Constipation Diary 1.6

NEUROGUT 2018 CONSTIPATION STOOL INSTRUMENT

Basic description: The Constipation Stool Instrument (CSI) is a tool consisting of patient-reported symptoms specifically designed for the evaluation of bowel issues associated with constipation. It addresses a common problem affecting 15% of the US population, encompassing various symptoms that depict the frequency and difficulty experienced during bowel movements. Due to the complexity of symptoms, the inconsistent nature of bowel habits, and the challenge of recalling symptoms accurately, prospective assessment of patient-reported bowel symptoms becomes crucial. CSI is invaluable for clinical trials and the evaluation of constipated patients.

Authors: Neurogut Incorporated (USA)

Objective: The aim is to evaluate the presence and severity of patient-reported bowel and abdominal symptoms connected with constipation, primarily for clinical trials and patient assessment purposes.

• Therapeutic Areas:
• 1. Gastrointestinal and Digestive System Diseases
  2. 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 CSI is a daily, self-administered questionnaire devised to evaluate bowel habits. Respondents are required to complete all 11 items per day related to each bowel movement by responding on each screen provided. It takes approximately 1 minute to complete this task for each bowel movement.

Purpose of survey:

• To meticulously document each subject’s bowel and stooling habits
• To gain better insight into the subject's constipation issue
• To utilize information gathered to enhance a constipated patient’s overall health

Benefits to the Respondent:

• To enhance constipation diagnosis and determine the subject's particular subtype of constipation
• To aid in developing appropriate treatment plans tailored to individual needs
• To contribute to the advancement of novel treatment options for constipation management