1. Optimal diagnostic accuracy of quantitative faecal immunochemical test positivity thresholds for colorectal cancer detection in primary health care: A community‐based cohort study
- Author
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Joaquín Cubiella, Luis Bujanda, María A. Gutierrez-Stampa, Vanessa Aguilar-Gama, Isabel Portillo, Laura García Nimo, Noel Pin-Vieito, and Begona Román Alonso
- Subjects
Male ,medicine.medical_specialty ,Colorectal cancer ,Colon ,faecal haemoglobin ,Primary health care ,Colonoscopy ,Diagnostic accuracy ,colorectal cancer ,Sensitivity and Specificity ,03 medical and health sciences ,Feces ,Hemoglobins ,0302 clinical medicine ,diagnostic performance ,Internal medicine ,Primary health ,medicine ,Humans ,faecal biomarkers ,3207.03 Carcinogénesis ,Early Detection of Cancer ,Aged ,Retrospective Studies ,Community based ,Aged, 80 and over ,medicine.diagnostic_test ,Primary Health Care ,business.industry ,2302.16 Inmunoquímica ,Gastroenterology ,Middle Aged ,medicine.disease ,faecal immunochemical test ,Immunohistochemistry ,3212 Salud Publica ,Test (assessment) ,Oncology ,Spain ,030220 oncology & carcinogenesis ,Occult Blood ,030211 gastroenterology & hepatology ,Original Article ,Female ,business ,Colorectal Neoplasms ,Cohort study - Abstract
Background Optimizing colonoscopy resources is challenging, and information regarding performing diagnostic quantitative faecal immunochemical test (FIT) in daily clinical practice in primary health care is still limited. This study aimed to assess the sensitivity, specificity, positive predictive value and negative predictive value of varying FIT positivity thresholds on colorectal cancer (CRC) detection in primary health care. Methods A retrospective cohort study of 38,675 asymptomatic and symptomatic patients with a FIT (OC-Sensor™) performed between 2012 and 2016 in a primary health-care setting, using a clinical laboratory database of two Spanish areas linked with the National Health System's Hospital Discharge Records Database. The primary outcome was 2-year CRC incidence. Results The mean age of the participants was 63.2 years; 17,792 (46.0%) were male. CRC prevalence was 1.7% (650/38,675). The percentage of patients with a FIT result above the threshold was 20.7% and 14.6% for 10 μg Hb/g faeces and 20 μg Hb/g faeces thresholds, respectively. Sensitivity was 90.5% (95% confidence interval 88.0%–92.5%) at a 10 μg Hb/g faeces threshold, and this decreased by 3.1% when a 20 μg Hb/g faeces threshold was used. The negative predictive value for CRC was at least 99.2% in any subgroup analysed. At a 20 μg Hb/g faeces threshold, less than one additional CRC would be missed per 1000 patients investigated, while approximately 1.3 times more colonoscopy examinations were needed to identify an incidence of CRC using the lowest threshold for any situation analysed. Conclusions In primary health care, a quantitative FIT threshold should be tailored to colonoscopy capacity and CRC prevalence in specific populations. Instituto de Salud Carlos III, España | Ref. PI17/00837
- Published
- 2021