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Protocol - Autoimmune Diseases Related to Type I Diabetes

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Protocol Name from Source:

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

Availability:

Publicly available

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

[img[140101_Autoimmune_Disease_1.jpg|]]

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
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:

Child, Adolescent, Adult, Senior

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

Research Domain Information

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).

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 Text3065875CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Autoimmune dis type 1 diabetes proto62789-3LOINC

Process and Review

The [link[phenx.org/Default.aspx?tabid=872|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[phenxtoolkitdev.rti.org/index.php?pageLink=browse.archive.protocols&id=140000|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_Multiple_SclerosisPX140101010100Do you (Does your child) have any of the following diseases? Multiple sclerosis4N/A
PX140101_Autoimmune_Diseases_Celiac_DiseasePX140101010200Do you (Does your child) have any of the following diseases? Celiac disease4N/A
PX140101_Autoimmune_Diseases_Thyroid_DiseasePX140101010300Do you (Does your child) have any of the following diseases? Thyroid disease4N/A
PX140101_Autoimmune_Diseases_Myasthenia_GravisPX140101010400Do you (Does your child) have any of the following diseases? Myasthenia gravis4N/A
PX140101_Autoimmune_Diseases_Pernicious_AnemiaPX140101010500Do you (Does your child) have any of the following diseases? Pernicious anemia4N/A
PX140101_Autoimmune_Diseases_Lupus_Or_SLEPX140101010600Do you (Does your child) have any of the following diseases? Lupus or SLE4N/A
PX140101_Autoimmune_Diseases_Rheumatoid_ArthritisPX140101010700Do you (Does your child) have any of the following diseases? Rheumatoid arthritis4N/A
PX140101_Autoimmune_Diseases_Inflammatory_Bowel_DiseasePX140101010800Do you (Does your child) have any of the following diseases? Inflammatory bowel disease4Variable Mapping
PX140101_Autoimmune_Diseases_VitiligoPX140101010900Do you (Does your child) have any of the following diseases? Vitiligo4N/A
PX140101_Autoimmune_Diseases_Addisons_DiseasePX140101011000Do you (Does your child) have any of the following diseases? Addisons disease4N/A
PX140101_Autoimmune_Diseases_PsoriasisPX140101011100Do you (Does your child) have any of the following diseases? Psoriasis4N/A
PX140101_Autoimmune_Diseases_NonePX140101011200Do you (Does your child) have any of the following diseases? None of the above4N/A
PX140101_Autoimmune_Diseases_Dont_KnowPX140101011300Do you (Does your child) have any of the following diseases? Don't know4N/A