The impact of multi-target stool DNA testing in clinical practice in the United States: A real-world evidence retrospective study

Abstract

Widely endorsed screening modalities for colorectal cancer (CRC) include structural visualization (e.g. colonoscopy) and stool-based tests including multitarget stool DNA (mt-sDNA), fecal immunochemical tests (FIT), or high-sensitivity guaiac-based fecal occult blood tests (gFOBT). However, CRC screenings are underutilized, hence understanding the screening utilization trends is important, particularly with respect to the newest guideline-endorsed option (mt-sDNA). The objective of this study was to assess patterns in overall CRC screenings following clinical availability of the mt-sDNA test among average-risk individuals in the Ascension Wisconsin healthcare system focusing primarily on individuals aged 50-75 years old. We also reported CRC screening behaviors among individuals < 50 and > 75 years old. Electronic medical records of individuals aged ≥ 40 years from 2015 to 2018 were reviewed to identify average-risk and screen-eligible members. For those with screening data available, we determined the proportion who were up-to-date with any United States Preventive Services Task Force (USPSTF) recommended screening strategy; the number of screening tests performed in the measurement year; and the distribution of screening modalities. Temporal trends were assessed using regression analysis, including subgroup analyses across age groups and screening modalities. A total of 172,045 unique patients aged ≥ 40 years were included, of which 115,708 individuals aged 50-75 years. When considering all individuals up-to-date and screened in the measurement year, overall adherence increased significantly over the 4-year study period, from 39,105 to 49,698 patients or 47 % to 59 % (p < 0.0001). The screening incidence between 2015 and 2018 increased from 19.44 to 23.66 tests per 1,000 persons for gFOBT and FIT, a 1.2-fold increase, and from 6.54 to 29.78 tests per 1,000 persons for mt-sDNA (p < 0.05), a 4.6-fold increase. During the same time period, the screening incidence of colonoscopy decreased from 119.99 to 110.58 tests per 1,000 persons, corresponding to a decrease of 8 %. Similar patterns in screening incidence rates were observed among those aged < 50 and > 75 years old. Growing adoption, higher preference, and the broad availability of mt-sDNA testing may be associated with an increase in overall CRC screening rates in the average-risk population, in parallel with a slight increase in the use of other non-invasive CRC screening tests.

Keywords: Colonoscopy Stool-based tests; Colorectal Cancer; Real-World; Screening.

Fig. 1

Study Flow Schema.

Fig. 2

Screening Adherence (Overall and by Age groups).