Constipation Diary

©NEUROGUT 2018 CONSTIPATION STOOL INSTRUMENT

Basic description: The Constipation Stool Instrument (CSI) is a list of patient-reported symptoms for the evaluation of bowel problems associated with constipation. Constipation affects 15% of the US population. Constipation comprises of multiple symptoms that describe the frequency and difficulty with bowel movements. Because of the irregular nature of bowel habit, the multiple and variable symptoms, and difficulty with remembering symptoms as well as recall bias, it is important to prospectively assess patient-reported bowel symptoms, for use in clinical trials, and for the assessment of patients with constipation.

Authors: Neurogut Incorporated (USA)

Objective: To assess the presence of and severity of patient-reported bowel and abdominal symptoms related to constipation, for use in clinical trials, and assessment of patients with constipation

Therapeutic Areas: Gastrointestinal and Digestive System Diseases Pathological conditions, Signs and Symptoms

Therapeutic indication: Constipation Dyssynergic defecation Anorectal and Colorectal diseases

Type of Clinical Outcome Assessment (COA) Patient Reported Outcome (PRO) assessment

Original language English for the USA

Bibliographic reference for the original questionnaire: Meduri K, Brown CK, Attaluri A, Valestin J, Rao SSC. Validation of a Prospective Stool Diary for Assessment of Constipation. Neurogastroenterol Motil 2011; 23 (Supplement 1): 21.

Administration: The Constipation Stool Instrument (CSI) is a daily, self-administered questionnaire for the assessment of bowel habit. The subject is instructed to fill out all 11 items for one day by responding on each screen presented, and as it relates to each bowel movement. It takes 1 minute to complete this App for each bowel movement.

Purpose of survey: To accurately and more completely record each subject’s bowel and stooling habit To better understand the subject’s constipation problem To use the information to improve the health of a patient with constipation

Benefits to the Respondent: To improve diagnosis of constipation and to identify the subject’s subtype of constipation To help develop appropriate treatment plan To help develop new treatments