Protocol - Autoimmune Diseases Related to Type 1 Diabetes
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.
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
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.
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.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Child, Adolescent, Adult, Senior
Adult aged 18 or older. The protocol can also be administered to a child through an adult proxy.
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
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.
English, French, Hindi, Spanish
|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|
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)
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).
American Diabetes Association. (2014). Diagnosis and classification of diabetes mellitus. Diabetes Care, 37(Supplement 1), S81 - S90.
|Variable Name||Variable ID||Variable Description||Version||dbGaP 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|
Autoimmune Diseases Related to Type I Diabetes
October 1, 2015
A questionnaire to ascertain a study participant’s history of autoimmune diseases.
In Type 1 diabetes, insulin deficiency is caused by autoimmune destruction of pancreatic beta cells (American Diabetes Association, 2014).
Diabetes, multiple sclerosis , celiac disease, thyroid disease, myasthenia gravis