A hierarchical regression approach to meta-analysis of diagnostic test accuracy evaluations. // The faecal immunochemical test (FIT) is a screening test for bowel cancer that can be completed in the privacy of your home. According to editorialists Senore and Zorzi, the study sheds new light on the tests sensitivity with respect to tumor characteristics. 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. People in this group were more likely to have their cancer detected only after symptoms appeared, when the cancer was more advanced. It tests for hidden blood in the stool, which can be an early sign of cancer. Amersi In one study, researchers obtained fecal samples from 435 patients with newly diagnosed CRC, calculating sensitivities of aquantitative FIT at cutoffs recommended by the manufacturer and at alternative cutoffs for tumors at different stages. Corresponding Author: Anastasia Katsoula, MD, MSc, Hippokration General Hospital of Thessaloniki 54642, Thessaloniki, Greece (anastkatsoula@gmail.com). 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. midas: meta-analysis of diagnostic accuracy studies. There are two types of stool tests for colon 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. The study should also evaluate the location and detection rate of advanced adenomas and quantitative fecal hemoglobin results during the rounds of testing. Terhaar sive Droste Main Characteristics of Studies Included in the Systematic Review and Meta-analysis, Table 2. 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). From these findings, they concluded that a periodic FIT was an accurate test in people with average CRC risk. It looks for tiny traces of blood that you might not be able to see and which could be a sign of cancer. Positive and negative predictive values were 7.7% and 99.9%, respectively. keeping a . May 5, 2022 , by Elia Ben-Ari. Heterogeneity and small sample size limit the precision of the results. Quiz Ref IDDespite the use of an exhaustive and meticulous search strategy, we could only find 12 eligible studies. The rate of early-stage disease was also higher in this group (51.3%) than in the group 2 (45.5%). by Sharon Reynolds, National Cancer Institute JPT, Green et al. FIT testing is recommended annually, and Cologuard every three years if testing is negative, but positive test results require a follow-up with colonoscopy. Data extraction and quality assessment were conducted in duplicate. False positives and false negatives do happen in Cologuard tests. AACC uses cookies to ensure the best website experience. CA. We synthesized existing data using hierarchical models to account for the correlation between sensitivity and specificity. This test uses antibodies that specifically react with a blood protein in the stool. 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). Our main analysis is based on data from 6204 participants. The fecal immunochemical test (FIT) is a screening test for colon cancer. 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). We estimated whether non-compliance with colonoscopy after a positive FIT is associated with increased CRC incidence and mortality. Advanced colonic neoplasia in the first degree relatives of colon cancer patients: A colonoscopy-based study. 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. et al. Hazazi Seven studies were deemed at high or unclear risk of bias. P, Abstract. Methodological quality of included studies graph: review authors' judgments about each item presented as percentages across all included studies, eFigure 4. R, Sampling done at home. A positive FIT is not a colorectal cancer diagnosis, but we do know that it can cause a great deal of anxiety. On the other hand, our results also show that FIT could diagnose only half of the cases with AN. 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. In 3 relevant studies, sensitivity for CRC varied from 67% to 100% and specificity from 83% to 95%. ST, Oort Eligible studies had to provide quantitative information on sensitivity and specificity or sufficient information to calculate them, and/or the area under the ROC curve (AUC/c statistic) for detection of CRC, AA or any advanced neoplasm (AN), and examine these outcomes for FIT alone and for the combination of FIT and a blood (serum/plasma) test. So, in 10 percent of cases using . Mean age ranged from 46.0 to 63.2 years, and percentage of males ranged from 30.2 to 50.6%. 51% will have a precancerous polyp. Hierarchical models were used to synthesize available evidence. A sensitivity analysis excluding studies at high or unclear risk of bias verified robustness of our conclusions. A, Bujanda Only about 4% of people will have cancer found on colonoscopy. This specific protein attaches to hemoglobin, the oxygen-carrying part of red blood cells. 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. VC, JJ, Altman L, We assessed the quality of evidence by means of Grading of Recommendations Assessment, Development and Evaluation (GRADE).16-20 Two authors (A.K. CM, Dunfield J, Rivera J, Altman B, Lieberman Just 0.7 per 1,000 subjects 50 to 59 years of age had cancer. Dr. Corley, who is the lead investigator for the colon cancer component of PROSPR, stressed the effectiveness of colorectal cancer screening. 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. A, 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. Fraser Such a strategy is associated with higher cost, lower adherence, and higher risk for rare, but serious, complications.2-6. et al; GRADE Working Group. C, doi:10.1001/jamainternmed.2017.2309. Second Generation FIT Colon Cancer Test. independently assessed risk of bias, inconsistency, indirectness, imprecision, and publication bias. The methodological quality assessment of the included studies is summarized in eFigures 2 and 3 in the Supplement. Of the 432 participants who had a positive fecal immunochemical test, 285 underwent a colonoscopy (235 participants showed no polyps or cancer, 47 had polyps identified, and three had colorectal cancer identified). 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, P, Leshno A higher detection rate for colorectal cancer and advanced adenomatous polyp for screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. D, Liberati Stool samples collected at home are sent in for analysis. This test examines DNA in your stool for evidence of cells shed by colorectal cancer. 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. Colonoscopy-controlled intra-individual comparisons to screen relevant neoplasia: faecal immunochemical test vs. guaiac-based faecal occult blood test. Anyway, if you get a positive test, do yourself a favor, don't diagnose yourself and stay off the internet. Screening for colorectal cancer: updated evidence report and systematic review for the US Preventive Services Task Force. et al. The test isn't always accurate. U. National Comprehensive Cancer Network. Robertson 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). Vleugels 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. and P.P.) EA, Jaeschke Testing for fecal occult blood is commonly used as a cancer screen for colon cancer. Respective values for AN were sensitivity, 47% (95% CI, 37%-58%); specificity, 93% (95% CI, 91%-95%); LR+, 6.90 (95% CI, 4.90-9.70); and LR, 0.56 (95% CI, 0.46-0.69). 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. 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. PF, Rutjes Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. S, ed. Nearly all of the people who had a follow-up colonoscopy did so within a year of the positive FIT result. RJ, Privacy Policy| Arditi Get the colonoscopy!" Our objective was to describe FIT PPV and the . This test is able to look for a specific type of blood in your stool which helps identify if you have any polyps (pre-cancerous growths) in your colon. 900 Seventh Street, NW Suite 400 CR, et al; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. It is thus imperative for future studies to include larger and better-defined patient populations. 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. 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. 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. C, Zubiaurre FIT is one of the most widely used colorectal cancer screening tests worldwide. FIT has high overall diagnostic accuracy for CRC in increased-risk individuals. Respective values for AN were sensitivity, 46% (95% CI, 37%-56%); specificity, 93% (95% CI, 90%-95%); LR+, 6.60 (95% CI, 4.90-8.70); and LR, 0.58 (95% CI, 0.48-0.69). Low adherence to colonoscopy in the screening of first-degree relatives of patients with colorectal cancer. You can also reduce your risk of bowel cancer by: keeping physically active. By contrast, in the no-colonoscopy group, new cases went up more gradually but continued rising over 10 years. et al; GRADE Working Group. 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. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. 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. The type of FIT used and cutoff threshold were the most important contributors to the heterogeneity of results. . Harbord Quantitative and 1-sample FIT showed adequate test performance, but data on other FIT brands and multiple samples were insufficient. et al. P. metandi: meta-analysis of diagnostic accuracy using hierarchical logistic regression. Fairly inexpensive. 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. FN indicates false-negative results; FP, false-positive results; TN, true-negative results; TP, true-positive results. Brozek Customize your JAMA Network experience by selecting one or more topics from the list below. Whiting 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). AZ, 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. F, De Wijkerslooth and P.P.) et al. 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. Yet theres clearly room for improvement. Quintero 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). H, 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. 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. Wong 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. They used Union for International Cancer Control (UICC) stage and T stage (infiltration) to measure sensitivity. et al. M, Fendrick Are fit tests accurate? Heterogeneity and wide confidence intervals limit the trustworthiness of our findings. Cloud VA Health Care System would be predicted to reduce the reflex to colonoscopy, based only on . See an example negative result letter. This is especially important for those who are averse to colonoscopy. AACC.org Meaning FJ, 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%. Given the safety, simplicity, low cost, and minimal discomfort of FIT, it is a viable alternative screening strategy for patients at increased risk for CRC. JE, Halloran Study selection methods. This important new program offers colorectal cancer screening to asymptomatic men and women between the ages of 50 and 74. Over that time, about 2 percent of the people, about 2,700 of them, had positive tests. After deduplication, we screened 2154 titles and abstracts and rejected 1952 records as noneligible. 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. 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). A prospective, controlled, feasibility study. 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. Tumors were stratified by location. Doctors call this a false-positive result. 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). Colon cancer screening is appropriate for: Adults 45 and older with an average risk for colon cancer. 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. 2017;177(8):11101118. Although this looks like a clear advantage for fecal DNA (60 of 65 cancers detected compared . At 76.6-85.8%, 1 the specificity of FIT at a cut-off of 10 is relatively high but this means that up to 25% of patients will have a false-positive result. 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.. A, Tetzlaff Brozek By continuing to use our site, or clicking "Continue," you are agreeing to our, Figure 2. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. 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. . Appropriateness of colonoscopy in Europe (EPAGE II). Results for all subgroup analyses are summarized in Table 2. 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 . O, De Chiara 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. // How Fit Is FIT for Detecting Colorectal Cancer? R, TR, Conclusions and Relevance The main findings of our study. C, SP, Young et al. NC. LM, Rooney In asymptomatic people without risk factors who had a negative FIT within 2 years, colonoscopy had a very small chance of finding CRC. To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk. A sample of the stool is placed in a tube or on a card and sent away to the doctor or laboratory for testing. Diagnostic tests 4: likelihood ratios. How Fit Is FIT for Detecting Colorectal Cancer? Statistical analysis was performed with Stata software version 13.0 (Stata Corporation), using metandi and midas modules. Most of these were at high or unclear risk of bias due to suboptimal study design. 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. 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. A review article, Rockey DC: Occult gastrointestinal bleeding. These data therefore are providing additional evidence supporting the adoption of a 2-year interval for FIT screening, wrote Senore and Zorzi. Apparently false-positive FIT results were found for 378 participants (8.1%). 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.
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