Table 2.
Patient-reported GI signs and symptoms and their bother, worry, and impact
| Concepta | Ratings/Patientsb | Bother ratingc | Worry ratingc | Impact ratingc | |||
|---|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | ||
| Diarrhea (n = 13) | 11/13 | 11 | 6.4 (2.0) | 11 | 3.5 (2.9) | 11 | 5.1 (3.3) |
| Bloating (n = 10) | 9/10 | 9 | 4.9 (2.3) | 9 | 3.6 (3.2) | 9 | 3.3 (3.3) |
| Constipation (n = 10) | 9/10 | 9 | 6.4 (3.0) | 9 | 5.5 (3.3) | 9 | 5.8 (2.8) |
| Cramping (n = 9) | 8/9 | 8 | 6.5 (2.3) | 8 | 4.4 (2.7) | 7 | 6.0 (3.4) |
| Stomach pain (n = 7) | 7/7 | 7 | 6.1 (2.9) | 7 | 4.9 (1.7) | 7 | 5.0 (2.9) |
| Nausea (n = 6) | 5/6 | 5 | 6.2 (2.8) | 5 | 2.4 (1.9) | 5 | 4.0 (3.5) |
| Gas (n = 4) | 4/4 | 4 | 3.8 (3.3) | 4 | 4.5 (5.3) | 4 | 5.0 (4.2) |
| Heartburn (n = 4) | 4/4 | 4 | 5.5 (3.7) | 4 | 4.5 (3.8) | 4 | 3.8 (1.7) |
| Upset stomach (n = 4) | 3/4 | 3 | 5.7 (2.1) | 3 | 3.0 (2.6) | 3 | 5.0 (4.4) |
| Gas pain (n = 3) | 2/3 | 2 | 6.5 (0.7) | 2 | 3.0 (4.2) | 2 | 4.5 (4.9) |
| Frequent bowel movements (n = 2) | 1/2 | 1 | 7.0 | 1 | 8.0 | 1 | 6.0 |
| Burping (n = 1) | 0/1 | 0 | – | 0 | – | 0 | – |
| Vomiting (n = 1) | 1/1 | 1 | 8.0 | 1 | 4.0 | 1 | 5.0 |
CEI concept elicitation interview, GI gastrointestinal, SD standard deviation
aBased on the CEIs
bIndicates the number of patients who provided a symptom rating out of the total number of patients reported experiencing the symptom during the open-ended discussion. The number of patients who had the opportunity to provide a rating for the symptom may be less than the total frequency count for some symptoms as patients were only able to rate symptoms that the interviewer specifically asked about during the interview, prior to the complete analysis of qualitative data
cRated on a 0–10 scale where a higher score indicates more bother, worry, or impact