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

Research output: Contribution to journalArticle

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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.

LanguageEnglish
Pages485-496
Number of pages12
JournalGut
Volume67
Issue number3
Early online date8 Feb 2018
DOIs
Publication statusPublished - Mar 2018

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Colorectal Neoplasms
Hemoglobins
Population
Early Detection of Cancer
Adenoma
Italy
Randomized Controlled Trials
Neoplasms

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, Basilio ; Malaspina, Morena ; Fraser, Callum G ; Tintori, Beatrice ; Carlani, Angela ; D'Angelo, Valentina ; Galeazzi, Paola ; Di Dato, Eugenio ; Mariotti, Loretta ; Bulletti, Simonetta ; D'Amico, Maria Rosaria ; Gustinucci, Daniela ; Martinelli, Nadia ; Spita, Nicoletta ; Cesarini, Elena ; Rubeca, Tiziana ; Giaimo, Mariadonata ; Segnan, Nereo ; Senore, Carlo. / 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. In: Gut. 2018 ; Vol. 67, No. 3. pp. 485-496.
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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.",
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",
author = "Basilio Passamonti and Morena Malaspina and Fraser, {Callum G} and Beatrice Tintori and Angela Carlani and Valentina D'Angelo and Paola Galeazzi and {Di Dato}, Eugenio and Loretta Mariotti and Simonetta Bulletti and D'Amico, {Maria Rosaria} and Daniela Gustinucci and Nadia Martinelli and Nicoletta Spita and Elena Cesarini and Tiziana Rubeca and Mariadonata Giaimo and Nereo Segnan and Carlo Senore",
note = "The study was funded by the Umbria Regional Health Authority Kyowa Medex and Menarini provided the faecal immunochemical test used in the study.",
year = "2018",
month = "3",
doi = "10.1136/gutjnl-2016-312716",
language = "English",
volume = "67",
pages = "485--496",
journal = "Gut",
issn = "0017-5749",
publisher = "BMJ Publishing Group",
number = "3",

}

Passamonti, B, Malaspina, M, Fraser, CG, Tintori, B, Carlani, A, D'Angelo, V, Galeazzi, P, Di Dato, E, Mariotti, L, Bulletti, S, D'Amico, MR, 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, vol. 67, no. 3, pp. 485-496. https://doi.org/10.1136/gutjnl-2016-312716

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

In: Gut, Vol. 67, No. 3, 03.2018, p. 485-496.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Passamonti, Basilio

AU - Malaspina, Morena

AU - Fraser, Callum G

AU - Tintori, Beatrice

AU - Carlani, Angela

AU - D'Angelo, Valentina

AU - Galeazzi, Paola

AU - Di Dato, Eugenio

AU - Mariotti, Loretta

AU - Bulletti, Simonetta

AU - D'Amico, Maria Rosaria

AU - Gustinucci, Daniela

AU - Martinelli, Nadia

AU - Spita, Nicoletta

AU - Cesarini, Elena

AU - Rubeca, Tiziana

AU - Giaimo, Mariadonata

AU - Segnan, Nereo

AU - Senore, Carlo

N1 - The study was funded by the Umbria Regional Health Authority Kyowa Medex and Menarini provided the faecal immunochemical test used in the study.

PY - 2018/3

Y1 - 2018/3

N2 - 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.

AB - 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.

KW - Aged

KW - Colorectal Neoplasms/diagnosis

KW - Comparative Effectiveness Research

KW - Early Detection of Cancer/methods

KW - Feces/chemistry

KW - Female

KW - Hemoglobins/analysis

KW - Humans

KW - Male

KW - Middle Aged

KW - Patient Acceptance of Health Care/statistics & numerical data

KW - Predictive Value of Tests

KW - Colorectal Cancer Screening

KW - Screening

KW - Cancer Prevention

U2 - 10.1136/gutjnl-2016-312716

DO - 10.1136/gutjnl-2016-312716

M3 - Article

VL - 67

SP - 485

EP - 496

JO - Gut

T2 - Gut

JF - Gut

SN - 0017-5749

IS - 3

ER -