首页> 外文学位 >The risk of idiopathic thrombocytopenic purpura (ITP) following measles, mumps, and rubella (MMR) vaccination: Attributable risk and a simulation study to evaluate four study designs.
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The risk of idiopathic thrombocytopenic purpura (ITP) following measles, mumps, and rubella (MMR) vaccination: Attributable risk and a simulation study to evaluate four study designs.

机译:麻疹,腮腺炎和风疹(MMR)疫苗接种后特发性血小板减少性紫癜(ITP)的风险:可归因的风险和模拟研究,以评估四种研究设计。

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摘要

Using the Vaccine Safety Datalink databases---a multi-site project representing 8 managed care organizations from across the United States---I identified 216 cases of childhood idiopathic thrombocytopenic purpura (ITP). This case population was used to examine the risk of developing ITP in a 42-day risk period following MMR vaccination and to conduct an investigation of the natural history of ITP. Two study methods were used to analyze the association between MMR and ITP---a risk-interval and self-controlled case series (SCCS). The risk-interval analyses included a cohort of over 780,000 MMR-vaccinated children, while the SCCS method involved comparing time periods before and after vaccination in a fraction of the cases. Both analyses demonstrated a greater than 2-fold risk for developing ITP in the 42-day risk period following vaccination. The risk-interval analysis demonstrated an attributable risk of 1 case per 50,000 doses of MMR in children ages 12--15 months.; I also conducted a simulation study to empirically compare the validity and stability of incidence rate ratio (IRR) estimates and the ability to control for confounding across four study designs (cohort, risk-interval, SCCS and case-control) by using actual vaccine safety data and simulated cases of an acute illness. I simulated 250 case sets within the cohort and constructed the other three study designs from the cohort at four different IRRs (1.50, 2.00, 3.00 and 4.00). I compared the designs at 18 levels of decreasing prevalence (from 400 to less than 10 simulated cases), and two confounding levels (20%, 40%). Each of the design-specific study samples was analyzed with the appropriate regression model. The subsequent means and standard errors of the IRR estimates were compared across the study designs, using the cohort as the gold standard. The IRR estimates of the risk-interval, SCCS and case-control designs were within three percent of the cohort estimates. However, when compared to the other study designs, the estimates of the case-control design were less precise, less powerful and biased in the presence of confounding. The SCCS and risk-interval designs, in contrast, proved to be efficient and valid alternatives to the cohort study design.
机译:使用疫苗安全性数据链数据库-一个代表美国8个管理医疗机构的多站点项目-我确定了216例儿童特发性血小板减少性紫癜(ITP)病例。该病例人群用于检查MMR疫苗接种后42天的风险期内发展ITP的风险,并对ITP的自然病史进行调查。两种研究方法用于分析MMR和ITP之间的关联-风险间隔和自控病例系列(SCCS)。风险间隔分析包括超过780,000名接受MMR疫苗接种的儿童队列,而SCCS方法涉及在一部分病例中比较疫苗接种前后的时间段。两项分析均显示,在接种疫苗后的42天风险期内,发生ITP的风险要大于2倍。风险间隔分析表明,在12--15个月的儿童中,每50,000剂MMR发生1例风险。我还进行了模拟研究,通过使用实际的疫苗安全性,对四种研究设计(队列,风险区间,SCCS和病例对照)的发生率比(IRR)估计值的有效性和稳定性以及混淆控制的能力进行了经验比较。急性疾病的数据和模拟病例。我模拟了该队列中的250个案例集,并根据该队列在四个不同的IRR(1.50、2.00、3.00和4.00)下构建了其他三个研究设计。我比较了18种减少患病率的设计(从400例减少到少于10种模拟病例)和两种混淆程度(20%,40%)。每个设计特定的研究样本都使用适当的回归模型进行了分析。使用队列作为金标准,在整个研究设计中比较了IRR估算的后续均值和标准误。风险间隔,SCCS和病例对照设计的IRR估算值在同类人群估算值的百分之三以内。但是,与其他研究设计相比,病例对照设计的估计值不那么精确,功能更强大,并且在存在混淆的情况下存在偏差。相反,事实证明,SCCS和风险间隔设计是同类研究设计的有效替代方案。

著录项

  • 作者

    Glanz, Jason M.;

  • 作者单位

    University of Colorado Health Sciences Center.;

  • 授予单位 University of Colorado Health Sciences Center.;
  • 学科 Health Sciences Public Health.
  • 学位 Ph.D.
  • 年度 2005
  • 页码 126 p.
  • 总页数 126
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 预防医学、卫生学;
  • 关键词

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