Clinical validation of precision medicine protocols: the last mile is the longest
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EDITORIAL
Clinical validation of precision medicine protocols: the last mile is the longest Michael P. Casaer1* , Audrey De Jong2,3 and Anders Perner4 © 2020 Springer-Verlag GmbH Germany, part of Springer Nature
Advanced understanding of the complex pathophysiology of critical illness drives the development and optimization of sophisticated therapeutic protocols with the ambition to improve short- and long-term outcomes for every patient [1]. During the last decade, individualized, titrated, precision and/or target-driven approaches have proliferated [2]. Such strategies aim to replace or supplement more generic one-size-fits-all therapies or more simple clinical titration, through detailed measurements of markers of pathophysiological derangement followed by protocolized corrective or reactive interventions. While the development of such more individualized treatment strategies can be challenging, their final clinical validation may prove to be the ultimate hurdle [3–5]. The replacement of nutritional targets based on simple bodyweight-age-gender-calculations with individual measurements of energy expenditure and nitrogen losses was a promising strategy according to observational data. Yet, this sophisticated and dynamic approach to ICUnutrition did not improve functional outcomes when evaluated against standard care in the EAT-ICU trial [6]. In severely burned patients, thermo-dilution-based hemodynamic monitoring created the opportunity to dynamically titrate fluid resuscitation based on patients’ intrathoracic volumes and cardiac indices, rather than providing a fixed rate infusion calculated by body weight and total burned surface area [7]. Surprisingly, when tested in a randomized clinical trial (RCT) in 50 burned patients, the thermodilution-guided resuscitation increased the volume of crystalloids infused over the first
*Correspondence: [email protected] 1 Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000 Leuven, Belgium Full author information is available at the end of the article
24 h by more than 10 L without improving cardiac output parameters or vital functions. The authors reported more pronounced subcutaneous edema in the thermodilutiongroup without further details [7]. Both these trials demonstrate the importance of evaluating novel therapies in randomized clinical trials before broad implementation of a new strategy, even when they appear intuitively and pathophysiologically superior. From this perspective, it makes some sense that the “European guidelines on management of major bleeding and coagulopathy following trauma: 4th edition” formulated a recommendation graded 1C for the use of Viscoelastic Hemostatic Assay (VHA) guided correction of coagulopathy, while the more simple approach using Conventional Coagulation Tests (CCT) (prothrombin time, activated partial thromboplastin time, platelet counts and fibrinogen) received a 1A recommendation [8]. VHA offers many potential advantages a
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