Climbing the steps of the evidence-based medicine pyramid: highlights from Annals of Nuclear Medicine 2019

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REVIEW ARTICLE

Climbing the steps of the evidence-based medicine pyramid: highlights from Annals of Nuclear Medicine 2019 Fabrizia Gelardi 1,2

&

Margarita Kirienko 3

&

Martina Sollini 1,2

Received: 30 August 2020 / Accepted: 12 October 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract We aimed to provide an overview on research path in nuclear medicine climbing the steps of the Evidence-Based Medicine (EBM) pyramid using review of 14 subjectively selected papers out of 111 published in the Annals of Nuclear Medicine during January–December 2019. Following the structure of the EBM hierarchy, we chose at least one study for each step of the pyramid from the basis (pre-clinical research, expert opinion, case report and case series), to the middle (case-control and cohort studies, randomised controlled trials), towards the top (meta-analyses and systematic reviews). Additionally, we collected information on the promoter of each included study: investigator-initiated trials (IITs) vs industry-sponsored trials (ISTs). We found that preclinical studies are primarily focused on the development of novel molecular targets in cancer, with promising results. At the same time, clinical investigations deal with cardiological, neurological, infectious and oncological applications using both SPECT and PET modalities. Additionally, radionuclide therapy gained interest and is experiencing comprehensive clinical implementation. Our overview confirms the current central role of IITs as compared with ISTs. Challenges and future directions in Nuclear Medicine research are discussed. Keywords Evidence-based medicine . Study design . Investigator-initiated trials . Industry-sponsored trials . Nuclear medicine . Trials methodology

Introduction In 2016, the joined initiative between the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) and the Annals of Nuclear Medicine (ANM) [1] started, which has opened and promoted an inspiring and fruitful scientific collaboration between European and Japanese scientists, clinicians and researchers. Several review articles dealing with different topics in the field of the best imaging research have been published within this program [2–8].

This article is part of the Topical Collection on Miscellanea * Margarita Kirienko [email protected] 1

Humanitas University, Pieve Emanuele, Milan, Italy

2

Humanitas Clinical and Research Center – IRCCS, Rozzano, Milan, Italy

3

Nuclear Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133 Milan, Italy

The best research evidence together with clinical expertise and patient value defines the evidence-based medicine (EBM), one of the most important milestones that shaped modern medicine [9]. According to the principles of EBM, the scientific literature is stratified in hierarchy levels based on research methodology (Fig. 1). The EBM pyramid moves from pre-clinical research, expert opinion, case report and case series—on the basis—to case-control and cohort studies, randomised