A multi-centre randomised control trial of directly observed therapy to promote medication adherence in paediatric heart transplant recipients.

Medication non-adherence remains a significant challenge for adolescent heart transplant recipients. Building on the success of a pilot intervention study, herein we describe the protocol for a follow-up randomised control trial using mobile video directly observed therapy, featuring several innovations, to promote medication adherence in a multi-centre sample of adolescent heart transplant patients.

Demographic Factors, Medication Adherence, and Post-transplant Health Outcomes: A Longitudinal Multilevel Modeling Approach.

Few studies in pediatric solid organ transplantation have examined non-adherence to immunosuppressive medication over time and its associations with demographic factors and post-transplant outcomes including late acute rejection and hospitalizations. We examined longitudinal variation in patient Medication Level Variability Index (MLVI) adherence data from pediatric kidney, liver, and heart transplant recipients. Patient and administrative data from the United Network for Organ Sharing were linked with electronic health records and MLVI values for 332 patients. Multilevel mediation modeling indicated comparatively more variation in MLVI values between patients than within patients, longitudinally, over 10 years post transplant. MLVI values significantly predicted late acute rejection and hospitalization. MLVI partially mediated patient factors and post-transplant outcomes for patient age indicating adolescents may benefit most from intervention efforts. Results demonstrate the importance of longitudinal assessment of adherence and differences among patients. Efforts to promote medication adherence should be adapted to high-risk patients to increase likelihood of adherence.

Engaging Adolescent Heart Transplant Recipients Through In-App Messaging During Mobile Health Intervention.

Introduction: Adolescents heart transplant recipients experience difficulty with adherence to immunosuppressive medication leading to increased risk of organ rejection, hospitalization, and mortality. Few interventions have been successful to promote medication adherence in adolescent heart transplant patients as most fail to engage the patient in the behavioral change process and support patient-provider communication. The purpose of this study was to explore the nature and degree of in-app communication between adolescent heart transplant recipients and nursing staff during an asynchronous mobile video directly observed therapy intervention. Methods: A content analysis of 894 in-app messages exchanged between 10 adolescent patients and nurses during a 12-week mobile-based intervention was conducted. Two authors used an inductive, iterative process to guide a thematic analysis of the asynchronous in-app messages with high interrater reliability ranging from 81.5% to 100%. Findings: In-app messages fell under 3 broad content categories: (1) interpersonal support and rapport-building, (2) medically related questions and information, or (3) functional information about the intervention and the mHealth app. Results demonstrated the degree to which interpersonal engagement occurred during the intervention, the nature of these exchanges, and their relationship to medication adherence. Conclusions: The study provided insights into the feasibility and benefits of 2-way communication features of the directly observed therapy intervention in promoting engagement and in improving medication adherence among adolescent heart transplant patients. Continued research and clinical focus on patient engagement and impactful aspects of interpersonal communication could aid in the translation of this intervention into standard clinical care at pediatric transplant centers.

Prediction of Outcomes After Heart Transplantation in Pediatric Patients Using National Registry Data: Evaluation of Machine Learning Approaches.

BACKGROUND: The prediction of posttransplant health outcomes for pediatric heart transplantation is critical for risk stratification and high-quality posttransplant care. OBJECTIVE: The purpose of this study was to examine the use of machine learning (ML) models to predict rejection and mortality for pediatric heart transplant recipients. METHODS: Various ML models were used to predict rejection and mortality at 1, 3, and 5 years after transplantation in pediatric heart transplant recipients using United Network for Organ Sharing data from 1987 to 2019. The variables used for predicting posttransplant outcomes included donor and recipient as well as medical and social factors. We evaluated 7 ML models-extreme gradient boosting (XGBoost), logistic regression, support vector machine, random forest (RF), stochastic gradient descent, multilayer perceptron, and adaptive boosting (AdaBoost)-as well as a deep learning model with 2 hidden layers with 100 neurons and a rectified linear unit (ReLU) activation function followed by batch normalization for each and a classification head with a softmax activation function. We used 10-fold cross-validation to evaluate model performance. Shapley additive explanations (SHAP) values were calculated to estimate the importance of each variable for prediction. RESULTS: RF and AdaBoost models were the best-performing algorithms for different prediction windows across outcomes. RF outperformed other ML algorithms in predicting 5 of the 6 outcomes (area under the receiver operating characteristic curve [AUROC] 0.664 and 0.706 for 1-year and 3-year rejection, respectively, and AUROC 0.697, 0.758, and 0.763 for 1-year, 3-year, and 5-year mortality, respectively). AdaBoost achieved the best performance for prediction of 5-year rejection (AUROC 0.705). CONCLUSIONS: This study demonstrates the comparative utility of ML approaches for modeling posttransplant health outcomes using registry data. ML approaches can identify unique risk factors and their complex relationship with outcomes, thereby identifying patients considered to be at risk and informing the transplant community about the potential of these innovative approaches to improve pediatric care after heart transplantation. Future studies are required to translate the information derived from prediction models to optimize counseling, clinical care, and decision-making within pediatric organ transplant centers.

The Integration of Behavioral Health and Primary Care for Hispanic/Latino Patients with Depression and Comorbid PTSD.

Comorbid PTSD and depression are notably high within primary care settings serving low-income and/or immigrant Hispanic/Latino populations. There is limited research examining how comorbid PTSD impacts the response to depression treatment for patients within these settings. The purpose of this study was to examine PTSD-depression comorbidity and its association with treatment outcomes among Hispanic/Latino patients enrolled in an integrated behavioral health intervention for depression. Participants were Hispanic/Latino adult primary care patients who met the criteria for depression and were not currently in treatment. Depression and anxiety severity were assessed at baseline and the 6 and 12 month follow-ups. Outcomes were compared between participants who met the criteria for a PTSD diagnosis and those that did not. Depression and anxiety scores significantly decreased through the 1-year intervention period regardless of PTSD diagnosis. More research is needed to understand what elements of culturally adapted, linguistically concordant treatment benefit diverse patients the most.

Directly observed therapy to promote medication adherence in adolescent heart transplant recipients.

PURPOSE: HT recipients experience high levels of medication non-adherence during adolescence. This pilot study examined the acceptability and feasibility of an asynchronous DOT mHealth application among adolescent HT recipients. The app facilitates tracking of patients' dose-by-dose adherence and enables transplant team members to engage patients. The DOT application allows patients to self-record videos while taking their medication and submit for review. Transplant staff review the videos and communicate with patients to engage and encourage medication adherence. METHODS: Ten adolescent HT recipients with poor adherence were enrolled into a single-group, 12-week pilot study examining the impact of DOT on adherence. Secondary outcomes included self-report measures from patients and parents concerning HRQOL and adherence barriers. Long-term health outcomes assessed included AR and hospitalization 6 months following DOT. FINDINGS: Among 14 adolescent HT patients approached, 10 initiated the DOT intervention. Of these, 8 completed the 12-week intervention. Patients and caregivers reported high perceptions of acceptability and accessibility. Patients submitted 90.1% of possible videos demonstrating medication doses taken. MLVI values for the 10 patients initiating DOT decreased from 6 months prior to the intervention (2.86 ± 1.83) to 6 months following their involvement (2.08 ± 0.87) representing a 21.7% decrease in non-adherence, though not statistically significant given the small sample size. CONCLUSIONS: Result of this pilot study provides promising insights regarding the feasibility, acceptability, and potential impact of DOT for adolescent HT recipients. Further randomized studies are required to confirm these observations.

Latent profile analysis of stress and resilience among rural women: A cross-sectional study.

Stress is a cardiovascular disease risk factor, and resilience may serve as a buffer for stress. Little is known about stress and resilience among rural women. OBJECTIVE: The purposes of this study were to identify profiles of rural women based upon indicators of psychosocial and environmental stress and to examine the relationships between the identified profiles and resilience. DESIGN AND SAMPLE: A cross-sectional, descriptive design was used to explore stress, social support, and resilience among a representative sample of women (n = 354). MEASURES: Data were collected to measure perceived stress, social support, chronic stress, and resilience. RESULTS: A latent profile analysis identified three profiles (59.9% Low Stress, 25.4% Moderate Stress, and 14.7% High Stress). Women in the High Stress profile were less likely to afford necessities and have attended college and more likely to be employed. Women in the Low Stress profile had the highest scores for all five resilience subscales. CONCLUSION: The current study demonstrates the social and environmental impact of stress and how this stress can manifest differently for different women. Underserved women may benefit from strategies that reduce stress and improve social support and resilience. Future research is needed for advancing health equity in rural populations.

Depression education fotonovela for engagement of Hispanic patients in treatment: a randomized clinical trial.

BACKGROUND: We report the primary outcomes from a randomized clinical trial testing a novel culturally-adapted patient education intervention to increase engagement of Hispanic patients in depression treatment. The Depression Education Fotonovela (DEF), Secret Feelings, incorporates popular images, cultural norms, and vivid pictures embedded within a soap opera narrative to increase depression knowledge and dispel myths about treatment. We then assessed engagement in a integrated care treatment model in response to the education intervention and subsequent changes in depression symptoms in a large community-based clinic whose patient population is majority Hispanic. METHOD: The sample included 150 adult Hispanic patients with a confirmed diagnosis of depression who were randomly assigned to either: [1] integrated care + fotonovela; or [2] integrated care + standard education. Differences between treatment groups were examined as were changes in depression, anxiety, depression knowledge, and stigma scores over time and engagement in treatment. RESULTS: Results indicated that while depression scores significantly decreased over time for participants (F [2.811, 416.054] = 197.69, p < .001, η2 = .572), no differences between the two education groups were found (F [1, 148] = 0.70, p = .403, η2 = .005). At 12-month follow-up, 101 patients (80.8%) reported a 50% of greater reduction in depression scores from baseline. CONCLUSIONS: We found little difference between the two education groups, suggesting that either may helpful for engaging Hispanic patients into care. Better tailoring of patient education, with the fotonovela or similarly adapted tools, will require more directly addressing the stigma associated with antidepressant medication. TRIAL REGISTRATION: The study was registered with www.clinicaltrials.gov : NCT02702596 , on 03/20/2016. Retrospectively registered.

Corrigendum to: Machine learning-based prediction of health outcomes in pediatric organ transplantation recipients.

[This corrects the article DOI: 10.1093/jamiaopen/ooab008.].

Psychometric Properties of Three Measures of Stigma Among Hispanics with Depression.

While many measures of mental illness stigma have been developed, few have been validated in Hispanic populations. This study examined the psychometric properties of three stigma measures (Stigma Concerns about Mental Health Care [SCMHC], Social Distance Scale [SDS], and Latino Scale for Antidepressant Stigma [LSAS]) among a depressed, Hispanic sample. Data were collected during baseline assessments for two studies taking place in primary care settings (N = 500). Psychometric and factor validity were tested for each measure. Confirmatory factor analyses indicated adequate model fit, and adequate internal consistency reliability was found for all three measures. Stigma scores significantly differed by education level and gender. Findings from this analysis provide support for the use of the SCMHC, SDS, and LSAS in a depressed, Hispanic population. Assessing barriers to depression treatment, including stigma, are critical in engaging Hispanics in care and eliminating disparities for the population.

Directly observed therapy to promote medication adherence in paediatric heart transplant recipients.

Medication non-adherence causes poor outcomes in paediatric organ transplantation. COVID-19 pandemic has led to an exponential use of mobile health approaches for patient care. Herein, we describe a pilot intervention study using mobile video directly observed therapy building on emerging trends in research and clinical practice pertaining to medication adherence in paediatric organ transplantation.

Machine learning-based prediction of health outcomes in pediatric organ transplantation recipients.

OBJECTIVES: Prediction of post-transplant health outcomes and identification of key factors remain important issues for pediatric transplant teams and researchers. Outcomes research has generally relied on general linear modeling or similar techniques offering limited predictive validity. Thus far, data-driven modeling and machine learning (ML) approaches have had limited application and success in pediatric transplant outcomes research. The purpose of the current study was to examine ML models predicting post-transplant hospitalization in a sample of pediatric kidney, liver, and heart transplant recipients from a large solid organ transplant program. MATERIALS AND METHODS: Various logistic regression, naive Bayes, support vector machine, and deep learning (DL) methods were used to predict 1-, 3-, and 5-year post-transplant hospitalization using patient and administrative data from a large pediatric organ transplant center. RESULTS: DL models generally outperformed traditional ML models across organtypes and prediction windows with area under the receiver operating characteristic curve values ranging from 0.750 to 0.851. Shapley additive explanations (SHAP) were used to increase the interpretability of DL model results. Various medical, patient, and social variables were identified as salient predictors across organ types. DISCUSSION: Results demonstrate the utility of DL modeling for health outcome prediction with pediatric patients, and its use represents an important development in the prediction of post-transplant outcomes in pediatric transplantation compared to prior research. CONCLUSION: Results point to DL models as potentially useful tools in decision-support systems assisting physicians and transplant teams in identifying patients at a greater risk for poor post-transplant outcomes.

Profiles of depression in a treatment-seeking Hispanic population: Psychometric properties of the Patient Health Questionnaire-9.

OBJECTIVES: Screening instruments can be powerful tools in assisting primary care providers with detecting depression in their patients and monitoring treatment response. Health disparities among racial and ethnic minorities result from inaccurate assessment in primary care. METHODS: The current study used baseline data from two federally funded research studies of treatment for depression among Hispanics in primary care. The Patient Health Questionnaire-9 (PHQ-9) was administered at baseline prior to the study interventions, and 499 participants provided responses. RESULTS: Confirmatory factor analyses found excellent factor validity for the PHQ-9, yet reliability remained poor. Possible heterogeneity in depressive item scores was examined, and latent profile analysis identified four distinct profiles of PHQ-9 responses. Profiles included a lower depression, moderate/somatization, moderate/negative self-view, and severe depression profiles. Results indicate modest support for the PHQ-9 and its use among Hispanics for the purpose of depression screening. CONCLUSION: Capturing four profiles of depression in a large primary care sample helps characterize the manifestation of depression in a Hispanic population. The single item related to fatigue had the greatest variation across groups indicating it might be useful as a screening item. Inadequate evaluation of symptoms could lead to significant under identification of the disorder among Hispanics.

Hispanic participants in the National Institute on Drug Abuse's Clinical Trials Network: A scoping review of two decades of research.

INTRODUCTION: Hispanics significantly underutilize substance abuse treatment and are at greater risk for poor treatment outcomes and dropout. Two decades of research from the National Drug Abuse Treatment Clinical Trials Network (CTN) offers an opportunity to increase our understanding in how to address the disparities experienced by Hispanics in substance abuse treatment. METHODS: A scoping review was utilized to determine what has been learned from the CTN about Hispanic populations with substance use disorder. A systematic search was conducted within the CTN Dissemination Library and nine databases. Potentially relevant studies were independently assessed by two reviewers for inclusion. RESULTS: Twenty-four studies were included in the review. Results identified issues in measurement, characteristics of Hispanic substance use, effective interventions, and gaps for future research. Characteristics that interfere with treatment participation were also identified including low employment rates, less likelihood of having insurance, lower rates of internet access, and increased travel time to services, as were treatment issues such as high rates of alcohol and tobacco use. Effective interventions were identified; however, the effectiveness of these interventions may be limited to specific factors. CONCLUSIONS: Despite efforts to improve inclusion of minority populations, Hispanics remain underrepresented in clinical trials. Future research including Hispanic populations should examine measurement equivalence and consider how cultural and historical experiences, as well as patient characteristics, influence utilization of services. Finally, more studies are needed that examine the impact of structural factors that act as barriers to treatment access and engagement and result in significant disparities in treatment outcomes.

Measurement of health-related quality of life in pediatric organ transplantation recipients: a systematic review of the PedsQL transplant module.

OBJECTIVE: To collect and assess the extant empirical literature assessing disease-specific health-related quality of life (HRQOL) in pediatric transplant recipients using the PedsQL 3.0 Transplant Module (PedsQL-TM) assessment. STUDY DESIGN: A systematic search and review procedure was conducted of research reporting use and results of the PedsQL-TM with samples of pediatric heart, liver, kidney, and lung transplantation. Searches were conducted in nine scholarly databases and two additional sources to identify unpublished research. Multiple reviewers screened studies meeting inclusion criteria in accordance with PRISMA guidelines. RESULTS: A final sample of nine studies reported findings for the PedsQL-TM with pediatric organ transplant recipients. Most studies relied on either kidney or liver transplant recipients from single pediatric transplant centers. Factor validity of the PedsQL-TM and inter-rater reliability (IRR) between patients and parents have not been adequately determined. Internal consistency reliability was found as acceptable or excellent across multiple studies. PedsQL-TM scores were found to vary with other HRQOL issues, yet few studies examined their association with medication adherence or posttransplant health outcomes. CONCLUSIONS: With the goal of enhancing and sustaining HRQOL in pediatric organ transplant recipients, the need for a psychometrically valid and reliable measure of transplant-specific HRQOL is apparent. Research on the PedsQL-TM supports the promise of this measure although future efforts should be taken to examine measurement issues such as factor validity and IRR. Assessing transplant-specific HRQOL in these patients is paramount for their care and appropriate decision-making by patients, families, and the transplant team.

Caregiver identity theory and predictors of burden and depression: Findings from the REACH II study.

Objective: To examine the relationship between care recipient (person with Alzheimer's disease) ability to perform daily tasks and caregivers' (CG) perceived burden and depression, guided by the caregiver identity theory. We also examine the mediating effect of CG abilities to meet their basic needs.Methods: This study utilizes the baseline data of the REACH II study. Spearman's rho (ρ) was used to test for relationships between burden, reported depression, and each ADLs and IADLs. To further explore the relationship between burden and each ADLs and IADLs, structural equation modeling was conducted using Mplus 8.0.Results: Reported CG total scores indicated increased perceived CG burden with greater number of assisted daily activities. CG depression scores were significantly predicted by reported burden scores and caregiver's ability to pay for basic needs. Importantly, 34.6% of variation in CG reported depressions scores were explained by reported burden scores. A multivariate regression model with reported burden scores, controlling for caregiver's ability to pay for basic needs, explained 36.6% of the variance in CG depression scores. Burden scores and CG ability to pay for basic needs significantly predicted depression scores. Results from the three models indicated that CG burden fully mediated the relationship between daily living skill scores and CG depression.Conclusion: Our study findings suggest the need to more closely examine the link between AD caregiving, financial instability, and mental health and bolster support for policies and programs that offer tangible supports and services to offset the costs of informal AD CG.

Culturally adapted depression education and engagement in treatment among Hispanics in primary care: outcomes from a pilot feasibility study.

BACKGROUND: Low use of anti-depressant medication, poor doctor-patient communication, and persistent stigma are key barriers to the treatment of depression in Hispanics. Common concerns include fears about the addictive and harmful properties of antidepressants, worries about taking too many pills, and the stigma attached to taking medications and seeking mental health treatments. In 2014, the Center for Medicare and Medicaid Services (CMS) funded the Depression Screening and Education: Options to Reduce Barriers to Treatment (DESEO) project to implement an education intervention designed to increase disease literacy and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. METHODS: The DESEO study utilized a one-group pretest-posttest design to assess the effects a culturally-adapted Depression Education Intervention's (DEI) on depression knowledge, stigma, and engagement in treatment in a sample of 350 Hispanic primary care patients with depression. The DEI utilized a fotonovela, a health education tool available in English and Spanish that uses posed photographs, captions, and soap opera narratives to raise awareness about depression and depression treatments. RESULTS: Participants reported significant decreases in depression symptoms and reported stigma about mental health care. Additionally, participants reported increased knowledge of depression yet greater negative perceptions about antidepressant medication. Finally, 89.5% of participants reported entering some form of treatment at follow-up. CONCLUSIONS: Culturally adapted depression education shows promise in increasing understanding of depression, decreasing stigma, and increasing treatment engagement among Hispanic patients in a community-based health center. Results have implications for practice in addressing common concerns about depression treatments which include fears about the addictive and harmful properties of antidepressants, worries about taking too many pills, and the stigma attached to taking psychotropic medications. TRIAL REGISTRATION: The study was retrospectively registered with www.clinicaltrials.gov : NCT02491034 July 2, 2015.

The Concise Health Risk Tracking-Self Report: Psychometrics within a placebo-controlled antidepressant trial among depressed outpatients.

BACKGROUND/AIMS: While substantial prior research has evaluated the psychometric properties of the 12-item Concise Health Risk Tracking-Self Report (CHRT-SR12), a measure of suicide propensity and suicidal thoughts, no prior research has investigated its factor structure, sensitivity to change over time, and other psychometric properties in a placebo-controlled trial of antidepressant medication, nor determined whether symptoms change throughout treatment. METHODS: Participants in the multi-site Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study ( n=278) provided data to evaluate the factor structure and sensitivity to change over time of the CHRT-SR12 through eight weeks of a clinical trial in which participants received either placebo or antidepressant medication (sertraline). RESULTS/OUTCOMES: Factor analysis confirmed two factors: propensity (comprised of first-order factors including pessimism, helplessness, social support, and despair) and suicidal thoughts. Internal consistency (α's ranged from 0.69-0.92) and external validity were both acceptable, with the total score and propensity factor scores significantly correlated with total scores and single-item suicidal-thoughts scores on the self-report Quick Inventory of Depressive Symptoms and the clinician-rated 17-item Hamilton Rating Scale for Depression. Through analyzing CHRT-SR12 changes over eight treatment weeks, the total score and both the factors decreased regardless of baseline suicidal thoughts. Change in clinician-rated suicidal thoughts was reflected by change in both the total score and propensity factor score. CONCLUSIONS/INTERPRETATION: These results confirm the reliability, validity, and applicability of the CHRT-SR12 to a placebo-controlled clinical trial of depressed outpatients receiving antidepressant medication.