The development of the Belgian paediatric clinical trial network.

Paediatric clinical trials are critical to ensure that medications prescribed to children are safe and effective. However, evidence-based dosing and labelling of such medications remain limited, and most clinical trials in paediatrics fail. Factors for lack of trial completion include performance at site level (limited patient recruitment, limited site staff experience and lack of infrastructure), the sponsor team (limited paediatric specific expertise in design, uncertainties on robustness of biomarkers or outcome variables) as well as regulatory and administrative burdens. As a result of the growing demand for site support, the Belgian Paediatric Clinical Research Network (BPCRN) established in 2009 has been relaunched in 2018 to improve paediatric clinical trials, with the support of innovative-medicines-initiative 2 (IMI2) pan-European network conect4children (c4c) and the transatlantic network I-ACT for Children (US).This paper highlights the formation of the BPCRN and the practical insights it offers for advancing paediatric clinical trials through national networks. A national network can improve trial quality, safety and efficiency, provide clinical research expertise, identify suitable sites, and help with troubleshooting of common trial issues. The BPCRN's centralized approach has advanced paediatric clinical trials by streamlining communication and standardizing trial conduct. Challenges and opportunities have arisen, including a relaunch in 2018, orphan medicine trials, and network sustainability. Collaboration between network activities, government support, site-level improvements, efficient communication, and interaction with industry are key to achieve lasting transformation in paediatric medicine research.

Performance of two new, automated chemiluminescence assay panels for anticardiolipin and anti-beta2-glycoprotein I antibodies in the laboratory diagnosis of the antiphospholipid syndrome.

INTRODUCTION: Anticardiolipin (aCL) and anti-ß2-glycoprotein I (aß2GPI) antibodies are two of the three laboratory criteria for antiphospholipid syndrome (APS). All assays for antiphospholipid antibodies (aPL), coagulation assays as well as ELISAs, show methodological shortcomings, which makes the search for better assays everlasting. The purpose of this study was to investigate the diagnostic performance of two new, fully automated systems (Zenit RA and HemosIL Acustar) applying chemiluminescent technology for aPL detection. METHODS: The study cohort consisted of a patient population presenting with thrombosis. In such patient population, the demonstration of aPL determines whether a patient has APS or not with implications for treatment. One hundred and twenty-four patients with thrombotic complications, of whom 26 were patients with definite APS, were integrated in this study. Besides, aPL titres were compared to the Sapporo standards. RESULTS: Results of both systems agreed well with ELISA and mutually. Analysis of the discrepant results between Zenit and Acustar finally led to one misclassification as APS. CONCLUSION: Diagnostic performances of both Zenit RA and HemosIL Acustar were comparable with odds ratios lower limits of CI of 5 for aß2 GPI IgG for Zenit and Acustar and 6 and 5 for aCl IgG on Zenit and Acustar, respectively. However, even with these new automated systems, titres differed largely between systems, especially for aß2 GPI IgG.

[The specialty of geriatrics and geriatric education. The origins and functions of a geriatric department in a general hospital]. / Bijdragen over het specialisme geriatrie en de opleiding tot geriater. Het ontstaan en functioneren van een GAAZ.

In 1973 a geriatric ward was set up as part of the general hospital Hoog-Laren (now part of 'Gooi-Noord'). Its function is the examination, observation and medical treatment of elderly patients showing disordered behaviour. In this article we describe the history, goals, organization and methods/activities of this geriatric ward. Experience taught us that disordered behaviour of elderly patients is not a matter of mental illness, but arises in general as result of a disturbance of the somato-psychic-social equilibrium. Before it is possible to start a specific treatment, we try to determine the nature and extent of the disturbance by examining all known aspects of the somato-psychic-social equilibrium in a multidisciplinary manner. Then a therapeutic plan is designed and a recommendation for the future is given. Recently the activities were extended to include policlinical screening of patients.