title: Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests.
abstract: OBJECTIVE
  We compared the ability of biennial fecal immunochemical testing (FIT) and one-time sigmoidoscopy to detect colon side-specific advanced neoplasms in a population-based, multicenter, nationwide, randomized controlled trial.
  
  
  METHODS
  We identified asymptomatic men and women, 50-69 years old, through community health registries and randomly assigned them to groups that received a single colonoscopy examination or biennial FIT. Sigmoidoscopy yield was simulated from results obtained from the colonoscopy group, according to the criteria proposed in the UK Flexible Sigmoidoscopy Trial for colonoscopy referral. Patients who underwent FIT and were found to have ≥75 ng hemoglobin/mL were referred for colonoscopy. Data were analyzed from 5059 subjects in the colonoscopy group and 10,507 in the FIT group. The main outcome was rate of detection of any advanced neoplasm proximal to the splenic flexure.
  
  
  RESULTS
  Advanced neoplasms were detected in 317 subjects (6.3%) in the sigmoidoscopy simulation group compared with 288 (2.7%) in the FIT group (odds ratio for sigmoidoscopy, 2.29; 95% confidence interval, 1.93-2.70; P = .0001). Sigmoidoscopy also detected advanced distal neoplasia in a higher percentage of patients than FIT (odds ratio, 2.61; 95% confidence interval, 2.20-3.10; P = .0001). The methods did not differ significantly in identifying patients with advanced proximal neoplasms (odds ratio, 1.17; 95% confidence interval, 0.78-1.76; P = .44). This was probably due to the lower performance of both strategies in detecting patients with proximal lesions (sigmoidoscopy detected these in 19.1% of patients and FIT in 14.9% of patients) vs distal ones (sigmoidoscopy detected these in 86.8% of patients and FIT in 33.5% of patients). Sigmoidoscopy, but not FIT, detected proximal lesions in lower percentages of women (especially those 50-59 years old) than men.
  
  
  CONCLUSIONS
  Sigmoidoscopy and FIT have similar limitations in detecting advanced proximal neoplasms, which depend on patients' characteristics; sigmoidoscopy underperforms for women 50-59 years old. Screening strategies should be designed on the basis of target population to increase effectiveness and cost-effectiveness. ClinicalTrials.gov number: NCT00906997.
authors.affiliation: Department of Gastroenterology, Hospital Clínic, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), IDIBAPS, University of Barcelona, Barcelona, Catalonia. Electronic address: castells@clinic.cat.
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authors.lastname: Castells
authors.affiliation: Department of Gastroenterology, Hospital Universitario de Canarias, Universidad de La Laguna, Tenerife. Electronic address: equinter@gmail.com.
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authors.lastname: Quintero
authors.affiliation: Department of Gastroenterology, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Pompeu Fabra University, Barcelona, Catalonia.
authors.forename: Cristina
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authors.lastname: Álvarez
authors.affiliation: Department of Gastroenterology, Donostia Hospital-Instituto Biodonostia, CIBERehd, University of Basque Country (UPV/EHU), San Sebastián.
authors.forename: Luis
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authors.lastname: Bujanda
authors.affiliation: Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense.
authors.forename: Joaquín
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authors.lastname: Cubiella
authors.affiliation: Colorectal Cancer Screening Program, Dirección General de Salud Pública, Conselleria de Sanitat, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region FISABIO, Valencia.
authors.forename: Dolores
authors.initials: D
authors.lastname: Salas
authors.affiliation: Servicio de Aparato Digestivo, Hospital Clínico Universitario, IIS Aragón, University of Zaragoza, CIBERehd, Zaragoza.
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authors.initials: A
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authors.affiliation: Unidad de Gestión Clínica de Digestivo, Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria, Universidad de Murcia, Murcia.
authors.forename: Fernando
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authors.lastname: Carballo
authors.affiliation: Department of Gastroenterology, Hospital Clínico San Carlos, Madrid.
authors.forename: Juan Diego
authors.initials: JD
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authors.affiliation: Department of Epidemiology and Evaluation, Parc de Salut Mar, IMIM, Barcelona, Catalonia.
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authors.affiliation: Gastroenterology Unit, Hospital General Universitario de Alicante, Alicante.
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authors.affiliation: Department of Gastroenterology, Donostia Hospital-Instituto Biodonostia, CIBERehd, University of Basque Country (UPV/EHU), San Sebastián.
authors.forename: Elizabeth
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authors.affiliation: Centro Coordinador del Programa de Cribado de Cáncer Colorrectal, Organización Central de Osakidetza-Servicio Vasco de Salud, Bilbao.
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authors.initials: I
authors.lastname: Portillo
authors.affiliation: Centro Coordinador del Programa de Cribado de Cáncer Colorrectal, Organización Central de Osakidetza-Servicio Vasco de Salud, Bilbao; Department of Surgery, Hospital Donostia-Instituto Biodonostia, University of Basque Country (UPV/EHU), San Sebastián.
authors.forename: José M
authors.initials: JM
authors.lastname: Enríquez-Navascués
authors.affiliation: Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, Vigo.
authors.forename: Vicent
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authors.affiliation: Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, Vigo.
authors.forename: Alfonso
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authors.affiliation: Centro de Salud A Cuña-Mariñamansa, Ourense.
authors.forename: Carlos
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authors.affiliation: Department of Clinical Analysis, Complexo Hospitalario Universitario de Vigo, Vigo.
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authors.affiliation: Colorectal Cancer Screening Program, Dirección General de Salud Pública, Conselleria de Sanitat, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region FISABIO, Valencia.
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authors.initials: T
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authors.affiliation: Department of Gastroenterology, Hospital Universitario La Fe, Valencia.
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authors.affiliation: Colorectal Cancer Screening Program, Dirección General de Salud Pública, Conselleria de Sanitat, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region FISABIO, Valencia.
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authors.affiliation: Colorectal Cancer Screening Program, Dirección General de Salud Pública, Conselleria de Sanitat, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region FISABIO, Valencia.
authors.forename: Gloria
authors.initials: G
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authors.affiliation: Department of Gastroenterology, Consorcio Hospitalario de Castellón, Castellón.
authors.forename: Antonio
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authors.affiliation: Servicio de Aparato Digestivo, Hospital Clínico Universitario, IIS Aragón, University of Zaragoza, CIBERehd, Zaragoza.
authors.forename: Federico
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authors.affiliation: Servicio de Aparato Digestivo, Hospital Clínico Universitario, IIS Aragón, University of Zaragoza, CIBERehd, Zaragoza.
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authors.affiliation: Department of Gastroenterology, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Pompeu Fabra University, Barcelona, Catalonia.
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authors.affiliation: Unitat d'Avaluació, Suport i Preventiva, Hospital Clínic, Barcelona, Catalonia.
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authors.affiliation: Unitat d'Avaluació, Suport i Preventiva, Hospital Clínic, Barcelona, Catalonia.
authors.forename: Àngels
authors.initials: À
authors.lastname: Pozo
authors.affiliation: Department of Gastroenterology, Hospital Clínic, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), IDIBAPS, University of Barcelona, Barcelona, Catalonia.
authors.forename: Maria
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authors.affiliation: Department of Gastroenterology, Hospital Clínic, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), IDIBAPS, University of Barcelona, Barcelona, Catalonia.
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authors.forename: Francisco
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authors.affiliation: Department of Gastroenterology, Hospital Universitario de Canarias, Universidad de La Laguna, Tenerife.
authors.forename: Inmaculada
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authors.affiliation: Department of Gastroenterology, Hospital Universitario de Canarias, Universidad de La Laguna, Tenerife.
authors.forename: Marta
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authors.affiliation: Colorectal Cancer Screening Program of the Comunidad de Canarias, Servicio Canario de la Salud.
authors.forename: Mariola
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authors.affiliation: Centro de Salud Laín Entralgo, Madrid.
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authors.affiliation: Centro de Salud de Los Ángeles, Madrid.
authors.forename: Javier
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authors.affiliation: Centro de Salud del Valle de la Oliva, Madrid.
authors.forename: José Manuel
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authors.affiliation: Centro de Salud Santa Hortensia, Madrid.
authors.forename: Rocio
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authors.affiliation: Subdirección de Calidad, Dirección General Atención al Paciente, SERMAS, Madrid.
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authors.forename: Ma José
authors.initials: MJ
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authors.affiliation: Department of Gastroenterology, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Pompeu Fabra University, Barcelona, Catalonia.
authors.forename: Montserrat
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authors.affiliation: Department of Gastroenterology, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Pompeu Fabra University, Barcelona, Catalonia.
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mesh_terms: D000368:Aged; D003106:Colon / Q000473:pathology*; D003110:Colonic Neoplasms / Q000175:diagnosis*; D003362:Cost-Benefit Analysis; D005243:Feces / Q000737:chemistry*; D005260:Female; D006801:Humans; D007150:Immunohistochemistry / Q000191:economics / Q000379:methods*; D008297:Male; D008403:Mass Screening / Q000191:economics / Q000379:methods; D008875:Middle Aged; D012812:Sigmoidoscopy / Q000191:economics / Q000379:methods*; D006113:United Kingdom
keywords: Colorectal Cancer; Endoscopy; Fecal Occult Blood Testing; Prevention; Screening