Appendix A: Focus Group Moderator’s Guide
TOPIC / MAIN POINTS / APPROX. TIME (min.)Introduction / Welcome and thanks for participation.
Definition of focus group and who is attending.
Ultimate goal of the discussion.
Introduction of moderator and other researchers in the room.
Confidentiality. / 5
Ground Rules / Goal is to hear everybody’s opinions and experiences.
No right or wrong answers; no need for agreement.
Protection of each other’s privacy.
Personal brief introductions with first names only. / 5
GI Symptoms Question Guide / Range of symptoms which might include: pain, gas and/or bloating, diarrhea, constipation, “incontinence or having accidents”, nausea or queasiness, vomiting, heartburn or reflux, and difficulty swallowing.
List is generated based on those more relevant to the group. / 15
Generic Probes / How do you know when [symptom] is getting worse?
What kinds of things only happen when you are really sick?
What things occur and consistently increase as you get sicker?
How do you know you are getting better?
When you start a treatment to control your symptoms, how do you know the treatment is working? / 30
Symptom-specific Probes (to be discussed with each symptom to clarify definitions and language) / Gastrointestinal Pain:
Are there different kinds of GI pain?
Are GI pain and discomfort the same?
Are there differences in GI pain based on qualifiers (intensity, location, radiation, sharp/dull, extra-abdominal, postprandial, pre-defecatory, postdefecatory, etc.)?
Are discomfort and pain related?
Is very mild pain equal to discomfort? / 30
Gas/bloat:
Are bloating and distension the same?
Is there a difference between how gas/bloating looks and how it feels?
Diarrhea:
Are there different kinds of diarrhea?
Are there different kinds of diarrhea based on stool consistency?
Are there different kinds of diarrhea based on stool frequency?
Are there different kinds of diarrhea based on bowel urgency (e.g., how long can you “hold it in”)?
Constipation:
Are there different kinds of constipation?
Are there different kinds of constipation that are based on the stool consistency? (e.g. hard like pellets)
Are there different kinds of constipation based on how frequent you have bowel movements?
Incontinence:
Are there different kinds of incontinence?
Are there differences based on presence of urgency, or nocturnal symptoms?
Are incontinence and diarrhea related? Does severe diarrhea lead to incontinence?
Heartburn/Reflux
Is there a difference between heartburn and reflux?
Is there a difference between nausea, upset stomach, and queasiness?
Are nausea, queasiness, and vomiting related? How?
Is heartburn the same as nausea or queasiness?
Closure / Any issues regarding symptoms that have not been discussed?
Thanks for participation. / 5
Appendix B: Probes used in Cognitive Interviews
Response Options / What were you thinking about when you answered, “[fill in choice]”?
How did you decide upon your answer of “[fill in choice]”?
What were you thinking about when you answered “[insert choice]”? / Never, Rarely, Sometimes, Often, Always
Once, 2-4 times, 5-7 times, 8-10 times, More than 10 times
Not at all, A little bit, Somewhat, Quite a bit, Very much
Domain thoroughly completed / Are there any other questions we should have asked that we did not ask?
Symptom concept and definition / What did you think of by “symptom”? Is this the same of different from “other symptom”?
What do the words “symptom” mean to you?
Are there any other words that are better to describe this feeling? / How many days did you have loose or watery stool?
How often did you have nausea or feel sick to your stomach?
How often did you have poor appetite?
Concept understanding / What does “interfere with your day-to-day activities” mean to you?
What does “at its worst” mean to you? How does it differ from “on average”?
Which way is a better description of your pain experience, “average” or “worst”? / How would you rate your belly pain at its worst?
Not bad at all, A little bad, Somewhat bad, Quite bad, Very bad
How would you rate your belly pain at its worst?
Concept and response option definition / Why did [symptom] bother you [insert answer]? What does the word “bother” mean to you? Are there other words that are preferable to bother?
When you answered did you have in mind an average of symptoms over the past 7 days, the most recent episode, or the worst episode over the past 7 days? / How much did your heartburn bother you?
How severe did your bloating feel in general?
Not at all, A little bit, Somewhat, Quite a bit, Very much
Best way to ask about a symptom / Are the last two questions the same or different to you? Why? Which of the two previous questions is a better way to ask about this? / How well could you predict when you would feel bloating?
How well were you able to know in advance when you would feel bloated?
Appendix C: NIH PROMIS® GI Symptom Scale
[Note: Internal branching and scoring algorithms will be posted electronically by the NIH Assessment Center – before then available upon request from the authors]
Please respond to each item by marking one box per row.
Gastroesophageal Reflux
In the past 7 days…
None / Enough to fill a little bit of my mouth / Enough to fill some of my mouth / Enough to fill most of my mouth / So much that it filled my entire mouthGI3 / What was the most food or liquid you had come back into your mouth at one time? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / Rarely / Sometimes / Often / Always
GI9 / After eating a meal, how often did food or liquid come back into your throat or mouth without vomiting? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI10 / How often did you re-swallow food that came back into your throat? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI12 / How often did you feel like there was too much saliva in your mouth? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI21 / How often did you feel burning in your throat? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI25 / How often did you have hiccups? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI28 / How often did you feel like there was a lump in your throat? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / One day / 2-6 days / Once a day / More than once a day
GI2 / How often did you have regurgitation—that is, food or liquid coming back up into your throat or mouth without vomiting? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / One day / 2-6 days / Once a day / More than once a day
GI11 / How often did you feel like you were going to burp, but food or liquid came up instead? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI22 / How often did you burp? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI14 / How frequently did you feel burning in the red area show in the picture—that is, behind the breastbone? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Not at all / A little bit / Somewhat / Quite a bit / Very much
GI24 / How much did burping bother you? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Disrupted Swallowing
In the past 7 days…
Never / Rarely / Sometimes / Often / AlwaysGI31 / How often did food get stuck in your chest when you were eating? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI32 / How often did food get stuck in your throat when you were eating? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI33 / How often did you feel pain in your chest when swallowing food? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI34 / How often did you have difficulty swallowing sold foods like meat, chicken or raw vegetables, even after lots of chewing? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI35 / How often did you have difficulty swallowing soft foods like ice cream, apple sauce, or mashed potatoes? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI36 / How often did you have difficulty swallowing liquids? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI37 / How often did you have difficulty swallowing pills? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Diarrhea
In the past 7 days…
No days / 1 day / 2 days / 3-5 days / 6-7 daysGI38 / How many days did you have loose or watery stools? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Not at all / A little bit / Somewhat / Quite a bit / Very much
GI40 / How much did having loose or watery stools interference with your day-to-day activities? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI41 / How much did having loose or watery stools bother you? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI43 / How much did feeling you needed to empty your bowels right away interfere with your day-to-day activities? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / One time during the past 7 days / 2-6 days during the past 7 days / Once a day / More than once a day
GI42 / How often did you feel like you needed to empty your bowels right away or else you would have an accident? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Bowel Incontinence/Soilage
In the past 7 days…
No days / 1 day / 2-3 days / 4-5 days / 6-7 daysGI45 / How often did you have bowel incontinence—that is, have an accident because you could not make it to the bathroom in time? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI46 / How often did you soil or dirty your underwear before getting to a bathroom? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI47 / How often did you leak stool or soil your underwear? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / Rarely / Sometimes / Often / Always
GI48 / How often did you think you were going to pass gas, but stool or liquid came out instead? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Nausea and Vomiting
In the past 7 days…
Never / Rarely / Sometimes / Often / AlwaysGI49 / How often did you have nausea—that is a feeling like you could vomit? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI52 / How often did you know that you would have nausea before it happened? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI55 / How often did you have a poor appetite? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / One day / 2-6 days / Once a day / More than once a day
GI59 / How often did you throw up or vomit? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Constipation
In the past 7 days…
Not at all / A little bit / Somewhat / Quite a bit / Very muchGI64 / How much did hard or lumpy stools bother you? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI66 / How much did you usually strain while trying to have a bowel movement? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI67 / How much did straining during bowel movements bother you? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / One day / 2-6 days / Once a day / More than once a day
GI63 / How often did you pass very hard or lumpy stools? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / Rarely / Sometimes / Often / Always
GI65 / How often did you strain while trying to have bowel movements? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI68 / How often did you feel pain in your rectum or anus while trying to have bowel movements? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI72 / How often after a bowel movement did you feel unfinished—that is, that you had not passed all your stool? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI74 / How often did you use your finger or toilet paper to get out a stool? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Not bad at all / A little bad / Somewhat bad / Quite bad / Very bad
GI69 / At its worst, how would you rate the pain in your rectum or anus during bowel movements? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Belly Pain
Area 1 / Area 2 / Area 3 / Area 4 / Area 5 / Area 6 / Area 7 / Area 8 / Area 9
¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5 / ¨
6 / ¨
7 / ¨
8 / ¨
9
In the past 7 days…
Never / One Day / 2-6 days / Once a day / More than once a dayGI78 / How often did you have belly pain? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Never / Rarely / Sometimes / Often / Always
GI92 / How often did you have discomfort in your belly? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Not at all / A little bit / Somewhat / Quite a bit / Very much
GI90 / How much did belly pain interfere with your day-to-day activities? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
GI91 / How much did belly pain bother you? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Not bad at all / A little bad / Somewhat bad / Quite bad / Very bad
GI79 / At its worst, how would you rate your belly pain? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Gas/Bloat/Flatulence
In the past 7 days…
Not bad at all / A little bad / Somewhat bad / Quite bad / Very badGI95 / How bad did the swelling in your belly get? / ¨
1 / ¨
2 / ¨
3 / ¨
4 / ¨
5
Not at all / A little bit / Somewhat / Quite a bit / Very much
GI96 / How much did the swelling in your belly interfere with your day-to-day activities? / ¨
1 / ¨
2 / ¨
3 / ¨