Plenary
Chair: Kath Hayden
Clinical decision support system-based integration of plasma steroidomics with artificial intelligence: A blending of technologies for diagnostic stratification of primary aldosteronism
Graeme Eisenhofer,1 Georgiana Constantinescu,1 Manuel Schulze,2 Mirko Peitzsch,1 Hanna Remde,3 Lydia Kürzinger,3 Sven Gruber,4 Jun Yang,5 Andrea R Horvath,6 Tracy A Williams,7 Lisa Müller,7 Martin Reincke,7 Felix Beuschlein,4 Jacques W.M. Lenders,8 Christina Pamporaki.1
1University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; 2Center for Interdisciplinary Digital Sciences, Technische Universität Dresden, Germany; 3University Hospital, University of Würzburg, Germany; 4University Hospital Zurich, Zurich, Switzerland; 5Hudson Institute of Medical Research, Clayton, Victoria, Australia; 6New South Wales Health Pathology, Prince of Wales Hospital, Sydney, Australia; 7University Hospital, Ludwig Maximilian University Munich, Munich, Germany; 8Radboud University Medical Center, Nijmegen, the Netherlands.
With advances in clinical mass spectrometry (MS) that allow for simultaneous measurements of multiple analytes there is need for systems to facilitate interpretation of multidimensional data and conveyance to physicians in an easily digestible form. This can be achieved by a blending of laboratory and artificial intelligence (AI) technologies within a clinical decision support system (CDSS), which for laboratory medicine must satisfy not only regulatory requirements for in vitro diagnostics but also those for a CDSS as a medical device. For medical device regulation (MDR), the CDSS should not only provide valid support of clinical decisions, but should also be robust, efficient, cost-effective and safe for the designated task. In diagnostics, applications of AI usually involve supervised machine learning (ML) with algorithms for disease classification to generate mathematical models that are then applied to laboratory and other clinical data. MS-based steroidomics for diagnostic stratification of patients with primary aldosteronism is one area of laboratory medicine for which we have blended the various technologies within a CDSS to convey steroidomic data and ML model-derived interpretations to physicians. The CDSS has been applied in a prospective multicenter study (PROSALDO) of over 800 patients with hypertension recruited to validate previously established ML models developed for screening purposes and stratification of patients for therapeutic intervention. To satisfy MDR requirements, robustness of the CDSS has been tested by reproducibility of generated steroid probability scores within and between different laboratories. Effectiveness and efficiency of the CDSS has been established from steroid probability scores that for screening purposes compare favourably with conventional use of the aldosterone:renin ratio, but more importantly enable identification of a subset of patients as candidates for adrenalectomy. Such patients, with imaging evidence of a unilateral mass, may thereby escape need for confirmatory tests as well as expensive and invasive adrenal venous sampling studies. Minimized need for withdrawal of antihypertensive medications further supports MDR requirements for cost-effectiveness, efficiency and safety of the CDSS.