to underlying statistical assumptions. Other services use did not significantly differ between interventions at 12 months. LIMITATION: Data are self-reported, and findings are sensitive to modeling assumptions. CONCLUSION: In contrast to 6-month results, no consistent effects of CEP on reducing the likelihood of poor MHRQL and behavioral health hospitalizations were found at 12 months. Still, given the needs of underresourced communities, the favorable profile of CEP, and the lack of evidence-based alternatives, CEP remains a viable strategy for policymakers and communities to consider. PRIMARY FUNDING SOURCE: National Institute of Mental Health, Robert Wood Johnson Foundation, California Community Foundation, National Library of Medicine, and National Institutes of Health/National Center for Advancing Translational Science for the UCLA Clinical and Translational Science Institute.

Performance of a quality assurance program for assessing dental health in methamphetamine users.

BACKGROUND: Systematic characterization of the dental consequences of methamphetamine (MA) abuse presupposes a rigorous quality assurance (QA) program to ensure the credibility of the data collected and the scientific integrity and validity of the clinical study. In this report we describe and evaluate the performance of a quality assurance program implemented in a large cross-sectional study of the dental consequences of MA use. METHODS: A large community sample of MA users was recruited over a 30 month period during 2011-13 and received comprehensive oral examinations and psychosocial assessments by site examiners based at two large community health centers in Los Angeles. National Health and Nutrition Examination Survey (NHANES) protocols for oral health assessments were utilized to characterize dental disease. Using NHANES oral health quality assurance guidelines, examiner reliability statistics such as Cohen's Kappa coefficients and inter-class correlation coefficients were calculated to assess the magnitude of agreement between the site examiners and a reference examiner to ensure conformance and comparability with NHANES practices. RESULTS: Approximately 9% (n = 49) of the enrolled 574 MA users received a repeat dental caries and periodontal examination conducted by the reference examiner. There was high concordance between the reference examiner and the site examiners for identification of untreated dental disease (Kappa statistic values: 0.57-0.75, percent agreement 83-88%). For identification of untreated caries on at least 5 surfaces of anterior teeth, the Kappas ranged from 0.77 to 0.87, and percent agreement from 94 to 97%. The intra-class coefficients (ICCs) ranged from 0.87 to 89 for attachment loss across all periodontal sites assessed and the ICCs ranged from 0.79 to 0.81 for pocket depth. For overall gingival recession, the ICCs ranged from 0.88 to 0.91. When Kappa was calculated based on the CDC/AAP case definitions for severe periodontitis, inter-examiner reliability for site examiners was low (Kappa 0.27-0.67). CONCLUSION: Overall, the quality assurance program confirmed the procedural adherence of the quality of the data collected on the distribution of dental caries and periodontal disease in MA-users. Examiner concordance was higher for dental caries but lower for specific periodontal assessments.

Multiple imputation for high-dimensional mixed incomplete continuous and binary data.

It is common in applied research to have large numbers of variables measured on a modest number of cases. Even with low rates of missingness of individual variables, such data sets can have a large number of incomplete cases with a mix of data types. Here, we propose a new joint modeling approach to address the high-dimensional incomplete data with a mix of continuous and binary data. Specifically, we propose a multivariate normal model encompassing both continuous variables and latent variables corresponding to binary variables. We apply a parameter-extended Metropolis­Hastings algorithm to generate the covariance matrix of a mixture of continuous and binary variables. We also introduce prior distribution families for unstructured covariance matrices to reduce the dimension of the parameter space. In several simulation settings, the method is compared with available-case analysis, a rounding method, and a sequential regression method.

A Remote Oral Self-Care Behaviors Assessment System in Vulnerable Populations: Usability and Feasibility Study.

BACKGROUND: Preventative self-care can reduce dental disease that disproportionately burdens vulnerable populations. Personalized digital oral self-care behavioral interventions offer a promising solution. However, the success of these digital interventions depends on toothbrushing data collection e-platforms attuned to the needs and preferences of vulnerable communities. OBJECTIVE: The aim of this study is to assess the usability and feasibility of the Remote Oral Behaviors Assessment System (ROBAS), which has been adapted to address the unique requirements of socioeconomically disadvantaged minority individuals. METHODS: A cohort of 53 community-clinic participants, including 31 (58%) Latino and 22 (42%) Black individuals with no prior experience using electric toothbrushes, were recruited to use ROBAS, with planned assessments at baseline, 2 months, and 4 months. Beyond evaluating ROBAS's technical performance, extensive feedback was gathered to gauge users' experiences, viewpoints, and overall contentment. The System Usability Scale (SUS) served as a primary metric for assessing user satisfaction and acceptability. RESULTS: ROBAS exhibited largely reliable and consistent data-gathering capabilities. SUS scores (mean 75.6, SD 14.5) reflected participant contentment within a range of values for other commonly used digital devices and technologies. Among participants who answered questions about willingness to pay for ROBAS, 97% (30/31) indicated that they were willing to pay for ROBAS either as a one-time payment or as a subscription-based service. Additionally, 87.5% of participants expressed that they would endorse it to acquaintances. Most participants expressed no reservations about privacy; among those who expressed privacy concerns (n=20, 50%), the concerns included exposure of information (n=18, 45%), monitoring of brushing habits (n=12, 30%), and collection of information (n=14, 35%), although these concerns did not significantly correlate with specific participant traits. In qualitative terms, users valued ROBAS's ability to monitor brushing habits but called for refinements, especially in Wi-Fi and application connectivity. Recommendations for system improvements encompassed enhanced app functionality, individualized coaching, more comprehensive brushing data, and the addition of flossing activity tracking. CONCLUSIONS: The research highlights ROBAS's promise as a digital platform for unobtrusively tracking daily oral self-care activities in marginalized communities. The system proved to be both feasible, as evidenced by its stable and accurate data capture of brushing behaviors, and user-friendly, as reflected by strong SUS scores and positive user feedback. Influential factors for its uptake included ease of learning and operation, and the feedback provided.

Extended observation of reduced methamphetamine use with combined naltrexone plus bupropion in the ADAPT-2 trial.

BACKGROUND AND AIMS: A 12-week placebo-controlled, sequential parallel Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (ADAPT-2) trial evaluated the effects of extended-release injectable naltrexone plus extended-release oral bupropion (NTX + BUPN) on methamphetamine (MA) use over two stages. This study reports on the previously unpublished stage 2 MA use in participants randomized at stage 1 to receive NTX + BUPN through both stages compared with those assigned to placebo. DESIGN: This is a secondary analysis of the US National Institute on Drug Abuse (NIDA) ADAPT-2 network trial. SETTING: The parent ADAPT-2 trial was carried out across multiple NIDA Clinical Trials Network (CTN) sites in the United States. PARTICIPANTS: This analysis includes 403 people with MA use disorder who participated in the ADAPT-2 CTN trial. INTERVENTION AND COMPARATOR: NTX + BUPN was compared with placebo over the course of the trial. MEASUREMENT: MA use was measured by urine drug screens conducted twice weekly for 12 weeks, then once in week 13 and once in week 16 post-treatment follow-up. FINDINGS: Participants on NTX + BUPN in stage 1 showed an additional 9.2% increase [95% confidence interval (CI), 0.09%-17.9%, P = 0.038] during stage 2 in their probability of testing negative for MA, with a total increase of 27.1% (95% CI, 13.2%-41.1%, P < 0.001) over the full 12 weeks of treatment. In contrast, participants on placebo in both stages increased in probability of testing MA-negative by a total of 11.4% (95% CI, 4.1%-18.6%, P = 0.002) over all 12 weeks. The 12-week increase among participants on NTX + BUPN was significantly greater-by 15.8% (95% CI, 4.5%-27.0%, P = 0.006)-than the increase among those on placebo. CONCLUSION: For people with methamphetamine (MA) use disorder receiving treatment with extended-release injectable naltrexone plus extended-release oral bupropion (NTX + BUPN), continued treatment with NTX + BUPN after 6 weeks is associated with additional reductions in MA use up to 12 weeks.

Community-partnered evaluation of depression services for clients of community-based agencies in under-resourced communities in Los Angeles.

BACKGROUND: As medical homes are developing under health reform, little is known regarding depression services need and use by diverse safety-net populations in under-resourced communities. For chronic conditions like depression, primary care services may face new opportunities to partner with diverse community service providers, such as those in social service and substance abuse centers, to support a collaborative care model of treating depression. OBJECTIVE: To understand the distribution of need and current burden of services for depression in under-resourced, diverse communities in Los Angeles. DESIGN: Baseline phase of a participatory trial to improve depression services with data from client screening and follow-up surveys. PARTICIPANTS: Of 4,440 clients screened from 93 programs (primary care, mental health, substance abuse, homeless, social and other community services) in 50 agencies, 1,322 were depressed according to an eight-item Patient Health Questionnaire (PHQ-8) and gave contact information; 1,246 enrolled and 981 completed surveys. Ninety-three programs, including 17 primary care/public health, 18 mental health, 20 substance abuse, ten homeless services, and 28 social/other community services, participated. MAIN MEASURES: Comparisons by setting in 6-month retrospective recall of depression services use. KEY RESULTS: Depression prevalence ranged from 51.9 % in mental health to 17.2 % in social-community programs. Depressed clients used two settings on average to receive depression services; 82 % used any setting. More clients preferred counseling over medication for depression treatment. CONCLUSIONS: Need for depression care was high, and a broad range of agencies provide depression care. Although most participants had contact with primary care, most depression services occurred outside of primary care settings, emphasizing the need to coordinate and support the quality of community-based services across diverse community settings.

Community-partnered cluster-randomized comparative effectiveness trial of community engagement and planning or resources for services to address depression disparities.

BACKGROUND: Depression contributes to disability and there are ethnic/racial disparities in access and outcomes of care. Quality improvement (QI) programs for depression in primary care improve outcomes relative to usual care, but health, social and other community-based service sectors also support clients in under-resourced communities. Little is known about effects on client outcomes of strategies to implement depression QI across diverse sectors. OBJECTIVE: To compare the effectiveness of Community Engagement and Planning (CEP) and Resources for Services (RS) to implement depression QI on clients' mental health-related quality of life (HRQL) and services use. DESIGN: Matched programs from health, social and other service sectors were randomized to community engagement and planning (promoting inter-agency collaboration) or resources for services (individual program technical assistance plus outreach) to implement depression QI toolkits in Hollywood-Metro and South Los Angeles. PARTICIPANTS: From 93 randomized programs, 4,440 clients were screened and of 1,322 depressed by the 8-item Patient Health Questionnaire (PHQ-8) and providing contact information, 1,246 enrolled and 1,018 in 90 programs completed baseline or 6-month follow-up. MEASURES: Self-reported mental HRQL and probable depression (primary), physical activity, employment, homelessness risk factors (secondary) and services use. RESULTS: CEP was more effective than RS at improving mental HRQL, increasing physical activity and reducing homelessness risk factors, rate of behavioral health hospitalization and medication visits among specialty care users (i.e. psychiatrists, mental health providers) while increasing depression visits among users of primary care/public health for depression and users of faith-based and park programs (each p < 0.05). Employment, use of antidepressants, and total contacts were not significantly affected (each p > 0.05). CONCLUSION: Community engagement to build a collaborative approach to implementing depression QI across diverse programs was more effective than resources for services for individual programs in improving mental HRQL, physical activity and homelessness risk factors, and shifted utilization away from hospitalizations and specialty medication visits toward primary care and other sectors, offering an expanded health-home model to address multiple disparities for depressed safety-net clients.