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Data harmonization is the process by which each of the variables from different research studies are standardized to similar units resulting in comparable datasets. These data may be integrated for more powerful and accurate examination and prediction of outcomes for use in the intelligent and smart electronic health software programs and systems. Prospective harmonization is performed when researchers create guidelines for gathering and managing the data before data collection begins. In contrast, retrospective harmonization is performed by pooling previously collected data from various studies using expert domain knowledge to identify and translate variables. In nutritional epidemiology, dietary data harmonization is often necessary to construct the nutrient and food databases necessary to answer complex research questions and develop effective public health policy. In this paper, we review methods for effective data harmonization, including developing a harmonization plan, which common standards already exist for harmonization, and defining variables needed to harmonize datasets. Currently, several large-scale studies maintain harmonized nutrient databases, especially in Europe, and steps have been proposed to inform the retrospective harmonization process. As an example, data harmonization methods are applied to several U.S longitudinal diet datasets. Based on our review, considerations for future dietary data harmonization include user agreements for sharing private data among participating studies, defining variables and data dictionaries that accurately map variables among studies, and the use of secure data storage servers to maintain privacy. These considerations establish necessary components of harmonized data for smart health applications which can promote healthier eating and provide greater insights into the effect of dietary patterns on health.

Background Motivational messaging is a frequently used digital intervention to promote positive health behavior changes, including smoking cessation. Typically, motivational messaging systems have not actively sought feedback on each message, preventing a closer examination of the user-system engagement. This study assessed the granular user-system engagement around a recommender system (a new system that actively sought user feedback on each message to improve message selection) for promoting smoking cessation and the impact of engagement on cessation outcome. Methods We prospectively followed a cohort of current smokers enrolled to use the recommender system for 6 months. The system sent participants motivational messages to support smoking cessation every 3 days and used machine learning to incorporate user feedback (i.e., user’s rating on the perceived influence of each message, collected on a 5-point Likert scale with 1 indicating strong disagreement and 5 indicating strong agreement on perceiving the influence on quitting smoking) to improve the selection of the following message. We assessed user-system engagement by various metrics, including user response rate (i.e., the percent of times a user rated the messages) and the perceived influence of messages. We compared retention rates across different levels of user-system engagement and assessed the association between engagement and the 7-day point prevalence abstinence (missing outcome = smoking) by using multiple logistic regression. Results We analyzed data from 731 participants (13% Black; 73% women). The user response rate was 0.24 (SD = 0.34) and user-perceived influence was 3.76 (SD = 0.84). The retention rate positively increased with the user response rate (trend test P Conclusions High user-system engagement was positively associated with both high retention rate and smoking cessation, suggesting that investigation of methods to increase engagement may be crucial to increase the impact of the recommender system for smoking cessation. Trial registration Registration Identifier: NCT03224520. Registration date: July 21, 2017.

Background Six million Americans suffer from atrial fibrillation (AF), a heart rhythm abnormality that significantly increases the risk of stroke. AF is responsible for 15% of ischemic strokes, which lead to permanent disability in 60% of cases and death in up to 20%. Anticoagulation (AC) is the mainstay for stroke prevention in patients with AF. Despite guidelines recommending AC for patients, up to half of eligible patients are not on AC. Clinical decision support tools in the electronic health record (EHR) can help bridge the disparity in AC prescription for patients with AF. Objective To enhance and assess the effectiveness of our previous rule-based alert on AC initiation and persistence in a diverse patient population from UMass-Memorial Medical Center and University of Florida at Jacksonville. Methods/Results Using the EHR, we will track AC initiation and persistence. We will interview both patients and providers to determine a measure of satisfaction with AC management. We will track digital crumbs to better understand the alert's mechanism of effect and further add enhancements. These enhancements will be used to refine the alert and aid in developing an implementation toolkit to facilitate use of the alert at other health systems. Conclusion If the number of AC starts, the likelihood of persisting on AC, and the frequency alert use are found to be higher among intervention vs control providers, we believe such findings will confirm our hypothesis on the effectiveness of our alert.

Background: Breastfeeding and Kangaroo Mother Care (KMC) are interventions to reduce neonatal mortality and undernutrition. We investigated the knowledge of allopathic and Ayurvedic, Yoga-naturopathy, Siddha, and Homeopathic (AYUSH) general practitioners in rural western India and identified attributes associated with awareness and knowledge on these topics. Methods: This cross-sectional study of general practitioners in the Anand district of Gujarat, India, used an anonymous self-reported survey. Multivariable regression models were used to identify practitioner attributes associated with awareness and knowledge. Results: Among the 158 respondents, a quarter (26.0%) were trained in allopathic medicine and 63.0% had practiced for 5 years or more. The average score of breastfeeding knowledge was 8.0 of 13. Most (79.1%) did not have any awareness of KMC. After adjusting for potential confounders, knowledge of breastfeeding practices among AYUSH practitioners was 4-fold greater than that of allopathic practitioners (incidence rate ratio: 3.9; 95% CI: 3.2-4.6). By contrast, AYUSH practitioners had 80% decreased odds of awareness about KMC compared with allopathic practitioners (odds ratio: 0.2; 95% CI: 0.1-0.3). Discussion: This study demonstrates distinct knowledge gaps among allopathic and AYUSH general practitioners regarding breastfeeding and KMC. There is a need for tailored continuing medical education among general practitioners to enhance their clinical knowledge of newborn care practices to achieve improvements in neonatal health.

This research tests the independent contribution of social capital and the use of the internet to obtain health information to support maternal-child communication about peer pressure to have sex among Puerto Rican families. A sample of 413 Puerto Rican households in Springfield, MA provides the data to independently test these hypotheses. The results of a logistic regression model suggest that Puerto Rican mothers with increased social capital and who accessed the internet for health information are more likely to communicate with their adolescent children about peer pressure to have sex. The combination of these two mechanisms provide opportunities to convey culturally generated resources to Puerto Rican mothers to assist them in helping their children develop healthy sexual behaviors.

Background: Causal mediation analysis is conducted in biomedical research with the goal of investigating causal mechanisms that consist of both direct causal pathways between the treatment and outcome variables and intermediate causal pathways through mediators. Recently, this type of analysis has been applied in the context of bioinformatics; however, it encounters the obstacle of high-dimensional and semi-continuous mediators with clumping at zero. Methods: In this article, we develop a methodology to conduct high-dimensional causal mediation analysis with a modeling framework that involves (i) a nonlinear model for the outcome variable, (ii) two-part models for semi-continuous mediators with clumping at zero, and (iii) sophisticated variable-selection techniques using machine learning. We conducted simulations and investigated the performance of the proposed method. It is shown that the proposed method can provide reliable statistical information on the causal effects with high-dimensional mediators. The method is adopted to assess the contribution of the intestinal microbiome to the risk of bacterial pathogen colonization in older adults from US nursing homes. Conclusions: The proposed high-dimensional causal mediation analysis with nonlinear models is an innovative and reliable approach to conduct causal inference with high-dimensional mediators.

Purpose: Perinatal depression affects upwards of one in seven women and is associated with significant negative maternal and child consequences. Despite this, it remains under-detected and under-treated. We sought to identify clinician practices, self-efficacy, and remaining barriers to comprehensively addressing perinatal depression care. Materials and Methods: Surveys were administered to obstetric clinicians in Massachusetts that queried frequency of depression screening and Likert questions about subsequent depression management. Results: Approximately 79.0% of clinicians approached completed the survey. Whereas most clinicians (93.5%) screened for perinatal depression at 6 weeks postpartum, fewer clinicians (66.1%) screened during pregnancy. Most reported they were comfortable providing support to their patients (98.4%), but fewer endorsed being able to treat them on their own (43.0%). Most noted an ability to treat with antidepressants (77.9%); however, fewer endorsed adequate access to nonmedication treatment (45.5%). Conclusions: The majority of surveyed clinicians screen for depression consistent with guidelines. However, efforts are focused on the postpartum period, despite literature citing two-thirds of patients experiencing onset before or during pregnancy. Respondents indicated an ability to treat with medication management, while noting greater challenge with referral. These findings describe the challenges of interdisciplinary coordination as a barrier to comprehensive perinatal mental health care. Clinical Trial Registration Number: NCT02760004.

Introduction:The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613–615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377–381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant’s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529–534.).Methods:We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information.Results:The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers.Conclusions:Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.

ImportanceNovel data science and marketing methods of smoking-cessation intervention have not been adequately evaluated.ObjectiveTo compare machine learning recommender (ML recommender) computer tailoring of motivational text messages vs a standard motivational text–based intervention (standard messaging) and a viral peer-recruitment tool kit (viral tool kit) for recruiting friends and family vs no tool kit in a smoking-cessation intervention.Design, Setting, and ParticipantsThis 2 ×2 factorial randomized clinical trial with partial allocation, conducted between July 2017 and September 2019 within an online tobacco intervention, recruited current smokers aged 18 years and older who spoke English from the US via the internet and peer referral. Data were analyzed from March through May 2022.InterventionsParticipants registering for the online intervention were randomly assigned to the ML recommender or standard messaging groups followed by partially random allocation to access to viral tool kit or no viral tool kit groups. The ML recommender provided ongoing refinement of message selection based on user feedback and comparison with a growing database of other users, while the standard system selected messages based on participant baseline readiness to quit.Main Outcomes and MeasuresOur primary outcome was self-reported 7-day point prevalence smoking cessation at 6 months.ResultsOf 1487 participants who smoked (444 aged 19-34 years [29.9%], 508 aged 35-54 years [34.1%], 535 aged ≥55 years [36.0%]; 1101 [74.0%] females; 189 Black [12.7%] and 1101 White [78.5%]; 106 Hispanic [7.1%]), 741 individuals were randomly assigned to the ML recommender group and 746 individuals to the standard messaging group; viral tool kit access was provided to 745 participants, and 742 participants received no such access. There was no significant difference in 6-month smoking cessation between ML recommender (146 of 412 participants [35.4%] with outcome data) and standard messaging (156 of 389 participants [40.1%] with outcome data) groups (adjusted odds ratio, 0.81; 95% CI, 0.61-1.08). Smoking cessation was significantly higher in viral tool kit (177 of 395 participants [44.8%] with outcome data) vs no viral tool kit (125 of 406 participants [30.8%] with outcome data) groups (adjusted odds ratio, 1.48; 95% CI, 1.11-1.98).Conclusions and RelevanceIn this study, machine learning–based selection did not improve performance compared with standard message selection, while viral marketing did improve cessation outcomes. These results suggest that in addition to increasing dissemination, viral recruitment may have important implications for improving effectiveness of smoking-cessation interventions.Trial RegistrationClinicalTrials.gov Identifier: NCT03224520

Background Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers. Objective The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam. Methods We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period. Results Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022. Conclusions This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers. Trial Registration ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993. International Registered Report Identifier (IRRID) DERR1-10.2196/30947

BACKGROUND Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers. OBJECTIVE The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam. METHODS We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period. RESULTS Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022. CONCLUSIONS This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers. CLINICALTRIAL ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30947

Background. John Henryism is defined as a measure of active coping in response to stressful experiences. John Henryism has been linked with health conditions such as diabetes, prostate cancer, and hypertension, but rarely with health behaviors. Aims. We hypothesized that reporting higher scores on the John Henryism Scale may be associated with poorer medication adherence, and trust in providers may mediate this relationship. Method. We tested this hypothesis using data from the TRUST study. The TRUST study included 787 African Americans with hypertension receiving care at a safety-net hospital. Ordinal logistic regression was used to examine the relationship between John Henryism and medication adherence. Results. Within our sample of African Americans with hypertension, lower John Henryism scores was associated with poorer self-reported adherence (low, 20.62; moderate, 19.19; high, 18.12; p < .001). Higher John Henryism scores were associated with lower trust scores (low John Henryism: 40.1; high John Henryism: 37.9; p < .001). In the adjusted model, each 1-point increase in the John Henryism score decreased the odds of being in a better cumulative medication adherence category by a factor of 4% (odds ratio = 0.96, p = .014, 95% confidence interval = 0.93-0.99). Twenty percent of the association between medication adherence and John Henryism was mediated by trust (standard deviation = 0.205, 95% confidence interval = 0.074-0.335). Discussion. This study provides important insights into the complex relationship between psychological responses and health behaviors. It also contributes to the body of literature examining the construct of John Henryism among African Americans with hypertension. Conclusion. The findings of this study support the need for interventions that promote healthful coping strategies and patient–provider trust.

Objective To discuss the study design and data analysis for three-phase interrupted time series (ITS) studies to evaluate the impact of health policy, systems, or environmental interventions. Simulation methods are used to conduct power and sample size calculation for these studies. Methods We consider the design and analysis of three-phase ITS studies using a study funded by National Institutes of Health as an exemplar. The design and analysis of both one-arm and two-arm three-phase ITS studies are introduced. Results A simulation-based approach, with ready-to-use computer programs, was developed to determine the power for two types of three-phase ITS studies. Simulations were conducted to estimate the power of segmented autoregressive (AR) error models when autocorrelation ranged from -0.9 to 0.9 with various effect sizes. The power increased as the sample size or the effect size increased. The power to detect the same effect sizes varied largely, depending on testing level change, trend changes, or both. Conclusion This article provides a convenient tool for investigators to generate sample sizes to ensure sufficient statistical power when three-phase ITS study design is implemented.

Background Early detection of Atrial Fibrillation (AF) is a public health priority across the globe because AF-related strokes are preventable. Despite an ongoing stroke epidemic in India, a public health strategy for AF screening and treatment is missing because the epidemiology of AF in India remains poorly defined. Methods This population-based study used mobile technology to derive age and sex-stratified AF prevalence by screening 7 participants in each of six age and sex strata (age 40–55, 56–65, 65+, and male and female) from 50 villages (2100 participants). A health worker from each village used a handheld digital electrocardiogram (iECG) device (Kardia) to screen for AF on 3 separate days, and administered a questionnaire. All abnormal (AF or unclassified) iECGs were reviewed by the Indian cardiologist and AF determination confirmed by a US-based cardiac electrophysiologist. Results Of the 2100 individuals enrolled, iECGs were collected from 2074 participants (98.8%) and 1947 (92.7%) participants responded to the questionnaire. AF was identified in 33 participants (1.6%), two-thirds on the first iECG. AF prevalence was higher among males (2.3% vs 1.0%, p = 0.03) and in older people (0.6%, 0.9%, 2.1%, 5.6%; p Conclusions The prevalence of AF observed in our population-based sample is comparable to rates found in studies from North America and Western Europe and increases similarly with age. AF screening using village health workers in rural India is feasible and presents an opportunity for a strategy to address the stroke epidemic in India through primary prevention.

Mini-sabbaticals are formal short-term training and educational experiences away from an investigator’s home research unit. These may include rotations with other research units and externships at government research or regulatory agencies, industry and non-profit programs, and training and/or intensive educational programs. The National Institutes of Health have been encouraging training institutions to consider offering mini-sabbaticals, but given the newness of the concept, limited data are available to guide the implementation of mini-sabbatical programs. In this paper, we review the history of sabbaticals and mini-sabbaticals, report the results of surveys we performed to ascertain the use of mini-sabbaticals at Clinical and Translational Science Award hubs, and consider best practice recommendations for institutions seeking to establish formal mini-sabbatical programs.

Objective Perinatal depression is a common pregnancy complication and universal screening is recommended. The Practice Readiness to Evaluate and address Perinatal Depression (PREPD) was developed to measure obstetric practice readiness to integrate depression care into workflows. Objectives were to describe: (1) the PREPD; (2) associated characteristics by readiness level; and (3) use of the assessment to measure change. Method The PREPD has four components, each scored to a 16-point maximum: (1) Environmental Scan (10% of PREPD); (2) Depression Detection, Assessment, and Treatment Questionnaire (30%); (3) Depression-related Policies Questionnaire (10%); and (4) Chart Abstraction (50%). Components were weighted and summed for an overall score. Summary and component scores were calculated by patient, practice, and provider. Results Average overall PREPD score was 7.3/16 (range: 4.8–9.9); scores varied between practices. The Environmental Scan averaged 2.0/16 (range: 0–5.2); Detection, Assessment, and Treatment averaged 8.3/16 (range: 3.0–11.5); Chart Abstraction averaged 7.2/16 (range: 5.1–9.6); and Depression-related Policies averaged 10.4/16 (range: 7.5–15). Conclusion We found wide variation in obstetric practices’ readiness to implement interventions for depression; most were minimally prepared. These data may be used to tailor practice intervention goals and as benchmarks with which to measure changes in integration of depression care over time.

Importance Better patient management can reduce emergency department (ED) use. Performance measures should reward plans for reducing utilization by predictably high-use patients, rather than rewarding plans that shun them. Objective The objective of this study was to develop a quality measure for ED use for people diagnosed with serious mental illness or substance use disorder, accounting for both medical and social determinants of health (SDH) risks. Design Regression modeling to predict ED use rates using diagnosis-based and SDH-augmented models, to compare accuracy overall and for vulnerable populations. Setting MassHealth, Massachusetts' Medicaid and Children's Health Insurance Program. Participants MassHealth members ages 18-64, continuously enrolled for the calendar year 2016, with a diagnosis of serious mental illness or substance use disorder. Exposures Diagnosis-based model predictors are diagnoses from medical encounters, age, and sex. Additional SDH predictors describe housing problems, behavioral health issues, disability, and neighborhood-level stress. Main outcome and measures We predicted ED use rates: (1) using age/sex and distinguishing between single or dual diagnoses; (2) adding summarized medical risk (DxCG); and (3) further adding social risk (SDH). Results Among 144,981 study subjects, 57% were women, 25% dually diagnosed, 67% White/non-Hispanic, 18% unstably housed, and 37% disabled. Utilization was higher by 77% for those dually diagnosed, 50% for members with housing problems, and 18% for members living in the highest-stress neighborhoods. SDH modeling predicted best for these high-use populations and was most accurate for plans with complex patients. Conclusion To set appropriate benchmarks for comparing health plans, quality measures for ED visits should be adjusted for both medical and social risks.

Obesity is associated with significant comorbidities and financial costs. While behavioral interventions produce clinically meaningful weight loss, weight loss maintenance is challenging. The objective was to improve understanding of the neural and psychological mechanisms modified by mindfulness that may predict clinical outcomes. Individuals who intentionally recently lost weight were randomized to Mindfulness-Based Stress Reduction (MBSR) or a control healthy living course. Anthropometric and psychological factors were measured at baseline, 8 weeks and 6 months. Functional connectivity (FC) analysis was performed at baseline and 8 weeks to examine FC changes between regions of interest selected a priori, and independent components identified by independent component analysis. The association of pre-post FC changes with 6-month weight and psychometric outcomes was then analyzed. Significant group x time interaction was found for FC between the amygdala and ventromedial prefrontal cortex, such that FC increased in the MBSR group and decreased in controls. Non-significant changes in weight were observed at 6 months, where the mindfulness group maintained their weight while the controls showed a weight increase of 3.4% in BMI. Change in FC at 8-weeks between ventromedial prefrontal cortex and several ROIs was associated with change in depression symptoms but not weight at 6 months. This pilot study provides preliminary evidence of neural mechanisms that may be involved in MBSR’s impact on weight loss maintenance that may be useful for designing future clinical trials and mechanistic studies.

Introduction: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups. Methods: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components. Results: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a “storytelling” intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process. Conclusions: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

IMPORTANCE: Most trials of behavioral or pharmaceutical interventions for people who smoke are limited to individuals reporting they are ready to quit smoking. Engaging individuals who initially report they are not yet ready to quit in brief, precessation, skills-building interventions (eg, practice quit attempts or nicotine replacement therapy [NRT] sampling) is challenging. OBJECTIVE: To test an integrated behavioral plus NRT-sampling intervention using a gamification approach supported by mobile health. DESIGN, SETTING, AND PARTICIPANTS: A multisite randomized clinical trial with site-level 1-to-1 allocation into 2 conditions was conducted in 4 US health care systems. A total of 433 individuals who were currently smoking and reported at enrollment that they were not ready to quit smoking were enrolled. The study was conducted from November 7, 2016, to July 31, 2020. INTERVENTIONS: Take a Break (TAB) was a 3-week game experience and included 5 behavioral components (motivational messaging, challenge quizzes, brief abstinence goal setting, mobile health apps for cravings management, and reward points for participation) integrated with NRT sampling. TAB draws on social cognitive theory and game mechanics concepts to engage participants in health behavior change. The comparison included NRT sampling only. MAIN OUTCOMES AND MEASURES: Time to first quit attempt (duration from TAB experience to primary outcome) and carbon monoxide level–verified smoking cessation at 6-month follow-up. All analyses used an intention-to-treat approach. RESULTS: Of the 433 individuals included in the trial, 223 were women (52%); mean (SD) age was 54 (13) years. More than half (53% [112 of 213]) of the TAB participants completed 100% of the daily challenge quizzes in the first week, 73% (145 of 199) of participants who completed the goal-setting call set a brief abstinence goal (most frequently 1-2 days of abstinence from cigarettes), and 75% (159 of 213) of participants used the mobile health apps to manage nicotine cravings. Time to the first quit attempt was lower for the TAB vs comparison group (hazard ratio, 1.68; 95% CI, 1.09-2.60; P = .02). At the 6-month follow-up, 18% (28 of 160) of TAB participants and 10% (17 of 171) of the comparison (χ(2) test, P = .045) participants obtained carbon monoxide level–verified smoking cessation (accounting for clustering of outcomes by site; odds ratio, 1.92; 95% CI, 1.01-3.68; P = .048). CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial demonstrate that individuals not yet ready to quit smoking could be engaged in a brief abstinence game. Six months later, the TAB group had nearly double the rate of smoking cessation vs the NRT sampling comparison group. Integrating a skills-building game experience with brief NRT sampling can enhance long-term cessation among those not yet ready to quit smoking. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02973425

Obesity is associated with significant comorbidities and financial costs. While behavioral interventions produce clinically meaningful weight loss, weight loss maintenance is challenging. The objective was to improve understanding of the neural and psychological mechanisms modified by mindfulness that may predict clinical outcomes.Individuals who intentionally recently lost weight were randomized to Mindfulness-Based Stress Reduction (MBSR) or a control healthy living course. Anthropometric and psychological factors were measured at baseline, 8 weeks and 6 months. Functional connectivity (FC) analysis was performed at baseline and 8 weeks to examine FC changes between regions of interest selected a priori, and independent components identified by independent component analysis. The association of pre-post FC changes with 6-month weight and psychometric outcomes was then analyzed.Significant group x time interaction was found for FC between the amygdala and ventromedial prefrontal cortex, such that FC increased in the MBSR group and decreased in controls. Non-significant changes in weight were observed at 6 months, where the mindfulness group maintained their weight while the controls showed a weight increase of 3.4% in BMI. Change in FC at 8-weeks between ventromedial prefrontal cortex and several ROIs was associated with change in depression symptoms but not weight at 6 months. This pilot study provides preliminary evidence of neural mechanisms that may be involved in MBSR’s impact on weight loss maintenance that may be useful for designing future clinical trials and mechanistic studies.

Background: Home remedies (HRs) are described as foods, herbs, and other house­hold products used to manage chronic conditions. The objective of this study was to examine home remedy (HR) use among Blacks with hypertension and to determine if home remedy use is correlated with blood pressure and medication adherence. Methods: Data for this cross-sectional study were obtained from the TRUST study con­ducted between 2006-2008. Medication adherence was measured using the Morisky Medication Adherence Scale, and HR use was self-reported. Multivariable associa­tions were quantified using ordinal logistic regression. Results: The study sample consisted of 788 Blacks with hypertension living in the south­ern region of the United States. HR use was associated with higher systolic (HR users 152.79, nonusers 149.53; P=.004) and diastolic blood pressure (HR users 84.10, nonusers 82.14 P=.005). Use of two or more HRs was associated with low adher­ence (OR: .55, CI: .36-.83, P= .004). Conclusion: The use of HR and the number of HRs used may be associated with medi­cation nonadherence, and higher systolic and diastolic blood pressure among Blacks with hypertension. Medication nonadher­ence is of critical importance for individuals with hypertension, and it is essential that health care providers be aware of health behaviors that may serve as barriers to medication adherence, such as use of home remedies. Ethn Dis . 2020;30(3):451-458; doi:10.18865/ed.30.3.451

Objective Smokers are greatly influenced by those living with them, but strategies that increase partner support for smoking cessation are lacking. Using a cross-sectional study design, we explored factors associated with willingness to engage a partner in smoking cessation in smokers registered on a web-assisted tobacco intervention trial. Results Study participants (n = 983) were recruited between July 2018 and March 2019. About 28% of smokers were willing to engage their partner in cessation efforts. The odds of willingness to engage a partner were more than two-fold for smokers reporting presence of other smokers in the immediate family (adjusted odds ratio (aOR): 2.18; 95% confidence interval (CI) 1.51–3.15 for 1–3 smokers; aOR, 3.12; 95% CI 1.95–4.98 for ≥ 4 smokers) compared to those with no smokers in the immediate family. Women had lower odds of willingness to engage (aOR; 0.82; 95% CI 0.58–1.16) than men, but this was not statistically significant. Use of e-cigarettes and visitation to a smoking cessation website prior to the intervention were both positively associated with willingness to engage partners in cessation. Future research should assess whether interventions tailored to smokers willing to engage partners or spouses could increase effectiveness of partner support during cessation.

BackgroundTo address the gap in knowledge about how to design feasible and acceptable trainings for clinicians that aim to mitigate implicit bias in clinical encounters, we report the early insights from the COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT) Trial.MethodsWe engaged academic and community stakeholders to design, pilot test and implement a training program addressing healthcare disparities knowledge, bias awareness, and communication skills focused on bias mitigation. A stepped wedge cluster randomized trial was developed to determine intervention dose effects. We assessed the CONSULT training program through structured feedback using online surveys, real-time comments, and individualized feedback from trainees, faculty and standardized patients.ResultsThe first training cohort completed the intervention (N = 64). Feedback prompted training program revisions as follows: reducing overall time burden and the number of implicit bias assessments; supplementing on-line learning with augmented in-person interactive sessions. Feedback also reinforced the critical importance of having highly skilled facilitators versed in implicit bias.ConclusionsIterative stakeholder engagement is essential for developing and revising educational interventions aimed at raising bias awareness and mitigating the effects of implicit bias.Trial RegistrationClinicalTrials.gov, NCT 03375918. Registered December 18, 2017, https://clinicaltrials.gov/ct2/show/NCT03375918?id=NCT+03375918&draw=2&rank=1

Background Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster randomized trial design. Methods Sixteen communities will be randomized to either an intervention (8 communities) or a comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a “storytelling intervention,” which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well. Discussion Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam. Trial registration ClinicalTrials.gov NCT03590691. Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019.

Objective: The purpose of this study was to present the design, model, and data analysis of an interrupted time series (ITS) model applied to evaluate the impact of health policy, systems, or environmental interventions using count outcomes. Simulation methods were used to conduct power and sample size calculations for these studies. Methods: We proposed the models and analyses of ITS designs for count outcomes using the Strengthening Translational Research in Diverse Enrollment (STRIDE) study as an example. The models we used were observation-driven models, which bundle a lagged term on the conditional mean of the outcome for a time series of count outcomes. Results: A simulation-based approach with ready-to-use computer programs was developed to calculate the sample size and power of two types of ITS models, Poisson and negative binomial, for count outcomes. Simulations were conducted to estimate the power of segmented autoregressive (AR) error models when autocorrelation ranged from −0.9 to 0.9, with various effect sizes. The power to detect the same magnitude of parameters varied largely, depending on the testing level change, the trend change, or both. The relationships between power and sample size and the values of the parameters were different between the two models. Conclusion: This article provides a convenient tool to allow investigators to generate sample sizes that will ensure sufficient statistical power when the ITS study design of count outcomes is implemented. Keywords: Policy evaluation, Interrupted time series, Count outcomes, Segmented regression, Quasi-experimental design, Power, Sample size calculation

Korean American women have substantially greater incidence rates of cervical cancer and the lowest rates of cervical cancer screening in the United States. However, there has been minimal research to promote human papillomavirus (HPV) vaccination among this population. A pilot randomized controlled trial was conducted to evaluate preliminary effectiveness of a storytelling video intervention using mobile, Web-based technology. One hundred and four Korean American college women were randomized to the experimental group (storytelling video) or the comparison group (information-based written material). The effects of the intervention were assessed immediately postintervention and at the 2-month follow-up. Both groups improved in knowledge of and attitude toward the HPV vaccine at the postintervention. At the 2-month follow-up, the experimental group was twice as likely to receive the HPV vaccine compared to the comparison group. This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.