Zusammenfassung
Randomisierte kontrollierte Studien (RCT), die aufgrund eines vorteilsbedingten Therapieeffekts vorzeitig abgebrochen werden, nehmen einen immer größeren Stellenwert in der urologischen Literatur ein und genießen darüber hinaus oft eine große Beachtung in der Öffentlichkeit. Urologen, die eine evidenzbasierte Medizin praktizieren, sollten sich den potentiellen Biases von vorzeitig abgebrochenen RCT und den möglichen Auswirkungen auf die Ergebnisse bewusst sein. Dieses Review soll die verschiedenen Ursachen für einen vorzeitigen Studienabbruch und die damit einhergehende Problematik verdeutlichen.
Abstract
Randomized controlled trials (RCTs) stopped prematurely for beneficial therapy effects are becoming increasingly more prevalent in the urological literature and often receive great attention in the public and medical media. Urologists who practice evidence-based medicine should be aware of the potential bias and the different reasons why and how early termination of RCTs can and will affect the results. This review provides insights into the challenges clinical urologists face by interpreting the results of prematurely terminated RCTs.
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Literatur
Poldermans D, Boersma E, Bax JJ et al (1999) The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. N Engl J Med 341(24):1789–1794
Berghe G van den, Wouters P, Weekers F et al (2001) Intensive insulin therapy in critically ill patients. N Engl J Med 345(19):1359–1367
National Institute for Health and Clinical Excellence (2009) Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma. NICE technology appraisal. Guidance 169. NICE, London, http://guidance.nice.org.uk. Zugegriffen: June 2010
Attard G, Belldegrun AS, Bono JS de (2005) Selective blockade of androgenic steroid synthesis by novel lyase inhibitors as a therapeutic strategy for treating metastatic prostate cancer. BJU Int 96(9):1241–1246
Bono JS de, Logothetis CJ, Molina A et al (2011) Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 364(21):1995–2005
Montori V, Devereaux PJ, Schunemann H et al (2008) Randomized trials stopped early to benefit. In: Guyatt GH, Drummond R, Meade MO, Cook DJ (eds) Users‘ guides to the medical literature: a manual for evidence-based clinical practice, 2. edn. American Medical Association, New York, pp 153–165
Montori VM, Devereaux PJ, Adhikari NK et al (2005) Randomized trials stopped early for benefit: a systematic review. JAMA 294:2203–2209
Bassler D, Briel M, Montori VM et al (2010) Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and metaregression analysis. JAMA 303:1180–1187
Fleming TR, Harrington DP, O’Brien PC (1984) Designs for group sequential tests. Control Clin Trials 5(4):348–361
Guyatt G, Oxman AD, Akl EA et al (2011) GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 64(4):383–394
Canfield SE, Dahm P, Evidence-Based Urology Working Group (2010) Evidence-based urology in practice: incorporating patient values in evidence-based clinical decision making. BJU Int 105:4–5
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Dr. Luis A. Kluth und Dr. Michael Rink waren zu gleichen Teilen an der Manuskripterstellung beteiligt.
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Kluth, L., Rink, M., Ahyai, S. et al. Vorzeitiger Abbruch randomisierter kontrollierter Studien. Urologe 52, 1080–1083 (2013). https://doi.org/10.1007/s00120-013-3144-2
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DOI: https://doi.org/10.1007/s00120-013-3144-2