Social and Mathematical Epidemiology Group, Department of Global Health and Development, London School of Hygiene and Tropical Medicine,WC1H 9SH London, UK.
Contraception. 2011 Jan;83(1):10-5. doi: 10.1016/j.contraception.2010.06.009. Epub 2010 Aug 7.
In the last decade, several large-scale, clinical trials evaluating the efficacy of novel HIV prevention products have been completed, and eight are currently underway or about to be reported. Little attention has been given in the literature to the level of protection sufficient to warrant introduction, and there is concern that using the term "efficacy" to describe the effect of user-controlled methods such as microbicides may mislead policymakers.
We review how the fields of family planning, vaccine science and mathematical modelling understand and use the terms efficacy and effectiveness, and explore with simple mathematical models how trial results of user-controlled products relate to common understandings of these terms.
Each field brings different assumptions, a different evidence base and different expectations to interpretations of efficacy and effectiveness - a reality that could cloud informed assessment of emerging data.
When making judgments on the utility of new health technologies, it is important to use standards that yield appropriate comparisons for the innovation and that take into account the local epidemic and available alternatives.
在过去的十年中,已经完成了几项评估新型 HIV 预防产品疗效的大规模临床试验,目前有八项正在进行或即将报告。文献中几乎没有关注足以保证引入的保护水平,有人担心使用“疗效”一词来描述诸如杀微生物剂等用户控制方法的效果可能会误导政策制定者。
我们回顾了计划生育、疫苗科学和数学建模领域如何理解和使用疗效和有效性这两个术语,并通过简单的数学模型探讨了用户控制产品的试验结果与这些术语的常见理解之间的关系。
每个领域都为疗效和有效性的解释带来了不同的假设、不同的证据基础和不同的期望——这种现实可能会使对新兴数据的知情评估变得复杂。
在对新的卫生技术的实用性进行判断时,重要的是使用能够为创新产生适当比较的标准,并考虑到当地的流行情况和可用的替代方案。