Challenges in evaluating surgical innovation.
Challenges in evaluating surgical innovation.
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DOI：
10.1016/s0140-6736(09)61086-2
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发表时间：
2009-09-26
期刊：
影响因子：
168.9
通讯作者：
Seiler, Christoph M.
中科院分区：
文献类型：
--
作者：
Ergina, Patrick L.;Cook, Jonathan A.;Blazeby, Jane M.;Boutron, Isabelle;Clavien, Pierre-Alain;Reeves, Barnaby C.;Seiler, Christoph M.
手术干预的研究与几个方法和实际的挑战，其中很少，如果有的话，只适用于手术。然而，手术评估是特别苛刻的，因为这些挑战中有许多是一致的。在这篇关于手术创新和评估的三篇报告中的第二篇，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。我们还描述了与外科手术的性质相关的问题，例如，它们的复杂性，外科医生相关因素和结果的范围。虽然困难，手术评估是可以实现的和必要的。为外科研究量身定制的解决方案和用于生成外科实践基础证据的框架至关重要。
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.