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Randomized controlled trials (RCTs) in surgery face methodological challenges, which often result in low quality or failed trials. The Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework proposes preliminary prospective collaborative cohort studies with specific properties (IDEAL 2b studies) to increase the quality and feasibility of surgical RCTs. Little empirical evidence exists for this proposition, and specifically designed 2b studies are currently uncommon. Prospective collaborative cohort studies are, however, relatively common, and might provide similar benefits. We will, therefore, assess the association between prior ‘IDEAL 2b-like’ cohort studies and the quality and impact of surgical RCTs.We propose a systematic review using two parallel case–control analyses, with surgical RCTs as subjects and study quality and journal impact factor (IF) as the outcomes of interest. We will search for surgical RCTs published between 2015 and 2019 and and prior prospective collaborative cohort studies authored by any of the RCT investigators. RCTs will be categorized into cases or controls by (1) journal (IF ≥or <5) and (2) study quality (PEDro score ≥or < 7). The case/control OR of exposure to a prior ‘2b like’ study will be calculated independently for quality and impact. Cases will be matched 1: 1 with controls by year of publication, and confounding by peer-reviewed funding, author academic affiliation and trial protocol registration will be examined using multiple logistic regression analysis.This study will examine whether preparatory IDEAL 2b-like studies are associated with higher quality and impact of subsequent RCTs.

A growing number of artificial intelligence (AI)-based clinical decision support systems are showing promising performance in preclinical, in silico, evaluation, but few have yet demonstrated real benefit to patient care. Early stage clinical evaluation is important to assess an AI system’s actual clinical performance at small scale, ensure its safety, evaluate the human factors surrounding its use, and pave the way to further large scale trials. However, the reporting of these early studies remains inadequate. The present statement provides a multistakeholder, consensus-based reporting guideline for the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI). We conducted a two round, modified Delphi process to collect and analyse expert opinion on the reporting of early clinical evaluation of AI systems. Experts were recruited from 20 predefined stakeholder categories. The final composition and wording of the guideline was determined at a virtual consensus meeting. The checklist and the Explanation & Elaboration (E&E) sections were refined based on feedback from a qualitative evaluation process. 123 experts participated in the first round of Delphi, 138 in the second, 16 in the consensus meeting, and 16 in the qualitative evaluation. The DECIDE-AI reporting guideline comprises 17 AI specific reporting items (made of 28 subitems) and 10 generic reporting items, with an E&E paragraph provided for each. Through consultation and consensus with a range of stakeholders, we have developed a guideline comprising key items that should be reported in early stage clinical studies of AI-based decision support systems in healthcare. By providing an actionable checklist of minimal reporting items, the DECIDE-AI guideline will facilitate the appraisal of these studies and replicability of their findings.

BackgroundThe management of acute deterioration following surgery remains highly variable. Patients and families can play an important role in identifying early signs of deterioration but effective contribution to escalation of care can be practically difficult to achieve. This paper reports the enablers and barriers to the implementation of patient-led escalation systems found during a process evaluation of a quality improvement programme Rescue for Emergency Surgery Patients Observed to uNdergo acute Deterioration (RESPOND).MethodsThe research used ethnographic methods, including over 100 hours of observations on surgical units in three English hospitals in order to understand the everyday context of care. Observations focused on the coordination of activities such as handovers and how rescue featured as part of this. We also conducted 27 interviews with a range of clinical and managerial staff and patients. We employed a thematic analysis approach, combined with a theoretically focused implementation coding framework, based on Normalisation Process Theory.ResultsWe found that organisational infrastructural support in the form of a leadership support and clinical care outreach teams with capacity were enablers in implementing the patient-led escalation system. Barriers to implementation included making changes to professional practice without discussing the value and legitimacy of operationalising patient concerns, and ensuring equity of use. We found that organisational work is needed to overcome patient fears about disrupting social and cultural norms.ConclusionsThis paper reveals the need for infrastructural support to facilitate the implementation of a patient-led escalation system, and leadership support to normalise the everyday process of involving patients and families in escalation. This type of system may not achieve its goals without properly understanding and addressing the concerns of both nurses and patients.

OBJECTIVES The aim of this study was to perform a meta-analysis of studies reporting outcomes in patients with liver dysfunction addressed by the model of end-stage liver disease and Child–Turcotte–Pugh scores undergoing cardiac surgery. METHODS A systematic literature search was conducted to identify contemporary studies reporting short- and long-term outcomes in patients with liver dysfunction compared to patients with no or mild liver dysfunction undergoing cardiac surgery (stratified in high and low score group based on the study cut-offs). Primary outcome was perioperative mortality. Secondary outcomes were perioperative neurological events, prolonged ventilation, sepsis, bleeding and/or need for transfusion, acute kidney injury and long-term mortality. RESULTS A total of 33 studies with 48 891 patients were included. Compared with the low score group, being in the high score group was associated with significantly higher risk of perioperative mortality [odds ratio (OR) 3.72, 95% confidence interval (CI) 2.75–5.03, P < 0.001]. High score group was also associated with a significantly higher rate of perioperative neurological events (OR 1.49, 95% CI 1.30–1.71, P < 0.001), prolonged ventilation (OR 2.45, 95% CI 1.94–3.09, P < 0.001), sepsis (OR 3.88, 95% CI 2.07–7.26, P < 0.001), bleeding and/or need for transfusion (OR 1.95, 95% CI 1.43–2.64, P < 0.001), acute kidney injury (OR 3.84, 95% CI 2.12–6.98, P < 0.001) and long-term mortality (incidence risk ratio 1.29, 95% CI 1.14–1.46, P < 0.001) CONCLUSIONS The analysis suggests that liver dysfunction in patients undergoing cardiac surgery is independently associated with higher risk of short and long-term mortality and also with an increased occurrence of various perioperative adverse events.

Simultaneous bilateral total knee arthroplasty (SBTKA) may present a higher risk for postoperative complications than unilateral surgery. The authors retrospectively identified 561 patients who underwent SBTKA between 2013 and 2015. The cohort was stratified according to the following appropriateness of care criteria (AOCC): (1) age younger than 70 years; (2) absence of cardiac disease; (3) controlled diabetes; and (4) body mass index less than 30 kg/m 2 . The authors created an AOCC score, with 0 representing the most ideal candidates and 4 representing the least ideal candidates. The cohort included 140 (25%) ideal candidates with a score of 0; the cohort also included 299 (53%) non-ideal candidates with a score of 1, 105 (19%) with a score of 2, 14 (2%) with a score of 3, and 3 (1%) with a score of 4. Ideal candidates had the shortest mean length of stay at 3.6±1.2 days. Length of stay was longer for patients with an AOCC score of greater than 2 compared with those with an AOCC score of 2 or less (5.2±4.3 vs 3.8±1.6 days, P <.001). Ideal candidates were discharged to home more often than other patients (26% vs 13%, P <.001). Although there was no difference in 90-day all-cause complications between ideal and non-ideal candidates (13% vs 16%, P =.400), medical complications trended strongly (6% vs 11%, P =.086). Appropriateness of care criteria for SBTKA patients were associated with shorter length of stay, higher rates of home discharge, and a trend toward lower complication rates. Simultaneous bilateral total knee arthroplasty can offer better outcomes in a subgroup of patients appropriately selected for surgery. Physicians can use these results to counsel their patients about risks and benefits of undergoing SBTKA. [ Orthopedics. 2018; 41(5):293–298.]

OBJECTIVES Midline sternotomy is the main surgical access for cardiac surgeries. The most prominent complication of sternotomy is sternal wound infection (SWI). The use of a thorax support vest (TSV) that limits thorax movement and ensures sternal stability has been suggested to prevent postoperative SWI. METHODS We performed a meta-analysis to evaluate differences in clinical outcomes with and without the use of TSV after cardiac surgery in randomized trials. The primary outcome was deep SWI (DSWI). Secondary outcomes were superficial SWI, sternal wound dehiscence, and hospital length of stay (LOS). A trial sequential analysis was performed. Fixed (F) and random effects (R) models were calculated. RESULTS A total of 4 studies (3820 patients) were included. Patients who wore the TSV had lower incidence of DSWI [odds ratio (OR) = F: 0.24, 95% confidence interval (CI), 0.13–0.43, P < 0.01; R: 0.24, 0.04–1.59, P = 0.08], sternal wound dehiscence (OR = F: 0.08, 95% CI, 0.02–0.27, P < 0.01; R: 0.10, 0.00–2.20, P = 0.08) and shorter hospital LOS (standardized mean difference = F: −0.30, −0.37 to −0.24, P < 0.01; R: −0.63, −1.29 to 0.02, P = 0.15). There was no difference regarding the incidence of superficial SWI (OR = F: 0.71, 95% CI, 0.34–1.47, P = 0.35; R: 0.64, 0.10, 4.26, P = 0.42). The trial sequential analysis, however, showed that the observed decrease in DSWI in the TSV arm cannot be considered conclusive based on the existing evidence. CONCLUSIONS This meta-analysis suggests that the use of a TSV after cardiac surgery could potentially be associated with a reduction in sternal wound complications. However, despite the significant treatment effect in the available studies, the evidence is not solid enough to provide strong practice recommendations. Currently, midline sternotomy is a widespread method for direct thorax access [1], and despite advancements in minimally invasive surgery, the majority of complex cardiac procedures are performed through midline sternotomy.

There is ample evidence supporting the use of different manipulative therapy techniques for Cervicogenic Headache (CgH). However, no technique can be singled as the best available treatment for patients with CgH. Therefore, the objective of the study is to find and compare the clinical effects of cervical spine over thoracic spine manipulation and conventional physiotherapy in patients with CgH. It is a prospective, randomized controlled study conducted between July 2020 and January 2023 at the University hospital. N = 96 eligible patients with CgH were selected based on selection criteria and they were divided into cervical spine manipulation (CSM; n = 32), thoracic spine manipulation (TSM; n = 32) and conventional physiotherapy (CPT; n = 32) groups, and received the respective treatment for four weeks. Primary (CgH frequency) and secondary CgH pain intensity, CgH disability, neck pain frequency, neck pain intensity, neck pain threshold, cervical flexion rotation test (CFRT), neck disability index (NDI) and quality of life (QoL) scores were measured. The effects of treatment at various intervals were analyzed using a 3 × 4 linear mixed model analysis (LMM), with treatment group (cervical spine manipulation, thoracic spine manipulation, and conventional physiotherapy) and time intervals (baseline, 4 weeks, 8 weeks, and 6 months), and the statistical significance level was set at P < 0.05. The reports of the CSM, TSM and CPT groups were compared between the groups. Four weeks following treatment CSM group showed more significant changes in primary (CgH frequency) and secondary (CgH pain intensity, CgH disability, neck pain frequency, pain intensity, pain threshold, CFRT, NDI and QoL) than the TSM and CPT groups (p = 0.001). The same gradual improvement was seen in the CSM group when compared to TSM and CPT groups (p = 0.001) in the above variables at 8 weeks and 6 months follow-up. The reports of the current randomized clinical study found that CSM resulted in significantly better improvements in pain parameters (intensity, frequency and threshold) functional disability and quality of life in patients with CgH than thoracic spine manipulation and conventional physiotherapy. Clinical trial registration: CTRI/2020/06/026092 trial was registered prospectively on 24/06/2020.

Inflammatory and autoimmune diseases are now understood to be significantly influenced by the intricate interactions between the microbiome and host physiology. This review investigates the function of epigenetic dysregulation in microbiome–host interaction and its consequences for health and disease. Epigenetic modifications, including DNA methylation, histone modifications, and non-coding RNA-associated regulation, are key mechanisms that control gene expression without altering the underlying DNA sequence. Microbial metabolites and community composition alterations can cause disruptions in these epigenetic processes, resulting in dysregulated immune responses and the initiation of chronic inflammatory conditions. In particular, the diversity of gut microbiota alters host epigenetic patterns, affecting T cell differentiation, inflammatory modulation, and tissue homeostasis. Aberrant epigenetic modifications contribute to the pathogenesis of autoimmune diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) by promoting inflammation and autoimmunity. Similarly, gut microbiota dysbiosis has been implicated in the development and progression of inflammatory bowel disease (IBD). Identifying the reciprocal interaction between epigenetic alterations and microbiome dynamics provides unique insights into therapeutic options targeted at restoring microbial homeostasis to prevent disease progress. Consequently, understanding the intricacies of epigenetic dysregulation in microbiome–host interactions represents a significant sector in biomedical research and highlights the promise for precision medicine approaches in treating inflammatory and autoimmune diseases. The potential for microbiome-based therapies to affect host epigenetic landscapes requires additional research, paving the way for innovative therapeutic paradigms targeted at improving host resilience and restoring immunological balance. The purpose of this review is to synthesize current knowledge on how epigenetic dysregulation and microbiome–host interactions drive inflammatory and autoimmune diseases and to highlight emerging therapeutic opportunities.

Introduction Sudan’s already under-resourced health system has been strained by war, with over 10 million people displaced and 67% of hospitals rendered non-operational. The disruption has led to limited access to essential services. Children face both physical and psychological consequences. This study explores caregivers’ use of health services, observed behavioral changes in children, reports of sexual harassment, and alignment between caregiver experiences and facility data. Method This descriptive cross-sectional community-based study was conducted among internally displaced caregivers of children in four relatively safe states—Red Sea, Northern, Nahr Elnil, and Kassala—using questionnaires for both caregivers and health facility directors. A total of 437 caregivers and 12 facilities participated. A multistage sampling method was followed by convenience sampling at the community level. Data were analyzed using SPSS version 25 with descriptive and inferential statistics. Results The study included 437 caregivers, 86% of whom were women, with a mean age of 35.4 years (± 9.2 SD). The average age of the children involved in the study was 4.4 ± 4.2 years. Despite 91.8% of children under five having access to basic immunizations, 10% missed essential vaccines, with measles accounting for 50% of missed doses. Pneumonia and gastroenteritis were the most frequently reported illnesses. Psychosocial impacts were prevalent, with 26.8% of children exhibiting fearfulness, anxiety, or irritability. Health facilities findings revealed that 66.7% of facilities experienced disruptions in working hours. Only 25% of facilities had pediatric intensive care units. Key emergency resources, including oxygen therapy (81.8%) and insulin (90.9%), were available in most facilities. T availability of key support staff—such as psychologists and social workers—was notably limited (16.7%). Conclusion Overall, the study’s findings are in partial agreement with other conflict-region research, notably on disease burden, psychosocial impact, and health system degradation. However, Sudan’s context reveals some unique features. Despite extreme displacement, immunization outreach and breastfeeding practices showed higher-than-expected retention. Nevertheless, the weak critical care infrastructure, referral breakdowns, and mental health service gaps highlight urgent needs that require national and international collaboration.