Berry Dianne C, Raynor D K, Knapp Peter, Bersellini Elisabetta
Department of Psychology, University of Reading, Whiteknights, Reading, United Kingdom.
Drug Saf. 2003;26(1):1-11. doi: 10.2165/00002018-200326010-00001.
Patients want and need comprehensive and accurate information about their medicines so that they can participate in decisions about their healthcare. In particular, they require information about the likely risks and benefits that are associated with the different treatment options. However, to provide this information in a form that people can readily understand and use is a considerable challenge to healthcare professionals. One recent attempt to standardise the language of risk has been to produce sets of verbal descriptors that correspond to specific probability ranges, such as those outlined in the European Commission (EC) Pharmaceutical Committee guidelines in 1998 for describing the incidence of adverse effects. This paper provides an overview of a number of studies involving members of the general public, patients, and hospital doctors, that evaluated the utility of the EC guideline descriptors (very common, common, uncommon, rare, very rare). In all studies it was found that people significantly over-estimated the likelihood of adverse effects occurring, given specific verbal descriptors. This in turn resulted in significantly higher ratings of their perceived risks to health and significantly lower ratings of their likelihood of taking the medicine. Such problems of interpretation are not restricted to the EC guideline descriptors. Similar levels of misinterpretation have also been demonstrated with two other recently advocated risk scales (Calman's verbal descriptor scale and Barclay, Costigan and Davies' lottery scale). In conclusion, the challenge for risk communicators and for future research will be to produce a language of risk that is sufficiently flexible to take into account different perspectives, as well as changing circumstances and contexts of illness and its treatments. In the meantime, we urge the EC and other legislative bodies to stop recommending the use of specific verbal labels or phrases until there is a stronger evidence base to support their use.
患者希望并需要获得有关其药物的全面、准确信息,以便他们能够参与有关自身医疗保健的决策。特别是,他们需要了解与不同治疗方案相关的可能风险和益处的信息。然而,以人们能够轻松理解和使用的形式提供此类信息,对医疗保健专业人员来说是一项相当大的挑战。最近一项使风险语言标准化的尝试是制定一系列与特定概率范围相对应的口头描述词,例如欧盟委员会(EC)药品委员会1998年指南中概述的用于描述不良反应发生率的那些描述词。本文概述了一些涉及普通公众、患者和医院医生的研究,这些研究评估了EC指南描述词(非常常见、常见、不常见、罕见、非常罕见)的效用。在所有研究中都发现,给定特定的口头描述词时,人们会显著高估不良反应发生的可能性。这反过来又导致他们对自身健康风险的感知评级显著更高,而对服药可能性的评级显著更低。这种解释问题并不局限于EC指南描述词。另外两种最近倡导的风险量表(卡尔曼口头描述词量表以及巴克利、科斯蒂根和戴维斯的彩票式量表)也显示出类似程度的误解。总之,风险沟通者和未来研究面临的挑战将是创造一种足够灵活的风险语言,以考虑不同的观点以及疾病及其治疗的不断变化的情况和背景。与此同时,我们敦促欧盟委员会和其他立法机构在有更有力的证据支持其使用之前,停止推荐使用特定的口头标签或短语。