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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962655PMC
http://dx.doi.org/10.1053/j.gastro.2023.06.035DOI Listing

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Objective: Recently, results on colorectal cancer (CRC) incidence and mortality reduction by the offer of screening colonoscopy were reported for the first time from a randomized controlled trial (RCT), the Nordic-European Initiative on Colorectal Cancer (NordICC) trial. Despite randomization, there was a substantially lower proportion of post-randomization exclusions of CRC cases due to cancer registry-recorded date of diagnosis before recruitment in the invited group than in the usual-care group. We aimed to evaluate the impact of such differential exclusions on the trial's effect estimates on CRC risk.

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Background: Colonoscopy as a common screening practice to prevent colorectal cancer lacks strong evidence. NordICC, the first randomized trial of colonoscopy screening, reported no clear clinical benefit for colonoscopy in the intention-to-screen population with suggested benefit in the risk of colorectal incidence and cancer-specific mortality in the per-protocol analyses. However, although the study was designed to perform survival analysis, no survival outcomes were reported since the underlying assumption for hazard ratio was not valid.

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Article Synopsis
  • In 2013, the SPIRIT group introduced guidelines to enhance reporting quality in randomized controlled trials (RCTs), specifically targeting studies on endoscopic colorectal cancer screening.
  • A review of five RCTs showed adherence to SPIRIT guidelines between 82.4% to 92.2%, with significant gaps in trial registration and informed consent reporting.
  • Overall, 37% of participants invited to screening actually underwent the procedure, highlighting discrepancies in protocol adherence, particularly with one trial showing notably lower rates.
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