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Protocol - Autoimmune Diseases Related to Type 1 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.

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

Protocol Name from Source:

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

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

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

Life Stage:

Child, Adolescent, Adult, Senior

Participants:

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

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

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
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
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)

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 NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX140101_Autoimmune_Diseases_Addisons_Disease PX140101011000 Do you (Does your child) have any of the following diseases? Addisons disease 4 N/A
PX140101_Autoimmune_Diseases_Celiac_Disease PX140101010200 Do you (Does your child) have any of the following diseases? Celiac disease 4 N/A
PX140101_Autoimmune_Diseases_Dont_Know PX140101011300 Do you (Does your child) have any of the following diseases? Don't know 4 N/A
PX140101_Autoimmune_Diseases_Inflammatory_Bowel_Disease PX140101010800 Do you (Does your child) have any of the following diseases? Inflammatory bowel disease 4 Variable Mapping
PX140101_Autoimmune_Diseases_Lupus_Or_SLE PX140101010600 Do you (Does your child) have any of the following diseases? Lupus or SLE 4 N/A
PX140101_Autoimmune_Diseases_Multiple_Sclerosis PX140101010100 Do you (Does your child) have any of the following diseases? Multiple sclerosis 4 N/A
PX140101_Autoimmune_Diseases_Myasthenia_Gravis PX140101010400 Do you (Does your child) have any of the following diseases? Myasthenia gravis 4 N/A
PX140101_Autoimmune_Diseases_None PX140101011200 Do you (Does your child) have any of the following diseases? None of the above 4 N/A
PX140101_Autoimmune_Diseases_Pernicious_Anemia PX140101010500 Do you (Does your child) have any of the following diseases? Pernicious anemia 4 N/A
PX140101_Autoimmune_Diseases_Psoriasis PX140101011100 Do you (Does your child) have any of the following diseases? Psoriasis 4 N/A
PX140101_Autoimmune_Diseases_Rheumatoid_Arthritis PX140101010700 Do you (Does your child) have any of the following diseases? Rheumatoid arthritis 4 N/A
PX140101_Autoimmune_Diseases_Thyroid_Disease PX140101010300 Do you (Does your child) have any of the following diseases? Thyroid disease 4 N/A
PX140101_Autoimmune_Diseases_Vitiligo PX140101010900 Do you (Does your child) have any of the following diseases? Vitiligo 4 N/A
Research Domain Information
Measure Name:

Autoimmune Diseases Related to Type I Diabetes

Release Date:

October 1, 2015

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