Gruner Laura Fiona, Hoffmeister Michael, Ludwig Leopold, Brenner Hermann
Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany.
Medical Faculty Heidelberg, University of Heidelberg, Heidelberg, Germany.
JMIR Res Protoc. 2020 Apr 3;9(4):e16413. doi: 10.2196/16413.
Fecal occult blood testing has been offered for many years in the German health care system, but participation rates have been notoriously low.
The aim of this study is to evaluate the effect of various personal invitation schemes on the use of fecal immunochemical tests (FITs) in persons aged 50-54 years.
This study consists of a three-armed randomized controlled trial: (1) arm A: an invitation letter from a health insurance plan including a FIT test kit, (2) arm B: an invitation letter from a health insurance plan including an offer to receive a free FIT test kit by mail upon easy-to-handle request (ie, by internet, fax, or reply mail), and (3) arm C: an information letter on an existing colonoscopy offer (ie, control). Within arms A and B, a random selection of 50% of the study population will receive reminder letters, the effects of which are to be evaluated in a substudy.
A total of 17,532 persons aged 50-54 years in a statutory health insurance plan in the southwest of Germany-AOK Baden-Wuerttemberg-were sent an initial invitation, and 5825 reminder letters were sent out. The primary end point is FIT usage within 1 year from receipt of invitation or information letter. The main secondary end points include gender-specific FIT usage within 1 year, rates of positive test results, rates of colonoscopies following a positive test result, and detection rates of advanced neoplasms. The study was launched in September 2017. Data collection and workup were completed in fall 2019.
This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system.
German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16413.
粪便潜血检测在德国医疗保健系统中已开展多年，但参与率一直极低。
本研究旨在评估各种个人邀请方案对50 - 54岁人群粪便免疫化学检测（FIT）使用情况的影响。
本研究为三臂随机对照试验：（1）A组：来自健康保险计划的邀请信，附带一个FIT检测试剂盒；（2）B组：来自健康保险计划的邀请信，包括可通过简便方式（即通过互联网、传真或回邮）申请免费邮寄FIT检测试剂盒的提议；（3）C组：关于现有结肠镜检查提议的信息信（即对照组）。在A组和B组中，随机选择50%的研究人群将收到提醒信，其效果将在一项子研究中进行评估。
德国西南部法定健康保险计划-AOK巴登-符腾堡州-中，共有17532名50 - 54岁的人收到了初始邀请，并发出了5825封提醒信。主要终点是从收到邀请信或信息信起1年内的FIT使用情况。主要次要终点包括1年内按性别划分的FIT使用情况、检测结果为阳性的比例、检测结果为阳性后进行结肠镜检查的比例以及晚期肿瘤的检出率。该研究于2017年9月启动。数据收集和整理于2019年秋季完成。
这项随机对照试验将为加强德国医疗保健系统中的结直肠癌筛查提供重要的实证依据。
德国临床试验注册中心（DRKS）DRKS00011858；https://bit.ly/2UBTIdt。
国际注册报告识别码（IRRID）：DERR1-10.2196/16413。
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