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Study Objective Preoperative detection of uterine leiomyosarcoma is important in hysterectomies performed for presumed benign indications. This study examined the effectiveness of endometrial sampling for preoperative diagnosis of leiomyosarcoma and the factors associated with a false negative. Design This is a retrospective analysis of linked data from the New York Statewide Planning and Research Cooperative System and the New York State Cancer Registry. Using procedure codes, we identified women who underwent preoperative endometrial sampling and hysterectomy in 2003-2015. We further limited the sample to women who had a subsequent diagnosis of uterine leiomyosarcoma based on histology, site and behavioral codes. We estimated the proportion of patients whose leiomyosarcoma was diagnosed preoperatively, and compared their characteristics with patients whose leiomyosarcoma was missed preoperatively (i.e., diagnosed postoperatively) using chi-square/Fisher's exact test and Wilcoxon rank sum test. Setting Inpatient and outpatient encounters at civilian hospitals and ambulatory surgery centers in New York state. Patients or Participants 79 adult women with leiomyosarcoma who underwent endometrial sampling (biopsy or dilation and curettage) within 90 days before hysterectomy. Interventions N/A Measurements and Main Results Among the 79 patients with leiomyosarcoma, 46 (58.2%) were diagnosed preoperatively, whereas 33 (41.8%) were diagnosed postoperatively. Patients diagnosed postoperatively did not differ significantly from those diagnosed preoperatively in cancer stage, grade, age, bleeding symptoms, or comorbidities. However, tumor size was larger among patients who were diagnosed postoperatively than those diagnosed preoperatively (median=12 versus 9 centimeters, p=0.04). The rate of preoperative diagnosis was higher among patients who underwent sampling with hysteroscopic guidance (66.7%) than sampling without hysteroscopic guidance (31.6%) (p=0.007). Among patients diagnosed postoperatively, 21.2% underwent a supracervical hysterectomy, compared to 0% among those diagnosed preoperatively (p=0.002). Conclusion Endometrial sampling was instrumental in diagnosing approximately half of uterine leiomyosarcomas preoperatively, which was more commonly achieved with hysteroscopic guidance.

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.

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

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.

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.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.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 a10% 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.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.

Objective To examine interhospital variation in admissions to neonatal intensive care units (NICU) and reasons for the variation. Study design 2010–2012 linked birth certificate and hospital discharge data from 35 hospitals in California on live births at 35–42 weeks gestation and ≥1500 g birth weight were used. Hospital variation in NICU admission rates was assessed by coefficient of variation. Patient/hospital characteristics associated with NICU admissions were identified by multivariable regression. Results Among 276,489 newborns, 6.3% were admitted to NICU with 34.5% of them having mild diagnoses. There was high interhospital variation in overall risk-adjusted rate of NICU admission (coefficient of variation = 26.2) and NICU admission rates for mild diagnoses (coefficient of variation: 46.4–74.0), but lower variation for moderate/severe diagnoses (coefficient of variation: 8.8–14.1). Births at hospitals with more NICU beds had a higher likelihood of NICU admission. Conclusion Interhospital variation in NICU admissions is mostly driven by admissions for mild diagnoses, suggesting potential overuse.

Objective Trial of labor after cesarean delivery has been mostly studied in the setting of one prior cesarean delivery; controversy remains regarding the risks and benefits of trial of labor for women with two prior cesarean deliveries. This study aimed to examine utilization, success rate, and maternal and neonatal outcomes of trial of labor in this population. Methods Using linked hospital discharge and birth certificate data, we retrospectively analyzed a cohort of mothers with nonanomalous, term, singleton live births in California between 2010-2012 and had two prior cesarean deliveries and no clear contraindications for trial of labor. We measured whether they attempted labor and, if so, whether they delivered vaginally. Association of patient and hospital characteristics with the likelihood of attempting labor and successful vaginal birth was examined using multivariable regressions. We compared composite severe maternal morbidities and composite severe newborn complications in those who underwent trial of labor as opposed to planned cesarean delivery using a propensity score-matching approach. Results Among 42,771 women who met sample eligibility criteria, 1,228 (2.9%) attempted labor, of whom 484 (39.4%) delivered vaginally. There was no significant difference in the risk of composite severe maternal morbidities, but there was a modest increase in the risk of composite severe newborn complications among women who attempted labor compared with those who did not (2.0% vs 1.4%, P=.04). After accounting for differences in patient and hospital characteristics, propensity score-matched analysis showed no significant association between trial of labor and the risk of composite severe maternal morbidities (odds ratio [OR] 1.16, 95% CI 0.70-1.91), but trial of labor was associated with a higher risk for the composite of severe newborn complications (OR 1.78, 95% CI 1.04-3.04). Conclusion Among women with two prior cesarean deliveries, trial of labor was rarely attempted and was successful in 39.4% of attempts. Trial of labor in this population was associated with a modest increase in severe neonatal morbidity.

We aimed to investigate the potential of individual isotoxic dose escalation based on normal tissue constraints (NTC), hypothesizing that high dose radiation therapy would be superior to standard-dose in concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer (NSCLC).Individually prescribed radiation doses were calculated based on NTC. Patients with total tumour radiation doses ≥66 Gy were assigned to the high dose (HD, ≥66 Gy) group, and all other patients were assigned to the standard-dose (SD,66 Gy) group. Each patient was retrospectively assigned an Eighth edition of American Joint Committee on Cancer disease stage based on the imaging data of initial diagnosis to avoid over- and under-staging. Intensity modulated radiation therapy plans were optimized to minimize the volumes of organs at risk exposed to radiation. The primary endpoint was overall survival.From March 2006 to September 2012, 140 patients were enrolled and assigned to two groups: 71 patients into the HD group and 69 patients into the SD group. The median survival time (MST) was significantly higher in the HD group (33.5 months) than in the SD group (21 months), (p 0.0001). Overall 5-year survival rates were significantly higher in the HD group than in the SD group (37.8% vs 16.7%). Median progression-free survival was 19 months in the HD group and 11 months in the SD group (p 0.0001). No difference in severe (grade 3-5) toxic effects was noted between the two groups.The significant positive association observed between prescribed dose and survival suggests that individualized isotoxic dose-escalated radiation based on NTC might improve survival in this cohort of stage III NSCLC Chinese patients.

Background Misclassification of Medicare beneficiaries' race/ethnicity in administrative data sources is frequently overlooked and a limitation in health disparities research. Objective To compare the validity of 2 race/ethnicity variables found in Medicare administrative data [enrollment database (EDB) and Research Triangle Institute (RTI) race] against a gold-standard source also available in the Medicare data warehouse: the self-reported race/ethnicity variable on the home health Outcome and Assessment Information Set (OASIS). Subjects Medicare beneficiaries over the age of 18 who received home health care in 2015 (N=4,243,090). Measures Percent agreement, sensitivity, specificity, positive predictive value, and Cohen κ coefficient. Results The EDB and RTI race variable have high validity for black race and low validity for American Indian/Alaskan Native race. Although the RTI race variable has better validity than the EDB race variable for other races, κ values suggest room for future improvements in classification of whites (0.90), Hispanics (0.87), Asian/Pacific Islanders (0.77), and American Indian/Alaskan Natives (0.44). Discussion The status quo of using "good-enough for government" race/ethnicity variables contained in Medicare administrative data for minority health disparities research can be improved through the use of self-reported race/ethnicity data, available in the Medicare data warehouse. Health services and policy researchers should critically examine the source of race/ethnicity variables used in minority health and health disparities research. Future work to improve the accuracy of Medicare beneficiaries' race/ethnicity data should incorporate and augment the self-reported race/ethnicity data contained in assessment and survey data, available within the Medicare data warehouse.

This study describes racial and ethnic variation in dementia diagnosis and survival time between diagnosis and death for Medicare beneficiaries aged 50 years and older who died in 2018 (n=1,998,282). The prevalence of diagnosed dementia was higher among non-Hispanic white (45.7%), Black (45.5%), and American Indian/Alaska Native (44.1%) decedents compared to Asian American/Pacific Islander (42.7%), and Hispanic (38.5%) decedents. Median survival time in years was shorter for American Indian/Alaska Native (2.51, IQR 0.7-6.0) and white (2.85, IQR 0.8-6.3) beneficiaries, and longer for Asian American/Pacific Islander (3.36, IQR 1.0-7.3), Black (3.38, IQR 0.9-7.4), and Hispanic (3.83, IQR 1-8.2) beneficiaries. Median survival time also varied by geography and was shortest for Hispanic decedents in Arizona (2.37, IQR 0.6-6.0) and New Mexico (2.92, IQR 0.8-7.0) compared to New Jersey (4.85, IQR 1.5-8.9) and Puerto Rico (5.45, IQR 1.1-12.8). Among Black decedents, survival was longest in New Jersey (3.80, 1.1-7.9) and Arkansas (4.22, 1.0-8.5).

Death at home is preferred by most people and has become a key indicator of the end-of-life care quality; however cultural attitudes about death and dying may vary by race and ethnicity. This study describes racial and ethnic variation in place of death among Medicare beneficiaries aged 50 years and older who died in 2018 with a dementia diagnosis (n=902,208) and without a dementia diagnosis (n=1,096,074). Among those with dementia, 60% died at home, with the highest percentage for non-Hispanic white (62%) beneficiaries, followed by Black/African American (55%), Hispanic (61%), Asian American/Pacific Islander (58%), and American Indian/Alaska Native (58%) beneficiaries. Among those without dementia 61% died at home, with the highest percentage for non-Hispanic white (60%) beneficiaries, followed by Black (57%), Hispanic (65%), Asian American (65%), and American Indian (60%) beneficiaries. Among those who died at home, about half without dementia received hospice care compared to the majority with dementia.

Timing of hospice referral is critical to patient’s and family’s quality of life and satisfaction with hospice care. This study examined racial/ethnic variation in hospice use and factors associated with death at home among Medicare beneficiaries aged 50 years and older who died in 2018 (n=1,998,282). Hospice use was most frequent among non-Hispanic white beneficiaries (55.8%) followed by Hispanic (46.2%), Asian American (44.5%), Black (42.7%), and American Indian (42.1%) beneficiaries. Among decedents diagnosed with dementia, initiation of hospice prior to the last day of life was significantly associated with death at home among all racial/ethnic groups: non-Hispanic white (OR=2.62), Black (OR=2.04), Hispanic (OR=2.17), Asian American (OR=2.54), and American Indian (OR=2.76). Among decedents not diagnosed with dementia, initiation of hospice prior to the last day of life was less strongly associated with death at home: white (OR=1.33), Black (OR=0.83), Hispanic (OR=1.32), Asian American (OR=1.69), and American Indian (OR=1.56).

Background Persons living with human immunodeficiency virus (HIV; PLWH) experience a high burden of cancer. It remains unknown which cancer types are reduced in PLWH with earlier initiation of antiretroviral therapy (ART). Methods We evaluated AIDS-free, ART-naive PLWH during 1996–2014 from 22 cohorts participating in the North American AIDS Cohort Collaboration on Research and Design. PLWH were followed from first observed CD4 of 350–500 cells/µL (baseline) until incident cancer, death, lost-to-follow-up, or December 2014. Outcomes included 6 cancer groups and 5 individual cancers that were confirmed by chart review or cancer registry linkage. We evaluated the effect of earlier (in the first 6 months after baseline) versus deferred ART initiation on cancer risk. Marginal structural models were used with inverse probability weighting to account for time-dependent confounding and informative right-censoring, with weights informed by subject’s age, sex, cohort, baseline year, race/ethnicity, HIV transmission risk, smoking, viral hepatitis, CD4, and AIDS diagnoses. Results Protective results for earlier ART were found for any cancer (adjusted hazard ratio [HR] 0.57; 95% confidence interval [CI], .37–.86), AIDS-defining cancers (HR 0.23; 95% CI, .11–.49), any virus-related cancer (HR 0.30; 95% CI, .16–.54), Kaposi sarcoma (HR 0.25; 95% CI, .10–.61), and non-Hodgkin lymphoma (HR 0.22; 95% CI, .06–.73). By 15 years, there was also an observed reduced risk with earlier ART for virus-related NADCs (0.6% vs 2.3%; adjusted risk difference −1.6; 95% CI, −2.8, −.5). Conclusions Earlier ART initiation has potential to reduce the burden of virus-related cancers in PLWH but not non-AIDS-defining cancers (NADCs) without known or suspected viral etiology.

Objectives To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying analytical approaches with three aims in mind: to clarify uncertainties about the cardiovascular risk of rosiglitazone; to determine whether different analytical approaches are likely to alter the conclusions of adverse event meta-analyses; and to inform efforts to promote clinical trial transparency and data sharing. Design Systematic review and meta-analysis of randomized controlled trials. Data sources GlaxoSmithKline’s (GSK’s) ClinicalStudyDataRequest.com for individual patient level data (IPD) and GSK’s Study Register platforms, MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Registry of Controlled Trials, Scopus, and ClinicalTrials.gov from inception to January 2019 for summary level data. Eligibility criteria for selecting studies Randomized, controlled, phase II-IV clinical trials that compared rosiglitazone with any control for at least 24 weeks in adults. Data extraction and synthesis For analyses of trials for which IPD were available, a composite outcome of acute myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death was examined. These four events were examined independently as secondary analyses. For analyses including trials for which IPD were not available, myocardial infarction and cardiovascular related death were examined, which were determined from summary level data. Multiple meta-analyses were conducted that accounted for trials with zero events in one or both arms with two different continuity corrections (0.5 constant and treatment arm) to calculate odds ratios and risk ratios with 95% confidence intervals. Results 33 eligible trials were identified from ClinicalStudyDataRequest.com for which IPD were available (21 156 patients). Additionally, 103 trials for which IPD were not available were included in the meta-analyses for myocardial infarction (23 683 patients), and 103 trials for which IPD were not available contributed to the meta-analyses for cardiovascular related death (22 772 patients). Among 29 trials for which IPD were available and that were included in previous meta-analyses using GSK’s summary level data, more myocardial infarction events were identified by using IPD instead of summary level data for 26 trials, and fewer cardiovascular related deaths for five trials. When analyses were limited to trials for which IPD were available, and a constant continuity correction of 0.5 and a random effects model were used to account for trials with zero events in only one arm, patients treated with rosiglitazone had a 33% increased risk of a composite event compared with controls (odds ratio 1.33, 95% confidence interval 1.09 to 1.61; rosiglitazone population: 274 events among 11 837 patients; control population: 219 events among 9319 patients). The odds ratios for myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death were 1.17 (0.92 to 1.51), 1.54 (1.14 to 2.09), 1.15 (0.55 to 2.41), and 1.18 (0.60 to 2.30), respectively. For analyses including trials for which IPD were not available, odds ratios for myocardial infarction and cardiovascular related death were attenuated (1.09, 0.88 to 1.35, and 1.12, 0.72 to 1.74, respectively). Results were broadly consistent when analyses were repeated using trials with zero events across both arms and either of the two continuity corrections was used. Conclusions The results suggest that rosiglitazone is associated with an increased cardiovascular risk, especially for heart failure events. Although increased risk of myocardial infarction was observed across analyses, the strength of the evidence varied and effect estimates were attenuated when summary level data were used in addition to IPD. Because more myocardial infarctions and fewer cardiovascular related deaths were reported in the IPD than in the summary level data, sharing IPD might be necessary when performing meta-analyses focused on safety. Systematic review registration OSF Home https://osf.io/4yvp2/ .

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.

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.

INTRODUCTION Despite evidence supporting the safety of low-interventional approaches to intrapartum care, defined by the American College of Obstetricians and Gynecologists as "practices that facilitate a physiologic labor process and minimize intervention," little is known about how frequently such practices are utilized. We examined hospital use of low-interventional practices, as well as variation in utilization across hospitals. METHODS Data came from 185 California hospitals completing a survey of intrapartum care, including 9 questions indicating use of low- versus high-interventional practices (eg, use of intermittent auscultation, nonpharmacologic pain relief, and admission of women in latent labor). We performed a group-based latent class analysis to identify distinct groups of hospitals exhibiting different levels of utilization on these 9 measures. Multivariable logistic regression identified institutional characteristics associated with a hospital's likelihood of using low-interventional practices. Procedure rates and patient outcomes were compared between the hospital groups using bivariate analysis. RESULTS We identified 2 distinct groups of hospitals that tended to use low-interventional (n = 44, 23.8%) and high-interventional (n = 141, 76.2%) practices, respectively. Hospitals more likely to use low-interventional practices included those with midwife-led or physician-midwife collaborative labor management (adjusted odds ratio [aOR], 7.52; 95% CI, 2.53-22.37; P < .001) and those in rural locations (aOR, 3.73; 95% CI, 1.03-13.60; P = .04). Hospitals with a higher proportion of women covered by Medicaid or other safety-net programs were less likely to use low-interventional practices (aOR, 0.96; 95% CI, 0.93-0.99; P = .004), as were hospitals in counties with higher medical liability insurance premiums (aOR, 0.53; 95% CI, 0.33-0.85; P = .008). Hospitals in the low-intervention group had comparable rates of severe maternal and newborn morbidities but lower rates of cesarean birth and episiotomy compared with hospitals in the high-intervention group. DISCUSSION Only one-quarter of hospitals used low-interventional practices. Attention to hospital culture of care, incorporating the midwifery model of care, and addressing medical-legal concerns may help promote utilization of low-interventional intrapartum practices.

Purpose/Objective(s) To assess the safety and tolerability of neoadjuvant radiotherapy combined with toripalimab for locally advanced, resectable esophageal squamous cell cancer (ESCC). Materials/Methods A total of 22 patients with newly diagnosed locally advanced, resectable ESCC (clinical stage: T3-4N0M0/T1-4N+M0, according to the 8th AJCC stage system) were enrolled. Patients received neoadjuvant radiotherapy (NRT) with 41.4 Gy in 23 fractions by intensity modulated radiotherapy (IMRT) combined with 4 cycles (240mg, Q3W) of toripalimab. Surgery was performed within 7-8 weeks after completion of NRT. The primary endpoints are treatment-related adverse events (TRAEs). The second endpoints are pathological complete response (pCR) and objective response rate (ORR). ORR was evaluated after NRT according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Results A total of 22 patients were enrolled between October 2019 to December 2020. 17 patients were male and 5 patients were female. The median age was 60 years (range, 48 to 70 years). 9 patients were in stage II and 13 patients were in stage III. All patients finished NRT as planned, 3 (13.6%) patients discontinued toripalimab treatment, one for progressive disease after 3 cycles of toripalimab, one for treatment-related AEs after 2 cycles and one for patient wishes after 2 cycles. 2 (9.1%) patients achieved complete response, 13 (59.1%) patients achieved partial response of which 1 patient had liver metastasis after 4 cycles of toripalimab, 6 (27.3%) patients remained stable disease, and 1 (4.5%) patient had progression disease. ORR was 68.2% (15/22), and disease control rate (DCR) was 95.5% (21/22). As of Feb. 26, 2021, 14 (63.6%) patients had received radical surgery, among them 7 (50.0%) experienced pCR of primary tumor and lymph nodes, 8 (57.1%) presented primary tumor pCR, and 9 (64.3%) had a major pathological response (MPR), 2 (9.1%) patients did not undergo surgery for progressive disease (1 patient of left supraclavicular lymph node metastasis and 1 patient of liver metastasis), and the remaining 6 patients still awaits radical surgery as scheduled. 15 (68.2%) patients experienced TRAEs. The common TRAEs were mild (grade 1 or 2) including leukopenia (n = 9), radiation esophagitis (n = 8) and aspartate transaminase (AST) elevation (n = 5), pruritus (n = 2), alanine transaminase (ALT) elevation (n = 1) and pneumonitis (n = 1). Only 1 (4.5%) patient developed grade 3 myocarditis, grade 3 AST elevation and grade 3 ALT elevation 2 weeks after NRT, improved after treatment with methylprednisolone, and is currently waiting for radical surgery. Conclusion The trial showed that NRT plus toripalimab demonstrated a manageable safety profile and encouraging therapeutic effect in patients with locally advanced, resectable ESCC, which warrants additional investigations in larger cohorts. The trial was registered in Chictr.org.cn ((Registration Number: ChiCTR1900022282).

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.

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.

BackgroundWidespread early dementia detection could drastically increase clinical trial candidates and enable early interventions. Since the Clock Drawing Test (CDT) can be potentially used for diagnosing dementia related diseases, it can be leveraged to devise a computer-aided screening tool.ObjectiveThis work aims to develop an online screening tool by leveraging Artificial Intelligence and the CDT.MethodsImages of an analog clock drawn by 3, 263 cognitively intact and 160 impaired subjects were used. First, we processed the images from the CDT by a deep learning algorithm to obtain dementia scores. Then, individuals were classified as belonging to either category by combining CDT image scores with the participant’s age.ResultsWe have evaluated the performance of the developed models by applying 5-fold cross validation on 20% of the dataset. The deep learning model generates dementia scores for the CDT images with an Area Under the ROC Curve (AUC) of 81.3% ± 4.3%. A composite logistic regression model using age and the generated dementia scores, yielded an average AUC and average weighted F1 score of 92% ± 0.8% and 94.4% ± 0.7%, respectively.DiscussionCDT images were subjected to distortion consistent with an image drawn on paper and photographed by a cell phone. The model offers a cost-effective and easily deployable mechanism for detecting cognitive impairment online, without the need to visit a clinic.

Objective To determine whether electronic health record alerts for acute kidney injury would improve patient outcomes of mortality, dialysis, and progression of acute kidney injury. Design Double blinded, multicenter, parallel, randomized controlled trial. Setting Six hospitals (four teaching and two non-teaching) in the Yale New Haven Health System in Connecticut and Rhode Island, US, ranging from small community hospitals to large tertiary care centers. Participants 6030 adult inpatients with acute kidney injury, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria. Interventions An electronic health record based “pop-up” alert for acute kidney injury with an associated acute kidney injury order set upon provider opening of the patient’s medical record. Main outcome measures A composite of progression of acute kidney injury, receipt of dialysis, or death within 14 days of randomization. Prespecified secondary outcomes included outcomes at each hospital and frequency of various care practices for acute kidney injury. Results 6030 patients were randomized over 22 months. The primary outcome occurred in 653 (21.3%) of 3059 patients with an alert and in 622 (20.9%) of 2971 patients receiving usual care (relative risk 1.02, 95% confidence interval 0.93 to 1.13, P=0.67). Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary outcome (relative risk 1.49, 95% confidence interval 1.12 to 1.98, P=0.006). More deaths occurred at these centers (15.6% in the alert group v 8.6% in the usual care group, P=0.003). Certain acute kidney injury care practices were increased in the alert group but did not appear to mediate these outcomes. Conclusions Alerts did not reduce the risk of our primary outcome among patients in hospital with acute kidney injury. The heterogeneity of effect across clinical centers should lead to a re-evaluation of existing alerting systems for acute kidney injury. Trial registration ClinicalTrials.gov NCT02753751 .

ObjectiveTo examine prevalence and characteristics of newly diagnosed diabetes (NDD) in younger adults hospitalised with acute myocardial infarction (AMI) and investigate whether NDD is associated with health status and clinical outcomes over 12-month post-AMI.MethodsIn individuals (18–55 years) admitted with AMI, without established diabetes, we defined NDD as (1) baseline or 1-month HbA1c≥6.5%; (2) discharge diabetes diagnosis or (3) diabetes medication initiation within 1 month. We compared baseline characteristics of NDD, established diabetes and no diabetes, and their associations with baseline, 1-month and 12-month health status (angina-specific and non-disease specific), mortality and in-hospital complications.ResultsAmong 3501 patients in Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients study, 14.5% met NDD criteria. Among 508 patients with NDD, 35 (6.9%) received discharge diagnosis, 91 (17.9%) received discharge diabetes education and 14 (2.8%) initiated pharmacological treatment within 1 month. NDD was more common in non-White (OR 1.58, 95% CI 1.23 to 2.03), obese (OR 1.72, 95% CI 1.39 to 2.12), financially stressed patients (OR 1.27, 95% CI 1.02 to 1.58). Compared with established diabetes, NDD was independently associated with better disease-specific health status and quality of life (p≤0.04). No significant differences were found in unadjusted in-hospital mortality and complications between NDD and established or no diabetes.ConclusionsNDD was common among adults≤55 years admitted with AMI and was more frequent in non-White, obese, financially stressed individuals. Under 20% of patients with NDD received discharge diagnosis or initiated discharge diabetes education or pharmacological treatment within 1 month post-AMI. NDD was not associated with increased risk of worse short-term health status compared with risk noted for established diabetes.Trial registration numberNCT00597922.

Background There have been remarkable advances in overall survival following the diagnosis of acute lymphoblastic leukemia in childhood, but toxicities, including pancreatitis, remain a concern. Pancreatitis occurs early in therapy, before extensive exposure to the chemotherapy agents associated with its development, indicating there are underlying risk factors for some children. The role of race/ethnicity in treatment-related pancreatitis has not been well established. Objective The aim of this study was to examine the relationship between race/ethnicity and pancreatitis in children hospitalized with acute lymphoblastic leukemia in the United States in 2016. Methods This was an analysis of a nationally representative database of pediatric hospitalizations. The sample consisted of 21 775 records with documentation of the diagnosis of acute lymphoblastic leukemia. Statistical methods included descriptive statistics, bivariate analyses using the χ test, and multilevel logistic regression models. Results Pancreatitis was documented in 1.6% of hospital discharges. Compared with white children, Hispanic children were at increased risk of pancreatitis during hospitalization (P = .002). There were no differences among black (P = .469), Asian (P = .364), or other-race children (P = .937). Conclusions Hispanic children hospitalized with acute lymphoblastic leukemia are at greater risk of pancreatitis than white children. Reasons for this disparity are likely due to both genetic and social factors. Implications for practice Nurses must be active participants in the research process with the goal of enrolling patients with diverse backgrounds in clinical trials. Inclusive research will provide increased understanding of a holistic toxicity risk profile.

Background: Although increased age is associated with higher systolic blood pressure (SBP) in general, there may be variation across individuals in how SBP changes over time. The goal of this paper is to identify heterogeneity in SBP trajectories among young adults with similar initial values and identify personal characteristics associated with different trajectory patterns. This may have important implications for prevention and prognosis. Methods: A cohort of 12,468 individuals aged 18–35 years in the Qingdao Port Cardiovascular Health Study in China was followed yearly during 2000–2011. Individuals were categorized into three strata according to their baseline SBP: ≤110 mmHg, 111–130 mmHg, and >130 mmHg. Within each stratum, group-based trajectory analyses were conducted to identify distinct SBP trajectory patterns, and their association with sociodemographic and baseline health characteristics was assessed by ordinal logistic regression. Results: Five distinct groups of individuals exhibiting divergent patterns of increasing, stable or decreasing SBP trends were identified within each stratum. This is a first report to identify a subgroup with decreasing trend in SBP. Individuals with more advanced age, having less than high school education, family history of cardiovascular diseases, greater body mass index, greater waist circumference, and hyperlipidemia at baseline were more likely to experience trajectories of higher SBP within each stratum. Conclusions: The diverging trajectories among young adults with similar initial SBP highlight the need for prevention and feasibility of effective blood pressure control, while the identified risk factors may inform targeted interventions.

OBJECTIVES: Efforts to study potential overuse of NICU admissions and hospital variation in practice are often hindered by a lack of an appropriate data source. We examined the concordance of hospital-level NICU admission rates between birth certificate data and California Children’s Services (CCS) data to inform the utility of birth certificate data in studying hospital variation in NICU admissions. METHODS: We analyzed birth certificate data from California in 2012 and hospital-specific summary data from CCS regarding NICU admissions. NICU admission rates were calculated for both data sets while using CCS data as the gold standard. The difference between birth certificate–based and CCS-based NICU admission rates was assessed by using the Wilcoxon signed rank test, and concordance between the 2 rates was evaluated by using Lin’s concordance correlation coefficient and Kendall’s W concordance coefficient. RESULTS: Among a total of 103 hospitals that were linked between the 2 data sets, birth certificate data generally underreported NICU admission rates compared with CCS data (median = 7.72% vs 11.51%; P < .001). However, in a subset of 35 hospitals where the difference in NICU admission rates between the 2 data sets was small, the birth certificate–based NICU admission rate showed good concordance with the rate from CCS data (Lin’s concordance correlation coefficient = 0.91; 95% confidence interval: 0.84–0.95; Kendall’s W concordance coefficient = 0.99; P < .001). Hospitals with good-concordance data did not differ from other hospitals in the institutional characteristics assessed. CONCLUSIONS: For a selected subset of hospitals, birth certificate data may offer a reasonable means to investigate hospital variation in NICU admissions.

Background People living with human immunodeficiency virus (HIV; PLWH) have a markedly elevated anal cancer risk, largely due to loss of immunoregulatory control of oncogenic human papillomavirus infection. To better understand anal cancer development and prevention, we determined whether recent, past, cumulative, or nadir/peak CD4+ T-cell count (CD4) and/or HIV-1 RNA level (HIV RNA) best predict anal cancer risk. Methods We studied 102 777 PLWH during 1996–2014 from 21 cohorts participating in the North American AIDS Cohort Collaboration on Research and Design. Using demographics-adjusted, cohort-stratified Cox models, we assessed associations between anal cancer risk and various time-updated CD4 and HIV RNA measures, including cumulative and nadir/peak measures during prespecified moving time windows. We compared models using the Akaike information criterion. Results Cumulative and nadir/peak CD4 or HIV RNA measures from approximately 8.5 to 4.5 years in the past were generally better predictors for anal cancer risk than their corresponding more recent measures. However, the best model included CD4 nadir (ie, the lowest CD4) from approximately 8.5 years to 6 months in the past (hazard ratio [HR] for Conclusions Our results are consistent with anal cancer promotion by severe, prolonged HIV-induced immunosuppression. Nadir and cumulative CD4 may represent useful markers for identifying PLWH at higher anal cancer risk.

Background This study aims to examine hospital variation in both maternal and neonatal morbidities and identify institutional characteristics associated with hospital performance in a combined measure of maternal and neonatal outcomes. Methods Using the California Linked Birth File containing data from birth certificate and hospital discharge records, we identified 1 322 713 term births delivered at 248 hospitals during 2010-2012. For each hospital, a risk-standardized rate of severe maternal morbidities and a risk-standardized rate of severe newborn morbidities were calculated after adjusting for patient clinical risk factors. Hospitals were ranked based on combined information on their maternal and newborn morbidity rates. Results Risk-standardized severe maternal and severe newborn morbidity rates varied substantially across hospitals (10th to 90th percentile range = 67.5-148.2 and 141.8-508.0 per 10 000 term births, respectively), although there was no significant association between the two (P = 0.15). Government hospitals (non-Federal) were more likely than other hospitals to be in worse rank quartiles (P value for trend = 0.004), whereas larger volume was associated with better rank among hospitals in the first three quartiles (P = 0.004). The most prevalent morbidities that differed progressively across hospital rank quartiles were severe hemorrhage, disseminated intravascular coagulation, and heart failure during procedure/surgery for mothers, and severe infection, respiratory complication, and shock/resuscitation for neonates. Conclusions Hospitals with low maternal morbidity rates may not have low neonatal morbidity rates and vice versa, highlighting the importance of assessing joint maternal-newborn outcomes in order to fully characterize a hospital's obstetrical performance. Hospitals with smaller volume and government ownership tend to have less desirable outcomes and warrant additional attention in future quality improvement efforts.

BACKGROUND Cutaneous melanoma incidence may be modestly elevated in people with HIV (PWH) vs. people without HIV. However, little is known about the relationship of immunosuppression, HIV replication, and antiretroviral therapy (ART) with melanoma risk. METHODS PWH of white race in the North American AIDS Cohort Collaboration on Research and Design were included. A standardized incidence ratio was calculated comparing risk with the white general population, standardizing by age, sex, and calendar period. Associations between melanoma incidence and current, lagged, and cumulative measures of CD4 count, HIV RNA level, and ART use were estimated with Cox regression, adjusting for established risk factors such as age and annual residential ultraviolet B (UVB) exposure. RESULTS Eighty melanomas were diagnosed among 33,934 white PWH (incidence = 40.75 per 100,000 person-years). Incidence was not elevated compared with the general population [standardized incidence ratio = 1.15, 95% confidence interval (95% CI) = 0.91 to 1.43]. Higher melanoma incidence was associated with older age [adjusted hazard ratio (aHR) per decade increase = 1.50, 95% CI = 1.20 to 1.89] and higher UVB exposure (aHR for exposure ≥35 vs.

Background Schizophrenia is a chronic disabling disorder for which current treatments are only partially effective. While the evaluation of novel interventions is a high priority, loss to follow-up is a major threat to validity. Methods Pattern mixture modeling is a statistical technique that incorporates information on patterns of retention that may bias comparisons between randomized treatment groups. This study used pattern mixture mixed model (PMMM) in the analysis of outcomes of a two-year cluster-randomized trial, the Recovery after an Initial Schizophrenia Episode-Early Treatment Program, which compared a coordinated specialty care intervention called NAVIGATE to usual community care (CC). PMM-adjusted outcome differences between NAVIGATE and CC were estimated by the weighted-average of effects across the retention patterns. Results Compared to the original analysis, PMMM improved model fit and the estimated effectiveness of NAVIGATE as compared to CC. On the Quality of Life Scale NAVIGATE effectiveness increased by 1.50 points (25.4%); on the Positive and Negative Syndrome Scale, by 1.72 points (39.8%), and on the Calgary Depression Scale by 0.49 points (62.1%). PMMM did not improve model fit for employment days, substance use days, or hospital days. Conclusion Use of PMMM improved model fit and increased the estimated differences between NAVIGATE and CC for major outcomes. Patients with differential retention patterns may have different outcome trajectories. PMMM is a useful tool for addressing potential biases arising from these differences.

Prostate-specific antigen (PSA) measurements after primary treatment reflect residual tumor burden among men with prostate cancer. Using a mixture model analysis, we identified distinct trajectories of post-treatment PSA measurements and evaluated their associations with prostate cancer mortality. The study sample included 623 US Veterans treated for prostate cancer with curative intent during 1991–1995; 225 men received surgery and 398 men received radiation therapy. Post-treatment PSA measurements over a 2-year period for each patient were evaluated in latent class mixture models using the SAS TRAJ procedure, and groups of men with distinct trajectories of PSA were identified. These groups were then assessed for associations with 10-year prostate cancer mortality using proportional hazards analysis. Analyses identified three distinct groups—representing patterns of both initial values and changes in PSA over time—after surgery (n=172/31/14) and radiation therapy (n=253/103/22). Men in groups with patterns of higher (compared with the group with lowest) PSA values tended to have worse survival experience: HRs for prostate cancer mortality were 3.45 (P=0.18) and 22.7 (P

OBJECTIVE:To estimate the prevalence of corpus uteri, cervix uteri, and ovarian malignancy in women undergoing hysterectomy or myomectomy for presumed benign indications.METHODS:We conducted a secondary analysis of data from the 2014–2015 American College of Surgeons National Surgical Quality Improv

Background and objectives Electronic alerts for heterogenous conditions such as AKI may not provide benefit for all eligible patients and can lead to alert fatigue, suggesting that personalized alert targeting may be useful. Uplift-based alert targeting may be superior to purely prognostic-targeting of interventions because uplift models assess marginal treatment effect rather than likelihood of outcome. Design, setting, participants, & measurements This is a secondary analysis of a clinical trial of 2278 adult patients with AKI randomized to an automated, electronic alert system versus usual care. We used three uplift algorithms and one purely prognostic algorithm, trained in 70% of the data, and evaluated the effect of targeting alerts to patients with higher scores in the held-out 30% of the data. The performance of the targeting strategy was assessed as the interaction between the model prediction of likelihood to benefit from alerts and randomization status. The outcome of interest was maximum relative change in creatinine from the time of randomization to 3 days after randomization. Results The three uplift score algorithms all gave rise to a significant interaction term, suggesting that a strategy of targeting individuals with higher uplift scores would lead to a beneficial effect of AKI alerting, in contrast to the null effect seen in the overall study. The prognostic model did not successfully stratify patients with regards to benefit of the intervention. Among individuals in the high uplift group, alerting was associated with a median reduction in change in creatinine of −5.3% (P=0.03). In the low uplift group, alerting was associated with a median increase in change in creatinine of +5.3% (P=0.005). Older individuals, women, and those with a lower randomization creatinine were more likely to receive high uplift scores, suggesting that alerts may benefit those with more slowly developing AKI. Conclusions Uplift modeling, which accounts for treatment effect, can successfully target electronic alerts for AKI to those most likely to benefit, whereas purely prognostic targeting cannot.

Objective To examine hospital variation in cost of childbirth hospitalizations and identify factors that contribute to the variation. Design Cross-sectional analysis of linked birth certificate and hospital discharge data. Setting 220 hospitals in California delivering ≥100 births per year. Population 405,908 nulliparous term singleton vertex births during 2010-2012. Methods Cost of childbirth hospitalizations was compared across hospitals after accounting for differences in patient clinical risk factors. Relative contribution of patient sociodemographic, obstetric intervention, birth attendant, and institutional characteristics to variation in cost was assessed by further adjusting for these factors in hierarchical generalized linear models. Main Outcome Measures Cost of childbirth hospitalization. Results Median risk-standardized cost of childbirth was $7,149 among the hospitals (10th-90th percentile range: $4,760-$10,644). Maternal sociodemographic characteristics and type of birth attendant did not explain hospital variation in cost. Adjustment for obstetric interventions overall reduced within-hospital variance by 15.8% (P