High-quality evidence for incorporating new medical devi-ces, technology, and surgical techniques into public healthcare with safety, efficiency, and consideration for cost-effectiveness requires analysis [1]. Laparoscopic techniqueshave revolutionized surgery. Indeed, minimally invasiveapproaches that can dramatically improve a patient’s out-comes have been evolved rapidly over the past two decades.But how fast can new surgical techniques (e.g., laparo-scopic colectomy) be translated into a wide clinical usewhen evidence-based processes including comparative-effectiveness research (CER) have been completed? Thisquestion about laparoscopic colectomy in the United Statesis highlighted by Singla et al. [2] in the March issue ofSurgical Endoscopy.UsingtheNationwideInpatientSample(NIS,1998–2006),the authors identified a total of 209,769 patients whounderwent laparoscopic or open elective colon resection.The hospitals in which colectomies were performed weredivided according to hospital volume into equal thirds, withthe highest third defined as high volume and the lower two-thirds defined as low volume. The primary end point was theuse of laparoscopy after adjustment for patient and hospitalcovariates.Colorectal cancer, one of the major cancer types, sug-gests a major problem not only in the United States but alsoworldwide. Although Singla et al. [2] in their report do notprovide precise data on the benign or malignant type of thedisease, most colon resections are performed because ofcolon cancer. Over recent decades, open surgery has beenstandardized, including adequate resection of the primarytumor and regional lymph nodes, resulting in completeresection with no macroscopic or microscopic evidence ofresidual tumor (R0 resection).Is laparoscopic R0 colectomy feasible, safe, equallyeffective in terms of oncologic outcomes, and favorableregarding quality of life (QOL) compared with open sur-gery? In this evidence-based medicine era and U.S. healthreform, requirements and rules for approving new diag-nostic and therapeutic procedures have become moreintensive, with emphasis given to more robust evidence.In deciding whether to pay for new medical technologies,the Centers for Medicare and Medicaid Services (CMS) isbecoming more specific about its requirements for evidenceof improved health outcomes in the Medicare population[3]. A recent example involves the CMS decision not tocover computed tomographic (CT) colonography becauseof insufficient evidence for screening benefits [3].The heightened emphasis on evidence will almost cer-tainly continue as more people recognize that the oldapproach is unsustainable. The $1.1 billion for comparativeeffectiveness research (CER) included in the AmericanRecovery and Reinvestment Act underscores an emergingappreciation that we need better mechanisms for generatingrelevant evidence and for enabling patients, clinicians, andpayers to use that evidence in decision making [3–5]. Thebest tools of CER are thought to be randomized controlledtrials (RCTs) and metaanalysis [5].Under the rules and requirements set by the U.S. Foodand Drug Administration, CER, and CMS, what is thegrade of evidence supporting laparoscopic surgery for
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Mar 7, 2011
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Open Access