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CURRENT PARADIGMS OF CLINICAL RESEARCH IN SURGERY : Diovan

Posted by Surgery on Jul 11, 2008
From the late nineteenth century on, when William Stewart Halsted introduced the concept of surgery as a viable academic discipline, surgical research has been responsible for ongoing advancements in patient care (4,5). Since this time, the cornerstone of clinical research in surgery has been observation only (6,7). Observation begins with careful assessment of the results of one’s own outcomes in his or her patients and extends to the study that is currently the backbone of clinical research in surgery (8,9).
Observational studies have provided much valuable information advancing the cause of patient care.

However, overreliance on the results of these studies to the exclusion of applying more scientifically rigorous methods has also allowed ineffective and even harmful treatments to persist for many years. Barnes reviewed an extensive series of surgical procedures that were supported by published observational studies, but that were subsequently found to be ineffective and were abandoned (10: ). A modern example of a procedure widely supported by observational studies until subjected to rigorous scientific inquiry is the extracranial-intracranial bypass operation. This operation was shown in many different observational studies to reduce stroke risk over medical therapy for intracranial carotid disease (11,12: ). A subsequent randomized controlled trial showed it to be ineffective, and that bias in the observational studies had led to the wrong conclusion and subsequently the wrong therapy for many patients (13). The evolution of breast cancer therapy in the United States provides an example of how rigorous scientific inquiry can dramatically alter a previously accepted approach to surgical disease (14,15,16). Prospective randomized clinical trials have resulted in significant advances in the surgical management of carotid artery disease, adenocarcinoma of the colon, and many other diseases (17,18,19,20,21: ). Despite the dramatic impact of these studies on surgical care, the application of rigorous scientific inquiry to clinical questions in surgery remains the exception rather than the rule (22,23,24: ).

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