Institute for Research in Operative Medicine, Faculty of Medicine, Campus Cologne-Merheim, University of Witten/Herdecke, Ostmerheimer Str. 200, 51109, Cologne, Germany.
Surg Endosc. 2010 Jul;24(7):1594-615. doi: 10.1007/s00464-009-0818-3. Epub 2010 Jan 7.
Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness.
An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon.
The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given.
Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.
根据欧洲内镜外科学会（EAES）的授权，制定了内镜外科创新管理方法指南。本指南的主要重点是患者安全、疗效和有效性。
邀请国际专家小组制定评估和引入外科创新的建议。共识发展会议（CDC）于 2009 年 5 月采用名义群体流程（NGP）的方法举行。建议于 2009 年 6 月 18 日在捷克共和国布拉格举行的 EAES 年会上提出讨论并进一步提出意见。在专家之间进行进一步的 Delphi 流程后，最终达成了建议。
本指南涉及手术创新的开发和实施，分为五个部分：（1）创新定义，（2）临床前和（3）临床科学发展，（4）科学批准，（5）实施和监测。在本指南中，每个部分和几个步骤都有定义，并且在每个类别中都根据现有证据达成了一些建议。不同步骤的综合工作流程在算法中给出。此外，还介绍了用于估计效率的卫生技术评估（HTA）问题，然后是道德指令。
应将创新引入临床实践，以确保患者尽可能高的安全等级（nil nocere：不要伤害）。这些建议有助于实现这一目标，而不会阻止未来在外科和相关技术领域出现有前途的诊断和治疗创新。
