title: The fecal hemoglobin concentration, age and sex test score: Development and external validation of a simple prediction tool for colorectal cancer detection in symptomatic patients.
abstract: Prediction models for colorectal cancer (CRC) detection in symptomatic patients, based on easily obtainable variables such as fecal haemoglobin concentration (f-Hb), age and sex, may simplify CRC diagnosis. We developed, and then externally validated, a multivariable prediction model, the FAST Score, with data from five diagnostic test accuracy studies that evaluated quantitative fecal immunochemical tests in symptomatic patients referred for colonoscopy. The diagnostic accuracy of the Score in derivation and validation cohorts was compared statistically with the area under the curve (AUC) and the Chi-square test. 1,572 and 3,976 patients were examined in these cohorts, respectively. For CRC, the odds ratio (OR) of the variables included in the Score were: age (years): 1.03 (95% confidence intervals (CI): 1.02-1.05), male sex: 1.6 (95% CI: 1.1-2.3) and f-Hb (0-<20 µg Hb/g feces): 2.0 (95% CI: 0.7-5.5), (20-<200 µg Hb/g): 16.8 (95% CI: 6.6-42.0), ≥200 µg Hb/g: 65.7 (95% CI: 26.3-164.1). The AUC for CRC detection was 0.88 (95% CI: 0.85-0.90) in the derivation and 0.91 (95% CI: 0.90-093; p = 0.005) in the validation cohort. At the two Score thresholds with 90% (4.50) and 99% (2.12) sensitivity for CRC, the Score had equivalent sensitivity, although the specificity was higher in the validation cohort (p < 0.001). Accordingly, the validation cohort was divided into three groups: high (21.4% of the cohort, positive predictive value-PPV: 21.7%), intermediate (59.8%, PPV: 0.9%) and low (18.8%, PPV: 0.0%) risk for CRC. The FAST Score is an easy to calculate prediction tool, highly accurate for CRC detection in symptomatic patients.
authors.affiliation: Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.|Instituto de Investigación Biomedica (IBI) Ourense, Pontevedra y Vigo, Vigo, Spain.
authors.forename: Joaquín
authors.identifier: http://orcid.org/0000-0002-9994-4831
authors.initials: J
authors.lastname: Cubiella
authors.affiliation: Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom.
authors.forename: Jayne
authors.initials: J
authors.lastname: Digby
authors.affiliation: Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.|Ciber de Epidemiología y Salud Pública (CIBERESP), Spain.
authors.forename: Lorena
authors.initials: L
authors.lastname: Rodríguez-Alonso
authors.affiliation: Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Vega
authors.affiliation: Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Salve
authors.affiliation: Clinical Analysis Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Díaz-Ondina
authors.affiliation: Blood Sciences, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Strachan
authors.affiliation: Department of Gastroenterology, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom.
authors.forename: Craig
authors.initials: C
authors.lastname: Mowat
authors.affiliation: Kings Cross Hospital, Scottish Bowel Screening Centre, Dundee, Scotland, United Kingdom.
authors.forename: Paula J
authors.initials: PJ
authors.lastname: McDonald
authors.affiliation: Department of Pathology, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom.
authors.forename: Francis A
authors.initials: FA
authors.lastname: Carey
authors.affiliation: Department of Biochemistry, Monklands Hospital, Airdrie, Lanarkshire, Scotland, United Kingdom.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Godber
authors.affiliation: Department of Surgery, Wishaw General Hospital, Wishaw, Lanarkshire, Scotland, United Kingdom.
authors.forename: Hakim Ben
authors.initials: HB
authors.lastname: Younes
authors.affiliation: Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.|Ciber de Epidemiología y Salud Pública (CIBERESP), Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Rodriguez-Moranta
authors.affiliation: Gastroenterology Department, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, Tenerife, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Quintero
authors.affiliation: Gastroenterology Department, Complejo Hospitalario de Pontevedra, Pontevedra, Spain.
authors.forename: Victoria
authors.initials: V
authors.lastname: Álvarez-Sánchez
authors.affiliation: Gastroenterology Department, Hospital Universitari Mútua de Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Terrassa, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Fernández-Bañares
authors.affiliation: Gastroenterology Department, Consorci Sanitari de Terrassa, Terrassa, Spain.
authors.forename: Jaume
authors.initials: J
authors.lastname: Boadas
authors.affiliation: Gastroenterology Department, Hospital de Sabadell, Corporació Sanitària i Universitària Parc Taulí, Sabadell, Spain.
authors.forename: Rafel
authors.initials: R
authors.lastname: Campo
authors.affiliation: Donostia Hospital, Biodonostia Institute, University of the Basque Country UPV/EHU (CIBERehd), San Sebastian, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Bujanda
authors.affiliation: Gastroenterology Department, Hospital de Sagunto, Sagunto, Valencia, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Garayoa
authors.affiliation: Servicio de Aparato Digestivo, Hospital Clínico Universitario, IIS Aragón, University of Zaragoza, (CIBERehd), Zaragoza, Spain.
authors.forename: Ángel
authors.initials: Á
authors.lastname: Ferrandez
authors.affiliation: Gastroenterology Department, Hospital Dr. Josep Trueta, Girona, Spain.
authors.forename: Virginia
authors.initials: V
authors.lastname: Piñol
authors.affiliation: Digestive Disease Section, Hospital Universitario de Móstoles, Madrid, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Rodríguez-Alcalde
authors.affiliation: Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.|Ciber de Epidemiología y Salud Pública (CIBERESP), Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Guardiola
authors.affiliation: Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom.
authors.forename: Robert J C
authors.initials: RJ
authors.lastname: Steele
authors.affiliation: Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom.
authors.forename: Callum G
authors.initials: CG
authors.lastname: Fraser
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D019540:Area Under Curve; D003113:Colonoscopy / Q000379:methods*; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000378:metabolism; D003955:Diagnostic Tests, Routine / Q000379:methods*; D055088:Early Detection of Cancer; D005243:Feces / Q000737:chemistry*; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D011379:Prognosis; D012737:Sex Factors; D055815:Young Adult
chemical_list: D006454:Hemoglobins
keywords: advanced colorectal neoplasia; colonoscopy; colorectal cancer; diagnostic accuracy; fecal immunochemical test; inflammatory bowel disease; risk stratification