Gender Differences in Fecal Immunochemical Test Performance for Early Detection of Colorectal Neoplasia

Atija Kapidzic; Miriam P van der Meulen; Lieke Hol; Aafke H C van Roon; Caspar W N Looman; Iris Lansdorp-Vogelaar; Marjolein van Ballegooijen; Anneke J van Vuuren; Jacqueline C I Y Reijerink; Monique E. van Leerdam; Ernst J Kuipers

doi:10.1016/j.cgh.2015.02.023

Gender Differences in Fecal Immunochemical Test Performance for Early Detection of Colorectal Neoplasia

Atija Kapidzic^*, Miriam P van der Meulen, Lieke Hol, Aafke H C van Roon, Caspar W N Looman, Iris Lansdorp-Vogelaar, Marjolein van Ballegooijen, Anneke J van Vuuren, Jacqueline C I Y Reijerink, Monique E. van Leerdam, Ernst J Kuipers

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND & AIMS: Fecal immunochemical tests (FITs) are used widely in colorectal cancer screening. Programs use the same fecal hemoglobin threshold for colonoscopy referral for men and women, but it is unclear whether FIT performs equally in both sexes. We therefore assessed FIT performance in men and women.

METHODS: A prospective cohort study was performed, in which a total of 10,008 average-risk subjects (age, 50-74 y) were invited for first-round screening and 8316 average-risk subjects (age, 51-74 y) were invited for second-round screening with a single FIT. Subjects with a hemoglobin (Hb) level of 10 μg hemoglobin (Hb)/g (or ≥50 ng/mL) feces or higher were referred for colonoscopy. The test characteristics were assessed by sex for a range of FIT cut-off values.

RESULTS: In total, 59.8% of men and 64.6% of women participated in the first round (P < .001). At a cut-off level of 10 μg Hb/g feces, the positivity rate was significantly higher among men (10.7%) compared with women (6.3%; P < .001) in the first round. The detection rate of advanced neoplasia was 4.4% for men and 2.2% for women (P < .001) in the first round. The positive predictive value for advanced neoplasia in the first round was 42% for men and 37% for women (P = .265). A significantly higher false-positive rate in men (6.3%) than in women (4.1%; P < .001) was found. Similar differences in these test characteristics were seen in the second round.

CONCLUSIONS: At a cut-off level of 10 μg Hb/g feces the FIT positivity rate was higher in men, reflected by both a higher detection rate and a higher false-positive rate. The use of the same cut-off value in men and women in FIT screening is recommended based on equal test performance in terms of positive predictive value.

Original language	English
Pages (from-to)	1464-1471.e4
Journal	Clinical Gastroenterology and Hepatology
Volume	13
Issue number	8
DOIs	https://doi.org/10.1016/j.cgh.2015.02.023
Publication status	Published - Aug 2015
Externally published	Yes

Keywords

Aged
Clinical Laboratory Techniques/methods
Colorectal Neoplasms/diagnosis
Diagnostic Tests, Routine/methods
Feces/chemistry
Female
Hemoglobins/analysis
Humans
Immunoassay/methods
Male
Mass Screening/methods
Middle Aged
Prospective Studies
Sex Factors

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10.1016/j.cgh.2015.02.023

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Kapidzic, A., van der Meulen, M. P., Hol, L., van Roon, A. H. C., Looman, C. W. N., Lansdorp-Vogelaar, I., van Ballegooijen, M., van Vuuren, A. J., Reijerink, J. C. I. Y., van Leerdam, M. E., & Kuipers, E. J. (2015). Gender Differences in Fecal Immunochemical Test Performance for Early Detection of Colorectal Neoplasia. Clinical Gastroenterology and Hepatology, 13(8), 1464-1471.e4. https://doi.org/10.1016/j.cgh.2015.02.023

@article{5d4d440e9cc040a3b14f33f6cea45c67,

title = "Gender Differences in Fecal Immunochemical Test Performance for Early Detection of Colorectal Neoplasia",

abstract = "BACKGROUND & AIMS: Fecal immunochemical tests (FITs) are used widely in colorectal cancer screening. Programs use the same fecal hemoglobin threshold for colonoscopy referral for men and women, but it is unclear whether FIT performs equally in both sexes. We therefore assessed FIT performance in men and women.METHODS: A prospective cohort study was performed, in which a total of 10,008 average-risk subjects (age, 50-74 y) were invited for first-round screening and 8316 average-risk subjects (age, 51-74 y) were invited for second-round screening with a single FIT. Subjects with a hemoglobin (Hb) level of 10 μg hemoglobin (Hb)/g (or ≥50 ng/mL) feces or higher were referred for colonoscopy. The test characteristics were assessed by sex for a range of FIT cut-off values.RESULTS: In total, 59.8% of men and 64.6% of women participated in the first round (P < .001). At a cut-off level of 10 μg Hb/g feces, the positivity rate was significantly higher among men (10.7%) compared with women (6.3%; P < .001) in the first round. The detection rate of advanced neoplasia was 4.4% for men and 2.2% for women (P < .001) in the first round. The positive predictive value for advanced neoplasia in the first round was 42% for men and 37% for women (P = .265). A significantly higher false-positive rate in men (6.3%) than in women (4.1%; P < .001) was found. Similar differences in these test characteristics were seen in the second round.CONCLUSIONS: At a cut-off level of 10 μg Hb/g feces the FIT positivity rate was higher in men, reflected by both a higher detection rate and a higher false-positive rate. The use of the same cut-off value in men and women in FIT screening is recommended based on equal test performance in terms of positive predictive value.",

keywords = "Aged, Clinical Laboratory Techniques/methods, Colorectal Neoplasms/diagnosis, Diagnostic Tests, Routine/methods, Feces/chemistry, Female, Hemoglobins/analysis, Humans, Immunoassay/methods, Male, Mass Screening/methods, Middle Aged, Prospective Studies, Sex Factors",

author = "Atija Kapidzic and {van der Meulen}, {Miriam P} and Lieke Hol and {van Roon}, {Aafke H C} and Looman, {Caspar W N} and Iris Lansdorp-Vogelaar and {van Ballegooijen}, Marjolein and {van Vuuren}, {Anneke J} and Reijerink, {Jacqueline C I Y} and {van Leerdam}, {Monique E.} and Kuipers, {Ernst J}",

note = "Copyright {\textcopyright} 2015. Published by Elsevier Inc.",

year = "2015",

month = aug,

doi = "10.1016/j.cgh.2015.02.023",

language = "English",

volume = "13",

pages = "1464--1471.e4",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders",

number = "8",

}

Kapidzic, A, van der Meulen, MP, Hol, L, van Roon, AHC, Looman, CWN, Lansdorp-Vogelaar, I, van Ballegooijen, M, van Vuuren, AJ, Reijerink, JCIY, van Leerdam, ME & Kuipers, EJ 2015, 'Gender Differences in Fecal Immunochemical Test Performance for Early Detection of Colorectal Neoplasia', Clinical Gastroenterology and Hepatology, vol. 13, no. 8, pp. 1464-1471.e4. https://doi.org/10.1016/j.cgh.2015.02.023

TY - JOUR

T1 - Gender Differences in Fecal Immunochemical Test Performance for Early Detection of Colorectal Neoplasia

AU - Kapidzic, Atija

AU - van der Meulen, Miriam P

AU - Hol, Lieke

AU - van Roon, Aafke H C

AU - Looman, Caspar W N

AU - Lansdorp-Vogelaar, Iris

AU - van Ballegooijen, Marjolein

AU - van Vuuren, Anneke J

AU - Reijerink, Jacqueline C I Y

AU - van Leerdam, Monique E.

AU - Kuipers, Ernst J

PY - 2015/8

Y1 - 2015/8

N2 - BACKGROUND & AIMS: Fecal immunochemical tests (FITs) are used widely in colorectal cancer screening. Programs use the same fecal hemoglobin threshold for colonoscopy referral for men and women, but it is unclear whether FIT performs equally in both sexes. We therefore assessed FIT performance in men and women.METHODS: A prospective cohort study was performed, in which a total of 10,008 average-risk subjects (age, 50-74 y) were invited for first-round screening and 8316 average-risk subjects (age, 51-74 y) were invited for second-round screening with a single FIT. Subjects with a hemoglobin (Hb) level of 10 μg hemoglobin (Hb)/g (or ≥50 ng/mL) feces or higher were referred for colonoscopy. The test characteristics were assessed by sex for a range of FIT cut-off values.RESULTS: In total, 59.8% of men and 64.6% of women participated in the first round (P < .001). At a cut-off level of 10 μg Hb/g feces, the positivity rate was significantly higher among men (10.7%) compared with women (6.3%; P < .001) in the first round. The detection rate of advanced neoplasia was 4.4% for men and 2.2% for women (P < .001) in the first round. The positive predictive value for advanced neoplasia in the first round was 42% for men and 37% for women (P = .265). A significantly higher false-positive rate in men (6.3%) than in women (4.1%; P < .001) was found. Similar differences in these test characteristics were seen in the second round.CONCLUSIONS: At a cut-off level of 10 μg Hb/g feces the FIT positivity rate was higher in men, reflected by both a higher detection rate and a higher false-positive rate. The use of the same cut-off value in men and women in FIT screening is recommended based on equal test performance in terms of positive predictive value.

AB - BACKGROUND & AIMS: Fecal immunochemical tests (FITs) are used widely in colorectal cancer screening. Programs use the same fecal hemoglobin threshold for colonoscopy referral for men and women, but it is unclear whether FIT performs equally in both sexes. We therefore assessed FIT performance in men and women.METHODS: A prospective cohort study was performed, in which a total of 10,008 average-risk subjects (age, 50-74 y) were invited for first-round screening and 8316 average-risk subjects (age, 51-74 y) were invited for second-round screening with a single FIT. Subjects with a hemoglobin (Hb) level of 10 μg hemoglobin (Hb)/g (or ≥50 ng/mL) feces or higher were referred for colonoscopy. The test characteristics were assessed by sex for a range of FIT cut-off values.RESULTS: In total, 59.8% of men and 64.6% of women participated in the first round (P < .001). At a cut-off level of 10 μg Hb/g feces, the positivity rate was significantly higher among men (10.7%) compared with women (6.3%; P < .001) in the first round. The detection rate of advanced neoplasia was 4.4% for men and 2.2% for women (P < .001) in the first round. The positive predictive value for advanced neoplasia in the first round was 42% for men and 37% for women (P = .265). A significantly higher false-positive rate in men (6.3%) than in women (4.1%; P < .001) was found. Similar differences in these test characteristics were seen in the second round.CONCLUSIONS: At a cut-off level of 10 μg Hb/g feces the FIT positivity rate was higher in men, reflected by both a higher detection rate and a higher false-positive rate. The use of the same cut-off value in men and women in FIT screening is recommended based on equal test performance in terms of positive predictive value.

KW - Aged

KW - Clinical Laboratory Techniques/methods

KW - Colorectal Neoplasms/diagnosis

KW - Diagnostic Tests, Routine/methods

KW - Feces/chemistry

KW - Female

KW - Hemoglobins/analysis

KW - Humans

KW - Immunoassay/methods

KW - Male

KW - Mass Screening/methods

KW - Middle Aged

KW - Prospective Studies

KW - Sex Factors

U2 - 10.1016/j.cgh.2015.02.023

DO - 10.1016/j.cgh.2015.02.023

M3 - Article

C2 - 25724706

SN - 1542-3565

VL - 13

SP - 1464-1471.e4

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 8

ER -

Gender Differences in Fecal Immunochemical Test Performance for Early Detection of Colorectal Neoplasia

Abstract

Keywords

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