Repici Alessandro, Khalaf Kareem, Troncone Edoardo, Subramaniam Sharmila, Hassan Cesare, Bhandari Pradeep
Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy; Humanitas Clinical and Research Centre -IRCCS-, Endoscopy Unit, Rozzano, Italy.
Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy; Division of Gastroenterology, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Dig Liver Dis. 2024 Feb;56(2):322-329. doi: 10.1016/j.dld.2023.07.026. Epub 2023 Aug 7.
BACKGROUND/OBJECTIVE: Increasing infectious rate estimates and low microbiological surveillance affect safety of gastrointestinal endoscopy globally. Single use endoscopes and accessories have been claimed to improve safety, but there is lack of data on their indication and sustainability. We aimed to identify a series of best practice recommendations for the use of single use endoscopes and accessories using a modified Delphi.
METHODS/DESIGN: Consensus statements for the use of single use endoscopy and accessories were developed using a modified Delphi process, utilizing an international endoscopist expert panel of 62 experts from 33 nations. The main steps in the process were selecting the consensus group, conducting systematic literature reviews, developing statements, and anonymous voting on the statements until consensus was reached. High-risk patients were defined as those with multi-drug-resistant infections, immunosuppressive medication or chemotherapy, post-transplantation, or with severe neutropenia.
Of the 26 statements that were voted upon through two rounds, 17 statements reached consensus. Category 1: single use accessories (8 statements), related to defining recommendations for the use of single use accessories in all patient populations or high-risk patients. Category 2: clinical indication for single use endoscopes (9 statements), including indications to high-risk patients, protecting the endoscope apparatus and contamination measures in endoscopy units. Category 3: technical factors (4 statements), related to superior performance and technical specifications with the new innovation. Category 4: environmental issues (2 statements), concerning mechanisms that reduce the detrimental burden to the environment. Category 5: financial implications (3 statements), related to healthcare policies, cost neutrality and other financial associations of single use endoscopy.
This is the first international initiative in determining clinical indications for single use endoscopy and accessories. The study's findings should serve as a framework for future physicians to guide future research and aid the proper evidence-based indications for the implementation of single use endoscopes in clinical practice.
背景/目的：全球范围内，不断上升的感染率估计以及微生物监测的不足影响着胃肠内镜检查的安全性。一次性使用的内镜及附件据称可提高安全性，但关于其适应证及可持续性的数据却很匮乏。我们旨在通过改良德尔菲法确定一系列关于一次性使用内镜及附件使用的最佳实践建议。
方法/设计：使用改良德尔菲法，利用来自33个国家的62位内镜专家组成的国际专家小组，制定一次性使用内镜及附件使用的共识声明。该过程的主要步骤包括选择共识小组、进行系统的文献综述、制定声明以及对声明进行匿名投票，直至达成共识。高危患者被定义为患有多重耐药感染、接受免疫抑制药物治疗或化疗、移植后或患有严重中性粒细胞减少症的患者。
在两轮投票的26项声明中，17项声明达成了共识。类别1：一次性使用附件（8项声明），涉及为所有患者群体或高危患者使用一次性使用附件定义建议。类别2：一次性使用内镜的临床适应证（9项声明），包括对高危患者的适应证、保护内镜设备以及内镜检查单位的污染控制措施。类别3：技术因素（4项声明），与新技术的卓越性能和技术规格有关。类别4：环境问题（2项声明），涉及减少对环境有害负担的机制。类别5：财务影响（3项声明），与医疗政策、成本中性以及一次性使用内镜检查的其他财务关联有关。
这是确定一次性使用内镜及附件临床适应证的首个国际倡议。该研究结果应作为未来医生的框架，以指导未来的研究，并有助于在临床实践中为一次性使用内镜的实施提供适当的循证适应证。
