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Protocol - Autoimmune Diseases Related to Type I Diabetes

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Description

The interviewer asks the respondents whether they (or their child) had certain autoimmune diseases. The study participants are handed a cue card to help them identify the autoimmune diseases that they or their child may have had.

Specific Instructions

The Expert Review Panel recommends that the list of diseases in Item 1 should also include autoimmune hepatitis, Guillain-Barré syndrome, and Sjögren’s syndrome

Protocol

1. Do you (Does your child) have any of the following diseases?

HAND PARTICIPANT CUE CARD AND MARK ALL REPORTED RESPONSES.

[ ] a 1 Multiple sclerosis

[ ] b 1 Celiac disease

[ ] c 1 Thyroid disease

[ ] d 1 Myasthenia gravis

[ ] e 1 Pernicious anemia

[ ] f 1 Lupus or SLE

[ ] g 1 Rheumatoid arthritis

[ ] h 1 Inflammatory Bowel Disease

[ ] I 1 Vitiligo

[ ] j 1 Addisons Disease

[ ] k 1 Psoriasis

[ ] L 8 None of the above

[ ] m 9 Don’t know

Availability

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

These questions can be administered in a computerized or non-computerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

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

Lifestage

Child, Adolescent, Adult, Senior

Participants

Adult aged 18 or older. The protocol can also be administered to a child through an adult proxy.

Selection Rationale

This questionnaire from the Type 1 Diabetes Genetics Consortium (T1DGC) was vetted against similar protocols and selected because it is a validated instrument that is low burden to respondents and investigators.

Language

English, French, Hindi, Spanish

Standards
StandardNameIDSource
caDSR Common Data Elements (CDE) Person Type 1 Diabetes Related Autoimmune Disease Personal Medical History Assessment Description Text 3065875 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Autoimmune dis type 1 diabetes proto 62789-3 LOINC
Human Phenotype Ontology Diabetes Mellitus HP:0000819 HPO
Derived Variables

None

Process and Review

The Expert Review Panel #1 reviewed the measures in the Anthropometrics, Diabetes, Physical Activity and Physical Fitness, and Nutrition and Dietary Supplements domains.

Guidance from the ERP includes:

• Revised descriptions of measure

Back-compatible: no changes to Data Dictionary

Previous version in Toolkit archive (link)

Protocol Name from Source

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Affected Sib-Pair Exam Form

Source

US Department of Health and Human Services. National Institutes of Health. National Institute of Diabetes, Digestive and Kidney Diseases. National Institute of Diabetes. Type 1 Diabetes Genetic Consortium. 2004. Affected Sib-Pair Exam Form. Question number 8 (question 1).

General References

American Diabetes Association. (2014). Diagnosis and classification of diabetes mellitus. Diabetes Care, 37(Supplement 1), S81 - S90.

Protocol ID

140101

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX140101_Autoimmune_Diseases_Addisons_Disease
PX140101011000 Do you (Does your child) have any of the more
following diseases? Addisons disease show less
N/A
PX140101_Autoimmune_Diseases_Celiac_Disease
PX140101010200 Do you (Does your child) have any of the more
following diseases? Celiac disease show less
Variable Mapping
PX140101_Autoimmune_Diseases_Dont_Know
PX140101011300 Do you (Does your child) have any of the more
following diseases? Don't know show less
N/A
PX140101_Autoimmune_Diseases_Inflammatory_Bowel_Disease
PX140101010800 Do you (Does your child) have any of the more
following diseases? Inflammatory bowel disease show less
Variable Mapping
PX140101_Autoimmune_Diseases_Lupus_Or_SLE
PX140101010600 Do you (Does your child) have any of the more
following diseases? Lupus or SLE show less
Variable Mapping
PX140101_Autoimmune_Diseases_Multiple_Sclerosis
PX140101010100 Do you (Does your child) have any of the more
following diseases? Multiple sclerosis show less
Variable Mapping
PX140101_Autoimmune_Diseases_Myasthenia_Gravis
PX140101010400 Do you (Does your child) have any of the more
following diseases? Myasthenia gravis show less
Variable Mapping
PX140101_Autoimmune_Diseases_None
PX140101011200 Do you (Does your child) have any of the more
following diseases? None of the above show less
Variable Mapping
PX140101_Autoimmune_Diseases_Pernicious_Anemia
PX140101010500 Do you (Does your child) have any of the more
following diseases? Pernicious anemia show less
N/A
PX140101_Autoimmune_Diseases_Psoriasis
PX140101011100 Do you (Does your child) have any of the more
following diseases? Psoriasis show less
N/A
PX140101_Autoimmune_Diseases_Rheumatoid_Arthritis
PX140101010700 Do you (Does your child) have any of the more
following diseases? Rheumatoid arthritis show less
Variable Mapping
PX140101_Autoimmune_Diseases_Thyroid_Disease
PX140101010300 Do you (Does your child) have any of the more
following diseases? Thyroid disease show less
Variable Mapping
PX140101_Autoimmune_Diseases_Vitiligo
PX140101010900 Do you (Does your child) have any of the more
following diseases? Vitiligo show less
N/A
Diabetes
Measure Name

Autoimmune Diseases Related to Type I Diabetes

Release Date

May 10, 2010

Definition

A questionnaire to ascertain a study participant’s history of autoimmune diseases.

Purpose

In Type 1 diabetes, insulin deficiency is caused by autoimmune destruction of pancreatic beta cells (American Diabetes Association, 2014).

Keywords

Diabetes, multiple sclerosis , celiac disease, thyroid disease, myasthenia gravis

Measure Protocols
Protocol ID Protocol Name
140101 Autoimmune Diseases Related to Type I Diabetes
Publications

There are no publications listed for this protocol.