Abstract
Background:
We determined the impact of an increased two-stool FIT cutoff on colonoscopy positivity and relative sensitivity and specificity in the randomised controlled screening trial SCREESCO conducted in Sweden.
Methods:
We performed a cross-sectional analysis of participants in the FIT arm that performed FIT between March 2014 and March 2020 within the study registered with ClinicalTrials.gov, NCT02078804, who had a fecal hemoglobin concentration of at least 10 μg/g in at least one of two stool samples and who underwent a colonoscopy (n=3841). For each increase in cutoff, we computed the positive predictive value (PPV), numbers needed to scope (NNS), sensitivity and specificity for finding colorectal cancer (CRC) and advanced neoplasia (AN; advanced adenoma or CRC) relative to cutoff 10 μg/g.
Results:
The PPV for AN increased from 23.0% (95% CI: 22.3-23.6%) at cutoff 10 μg/g to 28.8% (95% CI: 27.8-29.7%) and 33.1% (95% CI: 31.9-34.4%) at cutoffs 20 and 40 μg/g respectively while the NNS to find a CRC correspondingly decreased from 41 to 27 and 19. The PPV for AN was higher in men than women at each cutoff, e.g. 31.5% (95% CI: 30.1-32.8%) in men and 25.6% (95% CI: 24.3-27.0%) in women at 20 μg/g. The relative sensitivity and relative specificity were similar in men and women at each cutoff.
Conclusion:
A low cutoff of around 20 to 40 μg/g allows detection and removal of many advanced neoplasia compared to 10 μg/g while reducing the number of colonoscopies in both men and women.
We determined the impact of an increased two-stool FIT cutoff on colonoscopy positivity and relative sensitivity and specificity in the randomised controlled screening trial SCREESCO conducted in Sweden.
Methods:
We performed a cross-sectional analysis of participants in the FIT arm that performed FIT between March 2014 and March 2020 within the study registered with ClinicalTrials.gov, NCT02078804, who had a fecal hemoglobin concentration of at least 10 μg/g in at least one of two stool samples and who underwent a colonoscopy (n=3841). For each increase in cutoff, we computed the positive predictive value (PPV), numbers needed to scope (NNS), sensitivity and specificity for finding colorectal cancer (CRC) and advanced neoplasia (AN; advanced adenoma or CRC) relative to cutoff 10 μg/g.
Results:
The PPV for AN increased from 23.0% (95% CI: 22.3-23.6%) at cutoff 10 μg/g to 28.8% (95% CI: 27.8-29.7%) and 33.1% (95% CI: 31.9-34.4%) at cutoffs 20 and 40 μg/g respectively while the NNS to find a CRC correspondingly decreased from 41 to 27 and 19. The PPV for AN was higher in men than women at each cutoff, e.g. 31.5% (95% CI: 30.1-32.8%) in men and 25.6% (95% CI: 24.3-27.0%) in women at 20 μg/g. The relative sensitivity and relative specificity were similar in men and women at each cutoff.
Conclusion:
A low cutoff of around 20 to 40 μg/g allows detection and removal of many advanced neoplasia compared to 10 μg/g while reducing the number of colonoscopies in both men and women.
| Original language | English |
|---|---|
| Pages (from-to) | 187-199 |
| Number of pages | 13 |
| Journal | Journal of Internal Medicine |
| Volume | 296 |
| Issue number | 2 |
| Early online date | 6 Jun 2024 |
| DOIs | |
| Publication status | Published - 15 Jul 2024 |
Bibliographical note
Publisher Copyright:© 2024 The Author(s). Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.
