Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial.

BACKGROUND: Human hookworm is a cause of enormous global morbidity. Current treatments have insufficient efficacy and their extensive and indiscriminate distribution could also result in drug resistance. Therefore, we tested the efficacy and safety of emodepside, a strong anthelmintic candidate that is currently undergoing clinical development for onchocerciasis and soil-transmitted helminth infections. METHODS: We conducted a double-blind, superiority, phase 2b, randomised controlled clinical trial comparing emodepside and albendazole. Participants in the emodepside group received six 5 mg tablets of emodepside (totalling 30 mg) and one placebo; participants in the albendazole group received one 400 mg tablet of albendazole and six placebos. Participants were recruited from four endemic villages and three secondary schools in Pemba Island, Tanzania. Participants aged 12-60 years were eligible for treatment if they were positive for hookworm infection, and they had 48 or more eggs per gram from four Kato-Katz thick smears and at least two slides had more than one hookworm egg present. Participants' treatment allocation was stratified by infection intensity and efficacy was measured by cure rate: participants who were hookworm positive and became hookworm negative after treatment. Adverse events were reported at 3 h, 24 h, 48 h, and 14-21 days post-treatment. The trial is registered at ClinicalTrials.gov, NCT05538767. FINDINGS: From Sept 15 to Nov 8, 2022, and from Feb 15 to March 15, 2023, 1609 individuals were screened for hookworm. Of these, 293 individuals were treated: 147 with albendazole and 146 with emodepside. Emodepside demonstrated superiority, with an observed cure rate against hookworm of 96·6%, which was significantly higher compared with albendazole (cure rate 81·2%, odds ratio 0·14, 95% CI 0·04-0·35; p=0·0001). The most common adverse event in the emodepside treatment group was vision blur at 3 h after treatment (57 [39%] of 146). Other common adverse events were vision blur at 24 h after treatment (55 [38%]), and headache and dizziness at 3 h after treatment (55 [38%] for headache and 43 [30%] for dizziness). In the emodepside treatment group, 298 (93%) of the 319 adverse events were mild. The most commonly reported adverse events in the albendazole treatment group were headache and dizziness at 3 h after treatment (27 [18%] of 147 for headache and 14 [10%] for dizziness). No serious adverse events were reported. INTERPRETATION: This phase 2b clinical trial confirms the high efficacy of emodepside against hookworm infections, solidifying emodepside as a promising anthelmintic candidate. However, although the observed safety events were generally mild in severity, considerations must be made to balance the strong efficacy outcomes with the increased frequency of adverse events compared with albendazole. FUNDING: European Research Council.

Short-Term Out-of-Pocket and Total Costs of Care After Ablation, Resection, or Transplant for Early-Stage Hepatocellular Carcinoma: A National SEER-Medicare Cost Comparison.

BACKGROUND. Differences in survival and morbidity among treatment options (ablation, surgical resection, and transplant) for early-stage hepatocellular carcinoma (HCC) have been well studied. Additional understanding of the costs of such care would help to identify drivers of high costs and potential barriers to care delivery. OBJECTIVE. The purpose of this article was to quantify total and patient out-of-pocket costs for ablation, surgical resection, and transplant in the management of early-stage HCC and to identify factors predictive of these costs. METHODS. This retrospective U.S. population-based study used the SEER-Medicare linked dataset to identify a sample of 1067 Medicare beneficiaries (mean age, 73 years; 674 men, 393 women) diagnosed with early-stage HCC (size ≤ 5 cm) treated with ablation (n = 623), resection (n = 201), or transplant (n = 243) between January 2009 and December 2016. Total costs and patient out-of-pocket costs for the index procedure as well as for any care within 30 and 90 days after the procedure were identified and stratified by treatment modality. Additional comparisons were performed among propensity score-matched subgroups of patients treated by ablation or resection (each n = 172). Multivariable linear regression models were used to identify factors predictive of total costs and out-of-pocket costs for index procedures as well as for 30- and 90-day post-procedure periods. RESULTS. For ablation, resection, and transplant, median index-procedure total cost was US$6689, US$25,614, and US$66,034; index-procedure out-of-pocket cost was US$1235, US$1650, and US$1317; 30-day total cost was US$9456, US$29,754, and US$69,856; 30-day out-of-pocket cost was US$1646, US$2208, and US$3198; 90-day total cost was US$14,572, US$34,984, and US$88,103; and 90-day out-of-pocket cost was US$2138, US$2462, and US$3876, respectively (all p < .001). In propensity score-matched subgroups, ablation and resection had median index-procedure, 30-day, and 90-day total costs of US$6690 and US$25,716, US$9995 and US$30,365, and US$15,851 and US$34,455, respectively. In multivariable analysis adjusting for socioeconomic factors, comorbidities, and liver-disease prognostic indicators, surgical treatment (resection or transplant) was predictive of significantly greater costs compared with ablation at all time points. CONCLUSION. Total and out-of-pocket costs for index procedures as well as for 30-day and 90-day postprocedure periods were lowest for ablation, followed by resection and then transplant. CLINICAL IMPACT. This comprehensive cost analysis could help inform future cost-effectiveness analyses.

Beyond Survival: Adverse Events and Care Delivery Outcomes after Early Liver Cancer Treatment in a Nationally Representative Cohort.

PURPOSE: To compare secondary outcomes after ablation (AB), surgical resection (SR), and liver transplant (LT) for small hepatocellular carcinomas (HCCs), including resource utilization and adverse event (AE) rates. MATERIALS AND METHODS: Using Surveillance, Epidemiology, and End Results Program (SEER)-Medicare, HCCs <5 cm that were treated with AB, SR, or LT in 2009-2016 (n = 1,067) were identified using Healthcare Common Procedure Coding System codes through Medicare claims. Index procedure length of stay, need for intensive care unit (ICU) level care, readmission rates, and AE rates at 30 and 90 days were compared using chi-square tests or Fisher exact tests. Examined AEs included hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, liver failure, and anesthesia-related AEs, identified by International Classification of Diseases, Ninth/10th Revision, codes. RESULTS: The median length of stay for initial treatment was 1 day, 6 days, and 7 days for AB, SR, and LT, respectively (P < .001). During initial hospital stay, 5.0%, 40.8%, and 63.4% of AB, SR, and LT cohorts, respectively, received ICU-level care (P < .001). By 30 and 90 days, there were significant differences among the AB, SR, and LT cohorts in the rate of postprocedural hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, and anesthesia-related AEs (P < .05). By 90 days, the readmission rates after AB, SR, and LT were 18.6%, 28.2%, and 40.6% (P < .001), respectively. CONCLUSIONS: AB results in significantly less healthcare utilization during the initial 90 days after procedure compared with that after SR and LT due to shorter length of stay, lower intensity care, fewer readmissions, and fewer AEs.

Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium.

BACKGROUND: Elicitation of patients' preferences is an integral part of shared decision-making, the recommended approach for prostate cancer decision-making. Existing decision aids for this population often do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patients' treatment preferences and is designed for a low health literate population. OBJECTIVE: This study used a randomized controlled trial to evaluate whether Healium, designed to target preference elicitation, is as efficacious as Healing Choices, a comprehensive education and decision tool, in improving outcomes for decision-making and emotional quality of life. METHODS: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, a decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6 weeks, and 3 months post baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, and preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy. RESULTS: A total of 327 individuals consented to participate in the study (171 were randomized to the Healium intervention arm and 156 were randomized to Healing Choices). The majority of the sample was non-Hispanic (272/282, 96%), White (239/314, 76%), married (251/320, 78.4%), and was on average 62.4 (SD 6.9) years old. Within both arms, there was a significant decrease in decisional conflict from baseline to 6 weeks postbaseline (Healium, P≤.001; Healing Choices, P≤.001), and a significant increase in satisfaction with one's decision from 6 weeks to 3 months (Healium, P=.04; Healing Choices, P=.01). Within both arms, anxiety/tension (Healium, P=.23; Healing Choices, P=.27) and depression (Healium, P=.001; Healing Choices, P≤.001) decreased from baseline to 6 weeks, but only in the case of depression was the decrease statistically significant. CONCLUSIONS: Healium, our brief decision aid focusing on treatment preference elicitation, is as successful in reducing decisional conflict as our previously tested comprehensive decision aid, Healing Choices, and has the added benefit of brevity, making it the ideal tool for integration into the physician consultation and electronic medical record. TRIAL REGISTRATION: ClinicalTrials.gov NCT05800483; https://clinicaltrials.gov/study/NCT05800483.

The Effects of Osteoarthritis on Depressive Symptomatology Among Older U.S. Military Veterans.

Osteoarthritis (OA) is a leading cause of disability among older adults. By 2050, approximately 60 million will suffer from arthritis adding up to a total societal cost of $65 billion. Chronic illnesses resulting in pain, and functional decline have been associated with depression in previous studies.A causal model was developed and tested using structural equation modeling that examined depression scores of 503 older (age 50-85), male Veterans with moderate to severe symptomatic OA of the knee\hip.The results of the structural equation modeling produced a final model of depressive symptomatology that fit the data well (Chi square = 12.23, DF = 11, p = .346; TLI = .99; CFI = 1.00; RMSEA = .02).The findings indicate the central role that OA severity (pain, stiffness, and functional difficulties) plays in the mental health of older Veterans in terms of the level of reported depressive symptoms.

Immunostimulant potential of Moringa Oleifera leaves alcoholic extract versus Oregano Essential Oil (OEO) against cyclophosphamide-induced immunosuppression in broilers chicks.

The current study was conducted to evaluate the immunoenhancement effect of Moringa oleifera leaves alcoholic extract (MOLE) versus Oregano essential oil (OEO) against cyclophosphamide induced immunosuppression in broilers chicks. A total of a three hundred one-day-old chicks were assigned randomly into three main dietary groups, control, MOLE, and OEO for 14 days. After 14 days the three main experimental groups were subdivided into six groups, control, cyclophosphamide, MOLE, MOLE and Cyclophosphamide, OEO, and OEO and cyclophosphamide. Each group of these six groups was subdivided into three subgroups. Supplementation of broiler chicks with MOLE and OEO for 14 days significantly increased body weight compared to the control group. However, injection of broiler chicks with cyclophosphamide significantly induced body weight loss, impaired immunological response represented by decreasing total leukocytic count, differential leukocytic count, phagocytic activity, phagocytic index, and hemagglutinin inhibition titer for New Castle disease virus, lymphoid organs depletion, and increased the mortality rate. In contrast, supplementation of cyclophosphamide treated chicks with MOLE and OEO significantly reduced cyclophosphamide induced body weight loss and impaired immunological responses, as it showed significant increase in body weight, total leukocytic count, differential leukocytic count, phagocytic activity, phagocytic index, and hemagglutinin inhibition titer for New Castle disease virus, lymphoid organs proliferation, and reduced the mortality rate. This study indicated that MOLE and OEO supplementation ameliorated cyclophosphamide induced body weight loss and impaired immunological responses.

Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial.

BACKGROUND: Millions of young adolescents in low- and middle-income countries (LMICs) affected by humanitarian crises experience elevated rates of poor mental health. There is a need for scalable programs that can improve the mental health of young adolescents. This study evaluated the effectiveness of a nonspecialist delivered group-based intervention (Early Adolescent Skills for Emotions (EASE)) to improve young adolescents' mental health. METHODS AND FINDINGS: In this single-blind, parallel, controlled trial, Syrian refugees aged 10 to 14 years in Jordan were identified through screening of psychological distress as defined by scores ≥15 on the Paediatric Symptom Scale. Participants were randomised to either EASE or enhanced usual care (EUC) involving referral to local psychosocial services (on a 1:1.6 ratio). Participants were aware of treatment allocation but assessors were blinded. Primary outcomes were scores on the Paediatric Symptom Checklist (PSC; internalising, externalising, and attentional difficulty scales) assessed at week 0, 9 weeks, and 3 months after treatment (primary outcome time point). It was hypothesised that EASE would result in greater reductions on internalising symptoms than EUC. Secondary outcomes were depression, posttraumatic stress, well-being, functioning, school belongingness, and caregivers' parenting and mental health. Between June 2019 and January 2020, 1,842 young adolescent refugees were screened for eligibility on the basis of psychological distress. There were 520 adolescents (28.2%) who screened positive, of whom 471 (90.6%) agreed to enter the trial. Overall, 185 were assigned to EASE and 286 to EUC, and 169 and 254 were retained at 3 months for EASE and EUC, respectively. Intent-to-treat analyses indicated that at 3 months, EASE resulted in greater reduction on the PSC-internalising scale than EUC (estimated mean difference 0.69, 95% CI 0.19 to 1.19; p = 0.007; effect size, 0.38) but there were no differences for PSC-externalising (estimated mean difference 0.24, 95% CI -0.43 to 0.91; p = 0.49; effect size, -0.10), PSC-attentional problem (estimated mean difference -0.01, 95% CI -0.51 to 0.54; p = 0.97; effect size, -0.01) scores, or on depression, posttraumatic stress, well-being, functioning, or school belongingness. Relative to EUC, caregivers in EASE had less psychological distress (estimated mean difference 1.95, 95% CI 0.71 to 3.19; p = 0.002) and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < 0.001). Secondary analyses that (a) focused on adolescents with probable internalising disorders; (b) completed the 3-month assessment; and (c) controlled for trauma exposure did not alter the primary results. Mediation analysis indicated that for caregivers in the EASE condition, reduction in inconsistent disciplinary parenting was associated with reduced attentional (ß = 0.11, SE 0.07; 95% CI 0.003, 0.274) and internalising (ß = 0.11, SE 0.07; 95% CI 0.003, 0.274) problems in their children. No adverse events were attributable to the intervention. A limitation was that EUC was not matched to EASE in terms of facilitator attention or group involvement. CONCLUSIONS: EASE led to reduced internalising problems in young refugee adolescents and was associated with reduced distress and less inconsistent disciplinary parenting in caregivers. This intervention has the potential as a scalable intervention to mitigate young adolescents' emotional difficulties in LMIC. TRIAL REGISTRATION: Prospectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619000341123.

Association Between Patient Diversity in Hospitals and Racial/Ethnic Differences in Patient Length of Stay.

BACKGROUND: Hospitals serving a disproportionate share of racial/ethnic minorities have been shown to have poorer quality outcomes. It is unknown whether efficiencies in inpatient care, measured by length of stay (LOS), differ based on the proportion patients served by a hospital who are minorities. OBJECTIVE: To examine the association between the racial/ethnic diversity of a hospital's patients and disparities in LOS. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: One million five hundred forty-six thousand nine hundred fifty-five admissions using the 2017 New York State Inpatient Database from the Healthcare Cost and Utilization Project. MAIN MEASURE: Differences in mean adjusted LOS (ALOS) between White and Black, Hispanic, and Other (Asian, Pacific Islander, Native American, and Other) admissions by Racial/Ethnic Diversity Index (proportion of non-White patients admitted to total patients admitted to that same hospital) in quintiles (Q1 to Q5), stratified by discharge destination. Mean LOS was adjusted for patient demographic, clinical, and admission characteristics and for individual intercepts for each hospital. KEY RESULTS: In both unadjusted and adjusted analysis, Black-White and Other-White mean LOS differences were smallest in the most diverse hospitals (Black-White: unadjusted, -0.07 days [-0.1 to -0.04], and adjusted, 0.16 days [95% CI: 0.16 to 0.16]; Other-White: unadjusted, -0.74 days [95% CI: -0.77 to -0.71], and adjusted, 0.01 days [95% CI: 0.01 to 0.02]). For Hispanic patients, in unadjusted analysis, the mean LOS difference was greatest in the most diverse hospitals (-0.92 days, 95% CI: -0.95 to -0.89) but after adjustment, this was no longer the case. Similar patterns across all racial/ethnic groups were observed after analyses were stratified by discharge destination. CONCLUSION: Mean adjusted LOS differences between White and Black patients, and White and patients of Other race was smallest in most diverse hospitals, but not differences between Hispanic and White patients. These findings may reflect specific structural factors which affect racial/ethnic differences in patient LOS.

Capitated versus fee-for-service reimbursement and quality of care for chronic disease: a US cross-sectional analysis.

BACKGROUND: Upcoming alternative payment models Primary Care First (PCF) and Kidney Care Choices (KCC) incorporate capitated payments for chronic disease management. Prior research on the effect of capitated payments on chronic disease management has shown mixed results. We assessed the patient, physician, and practice characteristics of practices with capitation as the majority of revenue, and evaluated the association of capitated reimbursement with quality of chronic disease care. METHODS: We performed a cross-sectional analysis of visits in the United States' National Ambulatory Medical Care Survey (NAMCS) for patients with hypertension, diabetes, or chronic kidney disease (CKD). Our predictor was practice reimbursement type, classified as 1) majority capitation, 2) majority FFS, or 3) other reimbursement mix. Outcomes were quality indicators of hypertension control, diabetes control, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (ACEi/ARB) use, and statin use. RESULTS: About 9% of visits were to practices with majority capitation revenue. Capitated practices, compared with FFS and other practices, had lower visit frequency (3.7 vs. 5.2 vs. 5.2, p = 0.006), were more likely to be located in the West Census Region (55% vs. 18% vs. 17%, p < 0.001), less likely to be solo practice (21% vs. 37% vs. 35%, p = 0.005), more likely to be owned by an insurance company, health plan or HMO (24% vs. 13% vs. 13%, p = 0.033), and more likely to have private insurance (43% vs. 25% vs. 19%, p = 0.004) and managed care payments (69% vs. 23% vs. 26%, p < 0.001) as the majority of revenue. The prevalence of controlled hypertension, controlled diabetes, ACEi/ARB use, and statin use was suboptimal across practice reimbursement types. Capitated reimbursement was not associated with differences in hypertension, diabetes, or CKD quality indicators, in multivariable models adjusting for patient, physician, and practice characteristics. CONCLUSIONS: Practices with majority capitation revenue differed substantially from FFS and other practices in patient, physician, and practice characteristics, but were not associated with consistent quality differences. Our findings establish baseline estimates of chronic disease quality of care performance by practice reimbursement composition, informing chronic disease care delivery within upcoming payment models.

Are Income-based Differences in TKA Use and Outcomes Reduced in a Single-payer System? A Large-database Comparison of the United States and Canada.

BACKGROUND: Income-based differences in the use of and outcomes in TKA have been studied; however, it is not known if different healthcare systems affect this relationship. Although Canada's single-payer healthcare system is assumed to attenuate the wealth-based differences in TKA use observed in the United States, empirical cross-border comparisons are lacking. QUESTIONS/PURPOSES: (1) Does TKA use differ between Pennsylvania, USA, and Ontario, Canada? (2) Are income-based disparities in TKA use larger in Pennsylvania or Ontario? (3) Are TKA outcomes (90-day mortality, 90-day readmission, and 1-year revision rates) different between Pennsylvania and Ontario? (4) Are income-based disparities in TKA outcomes larger in Pennsylvania or Ontario? METHODS: We identified all patients hospitalized for primary TKA in this cross-border retrospective analysis, using administrative data for 2012 to 2018, and we found a total of 161,244 primary TKAs in Ontario and 208,016 TKAs in Pennsylvania. We used data from the Pennsylvania Health Care Cost Containment Council, Harrisburg, PA, USA, and the ICES (formally the Institute for Clinical Evaluative Sciences), Toronto, Ontario, Canada. We linked patient-level data to the respective census data to determine community-level income using ZIP Code or postal code of residence and stratified patients into neighborhood income quintiles. We compared TKA use (age and gender, standardized per 10,000 population per year) for patients residing in the highest-income versus the lowest-income quintile neighborhoods. Similarly secondary outcomes 90-day mortality, 90-day readmission, and 1-year revision rates were compared between the two regions and analyzed by income groups. RESULTS: TKA use was higher in Pennsylvania than in Ontario overall and for all income quintiles (lowest income quartile: 31 versus 18 procedures per 10,000 population per year; p < 0.001; highest income quartile: 38 versus 23 procedures per 10,000 population per year; p < 0.001). The relative difference in use between the highest-income and lowest-income quintile was larger in Ontario (28% higher) than in Pennsylvania (23% higher); p < 0.001. Patients receiving TKA in Pennsylvania were more likely to be readmitted within 90 days and were more likely to undergo revision within the first year than patients in Ontario, but there was no difference in mortality at 1 year. When comparing income groups, there were no differences between the countries in 90-day mortality, readmission, or 1-year revision rates (p > 0.05). CONCLUSION: These results suggest that universal health insurance through a single-payer may not reduce the income-based differences in TKA access that are known to exist in the United States. Future studies are needed determine if our results are consistent across other geographic regions and other surgical procedures. LEVEL OF EVIDENCE: Level III, therapeutic study.

Racial and Neighborhood-Level Disparities in COVID-19 Incidence among Patients on Hemodialysis in New York City.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has disproportionately affected socially disadvantaged populations. Whether disparities in COVID-19 incidence related to race/ethnicity and socioeconomic factors exist in the hemodialysis population is unknown. METHODS: Our study involved patients receiving in-center hemodialysis in New York City. We used a validated index of neighborhood social vulnerability, the Social Vulnerability Index (SVI), which comprises 15 census tract-level indicators organized into four themes: socioeconomic status, household composition and disability, minority status and language, and housing type and transportation. We examined the association of race/ethnicity and the SVI with symptomatic COVID-19 between March 1, 2020 and August 3, 2020. COVID-19 cases were ascertained using PCR testing. We performed multivariable logistic regression to adjust for demographics, individual-level social factors, dialysis-related medical history, and dialysis facility factors. RESULTS: Of the 1378 patients on hemodialysis in the study, 247 (17.9%) developed symptomatic COVID-19. In adjusted analyses, non-Hispanic Black and Hispanic patients had significantly increased odds of COVID-19 compared with non-Hispanic White patients. Census tract-level overall SVI, modeled continuously or in quintiles, was not associated with COVID-19 in unadjusted or adjusted analyses. Among non-Hispanic White patients, the socioeconomic status SVI theme, the minority status and language SVI theme, and housing crowding were significantly associated with COVID-19 in unadjusted analyses. CONCLUSIONS: Among patients on hemodialysis in New York City, there were substantial racial/ethnic disparities in COVID-19 incidence not explained by neighborhood-level social vulnerability. Neighborhood-level socioeconomic status, minority status and language, and housing crowding were positively associated with acquiring COVID-19 among non-Hispanic Whites. Our findings suggest that socially vulnerable patients on dialysis face disparate COVID-19-related exposures, requiring targeted risk-mitigation strategies.

Bilateral vs Unilateral Total Knee Arthroplasty: Racial Variation in Utilization and In-Hospital Major Complication Rates.

BACKGROUND: We sought to examine bilateral total knee arthroplasty (BTKA) vs unilateral TKA (UTKA) utilization and in-hospital complications comparing African Americans (AAs) and Whites. METHODS: In this retrospective analysis of patients ≥50 years who underwent elective primary TKA, the (2007-2016) database of the Healthcare Cost and Utilization Project (National Inpatient Sample) was used. We computed differences in temporal trends in utilization and major in-hospital complication rates of BTKA vs UTKA comparing AAs and Whites. We performed multivariable logistic regression models to assess racial differences in trends adjusting for individual-, hospital- and community-level variables. Discharge weights were used to enable nationwide estimates. We used multiple imputation procedures to impute values for 12% missing race information. RESULTS: An estimated 276,194 BTKA and 5,528,429 UTKA were performed in the US. The proportion of BTKA among all TKAs declined, and AAs were significantly less likely to undergo BTKA compared to Whites throughout the study period (trend P = .01). In-hospital complication rates for UTKA were higher in AAs compared to Whites throughout the study period (trend P < .0001). However, for BTKA, the in-hospital complication rates varied between Whites and AAs throughout the study period (trend P = .09). CONCLUSION: In this nationwide sample of patients who underwent total knee arthroplasty from 2007 to 2016, the utilization of BTKA was higher in Whites compared to AAs. On the other hand, while AAs have consistently higher in-hospital complication rates in UTKA over the time period, this pattern was not consistent for BTKA.

Accuracy of Hospital Discharge Codes in Medicare Claims for Knee and Hip Replacement Patients.

BACKGROUND: Despite the importance of the hospital discharge destination field ("discharge code" hereafter) for research and payment reform, its accuracy is not well established. OBJECTIVES: The aim of this study was to examine the accuracy of discharge codes in Medicare claims. DATA SOURCES: 2012-2015 Medicare claims of knee and hip replacement patients. RESEARCH DESIGN: We identified patients' discharge location in claims and compared it with the discharge code. We also used a mixed-effects logistic regression to examine the association of patient and hospital characteristics with discharge code accuracy. RESULTS: Approximately 9% of discharge codes were inaccurate. Long-term care hospital discharge codes had the lowest accuracy rate (41%), followed by acute care transfers (72%), inpatient rehabilitation facility (80%), and home discharges (83%). Most misclassifications occurred within 2 broad groups of postacute care settings: home-based and institutional care. The odds of inaccurate discharge codes were higher for Medicaid-enrolled patients and safety-net and low-volume hospitals. CONCLUSIONS: Inaccurate hospital discharge coding may have introduced bias in studies relying on these codes (eg, evaluations of Medicare bundled payment models). Inaccuracy was more common among Medicaid-enrolled patients and safety-net and low-volume hospitals, suggesting more potential bias in existing study findings pertaining to these patients and hospitals.

Pain Catastrophizing and Arthritis Self-Efficacy as Mediators of Sleep Disturbance and Osteoarthritis Symptom Severity.

OBJECTIVE: Sleep and pain-related experiences are consistently associated, but the pathways linking these experiences are not well understood. We evaluated whether pain catastrophizing and arthritis self-efficacy mediate the association between sleep disturbance and osteoarthritis (OA) symptom severity in patients with knee OA. METHODS: We analyzed cross-sectional baseline data collected from Veterans Affairs (VA) patients enrolled in a clinical trial examining the effectiveness of a positive psychology intervention in managing pain from knee OA. Participants indicated how often in the past two weeks they were bothered by trouble falling asleep, staying asleep, or sleeping too much. We used validated scales to assess the primary outcome (OA symptom severity) and potential mediators (arthritis self-efficacy and pain catastrophizing). To test the proposed mediation model, we used parallel multiple mediation analyses with bootstrapping, controlling for sociodemographic and clinical characteristics with bivariate associations with OA symptom severity. RESULTS: The sample included 517 patients (Mage = 64 years, 72.9% male, 52.2% African American). On average, participants reported experiencing sleep disturbance at least several days in the past two weeks (M = 1.41, SD = 1.18) and reported moderate OA symptom severity (M = 48.22, SD = 16.36). More frequent sleep disturbance was associated with higher OA symptom severity directly (b = 3.08, P <0.001) and indirectly, through higher pain catastrophizing (b = 0.60, 95% confidence interval [CI] = 0.20 to 1.11) and lower arthritis self-efficacy (b = 0.84, 95% CI = 0.42 to 1.42). CONCLUSIONS: Pain catastrophizing and arthritis self-efficacy partially mediated the association between sleep disturbance and OA symptom severity. Behavioral interventions that address pain catastrophizing and/or self-efficacy may buffer the association between sleep disturbance and OA symptom severity.

Musculoskeletal Urgent Care Centers in Connecticut Restrict Patients with Medicaid Insurance Based on Policy and Location.

BACKGROUND: Musculoskeletal urgent care centers are a new development in the urgent care landscape. Anecdotally, these centers are known to screen patients based on their insurance status, denying care to those with Medicaid insurance. It is important to know whether the practice of denying musculoskeletal urgent care to patients with Medicaid insurance is widespread because this policy could exacerbate existing musculoskeletal healthcare disparities. QUESTIONS/PURPOSES: (1) Do musculoskeletal urgent care centers in Connecticut provide access for patients with Medicaid insurance? (2) Do musculoskeletal urgent care centers have the same Medicaid policies as the entities that own them? (3) Are musculoskeletal urgent care centers more likely to be located in affluent neighborhoods? METHODS: An online search was conducted to create a list of musculoskeletal urgent care centers in Connecticut. Each center was interviewed over the telephone using a standardized list of questions to determine ownership and Medicaid policy. Next, the entities that owned these musculoskeletal centers were called and asked the same questions about their Medicaid policy. Medicaid policy was compared between musculoskeletal urgent care centers and the practices that owned them. The median household income for each ZIP code containing a musculoskeletal urgent care center was compared with the median household income for Connecticut. The median household income was also compared between the ZIP codes of musculoskeletal urgent care centers that accepted or denied patients with Medicaid insurance. RESULTS: Of the 29 musculoskeletal urgent care centers in Connecticut, only four (13%) accepted patients regardless of their insurance type, 19 (66%) did not accept any form of Medicaid insurance, and six (21%) required that certain requisites and stipulations be met for patients with Medicaid insurance to receive access, such as only permitting a patient for an initial visit and then referring them to a local hospital system for all future encounters, or only permitting patients with Medicaid insurance who lived in the same town as the clinic. All 29 musculoskeletal urgent care centers were owned by private practice groups and nine of 14 of these groups had the same policy towards patients with Medicaid insurance as their respective musculoskeletal urgent care centers. All 29 musculoskeletal urgent care centers were co-located in a private practice clinic office. Musculoskeletal urgent care centers were located in areas with greater median household incomes than the Connecticut state median (95% CI, USD 112,322 to USD 84,613 versus the state median of USD 73,781; p = 0.001). CONCLUSIONS: Most musculoskeletal urgent care centers in Connecticut do not accept patients with Medicaid insurance and have similar or stricter Medicaid policies as the groups that own them. Additionally, musculoskeletal urgent care centers were located in affluent neighborhoods. These findings are important because they suggest private practices are using musculoskeletal urgent care centers to capture patients with more favorable insurance. This is likely a result of the relatively low Medicaid reimbursement rates in Connecticut and reflects a need for an increase in either reimbursement or incentives to treat patients with Medicaid insurance. The financial impact of capturing well-insured patients from public and academic medical centers and directing Medicaid patients to these urgent care centers is not known. Additionally, although most of these 29 musculoskeletal urgent care clinics denied care to patients with Medicaid, the specific healthcare disparities caused by decreased access to care must be further studied.

Trends in Maternal and Fetal Outcomes Among Pregnant Women With Systemic Lupus Erythematosus in the United States: A Cross-sectional Analysis.

Background: Although pregnancy in systemic lupus erythematosus (SLE) carries a high risk for mother and fetus, outcomes may be improving. Objective: To assess nationwide trends and disparities in maternal and fetal complications among pregnant women with SLE. Design: Retrospective cohort study. Setting: United States, 1998 to 2015. Patients: Adult pregnant women with and without SLE who had hospitalizations recorded in the National Inpatient Sample (NIS) database. Measurements: Outcome measures were in-hospital maternal mortality, fetal mortality, preeclampsia or eclampsia, caesarean sections, non-delivery-related admissions, and length of stay. To assess whether trends in outcomes over time differed between patients with SLE and those without SLE, logistic or linear regression with an interaction term between year and SLE (yes or no) was used. Nationwide population estimates incorporating sampling and poststratification weights were obtained. Results: An estimated 93 820 pregnant women with SLE and 78 045 054 without SLE were hospitalized in the United States from 1998 through 2015. Outcomes improved during those 18 years. In-hospital maternal deaths (per 100 000 admissions) declined among patients with as well as those without SLE (442 vs. 13 for 1998 to 2000 and <50 vs. 10 for 2013 to 2015), although the decrease was greater in women with SLE (difference in trends, P < 0.002). The percentage of patients with SLE in all pregnancy-related, as well as delivery-related, admissions increased significantly. Limitations: The sample for this analysis was identified by using diagnostic codes; detailed information on hospital-specific trends, SLE disease activity, and medications was not available. Race trends could not be analyzed. Given that NIS uses weighted estimates, the incidence of outcomes reported may not be exact. Conclusion: In this large study examining SLE and non-SLE pregnancies over 18 years, in-hospital maternal mortality and overall outcomes improved markedly, particularly among women with SLE. However, improvement is still needed, because SLE pregnancy risks remain high. Primary Funding Source: None.

Social determinants of health and survivorship in parotid cancer: An analysis of the National Cancer Database.

BACKGROUND: Given the rarity of parotid cancer, there is relatively few data published regarding outcomes. Utilizing the large sample population of the National Cancer Database (NCDB), we aim to examine the relationship between two key social determinants of health, demographics and socioeconomic status (SES), and parotid malignancy survival rates. METHODS: Our analytic sample consists of patients with a diagnosis of primary malignancy of the parotid gland between 2004 and 2012 in the NCDB. We used univariable and multivariable Cox proportional hazard models to evaluate the relationship between overall survival rate and two key social determinants of health: demographics and SES. RESULTS: 15,815 cases met inclusion criteria. Average age was 60.1 years and 8255 were male (52.2%). Median overall survival was 121 months with 5-year overall survival of 67.4%. Male sex and older age at diagnosis were associated with poorer overall survival (p < 0.0001). We found that Asian Americans compared to whites had better overall survival (HR 0.75; 95% CI [0.58-0.95]). Black patients had improved survival compared to whites on univariate (HR 0.71; 95% CI [0.64-0.79]); but not multivariate analysis. Hispanic ethnicity and higher education level were protective (HR 0.76 95% CI [0.63-0.91] and HR 0.84 95% CI [0.74-0.96], respectively). We found no significant survival association based on income level. CONCLUSION: In this national sample of patients with parotid malignancy, a rare form of cancer, we found a significant correlation between important social determinants of health and overall survival rate. Females, Asian-Americans, Hispanics, and patients with higher education level have better overall survival.

Hydroxychloroquine and Chloroquine in COVID-19: A Survey of Prescription Patterns Among Rheumatologists.

OBJECTIVE: With hydroxychloroquine (HCQ) and chloroquine (CQ) emerging as potential therapies for coronavirus disease 2019 (COVID-19), shortages have been reported. We aimed to understand how rheumatologists, one of the most common prescribers of HCQ/CQ, prescribed these medications to manage COVID-19 and to understand if their patients are affected by shortages. METHODS: Between April 8 and April 27, 2020, an online survey was distributed to a convenience sample of rheumatologists who practice medicine in a diverse range of settings globally, resulting in 506 responses. Adjusted Poisson regression models were calculated. RESULTS: Only 6% of respondents prescribed HCQ/CQ for COVID-19 prophylaxis, and only 12% for outpatient treatment of COVID-19. Compared to the United States, the likelihood of prescribing HCQ/CQ for prophylaxis was higher in India (adjusted risk ratio [aRR], 6.7; 95% confidence interval [CI], 2.7-16.8; p < 0.001). Further, compared to the United States and those with 1 to 5 years of experience, rheumatologists in Europe (aRR, 2.9; 95% CI, 1.6-5.3; p < 0.001) and those with 10+ years of experience (11-20 years: aRR, 2.5; 95% CI, 1.2-5.3; p = 0.015; 21+ years: aRR = 3.3; 95% CI, 1.4-7.4; p = 0.004) had a higher likelihood of prescribing HCQ/CQ for outpatient treatment. Of note, 71% of all rheumatologists reported that their patients were directly affected by HCQ/CQ shortages. CONCLUSION: The results suggest that only a small percentage of rheumatologists are prescribing HCQ/CQ for prophylaxis or outpatient treatment of COVID-19. Medication shortages experienced by large numbers of autoimmune disease patients are concerning and should play a role in decisions, especially given poor efficacy data for HCQ/CQ in COVID-19.

Advancing Health Services Research to Eliminate Health Care Disparities.

Findings from health services research highlight continuing health care disparities in the United States, especially in the areas of access to health care and quality of care. Although attention to health care disparities has increased, considerable knowledge gaps still exist. A better understanding of how cultural, behavioral, and health system factors converge and contribute to unequal access and differential care is needed. Research-informed approaches for reducing health care disparities that are feasible and capable of sustained implementation are needed to inform policymakers. More important, for health equity to be achieved, it is essential to create a health care system that provides access, removes barriers to care, and provides equally effective treatment to all persons living in the United States.