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, Peter D Guarino

Journal: The American journal of gastroenterology 2017;112(11):1736-1746

PMID: 29016565

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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).

Address: VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle, Washington, USA.; VA Medical Center, White River Junction, Vermont and Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.; VA Eastern Colorado Health Care System, Denver, Colorado, USA.; Division of Gastroenterology, Department of Medicine, University of California San Francisco, Kaiser Division of Research, San Francisco, California, USA.; Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, Connecticut, USA.; Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico, USA.; Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA.; Cooperative Studies Program Central Office, Office of Research and Development, Washington, DC, USA.; Center for Innovation, Health Services Research and Development, Richard L. Roudebush VA Medical Center and Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.; VA Puget Sound Health Care System, Seattle, Washington, USA.; Portland VA Health Care System, Portland, Oregon, USA.; Office of Research and Development Veterans Health Administration Washington DC and Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA.; VA Cooperative Studies Epidemiology Center-Durham and Duke University Medical Center, Durham, North Carolina, USA.; Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Healthcare System, Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis, Minnesota, USA.; White River Junction VA Medical Center, White River Junction, Vermont, USA.; Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT and the Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.

DOI: 10.1038/ajg.2017.286

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MeSH Terms: Aged, Carcinoma, Colonoscopy, Colorectal Neoplasms, Early Detection of Cancer, Feces, Female, Hemoglobins, Humans, Immunochemistry, Male, Middle Aged, Occult Blood, United States, United States Department of Veterans Affairs