Comparing the Real-World Effectiveness of Competing Colonoscopy Preparations: Results of a Prospective Trial

Gu, Phillip; Lew, Daniel; Oh, Sun Jung; Vipani, Aarshi; Ko, Justine S.; Hsu, Kevin; Mirakhor, Ebrahim; Pattisapu, Varun; Bullen, Tia; Fuller, Garth; Spiegel, Brennan M.; Almario, Christopher V.

doi:10.14309/ajg.0000000000000057

Cited by 35 publications

(28 citation statements)

References 44 publications

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“…128 In recent years, a new bowel preparation agent containing magnesium sulfate, which can be used in both the 1-day preparation and split dosing method, has been used in the US. Even in non-RCTs, it showed that it was as effective as other bowel preparation agents, 129 with clinical trials currently ongoing in Japan.…”

Section: Introductionmentioning

confidence: 99%

Colonoscopy screening and surveillance guidelines

Saito

Oka

Kawamura

et al. 2021

Digestive Endoscopy

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The Colonoscopy Screening and Surveillance Guidelines were developed by the Japan Gastroenterological Endoscopy Society as basic guidelines based on the scientific methods. The importance of endoscopic screening and surveillance for both detection and post-treatment follow-up of colorectal cancer has been recognized as essential to reduce disease mortality. There is limited high-level evidence in this field; therefore, we had to focus on the consensus of experts. These clinical practice guidelines consist of 20 clinical questions and eight background knowledge topics that have been determined as the current guiding principles.

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Section: Introductionmentioning

confidence: 99%

Colonoscopy screening and surveillance guidelines

Saito

Oka

Kawamura

et al. 2021

Digestive Endoscopy

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“…Gu et al found in a large non-commercial ‘real-world’ prospective multicenter trial with 4339 colonoscopies and 75 endoscopists that MiraLAX with Gatorade, MoviPrep and Suprep were associated with superior tolerability and bowel cleansing. 8 As tolerability of bowel preps should be optimised for clinical trial participants with active IBD, bowel preps should be selected accordingly. Polyethylene glycol 3350 and some form of an electrolyte balanced sports drink may be ubiquitously available, and this combination may also be optimal because PEG based bowel prep regimens seem to have the lowest rate of bowel prep induced mucosal artefacts.…”

Section: Acquisition Stagementioning

confidence: 99%

Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments

Gottlieb

Usiskin²,

Sands

et al. 2020

Gut

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Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument). In this review, academic and industry experts review scoring systems, and propose a theoretical framework for central reading that predicts when improvements in statistical power, affecting trial size and chances of success, can be expected: Multireader models can be conceptualised as statistical or non-statistical (social). Important organisational and operational factors, such as training and retraining of readers, optimal bowel preparation for colonoscopy, video quality, optimal or at least acceptable read duration times and other quality control matters, are addressed as well. The theory and practice of central reading and the conduct of endoscopy in clinical trials are interdisciplinary topics that should be of interest to many, regulators, clinical trial experts, gastroenterology societies and those in the academic community who endeavour to develop new scoring systems using traditional and machine learning approaches.

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“…Gu et al provided a prospective, naturalistic comparative effectiveness study to assess the effectiveness and tolerability of different colonoscopy preparations. 10 This makes it more applicable to the outpatient setting, as patient tolerability can determine preparation effectiveness and was Mrs. Smith's primary concern. The level of evidence of this study is 2 using the SORT algorithm, as it is an observational study.…”

Section: Related Literaturementioning

confidence: 99%

“…Patients were also not excluded for having chronic conditions such as chronic opioid use, inflammatory bowel disease, chronic kidney disease, congestive heart failure, and cirrhosis. 10 This is in contrast to the RCTs previously listed, which typically include fewer, more controlled regimens and excluded patients with chronic conditions. 1,4,5 This study was also free of the Hawthorne effect and remuneration, as it was not a RCT.…”

Section: Critical Appraisalmentioning

confidence: 99%