Changes in Medication Adherence Across the Posttransplant Period in Pediatric Organ Transplant Recipients.

INTRODUCTION: Limited research has explored immunosuppressant medication adherence over time in pediatric transplant patients, who often struggle with posttransplant regimen adherence, resulting in poor outcomes. METHODS: This study investigated the longitudinal growth in immunosuppressive medication levels following transplantation. Medication level variability index (MLVI) scores from tacrolimus blood levels of pediatric organ transplant recipients at a major medical center were analyzed. Linear mixed effect models (LMEM) assessed individual MLVI change trajectories and predictors of growth, exploring both linear and curvilinear growth patterns posttransplant. RESULTS: A sample of 181 patients with at least 4 years of MLVI data were analyzed. Growth curve modeling identified the cubic model as the best fit for the quarterly MLVI values, which significantly decreased within the first 2 years posttransplant before stabilizing. Gender significantly predicted MLVI change, with females showing greater MLVI decreases, while age at transplant did not significantly predict changes. Significant variation in MLVI among individual patients was found in all models. CONCLUSIONS: The study demonstrated a significant decrease in MLVI values over time, indicating improved medication adherence in pediatric transplant patients, with females exhibiting more adherent growth patterns than males. Future research should aim to identify pediatric patients at high risk of nonadherence.

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.

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.

Posttraumatic Growth in Youth, Young Adults, and Caregivers Who Experienced Solid Organ Transplant.

OBJECTIVE: To explore posttraumatic growth (PTG) in pediatric patients who have undergone solid organ transplant (SOT) and their caregivers, and to examine potential correlates of PTG. METHOD: Youth and young adults with a history of SOT (heart, kidney, liver) at least 1 month prior to participation and caregivers completed measures of PTG, demographic, and medical factors. In total, 59 youth (M = 12.68 years, SD = 1.91), 21 young adults (M = 19.37, SD = 0.82), and 95 caregivers (M = 37.95 years, SD = 9.37) participated. RESULTS: Overall, 67% of youth, 76% of young adults, and 89% of caregivers reported PTG within the medium to very high range. Appreciation of Life was the highest PTG subscale across all groups. Youth and caregiver PTG scores were significantly positively correlated. Religious affiliation and religious coping were positively associated with PTG for caregivers, and the relationship yielded large effect sizes for young adults. Caregivers of children with kidney transplants endorsed lower PTG than other organ types and caregivers of children who had an acute medical condition endorsed greater PTG than caregivers of children who had chronic illness. CONCLUSION: Findings suggest the pediatric SOT experience can yield positive changes such as a greater appreciation of life. Although small sample sizes may have led to reduced power for detecting significant findings for some analyses, results suggest religious, medical, and parent-child relationship factors are likely related to PTG in pediatric SOT and warrant future investigation.

Psychometric Evaluation of the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire in a General Youth Population.

Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire is a brief 15-item self-report measure of quality of life and life satisfaction originally developed for clinical populations (6 to 17 years old). The current paper examines the initial factor structure proposed by the developers and underlying psychometric properties of the measure in a non-clinical population of teens. A cross-sectional adolescent sample (N = 3222) completed self-report measures as part of mental health promotion program. A confirmatory factor analysis was conducted with construct validity analyses. The original factor structure was replicated with strong internal consistency (Cronbach α = .912). Strong construct validity (e.g. resilience, well-being, depression, and anxiety) was found. Minimal differences were found based on gender, race, and ethnicity. PQ-LES-Q has strong, replicable psychometric properties, which makes it a generally reliable and valid assessment tool to evaluate the quality of life and life satisfaction in adolescents.

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.

Medication Barriers and Adherence: Experiences of Pediatric Transplant Recipients.

This study examined associations between scores on the Adolescent Medication Barriers Scale (AMBS) and the Parent Medication Barriers Scale (PMBS), patient and family factors, and medication adherence outcomes. Patients and caregivers from a pediatric solid organ transplantation (SOT) program were recruited for participation. Pediatric SOT recipients ages 10 to 21 years were eligible for participation. Analyses included reliability analyses and regression modeling with posttransplant medication adherence measured by Medication Level Variability Index scores. Seventy-three patients and caregivers completed an AMBS or PMBS questionnaire. Patient-caregiver inter-rater reliability was poor to fair. Greater medication barriers were reported among younger and female patients and families with more children. AMBS scores predicted greater nonadherence, while the PMBS was not predictive of adherence. Results point to the difficulty of assessing barriers to medication adherence and the lack of agreement between adolescent patients and caregivers. AMBS scores were more closely aligned with medication nonadherence, whereas PMBS scores may have been more influenced by family social factors. Adolescent reports of medication barriers may offer multidisciplinary transplant teams greater clinical utility when addressing these challenges with patients. Transplant social workers and psychologists should engage adolescents and caregivers in efforts to address medication nonadherence.

Examining the association of medical complications and posttraumatic stress symptoms in pediatric solid organ transplant patients and their caregivers.

BACKGROUND: Post-traumatic stress symptoms (PTSS) have been reported by pediatric solid organ transplant (SOT) patients and their caregivers well after transplantation. This study examined the relationship between PTSS, medication adherence, and medical complications in SOT patients and their caregivers. A secondary aim examined the association between patient and caregiver-reported PTSS. METHODS: Pediatric SOT patients (N = 69) and caregivers (N = 73) reported on PTSS by completing the Child PTSD Symptom Scale (patients 8-17 years) or the Impact of Events Scale-Revised (patients 18 years and older and caregivers). Patient medication adherence was assessed using the Medication Level Variability Index (MLVI). Patients were dichotomized as experiencing a post-transplant medical complication (ie, transplant-related hospital admission prior to the year completing measures of PTSS) or no complications. RESULTS: Medication adherence was not significantly associated with patient or caregiver PTSS. A moderate effect size was found for elevated young adult and caregiver PTSS and the presence of a medical complication. Generally, the association between self-reported patient and caregiver PTSS was low. CONCLUSIONS: The presence of elevated PTSS in young adult patients may be partially explained by the presence of proximal medical complications and more so by comorbid psychiatric diagnoses in child and adolescent patients (based on exploratory analyses). Caregivers of patients with medical complications within the past year reported higher levels of PTSS. Overall, transplantation and its associated impact on PTSS may be unique experience for patients versus caregivers. Qualitative research may further elucidate these experiences and inform future clinical interventions.

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.

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.

Type 1 diabetes can present before the age of 6 months and is characterised by autoimmunity and rapid loss of beta cells.

AIMS/HYPOTHESIS: Diabetes diagnosed at <6 months of age is usually monogenic. However, 10-15% of affected infants do not have a pathogenic variant in one of the 26 known neonatal diabetes genes. We characterised infants diagnosed at <6 months of age without a pathogenic variant to assess whether polygenic type 1 diabetes could arise at early ages. METHODS: We studied 166 infants diagnosed with type 1 diabetes at <6 months of age in whom pathogenic variants in all 26 known genes had been excluded and compared them with infants with monogenic neonatal diabetes (n = 164) or children with type 1 diabetes diagnosed at 6-24 months of age (n = 152). We assessed the type 1 diabetes genetic risk score (T1D-GRS), islet autoantibodies, C-peptide and clinical features. RESULTS: We found an excess of infants with high T1D-GRS: 38% (63/166) had a T1D-GRS >95th centile of healthy individuals, whereas 5% (8/166) would be expected if all were monogenic (p < 0.0001). Individuals with a high T1D-GRS had a similar rate of autoantibody positivity to that seen in individuals with type 1 diabetes diagnosed at 6-24 months of age (41% vs 58%, p = 0.2), and had markedly reduced C-peptide levels (median <3 pmol/l within 1 year of diagnosis), reflecting rapid loss of insulin secretion. These individuals also had reduced birthweights (median z score -0.89), which were lowest in those diagnosed with type 1 diabetes at <3 months of age (median z score -1.98). CONCLUSIONS/INTERPRETATION: We provide strong evidence that type 1 diabetes can present before the age of 6 months based on individuals with this extremely early-onset diabetes subtype having the classic features of childhood type 1 diabetes: high genetic risk, autoimmunity and rapid beta cell loss. The early-onset association with reduced birthweight raises the possibility that for some individuals there was reduced insulin secretion in utero. Comprehensive genetic testing for all neonatal diabetes genes remains essential for all individuals diagnosed with diabetes at <6 months of age. Graphical abstract.

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.

The Concise Health Risk Tracking Self-Report (CHRT-SR) assessment of suicidality in depressed outpatients: A psychometric evaluation.

BACKGROUND: The 12-item Concise Health Risk Tracking Self-Report (CHRT-SR12 ) is a brief, self-report measure that systematically assesses both suicidal thinking and associated thoughts that may indicate the propensity for suicidal acts. It can be used as a tool to both assess risk and guide treatment interventions targeting associated cognitions. METHODS: This report used acute treatment data from a clinically representative sample of outpatients with nonpsychotic major depressive disorder (N = 665) participating in the Combining Medications to Enhance Depression Outcomes trial, who received up to 12 weeks of escitalopram, escitalopram plus bupropion SR, or venlafaxine XR plus mirtazapine. Outcome assessors and patients were masked to treatment. RESULTS: Factor analysis of CHRT-SR12 confirmed that the 12 items have higher order structure with two subscales (Propensity, Suicidal Thoughts) and a total score. Internal consistencies were acceptable for both subscales and total score. All three scales were modestly correlated with overall depression severity (r = 0.54 to r = 0.21) and highly discriminating among patients grouped by suicide item ratings on three different depressive symptom ratings. The three scales also distinguished change over the acute phase treatment for those with different levels of baseline suicidal ideation (measured by 30-item Inventory of Depressive Symptomatology (item 18) and for those with change in suicidal ideation (baseline to last visit). CONCLUSIONS: The CHRT-SR12 has good to excellent psychometric properties and is sensitive to change in suicidal thinking and propensity toward suicidal behavior in outpatients with major depressive disorder. It allows for the monitoring of thoughts and feelings associated with increased suicidal risk as well as levels of thoughts about suicide.

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.

Pilot Study of a Single Session Heart Rate Variability Biofeedback Intervention on Veterans' Posttraumatic Stress Symptoms.

Veterans with posttraumatic stress symptoms exhibit reduced heart rate variability characteristic of autonomic nervous system dysregulation. Studies show heart rate variability biofeedback (HRVB) is effective in reducing posttraumatic stress symptoms by improving autonomic functioning. Participants in this pilot study were veterans of different war eras with military-related posttraumatic stress symptoms. The study aims were to examine the impact of a single session HRVB intervention on posttraumatic stress symptoms and heart rate variability, test persistence of effects, and determine if veterans would find the intervention acceptable. One group (n = 6) received training in diaphragmatic breathing and heart rate variability biofeedback, augmented by twice-daily practice using a smart phone and breath pacing app. A second group (n = 6) received only a single session of diaphragmatic breathing training. After 4 weeks, participants in the second group (n = 5) received the full intervention. HRVB significantly reduced global posttraumatic stress symptoms, whereas diaphragmatic breathing alone did not. Further, veterans found the approach acceptable, as demonstrated by a high degree of adherence with prescribed practice, low study attrition, and continued use over time. Results of this pilot study warrant further refinement of a protocol utilizing mHealth to treat posttraumatic stress symptoms in military populations.

Positive aspects of having had cancer: A mixed-methods analysis of responses from the American Cancer Society Study of Cancer Survivors-II (SCS-II).

OBJECTIVE: This study focused on understanding positive aspects of cancer among a large, national sample of survivors, 2, 5, and 10 years' postcancer diagnosis, who responded to the American Cancer Society Study of Cancer Survivors - II (SCS-II) survey "Please tell us about any positive aspects of having cancer." METHODS: A sequential mixed methods approach examined (1) thematic categories of positive aspects from cancer survivors (n = 5149) and (2) variation in themes by sociodemographics, cancer type, stage of disease, and length of survivorship. RESULTS: Themes comprised 21 positive aspects within Thornton's typology of benefits that cancer survivors attribute to their illness: life perspectives, self, and relationships. New themes pertaining to gratitude and medical support during diagnosis and treatment, health-related changes, follow-up/surveillance, and helping others emerged that are not otherwise included in widely used existing benefit finding cancer scales. Gratitude and appreciation for life were the most frequently endorsed themes. Sociodemographics and stage of disease were associated with positive aspect themes. Themes were not associated with survivor cohorts. CONCLUSIONS: No differences in perceived positive aspects across survivor cohorts suggest that positive aspects of cancer may exist long after diagnosis for many survivors. However, variation across sociodemographics and clinical variables suggests cancer survivors differentially experience positive aspects from their cancer diagnosis. IMPLICATIONS FOR CANCER SURVIVORS: This analysis provides new information about cancer survivors' perceptions of positive aspects from their cancer and factors associated with benefit finding and personal growth. This information can be useful in further refining quality-of-life measures and interventions for cancer survivors.

Psychosocial predictors of medication non-adherence in pediatric organ transplantation: A systematic review.

Adherence to immunosuppressant medication is critical to health and quality-of-life outcomes for children who have received a solid organ transplant. Research on the psychological and social predictors of medication adherence is essential to the advancement of pretransplant assessments and transplant psychosocial services. Despite the importance of identifying risk factors, the literature remains limited regarding psychosocial predictors of non-adherence. A systematic search was conducted to identify studies of the psychosocial predictors of post-transplant medication non-adherence in pediatric solid organ transplantation. From 1363 studies identified in searches of empirical literature, a final sample consisted of 54 publications representing 49 unique studies. Findings regarding psychosocial predictors were inconsistent with non-adherence associated largely with adolescence, racial/ethnic minority status, and presence of mental health issues. Familial predictors of non-adherence problems included single-parent households, lower socioeconomic status, lower family cohesion, presence of family conflict, and poor family communication. Several studies reported an association between non-adherence and social pressures (eg, peer social interaction, wanting to feel normal) among adolescent transplant recipients. While significant methodological and substantive gaps remain in this body of knowledge, this review synthesizes current evidence for assessment for transplant clinicians and researchers.