Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 26, 2019
Date Accepted: Nov 26, 2019
Effect of Various Invitation Schemes on Use of Fecal Immunochemical Tests (FITs) for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Fecal occult blood testing has been offered for many years in the German healthcare system, but participation rates have been notoriously low.
Objective:
The aim of this study is to evaluate the effect of various personal invitation schemes on the use of fecal immunochemical tests (FITs) in the 50-54 year-old population.
Methods:
Three-armed randomized controlled trial: (A) invitation letter from health insurance plan including FIT test kit; (B) invitation letter from health insurance plan including offer to receive free FIT test kit by mail upon easy-to-handle request (by internet, fax, or reply mail); (C) information letter on existing colonoscopy offer (control). Within Arms A and B random selection of 50% of study population to receive reminder letters, the effects of which are to be evaluated in a substudy.
Results:
17,532 persons aged 50-54 years in a statutory health insurance plan in the southwest of Germany (AOK Baden-Wuerttemberg) receive an initial invitation. Primary endpoint is FIT usage within one year from invitation or information letter. Main secondary endpoints include gender-specific FIT usage within one year, rates of positive test results, rates of colonoscopies following a positive test result, and detection rates of advanced neoplasms.
Conclusions:
This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German healthcare system. Clinical Trial: German Clinical Trials Register (DRKS) DRKS00011858, https://www.drks.de/drks_web/setLocale_EN.do
Citation
The author of this paper has made a PDF available, but requires the user to login, or create an account.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.