title: A comparative effectiveness trial of two faecal immunochemical tests for haemoglobin (FIT). Assessment of test performance and adherence in a single round of a population-based screening programme for colorectal cancer.
abstract: To compare acceptability and diagnostic accuracy of a recently available faecal immunochemical test (FIT) system (HM-JACKarc) with the FIT routinely used in an established screening programme (OC-Sensor).
  
  
  
  Randomised controlled trial (ISRCTN20086618) within a population-based colorectal cancer (CRC) screening programme. Subjects eligible for invitation in the Umbria Region (Italy) programme were randomised (ratio 1:1) to be screened using one of the FIT systems.
  
  
  
  Screening uptake among the 48 888 invitees was the same for both systems among subjects invited in the first round and higher with OC-Sensor than with HM-JACKarc (relative risk (RR): 1.03; 95% CI 1.02 to 1.04) among those invited in subsequent rounds. Positivity rate (PR) was similar with OC-Sensor (6.5%) as with HM-JACKarc (6.2%) among subjects performing their first FIT screening and higher with OC-Sensor (5.6%, RR: 1.25, 95% CI 1.12 to 1.40) than with HM-JACKarc (4.4%) among those screened in previous rounds. Positive predictive value (PPV) (OC-Sensor: 25.9%, HM-JACKarc: 25.6%) and detection rate (DR) (OC-Sensor: 1.40%; HM-JACKarc: 1.42%) for advanced neoplasia (AN: CRC + advanced adenoma) were similar among subjects performing their first FIT screening. The differences in the AN PPV (OC-Sensor: 20.3%, HM-JACKarc: 22.6%) and DR (OC-Sensor: 0.96%, HM-JACKarc: 0.83%) among those screened in previous rounds were not statistically significant. The number needed to scope to detect one AN was 3.9 (95% CI 5.8 to 2.9) and 3.9 (95% CI 5.5 to 2.9) at first and 4.9 (95% CI 5.8 to 4.2) and 4.4 (95% CI 5.3 to 3.7) at subsequent screening, with OC-Sensor and HM-JACKarc, respectively.
  
  
  
  Our results suggest that acceptability and diagnostic performance of HM-JACKarc and of OC-Sensor systems are similar in a screening setting.
  
  
  
  ISRCTN20086618; Results.
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Basilio
authors.initials: B
authors.lastname: Passamonti
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Morena
authors.initials: M
authors.lastname: Malaspina
authors.affiliation: Centre for Research into Cancer Prevention and Screening, University of Dundee School of Medicine, Dundee, UK.
authors.forename: Callum G
authors.initials: CG
authors.lastname: Fraser
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Tintori
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Carlani
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: D'Angelo
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Galeazzi
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Di Dato
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Loretta
authors.initials: L
authors.lastname: Mariotti
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Bulletti
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: D'Amico
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Gustinucci
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Nadia
authors.initials: N
authors.lastname: Martinelli
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Spita
authors.affiliation: Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Cesarini
authors.affiliation: Laboratorio Regionale Prevenzione Oncologica ISPO-Istituto per lo Studio e la Prevenzione Oncologica, Firenze, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Rubeca
authors.affiliation: Servizio Prevenzione, Sanità Veterinaria, Direzione Regionale Salute, Perugia, Italy.
authors.forename: Mariadonata
authors.initials: M
authors.lastname: Giaimo
authors.affiliation: Città della Salute e della Scienza University Hospital, SC Epidemiology, Screening, Cancer Registry, CPO, Turin, Italy.
authors.forename: Nereo
authors.initials: N
authors.lastname: Segnan
authors.affiliation: Città della Salute e della Scienza University Hospital, SC Epidemiology, Screening, Cancer Registry, CPO, Turin, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Senore
mesh_terms: D000368:Aged; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D057186:Comparative Effectiveness Research; D055088:Early Detection of Cancer / Q000379:methods*; D005243:Feces / Q000737:chemistry*; D005260:Female; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D011237:Predictive Value of Tests
chemical_list: D006454:Hemoglobins
keywords: CANCER PREVENTION; COLORECTAL CANCER SCREENING; SCREENING