scholarly journals Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening in a large, nationally insured cohort

2021 ◽  
Author(s):  
Lesley-Ann Miller-Wilson ◽  
Lila J Finney Rutten ◽  
Jack Van Thomme ◽  
A Burak Ozbay ◽  
Paul J Limburg
Keyword(s):  
Colorectal Cancer ◽  
National Sample ◽  
Adherence Rate ◽  
Average Risk ◽  
Cross Sectional ◽  
Commercial Insurance ◽  
Dna Test ◽  
Crc Screening ◽  
Stool Dna ◽  
Insured Patients

Abstract Purpose Colorectal cancer (CRC) is the second most deadly cancer in the USA. Early detection can improve CRC outcomes, but recent national screening rates (62%) remain below the 80% goal set by the National Colorectal Cancer Roundtable. Multiple options are endorsed for average-risk CRC screening, including the multi-target stool DNA (mt-sDNA) test. We evaluated cross-sectional mt-sDNA test completion in a population of commercially and Medicare-insured patients. Methods Participants included individuals ages 50 years and older with commercial insurance or Medicare, with a valid mt-sDNA test shipped by Exact Sciences Laboratories LLC between January 1, 2018, and December 31, 2018 (n = 1,420,460). In 2020, we analyzed cross-sectional adherence, as the percent of successfully completed tests within 365 days of shipment date. Results Overall cross-sectional adherence was 66.8%. Adherence was 72.1% in participants with Traditional Medicare, 69.1% in participants with Medicare Advantage, and 61.9% in participants with commercial insurance. Adherence increased with age: 60.8% for ages 50–64, 71.3% for ages 65–75, and 74.7% for ages 76 + years. Participants with mt-sDNA tests ordered by gastroenterologists had a higher adherence rate (78.3%) than those with orders by primary care clinicians (67.2%). Geographically, adherence rates were highest among highly rural patients (70.8%) and ordering providers in the Pacific region (71.4%). Conclusions Data from this large, national sample of insured patients demonstrate high cross-sectional adherence with the mt-sDNA test, supporting its role as an accepted, noninvasive option for average-risk CRC screening. Attributes of mt-sDNA screening, including home-based convenience and accompanying navigation support, likely contributed to high completion rates.

Cross-sectional adherence with the multitarget stool DNA test for colorectal cancer screening in a large, national study of insured patients.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 27-27
Author(s):  
Lesley-Ann Miller-Wilson ◽  
Lila J Finney Rutten ◽  
Jack Van Thomme ◽  
Burak Ozbay ◽  
Paul J. Limburg
Keyword(s):  
Colorectal Cancer ◽  
Central Region ◽  
National Sample ◽  
Average Risk ◽  
Cross Sectional ◽  
Crc Screening ◽  
Test Kit ◽  
Navigation Support ◽  
Stool Dna ◽  
Insured Patients

27 Background: Colorectal cancer (CRC) is the second most deadly and fourth most frequently diagnosed cancer in the United States. Early detection can improve CRC outcomes, but overall screening rates (62%) remain below the 80% goal set by the National Colorectal Cancer Roundtable. Multiple options are endorsed for average-risk CRC screening, including the multi-target stool DNA (mt-sDNA) test, which includes patient and provider navigation support. Cross-sectional adherence with the mt-sDNA test was previously reported in a large Medicare population (71%). In the current study we investigated cross-sectional adherence with the mt-sDNA test in a broader, national sample of insured patients. Methods: Aggregate data from Exact Sciences Laboratories LLC (ESL; Madison, WI) were retrospectively analyzed in compliance with HIPAA requirements. Study participants included individuals ages 50 years and older who were covered by commercial insurance or Medicare, had a valid mt-sDNA test order placed between January 1–December 31, 2018, and received a test kit shipped from ESL. Cross-sectional adherence, defined as successful completion and return of the test kit within 365 days of the shipment date, was assessed overall and by patient- and provider-level factors. Results: In total, 1,420,460 participants met the study criteria (61.2% women; mean age 65.7 years). Overall cross-sectional adherence was 66.8%. Adherence was 72.1% in participants with Traditional Medicare, 69.1% in participants with Medicare Advantage, and 61.9% in participants with commercial insurance (p<0.001). Adherence increased by participant age (p<0.001): 60.8% for ages 50-64, 71.3% for ages 65-75, and 74.7% for ages 76+ years. For Traditional Medicare patients, ages 65-75, adherence was 73.6%. Participants with mt-sDNA tests ordered placed by gastroenterologists had a higher adherence rate (78.3%) than those with orders placed by primary care clinicians (67.2%) (p<0.001). Adherence rates were highest among patients with ordering providers in the Pacific region (71.4%) and West North Central region (70.1%), and lowest in the Mid-Atlantic region (65.7%), New England (65.2%), West South Central region (64.6%), and Puerto Rico and US territories (60.7%). Conclusions: Novel data from this large, national sample of insured patients demonstrate high cross-sectional adherence with the mt-sDNA test (66.8%), supporting the substantial contribution this guideline-endorsed option plays in average-risk CRC screening. At the patient-level, adherence increased with patient age, and was highest in those covered by Traditional Medicare. Provider-level stratification showed the highest adherence for mt-sDNA tests ordered by gastroenterologists. This study adds to data regarding the impact of accompanying navigation support and at-home convenience of mt-sDNA on screening completion rates.

Fecal DNA Testing for Colorectal Cancer Screening

2020 ◽  
Vol 71 (1) ◽  
pp. 59-69 ◽  
Author(s):  
John M. Carethers
Keyword(s):  
Colorectal Cancer ◽  
Average Risk ◽  
Fecal Dna ◽  
Polyp Detection ◽  
Serrated Polyps ◽  
Crc Screening ◽  
Epigenetic Biomarkers ◽  
Life Years ◽  
Screening Strategies ◽  
Stool Dna

Fecal (or stool) DNA examination is a noninvasive strategy recommended by several medical professional societies for colorectal cancer (CRC) screening in average-risk individuals. Fecal DNA tests assay stool for human DNA shed principally from the colon. Colonic lesions such as adenomatous and serrated polyps and cancers exfoliate cells containing neoplastically altered DNA that may be detected by sensitive assays that target specific genetic and epigenetic biomarkers to discriminate neoplastic lesions from non-neoplastic tissue. Cross-sectional validation studies confirmed initial case-control studies’ assessment of performance of an optimized multitarget stool DNA (mt-sDNA) test, leading to approval by the US Food and Drug Administration in 2014. Compared to colonoscopy, mt-sDNA showed sensitivity of 92% for detection of CRC, much higher than the 74% sensitivity of another recommended noninvasive strategy, fecal immunochemical testing (FIT). Detections of advanced adenomas and sessile serrated polyps were higher with mt-sDNA than FIT (42% versus 24% and 42% versus 5%, respectively), but overall specificity for all lesions was lower (87% versus 95%). The mt-sDNA test increases patient life-years gained in CRC screening simulations, but its cost relative to other screening strategies needs to be reduced by 80–90% or its sensitivity for polyp detection enhanced to be cost effective. Noninvasive CRC screening strategies such as fecal DNA, however, have the potential to significantly increase national screening rates due to their noninvasive nature and convenience for patients.

scholarly journals Assessing Colorectal Cancer Screening Adherence of Medicare Fee-for-Service Beneficiaries Age 76 to 95 Years

2016 ◽  
Vol 12 (6) ◽  
pp. e670-e680 ◽  
Author(s):  
John Bian ◽  
Charles Bennett ◽  
Gregory Cooper ◽  
Alessandra D'Alfonso ◽  
Deborah Fisher ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Odds Ratio ◽  
Patient Adherence ◽  
Adherence Rate ◽  
Average Risk ◽  
Fee For Service ◽  
Medicare Beneficiaries ◽  
Crc Screening ◽  
The Status ◽  
Screening Adherence

Introduction: There are concerns about potential overuse of colorectal cancer (CRC) screening services among average-risk individuals older than age 75 years. Materials and Methods: Using a 5% random noncancer sample of Medicare beneficiaries who resided in the SEER areas, we examined rates of CRC screening adherence, defined by the Medicare coverage policy, among average-risk fee-for-service beneficiaries age 76 to 95 years from 2002 to 2010. The two outcomes are the status of overall CRC screening adherence, and the status of adherence to colonoscopy (v other modalities) conditional on patient adherence. Results: Overall CRC screening adherence rates of Medicare beneficiaries age 76 to 95 years increased from 13.0% to 21.4% from 2002 to 2010. In 2002, 2.2% of beneficiaries were adherent to colonoscopy, and 10.7%, by other modalities; the corresponding rates were 19.5% and 1.9%, respectively, in 2010. Specifically, rates of adherence to colonoscopy were 1.1% for those age 86 to 90 years and almost nil for those age 91 to 95 years in 2002, but the rates became 13.5% and 8.2%, respectively, in 2010. Compared with white beneficiaries, black beneficiaries age 76 to 95 years had a 7-percentage-point lower adherence rate. However, overall adherence rates among blacks increased by 168.6% from 2002 to 2010, whereas rates among whites increased by 63.0%. Logistic regressions showed that blacks age 86 to 95 years were less likely than whites to be adherent (odds ratio, 0.56; 95% CI, 0.47 to 0.59) but were more likely to be adherent to colonoscopy (odds ratio, 2.34; 95% CI, 1.47 to 3.91). Conclusion: High proportions of average-risk Medicare fee-for-service beneficiaries screened by colonoscopy may represent opportunities for improving appropriateness and allocative efficiency of CRC screening by Medicare.

scholarly journals Multitarget Stool DNA Test Performance in an Average-Risk Colorectal Cancer Screening Population

2019 ◽  
Vol 114 (12) ◽  
pp. 1909-1918 ◽  
Author(s):  
L.J.W. Bosch ◽  
V. Melotte ◽  
S. Mongera ◽  
K.L.J. Daenen ◽  
V.M.H. Coupé ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Screening ◽  
Colorectal Cancer Screening ◽  
Test Performance ◽  
Average Risk ◽  
Dna Test ◽  
Screening Population ◽  
Stool Dna

scholarly journals Unintended Consequences of Health Information Technology: Evidence From Veterans Affairs Colorectal Cancer Oncology Watch Intervention

2012 ◽  
Vol 30 (32) ◽  
pp. 3947-3952 ◽  
Author(s):  
John Bian ◽  
Charles L. Bennett ◽  
Deborah A. Fisher ◽  
Maria Ribeiro ◽  
Joseph Lipscomb
Keyword(s):  
Colorectal Cancer ◽  
Fixed Effects ◽  
Veterans Affairs ◽  
Unintended Consequences ◽  
Screening Colonoscopy ◽  
Average Risk ◽  
Cross Sectional ◽  
Risk Screening ◽  
Crc Screening ◽  
Clinical Reminder

Purpose We evaluated the Colorectal Cancer (CRC) Oncology Watch intervention, a clinical reminder implemented in Veterans Integrated Service Network 7 (including eight hospitals) to improve CRC screening rates in 2008. Patients and Methods Veterans Affairs (VA) administrative data were used to construct four cross-sectional groups of veterans at average risk, age 50 to 64 years; one group was created for each of the following years: 2006, 2007, 2009, and 2010. We applied hospital fixed effects for estimation, using a difference-in-differences model in which the eight hospitals served as the intervention sites, and the other 121 hospitals served as controls, with 2006 to 2007 as the preintervention period and 2009 to 2010 as the postintervention period. Results The sample included 4,352,082 veteran-years in the 4 years. The adherence rates were 37.6%, 31.6%, 34.4%, and 33.2% in the intervention sites in 2006, 2007, 2009, and 2010, respectively, and the corresponding rates in the controls were 31.0%, 30.3%, 32.3%, and 30.9%. Regression analysis showed that among those eligible for screening, the intervention was associated with a 2.2–percentage point decrease in likelihood of adherence (P < .001). Additional analyses showed that the intervention was associated with a 5.6–percentage point decrease in likelihood of screening colonoscopy among the adherent, but with increased total colonoscopies (all indicators) of 3.6 per 100 veterans age 50 to 64 years. Conclusion The intervention had little impact on CRC screening rates for the studied population. This absence of favorable impact may have been caused by an unintentional shift of limited VA colonoscopy capacity from average-risk screening to higher-risk screening and to CRC surveillance, or by physician fatigue resulting from the large number of clinical reminders implemented in the VA.

scholarly journals A64 REVIEW OF PATIENTS REFERRED TO THE DIVISION OF DIGESTIVE CARE AND ENDOSCOPY AT DALHOUSIE UNIVERSITY FOR COLORECTAL CANCER SCREENING BASED ON A FAMILY HISTORY OF COLORECTAL CANCER: HOW MANY UNDERWENT COLONOSCOPY?

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 23-25
Author(s):  
M Miles
Keyword(s):  
Colorectal Cancer ◽  
Family History ◽  
High Risk ◽  
Average Risk ◽  
Cross Sectional ◽  
Crc Screening ◽  
Increased Risk ◽  
Fit Testing ◽  
Quality Assessment Study ◽  
History Of

Abstract Background Nova Scotia has provincial colorectal cancer (CRC) screening for asymptomatic, average risk individuals age 50–74 using fecal immunochemical testing (FIT) every 2 years. However, individuals with 1 or more first degree relatives (FDR) diagnosed with CRC by age 60 have a 2–4 fold increased risk for developing CRC. For these high risk individuals, current guidelines recommend CRC screening with colonoscopy rather than FIT testing. Annually, the Division of Digestive Care & Endoscopy (DCE) at Dalhousie University receives many referrals for patients with a family history of CRC but the percentage of patients who require this procedure is unclear. Aims The objectives of this quality assessment study were to review patients referred to DCE for a family history of CRC to (1) better understand the indication for referral; and (2) determine the percentage of patients undergoing colonoscopy Methods This was a retrospective cross sectional review of a prospectively updated database. The study population was patients referred to DCE from 2012–2019 based on a family history of CRC, as indicated on the referral. Family history of CRC was defined as 1 or more FDRs diagnosed with CRC. High risk patients were those with 2 or more FDRs with CRC or 1 FDR diagnosed by age 60. All patients were reviewed by a single gastroenterologist in clinic. Results A total of 107 referrals from 2012–2019 were reviewed. Of patients age 50 or older, 51/78 (65.4%) had performed at least 1 FIT. The indications for referral were 2 or more FDR diagnosed with CRC for 6/107 (5.6%) patients, 1 FDR diagnosed with CRC by age 60 for 37/107 patients (34.6%) and 1 FDR diagnosed with CRC over age 60 for 33/107 patients (30.8%). The remaining 31/107 patients (29.0%) had no FDR with CRC. Of the 43/107 patients (40.2%) considered high risk based on family history alone, 34/43 (79.1%) underwent colonoscopy and 8/43 (18.6%) opted for FIT testing. Of the 64/107 patients (59.8%) considered average risk based on family history alone, 26/64 (40.6%) had another indication for colonoscopy and 35/64 (54.7%) resumed FIT testing. Conclusions The majority of patients (71.0%) referred to the DCE for a family history of CRC had at least 1 FDR with CRC. Just over half of patients (55.1%) referred to the DCE for a family history of CRC underwent colonoscopy. Strategies to improve the referral process by better capturing high risk individuals are needed. Funding Agencies None

scholarly journals Stool DNA Test Targeting Methylated Syndecan-2 (SDC2) as a Noninvasive Screening Method for Colorectal Cancer

2021 ◽  
Author(s):  
Wei-Chih Su ◽  
Wei-Yu Kao ◽  
Tsung-Kun Chang ◽  
Hsiang-Lin Tsai ◽  
Ching-Wen Huang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Characteristic Curve ◽  
Screening Method ◽  
Occult Blood ◽  
Screening Tests ◽  
Fecal Occult Blood ◽  
Dna Test ◽  
Crc Screening ◽  
Stool Dna ◽  
Healthy Participants

Despite the steadily increasing worldwide incidence of colorectal cancer (CRC), an effective noninvasive approach for early detection of CRC is still under investigation. The guaiac-based fecal occult blood test (FOBT) and fecal immunochemical test (FIT) have gained popularity as noninvasive CRC screening tests owing to their convenience and relatively low costs. However, the FOBT and FIT have limited sensitivity and specificity. To develop a noninvasive tool for the detection of CRC, we investigated the sensitivity, specificity, and accuracy of a stool DNA test targeting methylated syndecan-2 (SDC2), which is frequently methylated in patients with CRC. This study enrolled 62 patients diagnosed as having stage 0–IV CRC and 76 healthy participants between July 2018 and June 2019 from two institutions. Approximately 4.5g of stool sample was collected from each participant for detection of human methylated SDC2 gene. In total, 48 of 62 (77.4%) patients with CRC showed positive results, whereas 67 out of 76 (88.2%) healthy participants showed negative results. The area under the curve of the receiver operating characteristic curve constructed was 0.872 for discrimination between patients with CRC and healthy individuals. This study highlights the potential of the fecal methylated SDC2 test as a noninvasive detection method for CRC screening with a relatively favorable sensitivity of 77.4%, a specificity of 88.2% and a positive predictive value of 84.2% compared to other available fecal tests. Further multicenter clinical trials comprising subjects of varied ethnicities are required to validate this test for the mass screening of patients with CRC.

scholarly journals Alaska Native Patient and Provider Perspectives on the Multitarget Stool DNA Test Compared With Colonoscopy for Colorectal Cancer Screening

2019 ◽  
Vol 10 ◽  
pp. 215013271988429
Author(s):  
Diana G. Redwood ◽  
Ian D. Blake ◽  
Ellen M. Provost ◽  
John B. Kisiel ◽  
Frank D. Sacco ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Health Care ◽  
Health Care Providers ◽  
Alaska Native ◽  
Response Rate ◽  
Care Providers ◽  
Younger Patients ◽  
Dna Test ◽  
Crc Screening ◽  
Stool Dna

Objective: Alaska Native (AN) people have among the world’s highest rate of colorectal cancer (CRC). We assessed perceptions of AN people and their health care providers of a new take-home multitarget stool DNA test (MT-sDNA; Cologuard) relative to colonoscopy. Methods: Cross-sectional surveys of AN people aged 40 to 75 years (mailed) and providers (online). Results: Participants included 1616 AN patients (19% response rate) and 87 providers (26% response rate; 57% AN people). Over half (58%) of patients preferred colonoscopy for CRC screening, while 36% preferred MT-sDNA. Unscreened patients were significantly more likely to state a preference for MT-sDNA than previously screened patients (42% vs 31%, P < .05) as were younger patients (<60 years old) compared with older patients (40% vs 30%, P < .05). Most providers thought that MT-sDNA would improve screening rates (69%), would recommend if available (79%), and be implementable (79%). Perceived barriers differed substantially between patients and providers in both type and magnitude. Leading colonoscopy barriers reported by patients were travel (44%) and bowel preparation (40%), while providers thought that fear of pain (92%) and invasiveness of the test (87%) were the primary barriers. For MT-sDNA, patients’ belief that colonoscopy was better (56%) and not knowing how to do the test (40%) were primary barriers, while providers thought stool collection (67%) and having a stool sample in their home (63%) were leading barriers. Conclusions: This study found that MT-sDNA has potential acceptability among AN people and their health care providers. Both groups reported a willingness to use MT-sDNA and did not perceive major barriers to its use. This preference was especially true of unscreened and younger patients. The majority of providers indicated they would use MT-sDNA if available and that it would improve CRC screening rates. In this population, where colonoscopy access is limited, MT-sDNA has the potential to improve CRC screening adherence.

scholarly journals Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening: Real-world data from a large cohort of older adults

2020 ◽  
pp. 096914132090375 ◽  
Author(s):  
Emily Weiser ◽  
Philip D Parks ◽  
Rebecca K Swartz ◽  
Jack Van Thomme ◽  
Philip T Lavin ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Older Adults ◽  
Cancer Screening ◽  
Colorectal Cancer Screening ◽  
Real World ◽  
Real World Data ◽  
Cross Sectional ◽  
Dna Test ◽  
Test Order ◽  
Stool Dna

Objective To determine cross-sectional adherence with the multi-target stool DNA test used for colorectal cancer screening in a large, fully insured Medicare population. Methods All patients aged 65–85 with a valid multi-target stool DNA test order from 1 September 2016 to 31 August 2017 identified from the Exact Sciences Laboratories (Madison, WI; sole-source national multi-target stool DNA test provider) database were evaluated for test adherence. Cross-sectional adherence, defined as multi-target stool DNA test completion within 365 days from order date, was analyzed overall and by time to adherence, as well as by available patient (age, sex, test order date, Medicare coverage type) and provider (specialty, year of first multi-target stool DNA test order, multi-target stool DNA test order frequency, and practice location) factors. Results Among 368,494 Medicare beneficiaries (64% female), overall cross-sectional adherence was 71%. Cumulative adherence rates increased more rapidly at 30 (44%) and 60 (65%) days, followed by more gradual increases at 90 (67%), 180 (70%), and 365 (71%) days. By provider specialty, primary care clinicians represented a higher percentage of multi-target stool DNA orders than gastroenterologists (88% vs. 6%), but had a lower associated patient adherence rate (71% vs. 78%). Conclusions In this large, national sample of Medicare insured older adults, nearly three-quarters of patients adhered with a multi-target stool DNA order for colorectal cancer screening. These real-world data should inform further clinical and population health applications, reimbursement model simulations, and guideline-endorsed colorectal cancer screening strategies adherence.

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