Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-Collection Devices: Preliminary Results from a Randomized Controlled Trial
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Background/Aims: We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional container). Methods: In total, 1,701 individuals (age range, 50 to 74 years) were randomized into the sampling bottle group (intervention arm) or the conventional container group (control arm). In both groups, we evaluated the FIT positivity rate, the positive predictive value for advanced neoplasia, and the detection rate for advanced neoplasia. Results: The FIT positivity rates were 4.1% for the sampling bottles and 2.0% for the conventional containers; these values were significantly different. The positive predictive values for advanced neoplasia in the sampling bottles and conventional containers were 11.1% (95% confidence interval [CI], –3.4 to 25.6) and 12.0% (95% CI, –0.7 to 24.7), respectively. The detection rates for advanced neoplasia in the sampling bottles and conventional containers were 4.5 per 1,000 persons (95% CI, 2.0 to 11.0) and 2.4 per 1,000 persons (95% CI, 0.0 to 5.0), respectively. Conclusions: The impact of these findings on FIT screening performance was unclear in this interim analysis. This impact should therefore be evaluated in the final analysis following the final enrollment period.
Abstract
Background/Aims: We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional container). Methods: In total, 1,701 individuals (age range, 50 to 74 years) were randomized into the sampling bottle group (intervention arm) or the conventional container group (control arm). In both groups, we evaluated the FIT positivity rate, the positive predictive value for advanced neoplasia, and the detection rate for advanced neoplasia. Results: The FIT positivity rates were 4.1% for the sampling bottles and 2.0% for the conventional containers; these values were significantly different. The positive predictive values for advanced neoplasia in the sampling bottles and conventional containers were 11.1% (95% confidence interval [CI], –3.4 to 25.6) and 12.0% (95% CI, –0.7 to 24.7), respectively. The detection rates for advanced neoplasia in the sampling bottles and conventional containers were 4.5 per 1,000 persons (95% CI, 2.0 to 11.0) and 2.4 per 1,000 persons (95% CI, 0.0 to 5.0), respectively. Conclusions: The impact of these findings on FIT screening performance was unclear in this interim analysis. This impact should therefore be evaluated in the final analysis following the final enrollment period.
참고문헌 (28)
- Allison JE, "Screening for colorectal neoplasms with new fecal occult blood tests: update on performance characteristics", J Natl Cancer Inst, 99, pp.1462~1470 (2007)
- Jin P, "Colorectal cancer screening with fecal occult blood test: a 22-year cohort study", Oncol Lett, 6, pp.576~582 (2013)
- Power E, "Uptake of colorectal cancer screening: system, provider and individual factors and strategies to improve participation", Future Oncol, 5, pp.1371~1388 (2009)
- 서민아, "Trends in Cancer Screening Rates among Korean Men and Women: Results from the Korean National Cancer Screening Survey, 2004-2012", Cancer Research and Treatment, 45(2), pp.86~94 (2013), 대한암학회
- Green BB, "An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial", Ann Intern Med, 158(5 Pt 1), pp.301~311 (2013)
- Ritvo PG, "Personal navigation increases colorectal cancer screening uptake", Cancer Epidemiol Biomarkers Prev, 24, pp.506~511 (2015)
- Baker DW, "Comparative effectiveness of a multifaceted intervention to improve adherence to annual colorectal cancer screening in community health centers: a randomized clinical trial", JAMA Intern Med, 174, pp.1235~1241 (2014)
- Vilkin A, "Performance characteristics and evaluation of an automated-developed and quantitative, immunochemical, fecal occult blood screening test", Am J Gastroenterol, 100, pp.2519~2525 (2005)
- 유수진, "분변 검체의 분석 전 보관 상태가 분변잠혈반응검사 결과에 미치는 영향", Annals of Laboratory Medicine, 29(3), pp.262~267 (2009), 대한진단검사의학회
- Shin HY, "The effect of changing stool collection processes on compliance in nationwide organized screening using a fecal occult blood test (FOBT) in Korea: study protocol for a randomized controlled trial", Trials, 15, pp.461~ (2014)
- Lieberman DA, "Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer", Gastroenterology, 143, pp.844~857 (2012)
- Park B, "Cancer screening status in Korea, 2011: results from the Korean National Cancer Screening Survey", Asian Pac J Cancer Prev, 13, pp.1187~1191 (2012)
- Whitlock EP, "Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force", Ann Intern Med, 149, pp.638~658 (2008)
- van Rossum LG, "Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population", Gastroenterology, 135, pp.82~90 (2008)
- Hol L, "Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels", Br J Cancer, 100, pp.1103~1110 (2009)
- Hol L, "Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy", Gut, 59, pp.62~68 (2010)
- van Roon AH, "Diagnostic yield improves with collection of 2 samples in fecal immunochemical test screening without affecting attendance", Clin Gastroenterol Hepatol, 9, pp.333~339 (2011)
- de Wijkerslooth TR, "Immunochemical fecal occult blood testing is equally sensitive for proximal and distal advanced neoplasia", Am J Gastroenterol, 107, pp.1570~1578 (2012)
- Castiglione G, "Basic variables at different positivity thresholds of a quantitative immunochemical test for faecal occult blood", J Med Screen, 9, pp.99~103 (2002)
- Grazzini G, "Immunochemical faecal occult blood test: number of samples and positivity cutoff. What is the best strategy for colorectal cancer screening?", Br J Cancer, 100, pp.259~265 (2009)
- Van Roosbroeck S, "Population-based screening for colorectal cancer using an immunochemical faecal occult blood test: a comparison of two invitation strategies", Cancer Epidemiol, 36, pp.e317~e324 (2012)
- Park MJ, "A comparison of qualitative and quantitative fecal immunochemical tests in the Korean national colorectal cancer screening program", Scand J Gastroenterol, 47, pp.461~466 (2012)
- James E. Allison, "Population Screening for Colorectal Cancer Means Getting FIT: The Past, Present, and Future of Colorectal Cancer Screening Using the Fecal Immunochemical Test for Hemoglobin (FIT)", Gut and Liver, 8(2), pp.117~130 (2014), 거트앤리버 발행위원회
- van Rossum LG, "False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening", Int J Cancer, 125, pp.746~750 (2009)
- van Rossum LG, "Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme", Br J Cancer, 101, pp.1274~1281 (2009)
- Brenner H, "Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy", Eur J Cancer, 49, pp.3049~3054 (2013)
- Hamza S, "Diagnostic yield of a one sample immunochemical test at different cut-off values in an organised screening programme for colorectal cancer", Eur J Cancer, 49, pp.2727~2733 (2013)
- Wong MC, "A validated tool to predict colorectal neoplasia and inform screening choice for asymptomatic subjects", Gut, 63, pp.1130~1136 (2014)