Longitudinal Assessment of Educational Risk for K-12 Students with Cystic Fibrosis.

OBJECTIVES: To assess the use of services provided by a cystic fibrosis (CF) center school specialist and evaluate relationships among student educational risk scores, family concerns for school engagement and performance, and disease severity. STUDY DESIGN: This was a retrospective review of medical records for 126 children with CF in grades K-12 who were screened for educational risk or used school intervention services during the 2017- 020 school years. Regression analyses were performed to identify and quantify predictors of educational risk, family concern for school performance and ability to advocate, and use of school specialist services. RESULTS: Most children with CF (62%-82%) were at moderate-to-high educational risk. Sixteen or more school absences, family concerns for their child's school performance or inability to advocate for their school needs, child mental health visits, and greater frequency of hospitalization predicted greater educational risk scores and more encounters with the school specialist. Better lung function and lower grade level were associated with lower educational risk. Number of encounters with the School Specialist remained high across three pre-coronavirus disease 2019 school years. CONCLUSIONS: Our experience illustrates a need to identify educational risk and support school experiences of children and youth with CF as a component of the care model. Tailored support, based on identification of risk predictors, has potential to improve educational outcomes.

A Pilot Study of Mindfulness-Based Cognitive Therapy to Improve Well-Being for Health Professionals Providing Chronic Disease Care.

OBJECTIVE: To assess the efficacy of mindfulness-based cognitive therapy delivered onsite during work hours in reducing stress and improving well-being in an interdisciplinary chronic care health care team. STUDY DESIGN: A longitudinal, mixed methods, observational pilot study using a survey created from validated assessment tools to measure effectiveness of training. Surveys were completed before training, and 1 and 15 months after training. Twenty-four professionals in the cystic fibrosis Centers at Cincinnati Children's Hospital and the University of Cincinnati participated in 6 mindfulness-based cognitive therapy training sessions. Sessions incorporated mindfulness, cognitive therapy, and experiential exercises for processing feelings related to stress and burnout. RESULTS: The presurvey and 1-month postsurvey responses revealed statistically significant improvements for empathy, perceived stress, depersonalization, anxiety, perspective taking, resilience, and negative affect. Sustained effects were seen at 15 months for empathy, perspective taking, and depressive symptoms. The 1-month post-training surveys reported a quarter of respondents (25%) practiced skills at least 5 times in between sessions; at 15 months, 35% reported practicing at the same frequency. Participants reported using mindfulness skills for personal stressful events (74%), work-related general stress (65%), patient-related stress (30%), sleep or general relaxation (22%), and wellness (13%). CONCLUSIONS: Group mindfulness-based cognitive therapy training was feasible and effective in decreasing stress for interdisciplinary cystic fibrosis care team members who elected to participate. Further investigation is needed to determine optimal dose of training, durability of perceived benefits, and generalizability to health care professionals working with other chronic disorders.

Assessing psychosocial risk in pediatric inflammatory bowel disease: validation of the Psychosocial Assessment Tool 2.0_General.

AIM: The aim of this study was to present the preliminary psychometric properties of the Psychosocial Assessment Tool 2.0_General (PAT2.0_GEN), a brief screener for psychosocial risk in families of children with inflammatory bowel disease (IBD). METHODS: Caregivers of 42 youth with IBD were recruited and administered a battery of measures including the PAT2.0_GEN and well-validated measures of child emotional and behavioral functioning at baseline and at a 6-month follow-up. RESULTS: Internal consistency for the PAT2.0_GEN total score was good (α=0.82). Baseline was significantly associated with the 6-month follow-up (r=0.79, P<0.001). Significant correlations between the baseline PAT2.0 _GEN total score and caregiver-reported Child Behavior Checklist total scores at baseline (r=0.74, P<0.001) and at a 6-month follow-up (r=0.62, P<0.001) support the content and predictive validity of the PAT2.0_GEN. Baseline PAT2.0_GEN was also significantly correlated with youth-reported Child Behavior Checklist total scores at baseline (r=0.37, P=0.02) but not at the 6-month follow-up (r=0.23, P=0.17). CONCLUSIONS: A number of indicators support the concurrent and predictive utility of the PAT2.0_GEN. The PAT2.0_GEN is a promising tool for screening psychosocial risk that could facilitate the provision of psychosocial services to those patients most in need.

Education-related needs for children with cystic fibrosis: Perspectives of US pediatric care teams.

OBJECTIVE: Patients with cystic fibrosis (CF) often bring education-related concerns to their medical teams. Concerns around the ability for CF care teams to identify and address these concerns exist. We sought to describe CF care team perceptions of (1) patient and family education-related needs, (2) how these needs are identified, documented and addressed, and (3) education-related resource gaps. METHODS: A survey was emailed to pediatric care teams in the CF Foundation Care Center Network in April 2022. Individuals or care teams could complete the survey. Responses were aggregated for descriptive analysis. RESULTS: Sixty-seven programs responded representing 52% of United States pediatric CF centers. Most centers (88%) indicated social workers primarily address school concerns. Care teams often complete school forms (99%), coach families to communicate with schools (96%), communicate with schools directly (90%), and develop educational plans (76%). Formal education risk assessment and support programs are relatively uncommon (19%). Common student-specific needs include carrying medications (75%) and leaving class for gastrointestinal issues (54%). Needs reported are informational materials for families and schools (94%), staff education about school concerns and how to address them (91%), additional staff for education-related issues (65%), and expertise in education plan development (62%). CONCLUSION: CF care teams often lack comprehensive resources to identify and address education-related concerns. Systematically performing needs assessments, improving training for providers, and evaluating the benefits of education specialists on care teams may better identify and address education-related needs. Supporting educational progression will foster continued independence and well-being in adulthood.

Building a regional pediatric asthma learning health system in support of optimal, equitable outcomes.

Introduction: Asthma is characterized by preventable morbidity, cost, and inequity. We sought to build an Asthma Learning Health System (ALHS) to coordinate regional pediatric asthma improvement activities. Methods: We generated quantitative and qualitative insights pertinent to a better, more equitable care delivery system. We used electronic health record data to calculate asthma hospitalization rates for youth in our region. We completed an "environmental scan" to catalog the breadth of asthma-related efforts occurring in our children's hospital and across the region. We supplemented the scan with group-level assessments and focus groups with parents, clinicians, and community partners. We used insights from this descriptive epidemiology to inform the definition of shared aims, drivers, measures, and prototype interventions. Results: Greater Cincinnati's youth are hospitalized for asthma at a rate three times greater than the U.S. average. Black youth are hospitalized at a rate five times greater than non-Black youth. Certain neighborhoods bear the disproportionate burden of asthma morbidity. Across Cincinnati, there are many asthma-relevant activities that seek to confront this morbidity; however, efforts are largely disconnected. Qualitative insights highlighted the importance of cross-sector coordination, evidence-based acute and preventive care, healthy homes and neighborhoods, and accountability. These insights also led to a shared, regional aim: to equitably reduce asthma-related hospitalizations. Early interventions have included population-level pattern recognition, multidisciplinary asthma action huddles, and enhanced social needs screening and response. Conclusion: Learning health system methods are uniquely suited to asthma's complexity. Our nascent ALHS provides a scaffold atop which we can pursue better, more equitable regional asthma outcomes.

Body composition and functional correlates of CF youth experiencing pulmonary exacerbation and recovery.

BACKGROUND: Youth with cystic fibrosis (CF) and pulmonary exacerbation (PEx) often experience weight loss, then rapid weight gain. Little is known about body composition and its relationship to functional outcomes during this critical period. METHODS: Twenty CF youth experiencing PEx were assessed on the day following admission and 7-17 days later at discharge for body mass index (BMI), fat mass index (FMI), lean mass index (LMI), skeletal muscle mass index (SMMI), and functional measures: percent predicted forced expiratory volume in 1 second (FEV1) (ppFEV1), maximal inspiratory and expiratory pressures (MIPs and MEPs), and handgrip strength (HGS). Changes from admission to discharge and correlations among body composition indices and functional measures at both times are reported. RESULTS: Upon admission, participant BMI percentile and ppFEV1 varied from 2 to 97 and 29 to 113, respectively. Thirteen had an LMI below the 25th percentile and nine had a percent body fat above the 75th percentile. BMI and FMI increased significantly (p = 0.03, 0.003) during hospitalization. LMI and SMMI did not change. FEV1 and MIPS increased (p = 0.0003, 0.007), independent of weight gain, during treatment. HGS did not improve. CONCLUSIONS: Many youth with CF, independent of BMI, frequently carried a small muscle mass and disproportionate fat at the time of PEx. During hospital treatment, weight gain largely represented fat deposition; muscle mass and strength did not improve. A need for trials of interventions designed to augment muscle mass and function, and limit fat mass accretion, at the time of PEx is suggested by these observations.

Longitudinal mental health trends in cystic fibrosis.

BACKGROUND: Mental health screening in accordance with consensus guidelines became routine clinical practice in our cystic fibrosis (CF) Center in 2015. We hypothesized improvement in anxiety and depression symptoms over time and associations between elevated screening scores and disease severity. We aimed to observe the impact of the COVID-19 pandemic and modulator use on mental health symptoms. METHODS: Retrospective chart reviews were conducted for people 12 years and older with at least one Generalized Anxiety Disorder-7 (GAD-7) or Patient Health Questionnaire-9 (PHQ-9) screening for six years. Descriptive statistics were used to summarize demographic variables and logistic regression and linear mixed models were used to evaluate the relationship between screening scores and clinical variables. RESULTS: Analyses included 150 participants (ages 12-22 years). The percentage of minimal to no symptom scores increased over time for anxiety and depression. Increased mental health visits and CFRD were associated with higher PHQ-9 and GAD-7 scores. Higher FEV1pp was associated with lower GAD-7 and PHQ-9 scores. More effective modulator use was associated with lower PHQ-9 scores. Mean PHQ-9 and GAD-7 scores were not significantly different when comparing pre-pandemic and pandemic scores. CONCLUSION: Disruptions in screening during the pandemic were minimal and symptom scores remained stable. Individuals with higher mental health screening scores were more likely to have CFRD and utilization of mental health services. Consistent mental health monitoring and support is needed so individuals with CF can endure anticipated and unanticipated stressors including changes in physical health, healthcare, and societal stressors such as COVID-19 pandemic.

Behavioral functioning and treatment adherence in pediatric eosinophilic gastrointestinal disorders.

OBJECTIVE: To examine behavioral predictors of treatment adherence in patients with eosinophilic gastrointestinal disorders (EGID). METHODS: Participants were 96 patients 2.5-18 yr of age with eosinophilic esophagitis or eosinophilic gastroenteritis and their caregivers (mother, father). We assessed maternal and paternal report of child/adolescent internalizing symptoms (e.g., anxiety, depression) and externalizing symptoms (e.g., aggression, anger) using the Behavior assessment system for children, 2nd edition (BASC-2). A multi-informant adherence assessment approach and an 80% cut point were used to classify patients as adherent or non-adherent. RESULTS: Sociodemographic predictors did not distinguish between adherent and non-adherent patients. Maternal report of internalizing symptoms significantly correlated with non-adherence (p < 0.001). Post hoc probing revealed a significant contribution of depression, with depressed patients being more likely (OR = 7.27; p < 0.05) to be non-adherent than non-depressed patients. Paternal report of internalizing and externalizing symptoms was not associated with non-adherence. CONCLUSIONS: Maternal report of patient internalizing behavioral symptoms, particularly depression, is significantly associated with non-adherence in patients with EGID. These symptoms are potential risk factors and should be considered when assessing and treating non-adherence. Clinical care of patients with EGID should include routine screening for depression.

Treatment adherence in pediatric eosinophilic gastrointestinal disorders.

OBJECTIVE: Examine treatment adherence rates in pediatric eosinophilic gastrointestinal disorders (EGID). METHODS: Participants were children aged 2.5-18 years with eosinophilic esophagitis or eosinophilic gastroenteritis (EGE) and their caregivers. A multimethod, multi-informant assessment including parent report and electronic monitoring was utilized, with a 90% cut point for nonadherence. RESULTS: Medication nonadherence prevalence was 30%. Adherence frequency was 91% ± 14% (0-100%) per parent report and 100% ± 69% (0-194%) per electronic monitors. Tube-feeding adherence was 99% ± 3%. Food allergen exposures were less than 1 per 2 weeks, with 33% nonadherence prevalence. Patients with EGE and toddlers with both conditions demonstrated poorer medication adherence (p's < .05). Caregivers reported higher number of missed medication doses than food exposures (p < .05). CONCLUSIONS: The prevalence and range of nonadherence demonstrates that subsets of these patients are nonadherent. Adherence to treatment in EGID is complex and multifaceted, with nonadherence varying across treatments.

Individually tailored treatment of medication nonadherence.

OBJECTIVE: Nonadherence is a significant health care issue in pediatric inflammatory bowel disease (IBD) that requires intervention to improve outcomes. This pilot randomized controlled trial was designed to evaluate the feasibility, acceptability, and preliminary efficacy of an individually tailored behavioral treatment for nonadherence in adolescents with IBD. PATIENTS AND METHODS: Fourteen adolescents ages 14.89 ± 2.01 years were randomly assigned to immediate care or wait list control conditions and received a manualized individually tailored behavioral intervention for nonadherence. Medication adherence, measured by pill count, served as the primary endpoint. Parents provided demographic data and ratings of intervention acceptability and patients provided disease-severity data. RESULTS: Feasibility of the treatment was demonstrated by 100% treatment session attendance for all of the patients enrolled in the trial. Both parent and patient acceptability ratings were favorable. Comparison of baseline with posttreatment percent adherence across both conditions demonstrated that treatment resulted in a 4% gain in 6-mercaptopurine/azathioprine adherence (52% at baseline; 56% at posttreatment; δ = 0.07) and a 25% gain in mesalamine adherence (43% at baseline; 68% at posttreatment; δ = 0.57). CONCLUSIONS: Individually tailored treatment of nonadherence in adolescents with IBD is feasible and may result in substantial improvement in medication adherence. Differential effect of the intervention on medications requires further investigation, but it may reflect differences in regimen complexity, concerns about medication adverse effects, and/or patient/parent preference to target more complex regimens. Large-scale testing of this intervention is needed to demonstrate effect on clinical outcomes.

Assessment of treatment burden and complexity in cystic fibrosis: A quality improvement project.

BACKGROUND: Treatment regimens for cystic fibrosis (CF) continue to evolve and grow in complexity. Treatment regimen burden, and associated sequelae, are incompletely understood. OBJECTIVE: Quality improvement (QI) methods were used to investigate treatment burden of CF care, family and care team partnerships, and potential interventions to reduce burden. METHODS: Patients 6-24 years with CF and caregivers of patients 6-13 years were surveyed. Portions of validated tools and existing surveys measured burden and family-care team partnership. An automated report calculated treatment complexity. Plan-do-study-act cycles tested survey administration during CF visits and run charts tracked progress. Interventions to reduce burden were tracked, and bidirectional assessments explored partnerships among patients, families and clinicians. RESULTS: Over 6 months, 110 patients and 62 caregivers completed assessments. Caregivers reported lower burden/higher quality of life (74.0, range 22.2-100) than patients (66.5, range 16.7-100). The mean treatment complexity score was 17.2 (range 6-34). Treatment complexity and burden increased with patient age (p < .05 and p < .01 respectively). Lower lung function correlated with higher patient-reported burden (p < .01) and higher treatment complexity (p < .0001). As burden increased, providers more often performed select interventions (discussed combining treatments, simplified regimens, or involved other team members (p < .05 for each)). Families reported high partnership (mean scores 4.7-4.8, 5 = high), and providers reported high utilization of partnership tools (tool used in 77% of encounters). CONCLUSION: We assessed, quantified, and responded to treatment burden and complexity in real-time during outpatient CF visits. Systematic and individualized assessments of treatment complexity and burden may enhance treatment adherence while preserving quality of life.

Sleep disturbance and sleep insufficiency in primary caregivers and their children with cystic fibrosis.

BACKGROUND: Chronically ill children and their parents are at risk for sleep disorders and associated morbidity. Sleep disturbance prevalence and the relationships between parent and child sleep among children with CF are not well defined. Clarifying the presence and impact of sleep disturbances among pediatric CF patients and their parents could lead to improved health in this population. METHODS: Cross-sectional study assessing parent-reported sleep in ninety-one CF patients (mean age 8.8 years; 53.8% female) and their primary caregivers. Sleep sufficiency determined using American Academy of Sleep Medicine guidelines; correlation coefficients computed for sleep problem domains; stepwise multiple linear regression determined predictive models for sleep duration. RESULTS: Parents reported concerns about their own sleep and that of their children. Night waking and daytime sleepiness were most common in parents; prolonged sleep latency was most common for children. Most parents and children had inadequate sleep duration. School-age children had the highest frequencies of overall sleep concerns and inadequate sleep. Most parent and child sleep problem domains were significantly associated, with large effects for similar parent and child problems. Stepwise multiple linear regression demonstrated that CF caregiver/patient sleep duration was significantly predicted by insomnia symptoms. CONCLUSIONS: Many CF children and their parents experience sleep difficulties including inadequate sleep duration, with presence of sleep problems in many families whose children with CF had normal lung function. These data suggest that sleep health should be a CF Care Model component and should be a health care focus for families of children with other chronic illness.

Assessing and responding to stress related to pulmonary function testing in cystic fibrosis through quality improvement.

BACKGROUND: Pulmonary function tests (PFTs) are performed routinely to evaluate lung function in patients with cystic fibrosis (CF). Staff at the Cincinnati Children's Hospital Medical Center CF Center observed stress in patients before PFTs. An interdisciplinary quality improvement (QI) team was assembled to address this clinical issue. METHODS: The Plan-Do-Study-Act method of QI was used to investigate feasibility of assessing stress and offering brief interventions to reduce stress before PFTs. Interventions included listening to music, covering the PFT screen, or doing breathing meditation before PFTs. Patients rated stress levels on a 1 to 5 Likert scale before and after testing. RESULTS: Of 75 patient encounters, interventions were trialed in 20. Fifteen patients who tried an intervention reported wanting to use the intervention again (five encounters had missing data); patients reported that the intervention benefited performance on PFTs in eight encounters (40%). The average pre-PFT stress rating for encounters that trialed an intervention was 2.1 and post-PFT rating was 2.0. Average stress pre-PFT and post-PFT ratings were 1.7 and 1.6 respectively, for encounters that did not trial an intervention. Median length of PFT encounter was 15 minutes regardless of whether intervention was trialed. CONCLUSION: Some patients with CF utilized interventions, while many opted out. This QI effort identified feasible outpatient clinic interventions that did not negatively impact clinic flow. Finding ways to reduce stress associated with PFTs could have a meaningful impact on patient performance and emotional well-being for a subset of patients.

Integration of the Safe Environment for Every Kid (SEEK) Model Across Primary Care Settings.

This project sought to assess the generalizability, barriers, and facilitators of implementing the Safe Environment for Every Kid (SEEK) model for addressing psychosocial risk factors for maltreatment across multiple primary care settings, including a pediatric practice, federally qualified health center, and family medicine practice. The SEEK model includes screening caregivers for psychosocial risk factors at well-child visits age 0 to 5 years, brief intervention incorporating principles of motivational interviewing to engage caregivers, and referral to treatment. All practices successfully implemented SEEK, with screening completion rates from 75% to 93% and brief intervention rates from 61% to 81%. Major parental stress (14%) and food insecurity (11%) were the most common risk factors. Providers found SEEK worthwhile for improving their knowledge, skills, and ability to address psychosocial concerns and provide whole person care. Barriers included limited time and resources, incomplete resource knowledge, and lack of follow-up. Facilitators included on-site support staff to assist with communication and referrals.

The Telehealth Enhancement of Adherence to Medication (TEAM) in pediatric IBD trial: Design and methodology.

Medication nonadherence is a significant health care issue requiring regular behavioral treatment. Lack of sufficient health care resources and patient/family time commitment for weekly treatment are primary barriers to receiving appropriate self-management support. We describe the methodology of the Telehealth Enhancement of Adherence to Medication (TEAM) trial for medication nonadherence in pediatric inflammatory bowel disease (IBD). For this trial, participants 11-18 years of age will be recruited from seven pediatric hospitals and will complete an initial 4-week run in to assess adherence to a daily medication. Those who take less than 90% of their prescribed medication will be randomized. A total of 194 patients with IBD will be randomized to either a telehealth behavioral treatment (TBT) arm or education only (EO) arm. All treatments will be delivered via telehealth video conferencing. The patients will be assessed at baseline, post-treatment, 3, 6, and 12 months. We anticipate that participants in the TBT arm will demonstrate a statistically significant improvement at post-treatment and 3-, 6-, and 12-month follow-up compared to participants in the EO arm for both medication adherence and secondary outcomes (i.e., disease severity, patient quality of life, and health care utilization). If efficacious, the TEAM intervention could be disseminated broadly and reduce health care access barriers so that the patients could receive much needed self-management intervention.

Telehealth behavioral treatment for medication nonadherence: a pilot and feasibility study.

OBJECTIVE: To evaluate an individually tailored multicomponent nonadherence treatment protocol using a telehealth delivery approach in adolescents with inflammatory bowel disease. METHODS: Nine participants, age 13.71±1.35 years, completed a brief treatment online through Skype. Medication nonadherence, severity of disease, and feasibility/acceptability data were obtained. RESULTS: Adherence increased markedly from 62% at baseline to 91% for mesalamine (δ=0.63), but decreased slightly from 61% at baseline to 53% for 6-mercaptopurine /azathioprine. The telehealth delivery approach resulted in cost savings of $100 in mileage and 4 h of travel time/patient. Treatment session attendance was 100%, and the intervention was rated as acceptable, particularly in terms of treatment convenience. CONCLUSION: Individually tailored treatment of nonadherence through telehealth delivery is feasible and acceptable. This treatment shows promise for clinical efficacy to improve medication adherence and reduce costs. Large-scale testing is necessary to determine the impact of this intervention on adherence and health outcomes.

The clinical utility of health-related quality of life screening in a pediatric inflammatory bowel disease clinic.

BACKGROUND: Adjusting to symptom flares, treatment regimens, and side effects places youth with inflammatory bowel disease (IBD) at increased risk for emotional and behavioral problems and adverse disease outcomes. Implementation of psychosocial screening into clinical practice remains a challenge. This study examines the clinical utility of health-related quality of life (HRQOL) screening in predicting disease outcome and healthcare utilization. METHODS: One hundred twelve youth of 7 to 18 years diagnosed with IBD and their parents. Youth completed standardized measures of HRQOL and depression. Parents completed a proxy report of HRQOL. Pediatric gastroenterologists provided the Physician Global Assessment. Families were recruited from a pediatric gastroenterology clinic. Retrospective chart reviews examined disease outcome and healthcare utilization for 12 months after baseline measurement. RESULTS: Linear regressions, controlling for demographic and disease parameters, revealed that baseline measurement of youth and parent proxy-reported HRQOL predicted the number of IBD-related hospital admissions, gastroenterology clinic visits, emergency department visits, psychology clinic visits, telephone contacts, and pain management referrals over the next 12 months. Disease outcome was not significant. CONCLUSIONS: Lower HRQOL was predictive of increased healthcare utilization among youth with IBD. Regular HRQOL screening may be the impetus to providing better case management and allocating resources based on ongoing care needs and costs. Proactive interventions focused on patients with poor HRQOL may be an efficient approach to saving on healthcare costs and resource utilization.

Evaluation of a group-based behavioral intervention to promote adherence in adolescents with inflammatory bowel disease.

OBJECTIVE: To pilot test the feasibility and acceptability of a family-based group behavioral intervention and to improve medication adherence in adolescents diagnosed with inflammatory bowel disease. METHODS: Participants were 40 adolescents aged 11-18 years diagnosed with inflammatory bowel disease and their primary caregivers, who were randomized to either a four-session Family-Based Group Behavioral Treatment or Usual Care over a 6-week period. Adherence was measured using a multi-method, multi-informant assessment involving caregiver-report and patient-report, pill count data, and electronic monitoring. RESULTS: Adherence rates ranged from 66 to 89% for 6-mercaptopurine/azathioprine and 51 to 93% for mesalamine across assessment methods. The intervention was feasible, as evidenced by the 99% treatment session attendance rate, and acceptable based on patient and caregiver report. Repeated measures analysis of variance tests revealed nonsignificant differences between the conditions from baseline to post-treatment assessments for pill count, electronic monitor, and primary caregiver-reported adherence (P's>0.05). There was a statistically significant improvement in patient-reported mesalamine adherence represented by a significant main effect for Condition (F=22.24, P<0.01; δ=0.79) and Condition×Time interaction (F=13.32, P<0.05; δ=0.69). CONCLUSION: Findings suggest potential for use of behavioral intervention to improve medication adherence in this population. This intervention may be more effective with more complex regimens (e.g. multiple doses per day) such as those prescribed with mesalamine. Further research is needed to examine this type of intervention in more diverse samples with more active disease. Use of alternative adherence measurement approaches, including electronic pill boxes and/or real-time self-report (e.g. by text messaging, electronic diaries, etc.) is also recommended.