JJ, Altman et al. Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment of the quality of the body evidence regarding the diagnostic accuracy of FIT. et al. Rutter AZ, Quintero Traces of blood in your poo can be caused by other medical conditions and doesn't necessarily mean you have cancer. Conflict of Interest Disclosures: None reported. In the case of permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title; e.g., Colonoscopy after Positive FIT Test Cuts Risk of Colorectal Cancer Death was originally published by the National Cancer Institute., January 12, 2023, To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk. 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. Parekh independently reviewed and screened titles and abstracts of articles retrieved and determined final eligibility through examination of full texts. To fully evaluate FIT sensitivity and effectiveness, a longitudinal study should assess its performance over several rounds of testing, taking into account the stage and site distribution of screen-detected CRCs and [interval CRCs] ICs in each round, they suggested. Three-year survival was greater in the CRC group diagnosed after a positive FIT (72% vs 59%). Terhaar sive Droste Main Outcomes and Measures F, De Wijkerslooth Quintero It is a noninvasive, private way to check for colon cancer without having to leave your house. In recent years fecal immunochemical tests (FITs) have been offered as a primary screening test for colorectal cancer (CRC) in a growing number of countries. Diagnostic yield of the immunochemical fecal occult blood test in asymptomatic first degree relatives of colorectal cancer patients. The FIT identified that there was blood in the stool. C, Zubiaurre This follow-up rate is comparable to some of the best follow-up rates in the United States and elsewhere, Dr. Corley said. Pooled test characteristic estimates for diagnosing CRC were sensitivity, 97% (95% CI, 62%-100%); specificity, 91% (95% CI, 89%-93%); LR+, 11.20 (95% CI, 8.30-15.10); and LR, 0.03 (95% CI, 0.00-0.60). In 3 studies, individuals with positive FIT results underwent immediate colonoscopy, whereas individuals with negative FIT results underwent delayed colonoscopy, introducing potential differential verification bias.26,34,37 Moreover, 3 studies used an unacceptable interval (>3 months) between FIT and reference standard,26,34,37 while 2 studies provided no relevant details.30,36 In the rest of the studies, the interval between FIT and reference standard was less than 1 month in 5 studies27,29,31,33,35 and 2 months in 1 study.28. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. Reading about positive fit tests all state a high fit test only point towards cancer. 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. Objective The ongoing NCI-funded PROSPR program aims to better understand how to improve the cancer screening process and reduce disparities in colorectal and other cancer screening in community health care settings in the United States. FIT testing is recommended annually, and Cologuard every three years if testing is negative, but positive test results require a follow-up with colonoscopy. However, in 3 studies, the time interval between FIT and colonoscopy depended on the FIT result, such that colonoscopy was delayed more so in those with a negative FIT.26,34,37. 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. independently extracted data from each included study, using Systematic Review Data Repository.13 For studies presenting results for multiple FIT thresholds, we extracted all data to maximize the yield of information. independently evaluated the quality of included studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool.15 Discrepancies were resolved by consensus. 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. You can also reduce your risk of bowel cancer by: keeping physically active. Medicines and food do not interfere with the test. keeping a . 3. Annual fecal immunochemical testing (FIT) is cost-effective for colorectal cancer (CRC) screening. Clinical Laboratory News Quiz Ref IDColorectal cancer (CRC) is the third most common type of cancer in men and the second most common in women worldwide.1 Early detection of CRC through widely applied screening programs has proven to be effective in reduction of cancer-related mortality. by Carmen Phillips, December 2, 2022, . The pooled test characteristics for CRC were sensitivity, 97% (95% CI, 31%-100%); specificity, 91% (95% CI, 89%-93%); LR+, 10.80 (95% CI, 8.00-14.60); and LR, 0.04 (95% CI, 0.00-2.02). J, Kallenberg Salimzadeh A prospective, controlled, feasibility study. Otero-Estevez As tests evolve and costs of cancer care rise: reappraising stool-based screening for colorectal neoplasia. We explored the diagnostic accuracy at 3 different FIT thresholds (<15 g Hb/g, 15 to 25 g Hb/g, >25 g Hb/g feces) based on existing practice and to maximize sensitivity for an increased-risk population. This important new program offers colorectal cancer screening to asymptomatic men and women between the ages of 50 and 74. This review was based on a prespecified protocol registered with PROSPERO 2016 (CRD42016037924) and is reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement.12. A positive FIT can also be due to a polyp, a pre . // The DNA test is 92% effective at detecting cancers. We converted units for FIT cutoff thresholds to micrograms of hemoglobin (Hb) per gram of feces.14 Two authors (A.K. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. If you get a positive 'blood test' (there is no good blood test for colon cancer, BTW) you still need a colonoscopy; if you get a negative 'blood test' you still need a colonoscopy! It is also important to establish optimal thresholds, test cutoff values, and number and frequency of FIT samples.10 Our results also should prompt randomized trials to assess the implementation of FIT either alone or in combination with other screening procedures into screening strategies for increased-risk individuals. We assessed the full text of the remaining 202 reports. 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. In the new study, researchers found that people who had a positive FIT result (signs of blood in the stool) but did not have a follow-up colonoscopy were twice as likely to die as those who did have a follow-up colonoscopy. Colorectal Cancer: Estimated Incidence, Mortality and Prevalence Worldwide in 2012. Two authors (A.K. These data support the annual use of FIT in individuals at increased risk for CRC as an alternative screening strategy for patients who refuse to use colonoscopy. 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. No pre-test diet or medication changes needed. According to a 2014 clinical study, about 13% of results from Cologuard were false positives and 8% were false negatives. A, Studies have shown that this type of test detects cancer with 92 percent accuracy. DC, Curry Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. Thus, our results suggest that in increased-risk individuals FIT has high diagnostic accuracy for CRC. LG, van Rijn AS, Rutjes D, Hernndez-Guerra The greatest concern regarding applicability was due to the FIT and the reference standard used. New research underlines the importance of following up with a colonoscopy exam after a positive (abnormal) result on an at-home stool test to screen for colorectal cancer. Brozek The average sensitivity of FIT for CRC was 93% (95% CI, 53%-99%), and the average specificity was 91% (95% CI, 89%-92%), yielding a positive likelihood ratio (LR+) of 10.30 (CI 7.7-13.9) and a negative likelihood ratio (LR) of 0.08 (95% CI, 0.01-0.75) (GRADE: very low). World Health Organization International Agency for Research on Cancer. In the study, Imperiale and his colleagues determined that when the FIT was set to be more sensitive, the test caught 95 percent of cancers, but resulted in 10 percent false positives. Several limitations have to be acknowledged about the evidence and the review itself. 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. and P.P.) Chemical and immunological testing for faecal occult blood in screening subjects at risk of familial colorectal cancer. DJ, Lee Guaiac-based fecal occult blood . 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. But the program in northeast Italy, which started in 2002, has maintained colonoscopy rates of 80% at just 3 months after a positive test result, they noted. Understanding why some people are willing to be screened but do not follow up can lead to improvements in the effectiveness of the screening process.. Subgroup analyses indicated that FIT cutoff values between 15- and 25-g/g feces provided the best combination of sensitivity and specificity for the diagnosis of CRC (93% and 94%, respectively). J, Altman C, The initial sharp rise was expected, the researchers noted, due to colorectal cancer being found during follow-up colonoscopy. EA, Alonso-Coello Pooled estimates for CRC were sensitivity, 91% (95% CI, 51%-99%); specificity, 92% (95% CI, 88%-94%); LR+, 10.80 (95% CI, 6.60-17.80); and LR, 0.1 (95% CI, 0.01-0.80). Colonoscopy-controlled intra-individual comparisons to screen relevant neoplasia: faecal immunochemical test vs. guaiac-based faecal occult blood test. We assessed the stability of our findings in a series of sensitivity analyses (eTable 1 in the Supplement). M, Parra-Blanco This delayed diagnosis likely explains the higher death rate from colorectal cancer in this group, Dr. Breslau said. P, Hazazi Pooled estimates of sensitivity and specificity for CRC were 93% (95% CI, 53%-99%) and 91% (95% CI, 89%-92%), yielding a positive likelihood ratio (LR+) of 10.30 (95% CI, 7.7-13.9) and a negative likelihood ratio (LR) of 0.08 (95% CI, 0.01-0.75). FIT detects 74% of colon cancers and 24% of large colorectal polyps. K, Robinson CM, Gatsonis N Engl J Med 1999;341:38-46 addresses some questions you might have if you turned out to have a positive test. Harbord Eleven studies were cross-sectional and 1 was a randomized clinical trial.34 Two studies were reported only in abstract form.26,36 Nine studies included only first-degree relatives of CRC patients.26-28,30,32-34,36,37 Three studies included individuals either with a family history of CRC or prior history of CRC or advanced adenomas.29,31,35 Of these, only 2 studies reported results for subgroups.31,35, Eight studies evaluated quantitative FIT (OC-sensor/OC-micro, Eiken Chemical),26,27,29,31,33-36 while 4 studies used qualitative FITs (Hemosure, W.H.P.M. AM, Ladabaum Colonoscopy is a good test for finding polyps or cancer in the bowel. Finally, we could not calculate the pooled estimates in a sensitivity analysis including only studies at low risk of bias in patients with family history of CRC that used immediate colonoscopy due to limited data. In this meta-analysis, FIT has high overall diagnostic accuracy for CRC and moderate accuracy for advanced neoplasia. et al; GRADE Working Group. Terms of Use| de Wijkerslooth By contrast, in the no-colonoscopy group, new cases went up more gradually but continued rising over 10 years. MA, Perdue We estimated whether non-compliance with colonoscopy after a positive FIT is associated with increased CRC incidence and mortality. Findings from the study, which was conducted in Italy, were published March 31 in Gut. Our results suggest that given FIT safety, simplicity, low cost, and low discomfort, it could be used as an acceptable alternative for screening of individuals at increased risk for CRC. TR, de Haan Twelve studies met the inclusion criteria and were included in the systematic review.26-37, The main characteristics of included studies are displayed in Table 1. Lin 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. My test results came back positive. Many colorectal cancer screening programs, including some in the United States, struggle to ensure timely colonoscopy completion among those with a positive FIT, with rates as low as 50%, Dr. Zorzi and his colleagues wrote. Berger et al; GRADE Working Group. In our main analysis, FIT sensitivity and specificity for diagnosing CRC ranged from 0.25 to 1.00 (median, 0.81) and from 0.87 to 0.95 (median, 0.91), respectively. The fecal immunochemical test (FIT) is a screening test for colon cancer. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false-positive (FP) results adding to colonoscopy burden without improving cancer detection. A review article, Rockey DC: Occult gastrointestinal bleeding. S, Vilkin Conclusions and Relevance 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. We excluded studies with symptomatic patients or patients with inflammatory bowel disease, hereditary nonpolyposis colorectal cancer, familial adenomatous polyposis, or studies for which 22 diagnostic tables could not be inferred. We explored robustness of our findings by means of a series of prespecified sensitivity analyses, excluding studies at high or unclear risk of bias, studies recruiting patients with prior history of CRC or advanced adenomas (potential for spectrum bias),25 or studies that used delayed colonoscopy in patients with FIT-negative results as reference standard (potential for differential reference bias). et al; EPAGE II Study Group. Colorectal cancer screening comparing no screening, immunochemical and guaiac fecal occult blood tests: a cost-effectiveness analysis. D, Liberati As the broader DG30 criteria create a potentially enormous pool of low-risk patients, triage with FIT may lead to an overall increase in patients with false-positive . 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. Finally, the effects on quality of life, morbidity, mortality and overall cost-effectiveness need to be clarified in future studies.49-51. AH. One study we published showed that by increasing screening rates from 40% to 80%, we could cut the incidence of colorectal cancer deaths in half, he said. Brozek Levi what percentage of positive fit tests are cancer? Statistical analysis: Katsoula, Paschos, Haidich, Tsapas. Importance The potential role of the fecal immunochemical test (FIT) for screening patients at increased risk for colorectal . GPs can confidently avoid secondary care referrals for colorectal cancer investigation for patients who have had a negative result to a faecal immunochemical test (FIT), a study has concluded. Finally, we evaluated the clinical utility of FIT utilizing Fagan nomograms to depict posttest probability in patients at increased risk for CRC and AN. Broek Heterogeneity and wide confidence intervals limit the trustworthiness of our findings. Less than 1 percent of these (601 cases) were advanced cancers. SP. How Fit Is FIT for Detecting Colorectal Cancer? The Cologuard test has a 12% false-positive rate, which means 1 in 10 positive tests will incorrectly identify cancer or polyps. The use of FIT in symptomatic patients is associated with a better prognosis in CRC. et al. M, et al. I didn't follow that and put myself through agony for weeks. Get the colonoscopy!" Screening for colorectal cancer, the second leading cause of cancer-related deaths in the United States and other high-income countries, has been shown to reduce deaths from this disease. eFigure 2. moderator 3rd September 2020. et al. In the study, 3 percent of the people with positive FIT results were diagnosed with colorectal cancer (2,191 total cases). Second Generation FIT Colon Cancer Test. Complications of colonoscopy. 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. Fecal Immunochemical Test (FIT) and Stool DNA (Cologuard). Six studies were deemed at high risk of bias,26,28,30,32,34,37 1 study at unclear risk,36 and 5 studies at low risk of bias.27,29,31,33,35, All but 1 study reported use of consecutive or random sampling.30 FIT was used prior to the reference standard in 11 studies, and only 1 study did not provide relevant data.36 All studies used prespecified FIT thresholds. 2023 American Medical Association. PS, Bostock Testing for fecal occult blood is commonly used as a cancer screen for colon cancer. 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). ME, Finally, 3 studies were prone to differential verification bias as they invited participants with negative FIT results to undergo a delayed colonoscopy as the reference standard.26,34,37 Most analyses had high heterogeneity and wide confidence intervals of pooled estimates, hence raising concerns about the reliability of our findings. et al. The observed trend toward a reduction of the protective effect of FIT screening with increasing interval since the last negative test also is consistent with previous findings. A hierarchical regression approach to meta-analysis of diagnostic test accuracy evaluations. To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk. If you get a positive Cologuard result, it means the test detected signs of colon cancer or precancerous polyps. The latest US Preventive Services Task Force recommendations for colorectal screening support that the best screening test is the one that gets done, and that the ultimate goal of screening strategies is maximization of screening uptake to reduce CRC mortality.45, Although our results verify the diagnostic accuracy of FIT for CRC in individuals at increased risk, this body of evidence is limited by a relatively small sample size. We conducted a systematic review and meta-analysis to explore the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic individuals with a familial or personal history of CRC. People with a positive FIT test result are advised to have a colonoscopy to investigate the cause of the bleeding because a FIT test alone cannot diagnose cancer. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. 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. GM, Baron Heterogeneity and small sample size limit the precision of the results. 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. According to editorialists Senore and Zorzi, the study sheds new light on the tests sensitivity with respect to tumor characteristics. MH, Hardcastle For the study, Manuel Zorzi, M.D., M.Sc., of the Veneto Tumour Registry in Padua, Italy, and his colleagues, examined the medical records of participants in a regional colorectal screening program who took a FIT test between January 1, 2004, and September 30, 2017. National Comprehensive Cancer Network. Quiz Ref IDThe type of FIT used and cutoff threshold were the most important contributors to the heterogeneity of results. Nevertheless, all included studies evaluated 1-time application of the test, and results could not be transferred to repeat screening programs. Fecal DNA testing was 92% sensitive and 87% specific, whereas FIT was 74% sensitive and 95% specific. Findings come from a study that is part of a larger effort to address screening disparities. et al; QUADAS-2 Group. AW, Scholten TH, Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Having a stool DNA test may lead to additional testing. The FIT has high overall diagnostic accuracy for CRC but moderate accuracy for AN in patients at above-average personal or familial risk.
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