Bhandari Pradeep, Subramaniam Sharmila, East James E
Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth, UK.
Translational Gastroenterology Unit, Experimental Medicine Division, Nuffield Department of Clinical Medicine and Oxford NIHR Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, UK.
Frontline Gastroenterol. 2019 Apr;10(2):155-159. doi: 10.1136/flgastro-2018-101074. Epub 2019 Feb 2.
Endoscopy has rapidly evolved from a diagnostic modality to a therapeutic tool with the advent of new technologies (medical devices or imaging) and techniques (types of procedures). Although the rapid advancement of technology is welcomed, this can pose its own problems if there is no robust system in place to assess the safety and efficacy of new endoscopic devices or practices or guide its use among clinicians prior to adoption. This is unlike the rigorous process that medical drugs need to go through from preclinical to clinical phases of development, often with controlled trials being conducted prior to integration of a new drug into clinical practice. In this review, we will identify the problems related to implementation of new technologies and techniques as well as propose solutions. We will outline the use of comparative effectiveness studies as a model for assessing new technologies and provide a structured pathway to support clinicians in their endeavour to introduce new devices or procedures in their clinical practice safely. We will also discuss the role of the British Society of Gastroenterology in risk stratifying new techniques and supporting clinicians in setting up national registries, training and business case development. This review will provide a framework for improving the quality and safety of our current practice of implementing new endoscopic technologies and techniques in the National Health Service.
随着新技术(医疗设备或成像技术)和技术(手术类型)的出现,内窥镜检查已迅速从一种诊断方式发展成为一种治疗工具。尽管技术的快速进步是值得欢迎的,但如果没有一个强大的系统来评估新的内窥镜设备或操作的安全性和有效性,或者在临床医生采用之前指导其使用,这可能会带来自身的问题。这与药物从临床前到临床开发阶段需要经历的严格过程不同,新药在整合到临床实践之前通常要进行对照试验。在这篇综述中,我们将识别与新技术和技术实施相关的问题,并提出解决方案。我们将概述使用比较有效性研究作为评估新技术的模型,并提供一个结构化的途径,以支持临床医生在临床实践中安全地引入新设备或手术。我们还将讨论英国胃肠病学会在对新技术进行风险分层以及支持临床医生建立国家登记处、培训和商业案例开发方面的作用。这篇综述将为提高我们目前在国民医疗服务体系中实施新的内窥镜技术和操作的质量和安全性提供一个框架。