How Fit Is FIT for Detecting Colorectal Cancer? L, The positive test result Bayesian multiplier (here, 6.8) raised our estimate of the probability of colon cancer from 0.7% to 5%, supporting getting the colonoscopy, which turned out to be negative (no cancer detected). Quantitative and 1-sample FIT showed adequate test performance, but data on other FIT brands and multiple samples were insufficient. Grading quality of evidence and strength of recommendations in clinical practice guidelines: part 2 of 3. the GRADE approach to grading quality of evidence about diagnostic tests and strategies. et al. Fecal occult blood test: The fecal occult blood test (FOBT) is a lab test used to check stool samples for hidden (occult) blood. E, Nicols-Prez Two authors (A.K. V, 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. Conflict of Interest Disclosures: None reported. 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. Although this looks like a clear advantage for fecal DNA (60 of 65 cancers detected compared . People with a positive FIT result are contacted by phone by trained individuals and a follow-up colonoscopy exam is offered free of charge. Assuming a pretest probability of 0.8% for CRC and 10.2% for AN (median prevalence in 7 and 12 studies included in the present meta-analysis, respectively), a positive result increases the probability of CRC to 8.0% and probability of AN to 42.0%. Terms of Use| Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. 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. CG, Allison Sample size of studies ranged from 116 to 1041 patients. The researchers identified 268 cases of CRC from a database search of 96,804 subjects ages 5075 years with initial negative FIT results. midas: meta-analysis of diagnostic accuracy studies. et al; GRADE Working Group. This delayed diagnosis likely explains the higher death rate from colorectal cancer in this group, Dr. Breslau said. Castro A sensitivity analysis excluding studies at high or unclear risk of bias verified robustness of our conclusions. Faecal immunochemical test accuracy in patients referred for surveillance colonoscopy: a multi-centre cohort study. by Carmen Phillips, December 2, 2022, BM, Parton To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk. Administrative, technical, or material support: Katsoula, Paschos, Tsapas, Giouleme. Arditi Brozek The methodological quality assessment of the included studies is summarized in eFigures 2 and 3 in the Supplement. Quiz Ref IDDespite the use of an exhaustive and meticulous search strategy, we could only find 12 eligible studies. How often does cologuard give a false negative? Study selection methods. Fairly inexpensive. Reitsma Main Outcomes and Measures et al; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. Fecal immunochemical test (FIT) or immunochemical FOBT. However, 14 percent of tests deliver false positive resultsfar higher than the FIT test. In a pragmatic trial34 assessing the effectiveness of a diagnostic strategy using annual FIT for 3 years for detection of AN vs colonoscopy in asymptomatic patients with a family history of CRC, annual FIT was as good as colonoscopy for AN; however, it missed almost 40% of advanced adenomas. Corresponding Author: Anastasia Katsoula, MD, MSc, Hippokration General Hospital of Thessaloniki 54642, Thessaloniki, Greece (anastkatsoula@gmail.com). Quiz Ref IDColonoscopy is currently the only recommended screening modality for participants at increased risk of CRC owing to personal or family history.3 However, no study has documented the effectiveness of this policy on CRC incidence or mortality. Jiang Also, there are no diet or drug restrictions. JD, Armitage A single FIT test detects about 73 percent of colorectal cancers. However, it was restored in a post hoc analysis excluding studies with qualitative FIT or utilizing a threshold of less than 25 g Hb/g feces. Broek Second Generation FIT Colon Cancer Test. J, Kallenberg Studies have shown that this type of test detects cancer with 92 percent accuracy. The study should also evaluate the location and detection rate of advanced adenomas and quantitative fecal hemoglobin results during the rounds of testing. Positive and negative predictive values were 7.7% and 99.9%, respectively. You just need to follow instructions with the FIT kit to obtain a stool sample and return it to a lab. Medicines and foods do not interfere with the test. 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). Our objective was to describe FIT PPV and the . What is a FIT? I'm reading theres a 13 percent chance of false positive. AZ, Diagnostic studies evaluating the accuracy of FIT for CRC or AN in patients with a personal or familial history of CRC using colonoscopy as the reference standard. Can patients at high risk for significant colorectal neoplasms and having normal quantitative faecal occult blood test postpone elective colonoscopy? Screening colonoscopy was better at finding cancer and pre-cancerous polyps than both Cologuard and the FIT test. Until now, there hasnt been much information on how a lack of follow-up testing after a positive FIT result may affect peoples risk of dying from colorectal cancer, Dr. Corley noted. . 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. M, Washington, DC 20001 I asked what did it show, because they test for 11 different cancers or categories. The diagnostic odds ratio (DOR) for diagnosis of CRC and AN was 129 (95% CI, 11-1579) and 11 (95% CI, 8-17), respectively. The findings also highlight the need to identify opportunities to improve what is currently being done to ensure that people get the follow-up tests they need, Dr. Breslau said. CR, et al. Finally, we explored the clinical utility of FIT for patients at increased risk of CRC by means of Fagan nomogram. JPT, Green H, Bishehsari Data Sources So, in 10 percent of cases using . The main advantage of this test, which costs . Beyond diagnostic accuracy: the clinical utility of diagnostic tests. 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. M, Hernndez-Guerra 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. E, Castells AF, Laheij World Health Organization International Agency for Research on Cancer. E, Carrillo MEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016. TH, 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. The first stool tests developed were based on the finding of occult, or hidden, blood. Any disagreement was resolved through discussion or by consulting a third author (A.T.). Tests and investigations for colorectal cancer screening. 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. 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). According to editorialists Senore and Zorzi, the study sheds new light on the tests sensitivity with respect to tumor characteristics. Respective estimates for AN were sensitivity, 47% (95% CI, 39%-55%); specificity, 94% (95% CI, 91%-96%); LR+, 8.10 (95% CI, 5.90-11.20); and LR, 0.56 (95% CI, 0.49-0.65) (eFigure 6 in the Supplement). EM, Forest plots demonstrate a high degree of heterogeneity for sensitivity estimates for (A) colorectal cancer and (B) advanced neoplasia. The low incidence of colorectal cancer after that was likely due to the early detection of cancers and the removal of precancerous lesions during colonoscopy, Dr. Breslau explained. I didn't follow that and put myself through agony for weeks. SP, Young This is especially important for those who are averse to colonoscopy. SP. Sensitivity was particularly low for T1 and stage I cancers in the distal colon (32% and 52%, respectively) although generally very high for cancers with higher T stage (T2-T4) and more advanced stage (UICC stage IIIV) overall. 12 Data from outside the United States . There are two types of stool tests for colon cancer. 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. 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. FIT is one of the most widely used colorectal cancer screening tests worldwide. Fraser On subsequent colonoscopy, 40% of those with positive tests had either advanced adenomas or cancer. No pre-test diet or medication changes needed. 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. Over that time, about 2 percent of the people, about 2,700 of them, had positive tests. Hierarchical models were used to synthesize available evidence. 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, The pooled sensitivity and specificity for AN were 48% (95% CI, 39%-57%) and 93% (95% CI, 91%-94%), yielding an LR+ of 6.5 (95% CI, 5.0-8.5) and an LR of 0.57 (95% CI, 0.48-0.67). Use 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). FIT LR+ is more than 10 and LR is less than 0.1, hence having a significant effect on pretest probabilities and providing strong evidence for the presence or absence of CRC, respectively.47 In a population with a prevalence of CRC equal to 0.8%, a negative result decreases the posttest probability to less than 0.1%, whereas a positive result increases the posttest probability to 8.0%, which crosses a conventional threshold of risk to perform colonoscopy. Data Extraction and Synthesis Fecal DNA testing was 92% sensitive and 87% specific, whereas FIT was 74% sensitive and 95% specific. 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. et al. The test looks for tiny traces of blood in the stool, a way of screening people for colon cancer. Sensitivity 98%; . Experts generally recommend that people repeat this test every 1 to 2 years. Only about 4% of people will have cancer found on colonoscopy. We assessed the full text of the remaining 202 reports. Pooled test characteristics estimates for diagnosing CRC were sensitivity, 86% (95% CI, 31%-99%); specificity, 91% (95% CI, 89%-93%); LR+, 10.00 (95% CI, 5.80-17.5); and LR, 0.16 (95% CI, 0.02-1.48). F, Amani // R, L, Sarasqueta 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). A positive FIT is not a colorectal cancer diagnosis, but we do know that it can cause a great deal of anxiety. B, Lieberman G, Mustafa This study doesnt help us understand why people arent following up, Dr. Corley said. Sensitivity Estimates of Colorectal Cancer and Advanced Neoplasia, Table 1. A review article, Rockey DC: Occult gastrointestinal bleeding. Objective Two authors (A.K. Hi @ robm447, a positive FIT test does not mean you have cancer but it means you have blood in your stool and it is one of the symptoms of bowel cancer, so it should be checked. B, Hierarchical models were used to synthesize available evidence. DG. F, Agustin 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. et al. Finally, the effects on quality of life, morbidity, mortality and overall cost-effectiveness need to be clarified in future studies.49-51. The test isn't always accurate. Having a stool DNA test may lead to additional testing. JK, Liles 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. JB, Linnet Used not only as a screening test, colonoscopies are also used as a diagnostic procedure to follow up after positive results from a fecal occult blood test (FOBT) or fecal immunochemical test (FIT), fecal DNA test, sigmoidoscopy . Why is a FIT done? Most of these were at high or unclear risk of bias due to suboptimal study design.26,28,30,32,34,36,37 Only 3 studies had a mixed population with personal or familial history of CRC,29,31,35 and 2 studies presented results separately based on the patient history.31,35 A post hoc analysis of studies in individuals with family history of CRC using quantitative FIT resulted in similar summary estimates with the main analysis. Several limitations have to be acknowledged about the evidence and the review itself. According to a 2014 clinical study, about 13% of results from Cologuard were false positives and 8% were false negatives. The American Cancer Society estimates more than 153,000 Americans will be diagnosed with colorectal cancer this year making it one of the most common cancers in both men and women. JAMA Intern Med. FIT costs about $20 or less and is covered by Medicare and most health insurance plans. JA, Eisen A, L, Rodriguez-Berrocal US Department of Health & Human Services Agency for Healthcare Research and Quality. 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. Of those, about 1.2% have a positive fit test result. The pooled sensitivity was approximately 93% for CRC but much lower for AN (48%). TR, Corley at the National Institutes of Health, An official website of the United States government, Colonoscopy after Positive FIT Test Cuts Risk of Colorectal Cancer Death, has been shown to reduce deaths from this disease, were twice as likely to die as those who did have a follow-up colonoscopy, peoples fears about the preparation for colonoscopy, cut the incidence of colorectal cancer deaths in half, Drug Targets Common Mutation in Pancreatic Cancer. R, Moreover, we conducted a sensitivity analysis excluding studies that used delayed colonoscopy as the reference standard. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. The program offers free FIT testing once every 2 years to people 5069 years old. JB, Glas In 3 relevant studies, sensitivity for CRC varied from 67% to 100% and specificity from 83% to 95%. However, most studies had a small sample size or low prevalence of CRC or AN, limiting the precision of effect estimates. Heterogeneity and small sample size limit the precision of the results. 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. The area under the ROC (AUC) for diagnosis of CRC and AN was 0.93 (95% CI, 0.90-0.95) and 0.86 (95% CI, 0.83-0.89), respectively (eFigure 4 in the Supplement). GRADE handbook for grading quality of evidence and strength of recommendations. CM, Dunfield Can miss many polyps and some cancers. EA, Compalati 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). The FIT identified that there was blood in the stool. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. Stool samples collected at home are sent in for analysis. 2017;177(8):11101118. The Cologuard test has a 13% false-positive rate, which means 1 in 10 positive tests will incorrectly identify cancer or polyps. FIT detects 74% of colon cancers and 24% of large colorectal polyps. and P.P.) All studies assessed the accuracy of FIT for AN,26-37 but only 7 studies (4790 patients) reported data specifically for CRC.27,29,31-35 Prevalence of AN ranged between 3.2% and 14.5% and between 0.6% and 2.1% for CRC. Complications of colonoscopy. et al. GM, Baron C, Zubiaurre These findings confirm the results of previous reports that showed that early stage CRCs and advanced adenomas are less likely to bleed than advanced-stage CRCs, as well as studies that reported that FIT sensitivity (especially for early-stage CRC or advanced adenomas) decreases with higher cutoff levels, they summarized. et al; EPAGE II Study Group. Seven studies were deemed at high or unclear risk of bias. The positive result could be caused by a stomach ulcer, hemorrhoids, other inflammation. AW, Scholten 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). FIT works in a similar way to the current test by detecting hidden traces of blood in poo that could indicate bowel cancer or pre-cancerous growths known as polyps. M, Parra-Blanco MC, Stoop MA, Levin by Elia Ben-Ari, December 22, 2022, It's also possible for the test to miss some cancers, which is called a false-negative result. Question 1 Between 2015 and 2017, there were around 16,300 CRC deaths in the UK every year, equivalent to 45 deaths every day. D, Hernndez-Guerra 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. 1 In order to reduce mortality and incidence of CRC, the National Health Service Bowel Cancer Screening Programme (NHS BCSP) in . S, Vilkin This test examines DNA in your stool for evidence of cells shed by colorectal cancer. Traces of blood in your poo can be caused by other medical conditions and doesn't necessarily mean you have cancer. Grading quality of evidence and strength of recommendations in clinical practice guidelines: part 3 of 3. the GRADE approach to developing recommendations. 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. 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). . Further research with rigorous diagnostic accuracy studies and randomized clinical trials is warranted to assess the full effectiveness of FIT implementation as a means to promote more individualized and more flexible alternative screening options in patients at higher risk of CRC based on their own values and preferences. Respective values for AN varied from 37% to 56% for sensitivity and 92 to 98% for specificity. G, Huang The new study, published in Alimentary Pharmacology & Therapeutics, concluded that a positive test of ten micrograms or more of haemoglobin per gram of sample detects 91% of underlying cancers. Such a strategy is associated with higher cost, lower adherence, and higher risk for rare, but serious, complications.2-6. Z, Birkenfeld Low adherence to colonoscopy in the screening of first-degree relatives of patients with colorectal cancer. Can have false-positive test results. 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. FIT (Faecal Immunochemical Test) is a test that looks for blood in a sample of your poo. JJ, Burnand JL, Akl 900 Seventh Street, NW Suite 400 FIT (Fecal Immunochemical Test) is a stool test used to look for possible signs of colorectal cancer. The potential role of the fecal immunochemical test (FIT) for screening patients at increased risk for colorectal cancer (CRC) has not yet been elucidated. Bacchus A. This test uses a specialized protein called an antibody. Bibbins-Domingo I, Cubiella Mean age ranged from 46.0 to 63.2 years, and percentage of males ranged from 30.2 to 50.6%. Chubak et al reported that the return rate of any stool blood test after kit mailing within 6 months was 69% versus 64% (P < .005) for 1-sample versus 2-sample testing, respectively, 11 whereas Mosen et al reported that the kit return rate within 6 months was 43.4% versus 39.6% (P = .012), respectively. et al; American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee. For studies using multiple-sample FIT, positivity was rated based on the highest amount of fecal Hb measured in patient samples. 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. Importance The potential role of the fecal immunochemical test (FIT) for screening patients at increased risk for colorectal . U. Because the fecal occult blood test (FOBT) was not as accurate, the fecal immunochemical test (FIT) was developed. The greatest risk for bias occurred owing to flow and timing. This important new program offers colorectal cancer screening to asymptomatic men and women between the ages of 50 and 74. Drafting of the manuscript: Katsoula, Paschos, Tsapas. In the study, 3 percent of the people with positive FIT results were diagnosed with colorectal cancer (2,191 total cases). SC, 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). AZ, Quintero Study concept and design: Katsoula, Paschos, Tsapas, Giouleme. Meaning 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. Grading quality of evidence and strength of recommendations in clinical practice guidelines: part 1 of 3. an overview of the GRADE approach and grading quality of evidence about interventions. Tumors were stratified by location. First and foremost, a positive result on the Cologuard test means that you need to have a colonoscopy. The PPV was 5.0% to 18.7% in the trials using nonrehydrated slides (Funen and Nottingham studies), and it was 0.9% to 6.1% in the trials using rehydrated slides (Goteborg and Minnesota studies). Study supervision: Katsoula, Haidich, Tsapas, Giouleme. et al. Heterogeneity and wide confidence intervals limit the trustworthiness of our findings. C, This test uses antibodies that specifically react with a blood protein in the stool. S, Levin Sensitivity was particularly low for T1 and stage I cancers in the distal colon (32% and 52%, respectively) although generally very high for cancers with higher T stage (T2-T4) and more advanced stage (UICC stage . Data extraction and quality assessment were conducted in duplicate. Cloud VA Health Care System would be predicted to reduce the reflex to colonoscopy, based only on . Heterogeneity and small sample size limit the precision of the results. 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. Colonoscopy is an invasive, expensive procedure with an established risk of complications.40,41 Population-based studies and randomized trials suggest that adherence to use of colonoscopy for screening in average and increased-risk populations is usually suboptimal.42 This undermines the efficacy of screening programs43 and underlines the need for alternative screening modalities that may limit the need for colonoscopy only to those participants with positive results. This meta-analysis assesses the diagnostic accuracy of fecal immunochemical tests for colorectal cancer or advanced neoplasia in asymptomatic patients with an a . 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. Customize your JAMA Network experience by selecting one or more topics from the list below. 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