Retrospective Cohort Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 21, 2017; 23(3): 464-471
Published online Jan 21, 2017. doi: 10.3748/wjg.v23.i3.464
Multitarget stool DNA tests increases colorectal cancer screening among previously noncompliant Medicare patients
Mark Prince, Lynn Lester, Rupal Chiniwala, Barry Berger
Mark Prince, USMD Health System, Arlington, TX 76017, United States
Lynn Lester, USMD Health System, Fort Worth, TX 76104, United States
Rupal Chiniwala, USMD Health System, Irving Texas, TX 75039, United States
Barry Berger, Exact Sciences Corporation, Madison, WI 53729, United States
Author contributions: Prince M, Lester L and Berger B contributed to study concept and design; Prince M, Lester L, Chiniwala R and Berger B contributed to data acquisition; Prince M and Berger B contributed to analysis, interpretation and manuscript drafting and revision; Prince M, Lester L, Chiniwala R and Berger B contributed to critical revision for intellectual content; Prince M and Berger B contributed to statistical analysis; Prince M and Lester L contributed to clinical study supervision and clinical data acquisition; Berger B contributed to laboratory data acquisition and histopathologic report analysis.
Institutional review board statement: This cohort study was performed under the peer-reviewed quality assurance guidelines involving only retrospective records review by the medical institutions involved in the care of patients and was waived for IRB review.
Conflict-of-interest statement: Mark Prince, Lynn Lester, and Rupal Chiniwala have no conflict of interest related to the manuscript. Barry Berger is an employee and owns stock in Exact Sciences Corporation.
Data sharing statement: De-identified medical records have been archived for review at USMD by Mark Prince, MD, MBA, AGAF Director of Gastroenterology USMD Health System, 801 W Interstate 20, Ste 132, Arlington, TX 76017, United States.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Barry Berger, MD, Exact Sciences Corporation, 441 Charmany Drive, Madison, WI 53719, United States. bberger@exactsciences.com
Telephone: +1-617-2937738
Received: October 13, 2016
Peer-review started: October 14, 2016
First decision: November 21, 2016
Revised: December 10, 2016
Accepted: December 21, 2016
Article in press: December 21, 2016
Published online: January 21, 2017
Processing time: 93 Days and 4.1 Hours
Abstract
AIM

To determine the uptake of noninvasive multitarget stool DNA (mt-sDNA) in a cohort of colorectal cancer (CRC) screening non-compliant average-risk Medicare patients.

METHODS

This cross sectional primary care office-based study examined mt-sDNA uptake in routine clinical practice among 393 colorectal cancer screening non-compliant Medicare patients ages 50-85 ordered by 77 physicians in a multispecialty group practice (USMD Physician Services, Dallas, TX) from October, 2014-September, 2015. Investigators performed a Health Insurance Portability and Accountability Act compliant retrospective review of electronic health records to identify mt-sDNA use in patients who were either > 10 years since last colonoscopy and/or > 1 year since last fecal occult blood test. Test positive patients were advised to get diagnostic colonoscopy and thereafter patients were characterized by the most clinically significant lesion documented on histopathology of biopsies or excisional tissue. Descriptive statistics were employed. Key outcome measures included mt-sDNA compliance and diagnostic colonoscopy compliance on positive cases.

RESULTS

Over 12 mo, 77 providers ordered 393 mt-sDNA studies with 347 completed (88.3% compliance). Patient mean age was 69.8 (50-85) and patients were 64% female. Mt-sDNA was negative in 85.3% (296/347) and positive in 14.7% (51/347). Follow-up colonoscopy was performed in 49 positive patients (96.1% colonoscopy compliance) with two patients lost to follow up. Index findings included: colon cancer (4/49, 8.2%), advanced adenomas (21/49, 42.9%), non-advanced adenomas (15/49, 30.6%), and negative results (9/49, 18.4%). The positive predictive value for advanced colorectal lesions was 51.0% and for any colorectal neoplasia was 81.6%. The mean age of patients with colorectal cancer was 70.3 and all CRC's were localized Stage I (2) and Stage II (2), three were located in the proximal colon and one was located in the distal colon.

CONCLUSION

Mt-sDNA provided medical benefit to screening noncompliant Medicare population. High compliance with mt-sDNA and subsequent follow-up diagnostic colonoscopy identified patients with clinically critical advanced colorectal neoplasia.

Keywords: Multitarget stool DNA; Advanced adenoma; Screening compliance; Colonoscopy; Colorectal cancer screening; Preventive

Core tip: The availability of multitarget stool DNA (mt-sDNA) colorectal cancer screening led to high screening compliance (88%) and diagnostic colonoscopy compliance on mt-sDNA positive cases (96%) in a cohort of previously screening non-compliant Medicare patients ages 50-85 years in a multi-specialty group practice setting.