Adherence

Studies have indicated that adherence with multi-target stool DNA (mt-sDNA) testing is high,1,2,7 even among previously non-adherenta patients.2 Up to 40% of patients using mt-sDNA have reported screening for the first time, and nearly 1 in 4 of these appear to be overdue to initiate screening by 10 years or more.3  Studies also suggest that adherence with a follow-up colonoscopy is high after a positive mt-sDNA result,3,4 and significantly higher than in those screened with fecal immunochemical (FIT) or guaiac fecal occult blood tests (FOBT).4 Modeling has suggested that at adherence rates of 65-70% or higher for mt-sDNA, deaths averted would be equal to or exceed those of colonoscopy.5


One-year adherence to mt-sDNA screening was 71.1-88.3% in studied populations (Medicare, one population previously non-adherent)1,2



96.1% of patients with a positive mt-sDNA result were adherent with follow-up colonoscopy (Medicare, previously non-adherent)2



84.9% of patients with a positive mt-sDNA result vs 42.6% of those with a positive FIT/FOBT result adhered to a follow-up colonoscopy within 6 months (average risk population)4


ADHERENCE TO mt-sDNA SCREENING IN A NATIONAL SAMPLE OF MEDICARE PATIENTS (N=368,494)1,b


Line graph showing cumulative adherence rate
  • Nearly three-quarters of the Medicare cohort beneficiaries adhered with an mt-sDNA order for CRC screening1
  • Cross-sectional adherence rates were similar across patient age group, Medicare coverage type, and patient gender1
  • Cumulative adherence rates increased more rapidly at 30 and 60 days, followed by more gradual increases at 90, and 180 days1

FOLLOW UP COLONOSCOPY RATES AFTER A POSITIVE STOOL TEST4,c

 

   Positive result
n (%)
6-month follow-up
colonoscopy rate
 mt-sDNA 322 (12.2%) 84.9%
FIT/FOBT 53 (18.7%) 42.6%
 P-value for
6mo follow-up

0.0002 
 

In this study of 5818 adults ages 50-75, adherence with a follow-up colonoscopy within 6 months after a positive mt-sDNA (84.9% ) was significantly higher compared with those with a positive FIT/FOBT (42.6%)4

CASE STUDY OF ADHERENCE WITH mt-sDNA SCREENING AND FOLLOW-UP DIAGNOSTIC COLONOSCOPY IN A LOCALIZED SAMPLE OF AVERAGE RISK, PREVIOUSLY NON-ADHERENTa MEDICARE PATIENTS (N=393)2,d

 

Compliance data pie charts

  • 88.3% of previously non-adherenta patients were compliant with mt-sDNA over 12 months2
  • 96.1% of patients with a positive mt-sDNA result were adherent with follow-up colonoscopy2
  • mt-sDNA had a PPV of 51.0% for any advanced colorectal neoplasiae and 81.6% for any colorectal neoplasia2

 

TOP REASONS FOR LACK OF FOLLOW-UP POST-POSITIVE FIT OR mt-sDNA6,f


 
  FIT
(n=164)
n (%)
 mt-sDNA
(n=92)
n (%)
 System Barriers:    
  • GI clinic referral
 48 (29.3) 11 (12.0)
  • COL not scheduled
5 (3.0) 17 (18.5)
 Provider level Barriers:    
  • Attributed to false positive
3 (1.8) 0 (0.0)
  • Failure to inform patient
0 (0.0) 7 (7.6)
  • Other reasons
39 (23.8) 1 (1.1)
  • Recent COL done
 24 (14.6) 1 (1.1)
  • Other health issues
8 (4.9) 11 (12.0)
 Patient Level Barriers:    
  • Patient refused (prior to order)
8 (4.9) 8 (8.7)
  • Patient refused (post order)
4 (2.5) 15 (16.3)
  • No show/cancellation
42 (25.6) 26 (28.3)

  • Even when screening occurs, there are further barriers to appropriate follow-up6
  • Only 46.7% of FIT positive and 71.5% of mt-sDNA positive patients underwent a follow-up colonoscopy within six months of a positive result6
  • After a positive screening test, barriers to follow-up care were reported on the patient, provider, and system levels6

Learn more about the full Indications/Contraindications for the mt-sDNA test.   Please see complete prescribing information for Cologuard in the Cologuard Clinician Brochure

References

Weiser E, Parks PD, Swartz RK, et al. Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening:  real-world data from a large cohort of older adults. J Med Screen. 2021;28(1):18-24.

 2 Prince M, Lester L, Chiniwala R, Berger B. Multitarget stool DNA tests increases colorectal cancer screening among previously noncompliant  Medicare patients. World J Gastroenterol.   2017;23(3):464-471.

Eckmann JD, Ebner DW, Bering J, et al. Multitarget stool DNA screening in clinical practice: High positive predictive value for colorectal neoplasia regardless of exposure to previous colonoscopy. Am J Gastroenterol. 2020;115(4):608-615.

Finney Rutten LJ, Jacobson DJ, Jenkins GD, et al. Colorectal cancer screening completion: An examination of differences by screening modality. Prev Med Rep. 2020 Sep 11;20:101202.

D’Andrea E, Ahnen DJ, Sussman DA, Najafzadeh M. Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality. Cancer Med.  2020;9(2):824-836.

Cooper GS, Grimes A, Werner J, et al. Barriers to follow-up colonoscopy after positive FIT or multitarget stool DNA testing. J Am Board Fam Med. 2021;34(1):61-69.

Miller-Wilson LA, Finney Rutten LJ, Van Thomme J, Ozbay, AB, Limburg PJ.  Cross‑sectional adherence with the multi‑target stool DNA test for colorectal cancer screening in a large, nationally insured cohort.  Int J of Colorectal Dis.  2021;s00384-021-03956-0.

Footnotes

Non-adherence with CRC screening recommendations was defined as >10 years since last colonoscopy and/or >1 year since last FOBT

Retrospective study of aggregate laboratory data as part of ongoing laboratory quality management processes and in compliance with the HIPAA. N=368,494. Age=65-85.

Population-based, retrospective study using the Rochester Epidemiology Project research medical records data linkage infrastructure. N=5,818. Age=50-75.

A retrospective, cross-sectional electronic health record-  based review of records based in a primary care office  was conducted from October 2014 until September  2015. 393 subjects were recruited. Age=50-85.

Advanced adenoma: colorectal adenoma or sessile serrated adenoma/polyp ≥1.0 cm in diameter, or adenoma with high-grade dysplasia or ≥25% villous component, of any size

Retrospective ambulatory EMR-based cohort study (n=631) in a large health care system in the Midwest evaluated the frequency of follow-up colonoscopy post-positive mt-sDNA or FIT and identified reasons for lack of colonoscopy follow-up (Jan 2016 – Jun 2018).

Last updated: 04/22/2023