Incidence Rate Research Articles

Pooled safety analysis from the VOLTAIRE clinical trials of adalimumab-adbm and adalimumab reference product in patients with rheumatoid arthritis, Crohn’s disease, and chronic plaque psoriasis

ABSTRACT Objectives This analysis reported the incidence of safety endpoints across five phase 3 randomized controlled clinical trials in patients with rheumatoid arthritis (RA), Crohn’s disease (CD), and chronic plaque psoriasis (PsO) who received ≥ 1 dose of adalimumab-adbm or adalimumab reference product (RP). Methods Exposure-adjusted incidence rates for safety endpoints were calculated per 100 patient-years and reported by disease indication and treatment arm. Subgroup analyses by patient age and sex were also conducted. Results The mean length of follow-up was 62 weeks, 48 weeks, and 32 weeks for patients with RA, CD, and PsO, respectively. Rates of SAEs and discontinuations due to AEs were similar among patients with RA and PsO, but slightly higher among those with CD. Incidence rates of all safety endpoints were consistent between the adalimumab-adbm and adalimumab RP treatment arms within each indication Subgroup analyses of patients with RA, CD, and PsO showed no between-group differences by age and sex. Conclusions In patients with RA, CD, and PsO, there were no differences between biosimilar adalimumab-adbm or the adalimumab RP regarding the rate of adverse events, serious adverse events, discontinuations due to adverse events, deaths, or any adverse events of special interest.

Nationwide Epidemiology and Outpatient Healthcare Resource Use of Children with Respiratory Syncytial Virus from 2005 to 2021.

Respiratory syncytial virus (RSV) poses a global health challenge, particularly among younger children. While the disease burden in Japan has been preliminarily quantified in short-term or inpatient settings, a comprehensive understanding of outpatient settings at a national level is still lacking. In this retrospective cohort study, we followed 697,802 children until they reached 60 months of age, amounting to 25,680,468 million person-months, using two nationally representative databases from the fiscal years 2005-2021. We analyzed trends in the epidemiology of RSV infections and associated outpatient health resource use. Incidence rates of RSV and associated hospitalizations among infants showed fluctuations of 50-100 cases and 20-30 hospitalizations per 1000 person-years, respectively, during the 2010s. These rates dropped to 8.7 cases and 2.2 hospitalizations per 1000 person-years in 2020, then returned to the same levels in the 2010s. Similar patterns were noted for RSV testing, outpatient visits, healthcare cost and the proportion of cases hospitalized (case-hospitalization risk). Whereas antibiotic use decreased from 56.4% in 2005 to 27.8% in 2021, palivizumab use increased from 95.2-195.9 days of therapy per 1000 person-years. Applying the calculated incidence rates to national data, annual outpatient healthcare costs for RSV infections were estimated to be 7-9 billion JPY (50-64 million USD) for children aged <60 months in the late 2010s. Our study highlights the changes in epidemiology and outpatient health resource utilization for children with RSV infections. These findings are valuable for policymakers and clinicians aiming to develop strategies, including newly developed maternal vaccines and single-dose long-acting monoclonal antibodies.

Analysis of Stroke Burden in China from 1990 to 2021 and Projections for the Next Decade

Introduction: This study aims to describe the temporal trends of stroke burden in different age and sex groups in China from 1990 to 2021, including incidence, prevalence, mortality, and disability-adjusted life years (DALYs), and to compare these data with global figures. Methods: Using data from the Global Burden of Disease (GBD) database from 1990 to 2021, we analyzed changes in stroke burden in China and globally. The average annual percentage change (AAPC) was calculated using Joinpoint software to reflect trends. Stroke burden differences across various age groups and sexes were compared, and the ARIMA model was utilized for future projections. Results: Between 1990 and 2021, the age-standardized incidence rate (ASIR) of stroke in China decreased from 226.938 to 204.753 per 100,000, while the global ASIR decreased from 180.973 to 141.553 per 100,000. The age-standardized prevalence rate (ASPR) in China increased from 1167.425 to 1301.42 per 100,000, whereas the global ASPR decreased from 1201.111 to 1099.31 per 100,000. The age-standardized mortality rate (ASMR) in China fell from 242.18 to 138.029 per 100,000, while the global ASMR decreased from 144.313 to 87.454 per 100,000. China's age-standardized DALY rate (ASDR) declined from 4834.791 to 2648.025 per 100,000, whereas the global ASDR decreased from 3078.952 to 1886.196 per 100,000. The AAPCs for ASIR, ASPR, ASMR, and ASDR in China were -0.370%, 0.326%, -1.793%, and -1.933%, respectively, compared to -0.291%, -0.807%, -1.601%, and -1.570% globally from 1990 to 2021. Age and sex significantly influenced the stroke burden, with higher incidence and mortality rates in males than in females. Projections for the next decade indicate that stroke incidence in China will remain stable, with an expected rise in ASPR, and declines in ASMR and ASDR. Globally, ASIR is expected to decline, while ASPR will rise, and ASMR and ASDR will continue to decrease. Conclusion: From 1990 to 2021, the incidence, mortality, and DALYs of stroke in China have decreased, while the prevalence has increased. Stroke burden is age-related, with higher prevalence in older adults and higher mortality in the elderly. Males are more susceptible to stroke and have a higher risk of death. Over the next decade, stroke prevalence in China is expected to rise, posing challenges due to population aging, even as mortality and disability rates decline. Sustained public health efforts will be necessary.

Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4.

To describe safety and efficacy of filgotinib 200 or 100 mg (FIL200/FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (LTE; NCT03025308). Patients who completed any of three parent studies (NCT02889796: inadequate response [IR] to methotrexate [MTX]; NCT02873936: IR to biologic disease-modifying antirheumatic drugs; NCT02886728: MTX-naïve) without rescue therapy could enter the LTE; patients taking FIL continued their dosage, and those who received comparators were rerandomised to FIL200 or FIL100. This analysis includes week 156 interim results. Among Japanese patients, 110 received FIL200, and 97 received FIL100. Mean (SD) FIL200 and FIL100 exposure was 157.0 (51.49) and 156.0 (52.45) weeks. The exposure-adjusted incidence rates (95% CI) for FIL200/FIL100 were 2.7 (1.4, 5.2)/2.4 (1.2, 5.1) for herpes zoster, 0.9 (0.3, 2.8)/1.0 (0.3, 3.2) for malignancy (excluding nonmelanoma skin cancer), and 0.6 (0.2, 2.4)/0.3 (0.0, 2.4) for major adverse cardiovascular events. More patients receiving FIL200 with prior FIL200 exposure achieved clinical remission vs other groups (including Clinical Disease Activity Index remission in 40% vs 27% or less at week 156). FIL200 and FIL100 were generally well tolerated by Japanese patients, without new, unexpected adverse events.

Evolution of Real-World Clinical Practice in Time to Surgery Following Thoracolumbar Spinal Cord Injury: An Observational Study of North American Trauma Centers from 2010 to 2020.

This study aims to estimate real-world clinical practice trends in time to surgery following thoracolumbar spinal cord injury (SCI) in trauma centers across North America over the last decade (2010-2020). A multi-center retrospective observational study was conducted using Trauma Quality Improvement Program data from 2010 to 2020. All surgically treated patients with thoracic and lumbar SCI were included. Descriptive plots and a multivariable Poisson regression model with time to spine surgery as the primary outcome were constructed. This study included 4350 adult patients with complete SCI surgically treated across 449 trauma centers. Within this group, 3978 (91.4%) patients were diagnosed with thoracic SCI and 372 (8.6%) patients were diagnosed with lumbar SCI. The overall mean time to surgery was 31.6 h (±34.1). Early surgery (≤24 h) was performed in 2599 patients (59.7%). An estimated annual reduction of 1.6 h in time to surgery was demonstrated over the study period, starting initially at a mean of 47.6 h (±40.6) in 2010, and reaching a mean of 25.3 h (±30) in 2020. Multivariable Poisson regression adjusting for patient, injury, and institution confounders, demonstrated a significant decrease in time to surgery by 5% per year over the study period (incidence rate ratios [IRR] = 0.95, 95% confidence interval [CI]: 0.93-0.96). Moreover, in a secondary analysis including 3270 patients with incomplete thoracolumbar SCI, a comparable significant annual reduction in time to surgery was demonstrated (IRR = 0.93, 95% CI: 0.91-0.94). This study provides real-world data on practice pattern trends with respect to time to spine surgery following traumatic thoracolumbar SCI. Over the years from 2010 to 2020, we found a significant reduction in time to surgery across trauma centers in North America.

Oral Cancer Incidence Among Adult Males With Current or Former Use of Cigarettes or Smokeless Tobacco: Population-Based Study.

Tobacco use has been identified as a risk factor for oral cancer worldwide. However, relative oral cancer incidence among adults who smoke cigarettes, use smokeless tobacco products (ST), have transitioned from cigarettes to ST, quit cigarettes and/or ST ("quitters"), or never used tobacco has not been well studied. We aim to present population-based oral cancer incidence rates for adults who smoke cigarettes, use ST, are former smokers who now use ST, or quit. We estimated cross-sectional incidence rates and incidence rate ratios (IRRs) using data from statewide cancer registries (Colorado, Florida, North Carolina, and Texas) and population counts derived from national surveys using combined data from 2014-2017. A random-effect meta-analysis approach was used to summarize estimates among these groups, based on multiple imputation-based IRR estimates by state and age group while considering potential heterogeneity. A total of 19,536 oral cancer cases were identified among adult males 35 years and older in the study geographies and period. The oral cancer incidence rate among adults who smoke was significantly higher than the ST group (2.6 times higher, 95% CI 2.0-3.3, P<.001), 3.6 (95% CI 3.2-4.1, P<.001) times higher than the never users, and 2.4 (95% CI 1.8-3.1, P<.001) times higher compared to former smokers who now use ST. The IRR among the ST group relative to never users was 1.4 (95% CI 1.1-1.9, P=.02). The IRR between former smokers who now use ST and those who quit was 1.4 (95% CI 1.0-2.1, P=.08). Findings from this population-based study with a large number of oral cancer cases support significantly high oral cancer incidence among adults who smoke and a lower risk of oral cancer incidence among never users, quitters, users of ST, and former smokers who now use ST compared to cigarettes. Future studies with detailed control of tobacco history and other relevant confounders are needed to confirm these findings.

Serum Magnesium concentration in normal and preeclamptic pregnancy: A tertiary center experience

Preeclampsia and maternal mortality are more prevalent in underdeveloped nations. Preeclampsia has an estimated 16% incidence rate in Bangladesh, which is extremely high. One of the body's major macronutrients is magnesium. It also serves a multitude of enzymes as a cofactor. This cross-sectional study was done in the department of Biochemistry of Mymensingh Medical College, Mymensingh, from July 2016 to June 2017. This study involved a total of 100 individuals, where 50 preeclamptic patients and 50 healthy pregnant women served as the case and control groups, respectively. The results were shown as mean ±SD. For both the case and control groups, the mean ±SD of serum magnesium levels were 1.75 ±0.22 mg/dl and 1.63 ±0.21, respectively. Comparison of the mean ±SD of serum magnesium in the case and control groups revealed a highly significant difference (P&lt;0.001). Students' unpaired ‘t’ test was used to compute the statistical difference. Mediscope 2024;11(2): 73-76

Risk of Major Adverse Cardiovascular Outcomes in Families With MASLD: A Population-Based Multigenerational Cohort Study.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a risk factor for cardiovascular disease. However, whether family members of individuals with MASLD also share an increased cardiovascular risk is unknown. We created a nationwide multigenerational cohort study identifying all family members of Swedish adults diagnosed with biopsy-proven MASLD (1969-2017) and of matched general population comparators (by age, sex, calendar year, and county of residence). We calculated incidence rates and used Cox models to calculate adjusted hazard ratios (aHRs) and 95% CIs for incident major adverse cardiovascular events (MACE), including acute myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death. Cox models were adjusted for education, country of birth, diabetes, hypertension, obesity, dyslipidemia, chronic kidney disease, chronic obstructive pulmonary disease, and the Charlson comorbidity index. We identified 22 267 MASLD first-degree relatives (FDRs; parents, siblings, and offspring) and 5687 MASLD spouses, as well as 118 056 comparator FDRs and 29 389 comparator spouses without earlier cardiovascular disease. Overall, the mean age was 41.8 years (SD, 18.0), and 51.5% were females. Over a median of 24.6 years, the incidence rate for MACE was higher in MASLD FDRs than in comparator FDRs (65.0 versus 62.5/10 000 person-years; aHR, 1.06 [95% CI, 1.01-1.11]). MASLD FDRs had higher rates of acute myocardial infarction (23.0 versus 20.9/10 000 person-years; aHR, 1.09 [95% CI, 1.01-1.18]) and cardiovascular death (aHR, 1.09 [95% CI, 1.01-1.18]). Across generations of FDRs, the risk of MACE was uniformly increased with no differences by relationship (ie, parents, siblings, and offspring; Pinteraction>0.05). MASLD spouses were also at an increased risk of MACE (117.6 versus 103.5/10 000 person-years; aHR, 1.09 [95% CI, 1.01-1.18]). First-degree relatives of individuals with biopsy-proven MASLD are at slightly higher risk of incident MACE, but absolute risks do not support early screening for cardiovascular disease. Shared lifestyle factors may be the main contributors, as spouses of MASLD patients also had higher risks of MACE.

Incidence of Acute Pulmonary Edema Before and After the Systematic Use of Ultrasound B-Lines

Introduction: Acute pulmonary edema (APE) due to fluid overload is considered the most feared complication in hemodialysis patients. Various diagnostic tests have been proposed to assess the fluid status in patients with end-stage kidney failure (ESKF); among these, lung ultrasound (measuring the number of B-lines) is emerging as a promising tool to identify pulmonary congestion in this patient population. Methods: We compared the incidence of APE before and after the implementation of lung ultrasound as a routine practice in our unit. The pre (from 1 January 2007 to 31 December 2008)- and post (from 1 January 2017 to 31 December 2018)-B-line implementation periods included 98 and 108 hemodialysis patients, respectively. By accurately reviewing their electronic medical records, all episodes of APE were collected. The 10-year interval between the two periods was specifically chosen to ensure no overlap between patients of the two cohorts whereas the single-center design was adopted to minimize the influence of center effect on the study results. Results: APE episodes occurred more frequently in patients from the pre-B-line implementation group (18/98, i.e., 18.4%) compared with those from the post B-line implementation group (6/108, i.e., 5.5%) (p = 0.004). An analysis based on repeated APE events showed that the incidence rate of APE was significantly higher during the pre-implementation period (2.0 APE episodes per 100 person-months, 95% CI: 1.4–2.7) than during the post-implementation period (0.3 APE episodes per 100 person-months, 95% CI: 0.1–0.7), with an incidence rate ratio (post- versus pre-) of 0.17 (95% CI: 0.07–0.40; p &lt; 0.001). The odds of experiencing APE episodes were 74% lower (odds ratio: 0.26, 95% CI: 0.10–0.69) in patients from the post B-line implementation period compared with those from the pre-implementation period. Notably, adjusting for potential confounders did not affect the strength of this association, which remained statistically significant (p ≤ 0.030). Finally, dominance analysis indicated that the implementation of B-lines was the primary factor explaining the difference in APE episodes between the two periods, followed by dialysis duration and intra-dialysis weight gain. Conclusions: The systematic use of lung ultrasound (a simple, easy-to-learn, rapid and non-invasive method, easily performed at the patient’s bed) in everyday clinical practice was associated with a drastic reduction in episodes of APE in hemodialysis patients. Further observational and interventional studies are needed to confirm these results.

SGLT-2 inhibitors and mortality among patients with heart failure with reduced ejection fraction: linked database study.

To investigate the association between sodium-glucose cotransporter-2 (SGLT-2) inhibitor use and risk of all cause mortality among patients with heart failure with reduced ejection fraction. Linked database study. National registers in Denmark, July 2020 to June 2023. Patients with heart failure, aged ≥45 years, with left ventricular ejection fraction ≤40%. The primary outcome was all cause mortality comparing initiation and continued treatment with SGLT-2 inhibitors versus continued treatment with other standard-of-care heart failure drugs and non-use of SGLT-2 inhibitors; secondary outcomes were the composite of cardiovascular mortality or admission to hospital with heart failure and its individual components. Hazard ratios were estimated using Cox regression adjusted using inverse probability of treatment weighting based on propensity scores. The study included 6776 patients who started SGLT-2 inhibitors (79% dapagliflozin; 21% empagliflozin) and 14 686 patients who remained on other standard-of-care heart failure drugs and did not use SGLT-2 inhibitors. Most SGLT-2 inhibitor users were male (70%), the mean age was 71.2 (standard deviation 10.6) years, and 20% had type 2 diabetes. During follow-up, 374 deaths occurred among SGLT-2 inhibitor users (incidence rate 5.8 per 100 person years) and 1602 among non-users (8.5 per 100 person years). The weighted hazard ratio for all cause mortality was 0.75 (95% confidence interval 0.66 to 0.85); the weighted incidence rate difference was -1.6 (95% confidence interval -2.5 to -0.8) per 100 person years. Secondary outcomes showed a weighted hazard ratio of 0.94 (0.85 to 1.04) for cardiovascular mortality or hospital admission with heart failure, 0.77 (0.64 to 0.92) for cardiovascular mortality, and 1.03 (0.92 to 1.15) for hospital admission with heart failure. The weighted hazard ratios for all cause mortality were consistent in patients with and without diabetes (0.73 (0.58 to 0.91) and 0.73 (0.63 to 0.85); P=0.99). In this large database study among patients with heart failure with reduced ejection fraction, SGLT-2 inhibitor use was associated with a 25% lower risk of all cause mortality, supporting their effectiveness in routine clinical practice.

Analysis of the incidence of influenza before and after the COVID-19 pandemic in South Korea.

Influenza outbreaks of varying size occur every year, but during the COVID-19 pandemic, many countries experienced influenza at lower levels. However, following the relaxation of COVID-19 prevention measures in 2022, the incidence of influenza began to increase gradually. Thus, this study compared the occurrence of influenza from week 36 of 2017, before the COVID-19 outbreak, until 2023. The analysis was conducted using influenza-like illness occurrence data available from the Korea Disease Control and Prevention Agency infectious disease website. Additionally, to examine the changes in COVID-19 and influenza occurrence during the pandemic, COVID-19 incidence data from 20 January 2020 to 31 August 2023 were obtained from the KDCA Coronavirus Disease 19 homepage. During the COVID-19 pandemic, which corresponds to the 2020/2021 and 2021/2022 influenza seasons, there was no seasonal influenza epidemic, and the incidence rates were below the usual outbreak levels. However, in the 2022/2023 season, when the spread of COVID-19 had eased, a seasonal pattern similar to that observed before the COVID-19 pandemic was noted. Furthermore, correlation analysis between the rates of influenza-like illness and COVID-19 incidence showed no significant correlation during the entire period. However, a significant correlation emerged in 2023 (r = 0.393, p <0.05). These results suggest that influenza was suppressed during the COVID-19 pandemic but returned to typical seasonal patterns after the COVID-19 prevention policies were eased. The positive correlation observed between the incidences of COVID-19 and influenza in 2023 indicates that COVID-19, no longer a novel pandemic-causing infectious disease, may have transitioned to an endemic pattern similar to seasonal influenza.

Growing burden of inflammatory bowel disease in China: Findings from the Global Burden of Diseases 2021 and predictions to 2035.

Inflammatory bowel disease (IBD) imposes a significant economic and social burden in China. We aim to assess the epidemiological trends of IBD in China, and to predict the burden in the near future. The incidence, mortality, prevalence, and disability-adjusted life year (DALYs) of IBD from 1990 to 2021 were obtained from Global Burden of Disease 2021. Estimated annual percentage change (EAPC), average annual percent change, total percent change, and age-period-cohort model were used to access trends. Bayesian age-period-cohort model was utilized to predict the risk of incidence and mortality. In 2021, IBD affected 168,077 people in China, with 24,941 new cases and 5640deaths. The age-standardized rate (ASR) of incidence and death was 1.4 and 0.3, respectively. The incidence and prevalence in China were lower than the global and high socio-demographic index (SDI) regions, but the ASR of incidence and prevalence (EAPC: 2.93 and 2.54, respectively) had rapidly increased from 1990 to 2021. The ASR of death and DALYs had significantly decreased (EAPC: -3.05 and -2.93, respectively). Middle-aged and elderly populations faced a severe burden of incidence and prevalence, while the elderly population faced a severe mortality burden. It is projected that by 2035, the ASR of incidence will continue to rise, whereas the death rate will continue to decline. The burden of IBD in China is serious and increasingly severe. Establishing a comprehensive disease management system in China will help better control the medical burden of IBD.

A novel approach to engineering three-dimensional bladder tumor models for drug testing.

Bladder cancer (BCa) poses a significant health challenge, particularly affecting men with higher incidence and mortality rates. Addressing the need for improved predictive models in BCa treatment, this study introduces an innovative 3D in vitro patient-derived bladder cancer tumor model, utilizing decellularized pig bladders as scaffolds. Traditional 2D cell cultures, insufficient in replicating tumor microenvironments, have driven the development of sophisticated 3D models. The study successfully achieved pig bladder decellularization through multiple cycles of immersion in salt solutions, resulting in notable macroscopic and histological changes. This process confirmed the removal of cellular components while preserving the native extracellular matrix (ECM). Quantitative analysis demonstrated the efficacy of decellularization, with a remarkable reduction in DNA concentration, signifying the removal of over 95% of cellular material. In the development of the in vitro bladder cancer model, muscle invasive bladder cancer patients' cells were cultured within decellularized pig bladders, yielding a three-dimensional cancer model. Optimal results were attained using an air-liquid interface technique, with cells injected directly into the scaffold at three distinct time points. Histological evaluations showcased characteristics resembling in vivo tumors derived from bladder cancer patients' cells. To demonstrate the 3D cancer model's effectiveness as a drug screening platform, the study treated it with Cisplatin (Cis), Gemcitabine (Gem), and a combination of both drugs. Comprehensive cell viability assays and histological analyses illustrated changes in cell survival and proliferation. The model exhibited promising correlations with clinical outcomes, boasting an 83.3% reliability rate in predicting treatment responses. Comparison with traditional 2D cultures and spheroids underscored the 3D model's superiority in reliability, with an 83.3% predictive capacity compared to 50% for spheroids and 33.3% for 2D culture. Acknowledging limitations, such as the absence of immune and stromal components, the study suggests avenues for future improvements. In conclusion, this innovative 3D bladder cancer model, combining decellularization and patient-derived cells, marks a significant advancement in preclinical drug testing. Its potential for predicting treatment outcomes and capturing patient-specific responses opens new avenues for personalized medicine in bladder cancer therapeutics. Future refinements and validations with larger patient cohorts hold promise for revolutionizing BCa research and treatment strategies.

The Major League Baseball Pitch Clock: one year position player injury analysis

ABSTRACT Background In 2023, Major League Baseball (MLB)implemented the pitch clock. The effects of the pitch clock on player injuryrates is largely unknown, and some, including the major league baseball playersassociation, have suggested that pitchers may be at an increased risk of injurywith its implementation. Position players have received little attention inthese discussions, even though they may be at the same theorized risk ofinjuries. The aim of this study is to determine if implementation of the 2023MLB pitch clock influenced the incidence of injuries in position players. It ishypothesized that implementation of the MLB pitch clock will lead to a rise ininjuries due to a reduction of time for the primary biological energy systemused by baseball to restore to normal levels. Methods Injury data was collected from thefangraphs.com injury database, the most comprehensive MLB data and statisticaldatabase website, for the 2021, 2022, and 2023 MLB seasons. The incidence rateratio was calculated and used to compare the injury rate for the 2023 season tothe 2021 and 2022 seasons for both major anatomical categories and anatomicalsubcategories. A z-test for proportions was used to determine significance. Results Incidence rate ratio comparison of the2023 MLB pitch clock season versus the 2021 MLB season showed a decrease in thetotal incidence of injuries (p < .001), lower extremity injuries (p < .001),and hamstring injuries (p = .032). Incidence rate ratio comparison of the 2023MLB pitch clock season versus the 2022 MLB season showed a decrease in thetotal incidence of injuries (p = .010), undisclosed injuries (p < .001), andknee injuries (p = .035). Conclusions Following the implementation of thepitch clock during the 2023 MLB season, the total number of injuries andseveral lower extremity injury categories decreased. Due to a decrease in theoverall time spent on the field in a single game and over a season, it could behypothesized that the pitch clock decreased the workload for position players,leading to this drop in injuries. Further longitudinal investigation must bedone to investigate if this influence of the MLB pitch clock persists overtime.

First Report of Lelliottia amnigena Causing Soft Rot on Purple Stem Mustards in China.

The purple stem mustards (Brassica rapa subsp. chinensis var. purpuraria) (Govaerts R, 2003) are widely cultivated along Yangtze River Valley in China, which is famous for its flavorful and nutritious edible stalks (Wang et al., 2022). In February 2023, a disease of soft rot was observed in multiple purple stem mustards planting fields in Wuhan city, Hubei province, China (30.41°N, 114.22°E). Disease incidence rates were almost 20 to 30% in the planting area (5 ha in size), causing severe economic loss. Infected plants displayed water-soaked symptoms at the base of the petioles, emitting a foul soft rot odor. The severely infected petioles, stems and roots exhibit pus symptoms leading to plant death. To identify the causal agent, small pieces of soft rot symptomatic tissue were cut from the margin of necrotic lesions and surface disinfected with 75% (v/v) ethanol for 30 seconds, followed by three successive rinses with sterile distilled water. The exudates from the clipped tissues were serially diluted and then incubated onto nutrient agar (NA) plates to obtain purified strains at 28°C for 48 hours (Koike et al., 2002). After incubation, 15 strains were obtained and the colonies of all strains were Gram-negative, aerobic, small, round, convex, whitish to dull white, and had smooth slimy edges. Three single bacterial strains CT020801 - CT020803, which were individually isolated from three different diseased samples, were selected as representative strains for further study. Biochemical tests using the BIOLOG GENIII microplate system (Biolog, Hayward, CA, USA) revealed that these strains were positive for methyl red, pectin, dextrin, D-Cellobiose, β-galactosidase, citrate, and maltose, but negative for indole, arginine dihydrolase, urease, ornithine decarboxylase, and gelatinase tests. The 16S ribosomal RNA gene and the three housekeeping genes, atpD, rpoB, and recN were amplified using genomic DNA of Lelliottia amnigena NCTC12124T as the template, with specially designed primers. All amplified fragments were sequenced and deposited in GenBank with accession numbers OQ954706-OQ954707, OQ954713, and OQ953873-OQ953881. BLAST alignments of the 16S rRNA, atpD, rpoB and recN sequences revealed that the sequences of Strain CT020801-03 exhibited the highest identity (100%, ≥97.97%, ≥98.85% and ≥94.52%, respectively) with L. amnigena （Figure S2）. Phylogenetic tree analysis based on multilocus sequence joint 16S rRNA - atpD - rpoB - recN revealed that CT020801 - CT020803 and L. amnigena clustered together in the same clade (Carrie et al., 2013). These results were consistent with those reported for Lelliottia amnigena (Osei et al., 2022). To confirm pathogenicity, healthy base petioles of three-week-old purple stem mustards seedlings were stab inoculated with 20 μL bacterial suspensions (approximately 108 CFU/mL) and then incubated at 28°C and 80% relative humidity in a growth chamber. A sterile liquid NB medium served as the negative control. The test was repeated thrice with each test consisting of five seedlings per treatment. After three days, soft rot symptoms appeared on the stem bases of the inoculated plants, consistent with the initial symptoms observed in the field. Control plants showed no symptoms. The strains were successfully re-isolated from symptomatic plants and identified as L. amnigena, fulfilling Koch's postulates. L. amnigena, a member of the Enterobacter genus (Birlutiu et al., 2023; Brady et al., 2013; Izard et al., 1981), is commonly found in soil and has been identified as an opportunistic pathogen responsible for plant soft rot disease (Reyes-García et al., 2020; Schroeder et al., 2009; Wu et al., 2023). Previous studies have linked L. amnigena to soft rot disease in potato tubers in China. However, this study marks the first documented case of L. amnigena causing soft rot disease in purple stem mustards in China. This discovery expands the known host range of the pathogenic bacteria and will help to provide essential information for making effective measures to manage this disease.

Time to Surgery Following Complete Cervical Spinal Cord Injury: Evolution of Clinical Practice Patterns Over a Decade from 2010 to 2020 Across North American Trauma Centers.

This study aims to quantify the change in time to surgery for treatment of complete traumatic cervical spinal cord injury (SCI) patients in American College of Surgeons accredited trauma centers across North America over the last decade (2010-2020). This multi-center retrospective observational cohort study used data from the Trauma Quality Improvement Program from 2010 to 2020. All surgically treated patients with complete traumatic cervical SCI were included. Primary outcome was time to spine surgery from treating hospital arrival in hours. Both descriptive statistics and a multi-variable Poisson regression model clustering standard of errors by each included trauma center were used to evaluate and quantify the annual change in time to surgical intervention. The study included 6855 complete traumatic cervical SCI patients managed across 484 trauma centers in North America. Median time to spine surgery was 14.6 h. A total of 4618 patients (67.3%) underwent surgical intervention within 24 h from hospital arrival. From 2010 to 2020, median time to surgery decreased by an average 0.6 h (±0.15) per year. A multi-variable adjusted model for time to surgery demonstrated a significant downward annual reduction of 5% in time to surgery between the years 2010 and 2020 (Incidence rate ratio = 0.95; 95% Confidence Interval: 0.93-0.96). This study provides compelling real-world based quantification of the change in time to surgical intervention following traumatic cervical SCI. A significant decreasing annual trend pertaining to surgical timing across trauma centers in North America over the past decade was demonstrated.

Impact of extreme bushfire seasons on rates of occupational injury and disease compensation claims in first responders.

This study aimed to use workers' compensation (WC) data to explore the impact of the extreme bushfires on injury/disease claim rates amongst first responders (FR) compared with other occupations and off-seasons. Data on WC claims for FR (ambulance officers, paramedics, firefighters, police) and other occupations were obtained from WorkSafe Victoria 2005-2022. Negative binomial regression models adjusting for age, gender and number of employed people were used to estimate incident rate ratios of all injury/disease, mental, musculoskeletal and respiratory claims among FR in summer and extreme bushfires compared to off-season/summer and other occupations. There were 120,022 claims in 2005-2022; 54% were musculoskeletal injuries. Claims rates were significantly higher for all injuries/diseases, mental, musculoskeletal and respiratory conditions in FR than other occupations across off-season, summers and extreme bushfires. FR were 1.5-3.9 times more likely to claim for mental health conditions during extreme bushfires than off-season compared with other occupations. Firefighters were at increased risk of all injury/disease and mental and musculoskeletal injury claims during summer and extreme bushfires than off-seasons. Ambulance officers and paramedics had the highest claim rates, particularly in off-seasons, with a higher risk of all injury/disease and mental claims in extreme bushfires than in summers. Respiratory and mental claims were increased amongst police and other occupations during extreme bushfires. Extreme bushfire events were associated with increased mental claims rates in all FR, with the highest in firefighters. Strategies to better prevent and manage injury/disease risk in FR are urgently required, particularly for mental health conditions.

Racing against time: Emergency ambulance dispatches and response times, a register-based study in Region Zealand, Denmark, 2013-2022.

The global strain on Emergency Medical Services (EMS) is reflected in the increasing number of emergency ambulance dispatches. Shorter EMS response times have demonstrated some effect on very specific and rare conditions. It is unknown if the increased number of ambulance dispatches compromises response times. This study aimed to describe trends in emergency ambulance dispatches and response times from 2013 to 2022 in Region Zealand, Denmark. Additionally, it aimed to outline the demographic profile of emergency ambulance patients, including age and comorbidities. Using administrative data from the Region Zealand emergency medical dispatch center, a register-based study spanning from January 1, 2013, to December 31, 2022, was conducted. Data were linked with nationwide registries and priority A (emergency), or B (urgent) ambulance dispatches were included. Trends were examined overall and stratified by catchment areas corresponding to the hospitals with emergency departments in the region. Poisson and ordinal logistic regressions were used to analyze data. The study encompassed 678,789 emergency ambulance dispatches, with 55.0% priority A and 45.0% priority B. Among these, 667,788 had a valid personal identification number allowing for further analysis. Within the study population, females comprised 48.5%, while 49.1% of patients were 65years or more. Overall, 47.5% of patients had no comorbidities, while 7.7% and 44.8% had mild and severe comorbidities, respectively. Emergency ambulance dispatches increased from 56,867 in 2013 to 81,080 in 2022 (143%). Correspondingly, the dispatch incidence rate per 1,000 residents per year increased from 69.2 to 95.5. Stratification by catchment areas revealed significant disparities. The median response time for priority A dispatches increased from 7min:14s in 2013 to 8min:20s in 2022 and for priority B dispatches from 12min:23s to 15min:6s. From 2013 to 2022, emergency ambulance dispatches both priorities A and B increased in absolute numbers and per 1000 residents per year. Ambulance response times also increased for both priorities during the study period. The study shows regional disparities regarding to the rate of emergency ambulance dispatches and response times indicating challenges in resource distribution in the future for maintaining emergency care standards.

Incidence and Risk Factors for Amputations in Persons with Diabetes Mellitus: A Retrospective Cohort Study.

The aim of this study was to identify and analyze the incidence rate of amputations and their risk factors in people with Diabetes Mellitus (DM) in two specialized outpatient clinics in Brazil. This is an epidemiological, retrospective cohort study using data collected from electronic health records of 281 adult diabetic patient types 1 or 2; attended in specialized outpatient service between 2015 and 2020. Statistical analyses were performed using the 2 sample t-test or Wilcoxon-Mann-Whitney test, for quantitative variables, and the Pearson's χ2 test or Fisher's exact test for categorical variables. The investigation of the risk factors for amputation was carried out through logistic regression. The study was approved by ethical committee. The sample mean age was 65.6 years (SD 13.05), predominating male gender n = 211 (75%), type 2 DM n = 223 (86.7%), with cardiovascular disease n = 143 (63.2%), and about 68.7% (n = 156) with peripheral arterial disease (PAD). Seventy-seven had lower limb amputation (LLA), with a rate incidence of 31.9% during five years. Logistic regression analysis showed the following associations with amputation: Diabetic peripheral neuropathy increased the rate of amputation by 3.6 times (OR = 3.631, 95% CI = 1.214-11.353; P = .022), and peripheral arterial disease increased by 10 times (OR = 10.631; 95% CI = 2.969-57.029; P = .001). The LLA in individuals with DM in two specialized outpatient services was higher compared to international literature; DPN and PAD were confirmed as risk factors for amputation, according to literature. This finding suggests that the study population faces an increased risk of amputation, highlighting the urgent need for targeted interventions and implementing robust preventive strategies to transform the current scenario and mitigate these severe outcomes. A comprehensive approach is essential to proactively address the underlying issues and reduce the prevalence and impact of amputations in Brazil.

Incidence and Risk Factors of Infection After Fracture Fixation: A Multicenter Cohort Study.

Infection after fracture fixation (IAFF) is a severe complication. There are few multicenter studies targeting IAFF. This paper identifies independent risk factors associated with IAFF by analyzing multicenter clinical data. Appropriate interventions should be implemented to reduce the risk of IAFF. This is a multicenter retrospective cohort study. This study screened medical records of patients who underwent internal fixation for fractures at participating medical institutions from January 1, 2011, to December 31, 2020. Data extraction included demographic characteristics, disease features, surgical variables, and laboratory indicators. Logistic regression analysis was employed to identify the relationship between relevant risk factors and IAFF. Research data were sourced from the hospital's electronic medical record system and self-constructed databases. In our study, 202 patients who underwent internal fixation for fractures experienced postoperative infections, which corresponds to an overall incidence rate of approximately 1.7%. The predominant pathogen identified in these infections was Staphylococcus aureus. A multifactorial analysis indicated that several factors were independently associated with the occurrence of IAFF. These factors included BMI ranges of 24.0-27.9 and 28.0-31.9, smoking, a high ASA score, high-energy trauma, diabetes, open fracture, seasonal timing of the surgery (summer), bone grafting, drainage duration, surgical duration ≥ 180 min, and A/G ratio < 1.2. We strongly recommend that orthopedic surgeons perform comprehensive preoperative assessments on fracture patients to identify factors that may increase the risk of infection. Through the implementation of targeted interventions and beneficial modifications to these modifiable risk factors, it is possible to lower the incidence of IAFF. Additionally, proactive screening, risk stratification, and thorough patient education should be prioritized for patients with high risk but nonmodifiable factors.