Introduction The purpose of this study was to pilot a new concept for device appraisal—leveraging international real-world data (RWD) from the International Consortium of Vascular Registries (ICVRs) to assess aggregate endovascular aortic repair (EVAR) performance against a conservative performance goal (PG) derived from open surgical repair (OSR), with the intention of helping refine device labelling in collaboration with industry and the US Food and Drug Administration.Research Design and Methods International retrospective, multicentre, single-arm cohort, open-label clinical PG-based study within the ICVRs. Because OSR patients may not have been anatomically EVAR-eligible, the OSR cohort used for PG derivation was restricted to smaller diameters (<6.5 cm men; <5.5 cm women) to include patients eligible for EVAR. Analyses performed at Weill Cornell Medicine (MDEpiNet Center).Results OSR PG cohort: 932 patients (72±9 years average; 83.8% men) with 30% in-hospital mortality. EVAR cohort: 219 patients (75±10 years average, 83.1% men) with larger aneurysms (EVAR 7.3±2.0 cm vs OSR 5.3±1.3 cm; p<0.001). In-hospital mortality after EVAR was 18% (upper 95% CI 13% to 23%), exceeding the PG (p<0.001). EVAR showed lower dialysis (10.6% vs 15.7%; p=0.02), bowel ischaemia (1.8% vs 7.5%; p<0.001) and reoperation for bleeding (2.7% vs 7.1%; p=0.004).Conclusions This proof-of-concept study shows harmonised international RWD can evaluate device performance in ruptured abdominal aortic aneurysm. Despite a comparator biased to favour OSR, EVAR met/exceeded the PG and reduced complications, supporting regulatory discussions to align instructions for use with guideline-endorsed EVAR-first strategies
This systematic review evaluates the impact, usability, technical performance and adherence of telemonitoring systems in adult cancer care. This systematic review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Peer Review of Electronic Search Strategies guideline. PubMed, MEDLINE and CINAHL were searched from June 2013 to March 2025. Search terms covered cancer care, telemonitoring systems, mobile health (mHealth), eHealth, health outcomes and evaluation tools. Included studies were randomised controlled trials, controlled clinical trials or prospective trials involving adult patients with cancer using telemonitoring systems for symptom management. Exclusion criteria included cross-sectional, retrospective or non-English studies. Two reviewers screened and extracted data, with a third reviewer resolving disagreements. Risk of bias was assessed using Cochrane Risk of Bias Tool V.1. Due to heterogeneity, a narrative synthesis was conducted, categorising studies by intervention type, clinical outcomes, adherence and usability. 16 studies were included. Telemonitoring appears to hold potential in oncology care, with indications of improved quality of life, symptom management and patient engagement, particularly when real-time clinician feedback is included. While mHealth apps were well received, asynchronous systems were associated with lower adherence. Few studies addressed data security or long-term outcomes. The search was aligned with European Union (EU) - assigned eHealth for Cancer Prevention & Care (eCAN Joint Action) priorities, which may have narrowed the results and limited the overall completeness of this systematic review. Telemonitoring shows promise in oncology care but requires personalisation, workflow integration and long-term evaluation. Real-time clinician support may enhance adherence and outcomes.PROSPERO registration numberCRD42023430639.
Objectives To perform the first-in-human concomitant robotic liver resection and cone-beam CT (CBCT)-guided ablation in a hybrid operating room (HARMONY). Design IDEAL stage 0/1 study outlining the preparatory steps and outcomes of the first-in-human HARMONY procedure. IDEAL stage 0 involved conceptualisation, team training and dry runs. The first HARMONY procedure was performed and the procedural technique is described in detail. Setting All procedures took place at a single academic medical centre. Participants Patients eligible for the HARMONY procedure are any adults eligible for combined ablation and resection of colorectal liver metastases. The HARMONY procedure was performed in a first patient. Outcomes of patients who underwent sequential robotic liver resection and CT hepatic arteriography-guided liver ablation in the preparatory phase are also reported. Intervention Concomitant robotic liver resection and CBCT-guided ablation in a hybrid operating room. Main outcome measures The primary outcome was technical feasibility of the HARMONY procedure defined as the technical success of both the robotic surgical resection and CBCT-guided ablation within the hybrid operating room. Results Between 2018 and 2024, 19 patients underwent sequential robotic liver resection and CT-guided ablation. Median interval between procedures was 4 days, with 36.8% treated during one admission. Intraoperative incidents occurred in three (15.8%) patients and two (10.5%) patients experienced severe complications requiring reintervention. The first-in-human HARMONY procedure was successfully completed without intraoperative complications. Conclusions The concomitant performance of robotic liver resection and CBCT-guided ablation is technically feasible in a hybrid operating room. Future studies should evaluate its reproducibility, safety and long-term outcomes. Trial registration number CCMO Research with human participants (NL-009169).
Objectives:This systematic review and meta-analysis evaluates the efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing seizure frequency in patients with epilepsy, synthesising evidence from randomised controlled trials (RCTs). Design:Systematic review and meta-analysis of RCTs conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020 guidelines. Setting:Literature search across international (PubMed, EMBASE, Cochrane, Scopus, ScienceDirect, Google Scholar) and Iranian (SID, Magiran, IranMedex) databases. Participants:Adult patients diagnosed with epilepsy, including those with drug-resistant focal epilepsy, from 14 included RCTs (total n=516). Interventions:Active low-frequency rTMS (0.3-1 Hz) compared with sham stimulation or active control (eg, antiepileptic drug therapy). Main outcome measures:The primary outcome was the mean change in weekly seizure frequency analysed using standardised mean difference (SMD). Results:From 1952 retrieved records, 14 RCTs were reviewed and 8 were meta-analysed (n=367). The pooled analysis showed a statistically significant reduction in seizure frequency favouring rTMS (SMD=-0.46, 95% CI -0.57 to -0.34, p=0.001, Z=-7.67), with low heterogeneity (I²=0.1%). The combined mean seizures were 6.1 (intervention) versus 7.4 (control) per week. No significant publication bias was detected (Egger's test p=0.086). Conclusions:Low-frequency rTMS demonstrates a significant short-term reduction in seizure frequency. However, the clinical durability of this effect remains uncertain due to limited follow-up in existing trials. Definitive conclusions require larger, standardised RCTs with longer-term outcomes. Trial registration:No human participants included.
Objective To investigate whether preoperative inflammatory biomarkers have prognostic value in terms of postoperative surgical morbidity in stage I–III resectable colorectal cancer.Design Prospective observational cohort study.Setting This is a single centre study conducted at the general surgery department of Djilali Belkhenchir, formerly Birtraria, Hospital, in Algeria.Participants We enrolled patients with non-metastatic colorectal cancer who underwent initial curative resection from May 2022 to May 2025.Main outcome measure Preoperative inflammatory biomarkers such as neutrophil to lymphocyte ratio, platelets to lymphocyte ratio, monocyte to lymphocyte ratio and lymphocyte×albumin (LA) were calculated based on blood samples taken 30 days prior to surgery. The primary outcome was postoperative morbidity and the secondary outcome was postoperative mortality.Results 230 patients met the inclusion criteria and had curative resection. Multivariable regression analysis showed that tumour size (OR 1.264, 95% CI 1.098 to 1.455, p<0.001), LA (OR 0.501, 95% CI 0.284 to 0.881, p=0.016) and rectal location (OR 2.569, 95% CI 1.138 to 5.798, p=0.023) were independent factors associated with postoperative complications.Conclusion The LA score, tumour size and tumour location were associated with post-operative morbidity in patients with stage I–III resectable colorectal cancer.
