BMJ. 2023 May 3;381:e073538. doi: 10.1136/bmj-2022-073538.
NO ABSTRACT
PMID:37137496 | DOI:10.1136/bmj-2022-073538
Tag: statistics
J Matern Fetal Neonatal Med. 2023 Dec;36(1):2208251. doi: 10.1080/14767058.2023.2208251.
ABSTRACT
OBJECTIVE: Severe preeclampsia diagnosed at or prior to 34 weeks is an indication for preterm delivery. Many patients with severe preeclampsia develop fetal growth restriction as a result of the placental dysfunction associated with both conditions. The ideal mode of delivery in cases of preterm severe preeclampsia with fetal growth restriction remains controversial, with providers often proceeding directly to cesarean delivery rather than attempting a trial of labor due to theoretic concerns about the harms of labor in the face of placental dysfunction. There are limited data supporting this approach. This study evaluates whether the presence of fetal growth restriction affects the ultimate mode of delivery or neonatal outcomes among pregnancies with severe preeclampsia undergoing induction of labor at or before 34 weeks.
METHODS: This was a retrospective cohort study of singletons with severe preeclampsia undergoing induction of labor ≤ 34 weeks at a single center between January 2015 and April 2022. The primary predictor was fetal growth restriction, defined as estimated fetal weight < 10th percentile for gestational age on ultrasound. Mode of delivery and neonatal outcomes were compared between those with and without fetal growth restriction using Fisher’s exact and Kruskal-Wallis tests, and multivariate logistic regression was used to obtain adjusted odds ratios.
RESULTS: 159 patients were included (N = 117 without fetal growth restriction, N = 42 with fetal growth restriction). There was no difference in vaginal delivery between the groups (70% vs 67%, p = .70). While those with fetal growth restriction had a higher incidence of respiratory distress syndrome and longer neonatal hospital stay, these differences were not statistically significant after adjusting for gestational age at delivery. There were no significant differences in other neonatal outcomes, including Apgar score, cord blood gases, intraventricular hemorrhage, necrotizing enterocolitis, neonatal sepsis, and neonatal demise.
CONCLUSION: For pregnancies complicated by severe preeclampsia that require delivery ≤ 34 weeks, the likelihood of successful vaginal delivery following induction of labor does not differ based on presence of fetal growth restriction. Furthermore, fetal growth restriction is not an independent risk factor for adverse neonatal outcomes in this population. Induction of labor should be considered a reasonable approach and should be routinely offered to patients with concurrent preterm severe preeclampsia and fetal growth restriction.
PMID:37137495 | DOI:10.1080/14767058.2023.2208251
BMJ. 2023 May 3;381:e074778. doi: 10.1136/bmj-2023-074778.
ABSTRACT
OBJECTIVES: To evaluate the risks of any menstrual disturbance and bleeding following SARS-CoV-2 vaccination in women who are premenopausal or postmenopausal.
DESIGN: A nationwide, register based cohort study.
SETTING: All inpatient and specialised outpatient care in Sweden from 27 December 2020 to 28 February 2022. A subset covering primary care for 40% of the Swedish female population was also included.
PARTICIPANTS: 2 946 448 Swedish women aged 12-74 years were included. Pregnant women, women living in nursing homes, and women with history of any menstruation or bleeding disorders, breast cancer, cancer of female genital organs, or who underwent a hysterectomy between 1 January 2015 and 26 December 2020 were excluded.
INTERVENTIONS: SARS-CoV-2 vaccination, by vaccine product (BNT162b2, mRNA-1273, or ChAdOx1 nCoV-19 (AZD1222)) and dose (unvaccinated and first, second, and third dose) over two time windows (one to seven days, considered the control period, and 8-90 days).
MAIN OUTCOME MEASURES: Healthcare contact (admission to hospital or visit) for menstrual disturbance or bleeding before or after menopause (diagnosed with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes N91, N92, N93, N95).
RESULTS: 2 580 007 (87.6%) of 2 946 448 women received at least one SARS-CoV-2 vaccination and 1 652 472 (64.0%) 2 580 007 of vaccinated women received three doses before the end of follow-up. The highest risks for bleeding in women who were postmenopausal were observed after the third dose, in the one to seven days risk window (hazard ratio 1.28 (95% confidence interval 1.01 to 1.62)) and in the 8-90 days risk window (1.25 (1.04 to 1.50)). The impact of adjustment for covariates was modest. Risk of postmenopausal bleeding suggested a 23-33% increased risk after 8-90 days with BNT162b2 and mRNA-1273 after the third dose, but the association with ChAdOx1 nCoV-19 was less clear. For menstrual disturbance or bleeding in women who were premenopausal, adjustment for covariates almost completely removed the weak associations noted in the crude analyses.
CONCLUSIONS: Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal. These findings do not provide substantial support for a causal association between SARS-CoV-2 vaccination and healthcare contacts related to menstrual or bleeding disorders.
PMID:37137493 | DOI:10.1136/bmj-2023-074778
Eur J Haematol. 2023 May 3. doi: 10.1111/ejh.13987. Online ahead of print.
ABSTRACT
BACKGROUND: Evidence regarding health-related quality of life (HRQoL) in patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD) is lacking. Evaluating HRQoL was a secondary objective of the HOVON 113 MSC trial. Here we describe the outcomes of the EQ-5D-5L, EORTC QLQ-C30, and FACT-BMT for all adult patients who completed these questionnaires at baseline (i.e., before the start of treatment; n = 26).
METHODS: Descriptive statistics were used to describe baseline patient and disease characteristics, EQ-5D dimension scores and values, EQ VAS scores, EORTC QLQ-C30 scale/item and summary scores, and FACT-BMT subscale and total scores.
RESULTS: The mean EQ-5D value was 0.36. In total, 96% of the patients reported problems with usual activities, 92% with pain/discomfort, 84% with mobility, 80% with self-care, and 72% with anxiety/depression. The mean EORTC QLQ-C30 summary score was 43.50. Mean scale/item scores ranged from 21.79 to 60.00 for functioning scales, from 39.74 to 75.21 for symptom scales, and from 5.33 to 91.67 for single items. The mean FACT-BMT total score was 75.31. Mean subscale scores ranged from 10.09 for physical well-being to 23.94 for social/family well-being.
CONCLUSION: Our study showed that HRQoL in patients with SR-aGvHD is poor. Improving HRQoL and symptom management in these patients should be a top priority.
PMID:37137484 | DOI:10.1111/ejh.13987
South Med J. 2023 May;116(5):410-414. doi: 10.14423/SMJ.0000000000001554.
ABSTRACT
OBJECTIVE: The purpose of this study was to describe the local communities served by major teaching hospitals.
METHODS: Using a dataset of hospitals around the United States provided by the Association of American Medical Colleges, we identified major teaching hospitals (MTHs) using the Association of American Medical Colleges’ definition of those with an intern-to-resident bed ratio above 0.25 and more than 100 beds. We defined the local geographic market surrounding these hospitals as the Dartmouth Atlas hospital service area (HSA). Using MATLAB R2020b software, data from each ZIP Code Tabulation Area from the US Census Bureau’s 2019 American Community Survey 5-Year Estimate Data tables were grouped by HSA and attributed to each MTH. One-sample t tests were used to evaluate for statistical differences between the HSAs and the US average data. We further stratified the data into regions as defined by the US Census Bureau: West, Midwest, Northeast, and South. One-sample t tests were used to evaluate for statistical differences between MTH HSA regional populations with their respective US regional population.
RESULTS: The local population surrounding 299 unique MTHs covered 180 HSAs and was 57% White, 51% female, 14% older than 65 years old, 37% with public insurance coverage, 12% with any disability, and 40% with at least a bachelor’s degree. Compared with the overall US population, HSAs surrounding MTHs had higher percentages of female residents, Black/African American residents, and residents enrolled in Medicare. In contrast, these communities also showed higher average household and per capita income, higher percentages of bachelor’s degree attainment, and lower rates of any disability or Medicaid insurance.
CONCLUSIONS: Our analysis suggests that the local population surrounding MTHs is representative of the wide-ranging ethnic and economic diversity of the US population that is advantaged in some ways and disadvantaged in others. MTHs continue to play an important role in caring for a diverse population. To support and improve policy related to the reimbursement of uncompensated care and care of underserved populations, researchers and policy makers must work to better delineate and make transparent local hospital markets.
PMID:37137475 | DOI:10.14423/SMJ.0000000000001554
South Med J. 2023 May;116(5):405-409. doi: 10.14423/SMJ.0000000000001557.
ABSTRACT
OBJECTIVES: Recent disease modeling suggests that pandemics are likely to increase in frequency and severity. As such, medical educators must learn from their experiences with coronavirus disease 2019 (COVID-19) to develop systematic strategies for ensuring that medical students receive hands-on training in the management of emerging diseases. Here, we outline the process by which the Florida International University Herbert Wertheim College of Medicine developed and updated guidelines for student participation in the care of patients with COVID-19 and report on students’ experiences.
METHODS: During the 2020-2021 academic year, Florida International University Herbert Wertheim College of Medicine students were not permitted to care for patients with COVID-19; however, academic year 2021-2022 guidelines did permit fourth-year students on subinternships or Emergency Medicine rotations to voluntarily care for patients with COVID-19. At the end of the 2021-2022 academic year, students completed an anonymous survey about their experience caring for patients with COVID-19. Likert-type and multiple-choice questions were analyzed using descriptive statistics and the short-answer responses were analyzed qualitatively.
RESULTS: One hundred two students (84%) responded to the survey. Sixty-four percent of respondents opted to provide care for patients with COVID-19. Most students (63%) cared for patients with COVID-19 during their required Emergency Medicine Selective. Twenty-eight percent of students wished they had more COVID-19 patient care opportunities, and 29% did not feel prepared to care for patients with COVID-19 on their first day of residency.
CONCLUSIONS: Many graduating students felt unprepared to care for patients with COVID-19 during residency and many wished they had had more opportunities to care for patients with COVID-19 during medical school. Curricular policies must evolve to allow students to gain competency in the care of patients with COVID-19 so that they are prepared for day one of residency.
PMID:37137474 | DOI:10.14423/SMJ.0000000000001557
Environ Res. 2023 May 1:115983. doi: 10.1016/j.envres.2023.115983. Online ahead of print.
ABSTRACT
The bio-based nanoparticles synthesis and assessment of their potential biomedical applications related research is rapidly emerging. The ability of an aqueous ethanolic bark extract of Mangifera indica to synthesize silver nanoparticles (AgNPs) as well as its antibacterial, anti-inflammatory, and anticancer activities were investigated in this study. Interestingly, the bark extract effectively synthesized the AgNPs, including an absorbance peak at 412 nm and sizes ranging from 56 to 89 nm. The Fourier Transform Infrared spectroscopy (FTIR) analysis confirmed that the presence of most essential functional groups belongs to the most bioactive compounds. Synthesized AgNPs showed fine antibacterial activity against the Urinary Tract Infection (UTI) causing bacterial pathogens such as Escherichia coli, Enterococcus faecalis, Klebsiella pneumoniae, Proteus mirabilis, and Staphylococcus saprophyticus at 50 μg mL-1 concentrations. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of AgNPs against these pathogens were found as 12.5 ± 0.8 & 13 ± 0.6, 13.6 ± 0.5 & 14 ± 0.7, 11.5 ± 0.3 & 11.5 ± 0.4, 13 ± 0.8 & 13 ± 0.7, and 11.8 ± 0.4 & 12 ± 0.8 μg mL-1 respectively. Interestingly, this AgNPs also possesses outstanding anti-inflammatory and anticancer activities as studied against the egg albumin denaturation (85%) inhibition and MCF 7 (Michigan Cancer Foundation-7: breast cancer cells) cell line (cytotoxicity: 80.1%) at 50 μg mL-1 concentration. Similarly at 50 μg mL-1 concentration showed 75% of DPPH radical scavenging potential. These activities were dose dependent, and the findings suggest that the M. indica bark aqueous ethanolic extract synthesized AgNPs can be used as antibacterial, anti-inflammatory, and anticancer agents after in-vivo testing.
PMID:37137456 | DOI:10.1016/j.envres.2023.115983
Int J Radiat Oncol Biol Phys. 2023 May 1:S0360-3016(23)00371-1. doi: 10.1016/j.ijrobp.2023.04.010. Online ahead of print.
ABSTRACT
BACKGROUND/PURPOSE: Intermediate-risk prostate cancer is a heterogeneous disease state with diverse treatment options. The 22-gene Decipher genomic classifier (GC) retrospectively has shown to improve risk stratification in these patients. Herein, we assess the performance of the GC in men with intermediate-risk disease enrolled on xxxx with updated follow-up.
METHODS: After National Cancer Institute approval, biopsy slides were collected from xxxx, a randomized phase III trial of men with intermediate-risk prostate cancer randomized to 70.2 Gy vs 79.2 Gy of radiotherapy without androgen deprivation therapy. RNA was extracted from the highest-grade tumor foci to generate the locked 22-gene GC model. The primary endpoint for this ancillary project was disease progression (composite of biochemical-, local-failure, distant metastasis, prostate cancer-specific mortality, and use of salvage therapy). Individual endpoints were also assessed. Fine-Gray or cause-specific Cox multivariable models were constructed adjusting for randomization arm and trial stratification factors.
RESULTS: Two-hundred and fifteen patient samples passed quality control for analysis. The median follow-up was 12.8 years (range 2.4-17.7). On multivariable analysis, the 22-gene GC (per 0.1 unit) was independently prognostic for disease progression (subdistribution hazard ratio [sHR] 1.12, 95%CI 1.00-1.26, p=0.04), biochemical failure (sHR 1.22, 95%CI 1.10-1.37, p<0.001), distant metastasis (sHR 1.28, 95%CI 1.06-1.55, p=0.01), and PCSM (sHR 1.45, 95%CI 1.20-1.76, p<0.001). 10-year distant metastasis in GC low patients was 4% compared to 16% for GC high risk patients. In patients with lower GC scores, the 10-year difference in metastasis-free survival rate between arms was -7%, compared to 21% for higher GC patients (p-interaction 0.04).
CONCLUSIONS: This study represents the first validation of a biopsy-based gene expression classifier, assessing both its prognostic and predictive value, using data from a randomized phase III trial of intermediate-risk prostate cancer. Decipher improves risk stratification and can aid in treatment decision-making in men with intermediate-risk disease.
PMID:37137444 | DOI:10.1016/j.ijrobp.2023.04.010
Rev Esp Cardiol (Engl Ed). 2023 May 1:S1885-5857(23)00112-3. doi: 10.1016/j.rec.2023.04.003. Online ahead of print.
ABSTRACT
INTRODUCTION AND OBJECTIVES: Despite medical advances, mortality after ST-elevation myocardial infarction (STEMI) remains high. Women are often underrepresented in trials and registries, limiting knowledge of their management and prognosis. It is unknown whether life expectancy in women of all ages treated with primary percutaneous coronary intervention (PPCI) is similar to that in a reference population free of the disease. The main objective of this study was to determine whether life expectancy in women undergoing PPCI and surviving the main event returns to a similar level to that in the general population of the same age and region.
METHODS: We included all patients diagnosed with STEMI from January 2014 to October 2021. We matched women to a reference population of the same age and region from the National Institute of Statistics to determine observed survival, expected survival, and excess mortality (EM) using the Ederer II method. We repeated the analysis in women aged ≤ 65 and > 65 years.
RESULTS: A total of 2194 patients were recruited, of whom 528 were women (23.9%). In women surviving the first 30 days, EM at 1, 5 and 7 years was 1.6% (95%CI, 0.3-4), 4.7% (95%CI, 0.3-10.1), and 7.2% (95%CI, 0.5-15.1), respectively.
CONCLUSIONS: EM was reduced in women with STEMI who were treated with PPCI and who survived the main event. However, life expectancy remained lower than that in a reference population of the same age and region.
PMID:37137427 | DOI:10.1016/j.rec.2023.04.003
Int J Cardiol. 2023 May 1:S0167-5273(23)00592-2. doi: 10.1016/j.ijcard.2023.04.038. Online ahead of print.
ABSTRACT
Guidelines recommend managing patients aged ≥75 with non-ST-segment elevation myocardial infarction (NSTEMI) similar to younger patients. We analyze disparities in NSTEMI management and compare those ≥80 years to those <80 years. This is a matched case-control study using the 2016 National Inpatient Sample data of adults with NSTEMI receiving percutaneous coronary intervention with drug-eluting stent (PCI-DES) – one artery or no intervention. We included the statistically significant variables in univariate analysis in exploratory multivariate logistic regression models. Total sample included 156,328 patients, out of which 43,265 were ≥ 80 years, and 113,048 were < 80 years. Patients ≥80 years were more likely to not have an intervention (73.3%) when compared to those <80 (44.1%), P < 0.0005. Regardless of age, PCI-DES-one artery improved survival compared to no intervention (Age < 80: OR 0.230, 95% CI 0.189-0.279, and ≥ 80: OR 0.265, 95% CI 0.195-0.361, P < 0.0005). Women (OR 0.785, 95% CI 0.766-0.804, P < 0.0005) and non-white race (OR 0.832, 95% CI 0.809-0.855, P < 0.0005) were less likely to receive an intervention. Non-Medicare/Medicaid insurance was associated with 40% lower likelihood of dying in <80 age group (OR 0.596, 95% CI 0.491-0.724, P < 0.0005), and 16% higher chance of intervention overall (OR 1.160, 95% CI 1.125-1.197, P < 0.0005). Patients aged ≥80 with NSTEMI were 29% less likely to receive an intervention compared to patients aged <80, even though patients >80 derived similar mortality benefits from the intervention. There were gender, payor, and race-based disparities in NSTEMI management in 2016.
PMID:37137356 | DOI:10.1016/j.ijcard.2023.04.038