Search

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]

Background: As far as we know, age-related macular degeneration (AMD) has become one of the predominant causes of visual impairments. Previous studies have revealed that AMD and many cardiovascular diseases (CVDs) share the same pathologic and genotypic factors, making the connection between AMD and CVD a hot topic. However, the conclusions of the available studies on the relationship between them are somewhat divergent. Methods: We screened 5523 eligible participants from the National Health and Nutrition Examination Survey (NHANES) database from 2005 through 2008 for an observational clinical study design. Binary logistic regression modelling was used to estimate the relations between AMD and various CVDs with and without adjustment for demographics, health status, and behaviours related to health. Results: Binary logistic regression analyses showed that AMD was able to increase the risk of CVDs in patients both unadjusted and after adjusting for confounding variables. Conclusions: Within this study, preventing the development of AMD might cut down the incidence of several CVDs, in particular, significantly lowering the stroke risk. These findings indicate that interventions to prevent AMD may also help to prevent CVDs. In general, late AMD has a more severe impact on the risk of CVDs compared with early AMD. These results could help clinical ophthalmology and cardiovascular medicine in their clinical education and interventions. [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]

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]

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: 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]

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]

Purpose. We investigated injury rates over the previous 12 months, associated factors, and injury characteristics in a cohort of recreational functional fitness training participants. Methods. A cross-sectional study was conducted with a convenience sample of 304 participants (175 females and 129 males; mean age: 32.6 ± 7.2 years; mean training experience: 27.6 ± 21.4 months) from three CrossFit™ affiliated gyms in Brazil. Data were collected via face-to-face interviews, using a questionnaire that focused on functional fitness-related injuries in the previous year and included data on participant demographics and training regimens. Results. Out of all the participants, 82 (27.0%) experienced a functional fitness-related injury with an incidence rate of 1.22 injuries/1000 hours of participation. The practice of other sports activities and dissatisfaction with joint mobility of the shoulders increased the odds of being injured in the multivariate logistic regression. The shoulder was the most affected body part (26.6%). A gradual injury mechanism was the most commonly reported (36.2%), and joint sprain (18.1%), cartilage injury (11.7%), and tendinopathy (10.6%) were the most common pathology types. Concerning symptom severity, in most cases, participants referred to the injury as severe (36.2%), with a sporting time loss greater than 28 days (50%). Conclusions. Injury prevalence over the last 12 months was 27.0% (82/304), with an incidence of 1.22 injuries/1000 hours. The practice of other sports activities and dissatisfaction with joint mobility of the shoulders increased the odds of injury. Most injuries occurred in the shoulder, with a gradual injury mechanism, and participants classified symptoms as severe, leading to significant sporting time loss. [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]

: 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]

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]

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]

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]

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]

Background: Vestibular migraine (VM), an intricate subtype of migraine, amalgamates the dual attributes of migraine and vestibular disorders. In clinical settings, individuals with VM frequently articulate concerns regarding the manifestation of subjective cognitive impairment. This cognitive dysfunction is intricately linked with diminished mobility, heightened susceptibility to falls, and increased absenteeism in afflicted patients. Consequently, comprehending the features of cognitive impairment in VM patients holds potential clinical significance. The pursuit of rapid and objective methods for detection and assessment is foundational and prerequisite for efficacious cognitive management of VM patients. Methods: The study encompassed 50 patients diagnosed with vestibular migraine and recruited 50 age-sex matched healthy controls. All participants underwent anti-saccade tasks, and cognitive evaluation was performed using the MMSE and MoCA to assess overall cognitive function. Additionally, RBANS scales were employed to measure specific cognitive domains. Results: The VM patients and normal controls demonstrated statistical parity in terms of age, gender, education, weight, and BMI, with no significant differences observed. Analysis of cognitive scores divulged a marked increase in the incidence of Mild Cognitive Impairment (MCI) in VM patients compared to Healthy Controls (HCs). Both MMSE and MoCA scores were notably lower in VM patients compared to their healthy counterparts. The RBANS cognitive test indicated significant impairment in immediate memory, visuospatial construction, language, attention, and delayed memory among VM patients. Notably, the Trail Making Test and Stroop Color-Word Test revealed compromised processing speed and executive function cognitive domains. The anti-saccadic task highlighted significantly elevated anti-saccadic latency and frequency of direction errors in vestibular migraine patients. Symptom severity, illness duration, and episode frequency in VM patients positively correlated with counter-scanning errors and negatively correlated with cognitive performance across diverse cognitive domains. Conclusion: VM patients exhibit cognitive decline across multiple cognitive domains during the interictal period. This cognitive impairment may not be fully reversible, underscoring its potential clinical significance for cognitive management in VM patients. The sensitivity of anti-saccade tasks to the cognitive status of VM patients positions them as promising objective indicators for diagnosis, intervention, and evaluation of cognitive impairment effects in VM in future applications. [ABSTRACT FROM AUTHOR]

Background: As an emerging infectious disease with a heterogenous and uncertain transmission pattern, coronavirus disease 2019 (COVID-19) has created a catastrophe in healthcare-associated infections (HAIs) and posed a significant challenge to infection control practices (ICPs) in healthcare settings. While the unique characteristics of psychiatric patients and clinical settings may make the implementation of ICPs difficult, evidence is lacking for compliance with ICPs among healthcare workers (HCWs) in a psychiatric setting during the COVID-19 pandemic. Methods: A cross-sectional multi-method study based on participant unobtrusive observation coupled with the completion of a self-administered ICP survey was conducted to assess compliance with ICPs among HCWs in a psychiatric inpatient ward in a regional hospital. An online checklist, called eRub, was used to record the performance of HCWs in hand hygiene (HH) and other essential ICPs. Furthermore, a well-validated questionnaire (i.e., Compliance with Standard Precautions Scale, CSPS) was used to collect the participants' self-reported ICP compliance for later comparison. Results: A total of 2,670 ICP opportunities were observed from January to April 2020. The overall compliance rate was 42.6%. HCWs exhibited satisfactory compliance to the wearing of mask (91.2%) and the handling of clinical waste (87.5%); suboptimal compliance to the handling of sharp objects (67.7%) and linen (72.7%); and poor compliance to HH (3.3%), use of gloves (40.9%), use of personal protective equipment (20%), and disinfection of used surface/area (0.4%). The compliance rates of the nurses and support staff to HH were significantly different (χ2 = 123.25, p < 0.001). In the self-reported survey, the overall compliance rate for ICPs was 64.6%. Conclusion: The compliance of HCWs in a psychiatric inpatient ward to ICPs during the COVID-19 pandemic ranged from poor to suboptimal. This result was alarming. Revisions of current ICP guidelines and policies that specifically target barriers in psychiatric settings will be necessary. [ABSTRACT FROM AUTHOR]

Background: Stroke, prevalent globally, particularly impacts low- and middleincome countries. Decreased lung function is one of the risk factors for stroke, and there is a lack of sufficient research on the association between the two, especially based on evidence from representative large samples. We aimed to explore the association between lung function and stroke incidence. Methods: We collected data from 13,371 participants from the 2007-2012 U.S. national cross-sectional study and 11,192 participants from the Chinese national cohort study during the 2011-2018 follow-up period. Multivariate logistic regression and Cox proportional hazards regression were used to assess crosssectional and longitudinal associations of peak expiratory flow with stroke risks. Additionally, we used publicly available GWAS data from a European population to conduct Mendelian randomization analysis, further exploring the potential causal relationship. Results: The results of the cross-sectional study suggest that a decline in peak expiratory flow may be associated with an increased risk of stroke. The cohort study revealed that, compared to the first tertile group, the risk of stroke incidence in the second and third tertile groups of PEF decreased by 19% (hazard ratio (HR) = 0.810, 95%CI = 0.684-0.960) and 21.4% (HR = 0.786, 95%CI = 0.647-0.956), respectively. Mendelian randomization analysis clarified that higher PEF levels are significantly associated with a reduced risk of stroke (OR = 0.852, 95%CI = 0.727-0.997). Conclusion: Decreased lung function is a risk factor for stroke. As a simple and accurate indicator of lung function, PEF can be used to monitor lung function in community populations and patients for primary stroke prevention. [ABSTRACT FROM AUTHOR]

Background: Observational studies have found that vitamin D supplementation is associated with improved cognition. Further, recent Mendelian randomization (MR) studies have shown that higher vitamin D levels, 25(OH)D, may protect against Alzheimer's disease. Thus, it is possible that 25(OH)D may protect against Alzheimer's disease by improving cognition. Objective: We assessed this hypothesis, by examining the relationship between 25(OH)D levels and seven cognitive measurements. Methods: To mitigate bias from confounding, we performed two-sample MR analyses. We used instruments from three publications: Manousaki et al. (2020), Sutherland et al. (2022), and the Emerging Risk Factors Collaboration/EPIC-CVD/Vitamin D Studies Collaboration (2021). Results: Our observational studies suggested a protective association between 25(OH)D levels and cognitive measures. An increase in the natural log of 25(OH)D by 1 SD was associated with a higher PACC score (BetaPACC score = 0.06, 95% CI = (0.04–0.08); p = 1.8×10-10). However, in the MR analyses, the estimated effect of 25(OH)D on cognitive measures was null. Specifically, per 1 SD increase in genetically estimated natural log of 25(OH)D, the PACC scores remained unchanged in the overall population, (BetaPACC score = –0.01, 95% CI (–0.06 to 0.03); p = 0.53), and amongst individuals aged over 60 (BetaPACC score = 0.03, 95% CI (–0.028 to 0.08); p = 0.35). Conclusions: In conclusion, our MR study found no clear evidence to support a protective role of increased 25(OH)D concentrations on cognitive performance in European ancestry individuals. However, our study cannot entirely dismiss the potential beneficial effect on PACC for individuals over the age of 60. [ABSTRACT FROM AUTHOR]

Aim: To explore clinical decision‐making by comparing the processes used by three groups of nurses in the emergency departments of three hospitals: in Norway, Finland and Ireland. Background: Clinical decision‐making in an emergency department environment is a complex process often occurring in times of crisis. It is an important aspect contributing to the quality of care. However, empirical research is limited regarding the decision‐making process in different nursing roles. Methods: In accordance with the consolidated criteria for reporting qualitative research, a qualitative and observational study was conducted to explore clinical decision‐making by comparing the processes used by three groups of nurses in the emergency departments of three hospitals: in Norway, Finland and Ireland. Six Registered Nurses, six Nurse Specialists and six Nurse Practitioners were observed. A total of 40 hours of observation was made at each setting according to a structured observation guideline, followed by clarifying questions. The data material was analysed by means of a qualitative manifest and latent content analysis. Results: Three themes arose: acting in accordance with routines, previous experience and intuition; considering patient experience; and facilitating new alternatives based on critical thinking. The Registered Nurses mainly used the first approach, the Nurse Specialists used the first and the second approaches, and the Nurse Practitioners used all three approaches. Conclusions: The results highlight the differences in decision‐making processes between these groups. Nurse Practitioners were the only group that facilitated and evaluated new alternatives using their clinical autonomy, such as stepping up and making independent and collaborative decision‐making. Implication: The results can be used in countries developing advanced practice nursing education and defining their scope of practice to inform stakeholders. [ABSTRACT FROM AUTHOR]

Aims: To describe trends in the use of anti‐obesity drugs in Norway during the period 2004–2022. Materials and Methods: We assessed the annual utilization of any available drug indicated for obesity recorded in the nationwide Norwegian Prescribed Drug Register for adults (age 18–79 years) from 1 January 2004 to 31 December 2022. Prevalence was stratified by sex and age group (18–29 years and 10‐year age groups thereafter). Additional analyses were performed in individuals initiating treatment with an anti‐obesity drug and on the cost of the anti‐obesity drugs since 2017. Results: The prevalence of anti‐obesity drug use decreased from 2009, when sibutramine and rimonabant were withdrawn from the market, and increased again after the approval of bupropion‐naltrexone in 2017 and liraglutide in 2018. The use of the peripheral‐acting anti‐obesity drug orlistat decreased from 2004. In 2022, 1.04% of the adult Norwegian population (72.8% women) filled at least one prescription of bupropion‐naltrexone, 0.91% used liraglutide (Saxenda; 74.2% women), and semaglutide without reimbursement was used by 0.68% (76.7% women). The prevalence increased with age, peaking in the age group 50 to 59 years, and decreased in older age groups. From 2017 to 2022, 2.8% of the adult residents initiated treatment with an anti‐obesity drug. The total sale of those drugs increased from 1.1 million euros in 2017 to 91.8 million euros in 2022. Conclusions: The use of anti‐obesity drugs in Norway has increased substantially in recent years, especially among women aged 40 to 59 years. Changes in availability and reimbursement have influenced the use of these drugs in recent years. [ABSTRACT FROM AUTHOR]

Aims: To determine the magnitude of the association between abdominal adiposity and low‐grade inflammation in persons with recently diagnosed type 2 diabetes (T2D) and to determine to what extent this association is mediated by low physical activity level, hyperinsulinaemia, hyperglycaemia, dyslipidaemia, hypertension, and comorbidities. Materials and Methods: We measured waist circumference, clinical characteristics, and inflammatory markers i.e. tumour necrosis factor‐alpha (TNF‐α), interleukin‐6 (IL‐6), and high‐sensitivity C‐reactive protein (hsCRP), in >9000 persons with recently diagnosed T2D. We applied multiple mediation analysis using structural equation modelling, with adjustment for age and sex. Results: Waist circumference as a proxy for abdominal adiposity was positively associated with all inflammatory markers. Hence, a one‐standard deviation (SD) increase in waist circumference (SD = 15 cm) was associated with a 22%, 35%, and 46% SD increase in TNF‐α (SD = 1.5 pg/mL), IL‐6 (SD = 4.4 pg/mL), and hsCRP (SD = 6.9 mg/L), respectively. The level of hyperinsulinaemia assessed by fasting C‐peptide was quantitatively the most important mediator, accounting for 9%–25% of the association between abdominal adiposity and low‐grade inflammation, followed by low physical activity (5%–7%) and high triglyceride levels (2%–6%). Although mediation of adiposity‐induced inflammation by greater comorbidity and higher glycated haemoglobin levels reached statistical significance, their impact was minor (1%–2%). Conclusions: In persons with recently diagnosed T2D, there was a clear association between abdominal adiposity and low‐grade inflammation. A considerable part (20%–40%) of this association was mediated by other factors, with hyperinsulinaemia as a potentially important driver of adiposity‐induced inflammation in T2D. [ABSTRACT FROM AUTHOR]

Background: Real-world data on starting intravenous (IV) vedolizumab (VDZ) and transitioning to subcutaneous (SC) treatment in inflammatory bowel disease (IBD) are scarce. Aims: To assess treatment outcomes of patients with IBD starting IV VDZ and switching to SC VDZ in routine clinical care. Methods: Adult patients with IBD switching from IV to SC VDZ treatment between 1 March 2020 and 31 December 2021 were identified from the Swedish IBD quality register. The primary outcome was SC VDZ persistence. Secondary outcomes included clinical remission, changes in quality of life (QoL) according to EuroQual 5-Dimensions 5-Levels (EQ-5D-5L) and the Short-Health Scale (SHS) and inflammatory markers, including faecal Calprotectin (FCP). Results: Altogether, 406 patients with IBD (Crohn's disease, n = 181; ulcerative colitis, n = 225) were identified. After a median follow-up of 30 months from starting IV VDZ treatment, the persistence rates were 98%(178/181) in Crohn's disease and 94% (211/225) in ulcerative colitis. Most patients (84%) transitioned during maintenance therapy, and the median follow-up from switch to SC VDZ was 10 months. Compared to baseline, statistically significant improvements were observed in all domains of the SHS, EQ-5D index value and visual analogue scale. Median (interquartile range) FCP concentrations (μg/g) decreased from 459 (185–1001) to 65 (26–227) in Crohn's disease (n = 45; p < 0.001) and from 646 (152–1450) to 49 (20–275) in ulcerative colitis (n = 58; p < 0.001). Conclusion: Initiating IV VDZ and switching to SC treatment was associated with high persistence rates and improvements in measures of QoL and FCP. These findings are reassuring for patients who start IV VDZ and switch to SC VDZ. [ABSTRACT FROM AUTHOR]

Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumour burden but also to the severity of underlying chronic liver disease. Moreover, advances in systemic therapies for HCC have increased the complexity of patient management. Randomised-controlled trials represent the gold standard for evidence generation across all areas of medicine and especially in the oncology field, as they allow for unbiased estimates of treatment effect without confounders. Observational studies have many problems that could reduce their internal and external validity. However, large prospective (well-conducted) observational real-world studies can detect rare adverse events or monitor the occurrence of long-term adverse events. How best to harness real world data, which refers to data generated from the routine care of patients, and real-world 'evidence', which is the evidence generated from real-world data, represents an open challenge. In this review article, we aim to provide an overview of the benefits and limitations of different study designs, particularly focusing on randomised-controlled trials and observational studies, to address important and not fully resolved questions in HCC research. [ABSTRACT FROM AUTHOR]

Objective: As multiple myeloma (MM) therapies advance, understanding patients', caregivers', and physicians' perspectives on, and satisfaction with, available treatment options and their impact on quality of life (QoL), is important. Methods: EASEMENT is a real‐world, observational, cross‐sectional study conducted in 19 sites within the UK, Canada, and Italy using retrospective chart reviews and surveys. Enrolled patients had clinical history available since diagnosis and had received ≥1 cycle of their current line of therapy. Primary objectives were to describe patient/caregiver QoL (EQ‐5D‐5L questionnaire), patient preference for oral/injectable therapies (single discrete‐choice question), and patient satisfaction (TSQM‐9 questionnaire). Results: Between October 2018 and March 2020, 399 patients were enrolled (n = 192 newly diagnosed multiple myeloma [NDMM], n = 206 relapsed/refractory multiple myeloma [RRMM], n = 1 missing). Among NDMM and RRMM patients, 78%/22% and 42%/58% were receiving injectables/orals, respectively. Both NDMM and RRMM patients significantly preferred orals versus injectables (p <.0001). No significant differences were reported in treatment satisfaction or QoL, but treatment convenience favoured orals over injectables with near significance (p =.053). Conclusion: MM patients perceived greater convenience and preference for orals versus injectables. Oral treatments are useful for patients who cannot or prefer not to travel to clinics, or cannot perform self‐injection within the community. [ABSTRACT FROM AUTHOR]

Background: Vestibular migraine (VM) is a common cause of recurrent vertigo. Migraine headache preventative therapies are currently prescribed to control vertigo symptoms in VM. Clinical trials of nutraceuticals for migraine headache prevention have shown positive outcomes, but, to date, there have been no studies to assess their effectiveness in the management of VM. Aims: To report the effects of nonprescription therapy management on VM symptoms. Methods: We undertook a prospective, questionnaire‐based assessment of patients diagnosed with VM between November 2019 and August 2021 at two Sydney tertiary referral clinics. Patients were advised on optimising sleep, hydration, exercise and nutrition and instructed to use an over‐the‐counter combination product containing riboflavin 200 mg, magnesium 150 mg, coenzyme Q10 75 mg and feverfew 200 mcg. Symptom severity and frequency were assessed using the Dizziness Handicap Inventory (DHI), the Vertigo Symptom Score short‐form (VSS‐sf) and two visual analogue scales for severity (VAS‐s) and frequency (VAS‐f) before and 3 months after commencing treatment. Result: In 82 participants (78% female; mean age, 44 ± 14 years) we recorded a decrease in DHI (mean, 16.8 [95% confidence interval (CI), 12.8–20.9], VSS‐sf (9.3, 7.1–11.5), VAS‐s (3.0, 2.2–3.8) and VAS‐f (2.8, 2.1–3.4), equating to an improvement of 44.1%, 44.9%, 44.1% and 38.9% for each measure respectively. On the DHI and VSS‐sf, 41 (50%) and 44 (53.7%) patients showed improvement in their symptoms; 39 (47.6%) and 36 (43.9%) patients noted no change and two patients reported worsening. The supplement was well‐tolerated. Conclusions: The results provide preliminary evidence that VM symptom frequency and severity can be reduced by using nonprescription therapies. [ABSTRACT FROM AUTHOR]

The purpose of this study is to illustrate how matching approaches based on different balancing scores lead to variations in the treatment effect estimators. We introduced a case study evaluating the effect of anti-thrombotic agents on the severe progression of patients with intracerebral hemorrhage. We extracted subpopulations based on propensity and prognostic scores and then estimated the relative risk between the treatment groups. Furthermore, to illustrate the situation where the treatment effect estimates varied depending on employed balancing scores, we conducted a simulation experiment. In the case study, the matching using different balancing scores extracted subpopulations with different characteristics. Then, the estimated relative risk (95% confidence interval) was 1.27 (0.98–1.94) among the propensity score matched cohort, whereas it was 0.91 (0.76–1.08) among the prognostic score matched cohort. In the simulation experiments, the results indicated that the matching schemes based on different balancing scores created distinct matched cohorts, leading to varying estimates under treatment effect heterogeneity. Moreover, the variability of the estimated effect becomes substantial when there are covariates strongly related to the dependent variable of the nuisance functions. The difference in the selected subpopulation via matching based on different balancing scores is a thoughtful factor that can result in different estimates when there is effect heterogeneity. In practice, we recommend assessing the characteristics of the matched subpopulation and employing the balancing score that can estimate the treatment effect among the target population of interest in each study. Plain Language Summary: This study aimed to understand why different methods of matching patients in a study can lead to different estimates of how well a treatment works. We used a real example of a study where the treatment's effectiveness varied for different patients and compared how different methods of matching patients affected the results. We also did a series of experiments to see how the different methods affected estimates of treatment effect when the effectiveness varied among patients. Our study found that the different matching methods extracted the different patients. The difference in the matched patients led to very different results, especially when the treatment's effectiveness was not the same for all patients. Therefore, it is important to check the characteristics of patients after matching and consider whether the treatment's effectiveness is not the same for all patients. [ABSTRACT FROM AUTHOR]

Introduction: Chronic pain (CP) and depression/anxiety often coexist, worsening each other's symptoms. Treating this comorbidity is challenging. Tricyclic antidepressants and serotonin noradrenaline reuptake inhibitors are the first-line treatment options for this comorbidity, although sometimes they are not effective and/or well tolerated by patients, and there is little clinical evidence that selective serotonin reuptake inhibitors are useful for controlling CP. The antidepressant vortioxetine, with a multimodal mechanism that may help reduce pain, has proven clinical efficacy in patients with major depressive disorder (MDD). This study investigated vortioxetine's effectiveness for MDD and CP in clinical practice. Methods: This was a 3-month, multicenter, prospective, open-label, non-interventional pharmacoepidemiologic study. Patients (n = 64) with MDD (9-item Patient Health Questionnaire [PHQ-9] score ≥ 15) and CP (visual analogue scale [VAS] score ≥ 4) were treated with vortioxetine for 3 months (initiated with 10 mg/day, with flexible dosing thereafter [5–20 mg/day]). VAS, Clinical Global Impression (CGI), and Patient Global Impression (PGI) scales were used at baseline and at 1 and 3 months. Brief Pain Inventory (BPI), PHQ-9 scale, and Satisfaction with Medicines Questionnaire (SATMED-Q) were used at baseline and at 3 months. Adverse Events (AEs) were recorded. Descriptive statistics, chi-square tests, and Student's t-tests were used for paired data. Results: MDD patients showed a statistically significant improvement in VAS from baseline (mean [standard deviation (SD)]: 7.42 [0.69]) to 1 month (mean [SD]: 6.1 [0.81], P < 0.001) and 3 months (mean [SD]: 5.09 [1.26], P < 0.0001). Similarly, BPI and PHQ-9 scores showed significant improvement from baseline (mean [SD]: 6.20 [0.80] and 16.63 [1.47], respectively) to 3 months (mean [SD]: 4.73 [0.98] and 7.30 [2.60], P < 0.0001, respectively). Patients showed clinical improvement with CGI and PGI scales and reported being satisfied with the treatment in the SATMED-Q. A few mild EAs were registered. Conclusion: Vortioxetine can relieve depressive and pain symptoms, with a good safety profile, in patients with MDD and CP. [ABSTRACT FROM AUTHOR]

Introduction: In people with type 2 diabetes (PwT2D) who also have obesity, efforts targeting weight loss, including lifestyle, medication and surgical interventions, are recommended. The objective of this study was to explore the relationship between glycemic control and obesity among PwT2D in Europe and Australia using recent real-world data and applying consistent methodology across countries. Methods: Retrospective study utilizing IQVIA electronic medical records (EMR) databases grouped into panels based on specialty of contributing physicians. General practitioner (GP) and endocrinologist/diabetologist (E/D) panels were used in Germany and France, while GP panels were used in Italy, UK and Australia. The Spanish database included all physician specialties. The sample included PwT2D with glycated hemoglobin A1c (HbA1c) and body mass index (BMI) values measured within 90 days of each other between January 2015 and December 2018 (second record termed the 'index date'). PwT2D had a 1-year baseline period and a recorded HbA1c at the end of the 1-year post-index period. Results: The final sample comprised 194,729 PwT2D. At baseline, across countries/panels, 36.8–58.0% were above HbA1c target (HbA1c ≥ 7%) and 39.4–56.7% had obesity (BMI ≥ 30.0 kg/m2). Mean HbA1c ranged from 6.9 to 7.6% and mean BMI ranged from 29.3–31.6 kg/m2. At baseline, a higher proportion of PwT2D with obesity (40.8–64.2%) were above HbA1c target compared to their counterparts without obesity (32.2–52.4%). A higher proportion of patients with obesity at baseline (38.1–60.6%) had post-index HbA1c above target compared to their counterparts without obesity (30.9–56.0%). In logistic regression, patients with obesity had substantially lower odds of post-index HbA1c below target compared to those without obesity in all countries/panels except for France (E/D), Spain and Australia. Conclusions: This study presents data on HbA1c and BMI among type 2 diabetes (T2D) populations in Europe and Australia. A notable proportion of PwT2D had obesity and were above HBA1c target. Higher BMI was associated with poorer glycemic control. [ABSTRACT FROM AUTHOR]

Objective actigraphy measures, 2 self-reports) of sleep health, is associated with higher levels of anxiety symptoms in midlife women. Participants and Methods: The participants in this longitudinal analysis included women from the SWAN Sleep I Study, a subcohort of the community-dwelling midlife women participating in the core Study of Women's Health Across the Nation (SWAN), which was initiated in 1996. Of the 370 participants enrolled in the Sleep Study, 270 were included in the analytic sample, and 100 who did not meet the inclusion criteria were excluded. Baseline measures of six dimensions of multidimensional sleep health (actigraphy measures: efficiency, duration, mid-sleep timing, regularity; self-report measures: alertness, satisfaction) were obtained between 2003 and 2005, corresponding to SWAN core annual/biennial assessments 5– 8. Associations of each dimension with self-reported anxiety symptoms (Generalized Anxiety Disorder – 7-item scale; GAD-7), collected during visits 12 (2009– 2011), 13 (2011– 2013), and 15 (2015– 2017), were examined using mixed models. The GAD-7 outcome was measured both continuously and as a categorical variable due to its skewed distribution. Results: No statistically significant associations were found between any of the six baseline sleep health dimensions and the GAD-7 score after adjustment for covariates. Conclusion: The reasons for the lack of support for our hypothesis, despite previous evidence supporting an association between sleep and anxiety, are unclear. There is considerable overlap between anxiety and sleep symptoms, which may complicate the interpretation of our the findings. Thus, the failure to identify associations is likely multifactorial, and more studies with shorter follow-up intervals are warranted to better understand these relationships. [ABSTRACT FROM AUTHOR]

Prescription opioid misuse has become one of the most frequent types of drug consumption among adolescents. Our objective was to report the prevalence, gender differences, and factors associated with prescription opioid misuse in school-aged adolescents. An observational study was conducted. We used the Spanish State Survey on Drug Use in Secondary Education 2018–2019, which covers drug use among students aged 14–18 years. Based on logistic multivariate regression models, we estimated the independent effect of each variable on prescription opioid misuse. Prescription opioid misuse was reported by 554 adolescents, with a greater prevalence in boys than girls (OR = 2.72). Misuse of tranquilizers, sedatives, sleeping pills, and other illicit psychoactive drugs (AOR = 9.32) are risk factors for prescription opioid misuse in both genders. Use of cannabis (AOR = 3.23) and cocaine (AOR = 2.28) is the predictor of prescription opioid misuse in females. There are differences in risk factors for prescription opioid misuse by gender. [ABSTRACT FROM AUTHOR]

Copyright of Biomédica: Revista del Instituto Nacional de Salud is the property of Instituto Nacional de Salud of Colombia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Disease-modifying therapies (DMTs) for multiple sclerosis (MS) reduce relapse frequency, magnetic resonance imaging (MRI) activity, and slow disability progression. Numerous DMTs are approved for relapsing forms of MS although real-world data on patient-reported outcomes (PROs) and quality of life (QoL) are needed to inform treatment choice. Immune reconstitution therapy with cladribine tablets is a highly effective treatment for relapsing MS (RMS). We present the protocol for an observational study to prospectively assess the effectiveness of cladribine tablets on clinical and MRI parameters as well as on PROs, including treatment satisfaction, QoL, sleep quality, self-perceived health, fatigue, and physical function. Enrolled patients at study sites in Italy will be adults with RMS (including relapsing-remitting and active secondary progressive MS) who are either treatment naïve or have received at least one firstline disease modifying DMT or no more than one second-line DMT. The primary objective will be change in global treatment satisfaction measured with the Treatment Satisfaction Questionnaire for Medication Version 1.4 approximately 24 months after initiating cladribine tablets in patients switching from previous DMTs. Secondary objectives will include global treatment satisfaction at earlier timepoints, will comprise treatment naïve patients, and will quantify treatment effectiveness and tolerability. We will also assess relapses, disability progression, MRI activity, and other PROs at approximately 12 and 24 months. The findings will provide insight from daily clinical practice into the patient's experience to complement data from controlled trials and inform treatment choice. EU PAS Registration Number EUPAS49334 filed 17/10/2022. [ABSTRACT FROM AUTHOR]

Background: In refractory cardiogenic shock, temporary mechanical support (tMCS) may be crucial for maintaining tissue perfusion and oxygen delivery. tMCS can serve as a bridge-to-decision to assess eligibility for left ventricular assist device (LVAD) implantation or heart transplantation, or as a bridge-to-recovery. ECPELLA is a novel tMCS configuration combining venoarterial extracorporeal membrane oxygenation with Impella. The present study presents the clinical parameters, outcomes, and complications of patients supported with ECPELLA. Methods: All patients supported with ECPELLA at University Medical Centre Utrecht between December 2020 and August 2023 were included. The primary outcome was 30-day mortality, and secondary outcomes were LVAD implantation/heart transplantation and safety outcomes. Results: Twenty patients with an average age of 51 years, and of whom 70% were males, were included. Causes of cardiogenic shock were acute heart failure (due to acute coronary syndrome, myocarditis, or after cardiac surgery) or chronic heart failure, respectively 70 and 30% of cases. The median duration of ECPELLA support was 164 h (interquartile range 98–210). In 50% of cases, a permanent LVAD was implanted. Cardiac recovery within 30 days was seen in 30% of cases and 30-day mortality rate was 20%. ECPELLA support was associated with major bleeding (40%), haemolysis (25%), vascular complications (30%), kidney failure requiring replacement therapy (50%), and Impella failure requiring extraction (15%). Conclusion: ECPELLA can be successfully used as a bridge to LVAD implantation or as a bridge-to-recovery in patients with refractory cardiogenic shock. Despite a significant number of complications, 30-day mortality was lower than observed in previous cohorts. [ABSTRACT FROM AUTHOR]

Objectives: To describe the current real-world treatment landscape, sequence of therapies, and outcomes in patients with prostate cancer (PC). Methods: A retrospective cohort study for PC patients diagnosed at King Abdullah Medical City Cancer Center in Makkah, Saudi Arabia, between January 2011 and December 2021. Data extracted from electronic medical records. Results: A total of 282 patients with PC, with a mean age of 70 years and body mass index of 27. Among them, 274 (99%) had no family history of cancer, while 164 (58%) had hypertension and 125 (44%) had diabetes mellitus. Adenocarcinoma was the most common histology, found in 275 (97%) patients, with 99 (35%) having a Gleason score of 9. Notably, 184 (65%) patients presented with metastatic disease, and 147 (52%) with bone metastasis. While 198 (70%) patients underwent surgery, 184 (65%) did not receive radiotherapy. The most common first-line metastatic therapy was abiraterone in 23 (8%) patients, followed by enzalutamide in 7 (2.5%). During the study period, 167 (59%) patients survived, with an average treatment duration of 2.5 years. Conclusion: This study provides insights into real-world treatment patterns and clinical outcomes in patients with PC. The findings of this study highlight the importance of adhering to treatment standards and making informed clinical decisions. [ABSTRACT FROM AUTHOR]

Background and Aims: Patellofemoral pain (PFP) is common in males, causing reduced physical activity and chronic pain. One proposed cause of PFP is aberrant biomechanics during tasks loading the patellofemoral joint. Consistent evidence exists for females with PFP, but it is uncertain if males with PFP have altered biomechanics. This study investigated the kinematics of males with PFP compared to pain‐free males during forward step‐down (StDn) and single‐leg squat (SLSq). Methods: A cross‐sectional study including 40 males aged 20–39 years (28.28 ± 5.46) was conducted (20 PFP, 20 pain‐free). Participants performed StDn and SLSq while motion was captured with a video‐based motion capture system (Motion Analysis Corporation). Triplanar peak angles and angular ranges of motion (ROM) of the trunk, pelvis, and weight‐bearing hip, knee, and ankle were dependent variables. Mixed‐model ANOVA tests were used to determine the presence of significant interactions and main effects of group and task. Results: Males with PFP had significantly lower peak knee adduction angles compared to pain‐free males (p = 0.01). Significant group x task interactions were found for hip and pelvis ROM (p < 0.05). PFP participants had increased hip and pelvis ROM during StDn in the frontal and transverse planes but reduced or nearly equal ROM for these variables during SLSq. Peak hip adduction, hip internal rotation, contralateral pelvic drop and anterior tilt, trunk flexion, and ankle dorsiflexion were greater during StDn compared to SLSq (p < 0.05). ROM of the hip, pelvis, trunk, and ankle were greater during StDn compared to SLSq (p < 0.05). Conclusion: Males with PFP had reduced peak knee adduction angles in StDn and SLSq. Males with PFP demonstrated increased hip and pelvis ROM during StDn versus SLSq, particularly in the frontal and transverse planes. Clinicians should consider StDn as a clinical test since aberrant movement may be easier to detect than in SLSq. Key points: Faulty kinematics are commonly reported in females with patellofemoral pain (PFP), but the kinematics of males with PFP are still uncertain.Males with PFP had reduced peak knee adduction angles during step‐down and single‐leg squatting. Compared to pain‐free males, the PFP group had greater hip and pelvis ranges of motion (ROM) during step‐down but reduced hip and pelvis ROM during squatting.The findings of this study indicate that males with PFP may have reduced knee adduction during weight‐bearing tasks. Excessive hip and pelvis ROM during step‐down may be present so may be a preferred clinical task to detect faulty kinematics. [ABSTRACT FROM AUTHOR]

Background: Despite programmatic protocolised care and structured support, considerable variation is observed in completeness of registration and achieving targets of cardiovascular risk management (CVRM) between individual GPs in the Netherlands. Aim: To determine whether completeness of registration and achieved targets of cardiovascular risk factors improves with practice visitation. Design & setting: Observational study utilising the care group's database (2016–2019), comparing changes in registration and achieved targets in non-visited practices and visited practices. Method: We compared completeness scores of registration and scores of targets achieved before visitation and 1 year after visitation. Data were analysed on patient level and GP level. Separate analyses were performed among GPs who were ranked in the lower 25% of score distributions. Results: We observed no clinically relevant improvements in completeness of registration and targets achieved in 2017, 2018, and 2019 that could be attributed to visitations in the previous year, both on individual patient level and on aggregated level per general practice. In practices ranked in the lower 25% of the distribution, improvements over time were clinically relevant and larger than the overall changes. Yet, these findings were irrespective of the number of practice visitations. Conclusion: Practice visitations in our setting did not seem to lead to improvements in practice performance, nor in completeness of registration of risk factors or in reaching predefined target goals for cardiovascular risk factors.

Several studies have documented a relationship between short-term exposure to atmospheric sulfur dioxide (SO2) and chronic obstructive pulmonary disease (COPD). However, findings vary across different regions. This meta-analysis employed a random-effects model to calculate the combined risk estimate for each 10-μg/m3 increase in ambient SO2 concentration. Subgroup analysis aimed to identify sources of heterogeneity. To assess potential bias, studies were evaluated using a domain-based assessment tool developed by the World Health Organization. Sensitivity analyses, based on bias risk, explored how model assumptions influenced associations. An evidence certainty framework was used to evaluate overall evidence quality. The study protocol was registered with PROSPERO (CRD42023446823). We thoroughly reviewed 191 full-text articles, ultimately including 15 in the meta-analysis. The pooled relative risk for COPD was 1.26 (95 % CI 0.94–1.70) per 10-μg/m3 increase in ambient SO2. Eleven studies were deemed high risk due to inadequate handling of missing data. Overall evidence certainty was rated as medium. Given SO2's significant public health implications, continuous monitoring is crucial. Future research should include countries in Africa and Oceania to enhance global understanding of atmospheric SO2-related health issues.

Background: It is unclear how perioperative hemoglobin decrease (ΔHb) influences the balance between risks and benefits of red blood cell transfusion after cardiac surgery. Methods: We retrospectively analyzed data on 8186 adults who underwent valve surgery and/or coronary artery bypass grafting under cardiopulmonary bypass at two large cardiology centers. We explored the potential association of ΔHb, defined relative to the preoperative level and postoperative nadir, with a composite outcome of in-hospital mortality, myocardial infarction, stroke, and acute kidney injury using multivariable logistic regression, restricted cubic spline, and piecewise-linear models. Results: Among 6316 patients without preoperative anemia, ΔHb ≥ 50 % was associated with an elevated risk of the composite outcome [adjusted odds ratio (aOR) 1.95, 95 % confidence interval (CI) 1.81–2.35]. Among 869 patients without preoperative anemia and with ΔHb ≥ 50 %, postoperative transfusion of no more than four units of red blood cell appeared to decrease the risk of the composite outcome, whereas transfusion of more than six units increased risk. Among 5447 patients without preoperative anemia and with ΔHb < 50 %, postoperative transfusion appeared not to decrease the risk of the composite outcome. Among 1870 patients with preoperative anemia, ΔHb ≥ 30 % significantly increased the risk of the composite outcome (aOR 1.61, 95 % CI 1.23–2.10), and this risk might be moderated by postoperative transfusion of no more than four units of red blood cell, but increased by transfusion of more than six units. Conclusions: ΔHb may influence the balance between risks and benefits of red blood cell transfusion after cardiac surgery.

Atopic dermatitis (AD) is the most common chronic inflammatory dermatitis in developed countries, and has a major impact on those affected. Little is known about AD in elderly patients. This prospective multicentre observational study described the clinical characteristics and burden of AD in elderly subjects ≥ 65 years, as well as the therapeutic options chosen for this population in routine care, and compared findings with those in young adults with AD

Background: While prevalence estimates differ by definition of metabolic syndrome (MetS), it is less clear how different definitions affect associations with alcohol consumption. Methods: We included 3051 adults aged 25–77 from the baseline examination of the Swedish INTERGENE cohort (2001–2004). Using multiple logistic regression, we investigated cross-sectional associations between ethanol intake and MetS defined according to the Adult Treatment Panel III (ATP III), the International Diabetes Federation (IDF), and the Joint Interim Statement (JIS). Alcohol exposure categories comprised abstinence, and low, medium, and high consumption defined via sex-specific tertiles of ethanol intake among current consumers. Covariates included sociodemographics, health, and lifestyle factors. Results: MetS prevalence estimates varied between 13.9 % (ATP III) and 25.3 % (JIS), with higher prevalence in men than women. Adjusted for age and sex, medium-high alcohol consumption was associated with lower odds of MetS compared to low consumption, while no difference was observed for abstainers. Only the most specific (and thus severe) definition of MetS (ATP III) showed decreasing odds for ethanol intake when adjusted for all covariates. Conclusion: Our study shows that alcohol-related associations differ by definition of MetS. The finding that individuals with the most stringently defined MetS may benefit from alcohol consumption calls for further well-controlled studies.