Title: A PHASE 2 EVALUATION OF A NEW FLAVORED PEG AND SULFATE
SOLUTION FOR Colonoscopy
Version: 3 Date: 18 Nov 2023
Reviewer's report:
The authors claim, “Unfortunately, there are few validated instruments for assessing bowel
preparation tolerance and none, to our knowledge, are widely accepted for this purpose.”
However, the validated tolerability instrument by Lawrance et al has been used in multiple
studies, including several large-scale studies (see below). The Lawrance instrument appears
to enjoy considerable acceptance in the academic community. In the absence of a superior
(validated) tolerability instrument, the Lawrance instrument results should be included in future
Phase 3 studies.
Reference:
Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire
and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci 2013;58:926-35.
Included in the following large studies:
Sey MSL, Von Renteln D, Sultanian R, et al. A Multicenter Randomized Controlled Trial
Comparing Two Bowel Cleansing Regimens for Colonoscopy After Failed Bowel Preparation,
Clinical Gastroenterology and Hepatology,
Volume 20, Issue 6, 2022, Pages e1283-e1291
Briot C, Faure P, Parmentier AL, et al. and The CLEAN Study Group. Efficacy, Tolerability,
and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases:
The French Multicentre CLEAN Study, Journal of Crohn's and Colitis, 2019, Pages 1121-1130
I accept the other comments of the authors and suggest that the paper be accepted for publication.
Title: A PHASE 2 EVALUATION OF A NEW FLAVORED PEG AND SULFATE
SOLUTION FOR Colonoscopy
Version: 3 Date: 18 Nov 2023
Reviewer's report:
The authors claim, “Unfortunately, there are few validated instruments for assessing bowel
preparation tolerance and none, to our knowledge, are widely accepted for this purpose.”
However, the validated tolerability instrument by Lawrance et al has been used in multiple
studies, including several large-scale studies (see below). The Lawrance instrument appears
to enjoy considerable acceptance in the academic community. In the absence of a superior
(validated) tolerability instrument, the Lawrance instrument results should be included in future
Phase 3 studies.
Reference:
Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire
and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci 2013;58:926-35.
Included in the following large studies:
Sey MSL, Von Renteln D, Sultanian R, et al. A Multicenter Randomized Controlled Trial
Comparing Two Bowel Cleansing Regimens for Colonoscopy After Failed Bowel Preparation,
Clinical Gastroenterology and Hepatology,
Volume 20, Issue 6, 2022, Pages e1283-e1291
Briot C, Faure P, Parmentier AL, et al. and The CLEAN Study Group. Efficacy, Tolerability,
and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases:
The French Multicentre CLEAN Study, Journal of Crohn's and Colitis, 2019, Pages 1121-1130
I accept the other comments of the authors and suggest that the paper be accepted for publication.
Please review this paper.
user
Title: A PHASE 2 EVALUATION OF A NEW FLAVORED PEG AND SULFATE
SOLUTION FOR Colonoscopy
Version: 3 Date: 18 Nov 2023
Reviewer's report:
The authors claim, “Unfortunately, there are few validated instruments for assessing bowel
preparation tolerance and none, to our knowledge, are widely accepted for this purpose.”
However, the validated tolerability instrument by Lawrance et al has been used in multiple
studies, including several large-scale studies (see below). The Lawrance instrument appears
to enjoy considerable acceptance in the academic community. In the absence of a superior
(validated) tolerability instrument, the Lawrance instrument results should be included in future
Phase 3 studies.
Reference:
Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire
and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci 2013;58:926-35.
Included in the following large studies:
Sey MSL, Von Renteln D, Sultanian R, et al. A Multicenter Randomized Controlled Trial
Comparing Two Bowel Cleansing Regimens for Colonoscopy After Failed Bowel Preparation,
Clinical Gastroenterology and Hepatology,
Volume 20, Issue 6, 2022, Pages e1283-e1291
Briot C, Faure P, Parmentier AL, et al. and The CLEAN Study Group. Efficacy, Tolerability,
and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases:
The French Multicentre CLEAN Study, Journal of Crohn's and Colitis, 2019, Pages 1121-1130
I accept the other comments of the authors and suggest that the paper be accepted for publication.
assistant