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Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial

BACKGROUND: Fecal occult blood testing has been offered for many years in the German health care 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...

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Autores principales: Gruner, Laura Fiona, Hoffmeister, Michael, Ludwig, Leopold, Brenner, Hermann
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7165303/
https://www.ncbi.nlm.nih.gov/pubmed/32242518
http://dx.doi.org/10.2196/16413
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author Gruner, Laura Fiona
Hoffmeister, Michael
Ludwig, Leopold
Brenner, Hermann
author_facet Gruner, Laura Fiona
Hoffmeister, Michael
Ludwig, Leopold
Brenner, Hermann
author_sort Gruner, Laura Fiona
collection PubMed
description BACKGROUND: Fecal occult blood testing has been offered for many years in the German health care 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 persons aged 50-54 years. METHODS: 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. RESULTS: 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. CONCLUSIONS: This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16413
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spelling pubmed-71653032020-04-28 Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial Gruner, Laura Fiona Hoffmeister, Michael Ludwig, Leopold Brenner, Hermann JMIR Res Protoc Protocol BACKGROUND: Fecal occult blood testing has been offered for many years in the German health care 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 persons aged 50-54 years. METHODS: 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. RESULTS: 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. CONCLUSIONS: This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16413 JMIR Publications 2020-04-03 /pmc/articles/PMC7165303/ /pubmed/32242518 http://dx.doi.org/10.2196/16413 Text en ©Laura Fiona Gruner, Michael Hoffmeister, Leopold Ludwig, Hermann Brenner. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.04.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Gruner, Laura Fiona
Hoffmeister, Michael
Ludwig, Leopold
Brenner, Hermann
Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
title Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
title_full Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
title_fullStr Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
title_full_unstemmed Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
title_short Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
title_sort effect of various invitation schemes on the use of fecal immunochemical tests for colorectal cancer screening: protocol for a randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7165303/
https://www.ncbi.nlm.nih.gov/pubmed/32242518
http://dx.doi.org/10.2196/16413
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