ELEVATE - evaluating Temozolomide and Nivolumab in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma with MGMT methylation: study protocol for a single arm phase II trial.

BACKGROUND: For patients with oesophagogastric adenocarcinoma, surgery is the only curative option and despite the use of multimodality therapy, which combines it with chemotherapy and/or radiotherapy, more than 50% of patients will relapse and die. Many UK patients present with advanced disease which is already inoperable or metastatic at diagnosis. For these patients, standard care chemotherapy only offers them survival of less than a year. Nivolumab, a checkpoint blockade inhibitor, has been found to work in some advanced cancers. It is proposed, for those where immunotherapy hasn't worked, that these immunologically evasive tumours need to be sensitized to immunotherapy drugs to allow them to act. METHODS: ELEVATE is a single arm phase II trial testing the overall response to nivolumab following temozolomide treatment in patients with advanced unresectable previously treated adenocarcinoma which is O6-methylguanine-DNA-methyltransferase (MGMT) methylated. 18 patients are being recruited from UK secondary care sites. To be eligible, participants must have been treated with at least 3 months of platinum and fluoropyrimidine chemotherapy. Participants will receive 50 mg/m2 temozolomide continuously for 3 months. If their disease progresses during the 3 months, they will stop temozolomide and start nivolumab at a dose of 240mg every 2 weeks. If there is no progression after 3 months the participant will continue taking temozolomide in combination with nivolumab. All treatment will stop once the participant progresses on nivolumab. The primary endpoint is the best overall response to nivolumab, using both Response Evaluation Criteria in Solid Tumours version 1.1 and immunotherapy modified Response Evaluation Criteria in Solid Tumours. Secondary endpoints include progression-free survival, overall survival, and quality of life. DISCUSSION: ELEVATE will provide evidence for whether giving nivolumab after temozolomide in patients with previously treated advanced oesophagogastric adenocarcinoma is safe and biologically effective prior to future randomised trials. TRIAL REGISTRATIONS: EudraCT Number: 2020-004771-41 (issued 01 October 2020); ISCRTN11398887 (registered 14 July 2021).

State Policies And Enrollees' Experiences In Medicaid: Evidence From A New National Survey.

Medicaid provides health insurance to more than seventy million Americans, yet there has been little systematic analysis of what factors influence enrollees' satisfaction with and access to care. Using a nationally representative survey of more than 270,000 Medicaid enrollees in 2014-15, we examined the consumer perspective on care in Medicaid. Average satisfaction ratings were 7.9 out of 10.0, but there were significant disparities across racial/ethnic groups. Satisfaction and access measures were generally similar among enrollees in managed care versus fee-for-service Medicaid. Access was significantly better in states where more physicians per capita accepted Medicaid patients: A one-standard-deviation increase in participating physicians per 100,000 population was associated with a 4.6-percentage-point increase in having a personal doctor. This was particularly true in fee-for-service Medicaid, and measures of physicians per capita were stronger predictors of patient experience than the simple percentage of doctors who accept Medicaid. Among those in Medicaid managed care, greater spending per enrollee was a significant predictor of satisfaction and access. Our findings emphasize that physician availability makes a difference in patients' experiences in Medicaid, and they indicate that racial/ethnic disparities in those experiences persist even among a uniformly insured population.

Adverse Events and Patient Outcomes Among Hospitalized Children Cared for by General Pediatricians vs Hospitalists.

Importance: Pediatric hospital medicine is a relatively new and growing specialty. However, research remains inconclusive on outcomes for inpatients cared for by pediatric hospitalists compared with those cared for by general pediatricians. Objective: To analyze outcomes, adverse events (AEs), and types of AEs associated with care provided for pediatric patients by hospitalists vs general pediatricians. Design, Setting, and Participants: This cross-sectional study used data from the medical records of a US urban academic children's hospital comprising 1423 hospitalizations between January 1, 2009, and August 31, 2015, for 57 diagnoses of patients cared for by either a hospitalist or general pediatrician. General pediatricians worked primarily in the hospital's outpatient clinic, serving a few inpatient weeks per year, and were not the patients' primary care physician. Data analysis was performed from July 1, 2017, to October 10, 2018. Main Outcomes and Measures: Outcomes were length of stay, total costs, 30-day readmission rates, and AEs. Adverse events were documented by International Classification of Diseases, Ninth Revision, Clinical Modification codes determined by review of medical records. Adverse event categories were drug events, infections, and device-related AEs. Generalized linear models were used to analyze patient outcomes, with standard errors clustered by physician. Models were adjusted for patient characteristics, including Chronic Condition Indicators. Models were estimated with and without adjustment for physician characteristics. Results: The data set contained 1423 hospitalizations among 726 female patients and 697 male patients (mean [SD] age, 6.1 [6.3] years). Hospitalists cared for 870 patients, and general pediatricians cared for 553 patients. Among the physicians, there were 57 women and 38 men; physicians were a mean (SD) 11.1 (8.1) years out of medical school. Patients cared for by general pediatricians were younger than those cared for by hospitalists (mean [SD] age, 5.4 [6.0] vs 6.5 [6.4] years; P = .001) but had similar mean (SD) Chronic Condition Indicator scores (1.5 [1.0] vs 1.5 [1.0]). A total of 33 of 56 general pediatricians (58.9%) and 24 of 39 hospitalists (61.5%) were women (P = .006), and general pediatricians were in practice twice as long as hospitalists on average (mean [SD], 16.0 [10.3] vs 7.9 [3.8] years out of medical school; P < .001). In multivariate models adjusting for patient-level features, there were no significant differences between general pediatricians and hospitalists for mean length of stay (4.7 vs 4.6 days), total costs ($14 490 vs $15 200), and estimated 30-day readmission rate (8.9% vs 6.4%), and results were similar with adjustments for physician characteristics. Device-related AEs were higher among hospitalists (3.0% vs 1.1%; odds ratio, 0.34; 95% CI, 0.12-1.00); this association became nonsignificant after adjusting for physician experience. Conclusions and Relevance: General pediatrician and hospitalist inpatient care had similar length of stay, total costs, and readmission rates. However, AEs differed between hospitalists and general pediatricians, with device-related AEs more common among hospitalists, which may be associated with hospitalists' fewer years in practice. Such findings can inform hospitals in planning their inpatient staffing and patient safety oversight.

Hospitalization rates in female US Army recruits associated with a screening program for Chlamydia trachomatis.

BACKGROUND: A volunteer program to test non-healthcare-seeking women for genital Chlamydia trachomatis infection was instituted at the US Army's largest basic training center and evaluated for its effectiveness in reducing sequelae. GOAL: To compare hospitalization rates between women with positive test results for C trachomatis and those with negative results, and between women tested and those not tested for C trachomatis. STUDY DESIGN: For this study, 28,074 women who entered the Army in 1996 and 1997 were followed for hospitalizations through December 1998. Of these women, 7053 were tested for C trachomatis, and 21,021 were not screened. Hospital admissions were calculated per person-year, and adjusted relative risks were determined. RESULTS: The overall prevalence of C trachomatis in the screened group was 9.1%. The relative risk of hospitalization for pelvic inflammatory disease in the screened cohort was 0.94 (95% CI, 0.69-1.29), as compared with those not screened. The relative risk of hospitalization for any reason was 0.94 (95% CI, 0.90-0.99). Among women screened, no difference was found in pelvic inflammatory disease hospitalizations between women with positive test results who were being treated for C trachomatis and those with negative test results. CONCLUSIONS: The investigated C trachomatis intervention program for female Army recruits was associated with a lower overall hospitalization rate in screened volunteers, as compared with unscreened women. The pelvic inflammatory disease hospitalization rate in women with C trachomatis who were screened and treated was similar to that observed in uninfected women.