BACKGROUND: Data have shown that vitamin B12 has immunomodulatory effects via different pathways, which could influence the pathophysiology of sepsis. The objective of this study was to investigate whether vitamin B12 levels, assessed by the measurement of holotranscobalamin (HTC), total vitamin B12 (B12), and methylmalonic acid (MMA, which accumulates in case of B12 deficiency), are associated with the development of sepsis in patients with onset of bacterial infection.
METHODS: This was a single-center, prospective observational pilot study. Adult patients who presented to the emergency department with bacterial infection confirmed by a positive microbiological culture result were included in the study and followed up for 6 days to assess whether they developed sepsis or not. The primary objective was to compare HTC concentration in patients who developed sepsis to those who did not develop sepsis. Secondary objectives were the evaluation of B12 and MMA concentrations in those two groups. Multiple logistic regression models were used, with presence of sepsis as the outcome variable, and HTC, B12, and MMA concentrations as predictor variables, separately, and adjusted for potential confounders.
RESULTS: From 2019 to 2022, 2131 patients were assessed for eligibility, of whom 100 met the inclusion criteria. One patient was excluded from the analysis due to missing data. Of the 99 patients, 29 developed sepsis. There was no evidence for an association between HTC or B12 concentration and the development of sepsis (OR 0.65, 95% CI 0.31-1.29, p = 0.232, OR 0.84, 95% CI 0.44-1.54, p = 0.584, respectively). There was an association between MMA concentration and the development of sepsis, with a positive effect, i.e. with increasing MMA, the odds for sepsis increased (OR 2.36, 95% CI 1.21-4.87, p = 0.014). This association remained significant when adjusted for confounders (OR 2.72, 95% CI 1.23-6.60, p = 0.018).
CONCLUSIONS: Our study found an association between elevated MMA concentration and the development of sepsis. We did not find an association between HTC and B12 concentrations and the development of sepsis. Further, larger studies are warranted, as it could lead to interventional trials investigating whether B12 supplementation provides a clinical benefit to patients with infection or sepsis.
BACKGROUND: The study was registered on ClinicalTrials.gov under the identifier NCT04008446 on June 17, 2019.

Patient-reported outcomes (PROs) are essential for understanding the effects of MS and its treatments on patients\' lives; they play an important role in multiple sclerosis (MS) research and practice. We present the protocol for an observational study to prospectively assess the effect of cladribine tablets on PROs and their correlation to disability and physical activity in adults with highly active relapsing MS switching from a first disease modifying drug (DMD) to cladribine tablets in routine clinical practice at study sites in Italy. The primary objective will be to evaluate changes from baseline in the impact of highly active MS on self-assessed physical functioning 52 weeks after the switch to cladribine tablets using the Multiple Sclerosis Impact Scale-29 (MSIS-29). Secondary objectives will include self-assessed psychological impact of highly active MS in daily life and general health after the switch to cladribine tablets as well as changes in cognitive function, anxiety, and depression symptoms. Additional PRO measures will include the Hospital Anxiety and Depression Scale (HADS), the EuroQoL 5-Dimension 5-Level (EQ-5D-5L), the Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), and the Patient-Reported Outcomes Measurement Information System (PROMIS). Wearable devices will acquire activity data (step counts, walking speed, time asleep, and energy expenditure). Additional clinical, radiological, and laboratory data will be collected when available during routine management. The findings will complement data from controlled trials by providing insight from daily clinical practice into the effect of cladribine tablets on the patient\'s experience and self-assessed impact of treatment on daily life.

UNASSIGNED: This study aims to explore the correlates of frailty in hospitalized elderly hypertensive patients and its impact on clinical prognosis, and to construct a predictive model for the occurrence of frailty in this population.
UNASSIGNED: A cross-sectional and prospective observational cohort study was conducted, involving 312 elderly hypertensive patients diagnosed at the institution from January to June 2022. Frailty was diagnosed using the Fried Frailty Phenotype (FP), while the Charlson Comorbidities Index (CCI) assessed the presence of chronic conditions. Data analysis was performed using SPSS 22.0. Binary logistic regression analysis was conducted with frailty as the dependent variable to identify risk factors. Patients were followed for one year to monitor readmission rates and all-cause mortality.
UNASSIGNED: Multivariate logistic regression identified CCI grade (P=0.030), gender (OR=21.618, 95% CI: 4.062-115.061, P < 0.001), age (OR=1.147, 95% CI: 1.086-1.211, P < 0.001), bedridden state (OR=11.620, 95% CI: 3.282-41.140, P < 0.001), arrhythmia (OR=14.414, 95% CI: 4.558-45.585, P < 0.001), heart failure (OR=5.439, 95% CI: 1.029-28.740, P < 0.05), along with several biochemical markers, as independent predictors of frailty. A predictive model was developed, demonstrating a robust discriminative ability with an area under the receiver operating characteristic curve (AUC) of 0.915. Statistically significant differences in readmission rates and all-cause mortality were observed among the frail, pre-frail, and non-frail groups (P<0.001), with the frail group exhibiting the highest incidence of these adverse outcomes. Notably, frailty emerged as a significant predictor of readmission (P<0.05) but not of all-cause mortality in this cohort.
UNASSIGNED: This study establishes a robust frailty prediction model for elderly hypertensive patients, highlighting the influence of CCI grade, gender, age, and other clinical and biochemical factors on frailty. The model offers a valuable tool for healthcare providers to identify at-risk elderly individuals, facilitating targeted intervention strategies for cardiovascular disease management.

BACKGROUND: Obesity has been linked to arterial stiffness, while no consensus was reached on the association. We aimed to clarify the association of general and central obesity with arterial stiffness by combining observational studies and Mendelian randomization (MR) study.
METHODS: Two cross-sectional studies were performed in UK Biobank and Fuqing Cohort, respectively. Two-sample MR study was conducted using summary data of GWASs from GIANT consortium and UK Biobank. General obesity and central obesity were measured using body mass index (BMI) and waist circumference (WC), respectively. Arterial stiffness was measured by arterial stiffness index (ASI) in UK Biobank or branchial-ankle pulse wave velocity (baPWV) in Fuqing Cohort.
RESULTS: Two observational studies found a consistent positive association of BMI and WC with arterial stiffness when adjusting for age, sex, education, smoking, alcohol drinking, physical activity, and LDL cholesterol. However, when additionally adjusting for metabolic traits (i.e., systolic blood pressure, diastolic blood pressure, blood glucose, triglycerides, high-density lipoprotein cholesterol, and WC or BMI), the association with BMI changed to be inverse. As compared to the lowest quintile group, the adjusted ORs across groups of second to fifth quintile were 0.93, 0.90, 0.83, and 0.72 in UK Biobank and 0.88, 0.65, 0.63, and 0.50 in Fuqing Cohort. In contrast, the positive relationship with WC remained stable with the adjusted ORs of 1.23, 1.46, 1.60, and 1.56 in UK Biobank and 1.35, 1.44, 1.77, and 1.64 in Fuqing Cohort. MR analyses provided supportive evidence of the negative association with BMI (OR = 0.97, 95%CI = 0.94-1.00) and the positive association with WC (OR = 1.14, 95%CI = 1.08-1.20).
CONCLUSIONS: Observational and genetic analyses provide concordant results that central obesity is independently related to arterial stiffness, while the role of general obesity depends on metabolic status.

Background In the pediatric population, acute post-streptococcal glomerulonephritis (PSGN) is a common glomerular etiology of hematuria and acute hypertension leading to hospitalization. We conducted this study to know the clinical profile and occurrence of acute PSGN in patients presenting with features of acute nephritic syndrome. Methods This prospective observational study was conducted on children aged between two and 18 years, presenting with clinical features of acute glomerular nephritis (AGN). After due ethical considerations, all eligible patients were enrolled and underwent detailed clinical assessment, laboratory, and imaging evaluation, followed by protocolized treatment. Relevant data were collected and analyzed to reach valid results. Results Out of 60 patients with AGN, PSGN was found in 83.3% of the patients (50/60). The age group under five years was the most commonly involved, with a male/female ratio of 1.6:1. Around half of the studied patients were from the lower middle class, and 40 (80%) were from rural backgrounds. Facial puffiness was the most common clinical presentation, seen in 45 (90%) patients. Hypocomplementemia and proteinuria were seen in all PSGN patients. Pyoderma was the most common preceding infection, seen in 38 (76%) patients, followed by pharyngitis. Acute kidney injury (AKI) was the most common complication, seen in 12 (24%) patients. Complete resolution of the signs and symptoms was seen in 37 (74%) patients at the time of discharge, which increased to 47 (94%) patients at six months post discharge. Conclusion PSGN stands to be the most common cause of pediatric AGN. The population under five years of age, with a past history of pyoderma, is more predisposed to PSGN. The potential for the occurrence of AKI and other life-threatening complications is high, for which early diagnosis and institution of proper treatment would be very beneficial.

Estimating sample size and statistical power is an essential part of a good epidemiological study design. Closed-form formulas exist for simple hypothesis tests but not for advanced statistical methods designed for exposure mixture studies. Estimating power with Monte Carlo simulations is flexible and applicable to these methods. However, it is not straightforward to code a simulation for non-experienced programmers and is often hard for a researcher to manually specify multivariate associations among exposure mixtures to set up a simulation. To simplify this process, we present the R package mpower for power analysis of observational studies of environmental exposure mixtures involving recently-developed mixtures analysis methods. The components within mpower are also versatile enough to accommodate any mixtures methods that will developed in the future. The package allows users to simulate realistic exposure data and mixed-typed covariates based on public data set such as the National Health and Nutrition Examination Survey or other existing data set from prior studies. Users can generate power curves to assess the trade-offs between sample size, effect size, and power of a design. This paper presents tutorials and examples of power analysis using mpower.

UNASSIGNED: Although observational studies are valuable sources of scientific evidence, they are prone to bias and confounding. This study aimed to assess the quality of observational studies in Traditional Persian medicine (TPM).
UNASSIGNED: A systematic search was conducted in national and international databases up to the end of 2022 to identify observational studies on TPM. The quality of articles was evaluated using the STROBE checklist and CARE guidelines.
UNASSIGNED: Out of the 192 articles identified, 109 met the eligible criteria for quality assessment. Cross-sectional and case-control studies had a mean STROBE score of 1.2±0.51 out of 2, with the introduction section scoring highest and the results and methods sections scoring lowest. The worst reported items in the method section involved sensitivity analyses, bias control, and management of missing data. Case reports and case series had a mean score of 1.4±0.55 out of 2, with the section on therapeutic interventions scoring the highest. Other sections like keywords, follow-up and outcomes, diagnostic assessment, patient perspective, and informed consent scored below one.
UNASSIGNED: Many reviewed articles did not adhere to the recommended formatting in the evaluation tools, making it challenging to assess their quality. Having said that, the quality of observational studies in the field of TPM is a point of concern.

BACKGROUND: Yunnan province borders Myanmar, Laos, and Vietnam, giving it one of the longest borders in China. We aimed to determine the trends in prevalence and impact of COVID-19 on depressive symptoms among adolescents (12-18 years) from 2018 to 2022 in Yunnan, southwest China.
OBJECTIVE: We evaluated the impact of the COVID-19 epidemic on adolescents\' mental health, with the aim of reducing the effect of psychological emergency syndrome and promoting healthy, happy adolescent growth.
METHODS: This longitudinal, observational study used Students\' Health Survey data on adolescents\' depressive symptoms from 2018 to 2022 (before and during COVID-19) in Yunnan. We used multistage, stratified sampling in 3 prefectures in 2018 and 16 prefectures from 2019 to 2022. In each prefecture, the study population was classified by gender and residence (urban or rural), and each group was of equal size. Depressive symptoms were diagnosed based on Center for Epidemiological Studies Depression Scale (CES-D) scores. We used ANOVA to assess the differences in mean CES-D scores stratified by gender, age, residence, grade, and ethnicity. Chi-square tests were used to compare depressive symptoms by different variables. For comparability, the age-standard and gender-standard population prevalences were calculated using the 2010 China Census as the standard population. The association between COVID-19 and the risk of a standardized prevalence of depressive symptoms was identified using unconditional logistic regression analysis.
RESULTS: The standardized prevalence of depressive symptoms for all participants was 32.98%: 28.26% in 2018, 30.89% in 2019, 29.81% in 2020, 28.77% in 2021, 36.33% in 2022. The prevalences were 30.49% before COVID-19,29.29% in early COVID-19, and 36.33% during the COVID-19 pandemic. Compared with before COVID-19, the risks of depressive symptoms were 0.793 (95% CI 0.772-0.814) times higher in early COVID-19 and 1.071 (95% CI 1.042-1.100) times higher than during COVID-19. The average annual increase in depressive symptoms was 1.61%. During the epidemic, the prevalence of depressive symptoms in girls (36.87%) was higher than that in boys (28.64%), and the acceleration rate of girls was faster than that of boys. The prevalences of depressive symptoms and acceleration rates by age group were as follows: 27.14% and 1.09% (12-13 years), 33.99% and 1.8% (14-15 years), 36.59% and 1.65% (16-18 years). Prevalences did not differ between Han (32.89%) and minority (33.10%) populations. However, the acceleration rate was faster for the former than for the latter. The rate for senior high school students was the highest (34.94%). However, the acceleration rate for vocational high school students was the fastest (2.88%), followed by that for junior high school students (2.32%). Rural residents (35.10%) had a higher prevalence and faster acceleration than urban residents (30.16%).
CONCLUSIONS: From 2018 to 2022, there was a significant, continuous increase in the prevalence of depressive symptoms among adolescents in Yunnan, China, especially during the COVID-19 pandemic. This represents an emergency public health problem that should be given more attention. Effective, comprehensive psychological and lifestyle intervention measures should be used to reduce the prevalence of mental health issues in adolescents.

BACKGROUND: Video-capsule endoscopy (VCE) is an efficient tool that has proven to be highly useful in approaching several gastrointestinal diseases. VCE was implemented in Colombia in 2003, however current characterization of patients undergoing VCE in Colombia is limited, and mainly comes from two investigations conducted before the SARS-CoV-2 pandemic period.
OBJECTIVE: To describe the characteristics of patients undergoing VCEs and establish the main indications, findings, technical limitations, and other outstanding features.
METHODS: A descriptive study was carried out using data from reports of VCE (PillCam SB3 system) use in a Gastroenterology Unit in Bogotá, Colombia between September 2019 and January 2023. Demographic and clinical variables such as indication for the VCE, gastric and small bowel transit times (GTT, SBTT), endoscopic preparation quality, and limitations were described [n (%), median (IQR)].
RESULTS: A total of 133 VCE reports were analyzed. Most were in men with a median age of 70 years. The majority had good preparation (96.2%), and there were technical limitations in 15.8% of cases. The main indications were unexplained anemia (91%) or occult bleeding (23.3%). The median GTT and SBTT were 14 and 30 minutes, respectively. The frequencies of bleeding stigma (3.79%) and active bleeding (9.09%) were low, and the most frequent abnormal findings were red spots (28.3%), erosions (17.6%), and vascular ectasias (12.5%).
CONCLUSIONS: VCE showed high-level safety. The main indication was unexplained anemia. Active bleeding was the most frequent finding. Combined with artificial intelligence, VCE can improve diagnostic precision and targeted therapeutic interventions.

UNASSIGNED: Perioperative practices have been introduced over the last decade to decrease the risk of periprosthetic joint infection (PJI). We sought to determine whether rates of revision total knee arthroplasty (TKA) for PJI decreased during the period 2006-2016.
UNASSIGNED: This observational cohort study used data from the New York Statewide Planning and Research Cooperative System to identify patients undergoing TKA in 2006-2016. Data through 2017 were used to determine if patients underwent revision TKA for PJI (including debridement, antibiotics and implant retention) within 1 year of the primary surgery. A generalized estimating equation model, clustered by hospital, was used to examine the impact of time on likelihood of revision TKA for PJI.
UNASSIGNED: In 2006-2016, 233,165 primary TKAs performed were included. Mean age was 66.1 (standard deviation 10.3) years, and 65% were women. Overall, 0.5% of the patients underwent revision TKA for PJI within 1 year of surgery. The generalized estimating equation model showed that for primary TKA performed in 2006-2013, year of surgery did not impact the likelihood of revision TKA for PJI (odds ratio 1.00, 95% confidence interval 0.97-1.03, P = .9221), but that for primary TKA performed in 2014-2016, the likelihood decreased by year (odds ratio 0.76, 95% confidence interval 0.66-0.88, P = .0002).
UNASSIGNED: The likelihood of revision TKA for PJI was stable from 2006 to 2013 but declined during the period 2014-2016 across patient and hospital categories. This decline could be due to infection mitigation strategies or other unmeasured factors.