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Hamostaseologie 2023; 43(01): 016-021
DOI: 10.1055/a-1985-7660
Review Article

Evidence-Based Medicine: Principles and Values as Illustrated by the Case of Patient Blood Management

Hans Van Remoortel
1   Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium
2   Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, KU Leuven, Leuven, Belgium
,
Emmy De Buck
1   Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium
2   Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, KU Leuven, Leuven, Belgium
,
Erhard Seifried
3   German Red Cross Blood Service BaWüHe, Frankfurt, Germany
4   Institute for Transfusion Medicine and Immunohematology, Goethe University, Frankfurt, Germany
,
Philippe Vandekerckhove
2   Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, KU Leuven, Leuven, Belgium
5   Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch Central, Stellenbosch, South Africa
6   Belgian Red Cross, Mechelen, Belgium
› Author Affiliations Funding/Acknowledgment This work was made possible through funding from the Foundation for Scientific Research of the Belgian Red Cross.
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Abstract

Evidence-based medicine is considered 1 of the 15 great inventions in medicine. It aims to remove bias in medical decision-making as much as possible through a rigorous process. In this article, the principles of evidence-based medicine are illustrated using the case of patient blood management (PBM). Acute or chronic bleeding, iron deficiency, and renal and oncological diseases may lead to preoperative anemia. To compensate for severe and life-threatening blood loss during surgery, doctors transfuse red blood cells (RBCs). PBM is an approach to take care of patients at risk for anemia, which includes detecting and treating anemia before surgery. Alternative interventions to treat preoperative anemia are the use of iron supplementation with or without erythro-stimulating agents (ESAs). The best available scientific evidence today indicates that preoperative intravenous (IV) or oral iron monotherapy may not be effective to reduce RBC utilization (low-certainty evidence). Preoperative IV iron supplementation in addition to ESAs is probably effective to reduce RBC utilization (moderate-certainty evidence), whereas oral iron supplementation in addition to ESAs may be effective to reduce RBC utilization (low-certainty evidence). The adverse events of preoperative oral/IV iron and/or ESAs and their impact on patient-important outcomes (morbidity, mortality, quality of life) remain unclear (very low-certainty evidence). Since PBM is a patient-centered approach, emphasis on monitoring and evaluation of patient-important outcomes in future research is urgently needed. Finally, the cost-effectiveness of preoperative oral/IV iron monotherapy is unproven, whereas preoperative oral/IV iron in addition to ESAs is extremely cost-ineffective.

Zusammenfassung

Die evidenzbasierte Medizin gilt als eine der 15 großen Entdeckungen in der Medizin. Hintergrund ist, medizinische Entscheidungen durch strenge und transparente Prozesse ohne „Bias“ treffen zu können. In dieser Arbeit werden die Prinzipien der evidenzbasierten Medizin am Beispiel des Patient Blood Management (PBM) beleuchtet.

Akute oder chronische Blutungen, Eisenmangel, Nieren- oder Krebserkrankungen können zu einer präoperativen Anämie führen. Um einen schweren und lebensbedrohlichen Blutverlust während Operationen auszugleichen, werden üblicherweise Erythrozyten durch die Gabe von Erythrozytenkonzentraten (RBCs) transfundiert. PBM ist ein Ansatz zur Behandlung von Patienten mit einem Risiko für Blutverlust und/oder Anämie, der die Diagnose und präoperative Anämiebehandlung miteinschließt. Alternative Maßnahmen neben der Transfusion von Erythrozytenkonzentraten, um eine präoperative Anämie zu behandeln, sind die Substitution von Eisen mit oder ohne Erythropoese-stimulierenden Substanzen (ESAs). Unter bestmöglichen wissenschaftlichen Evidenzkriterien zum jetzigen Zeitpunkt ist die präoperative intravenöse (i.v.) oder orale Eisenmonotherapie nicht geeignet, den Bedarf an Erythrozytentransfusionen zu senken. Dem entgegen ist die kombinierte i. v. Eisensubstitution mit ESAs wahrscheinlich geeignet, die Erythrozytentransfusionsrate zu reduzieren, währenddessen dies für die Gabe der oralen Eisensubstitution zusammen mit ESAs nur sein kann. Dabei ist unklar, inwiefern unerwünschte Wirkungen/Nebenwirkungen der präoperativen Gabe oralen oder i. v. Eisens und/oder die Gabe von ESAs sich auf die Behandlungsergebnisse der Patienten wie z. B. Mortalität, Morbidität, Lebensqualität auswirken. Da PBM eine personalisierte Vorgehensweise der Behandlung ist, ist zukünftig eine Gewichtung der Forschung auf Monitoring und Evaluation der für den einzelnen Patienten wichtigen Behandlungsergebnisse erforderlich. Von wesentlicher Bedeutung ist die wirtschaftliche Bewertung von PBM-Maßnahmen: Während der Kosten-Nutzen-Effekt der präoperativen Eisenmonotherapie (oral/i. v.) nicht belegt ist, ist auf Basis der Evidenz die präoperative orale/i. v. Eisengabe zusätzlich zu ESAs extrem unwirtschaftlich.

Keywords

evidence-based medicine - patient blood management - anemia - erythro-stimulating agents - iron supplementation

Schlüsselwörter

evidenzbasierte Medizin - Patient Blood Management - Anämie - Erythropoese-stimulierende Substanzen - Eisensupplementation


Publication History

Received: 14 October 2022

Accepted: 22 November 2022

Article published online:
20 February 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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