E0175 - A Prospective Study Evaluating Cologuard® Ordering in the Community Setting

Eesha Sachdeva, BA¹, Vibhuti Khatri, MBBS², Monica Arora, DO², Justin Crocker, MD, FACG³, Sanjay Jagannath, ^4
1Boston University School of Medicine, Boston, MA; ²Wake Endoscopy Center, Raleigh, NC; ³Duke University, Raleigh, NC; ⁴RMG Gastroenterology, Raleigh, NC

Introduction: Colonoscopy remains the gold standard screening test for colorectal cancer1. Cologuard® (CG), a non-invasive mtsDNA-FIT test, is indicated for use in asymptomatic patients without risk factors2. Our previous studies suggested inappropriate use of CG® in the community setting. This prospective follow-up study was conducted to evaluate the true rate of adherence to approved criteria for CG® testing.

Methods: This prospective study enrolled all referred patients with a positive CG® test from 5/2021 to 5/2022. All records were reviewed. Patients were asked if they had seen blood in their stool, were hemoccult positive, had a personal history of polyps or a family history of colon cancer. Data was collected from patients at the time of procedure. Colonoscopy results and patient demographics were analyzed. Follow-up discussions with referring primary care physicians (PCPs) were conducted after data collection.

Results: 123 patients (58M:65F) with a positive CG® test were enrolled. Mean age was 63.5y (97.6% patients >50y). 17% (21/123) were diabetic. 83.7% identified as White, 11.4% as Black, 1.6% as Hispanic, 0.8% as Asian and 2.4% with >2 races.

Prior to CG® prescription, 23.6% (29/123) of patients reported visible bleeding. 15.4% (19/123) reported a positive hemoccult test. 26.0% (32/123) reported either visible bleeding or a positive hemoccult test or both.

18.7% (23/123) of patients reported a personal history of polyps and 13.0% (16/123) of patients indicated a family history of colon cancer. In total, 46.3% (57/123) of patients presented with at least one contraindication (bleeding or history) for CG® prescription.

Of these patients, 44/123 (35.8%) had a negative colonoscopy or a non-adenomatous polyp. 36/123 (29.3%) had a non-advanced adenoma while 39/123 (31.7%) had an advanced adenoma. 4/123 (3.25%) had an invasive adenocarcinoma.

Discussion: This prospective study reveals, in our large community practice, 46.3% of CG®-positive patients were tested incorrectly. Widespread erroneous testing leads to increased cost to the system and patient. Even though colonoscopy is readily accessible in our community, conversations with referring PCPs reveal that PCPs often order CG® when patients are resistant to bowel prepping for colonoscopy despite being aware of contraindications.

1. 
   Am J Gastroenterol. 2021 Mar 1;116(3):458-479.
   
   


2. 
   N Engl J Med. 2014 Apr 3; 370(14):1287-97.
   
   

Disclosures:


Eesha Sachdeva, BA¹, Vibhuti Khatri, MBBS², Monica Arora, DO², Justin Crocker, MD, FACG³, Sanjay Jagannath, ⁴. E0175 - A Prospective Study Evaluating Cologuard® Ordering in the Community Setting, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.