How should I manage a patient with a positive Cologuard who refuses colonoscopy?

Management of a Patient with Positive Cologuard Who Refuses Colonoscopy

You must counsel the patient that refusing colonoscopy after a positive Cologuard significantly increases their risk of colorectal cancer death by 1.64-fold and their risk of advanced-stage disease by up to 3.22-fold if delayed beyond 12 months, and colonoscopy remains the only recommended follow-up test. 1, 2

Primary Recommendation: Intensive Counseling for Colonoscopy

Colonoscopy is the sole recommended follow-up test for all patients with positive stool-based screening tests (including Cologuard/FIT-DNA), with no acceptable alternatives. 3, 4 The U.S. Multi-Society Task Force on Colorectal Cancer explicitly states that colonoscopy is optimal because it directly evaluates the entire colorectal mucosa and simultaneously allows removal of significant neoplasia when detected. 3, 4

Key Counseling Points to Address Patient Refusal

Mortality and morbidity data:

• Patients who refuse colonoscopy after a positive FIT have a 64% increased risk of death from colorectal cancer compared to those who complete colonoscopy. 1
• Delays beyond 10 months result in significantly higher rates of advanced-stage disease (stage III/IV), with a 97% increased risk at 10-12 months and a 222% increased risk beyond 12 months. 1, 2
• The positive predictive value for significant neoplasia is high with a positive Cologuard result—in one study, 30% of patients with prior normal colonoscopy and subsequent positive Cologuard had advanced adenomas on follow-up. 5

Address specific barriers systematically:

• Fear or anxiety about the procedure: Explain that patient-reported experiences with colonoscopy are generally positive, with pain/discomfort experienced by only 10-21% during the test and 14.8-22% post-procedure. 6
• Bowel preparation concerns: Acknowledge this is the most common complaint (10-41% of patients), but emphasize it is temporary and manageable. 6
• Perceived threat: Higher perceived threat of cancer increases willingness to undergo colonoscopy (adjusted OR 1.62). 1
• System barriers: Ensure the patient receives a specific colonoscopy appointment within 2 weeks of notification, as immediate scheduling improves adherence. 1

What NOT to Offer as Alternatives

Do not offer repeat stool testing as an alternative. 3, 4 A positive Cologuard mandates colonoscopy regardless of subsequent negative tests, as the initial positive result indicates significant risk.

Do not offer CT colonography as a routine alternative unless the patient has absolute contraindications to colonoscopy (such as severe cardiopulmonary disease precluding sedation). 1 Even then, CT colonography requires bowel preparation and cannot remove polyps if found, necessitating colonoscopy anyway.

Do not routinely add upper endoscopy unless the patient has iron deficiency anemia or active upper GI symptoms (dysphagia, persistent nausea/vomiting, epigastric pain). 3, 4 One regional study from Appalachia suggested potential benefit of upper endoscopy in high-risk populations, but this contradicts established guidelines and should not guide routine practice. 7

Acceptable Timing if Patient Needs Time to Decide

If the patient requires time to consider, schedule colonoscopy within 3 months as the target, with an absolute maximum of 6 months. 1, 3, 4

• Delays up to 9 months show nonsignificant increased risk, but this is not recommended practice. 2
• At 10-12 months, risk of any colorectal cancer increases significantly (OR 1.48) and advanced-stage disease nearly doubles (OR 1.97). 2
• Beyond 12 months, risk of colorectal cancer more than doubles (OR 2.25) and advanced-stage disease more than triples (OR 3.22). 2

System-Level Actions to Improve Adherence

Implement patient navigation: Contact the patient by telephone within 2 weeks of the positive result to schedule the appointment, as navigation programs significantly increase colonoscopy completion rates. 1, 3

Document the refusal and establish a tracking system to ensure the patient is contacted repeatedly with offers for colonoscopy scheduling, as 100% of positive test patients should receive outreach attempts. 1

Explore whether system barriers are contributing to the refusal, such as difficulty scheduling, lack of transportation, cost concerns, or inadequate explanation of the test result. 1

Common Pitfalls to Avoid

• Never accept "watchful waiting" or repeat Cologuard testing in 1-3 years as a management plan for a positive result. 3, 4
• Never delay colonoscopy to perform upper endoscopy first unless iron deficiency anemia or upper GI symptoms are present. 4
• Never assume the patient understands the implications of refusing colonoscopy—explicitly state the mortality and morbidity risks in clear terms. 1
• Never document refusal without establishing a follow-up plan for continued outreach and re-counseling at subsequent visits. 1