Journal
CLINICAL TRIALS
Volume 5, Issue 3, Pages 240-247Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/1740774508091749
Keywords
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Categories
Funding
- NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES [R01DK062290] Funding Source: NIH RePORTER
- WOMEN&apos
- S HEALTH INITIATIVE - OFFICE OF THE DIRECTOR NIH [N01WH032122, N01WH022110, N01WH042129, N01WH032115, N01WH032100, N01WH042107, N01WH032111, N01WH032105, N01WH032108, N01WH032118] Funding Source: NIH RePORTER
- NIDDK NIH HHS [R01 DK066401, R01 DK062290-05, R01 DK062290] Funding Source: Medline
- WHI NIH HHS [N01WH44221, N01WH32118-32119, N01WH24152, N01WH32115, N01WH22110, N01WH32111-13, N01WH32108-9, N01WH32105-6, N01WH32122, N01WH42129-32, N01WH32100-2, N01WH42107-26] Funding Source: Medline
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Objective Although diabetes is conveniently assessed by self-report, few validation studies have been performed. Therefore, we studied whether self-report of prevalent and incident diabetes in Women's Health Initiative (WHI) participants was concordant with other diagnostic evidence of diabetes. Study Design and Setting A total of 161808 postmenopausal women aged 50-79 were enrolled at 40 clinical centers in the U.S. in 1993-1998 and followed prospectively. At baseline, prevalent medication treated diabetes was defined as a 5elf-report of physician diagnosis and treatment with insulin or oral antidiabetic drugs. During followup, incident treated diabetes was defined as a self-report of a new physician diagnosis of diabetes treated with insulin or oral drugs. Diabetes self-reports were compared with medication inventories and fasting glucose levels at baseline and during follow-up. Results At baseline, self-reported treated diabetes was concordant with the medication inventory in 79% of clinical trial, and 77% of observational study participants. Self-reported incident treated diabetes was concordant with the medication inventory in 78% between baseline and Year 1 in the clinical trials, in 62% between Year 1 and Year 3 in the clinical trials, and in 72% between baseline and Year 3 in the observational study. Over similar periods, 99.9% of those who did not report treated diabetes had no oral antidiabetic drugs or insulin in the medication inventory. At baseline, about 3% not reporting diabetes had fasting glucose >126 mg/dl, and 88% of these subjects subsequently reported treated diabetes during 6.9 years of follow-up. Limitations Incident self-reported diabetes treated by lifestyle alone was not determined in WHI. Medication inventories may have been incomplete and fasting glucose may have been lowered by treatment; therefore, concordance with self-reported treatment or fasting glucose >= 126 may have been underestimated. Conclusion In the WHI, self-reported prevalent and incident diabetes was consistent with medication inventories, and a high proportion of those with undiagnosed diabetes subsequently reported diabetes treatment. Self-reports of 'treated diabetes' are sufficiently accurate to allow use in epidemiologic studies.
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