Berry D C, Knapp P, Raynor D K
Lancet. 2002 Mar 9;359(9309):853-4. doi: 10.1016/s0140-6736(02)07923-0.
To make informed decisions about taking medicinal drugs, people need accurate information about side-effects. A European Union guideline now recommends use of qualitative descriptions for five bands of risk, ranging from very rare (affecting <0.01% of the population), to very common (>10%). We did four studies of more than 750 people, whom we asked to estimate the probability of having a side-effect on the basis of qualitative and quantitative descriptions. Our results showed that qualitative descriptions led to gross overestimation of risk. Until further work is done on how patients taking the drugs interpret these terms, the terms should not be used in drug information leaflets.
为了在服用药物时做出明智的决定,人们需要有关副作用的准确信息。欧盟的一项指导方针现在建议对五个风险等级使用定性描述,范围从非常罕见(影响人口的<0.01%)到非常常见(>10%)。我们对750多人进行了四项研究,要求他们根据定性和定量描述来估计出现副作用的概率。我们的结果表明,定性描述导致对风险的严重高估。在对服用药物的患者如何理解这些术语进行进一步研究之前,这些术语不应在药品说明书中使用。