Table 4. Conceptual framework of the FDSD TSSa.
| Domain | Concept | FDSD Item | ||
|---|---|---|---|---|
| FD symptom severity (TSS) | → | Burning in the stomach | → | Item 1 |
| Stomach pain | → | Item 2 | ||
| Bloating | → | Item 4 | ||
| Postprandial fullness | → | Item 5 | ||
| Early satiety | → | Item 6 |
FD, functional dyspepsia; FDSD, Functional Dyspepsia Symptom Diary; TSS, Total Symptom Score.
a
Item 3 (nausea), Item 7 (burping/belching rating), and Item 8 (burping/belching bother) are included in the FDSD; however, because they are considered supplementary assessments and are not anticipated to be included in the TSS or used in trial endpoints, they are not included in the conceptual framework (they will instead be scored as individual items).