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Abstract

Thank you for your letter. We agree that the purpose of the fecal immunochemical test (FIT) is to detect polyps and early colorectal cancer (CRC) for the benefit of reducing the burden of CRC. We regret that the intention of our statement that primary care providers “should refrain from ordering FITs for patients who are not agreeable to colonoscopy if FIT is positive” was interpreted negatively.1May F.P. et al.Clin Gastroenterol Hepatol. 2019; 17: 469-476Google Scholar Yes, “The secret in the care of the patient, is in caring for the patient,” which is why we engage in this critical research to improve Veterans’ outcomes. We would like to provide some context for our recommendation. First, FIT is a 2-step screening test that is only effective when those with positive results undergo colonoscopy to detect high-risk lesions.2US Preventive Services Task Force et al.JAMA. 2016; 315: 2564-2575Google Scholar Our recommendation is aimed at improving the integrity of this 2-step screening process. It is consistent with the US Multi-Society Task Force recommendation that “when FIT is positive, the PPV [positive predictive value] for significant neoplasia is high. Colonoscopy is the one structural examination that both directly evaluates the entire colorectal mucosa and affords the opportunity to simultaneously remove significant neoplasia . . . it is the optimal test to follow up on a positive screen.”3Robertson D.J. et al.Am J Gastroenterol. 2017; 112: 37-53Google Scholar This recommendation was a strong one based on moderate-quality evidence that also accounted for the availability of computerized tomographic colonography (CT colonography) and colon capsule endoscopy as available structural tests.3Robertson D.J. et al.Am J Gastroenterol. 2017; 112: 37-53Google Scholar A positive FIT without a colonoscopy is an incomplete screening process, which can reduce the effectiveness of a screening program. Second, our statement is consistent with National Comprehensive Cancer Network guidelines: “CRC screening should be performed as part of a program that includes a systematic method for identifying those who are eligible for and who wish to undergo screening . . . and a mechanism for follow up of those with a positive test.”4National Comprehensive Cancer NetworkColorectal Cancer Screening (version 2. 2017).https://www2.tri-kobe.org/nccn/guideline/colorectal/english/colorectal_screening.pdfGoogle Scholar The guidelines emphasize the importance of identifying appropriate screening candidates and educating patients about alternative screening modalities. It is critical to explain to patients at the time of FIT administration that FIT is a 2-step test that is designed to identify individuals who require further evaluation with colonoscopy. Although CT colonography and colon capsule endoscopy, as you suggest, allow us to visualize polyps and malignant lesions, they lack ideal test characteristics and the ability to remove polyps or diagnose cancer.4National Comprehensive Cancer NetworkColorectal Cancer Screening (version 2. 2017).https://www2.tri-kobe.org/nccn/guideline/colorectal/english/colorectal_screening.pdfGoogle Scholar, 5Plumb A.A. et al.Eur Radiol. 2014; 24: 1049-1058Google Scholar, 6Holleran G. et al.Endoscopy. 2014; 46: 473-478Google Scholar A meta-analysis evaluating the benefit of CT colonography and capsule endoscopy for patients with positive stool tests showed poor specificity for adenomas, inability to complete a colon evaluation in almost a third of patients, and concerns for over-reporting of equivocal findings.5Plumb A.A. et al.Eur Radiol. 2014; 24: 1049-1058Google Scholar, 6Holleran G. et al.Endoscopy. 2014; 46: 473-478Google Scholar More importantly, an individual with a positive FIT who undergoes a CT colonography still requires colonoscopy when the CT colonography is abnormal.3Robertson D.J. et al.Am J Gastroenterol. 2017; 112: 37-53Google Scholar Pursuing CT colonography or capsule endoscopy after a positive FIT has the potential to contribute to additional costs, delays in care, and low attrition between FIT and colonoscopy. Third, the contested statement as written was a means to emphasize our sentence that “Improved patient counseling about FIT screening, and education about the need for colonoscopy if FIT is positive may reduce the number of declined procedures that contribute to the low follow-up rates.”1May F.P. et al.Clin Gastroenterol Hepatol. 2019; 17: 469-476Google Scholar The National Comprehensive Cancer Network guidelines also highlight the importance of shared decision making about screening initiation, the choice of screening modality, and follow-up evaluation of positive tests. Patients who state they will not be interested in completing the screening process under any circumstance have the right to make the informed decision to not participate in screening. Finally, we would like to address the potential for manipulation of CRC screening survey scores. Currently, Healthcare Effectiveness Data and Information Set (HEDIS) and other CRC screening measures are based on FIT completion alone, without consideration for whether those with a positive FIT result complete the screening process with colonoscopy. If anything, we believe that this is the “creative manipulation” of modern-day screening programs. We can improve the integrity of CRC screening by testing individuals who agree with the full screening process, which will correct the potential artificial inflation of screening scores that may occur when crediting FIT screens that do not complete the required second step. In summary, our recommendation should prompt discussions between providers and patients on the efficacy and goals of CRC screening so that patients can make informed choices about FIT tests and complete screening. Is it Time to Reevaluate the Gold Standard?Clinical Gastroenterology and HepatologyVol. 17Issue 10PreviewThe purpose of fecal immunochemical testing (FIT) is to screen for polyps and cancer to reduce the morbidity and mortality of colorectal cancer.1,2 The study identified patient and systemic issues contributing to colonoscopy follow-up below target guidelines for a positive FIT. To improve their institutional positive FIT follow-up colonoscopy rate the authors’ suggest that primary care physicians “should refrain from ordering FITs for patients who are not agreeable to colonoscopy if the FIT is positive.” Full-Text PDF Does Screening Colonoscopy Pass the Smell Test?Clinical Gastroenterology and HepatologyVol. 18Issue 5PreviewColonoscopy as the screening gold standard for colorectal cancer may jeopardize public health. Its use as a screening study is rejected by Canada, Europe, and most of the world.1 The US Preventive Health Task Force did not identify colonoscopy as more effective than fecal immunochemistry test (FIT). The gastroenterology Multi-Society Task Force on Colorectal Cancer states that FIT and colonoscopy are equivalent options. Colonoscopy has the highest risk, discomfort, cost, preparation, loss of work, time intensity, and operator and quality variability. Full-Text PDF Fibrosis Changes in the Placebo Arm of NASH Clinical TrialsClinical Gastroenterology and HepatologyVol. 17Issue 11PreviewWe thank Drs Sobokota and Levin for their interest in our systematic review and meta-analysis.1 We agree with their comments that fibrosis is a very important surrogate outcome in nonalcoholic steatohepatitis (NASH) clinical trials. Indeed, it is particularly important because fibrosis has been shown to be the only predictor of patients’ important outcomes (eg, mortality).2 Although changes in Nonalcoholic Fatty Liver Disease Activity Score and intrahepatic triglycerides were the main outcomes in our study, we have assessed changes in fibrosis (≥1-stage improvement in fibrosis) as well. Full-Text PDF