Department of Surgery, Cambridge Health Alliance, 1493 Cambridge Street, Cambridge, MA 02139, USA.
Surg Endosc. 2013 Aug;27(8):2673-7. doi: 10.1007/s00464-012-2504-0. Epub 2013 Jun 11.
The introduction of innovative techniques and novel technologies into clinical practice is a challenge that confronts all aspects of healthcare delivery. Upheaval from shrinking research funding and declining healthcare reimbursements now forces patients, doctors, hospitals, payers, regulators, and even health systems into conflict as new therapies struggle to find a place in the therapeutic armamentarium. The escalating costs of healthcare force all parties to consider both the medical risks/benefits as well as the economic efficiency of proposed tools and therapies. We highlight these challenges by examining the process of initiating and conducting a "society-as-investigator" clinical trial to assess the safety of the natural orifice translumenal endoscopic surgery (NOTES) approach to cholecystectomy in the context of the issues that confront technology diffusion today.
将创新技术和新技术引入临床实践是医疗保健服务各个方面面临的挑战。研究资金减少和医疗保健报销下降，迫使患者、医生、医院、支付方、监管机构甚至卫生系统陷入冲突，因为新疗法在治疗武器库中难以立足。医疗保健成本的不断上升迫使各方不仅考虑拟议工具和疗法的医疗风险/益处，还要考虑其经济效益。我们通过检查发起和进行“社会作为研究者”临床试验的过程来强调这些挑战，以评估在当今技术扩散所面临的问题背景下，自然腔道内镜手术（NOTES）方法用于胆囊切除术的安全性。
