This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in pre-operative patients with known colorectal cancer. The test, known as the fecal immunochemical test (FIT), checks for traces of blood in patient-collected stool samples, which can be an early sign of cancer. FJ, If FIT testing is utilized as a CRC screening method, single-vial FIT screening is recommended by Polymedco, the National Cancer Institute, and the VHA. You just need to follow instructions with the FIT kit to obtain a stool sample and return it to a lab. This follow-up rate is comparable to some of the best follow-up rates in the United States and elsewhere, Dr. Corley said. Data have been presented for the as-screened population, because . FIT costs about $20 or less and is covered by Medicare and most health insurance plans. Thus, our results suggest that in increased-risk individuals FIT has high diagnostic accuracy for CRC. For example, peoples fears about the preparation for colonoscopy continue to be a major barrier. We pooled results from 5 studies that were deemed at low risk of bias. Wong No bowel prep. Colonoscopy-controlled intra-individual comparisons to screen relevant neoplasia: faecal immunochemical test vs. guaiac-based faecal occult blood test. Washington, DC 20001 Only about 4% of people will have cancer found on colonoscopy. This test examines DNA in your stool for evidence of cells shed by colorectal cancer. et al. Diagnostic tests 4: likelihood ratios. R, Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Findings come from a study that is part of a larger effort to address screening disparities. Quiz Ref IDUse of cutoff values between 15 to 25 g Hb/g feces had the best combination of sensitivity and specificity for the diagnosis of CRC (93% and 94%, respectively), as well as the highest LR+ (15.1) and lowest LR (0.07). Synopsis of Results From Subgroup Analyses Depending on Cutoff Value, Type of FIT and Number of FIT Samples Used for the Diagnosis of Colorectal Cancer or Advanced Neoplasia. et al. Study selection methods. JE, Halloran Moreover, we conducted a sensitivity analysis excluding studies that used delayed colonoscopy as the reference standard. MH, Hardcastle In November 2013 British Columbia's Colon Screening Program became fully available across the province. et al; QUADAS-2 Group. P, Hazazi We explored the robustness of our results in a post hoc sensitivity analysis including only studies in patients with family history of CRC that used quantitative FIT with a cut-off value of less than 25 g Hb/g feces. by Carmen Phillips, December 2, 2022, A review article, Rockey DC: Occult gastrointestinal bleeding. Accuracy of immunochemical faecal occult blood test for colorectal cancer: meta-analysis [article in Chinese]. Some people may have had other illnesses that precluded them from having a colonoscopy or made them feel that they were more likely to die from causes other than colorectal cancer, he explained. Levi independently assessed risk of bias, inconsistency, indirectness, imprecision, and publication bias. We included studies that reported the diagnostic accuracy of FIT for CRC or advanced neoplasia (CRC, or adenomas 10 mm or with 25% villous component and/or high-grade dysplasia) in asymptomatic adults with family history of CRC or personal history of CRC or advanced adenomas and used colonoscopy or follow-up as the reference standard. However, the robustness of our results was verified in a series of subgroup analyses. What is the diagnostic accuracy of fecal immunochemical testing (FIT) for screening of colorectal cancer (CRC) or advanced neoplasia in asymptomatic high-risk populations? There are two types of stool tests for colon cancer. FIT is the dominant screening test for colorectal cancer in most economically advanced countries, and the results support the accuracy of widespread periodic FIT screening, they added. et al. By contrast, in the no-colonoscopy group, new cases went up more gradually but continued rising over 10 years. Forest plots demonstrated a high degree of heterogeneity for sensitivity estimates (Figure 2). et al; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. C, Critical revision of the manuscript for important intellectual content: All authors. Offering colonoscopy to participants with a negative fit and a first degree relative with CRC increases the detection of advanced neoplasia in a screening program. It is a very sensitive test, and that polyps, hemorrhoids (both internal and external), and ulcers can all cause a positive fit test. This research provides additional valuable information to the body of high-quality comparative evidence about the diagnostic accuracy of FIT screening compared with other fecal tests or colonoscopy, Carlo Senore, MD, and Manuel Zorzi, MD, wrote in a related editorial. M, What Causes Immunotherapys Heart-Related Side Effects? May 5, 2022 , by Elia Ben-Ari. Carroll Respective values for AN were sensitivity, 44% (95% CI, 34%-53%); specificity, 94% (95% CI, 92%-96%); LR+, 7.70 (95% CI, 5.10-11.70), and LR, 0.60 (95% CI, 0.51-0.71) (eFigure 5 in the Supplement). MA, Perdue This demonstrates the longer-term protective value of completing the screening process, which is another new piece of information provided by the study, Dr. Corley said. AW, Westwood A, After deduplication, 2154 titles and abstracts were screened and 1952 records were rejected or deemed ineligible. That . eFigure 2. We assessed the full text of the remaining 202 reports. CA. Cost. GRADE handbook for grading quality of evidence and strength of recommendations. On average, the review found that FITs catch about 79 percent of colon cancers, and their specificity consistently tops 90 percent . What is the diagnostic accuracy of fecal immunochemical testing (FIT) for screening of colorectal cancer (CRC) or advanced neoplasia in asymptomatic high-risk populations? JA, Eisen The study points to the importance of more closely monitoring people who do not follow recommendations after a positive FIT result, said Erica Breslau, Ph.D., M.P.H., of NCIs Healthcare Delivery Research Program, who also was not involved in the study. Findings Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. Results Can miss many polyps and some cancers. Sample size of studies ranged from 116 to 1041 patients. How Fit Is FIT for Detecting Colorectal Cancer? Gimeno-Garca Most of these were at high or unclear risk of bias due to suboptimal study design. I, Cubiella HermannBrenner,MD, MPH; SilviaCalderazzo,PhD; ThomasSeufferlein,MD; LeopoldLudwig,MD; NektariosDikopoulos,MD; JrgMangold,MD; WolfgangBck,MD; ThomasStolz,MD; ThomasEisenbach,MD; ThomasBlock,MD; AnnetteKopp-Schneider,PhD; DavidCzock,MD; KajaTikk,PhD, Fecal Immunochemical Tests in Patients at Increased Risk for CRC, Assessment of Quality of Body of Evidence, Get the latest from JAMA Internal Medicine, To register for email alerts, access free PDF, and more, Get unlimited access and a printable PDF ($40.00), 2023 American Medical Association. Y, Liu et al. As patients with an abnormal result are at greater risk for precancerous polyps or cancer, it is important to attend to follow-up procedures. This is especially important for those who are averse to colonoscopy. F, De Wijkerslooth V, Fecal DNA testing was 92% sensitive and 87% specific, whereas FIT was 74% sensitive and 95% specific. Finally, we explored the clinical utility of FIT for patients at increased risk of CRC by means of Fagan nomogram. Otero-Estevez In this meta-analysis, FIT has high overall diagnostic accuracy for CRC and moderate accuracy for advanced neoplasia. All Rights Reserved, Challenges in Clinical Electrocardiography, Clinical Implications of Basic Neuroscience, Health Care Economics, Insurance, Payment, Scientific Discovery and the Future of Medicine, 2017;177(8):1110-1118. doi:10.1001/jamainternmed.2017.2309. In the study, 3 percent of the people with positive FIT results were diagnosed with colorectal cancer (2,191 total cases). Positive and negative predictive values were 43.8% and 94.0%, respectively. et al. Despite the use of an exhaustive and meticulous search strategy, we could only find 12 eligible studies. After deduplication, we screened 2154 titles and abstracts and rejected 1952 records as noneligible. AZ, Quintero the bowel cancer screening test detects most (up to 85%) but not all bowel cancers; This is why it's important to do the screening test every 2 years between 50 and 74. The average sensitivity of FIT for AN was 48% (95% CI, 39%-57%); and the average specificity was 93% (95% CI, 91%-94%), yielding an LR+ of 6.55 (95% CI, 5.0-8.5) and an LR of 0.57 (95% CI, 0.48-0.67) (GRADE: very low). In this systematic review and meta-analysis, we found reasonable diagnostic accuracy of FIT for CRC (AUC, 0.93) and AN (AUC, 0.86) in individuals with either a personal or family history of CRC. Reitsma GP; Expert Working Group on Fecal Immunochemical Tests for Hemoglobin, Colorectal Cancer Screening Committee, World Endoscopy Organization. FIT only detects human blood from the lower intestines. For each study we recalculated the sensitivity and specificity with 95% CIs from the true-positive (TP), false-positive (FP), false-negative (FN), and true-negative (TN) results, using Review Manager 5.3 (Cochrane Community). About 60% of the time, they'll find nothing; about 35%, a polyp; about 4%, a very early cancer; about 1% a less early cancer. Data extraction and quality assessment were conducted in duplicate. It is really a good thing that you are fast tracked for a colonoscopy, as it will be the only way to know what's going on. The program offers free FIT testing once every 2 years to people 5069 years old. The main findings of our study. C, Gonvers They used Union for International Cancer Control (UICC) stage and T stage (infiltration) to measure sensitivity. 2023 American Medical Association. The Journal of Applied Laboratory Medicine, A Global Strategy to Eliminate Cervical Cancer, A New Model for Personalized Reference Intervals, How Fit Is FIT for Detecting Colorectal Cancer, How Underspecification Undermines Artificial Intelligence, The Sprint Toward a Better SARS CoV 2 Diagnostics Data System, Commission on Accreditation in Clinical Chemistry. et al; GRADE Working Group. [This] raises the importance of being able to get the individual steps correct and completed as best you can because every step where you lose some people in follow-up can have a big impact., Study Adds to Debate about Screening for Melanoma, Ivosidenib with Chemotherapy New Option for Some People with AML, If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. PM, Zwinderman et al. By continuing to use our site, or clicking "Continue," you are agreeing to our, Figure 2. BA, Sylvester Fraser Based on GRADE summaries (eTable 2 in the Supplement) we deemed the quality of the evidence to be low or very low. Mean age ranged from 46.0 to 63.2 years, and percentage of males ranged from 30.2 to 50.6%. Colonoscopy is a good test for finding polyps or cancer in the bowel. Hierarchical summary receiver operating curve (HSROC) plot of sensitivity versus specificity for performance of FIT in studies using quantitative FIT with cut off value less than 25g/g only in patients with familial risk of CRC, eTable 1. We deemed all 4 studies employing qualitative FITs28,30,32,37 and all 3 studies using delayed colonoscopy as a reference standard26,34,37 as high risk. . DJ, Lee JS, Piper Sensitivity Estimates of Colorectal Cancer and Advanced Neoplasia, Table 1. In this cohort, the overall rate of cancer was 1.4 per 1,000. DA, McFarland It tests for non-visible blood in poo, which can be an early sign of bowel cancer. On the other hand, our results also show that FIT could diagnose only half of the cases with AN. GM, Baron Dominitz Author Contributions: Dr Tsapas had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Several recently published guidelines support the use of FIT for screening of average-risk participants.44,45 The Canadian Task Force on Preventive Health Care excludes colonoscopy as a primary screening test and recommends screening only with FIT, guaiacbased fecal occult blood tests, or flexible sigmoidoscopy.46 Our results are in line with these suggestions and support use of FIT for screening of increased-risk individuals. . Brozek Annual fecal immunochemical testing (FIT) is cost-effective for colorectal cancer (CRC) screening. We included 12 studies (6204 participants). Published Online: June 19, 2017. doi:10.1001/jamainternmed.2017.2309. Colon cancer screening is appropriate for: Adults 45 and older with an average risk for colon cancer. Study concept and design: Katsoula, Paschos, Tsapas, Giouleme. FIT testing is recommended annually, and Cologuard every three years if testing is negative, but positive test results require a follow-up with colonoscopy. Brozek Can Cologuard detect cancer? It may not seem like 7 years is a huge difference, but the colorectal cancer prevalence from the under 45 age bracket is much lower than 50+. MEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016. Statistical analysis was performed with Stata software version 13.0 (Stata Corporation), using metandi and midas modules. Terms of Use| However, the validity of our conclusions is undermined by low or very low quality of the body of evidence. The first stool tests developed were based on the finding of occult, or hidden, blood. Quality assessment summary: review authors judgments about each risk of bias item for each included study, eFigure 3. JK, Boland Berger Lastly, she said that 3 out of four people have polyps, hemorrhoids, ulcers, or a combination of the three. RC. Can patients at high risk for significant colorectal neoplasms and having normal quantitative faecal occult blood test postpone elective colonoscopy? This test uses antibodies that specifically react with a blood protein in the stool. Conflict of Interest Disclosures: None reported. Future studies should investigate determinants of false-negative FITs in different CRC stages, Tobias Niedermaier, MPH, PhD,clinical epidemiology and aging research scientist at German Cancer Research Center and the studys corresponding author, told CLN Stat. Eight studies used 1-sample FIT,26,28,30,32-34,36,37 2 studies used 2-sample FIT,27,35 and 2 studies used 3-sample FIT.29,31, All studies used colonoscopy as a reference standard. Experts generally recommend that people repeat this test every 1 to 2 years. This test looks for hidden blood in the stool. Results were at least as good as from previous systematic reviews focusing n average-risk individuals.10,11,38 To ensure internal validity of our conclusions, we implemented current guidelines for the conduct and reporting of systematic reviews12,39 and used a prespecified protocol. EA, Jaeschke Two authors (A.K. It's also possible for the test to miss some cancers, which is called a false-negative result. A follow-up, or diagnostic, colonoscopy can find not only colorectal cancer but also precancerous growths, or polyps, that doctors can remove during the procedure, reducing the risk of future cancers. The initial sharp rise was expected, the researchers noted, due to colorectal cancer being found during follow-up colonoscopy. These data indicate that participants who begin screening at the . Both studies focused on a single screening episode analysis, which cannot account for the potential contribution of repeated FIT applications to overall screening effectiveness, they added. PF, Rutjes Arditi Finally, the effects on quality of life, morbidity, mortality and overall cost-effectiveness need to be clarified in future studies.49-51. To our knowledge, this is the first systematic review and meta-analysis evaluating the diagnostic accuracy of FIT in individuals at increased risk for CRC. MC, Stoop LM, Rooney et al. independently extracted data and evaluated study quality using the Quality Assessment of Diagnostic Accuracy Studies2 tool, and evaluated the quality of the body of evidence by means of GRADE (Grading of Recommendations Assessment, Development, and Evaluation). SP. Colonoscopy - A procedure where a doctor looks into the rectum and the entire colon using a flexible narrow tube to identify colorectal cancer or precancerous polyps. This test uses a specialized protein called an antibody. When a guaiac FOBT is performed every one to two years in adults 50 to 80 years old, it can reduce deaths from colorectal cancer by 15 to 33 percent, according to the National Cancer Institute . This points to one possible reason why people in this group, on average, were less likely to get follow-up colonoscopy exams, Dr. Corley said. JD, Armitage Drafting of the manuscript: Katsoula, Paschos, Tsapas. et al. About 10-15 percent of people screened with FIT will have an abnormal result and will require additional testing. Fecal occult blood test: The fecal occult blood test (FOBT) is a lab test used to check stool samples for hidden (occult) blood. Apparently false-positive FIT results were found for 378 participants (8.1%). Two authors (A.K. The researchers compared the numbers of new colorectal cancer cases diagnosed, deaths from colorectal cancer, and deaths from any cause in the two groups over time for up to 10 years after an initial positive FIT result.