Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study



Status:Completed
Conditions:Infectious Disease, Endocrine
Therapuetic Areas:Endocrinology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:April 2002
End Date:December 2006

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Autoimmune diseases may involve nearly any organ and are characterized by abnormal
activation or response of certain cells. Evidence suggests that farm work, exposure to
silica from farming activities and exposure to pesticides may contribute to the development
of autoimmune disease. Associations between autoimmune diseases and farming, however, have
not been extensively investigated, and exposure data in the currently available studies are
extremely limited.

One of the major challenges in conducting population-based research on autoimmune diseases
is case ascertainment. Self-report of previous diagnosis has proven to be unreliable. This
protocol outlines a strategy to confirm self-reported diagnoses of systemic autoimmune
diseases (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and Sjogren
syndrome) within the Agricultural Health Study group (AHS; a group of licensed pesticide
applicators and spouses who completed a questionnaire). The confirmed cases will constitute
a refined case group to allow analyses of pesticides and other farming-related exposures as
possible risk factors for these diseases using data that have already been collected.

Subjects will be selected from participants in the AHS who reported one of the diseases
being studied. A short telephone interview will be conducted with participants, who will be
requested to provide written consent for review of information from medical records. To
confirm the self-diagnosis, participants' physicians will be contacted. Specific information
will be requested in the form of a checklist. Responses will be reviewed for evidence of
diagnosis and classified as confirmed, probable, physician-diagnosed, or unconfirmed.

Secondary objectives of this study are to:

- assess the correct interpretation of conflicting self-reports that are provided at two
different times.

- evaluate the usefulness of specific questions that could potentially be used in future
studies to validate self-reported cases of rheumatoid arthritis in men.

Farming-related exposures (including pesticides and silica) may contribute to the etiology
of autoimmune diseases. However, associations between autoimmune diseases and farming have
not been extensively investigated, and exposure data in the currently available studies is
extremely limited. One of the major challenges in conducting population-based research on
autoimmune diseases is case ascertainment. Self-report of previous diagnosis has been shown
to be very unreliable. This protocol outlines a strategy to confirm self-reported diagnoses
of systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus,
scleroderma, and Sjogren syndrome) within the Agricultural Health Study (AHS) cohort. The
confirmed cases will constitute a refined case group to allow etiologic analyses of
pesticides and other farming-related exposures as possible risk factors for these diseases
using data that have already been collected. The codes can also be used in a nested
case-control study that could be designed to collect additional exposure data (for example,
on silica-related exposures).

- INCLUSION CRITERIA:

Agricultural workers and their spouses.

EXCLUSION CRITERIA:

Children will not be included.

There are no exclusions based on ethnicity or race.

Participants who are unable to complete a telephone interview because of chronic illness
(including cognitive impairment) or language or hearing difficulties will not be eligible.
We found this trial at
3
sites
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Research Triangle Park, North Carolina 27709
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