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Appendix A: Focus Group Moderator’s Guide

|TOPIC |MAIN POINTS |APPROX. TIME (min.) |

|Introduction |Welcome and thanks for participation. |5 |

| |Definition of focus group and who is attending. | |

| |Ultimate goal of the discussion. | |

| |Introduction of moderator and other researchers in the room. | |

| |Confidentiality. | |

|Ground Rules |Goal is to hear everybody’s opinions and experiences. |5 |

| |No right or wrong answers; no need for agreement. | |

| |Protection of each other’s privacy. | |

| |Personal brief introductions with first names only. | |

|GI Symptoms Question Guide|Range of symptoms which might include: pain, gas and/or bloating, diarrhea, constipation, |15 |

| |“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. | |

|Generic Probes |How do you know when [symptom] is getting worse? |30 |

| |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? | |

|Symptom-specific Probes |Gastrointestinal Pain: |30 |

|(to be discussed with each|Are there different kinds of GI pain? | |

|symptom to clarify |Are GI pain and discomfort the same? | |

|definitions and language) |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? | |

| |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? |5 |

| |Thanks for participation. | |

Appendix B: Probes used in Cognitive Interviews

|TOPIC |PROBE |ITEM/RESPONSE OPTIONS EXAMPLE |

|Response Options |What were you thinking about when you answered,|Never, Rarely, Sometimes, Often, Always |

| |“[fill in choice]”? | |

| | | |

| |How did you decide upon your answer of “[fill |Once, 2-4 times, 5-7 times, 8-10 times, More than|

| |in choice]”? |10 times |

| | | |

| |What were you thinking about when you answered |Not at all, A little bit, Somewhat, Quite a bit, |

| |“[insert choice]”? |Very much |

|Domain thoroughly |Are there any other questions we should have | |

|completed |asked that we did not ask? | |

|Symptom concept and |What did you think of by “symptom”? Is this the|How many days did you have loose or watery stool?|

|definition |same of different from “other symptom”? | |

| | | |

| |What do the words “symptom” mean to you? |How often did you have nausea or feel sick to |

| | |your stomach? |

| | | |

| |Are there any other words that are better to |How often did you have poor appetite? |

| |describe this feeling? | |

|Concept understanding |What does “interfere with your day-to-day |How would you rate your belly pain at its worst? |

| |activities” mean to you? |Not bad at all, A little bad, Somewhat bad, Quite|

| | |bad, Very bad |

| | | |

| | |How would you rate your belly pain at its worst? |

| |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”? | |

|Concept and response |Why did [symptom] bother you [insert answer]? |How much did your heartburn bother you? |

|option definition |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 |How severe did your bloating feel in general? |

| |average of symptoms over the past 7 days, the |Not at all, A little bit, Somewhat, Quite a bit, |

| |most recent episode, or the worst episode over |Very much |

| |the past 7 days? | |

|Best way to ask about |Are the last two questions the same or |How well could you predict when you would feel |

|a symptom |different to you? Why? Which of the two |bloating? |

| |previous questions is a better way to ask about|How well were you able to know in advance when |

| |this? |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 |Enough to fill |Enough to fill |So much that it |

| | | |little bit of my |some of my mouth |most of my mouth|filled my entire |

| | | |mouth | | |mouth |

|GI3 |What was the most food or liquid you had come back into your |( |( |( |( |( |

| |mouth at one time? |1 |2 |3 |4 |5 |

|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 |

| |How often did you have regurgitation—that is, food or liquid |( |( |( |( |( |

|GI2 |coming back up into your throat or mouth without vomiting? |1 |2 |3 |4 |5 |

| |How often did you feel like you were going to burp, but food |( |( |( |( |( |

|GI11 |or liquid came up instead? |1 |2 |3 |4 |5 |

| |How often did you burp? |( |( |( |( |( |

|GI22 | |1 |2 |3 |4 |5 |

| |How frequently did you feel burning in the red area show in the picture—that is, behind the breastbone? |

|GI14 | |

| | |Not at all |A little bit |Somewhat |Quite a bit |Very much |

|GI24 |How much did burping bother you? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI31 |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 |

|GI38 |How many days did you have loose or watery stools? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|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 |

|GI45 |How often did you have bowel incontinence—that is, have an |( |( |( |( |( |

| |accident because you could not make it to the bathroom in |1 |2 |3 |4 |5 |

| |time? | | | | | |

|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 | |

|GI48 |How often did you think you were going to pass gas, but stool |( |( |( |( |( |

| |or liquid came out instead? |1 |2 |3 |4 |5 |

|GI49 |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 |

|GI59 |How often did you throw up or vomit? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI64 |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 |

|GI63 |How often did you pass very hard or lumpy stools? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|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 |

|GI69 |At its worst, how would you rate the pain in your rectum or anus during bowel movements? |

|Area 1 |Area 2 |Area 3 |Area 4 |Area 5 |Area 6 |Area 7 |

|GI78 |How often did you have belly pain? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

| | | | | | | |

|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 |

|GI79 |At its worst, how would you rate your belly pain? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI95 |How bad did the swelling in your belly get? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI96 |How much did the swelling in your belly interfere with your |( |( |( |( |( |

| |day-to-day activities? |1 |2 |3 |4 |5 |

|GI97 |How much did having swelling in your belly bother you? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI99 |In general, how severe was your bloating? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI |How much did feeling bloated bother you? |( |( |( |( |( |

|GI104 | |1 |2 |3 |4 |5 |

|GI100 |At its worst, how severe was your bloating? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI101 |In general, how severe did your bloating feel? |( |( |( |( |( |

| | |1 |2 |3 |4 |5 |

|GI105 |How often did you pass gas? |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |33,8 |

|1 |7 |1 |36.2 |

|2 |16 |1 |38.8 |

|3 |24 |1 |42.2 |

|4 |32 |2 |44.5 |

|5 |40 |2 |46.8 |

|6 |45 |2 |48.9 |

|7 |49 |2 |51.3 |

|8 |54 |3 |52.5 |

|9 |58 |3 |53.5 |

|10 |61 |3 |54.7 |

|11 |64 |3 |55.0 |

|12 |67 |3 |55.4 |

|13 |69 |3 |56.0 |

|14 |71 |3 |56.4 |

|15 |74 |3 |57.0 |

|16 |76 |4 |57.5 |

|17 |78 |4 |58.6 |

|18 |79 |4 |59.6 |

|19 |81 |4 |60.3 |

|20 |82 |4 |61.1 |

|21 |84 |4 |62.2 |

|22 |86 |4 |62.6 |

|23 |88 |4 |63.0 |

|24 |89 |4 |63.2 |

|25 |90 |4 |63.5 |

|26 |92 |4 |63.6 |

|27 |93 |4 |63.8 |

|28 |94 |4 |64.1 |

|29 |95 |4 |64.5 |

|30 |95 |4 |64.9 |

|31 |96 |4 |65.1 |

|32 |96 |4 |66.0 |

|33 |97 |4 |67.3 |

|34 |97 |4 |68.0 |

|35 |98 |4 |68.8 |

|36 |98 |4 |70.3 |

|37 |98 |4 |71.2 |

|38 |98 |4 |72.3 |

|39 |99 |4 |72.9 |

|40 |99 |4 |74.2 |

|41 |99 |4 |74.9 |

|42 |99 |4 |76.8 |

|43 |99 |4 |78.2 |

|44 |99 |4 |81.1 |

|45 |99 |4 |83.1 |

|46 |99 |4 |84.3 |

|47 |99 |4 |87.1 |

|48 |99 |4 |89.2 |

|49 |99 |4 |92.1 |

|50 |99 |4 |93.9 |

|51 |99 |4 |95.5 |

Lookup and crosswalk table for disrupted swallowing scale:

| |Swallowing |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |40.6 |

|1 |17 |1 |45.3 |

|2 |32 |2 |48.8 |

|3 |43 |2 |52.1 |

|4 |51 |3 |54.0 |

|5 |58 |3 |56.6 |

|6 |64 |3 |58.4 |

|7 |70 |3 |59.5 |

|8 |74 |3 |60.7 |

|9 |77 |4 |62.5 |

|10 |81 |4 |63.7 |

|11 |83 |4 |64.8 |

|12 |85 |4 |65.6 |

|13 |88 |4 |66.7 |

|14 |91 |4 |67.2 |

|15 |93 |4 |67.7 |

|16 |95 |4 |68.3 |

|17 |96 |4 |69.0 |

|18 |97 |4 |70.1 |

|19 |97 |4 |71.7 |

|20 |97 |4 |73.3 |

|21 |98 |4 |74.5 |

|22 |98 |4 |76.2 |

|23 |98 |4 |77.5 |

|24 |98 |4 |79.3 |

|25 |98 |4 |82.7 |

|26 |98 |4 |85.2 |

|27 |98 |4 |87.7 |

|28 |99 |4 |91.3 |

Lookup and crosswalk table for diarrhea scale:

| |Diahrrea |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |40.3 |

|1 |10 |1 |41.6 |

|2 |20 |1 |46.9 |

|3 |28 |2 |52.3 |

|4 |35 |2 |53.6 |

|5 |42 |2 |55.5 |

|6 |48 |2 |57.5 |

|7 |53 |3 |58.7 |

|8 |57 |3 |59.3 |

|9 |62 |3 |59.8 |

|10 |67 |3 |59.8 |

|11 |71 |3 |60.5 |

|12 |75 |3 |60.2 |

|13 |78 |4 |59.4 |

|14 |81 |4 |59.7 |

|15 |84 |4 |60.2 |

|16 |86 |4 |61.4 |

|17 |88 |4 |63.1 |

|18 |91 |4 |65.3 |

|19 |93 |4 |68.2 |

|20 |95 |4 |70.3 |

|21 |97 |4 |74.0 |

|22 |97 |4 |76.7 |

|23 |98 |4 |79.8 |

|24 |99 |4 |84.1 |

Lookup and crosswalk table for incontinence scale:

| |Incontinence |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |43.8 |

|1 |30 |2 |50.2 |

|2 |48 |2 |56.8 |

|3 |58 |3 |64.1 |

|4 |67 |3 |67.2 |

|5 |74 |3 |67.9 |

|6 |78 |4 |67.9 |

|7 |82 |4 |67.9 |

|8 |87 |4 |67.9 |

|9 |92 |4 |68.4 |

|10 |94 |4 |69.9 |

|11 |95 |4 |73.8 |

|12 |96 |4 |79.6 |

|13 |98 |4 |84.6 |

|14 |98 |4 |91.6 |

|15 |98 |4 |97.2 |

|16 |99 |4 |99.9 |

Lookup and crosswalk table for nausea/vomiting scale:

| |Nausea |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |41.1 |

|1 |24 |1 |45.4 |

|2 |42 |2 |50.4 |

|3 |56 |3 |54.7 |

|4 |67 |3 |57.6 |

|5 |75 |3 |60.9 |

|6 |81 |4 |63.6 |

|7 |87 |4 |65.8 |

|8 |91 |4 |67.3 |

|9 |93 |4 |69.6 |

|10 |95 |4 |71.6 |

|11 |96 |4 |73.8 |

|12 |97 |4 |77.5 |

|13 |98 |4 |79.9 |

|14 |99 |4 |83.6 |

|15 |99 |4 |87.9 |

|16 |99 |4 |89.8 |

Lookup and crosswalk table for constipation scale:

| |Constipation |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |36.0 |

|1 |9 |1 |40.7 |

|2 |17 |1 |43.5 |

|3 |25 |1 |46.8 |

|4 |33 |2 |49.4 |

|5 |39 |2 |51.5 |

|6 |43 |2 |52.3 |

|7 |47 |2 |53.0 |

|8 |51 |3 |54.3 |

|9 |55 |3 |54.8 |

|10 |59 |3 |55.5 |

|11 |63 |3 |55.9 |

|12 |66 |3 |56.5 |

|13 |70 |3 |56.9 |

|14 |73 |3 |57.8 |

|15 |75 |3 |58.1 |

|16 |78 |4 |58.7 |

|17 |81 |4 |59.1 |

|18 |84 |4 |59.6 |

|19 |87 |4 |60.6 |

|20 |89 |4 |60.7 |

|21 |90 |4 |61.3 |

|22 |92 |4 |62.6 |

|23 |93 |4 |63.1 |

|24 |93 |4 |64.7 |

|25 |94 |4 |65.3 |

|26 |95 |4 |66.7 |

|27 |96 |4 |66.9 |

|28 |97 |4 |70.7 |

|29 |97 |4 |72.6 |

|30 |98 |4 |74.4 |

|31 |98 |4 |77.1 |

|32 |98 |4 |80.1 |

|33 |99 |4 |82.5 |

|34 |99 |4 |85.7 |

|35 |99 |4 |88.7 |

|36 |99 |4 |92.2 |

Lookup and crosswalk table for belly pain scale:

| |Belly Pain |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |40.1 |

|1 |9 |1 |45.0 |

|2 |16 |1 |48.8 |

|3 |20 |1 |51.7 |

|4 |25 |1 |53.5 |

|5 |32 |2 |55.6 |

|6 |39 |2 |57.2 |

|7 |46 |2 |58.5 |

|8 |52 |3 |59.0 |

|9 |58 |3 |59.5 |

|10 |63 |3 |60.2 |

|11 |69 |3 |61.1 |

|12 |76 |4 |61.3 |

|13 |81 |4 |61.9 |

|14 |85 |4 |62.6 |

|15 |88 |4 |63.2 |

|16 |90 |4 |63.9 |

|17 |92 |4 |64.5 |

|18 |94 |4 |65.0 |

|19 |95 |4 |66.3 |

|20 |96 |4 |67.3 |

|21 |97 |4 |69.5 |

|22 |97 |4 |71.7 |

|23 |98 |4 |73.6 |

|24 |99 |4 |76.4 |

|25 |99 |4 |77.8 |

|26 |99 |4 |79.3 |

|27 |99 |4 |81.0 |

|28 |99 |4 |79.6 |

|29 |99 |4 |82.2 |

Lookup and crosswalk table for gas/bloat scale:

| |Gas/Bloating |

|Raw score |Percentile |Quartile |T-score |

|0 |  | |33.7 |

|1 |17 |1 |38.4 |

|2 |30 |2 |42.5 |

|3 |39 |2 |45.5 |

|4 |45 |2 |48.4 |

|5 |50 |2 |51.7 |

|6 |54 |3 |52.9 |

|7 |58 |3 |54.5 |

|8 |61 |3 |55.8 |

|9 |64 |3 |56.6 |

|10 |67 |3 |57.4 |

|11 |69 |3 |57.9 |

|12 |72 |3 |58.0 |

|13 |74 |3 |59.1 |

|14 |76 |4 |59.3 |

|15 |77 |4 |59.6 |

|16 |79 |4 |59.9 |

|17 |81 |4 |60.1 |

|18 |82 |4 |60.4 |

|19 |82 |4 |60.6 |

|20 |83 |4 |60.9 |

|21 |85 |4 |61.2 |

|22 |86 |4 |61.4 |

|23 |87 |4 |61.6 |

|24 |88 |4 |61.7 |

|25 |89 |4 |62.0 |

|26 |91 |4 |62.3 |

|27 |91 |4 |62.4 |

|28 |92 |4 |62.8 |

|29 |93 |4 |62.9 |

|30 |93 |4 |63.2 |

|31 |94 |4 |63.4 |

|32 |95 |4 |63.8 |

|33 |95 |4 |64.2 |

|34 |96 |4 |64.5 |

|35 |96 |4 |64.7 |

|36 |97 |4 |65.9 |

|37 |97 |4 |66.6 |

|38 |97 |4 |66.4 |

|39 |98 |4 |68.9 |

|40 |98 |4 |70.5 |

|41 |98 |4 |72.0 |

|42 |99 |4 |73.0 |

|43 |99 |4 |74.9 |

|44 |99 |4 |78.9 |

|45 |99 |4 |82.0 |

|46 |99 |4 |85.1 |

|47 |99 |4 |89.5 |

Appendix E: NIH PROMIS® GI Symptom Scales Item Response Theory (IRT) Calibrations

Reflux calibrations

Variable

Name |Item Stem |Responses and Scores |C=Calibrated

U=Uncalibrated

E=Excluded |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 |Collapsed Categories | |GISX2 |How often did you have regurgitation—that is, food or liquid coming back up into your throat or mouth without vomiting? |1=Never

2=One day

3=2-6 days

4=Once a day

5=More than

once a day |C |2.44643 |0.15299 |0.96908 |1.77857 |2.26503 |  | |GISX3 |What was the most food or liquid you had come back up into your mouth at one time? |1=None

2=Enough to fill

a little of my mouth

3=Enough to fill

some of my mouth

4=Enough to fill

most of my mouth

5=So much that it

filled my entire mouth |C |1.20274 |-1.56214 |1.47799 |2.67311 |3.629 |  | |GISX9 |After eating a meal, how often did food or liquid come back into your throat or mouth without vomiting? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |3.33081 |0.02148 |0.90382 |1.92112 |2.77284 |  | |GISX10 |How often did you re-swallow food that came back into your throat? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |1.18916 |-0.40566 |1.04886 |2.09284 |2.83297 |  | |GISX11 |How often did you feel like you were going to burp, but food or liquid came up instead? |1=Never

2=One day

3=2-6 days

4=Once a day

5=More than

once a day |C |2.83146 |0.18788 |1.16074 |1.90553 |2.37129 |  | |GISX12 |How often did you feel like there was too much saliva in your mouth? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |1.30525 |-0.05598 |1.03417 |2.29969 |3.59589 |  | |GISX14 |How frequently did you feel burning in the red area shown in the picture — that is, behind the breastbone? |1=Never

2=One day

3=2-6 days

4=Once a day

5=More than

once a day |C |1.20149 |-1.36601 |0.63032 |2.10694 |2.85506 |  | |GISX21 |How often did you feel burning in your throat? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.56797 |-0.05489 |0.72717 |1.67349 |2.67978 |  | |GISX22 |How often did you burp? |1=Never

2=One day

3=2-6 days

4=Once a day

5=More than once a day |C |0.67409 |-3.14665 |-0.9323 |1.55918 |  |Collapse

"2-6 days"

and

"Once a day" | |GISX24 |How much did burping bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |1.76305 |0.22106 |1.25297 |2.00493 |2.71332 |  | |GISX25 |How often did you have hiccups? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Very often |C |0.80771 |-0.62705 |1.79262 |3.85648 |5.82536 |  | |GISX28 |How often did you feel like there was a lump in your throat? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Very often |C |1.74829 |0.17865 |0.96457 |2.0222 |2.72366 |  | |GISX30 |How much did having a lump in your throat bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |1.35294 |-0.54977 |1.08861 |2.16212 |3.12813 |  | |

Disrupted Swallowing Calibrations

Variable

Name |Item Stem |Responses and Scores |C=Calibrated

U=Uncalibrated

E=Excluded |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 | |GISX31 |How often did food get stuck in your chest when you were eating? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |1.9381 |-0.4938 |0.6569 |1.8020 |2.8683 | |GISX32 |How often did food get stuck in your throat when you were eating? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.4264 |-0.4194 |0.6890 |1.7571 |2.9196 | |GISX33 |How often did you feel pain in your chest when swallowing food? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.1115 |-0.2580 |0.7821 |2.0789 |3.0942 | |GISX34 |How often did you have difficulty swallowing solid foods like meat, chicken or raw vegetables, even after lots of chewing? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.9508 |-0.3049 |0.5878 |1.5234 |2.3936 | |GISX35 |How often did you have difficulty swallowing soft foods like ice cream, apple sauce, or mashed potatoes? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |3.0314 |0.5659 |1.3580 |2.1443 |3.0179 | |GISX36 |How often did you have difficulty swallowing liquids? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.0404 |0.3669 |1.4488 |2.5613 |3.4270 | |GISX37 |How often did you have difficulty swallowing pills? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |0.9315 |-1.0311 |0.7214 |2.4193 |3.8256 | |

Diarrhea Calibrations

Variable

Name

|Item Stem |Responses and Scores |C=Calibrated

U=Uncalibrated

E=Excluded |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 | |GISX38 |How many days did you have loose or watery stools? |1=No days

2=1 day

3=2 days

4=3-5 days

5=6-7 days |C |0.98704 |-1.77022 |-0.35016 |0.94842 |2.33045 | |GISX40 |How much did having loose or watery stools interfere with your day-to-day activities? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |3.79911 |-0.74725 |0.23284 |0.86209 |1.60257 | |GISX41 |How much did having loose or watery stools bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |4.0634 |-1.06242 |-0.06765 |0.53723 |1.21814 | |GISX42 |How often did you feel like you needed to empty your bowels right away or else you would have an accident? |1=Never

2=One time during the

past 7 days

3=2-6 times during the

past 7 days

4=Often once a day

5=More than once

a day |C |1.53563 |-1.5035 |0.12943 |1.49544 |1.8868 | |GISX43 |How much did feeling you needed to empty your bowels right away interfere with your day-to-day activities? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |4.35337 |-0.89763 |0.05821 |0.77572 |1.44844 | |GISX44 |How much did feeling you needed to empty your bowels right away bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |4.00858 |-1.15796 |-0.15361 |0.46968 |1.19856 | |

Incontinence Calibrations

Variable

Name |Item Stem |Responses and Scores |C=Calibrated

U=Uncalibrated

E=Excluded |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 | |GISX45 |How often did you have bowel incontinence—that is, have an accident because you could not make it to the bathroom in time? |1=No days

2=1 day

3=2-3 days

4=4-5 days

5=6-7 days |C |2.8220 |0.2284 |1.0398 |1.8270 |2.5296 | |GISX46 |How often did you soil or dirty your underwear before getting to a bathroom? |1=No days

2=1 day

3=2-3 days

4=4-5 days

5=6-7 days |C |23.3730 |-0.0279 |0.8284 |1.5216 |1.9766 | |GISX47 |How often did you leak stool or soil your underwear? |1=No days

2=1 day

3=2-3 days

4=4-5 days

5=6-7 days |C |2.9012 |-0.1351 |0.7755 |1.5503 |2.0173 | |GISX48 |How often did you think you were going to pass gas, but stool or liquid came out instead? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |0.9770 |-2.7848 |0.3315 |2.3786 |4.5571 | |

Nausea Calibrations

Variable

Name |Item Stem |Responses and Scores |C=Calibrated

U=Uncalibrated

E=Excluded |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 | |GISX49 |How often did you have nausea—that is, a feeling like you could vomit? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.32032 |-0.78473 |0.34137 |1.39745 |2.38462 | |GISX52 |How often did you know that you would have nausea before it happened? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.41088 |0.00126 |0.91039 |1.90994 |2.78803 | |GISX55 |How often did you have a poor appetite? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |0.69857 |-2.68381 |0.08782 |2.39831 |4.91927 | |GISX59 |How often did you throw up or vomit? |1=Never

2=One day

3=2-6 days

4=Once a day

5=More than once a day |C |1.74098 |0.86773 |1.67979 |2.60821 |3.13949 | |

Constipation Calibrations

Variable

Name |Item Stem |Responses and Scores |C=Calibrated

U=Uncalibrated

E=Excluded |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 | |GISX63 |How often did you pass very hard or lumpy stools? |1=Never

2=One day

3=2-6 days

4=Once a day

5=More than once a day |C |0.98468 |-0.81595 |0.6582 |2.61901 |3.74119 | |GISX64 |How much did hard or lumpy stools bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |2.61952 |-0.69095 |0.27651 |1.04326 |1.8558 | |GISX65 |How often did you strain while trying to have bowel movements? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |3.1297 |-1.03516 |-0.0924 |0.93138 |1.77424 | |GISX66 |How much did you usually strain while trying to have a bowel movement? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |4.07418 |-1.02889 |0.19558 |0.99629 |1.82342 | |GISX67 |How much did straining during bowel movements bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |5.23008 |-0.61909 |0.22714 |0.84107 |1.48734 | |GISX68 |How often did you feel pain in your rectum or anus while trying to have bowel movements? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.07678 |-0.438 |0.43221 |1.38817 |2.24803 | |GISX69 |At its worst, how would you rate the pain in your rectum or anus during bowel movements? |1=Not bad at all

2=A little bad

3=Somewhat bad

4=Quite bad

5=Very bad |C |1.72162 |-0.86 |0.6074 |1.6453 |2.56554 | |GISX72 |How often after a bowel movement did you feel unfinished - that is, that you had not passed all your stool? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |1.43129 |-1.65078 |-0.40509 |1.00831 |2.50225 | |GISX74 |How often did you use your finger or toilet paper to get out a stool? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |1.16996 |0.92572 |1.71393 |2.78395 |4.15903 | |

Belly Pain Calibrations

Variable

Name |Item Stem |Responses and Scores |CUE |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 |Calibration Statistics - Location Threshold 5 |Calibration Statistics - Location Threshold 6 |Calibration Statistics - Location Threshold 7 |Calibration Statistics - Location Threshold 8 |Calibration Statistics - Location Threshold 9 | |GISX78 |How often did you have belly pain? |1=Never

2=One day

3=2-6 days

4=Once a day

5=More than

once a day |C |1.9826 |-1.5974 |-0.0272 |1.1349 |1.5388 |  |  |  |  |  | |GISX79 |At its worst, how would you rate your belly pain? |1=Not bad at all

2=A little bad

3=Somewhat bad

4=Quite bad

5=Very bad |C |3.1285 |-1.0352 |0.1190 |1.0390 |1.7513 |  |  |  |  |  | |GISX81 |Area 1 |1 | |  |  |  |  |  |  |  |  |  |  | |GISX82 |Area 4 |4 | |  |  |  |  |  |  |  |  |  |  | |GISX83 |Area 7 |7 | |  |  |  |  |  |  |  |  |  |  | |GISX84 |Area 2 |2 | |  |  |  |  |  |  |  |  |  |  | |GISX85 |Area 5 |5 | |  |  |  |  |  |  |  |  |  |  | |GISX86 |Area 8 |8 | |  |  |  |  |  |  |  |  |  |  | |GISX87 |Area 3 |3 | |  |  |  |  |  |  |  |  |  |  | |GISX88 |Area 6 |6 | |  |  |  |  |  |  |  |  |  |  | |GISX89 |Area 9 |9 | |  |  |  |  |  |  |  |  |  |  | |GISX8189CT |  |count of areas(GISX81-GISX89):

range=0-9 |C |1.2207 |-2.1976 |-0.6503 |0.3420 |1.4228 |2.3019 |2.8652 |3.4934 |4.0747 |4.2306 | |GISX90 |How much did belly pain interfere with your day-to-day activities? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |4.0471 |-0.5796 |0.3553 |1.0840 |1.7142 |  |  |  |  |  | |GISX91 |How much did belly pain bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |5.5501 |-1.1924 |0.0124 |0.7247 |1.4205 |  |  |  |  |  | |GISX92 |How often did you have discomfort in your belly? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.4271 |-2.4149 |-0.3483 |0.7682 |1.8308 |  |  |  |  |  | |

Gas/Bloat Calibrations

Variable

Name |Item Stem |Responses and Scores |CUE |Calibration Statistics -

Discrimination

(Slope) |Calibration Statistics - Location Threshold 1 |Calibration Statistics - Location Threshold 2 |Calibration Statistics - Location Threshold 3 |Calibration Statistics - Location Threshold 4 |Collapsed Categories? | |GISX95 |How bad did the swelling in your belly get? |1=Not bad at all

2=A little bad

3=Somewhat bad

4=Quite bad

5=Very bad |C |3.74629 |-0.18026 |0.7413 |1.37527 |1.92581 |  | |GISX96 |How much did the swelling in your belly interfere with your day-to-day activities? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |3.22737 |0.17997 |0.92027 |1.55083 |2.08722 |  | |GISX97 |How much did having swelling in your belly bother you? * |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |3.48413 |-0.50444 |0.47659 |1.08891 |1.6317 |  | |GISX98 |How often did you feel bloated? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |3.14575 |-0.6792 |0.04556 |0.86817 |1.70662 |  | |GISX99 |In general, how severe was your bloating? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |5.30408 |-0.53047 |0.40215 |1.05078 |1.73324 |  | |GISX100 |At its worst, how severe was your bloating? |1=Not at all severe

2=A little bit severe

3=Somewhat severe

4=Quite a bit severe

5=Very severe |C |6.17367 |-0.03363 |0.6463 |1.19237 |1.78017 |  | |GISX101 |In general, how severe did your bloating feel? ** |1=Not at all severe

2=A little bit severe

3=Somewhat severe

4=Quite a bit severe

5=Very severe |C |7.76527 |0.01966 |0.66169 |1.17579 |1.78329 |  | |GISX102 |How often did you know that you would feel bloated before it happened? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |2.13574 |0.23294 |0.98682 |1.74062 |2.51532 |  | |GISX103 |How much did feeling bloated interfere with your day-to-day activities? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |4.21976 |0.17071 |0.81412 |1.41225 |1.92435 |  | |GISX104 |How much did feeling bloated bother you? |1=Not at all

2=A little bit

3=Somewhat

4=Quite a bit

5=Very much |C |4.51301 |-0.34165 |0.49582 |0.99879 |1.57862 |  | |GISX105 |How often did you pass gas? |1=Never

2=Rarely (only once or twice a day)

3=About every 3-4 hours

4=About every 2 hours

5=About every hour |C |0.79979 |-5.03653 |0.17284 |2.09169 |  |Collapse "About every 2 hours" and "About every hour" | |GISX109 |How often did you have gurgling or rumbling in your belly when you were not hungry? |1=Never

2=Rarely

3=Sometimes

4=Often

5=Always |C |1.06687 |-1.88705 |-0.03991 |1.64931 |3.41784 |  | |

-----------------------

[1] The Graded Response Model (GRM) was originally employed to obtain patient symptom estimates. Because the GRM includes a slope parameter that differs across items, there is not an inherent one-to-one relationship between total scores and ability estimates. The adjusted t-scores presented here were determined from a simulation exercise based on the GRM estimates. The correlations between the original and adjusted t-scores exceeded .94 to .98. See attachment for an extended explanation of the method used

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