Overestimated Sensitivity of Fecal Immunochemical Tests in Screening Cohorts With Registry-Based Follow-up.
Am J Gastroenterol
; 114(11): 1795-1801, 2019 11.
Article
de En
| MEDLINE
| ID: mdl-31658130
ABSTRACT
OBJECTIVES:
Several recent studies have reported very high estimates of sensitivity and specificity of fecal immunochemical tests (FITs) at seemingly high levels of precision using registry-based follow-up of participants in very large FIT-based screening programs. We aimed to assess the validity of estimates of diagnostic performance parameters derived by this indirect approach.METHODS:
We modeled expected values of sensitivity and specificity of colorectal cancer detection in studies using the indirect approach and their deviation from true values under a broad range of plausible assumptions, and we compared these expected values with recently reported estimates of FIT sensitivity and specificity from such studies.RESULTS:
Using a sensitivity of 75% and specificity of 93.6% (from studies using a direct approach, i.e., colonoscopy follow-up of all participants), the indirect approach would be expected to yield sensitivities between 84.5% and 91.1% and specificities between 93.4% and 93.6% under a range of realistic assumptions regarding colonoscopic follow-up rates of positive FITs and clinical manifestation rates of preclinical colorectal cancer.DISCUSSION:
Very high sensitivities of FITs recently reported with seemingly very high levels of precision by several large-scale registry-based studies, which are in line with expected results based on our model calculations, are likely to be strongly overestimated and need to be interpreted with due caution.
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Immunohistochimie
/
Tumeurs colorectales
/
Dépistage précoce du cancer
/
Fèces
Type d'étude:
Diagnostic_studies
/
Prognostic_studies
/
Screening_studies
Limites:
Humans
Langue:
En
Journal:
Am J Gastroenterol
Année:
2019
Type de document:
Article
Pays d'affiliation:
Allemagne