External validity of randomized clinical trials in vascular surgery: systematic review of demographic factors of patients recruited to randomized clinical trials with comparison to the National Vascular Registry

Background: Evidence-based medicine relies on randomized clinical trials, which should represent the patients encountered in clinical practice. Characteristics of patients recruited to randomized clinical trials involving vascular index operations (carotid endarterectomy, abdominal aortic aneurysm repair, infrainguinal bypass and major lower limb amputations) were compared with those recorded in the National Vascular Registry across England and Wales. Methods: MEDLINE, Embase, Web of Science, CENTRAL, clinicaltrials.gov and World Health Organization International Trials Registry Platform (CRD42021247905) were searched for randomized clinical trials involving the index operations. Demographic (age, sex, ethnicity) and clinical (co-morbidities, medications, body mass index, smoking, alcohol, cognition) data were extracted, by operation. Characteristics of operated on patients were extracted from publicly available National Vascular Registry reports (2014–2020). All findings are reported according to PRISMA guidelines. Rayyan.AI, Excel and GraphPad Prism were used for screening and analysis. Results: A total of 307 randomized clinical trials (66 449 patients) were included and compared with National Vascular Registry data for 119 019 patients. Randomized clinical trial patients were younger across all operations; for carotid endarterectomy, bypass and major lower limb amputation randomized clinical trials, there were differences in female patient representation. Further comparisons were limited by the insufficient baseline data reporting across randomized clinical trials, though reporting improved over decades. National Vascular Registry reports lacked information on patient factors such as patient ethnicity or body mass index. Conclusions: There are significant differences in demographic and clinical factors between patients recruited to vascular surgery randomized clinical trials and the real-world National Vascular Registry vascular surgery patient population. Minimum reporting standards for baseline data should be defined to allow future randomized clinical trials to represent real-world patient populations and ensure the external validity of their results

A systematic review and meta-analysis of operative versus non-operative management for first time traumatic anterior shoulder dislocation in young adults

Background: The most appropriate management following primary traumatic anterior shoulder dislocation in young adults is unclear. This systematic review and meta-analysis evaluated operative versus non-operative management. The primary outcome measure was re-dislocation rate, in contrast to the often reported ‘recurrent instability’, which includes subjective instability. Methods: Our review was prospectively registered with PROSPERO (CRD42022322600) and reported as per PRISMA guidelines. Selection criteria included mean age of participants between 15 and 25 and minimum follow-up of 1 year. Results: 21 studies meet the inclusion criteria with 5142 patients included. The mean age of patients was 23, with 87% male. There was a median of 54 patients per study and a mean follow up of 46 months per study. The mean re-dislocation rate was 16.08% in the operative group and 24.84% in the non-operative group. In the subgroup meta-analysis, including only RCTs, comparing arthroscopic stabilisation vs non-operative there was an odds ratio of 0.09, strongly favouring intervention. Discussion: This systematic review found the literature available supports surgical intervention in patients under the age of 25, in order to reduce re-dislocation. However, there is a lack of cost-effectiveness data to support these findings, and this should be an area of future research

The effectiveness of waxing or epilation compared to conventional methods of hair removal in reducing the incidence of surgical site infections: a systematic review and meta-analysis

Background: Surgical site infections (SSIs) pose a significant challenge to healthcare systems by elevating patient morbidity and mortality and driving up financial costs. Preoperative skin preparation is crucial for preventing SSIs; however, certain traditional methods of hair removal have been found to increase the risk of SSI development. Mechanical epilation and waxing constitute two relatively explored methods of hair removal, which may hold potential to accelerate wound healing due to the activation of stem cells within hair follicles. This review assesses the efficacy of preoperative hair removal via waxing and mechanical epilation in reducing SSI incidence. Methods: This systematic review was prospectively registered with PROSPERO (ref: CRD42023423798) and a protocol previously published in a peer-reviewed journal. All findings are reported according to PRISMA guidelines. A comprehensive search of Medline, Embase, CENTRAL, ClinicalTrials.gov and CINAHL. Inclusion criteria encompassed adult patients undergoing any surgical procedure, comparing waxing or epilation against other hair removal methods or no hair removal, with SSI incidence as the primary outcome. There was no restriction on study size or quality to ensure a comprehensive literature evaluation. Results: The review found no studies meeting the selection criteria out of 576 records screened. Discussion / Conclusion: This review has identified no literature regarding the use of waxing and mechanical epilation as methods of preoperative hair removal. The lack of experimental evidence combined with the potential physiological advantages of these techniques indicate that this could be a valuable area of future research. These techniques may represent novel approaches to SSI prevention, particularly beneficial in high-risk surgical disciplines like vascular surgery

Two doses of SARS-CoV-2 vaccination induce robust immune responses to emerging SARS-CoV-2 variants of concern

The extent to which immune responses to natural infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and immunization with vaccines protect against variants of concern (VOC) is of increasing importance. Accordingly, here we analyse antibodies and T cells of a recently vaccinated, UK cohort, alongside those recovering from natural infection in early 2020. We show that neutralization of the VOC compared to a reference isolate of the original circulating lineage, B, is reduced: more profoundly against B.1.351 than for B.1.1.7, and in responses to infection or a single dose of vaccine than to a second dose of vaccine. Importantly, high magnitude T cell responses are generated after two vaccine doses, with the majority of the T cell response directed against epitopes that are conserved between the prototype isolate B and the VOC. Vaccination is required to generate high potency immune responses to protect against these and other emergent variants

Maggot debridement therapy for the treatment of diabetic foot ulcers: robbing the rich past to give to the sore

A diabetic foot ulcer (DFU) is a serious complication of diabetes mellitus that results in significant morbidity and mortality. The lifetime risk of a patient with diabetes developing a DFU is 15-25%1. Furthermore, the incidence of DFUs is increasing in line with the growing burden of diabetes worldwide. The number of lower limb amputations secondary to diabetes has reached an all-time high in England, with 26,378 recorded from 2014-2017, an increase of 19.4% from 2010-20132. Maggot debridement therapy (MDT) involves the application of sterile larvae, usually of the species Lucilla sericata (common green bottle fly), which remove devitalised tissue to promote wound healing. This historical therapy re-emerged in the 1990s to combat the increasing incidence of recalcitrant wounds, such as DFUs. Since its reintroduction, there has been ongoing debate in the medical literature regarding the efficacy of MDT in the treatment of DFUs and other chronic wounds. We present the case of a 57-year-old male admitted with diabetic foot sepsis and multiorgan failure and discuss how MDT was used to complement initial surgical and antibiotic management. A 14-day course of MDT improved wound debridement and decreased necrotic tissue burden, after which no further surgical interventions were needed. This case provides further evidence that MDT is effective in the selective debridement of necrotic tissue and can aid the preservation of limb length in DFU patients, thereby highlighting the importance of MDT in multispecialist diabetic foot care.</jats:p

Comparative Performance Of Clinician And Computational Approaches In Forecasting Adverse Outcomes In Intermittent Claudication

Introduction and ObjectivesMachine learning (ML) based prediction modelling has demonstrated superior abilities in analysing non-linear data with complex relationships. Pilot work in this work-stream has shown that ML techniques can accurately forecast adverse cardiovascular and limb events in patients with intermittent claudication. This is the first study to compare the predictive performance of ML approaches, traditional regression, and clinician prediction

Loss of tetraspanin-7 expression reduces pancreatic β-cell exocytosis Ca2+ sensitivity but has limited effect on systemic metabolism.

Tetraspanin-7 (Tspan7) is an islet autoantigen involved in autoimmune type 1 diabetes and known to regulate β-cell L-type Ca2+ channel activity. However, the role of Tspan7 in pancreatic β-cell function is not yet fully understood.info:eu-repo/semantics/publishe

Comparative Performance of Clinician and Computational Approaches in Forecasting Adverse Outcomes in Intermittent Claudication

Background: Recent evidence has shown that machine learning (ML) techniques can accurately forecast adverse cardiovascular and limb events in patients with intermittent claudication. This is the first study to compare the predictive performance of ML versus traditional logistic regression (LR) and clinicians. Methods: An anonymized dataset of 99 patients with 27 baseline characteristics, compliance with best medical therapy/smoking cessation was used for comparison. Predictive performance was assessed using area under the receiver operating characteristic curve, F1 score, and Brier score. ML, LR, and clinicians were compared in their ability to predict outcomes including progression to chronic limb-threatening ischemia (CLTI) at 2 and 5 years, and probability of major adverse cardiovascular events or limb events upto 5 years. Independent variable importance ranking was performed to identify the most influential predictors. Results: The Least Absolute Shrinkage and Selection Operator based ML model was compared with (LR) and predictions from 8 clinicians. ML significantly outperformed LR and clinicians across all outcomes. Area under the receiver operating characteristic curve for CLTI at 2 years: ML 0.885, LR 0.74, best clinician 0.63; CLTI at 5 years: ML 0.936, LR 0.808, best clinician 0.639; major adverse cardiovascular event at 5 years: ML 0.963, LR 0.759, best clinician 0.611; major adverse limb event: ML 0.957, LR 0.9, best clinician 0.677. Brier scores for the ML model demonstrated excellent accuracy: ML (0.03–0.07), compared to LR (0.10–0.22) and clinicians (>0.31).The ML model demonstrated superior predictive performance with F1 scores ranging from 0.80 to 0.86 across all outcomes, consistently outperforming both LR (F1 scores: 0.61–0.72) and individual clinicians (F1 scores: 0.50–0.59). Conclusion: ML-based prediction models significantly outperform traditional regression and clinician judgment, primarily due to their ability to capture complex nonlinear associations between variables