Reporting Quality of Endoscopic Colorectal Cancer Screening Randomized Controlled Trials: Adherence to...

Area of Science:

• Clinical Trials
• Gastroenterology
• Public Health

Background:

• Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines were published in 2013 to standardize randomized controlled trial (RCT) reporting.
• Assessing adherence to SPIRIT guidelines is crucial for the quality and transparency of clinical research.

Purpose of the Study:

• To evaluate adherence to SPIRIT reporting guidelines in RCTs for endoscopic colorectal cancer (CRC) screening.
• To assess participant adherence to trial protocols in these CRC screening RCTs.

Main Methods:

• A systematic search for RCTs on flexible sigmoidoscopy or colonoscopy for CRC screening was conducted up to September 2023.
• Five eligible RCTs were analyzed for adherence to 51 SPIRIT items, and participant adherence was calculated as the proportion screened versus invited.

Main Results:

• Adherence to SPIRIT guidelines ranged from 82.4% to 92.2%, with universal non-compliance for trial registration (item 2b).
• Reporting of informed consent materials (item 32) and blinding (item 17a & b) showed lower adherence at 20% and 40%, respectively.
• Overall participant adherence to CRC screening protocols was 69.8%, but varied significantly, with one trial showing 42% adherence.

Conclusions:

• Endoscopic CRC screening RCTs generally adhere well to SPIRIT reporting guidelines.
• Improvements are recommended in reporting consent forms and comprehensive trial registration data.
• Participant adherence to screening protocols in RCTs is acceptable but warrants attention for optimization.