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The American Journal of the Medical... Jun 2024Idiopathic edema (IE) is a disease that occurs predominantly in women. It is characterized by increasing weight gain of > 1.4 kg from morning to night, increasing edema,... (Review)
Review
Idiopathic edema (IE) is a disease that occurs predominantly in women. It is characterized by increasing weight gain of > 1.4 kg from morning to night, increasing edema, increasing truncal and abdominal girth with bloating when assuming an upright position and nocturia that is unrelated to menses. There is an increase in morbidity but not mortality. Increased capillary membrane leakage appears to be the underlying pathophysiologic abnormality that explains the myriad of clinical presentations. We present 2 cases of life-threatening complications of IE that resulted in seizures related to acute hyponatremia in one and extreme postural dizziness and fainting induced by postural hypotension in the other. The first patient was successfully treated with salt restriction, timely use of furosemide and limitation of water intake; the other was successfully treated by use of support hose. Treatment of these patients required a fundamental understanding of the intricate pathophysiological consequences of a leaky capillary membrane, an understanding of Starling forces and detailing the effectiveness of a low salt diet, use of diuretics and limited water intake in one and why support hose would be beneficial in the other patient. Both patients experienced significant physical and emotional benefits that substantially improved quality of life.
PubMed: 38942171
DOI: 10.1016/j.amjms.2024.06.024 -
The Lancet. Oncology Jun 2024The standard of care for patients with intermediate-to-high risk renal cell carcinoma is partial or radical nephrectomy followed by surveillance. We aimed to investigate...
Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study.
BACKGROUND
The standard of care for patients with intermediate-to-high risk renal cell carcinoma is partial or radical nephrectomy followed by surveillance. We aimed to investigate use of nivolumab before nephrectomy followed by adjuvant nivolumab in patients with high-risk renal cell carcinoma to determine recurrence-free survival compared with surgery only.
METHODS
In this open-label, randomised, phase 3 trial (PROSPER EA8143), patients were recruited from 183 community and academic sites across the USA and Canada. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1, with previously untreated clinical stage T2 or greater or T N+ renal cell carcinoma of clear cell or non-clear cell histology planned for partial or radical nephrectomy. Selected patients with oligometastatic disease, who were disease free at other disease sites within 12 weeks of surgery, were eligible for inclusion. We randomly assigned (1:1) patients using permuted blocks (block size of 4) within stratum (clinical TNM stage) to either nivolumab plus surgery, or surgery only followed by surveillance. In the nivolumab group, nivolumab 480 mg was administered before surgery, followed by nine adjuvant doses. The primary endpoint was investigator-reviewed recurrence-free survival in patients with renal cell carcinoma assessed in all randomly assigned patients regardless of histology. Safety was assessed in all randomly assigned patients who started the assigned protocol treatment. This trial is registered with ClinicalTrials.gov, NCT03055013, and is closed to accrual.
FINDINGS
Between Feb 2, 2017, and June 2, 2021, 819 patients were randomly assigned to nivolumab plus surgery (404 [49%]) or surgery only (415 [51%]). 366 (91%) of 404 patients assigned to nivolumab plus surgery and 387 (93%) of 415 patients assigned to surgery only group started treatment. Median age was 61 years (IQR 53-69), 248 (30%) of 819 patients were female, 571 (70%) were male, 672 (88%) were White, and 77 (10%) were Hispanic or Latino. The Data and Safety Monitoring Committee stopped the trial at a planned interim analysis (March 25, 2022) because of futility. Median follow-up was 30·4 months (IQR 21·5-42·4) in the nivolumab group and 30·1 months (21·9-41·8) in the surgery only group. 381 (94%) of 404 patients in the nivolumab plus surgery group and 399 (96%) of 415 in the surgery only group had renal cell carcinoma and were included in the recurrence-free survival analysis. As of data cutoff (May 24, 2023), recurrence-free survival was not significantly different between nivolumab (125 [33%] of 381 had recurrence-free survival events) versus surgery only (133 [33%] of 399; hazard ratio 0·94 [95% CI 0·74-1·21]; one-sided p=0·32). The most common treatment-related grade 3-4 adverse events were elevated lipase (17 [5%] of 366 patients in the nivolumab plus surgery group vs none in the surgery only group), anaemia (seven [2%] vs nine [2%]), increased alanine aminotransferase (ten [3%] vs one [<1%]), abdominal pain (four [1%] vs six [2%]), and increased serum amylase (nine [2%] vs none). 177 (48%) patients in the nivolumab plus surgery group and 93 (24%) in the surgery only group had grade 3-5 adverse events due to any cause, the most common of which were anaemia (23 [6%] vs 19 [5%]), hypertension (27 [7%] vs nine [2%]), and elevated lipase (18 [5%] vs six [2%]). 48 (12%) of 404 patients in the nivolumab group and 40 (10%) of 415 in the surgery only group died, of which eight (2%) and three (1%), respectively, were determined to be treatment-related.
INTERPRETATION
Perioperative nivolumab before nephrectomy followed by adjuvant nivolumab did not improve recurrence-free survival versus surgery only followed by surveillance in patients with high-risk renal cell carcinoma.
FUNDING
US National Institutes of Health National Cancer Institute and Bristol Myers Squibb.
PubMed: 38942046
DOI: 10.1016/S1470-2045(24)00211-0 -
Gynecologic Oncology Jun 2024Mirvetuximab soravtansine may be a potentially effective therapeutic option for ovarian low-grade serous carcinoma (LGSC), but the prevalence of folate receptor alpha...
OBJECTIVE
Mirvetuximab soravtansine may be a potentially effective therapeutic option for ovarian low-grade serous carcinoma (LGSC), but the prevalence of folate receptor alpha (FRα) overexpression in this tumor type is unknown. We sought to characterize FRα expression in LGSC and its association with clinical and molecular features.
METHODS
FRα immunohistochemistry was performed on a tissue microarray comprised of 89 LGSCs and 42 ovarian serous borderline tumors (SBTs). Clinical tumor-normal panel-based sequencing was performed on 78 LGSCs. Associations between FRα-high status and clinicopathologic characteristics and survival outcomes were examined.
RESULTS
Of 89 LGSCs, 36 (40%) were FRα-high (≥75% of viable tumor cells exhibiting moderate-to-strong membranous expression). Of 9 patients with LGSC and samples from different timepoints, 4 (44%) had discordant results, with conversion from FRα-negative to FRα-high in 3 (33%) cases. There was no association between FRα-high status with age, race, or progression-free/overall survival. A MAPK pathway genetic alteration, most commonly involving KRAS (n = 23), was present in 45 (58%) LGSCs. Those lacking MAPK pathway alterations were more likely to be FRα-high compared to MAPK-altered LGSCs (61% vs 20%, p < 0.001). In SBTs, FRα-high expression was associated with high-risk (micropapillary) histology and/or subsequent LGSC recurrence compared to conventional SBTs without malignant recurrence (53% vs 9%, p = 0.008).
CONCLUSIONS
Future studies of FRα-directed therapy in patients with LGSC are warranted. Discordant FRα status at recurrence suggests potential benefit for retesting. A biomarker-driven approach to direct treatment selection in LGSC is recommended. As high FRα expression is more common amongst tumors lacking MAPK pathway genetic alterations, FRα testing to determine eligibility for mirvetuximab soravtansine therapy is particularly recommended for this subgroup.
PubMed: 38941962
DOI: 10.1016/j.ygyno.2024.06.008 -
Injury Jun 2024
Both the level of lumbar fixation as well as the type of triangular construct should be adapted on an individual basis during spinopelvic fixation for unstable U-shaped sacral fractures and Tile C pelvic ring disruptions.
PubMed: 38941911
DOI: 10.1016/j.injury.2024.111703 -
The Journal of Surgical Research Jun 2024Firearm-related suicides among children present a significant public health concern and a tragic loss of young lives. This study explores the relationship between...
INTRODUCTION
Firearm-related suicides among children present a significant public health concern and a tragic loss of young lives. This study explores the relationship between firearm-related suicides, gun ownership, and state-specific gun laws.
METHODS
This retrospective cohort study collected data from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research on children under 18 who died by firearm-related suicides between 2009 and 2016 in all 50 states and D.C. It also utilized data from the RAND State-Level Estimates of Household Firearm Ownership. The study focused on the rate of child firearm suicide deaths per 100,000 individuals. The key variable of interest was the percentage of guns owned per household in each state. Univariable analysis was conducted to examine the association between individual gun laws and child firearm suicide mortalities, while multivariable regression, adjusting for household gun ownership and significant firearm legislation, was employed to assess connection to child firearm suicide mortality.
RESULTS
From 2009 to 2016, 3903 children died from firearm-related suicides in the United States. In our analysis, 15 out of 44 firearm laws were found to be associated with reducing the rates of firearm suicides among children (P < 0.05). However, multivariable regression showed that higher state gun ownership rates were the primary predictor of increased child fatalities from firearms, with children in such states being 325% more likely to die when analyzing handgun laws and 337% more likely when analyzing long gun laws, as indicated by coefficients of 4.25 and 4.37, respectively. No state laws alone notably improved death rates.
CONCLUSIONS
Gun ownership has a stronger association with child suicide rates than state-specific gun laws. Given the weight of gun ownership, future research should prioritize comprehensive public health initiatives to prevent child firearm-related suicides.
PubMed: 38941715
DOI: 10.1016/j.jss.2024.04.066 -
Health & Place Jun 2024Traditional planning processes have perpetuated the exclusion of historically marginalized communities, imposing vulnerability to climate (health) crises. We investigate...
Exploring ownership of change and health equity implications in neighborhood change processes: A community-led approach to enhancing just climate resilience in Everett, MA.
Traditional planning processes have perpetuated the exclusion of historically marginalized communities, imposing vulnerability to climate (health) crises. We investigate how ownership of change fosters equitable climate resilience and community well-being through participatory action research. Our study highlights the detrimental effects of climate gentrification on community advocacy for climate security and health, negatively impacting well-being. We identify three key processes of ownership of change: ownership of social identity, development and decision-making processes, and knowledge. These approaches emphasize community-led solutions to counter climate health challenges and underscore the interdependence of social and environmental factors in mental health outcomes in climate-stressed communities.
PubMed: 38941653
DOI: 10.1016/j.healthplace.2024.103294 -
Quality Management in Health CarePatient experience is a key factor in measuring hospital performance, and the Hospital Consumer Assessment of Healthcare Providers and Systems survey tool is used to...
BACKGROUND AND OBJECTIVES
Patient experience is a key factor in measuring hospital performance, and the Hospital Consumer Assessment of Healthcare Providers and Systems survey tool is used to assess patient perceptions. Hospitals with positive patient experience tend to have a better quality of clinical care, lower readmission and mortality rates, and an overall shorter inpatient length of stay. Studies have identified several organizational determinants of high- and low-rated patient experiences, including hospital size, type, staffing levels, and patient demographics.This study aims to explore the determinants of consistently high- and low-rated patient experience, as well as factors associated with positive and negative changes in patient experience over time.
METHOD
The 2014 to 2019 American Hospital Association annual survey and the Centers for Medicare and Medicaid Services Hospital Value-Based Purchasing database were used. A total of 2801 acute-care hospitals were included in this study. A series of multivariate logistic regressions were used to model the probability of "1" (being a superior hospital or an inferior hospital). In addition, a generalized linear mixed model for binary responses was used to analyze the change (probability of positive and negative change).
RESULTS
The results showed that most hospitals did not sustain superior or inferior performance, and competition decreased the likelihood of a hospital consistently performing well in terms of patient experience. Superior performance was associated with hospital ownership (P < .001), size (P = .026), location (P = .002), teaching status (P = .009), average Herfindahl-Hirschman Index value (P = .005), and Medicaid and Medicare patient population. On the other hand, inferior performance was associated with hospital ownership (P = .003), size (P < .001), teaching status (P = .003), safety net status (P = .020), and Medicaid and Medicare patient population.
CONCLUSION
This study aimed to examine the trends in hospital patient experience performance and the influence of hospital organizational characteristics on those trends. Our findings allow us to question the widely held belief that patient experience is a metric of differentiation and industry competition, suggesting that performance in this domain has not been utilized by most hospitals as a source of sustainable competitive advantage. The findings from this study highlight the importance of considering changes in performance over time and the need for significant organizational efforts to improve hospital performance in terms of patient experience.
Topics: Humans; United States; Patient Satisfaction; Hospitals; Quality of Health Care; Surveys and Questionnaires
PubMed: 38941580
DOI: 10.1097/QMH.0000000000000470 -
PloS One 2024Many have argued that discrimination against pit bulls is rooted in the breed's association with Black owners and culture. We theoretically and empirically interrogate...
Many have argued that discrimination against pit bulls is rooted in the breed's association with Black owners and culture. We theoretically and empirically interrogate that argument in a variety of ways and uncover striking similarities between the racialization of pit bulls and other racialized issues (e.g., poverty and crime) in public opinion and policy implementation. After detailing the reasons to expect pit bulls to be racialized as Black despite dog ownership in the U.S. generally being raced as white, the article shows: (1) Most Americans associate pit bulls with Black people. (2) Anti-Black attitudes, in general, are significant, independent, predictors of both anti-pit views and of preferring other breeds over them; (3) stereotypes of Black men as violent, in particular, are significant, independent, predictors of both anti-pit views and of preferring other breeds over them. (4) Implicit racialization through a national survey experiment further eroded support for legalizing pits, with the treatment effect significantly conditioned by respondent's race. And (5) state-level racial prejudice is a significant negative predictor of enacting legislation to preempt breed-specific bans. We conclude with our findings' broader insights into the nature of U.S. racial politics. Michael Tesler, [email protected], corresponding author, is Professor of Political Science at UC Irvine; Mary McThomas, [email protected], is Associate Professor of Political Science at UC Irvine. An earlier version of this paper was presented at the American Political Science Association's annual meeting. We thank Maneesh Arora, Rachel Bernhard, Nathan Chan, Louis Pickett, David Sears, DeSipio, Adam Duberstein, Jane Junn, Claire Kim, Jessica Manforti, J. Scott Matthews, Justin.
Topics: Animals; Dogs; Humans; Racism; Politics; Male; United States; Black or African American; Public Opinion; Female; Attitude
PubMed: 38941314
DOI: 10.1371/journal.pone.0305959 -
Journal of Primary Health Care Jun 2024Introduction From a coronavirus disease (COVID-19) pandemic perspective, Aotearoa New Zealand (NZ) rural residents formed an at-risk population, and disparities between...
He Aroka Urutā. Rural health provider perspectives of the COVID-19 vaccination rollout in rural Aotearoa New Zealand with a focus on Māori and Pasifika communities: a qualitative study.
Introduction From a coronavirus disease (COVID-19) pandemic perspective, Aotearoa New Zealand (NZ) rural residents formed an at-risk population, and disparities between rural and urban COVID-19 vaccination coverage have been found. Aim To gain insight into factors contributing to the urban-rural COVID-19 vaccination disparity by exploring NZ rural health providers' experiences of the vaccine rollout and pandemic response in rural Māori and Pasifika communities. Methods Rural health providers at four sites participated in individual or focus group semi-structured interviews exploring their views of the COVID-19 vaccine rollout. Thematic analysis was undertaken using a framework-guided rapid analysis method. Results Twenty interviews with 42 participants were conducted. Five themes were identified: Pre COVID-19 rural situation, fragile yet resilient; Centrally imposed structures, policies and solutions - urban-centric and Pakehā focused; Multiple logistical challenges - poor/no consideration of rural context in planning stages resulting in wasted resource and time; Taking ownership - rural providers found geographically tailored, culturally anchored and locally driven solutions; Future directions - sustained investment in rural health services, including funding long-term integrated (rather than 'by activity') health services, would ensure success in future vaccine rollouts and other health initiatives for rural communities. Discussion In providing rural health provider perspectives from rural areas serving Māori and Pasifika communities during the NZ COVID-19 vaccine rollout, the importance of the rural context is highlighted. Findings provide a platform on which to build further research regarding models of rural health care to ensure services are designed for rural NZ contexts and capable of meeting the needs of diverse rural communities.
Topics: Humans; New Zealand; COVID-19 Vaccines; COVID-19; Qualitative Research; Native Hawaiian or Other Pacific Islander; Rural Health Services; Rural Population; SARS-CoV-2; Female; Health Personnel; Interviews as Topic; Male; Focus Groups; Healthcare Disparities; Attitude of Health Personnel; Pandemics; Adult; Maori People
PubMed: 38941251
DOI: 10.1071/HC23171 -
Public Health Research (Southampton,... Jun 2024Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being.
OBJECTIVE
The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils' social and emotional well-being.
DESIGN
This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package).
SETTING
The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools.
PARTICIPANTS
A total of 2639 pupils in Scotland.
INTERVENTION
The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist).
MAIN OUTCOME MEASURE
The primary outcome was pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline.
RESULTS
The primary outcome, pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk -1.30 (95% confidence interval -1.87 to -0.73), standardised effect size -0.27 (95% confidence interval -0.39 to -0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk -2.36 (95% confidence interval -3.62 to -1.11), standardised effect size -0.42 (95% confidence interval -0.64 to -0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice.
LIMITATIONS
It was a challenge to retain schools over five waves of data collection.
CONCLUSIONS
This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions.
FUTURE WORK
Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions.
TRIAL REGISTRATION
This trial is registered as ISRCTN51707384.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in ; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.
Topics: Humans; Child; Male; Female; Scotland; Schools; Child, Preschool; Emotions; Surveys and Questionnaires; Cluster Analysis; School Health Services; Cost-Benefit Analysis
PubMed: 38940833
DOI: 10.3310/LYRQ5047