Løkkegaard Ellen Leth, Johnsen Søren Påske, Heitmann Berit Lillienthal, Stahlberg Claudia, Pedersen Anette Tønnes, Obel Erik Bernhard, Hundrup Yrsa Andersen, Hallas Jesper, Sørensen Henrik Toft
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark.
Acta Obstet Gynecol Scand. 2004 May;83(5):476-81. doi: 10.1111/j.0001-6349.2004.00376.x.
Recent findings from randomized clinical trials on the effects of hormone replacement therapy (HRT) among postmenopausal women contradict findings from observational studies indicating a protective effect on the development of cardiovascular disease. Most observational studies on HRT are based on self-reported data, although data on the validity of HRT in postmenopausal women are sparse.
We examined self-reported HRT use from questionnaires administered in 1993 (n = 2694) and again in 1999 (n = 2666) to a cohort of Danish nurses living in two Danish counties compared with prescription-reimbursement data from two administrative databases through the Danish National Health Service.
The sensitivity and specificity of the self-reported, current HRT use in 1993 were 78.4%[95% confidence interval (95% CI) 75.4-81.4] and 98.4% (95% CI 97.8-98.9), respectively. In 1999, the estimates were 74.8% (95% CI 72.0-77.7) and 98.0% (95% CI 97.3-98.8), respectively. None of the factors examined--including age, alcohol intake, physical activity, smoking, presence of hypertension, and body mass index--was strongly associated with validity. We found a relatively high validity of self-reported data on HRT use. Furthermore, agreement between self-reported and registry-based data was not strongly associated with a range of demographic and lifestyle factors.
These findings suggest that use of self-reported data is not an important contributor to the apparent discrepancy between observational studies and randomized trials on the cardiovascular effects of HRT use.
近期关于绝经后女性激素替代疗法(HRT)效果的随机临床试验结果与观察性研究结果相矛盾,观察性研究表明HRT对心血管疾病的发生有保护作用。大多数关于HRT的观察性研究基于自我报告的数据,尽管关于绝经后女性HRT有效性的数据很少。
我们研究了1993年(n = 2694)和1999年(n = 2666)对居住在丹麦两个县的一组丹麦护士进行问卷调查时自我报告的HRT使用情况,并通过丹麦国家医疗服务体系,将其与两个行政数据库中的处方报销数据进行比较。
1993年自我报告的当前HRT使用情况的敏感性和特异性分别为78.4%[95%置信区间(95%CI)75.4 - 81.4]和98.4%(95%CI 97.8 - 98.9)。1999年,估计值分别为74.8%(95%CI 72.0 - 77.7)和98.0%(95%CI 97.3 - 98.8)。所检查的因素,包括年龄、酒精摄入量、身体活动、吸烟、高血压的存在以及体重指数,均与有效性无强关联。我们发现自我报告的HRT使用数据具有相对较高的有效性。此外,自我报告数据与基于登记处的数据之间的一致性与一系列人口统计学和生活方式因素无强关联。
这些发现表明,自我报告数据的使用并非观察性研究与HRT使用心血管效应随机试验之间明显差异的重要因素。