MEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016. van Rossum Can miss many polyps and some cancers. G, Mustafa It tests for hidden blood in the stool, which can be an early sign of cancer. Hierarchical summary receiver operating curve (HSROC) plot of sensitivity versus specificity for performance of FIT in studies with low risk of bias or concerns for applicability (QUADAS2), eFigure 6. 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. 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). 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. E, Castells 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 . R, Rozen TR, Corley 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. GRADE handbook for grading quality of evidence and strength of recommendations. 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. Higgins Also, please keep in mind the percentage of positive tests that lead to cancer, I think it's somewhere around 3%. H, CLN Stat Gimeno-Garcia L, Two authors (A.K. DA, McFarland DJ, Lee Respective values for AN varied from 37% to 56% for sensitivity and 92 to 98% for specificity. Inc32,37; OC-light, Eiken Chemical28; and HemeSelect, Smith-Kline Diagnostics30). 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. 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). 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. 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. 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 will be needed if abnormal. Screening colonoscopy was better at finding cancer and pre-cancerous polyps than both Cologuard and the FIT test. Oort 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. About 10-15 percent of people screened with FIT will have an abnormal result and will require additional testing. Gopalakrishna A sample of the stool is placed in a tube or on a card and sent away to the doctor or laboratory for testing. It is a noninvasive, private way to check for colon cancer without having to leave your house. We assessed the quality of the evidence in our main analysis but also separately for patients with family history or personal history of CRC. Diagnostic tests 4: likelihood ratios. Meaning MH, Hardcastle Reading about positive fit tests all state a high fit test only point towards cancer. et al. People in this group were more likely to have their cancer detected only after symptoms appeared, when the cancer was more advanced. 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! Brozek Tumors were stratified by location. Brozek It looks for tiny traces of blood that you might not be able to see and which could be a sign of cancer. Diagnostic yield of the immunochemical fecal occult blood test in asymptomatic first degree relatives of colorectal cancer patients. VC, et al. Positive and negative predictive values were 7.7% and 99.9%, respectively. Respective values for diagnosing AN ranged from 0.29 to 0.83 (median, 0.50) and from 0.85 to 0.98 (median, 0.92). E, Nicols-Prez Forest plots demonstrate a high degree of heterogeneity for sensitivity estimates for (A) colorectal cancer and (B) advanced neoplasia. I asked what did it show, because they test for 11 different cancers or categories. Having bowel cancer screening reduces your risk of dying from bowel cancer by at least 25% [footnote 1]. Colorectal cancer: epidemiology, risk factors, and health services. 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. A prospective, controlled, feasibility study. AACC.org The full text of the remaining 202 reports were assessed, and 12 studies met the inclusion criteria and were included in the systematic review.26-37 DARE indicates Database of Abstracts of Reviews of Effects. et al. 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. B, These data indicate that participants who begin screening at the . Otero-Estevez FIT only detects human blood from the lower intestines. et al. We undertook a comprehensive search of multiple electronic databases and gray literature sources without imposing any restrictions based on language or publication type. Accuracy of immunochemical faecal occult blood test for colorectal cancer: meta-analysis [article in Chinese]. M, Ko As tests evolve and costs of cancer care rise: reappraising stool-based screening for colorectal neoplasia. 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. Data Extraction and Synthesis 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. I had problems a few years back and did a colonoscopy, which came back ok. Now this!! Medicines and foods do not interfere with the test. et al. JY, Chan CY. A, Bujanda et al. FIT stands for fecal immunochemical test. Objective Quiz Ref IDThe type of FIT used and cutoff threshold were the most important contributors to the heterogeneity of results. No bowel prep. Not a virtual colonoscopy, or another stool test, or another scan of some sortyou need a real optical colonoscopy. Sample size of studies ranged from 116 to 1041 patients. CM, Dunfield 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. 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. EM, 1 In order to reduce mortality and incidence of CRC, the National Health Service Bowel Cancer Screening Programme (NHS BCSP) in . As with the gFOBT, you perform at home with no bowel prep. The FIT identified that there was blood in the stool. PM, Zwinderman However, recommendations for increased-risk individuals are more aggressive and support only use of colonoscopy. What is a FIT? J, Rivera Studies have shown that this type of test detects cancer with 92 percent accuracy. 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, Get the colonoscopy!" Male sex (OR = 1.30, 95%CI 1.03, 1.62), age 65 years (OR = 1.27, 95%CI 1.01, . The type of FIT used and cutoff threshold were the most important contributors to the heterogeneity of results. 2023 American Medical Association. et al; GRADE Working Group. For studies using multiple-sample FIT, positivity was rated based on the highest amount of fecal Hb measured in patient samples. and P.P.) A quantitative immunochemical fecal occult blood test for colorectal neoplasia. 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. FIT detects 74% of colon cancers and 24% of large colorectal polyps. // 51% will have a precancerous polyp. Specifically, the investigators wanted to see if a colonoscopy identified any cancer missed by the FIT. Such factors include the patients personal circumstances (for example, access to transportation), whether they have health insurance, whether they can get timely access to colonoscopy, and whether they have had an adequate conversation with their doctor about screening. RM, Whiting 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. AM, Ladabaum AW, Scholten AACC uses cookies to ensure the best website experience. Moher Methodological quality of included studies graph: review authors' judgments about each item presented as percentages across all included studies, eFigure 4. In the study, 3 percent of the people with positive FIT results were diagnosed with colorectal cancer (2,191 total cases). Wong A single FIT test detects about 73 percent of colorectal cancers. Colonoscopy is currently the only recommended screening modality for participants at increased risk of CRC owing to personal or family history. Bacchus D, Liberati Only about 4% of people will have cancer found on colonoscopy. 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). Multiple factors can contribute to people not getting follow-up colonoscopy exams, both he and Dr. Breslau said. 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. 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). 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). B, Lieberman P, Leshno MC, Stoop After deduplication, we screened 2154 titles and abstracts and rejected 1952 records as noneligible. 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). AW, Westwood Just 0.7 per 1,000 subjects 50 to 59 years of age had cancer. Colorectal cancer (CRC) is the third most common type of cancer in men and the second most common in women worldwide. Findings come from a study that is part of a larger effort to address screening disparities. 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. AS, Rutjes A, Tetzlaff In asymptomatic people without risk factors who had a negative FIT within 2 years, colonoscopy had a very small chance of finding CRC. Date: DEC.17.2020 CM, Gatsonis I didn't follow that and put myself through agony for weeks. keeping a . . The most common types of cancer that lead to positive fit test results include colorectal, breast, and lung cancers. The program offers free FIT testing once every 2 years to people 5069 years old. Our objective was to describe FIT PPV and the . The primary outcome was the diagnostic performance of FIT for detecting CRC or AN. FA, Terhaar Sive Droste Data Sources This study emphasizes that cancer screening is really a process, not a single step, and shows the importance of completing all steps of the process, said gastroenterologist Douglas Corley, M.D., Ph.D., of Kaiser Permanente, Northern California, who was not involved in the study. Recommendations on screening for colorectal cancer in primary care. EA, Compalati 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. and P.P.) The test, known as the fecal immunochemical test (FIT), checks for traces of blood in patient-collected stool samples, which can be an early . J, Altman Individuals at average risk are screened using the fecal immunochemical test (FIT), which has been available in British Columbia for the past 5 years FIT costs about $20 or less and is covered by Medicare and most health insurance plans. Effectiveness: According to the USPSTF report, when the patient has colon cancer, the test is likely to indicate its presence 62% to 79% of the time. We synthesized data regardless of the FIT cutoff used. 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. Results for all subgroup analyses are summarized in Table 2. Question 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. M, Parra-Blanco C, Zubiaurre We also conducted a series of prespecified subgroup analyses, based on type of FIT (qualitative or quantitative), number of samples (1, 2, or 3), or FIT cutoff used. Levi A review article, Rockey DC: Occult gastrointestinal bleeding. eFigure 2. 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. We conducted a comprehensive search of several electronic databases, including MEDLINE via PubMed, EMBASE via Ovid, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database, and the Cochrane Library, without imposing any date or language restrictions. and P.P.) 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+. K, Robinson Two authors (A.K. P, Hazazi 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. 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.. Quintero This means that when the test came out positive, there actually was an abnormality 90 percent of the time with Cologuard and 95 percent of the time with FIT. See an example negative result letter. Because the fecal occult blood test (FOBT) was not as accurate, the fecal immunochemical test (FIT) was developed. // The test looks for tiny traces of blood in the stool, a way of screening people for colon cancer. MR, Seaman The new faecal immunochemical test (FIT) is due to be introduced into the bowel cancer screening programme (BCSP) in England later this year to replace the current test. Gimeno-Garca Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. et al. It is a very sensitive test, and that polyps, hemorrhoids (both internal and external), and ulcers can all cause a positive fit test. However, those who did not get a follow-up colonoscopy were about twice as likely to die of colorectal cancer over a 10-year period as those who did have a follow-up colonoscopy. Most of these were at high or unclear risk of bias due to suboptimal study design. Reasons for participation and nonparticipation in colorectal cancer screening: a randomized trial of colonoscopy and CT colonography. JK, Boland 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. et al; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. 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. JA, Eisen AF, Verbeek Robertson 2 It is used to detect colon cancer, also known as colorectal cancer, which is the third most common cause of cancer deaths in the United States. 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. The main advantage of this test, which costs . GP; Expert Working Group on Fecal Immunochemical Tests for Hemoglobin, Colorectal Cancer Screening Committee, World Endoscopy Organization. These data therefore are providing additional evidence supporting the adoption of a 2-year interval for FIT screening, wrote Senore and Zorzi. LM, Rooney Why is a FIT done? 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. Parekh Clinical literature and commentary point to a new protocol for evaluating fecal immunochemical testing (FIT) and how well this modality flags colorectal cancer (CRC). MEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016. It tests for non-visible blood in poo, which can be an early sign of bowel cancer. However, the robustness of our results was verified in a series of subgroup analyses. doi:10.1001/jamainternmed.2017.2309. It's also possible for the test to miss some cancers, which is called a false-negative result. JB, Glas Findings from the study, which was conducted in Italy, were published March 31 in Gut. E, Carrillo This specific protein attaches to hemoglobin, the oxygen-carrying part of red blood cells. 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. 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 . Who should be screened for colon cancer? According to editorialists Senore and Zorzi, the study sheds new light on the tests sensitivity with respect to tumor characteristics. If cancer is detected, treatment is usually the next step. Terms of Use| 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. SJ, et al; American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee. SP. 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. The Bayesian estimate from the positive test result is almost seven times the assumed 0.7% prevalence. Whiting Cologuard is one of six approved methods for colon cancer screening in the United States, including one of three stool-based tests. While this is a relatively small percentage, it is important to note that a positive fit test result can be an indicator of cancer and should be taken seriously. Sampling done at home. We assessed quality using a meticulous, recently developed tool (QUADAS-2). Carroll 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. Bossuyt 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. R, Fecal occult blood test: The fecal occult blood test (FOBT) is a lab test used to check stool samples for hidden (occult) blood. The rate of early-stage disease was also higher in this group (51.3%) than in the group 2 (45.5%). et al. 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. However, the validity of our conclusions is undermined by low or very low quality of the body of evidence. Surveillance after polypectomy and after resection of colorectal cancer. RJ, Bossuyt M, Stool DNA testing. Are fit tests accurate? RW, what percentage of positive fit tests are cancer? . All Rights Reserved. So it tends to be more accurate and have fewer false positive results than other tests. Both studies appear in the Clinical Gastroenterology and Hepatology journal. A, Any disagreement was resolved through discussion or by consulting a third author (A.T.). 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. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Many successful colorectal cancer screening programs, including those in the United States, use some combination of stool-based tests, such as FIT, and screening colonoscopy, Dr. Corley said, so the new study results are very relevant to settings in the United States.. 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. Stool samples collected at home are sent in for analysis. Dwamena FIT is currently FDA-approved for spontaneous stool and DRE, however, samples are not commonly obtained by DRE. Effect of Single-Dose Aspirin Prior to FIT on Colorectal Cancer Detection. Sensitivity 98%; . This test looks for hidden blood in the stool. This important new program offers colorectal cancer screening to asymptomatic men and women between the ages of 50 and 74. A sensitivity analysis excluding studies at high or unclear risk of bias verified robustness of our conclusions. KG. A positive FIT test is concerning. A FIT kit is an alternative to a colonoscopy. MA, Perdue In other words, the . There are two types of stool tests for colon cancer. F, Amani From these findings, they concluded that a periodic FIT was an accurate test in people with average CRC risk. JE, Halloran You just need to follow instructions with the FIT kit to obtain a stool sample and return it to a lab. The DNA test is 92% effective at detecting cancers. L, Gorber 2023 American Medical Association. How Fit Is FIT for Detecting Colorectal Cancer? et al; US Preventive Services Task Force. 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. Cloud VA Health Care System would be predicted to reduce the reflex to colonoscopy, based only on . 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. Hunt Also, there are no diet or drug restrictions. The positive result could be caused by a stomach ulcer, hemorrhoids, other inflammation. 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. et al; GRADE Working Group. Arditi US Department of Health & Human Services Agency for Healthcare Research and Quality. TR, Terhaar sive Droste and P.P.) JJ, Burnand