Barkun Jeffrey S, Aronson Jeffrey K, Feldman Liane S, Maddern Guy J, Strasberg Steven M, Altman Douglas G, Barkun Jeffrey S, Blazeby Jane M, Boutron Isabell C, Campbell W Bruce, Clavien Pierre-Alain, Cook Jonathan A, Ergina Patrick L, Flum David R, Glasziou Paul, Marshall John C, McCulloch Peter, Nicholl Jon, Reeves Bournaby C, Seiler Christoph M, Meakins Jonathan L, Ashby Deborah, Black Nick, Bunker John, Burton Martin, Campbell Marion, Chalkidou Kalipso, Chalmers Iain, de Leval Marc, Deeks Jon, Grant Adrian, Gray Muir, Greenhalgh Roger, Jenicek Milos, Kehoe Sean, Lilford Richard, Littlejohns Peter, Loke Yoon, Madhock Rajan, McPherson Kim, Rothwell Peter, Summerskill Bill, Taggart David, Tekkis Parris, Thompson Matthew, Treasure Tom, Trohler Ulrich, Vandenbroucke Jan
McGill University Health Centre, Montreal, QC, Canada.
Lancet. 2009 Sep 26;374(9695):1089-96. doi: 10.1016/S0140-6736(09)61083-7.
Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.
手术创新是外科实践的重要组成部分。由于与外科实践相关的特质，其评估很复杂，但却是必要的，这样手术创新的引入和采用才能基于循证原则，而非反复试验。还需要一个监管框架来保护患者免受任何新手术潜在危害的影响。在关于手术创新与评估的三篇系列论文中的第一篇里，我们提出一个五阶段范式来描述创新性手术程序的发展。
