Margolis Karen L, Brzyski Robert, Bonds Denise E, Howard Barbara V, Kempainen Sarah, Robinson Jennifer G, Safford Monika M, Tinker Lesley T, Phillips Lawrence S
HealthPartners Research Foundation, Minneapolis, MN 55440-1524, USA,
Clin Trials. 2008;5(3):240-7. doi: 10.1177/1740774508091749.
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.
A total of 161 808 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 self-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.
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.
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 > or = 126 may have been underestimated.
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.
尽管糖尿病可通过自我报告方便地进行评估,但很少有验证研究。因此,我们研究了女性健康倡议(WHI)参与者中糖尿病患病率和发病率的自我报告是否与糖尿病的其他诊断证据一致。
1993年至1998年期间,美国40个临床中心共招募了161808名年龄在50 - 79岁的绝经后女性,并进行前瞻性随访。在基线时,已治疗的糖尿病患病率定义为自我报告的医生诊断以及使用胰岛素或口服降糖药治疗。在随访期间,新发治疗性糖尿病定义为自我报告的新的医生诊断为糖尿病且使用胰岛素或口服药物治疗。将糖尿病自我报告与基线及随访期间的药物清单和空腹血糖水平进行比较。
在基线时,临床试验中79%的参与者以及观察性研究中77%的参与者自我报告的已治疗糖尿病与药物清单一致。在临床试验中,基线至第1年期间,自我报告的新发治疗性糖尿病与药物清单一致的比例为78%;第1年至第3年期间为62%;在观察性研究中,基线至第3年期间为72%。在相似时间段内,未报告已治疗糖尿病的参与者中,99.9%的人在药物清单中没有口服降糖药或胰岛素。在基线时,约3%未报告糖尿病的人空腹血糖>126mg/dl,其中88%的受试者在6.9年的随访期间随后报告了已治疗糖尿病。
WHI中未确定仅通过生活方式治疗的新发自我报告糖尿病。药物清单可能不完整,且空腹血糖可能因治疗而降低;因此,与自我报告治疗或空腹血糖≥126的一致性可能被低估。
在WHI中,自我报告的糖尿病患病率和发病率与药物清单一致,且很大一部分未确诊糖尿病的人随后报告了糖尿病治疗。“已治疗糖尿病”的自我报告足够准确,可用于流行病学研究。