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The COLOFOL trial: study design and comparison of the study population with the source cancer population

INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial...

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Autores principales: Hansdotter Andersson, Pernilla, Wille-Jørgensen, Peer, Horváth-Puhó, Erzsébet, Petersen, Sune Høirup, Martling, Anna, Sørensen, Henrik Toft, Syk, Ingvar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734721/
https://www.ncbi.nlm.nih.gov/pubmed/26869813
http://dx.doi.org/10.2147/CLEP.S92661
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author Hansdotter Andersson, Pernilla
Wille-Jørgensen, Peer
Horváth-Puhó, Erzsébet
Petersen, Sune Høirup
Martling, Anna
Sørensen, Henrik Toft
Syk, Ingvar
author_facet Hansdotter Andersson, Pernilla
Wille-Jørgensen, Peer
Horváth-Puhó, Erzsébet
Petersen, Sune Høirup
Martling, Anna
Sørensen, Henrik Toft
Syk, Ingvar
author_sort Hansdotter Andersson, Pernilla
collection PubMed
description INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. RESULTS: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate). A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56%) were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized eligible patients. However, a difference was noted in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage and localization. The analyses will be stratified by these variables. Taken together, we conclude that our trial results will be robust and possible to extrapolate to the target population.
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spelling pubmed-47347212016-02-11 The COLOFOL trial: study design and comparison of the study population with the source cancer population Hansdotter Andersson, Pernilla Wille-Jørgensen, Peer Horváth-Puhó, Erzsébet Petersen, Sune Høirup Martling, Anna Sørensen, Henrik Toft Syk, Ingvar Clin Epidemiol Original Research INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. RESULTS: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate). A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56%) were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized eligible patients. However, a difference was noted in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage and localization. The analyses will be stratified by these variables. Taken together, we conclude that our trial results will be robust and possible to extrapolate to the target population. Dove Medical Press 2016-01-28 /pmc/articles/PMC4734721/ /pubmed/26869813 http://dx.doi.org/10.2147/CLEP.S92661 Text en © 2016 Hansdotter Andersson et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Hansdotter Andersson, Pernilla
Wille-Jørgensen, Peer
Horváth-Puhó, Erzsébet
Petersen, Sune Høirup
Martling, Anna
Sørensen, Henrik Toft
Syk, Ingvar
The COLOFOL trial: study design and comparison of the study population with the source cancer population
title The COLOFOL trial: study design and comparison of the study population with the source cancer population
title_full The COLOFOL trial: study design and comparison of the study population with the source cancer population
title_fullStr The COLOFOL trial: study design and comparison of the study population with the source cancer population
title_full_unstemmed The COLOFOL trial: study design and comparison of the study population with the source cancer population
title_short The COLOFOL trial: study design and comparison of the study population with the source cancer population
title_sort colofol trial: study design and comparison of the study population with the source cancer population
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734721/
https://www.ncbi.nlm.nih.gov/pubmed/26869813
http://dx.doi.org/10.2147/CLEP.S92661
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