Hüttner F J, Ulrich A, Mihaljevic A L, Probst P, Rossion I, Diener Markus K
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2015 Mar;58(3):248-55. doi: 10.1007/s00103-014-2113-2.
The benefit assessment of surgical procedures serves as the basis for the concept of evidence-based surgery. However, especially in the field of surgery, many interventions are lacking assessment in high-quality clinical trials. Therefore, a well-structured benefit assessment of surgical interventions in the future is imperative. Considering the different perspectives, e.g. of the patients, surgeons, industry or health care investors, the implications of the benefits and risks of a procedure can differ significantly. Researchers have to abide by different regulations, depending on the type of intervention being evaluated in a surgical trial. Furthermore, the benefit assessment of surgical procedures poses specific challenges, from the choice of a relevant endpoint to issues concerning the standardization of the interventions and the impact of learning curves. The IDEAL concept, which was established by a group of international experts in 2009, serves as a framework for the future development and assessment of innovations in the field of surgery. For example, the SDGC (Study Center of the German Society of Surgery) and CHIR-Net (Surgical Studies Network) indicate that such collaborations of clinicians and methodologists can lead to the creation of a qualified structure for the effective benefit assessment of surgical procedures. In the future, the aforementioned evidence gaps must be eliminated and innovations evaluated efficiently by the work of such networks.
外科手术的效益评估是循证外科理念的基础。然而,特别是在外科领域,许多干预措施缺乏高质量临床试验的评估。因此,未来对外科手术干预进行结构完善的效益评估势在必行。考虑到不同的视角,例如患者、外科医生、行业或医疗保健投资者的视角,一项手术的效益和风险所带来的影响可能会有显著差异。根据外科试验中所评估干预措施的类型,研究人员必须遵守不同的规定。此外,外科手术的效益评估带来了特定的挑战,从相关终点的选择到干预措施标准化问题以及学习曲线的影响。由一群国际专家于2009年确立的IDEAL概念,为外科领域创新的未来发展和评估提供了一个框架。例如,德国外科学会研究中心(SDGC)和外科研究网络(CHIR-Net)表明,临床医生和方法学家之间的这种合作能够为外科手术的有效效益评估创建一个合格的结构。未来,上述证据缺口必须消除,并且通过此类网络的工作高效评估创新成果。