TY - JOUR
T1 - Multitarget stool DNA test
T2 - clinical performance and impact on yield and quality of colonoscopy for colorectal cancer screening
AU - Johnson, David H.
AU - Kisiel, John B.
AU - Burger, Kelli N.
AU - Mahoney, Douglas W.
AU - Devens, Mary E.
AU - Ahlquist, David A.
AU - Sweetser, Seth
N1 - Publisher Copyright:
© 2017 The Authors
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Background and Aims Multitarget stool DNA (MT-sDNA) testing is now approved by the U.S. Food and Drug Administration for average-risk colorectal cancer screening. Trials leading to its approval used blinded colonoscopy as the reference standard. In the postapproval screen setting, the clinical performance and impact of MT-sDNA testing on unblinded colonoscopy has not been described. We measured the impact that knowledge of a positive MT-sDNA test result has on colonoscopy yield and quality. Methods The unblinded group comprised all patients with positive MT-sDNA results on screening from September 1, 2014 to September 30, 2015 at a single tertiary center. Off-label test patients were excluded. The blinded group included all MT-sDNA–positive participants in a preapproval screening study from the same center. Detailed colonoscopy findings and withdrawal times were recorded. Results There were 172 MT-sDNA–positive patients in the unblinded group and 72 in the blinded group. More total adenomatous/sessile serrated polyps (70% vs 53%, P =.013) and advanced neoplasms (28% vs 21%, P =.27) were detected in unblinded than in blinded groups. Median numbers of polyps detected were 2 (IQR, 1-4) and 1 (IQR, 0-2) in unblinded and blinded groups, respectively (P =.0007). Among polyps detected, flat or slightly raised lesions in the right side of the colon were proportionately more frequent with unblinded (40%) than with blinded examinations (9%) (P =.0017). Median withdrawal time was 19 minutes (IQR, 13-29) in the unblinded group compared with 13 minutes (IQR, 10-20) in the blinded group (P =.0001). Conclusions Knowledge of a positive MT-sDNA result appears to have a beneficial impact on the diagnostic yield and quality of subsequent colonoscopy.
AB - Background and Aims Multitarget stool DNA (MT-sDNA) testing is now approved by the U.S. Food and Drug Administration for average-risk colorectal cancer screening. Trials leading to its approval used blinded colonoscopy as the reference standard. In the postapproval screen setting, the clinical performance and impact of MT-sDNA testing on unblinded colonoscopy has not been described. We measured the impact that knowledge of a positive MT-sDNA test result has on colonoscopy yield and quality. Methods The unblinded group comprised all patients with positive MT-sDNA results on screening from September 1, 2014 to September 30, 2015 at a single tertiary center. Off-label test patients were excluded. The blinded group included all MT-sDNA–positive participants in a preapproval screening study from the same center. Detailed colonoscopy findings and withdrawal times were recorded. Results There were 172 MT-sDNA–positive patients in the unblinded group and 72 in the blinded group. More total adenomatous/sessile serrated polyps (70% vs 53%, P =.013) and advanced neoplasms (28% vs 21%, P =.27) were detected in unblinded than in blinded groups. Median numbers of polyps detected were 2 (IQR, 1-4) and 1 (IQR, 0-2) in unblinded and blinded groups, respectively (P =.0007). Among polyps detected, flat or slightly raised lesions in the right side of the colon were proportionately more frequent with unblinded (40%) than with blinded examinations (9%) (P =.0017). Median withdrawal time was 19 minutes (IQR, 13-29) in the unblinded group compared with 13 minutes (IQR, 10-20) in the blinded group (P =.0001). Conclusions Knowledge of a positive MT-sDNA result appears to have a beneficial impact on the diagnostic yield and quality of subsequent colonoscopy.
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U2 - 10.1016/j.gie.2016.11.012
DO - 10.1016/j.gie.2016.11.012
M3 - Article
C2 - 27884518
AN - SCOPUS:85008204235
SN - 0016-5107
VL - 85
SP - 657-665.e1
JO - Gastrointestinal endoscopy
JF - Gastrointestinal endoscopy
IS - 3
ER -