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Protocol - Assessment of Gallbladder Disease and Related Conditions

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Protocol Name from Source:

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

Availability:

Publicly available

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.

[img[gallbladder.jpg|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

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
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adult

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.
Research Domain Information

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.

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 Text3163048CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Assessment gallbladder disease proto62955-0LOINC

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_AgePX190201010000CHECK ITEM. REFER TO AGE OF SP.4N/A
PX190201_Pain_DiagramPX190201010100Please 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.4N/A
PX190201_Pain_Diagram_Area_1PX190201020100Sometimes 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?4N/A
PX190201_Pain_Diagram_Area_2PX190201020200Sometimes 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?4N/A
PX190201_Pain_Diagram_Area_3PX190201020300Sometimes 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?4N/A
PX190201_Longest_Time_Pain_LastedPX190201030000During the past 12 months, what is the longest time that one episode of this pain has lasted?4N/A
PX190201_Longest_Time_Pain_Lasted_UnitsPX190201030100During the past 12 months, what is the longest time that one episode of this pain has lasted? Units4N/A
PX190201_Number_Days_Had_PainPX190201040000On how many days in the past 12 months have you had this pain?4N/A
PX190201_Type_Of_PainPX190201050000When you had this pain, was it continuous, or did it tend to come and go?4N/A
PX190201_Moving_Helped_PainPX190201060000When you had the pain, if you moved around, did you hurt more, less, or was there no difference?4N/A
PX190201_Seen_Doctor_For_PainPX190201070000Have you ever seen a doctor about this pain?4N/A
PX190201_Doctor_Cause_Of_PainPX190201080000What did the doctor say caused the pain?4N/A
PX190201_Doctor_Cause_Of_Pain_SpecifyPX190201080100What did the doctor say caused the pain? Other, Specify4N/A
PX190201_Doctor_Diagnosed_GallstonesPX190201090000Has a doctor ever told you that you had gallstones?4N/A
PX190201_Reason_For_Doctor_VisitPX190201100000What was the reason you visited the doctor the time that he told you that you had gallstones?4N/A
PX190201_Reason_For_Doctor_Visit_OtherPX190201100100What was the reason you visited the doctor the time that he told you that you had gallstones? Other, Specify4N/A
PX190201_Treatment_To_Dissolve_Remove_GallstonesPX190201110000Have you ever had medical treatment to dissolve or remove gallstones? Do not include surgery.4N/A
PX190201_Had_Gallbladder_SurgeryPX190201120000Have you ever had gallbladder surgery?4N/A
PX190201_Age_At_Gallbladder_SurgeryPX190201130000How old were you when you had your gallbladder surgery?4N/A
PX190201_CheckpointPX190201140000CHECK ITEM. REFER TO 8, 10, AND 12.4N/A
PX190201_Pain_Continued_After_Gallbladder_SurgeryPX190201150000Did the pain that caused you to visit the doctor continue after your gallbladder surgery?4N/A
PX190201_Doctor_Diagnosed_Gallstones_75+PX190201160000Has a doctor ever told you that you had gallstones?4N/A
PX190201_Ever_Had_Gallbladder_Surgery_75+PX190201170000Have you ever had gallbladder surgery?4N/A
PX190201_Age_At_Gallbladder_Surgery_75+PX190201180000How old were you when you had your gallbladder surgery?4N/A