Table 4 Item Level Cognitive Debriefing

Item 1: Nausea (feeling sick to your stomach as if you were going to vomit or throw up)

n = 25, 100%

Patient “feeling sick to their stomach,” “feeling like they will throw up,” “sickness in the stomach,” “upset stomach,” and “queasy.”

One patient (4%) explained how she experiences different types of nausea and at times can experience nausea without feeling like she will throw up.

All patients thought the phrase in parentheses (“feeling sick to your stomach as if you were going to vomit or throw up”) was a clear and appropriate definition for nausea.

Item 2: Not able to finish a normal-sized meal (for a healthy person)

n = 24, 96%

Patient unable to eat a normal-sized meal, unable to finish a normal plate of food, a remature loss of appetite, or “getting full quickly.”

Patients explained that a regular meal for them would entail a half-sized portion of a “normal” meal such as half a cup of soup, half a sandwich, or half of a burger.

Patients correctly defined a normal-sized meal “for a healthy person,” explaining that it would entail a “well-balanced meal” consisting of “multiple servings or courses” or the “right” amount of protein, carbohydrates, vegetables, and fruit or dessert.

Item 3: Feeling excessively full after meals

n = 25, 100%

Patient terms such as “stuffed” or feeling like there is “too much food” in their stomach.

All but one patient (n = 24, 96%) successfully described the difference between Item 2 (early satiety) and Item 3 (post-prandial fullness).

No other comments

Item 4: Upper abdominal pain (above the navel)

n = 25, 100%

Patient pain above the navel/belly button or near the middle of the stomach and further described the feeling of pain as “sharp,” “deep,” “dull,” “burning,” and “uncomfortable.”

Most patients (n = 12, 48%) endorsed “upper abdominal pain (above the navel)”, as appropriate to capture their symptoms, while others preferred the term “abdominal pain” (n = 9, 36%) or did not have a preference (n = 2, 8%).

All patients expressed understanding of the term “navel.”

Item 5: During the past 24 h, how many episodes of vomiting did you have?

n = 25, 100%

Patient “episode” of vomiting as food or liquid being expelled from the mouth.

Most patients (n = 15, 60%) agreed that it was important to assess the frequency of vomiting, while others suggested that the item could assess the severity of vomiting (n = 3, 12%) or ask about retching and dry heaving (n = 3, 12%) as an indicator of symptom severity.

All patients demonstrated they could answer the vomiting item using the written response option space, and most patients (n = 23, 92%) provided a clear explanation for how to count their episodes of vomiting over the past 24 h. Two patients (8%) reported that they would experience some difficulty with counting their episodes of vomiting over the past 24 h due to high frequency of vomiting episodes.