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Background: Weakness of the shoulder girdle muscles has been reported in patients with chronic lateral elbow tendinopathy. The aim of this study was to assess the short- and long-term effects of a conventional treatment plus scapular exercises program in patients with chronic lateral elbow tendinopathy. Methods: A single-group prestudy and poststudy were conducted. The primary outcome was the Patient-Rated Tennis Elbow Evaluation questionnaire score. Secondary outcomes were grip strength; Disabilities of the Arm, Shoulder, and Hand questionnaire score; Visual Analogue Scale score at rest and at grip, and presence of scapular dyskinesis. Results: A total of 65 patients (72.3% females), with a mean age of 41.8 years, were analyzed. At the end of 6 weeks, the results showed clinically and statistically significant differences (P< .05). At 1-year follow-up, the differences were: Patient-Rated Tennis Elbow Evaluation -31 points (P<.001); grip strength +33.6% (P<.001); Disabilities of the Arm, Shoulder, and Hand -34.2 points (P < .001); Visual Analogue Scale at rest -2.5 cm (P < .001); and Visual Analogue Scale at grip -2.3 cm (P < .001). Conclusion: At the end of 6 weeks and at 1-year follow-up, conventional treatment plus scapular exercises program showed statistically and clinically significant differences in all functional outcomes assessed in patients with lateral elbow tendinopathy. [ABSTRACT FROM AUTHOR]

We explore one systematic review and meta-analysis of both observational and randomized studies examining COVID-19 vaccines in 5- to 11-year-olds, which reported substantial benefits associated with vaccinating this age group. We discuss the limitations of the individual studies that were used to estimate vaccination benefits. The review included five observational studies that evaluated vaccine effectiveness (VE) against COVID-19 severe disease or hospitalization. All five studies failed to adequately assess differences in underlying health between vaccination groups. In terms of vaccination harms, looking only at the randomized studies, a significantly higher odds of adverse events was identified among the vaccinated compared with the unvaccinated. Observational studies are at risk of overestimating the effectiveness of vaccines against severe disease if healthy vaccinee bias is present. Falsification endpoints can provide valuable information about underlying healthy vaccinee bias. Studies that have not adequately ruled out bias due to better health among the vaccinated or more vaccinated should be viewed as unreliable for estimating the VE of COVID-19 vaccination against severe disease and mortality. Existing systematic reviews that include observational studies of the COVID-19 vaccine in children may have overstated or falsely inferred vaccine benefits due to unidentified or undisclosed healthy vaccinee bias.

INTRODUCTION: Optimal venous thromboembolism (VTE) enoxaparin prophylaxis dosing remains elusive. Weight-based (WB) dosing safely increases anti-factor Xa levels without the need for routine monitoring but it is unclear if it leads to lower VTE risk. We hypothesized that WB dosing would decrease VTE risk compared with standard fixed dosing (SFD). METHODS: Patients from the prospective, observational CLOTT-1 registry receiving prophylactic enoxaparin (n=5539) were categorized as WB (0.45-0.55 mg/kg two times per day) or SFD (30 mg two times per day, 40 mg once a day). Multivariate logistic regression was used to generate a predicted probability of VTE for WB and SFD patients. RESULTS: Of 4360 patients analyzed, 1065 (24.4%) were WB and 3295 (75.6%) were SFD. WB patients were younger, female, more severely injured, and underwent major operation or major venous repair at a higher rate than individuals in the SFD group. Obesity was more common among the SFD group. Unadjusted VTE rates were comparable (WB 3.1% vs. SFD 3.9%; p=0.221). Early prophylaxis was associated with lower VTE rate (1.4% vs. 5.0%; p=0.001) and deep vein thrombosis (0.9% vs. 4.4%; p

Background: Risk scores facilitate the assessment of mortality risk in patients with community-acquired pneumonia (CAP). Despite their utilities, there is a scarcity of evidence comparing the various RS simultaneously. This study aims to evaluate and compare multiple risk scores reported in the literature for predicting 30-day mortality in adult patients with CAP. Methods: A retrospective cohort study on patients diagnosed with CAP was conducted across two hospitals in Colombia. The areas under receiver operating characteristic curves (ROC-curves) were calculated for the outcome of survival or death at 30 days using the scores obtained for each of the analyzed questionnaires. Results: A total of 7454 potentially eligible patients were included, with 4350 in the final analysis, of whom 15.2% (662/4350) died within 30 days. The average age was 65.4 years (SD: 21.31), and 59.5% (2563/4350) were male. Chronic kidney disease was 3.7% (9.2% vs. 5.5%; p < 0.001) (OR: 1.85) higher in subjects who died compared to those who survived. Among the patients who died, 33.2% (220/662) presented septic shock compared to 7.3% (271/3688) of the patients who survived (p < 0.001). The best performances at 30 days were shown by the following scores: PSI, SMART-COP and CURB 65 scores with the areas under ROC-curves of 0.83 (95% CI: 0.8–0.85), 0.75 (95% CI: 0.66–0.83), and 0.73 (95% CI: 0.71–0.76), respectively. The RS with the lowest performance was SIRS with the area under ROC-curve of 0.53 (95% CI: 0.51–0.56). Conclusion: The PSI, SMART-COP and CURB 65, demonstrated the best diagnostic performances for predicting 30-day mortality in patients diagnosed with CAP. The burden of comorbidities and complications associated with CAP was higher in patients who died. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion To establish trust in real‐world evidence (RWE) derived from CareLink Personal (CP), Medtronic's data management system for MiniMed system users, we show that this database and its analyses strictly adhere to the principles of RWE.The methodology is applicable to all MiniMed iterations. We described every step from raw data to predefined outcomes. In addition, we showed CP's fitness‐for‐research by the below metrics (using last year's MiniMed 780G system data as a case study): representative population, relevant endpoints, appropriate granularity, high data completeness, high data representativity and consistency in results.The process from raw data to outcomes has been validated, and metrics/logics adhere to established definitions. Over 95% of users have a CP account; with 96% providing consent, this allows the use of >91% of the census population. There is no rationale for an over‐representation of a specific phenotype among users not included. CP includes >50 endpoints, including ‘International Consensus on Time in Range’ based metrics. Data are recorded at 5‐min intervals (maximum 288 per day), and on average there were 263 data points per person per day. Ninety‐nine per cent of uploads were automated. For the last year, only 1 in 6 users had a data gap >1 day, and 1 in 50 had a gap >1 week. The time in range from in‐silico studies was similar to that of real‐world studies from different geographies and with ever growing populations.RWE from CP adheres to the principles of RWE and can serve as robust evidence on the performance and safety of MiniMed systems. [ABSTRACT FROM AUTHOR]

Objectives Materials and Methods Results Conclusion To investigate the utilization and costs of non‐insulin glucose‐lowering drugs (GLDs) in Australia from 2013 to 2023.We conducted a retrospective analysis of the Australian Pharmaceutical Benefits Scheme (PBS) administrative dataset of 118 727 494 GLD prescriptions. The main outcome measures were the annual number of GLD prescriptions dispensed, accounting for type 2 diabetes mellitus (T2DM) prevalence and healthcare system costs, adjusted for inflation.Utilization of GLDs doubled from 6.4 million prescriptions in 2013 to 15.6 million in 2023. The average annual percent increase in utilization was 8.1%, compared to the average annual increase in prevalence of T2DM of 1.8%. The biggest change was in sodium‐glucose cotransporter‐2 (SGLT2) inhibitors, for which there was an average annual increase in utilization of 59.4% (95% confidence interval [CI] 51.7%, 68.2%; p < 0.05) from 2014 (first full year of PBS listing), followed by glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs), which showed an increase of 31.4% (95% CI 28.5%, 33.8%; p < 0.05) annually (2013 to 2023). Dipeptidyl peptidase‐4 inhibitor utilization tripled, with an average annual increase of 10.9% (95% CI 8.1%, 13.8%; p < 0.05), but this plateaued from 2020. Metformin utilization increased by 4.7% (95% CI 2.0%, 6.9%; p < 0.05) annually. In contrast, sulphonylurea, glitazone and acarbose utilization declined. Total GLD costs increased threefold over the same period. Despite only accounting for 11.7% of utilization, GLP‐1RAs contributed to 35% of the costs.Utilization of GLDs doubled, and associated costs tripled over the past 11 years, with no sign of either utilization or costs plateauing, predominantly due to increased GLP‐1RA and SGLT2 inhibitor prescribing. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the effectiveness and safety of two different intravenous methylprednisolone (IVMP) pulse doses in patients with severe microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). Methods We emulated a target trial using observational data from the nationwide registry in Japan. Patients with severe glomerulonephritis or diffuse alveolar haemorrhage were selected and pseudo-randomized into three groups using propensity score-based overlap weighting as follows: non-IVMP, IVMP 0.5 g/day and IVMP 1.0 g/day. The primary outcome was all-cause mortality, and the secondary outcomes were composite all-cause mortality and kidney failure, severe relapse and serious infection from 2 to 48 weeks after treatment initiation. To estimate the treatment effects, the Cox proportional hazard model and Fine–Gray subdistribution hazard model were used. Results In this emulated target trial, of 201 eligible patients (MPA, 175; GPA, 26), 6 (3%) died, 4 (2.0%) had kidney failure, 11 (5.5%) had severe relapse, and 40 (19.9%) had severe infections. Hazard ratios (HR) for IVMP 0.5 g/day and IVMP 1.0 g/day pulse groups compared with non-IVMP pulse were as follows: all-cause mortality 0.46 (95% CI: 0.07, 2.81) and 0.07 (95% CI: 0.01, 0.41), respectively; all-cause mortality/kidney failure 1.18 (95% CI: 0.26, 5.31) and 0.59 (95% CI: 0.08, 4.52), respectively; subdistribution HRs for severe relapse were 1.26 (95% CI: 0.12, 13.70) and 3.36 (95% CI: 0.49, 23.29), respectively; and for serious infection 1.88 (95% CI: 0.76, 4.65) and 0.94 (95% CI: 0.28, 3.13), respectively. Conclusion IVMP 1.0 g/day pulse may improve 48-week mortality in patients with severe MPA/GPA. [ABSTRACT FROM AUTHOR]

Objective: This study aims to evaluate the roles and tasks of school nurses in the UAE, quantify the time spent on each, and identify areas for improvement in school health services. This aligns with the UAE government's initiative to enhance primary healthcare, focusing on illness prevention and health promotion for children and adolescents. Methods: The research adopts an observational study design, utilizing self‐observation through diary recordings by school nurses to collect data on their daily tasks and time allocation. A sample of total of 2024 school nurse activities were recorded and analyzed over 126 days and 1084 h of observation by eight school nurses using self‐report diaries. This method allowed for the collection of detailed information on how nursing time is allocated between core and noncore tasks. Results: In this study a total of 2024 tasks were observed over 1084 h. The findings reveal that core nursing tasks accounted for 78% of activities but only 53% of the total 1084 h observed, while non‐nursing tasks, making up 22% of activities, disproportionately consumed 47% of the hours. This discrepancy highlights the inefficiency of time allocation, with non‐nursing tasks such as administrative duties taking significantly longer than core patient care tasks. Conclusions: The study highlights a significant opportunity to enhance school health services in the UAE by optimizing the allocation of nursing time towards more illness prevention and health promotion interventions. By addressing the identified challenges, including the gaps in nurse competencies and the lack of structured practice frameworks, school health services can be improved. [ABSTRACT FROM AUTHOR]

Emotion regulation (ER) is a source of risk and resilience for psychological development and everyday functioning. Despite extensive research on various early contextual predictors of child ER capacity, few studies have integrated them into the same study. Therefore, our longitudinal study investigated the joint and independent contributions of several prominent contextual predictors of child ER capacity. We followed typically developing children and their caregivers (N = 118, 47% girls) at three time points (children ages 10, 12, and 18 months). At 10 months, mothers reported household chaos, social support, and parenting stress, and maternal sensitivity was observed and coded with the Ainsworth's Maternal Sensitivity Scales. At 12 months, child–mother attachment security was assessed using the Strange Situation Procedure. Finally, at 18 months, child ER was obtained with a Laboratory Temperament Assessment Battery frustration task. Correlational analyses revealed that household chaos and maternal sensitivity were significantly positively associated with child ER. Multiple regression analyses showed independent effects of household chaos and maternal sensitivity on child ER. Our partly counterintuitive results underscore the significance of cumulative risk and protective factors for ER development and suggest that household chaos and maternal sensitivity may contribute uniquely to better ER in typical toddlerhood. [ABSTRACT FROM AUTHOR]

Aims Materials and Methods Results Conclusions To investigate the independent contributions of glycated haemoglobin (HbA1c) reduction and weight loss to clinical outcomes in patients with type 2 diabetes (T2D) treated with antidiabetic drugs, including glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs).This observational, retrospective cohort study used deidentified electronic health record‐derived data from patients evaluated at the Cleveland Clinic (1 January 2000–31 December 2020). Cohort A included 8876 patients with newly diagnosed T2D treated with any of six antidiabetic drug classes. Cohort B included 4161 patients with T2D initiating GLP‐1RA treatment. The effects of body mass index (BMI) and HbA1c reduction, variability, and durability on clinical outcomes were investigated.In Cohort A, each 1% BMI reduction was associated with 3%, 1%, and 4% reduced risk of heart failure (p = 0.017), hypertension (p = 0.006), and insulin initiation (p = 0.001), respectively. Each 1% (~11 mmol/mol) HbA1c reduction was associated with 4% and 29% reduced risk of hypertension (p = 0.041) and insulin initiation (p = 0.001), respectively. In Cohort B, each 1% BMI reduction was associated with 4% and 3% reduced risk of cardiovascular disease (p = 0.008) and insulin initiation (p = 0.002), respectively. Each 1% (~11 mmol/mol) HbA1c reduction was associated with 4% and 16% reduced risk of chronic kidney disease (p = 0.014) and insulin initiation (p = 1 × 10−4), respectively. Lower BMI variability and greater BMI durability were associated with decreased risk of clinical outcomes in both cohorts.Antidiabetic medication‐associated, and specifically GLP‐1RA‐associated, weight loss and HbA1c reductions independently reduce real‐world clinical outcome risk. [ABSTRACT FROM AUTHOR]

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. Trial registration: The study was registered on ClinicalTrials.gov under the identifier NCT04008446 on June 17, 2019. [ABSTRACT FROM AUTHOR]

Aim Materials and Methods Results Conclusions The relative contributions of insulin secretory defects and possible additional contribution of insulin resistance for the development of cystic fibrosis (CF)‐related diabetes (CFRD) are poorly understood. We aimed to (a) determine which indices of insulin resistance predict progression to CFRD, and (b) to model the relative contributions of insulin secretory function and insulin resistance to predict the risk of CFRD.Three hundred and three individuals living with CF underwent a 2‐h oral glucose tolerance test with blood sampling every 30 min at 12–24‐month intervals until they developed CFRD or until the end of follow‐up (up to 15 years). Indices of insulin resistance (e.g. Stumvoll) and insulin secretion were calculated from oral glucose tolerance test glucose and insulin measurements. CFRD‐free survival was assessed by survival analysis.Estimated insulin resistance showed associations with glucose homeostasis and risk of progression to CFRD. The CFRD‐free survival was significantly different between quartiles of insulin resistance (p < 0.0001). When patients were subdivided according to both insulin resistance and insulin secretion (insulinogenic index), CFRD‐free survival was significantly lower in those with combined lowest insulin secretion and highest insulin resistance (Stumvoll) indices (hazard ratio: 11.2; p < 0.0001). There was no significant difference when the same analysis was performed for the nine other indices.Insulin resistance is correlated with glucose homeostasis and the risk of progression to CFRD. Patients combining low insulin secretion and high insulin resistance had the greatest odds of developing CFRD over a 15‐year period. [ABSTRACT FROM AUTHOR]

Aim Materials and Methods Results Conclusions To examine the associations of tea consumption (both frequency and type) with (1) prediabetes and diabetes and (2) urinary glucose and sodium excretion in Chinese community‐dwelling adults.In 1923 participants (457 with diabetes, 720 with prediabetes, and 746 with normoglycaemia), the frequency (occasional, frequent, daily, or nil) and type (green, black, dark, or other) of tea consumption were assessed using a standardized questionnaire. Morning spot urinary glucose and urine glucose‐to‐creatinine ratios (UGCRs) were assessed as markers of urinary glucose excretion. Tanaka's equation was used to estimate 24‐h urinary sodium excretion. Logistic and multivariate linear regression analyses were performed.Compared with non‐tea drinkers, the corresponding multivariable‐adjusted odds ratios (ORs) for prediabetes and diabetes were 0.63 (95% confidence interval [CI] 0.48, 0.83) and 0.58 (95% CI 0.41, 0.82) in participants drinking tea daily. However, only drinking dark tea was associated with reduced ORs for prediabetes (0.49, 95% CI 0.36, 0.66) and diabetes (0.41, 95% CI 0.28, 0.62). Dark tea consumption was associated with increased morning spot urinary glucose (0.22 mmol/L, 95% CI 0.11, 0.34 mmol/L), UGCR (0.15 mmol/mmol, 95% CI 0.05, 0.25 mmol/L) and estimated 24‐h urinary sodium (7.78 mEq/day, 95% CI 2.27, 13.28 mEq/day).Regular tea consumption, especially dark tea, is associated with a reduced risk of dysglycaemia and increased urinary glucose and sodium excretion in Chinese community‐dwelling adults. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background This study aimed to assess the prognosis of people with chronic kidney disease (CKD) in Japan using the Kidney Disease: Improving Global Outcomes (KDIGO) heatmap. Methods The prognoses of individuals with estimated glomerular filtration rates (eGFR) <90 mL/min/1.73 m2 were evaluated based on the KDIGO heatmap using an electronic medical record database in Japan. The primary outcome was major adverse cardiovascular events (MACE), a composite of myocardial infarction (MI), stroke, heart failure (HF) hospitalization and in-hospital death (referred to as MACE1). Additionally, ad hoc MACE2 (MI hospitalization, stroke hospitalization, HF hospitalization and in-hospital death) was examined. The secondary outcome was the renal outcome. Results Of the 543 606 individuals included, the mean age was 61.6 ± 15.3 years, 50.1% were male and 40.9% lacked urine protein results. The risk of MACEs increased independently with both eGFR decline and increasing proteinuria from the early KDIGO stages: hazard ratios (95% confidence interval) of MACE1 and MACE2, compared with G2A1 were 1.16 (1.12–1.20) and 1.17 (1.11–1.23), respectively, for G3aA1, and 1.17 (1.12–1.21) and 1.35 (1.28–1.43), respectively, for G2A2. This increased up to 2.83 (2.54–3.15) and 3.43 (3.00–3.93), respectively, for G5A3. Risks of renal outcomes also increased with CKD progression. Conclusions This study is the first to demonstrate the applicability of the KDIGO heatmap in assessing cardiovascular and renal risk in Japan. The risk increased from the early stages of CKD, indicating the importance of early diagnosis and intervention through appropriate testing. [ABSTRACT FROM AUTHOR]

This study sought to analyze an explanatory model on the relationship among sociodemographic factors, health-promoting lifestyle behaviors and psychological distress (depression, anxiety and stress) in college students. This is an observational, analytical and cross-sectional study conducted on a national sample of 4203 students who entered a macro university in Honduras in 2021, 2022 and 2023. We used a sociodemographic survey, the Health-Promoting Lifestyle Profile (HPLP-II) and the Depression, Anxiety and Stress Scales (DASS-21). Univariate analysis and a multivariate structural equation model were conducted. The average HPLP-II score was 117.45 (± 23.41), and the average DASS-21 score was 20.06 (± 14.16). The multivariate model showed a good data fit (comparative fit index = 0.951; Tucker–Lewis index = 0.957; root mean square error of approximation = 0.067 [90% CI = 0.067–0.068]). Results indicate that being a woman (β = 0.11; p  < 0.001) and being enrolled in biological and health sciences (β = 0.09; p  < 0.001) significantly predict HPLP-II scores. Furthermore, being a woman (β = 0.17; p  < 0.001), age (β = 0.10; p  < 0.001) and having pre-existing medical conditions (β = 0.16; p  < 0.001) significantly explain part of the variance of DASS-21. A significant reverse relationship between health-promoting behavior and psychological distress was shown (r  = −0.36; p  < 0.001). This study identifies protective and risky sociodemographic factors linked to health-promoting lifestyle behaviors and psychological distress. Our findings have implications for developing comprehensive intervention policies and strategies to promote health in higher education settings. [ABSTRACT FROM AUTHOR]

Aim: Studies examining the safety and effectiveness of sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) versus glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) among community‐dwelling adults may not generalize to nursing home (NH) residents, who are typically older and more multimorbid. We compared the safety and cardiovascular effectiveness of SGLT2is and GLP‐1RAs among US NH residents. Materials and Methods: Eligible individuals were aged ≥66 years with type 2 diabetes mellitus and initiated an SGLT2i or GLP‐1RA in an NH between 2013 and 2018. Safety outcomes included fall‐related injuries, hypoglycaemia, diabetic ketoacidosis (DKA), urinary tract infection or genital infection, and acute kidney injury in the year following treatment initiation. Cardiovascular effectiveness outcomes included death, major adverse cardiovascular events and hospitalization for heart failure. Per‐protocol adjusted hazard ratios (HR) were calculated using stabilized inverse probability of treatment and censoring weighted cause‐specific hazard regression models accounting for 127 covariates. Results: The study population included 7710 residents (31.08% SGLT2i, 68.92% GLP‐1RA). Compared with GLP‐1RA initiators, SGLT2i initiators had higher rates of DKA (HR 1.95, 95% confidence limits 1.27, 2.99) and death (HR 1.18, 95% confidence limits 1.02, 1.36). Rates of urinary tract infection or genital infection, acute kidney injury, major adverse cardiovascular events, and heart failure were also elevated, while rates of fall‐related injuries and hypoglycaemia were reduced, but all estimates were imprecise and highly compatible with no difference. Conclusions: SGLT2is do not have superior, and may have inferior, effectiveness compared with GLP‐1RAs for cardiovascular and mortality outcomes in NH residents. Residents initiating SGLT2is should be monitored closely for DKA. [ABSTRACT FROM AUTHOR]

Aim: Fatty acid esters of hydroxy fatty acids (FAHFA) are a class of bioactive lipids with anti‐inflammatory, antidiabetic and cardioprotective properties. FAHFA hydrolysis into its fatty acid (FA) and hydroxy fatty acid (HFA) constituents can affect the bioavailability of FAHFA and its subsequent biological effects. We aimed to investigate FAHFA levels and FAHFA hydrolysis activity in children with or without obesity, and in adults with or without coronary artery disease (CAD). Materials and Methods: Our study cohort included 20 children without obesity, 40 children with obesity, 10 adults without CAD and 28 adults with CAD. We quantitated plasma levels of four families of FAHFA [palmitic acid hydroxy stearic acid (PAHSA), palmitoleic acid hydroxy stearic acid (POHSA), oleic acid hydroxy stearic acid (OAHSA), stearic acid hydroxy stearic acid] and their corresponding FA and HFA constituents using liquid chromatography‐tandem mass spectrometry analysis. Surrogate FAHFA hydrolysis activity was estimated as the FA/FAHFA or HFA/FAHFA ratio. Results: Children with obesity had lower plasma PAHSA (p =.001), OAHSA (p =.006) and total FAHFA (p =.011) levels, and higher surrogate FAHFA hydrolysis activity represented by PA/PAHSA (p =.040) and HSA/OAHSA (p =.025) compared with children without obesity. Adults with CAD and a history of myocardial infarction (MI) had lower POHSA levels (p =.026) and higher PA/PAHSA (p =.041), POA/POHSA (p =.003) and HSA/POHSA (p =.038) compared with those without MI. Conclusion: Altered FAHFA metabolism is associated with obesity and MI, and inhibition of FAHFA hydrolysis should be studied further as a possible therapeutic strategy in obesity and MI. [ABSTRACT FROM AUTHOR]

Aim: The use of vitamin K antagonists (VKAs) may increase the risk of peripheral arterial disease (PAD) because vitamin K is a strong inhibitor of medial arterial calcification. Type 2 diabetes (T2D) exposes patients to an increased risk of PAD. We examined how the use of VKAs modulates the risk of incident PAD in people with T2D. Materials and Methods: SURDIAGENE is a French cohort including 1468 patients with T2D with a prospective follow‐up from 2002 to 2015. The primary outcome of the current analysis was the first occurrence of PAD, a composite of lower‐limb amputation (LLA) or lower‐limb revascularization. LLA and lower‐limb revascularization were considered individually as secondary outcomes. Results: During a 7‐year median follow‐up, PAD occurred in 147 (10%) of the 1468 participants. The use of VKAs was not significantly associated with the risk of PAD [multivariable adjusted hazard ratio (HR) 1.42, 95% confidence interval (CI), 0.88‐2.31]. During the study period, LLA and lower‐limb revascularization occurred in 82 (6%) and 105 (7%) participants, respectively. The use of VKAs was significantly associated with increased risk of LLA [multivariable adjusted HR 1.90 (95% CI, 1.04‐3.47)], but not lower‐limb revascularization [multivariable adjusted HR 1.08 (95% CI, 0.59‐1.97)]. Conclusions: In this prospective study, we did not observe any excess risk of PAD requiring lower‐limb revascularization in people with type 2 diabetes using VKAs. However, our data suggest a high risk of LLA in VKA users. Further studies are required to confirm this observation. [ABSTRACT FROM AUTHOR]

Aims: To investigate the associations of conicity index (C‐index) and relative fat mass (RFM) with incident type 2 diabetes mellitus (T2DM) among adults in China. Materials and Methods: A total of 10 813 participants aged over 18 years in Shenzhen Longhua district were enrolled in a follow‐up study conducted from 2018 to 2022. The participants were categorized based on quartiles (Q) of C‐index and RFM. The Cox proportional hazards model was performed to examine the relationships between C‐index, RFM and the risk of T2DM. Results: After adjusting for potential confounding factors, including age, sex, occupation, marital status, education level, smoking status, alcohol consumption, physical exercise, hypertension status, fasting blood glucose (FBG) and total cholesterol (TC), both C‐index and RFM showed positive and independent associations with risk of T2DM. The multivariable‐adjusted hazard ratios (95% confidence intervals) for T2DM risk in participants in C‐index Q3 and Q4 compared with those in C‐index Q1 were 1.50 (1.12, 2.02) and 1.73 (1.29, 2.30), and 1.94 (1.44, 2.63), 3.18 (1.79, 5.64), 4.91 (2.68, 9.00) for participants in RFM Q2, Q3 and Q4 compared with RFM Q1. These differences were statistically significant (all p < 0.05). Conclusion: C‐index and RFM are strongly associated with new‐onset T2DM and could be used to identify the risk of diabetes in large‐scale epidemiological studies. [ABSTRACT FROM AUTHOR]

Introduction: Food intake biomarkers are used to estimate dietary exposure; however, selecting a single biomarker to evaluate a specific dietary component is difficult due to the overlap of diverse compounds from different foods. Therefore, combining two or more biomarkers can increase the sensitivity and specificity of food intake estimates. Objective: This study aimed to evaluate the ability of metabolite panels to distinguish between self-reported fruit consumers and non-consumers among participants in the Longitudinal Study of Adult Health. Materials and methods: A total of 93 healthy adults of both sexes were selected from the Longitudinal Study of Adult Health. A 24-h dietary recall was obtained using the computer-assisted 24-h food recall GloboDiet software, and 24-h urine samples were collected from each participant. Metabolites were identified in urine using liquid chromatography coupled with high-resolution mass spectrometry by comparing their exact mass and fragmentation patterns using free-access databases. Multivariate receiver operating characteristic curve (ROC) analysis and partial least squares discriminant analysis were used to verify the ability of the metabolite combination to classify daily and non-daily fruit consumers. Fruit intake was identified using a 24 h dietary recall (24 h-DR). Results: Bananas, grapes, and oranges are included in the summary. The panel of biomarkers exhibited an area under the curve (AUC) > 0.6 (Orange AUC = 0.665; Grape AUC = 0.622; Bananas AUC = 0.602; All fruits AUC = 0.679; Citrus AUC = 0.693) and variable importance projection score > 1.0, and these were useful for assessing the sensitivity and predictability of food intake in our population. Conclusion: A panel of metabolites was able to classify self-reported fruit consumers with strong predictive power and high specificity and sensitivity values except for banana and total fruit intake. [ABSTRACT FROM AUTHOR]

Background: Chronic respiratory insufficiency from progressive muscle weakness causes morbidity and mortality in late-onset Pompe disease (LOPD). Previous Pompe Registry (NCT00231400) analyses for ≤ 5 years' alglucosidase alfa treatment showed a single linear time trend of stable forced vital capacity (FVC) % predicted. Methods: To assess longer term Pompe Registry data, piecewise linear mixed model regression analyses estimated FVC% predicted trajectories in invasive-ventilator-free patients with LOPD aged ≥ 5 years. We estimated annual FVC change 0–6 months, > 6 months–5 years, and > 5–13 years from treatment initiation, adjusting for baseline age, sex, and non-invasive ventilation. Findings: Among 485 patients (4612 FVC measurements; 8.3 years median follow-up), median ages at symptom onset, diagnosis, and alglucosidase alfa initiation were 34.3, 41.1, and 44.9 years, respectively. FVC% increased during the first 6 months' treatment (slope 1.83%/year; 95% confidence interval: 0.66, 3.01; P = 0.0023), then modestly declined −0.54%/year (−0.79, −0.30; P < 0.0001) during > 6 months–5 years, and −1.00%/year (−1.36, −0.63; P < 0.0001) during > 5–13 years. The latter two periods' slopes were not significantly different from each other (Pdifference = 0.0654) and were less steep than published natural history slopes (−1% to −4.6%/year). Estimated individual slopes were ≥ 0%/year in 96.1%, 30.3%, and 13.2% of patients during the 0–6 month, > 6 month–5 year, and > 5–13 year periods, respectively. Conclusion: These real-world data indicate an alglucosidase alfa benefit on FVC trajectory that persists at least 13 years compared with published natural history data. Nevertheless, unmet need remains since most individuals demonstrate lung function decline 5 years after initiating treatment. Whether altered FVC trajectory impacts respiratory failure incidence remains undetermined. Trial registration: This study was registered (NCT00231400) on ClinicalTrials.gov on September 30, 2005, retrospectively registered. [ABSTRACT FROM AUTHOR]

Background/Aims: Information regarding the use of wearable devices in clinical research, including disease areas, intervention techniques, trends in device types, and sample size targets, remains elusive. Therefore, we conducted a comprehensive review of clinical research trends related to wristband wearable devices in research planning and examined their applications in clinical investigations. Methods: As this study identified trends in the adoption of wearable devices during the planning phase of clinical research, including specific disease areas and targeted number of intervention cases, we searched ClinicalTrials.gov—a prominent platform for registering and disseminating clinical research. Since wrist-worn devices represent a large share of the market, we focused on wrist-worn devices and selected the most representative models among them. The main analysis focused on major wearable devices to facilitate data analysis and interpretation, but other wearables were also surveyed for reference. We searched ClinicalTrials.gov with the keywords "ActiGraph,""Apple Watch,""Empatica,""Fitbit,""Garmin," and "wearable devices" to obtain studies published up to 21 August 2022. This initial search yielded 3214 studies. After excluding duplicate National Clinical Trial studies (the overlap was permissible among different device types except for wearable devices), our analysis focused on 2930 studies, including simple, time-series, and type-specific assessments of various variables. Results: Overall, an increasing number of clinical studies have incorporated wearable devices since 2012. While ActiGraph and Fitbit initially dominated this landscape, the use of other devices has steadily increased, constituting approximately 10% of the total after 2015. Observational studies outnumbered intervention studies, with behavioral and device-based interventions being particularly prevalent. Regarding disease types, cancer and cardiovascular diseases accounted for approximately 20% of the total. Notably, 114 studies adopted multiple devices simultaneously within the context of their clinical investigations. Conclusions: Our findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3 years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention therapy utilizing apps is becoming more extensive, and we expect to see more examples that will lead to their approval as programmed medical devices in the future. [ABSTRACT FROM AUTHOR]

Objective: Managing the gap between the dressing and the wound bed can facilitate the healing of exuding wounds. A silicone foam dressing (Biatain Silicone; Coloplast A/S, Denmark) was developed for application to exuding wounds. A sub-analysis of the real-world, prospective, observational VIPES (Observatoire en Ville des Plaies ExSudatives) study was conducted to investigate the use and performance of the silicone foam dressing in a community nursing setting in France. Method: The sub-analysis included patients from the VIPES study who received the silicone foam dressing as a primary dressing for an acute or hard-to-heal (chronic) wound. Epidemiological and wound healing outcomes were reported via a smartphone application. Results: Overall, 64 patients were included in the sub-analysis. At baseline, most wounds (n=33/40; 82.5%) were in treatment failure (i.e., were stagnant, non-healing or had poor exudate management). At the last follow-up visit, a median of 22.5 (range: 3–151) days post baseline, 48.4% of wounds had healed and 25.0% were progressing towards healing. From baseline to the last follow-up visit, significant reductions in exudate level (p<0.0001) and exudate pooling (p<0.0001), and significant improvements in wound edges (p≤0.0001) and periwound skin (p<0.01) were observed. A total of 62.3% of patients had re-epithelialising wounds at the last follow-up visit. The majority of nurses (88.3%) and patients (85.0%) reported that the wound had improved and, at most dressing removals (93.5%), nurses reported that the dressing conformed closely to the wound bed. Conclusion: Overall, the data suggest that use of the silicone foam dressing in community practice supported the healing of wounds, illustrating the importance of exudate and gap management. [ABSTRACT FROM AUTHOR]

In pharmacoepidemiology, robust data are needed to judge the impact of drug treatment on pregnancy, pregnancy outcomes and breast‐fed infants. As pregnant and breastfeeding women are usually excluded from randomised clinical trials, observational studies are required. One of those data sources are pregnancy registers specifically developed to focus on certain diseases or disease groups. The German Rhekiss register investigates pregnancies in women with chronic inflammatory rheumatic diseases (IRD). Rhekiss is a nationwide, multicentre, longitudinal study, in which women aged 18 years or older with an underlying IRD can be enrolled by a rheumatologist either when planning a pregnancy or in the first half of pregnancy. Data are collected prospectively at regular follow‐up visits. Rheumatologists and patients provide information in a web‐based system before conception (if enrolment was at the time of pregnancy planning), during and after pregnancy. A smartphone app is available for patients. Maternal and clinical information, general laboratory markers, treatment with antirheumatic and other drugs, adverse events, items related to course and outcome of pregnancy and the health of the child are uniformly assessed for all diseases. Individual information on the IRD includes classification criteria, diagnosis‐specific laboratory parameters, clinical parameters and validated instruments to measure disease activity or damage. Furthermore, patient‐reported outcome measures are captured. A total of 2013 individual patients have been enrolled in the register, and data on 1801 completed pregnancies are available. In summary, Rhekiss is a comprehensive and complex register that can answer various research questions about pregnancy in women with chronic IRDs. [ABSTRACT FROM AUTHOR]

Aim Materials and Methods Results Conclusions To investigate the clinical significance of body weight changes on kidney outcomes among individuals with diabetes using sodium–glucose cotransporter‐2 (SGLT2) inhibitors.This is a retrospective cohort study using a nationwide epidemiological database, and we conducted an analysis involving 11 569 individuals with diabetes who were newly prescribed SGLT2 inhibitors. The main outcome was the rate of decline in estimated glomerular filtration rate (eGFR), determined through a linear mixed‐effects model with an unstructured covariance structure.The median age of the patients was 52 (Q1–Q3: 47–58) years, and the median fasting plasma glucose and glycated haemoglobin (HbA1c) levels were 144 (Q1–Q3: 124–175) mg/dL and 7.4 (Q1–Q3: 6.8–8.3)%, respectively. The median estimated eGFR was 77.7 (Q1–Q3: 67.2–89.1) mL/min/1.73 m2. The median follow‐up period was 1.7 (Q1–Q3: 1.0–2.6) years. Participants were stratified into three groups based on the body mass index change rate tertiles between baseline and 1 year after (tertile 1: <−4.55%, tertile 2: −4.55% to −1.43%, tertile 3: >−1.43%). The annual change in eGFR was −0.78 (−0.94 to −0.63) mL/min/1.73 m2 in tertile 1, −0.95 (−1.09 to −0.81) mL/min/1.73 m2 in tertile 2, and −1.65 mL/min/1.73 m2 (−1.84 to −1.47) in tertile 3 (pinteraction < 0.001). A variety of sensitivity analyses confirmed the relationship between the 1‐year body mass index decrease and favourable kidney outcomes after SGLT2 inhibitor administration.Our analysis of a nationwide epidemiological cohort revealed that kidney outcomes following the initiation of SGLT2 inhibitors would be more favourable, with greater body weight loss observed after the initiation of SGLT2 inhibitors. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusions To evaluate associations between social disadvantage and insulin pump use among adults with type 1 diabetes (T1D) in the context of a universal publicly funded insulin pump programme in Ontario, Canada, and to ascertain whether social disparities in insulin pump programme enrolment have decreased over time.Population‐based cross‐sectional studies were conducted using administrative healthcare data in Ontario, Canada. First, among adults aged older than 18 years diagnosed with T1D before 31 March 2021, logistic regression was used to assess the association between neighbourhood social disadvantage (Ontario marginalization index quintiles) and insulin pump use. Second, among all paediatric and adult applicants to the insulin pump programme from 1 September 2006 to 31 March 2022, ordinal logistic regression was used to evaluate associations between year of insulin pump initiation and social disadvantage.Among 27 453 adults with T1D, 60% used insulin pumps. Greater social disadvantage was associated with lower odds of insulin pump use (adjusted odds ratio [OR] 0.44 [95% confidence interval {CI} 0.39‐0.48] for greatest vs. lowest social disadvantage quintile). Among 21 002 paediatric and adult applicants to the insulin pump programme, social disparities in pump use decreased in the first 3 years of the programme, plateaued until 2020, then increased from 2020 to 2022, with no change in the odds of being in a higher social deprivation quintile for 2022 relative to 2007 (OR 1.09 [95% CI 0.83‐1.44]).Despite a universal pump programme for individuals with T1D, disparities by social disadvantage persist. Residual financial and non‐financial barriers must be addressed to promote equitable insulin pump uptake. [ABSTRACT FROM AUTHOR]

Background: To establish a normative database for macular vessel density (VD) measured by optical coherence tomography angiography (OCTA) and explore the parameters related to the VD. Methods: An observational study in epidemiology. 5840 healthy elderly participants in Beichen district, Tianjin, China underwent detailed ophthalmic and systemic examinations. OCTA was performed in all subjects using a 6 × 6-mm line scan mode centered on the macula and the built-in software was used to quantify VD and stratify the retina. Results: One thousand four hundred sixty-one healthy elderly citizens (30.4% men) were included, with a median age of 60.0 years (8.0 years) and an age range of 50 to 87 years.VDs in the different plexuses: superficial capillary plexus (SCP) 43.9% (3.2%), deep capillary plexus (DCP) 44.3% (2.8%), outer capillary plexus (OCP) 21.9% (5.9%), choriocapillaris (CC) 52.1% (1.4%). 90% medical reference range of the VDs at different plexuses was reported. Age was correlated with the VDs of each capillary plexus. Sex was correlated with the VDs of DCP and OCP, and the VDs of DCP (p < 0.001) and OCP (p = 0.015) in women were higher than that in men. After age and sex adjustment, choroid average thickness was positively correlated with VDs of SCP (R = 0.067, p = 0.010) and DCP (R = 0.108, p < 0.001), ganglion cell layer (GCL) average thickness (R = 0.072, p = 0.006) was positively correlated with the VD of OCP, best-corrected visual acuity (BCVA) (R = 0.082, p = 0.002) was positively correlated with the VD of CC. Conclusions: In this study, the normative VD database of the Chinese urban healthy elderly population measured by the OCTA was established, and parameters related to the VD of each capillary plexus were analyzed, providing new ideas for the future study of the relationship between macular VD and disease. Trial registration: The Beichen Eye Study had been registered on the Chinese Clinical Trial Registry website (registry number: ChiCTR2000032280) on April 25, 2020. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusions To investigate the associations of the Dietary Approaches to Stop Hypertension (DASH) score with subcutaneous (SAT) and visceral (VAT) adipose tissue volume and hepatic lipid content (HLC) in people with diabetes and to examine whether changes in the DASH diet were associated with changes in these outcomes.In total, 335 participants with recent‐onset type 1 diabetes (T1D) and type 2 diabetes (T2D) from the German Diabetes Study were included in the cross‐sectional analysis, and 111 participants in the analysis of changes during the 5‐year follow‐up. Associations between the DASH score and VAT, SAT and HLC and their changes were investigated using multivariable linear regression models by diabetes type. The proportion mediated by changes in potential mediators was determined using mediation analysis.A higher baseline DASH score was associated with lower HLC, especially in people with T2D (per 5 points: −1.5% [−2.7%; −0.3%]). Over 5 years, a 5‐point increase in the DASH score was associated with decreased VAT in people with T2D (−514 [−800; −228] cm3). Similar, but imprecise, associations were observed for VAT changes in people with T1D (−403 [−861; 55] cm3) and for HLC in people with T2D (−1.3% [−2.8%; 0.3%]). Body mass index and waist circumference changes explained 8%‐48% of the associations between DASH and VAT changes in both groups. In people with T2D, adipose tissue insulin resistance index (Adipo‐IR) changes explained 47% of the association between DASH and HLC changes.A shift to a DASH‐like diet was associated with favourable VAT and HLC changes, which were partly explained by changes in anthropometric measures and Adipo‐IR. [ABSTRACT FROM AUTHOR]

Aim Study Design and Setting Results Conclusion Non‐randomized studies on bariatric surgery have reported large reductions in mortality within 6‐12 months after surgery compared with non‐surgical patients. It is unclear whether these findings are the result of bias.We searched PubMed to identify all non‐randomized studies investigating the effect of bariatric surgery on all‐cause mortality compared with non‐surgical patients. We assessed these studies for potential confounding and time‐related biases. We conducted bias analyses to quantify the effect of these biases.We identified 21 cohort studies that met our inclusion criteria. Among those, 11 were affected by immortal time bias resulting from the misclassification or exclusion of relevant follow‐up time. Five studies were subject to potential confounding bias because of a lack of adjustment for body mass index (BMI). All studies used an inadequate comparator group that lacked indications for bariatric surgery. Bias analyses to correct for potential confounding from BMI shifted the effect estimates towards the null [reported hazard ratio (HR): 0.78 vs. bias‐adjusted HR: 0.92]. Bias analyses to correct for the presence of immortal time also shifted the effect estimates towards the null (adjustment for 2‐year wait time: reported HR: 0.57 vs. bias‐adjusted HR: 0.81).Several important sources of bias were identified in non‐randomized studies of the effectiveness of bariatric surgery versus non‐surgical comparators on mortality. Future studies should ensure that confounding by BMI is accounted for, considering the choice of the comparator group, and that the design or analysis avoids immortal time bias from the misclassification or exclusion. [ABSTRACT FROM AUTHOR]

Background: In northern rural Sweden, telemedicine is used to improve access to healthcare and to provide patient-centered care. In emergency care during on-call hours, video-conference systems are used to connect the physicians to the rest of the team – creating 'distributed teams'. Patient participation is a core competency for healthcare professionals. Knowledge about how distributed teamwork affects patient participation is missing. The aim was to investigate if and how teamwork affecting patient participation, as well as clinicians' perceptions regarding shared decision-making differ between co-located and distributed emergency teams. Methods: In an observational study with a randomized cross-over design, healthcare professionals (n = 51) participated in authentic teams (n = 17) in two scripted simulated emergency scenarios with a standardized patient: one as a co-located team and the other as a distributed team. Team performances were filmed and observed by independent raters using the PIC-ET tool to rate patient participation behavior. The participants individually filled out the Dyadic OPTION questionnaire after the respective scenarios to measure perceptions of shared decision-making. Scores in both instruments were translated to percentage of a maximum score. The observational data between the two settings were compared using linear mixed-effects regression models and the self-reported questionnaire data were compared using one-way ANOVA. Neither the participants nor the observers were blinded to the allocations. Results: A significant difference in observer rated overall patient participation behavior was found, mean 51.1 (± 11.5) % for the co-located teams vs 44.7 (± 8.6) % for the distributed teams (p = 0.02). In the PIC-ET tool category 'Sharing power', the scores decreased from 14.4 (± 12.4) % in the co-located teams to 2 (± 4.4) % in the distributed teams (p = 0.001). Co-located teams scored in mean 60.5% (± 14.4) when self-assessing shared decision-making, vs 55.8% (± 15.1) in the distributed teams (p = 0.03). Conclusions: Team behavior enabling patient participation was found decreased in distributed teams, especially regarding sharing power with the patient. This finding was also mirrored in the self-assessments of the healthcare professionals. This study highlights the risk of an increased power asymmetry between patients and distributed emergency teams and can serve as a basis for further research, education, and quality improvement. [ABSTRACT FROM AUTHOR]

Background: Risk scores (RS) evaluate the likelihood of short-term mortality in patients diagnosed with community-acquired pneumonia (CAP). However, there is a scarcity of evidence to determine the risk of long-term mortality. This article aims to compare the effectiveness of 16 scores in predicting mortality at three, six, and twelve months in adult patients with CAP. Methods: A retrospective cohort study on individuals diagnosed with CAP was conducted across two hospitals in Colombia. Receiver Operating Characteristic (ROC) curves were constructed at 3, 6, and 12 months to assess the predictive ability of death for the following scoring systems: CURB-65, CRB-65, SCAP, CORB, ADROP, NEWS, Pneumonia Shock, REA-ICU, PSI, SMART-COP, SMRT-CO, SOAR, qSOFA, SIRS, CAPSI, and Charlson Comorbidity Index (CCI). Results: A total of 3688 patients were included in the final analysis. Mortality at 3, 6, and 12 months was 5.2%, 8.3%, and 16.3% respectively. At 3 months, PSI, CCI, and CRB-65 scores showed ROC curves of 0.74 (95% CI: 0.71–0.77), 0.71 (95% CI: 0.67–0.74), and 0.70 (95% CI: 0.66–0.74). At 6 months, PSI and CCI scores showed performances of 0.74 (95% CI: 0.72–0.77) and 0.72 (95% CI: 0.69–0.74), respectively. Finally at 12 months, all evaluated scores showed poor discriminatory capacity, including PSI, which decreased from acceptable to poor with an ROC curve of 0.64 (95% CI: 0.61–0.66). Conclusion: When predicting mortality in patients with CAP, at 3 months, PSI, CCI, and CRB-65 showed acceptable predictive performances. At 6 months, only PSI and CCI maintained acceptable levels of accuracy. For the 12-month period, all evaluated scores exhibited very limited discriminatory ability, ranging from poor to almost negligible. [ABSTRACT FROM AUTHOR]

Objectives: This article aims to examine the ability of the Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT) risk score to predict the occurrence of serious infections in Japanese patients with rheumatoid arthritis (RA), after initiating their first biologic disease–modifying antirheumatic drug (bDMARD). Methods: We used data from the Institute of Rheumatology, Rheumatoid Arthritis cohort from 2008 to 2020. Patients with RA who were started on their first bDMARDs were included. Those with missing data required to calculate the score were excluded. A receiver operating characteristic curve was used to evaluate the discriminatory ability of the RABBIT score. Results: A total of 1081 patients were enrolled. During the 1-year observational period, 23 (1.7%) patients had serious infections; the most frequent one was bacterial pneumonia (n = 11, 44%). The median RABBIT score in the serious infection group was significantly higher than that in the non-serious infection group [2.3 (1.5–5.4) vs 1.6 (1.2–2.5), P < .001]. The area under the receiver operating characteristic curve for the occurrence of serious infections was 0.67 (95% confidence interval 0.52–0.79), suggesting that the score had low accuracy. Conclusions: Our present study revealed that the RABBIT risk score did not have sufficient discriminatory ability for predicting the development of severe infections in Japanese patients with RA after initiating their first bDMARD. [ABSTRACT FROM AUTHOR]

Aim: To investigate the association of gestational diabetes mellitus (GDM) with premature mortality and cardiovascular (CVD) outcomes and risk factors. Materials and Methods: Parous women recruited to the UK Biobank cohort during 2006‐2010 were followed up from their first delivery until 31 October 2021. The data were linked to Hospital Episode Statistics and mortality registries. Multivariate Cox proportional hazard models investigated associations of GDM with all‐cause mortality, CVD, diabetes, hypertension and dyslipidaemia. Results: The maximum total analysis time at risk and under observation was 9 694 090 person‐years. Among 220 726 women, 1225 self‐reported or had a recorded diagnosis of GDM. After adjusting for confounders and behavioural factors, GDM was associated with increased risk for premature mortality [hazard ratio (HR): 1.44, 95% confidence interval (CI): 1.12‐1.86], particularly CVD‐related death (HR: 2.38, 95% CI: 1.63‐3.48), as well as incident total CVD (HR: 1.50, 95% CI: 1.30‐1.74), non‐fatal CVD (HR: 1.41, 95% CI: 1.20‐1.65), diabetes (HR: 14.37, 95% CI: 13.51‐15.27), hypertension (HR: 1.49, 95% CI: 1.38‐1.60), and dyslipidaemia (HR: 1.30, 95% CI: 1.22‐1.39). The total CVD risk was greater in women with GDM who did not later develop diabetes than in those with GDM and diabetes. Conclusions: Women with GDM are at increased risk of premature death and have increased CV risk, emphasizing the importance of interventions to prevent GDM. If GDM develops, the diagnosis represents an opportunity for future surveillance and intervention to reduce CVD risk factors, prevent CVD and improve long‐term health. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to establish a prediction model in peritoneal dialysis patients to estimate the risk of technique failure and guide clinical practice. Methods: Clinical and laboratory data of 424 adult peritoneal dialysis patients were retrospectively collected. The risk prediction models were built using univariate Cox regression, best subsets approach and LASSO Cox regression. Final nomogram was constructed based on the best model selected by the area under the curve. Results: After comparing three models, the nomogram was built using the LASSO Cox regression model. This model included variables consisting of hypertension and peritonitis, serum creatinine, low‐density lipoprotein, fibrinogen and thrombin time, and low red blood cell count, serum albumin, triglyceride and prothrombin activity. The predictive model constructed performed well using receiver operating characteristic curve and area under the curve value, C‐index and calibration curve. Conclusion: This study developed and verified a new prediction instrument for the risk of technique failure among peritoneal dialysis patients. [ABSTRACT FROM AUTHOR]

Background: Diabetic dyslipidemia poses a significant risk factor for cardiovascular complications in patients with diabetes mellitus. Empagliflozin and liraglutide are two commonly used medications in diabetes management, yet their comparative efficacy and safety in treating diabetic dyslipidemia remain under-explored. Aims and Objectives: This study aimed to assess the effectiveness and safety of Empagliflozin versus liraglutide in managing diabetic dyslipidemia. Materials and Methods: The study enrolled 100 participants with diabetes and dyslipidemia, divided equally into empagliflozin and liraglutide treatment groups. Baseline characteristics, including age, gender distribution, ethnicity, and duration of diabetes, were assessed and compared between the groups. Lipid profiles, encompassing total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides, were evaluated at baseline and after 6 months of treatment. Safety outcomes, such as the occurrence of mild gastrointestinal symptoms, hypoglycemia, and serious adverse events, were also monitored. Results: Both treatment groups exhibited comparable baseline characteristics. Following 6 months of treatment, both empagliflozin and liraglutide demonstrated significant improvements in lipid profiles. Reductions in total cholesterol, LDL cholesterol, and triglycerides, along with increases in HDL cholesterol, were observed in both groups. Moreover, there were no significant differences in the occurrence of adverse events between the two treatment groups, indicating similar safety profiles. Conclusion: This study provides evidence supporting the effectiveness and safety of empagliflozin and liraglutide in managing diabetic dyslipidemia. These findings highlight the potential of both medications as viable therapeutic options for patients with diabetes and dyslipidemia. [ABSTRACT FROM AUTHOR]

Introduction: Empirical evidence indicates that when patients are actively involved in their own care, they acquire greater understanding about their own diagnosis and its consequences. An essential prerequisite for patient involvement is the establishment of a trustful relationship between patient and healthcare professionals. Aim: To explore how nursing students involve patients, and how the results can support organized systematic learning activities regarding patient involvement. Method: Observations during nursing care interaction with 12 nursing students and patients was analyzed using qualitative content analysis. Results: The meeting between student and patient is guided by task-centered purposes. Two themes were identified: Task-centered care dominated by context, and Person-centered care dominated by a trusting relationship. Conclusion: It is evident that nursing students' interaction with patients is driven by task-centered purpose. A focus on person-centered care in supervising students is necessary to transition from task-centered to person-centered care. [ABSTRACT FROM AUTHOR]

To assess reporting guideline and clinical trial registration requirements in rehabilitation journals. We examined rehabilitation journals with 5-year impact factors exceeding 1.00 from the 2021 Scopus CiteScore tool, alongside the 28 journals included in the 2014 rehabilitation and disability quality improvement initiative. Journals outside the traditional rehabilitation scope were excluded. A publicly-funded academic health center in the United States. N/A. The proportion of journals requiring/recommending reporting guideline use and clinical trial registration. Over 90% (57/63) of journals required/recommended clinical trial reporting guidelines, while 68% (39/57) specified guideline requirements for systematic review/meta-analysis protocols. The 2014 collaborative initiative journals demonstrated higher rates of requiring/recommending reporting guidelines for clinical trials (24/26; 92.3%), systematic reviews/meta-analyses (23/26; 88.5%), observational studies in epidemiology (22/25; 88%), and diagnostic accuracy studies (20/24; 83.3%). Conversely, the 2021 Scopus CiteScore journals displayed higher rates for the remaining study designs. Overall, 52/63 (82.5%) journals required/recommended trial registration. Trial registration policies were comparable, with a slight advantage favoring the 2021 Scopus CiteScore journals. Rehabilitation journals variably promoted reporting guideline use and clinical trial registration. Common study designs like clinical trials, observational studies in epidemiology, and diagnostic accuracy studies demonstrated robust requirement/recommendation rates, while less common designs like economic evaluations and animal research had suboptimal rates. Journals can enhance reporting guideline use and trial registration by directing authors to the EQUATOR Network, requiring adherence to registration and reporting standards, and clarifying language in author instructions. [ABSTRACT FROM AUTHOR]

Finding the dominant cause(s) of variation in process improvement projects is an important task. Before trying to reduce variation in the dominant cause or mitigate the effect of variation in the dominant cause to reduce output variation, it is strongly recommended that we verify we have identified the true (dominant) cause. This article is about how best to verify we have correctly identified a dominant cause, as the existing literature does not properly answer this question. Although it may seem that a randomized controlled experiment is sufficient for this purpose, we show that experimental studies alone cannot provide all the required information. An experiment identifies whether a suspect is a cause of variation; however, we also require additional information (i.e., from observational studies) to determine whether it is dominant and not just significant. This article lists some viable composite study designs, assesses their relative merits, and recommends proper sample sizes. We also investigate how to systematically conduct a verification study in the era of smart manufacturing. Moreover, we provide a tangible example to illustrate our proposed procedure. [ABSTRACT FROM AUTHOR]

Background: Regorafenib improves overall survival (OS) of patients with advanced progressive gastrointestinal stromal tumors (GISTs) after standard chemotherapy in phase III trials in the 3rd-line setting. This large-scale, prospective observational study evaluated the safety and effectiveness of regorafenib in Japanese patients with GIST in a real-world clinical setting. Methods: Patients with GIST received oral regorafenib at a maximum daily dose of 160 mg for weeks 1-3 of each 4-week cycle (dose could be modified at investigator’s discretion). The primary objective was to assess safety, particularly significant adverse drug reactions (ADRs), as well as the frequency of occurrence of ADRs, hand and foot syndrome (HFS), discontinuation of treatment due to disease progression and adverse events. A Cox proportional hazards model was used to evaluate associations between OS or time to treatment failure (TTF) and baseline characteristics or HFS. Results: Between August 2013 and March 2021, 143 evaluable patients were enrolled. ADRs occurred in 90.2% of patients and led to treatment discontinuation in 28.3%. The most frequent ADRs were HFS, hypertension, and liver injury. The overall response rate was 11.3% and disease control rate 56.5% (RECIST) based on investigators’ assessments. Median OS was 17.4 months (95% CI 14.24-23.68). Median TTF was 5.3 (95% CI 4.0-6.5) months. Improved. OS and TTF responses occurred in patients with an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1. Conclusion: The outcomes in this real-world study were consistent with those seen in clinical trials. No new safety concerns were identified. [ABSTRACT FROM AUTHOR]

Background: Faced with rising needs for patient support, palliative care is shifting towards a more community-based approach. Yet the profile of volunteers in this field is poorly known. Aim: To explore psychosocial characteristics of palliative care volunteers, by comparing them to two groups, volunteers from the health and social sector without contact with palliative patients, and people from the general population without volunteer activity. Design: Observational comparative study. Data were analyzed using descriptive statistics and logistic regression analysis. Participants: The 3 groups of participants were recruited in France between September 2020 and June 2021. They completed an online survey assessing sociodemographic characteristics and psychological resources (self-efficacy, hope, optimism, resilience, mindfulness, self-compassion, empathy, forgivingness, and gratitude). Results: Data from 559 participants were analyzed. Palliative care volunteers had overall significantly higher levels of psychological resources than control groups. Multivariate analysis revealed, among sociodemographic and psychological characteristics that showed differences between groups at the univariate level, the most efficient predictors of group status. The best criteria to distinguish palliative care volunteers from health and social sector volunteers were older age, having received training, and lower levels of self-compassion. To distinguish palliative care volunteers from people with no volunteer activity, older age and non-active professional status were the best criteria. Conclusions: Palliative care volunteers displayed more psychological resources than controls. However, older age and being trained for volunteering, emerged as stronger factors for distinguishing palliative care volunteers from controls. Pursuing research about these volunteers should facilitate recruitment, training, and retention. [ABSTRACT FROM AUTHOR]

For children living in the urban slums of Nairobi (Kenya), primary health conditions are not guaranteed, and oral diseases add further concern at social and institutional levels beyond the general poverty conditions. This study aims at determining the factors that influence the oral health status of children living in Nairobi slums. A cross-sectional study on school-aged subjects was conducted in June 2022 in three urban slum areas of Nairobi through a pediatric dental screening. The PI (Plaque Index), CPITN (Community Periodontal Index of Treatment Needs), and dmft (decayed, missing, and filled teeth index—deciduous) were considered as primary outcomes of dental health. Multivariate statistical analysis, based on ordinal and zero-inflated negative binomial regression models, was conducted to identify determinants of the oral outcomes in a wide set of potential predictors. A sample of 359 children aged 2–17 was examined. The PI was significantly associated with age, the type of bite, and the use of a toothbrush. The CPITN is influenced by different types of malocclusions, abnormal frenulum, dental trauma, and fluorosis. Dietary habits were found to significantly impact the susceptibility to dental caries. Fluorosis and a dental visit in the last year were highlighted as risk and protective factors, respectively, against higher rates of caries. The oral health features of children living in Nairobi slums are differently affected by socio-demographic conditions, dietary habits, dental characteristics, and oral care practices. [ABSTRACT FROM AUTHOR]

: Breastfeeding education, across all disciplines, is often inconsistent and lacking in expertise and confidence. However, recommendations from health professionals, the sociocultural environment, and previous knowledge and experiences significantly influence women’s decision to breastfeed. This study aimed to identify factors that promote the assignment of greater importance to breastfeeding and associated practical benefits. This retrospective cross-sectional study included 276 participants who completed a self-administered questionnaire. Descriptive and bivariate analyses were performed, and multivariate linear models were applied to identify factors influencing the importance assigned to breastfeeding. Most participants were married or in a relationship, were native Spaniards, had secondary or higher education, and had an average age of 32.6 years. Seventy percent met the physical activity recommendations, and 91% felt comfortable with their body image during pregnancy. The importance assigned to breastfeeding was high across various aspects, except for postpartum weight loss and body image. Group prenatal care was only significantly associated with the importance assigned to the breastfeeding technique (how to breastfeed). The obesogenic environment and the importance assigned to nutritional aspects and physical activity also turned out to be predictors, although not for all models. In our region, the educational strategy of antenatal care groups could contain gaps regarding the mother’s health, which should be addressed in the future to improve results regarding the initiation and continuation of breastfeeding. [ABSTRACT FROM AUTHOR]

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 be developed in future. The package allows users to simulate realistic exposure data and mixed-typed covariates based on public dataset such as the National Health and Nutrition Examination Survey or other existing dataset 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. [ABSTRACT FROM AUTHOR]

Interactions among intestinal bacteria and the immune system contribute to the maintenance of a functional intestinal barrier in healthy individuals, and possibly to systemic immune activity. We hypothesized that intestinal bacteria would be associated with systemic biomarkers of innate and adaptive immune responses in healthy adults. 79 immune function markers were subjected to factor analysis resulting in 17 Immune Factors (IFs), each composed of 2-10 immune variables. Bacterial taxa from stool samples were identified at the family and genus levels by 16S rRNA amplicon sequence analysis and their read counts and relative abundances were utilized in a multiple linear regression model to identify microbial taxa associated with the IFs. A total of 10 significant associations were identified between bacterial taxa and IFs. The family Rikenellaceae showed a positive association with innate IF5 (including 5 chemokines, 2 cytokines, 2 adhesion molecules, and the macrophage metabolite neopterin) and a negative association with adaptive IF4 (including T-cells with activation marker HLA-DR). Additionally, Pseudomonadaceae and its genus Pseudomonas showed a negative relationship with innate IF5, and adaptive IF13 (including T-cell cytokines IL-10, IL-17, and IFN-γ) was negatively associated with Butyrivibrio and positively associated with Slackia. These associations suggest ongoing interactions between gut bacteria and the systemic immune system in healthy adults. The association of these taxa with the IFs may result from specific microbial-immune system interactions that play a role in maintenance of a healthy barrier integrity in our cohort of healthy adults. IMPORTANCE Chronic inflammation may develop over time in healthy adults as a result of a variety of factors, such as poor diet directly affecting the composition of the intestinal microbiome, or by causing obesity, which may also affect the intestinal microbiome. These effects may trigger the activation of an immune response that could eventually lead to an inflammation-related disease, such as colon cancer. Before disease develops it may be possible to identify subclinical inflammation or immune activation attributable to specific intestinal bacteria normally found in the gut that could result in future adverse health impacts. In the present study, we examined a group of healthy men and women across a wide age range with and without obesity to determine which bacteria were associated with particular types of immune activation to identify potential preclinical markers of inflammatory disease risk. Several associations were found that may help develop dietary interventions to lower disease risk.