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We assessed quality using a meticulous, recently developed tool (QUADAS-2). You can change these settings at any time, but that may impair functionality on our websites. BM, Parton Corresponding Author: Anastasia Katsoula, MD, MSc, Hippokration General Hospital of Thessaloniki 54642, Thessaloniki, Greece (anastkatsoula@gmail.com). For example, peoples fears about the preparation for colonoscopy continue to be a major barrier. 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. Data Extraction and Synthesis The last search was performed in August 2016 (eFigure 1 in the Supplement). JPT, Green Tests and investigations for colorectal cancer screening. // Stool DNA testing. et al; GRADE Working Group. 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. 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. S, Vilkin SJ, Based on GRADE summaries (eTable 2 in the Supplement) we deemed the quality of the evidence to be low or very low. and P.P.) Colon cancer screening is appropriate for: Adults 45 and older with an average risk for colon cancer. Such a strategy is associated with higher cost, lower adherence, and higher risk for rare, but serious, complications.2-6. Respective values for AN varied from 37% to 56% for sensitivity and 92 to 98% for specificity. JL, Akl JA, Eisen In a study from the Netherlands, 4523 people (age range, 50-74) underwent FIT screening with OC-Sensor Micro; a hemoglobin concentration of 50 ng/mL was considered positive. Fecal Immunochemical Test (FIT): common questions. 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 L, Rodriguez-Berrocal The Journal of Applied Laboratory Medicine, A Global Strategy to Eliminate Cervical Cancer, A New Model for Personalized Reference Intervals, How Fit Is FIT for Detecting Colorectal Cancer, How Underspecification Undermines Artificial Intelligence, The Sprint Toward a Better SARS CoV 2 Diagnostics Data System, Commission on Accreditation in Clinical Chemistry. Finally, we explored the clinical utility of FIT for patients at increased risk of CRC by means of Fagan nomogram. 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). Complications of colonoscopy. In other words, the . et al. L, Gorber K, Moons Colonoscopy is a good test for finding polyps or cancer in the bowel. independently assessed risk of bias, inconsistency, indirectness, imprecision, and publication bias. EM, Individuals at average risk are screened using the fecal immunochemical test (FIT), which has been available in British Columbia for the past 5 years R, Rozen Harbord 20 participants of the 47 who had polyps had advanced adenomas . 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The use of FIT in symptomatic patients is associated with a better prognosis in CRC. Carroll et al. Critical revision of the manuscript for important intellectual content: All authors. We fitted hierarchical logistic regression models when 4 or more studies were available.21-24. and percentage of males ranged from 30.2 to 50.6%. This demonstrates the longer-term protective value of completing the screening process, which is another new piece of information provided by the study, Dr. Corley said. However, most studies had a small sample size or low prevalence of CRC or AN, limiting the precision of effect estimates. 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. I had problems a few years back and did a colonoscopy, which came back ok. Now this!! FIT is currently FDA-approved for spontaneous stool and DRE, however, samples are not commonly obtained by DRE. 12 Data from outside the United States . A positive FIT is not a colorectal cancer diagnosis, but we do know that it can cause a great deal of anxiety. by Sharon Reynolds, National Cancer Institute On the other hand, the posttest probability for CRC or AN following a negative result of FIT is 0% or 6.0% respectively (eFigure 7 in the Supplement). AZ, Customize your JAMA Network experience by selecting one or more topics from the list below. midas: meta-analysis of diagnostic accuracy studies. What is the diagnostic accuracy of fecal immunochemical testing (FIT) for screening of colorectal cancer (CRC) or advanced neoplasia in asymptomatic high-risk populations? E, Wong The researchers identified 268 cases of CRC from a database search of 96,804 subjects ages 5075 years with initial negative FIT results. Multiple factors can contribute to people not getting follow-up colonoscopy exams, both he and Dr. Breslau said. 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). 95 percent CI 5.1-9.3 percent predicts FIT will be positive in this low-risk symptomatic group, whereas 99.8 per cent CI 99.5-99.9 per cent predicts FIT would be negative. It has recently been suggested that fecal immunochemical testing (FIT) could be used for population-based screening owing to its high accuracy and adherence.7-9 Previous systematic reviews and meta-analyses have assessed the performance of FIT in average-risk populations.10,11 However, the potential role of FIT for screening of individuals at increased risk for CRC has not yet been fully elucidated. Diagnostic accuracy of faecal immunochemical test for screening individuals with a family history of colorectal cancer. 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. Cologuard is one of six approved methods for colon cancer screening in the United States, including one of three stool-based tests. It tests for non-visible blood in poo, which can be an early sign of bowel cancer. Finally, we evaluated the clinical utility of FIT utilizing Fagan nomograms to depict posttest probability in patients at increased risk for CRC and AN. B, Bacchus These data therefore are providing additional evidence supporting the adoption of a 2-year interval for FIT screening, wrote Senore and Zorzi. AS, Rutjes Bujanda Stool tests are done to look for signs of cancer by testing for blood in . Whiting 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. 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. So, in 10 percent of cases using . A negative Cologuard test means that the home test did not detect significant levels of DNA and/or hemoglobin biomarkers in the stool that are associated with colorectal cancer. Bibbins-Domingo Testing for fecal occult blood is commonly used as a cancer screen for colon cancer. U. 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. VC, We undertook a comprehensive search of multiple electronic databases and gray literature sources without imposing any restrictions based on language or publication type. 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. The most common types of cancer that lead to positive fit test results include colorectal, breast, and lung cancers. Cologuard found 93 percent of the cancers detected by screening colonoscopy. KG. M, Of those, about 1.2% have a positive fit test result. 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. 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. To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk. JS, Piper MA, Perdue Acquisition, analysis, or interpretation of data: All authors. Parekh 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. ME, Colorectal cancer screening comparing no screening, immunochemical and guaiac fecal occult blood tests: a cost-effectiveness analysis. 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. Positive and negative predictive values were 43.8% and 94.0%, respectively. Several recently published guidelines support the use of FIT for screening of average-risk participants.44,45 The Canadian Task Force on Preventive Health Care excludes colonoscopy as a primary screening test and recommends screening only with FIT, guaiacbased fecal occult blood tests, or flexible sigmoidoscopy.46 Our results are in line with these suggestions and support use of FIT for screening of increased-risk individuals. Medicines and foods do not interfere with the test. Advanced colonic neoplasia in the first degree relatives of colon cancer patients: A colonoscopy-based study. After deduplication, we screened 2154 titles and abstracts and rejected 1952 records as noneligible. 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. FIT detects 74% of colon cancers and 24% of large colorectal polyps. Robertson AZ, Quintero Doctors call this a false-positive result. E, Carrillo 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. RA, Davenport For each study we recalculated the sensitivity and specificity with 95% CIs from the true-positive (TP), false-positive (FP), false-negative (FN), and true-negative (TN) results, using Review Manager 5.3 (Cochrane Community). JK, Boland et al. Washington, DC 20001 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. JY, Chan Faecal immunochemical test accuracy in patients referred for surveillance colonoscopy: a multi-centre cohort study. 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. Reasons for participation and nonparticipation in colorectal cancer screening: a randomized trial of colonoscopy and CT colonography. Hazazi Dwamena 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. Background The risk of colorectal cancer (CRC) among subjects with a positive faecal immunochemical test (FIT) who do not undergo a colonoscopy is unknown. 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). C, Zubiaurre Terhaar sive Droste J, Altman AW, Westwood We estimated whether non-compliance with colonoscopy after a positive FIT is associated with increased CRC incidence and mortality. This study shows that even with a national health service that provides universal coverage, there are other barriers to obtaining care, Dr. Breslau said. 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. Forest plots demonstrated a high degree of heterogeneity for sensitivity estimates (Figure 2). A positive test can mean other conditions however. Clinical literature and commentary point to a new protocol for evaluating fecal immunochemical testing (FIT) and how well this modality flags colorectal cancer (CRC). Objective We synthesized data regardless of the FIT cutoff used. . van Rossum JK, Liles The main advantage of this test, which costs . L, Study selection methods. Overall quality was deemed very low, low, moderate, or high using GRADEpro version 3.6 (GRADEpro GDT). It's possible for a stool DNA test to show signs of cancer, but no cancer is found with other tests. My test results came back positive. Second Generation FIT Colon Cancer Test. Finally, the effects on quality of life, morbidity, mortality and overall cost-effectiveness need to be clarified in future studies.49-51. Get the colonoscopy!" 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). et al. In 3 relevant studies, sensitivity for CRC varied from 67% to 100% and specificity from 83% to 95%. 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.