UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.

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

BACKGROUND: Undernutrition during pregnancy is linked to adverse pregnancy and birth outcomes and has downstream effects on the growth and development of children. The gut microbiome has a profound influence on the nutritional status of the host. This phenomenon is understudied in settings with a high prevalence of undernutrition, and further investigation is warranted to better understand such interactions.
METHODS: This is a prospective, longitudinal observational study to investigate the relationship between prokaryotic and eukaryotic microbes in the gut and their association with maternal body mass index (BMI), gestational weight gain, and birth and infant outcomes among young mothers (17-24 years) in Matiari District, Pakistan. We aim to enrol 400 pregnant women with low and normal BMIs at the time of recruitment (<16 weeks of gestation). To determine the weight gain during pregnancy, maternal weight is measured in the first and third trimesters. Gut microbiome dynamics (bacterial and eukaryotic) will be assessed using 16S and 18S rDNA surveys applied to the maternal stool samples. Birth outcomes include birth weight, small for gestational age, large for gestational age, preterm birth and mortality. Infant growth and nutritional parameters include WHO z-scores for weight, length and head circumference at birth through infancy. To determine the impact of the maternal microbiome, including exposure to pathogens and parasites on the development of the infant microbiome, we will analyse maternal and infant microbiome composition, micronutrients in serum using metallomics (eg, zinc, magnesium and selenium) and macronutrients in the stool. Metatranscriptomics metabolomics and markers of inflammation will be selectively deployed on stool samples to see the variations in dietary intake and maternal nutritional status. We will also use animal models to explore the bacterial and eukaryotic components of the microbiome.
BACKGROUND: The study is approved by the National Bioethics Committee (NBC) in Pakistan, the Ethics Review Committee (ERC) at Aga Khan University and the Research Ethics Board (REB) at the Hospital for Sick Children, and findings will be published in peer-reviewed journals.
BACKGROUND: NCT05108675.

BACKGROUND: Shoulder pain is the third most common musculoskeletal disorder yet diagnosis remains challenging. In some cases, shoulder symptoms can be partially attributed to a cervical origin.
OBJECTIVE: To estimate the prevalence of cervical contribution in patients presenting with shoulder pain. To determine symptom reproduction and symptom modification (i.e., pain intensity and pain location) after cervical spine screening (CSS) and compare these changes between patients with and without cervical contribution.
METHODS: Observational study.
METHODS: Sixty patients were included. Cervical contribution was present if a ≥30.0% change in shoulder pain intensity on active movement was recorded after CSS. The CSS consisted of several tests and shoulder symptom modification or reproduction was noted. The presence of a centralization phenomenon was also noted and was considered to be present if the location of pain diminished from more distal areas after the CSS.
RESULTS: A 50.0% prevalence of cervical contribution (CI95% 37,35-62,65) was found. Cervical contribution was more likely in those that demonstrated centralization of their pain after the CSS (p = 0.002) and those that had a history of previous neck pain (p = 0.007). Symptom reproduction occurred for 23 out of the 60 participants (38.3%), being present in 18 of those with cervical contribution (60.0%). After the CSS, a statistically significant decrease of shoulder pain intensity was found for those classified as having cervical contribution (p < 0.001).
CONCLUSIONS: Cervical contribution is prevalent in 50% of patients presenting with shoulder pain; this was evidenced as shoulder symptom modification and, to a lesser extent, symptom reproduction following a CSS.

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.

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

BACKGROUND: The current literature inadequately addresses the extent to which remote monitoring should be integrated into care models for chronic respiratory diseases (CRDs).
OBJECTIVE: This study examined a remote monitoring program (RMP) in cystic fibrosis (CF) by exploring experiences, future perspectives, and use behavior over 3 years, with the aim of developing future directions for remote monitoring in CRDs.
METHODS: This was a mixed methods, multicenter, observational study in 5 Dutch CF centers following a sequential explanatory design. Self-designed questionnaires using the technology acceptance model were sent out to people with CF who had a minimum of 12 months of experience with the RMP and local health care professionals (HCPs). Questionnaire outcomes were used to inform semistructured interviews with HCPs and people with CF. Qualitative findings were reported following the COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist. Anonymous data on use frequency of all people with CF were analyzed.
RESULTS: Between the second quarter of 2020 and the end of 2022, a total of 608 people with CF were enrolled in the program, and a total of 9418 lung function tests and 2631 symptom surveys were conducted. In total, 65% (24/37) of HCPs and 89% (72/81) of people with CF responded to the questionnaire, and 7 HCPs and 12 people with CF participated in semistructured interviews. Both people with CF and HCPs were positive about remote monitoring in CF care and found the RMP a good addition to daily care (people with CF: 44/72, 61%; HCPs: 21/24, 88%). Benefits ranged from supporting individual patients to reducing health care consumption. The most valued monitoring tool was home spirometry by both people with CF (66/72, 92%) and HCPs (22/24, 92%). Downsides included the potential to lose sight of patients and negative psychosocial effects, as 17% (12/72) of people with CF experienced some form of stress due to the RMP. A large majority of people with CF (59/72, 82%) and HCPs (22/24, 92%) wanted to keep using the RMP in future, with 79% (19/24) of HCPs and 75% (54/72) of people with CF looking forward to more replacement of in-person care with digital care during periods of well-being. Future perspectives for the RMP were centered on creating hybrid care models, personalizing remote care, and balancing individual benefits with monitoring burden.
CONCLUSIONS: Remote monitoring has considerable potential in supporting people with CF and HCPs within the CF care model. We identified 4 practice-based future directions for remote monitoring in CF and CRD care. The strategies, ranging from patient driven to prediction driven, can help clinicians, researchers, and policy makers navigate the rapidly changing digital health field, integrate remote monitoring into local care models, and align remote care with patient and clinician needs.

Objectives: In holistic medicine, developing personalized treatment plans is challenging due to the multitude of possible therapy combinations. This study introduces the use of a statistical approach to identify the most effective herbal medicines prescribed in Persian medicine (PM) in a small-scale sample of patients with type 2 diabetes mellitus (T2DM). Methods: This prospective observational cohort study was conducted with 47 patients with T2DM referred to Behesht Clinic in Tehran, Iran. A physician prescribed individualized PM treatment for T2DM and related systemic issues. The fasting blood sugar (FBS) level of each patient was recorded at initial and two follow-up visits, with visit intervals and treatment modifications determined by patient health status. Patients who completed two follow-up visits were included in the final analysis (n = 27). Data were analyzed using R software. A general linear model was assumed for the mean response, along with an exponential covariance pattern model, to manage irregularly timed measurements. Results: Two fitted models showed that, after adjusting for confounders, the use of the \"Diabetes Capsule\" significantly reduced the average FBS by 17.14 mmol/L (p = 0.046). For each unit increase in the consumption of \"Diabetes Capsule\" or \"Hab-e-Amber Momiai,\" the average FBS decreased by 15.22 mmol/L (p = 0.015) and 14.14 mmol/L (p = 0.047), respectively. Conclusion: It is possible to observe which medications are most effective, even when treatments are applied in a holistic and personalized fashion. Preliminary studies such as these may identify promising products for testing in clinical trials conducted under standardized conditions, to inform initial choices for future personalized treatments.

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

BACKGROUND: 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.
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.
CONCLUSIONS: 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.