Medically unexplained physical symptoms in patients visiting the emergency department : an international multicentre retrospective study

Objective The objective of this study was to assess the incidence and characteristics of patients presenting with physical symptoms that remain medically unexplained at the emergency department (ED). Patients and methods A retrospective chart study was carried out in three hospitals in The Netherlands and Belgium. All patients (age > 18 years) visiting the ED in 4 selected weeks in 2013 at the Erasmus University Medical Center (Erasmus MC) in Rotterdam, The Netherlands, and 1 selected week in 2013 at the Haaglanden Medical Center, Westeinde HMC in The Hague, The Netherlands, and the University Hospital Ghent (UZG), Belgium, were included. Descriptive statistics were used for data analysis. Results A total of 2869 patients (Erasmus MC 1674, HMC 691, UZG 504) were included. Medically unexplained physical symptoms in the emergency department (EDMUPS) were present in 13.4% of all ED visits (Erasmus MC 12.5%, HMC 18.7%, UZG 9.1%). No EDMUPS were identified in trauma patients. When excluding trauma patients, EDMUPS were present in 18.5% (Erasmus MC 16.8%, HMC 26.5%, UZG 13.3%) of the visits. The characteristics of patients with and without EDMUPS differed significantly; patients with EDMUPS were more often younger, female, self-referred, frequent visitors, were prescribed less medication and more often had a psychiatric disease. Dutch and Belgian Hospital differed in the distribution of patients in triage categories and in the incidence of psychiatric illnesses. Conclusion Physical symptoms remain unexplained in a significant number of patients at the time of ED assessment. European Journal of Emergency Medicine 26: 249-254 Copyright (c) 2018 Wolters Kluwer Health, Inc. All rights reserved

Where is the pilot?: the changing shapes of governance in the European hospital sector

Hospital governance refers to the complex of checks and balances that determine how decisions are made within the top structures of hospitals. This article explores the essentials of the concept by analysing the root notion of governance and comparing it with applications in other sectors. Recent developments that put pressure on the decision-making system within hospitals are outlined. Examples from the UK, France and the Netherlands are presented. Based on an evaluation of the current state of affairs, a research framework is developed, focusing on the determinants of governance configurations within the national healthcare systems and the wider legal and socio-economic context, as well as on the impact of governance configurations on the efficiency of the governing bodies and overall hospital performance. The article concludes with a preview of the European Hospital Governance Project, which follows the outlines of the described research framework. New techniques of data mining that are used in this project are explained by means of a real data example

Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF). a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Background: Direct-acting oral anticoagulant use for stroke prevention in atrial fibrillation is limited by bleeding concerns. Asundexian, a novel, oral small molecule activated coagulation factor XIa (FXIa) inhibitor, might reduce thrombosis with minimal effect on haemostasis. We aimed to determine the optimal dose of asundexian and to compare the incidence of bleeding with that of apixaban in patients with atrial fibrillation. Methods: In this randomised, double-blind, phase 2 dose-finding study, we compared asundexian 20 mg or 50 mg once daily with apixaban 5 mg twice daily in patients aged 45 years or older with atrial fibrillation, a CHA2DS2-VASc score of at least 2 if male or at least 3 if female, and increased bleeding risk. The study was conducted at 93 sites in 14 countries, including 12 European countries, Canada, and Japan. Participants were randomly assigned (1:1:1) to a treatment group using an interactive web response system, with randomisation stratified by whether patients were receiving a direct-acting oral anticoagulant before the study start. Masking was achieved using a double-dummy design, with participants receiving both the assigned treatment and a placebo that resembled the non-assigned treatment. The primary endpoint was the composite of major or clinically relevant non-major bleeding according to International Society on Thrombosis and Haemostasis criteria, assessed in all patients who took at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT04218266, and EudraCT, 2019-002365-35. Findings: Between Jan 30, 2020, and June 21, 2021, 862 patients were enrolled. 755 patients were randomly assigned to treatment. Two patients (assigned to asundexian 20 mg) never took any study medication, resulting in 753 patients being included in the analysis (249 received asundexian 20 mg, 254 received asundexian 50 g, and 250 received apixaban). The mean age of participants was 73·7 years (SD 8·3), 309 (41%) were women, 216 (29%) had chronic kidney disease, and mean CHA2DS2-VASc score was 3·9 (1·3). Asundexian 20 mg resulted in 81% inhibition of FXIa activity at trough concentrations and 90% inhibition at peak concentrations; asundexian 50 mg resulted in 92% inhibition at trough concentrations and 94% inhibition at peak concentrations. Ratios of incidence proportions for the primary endpoint were 0·50 (90% CI 0·14–1·68) for asundexian 20 mg (three events), 0·16 (0·01–0·99) for asundexian 50 mg (one event), and 0·33 (0·09–0·97) for pooled asundexian (four events) versus apixaban (six events). The rate of any adverse event occurring was similar in the three treatment groups: 118 (47%) with asundexian 20 mg, 120 (47%) with asundexian 50 mg, and 122 (49%) with apixaban. Interpretation: The FXIa inhibitor asundexian at doses of 20 mg and 50 mg once daily resulted in lower rates of bleeding compared with standard dosing of apixaban, with near-complete in-vivo FXIa inhibition, in patients with atrial fibrillation. Funding: Bayer