Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV. Several different developments in the US either threaten to increase or promise to decrease PrEP out-of-pocket costs and access in the coming years. In a sample of 58,529 people with a new insurer-approved PrEP prescription, we estimated risk-adjusted percentages of patients who abandoned (did not fill) their initial prescription across six out-of-pocket cost categories. We then simulated the percentage of patients who would abandon PrEP under hypothetical changes to out-of-pocket costs, ranging from $0 to more than $500. PrEP abandonment rates of 5.5 percent at $0 rose to 42.6 percent at more than $500; even a small increase from $0 to $10 doubled the rate of abandonment. Conversely, abandonment rates that were 48.0 percent with out-of-pocket costs of more than $500 dropped to 7.3 percent when those costs were cut to $0. HIV diagnoses were two to three times higher among patients who abandoned PrEP prescriptions than among those who filled them. These results imply that recent legal challenges to the provision of PrEP with no cost sharing could substantially increase PrEP abandonment and HIV rates, upending progress on the HIV/AIDS epidemic.

Associations between area-level arsenic exposure and adverse birth outcomes: An Echo-wide cohort analysis.

BACKGROUND: Drinking water is a common source of exposure to inorganic arsenic. In the US, the Safe Drinking Water Act (SDWA) was enacted to protect consumers from exposure to contaminants, including arsenic, in public water systems (PWS). The reproductive effects of preconception and prenatal arsenic exposure in regions with low to moderate arsenic concentrations are not well understood. OBJECTIVES: This study examined associations between preconception and prenatal exposure to arsenic violations in water, measured via residence in a county with an arsenic violation in a regulated PWS during pregnancy, and five birth outcomes: birth weight, gestational age at birth, preterm birth, small for gestational age (SGA), and large for gestational age (LGA). METHODS: Data for arsenic violations in PWS, defined as concentrations exceeding 10 parts per billion, were obtained from the Safe Drinking Water Information System. Participants of the Environmental influences on Child Health Outcomes Cohort Study were matched to arsenic violations by time and location based on residential history data. Multivariable, mixed effects regression models were used to assess the relationship between preconception and prenatal exposure to arsenic violations in drinking water and birth outcomes. RESULTS: Compared to unexposed infants, continuous exposure to arsenic from three months prior to conception through birth was associated with 88.8 g higher mean birth weight (95% CI: 8.2, 169.5), after adjusting for individual-level confounders. No statistically significant associations were observed between any preconception or prenatal violations exposure and gestational age at birth, preterm birth, SGA, or LGA. CONCLUSIONS: Our study did not identify associations between preconception and prenatal arsenic exposure, defined by drinking water exceedances, and adverse birth outcomes. Exposure to arsenic violations in drinking water was associated with higher birth weight. Future studies would benefit from more precise geodata of water system service areas, direct household drinking water measurements, and exposure biomarkers.

Birth Outcomes in Relation to Prenatal Exposure to Per- and Polyfluoroalkyl Substances and Stress in the Environmental Influences on Child Health Outcomes (ECHO) Program.

BACKGROUND: Per- and polyfluoroalkyl substances (PFAS) are persistent and ubiquitous chemicals associated with risk of adverse birth outcomes. Results of previous studies have been inconsistent. Associations between PFAS and birth outcomes may be affected by psychosocial stress. OBJECTIVES: We estimated risk of adverse birth outcomes in relation to prenatal PFAS concentrations and evaluate whether maternal stress modifies those relationships. METHODS: We included 3,339 participants from 11 prospective prenatal cohorts in the Environmental influences on the Child Health Outcomes (ECHO) program to estimate the associations of five PFAS and birth outcomes. We stratified by perceived stress scale scores to examine effect modification and used Bayesian Weighted Sums to estimate mixtures of PFAS. RESULTS: We observed reduced birth size with increased concentrations of all PFAS. For a 1-unit higher log-normalized exposure to perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexane sulfonic acid (PFHxS), we observed lower birthweight-for-gestational-age z-scores of ß=-0.15 [95% confidence interval (CI): -0.27, -0.03], ß=-0.14 (95% CI: -0.28, -0.002), ß=-0.22 (95% CI: -0.23, -0.10), ß=-0.06 (95% CI: -0.18, 0.06), and ß=-0.25 (95% CI: -0.37, -0.14), respectively. We observed a lower odds ratio (OR) for large-for-gestational-age: ORPFNA=0.56 (95% CI: 0.38, 0.83), ORPFDA=0.52 (95% CI: 0.35, 0.77). For a 1-unit increase in log-normalized concentration of summed PFAS, we observed a lower birthweight-for-gestational-age z-score [-0.28; 95% highest posterior density (HPD): -0.44, -0.14] and decreased odds of large-for-gestational-age (OR=0.49; 95% HPD: 0.29, 0.82). Perfluorodecanoic acid (PFDA) explained the highest percentage (40%) of the summed effect in both models. Associations were not modified by maternal perceived stress. DISCUSSION: Our large, multi-cohort study of PFAS and adverse birth outcomes found a negative association between prenatal PFAS and birthweight-for-gestational-age, and the associations were not different in groups with high vs. low perceived stress. This study can help inform policy to reduce exposures in the environment and humans. https://doi.org/10.1289/EHP10723.

Changes in Food Insecurity Among Individuals Using a Telehealth and Nutrition Platform: Longitudinal Study.

BACKGROUND: Food insecurity is a complex public health problem affecting many individuals in the United States. Digital health interventions that promote behavior change and provide access to affordable and healthy food may help to alleviate food insecurity. OBJECTIVE: The aim of this study was to characterize food-insecure users of Foodsmart, a telehealth and nutrition platform with meal planning, food ordering, nutrition education, budgeting, and grocery discount features, and to evaluate changes in diet and food insecurity. METHODS: We retrospectively analyzed data collected from 4595 adults who used the Foodsmart platform between February and October 2021. Participants self-reported their diet, demographics, biometrics, and food insecurity status in a 56-item questionnaire. Participants were reported to be food insecure if they answered "sometimes" or "often" to the question "How often does the food you buy not last and you don't have money to get more?" from the United States Department of Agriculture's Household Food Security survey. We examined baseline characteristics of participants by food insecurity status, associations between characteristics and baseline food insecurity, and changes in diet quality and food insecurity status. To evaluate potential causes of reversing food insecurity, the use of 6 Foodsmart features was compared between food-insecure participants who achieved food security versus food-insecure participants who remained food insecure, based on their last response to the food insecurity question. RESULTS: We found that 16% (742/4595) of participants were food insecure at baseline. Participants who were food insecure at baseline were more likely to be obese, to have at least one chronic condition, to have a lower diet quality, to cook less frequently at home, to think healthy food is too expensive, and less likely to order takeout or eat at a restaurant. Among participants who were food insecure at baseline, 61% (451/742) improved their nutrition and 29% (217/742) responded that they were food secure at follow-up, with an increasing percentage achieving food security with longer enrollment time. Using a multivariable logistic regression model, we found that age, diabetes, prediabetes, BMI categories, and diet quality at baseline were statistically significantly associated with the likelihood of being food insecure at baseline. Among those who were food insecure at baseline, there was a higher relative proportion of participants who achieved food security and used the "deals" (28.6% higher), "CookItNow" (36.4% higher), and "telenutrition" (27.5% higher) features compared to those who remained food insecure. CONCLUSIONS: This study assesses the characteristics of individuals enrolled on the Foodsmart platform who answered the food insecurity question. We found that a significant number of participants who were food insecure at enrollment achieved food security. This finding shows that telehealth and nutrition platforms may potentially help users improve household food security.

Association Between Organizational Quality and Out-of-Network Primary Care Among Accountable Care Organizations That Care for High vs Low Proportions of Patients of Racial and Ethnic Minority Groups.

Importance: Medicare accountable care organizations (ACOs) that disproportionately care for patients of racial and ethnic minority groups deliver lower quality care than those that do not, potentially owing to differences in out-of-network primary care among them. Objective: To examine how organizational quality is associated with out-of-network primary care among ACOs that care for high vs low proportions of patients of racial and ethnic minority groups. Design Setting and Participants: A retrospective cohort study was conducted between March 2019 and October 2021 using claims data (2013 to 2016) from a national sample of Medicare beneficiaries. Among beneficiaries who were assigned to 1 of 528 Medicare ACOs, a distinction was made between those treated by organizations that cared for high (vs low) proportions of patients of racial and ethnic minority groups. For each ACO, the amount of out-of-network primary care that it delivered annually was determined. Multivariable models were fit to evaluate how the quality of care that beneficiaries received varied by the proportion of care provided to patients of racial and ethnic minority groups by the ACO and its amount of out-of-network primary care. Exposures: The degree of care provided to patients of racial and ethnic minority groups by the ACO and its amount of out-of-network primary care. Main Outcomes and Measures: The ACO quality assessed with 5 preventive care services and 4 utilization metrics. Results: Among 3 955 951 beneficiary-years (2 320 429 [58.7%] women; 71 218 [1.8%] Asian, 267 684 [6.8%] Black, 44 059 [1.1%] Hispanic, 4922 [0.1%] North American Native, and 3 468 987 [87.7%] White individuals and 56 157 [1.4%] of Other race and ethnicity), those assigned to ACOs serving many patients of racial and ethnic minority groups at the mean level of out-of-network primary care were less likely than those assigned to ACOs serving fewer patients of racial and ethnic minority groups to receive diabetic retinal examinations (predicted probability, 49.4% [95%CI, 49.0%-49.7%] vs 51.6% [95% CI, 51.5%-51.8%]), glycated hemoglobin testing (predicted probability, 58.5% [95% CI, 58.2%-58.5%] vs 60.4% [95% CI, 60.3%-60.6%]), or low-density lipoprotein cholesterol testing (predicted probability, 85.2% [95% CI, 85.0%-85.5%] vs 86.0% [95% CI, 85.9%-86.1%]). They were also more likely to experience all-cause 30-day readmissions (predicted probability, 16.4% [95% CI, 16.1%-16.7%] vs 15.7% [95% CI, 15.6%-15.8%]). However, as the level of out-of-network primary care decreased, these gaps closed substantially, such that beneficiaries at ACOs that served many and fewer patients of racial and ethnic minority groups in the lowest percentile of out-of-network primary care received care of comparable quality. Conclusions and Relevance: This large cohort study found that quality performance among ACOs serving many patients of racial and ethnic minority groups was negatively associated with their level of out-of-network primary care.

The Clinical Utility of the MOCA in iNPH Assessment.

Objectives: We sought to estimate reliable change thresholds for the Montreal Cognitive Assessment (MoCA) for older adults with suspected Idiopathic Normal Pressure Hydrocephalus (iNPH). Furthermore, we aimed to determine the likelihood that shunted patients will demonstrate significant improvement on the MoCA, and to identify possible predictors of this improvement. Methods: Patients (N = 224) presenting with symptoms of iNPH were given a MoCA assessment at their first clinic visit, and also before and after tap test (TT) or extended lumbar drainage (ELD). Patients who were determined to be good candidates for shunts (N = 71, 31.7%) took another MoCA assessment following shunt insertion. Reliable change thresholds for MoCA were derived using baseline visit to pre-TT/ELD assessment using nine different methodologies. Baseline characteristics of patients whose post-shunt MoCA did and did not exceed the reliable change threshold were compared. Results: All nine of reliable change methods indicated that a 5-point increase in MoCA would be reliable for patients with a baseline MoCA from 16 to 22 (38.4% of patients). Furthermore, a majority of reliable change methods indicated that a 5-point increase in MoCA would be reliable for patients with a baseline MoCA from 14 to 25. Reliable change thresholds varied across methods from 4 to 7 points for patients outside of this range. 10.1% had at least a 5-point increase from baseline to post-TT/ELD. Compared to patients who did not receive a shunt, patients who received a shunt did not have lower average MoCA at baseline (p = 0.88) or have better improvement in MoCA scores after the tap test (p = 0.17). Among shunted patients, 23.4% improved by at least 5 points on the MoCA from baseline to post-shunt. Time since onset of memory problems and post-TT/ELD gait function were the only clinical factors significantly associated with having a reliable change in MoCA after shunt insertion (p = 0.019; p = 0.03, respectively). Conclusions: In patients with iNPH, clinicians could consider using a threshold of 5 points for determining whether iNPH-symptomatic patients have experienced cognitive benefits from cerebrospinal fluid drainage at an individual level. However, a reliable change cannot be detected for patients with a baseline MoCA of 26 or greater, necessitating a different cognitive assessment tool for these patients.

Blood Pressure Control in Individuals With Hypertension Who Used a Digital, Personalized Nutrition Platform: Longitudinal Study.

BACKGROUND: While there is a strong association between adhering to a healthy dietary pattern and reductions in blood pressure, adherence remains low. New technologies aimed to help facilitate behavior change may have an effect on reducing blood pressure among individuals with hypertension. OBJECTIVE: This study aims to evaluate characteristics of participants with stage 2 hypertension who used Foodsmart and to assess changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP). METHODS: We analyzed demographic, dietary, and clinical characteristics collected from 11,934 adults with at least two blood pressure readings who used the Foodsmart platform. Stage 2 hypertension was defined as SBP ≥140 mmHg or DBP ≥90 mmHg. We calculated mean changes in blood pressure among participants with stage 2 hypertension and stratified by length of follow-up and the covariates associated with achieving blood pressure levels below stage 2 hypertension. We compared changes in diet quality and weight between participants with stage 2 hypertension at baseline who achieved stage 1 hypertension or below and those who did not. RESULTS: We found that 10.63% (1269/11,934) of participants had stage 2 hypertension at baseline. Among Foodsmart participants with stage 2 hypertension at baseline, SBP and DBP decreased, on average, by 5.7 and 4.0 mmHg, respectively; 33.02% (419/1269) of participants with stage 2 hypertension at baseline achieved blood pressure levels below stage 2 hypertension (SBP <140 mmHg and DBP <90 mmHg). Using a multivariable ordinal logistic regression model, changes in Nutriscore (P=.001) and weight (P=.04) were statistically significantly associated with changes in blood pressure categories for users with stage 2 hypertension at baseline. Using a multivariable logistic regression model, we found that baseline Nutriscore, change in Nutriscore, and change in weight were associated with greater likelihood of users with stage 2 hypertension at baseline achieving a lower blood pressure category. CONCLUSIONS: This study evaluated changes in SBP and DBP among users (with hypertension) of the Foodsmart platform and found that those with stage 2 hypertension, on average, improved their blood pressure levels over time.

Longitudinal patterns of urinary incontinence and associated predictors in women with type 1 diabetes.

AIMS: Urinary incontinence (UI) in women is a dynamic condition with numerous risk factors yet most studies have focused on examining its prevalence at a single time. The objective of this study was to describe the long-term time course of UI in women with type 1 diabetes (T1D). METHODS: Longitudinal data in women with T1D were collected from 568 women in the Epidemiology of Diabetes Interventions and Complications (EDIC) study, the observational follow-up of the Diabetes Control and Complications Trial (DCCT) cohort. Over a 12-year period, participants annually responded to whether they had experienced UI in the past year. RESULTS: We identified four categories of UI in this population over time: 205 (36.1%) women never reported UI (no UI), 70 (12.3%) reported it one or two consecutive years only (isolated UI), 247 (43.5%) periodically changed status between UI and no UI (intermittent UI), and 46 (8.1%) reported UI continuously after the first report (persistent UI). Compared to women reporting no/isolated UI, women displaying the intermittent phenotype were significantly more likely to be obese (OR: 1.86, 95% CI 1.15, 3.00) and report prior hysterectomy (OR: 2.57, 95% CI: 1.39, 4.77); whereas women with persistent UI were significantly more likely to have abnormal autonomic function (OR: 2.36, 95% CI: 1.16-4.80). CONCLUSIONS: UI is a dynamic condition in women with T1D. Varying risk factors observed for the different phenotypes of UI suggest distinctive pathophysiological mechanisms. These findings have the potential to be used to guide individualized interventions for UI in women with diabetes.

Changes in Glycemic Control Among Individuals With Diabetes Who Used a Personalized Digital Nutrition Platform: Longitudinal Study.

BACKGROUND: Diabetes-related costs are the highest across all chronic conditions in the United States, with type 2 diabetes accounting for up to 95% of all cases of diabetes. A healthy diet is strongly associated with lowering glycated hemoglobin A1c (HbA1c) levels among individuals with diabetes, which can help curtail other health complications. Digital health platforms can offer critical support for improving diet and glycemic control among individuals with diabetes. Less is known about the characteristics of people with diabetes who use digital health platforms (specifically, a platform that integrates personalized healthy meal plans and food ordering) and changes in their HbA1c levels. OBJECTIVE: The aim of this study is to characterize Foodsmart users with diabetes and evaluate the longitudinal impact of Foodsmart-a personalized digital nutrition platform with meal planning, food ordering, and nutrition education features-on changes in HbA1c levels. METHODS: We retrospectively analyzed data collected from 643 adults with at least two self-reported HbA1c entries in the Foodsmart platform between January 2016 and June 2021. Participants self-reported their HbA1c levels, height, weight, health conditions, and diet in a 53-item food frequency questionnaire. Diabetes was defined as HbA1c ≥6.5%. We analyzed distributions of characteristics by baseline diabetes status and examined the association of characteristics with the likelihood of having diabetes at baseline. To evaluate the change in HbA1c levels among Foodsmart users, we calculated mean changes (absolute and percent) in HbA1c among participants with diabetes and by length of follow-up. We also compared changes in HbA1c and weight between participants with diabetes at baseline who achieved a normal HbA1c level and those who did not. RESULTS: We found that 43.5% (280/643) of the participants with at least two HbA1c level entries had diabetes at baseline. Participants with diabetes at baseline were more likely to be male, have a higher weight and BMI, report high blood pressure, and have a poorer diet in comparison to participants without diabetes. Using a multivariable logistic regression model, we found that being male and obese were statistically significantly associated with baseline diabetes. Among participants with diabetes at baseline, HbA1c was reduced, on average, by 0.46%. In addition, 21.4% (60/280) of participants with diabetes achieved a normal HbA1c level (<6.5%) in their last HbA1c level entry; this percentage increased with longer follow-up time (39% [7/18] at >24 months). In a sensitivity analysis, users with an HbA1c ≥7.0% at baseline had an average absolute change of -0.62% and 31.2% (62/199) of these participants achieved HbA1c levels of less than 7.0%. CONCLUSIONS: This study assessed characteristics of individuals enrolled on the Foodsmart platform with HbA1c levels and found that users with diabetes had lower HbA1c levels over time and a sizable percentage of participants were successful in achieving normal levels.

Accountable Care Organizations and Spending for Patients Undergoing Long-Term Dialysis.

BACKGROUND AND OBJECTIVES: Despite representing 1% of the population, beneficiaries on long-term dialysis account for over 7% of Medicare's fee-for-service spending. Because of their focus on care coordination, Accountable Care Organizations may be an effective model to reduce spending inefficiencies for this population. We analyzed Medicare data to examine time trends in long-term dialysis beneficiary alignment to Accountable Care Organizations and differences in spending for those who were Accountable Care Organization aligned versus nonaligned. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this retrospective cohort study, beneficiaries on long-term dialysis between 2009 and 2016 were identified using a 20% random sample of Medicare beneficiaries. Trends in alignment to an Accountable Care Organization were compared with alignment of the general Medicare population from 2012 to 2016. Using an interrupted time series approach, we examined the association between Accountable Care Organization alignment and the primary outcome of total spending for long-term dialysis beneficiaries from prior to Accountable Care Organization implementation (2009-2011) through implementation of the Comprehensive ESRD Care model in October 2015. We fit linear regression models with generalized estimating equations to adjust for patient characteristics. RESULTS: During the study period, 135,152 beneficiaries on long-term dialysis were identified. The percentage of long-term dialysis beneficiaries aligned to an Accountable Care Organization increased from 6% to 23% from 2012 to 2016. In the time series analysis, spending on Accountable Care Organization-aligned beneficiaries was $143 (95% confidence interval, $5 to $282) less per beneficiary-quarter than spending for nonaligned beneficiaries. In analyses stratified by whether beneficiaries received care from a primary care physician, savings by Accountable Care Organization-aligned beneficiaries were limited to those with care by a primary care physician ($235; 95% confidence interval, $73 to $397). CONCLUSIONS: There was a substantial increase in the percentage of long-term dialysis beneficiaries aligned to an Accountable Care Organization from 2012 to 2016. Moreover, in adjusted models, Accountable Care Organization alignment was associated with modest cost savings among long-term dialysis beneficiaries with care by a primary care physician.