Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire

Background: Bowel cleansing is paramount for colonoscopy quality. Unfortunately, an adequate bowel preparation is often limited by side effects and/or patient's intolerance to bowel preparation solutions. Comparisons among different preparations are limited by the lack of validated instruments designed to assess patient's tolerability. Aim: To develop and validate a simple, comprehensive instrument to assess bowel preparation tolerability in patients undergoing colonoscopy. Methods: Development and validation by phases: Phase I (bibliographic search and questionnaire design); Phase II (assessment of content validity and modification of the questionnaire); Phase III (assessment of reproducibility, final validation, and definitive version of the questionnaire). Results: The initial draft of the questionnaire was generated based on a systematic literature review and feedback from a panel of consultants. Content validity was tested in a focus group of 25 patients undergoing colonoscopy. Patients' suggestions were reviewed by the research team and a second draft of the questionnaire was generated. Final validation and reproducibility were successfully tested (agreement: 86-100%, kappa: 0.77-1.00) in a convenience sample of 100 patients undergoing bowel preparation with different cleansing solutions. Conclusion: The Mayo Clinic Bowel Prep Tolerability Questionnaire is a simple, comprehensive instrument suitable to evaluate the tolerability of various types of bowel preparations. (C) 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.