Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation

ABSTRACT Background and Aims Patient-reported experience measures (PREMs) assessing the tolerability of endoscopic procedures are scarce. In this study, we designed and validated a PREM to assess tolerability of endoscopy using conscious sedation. Methods The patient-reported scale for tolerability of endoscopic procedures (PRO-STEP) consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas Domain 2 (postprocedural) consists of 4 questions including pain, nausea, distention and either throat or anal pain. All questions are scored on a Likert scale from 0 to 10. Cronbach’s alpha was used to measure internal consistency of the questions. Multivariable logistic regression was performed to assess predictors of higher scores, reported using adjusted odds ratios (AORs) and confidence intervals (CIs). Results A total of 255 patients (91 colonoscopy, 73 gastroscopy, and 91 endoscopic retrograde cholangiopancreatography) were included. Colonoscopy was the least tolerable procedure by recall, with mean intraprocedural awareness and discomfort scores of 5.1 +/- 3.8, and 2.6 +/- 2.7, respectively. Consistency between intraprocedural awareness and discomfort/pain yielded an acceptable Cronbach’s alpha of 0.71 (95% CI, 0.62 - 0.78). Higher use of midazolam during colonoscopy was inversely associated with an intraprocedural awareness score of 7 or higher (AOR, 0.23; 95% CI, 0.09-0.54 per additional mg). Conclusions PRO-STEP is a simple PREM that can be administered after multiple endoscopic procedures using conscious sedation. Future work should focus on its performance characteristics in adverse event prediction.