Does It work in Clinical Practice? A Comparison of Colonoscopy Cleansing Effectiveness in Clinical Practice Versus Efficacy from Selected Prospective Trials

Abstract

Background Adequate bowel preparation is essential for a high-quality colonoscopy. Many randomized controlled trials (RCTs) have investigated bowel preparation protocols, including split-dose and low-volume regimens. However, RCTs are conducted in an ideal, controlled setting, and translation of trial results to clinical practice is challenging. In this study, we compared the quality of bowel preparations of real-world patients from clinical practice with those enrolled in several prospective trials. Methods Bowel preparation quality, defined by the Ottawa Bowel Preparation Scale (OBPS), from four RCTs and one prospective trial were compared with two observational diary studies. Bowel preparations were polyethylene glycol preparation (PEG) or sodium picosulfate plus magnesium citrate (P/MC) taken via traditional or split-dose timing regimen. Age, sex, average number of bowel movements per day, comorbidities, colonoscopy indication and colonoscopy completion rates were also collected. Results Patients enrolled in prospective trials had a better OBPS by one point when compared with those in observational clinical practice studies (P<0.049), after controlling for age, sex, colonoscopy indication and type of bowel preparation used. We also found that each 10-year increase in age was associated with a 0.2 point increase in OBPS (P=0.008), and men were associated with a 0.5 increase in OBPS when compared with women P=0.014). Conclusion Patients from clinical practice have higher OBPS than prospective trial patients. Increased age and male sex were also associated with increased OBPS. We believe increased patient motivation and education around bowel preparation regimen plays an important role in the success of bowel preparations.

Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial

“…12 However, the study was not designed with ADR as an efficacy endpoint. An ADR of 31.5% is well Possible limitations of the study include a patient population that may not reflect the general population 31 (e.g., excluding certain GI disorders or prior procedures) and unknown adherence to mixing instructions for P/MC powder (stirring for full 2-3 min). The impact of these variables on the outcomes is unknown.…”

Mandatory vs. optional split-dose bowel preparation for morning colonoscopies: a pragmatic noninferiority randomized controlled trial

“…There are however, concerns that have been raised about the generalizability of current RCT findings to the general population undergoing colonoscopies [13]. Such as RCTs do not specifically evaluate early morning colonoscopies, include volunteer participants who may be more adherent to a challenging BP regimen (middle of the night intake of BP for the early morning procedures with SDBP), and involve This document was downloaded for personal use only.…”

“…There have however been concerns raised about the generalizability of the current RCT findings to the general population undergoing colonoscopies [13]. For example, the RCTs do not specifically evaluate early morning colonoscopies, include volunteer participants who may be more adherent to a challenging bowel preparation regimen (e. g. middle of the night intake of bowel preparation for the early morning procedures with SDBP), and involve research personnel who can provide more support and intensive instructions to those undergoing bowel preparation than is feasible in usual clinical practice.…”