IJC International Journal of Cancer
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 Joaquın Cubiella 1,2, Jayne Digby3, Lorena Rodrıguez-Alonso4,5, Pablo Vega1, Marıa Salve1, Marta Dıaz-Ondina6, Judith A. Strachan7, Craig Mowat8, Paula J. McDonald9, Francis A. Carey10, Ian M. Godber11, Hakim Ben Younes12, nchez14, Fernando Ferna ndez-Ban ~ares15, Francisco Rodriguez-Moranta4,5, Enrique Quintero13, Victoria Alvarez-S a ~ol21, Jaume Boadas16, Rafel Campo17, Luis Bujanda18, Ana Garayoa19, Angel Ferrandez20, Virginia Pin 22 4,5 3 3 Daniel Rodrıguez-Alcalde , Jordi Guardiola , Robert J.C. Steele , Callum G. Fraser , on behalf of the COLONPREDICT study investigators 1
Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain n Biomedica (IBI) Ourense, Pontevedra y Vigo, Vigo, Spain Instituto de Investigacio 3 Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom 4 Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L’Hospitalet de Llobregat, Barcelona, Spain 5 blica (CIBERESP), Spain Ciber de Epidemiologıa y Salud Pu 6 Clinical Analysis Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain 7 Blood Sciences, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom 8 Department of Gastroenterology, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom 9 Kings Cross Hospital, Scottish Bowel Screening Centre, Dundee, Scotland, United Kingdom 10 Department of Pathology, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom 11 Department of Biochemistry, Monklands Hospital, Airdrie, Lanarkshire, Scotland, United Kingdom 12 Department of Surgery, Wishaw General Hospital, Wishaw, Lanarkshire, Scotland, United Kingdom 13 n Gastroenterology Department, Hospital Universitario de Canarias, Instituto Universitario de Tecnologıas Biomedicas (ITB) & Centro de Investigacio Biomedica de Canarias (CIBICAN), Universidad de La Laguna, Tenerife, Spain
Key words: advanced colorectal neoplasia, colonoscopy, colorectal cancer, diagnostic accuracy, fecal immunochemical test, inflammatory bowel disease, risk stratification Abbreviations: AN: advanced neoplasia; AUC: area under the curve; CI: confidence interval; CRC: colorectal cancer; EPAGE: European Panel on the Appropriateness of Gastrointestinal Endoscopy; f-Hb: fecal haemoglobin concentration; FIT: fecal immunochemical test for haemoglobin; IBD: inflammatory bowel disease; LIMS: laboratory information management system; NICE: National Institute for Health and Care Excellence; NNS: number needed to scope; OR: odds ratio; PPV: positive predictive value; ROC: receiver operating characteristic; SCL: significant colonic lesion Additional Supporting Information may be found in the online version of this article. All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: JC and MS had financial support from Instituto de Salud Carlos III for the submitted work but they had no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. CGF has undertaken consultancy with Immunostics, Ocean, NJ, USA; and Kyowa-Medex Co., Ltd., Tokyo, Japan: and has received travel support from Alpha Labs, Eastleigh, UK. EQ has undertaken advisory for Sysmex Spain. The remaining authors had no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years and no other relationships or activities that could appear to have influenced the submitted work The ethical approval for each of the studies included are documented in detail in the relevant publications cited in the text This research was presented in the World Endoscopy Organization Colorectal Cancer Screening Committee Meeting held in Barcelona, October 23, 2015; the 23rd United European Gastroenterology Week, held in Barcelona, October 24–28, 2015 and in the XIX Reunion Nacional de la Asociacion Espa~ nola de Gastroenterologia held in Madrid, March, 1–4, 2016 JC, JD, FRM, RJCS and CGF participated in the model development design; JD, LRA, PV, MS, MDO, JAS, CM, PJMcD, FAC, IMG, HBY, FRM, EQ, VAS, FFB, JB, RC, LB, AG, AF, VP, DRA and JG in the recruitment of the derivation and validation cohorts; JC, JD, FRM, RJCS and CGF in the derivation and validation of the prediction model; JC, JD, RJCS and CGF in the preparation of drafts of the manuscript. All authors contributed to the writing of the paper. All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. JC acted as full guarantor of the research DOI: 10.1002/ijc.30639 History: Received 2 Oct 2016; Accepted 30 Jan 2017; Online 10 Feb 2017 Correspondence to: Joaquın Cubiella, Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, C/Ramon Puga 52-54, 32005 Ourense, Spain, Tel.: 134 988385399, Fax: 134 988385399, E-mail:
[email protected]
C 2017 UICC Int. J. Cancer: 140, 2201–2211 (2017) V
Cancer Epidemiology
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FAST score prediction tool
Gastroenterology Department, Complejo Hospitalario de Pontevedra, Pontevedra, Spain n Biomedica en Red de Enfermedades Hepaticas y tua de Terrassa, Centro de Investigacio Gastroenterology Department, Hospital Universitari Mu
Digestivas (CIBERehd), Terrassa, Spain Gastroenterology Department, Consorci Sanitari de Terrassa, Terrassa, Spain 17 Sanitaria i Universitaria Parc Taulı, Sabadell, Spain Gastroenterology Department, Hospital de Sabadell, Corporacio 18 Donostia Hospital, Biodonostia Institute, University of the Basque Country UPV/EHU (CIBERehd), San Sebastian, Spain 19 Gastroenterology Department, Hospital de Sagunto, Sagunto, Valencia, Spain 20 n, University of Zaragoza, (CIBERehd), Zaragoza, Spain Servicio de Aparato Digestivo, Hospital Clınico Universitario, IIS Arago 21 Gastroenterology Department, Hospital Dr. Josep Trueta, Girona, Spain 22 stoles, Madrid, Spain Digestive Disease Section, Hospital Universitario de Mo
Cancer Epidemiology
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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 (0–10 polyps of any histology, including serrated lesions), colitis (any aetiology), polyps 10 mm (including serrated lesions), complicated diverticular disease (diverticulitis, bleeding), colonic ulcer or bleeding angiodysplasia, In Scotland, again more simply, SCL was defined as any of CRC, AN or inflammatory bowel disease (IBD—Crohn’s or ulcerative colitis); other lesions (non-advanced adenomas, non-complicated diverticular disease, polyps
