title: Prospective cross-sectional study on faecal immunochemical tests: sex specific cut-off values to obtain equal sensitivity for colorectal cancer?
abstract: BACKGROUND
  Faecal immunochemical tests (FITs) are commonly used in colorectal cancer (CRC) screening. Diagnostic accuracy of FIT differs between males and females. This so far unexplained difference could result in a dissimilarity in screening outcome between both sexes. The aim of this study is to compare sensitivity and specificity of a FIT between males and females, and study potential explanatory variables.
  
  
  METHODS
  In this cross-sectional study, data were prospectively collected. 3,022 subjects performed a FIT prior to complete colonoscopy. Sensitivity, specificity, and ROC curves were compared for both sexes. Potential explanatory variables of the relation between sensitivity and sex were explored.
  
  
  RESULTS
  At all cut-off values, FIT sensitivity for CRC was higher (range 13-23%) and specificity was lower (range 2-4%) in males compared to females. At 75 ng/ml, sensitivity for CRC was 93% in males compared to 71% in females (p = 0.03), and specificity was 90% in males compared to 93% in females (p = <0.05). For advanced adenomas, males had a slightly higher sensitivity and lower specificity (not significant). At 75 ng/ml, sensitivity for advanced adenomas was 33% in males compared to 29% in females (p = 0.46), and specificity was 93% in males compared to 95% in females (p = 0.22). ROC curves were similar for both sexes, and equal combinations of sensitivity and specificity could be achieved by adjusting the cut-off values. For CRC, the difference in sensitivity could not be explained by age or location of the tumour.
  
  
  CONCLUSIONS
  FIT has a higher sensitivity and a lower specificity for CRC in males than in females. Equal test characteristics can be achieved by allowing separate cut-off values for both sexes. Location and age do not explain the observed differences in sensitivity.
authors.affiliation: Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, the Netherlands. s.vanturenhout@vumc.nl.
authors.forename: Sietze T
authors.initials: ST
authors.lastname: van Turenhout
authors.affiliation: Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, the Netherlands. f.oort@vumc.nl.
authors.forename: Frank A
authors.initials: FA
authors.lastname: Oort
authors.affiliation: Gastroenterology and Hepatology, Kennemer Gasthuis, Haarlem, the Netherlands. hulst@kg.nl.
authors.forename: René W M
authors.initials: RW
authors.lastname: van der Hulst
authors.affiliation: Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, the Netherlands. ap.visscher@vumc.nl.|Gastroenterology and Hepatology, Kennemer Gasthuis, Haarlem, the Netherlands. ap.visscher@vumc.nl.
authors.forename: Arjen P
authors.initials: AP
authors.lastname: Visscher
authors.affiliation: Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, the Netherlands. js.terhaar@vumc.nl.
authors.forename: Jochim S
authors.initials: JS
authors.lastname: Terhaar sive Droste
authors.affiliation: Gastroenterology and Hepatology, Sint Lucas Andreas Hospital, Amsterdam, the Netherlands. p.scholten@slaz.nl.
authors.forename: Pieter
authors.initials: P
authors.lastname: Scholten
authors.affiliation: Clinical Chemistry, VU University Medical Centre, Amsterdam, the Netherlands. a.bouman@vumc.nl.
authors.forename: Anneke A
authors.initials: AA
authors.lastname: Bouman
authors.affiliation: Pathology, VU University Medical Centre, Amsterdam, the Netherlands. ga.meijer@vumc.nl.
authors.forename: Gerrit A
authors.initials: GA
authors.lastname: Meijer
authors.affiliation: Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, the Netherlands. cjmulder@vumc.nl.
authors.forename: Chris J J
authors.initials: CJ
authors.lastname: Mulder
authors.affiliation: Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, the Netherlands. l.g.m.v.rossum@gr.nl.|Department for health evidence, Radboud University Medical Centre, Nijmegen, the Netherlands. l.g.m.v.rossum@gr.nl.
authors.forename: Leo G M
authors.initials: LG
authors.lastname: van Rossum
authors.affiliation: Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, the Netherlands. v.coupe@vumc.nl.
authors.forename: Veerle M H
authors.initials: VM
authors.lastname: Coupé
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D003430:Cross-Sectional Studies; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009780:Occult Blood; D011446:Prospective Studies; D012372:ROC Curve; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D006454:Hemoglobins