Kosmas I Paraskevas1, Gert J de Borst2, Frank J Veith3. 1. Department of Vascular and Endovascular Surgery, Royal Free Hospital, London, United Kingdom. Electronic address: paraskevask@hotmail.com. 2. Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The Netherlands. 3. Division of Vascular Surgery, New York University Langone Medical Center, New York, NY; Division of Vascular Surgery The Cleveland Clinic, Cleveland, Ohio.
Abstract
OBJECTIVE: Randomized controlled trials (RCTs) constitute level I evidence and are used as the backbone of guidelines and recommendations for treatment. Although RCTs are theoretically the studies of choice for the assessment of the effectiveness of health care interventions, these trials (and their interpretation) may sometimes result in erroneous conclusions, erroneous therapeutic decisions, and incorrect recommendations. We aimed to check the applicability of the results of RCTs to everyday practice. METHODS: We reviewed the literature for studies comparing the results of RCTs with observational or population-based studies in the field of vascular surgery, focusing on two specific topics: the results of carotid artery stenting vs carotid endarterectomy for the management of carotid artery stenosis; and the results of open surgical repair vs endovascular aneurysm repair for the management of ruptured abdominal aortic aneurysms. RESULTS: We found considerable discrepancy in the results of RCTs with real-life registries and observational studies in both topics. In the management of carotid artery stenosis, observational studies reported worse outcomes after carotid artery stenting compared with carotid endarterectomy. Regarding ruptured abdominal aortic aneurysms, population-based studies reported better results for endovascular aneurysm repair compared with open repair. In contrast, RCTs in both topics reported similar results for the two procedures. CONCLUSIONS: There is evidence that RCTs sometimes do not reflect clinical reality and are therefore potentially misleading to the reader. Every RCT has to be interpreted and applied carefully using complete available evidence and good clinical judgment.
OBJECTIVE: Randomized controlled trials (RCTs) constitute level I evidence and are used as the backbone of guidelines and recommendations for treatment. Although RCTs are theoretically the studies of choice for the assessment of the effectiveness of health care interventions, these trials (and their interpretation) may sometimes result in erroneous conclusions, erroneous therapeutic decisions, and incorrect recommendations. We aimed to check the applicability of the results of RCTs to everyday practice. METHODS: We reviewed the literature for studies comparing the results of RCTs with observational or population-based studies in the field of vascular surgery, focusing on two specific topics: the results of carotid artery stenting vs carotid endarterectomy for the management of carotid artery stenosis; and the results of open surgical repair vs endovascular aneurysm repair for the management of ruptured abdominal aortic aneurysms. RESULTS: We found considerable discrepancy in the results of RCTs with real-life registries and observational studies in both topics. In the management of carotid artery stenosis, observational studies reported worse outcomes after carotid artery stenting compared with carotid endarterectomy. Regarding ruptured abdominal aortic aneurysms, population-based studies reported better results for endovascular aneurysm repair compared with open repair. In contrast, RCTs in both topics reported similar results for the two procedures. CONCLUSIONS: There is evidence that RCTs sometimes do not reflect clinical reality and are therefore potentially misleading to the reader. Every RCT has to be interpreted and applied carefully using complete available evidence and good clinical judgment.
Authors: Christian Patry; Lukas D Sauer; Britta Höcker; Burkhard Tönshoff; Anja Sander; Kai Krupka; Alexander Fichtner; Jolanda Brezinski; Yvonne Geissbühler; Elodie Aubrun; Anna Grinienko; Luca Dello Strologo; Dieter Haffner; Jun Oh; Ryszard Grenda; Lars Pape; Rezan Topaloğlu; Lutz T Weber; Antonia Bouts; Jon Jin Kim; Agnieszka Prytula; Jens König; Mohan Shenoy Journal: Pediatr Nephrol Date: 2022-10-20 Impact factor: 3.651
Authors: Kosmas I Paraskevas; Dimitri P Mikhailidis; Hediyeh Baradaran; Alun H Davies; Hans-Henning Eckstein; Gianluca Faggioli; Jose Fernandes E Fernandes; Ajay Gupta; Mateja K Jezovnik; Stavros K Kakkos; Niki Katsiki; M Eline Kooi; Gaetano Lanza; Christos D Liapis; Ian M Loftus; Antoine Millon; Andrew N Nicolaides; Pavel Poredos; Rodolfo Pini; Jean-Baptiste Ricco; Tatjana Rundek; Luca Saba; Francesco Spinelli; Francesco Stilo; Sherif Sultan; Clark J Zeebregts; Seemant Chaturvedi Journal: J Stroke Date: 2021-05-31 Impact factor: 6.967