Cost-effectiveness of stepwise provisional versus systematic dual stenting strategies in patients with distal bifurcation left main stem lesions: Economic analysis of the EBC MAIN trial

\ua9 2024 BMJ Publishing Group. All rights reserved.Background In patients with distal bifurcation left main stem lesions requiring intervention, the European Bifurcation Club Left Main Coronary Stent Study trial found a non-significant difference in major adverse cardiac events (MACEs, composite of all-cause death, non-fatal myocardial infarction and target lesion revascularisation) favouring the stepwise provisional strategy, compared with the systematic dual stenting. Aims To estimate the 1-year cost-effectiveness of stepwise provisional versus systematic dual stenting strategies. Methods Costs in France and the UK, and MACE were calculated in both groups to estimate the incremental cost-effectiveness ratio (ICER). Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the healthcare provider with a time horizon of 1 year. Results The cost difference between the two groups was €-755 (€5700 in the stepwise provisional group and €6455 in the systematic dual stenting group, p value<0.01) in France and €-647 (€6728 and €7375, respectively, p value=0.08) in the UK. The point estimates for the ICERs found that stepwise provisional strategy was cost saving and improved outcomes with a probabilistic sensitivity analysis confirming dominance with an 80% probability. Conclusion The stepwise provisional strategy at 1 year is dominant compared with the systematic dual stenting strategy on both economic and clinical outcomes

Does intraoperative neuromonitoring of recurrent nerves have an impact on the postoperative palsy rate? Results of a prospective multicenter study

BACKGROUND: The impact of intraoperative neuromonitoring on recurrent laryngeal nerve palsy remains debated. Our aim was to evaluate the potential protective effect of intraoperative neuromonitoring on recurrent laryngeal nerve during total thyroidectomy. METHODS: This was a prospective, multicenter French national study. The use of intraoperative neuromonitoring was left at the surgeons\u27 choice. Postoperative laryngoscopy was performed systematically at day 1 to 2 after operation and at 6 months in case of postoperative recurrent laryngeal nerve palsy. Univariate and multivariate analyses and propensity score (sensitivity analysis) were performed to compare recurrent laryngeal nerve palsy rates between patients operated with or without intraoperative neuromonitoring. RESULTS: Among 1,328 patients included (females 79.9%, median age 51.2 years, median body mass index 25.6 kg/m), 807 (60.8%) underwent intraoperative neuromonitoring. Postoperative abnormal vocal cord mobility was diagnosed in 131 patients (9.92%), including 69 (8.6%) and 62 (12.1%) in the intraoperative neuromonitoring and nonintraoperative neuromonitoring groups, respectively. Intraoperative neuromonitoring was associated with a lesser rate of recurrent laryngeal nerve palsy in univariate analysis (odds ratio = 0.68, 95% confidence interval, 0.47; 0.98, P = .04) but not in multivariate analysis (oddsratio = 0.74, 95% confidence interval, 0.47; 1.17, P = .19), or when using a propensity score (odds ratio = 0.76, 95% confidence interval, 0.53; 1.07, P = .11). There was no difference in the rates of definitive recurrent laryngeal nerve palsy (0.8% and 1.3% in intraoperative neuromonitoring and non-intraoperative neuromonitoring groups respectively, P = .39). The sensitivity, specificity, and positive and negative predictive values of intraoperative neuromonitoring for detecting abnormal postoperative vocal cord mobility were 29%, 98%, 61%, and 94%, respectively. CONCLUSION: The use of intraoperative neuromonitoring does not decrease postoperative recurrent laryngeal nerve palsy rate. Due to its high specificity, however, intraoperative neuromonitoring is useful to predict normal vocal cord mobility. From the CHU de Nantes, Clinique de Chirurgie Digestive et Endocrinienne, Nantes, France; CHU Lille, Université de Lille, Chirurgie Générale et Endocrinienne, Lille, France; CHU Nancy-Hôpital de Brabois, Service de Chirurgie Digestive, Hépato-Biliaire, et Endocrinienne, Nancy, France; CHU Angers, Chirurgie Digestive et Endocrinienne, Angers, France; CHU de Toulouse-Hôpital Larrey, Chirurgie Thoracique, Pôle Voies Respiratoires, Toulouse; CHU Saint-Etienne-Hôpital Nord, ORL et Chirurgie Cervico-Faciale et Plastique, Saint-Etienne, France; CHU de Limoges-Hôpital Dupuytren, Chirurgie Digestive, Générale et Endocrinienne, Limoges, France; CHU de Besançon-Hôpital Jean Minjoz, Chirurgie Digestive, Besançon, France; Centre Hospitalier du Mans, Service ORL et Chirurgie Cervico-Faciale, Le Mans, France; Centre Hospitalier Lyon-Sud, Chirurgie Générale, Endocrinienne, Digestive et Thoracique, Pierre Bénite, France; AP-HM-Hôpital de La Conception, Chirurgie Générale, Marseille, France; CHU de Rennes-Hôpital Pontchaillou, Service ORL et Chirurgie Maxillo-Faciale, Rennes, France; CHU de Caen, ORL et Chirurgie Cervico-Faciale, Caen, France; CHU d\u27Angers, ORL et Chirurgie Cervico-Faciale, Angers, France; CHU de Nantes, Service ORL, Nantes, France; AP HP URCEco île-de-France, hôpital de l\u27Hôtel-Dieu, Paris, France; DRCI, département Promotion, Nantes, France

Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French multi-center, prospective, controlled randomized trial (Start-In!)

AIM: To compare the efficacy of three strategies for real-time continuous glucose monitoring (RT-CGM) over 12 months in children and adolescents with type 1 diabetes. METHODS: A French multicenter trial (NCT00949221) with a randomized, controlled, prospective, open, and parallel-group design was conducted. After 3 months of RT-CGM, patients were allocated to one of three groups: return to self-monitoring of blood glucose, continuous CGM (80% of the time), or discontinuous CGM (40% of the time). The primary outcome was hemoglobin A1c (HbA1c) levels from 3 to 12 months. The secondary outcomes were acute metabolic events, hypoglycemia, satisfaction with CGM and cost. RESULTS: We included 151 subjects, aged 2 to 17 years, with a mean HbA1c level of 8.5% (SD0.7; 69 mmol/mol). The longitudinal change in HbA1c levels was similar in all three groups, at 3, 6, 9 and 12 months. The medical secondary endpoints did not differ between groups. The rate of severe hypoglycemia was significantly lower than that for the pretreatment year for the entire study population. Subjects reported consistent use and good tolerance of the device, regardless of age or insulin treatment. The use of full-time RT-CGM for 3 months costs the national medical insurance system €2629 per patient. CONCLUSION: None of the three long-term RT-CGM strategies evaluated in pediatric type 1 diabetes was superior to the others in terms of HbA1c levels. CGM-use for 3 months decreased rates of severe hypoglycemia. Our results confirm the feasibility of long-term RT-CGM-use and the need to improve educational support for patients and caregivers

Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial

Introduction: We assessed whether modest systemic cooling started within 6 hours of symptom onset improves functional outcome at three months in awake patients with acute ischaemic stroke. Patients and methods: In this European randomised open-label clinical trial with blinded outcome assessment, adult patients with acute ischaemic stroke were randomised to cooling to a target body temperature of 34.0–35.0°C, started within 6 h after stroke onset and maintained for 12 or 24 h , versus standard treatment. The primary outcome was the score on the modified Rankin Scale at 91 days, as analysed with ordinal logistic regression. Results: The trial was stopped after inclusion of 98 of the originally intended 1500 patients because of slow recruitment and cessation of funding. Forty-nine patients were randomised to hypothermia versus 49 to standard treatment. Four patients were lost to follow-up. Of patients randomised to hypothermia, 15 (31%) achieved the predefined cooling targets. The primary outcome did not differ between the groups (odds ratio for good outcome, 1.01; 95% confidence interval, 0.48–2.13; p = 0.97). The number of patients with one or more serious adverse events did not differ between groups (relative risk, 1.22; 95% confidence interval, 0.65–1.94; p = 0.52). Discussion: In this trial, cooling to a target of 34.0–35.0°C and maintaining this for 12 or 24 h was not feasible in the majority of patients. The final sample was underpowered to detect clinically relevant differences in outcomes. Conclusion: Before new trials are launched, the feasibility of cooling needs to be improved

Mapping research activity on mental health disorders in Europe: Study protocol for the Mapping_NCD project

© 2016 The Author(s). Background: Mental health disorders (MHDs) constitute a large and growing disease burden in Europe, although they typically receive less attention and research funding than other non-communicable diseases (NCDs). This study protocol describes a methodology for the mapping of MHD research in Europe as part of Mapping_NCD, a 2-year project funded by the European Commission which seeks to map European research funding and impact for five NCDs in order to identify potential gaps, overlaps, synergies and opportunities, and to develop evidence-based policies for future research. Methods: The project aims to develop a multi-focal view of the MHD research landscape across the 28 European Union Member States, plus Iceland, Norway and Switzerland, through a survey of European funding entities, analysis of research initiatives undertaken in the public, voluntary/not-for-profit and commercial sectors, and expert interviews to contextualize the gathered data. The impact of MHD research will be explored using bibliometric analyses of scientific publications, clinical guidelines and newspaper stories reporting on research initiatives. Finally, these research inputs and outputs will be considered in light of various metrics that have been proposed to inform priorities for the allocation of research funds, including burden of disease, treatment gaps and cost of illness. Discussion: Given the growing burden of MHDs, a clear and broad view of the current state of MHD research is needed to ensure that limited resources are directed to evidence-based priority areas. MHDs pose a particular challenge in mapping the research landscape due to their complex nature, high co-morbidity and varying diagnostic criteria. Undertaking such an effort across 31 countries is further challenged by differences in data collection, healthcare systems, reimbursement rates and clinical practices, as well as cultural and socioeconomic diversity. Using multiple methods to explore the spectrum of MHD research funding activity across Europe, this project aims to develop a broad, high-level perspective to inform priority setting for future research