Home Health Care and Hospice Use Among Medicare Beneficiaries With and Without a Diagnosis of Dementia.

Background: Home health care is a core benefit of Medicare and Medicaid insurance programs and includes services to improve health, maintain health, or slow health decline. Objective: To examine the relationship between home health care use during the last three years of life and hospice use in the last six months of life among Medicare beneficiaries with and without dementia. Design: Nationally representative retrospective cohort study. Setting/Subjects: Medicare beneficiaries with at least three years of continuous enrollment who died in 2019 in the United States (n = 2,169,422). Measurements: The primary outcome was hospice use, and the secondary outcome was hospice duration. The independent variable was a composite of the presence and timing of home health care initiation during the last three years of life. Results: Home health care was used by 46.4% of Medicare beneficiaries and hospice care was used by 53.1% of beneficiaries, with 28.3% using both. Compared with beneficiaries who did not use home health care, those who started home health care before the last year of life (odds ratio [OR] = 1.57, 95% confidence interval [CI] = 1.56-1.58) or during the last year of life (OR = 1.75, 95% CI = 1.74-1.77) were more likely to use hospice. The effects were stronger in those without a diagnosis of dementia (OR = 1.92, 95% CI = 1.90-1.94) compared with those without a dementia diagnosis (OR = 1.34, 95% CI = 1.32-1.35) who started home health in the final year of life. Conclusions: Receiving home health care in the final years of life is associated with increased hospice use at the end-of-life in Medicare beneficiaries with and without a dementia diagnosis.

A Phase 1b Clinical Trial of Neoadjuvant Radio-immunotherapy for Esophageal Squamous Cell Cancer.

PURPOSE: Neoadjuvant chemoradiotherapy is the recommended treatment for patients with resectable esophageal cancer but is associated with a higher incidence of adverse effects. Given the efficacy of immunotherapy, we propose a chemotherapy-free regimen of neoadjuvant radio-immunotherapy (NRIT) to balance therapeutic efficacy and potential side effects or overtreatment. METHODS AND MATERIALS: In this phase 1b clinical trial, we assessed the safety and efficacy of NRIT in esophageal squamous cell cancer. The enrolled patients received 41.4 Gy of radiation and 4 cycles of 240 mg of toripalimab injection before surgery. The primary endpoint was treatment-related adverse events and the secondary endpoints were pathologic complete response and major pathologic response. Immunohistochemistry and multiplex immunofluorescence staining were used to evaluate the tumor microenvironment before and after neoadjuvant treatment. RESULTS: Of the 22 patients enrolled, 19 underwent R0 surgery. One patient discontinued neoadjuvant immune therapy due to experiencing a grade 3 treatment-related adverse event. Three patients did not undergo surgery due to tumor progression or side effects. Among the patients who underwent surgery, 3 patients experienced serious complications shortly after surgery. Upon pathologic evaluation, the pathologic complete response and major pathologic response rates were 47.4% and 68.4%, respectively. CONCLUSIONS: The NRIT regimen is safe and feasible for patients with esophageal squamous cell cancer.

Place of care in the last three years of life for Medicare beneficiaries.

BACKGROUND: Most older adults prefer aging in place; however, patients with advanced illness often need institutional care. Understanding place of care trajectory patterns may inform patient-centered care planning and health policy decisions. The purpose of this study was to characterize place of care trajectories during the last three years of life. METHODS: Linked administrative, claims, and assessment data were analyzed for a 10% random sample cohort of US Medicare beneficiaries who died in 2018, aged fifty or older, and continuously enrolled in Medicare during their last five years of life. A group-based trajectory modeling approach was used to classify beneficiaries based on the proportion of days of institutional care (hospital inpatient or skilled nursing facility) and skilled home care (home health care and home hospice) used in each quarter of the last three years of life. Associations between group membership and sociodemographic and clinical predictors were evaluated. RESULTS: The analytic cohort included 199,828 Medicare beneficiaries. Nine place of care trajectory groups were identified, which were categorized into three clusters: home, skilled home care, and institutional care. Over half (59%) of the beneficiaries were in the home cluster, spending their last three years mostly at home, with skilled home care and institutional care use concentrated in the final quarter of life. One-quarter (27%) of beneficiaries were in the skilled home care cluster, with heavy use of skilled home health care and home hospice; the remaining 14% were in the institutional cluster, with heavy use of nursing home and inpatient care. Factors associated with both the skilled home care and institutional care clusters were female sex, Black race, a diagnosis of dementia, and Medicaid insurance. Extended use of skilled home care was more prevalent in southern states, and extended institutional care was more prevalent in midwestern states. CONCLUSIONS: This study identified distinct patterns of place of care trajectories that varied in the timing and duration of institutional and skilled home care use during the last three years of life. Clinical, socioregional, and health policy factors influenced where patients received care. Our findings can help to inform personal and societal care planning.

Association of SGLT-2 Inhibitors With Treatment Satisfaction and Diabetes-Specific and General Health Status in Adults With Cardiovascular Disease and Type 2 Diabetes.

Background It is unknown if initiation of a sodium-glucose cotransporter-2 inhibitor (SGLT-2i) is associated with changes in patient-reported health status outside of clinical trials. Methods and Results Using a prospective observational study design, adults with type 2 diabetes and cardiovascular disease were recruited from 14 US hospitals between November 2019 and December 2021 if they were new users of noninsulin antidiabetic medications. The primary outcome was change in 6-month diabetes treatment satisfaction. Secondary outcomes included diabetes-related symptom distress, diabetes-specific quality of life, and general health status for all patients and based on cardiovascular disease type. Inverse probability of treatment weight using propensity score was performed to compare outcome changes based on medication use. Of 887 patients (SGLT-2i: n=242) included in the inverse probability of treatment weight analyses, there was no difference in changes in treatment satisfaction in SGLT-2i users compared with other diabetes medication users (0.99 [95% CI, -0.14 to 2.13] versus 1.54 [1.08 to 2.00], P=0.38). Initiating an SGLT-2i versus other diabetes medications was associated with a greater reduction in ophthalmological symptoms (-3.09 [95% CI, -4.99 to -1.18] versus -0.38 [-1.54 to 0.77], P=0.018) but less improvement in hyperglycemia (1.08 [-2.63 to 4.79] versus -3.60 [-5.34 to -1.86], P=0.026). In subgroup analyses by cardiovascular disease type, SGLT-2i use was associated with a greater reduction in total diabetes symptom burden and neurological sensory symptoms in patients with heart failure. Conclusions Among patients with type 2 diabetes and cardiovascular disease, initiating an SGLT-2i was not associated with changes in diabetes treatment satisfaction, total diabetes symptoms, diabetes-specific quality of life, or general health status.

Race, Neighborhood Opportunity, and Life-Threatening Complications in Children With Cancer: A Moderated Mediation Approach.

BACKGROUND: Racial disparities exist in the incidence and severity of life-threatening complications of childhood cancer and its treatment. Little research has been conducted to examine the sociocultural pathways that are underlying these inequities. OBJECTIVE: This study examined the association between race and complications and the intermediary pathway of a child's access to opportunity in the neighborhood environment. A secondary objective was to determine if this indirect effect differs as the child becomes older and exposure to the neighborhood environment increases. METHODS: This is an analysis of publicly available data. Regression models estimated direct associations between race and complications, as well as the effect of the mediator, neighborhood opportunity. Moderated-mediation analysis was used to determine the conditional influence of age. RESULTS: Compared with non-Hispanic White children, non-Hispanic Black and Hispanic children are at increased odds of developing 1 or more life-threatening complications when hospitalized with cancer. Neighborhood opportunity is a significant indirect pathway underlying these relationships. This intermediary effect is significant only for older children. CONCLUSIONS: Neighborhood opportunity is a significant indirect pathway underlying the racial inequities in the risk of life-threatening complications. This effect is significant only for older children. IMPLICATIONS FOR PRACTICE: The inclusion of indicators such as inequitable allocation of resources to highly segregated neighborhoods and rigorous statistical model development in outcomes research are critical in addressing and mitigating racial disparities in childhood cancer.

Psychometric Evaluation of the Patient-Nurse Trust Scale among Sexual and Gender Minorities.

PURPOSE: To assess the psychometric properties of a newly developed instrument patient-nurse trust scale (PNTS) among sexual and gender minorities (SGM). DESIGN: Secondary data analysis. METHODS: Reliability and construct validity of the PNTS were assessed. FINDINGS: The PNTS showed high internal consistency (Cronbach's alpha= 0.96). It also demonstrated a good fit to the data and confirmed construct validity. CONCLUSIONS: PNTS is a reliable and valid instrument to measure trust in the nurse-patient relationship with SGM youth. CLINICAL EVIDENCE: PNTS is a valid and reliable tool that quantifies patient-nurse trust relationship and can predict patient satisfaction, health behaviors and health outcomes.

Sex-specific impact of diabetes on all-cause mortality among adults with acute myocardial infarction: An updated systematic review and meta-analysis, 1988-2021.

Background: The prevalence of diabetes and its impact on mortality after acute myocardial infarction (AMI) are well-established. Sex-specific analyses of the impact of diabetes on all-cause mortality after AMI have not been updated and comprehensively investigated. Objective: To conduct a systematic review and meta-analysis that examined sex-specific short-term, mid-term and long-term all-cause mortality associated with diabetes among AMI survivors (diabetes versus non-diabetes patients in men and women separately), using up-to-date data. Methods: We systematically searched Embase and MEDLINE for studies that were published from inception to November 14, 2021. Studies were included if (1) they studied post-AMI all-cause-mortality in patients with and without diabetes, (2) sex-specific all-cause mortality at short-term (in-hospital or within 90 days after discharge), mid-term (>90 days and within 5 years), and/or long-term (>5 years) were reported. From eligible studies, we used random effects meta-analyses models to estimate pooled unadjusted and adjusted sex-specific risk ratio (RR) of all-cause mortality at short-, mid-, and long-term follow-up for adults with diabetes compared with those without diabetes. Results: Of the 3647 unique studies identified, 20 studies met inclusion criteria. In the unadjusted analysis (Total N=673,985; women=34.2%; diabetes patients=19.6%), patients with diabetes were at a higher risk for all-cause mortality at short-term (men: RR, 2.06; women: RR, 1.83); and mid-term follow-up (men: RR, 1.69; women: RR, 1.52) compared with those without diabetes in both men and women. However, when adjusted RRs were used (Total N=7,144,921; women=40.0%; diabetes patients=28.4%), the associations between diabetes and all-cause mortality in both men and women were attenuated, but still significantly elevated for short-term (men: RR, 1.16; 95% CI, 1.12-1.20; women: RR, 1.29; 95% CI, 1.15-1.46), mid-term (men: RR, 1.39; 95% CI, 1.31-1.46; women: RR, 1.38; 95% CI, 1.20-1.58), and long-term mortality (men: RR, 1.58; 95% CI, 1.22-2.05; women: RR, 1.76; 95% CI, 1.25-2.47). In men, all-cause mortality risk associated with diabetes tended to increase with the duration of follow-up (p<0.0001). Conclusions: Diabetes has substantial and sustained effects on post-AMI all-cause mortality at short-term, mid-term and long-term follow-up, regardless of sex. Tailoring AMI treatment based on patients' diabetes status, duration of follow-up and sex may help narrow the gap in all-cause mortality between patients with diabetes and those without diabetes.

Differences in elective epilepsy monitoring unit admission rates by race/ethnicity and primary payer in New Jersey.

Elective admission to the epilepsy monitoring unit (EMU) is an essential service provided by epilepsy centers, particularly for those with drug-resistant epilepsy. Given previously characterized racial and socioeconomic healthcare disparities in the management of epilepsy, we sought to understand access and utilization of this service in New Jersey (NJ). We examined epilepsy hospitalizations in NJ between 2014 and 2016 using state inpatient and emergency department (ED) databases. We stratified admissions by race/ethnicity and primary payer and used these to estimate and compare (1) admission rates per capita in NJ, as well as (2) admission rates per number of ED visits for each group. Patients without insurance underwent elective EMU admission at the lowest rates across all racial/ethnic groups and payer types studied. Black patients with Medicaid and private insurance were admitted at disproportionately low rates relative to their number of ED visits. Hispanic/Latino and Asian/Pacific Islanders with private insurance, Hispanic/Latinos with Medicaid, and Asian/Pacific Islanders with Medicare were also admitted at low rates per capita within each respective payer category. Future studies should focus on addressing causal factors driving healthcare disparities in epilepsy, particularly for patients without adequate health insurance coverage and those who have been historically underserved by the healthcare system.

Identifying quality of life outcome patterns to inform treatment choices in ischemic cardiomyopathy.

BACKGROUND: The Surgical Treatment for Ischemic Heart Failure (STICH) trial found that routine use of coronary artery bypass surgery (CABG) improved mean quality of life (QoL) scores relative to guideline-directed medical therapy (GDMT) in patients with ischemic cardiomyopathy. However, mean differences in QoL scores do not provide what patients want to know when facing a high-risk/high-benefit treatment choice. METHODS: We analyzed Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary scores in CABG and GDMT patients over 36 months using a combination of statistical methods to group QoL data into clinically relevant outcome patterns (phenotype trajectories) and to then identify the main baseline predictors of each phenotype. QoL outcome phenotypes were developed using mixture models to define the dominant phenotype trajectories present in STICH QoL data. Logistic regression models were used to predict each patient's probability of achieving each outcome pattern with each treatment. RESULTS: In STICH, 592 patients underwent CABG and 607 were managed with GDMT. Our analyses identified 3 phenotype trajectory patterns in both treatment groups. Two of the 3 trajectories showed improving patterns, and were classified as "good QoL trajectories," seen in 498 (84.1%) CABG and 449 (73.9%) GDMT patients. Defining a consequential CABG-GDMT treatment difference as a >10% higher absolute predicted probability of belonging to good QoL trajectories, 277 (23.5%) patients were more likely to have good outcome with CABG while 45 (3.8%) patients were more likely to have a good outcome with GDMT. For 644 (54.7%) patients, CABG and GDMT probabilities of a good outcome were within 5% of each other. CONCLUSIONS: The pattern of QoL outcomes after CABG compared with GDMT in STICH followed 3 main phenotypic trajectories, which could be predicted based on individual baseline features. Patient-specific predictions about expected QoL outcomes with different treatment choices provide an intuitive framework for personalizing patient decision making.

Comparison of concurrent chemoradiotherapy with radiotherapy alone for locally advanced esophageal squamous cell cancer in elderly patients: A randomized, multicenter, phase II clinical trial.

This randomized, multicenter, phase II clinical trial was performed to compare the safety and efficacy of concurrent chemoradiotherapy using S-1 (CCRT) with radiotherapy alone (RT) for elderly patients with locally advanced esophageal squamous cell carcinoma (ESCC). All eligible patients were randomly assigned to the CCRT group or the RT group at a 1:1 ratio. The CCRT group received 50.4 Gy radiotherapy concurrent with S-1 and the RT group received 59.4 Gy radiotherapy alone. The primary endpoints were toxicity and the overall response rate (ORR), and the secondary endpoints were overall survival (OS) and progression-free survival (PFS). In total, 157 elderly patients with ESCC were recruited from December 2016 to March 2020. By June 2021, the median follow-up duration had reached 38 months. No grade 5 toxicities occurred in either group and the overall rate of severe toxicities (≥grade 3) was higher in the CCRT group (19.2% vs 7.6%; P = .037), particularly neutropenia (7.7% vs 1.3%; P = .06). The CCRT group presented a significantly higher ORR (83.3% vs 68.4%; P = .009) and prolonged PFS (25.7 vs 13.9 months; P = .026) than the RT group. The median OS was 27.3 months in the CCRT group and 19.1 months in the RT group (P = .59). For patients older than 70 years with locally advanced ESCC, concurrent chemoradiotherapy with S-1 had tolerable adverse effects and improved ORR and PFS compared to radiotherapy alone.

Safety Warning about Laparoscopic Power Morcellation in Hysterectomy: A Cost-Effectiveness Analysis of National Impact.

Background: Following a 2014 safety warning (that laparoscopic power morcellation may increase tumor dissemination if patients have occult uterine cancer), hysterectomy practice shifted from laparoscopic to abdominal approach. This avoided morcellating occult cancer, but increased perioperative complications. To inform the national impact of this practice change, we examined the cost-effectiveness of hysterectomy practice in the postwarning period, in comparison to counterfactual hysterectomy practice had there been no morcellation warning. Materials and Methods: We constructed a decision tree model to simulate relevant outcomes over the lifetime of patients in the national population undergoing hysterectomy for presumed benign indications. The model accounted for both hysterectomy- and occult cancer-related outcomes. Probability-, cost-, and utility weight-related input parameters were derived from analysis of the State Inpatient Databases, State Ambulatory Surgery and Services Databases, data from the New York Statewide Planning and Research Cooperative System and New York State Cancer Registry, and published literature. Results: With an estimated national sample of 353,567 adult women, base case analysis showed that changes in hysterectomy practice after the morcellation warning led to a net gain of 867.15 quality-adjusted life years (QALYs), but an increase of $19.54 million in costs (incremental cost-effectiveness ratio = $22,537/QALY). In probabilistic sensitivity analysis, the practice changes were cost-effective in 54.0% of the simulations when evaluated at a threshold of $50,000/QALY, which increased to 70.9% when evaluated at a threshold of $200,000/QALY. Conclusion: Hysterectomy practice changes induced by the morcellation warning are expected to be cost-effective, but uncertainty in parameter values may affect the cost-effectiveness results.

Risk factors of esophageal fistula induced by re-radiotherapy for recurrent esophageal cancer with local primary site.

PURPOSE: The purpose of the present study was to investigate risk factors for esophageal fistula (EF) in patients with recurrent esophageal cancer receiving re-radiotherapy with or without chemotherapy. METHODS: We reviewed retrospectively the clinical characters and dosimetric parameters of 96 patients with recurrent esophageal cancer treated with re-radiotherapy in Cancer Hospital Affiliated to Shandong First Medical University between August 2014 and January 2021.Univariate and multivariate logistic regression analyses were provided to determine the risk factors of EF induced by re-radiotherapy. RESULTS: The median time interval between two radiotherapy was 23.35 months (range, 4.30 to 238.10 months). EF occurred in 19 patients (19.79%). In univariate analysis, age, T stage, the biologically equivalent dose in the re-radiotherapy, total biologically equivalent dose, hyperfractionated radiotherapy, ulcerative esophageal cancer, the length of tumor and the maximum thickness of tumor had a correlation with the prevalence of EF. In addition, age (HR = 0.170, 95%CI 0.030-0.951, p = 0.044), T stage (HR = 8.369, 95%CI 1.729-40.522, p = 0.008), ulcerative esophageal cancer (HR = 5.810, 95%CI 1.316-25.650, p = 0.020) and the maximum thickness of tumor (HR = 1.314, 95%CI 1.098-1.572, p = 0.003) were risk factors of EF in multivariate logistic regression analysis. CONCLUSIONS: The incidence of EF was significantly increased in patients with recurrent esophageal cancer who underwent re-radiotherapy. This study revealed that age, T stage, ulcerative esophageal cancer and the maximum thickness of the tumor were risk factors associated with EF. In clinical work, patients with risk factors for EF ought to be highly concerned and individualized treatment plans should be taken to reduce the occurrence of EF.

Clinical and EEG factors associated with antiseizure medication resistance in idiopathic generalized epilepsy.

OBJECTIVE: We sought to determine which combination of clinical and electroencephalography (EEG) characteristics differentiate between an antiseizure medication (ASM)-resistant vs ASM-responsive outcome for patients with idiopathic generalized epilepsy (IGE). METHODS: This was a case-control study of ASM-resistant cases and ASM-responsive controls with IGE treated at five epilepsy centers in the United States and Australia between 2002 and 2018. We recorded clinical characteristics and findings from the first available EEG study for each patient. We then compared characteristics of cases vs controls using multivariable logistic regression to develop a predictive model of ASM-resistant IGE. RESULTS: We identified 118 ASM-resistant cases and 114 ASM-responsive controls with IGE. First, we confirmed our recent finding that catamenial epilepsy is associated with ASM-resistant IGE (odds ratio [OR] 3.53, 95% confidence interval [CI] 1.32-10.41, for all study subjects) after covariate adjustment. Other independent factors seen with ASM resistance include certain seizure-type combinations (absence, myoclonic, and generalized tonic-clonic seizures [OR 7.06, 95% CI 2.55-20.96]; absence and generalized tonic-clonic seizures [OR 4.45, 95% CI 1.84-11.34]), as well as EEG markers of increased generalized spike-wave discharges (GSWs) in sleep (OR 3.43, 95% CI 1.12-11.36 for frequent and OR 7.21, 95% CI 1.50-54.07 for abundant discharges in sleep) and the presence of generalized polyspike trains (GPTs; OR 5.49, 95% CI 1.27-38.69). The discriminative ability of our final multivariable model, as measured by area under the receiver-operating characteristic curve, was 0.80. SIGNIFICANCE: Multiple clinical and EEG characteristics independently predict ASM resistance in IGE. To improve understanding of a patient's prognosis, clinicians could consider asking about specific seizure-type combinations and track whether they experience catamenial epilepsy. Obtaining prolonged EEG studies to record the burden of GSWs in sleep and assessing for the presence of GPTs may provide additional predictive value.

Endometrial Sampling for Preoperative Diagnosis of Uterine Leiomyosarcoma.

STUDY OBJECTIVES: To examine the effectiveness of endometrial sampling for preoperative detection of uterine leiomyosarcoma in women undergoing hysterectomy, identify factors associated with missed diagnosis, and compare the outcomes of patients who had a preoperative diagnosis with those of patients who had a missed diagnosis. DESIGN: Retrospective cohort study using linked data from the New York Statewide Planning and Research Cooperative System and New York State Cancer Registry from 2003 to 2015. SETTING: Inpatient and outpatient encounters at civilian hospitals and ambulatory surgery centers in New York State. PATIENTS: Women with uterine leiomyosarcoma who underwent a hysterectomy and a preoperative endometrial sampling within 90 days before the hysterectomy. INTERVENTIONS: Endometrial sampling. MEASUREMENTS AND MAIN RESULTS: A total of 79 patients with uterine leiomyosarcoma met the sample eligibility criteria. Of these patients, 46 (58.2%) were diagnosed preoperatively, and 33 (41.8%) were diagnosed postoperatively. Patients in the 2 groups did not differ significantly in age, race/ethnicity, bleeding symptoms, or comorbidities assessed. In multivariable regression analysis, women who had endometrial sampling performed with hysteroscopy (compared with women who had endeometrial sampling performed without hysteroscopy) had a higher likelihood of preoperative diagnosis (adjusted risk ratio [aRR] 3.03; 95% confidence interval [CI], 1.43-6.42). Patients with localized stage (vs distant stage) or tumor size >11 cm (vs <8 cm) were less likely to be diagnosed preoperatively (aRR 0.50; 95% CI, 0.28-0.89, and aRR 0.54; 95% CI, 0.30-0.99, respectively). Supracervical hysterectomy was not performed in any of the patients whose leiomyosarcoma was diagnosed preoperatively compared with 21.2% of the patients who were diagnosed postoperatively (p = .002). CONCLUSION: Endometrial sampling detected leiomyosarcoma preoperatively in 58.2% of the patients. The use of hysteroscopy with endometrial sampling improved preoperative detection of leiomyosarcoma by threefold. Patients with a missed diagnosis had a higher risk of undergoing suboptimal surgical management at the time of their index surgery.

Hypofractionated Simultaneous Integrated Boost Radiotherapy Versus Conventional Fractionation Radiotherapy of Early Breast Cancer After Breast-Conserving Surgery: Clinical Observation and Analysis.

Purpose: The objective of this retrospective study is to evaluate the efficacy and safety of hypofractionated simultaneous integrated boost radiotherapy for early breast cancer patients undergoing breast-conserving surgery. Methods: A total of 185 women with early breast cancer undergoing breast-conserving surgery were retrospectively divided into hypofractionated simultaneous integrated boost group and conventional fractionation group. Hypofractionated simultaneous integrated boost included 104 patients and the dose of whole-breast radiation reached 42.56 Gy in 16 fractions and simultaneously tumor bed boost to 48 Gy in 16 fractions, which course of radiotherapy was 22 days. The 81 patients of the conventional fractionation group received whole breast radiation to 50 Gy in 25 fractions and followed by tumor bed boost to 10 Gy in 5 fractions, which course of radiotherapy was 40 days. Clinical information including patients' characteristics, skin toxicity, myelosuppression, radiation pneumonia, and cosmetic effects was recorded to analyze the influence of age, chemotherapy, position, and breast volume on the results of radiotherapy. Results: Hypofractionated simultaneous integrated boost group had no case of recurrence after a median follow-up of 25.6 months (9-47 months)) as compared with 2 after a median follow-up of 33.4 months (25-45 months) in the conventional fractionation group. The 2 groups had similar results in skin toxicity, cosmetic outcomes, and radiation pneumonia. In terms of myelosuppression, grade 1, grade 2, and grade 3 of myelosuppression in the hypofractionated simultaneous integrated boost group accounted for 16.7%, 12.3%, and 3.5% as compared with 30.0%, 21.1%, and 12.3% of the conventional fractionation group, respectively (P = .000). Conclusions: HF-SIB RT is a considerable option in patients after breast-conserving surgery with a lower degree of myelosuppression and shorter treatment time.

Incremental biomarker and clinical outcomes after switch from enzyme therapy to eliglustat substrate reduction therapy in Gaucher disease.

In Gaucher disease (GD), genetic deficiency of acid ß-glucosidase leads to accumulation of its substrate glucosylceramide (GlcCer) and glucosylsphingosine (GlcSph). Lipid-laden cells, most prominently seen as macrophages engorged with GlcCer and GlcSph-laden lysosomes, trigger chronic metabolic inflammation and multisystemic phenotypes. Among the pleiotropic effects of inflammatory cascades, the induction of glucosylceramide synthase accentuates the primary metabolic defect. First-line therapies for adults with GD type 1 include Enzyme Replacement Therapy (ERT) and eliglustat Substrate Reduction Therapy (SRT). The ENCORE phase 3 clinical trial of eliglustat demonstrated non-inferiority compared to ERT. It is not known whether switching stable patients from long-term ERT to SRT results in the incremental reversal of the disease phenotype and its surrogate indicators. Herein, we report real-world experience from a single tertiary referral center of 38 adult GD type 1 patients, stable on long-term ERT (mean 13.3 years), who switched to eliglustat SRT (mean 3.1 years). After switch to SRT, there was significant reduction in spleen volume (P = 0.003) while liver volume, which was normal at baseline, remained unchanged. Platelet counts increased significantly (P = 0.026). Concomitantly, there was reduction of three validated biomarkers of Gaucher disease activity: plasma GlcSph decreased from 63.7 ng/ml (95% CI, 37.6-89.8) to 26.1 ng/ml (95% CI, 15.7-36.6) (P < 0.0001); chitotriosidase fell from 1136.6 nmol/ml/h (95% CI, 144.7-2128.6) to 466.9 nmol/ml/h (95% CI, 209.9-723.9) (P = 0.002); and glycoprotein non-metastatic melanoma B (gpNMB) decreased from 59.3 ng/ml (95% CI, 39.7-78.9) to 43.6 ng/ml (95% CI, 30.7-56.6) (P = 0.0006). There were no episodes of avascular necrosis or fractures in patients on SRT. Patients reported favorable experiences of switching from alternate week infusions to oral therapy. Collectively, these results demonstrate that the switch to eliglustat SRT from ERT leads to incremental response, even in stable patients after long-term ERT.

Timing of Home Health Care Initiation and 30-Day Rehospitalizations among Medicare Beneficiaries with Diabetes by Race and Ethnicity.

Older adults with diabetes are at elevated risk of complications following hospitalization. Home health care services mitigate the risk of adverse events and facilitate a safe transition home. In the United States, when home health care services are prescribed, federal guidelines require they begin within two days of hospital discharge. This study examined the association between timing of home health care initiation and 30-day rehospitalization outcomes in a cohort of 786,734 Medicare beneficiaries following a diabetes-related index hospitalization admission during 2015. Of these patients, 26.6% were discharged to home health care. To evaluate the association between timing of home health care initiation and 30-day rehospitalizations, multivariate logistic regression models including patient demographics, clinical and geographic variables, and neighborhood socioeconomic variables were used. Inverse probability-weighted propensity scores were incorporated into the analysis to account for potential confounding between the timing of home health care initiation and the outcome in the cohort. Compared to the patients who received home health care within the recommended first two days, the patients who received delayed services (3-7 days after discharge) had higher odds of rehospitalization (OR, 1.28; 95% CI, 1.25-1.32). Among the patients who received late services (8-14 days after discharge), the odds of rehospitalization were four times greater than among the patients receiving services within two days (OR, 4.12; 95% CI, 3.97-4.28). Timely initiation of home health care following diabetes-related hospitalizations is one strategy to improve outcomes.

Racial and Economic Differences in the Risk of Hyperglycemia in Children Hospitalized With Acute Lymphoblastic Leukemia.

Background: The underlying mechanism of hyperglycemia in children with acute lymphoblastic leukemia (ALL) is insulin resistance. Although race and economic status have been linked to increased insulin resistance in children, these have not been explored as predictors of hyperglycemia in children with ALL. The objective of this study was to analyze race and income as predictors of hyperglycemia in a diverse sample of children hospitalized with ALL in the United States in the year 2016. Methods: We performed a secondary analysis of 18,077 hospitalizations of White, Black, and Hispanic children under the age of 21 years with ALL contained in a nationally representative database. Multilevel binary logistic regression models were constructed to estimate the relationships between race, median household income, age, sex, and obesity and the odds of hyperglycemia in hospitalized children with ALL. Results: Hyperglycemia occurred during 5.3% of the hospitalizations. Black children were 37% more likely to develop hyperglycemia than White children. The risk for hyperglycemia did not differ between Hispanic and White children. Residing in areas where annual median income was below $54,000 was associated with 1.4-fold increased odds of hyperglycemia, compared to the wealthiest areas. Older children, females, and those diagnosed with obesity were also at increased risk for hyperglycemia. Discussion: An association has been found between treatment-induced hyperglycemia and increased mortality. For this reason, the racial and economic differences in the risk for hyperglycemia identified in this study deserve further consideration.

Racial Disparities in Post-Acute Home Health Care Referral and Utilization among Older Adults with Diabetes.

Racial and ethnic disparities exist in diabetes prevalence, health services utilization, and outcomes including disabling and life-threatening complications among patients with diabetes. Home health care may especially benefit older adults with diabetes through individualized education, advocacy, care coordination, and psychosocial support for patients and their caregivers. The purpose of this study was to examine the association between race/ethnicity and hospital discharge to home health care and subsequent utilization of home health care among a cohort of adults (age 50 and older) who experienced a diabetes-related hospitalization. The study was limited to patients who were continuously enrolled in Medicare for at least 12 months and in the United States. The cohort (n = 786,758) was followed for 14 days after their diabetes-related index hospitalization, using linked Medicare administrative, claims, and assessment data (2014-2016). Multivariate logistic regression models included patient demographics, comorbidities, hospital length of stay, geographic region, neighborhood deprivation, and rural/urban setting. In fully adjusted models, hospital discharge to home health care was significantly less likely among Hispanic (OR 0.8, 95% CI 0.8-0.8) and American Indian (OR 0.8, CI 0.8-0.8) patients compared to White patients. Among those discharged to home health care, all non-white racial/ethnic minority patients were less likely to receive services within 14-days. Future efforts to reduce racial/ethnic disparities in post-acute care outcomes among patients with a diabetes-related hospitalization should include policies and practice guidelines that address structural racism and systemic barriers to accessing home health care services.

Latent class mediator for multiple indicators of mediation.

This paper demonstrates the utility of latent classes in evaluating the effect of an intervention on an outcome through multiple indicators of mediation. These indicators are observed intermediate variables that identify an underlying latent class mediator, with each class representing a different mediating pathway. The use of a latent class mediator allows us to avoid modeling the complex interactions between the multiple indicators and ensures the decomposition of the total mediating effects into additive effects from individual mediating pathways, a desirable feature for evaluating multiple indicators of mediation. This method is suitable when the goal is to estimate the total mediating effects that can be decomposed into the additive effects of distinct mediating pathways. Each indicator may be involved in multiple mediation pathways and at the same time multiple indicators may contribute to a single mediating pathway. The relative importance of each pathway may vary across subjects. We applied this method to the analysis of the first 6 months of data from a 2-year clustered randomized trial for adults in their first episode of schizophrenia. Four indicators of mediation are considered: individual resiliency training; family psychoeducation; supported education and employment; and a structural assessment for medication. The improvement in symptoms was found to be mediated by the latent class mediator derived from these four service indicators. Simulation studies were conducted to assess the performance of the proposed model and showed that the simultaneous estimation through the maximum likelihood yielded little bias when the entropy of the indicators was high.