Social Disparities and Critical Illness during the Coronavirus Disease 2019 Pandemic: A Narrative Review.

The coronavirus disease 2019 (COVID-19) pandemic raised new considerations for social disparities in critical illness including hospital capacity and access to personal protective equipment, access to evolving therapies, vaccinations, virtual care, and restrictions on family visitation. This narrative review aims to explore evidence about racial/ethnic and socioeconomic differences in critical illness during the COVID-19 pandemic, factors driving those differences and promising solutions for mitigating inequities in the future. We apply a patient journey framework to identify social disparities at various stages before, during, and after patient interactions with critical care services and discuss recommendations for policy and practice.

Assessment of sociodemographic factors associated with time to self-reported COVID-19 infection among a large multi-center prospective cohort population in the southeastern United States.

OBJECTIVE: We aimed to investigate sociodemographic factors associated with self-reported COVID-19 infection. METHODS: The study population was a prospective multicenter cohort of adult volunteers recruited from healthcare systems located in the mid-Atlantic and southern United States. Between April 2020 and October 2021, participants completed daily online questionnaires about symptoms, exposures, and risk behaviors related to COVID-19, including self-reports of positive SARS CoV-2 detection tests and COVID-19 vaccination. Analysis of time from study enrollment to self-reported COVID-19 infection used a time-varying mixed effects Cox-proportional hazards framework. RESULTS: Overall, 1,603 of 27,214 study participants (5.9%) reported a positive COVID-19 test during the study period. The adjusted hazard ratio demonstrated lower risk for women, those with a graduate level degree, and smokers. A higher risk was observed for healthcare workers, those aged 18-34, those in rural areas, those from households where a member attends school or interacts with the public, and those who visited a health provider in the last year. CONCLUSIONS: We identified subgroups within healthcare network populations defined by age, occupational exposure, and rural location reporting higher than average rates of COVID-19 infection for our surveillance population. These subgroups should be monitored closely in future epidemics of respiratory viral diseases.

Self-Measured Blood Pressure-Guided Pharmacotherapy: A Systematic Review and Meta-Analysis of United States-Based Telemedicine Trials.

BACKGROUND: The optimal approach to implementing telemedicine hypertension management in the United States is unknown. METHODS: We examined telemedicine hypertension management versus the effect of usual clinic-based care on blood pressure (BP) and patient/clinician-related heterogeneity in a systematic review/meta-analysis. We searched United States-based randomized trials from Medline, Embase, CENTRAL, CINAHL, PsycINFO, Compendex, Web of Science Core Collection, Scopus, and 2 trial registries. We used trial-level differences in BP and its control rate at ≥6 months using random-effects models. We examined heterogeneity in univariable metaregression and in prespecified subgroups (clinicians leading pharmacotherapy [physician/nonphysician], self-management support [pharmacist/nurse], White versus non-White patient predominant trials [>50% patients/trial], diabetes predominant trials [≥25% patients/trial], and White patient predominant but not diabetes predominant trials versus both non-White and diabetes patient predominant trials]. RESULTS: Thirteen, 11, and 7 trials were eligible for systolic and diastolic BP difference and BP control, respectively. Differences in systolic and diastolic BP and BP control rate were -7.3 mm Hg (95% CI, -9.4 to -5.2), -2.7 mm Hg (-4.0 to -1.5), and 10.1% (0.4%-19.9%), respectively, favoring telemedicine. Greater BP reduction occurred in trials where nonphysicians led pharmacotherapy, pharmacists provided self-management support, White patient predominant trials, and White patient predominant but not diabetes predominant trials, with no difference by diabetes predominant trials. CONCLUSIONS: Telemedicine hypertension management is more effective than clinic-based care in the United States, particularly when nonphysicians lead pharmacotherapy and pharmacists provide self-management support. Non-White patient predominant trials achieved less BP reduction. Equity-conscious, locally informed adaptation of telemedicine interventions is needed before wider implementation.

Patient Characteristics Associated with Telemedicine Use for Diabetes Mellitus Care: Experience of a University Health System.

OBJECTIVES: The objective was to understand the characteristics of patients who used telemedicine for diabetes management to inform future implementation of telemedicine. METHODS: We examined patient characteristics associated with telemedicine use for diabetes mellitus (DM) care between March 1, 2020 and April 1, 2021 (the coronavirus disease 2019 pandemic period) in a large university health system when telemedicine visits increased rapidly. Logistic regression models assessed patient characteristics associated with telemedicine visits and delays in DM process measures (hemoglobin A1c checks, nephropathy, and retinopathy evaluations) during the pandemic period after adjusting for potential confounders and corresponding values before the pandemic period (March 1, 2019-February 29, 2020). RESULTS: A total of 45,159 patients were seen from 987,791 visits during the pandemic period. The number of visits averaged one visit less during the pandemic period than before the pandemic period. Approximately 5.4% of patients used telemedicine during the pandemic period from 42,750 visits. The mean (standard deviation) telemedicine visit was 1.28 (0.91). Men, Asian, Black, and other race (vs White), having Medicare or uninsured (vs private insurance), were less likely to use telemedicine. Patients with more visits before the pandemic period were more likely to use telemedicine and less likely to experience a delay in DM process measures during the pandemic period. Telemedicine users were 18% less likely to experience a delay in nephropathy visits than nonusers, but without difference for other process measures. CONCLUSIONS: Race, sex, insurance, and prepandemic in-person visits were associated with telemedicine use for DM management in a large health system. Telemedicine use was not associated with delays in hemoglobin A1c testing, nephropathy, and retinopathy assessments. Understanding reasons for not using telemedicine is important to be able to deliver equitable DM care.

Heterogeneity of the Effect of Telemedicine Hypertension Management Approach on Blood Pressure: A Systematic Review and Meta-analysis of US-based Clinical Trials.

Background: Telemedicine management of hypertension (TM-HTN) uses home blood pressure (BP) to guide pharmacotherapy and telemedicine-based self-management support (SMS). Optimal approach to implementing TM-HTN in the US is unknown. Methods: We conducted a systematic review and a meta-analysis to examine the effect of TM-HTN vs. usual clinic-based care on BP and assessed heterogeneity by patient- and clinician-related factors. We searched US-based randomized clinical trials among adults from Medline, Embase, CENTRAL, CINAHL, PsycInfo, and Compendex, Web of Science Core Collection, Scopus, and two trial registries to 7/7/2023. Two authors extracted, and a third author confirmed data. We used trial-level differences in systolic BP (SBP), diastolic BP (DBP) and BP control rate at ≥6 months using random-effects models. We examined heterogeneity of effect in univariable meta-regression and in pre-specified subgroups [clinicians leading pharmacotherapy (physician vs. non-physician), SMS (pharmacist vs. nurse), White vs. non-White patient predominant trials (>50% patients/trial), diabetes predominant trials (≥25% patients/trial) and in trials that have majority of both non-White patients and patients with diabetes vs. White patient predominant but not diabetes predominant trials. Results: Thirteen, 11 and 7 trials were eligible for SBP, DBP and BP control, respectively. Differences in SBP, DBP and BP control rate were -7.3 mmHg (95% CI: - 9.4, -5.2), -2.7 mmHg (-4.0, -1.5) and 10.1% (0.4%, 19.9%), respectively, favoring TM-HTN. More BP reduction occurred in trials with non-physician vs. physician led pharmacotherapy (9.3/4.0 mmHg vs. 4.9/1.1 mmHg, P<0.01 for both SBP/DBP), pharmacist vs. nurses provided SMS (9.3/4.1 mmHg vs. 5.6/1.0 mmHg, P=0.01 for SBP, P<0.01 for DBP), and White vs. non-White patient predominant trials (9.3/4.0 mmHg vs. 4.4/1.1 mmHg, P<0.01 for both SBP/DBP), with no difference by diabetes predominant trials. Lower BP reduction occurred in both diabetes and non-White patient predominant trials vs. White patient predominant but not diabetes predominant trials (4.5/0.9 mmHg vs. 9.5/4.2 mmHg, P<0.01 for both SBP/DBP). Conclusions: TM-HTN is more effective than clinic-based care in the US, particularly when non-physician led pharmacotherapy and pharmacist provided SMS. Non-White patient predominant trials seemed to achieve lesser BP reduction. Equity conscious, locally informed adaptation of TM-HTN is needed before wider implementation. Clinical Perspective: What Is New?: In this systematic review and meta-analysis of US-based clinical trials, we found that telemedicine management of hypertension (TM-HTN) was more effective in reducing and controlling blood pressure (BP) compared with clinic based hypertension (HTN) care.The BP reduction was more evident when pharmacotherapy was led by non-physician compared with physicians and HTN self-management support was provided by clinical pharmacists compared with nurses,Non-White patient predominant trials achieved lesser BP reductions than White patient predominant trials.What Are the Clinical Implications?: Before wider implementation of TM-HTN intervention in the US, locally informed adaptation, such as optimizing the team-based HTN care approach, can provide more effective BP control.Without equity focused tailoring, TM-HTN intervention implemented as such can exacerbate inequities in BP control among non-White patients in the US.

Prevalence and Correlates of Uncontrolled Hypertension, Persistently Uncontrolled Hypertension, and Hypertensive Crisis at a Healthcare System.

BACKGROUND: Uncontrolled hypertension significantly increases risk of cardiovascular disease and death. This study examined the prevalence of uncontrolled hypertension, persistently uncontrolled hypertension, and hypertensive crisis and factors associated with these outcomes in a real-world patient cohort. METHODS: Electronic medical records from a large healthcare system in North Carolina were used to identify adults with uncontrolled hypertension (last ambulatory blood pressure [BP] measurement ≥140/90); persistently uncontrolled hypertension (≥2 ambulatory BP measurements with all readings ≥140/90); and hypertensive crisis (any BP reading ≥180/120) in 2019. Generalized linear mixed models tested the association between patient and provider characteristics and each outcome. RESULTS: The study cohort included 213,836 patients (mean age 63.1 (±14.0) years, 55.5% female, 70.8% white). Of these, 29.7% and 13.1% had uncontrolled hypertension and hypertensive crisis, respectively. Among those experiencing hypertensive crisis, >50% did not have uncontrolled hypertension. Of the 171,061 patients with ≥2 BP measurements, 5.9% had persistently uncontrolled hypertension. The likelihood of uncontrolled hypertension, persistently uncontrolled hypertension, and hypertensive crisis was higher in patients with black race (vs. white), self-pay (vs. private), prior emergency room visit, and no attributed primary care provider. Readings taken in the evening (vs. morning) and at specialty (vs. primary care) practices were more likely to meet thresholds for uncontrolled hypertension and hypertensive crisis. CONCLUSIONS: Hypertension control remains a significant challenge in healthcare. Health systems may benefit from segmenting their patient population based on factors such as race, prior healthcare use, and timing of BP measurement to prioritize outreach and intervention.

Association between self-reported masking behavior and SARS-CoV-2 infection wanes from Pre-Delta to Omicron-predominant periods - North Carolina COVID-19 Community Research Partnership (NC-CCRP).

BACKGROUND: Wearing a face mask is a primary public health method to reduce SARS-CoV-2 transmission. METHODS: We performed a nested case-control analysis within the North Carolina COVID-19 Community Research Partnership (NC-CCRP) of adults who completed daily surveillance surveys, April 2020 - February 2022. We assessed the association between self-reported mask wearing behavior during nonhousehold interactions and COVID-19 infection during 3 pandemic periods using conditional logistic regression models of risk of infection that were adjusted for demographics, vaccination status, and recent known exposure to COVID-19. RESULTS: Among 3,901 cases and 27,813 date-matched controls, there was a significant interaction between mask use and time period (P < .001). Prior to July 2021, the odds of a reported infection were 66% higher (aOR = 1.66, 95% CI = 1.43-1.91) among participants reporting ≥1 day not wearing a mask compared to those who reported no days (1,592 cases, 11,717 controls). During the Delta-predominant period, the results were similar (aOR = 1.53, 95% CI = 1.23-1.89; 659 cases, 4,649 controls). This association was attenuated during the Omicron-predominant period, where odds of an infection was 16% higher (aOR = 1.16, 95% CI = 1.03-1.32; 1,563 cases, 10,960 controls). CONCLUSIONS: While the effect of not wearing a mask remains significant, during the Omicron-predominant period we observed a decrease in the association between self-reported mask wearing and risk of SARS-CoV-2 infection.

Disparities in Level of Care and Outcomes Among Patients with COVID-19: Associations Between Race/Ethnicity, Social Determinants of Health and Virtual Hospitalization, Inpatient Hospitalization, Intensive Care, and Mortality.

OBJECTIVE: To examine the role of race/ethnicity and social determinants of health on COVID-19 care and outcomes for patients within a healthcare system that provided virtual hospital care. METHODS: This retrospective cohort study included 12,956 adults who received care for COVID-19 within an integrated healthcare system between 3/1/2020 and 8/31/2020. Multinomial models were used to examine associations between race/ethnicity, insurance, neighborhood deprivation measured by Area Deprivation Index (ADI), and outcomes of interest. Outcomes included (1) highest level of care: virtual observation (VOU), virtual hospitalization (VACU), or inpatient hospitalization; (2) intensive care (ICU); and (3) all-cause 30-day mortality. RESULTS: Patients were 41.8% White, 27.2% Black, and 31.0% Hispanic. Compared to White patients, Black patients had 1.86 higher odds of VACU admission and 1.43 higher odds of inpatient hospitalization (vs. VOU). Hispanic patients had 1.24 higher odds of inpatient hospitalization (vs. VOU). In models stratified by race/ethnicity, Hispanic and Black patients had higher odds of inpatient hospitalization (vs. VOU) if Medicaid insured compared to commercially insured. Hispanic patients living in the most deprived neighborhood had higher odds of inpatient hospitalization, compared to those in the least deprived neighborhood. Black and Hispanic patients had higher odds of ICU admission and 30-day mortality after adjustment for other social determinants. CONCLUSIONS: Insurance and ADI were associated with COVID-19 outcomes; however, associations varied by race/ethnicity. Racial/ethnic disparities in outcomes are not fully explained by measured social determinants of health, highlighting the need for further investigation into systemic causes of inequities in COVID-19 outcomes.

Evaluating Racial/Ethnic Differences in Care Escalation Among COVID-19 Patients in a Home-Based Hospital.

The novel coronavirus disease 2019 (COVID-19) has infected over 414 million people worldwide with 5.8 million deaths, as of February 2022. Telemedicine-based interventions to expand healthcare systems' capacity and reduce infection risk have rapidly increased during the pandemic, despite concerns regarding equitable access. Atrium Health Hospital at Home (AH-HaH) is a home-based program that provides advanced, hospital-level medical care and monitoring for patients who would otherwise be hospitalized in a traditional setting. Our retrospective cohort study of positive COVID-19 patients who were admitted to AH-HaH aims to investigate whether the rate of care escalation from AH-HaH to traditional hospitalization differed based on patients' racial/ethnic backgrounds. Logistic regression was used to examine the association between care escalation within 14 days from index AH-HaH admission and race/ethnicity. We found approximately one in five patients receiving care for COVID-19 in AH-HaH required care escalation within 14 days. Odds of care escalation were not significantly different for Hispanic or non-Hispanic Blacks compared to non-Hispanic Whites. However, secondary analyses showed that both Hispanic and non-Hispanic Black patients were younger and with fewer comorbidities than non-Hispanic Whites. The study highlights the need for new care models to vigilantly monitor for disparities, so that timely and tailored adaptations can be implemented for vulnerable populations.

Variations in Receipt of Contraceptives by Insurance Status and Race/Ethnicity.

BACKGROUND Although use of contraceptives has increased among young women in the United States, more than half of pregnancies remain unplanned. The goal of this study was to examine the association between insurance status and receipt of contraceptives among young women receiving care within a large integrated health care system in the Southeastern United States to better inform strategies for increasing access to contraception.METHODS This retrospective study used electronic medical record data from an integrated health care system based in Charlotte, North Carolina. Data were analyzed for 51,900 women aged 18-29 who lived in Mecklenburg County and had at least 1 primary care visit between 2014 and 2016. Contraceptive orders were identified by service and procedure codes and grouped into long-acting reversible contraceptives (LARC) and non-LARC categories. Adjusted multinomial logistic regression models were used to assess the association between receipt of contraceptives and insurance status.RESULTS Compared to non-Hispanic White women with commercial insurance, non-Hispanic Black (OR = 1.25; 95% CI, 1.13-1.38) and Hispanic (OR = 2.25; 95% CI, 1.93-2.61) women with Medicaid had higher odds of receiving LARC. Similar variations by insurance and race/ethnicity were observed for the non-LARC group.LIMITATIONS Data were limited to a single health care system and did not capture contraceptive orders by unaffiliated providers. Analyses used the most frequent payor and did not account for changes in insurance status.CONCLUSION Findings indicate an important role of race/ethnicity and insurance coverage in contraceptive care. Higher receipt of LARC among Black and Hispanic women also suggests that implicit biases may influence contraception counseling and promotion practices. Future study is warranted to further delineate these relationships.

The effect of broadband access on electronic patient engagement activities: Assessment of urban-rural differences.

OBJECTIVES: Lack of access to high-speed internet may explain disparities in the use of technologies that support electronic patient engagement (EPE). This study describes trends in how people with and without fixed broadband connectivity in urban and rural communities used EPE tools to interact with health care providers between 2014 and 2018. METHODS: We linked Federal Communications Commission fixed broadband data with the Association of American Medical Colleges Consumer Survey of Health Care Access data for years 2014-2018 (n = 23,131). ZIP Codes with a 25Mbps download speed and 3Mbps upload speed were determined to have broadband connectivity access. We evaluated 6 activities involving the use of 4 EPE tools (email, text, website, chat, video, and mobile app) and the intensity of use (0 = none, 1-3 = low, 4-6 = high). Multivariate logistic and multinomial regression models were used to determine factors associated with EPE. RESULTS: More than half (57.1%) of those without broadband access lived in rural areas. Overall, the intensity in the use of EPE tools increased from 2014 to 2016, then declined steadily with higher increases in use observed in urban and suburban than in rural areas. Lack of broadband access was associated with increased odds of zero intensity versus low-intensity use of EPE tools in rural areas (OR = 1.72, 95% CI: 1.42-2.09). CONCLUSIONS: Inequality in broadband connectivity access may explain why rural communities lag in using various electronic tools for interacting with health care providers. Continued efforts to increase broadband connectivity in rural communities could improve their engagement with care providers.

Racial/Ethnic Disparities in Health Care Setting Choice for Adults Seeking Severe Acute Respiratory Syndrome Coronavirus 2 Testing.

OBJECTIVES: Equitable access to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing is important for reducing disparities. We sought to examine differences in the health care setting choice for SARS-CoV-2 testing by race/ethnicity and insurance. Options included traditional health care settings and mobile testing units (MTUs) targeting communities experiencing disproportionately high coronavirus disease 2019 (COVID-19) rates. METHODS: We conducted a retrospective, observational study among patients in a large health system in the Southeastern US. Descriptive statistics and multinomial logistic regression analyses were employed to evaluate associations between patient characteristics and health care setting choice for SARS-CoV-2 testing, defined as: (1) outpatient (OP) care; (2) emergency department (ED); (3) urgent care (UC); and (4) MTUs. Patient characteristics included race/ethnicity, insurance, and the existence of an established relationship with the health care system. RESULTS: Our analytic sample included 105,386 adult patients tested for SARS-CoV-2. Overall, 55% of patients sought care at OP, 24% at ED, 12% at UC, and 9% at MTU. The sample was 58% White, 24% Black, 11% Hispanic, and 8% other race/ethnicity. Black patients had a higher likelihood of getting tested through the ED compared with White patients. Hispanic patients had the highest likelihood of testing at MTUs. Patients without a primary care provider had a higher relative risk of being tested through the ED and MTUs versus OP. CONCLUSIONS: Disparities by race/ethnicity were present in health care setting choice for SARS-CoV-2 testing. Health care systems may consider implementing mobile care delivery models to reach vulnerable populations. Our findings support the need for systemic change to increase primary care and health care access beyond short-term pandemic solutions.

Realizing a learning health system through process, rigor and culture change.

While many healthcare organizations strive to achieve the patient care benefits of being a learning health system (LHS), myriad challenges stand in the way of successful implementation. The reality of creating a true LHS requires top-to-bottom commitment to culture change with the necessary vision, leadership, and investment. The Center for Outcomes Research and Evaluation (CORE) is a multidisciplinary research unit embedded within a large, vertically integrated healthcare system in the southeastern United States. We used a two-pronged approach to: a) methodically recruit a team of experts, while generating early wins that demonstrated real success; and b) build relationships and buy-in across organizational leadership. Building out a team with diverse expertise created the ability to deploy pragmatic, data-driven research designs that fit seamlessly into real-world care delivery, resulting in agile study execution that aligns with health system timelines. Case study examples from hospital readmissions and antibiotic stewardship illustrate how our LHS operationalizes practice-informed research and research-informed practice. Lessons from this experience can serve as a blueprint for other healthcare systems or networks seeking to expand the promise of the LHS framework to improve health for patients and communities.

Racial Disparities in Prostate Specific Antigen Screening and Referral to Urology in a Large, Integrated Health Care System: A Retrospective Cohort Study.

PURPOSE: Contemporary trends and racial disparities in prostate cancer screening and referral to urology for prostate cancer risk are not well characterized, despite consensus that Black men are at higher risk for poor prostate cancer outcomes. The objective of this study was to characterize current racial disparities in prostate cancer screening and referral from primary care to urology for prostate cancer concern within our large, integrated health care system. MATERIALS AND METHODS: This retrospective cohort study used data from Atrium Health's enterprise data warehouse, which includes patient information from more than 900 care locations across North Carolina, South Carolina and Georgia. We included all men seen in the ambulatory or outpatient setting between 2014 and 2019 who were ≥40 years old. Clinical and demographic data were collected for all men, including age and race. Racial outcomes were reported for all groups with >2% representation in the population. Between-group comparisons were determined using chi-squared analysis, Wilcoxon rank sum testing and multivariable logistic regression, with significance defined as p <0.05. RESULTS: We observed a significant decrease in prostate specific antigen testing across all age and racial groups in a cohort of 606,985 men at Atrium Health, including 87,189 Black men, with an overall relative decline of 56%. As compared to White men, Black men were more likely to undergo prostate specific antigen testing (adjusted OR 1.24, 95% CI 1.22-1.26) and be referred to urology for prostate cancer (adjusted OR 1.94, 95% CI 1.75-2.16). CONCLUSIONS: There was a continued significant decline in prostate cancer screening between 2014 and 2019. Despite having modestly elevated odds of being screened for prostate cancer compared to White men, Black men are relatively underscreened when considering that those who undergo prostate specific antigen screening are more likely to be referred by primary care to urology for additional prostate cancer diagnostic evaluation.

Patient and Caregiver Outcomes and Experiences With Team-Based Memory Care: A Mixed Methods Study.

Patients with dementia and their caregivers need ongoing educational and psychosocial support to manage their complex diagnosis. This mixed methods study evaluated the impact of a memory clinic with an embedded dementia navigator on the experiences and health outcomes of patients with dementia and their caregivers. At the 12-month follow-up, patients receiving memory clinic services (n = 238) had higher emergency department visits than a matched cohort with dementia (n = 938), although hospitalizations did not differ. Patient quality of life and caregiver burden scores also did not differ between baseline and 12-months. Interviews revealed that caregivers (n = 12) valued the educational and social support components of the memory clinic and perceived that the clinic had a positive impact on their experiences. Findings suggest that this embedded navigator model is useful for addressing caregiver needs and may have potential to stem increases in caregiver burden and patient quality of life that occur with disease progression.

Depiction of Breastfeeding in Newspapers in the United States: 2007-2016.

Introduction: Depictions of infant feeding practices in the media influence public attitudes toward breastfeeding and breastfeeding behaviors. Understanding how breastfeeding is represented in the media can provide insights into breastfeeding experiences and outcomes. This study describes trends in breastfeeding portrayals in the United States newsprint media between 2007 and 2016. Methods: We conducted a retrospective content analysis of 452 newspaper articles identified from the Nexis Uni database. Articles were coded for tone toward breastfeeding (supporting, neutral, or opposing), message frame, and region (Midwest, South, West, Northeast). We frequency weighted articles by publication circulation to account for differences in readership volume. Results: Findings indicate that breastfeeding has been positively portrayed and increasingly discussed. Among the four regions, the South had the most supportive tones, while the Midwest had the most opposing tones. The topics of Health Benefits and Breastfeeding Support and Resources received the most coverage. Positive portrayals surrounding Workplace/University Issues are increasing, while negative portrayals surrounding Indecent Exposure are decreasing. Conclusion: Positive portrayals of breastfeeding in newspapers may signify increased support for breastfeeding as a normal practice. Future research is needed to better understand the direct and indirect impact of newsprint messages on breastfeeding in the United States.