CRC screening trials exhibit ‘good adherence’ to guidelines, but improvements needed
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Key takeaways:
- The most missed recommendation was trial registrations (0%), followed by informed consent materials (20%).
- More than half of participants who underwent CRC screening adhered to the study protocol (69.8%).
Although adherence to standardized reporting guidelines ranged from 82.4% to 92.2% in published trials of colorectal cancer screening, researchers found that reporting of trial registration and informed consent materials could be improved.
“Comprehensive and structured reporting of trial design and results is important to understand its quality,” study author Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman Professor of Medicine at NYU Grossman School of Medicine, told Healio. “Having uniform requirements also allows for an apples-to-apples comparison. For randomized controlled trials, a group of experts has published recommended checklist and methodology but adoption is unknown.”
She continued: “We wanted to highlight the application of these guidelines to randomized controlled trials in the realm of colon cancer screening.”
Shaukat and colleagues assessed adherence to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines, established in 2007, by conducting a literature review of trials evaluating flexible sigmoidoscopy or colonoscopy for CRC screening through 2023.
They identified five randomized controlled trials for analysis — four on flexible sigmoidoscopy and one on colonoscopy — with 587,572 participants overall. Of these, 37% underwent CRC screening and 69.8% adhered to study protocols.
According to results published in Gastro Hep Advances, the SPIRIT domain with the lowest average adherence was “Appendices” (60%), followed by “Methods: Monitoring” (75%) and “Methods: Assignments of interventions” (76%). Researchers observed the highest adherence for the “Introduction” domain (100%), while other domains, including “Ethics and dissemination,” “Methods: Participants, interventions and outcomes,” “Methods: Data collection, management and analysis” and “Administrative information” demonstrated 80% to 98% adherence.
Among the most missed recommendations were item 2b, trial registrations, which scored 0 in all studies; item 32, informed consent materials, which scored 20%; and items 17a and 17b, blinding, which scored 40% each.
Of all five trials, the NordICC trial, which used a distinct invitation-based CRC screening approach, had a lower rate of adherence (42%). Excluding this trial raised participant adherence rates to 74.3%, researchers wrote.
“We were assured that published randomized controlled trials in colon cancer screening have good adherence to reporting guidelines by SPIRIT, but some improvements are needed,” Shaukat said. “We make changes to our patient care based on new evidence from published studies. The gold standard study design for efficacy is randomized clinical trials. By adhering to standard reporting guidelines, we can have higher confidence in the results and how these might apply to patient care.”
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