Ergina Patrick L, Cook Jonathan A, Blazeby Jane M, Boutron Isabelle, Clavien Pierre-Alain, Reeves Barnaby C, Seiler Christoph M, Altman Douglas G, Aronson Jeffrey K, Barkun Jeffrey S, Campbell W Bruce, Cook Jonathan A, Feldman Liane S, Flum David R, Glasziou Paul, Maddern Guy J, Marshall John C, McCulloch Peter, Nicholl Jon, Strasberg Steven 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
Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.
Lancet. 2009 Sep 26;374(9695):1097-104. doi: 10.1016/S0140-6736(09)61086-2.
Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.
手术干预研究面临若干方法学和实际操作方面的挑战，其中几乎没有（如果有的话）仅适用于外科手术的挑战。然而，手术评估的要求特别高，因为这些挑战中有许多同时出现。在本报告（关于手术创新与评估的三篇系列报告中的第二篇）中，我们讨论了与评估手术干预的随机对照试验和非随机研究的研究设计相关的障碍。我们还描述了与手术操作性质相关的问题，例如其复杂性、与外科医生相关的因素以及结果范围。尽管困难，但手术评估是可以实现且必要的。针对手术研究量身定制的解决方案以及生成用于指导手术实践的证据的框架至关重要。
