The Selah trial: A preference-based partially randomized waitlist control study of three stress management interventions.

Chronic stress undermines psychological and physiological health. We tested three remotely delivered stress management interventions among clergy, accounting for intervention preferences. United Methodist clergy in North Carolina enrolled in a partially randomized, preference-based waitlist control trial. The interventions were: mindfulness-based stress reduction (MBSR), Daily Examen prayer practice, and Stress Proofing (stress inoculation plus breathing skills). Co-primary outcomes were symptoms of stress (Calgary Symptoms of Stress Inventory) and 48-hour ambulatory heart rate variability (HRV) at 12 weeks compared to waitlist control. Survey data were collected at 0, 12, and 24 weeks and 48-hour ambulatory HRV at 0 and 12 weeks. The 255 participants were 91% White and 48% female. Forty-nine participants (22%) without a preference were randomly assigned between the three interventions (n = 40) and waitlist control (n = 9). Two hundred six participants (78%) with a preference were randomly assigned to waitlist control (n = 62) or their preferred intervention (n = 144). Compared to waitlist control, MBSR [mean difference (MD) = -0.30, 95% CI: -0.41, -0.20; P < .001] and Stress Proofing (MD = -0.27, 95% CI: -0.40, -0.14; P < .001) participants had lower stress symptoms at 12 weeks; Daily Examen participants did not until 24 weeks (MD = -0.24, 95% CI: -0.41, -0.08). MBSR participants demonstrated improvement in HRV at 12 weeks (MD = +3.32 ms; 95% CI: 0.21, 6.44; P = .036). MBSR demonstrated robust improvement in self-reported and objective physical correlates of stress; Stress Proofing and Daily Examen resulted in improvements in self-reported correlates of stress. These brief practices were sustainable and beneficial for United Methodist clergy during the heightened stressors of the COVID pandemic. ClinicalTrials.gov identifier: NCT04625777.

A common source of stress, which can harm physical and mental health, is work. Clergy engage in a profession that requires toggling between varied and interpersonally complex tasks, providing emotional labor, and experiencing stressors such as public criticism. Practical, brief practices are needed to manage occupational stress. We invited all United Methodist clergy in North Carolina to enroll in a stress management study. Participants chose their preferred of three interventions: mindfulness-based stress reduction (MBSR), Daily Examen prayer practice, or Stress Proofing (a combination of stress inoculation plus breathing skills). Clergy without a preference were randomly assigned to one of the three interventions and a waiting group. Clergy with a preference were randomly assigned to either begin the intervention or wait at least 6 months and provide data while waiting. Participants practiced each of the three interventions at high levels across 24 weeks. Compared to clergy who waited for an intervention, MBSR participants evidenced robust improvement in self-reported (stress and anxiety symptoms) and physiological (heart rate variability measured across 48 hours) outcomes, whereas Stress Proofing and the Daily Examen only resulted in improvements in self-reported outcomes. The three brief practices were sustainable and beneficial for United Methodist clergy during the heightened stressors of the COVID pandemic.

Comparative Effectiveness of Alternative Treatment Approaches to Secondary Hyperparathyroidism in Patients Receiving Maintenance Hemodialysis: An Observational Trial Emulation.

RATIONALE & OBJECTIVE: Optimal approaches to treat secondary hyperparathyroidism (SHPT) in patients on maintenance hemodialysis (HD) have yet to be established in randomized controlled trials (RCTs). STUDY DESIGN: Two observational clinical trial emulations. SETTING & PARTICIPANTS: Both emulations included adults receiving in-center HD from a national dialysis organization. The patients who had SHPT in the period between 2009 and 2014, were insured for≥180 days by Medicare as primary payer, and did not have contraindications or poor health status limiting theoretical trial participation. EXPOSURE: The parathyroid hormone (PTH) Target Trial emulation included patients with new-onset SHPT (first PTH 300-600pg/mL), with 2 arms defined as up-titration of either vitamin D sterols or cinacalcet within 30 days (lower target) or no up-titration (higher target). The Agent Trial emulation included patients with a PTH≥300 pg/mL while on≥6µg weekly of vitamin D sterol (paricalcitol equivalent dose) and no prior history of cinacalcet. The 2 arms were defined by the first dose or agent change within 30 days (vitamin D-favoring [vitamin-D was up-titrated] vs cinacalcet-favoring [cinacalcet was added] vs nondefined [neither applies]). Multiple trials per patient were allowed in trial 2. OUTCOME: The primary outcome was all-cause death over 24 months; secondary outcomes included cardiovascular (CV) hospitalization or the composite of CV hospitalization or death. ANALYTICAL APPROACH: Pooled logistic regression. RESULTS: There were 1,152 patients in the PTH Target Trial (635 lower target and 517 higher target). There were 2,726 unique patients with 6,727 patient trials in the Agent Trial (6,268 vitamin D-favoring trials and 459 cinacalcet-favoring trials). The lower PTH target approach was associated with reduced adjusted hazard of death (HR, 0.71 [95% CI, 0.52-0.93]), CV hospitalization (HR, 0.78 [95% CI, 0.63-0.98]), and their composite (HR, 0.74 [95% CI, 0.61-0.89]). The cinacalcet-favoring approach demonstrated lower adjusted hazard of death compared to the vitamin D-favoring approach (HR, 0.79 [95% CI, 0.62-0.99]), but not of CV hospitalization or the composite outcome. LIMITATIONS: Potential for residual confounding; low use of cinacalcet with low power. CONCLUSIONS: SHPT management that is focused on lower PTH targets may lower mortality and CV disease in patients receiving HD. These findings should be confirmed in a pragmatic randomized trial. PLAIN-LANGUAGE SUMMARY: Optimal approaches to treat secondary hyperparathyroidism (SHPT) have not been established in randomized controlled trials. Data from a national dialysis organization was used to identify patients with SHPT in whom escalated treatment may be indicated. The approach to treatment was defined based on observed upward titration of SHPT-controlling medications: earlier titration (lower target) versus delayed titration (higher target); and the choice of medication (cinacalcet vs vitamin D sterols). In the first trial emulation, we estimated a 29% lower rate of death and 26% lower rate of cardiovascular disease or death for patients managed with a lower versus higher target approach. Cinacalcet versus vitamin D-favoring approaches were not consistently associated with outcomes in the second trial emulation. This observational study suggests the need for additional clinical trials of SHPT treatment intensity.

Impact of a hospital service for adults with chronic childhood-onset disease: A propensity weighted analysis.

BACKGROUND: Young adults with chronic childhood-onset diseases (CCOD) transitioning care from pediatrics to adult care are at high risk for readmission after hospital discharge. At our institution, we have implemented an inpatient service, the Med-Peds (MP) line, to improve transitions to adult care and reduce hospital utilization by young adults with CCOD. OBJECTIVE: This study aimed to assess the effect of the MP line on length of stay (LOS) and 30-day readmission rates compared to other inpatient services. METHODS: This was an observational, retrospective cohort analysis of patients admitted to the MP line compared to other hospital service lines over a 2-year period. To avoid potential confounding by indication for admission to the MP line, propensity score weighting methods were used. RESULTS: The MP line cared for 302 patients with CCOD from June 2019 to July 2021. Compared to other service lines, there was a 33% reduction in relative risk of 30-day readmission (26.9% compared to 40.3%, risk ratio = 0.67, 95% confidence interval [CI] 0.55-0.81). LOS was 10% longer for the MP line (event time ratio (ETR): 1.10 95% CI 1.0-1.21) with median LOS 4.8 versus 4.5 days. Patients with sickle cell disease had less of a reduction in 30-day readmissions and longer LOS. CONCLUSION: Hospitalization for young adults with CCOD on a MP service line was associated with lower 30-day readmission rates and longer LOS than hospitalization on other services. Further research is needed to assess which components of the line most contribute to decreased utilization.

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health") is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. OBJECTIVE: The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. METHODS: We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. RESULTS: Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. CONCLUSIONS: There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. TRIAL REGISTRATION: ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47137.

Prevalence of Childhood Hearing Loss in Rural Alaska.

OBJECTIVES: Childhood hearing loss has well-known lifelong consequences. Certain rural populations are at higher risk for infection-related hearing loss. For Alaska Native children, historical data on hearing loss prevalence suggest a higher burden of infection-related hearing loss, but updated prevalence data are urgently needed in this high-risk population. DESIGN: Hearing data were collected as part of two school-based cluster-randomized trials in 15 communities in rural northwest Alaska over two academic years (2017-2019). All enrolled children from preschool to 12th grade were eligible. Pure-tone thresholds were obtained using standard audiometry and conditioned play when indicated. The analysis included the first available audiometric assessment for each child (n = 1634 participants, 3 to 21 years), except for the high-frequency analysis, which was limited to year 2 when higher frequencies were collected. Multiple imputation was used to quantify the prevalence of hearing loss in younger children, where missing data were more frequent due to the need for behavioral responses. Hearing loss in either ear was evaluated using both the former World Health Organization (WHO) definition (pure-tone average [PTA] > 25 dB) and the new WHO definition (PTA ≥ 20 dB), which was published after the study. Analyses with the new definition were limited to children 7 years and older due to incomplete data obtained on younger children at lower thresholds. RESULTS: The overall prevalence of hearing loss (PTA > 25 dB; 0.5, 1, 2, 4 kHz) was 10.5% (95% confidence interval [CI], 8.9 to 12.1). Hearing loss was predominately mild (PTA >25 to 40 dB; 8.9%, 95% CI, 7.4 to 10.5). The prevalence of unilateral hearing loss was 7.7% (95% CI, 6.3 to 9.0). Conductive hearing loss (air-bone gap of ≥ 10 dB) was the most common hearing loss type (9.1%, 95% CI, 7.6 to 10.7). Stratified by age, hearing loss (PTA >25 dB) was more common in children 3 to 6 years (14.9%, 95% CI, 11.4 to 18.5) compared to children 7 years and older (8.7%, 95% CI, 7.1 to 10.4). In children 7 years and older, the new WHO definition increased the prevalence of hearing loss to 23.4% (95% CI, 21.0 to 25.8) compared to the former definition (8.7%, 95% CI, 7.1 to 10.4). Middle ear disease prevalence was 17.6% (95% CI, 15.7 to 19.4) and was higher in younger children (23.6%, 95% CI, 19.7 to 27.6) compared to older children (15.2%, 95% CI, 13.2 to 17.3). High-frequency hearing loss (4, 6, 8kHz) was present in 20.5% (95% CI, 18.4 to 22.7 [PTA >25 dB]) of all children and 22.8% (95% CI, 20.3 to 25.3 [PTA >25 dB]) and 29.7% (95% CI, 27.0 to 32.4 [PTA ≥ 20 dB]) of children 7 years and older (limited to year 2). CONCLUSIONS: This analysis represents the first prevalence study on childhood hearing loss in Alaska in over 60 years and is the largest cohort with hearing data ever collected in rural Alaska. Our results highlight that hearing loss continues to be common in rural Alaska Native children, with middle ear disease more prevalent in younger children and high-frequency hearing loss more prevalent with increasing age. Prevention efforts may benefit from managing hearing loss type by age. Lastly, continued research is needed on the impact of the new WHO definition of hearing loss on field studies.

A Hybrid Deep Learning Approach to Identify Preventable Childhood Hearing Loss.

OBJECTIVE: Childhood hearing loss has well-known, lifelong consequences. Infection-related hearing loss disproportionately affects underserved communities yet can be prevented with early identification and treatment. This study evaluates the utility of machine learning in automating tympanogram classifications of the middle ear to facilitate layperson-guided tympanometry in resource-constrained communities. DESIGN: Diagnostic performance of a hybrid deep learning model for classifying narrow-band tympanometry tracings was evaluated. Using 10-fold cross-validation, a machine learning model was trained and evaluated on 4810 pairs of tympanometry tracings acquired by an audiologist and layperson. The model was trained to classify tracings into types A (normal), B (effusion or perforation), and C (retraction), with the audiologist interpretation serving as reference standard. Tympanometry data were collected from 1635 children from October 10, 2017, to March 28, 2019, from two previous cluster-randomized hearing screening trials (NCT03309553, NCT03662256). Participants were school-aged children from an underserved population in rural Alaska with a high prevalence of infection-related hearing loss. Two-level classification performance statistics were calculated by treating type A as pass and types B and C as refer. RESULTS: For layperson-acquired data, the machine-learning model achieved a sensitivity of 95.2% (93.3, 97.1), specificity of 92.3% (91.5, 93.1), and area under curve of 0.968 (0.955, 0.978). The model's sensitivity was greater than that of the tympanometer's built-in classifier [79.2% (75.5, 82.8)] and a decision tree based on clinically recommended normative values [56.9% (52.4, 61.3)]. For audiologist-acquired data, the model achieved a higher AUC of 0.987 (0.980, 0.993), had an equivalent sensitivity of 95.2 (93.3, 97.1), and a higher specificity of 97.7 (97.3, 98.2). CONCLUSIONS: Machine learning can detect middle ear disease with comparable performance to an audiologist using tympanograms acquired either by an audiologist or a layperson. Automated classification enables the use of layperson-guided tympanometry in hearing screening programs in rural and underserved communities, where early detection of treatable pathology in children is crucial to prevent the lifelong adverse effects of childhood hearing loss.

Telemedicine Referral to Improve Access to Specialty Care for Preschool Children in Rural Alaska: A Cluster-Randomized Controlled Trial.

OBJECTIVES: Preschool programs provide essential preventive services, such as hearing screening, but in rural regions, limited access to specialists and loss to follow-up compound rural health disparities. We conducted a parallel-arm cluster-randomized controlled trial to evaluate telemedicine specialty referral for preschool hearing screening. The goal of this trial was to improve timely identification and treatment of early childhood infection-related hearing loss, a preventable condition with lifelong implications. We hypothesized that telemedicine specialty referral would improve time to follow-up and the number of children receiving follow-up compared with the standard primary care referral. DESIGN: We conducted a cluster-randomized controlled trial in K-12 schools in 15 communities over two academic years. Community randomization occurred within four strata using location and school size. In the second academic year (2018-2019), an ancillary trial was performed in the 14 communities that had preschools to compare telemedicine specialty referral (intervention) to standard primary care referral (comparison) for preschool hearing screening. Randomization of communities from the main trial was used for this ancillary trial. All children enrolled in preschool were eligible. Masking was not possible because of timing in the second year of the main trial, but referral assignment was not openly disclosed. Study team members and school staff were masked throughout data collection, and statisticians were blinded to allocation during analysis. Preschool screening occurred once, and children who were referred for possible hearing loss or ear disease were monitored for follow-up for 9 months from the screening date. The primary outcome was time to ear/hearing-related follow-up from the date of screening. The secondary outcome was any ear/hearing follow-up from screening to 9 months. Analyses were conducted using an intention-to-treat approach. RESULTS: A total of 153 children were screened between September 2018 and March 2019. Of the 14 communities, 8 were assigned to the telemedicine specialty referral pathway (90 children), and 6 to the standard primary care referral pathway (63 children). Seventy-one children (46.4%) were referred for follow-up: 39 (43.3%) in the telemedicine specialty referral communities and 32 (50.8%) in the standard primary care referral communities. Of children referred, 30 (76.9%) children in telemedicine specialty referral communities and 16 (50.0%) children in standard primary care referral communities received follow-up within 9 months (Risk Ratio = 1.57; 95% confidence interval [CI], 1.22 to 2.01). Among children who received follow-up, median time to follow-up was 28 days (interquartile range [IQR]: 15 to 71) in telemedicine specialty referral communities compared with 85 days (IQR: 26 to 129) in standard primary care referral communities. Mean time to follow-up for all referred children was 4.5 (event time ratio = 4.5; 95% CI, 1.8 to 11.4; p = 0.045) times faster in telemedicine specialty referral communities compared with standard primary care referral communities in the 9-month follow-up time frame. CONCLUSIONS: Telemedicine specialty referral significantly improved follow-up and reduced time to follow-up after preschool hearing screening in rural Alaska. Telemedicine referrals could extend to other preventive school-based services to improve access to specialty care for rural preschool children.

Changing the Paradigm for School Hearing Screening Globally: Evaluation of Screening Protocols From Two Randomized Trials in Rural Alaska.

OBJECTIVES: Diagnostic accuracy was evaluated for various screening tools, including mobile health (mHealth) pure-tone screening, tympanometry, distortion product otoacoustic emissions (DPOAE), and inclusion of high frequencies to determine the most accurate screening protocol for identifying children with hearing loss in rural Alaska where the prevalence of middle ear disease is high. DESIGN: Hearing screening data were collected as part of two cluster randomized trials conducted in 15 communities in rural northwest Alaska. All children enrolled in school from preschool to 12th grade were eligible. Analysis was limited to data collected 2018 to 2019 (n = 1449), when both trials were running and measurement of high frequencies were included in the protocols. Analyses included estimates of diagnostic accuracy for each screening tool, as well as exploring performance by age and grade. Multiple imputation was used to assess diagnostic accuracy in younger children, where missing data were more prevalent due to requirements for conditioned responses. The audiometric reference standard included otoscopy, tympanometry, and high frequencies to ensure detection of infection-related and noise-induced hearing loss. RESULTS: Both the mHealth pure-tone screen and DPOAE screen performed better when tympanometry was added to the protocol (increase in sensitivity of 19.9%, 95% Confidence Interval (CI): 15.9 to 24.1 for mHealth screen, 17.9%, 95% CI: 14.0 to 21.8 for high-frequency mHealth screen, and 10.4%, 95% CI: 7.5 to 13.9 for DPOAE). The addition of 6 kHz to the mHealth pure-tone screen provided an 8.7 percentage point improvement in sensitivity (95% CI: 6.5 to 11.3). Completeness of data for both the reference standard and the mHealth screening tool differed substantially by age, due to difficulty with behavioral testing in young children. By age 7, children were able to complete behavioral testing, and data indicated that high-frequency mHealth pure-tone screen with tympanometry was the superior tool for children 7 years and older. For children 3 to 6 years of age, DPOAE plus tympanometry performed the best, both for complete data and multiply imputed data, which better approximates accuracy for children with missing data. CONCLUSIONS: This study directly evaluated pure-tone, DPOAE, and tympanometry tools as part of school hearing screening in rural Alaskan children (3 to 18+ years). Results from this study indicate that tympanometry is a key component in the hearing screening protocol, particularly in environments with higher prevalence of infection-related hearing loss. DPOAE is the preferred hearing screening tool when evaluating children younger than 7 years of age (below 2nd grade in the United States) due to the frequency of missing data with behavioral testing in this age group. For children 7 years and older, the addition of high frequencies to pure-tone screening increased the accuracy of screening, likely due to improved identification of hearing loss from noise exposure. The lack of a consistent reference standard in the literature makes comparing across studies challenging. In our study with a reference standard inclusive of otoscopy, tympanometry, and high frequencies, less than ideal sensitivities were found even for the most sensitive screening protocols, suggesting more investigation is necessary to ensure screening programs are appropriately identifying noise- and infection-related hearing loss in rural, low-resource settings.

Goal-Concordance in Children with Complex Chronic Conditions.

OBJECTIVES: To characterize delivery of goal-concordant end-of-life (EOL) care among children with complex chronic conditions and to determine factors associated with goal-concordance. STUDY DESIGN: This was a retrospective review of goals of care discussions for 272 children with at least 1 complex chronic condition who died at a tertiary care hospital between January 1, 2014, and December 31, 2017. Goals of care and code status were assessed before and within the last 72 hours of life. Goals of care discussions were coded as full interventions; considering withdrawal of interventions (palliation); planned transition to palliation; or actively transitioning/transitioned to palliation. RESULTS: In total, 158 children had documented goals of care discussions before and within the last 72 hours of life, 18 had goals of care discussions only >72 hours before death, 54 only in the last 72 hours of life, and 42 had no documented goals of care. For children with goals of care, EOL care was goal-concordant for 82.2%, discordant in 7%, and unclear in 10.8%. Black children had a greater than 8-fold greater odds of discordant care compared with White children (OR 8.34, P = .007). Comparison of goals of care and code status before and within the last 72 hours of life revealed trends toward nonescalation of care. Specifically, rates of active palliation increased from 11.7% to 63.0%, and code status shifted from 32.6% do not resuscitate to 65.2% (P < .001). CONCLUSIONS: In this cohort, a majority of children had documented goals of care discussions and received goal-concordant EOL care. However, Black children had greater odds of receiving goal-discordant care. Goals of care and code status shifted toward palliation during the last 72 hours of life.

Environmental Factors for Hearing Loss and Middle Ear Disease in Alaska Native Children and Adolescents: A Cross-Sectional Analysis from a Cluster Randomized Trial.

OBJECTIVES: Infection-related childhood hearing loss is one of the few preventable chronic health conditions that can affect a child's lifelong trajectory. This study sought to quantify relationships between infection-mediated hearing loss and middle ear disease and environmental factors, such as exposure to wood smoke, cigarette smoke, household crowding, and lack of access to plumbed (running) water, in a northwest region of rural Alaska. DESIGN: This study is a cross-sectional analysis to estimate environmental factors of infection-related hearing loss in children aged 3 to 21 years. School hearing screenings were performed as part of two cluster randomized trials in rural Alaska over two academic years (2017-2018 and 2018-2019). The first available screening for each child was used for this analysis. Sociodemographic questionnaires were completed by parents/guardians upon entry into the study. Multivariable regression was performed to estimate prevalence differences and prevalence ratios (PR). A priori knowledge about the prevalence of middle ear disease and the difficulty inherent in obtaining objective hearing loss data in younger children led to analysis of children by age (3 to 6 years versus 7 years and older) and a separate multiple imputation sensitivity analysis for pure-tone average (PTA)-based infection-related hearing loss measures. RESULTS: A total of 1634 children participated. Hearing loss was present in 11.1% of children sampled based on otoacoustic emission as the primary indicator of hearing loss and was not associated with exposure to cigarette smoke (PR = 1.07; 95% confidence interval [CI], 0.48 to 2.38), use of a wood-burning stove (PR = 0.85; 95% CI, 0.55 to 1.32), number of persons living in the household (PR = 1.06; 95% CI, 0.97 to 1.16), or lack of access to running water (PR = 1.38; 95% CI, 0.80 to 2.39). Using PTA as a secondary indicator of hearing loss also showed no association with environmental factors. Middle ear disease was present in 17.4% of children. There was a higher prevalence of middle ear disease in homes without running water versus those with access to running water (PR = 1.53; 95% CI, 1.03 to 2.27). There was little evidence to support any cumulative effects of environmental factors. Heterogeneity of effect models by age found sample prevalence of hearing loss higher for children aged 3 to 6 years (12.2%; 95% CI, 9.3 to 15.7) compared to children 7 years and older (10.6%; 95% CI, 8.9 to 2.6), as well as for sample prevalence of middle ear disease (22.7%; 95% CI, 18.9 to 26.9 and 15.3%; 95% CI, 13.3 to 17.5, respectively). CONCLUSIONS: Lack of access to running water in the home was associated with increased prevalence of middle ear disease in this rural, Alaska Native population, particularly among younger children (aged 3 to 6 years). There was little evidence in this study that cigarette smoke, wood-burning stoves, and greater numbers of persons in the household were associated with infection-mediated hearing loss or middle ear disease. Future research with larger sample sizes and more sensitive measures of environmental exposure is necessary to further evaluate these relationships. Children who live in homes without access to running water may benefit from earlier and more frequent hearing health visits.

Development of an Administrative Data-Based Frailty Index for Older Adults Receiving Dialysis.

Background: Frailty is present in ≥50% of older adults receiving dialysis. Our objective was to a develop an administrative data-based frailty index and assess the frailty index's predictive validity for mortality and future hospitalizations. Methods: We used United States Renal Data System data to establish two cohorts of adults aged ≥65 years, initiating dialysis in 2013 and in 2017. Using the 2013 cohort (development dataset), we applied the deficit accumulation index approach to develop a frailty index. Adjusting for age and sex, we assessed the extent to which the frailty index predicts the hazard of time until death and time until first hospitalization over 12 months. We assessed the Harrell's C-statistic of the frailty index, a comorbidity index, and jointly. The 2017 cohort was used as a validation dataset. Results: Using the 2013 cohort (n=20,974), we identified 53 deficits for the frailty index across seven domains: disabilities, diseases, equipment, procedures, signs, tests, and unclassified. Among those with ≥1 deficit, the mean (SD) frailty index was 0.30 (0.13), range 0.02-0.72. Over 12 months, 18% (n=3842) died, and 55% (n=11,493) experienced a hospitalization. Adjusted hazard ratios for each 0.1-point increase in frailty index in models of time to death and time to first hospitalization were 1.41 (95% confidence interval, 1.37 to 1.44) and 1.33 (95% confidence interval, 1.31 to 1.35), respectively. For mortality, C-statistics for frailty index, comorbidity index, and both indices were 0.65, 0.65, and 0.66, respectively. For hospitalization, C-statistics for frailty index, comorbidity index, and both indices were 0.61, 0.60, and 0.61, respectively. Data from the 2017 cohort were similar. Conclusions: We developed a novel frailty index for older adults receiving dialysis. Further studies are needed to improve on this frailty index and validate its use for clinical and research applications.

Redesigning Care of Hospitalized Young Adults With Chronic Childhood-Onset Disease.

Background Young adults with chronic childhood-onset disease (CCOD) are routinely admitted to internal medicine hospitalist services, yet most lack transition preparation to adult care. Providers and patients feel the strain of admissions to adult services in part due to their medical and social complexity. Methods We performed a descriptive study of a care redesign project for young adults with CCOD hospitalized at a large, tertiary care academic hospital. We describe the process of implementation of the Med-Peds (MP) service line and characterize patients cared for by the service. We measured and analyzed patient demographics, process implementation, healthcare screening, and healthcare utilization data. Results During the 16 months of the study period, 254 patients were cared for by the MP service line, accounting for 385 hospitalizations. The most common CCODs were sickle cell disease (22.4%) and type 1 diabetes (14.6%). The majority (76%) of patients completed transition readiness assessment, and 38.6% completed social determinant of health (SDH) screening during their admission. Patients had high prevalence of SDH with 66.7% having an unmet social need. The average length of stay was 6.6 days and the average 30-day readmission rate was 20.0%. Conclusions There is opportunity to redesign the inpatient care of young adult patients with CCOD. The MP service line is a care model that can be integrated into existing hospital medicine teams with MP physicians. Hospitals should consider redesigning care for young adults with CCOD to meet the transitional and social needs unique to this patient population.

Community-Based Malaria Testing Reduces Polypharmacy in a Population-Based Survey of Febrile Illness in Western Kenya.

Objective: The objective was to describe the relationship between the location of care, the malaria test result, and the type of medicine consumed for the fever, and to determine whether community-based access to malaria testing reduced polypharmacy. Methods: This is a secondary analysis of a cluster-randomized trial of an intervention designed to increase diagnostic testing and targeting of Artemesinin Combined Therapies (ACTs). Data collected at baseline, 12, and 18 months were analyzed to determine the impact of diagnostic testing on drug consumption patterns among febrile individuals. Results: Of the 5,756 participants analyzed, 60.1% were female, 42% were aged 5-17 years, and 58.1% sought care for fever in a retail outlet. Consumption of both ACT and antibiotics was 22.1% (n = 443/2008) at baseline. At endline, dual consumption had declined to 16.6%. There was reduced antibiotic consumption among those testing positive for malaria (39.5%-26.5%) and those testing negative (63.4%-55.1%), accompanied by a substantial decline in ACT use among malaria-negative participants. Conclusion: Diagnostic testing for malaria reduces dual consumption of ACTs and antibiotics, especially among those testing outside the formal healthcare sector.

Temporal Dynamics of Subclinical Malaria in Different Transmission Zones of Myanmar.

Countries in the Greater Mekong Subregion have committed to eliminate Plasmodium falciparum malaria by 2025. Subclinical malaria infections that can be detected by highly sensitive polymerase chain reaction (PCR) testing in asymptomatic individuals represent a potential impediment to this goal, although the extent to which these low-density infections contribute to transmission is unclear. To understand the temporal dynamics of subclinical malaria in this setting, a cohort of 2,705 participants from three epidemiologically distinct regions of Myanmar was screened for subclinical P. falciparum and P. vivax infection using ultrasensitive PCR (usPCR). Standard rapid diagnostic tests (RDTs) for P. falciparum were also performed. Individuals who tested positive for malaria by usPCR were followed for up to 12 weeks. Regression analysis was performed to estimate whether the baseline prevalence of infection and the count of repeated positive tests were associated with demographic, behavioral, and clinical factors. At enrollment, the prevalence of subclinical malaria infection measured by usPCR was 7.7% (1.5% P. falciparum monoinfection, 0.3% mixed P. falciparum and P. vivax, and 6.0% P. vivax monoinfection), while P. falciparum prevalence measured by RDT was just 0.2%. Prevalence varied by geography and was higher among older people and in those with outdoor exposure and travel. No difference was observed in either the prevalence or count of subclinical infection by time of year, indicating that even in low-endemicity areas, a reservoir of subclinical infection persists year-round. If low-density infections are shown to represent a significant source of transmission, identification of high-risk groups and locations may aid elimination efforts.

Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial.

BACKGROUND: School-based programmes, including hearing screening, provide essential preventive services for rural children. However, minimal evidence on screening methodologies, loss to follow-up, and scarcity of specialists for subsequent care compound rural health disparities. We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral. METHODS: In this cluster-randomised controlled trial conducted in 15 rural Alaskan communities, USA, we randomised communities to telemedicine specialty referral (intervention) or standard primary care referral (control) for school hearing screening. All children (K-12; aged 4-21 years) enrolled in Bering Straight School District were eligible. Community randomisation occurred within four strata using location and school size. Participants were masked to group allocation until screening day, and assessors were masked throughout data collection. Screening occurred annually, and children who screened positive for possible hearing loss or ear disease were monitored for 9 months from the screening date for follow-up. Primary outcome was the time to follow-up after a positive hearing screen; analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03309553. FINDINGS: We recruited participants between Oct 10, 2017, and March 28, 2019. 15 communities were randomised: eight (750 children) to telemedicine referral and seven (731 children) to primary care referral. 790 (53·3%) of 1481 children screened positive in at least one study year: 391 (52∤1%) in the telemedicine referral communities and 399 (50∤4%) in the primary care referral communities. Of children referred, 268 (68·5%) in the telemedicine referral communities and 128 (32·1%) in primary care referral communities received follow-up within 9 months. Among children who received follow-up, mean time to follow-up was 41·5 days (SD 55·7) in the telemedicine referral communities and 92·0 days (75·8) in the primary care referral communities (adjusted event-time ratio 17·6 [95% CI 6·8-45·3] for all referred children). There were no adverse events. INTERPRETATION: Telemedicine specialty referral significantly improved the time to follow-up after hearing screening in Alaska. Telemedicine might apply to other preventive school-based services to improve access to specialty care for rural children. FUNDING: Patient-Centered Outcomes Research Institute.

The Selah study protocol of three interventions to manage stress among clergy: a preference-based randomized waitlist control trial.

INTRODUCTION: Like many helping professionals in emotional labor occupations, clergy experience high rates of mental and physical comorbidities. Regular stress management practices may reduce stress-related symptoms and morbidity, but more research is needed into what practices can be reliably included in busy lifestyles and practiced at a high enough level to meaningfully reduce stress symptoms. METHODS AND ANALYSIS: The overall design is a preference-based randomized waitlist control trial. United Methodist clergy in North Carolina will be eligible to participate. The intervention and waitlist control groups will be recruited by email. The interventions offered are specifically targeted to clergy preference and include mindfulness-based stress reduction, Daily Examen, and stress inoculation training. Surveys will be conducted at 0, 12, and 24 weeks with heart rate data collected at 0 and 12 weeks. The primary outcomes for this study are self-reported symptoms of stress and heart rate at week 12 for each intervention compared to waitlist control; the secondary outcome is symptoms of anxiety comparing each intervention vs waitlist control. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Duke University Campus IRB (2019-0238). The results will be made available to researchers, funders, and members of the clergy community. STRENGTHS AND LIMITATIONS OF THIS STUDY: While evidence-based stress reduction practices such as mindfulness-based stress reduction (MBSR) exist, a wider variety of practices should be tested to appeal to different individuals. Clergy in particular may prefer, and consequently enact, spiritual practices like the Daily Examen, and individuals such as clergy who spend most of their time thinking and feeling may prefer experiential-based practices like stress inoculation training. If efficacious, the Daily Examen and stress inoculation training practices have high feasibility in that they require few minutes per day. This study is limited by the inclusion of Christian clergy of only one denomination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04625777 . November 12, 2020.

Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review.

Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used to evaluate complex, multicomponent interventions, and outcomes are often binary. Complete reporting of impact for binary outcomes means reporting both relative and absolute measures. We did a systematic review to assess reporting practices and potential to overstate impact in contemporary cluster randomised trials with binary primary outcome. We included all reports registered in the Cochrane Central Register of Controlled Trials of two-arm parallel cluster randomised trials with at least one binary primary outcome that were published in 2017. Of 73 cluster randomised trials, most (60 [82%]) showed incomplete reporting. Of 64 cluster randomised trials for which it was possible to evaluate, most (40 [63%]) reported results in such a way that impact could be overstated. Care is needed to report complete evidence of impact for the many interventions evaluated using the cluster randomised trial design worldwide.

Epic Allies: A Gamified Mobile App to Improve Engagement in HIV Care and Antiretroviral Adherence among Young Men Who have Sex with Men.

HIV incidence among young men who have sex with men (YMSM) is disproportionally high. Youth living with HIV demonstrate low rates of sustained virologic suppression (VS). Epic Allies, a theory-based behavioral intervention mobile app, utilizes self-management tools, gamification, and social support to improve engagement in care and antiretroviral adherence among YMSM living with HIV. A two-arm individually randomized-controlled trial enrolled 146 participants aged 16 to 24 years old to test the efficacy of Epic Allies to achieve VS. Both study arms showed improved VS at 26-weeks (62.9% intervention; 73.5% control; ARR = 0.93 (95% CI 0.73, 1.18)) and antiretroviral adherence; intervention effects were amplified in regular app users. Issues with recruitment and app usage metrics limit the ability to definitively say that the app was effective in causing behavior changes resulting in improved health outcomes. (ClinicalTrials.gov Identifier: NCT02782130).

Statins and atherosclerotic cardiovascular outcomes in patients on incident dialysis and with atherosclerotic heart disease.

Statins failed to reduce cardiovascular (CV) events in trials of patients on dialysis. However, trial populations used criteria that often excluded those with atherosclerotic heart disease (ASHD), in whom statins have the greatest benefit, and included outcome composites with high rates of nonatherosclerotic CV events that may not be modified by statins. Here, we study whether statin use associates with lower atherosclerotic CV risk among patients with known ASHD on dialysis, including in those likely to receive a kidney transplant, a group excluded within trials but with lower competing mortality risks. METHODS: Using data from the United States Renal Data System including Medicare claims, we identified adults initiating dialysis with ASHD. We matched statin users 1:1 to statin nonusers with propensity scores incorporating hard matches for age and kidney transplant listing status. Using Cox models, we evaluated associations of statin use with the primary composite of fatal/nonfatal myocardial infarction and stroke (including within prespecified subgroups of younger age [<50 years] and waitlisting status); secondary outcomes included all-cause mortality and the composite of all-cause mortality, nonfatal myocardial infarction, or stroke. RESULTS: Of 197,716 patients with ASHD, 47,562 (24%) were consistent statin users from which we created 46,186 matched pairs. Over a median 662 days, statin users had similar risk of fatal/nonfatal myocardial infarction or stroke overall (hazard ratio [HR] 1.00, 95% CI 0.97-1.02), or in subgroups (age< 50 years [HR = 1.05, 95% CI 0.95-1.17]; waitlisted for kidney transplant [HR 0.99, 95% CI 0.97-1.02]). Statin use was modestly associated with lower all-cause mortality (HR 0.96, 95% CI 0.94-0.98; E value = 1.21) and, similarly, a modest lower composite risk of all-cause mortality, nonfatal myocardial infarction, or stroke over the first 2 years (HR 0.90, 95% CI 0.88-0.91) but attenuated thereafter (HR 0.98, 95% CI 0.96-1.01). CONCLUSIONS: Our large observational analyses are consistent with trials in more selected populations and suggest that statins may not meaningfully reduce atherosclerotic CV events even among incident dialysis patients with established ASHD and those likely to receive kidney transplants.