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Reducing treatment burden is a priority for people with cystic fibrosis, whose health has benefited from using new modulators that substantially increase CFTR protein function. The SIMPLIFY study aimed to assess the effects of discontinuing nebulised hypertonic saline or dornase alfa in individuals using the CFTR modulator elexacaftor plus tezacaftor plus ivacaftor (ETI).The SIMPLIFY study included two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials at 80 participating clinics across the USA in the Cystic Fibrosis Therapeutics Development Network. We included individuals with cystic fibrosis aged 12-17 years with percent predicted FEVFrom Aug 25, 2020, to May 25, 2022, a total of 672 unique participants were screened for eligibility for one or both trials, resulting in 847 total random assignments across both trials with 594 unique participants. 370 participants were randomly assigned in the hypertonic saline trial and 477 in the dornase alfa trial. Participants across both trials had an average ppFEVIn individuals with cystic fibrosis on ETI with relatively well preserved pulmonary function, discontinuing daily hypertonic saline or dornase alfa for 6 weeks did not result in clinically meaningful differences in pulmonary function when compared with continuing treatment.

Using self-determination theory, we explored relationships between autonomous motivation (AM) and perceived competence (PC) with previously validated measures of motivation and adolescent-reported asthma medication adherence.Data were from adolescents (n = 260) enrolled in the School-Based Asthma Care for Teens study and taking preventive medication at baseline. Eligible adolescents (aged 12-16 years) had physician-diagnosed persistent asthma or poor control.Adolescents taking daily preventive medicine reported higher AM and PC for adherence, whereas adolescents likely to miss ≥1 dose in the next 2 weeks had lower AM and PC. Adolescents taking medicines as prescribed, with plans to continue, and those feeling able to follow provider care plans, had higher AM and PC. Findings remained significant in regressions with control variables.Many factors interfere with adolescent medication-taking. Clinicians' efforts to build AM and PC with patients and caregivers may be key to promoting adherence in this group.

Background Lower socioeconomic status (SES) has consistently been associated with poorer outcomes in individuals with cystic fibrosis (CF). Previous studies have compared outcomes for children with and without private insurance coverage, however the potential role of changes in insurance status on early health outcomes in children with CF remains unknown. Objectives To describe the variability in insurance status in early childhood and to evaluate whether insurance variability was associated with poorer outcomes at age 6. Methods Retrospective observational study using the Cystic Fibrosis Foundation Patient Registry. Insurance status was defined as: always private (including Tricare), exclusively public, or intermittent private insurance (private insurance and exclusively public insurance in separate years) during the first 6 years of life. Outcomes at age 6 included body mass index (BMI) and FEV1 percent predicted (maxFEV1pp). Results From a 2000–2011 birth cohort (n = 8,109), 42.3% always had private insurance, 30.0% had exclusively public insurance, and 27.6% had intermittent private insurance. BMI percentiles did not differ between groups; however, children with intermittent private insurance and exclusively public insurance had a 3.3% and 6.6% lower maxFEV1pp at age 6, respectively, compared to those with always private insurance. Conclusions A substantial proportion of young children in a modern CF cohort have public or intermittent private insurance coverage. While public insurance has been associated with poorer health outcomes in CF, variability in health insurance coverage may also be associated with an intermediate risk of disparities in lung function as early as age 6.

Background The prevalence of burnout and depressive symptoms is high among physician trainees. Research Question What is the burden of burnout and depressive symptoms among fellows training in pulmonary and critical care medicine (PCCM) and what are associated individual fellow, program, and institutional characteristics? Study Design and Methods We conducted a cross-sectional electronic survey of fellows enrolled in pulmonary, PCCM, and critical care medicine training programs in the United States to assess burnout and depressive symptoms. Burnout symptoms were measured using the Maslach Burnout Index two-item measure. The two-item Primary Care Evaluation of Mental Disorders Procedure was used to screen for depressive symptoms. For each of the two outcomes (burnout and depressive symptoms), we constructed three multivariate logistic regression models to assess individual fellow characteristics, program structure, and institutional polices associated with either burnout or depressive symptoms. Results Five hundred two of the 976 fellows who received the survey completed it—including both outcome measures—giving a response rate of 51%. Fifty percent of fellows showed positive results for either burnout or depressive symptoms, with 41% showing positive results for depressive symptoms, 32% showing positive results for burnout, and 23% showing positive results for both. Reporting a coverage system in the case of personal illness or emergency (adjusted OR [aOR], 0.44; 95% CI, 0.26-0.73) and access to mental health services (aOR, 0.14; 95% CI, 0.04-0.47) were associated with lower odds of burnout. Financial concern was associated with higher odds of depressive symptoms (aOR, 1.13; 95% CI, 1.05-1.22). Working more than 70 hours in an average clinical week and the burdens of electronic health record (EHR) documentation were associated with a higher odds of both burnout and depressive symptoms. Interpretation Given the high prevalence of burnout and depressive symptoms among fellows training in PCCM, an urgent need exists to identify solutions that address this public health crisis. Strategies such as providing an easily accessible coverage system, access to mental health resources, reducing EHR burden, addressing work hours, and addressing financial concerns among trainees may help to reduce burnout or depressive symptoms and should be studied further by the graduate medical education community.

Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy. Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies—alongside randomized controlled trials (RCTs)—in informing clinical decisions in pulmonary, critical care, and sleep medicine. Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines. Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; “sequential”). Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.

People with cystic fibrosis (CF) are living longer and healthier lives as a result of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies, and are pursuing pregnancy. As the number of pregnancies in CF continue to increase, clinician attitudes and practices regarding care of pregnant people with CF remain largely unknown.To evaluate the current attitudes and practices of CF clinicians regarding pregnancy planning and care in CF.We conducted a national survey investigating practice patterns related to pregnancy care in CF. We used descriptive statistics to summarize responses and paired t-tests to compare population means.A total of 93 clinicians completed the survey. Eighty-six percent of respondents believed family planning and pregnancy discussions should start before the age of 21 years, of which 67% believed these discussions should occur prior to age 18 years. Our results demonstrate variability in CF clinician comfort and management of various aspects of pregnancy care in CF including 1) potential complications of pregnancy 2) continuation of chronic CF therapies 3) continuation of CFTR modulators during pregnancy and lactation, and 4) approach to treatment of pulmonary exacerbation during pregnancy.As more people with CF pursue pregnancy in the era of CFTR modulators, CF providers should be initiating discussions surrounding pregnancy early and often. Establishing best practices in the management of pregnancy in CF, expanding peri‑pregnancy expertise within the CF community, and future studies investigating the maternal-fetal effects of CF therapies are needed.

Objective To identify differences in perspectives of people with cystic fibrosis (PwCF) and caregivers versus healthcare providers on adherence barriers. Mismatched perspectives may lead to miscommunication and missed opportunities to reduce barriers and improve CF outcomes. Methods PwCF, caregivers, and CF providers completed audio-taped, semi-structured interviews about adherence barriers. Interviews were transcribed and coded for themes. Themes were reviewed to identify when PwCF-caregiver perspectives differed from providers’. Results Participants included 14 adolescents with CF (mean age = 15.89 years, 64 % female, 71 % Caucasian), 14 adults with CF (mean age = 30.03 years, 64 % female, 57 % Caucasian), 29 caregivers (76 % female; 72 % Caucasian), and 42 providers. Four barriers were identified that could generate miscommunication between PwCF-caregivers and providers: Tired = Fatigued/Sleepy versus Tired = Burnout, Vacation and Travel, Knowledge and Skills About CF Regimen, and Daily Habits or Routines. PwCF and caregivers used similar words as providers, but conceptualized barriers differently. PwCF and caregivers discussed barriers pragmatically, however, providers viewed certain barriers more abstractly or unidimensionally, or did not discuss them. Conclusions PwCF-caregivers and providers may not align in how they discuss barriers, which may contribute to miscommunication about adherence challenges. Practice implications Patient-centered communication strategies may enhance providers’ understandings of PwCF-caregiver perspectives on barriers and facilitate adherence interventions.

Objective Among adolescents and young adults (AYAs) with chronic illness, effective provider communication is essential for patient-centered care during a sensitive developmental period. However, communication in chronic illness care for AYAs is not well studied. Our objectives were to describe the provider communication skills in pediatric chronic kidney disease (CKD) care visits; and determine if communication skills differ by AYA characteristics. Methods We adapted a global consultation rating system for pediatric subspecialty care using audiotaped clinic encounters of 18 pediatric nephrologists with 99 AYAs (age M(SD) = 14.9(2.6)) with CKD stages 1–5 and 96 caregivers. We hypothesized that provider communication skills would differ by AYA characteristics (age, gender, and race). Results The strongest provider skills included initiating the session and developing rapport; lowest rated skills were asking patient’s perspective and checking understanding. Communication scores did not consistently differ by AYA age or race, but were rated higher with female AYAs in several domains (ps Conclusions Pediatric providers generally had adequate or good communication scores with AYAs, but improvement in certain skills, particularly with male AYAs, may further support patient-centered care. Practice implications To achieve consistent, patient-centered communication with AYAs, an observation-based global assessment may identify areas for provider improvement.

Introduction: Despite robust evidence of its effectiveness for secondary prevention, cardiac rehabilitation (CR) is underutilized. Understanding individual-level predictors of CR use can guide interventions to boost CR participation. Hypothesis: Clinical, psychosocial and socioeconomic predictors impact CR participation. Methods: We studied 1,255 participants from the ARIC Study with cardiovascular disease (CVD) events eligible for CR (myocardial infarction, coronary revascularization, valve surgery) from data linked to Medicare claims (1991-2015). Predictors including comorbidities, functional status, cognitive function, social support, social network, educational attainment, and household income were ascertained from study visits and annual follow-up at the time point closest to the index CVD event. CR participation was defined as having Current Procedural Terminology codes 93797 and 93798. We examined multiple predictors using logistic regression with the Modified Allen-Cady stepwise backward selection of covariates in addition to age, race, sex, and ARIC center. Results: The mean age was 72.4 (SD 5.2) years (16% Black, 43% women) and 26% participated in CR. In multivariate analyses, variables associated with lower CR participation were income $50,000; < high school education (OR 0.48 [0.27 - 0.86]) vs. graduate/professional education; lowest quartile of cognitive function (OR 0.52 [0.32 - 0.85]) vs. the highest quartile; lowest quartile of social support (OR 0.65 [0.44 - 0.96]) vs. the highest quartile; and current smoking (OR 0.55 [0.31 - 0.96]). Comorbidities and social network were not associated with CR participation. Conclusions: Cognitive function, social support, and SES were robustly associated with CR participation. Efforts to address the gap in CR participation should focus on interventions that support patients with low cognitive function, social supports, and SES.

Objectives: Compare attended home blood pressure (BP) measurements (HBPM) with ambulatory BP monitor (ABPM) readings and examine if level of agreement between the measurement approaches differ overall and by subgroup. Methods: This was a secondary analysis of data from a 2-yr observational study of children 11-19 yrs (mean 15, SD=2.69) with chronic kidney disease. Participants had 3 standardized resting oscillometric home BPs taken by staff followed by 24-hr ABPM within 2 weeks of home BP. BP indices (measured BP/95%ile BP) were calculated for the mean triplicate attended HBPM and mean daytime ABPM readings. All paired HBPM and ABPM measurements taken during any of 5 study visits were compared using linear regression with robust standard errors. Generalized estimating equations-based logistic regression determined the sensitivity, specificity, negative, and positive predictive values with ABPM as the gold standard. Analyses were conducted for the group overall and by subgroup. Results: There were 103 participants who contributed 251 paired measurements. Indexed systolic BP did not differ between modalities (mean difference -0.002; 95% CI: -0.006, 0.003), and the difference in indexed diastolic BP was minimal (mean difference -0.033; 95% CI: -0.040, -0.025). The overall agreement between HBPM and ABPM in identifying abnormal BP was high (88.5%), and findings were consistent in each subgroup (Table). Conclusions: Attended HBPM may be a reasonable substitute for ABPM when monitoring BP. The greater accessibility and feasibility of attended HBPM has the potential to improve BP control among at-risk youth.

This study aimed to compare attended home blood pressure (BP) measurements (HBPM) with ambulatory BP monitor (ABPM) readings and examine if level of agreement between measurement modalities differs overall and by subgroup.This was a secondary analysis of data from a 2-year, multicenter observational study of children 11-19 years (mean 15, SD = 2.7) with chronic kidney disease. Participants had 3 standardized resting oscillometric home BPs taken by staff followed by 24-h ABPM within 2 weeks of home BP. BP indices (measured BP/95%ile BP) were calculated for mean triplicate attended HBPM and mean ABPM measurements. Paired HBPM and ABPM measurements taken during any of 5 study visits were compared using linear regression with robust standard errors. Generalized estimating equation-based logistic regression determined sensitivity, specificity, negative, and positive predictive values with ABPM as the gold standard. Analyses were conducted for the group overall and by subgroup.A total of 103 participants contributed 251 paired measurements. Indexed systolic BP did not differ between HBPM and daytime APBM (mean difference - 0.002; 95% CI: - 0.006, 0.003); the difference in indexed diastolic BP was minimal (mean difference - 0.033; 95% CI: - 0.040, - 0.025). Overall agreement between HBPM and 24-h ABPM in identifying abnormal BP was high (81.8%). HBPM had higher sensitivity (87.5%) than specificity (77.4%) and greater negative (89.8%) than positive (73.3%) predictive value, and findings were consistent in subgroups.Attended HBPM may be reasonable for monitoring BP when ABPM is unavailable. The greater accessibility and feasibility of attended HBPM may potentially help improve BP control among at-risk youth. A higher resolution version of the Graphical abstract is available as Supplementary information.

Background: Well-designed clinical research needs to obtain information that is applicable to the general population. However, most current studies fail to include substantial cohorts of racial/ethnic minority populations. Such underrepresentation may lead to delayed diagnosis or misdiagnosis of disease, wide application of approved interventions without appropriate knowledge of their usefulness in certain populations, and development of recommendations that are not broadly applicable. Goals: To develop best practices for recruitment and retention of racial/ethnic minorities for clinical research in pulmonary, critical care, and sleep medicine. Methods: The American Thoracic Society convened a workshop in May of 2019. This included an international interprofessional group from academia, industry, the NIH, and the U.S. Food and Drug Administration, with expertise ranging from clinical and biomedical research to community-based participatory research methods and patient advocacy. Workshop participants addressed historical and current mistrust of scientific research, systemic bias, and social and structural barriers to minority participation in clinical research. A literature search of PubMed and Google Scholar was performed to support conclusions. The search was not a systematic review of the literature. Results: Barriers at the individual, interpersonal, institutional, and federal/policy levels were identified as limiting to minority participation in clinical research. Through the use of a multilevel framework, workshop participants proposed evidence-based solutions to the identified barriers. Conclusions: To date, minority participation in clinical research is not representative of the U.S. and global populations. This American Thoracic Society research statement identifies potential evidence-based solutions by applying a multilevel framework that is anchored in community engagement methods and patient advocacy.

Urban minority preschool children are disproportionately affected by asthma with increased asthma morbidity and mortality. It is important to understand how families manage asthma in preschool children to improve asthma control.To evaluate family asthma management and asthma outcomes among a low-income urban minority population of Head Start preschool children.The family asthma management system scale (FAMSS) evaluates how families manage a child's asthma. A total of 388 caregivers completed the FAMSS at baseline. Asthma outcomes were evaluated at baseline and prospectively at 6 months, including asthma control (based on the Test for Respiratory and Asthma Control in Kids), courses of oral corticosteroids (OCSs) required, and caregiver health-related quality of life (Pediatric Asthma Caregiver's Quality of Life Questionnaire [PACQLQ]). Multiple regression models evaluated the relationship between the FAMSS total score, FAMSS subscales, and asthma outcomes.Higher FAMSS total scores were associated with fewer courses of OCSs required (b = -0.23, P.01) and higher PACQLQ scores (b = 0.07, P.05). At baseline, higher integration subscale scores (b = -0.19, P.05) were associated with fewer courses of OCSs required, and higher family response scores were associates with higher PACQLQ scores (b = 0.06, P.05). Nevertheless, higher collaboration scores were associated with lower PACQLQ at baseline (b = -0.06, P.05) and 6 months (b = -0.07, P.05).Among this population of low-income minority preschool children, understanding how a family manages their child's asthma may help identify gaps for education to possibly improve caregiver asthma-related quality of life and reduce courses of OCSs.ClinicalTrials.gov Identifier: NCT01519453 (https://clinicaltrials.gov/ct2/show/NCT01519453); protocol available from meakin1@jhmi.edu.

Background Females with cystic fibrosis (CF) have been shown to have worse pulmonary exacerbation (PEx) related outcomes compared to males. However, it is unknown if sex differences in treatment patterns are contributing to these outcomes. Thus, we sought to explore sex differences in treatment patterns in the Standardized Treatment of Pulmonary Exacerbations (STOP) cohort. Methods Data for 220 participants from the STOP cohort were analyzed. Multivariable regression models were used to assess if female sex was associated with duration of treatment with IV antibiotics and inpatient length of stay. Secondary outcomes included antibiotic selection, adjunctive therapies, mean FEV1pp and CFRSD-CRISS respiratory symptom scores at the four study assessments. Results In our adjusted model, the average number of IV antibiotic treatment days was 13% higher in females compared to males (IRR 1.13, 95% CI=1.02,1.25; p=0.02). We found no sex differences in inpatient length of stay, number of IV antibiotics, antibiotic selection or initiation of adjunctive therapies. Overall, females had higher CFRSD-CRISS scores at the end of IV therapy indicating worse symptom severity (23.6 for females vs. 18.5 for males, p=0.03). Conclusions Despite females having a longer treatment duration, our findings demonstrate that males and females are receiving similar treatments which suggest that the outcome disparities in females with CF may not be due to failure to provide the same level of care. Further research dedicated to sex differences in CF is necessary to understand why clinical outcomes differ between males and females.

The Johns Hopkins University School of Medicine organized 2 multistakeholder symposia on February 2, 2018 and January 11, 2019 to address the problem of high graft failure in adolescent and young adult (AYA) solid organ transplant (SOT) recipients. Participants included international experts in transplantation, behavioral psychology, patient/parent advocacy, and technology. The objectives of the symposia were as follows: (1) to identify and discuss the barriers to and facilitators of effective transfer of care for AYA SOT recipients; (2) to actively explore strategies and digital solutions to promote their successful transfer of care; and (3) to develop meaningful partnerships for the successful development, evaluation, implementation, and dissemination of these digital solutions. Additionally, data were collected from 152 AYA SOT recipients demonstrating a substantial gap in how this population uses technologies for health-related activities, alongside an increased interest in an app to help them manage their transplant.

Parents of children with cystic fibrosis (CF) are at risk of depression and anxiety symptoms, yet, they are an under-researched group. This national cross-sectional study investigated the prevalence of anxiety and depression in parents of children with CF, and examined the associations between these symptoms and their child’s physical health and quality of life. A total of 203 parents of children attending nine paediatric CF clinics across Ireland filled out a questionnaire pack containing: a background information questionnaire; the Hospital Anxiety and Depression Scale (HADS); the Centre for Epidemiological Studies Depression Scale (CES-D); and, the Cystic Fibrosis Quality of Life Scale—Revised Edition (CFQ-R). According to the HADS, 38% of parents had elevated anxiety and 12% had elevated depression symptoms. Just over a fifth (20.7%) had elevated depression symptoms on the CES-D. Mothers had significantly higher levels of anxiety than fathers. There were statistically significant negative linear correlations between parents’ HADS anxiety and depression scores and their child’s pulmonary function, and between parents’ HADS anxiety and depression scores and their child’s quality of life. These results indicate that parents are at risk of depression and anxiety symptoms, and that these are associated with the physical health and quality of life of their child with CF. The findings support the need for parents to have mental health screening annually in CF services, as recommended in international guidelines. There is also a need to integrate a family-centred approach into CF services with appropriate supports and mental health referral pathways for parents.

PURPOSE: Teen readiness assessments may provide a developmental indicator of the transfer of responsibility for health self-management from caregivers to teens. Among urban adolescents with asthma, we aimed to describe teen readiness for talking with providers and identify how readiness relates to responsibility for asthma management, medication beliefs, and clinical outcomes METHODS: Teens and caregivers enrolled in the School-based Asthma Care for Teens trial in Rochester, NY completed in-home surveys. We classified Ready Teens as those reporting a score of 5 on both items of the Transition Readiness Assessment Questionnaire talking with providers subscale. We performed bivariate analyses to detect differences between Ready Teens and Other Teens in teen- and caregiver-reported responsibility, teen medication beliefs, and clinical outcomes (medication adherence over the past 2 weeks, and healthcare use over the past year). RESULTS: Among this sample of 251 adolescents (mean age: 13.4yrs.), 35% were classified as „Ready.‟ Ready Teens were more likely than Other Teens to want to use a controller medication independently (7.6 vs. 6.5 out of 10, P

Despite the increasing proportion of women in U.S. medical schools, there are relatively few women in leadership positions, and a number of recent publications have highlighted many factors that could contribute to gender inequity and inequality in medicine. The Association of Pulmonary, Critical Care, and Sleep Division Directors, an organization of Division Directors from across the United States, convened a workshop to review data and obtain input from leaders on the state of gender equity in our field. The workshop identified a number of factors that could contribute to gender inequality and inequity: gender climate (including implicit and perceived biases); disproportionate family responsibilities; lack of women in leadership positions; poor retention of women; and lack of gender equality in compensation. The panel members developed a roadmap of concrete recommendations for societies, leaders, and individuals that should promote gender equity to achieve gender equality and improve retention of women in the field of pulmonary, critical care, and sleep medicine.

Substance use and mental health (SU/MH) disorders are insufficiently recognized in HIV care. We examined whether conveying SU/MH screening results to patients and providers increased SU/MH discussions and action plans. Intervention participants completed a computerized patient-reported questionnaire before their HIV visit; screened positive on ≥ 1 measure: depression, anxiety, PTSD symptoms, at-risk alcohol use, or drug use; and reviewed screening results to decide which to prioritize with their provider. Screening results and clinical recommendations were conveyed to providers via medical record. A historic control included patients with positive screens but no conveyance to patient or provider. The patient-provider encounter was audio-recorded, transcribed, and coded. For the overall sample (n = 70; 38 control, 32 intervention), mean age (SD) was 51.8 (10.3), 61.4% were male, and 82.9% were Black. Overall, 93.8% raised SU/MH in the intervention compared to 50.0% in the control (p

Urban adolescents with asthma often have inadequate preventive care. We tested the effectiveness of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity and preventive medication adherence. METHODS: Subjects/Setting- 12–16yr olds with persistent asthma in Rochester, NY schools. Design- 3-group randomized trial (2014–2019). SB-ACT Intervention- Two core components: 1) Directly observed therapy (DOT) of preventive asthma medications, provided in school for at least 6–8 weeks for the teen to learn proper technique and experience the benefits of daily preventive therapy; 2) 4–6 weeks later, 3 sessions of motivational interviewing (MI) to discuss potential benefits from DOT and enhance motivation to take medication independently. We included 2 comparison groups: 1) DOT-only for 6–8wks, and 2) asthma education (AE) attention control. Masked follow-up assessments were conducted at 3, 5, and 7mos. Outcomes- Mean number of symptom-free days (SFDs)/2 weeks and medication adherence. Analyses- Modified intention-to-treat repeated measures analysis. RESULTS: We enrolled 430 teens (56% Black, 32% Hispanic, 85% Medicaid). There were no group differences at baseline. We found no difference in SFDs at any follow-up timepoint. More teens in the SB-ACT and DOT-only reported having a preventive asthma medication at each follow-up (p

IMPORTANCE: Asthma is the most common chronic childhood disease, with Black children experiencing worse morbidity and mortality. It is important to evaluate the effectiveness of efficacious interventions in community settings that have the greatest likelihood of serving at-risk families. OBJECTIVE: To evaluate the effectiveness of a multilevel home- and school (Head Start)–based asthma educational program compared with a Head Start–based asthma educational program alone in improving asthma outcomes in children. DESIGN, SETTING, AND PARTICIPANT: This randomized clinical trial included 398 children with asthma enrolled in Head Start preschool programs in Baltimore, Maryland, and their primary caregivers. Participants were recruited from April 1, 2011, to November 31, 2016, with final data collection ending December 31, 2017. Data were analyzed from March 18 to August 30, 2018. INTERVENTIONS: Asthma Basic Care (ABC) family education combined with Head Start asthma education compared with Head Start asthma education alone. MAIN OUTCOMES AND MEASURES: Asthma control as measured by the Test for Respiratory and Asthma Control in Kids (TRACK) score. RESULTS: Among the 398 children included in the analysis (247 boys [62.1%]; mean [SD] age, 4.2 [0.7] years), the ABC plus Head Start program improved asthma control (β = 6.26; 95% CI, 1.77 to 10.75; P

Objective To evaluate whether engagement and affective communication among adolescents and young adults (AYAs) with chronic kidney disease (CKD), caregivers, and pediatric nephrology providers during outpatient clinic visits predicts antihypertensive medication adherence. Methods AYAs (n = 60, M age = 15.4 years, SD = 2.7, 40% female, 43% African American/Black) and caregivers (n = 60, 73% female) attended audio-recorded clinic visits with pediatric nephrologists (n = 12, 75% female). Recordings were analyzed using global affect ratings of the Roter Interactional Analysis System. Antihypertensive medication adherence was monitored electronically before and after clinic visits. A linear regression model evaluated associations between affect ratings and post-visit adherence. Results AYAs took 84% of doses (SD = 20%) pre-visit and 82% of doses (SD = 24%) post-visit. Higher AYA engagement (β = 0.03, p = .01) and the absence of provider negative affect (β=-0.15, p = .04) were associated with higher post-visit adherence, controlling for pre-visit adherence, AYA sex, age, and race, and clustered by provider. Conclusions Post-visit adherence was higher when AYAs were rated as more engaged and providers as less negative. Practice Implications AYAs with lower engagement may benefit from further adherence assessment. Communication strategies designed to more actively engage AYAs in their care and diminish provider conveyance of negative affect during clinic visits may positively influence adherence among AYAs with CKD.

The prevalence of burnout and depressive symptoms is high among physician trainees.What is the burden of burnout and depressive symptoms among fellows training in pulmonary and critical care medicine (PCCM) and what are associated individual fellow, program, and institutional characteristics?We conducted a cross-sectional electronic survey of fellows enrolled in pulmonary, PCCM, and critical care medicine training programs in the United States to assess burnout and depressive symptoms. Burnout symptoms were measured using the Maslach Burnout Index two-item measure. The two-item Primary Care Evaluation of Mental Disorders Procedure was used to screen for depressive symptoms. For each of the two outcomes (burnout and depressive symptoms), we constructed three multivariate logistic regression models to assess individual fellow characteristics, program structure, and institutional polices associated with either burnout or depressive symptoms.Five hundred two of the 976 fellows who received the survey completed it-including both outcome measures-giving a response rate of 51%. Fifty percent of fellows showed positive results for either burnout or depressive symptoms, with 41% showing positive results for depressive symptoms, 32% showing positive results for burnout, and 23% showing positive results for both. Reporting a coverage system in the case of personal illness or emergency (adjusted OR [aOR], 0.44; 95% CI, 0.26-0.73) and access to mental health services (aOR, 0.14; 95% CI, 0.04-0.47) were associated with lower odds of burnout. Financial concern was associated with higher odds of depressive symptoms (aOR, 1.13; 95% CI, 1.05-1.22). Working more than 70 hours in an average clinical week and the burdens of electronic health record (EHR) documentation were associated with a higher odds of both burnout and depressive symptoms.Given the high prevalence of burnout and depressive symptoms among fellows training in PCCM, an urgent need exists to identify solutions that address this public health crisis. Strategies such as providing an easily accessible coverage system, access to mental health resources, reducing EHR burden, addressing work hours, and addressing financial concerns among trainees may help to reduce burnout or depressive symptoms and should be studied further by the graduate medical education community.

OBJECTIVE The purpose of this study was to evaluate associations between executive functioning and caregiver adherence monitoring with objective antihypertensive medication adherence over 24 months in adolescents with chronic kidney disease (CKD). METHODS Adolescents (N = 97, 11-20 years old) with CKD taking antihypertensive medication and their caregivers were recruited from three pediatric nephrology clinics. At baseline, adolescents and caregivers reported on adolescents' executive functioning and caregivers reported on their adherence monitoring. Antihypertensive medication adherence was objectively assessed via electronic monitoring at baseline and every 6 months after for 24 months. Associations between executive functioning, caregiver monitoring, and longitudinal adherence were evaluated with linear mixed models. RESULTS Up to 38% of adolescents had elevated executive functioning scores indicating more severe impairments, with rates varying by scale and reporter (adolescent vs. caregiver). Caregiver monitoring showed a significant, negative association with adherence, but adolescents' executive functioning was not significantly associated with adherence. Neither variable was associated with the rate of change in adherence over time. CONCLUSIONS Given that adolescents' executive functioning was not associated with antihypertensive medication adherence or changes in adherence over time, adherence to daily pill-form medications may involve less cognitive effort than more complex medical regimens. Higher levels of caregiver monitoring were unexpectedly associated with lower adherence levels. This unanticipated finding may reflect increased caregiver monitoring efforts when faced with adolescents' medication nonadherence, but this finding warrants further investigation. Adolescents with CKD who are nonadherent may benefit from medication adherence-promoting strategies beyond increasing caregiver monitoring. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Significant advancements in the treatment of cystic fibrosis (CF) have led to drastically improved medical outcomes for those living with this illness. While these improvements have increased life expectancy and resulted in better quality of life, managing the daily care required to stay healthy is burdensome and complex. A time-intensive daily CF treatment regimen may be difficult to maintain and can interfere with many aspects of one’s life. Many factors impact how well an individual adheres to recommendations of their healthcare team. Understanding the barriers and facilitators of treatment adherence in CF is critical as well as the interventions available to help those with this disease live better lives while managing their health.

BACKGROUND: Urban minority children are at risk for poor asthma outcomes and may not receive appropriate primary or subspecialty care. OBJECTIVE: We hypothesized that preschool children with asthma whose caregivers reported more barriers to care would be less likely to have seen their primary care provider (PCP) or an asthma subspecialist and more likely to have had a recent emergency department (ED) visit for asthma. METHODS: The Barriers to Care Questionnaire (BCQ) measures expectations, knowledge, marginalization, pragmatics, and skills. We assessed asthma control via TRACK and these outcomes: PCP visits for asthma in past six months, subspecialty care (allergist or pulmonologist) in past two years, and ED visits in past three months. RESULTS: 395 caregivers (96% African-American, 82% low-income, 96% Medicaid) completed the BCQ. Sixty percent(N=236) of children had uncontrolled asthma, 86% had seen a PCP, 23% had seen a subspecialist, and 29% had an ED visit. Barriers related to marginalization were associated with decreased likelihood of PCP (OR 0.95, p=0.014) and subspecialty visits (OR 0.92, p=0.019). Overall BCQ score was associated with decreased likelihood of subspecialty care (OR 0.98, p=0.027). Barriers related to expectations, knowledge, pragmatics, and skills were not associated with any of the care outcomes. CONCLUSIONS: Among low-income, predominantly African-American preschool children with asthma, primary and subspecialty care were less likely if caregivers reported past negative experiences with the healthcare system (marginalization). Clinicians who serve at-risk populations should be sensitive to families’ past experiences and should consider designing interventions to target the most commonly reported barriers. WHAT’S NEW: In a group of preschool-age, urban, predominantly African-American children with asthma, caregiver-reported barriers related to marginalization were associated with decreased likelihood of primary and subspecialty asthma care, indicating a potential target for future interventions to improve asthma outcomes.

BACKGROUND: Medical provider assessment of nonadherence is known to be inaccurate. Researchers have suggested using a multimethod assessment approach; however, no study has demonstrated how to integrate different measures to improve accuracy. This study aimed to determine if using additional measures improves the accurate identification of nonadherence beyond provider assessment alone. METHODS: Eighty-seven adolescents and young adults (AYAs), age 11–19 years, with chronic kidney disease (CKD) [stage 1–5/end-stage renal disease (ESRD)] and prescribed antihypertensive medication, their caregivers, and 17 medical providers participated in the multisite study. Five adherence measures were obtained: provider report, AYA report, caregiver report, electronic medication monitoring (MEMS), and pharmacy refill data [medication possession ratio (MPR)]. Concordance was calculated using kappa statistic. Sensitivity, specificity, positive predictive power, and negative predictive power were calculated using MEMS as the criterion for measuring adherence. RESULTS: There was poor to fair concordance (kappas = 0.12–0.54), with 35–61% of AYAs classified as nonadherent depending on the measure. While both providers and MEMS classified 35% of the AYAs as nonadherent, sensitivity (0.57) and specificity (0.77) demonstrated poor agreement between the two measures on identifying which AYAs were nonadherent. Combining provider report of nonadherence and MPR < 75% resulted in the highest sensitivity for identifying nonadherence (0.90) and negative predictive power (0.88). CONCLUSIONS: Nonadherence is prevalent in AYAs with CKD. Providers inaccurately identify nonadherence, leading to missed opportunities to intervene. Our study demonstrates the benefit to utilizing a multimethod approach to identify nonadherence in patients with chronic disease, an essential first step to reduce nonadherence.

There are no updated, valid knowledge measures for adolescents with cystic fibrosis (CF). This study assessed the psychometric properties of the Knowledge of Disease Management-CF (KDM-CF). Participants (n = 266 age 11–20 years; 50% female) completed the KDM-CF. Items were examined based on floor/ceiling thresholds, clinical relevance, and correlation with its subscale. Item difficulty and discrimination, subscale structure, reliability, and convergent and discriminant validity were also examined. Two subscales were identified, Self-Management (12 items, M = 67.58, SD = 22.44) and Treatment Information (11 items, M = 65.69, SD = 22.22), in addition to Total Knowledge (M = 66.67, SD = 18.56). The KDM-CF demonstrated good subscale structure and internal consistency (α = 0.68–0.78). Convergent validity was found for age (older; β = 2.836–3.593); discriminant validity was found for gender (females had higher scores; F(1) = 4.945–6.47). The KDM-CF demonstrated adequate reliability and validity, good scale stru...

OBJECTIVES: To compare the abilities of teens with uncontrolled persistent asthma and their caregivers to identify inhaled medications and state correct indications for use; examine medication responsibility within dyads; and determine whether responsibility is associated with knowledge about inhaled therapies. DESIGN/METHODS: In the baseline survey for the School-Based Asthma Care for Teens (SB-ACT) trial, we separately asked caregivers and teens to: 1) identify the teen’s inhaled asthma therapies by name and from a picture chart (complete matches considered “concordant”); 2) describe indications of use for each medication; 3) describe the allocation of responsibility for medication use within dyads. We limited analyses to dyads in which either member reported at least one rescue and one inhaled controller medication; we used McNemar and Pearson chi-square tests. RESULTS: 136 dyads were analyzed. More caregivers than teens concordantly identified medications (63% vs 31%, p

Background Cystic fibrosis (CF) is a life-shortening, burdensome disease requiring complex knowledge to manage the disease. Significant gaps in knowledge have been documented for parents, which may lead to unintentionally poor adherence and insufficient transfer of treatment responsibility from parents to adolescents. There are no current, validated measures of parent knowledge for this population and there are no measures that assess the knowledge required for day-to-day behavioral management of CF. We assessed the psychometric properties of the parent version of the Knowledge of Disease Management-Cystic Fibrosis measure (KDM-CF-P) using data from iCARE (I Change Adherence and Raise Expectations), a randomized control adherence intervention trial. Methods A total of 196 parents in the iCARE standard care/control arm completed 35 items assessing their knowledge of disease management at their 12-month study visit, prior to beginning the intervention. Items were eliminated from the measure if they met the threshold for ceiling effects, were deemed clinically irrelevant, or did not correlate well with their intended scale. Item-to-total correlations, confirmatory factor analysis, discriminant function, reliability, and convergent validity were calculated. Results The KDM-CF-P (19 items) demonstrated internal consistency of KR20 = 0.60 on each scale and a two-scale structure. Convergent validity for knowledge scores was found with maternal education, family income, and type of medical insurance. Parents correctly answered approximately 85% of items on the KDM-CF-P. Conclusions The KDM-CF-P psychometrics support a two-scale measure with clinical utility. It is useful for assessing gaps in knowledge that can be remediated through individualized, tailored interventions.

Accuracy of body size estimation may impact motivation to adhere to treatment recommendations and health-related quality of life (HRQOL) in youth with cystic fibrosis (CF), but this has not yet been investigated. Thus, the goal of the current study was to examine accuracy of body size estimation in youth with CF, and associations with HRQOL, lung functioning, and dietary intake. Fifty-four youth diagnosed with CF (M = 13.61 years) completed the Figure Rating Scale, the Cystic Fibrosis Questionnaire–Revised, and a 24-h diet recall interview. Cohen’s Weighted Kappa Coefficient evaluated agreement between body size estimation and BMI percentile. Binary logistic regression analyses examined associations between body size accuracy and HRQOL, lung functioning, and dietary intake. A less than adequate agreement was found between youth body size estimation and BMI percentile. Most participants overestimated body size (69.8%). Body Image HRQOL, but neither lung functioning nor dietary intake, was significantly associated with body size estimation accuracy. Working with patients to improve perceptions of body size may also improve HRQOL scores and allow for discussion about treatment goals related to body size.

Cystic fibrosis (CF) is a progressive, genetic disease affecting multiple organ systems. Treatments are complex and take 2–4 h per day. Adherence is 50% or less for pulmonary medications, airway clearance, and enzymes. Prior research has identified demographic and psychological variables associated with better adherence; however, no study has extensively identified facilitators of treatment adherence (e.g., adaptive behaviors and cognitions) in a sample of parents and adolescents. Forty-three participants were recruited from four CF centers as part of a larger measurement study. Participants included 29 parents (72% mothers; 72% Caucasian) and 14 adolescents (ages 11–20, 64% female, 71% Caucasian). Participants completed semi-structured interviews to elicit barriers to adherence. However, facilitators of adherence naturally emerged, therefore indicating need for further exploration. Interviews were audiotaped, transcribed and content-analyzed in NVivo to identify those behaviors and beliefs that facilitated adherence, using a phenomenological analysis. Frequencies of these themes were tabulated. Nine themes emerged, with individual codes subsumed under each. Themes included social support, community support, organizational strategies, “intrinsic characteristics,” combining treatments with pleasurable activity, flexibility, easier or faster treatment, prioritizing treatments, and negative effects of non-adherence. Results demonstrated the importance of identifying strategies that positively affect adherence. Interventions that are strength-focused, build on prior success, and utilize positive models generated by those who have successfully integrated CF treatments into their lives are more likely to be efficacious.

Many advances in health care fail to reach patients. Implementation science is the study of novel approaches to mitigate this evidence-to-practice gap.The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement on implementation science in pulmonary, critical care, and sleep medicine. The committee used an iterative consensus process to define implementation science and review the use of conceptual frameworks to guide implementation science for the pulmonary, critical care, and sleep community and to explore how professional medical societies such as the ATS can promote implementation science.The committee defined implementation science as the study of the mechanisms by which effective health care interventions are either adopted or not adopted in clinical and community settings. The committee also distinguished implementation science from the act of implementation. Ideally, implementation science should include early and continuous stakeholder involvement and the use of conceptual frameworks (i.e., models to systematize the conduct of studies and standardize the communication of findings). Multiple conceptual frameworks are available, and we suggest the selection of one or more frameworks on the basis of the specific research question and setting. Professional medical societies such as the ATS can have an important role in promoting implementation science. Recommendations for professional societies to consider include: unifying implementation science activities through a single organizational structure, linking front-line clinicians with implementation scientists, seeking collaborations to prioritize and conduct implementation science studies, supporting implementation science projects through funding opportunities, working with research funding bodies to set the research agenda in the field, collaborating with external bodies responsible for health care delivery, disseminating results of implementation science through scientific journals and conferences, and teaching the next generation about implementation science through courses and other media.Implementation science plays an increasingly important role in health care. Through support of implementation science, the ATS and other professional medical societies can work with other stakeholders to lead this effort.

To advance implementation research (IR) in respiratory, sleep, and critical care medicine, the American Thoracic Society and the Division of Lung Diseases from the NHLBI cosponsored an Implementation Research Workshop on May 17, 2014. The goals of IR are to understand the barriers and facilitators of integrating new evidence into healthcare practices and to develop and test strategies that systematically target these factors to accelerate the adoption of evidence-based care. Throughout the workshop, presenters provided examples of IR that focused on the rate of adoption of evidence-based practices, the feasibility and acceptability of interventions to patients and other stakeholders who make healthcare decisions, the fidelity with which practitioners use specific interventions, the effects of specific barriers on the sustainability of an intervention, and the implications of their research to inform policies to improve patients’ access to high-quality care. During the discussions that ensued, investigators’ experience led to recommendations underscoring the importance of identifying and involving key stakeholders throughout the research process, ensuring that those who serve as reviewers understand the tenets of IR, managing staff motivation and turnover, and tackling the challenges of scaling up interventions across multiple settings.