Roberta Monardo, Sana Arif, Aparna Rege, Erin Simon, Leila Ledbetter, Arthur W Baker, Jason Stout, Manuela Carugati
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引用次数: 0
Abstract
Background: Although intravesical Bacillus Calmette-Guerin (BCG) immunotherapy usually exhibits a favorable safety profile, it can lead to the development of BCG infections, both localized and disseminated. Understanding of BCG infections following intravesical BCG immunotherapy is limited because of the lack of consensus definitions of BCG infections and limited post-instillation follow-up. We aim to perform a systematic review of the literature of BCG infections following intravesical BCG immunotherapy to elucidate the epidemiology, risk factors, and outcomes of BCG infections.
Methods: Systematic review of peer-reviewed published articles that describe the treatment of one or more persons with intravesical BCG and the occurrence of BCG infections among these patients. No temporal, geographic, or demographic limitations will be applied. Animal studies will be excluded. Gray literature, editorials, and comments will be excluded. Information sources will include the following databases: MEDLINE, Embase, and Web of Science. A search concept representing BCG and intravesical administration will be applied after validation against a set of pre-selected articles. Screening and data extraction will be performed in duplicate by two independent reviewers. Disagreements will be resolved by a third independent reviewer. The methodological quality of studies will be assessed using the Mixed Methods Appraisal Tool. A narrative synthesis of the extracted data will be provided in line with the guidance from the Centre for Reviews and Dissemination. The quality of evidence for all outcomes will be judged using the Grading of Recommendations Assessment, Development, and Evaluation working group methodology.
Discussion: The data generated by this review will assist clinicians in managing BCG-infected patients and inform future research efforts.
Systematic review registration: In accordance with international guidelines, our systematic review protocol was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) on February 26, 2024.
背景：虽然膀胱内卡介苗免疫治疗通常表现出良好的安全性，但它可能导致卡介苗感染的发展，包括局部和播散性感染。由于对卡介苗感染缺乏一致的定义和接种后随访有限，对卡介苗免疫治疗后卡介苗感染的了解有限。我们的目的是对膀胱内卡介苗免疫治疗后卡介苗感染的文献进行系统回顾，以阐明卡介苗感染的流行病学、危险因素和结果。方法：系统回顾同行评审发表的文章，这些文章描述了一个或多个膀胱内卡介苗患者的治疗以及这些患者中卡介苗感染的发生。没有时间、地理或人口限制。动物研究将被排除在外。灰色文献、社论和评论将被排除在外。信息来源将包括以下数据库：MEDLINE、Embase和Web of Science。在对一组预先选择的文章进行验证后，将应用代表BCG和体内给药的搜索概念。筛选和数据提取将由两名独立审查员执行，一式两份。分歧将由第三位独立审查员解决。研究的方法学质量将使用混合方法评估工具进行评估。将按照审查和传播中心的指导，对摘录的数据进行叙述综合。所有结果的证据质量将使用建议分级评估、发展和评估工作组的方法来判断。讨论：本综述产生的数据将有助于临床医生管理bcg感染患者，并为未来的研究工作提供信息。系统评价注册：根据国际指南，我们的系统评价方案已于2024年2月26日向国际前瞻性系统评价注册（PROSPERO）提交注册。
期刊介绍：
Systematic Reviews encompasses all aspects of the design, conduct and reporting of systematic reviews. The journal publishes high quality systematic review products including systematic review protocols, systematic reviews related to a very broad definition of health, rapid reviews, updates of already completed systematic reviews, and methods research related to the science of systematic reviews, such as decision modelling. At this time Systematic Reviews does not accept reviews of in vitro studies. The journal also aims to ensure that the results of all well-conducted systematic reviews are published, regardless of their outcome.
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