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Protocol - Assessment of Gallbladder Disease and Related Conditions

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Description:

This measure is used to assess whether the respondent has had symptoms as a result of gallstones or gallbladder problems and to determine whether the respondent received treatment for the gallbladder problem.

Protocol:

0. CHECK ITEM. REFER TO AGE OF SP.

[ ] 1 17–74 Years (1)

[ ] 2 75+ Years (16)

HAND CARD HAQ-4.

1. Please look at this diagram. During the past 12 months, have you had pain in the area shaded on the diagram? FOR FEMALES DO NOT INCLUDE MENSTRUAL PAIN.

[ ] 1 Y

[ ] 2 N (9)

[ ] 9 DK (9)

2. Sometimes people have more than one type of pain. I am going to ask you a few questions about the pain that has been the most uncomfortable in the past 12 months. For the pain that was most uncomfortable, please show me where the pain was located. MARK ALL AREAS INDICATED.

Gallbladder

3. During the past 12 months, what is the longest time that one episode of this pain has lasted?

_______
Number

[ ] 1 Minutes

[ ] 2 Hours

[ ] 3 Days

4. On how many days in the past 12 months have you had this pain?

_______ days
Number

5. When you had this pain, was it continuous, or did it tend to come and go?

[ ] 1 Continuous

[ ] 2 Come and go

[ ] 3 Both

6. When you had the pain, if you moved around, did you hurt more, less, or was there no difference?

[ ] 1 More

[ ] 2 Less

[ ] 3 No difference

[ ] 9 DK

7. Have you ever seen a doctor about this pain?

[ ] 1 Y

[ ] 2 N (9)

8. What did the doctor say caused the pain?

[ ] 01 Gallstones/gallbladder problems (11)

[ ] 02 Ulcer

[ ] 03 Appendicitis or appendix problems

[ ] 04 Spastic colon or irritable bowel

[ ] 05 Diverticulitis or diverticulosis

[ ] 06 Other 07 ____________________
                    Specify

9. Has a doctor ever told you that you had gallstones?

[ ] 1 Y

[ ] 2 N (12)

[ ] 9 DK (12)

10. What was the reason you visited the doctor the time that he told you that you had gallstones?

[ ] 1 pain

[ ] 2 other 3 _____________________
                    Specify

11. Have you ever had medical treatment to dissolve or remove gallstones? Do not include surgery.

[ ] 1 Y

[ ] 2 N

[ ] 9 DK

12. Have you ever had gallbladder surgery?

[ ] 1 Y

[ ] 2 N (14)

[ ] 9 DK (14)

13. How old were you when you had your gallbladder surgery?

_____ age

14. CHECK ITEM. REFER TO 8, 10, AND 12.

[ ] 1 GALLSTONES/GALLBLADDER PROBLEMS (1) MARKED IN 8 AND YES (1) IN 12

[ ] 1 PAIN (1) MARKED IN 10 AND YES (1) IN 12

[ ] 2 OTHER (END OF PROTOCOL)

15. Did the pain that caused you to visit the doctor continue after your gallbladder surgery?

[ ] 1 Y (END OF PROTOCOL)

[ ] 2 N (END OF PROTOCOL)

[ ] 9 DK (END OF PROTOCOL)

16. Has a doctor ever told you that you had gallstones?

[ ] 1 Y

[ ] 2 N

[ ] 9 DK

17. Have you ever had gallbladder surgery?

[ ] 1 Y

[ ] 2 N (END OF PROTOCOL)

[ ] 9 DK (END OF PROTOCOL)

18. How old were you when you had your gallbladder surgery?

_____ age

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Personnel and Training Required
The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews. The interviewer should be trained to prompt respondents further if a "don't know" response is provided.
Equipment Needs
The interviewer will need the show card containing the diagram of the upper body for assessing regions of pain.
Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Interviewer-administered questionnaire

Life Stage:

Adult

Participants:

Participants are aged 17 and older.

Specific Instructions:
The interviewer will provide the respondent with a show card containing a diagram of the upper body before asking the first question. Numbers that appear in parentheses after the answer choice are a skip pattern and direct the user to the next question in the series. These questions will not identify asymptomatic gallstones. For a more detailed assessment of gallbladder disease in adults, including identification of subjects with asymptomatic gallstones, see the National Health and Nutrition Examination Survey (NHANES) gallbladder ultrasound protocol in the Gastrointestinal Working Group Supplemental Information.
Selection Rationale

The National Health and Nutrition Examination Survey (NHANES) questions were selected because they address gallbladder disease issues briefly and reliably. Investigators can compare the results of their studies with this major national survey.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Person Gallbladder Disorder Assessment Description Text 3163048 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Assessment gallbladder disease proto 62955-0 LOINC
Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey (NHANES) III. Adult Household Questionnaire. Section J: Gallbladder Disease. Pages 17-18.

General References

Everhart, J. E., Khare, M., Hill, M., & Maurer, K. R. (1999). Prevalence and ethnic differences in gallbladder disease in the United States. Gastroenterology, 117, 632–639.

Ruhl, C. E., & Everhart, J. E. (2000). Association of diabetes, serum insulin, and C-peptide with gallbladder disease. Hepatology, 31, 299–303.

Protocol ID:

190201

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX190201_Age PX190201010000 CHECK ITEM. REFER TO AGE OF SP. 4 N/A
PX190201_Age_At_Gallbladder_Surgery PX190201130000 How old were you when you had your gallbladder surgery? 4 N/A
PX190201_Age_At_Gallbladder_Surgery_75+ PX190201180000 How old were you when you had your gallbladder surgery? 4 N/A
PX190201_Checkpoint PX190201140000 CHECK ITEM. REFER TO 8, 10, AND 12. 4 N/A
PX190201_Doctor_Cause_Of_Pain PX190201080000 What did the doctor say caused the pain? 4 N/A
PX190201_Doctor_Cause_Of_Pain_Specify PX190201080100 What did the doctor say caused the pain? Other, Specify 4 N/A
PX190201_Doctor_Diagnosed_Gallstones PX190201090000 Has a doctor ever told you that you had gallstones? 4 N/A
PX190201_Doctor_Diagnosed_Gallstones_75+ PX190201160000 Has a doctor ever told you that you had gallstones? 4 N/A
PX190201_Ever_Had_Gallbladder_Surgery_75+ PX190201170000 Have you ever had gallbladder surgery? 4 N/A
PX190201_Had_Gallbladder_Surgery PX190201120000 Have you ever had gallbladder surgery? 4 N/A
PX190201_Longest_Time_Pain_Lasted PX190201030000 During the past 12 months, what is the longest time that one episode of this pain has lasted? 4 N/A
PX190201_Longest_Time_Pain_Lasted_Units PX190201030100 During the past 12 months, what is the longest time that one episode of this pain has lasted? Units 4 N/A
PX190201_Moving_Helped_Pain PX190201060000 When you had the pain, if you moved around, did you hurt more, less, or was there no difference? 4 N/A
PX190201_Number_Days_Had_Pain PX190201040000 On how many days in the past 12 months have you had this pain? 4 N/A
PX190201_Pain_Continued_After_Gallbladder_Surgery PX190201150000 Did the pain that caused you to visit the doctor continue after your gallbladder surgery? 4 N/A
PX190201_Pain_Diagram PX190201010100 Please look at this diagram. During the past 12 months, have you had pain in the area shaded on the diagram? FOR FEMALES DO NOT INCLUDE MENSTRUAL PAIN. 4 N/A
PX190201_Pain_Diagram_Area_1 PX190201020100 Sometimes people have more than one type of pain. I am going to ask you a few questions about the pain that has been the most uncomfortable in the past 12 months. For the pain that was most uncomfortable, please show me where the pain was located. MARK ALL AREAS INDICATED. Area 1? 4 N/A
PX190201_Pain_Diagram_Area_2 PX190201020200 Sometimes people have more than one type of pain. I am going to ask you a few questions about the pain that has been the most uncomfortable in the past 12 months. For the pain that was most uncomfortable, please show me where the pain was located. MARK ALL AREAS INDICATED. Area 2? 4 N/A
PX190201_Pain_Diagram_Area_3 PX190201020300 Sometimes people have more than one type of pain. I am going to ask you a few questions about the pain that has been the most uncomfortable in the past 12 months. For the pain that was most uncomfortable, please show me where the pain was located. MARK ALL AREAS INDICATED. Area 3? 4 N/A
PX190201_Reason_For_Doctor_Visit PX190201100000 What was the reason you visited the doctor the time that he told you that you had gallstones? 4 N/A
PX190201_Reason_For_Doctor_Visit_Other PX190201100100 What was the reason you visited the doctor the time that he told you that you had gallstones? Other, Specify 4 N/A
PX190201_Seen_Doctor_For_Pain PX190201070000 Have you ever seen a doctor about this pain? 4 N/A
PX190201_Treatment_To_Dissolve_Remove_Gallstones PX190201110000 Have you ever had medical treatment to dissolve or remove gallstones? Do not include surgery. 4 N/A
PX190201_Type_Of_Pain PX190201050000 When you had this pain, was it continuous, or did it tend to come and go? 4 N/A
Research Domain Information
Measure Name:

Assessment of Gallbladder Disease and Related Conditions

Release Date:

December 13, 2010

Definition

This measure assesses gallbladder disease and related conditions.

Purpose

The measure ascertains whether a respondent has ever had a history of symptoms and problems with the gallbladder or gallstones and whether the respondent has received treatment for these conditions. These questions will not identify asymptomatic gallstones.

Keywords

Gastrointestinal, GI, Gallbladder, Gallstones, Pain, Surgery, Gastrointestinal