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 language | English (US) |
|---|---|
| Pages (from-to) | 1736-1746 |
| Number of pages | 11 |
| Journal | American Journal of Gastroenterology |
| Volume | 112 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 1 2017 |
Bibliographical note
Funding Information:1VA Puget Sound Health Care System and University of Washington School of Medicine , Seattle , Washington , USA ; 2VA Medical Center, White River Junction, Vermont and Geisel School of Medicine at Dartmouth , Hanover, New Hampshire , USA ; 3VA Eastern Colorado Health Care System , Denver, Colorado , USA ; 4Division of Gastroenterology, Department of Medicine, University of California San Francisco, Kaiser Division of Research, San Francisco , California , USA ; 5Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System , West Haven , Connecticut , USA ; 6Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque , New Mexico , USA ; 7Department of Biostatistics, Yale School of Public Health, New Haven , Connecticut , USA ; 8Cooperative Studies Program Central Office, Office of Research and Development , Washington , DC , USA ; 9Center 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 ; 10VA Puget Sound Health Care System , Seattle , Washington , USA ; 11Portland VA Health Care System , Portland , Oregon , USA ; 12Office of Research and Development Veterans Health Administration Washington DC and Department of Pathology, University of Maryland School of Medicine, Baltimore , Maryland , USA ; 13VA Cooperative Studies Epidemiology Center-Durham and Duke University Medical Center, Durham , North Carolina , USA ; 14Center 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 ; 15White River Junction VA Medical Center, White River Junction , Vermont , USA ; 16Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT and the Fred Hutchinson Cancer Research Center, Seattle , Washington , USA ; 17The first two authors shared equally in the writing of this manuscript and are co-first authors. 18The CONFIRM Study Group consists of the local site investigators who contributed to the refinement of the study design and led the enrollment of all study participants. See appendix A for the full listing of the CONFIRM Study Group . Correspondence: Jason A. Dominitz, MD, MHS, VA Puget Sound Health Care System, University of Washington School of Medicine , 1660S. Columbian Way (111-Gastro) , Seattle , Washington 98108 , USA . E-mail: [email protected] Received 9 May 2017 ; accepted 8 July 2017
Funding Information:
Guarantor of the article: Jason A. Dominitz, MD, MHS. Specific author contributions: (1) With respect to author contributions, all of the authors have approved the final version of the manuscript. The specific contributions are detailed below: Jason A. Dominitz: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Douglas J. Robertson: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Dennis J. Ahnen: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; James E. Allison: planning and conducting the study, interpreting data, and drafting the manuscript; Margaret Antonelli: planning and conducting the study, and drafting the manuscript; Kathy D. Boardman: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Maria Ciarleglio: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Barbara J. Del Curto: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Grant D. Huang: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Thomas F. Imperiale: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Meaghan F. Lar-son: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; David Lieberman: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Theresa O’Connor: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Timothy J. O’Leary: planning and conducting the study, interpreting data, and drafting the manuscript; Peter Peduzzi: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Dawn Provenzale: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Aasma Shaukat: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Shahnaz Sultan: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Amy Voorhees: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Robert Wallace: planning and conducting the study, collecting and interpreting data, and drafting the manuscript; Peter D. Guarino: planning and conducting the study, collecting and interpreting data, and drafting the manuscript. Financial support: This study is being funded by the Cooperative Studies Program, Department of Veterans Affairs, Off ice of Research and Development, Washington, DC. The Veterans Affairs Cooperative Studies Program is involved with the design and conduct of the study and the collection and management of study data. The Sponsor has reviewed and approved the manuscript, however, had no role in the decision to submit the manuscript for publication. Potential competing interests: Douglas J. Robertson: Medtronic, Scientific Advisory Board (Medtronic produces the PillCam Colon 2 system); Dennis J Ahnen: Data Monitoring Committee Member for Cancer Prevention Pharmaceuticals’ trial of sulindac and DFMO in FAP; Timothy J. O’Leary: i. GRAIL: Member of Population Health Study Scientific Advisory Board and ii. MioDx: Member of Scientific Advisory Board.
Funding Information:
Th is study is being funded by the Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development, Washington, DC. The views expressed in this article are those of the authors and do not necessarily represent the views of the U.S. Department of Veterans Affairs or U.S. Government.
Publisher Copyright:
© 2017 by the American College of Gastroenterology.
