Scale | Description |
---|---|
Primary outcome measure | |
Irritable Bowel Symptom Severity Scale (IBS-SSS) | This 5-item questionnaire provides a simple way to scale IBS symptoms and the progress of the disease. Items consider pain, distension, bowel dysfunction, and quality of life/global wellbeing. Scores show good reliability and sensitivity to change |
Secondary outcome measures | |
Symptom evaluation | |
IBS-Adequate Relief | A single yes/no question makes up this simple global measure of symptom relief in the past week |
IBS-Global Improvement | A single question provides a measure of improvement in the past week using a 7-point scale |
Daily Symptom Diary | Questions regarding subject symptoms will be completed daily for the 7-day period prior to visit 2 and visit 3 |
Quality of life | |
Short Form-12 Health Survey (SF-12) | This 12-item scale measures emotional and physical health and wellbeing |
Psychosocial | |
Patient Health Questionnaire-8 (PHQ-8) | An 8-item scale that is used as a diagnostic and severity measure for depressive disorders in clinical studies |
Generalized Anxiety Disorder-7 (GAD-7) | A 7-item scale that is used as a diagnostic and severity measure for anxiety disorders in clinical practice and research |
Visceral Sensitivity Index | A 15-item measure of gastrointestinal symptom-specific anxiety |
Pain Catastrophizing Scale | A scale that measures the tendency to magnify or exaggerate the seriousness of pain sensations |
Five Factor Inventory | A 60-item instrument that measures the “Big Five” dimensions of personality |
Interpersonal Support Evaluation List | Designed to measure perceptions of social support among individuals in the general population |
Balanced Inventory of Desirable Reach | Describes the tendency of respondents to answer questions that will be viewed favorably by others |
Patient experience | |
Consultation and Relational Empathy Measure | Assesses physician empathy and relational skills on 10 ordinal items, which are then summed |
Expectancy Question | “If I receive placebo/peppermint oil/no additional treatment, I expect my IBS symptoms to be: “(numerical rating scale running from zero “not improved at all” to 100 “completely improved”) |