Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM): Rationale for Study Design

Jason A. Dominitz, Douglas J. Robertson, Dennis J. Ahnen, James E. Allison, Margaret Antonelli, Kathy D. Boardman, Maria Ciarleglio, Barbara J. Del Curto, Grant D. Huang, Thomas F. Imperiale, Meaghan F. Larson, David Lieberman, Theresa O'Connor, Timothy J. O'Leary, Peter Peduzzi, Dawn Provenzale, Aasma Shaukat, Shahnaz Sultan, Amy Voorhees, Robert Wallace & 1 others Peter D. Guarino

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Rationale:Colorectal cancer (CRC) is preventable through screening, with colonoscopy and fecal occult blood testing comprising the two most commonly used screening tests. Given the differences in complexity, risk, and cost, it is important to understand these tests' comparative effectiveness.Study design:The CONFIRM Study is a large, pragmatic, multicenter, randomized, parallel group trial to compare screening with colonoscopy vs. the annual fecal immunochemical test (FIT) in 50,000 average risk individuals. CONFIRM examines whether screening colonoscopy will be superior to a FIT-based screening program in the prevention of CRC mortality measured over 10 years. Eligible individuals 50-75 years of age and due for CRC screening are recruited from 46 Veterans Affairs (VA) medical centers. Participants are randomized to either colonoscopy or annual FIT. Results of colonoscopy are managed as per usual care and study participants are assessed for complications. Participants testing FIT positive are referred for colonoscopy. Participants are surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC. The primary endpoint is CRC mortality. The secondary endpoints are (1) CRC incidence (2) complications of screening colonoscopy, and (3) the association between colonoscopists' characteristics and neoplasia detection, complications and post-colonoscopy CRC. CONFIRM leverages several key characteristics of the VA's integrated healthcare system, including a shared medical record with national databases, electronic CRC screening reminders, and a robust national research infrastructure with experience in conducting large-scale clinical trials. When completed, CONFIRM will be the largest intervention trial conducted within the VA (ClinicalTrials.gov identifier: NCT01239082).

Original languageEnglish (US)
Pages (from-to)1736-1746
Number of pages11
JournalAmerican Journal of Gastroenterology
Volume112
Issue number11
DOIs
StatePublished - Nov 1 2017

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Colonoscopy
Colorectal Neoplasms
Mortality
Veterans
Early Detection of Cancer
Occult Blood
Medical Records
Clinical Trials
Databases
Delivery of Health Care
Costs and Cost Analysis
Incidence
Research

Cite this

Dominitz, J. A., Robertson, D. J., Ahnen, D. J., Allison, J. E., Antonelli, M., Boardman, K. D., ... Guarino, P. D. (2017). Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM): Rationale for Study Design. American Journal of Gastroenterology, 112(11), 1736-1746. https://doi.org/10.1038/ajg.2017.286

Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) : Rationale for Study Design. / Dominitz, Jason A.; Robertson, Douglas J.; Ahnen, Dennis J.; Allison, James E.; Antonelli, Margaret; Boardman, Kathy D.; Ciarleglio, Maria; Del Curto, Barbara J.; Huang, Grant D.; Imperiale, Thomas F.; Larson, Meaghan F.; Lieberman, David; O'Connor, Theresa; O'Leary, Timothy J.; Peduzzi, Peter; Provenzale, Dawn; Shaukat, Aasma; Sultan, Shahnaz; Voorhees, Amy; Wallace, Robert; Guarino, Peter D.

In: American Journal of Gastroenterology, Vol. 112, No. 11, 01.11.2017, p. 1736-1746.

Research output: Contribution to journalArticle

Dominitz, JA, Robertson, DJ, Ahnen, DJ, Allison, JE, Antonelli, M, Boardman, KD, Ciarleglio, M, Del Curto, BJ, Huang, GD, Imperiale, TF, Larson, MF, Lieberman, D, O'Connor, T, O'Leary, TJ, Peduzzi, P, Provenzale, D, Shaukat, A, Sultan, S, Voorhees, A, Wallace, R & Guarino, PD 2017, 'Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM): Rationale for Study Design' American Journal of Gastroenterology, vol. 112, no. 11, pp. 1736-1746. https://doi.org/10.1038/ajg.2017.286
Dominitz, Jason A. ; Robertson, Douglas J. ; Ahnen, Dennis J. ; Allison, James E. ; Antonelli, Margaret ; Boardman, Kathy D. ; Ciarleglio, Maria ; Del Curto, Barbara J. ; Huang, Grant D. ; Imperiale, Thomas F. ; Larson, Meaghan F. ; Lieberman, David ; O'Connor, Theresa ; O'Leary, Timothy J. ; Peduzzi, Peter ; Provenzale, Dawn ; Shaukat, Aasma ; Sultan, Shahnaz ; Voorhees, Amy ; Wallace, Robert ; Guarino, Peter D. / Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) : Rationale for Study Design. In: American Journal of Gastroenterology. 2017 ; Vol. 112, No. 11. pp. 1736-1746.
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