Scientific Societies Should Start Sponsoring Observational Studies
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EDITORIAL
Scientific Societies Should Start Sponsoring Observational Studies Philippe L. Pereira1 Thierry de Baere6,7
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Thomas Helmberger2 • Julien Taieb3 • Vale´rie Vilgrain4,5
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Received: 5 August 2020 / Accepted: 10 September 2020 Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020
In this editorial, we argue that scientific societies are in the ideal position to sponsor and conduct high-quality prospective observational studies and should actively take motions to realise this. Should randomised controlled trials (RCTs) be considered the gold standard of medical research? While it cannot be denied that their rigorous methods are essential to show a therapy’s inferiority, equality or superiority, interventional radiologists should not underestimate the value of other study designs when considering best practices. As the scientific discourse on evidence-based medicine has developed, so has the understanding that in the absence of well-designed randomised controlled research, observational study designs can offer evidence strong enough to inform clinical decisionmaking [1] as acknowledged in the Oxford Centre for Evidence Based Medicine [2]. In some situations, the randomisation of patients to multiple arms is unfeasible or unethical: rare diseases may not offer sufficient patient volumes for randomisation; the experimental drug may be the only available treatment option [3]. Considering the heterogeneous and dynamic field of interventional radiology, the very elaborate RCT design is not always able to keep up with new technological developments and clinical insights, which may reduce the usefulness of RCT results in the clinical reality. At the same time, interventional radiology needs large data sets and compelling evidence from paradigm shifting research, rather than small studies that result only in incremental improvements [4]. Observational studies can fill the void created by these practical limitations and address the low generalisability of RCTs—provided they are well-designed and controlled. To that end, observational studies should be designed with the same rigour as RCTs: with clear outcome measures, welldefined inclusion and exclusion criteria, and precise follow-up periods. The high risk of selection and attrition bias must be acknowledged and accounted for in study design and results must be interpreted carefully, as they cannot establish if results
& Philippe L. Pereira [email protected] 1
SLK-Kliniken Heilbronn GmbH, Zentrum fu¨r Radiologie, Minimal-Invasive Therapien und Nuklearmedizin, Am Gesundbrunnen 20-26, 74078 Heilbronn, Germany
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Institut fu¨r Radiologie, Neuroradiologie und minimal-invasive Therapie, Mu¨nchen Klinik Bogenhausen, Englschalkinger Str. 77, 81925 Munich, Germany
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Universite´ Paris Descartes, Sorbonne Paris-Cite´, Assistance Publique Hoˆpitaux de Paris, Service d’hepatogastroente´rologie et d’oncologie digestive, Hoˆpital Europe´en Georges Pompidou, 20 R
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