Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

BACKGROUND: The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care. OBJECTIVE: This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers. METHODS: Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point. RESULTS: We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points). CONCLUSIONS: In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6926-7.

Correction: Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/50330.].

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.

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.

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.

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.

Hopefulness among individuals living with schizophrenia and their caregivers in Tanzania: an actor-partner interdependence model.

BACKGROUND: Hopefulness is a positive orientation or state of mind that can aid in the recovery and treatment of mental illness, as it can have significant impacts on clinical and psychosocial outcomes. As resource-constrained settings work to implement recovery-oriented care, there is a need to better understand hopefulness among people living with schizophrenia (PLWS) and caregivers in their extended family networks. This study seeks to examine the dyadic relationship of hopefulness and its associated correlates among PLWS attending outpatient psychiatric clinics and their caregivers in Tanzania. METHODS: This study utilized baseline and immediate post-intervention data collected as part of a randomized controlled trial testing a culturally tailored model of Family Psychoeducation, KUPAA, in Tanzania. The Herth Hope Index was used to measure hopefulness among PLWS (n = 33) and their caregivers (n = 33) at baseline and immediate post-intervention. Univariable and multivariable regression models were conducted to determine correlates of hopefulness at baseline, while the Actor-Partner Interdependence Model (APIM) was employed to examine the longitudinal, dyadic relationship of hopefulness among and between PLWS and their caregivers. RESULTS: Better family functioning was associated with higher levels of hopefulness in PLWS and their caregivers. Lower levels of stigma, lower symptom severity, and lower disability were associated with higher levels of hopefulness in PLWS. For PLWS and their caregivers, actor effects from the APIM model were less than one (PLWS, [Formula: see text]; caregivers, [Formula: see text]), indicating stability (within each person) in hopefulness over time. Regarding partner effects, a caregiver's baseline hopefulness had a positive effect on the hopefulness of their PLWS at follow-up ([Formula: see text]). This indicates that higher caregiver hope at time 0 is associated with higher levels of hope in PLWS at time 1. Baseline hopefulness levels for PLWS had a negative effect on caregivers' hopefulness at follow-up ([Formula: see text]). This suggests that higher hopefulness among PLWS at baseline is associated with lower levels of hope in caregivers at follow-up. CONCLUSION: Hopefulness is important to consider in family or caregiver-based treatments for PLWS because caregiver hopefulness may influence improvements in hopefulness among PLWS over time. Future studies should further explore the longitudinal dyadic relationship of hopefulness for these populations, as hope is a non-pharmacological and modifiable mechanism of change that is underutilized in care and treatment plans for PLWS globally. TRIAL REGISTRATION: Clinical Trials #NCT04013932, July 10, 2019.

Timeliness of Delivery Care and Maternal and Neonatal Health Outcomes in Private Facilities in Masaka Area, Uganda: A Quasi-Experimental Study.

OBJECTIVES: While access to basic emergency obstetric and newborn care is necessary to reduce maternal and neonatal morbidity in low- and middle-income countries, data on the timeliness and quality of care at lower-level facilities is limited. This study examines timeliness of labor and delivery interventions and maternal and neonatal health status following deliveries in Uganda. METHODS: Women were recruited from 6 rural, private facilities in the greater Masaka area, Uganda on admission to the labor ward. Research assistants directly observed timeliness and quality of care from admission through discharge. Research assistants also abstracted medical chart information. All 6 facilities received training from LifeNet International on quality-of-care interventions for maternal and newborn health. RESULTS: 321 participants were directly observed during delivery, and 304 participants were followed at 28 days postpartum. Labor and delivery processes were overall timely and reflect international guidance on labor interventions. Maternal and neonatal health was good at discharge (90.6% and 88.8%) and 28 days postpartum (93.1% and 87.5%). However, there was no association between health at discharge and at 28 days for mothers or neonates (p = 0.67, p = 1.0, respectively). Demographic characteristics associated with maternal and neonatal health on discharge were different than those associated with maternal and neonatal health at 28 days. CONCLUSIONS FOR PRACTICE: Evidence on timeliness and quality of care can help inform strategies to further decrease maternal and neonatal morbidity. Additional focus is needed to retain patients in care to identify those developing poor health after delivery.

Perceived burden and family functioning among informal caregivers of individuals living with schizophrenia in Tanzania: a cross-sectional study.

BACKGROUND: Globally, families play a critical role in providing care and support for persons living with schizophrenia. It is important to identify potentially modifiable factors that influence perceived caregiver burden in order to properly address the needs of caregivers. This is especially relevant in low-resource settings where psychiatric services are scarce and interventions could be most effective if targeted to both the individual living with schizophrenia and their caregiver. This study examines correlates of perceived burden among informal caregivers of individuals with schizophrenia in Tanzania, in particular, the association between burden and caregiver-reported family functioning. METHODS: This study used baseline data from an individually randomized controlled trial with 65 pairs of individuals with schizophrenia and their informal caregivers in Dar es Salaam and Mbeya, Tanzania. Caregiver burden was measured using the Burden Assessment Scale. Univariable and multivariable regression analyses were performed to determine the relationship between caregiver burden and family functioning and to explore other correlates of burden. RESULTS: Sixty-three percent of caregivers reported experiencing high burden as a result of caring for a relative with schizophrenia. Multivariable regression analyses revealed that poor family functioning and the caregiver being employed were associated with high caregiver burden, while higher levels of hopefulness in the caregiver was associated with low caregiver burden. CONCLUSION: Caregivers who were employed, reported poor family functioning, and/or had low levels of hopefulness were more likely to perceive high caregiver burden. Future interventions aiming to reduce caregiver burden may benefit from improving family functioning and nurturing hope among caregivers of individuals living with schizophrenia. Policies and programs should be cognizant of the needs of caregivers that work in addition to providing care for a relative with schizophrenia in order to better support them.

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).

Beneath the Surface: A Comparison of Methods for Assessment of Quality of Care for Maternal and Neonatal Health Care in Rural Uganda.

OBJECTIVES: Efforts to improve access to healthcare in low-income countries will not achieve the maternal and child health (MCH) Sustainable Development Goals unless a concomitant improvement in the quality of care (QoC) occurs. This study measures infrastructure and QoC indicators in rural Ugandan health facilities. Valid measure of the quality of current clinical practices in resource-limited settings are critical for effectively intervening to reduce adverse maternal and neonatal outcomes. METHODS: Facility-based assessments of infrastructure and clinical quality during labor and delivery were conducted in six primary care health facilities in the greater Masaka area, Uganda in 2017. Data were collected using direct observation of clinical encounters and facility checklists. Direct observation comprised the entire delivery process, from initial client assessment to discharge, and included emergency management (e.g. postpartum hemorrhage, neonatal resuscitation). Health providers were assessed on their adherence to best practice standards of care. RESULTS: The quality of facility infrastructure was relatively high in facilities, with little variation in availability of equipment and supplies. However, heterogeneity in adherence to best clinical practices was noted across procedure type and facility. Adherence to crude measures of clinical quality were relatively high but more sensitive measures of the same clinical practice were found to be much lower. CONCLUSIONS FOR PRACTICE: Standard indicators of clinical practice may be insufficient to validly measure clinical quality for maternal and newborn care if we want to document evidence of impact.

A Randomized Trial of an Online Risk Reduction Intervention for Young Black MSM.

HealthMpowerment.org (HMP), is a mobile optimized, online intervention to reduce sexual risk behaviors among HIV-positive and HIV-negative young Black men who have sex with men (BMSM) by providing information and resources, fostering social support, and including game-based elements. A randomized controlled trial with 474 young BMSM compared HMP to an information-only control website. The rate of self-reported condomless anal intercourse (CAI) at 3-months was 32% lower in the intervention group compared to the control group (IRR 0.68, 95% CI 0.43, 0.93), however this effect was not sustained at 12 months. Among HIV-positive participants, the rate of CAI at 3-month follow-up was 82% lower among participants with detectable viral loads in the intervention group compared to the control group (IRR 0.18, 95% CI 0.04, 0.32). In a secondary analysis, when we limited to those who used HMP for over 60 min during the 3-month intervention period (n = 50, 25.8%), we estimated 4.85 (95% CI 2.15, 7.53) fewer CAI events than we would have expected in control participants, had they used the intervention at the same rate as the intervention group. Findings suggest that exposure to an online intervention can reduce the rate of CAI among young BMSM, at least in the short term. Given the stronger effect seen among those participants who complied with HMP, additional intervention engagement strategies are warranted.

The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.

BACKGROUND: For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina. METHODS: Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network. DISCUSSION: For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care. TRIALS REGISTRATION: NCT03003403 . Registered December 28, 2016.

Neighborhood clustering of non-communicable diseases: results from a community-based study in Northern Tanzania.

BACKGROUND: In order to begin to address the burden of non-communicable diseases (NCDs) in sub-Saharan Africa, high quality community-based epidemiological studies from the region are urgently needed. Cluster-designed sampling methods may be most efficient, but designing such studies requires assumptions about the clustering of the outcomes of interest. Currently, few studies from Sub-Saharan Africa have been published that describe the clustering of NCDs. Therefore, we report the neighborhood clustering of several NCDs from a community-based study in Northern Tanzania. METHODS: We conducted a cluster-designed cross-sectional household survey between January and June 2014. We used a three-stage cluster probability sampling method to select thirty-seven sampling areas from twenty-nine neighborhood clusters, stratified by urban and rural. Households were then randomly selected from each of the sampling areas, and eligible participants were tested for chronic kidney disease (CKD), glucose impairment including diabetes, hypertension, and obesity as part of the CKD-AFRiKA study. We used linear mixed models to explore clustering across each of the samplings units, and we estimated absolute-agreement intra-cluster correlation (ICC) coefficients (ρ) for the neighborhood clusters. RESULTS: We enrolled 481 participants from 346 urban and rural households. Neighborhood cluster sizes ranged from 6 to 49 participants (median: 13.0; 25th-75th percentiles: 9-21). Clustering varied across neighborhoods and differed by urban or rural setting. Among NCDs, hypertension (ρ = 0.075) exhibited the strongest clustering within neighborhoods followed by CKD (ρ = 0.440), obesity (ρ = 0.040), and glucose impairment (ρ = 0.039). CONCLUSION: The neighborhood clustering was substantial enough to contribute to a design effect for NCD outcomes including hypertension, CKD, obesity, and glucose impairment, and it may also highlight NCD risk factors that vary by setting. These results may help inform the design of future community-based studies or randomized controlled trials examining NCDs in the region particularly those that use cluster-sampling methods.

Description of a school nurse visit syndromic surveillance system and comparison to emergency department visits, New York City.

OBJECTIVES: We compared school nurse visit syndromic surveillance system data to emergency department (ED) visit data for monitoring illness in New York City schoolchildren. METHODS: School nurse visit data recorded in an electronic health record system are used to conduct daily surveillance of influenza-like illness, fever-flu, allergy, asthma, diarrhea, and vomiting syndromes. We calculated correlation coefficients to compare the percentage of syndrome visits to the school nurse and ED for children aged 5 to 14 years, from September 2006 to June 2011. RESULTS: Trends in influenza-like illness correlated significantly (correlation coefficient = 0.89; P < .001) and 72% of school signals occurred on days that ED signaled. Trends in allergy (correlation coefficient = 0.73; P < .001) and asthma (correlation coefficient = 0.56; P < .001) also correlated and school signals overlapped with ED signals on 95% and 51% of days, respectively. Substantial daily variation in diarrhea and vomiting visits limited our ability to make comparisons. CONCLUSIONS: Compared with ED syndromic surveillance, the school nurse system identified similar trends in influenza-like illness, allergy, and asthma syndromes. Public health practitioners without school-based surveillance may be able to use age-specific analyses of ED syndromic surveillance data to monitor illness in schoolchildren.

Tuberculosis Is Associated with Chronic Hypoxemia among Kenyan Adults (CHAKA): A Case-Control Study.

Rationale: Data on risk factors for chronic hypoxemia in low- and middle-income countries are lacking. Objectives: We aimed to quantify the association between potential risk factors and chronic hypoxemia among adults hospitalized in Kenya. Methods: A hospital-based, case-control study was conducted at Moi Teaching and Referral Hospital in Eldoret, Kenya. Adult inpatients were screened on admission and enrolled in a 1:2 case-to-control ratio. Cases were patients with chronic hypoxemia, defined as resting oxygen saturation as measured by pulse oximetry (SpO2) ⩽ 88% on admission and either 1-month postdischarge SpO2 ⩽ 88% or, if they died before follow-up, documented SpO2 ⩽ 88% in the 6 months before enrollment. Control subjects were randomly selected, stratified by sex, among nonhypoxemic inpatients. Data were collected using questionnaires and structured chart review. Regression was used to assess the associations between chronic hypoxemia and age, sex, smoking status, biomass fuel use, elevation, and self-reported history of tuberculosis and human immunodeficiency virus diagnosis. Odds ratios (ORs) and 95% confidence intervals (CIs) are reported. Results: We enrolled 108 chronically hypoxemic cases and 240 nonhypoxemic control subjects into our Chronic Hypoxemia among Kenyan Adults (CHAKA) cohort. In multivariable analysis, compared with control subjects, chronically hypoxemic cases had significantly higher odds of older age (OR, 1.2 per 5-year increase [95% CI, 1.1-1.3]), female sex (OR, 3.6 [95% CI, 1.8-7.2]), current or former tobacco use (OR, 4.7 [95% CI, 2.3-9.6]), and prior tuberculosis (OR, 11.8 [95% CI, 4.7-29.6]) but no increase in the odds of human immunodeficiency virus diagnosis and biomass fuel use. Conclusions: These findings highlight the potential impact of prior tuberculosis on chronic lung disease in Kenya and the need for further studies on posttuberculosis lung disease.

Functioning and quality of life among treatment-engaged adults with psychotic disorders in urban Tanzania: Baseline results from the KUPAA clinical trial.

BACKGROUND: There is a treatment gap for those living with severe mental illnesses in low- and middle-income countries, yet not enough is known about those who are currently accessing clinical services. A better understanding of potentially modifiable factors associated with functioning and quality of life will help inform policies and programming. AIMS: To describe the functioning and quality of life for a psychiatric treatment-engaged population living with psychotic disorders in two urban areas of Tanzania, and to explore their respective correlates. METHODS: This study analyzed cross-sectional data from 66 individuals enrolled in the Kuwezeshana Kupata Uzima (KUPAA) pilot clinical trial who had a diagnosis of schizophrenia or schizoaffective disorder, recent relapse, and who were receiving outpatient treatment. Baseline functioning (WHO Disability Assessment Schedule 2.0) and quality of life (WHO Quality of Life BREF scale) were measured. Univariable and multivariable regression analyses were conducted to determine correlates of functioning and quality of life. RESULTS: Adjusted analyses indicated that higher disability was associated with higher food insecurity, more symptomatology, more self-stigma, less instrumental support, less hope, lower self-efficacy, and/or lower levels of family functioning. Higher quality of life was associated with higher levels of self-efficacy, more hopefulness, more instrumental support, less self-stigma, and better family functioning. CONCLUSIONS: Identification of factors associated with disability and quality of life can help clinicians and policymakers, as well as consumers of mental health services, to better co-design and target psychosocial interventions to optimize their impact in low-resource settings. TRIAL REGISTRATION: Trial registration: ClinicalTrials.gov # NCT04013932, July 10, 2019.

Hearing-related quality of life in children and adolescents in rural Alaska.

Objective: This study evaluated the Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire in rural Alaska, including an addendum crafted through community feedback to reflect the local context. The objectives were to assess whether HEAR-QL score was inversely correlated with hearing loss and middle ear disease in an Alaska Native population. Methods: The HEAR-QL questionnaires for children and adolescents were administered as part of a cluster randomized trial in rural Alaska from 2017 to 2019. Enrolled students completed an audiometric evaluation and HEAR-QL questionnaire on the same day. A cross-sectional evaluation of questionnaire data was utilized. Results: A total of 733 children (ages 7-12 years) and 440 adolescents (ages ≥13 years) completed the questionnaire. Median HEAR-QL scores were similar among children with and without hearing loss (Kruskal-Wallis, p = .39); however, adolescent HEAR-QL scores significantly decreased with increasing hearing loss (p < .001). Median HEAR-QL scores were significantly lower in both children (p = .02) and adolescents (p < .001) with middle ear disease compared with those without. In both children and adolescents, the addendum scores were strongly correlated with total HEAR-QL score (ρSpearman = 0.72 and 0.69, respectively). Conclusions: The expected negative association between hearing loss and HEAR-QL score was observed in adolescents. However, there was significant variability that could not be explained by hearing loss, and further investigation is warranted. The expected negative association was not observed in children. HEAR-QL scores were associated with middle ear disease in both children and adolescents, making it potentially valuable in populations where the prevalence of ear infections is high. Level of Evidence: Level 2 Clinicaltrials.gov registration numbers: NCT03309553.

Asthma, Airflow Obstruction, and Eosinophilic Airway Inflammation Prevalence in Western Kenya: A Population-Based Cross-Sectional Study.

Objectives: Determine the prevalence of airway disease (e.g., asthma, airflow obstruction, and eosinophilic airway inflammation) in Kenya, as well as related correlates of airway disease and health-related quality of life. Methods: A three-stage, cluster-randomized cross-sectional study in Uasin Gishu County, Kenya was conducted. Individuals 12 years and older completed questionnaires (including St. George's Respiratory Questionnaire for COPD, SGRQ-C), spirometry, and fractional exhaled nitric oxide (FeNO) testing. Prevalence ratios with 95% confidence intervals (CIs) were calculated. Multivariable models were used to assess correlates of airflow obstruction and high FeNO. Results: Three hundred ninety-two participants completed questionnaires, 369 completed FeNO testing, and 305 completed spirometry. Mean age was 37.5 years; 64% were women. The prevalence of asthma, airflow obstruction on spirometry, and eosinophilic airway inflammation was 21.7%, 12.3% and 15.7% respectively in the population. Women had significantly higher SGRQ-C scores compared to men (15.0 vs. 7.7). Wheezing or whistling in the last year and SGRQ-C scores were strongly associated with FeNO levels >50 ppb after adjusting for age, gender, BMI, and tobacco use. Conclusion: Airway disease is a significant health problem in Kenya affecting a young population who lack a significant tobacco use history.