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
Autor: | Mariadonata Giaimo, Callum G. Fraser, Valentina D’Angelo, Elena Cesarini, Maria Rosaria D’Amico, Basilio Passamonti, Tiziana Rubeca, Beatrice Tintori, Simonetta Bulletti, Nereo Segnan, Nadia Martinelli, Daniela Gustinucci, Paola Galeazzi, Nicoletta Spita, Loretta Mariotti, Eugenio Di Dato, Morena Malaspina, Angela Carlani, Carlo Senore |
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Rok vydání: | 2016 |
Předmět: |
medicine.medical_specialty
education.field_of_study Cancer prevention Colorectal cancer business.industry Comparative effectiveness research Population Gastroenterology medicine.disease Surgery law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law 030220 oncology & carcinogenesis Relative risk Internal medicine Predictive value of tests medicine 030211 gastroenterology & hepatology Test performance education business |
Zdroj: | Gut. 67:485-496 |
ISSN: | 1468-3288 0017-5749 |
Popis: | AimTo 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).DesignRandomised 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.ResultsScreening 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.ConclusionsOur results suggest that acceptability and diagnostic performance of HM-JACKarc and of OC-Sensor systems are similar in a screening setting.Trial registration numberISRCTN20086618; Results. |
Databáze: | OpenAIRE |
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