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| Name | Class |
|---|---|
| Grünenthal GmbH | INDUSTRY |
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Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. Aim of this study is to validate an IBS-specific electronic patient-reported outcome measure, based on the Experience Sampling Method-principle, for symptom assessment in IBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBS patients | IBS according to Rome IV criteria. | ||
| Healthy control group | Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS. |
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| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain scores as measured by the ESM tool. | Momentary measurements. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain scores as measured by the end-of-day diary. | Retrospective measurements with a recall period of one day. | 7 days |
| Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS. |
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Inclusion Criteria:
Exclusion Criteria:
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IBS patients.
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| Name | Affiliation | Role |
|---|---|---|
| Ad A.M. Masclee, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | 6229ER | Netherlands |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Retrospective measurements with a recall period of one week.
| 7 days |
| Symptom scores (other than abdominal pain) as measured using the ESM-tool. | Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment. | 7 days |
| Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary. | 7 days |
| Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS. | 7 days |
| Psychological symptom scores as measured using the PHQ-9. | 7 days |
| Psychological symptom scores as measured using the GAD-7. | 7 days |
| Quality of life scores as measured using SF-36. | 7 days |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |