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

Basilio Passamonti, Morena Malaspina (Lead / Corresponding author), Callum G Fraser, Beatrice Tintori, Angela Carlani, Valentina D'Angelo, Paola Galeazzi, Eugenio Di Dato, Loretta Mariotti, Simonetta Bulletti, Maria Rosaria D'Amico, Daniela Gustinucci, Nadia Martinelli, Nicoletta Spita, Elena Cesarini, Tiziana Rubeca, Mariadonata Giaimo, Nereo Segnan, Carlo Senore

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Abstract

Aim: 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).

Design: 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.

Results: 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.

Conclusions: Our results suggest that acceptability and diagnostic performance of HM-JACKarc and of OC-Sensor systems are similar in a screening setting.

Trial registration number: ISRCTN20086618; Results.

Original languageEnglish
Pages (from-to)485-496
Number of pages12
JournalGut
Volume67
Issue number3
Early online date8 Feb 2018
DOIs
Publication statusPublished - Mar 2018

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Keywords

  • Aged
  • Colorectal Neoplasms/diagnosis
  • Comparative Effectiveness Research
  • Early Detection of Cancer/methods
  • Feces/chemistry
  • Female
  • Hemoglobins/analysis
  • Humans
  • Male
  • Middle Aged
  • Patient Acceptance of Health Care/statistics & numerical data
  • Predictive Value of Tests
  • Colorectal Cancer Screening
  • Screening
  • Cancer Prevention

Cite this

Passamonti, B., Malaspina, M., Fraser, C. G., Tintori, B., Carlani, A., D'Angelo, V., Galeazzi, P., Di Dato, E., Mariotti, L., Bulletti, S., D'Amico, M. R., Gustinucci, D., Martinelli, N., Spita, N., Cesarini, E., Rubeca, T., Giaimo, M., Segnan, N., & Senore, C. (2018). 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. Gut, 67(3), 485-496. https://doi.org/10.1136/gutjnl-2016-312716