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Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test.
Ann G Zauber1, Sidney J Winawer2, Michael J O'Brien3
1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Gastroenterology
|March 22, 2023
Summary
Screening colonoscopy showed higher adherence than sequential fecal occult blood testing (HSgFOBT). Allowing crossover to colonoscopy improved detection of advanced neoplasia and serrated lesions (ADN-SERs) in HSgFOBT programs.
Area of Science:
- Gastroenterology and Oncology
- Clinical Trial Research
- Cancer Screening Modalities
Background:
- Colorectal cancer (CRC) screening guidelines recommend colonoscopy and high-sensitivity fecal occult blood testing (HSgFOBT), assuming similar effectiveness due to high adherence.
- Direct comparative data on adherence between screening colonoscopy and sequential HSgFOBT has been lacking.
- This study aimed to compare adherence and pathology findings between these two primary CRC screening methods.
Purpose of the Study:
- To compare adherence rates between a single screening colonoscopy and sequential high-sensitivity fecal occult blood testing (HSgFOBT).
- To evaluate the detection of advanced neoplasia or large serrated lesions (ADN-SERs) based on adherence to each screening method.
- To assess the impact of crossover from HSgFOBT to colonoscopy on lesion detection.
Main Methods:
- A randomized clinical trial enrolled 3523 participants aged 40-69 years across three clinical settings.
- Participants were randomized to either a single screening colonoscopy or sequential HSgFOBT (4-7 rounds).
- Key metrics included initial and sequential adherence, follow-up colonoscopy rates, crossover to colonoscopy, and ADN-SER detection.
Main Results:
- Screening colonoscopy demonstrated higher initial adherence (83.6%) compared to one round of HSgFOBT (73.1%).
- Sequential adherence to HSgFOBT over four rounds was suboptimal (38.3%).
- ADN-SER detection was significantly higher in the colonoscopy arm (8.2%) compared to non-sequentially adherent HSgFOBT participants (0.6%), and improved with crossover to colonoscopy (5.5%).
Conclusions:
- Sequential HSgFOBT adherence is suboptimal compared to a single screening colonoscopy.
- Non-sequential HSgFOBT adherence leads to inferior detection of ADN-SERs compared to sequential adherence.
- Incorporating a crossover option to screening colonoscopy can enhance the effectiveness of HSgFOBT programs for detecting significant lesions.
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