Institutional Review Board, Health Sciences/Behavioral Sciences, University of Michigan, 540 East Liberty, Ste 202, Ann Arbor, MI 48104, USA.
Theor Med Bioeth. 2012 Jun;33(3):207-20. doi: 10.1007/s11017-012-9215-3.
The use of quality of life (QOL) outcomes in clinical trials is increasing as a number of practical, ethical, methodological, and regulatory reasons for their use have become apparent. It is important, then, that QOL measurements and differences between QOL scores be readily interpretable. We study interpretation in two contexts: when determining QOL and when basing decisions on QOL differences. We consider both clinical situations involving individual patients and research contexts, e.g., randomized clinical trials, involving groups of patients. We note the ethical importance of such understanding: proper interpretation and communication facilitate health care decision making. Communication that facilitates interpretation is of moral significance since better communication can attenuate ethical problems and inform choices. Much of what is communication worthy about QOL assessments is determined by the particular QOL instrument used in the assessment and how it is administered. In practice, these choices will be driven by the purpose of the assessment, but, it is argued, to maximize understanding, we should combine the information garnered from traditional standardized QOL instruments, from individualized QOL assessments, and from a recently proposed dialogic paradigm, where QOL is determined by shared conversation regarding the interpretation of texts. And, while some studies can surely succeed using abbreviated methods of administration (e.g., postal surveys may suffice for certain purposes), we will focus on methods of administration involving interviewer-respondent interaction. We suggest that during the QOL elicitation process, interviewer and respondent should engage in a two-way conversation in order to achieve a shared understanding of the "answers" to QOL "questions" and, finally, to reach a shared interpretation of the individual's QOL.
生活质量(QOL)结果在临床试验中的应用正在增加,因为使用它们有许多实际的、伦理的、方法学的和监管方面的原因。因此,QOL 测量和 QOL 评分之间的差异应该易于解释。我们在两个背景下研究解释:当确定 QOL 时和当根据 QOL 差异做出决策时。我们考虑涉及个体患者的临床情况和研究情况,例如,涉及患者群体的随机临床试验。我们注意到这种理解的伦理重要性:正确的解释和沟通促进医疗保健决策。促进解释的沟通具有道德意义,因为更好的沟通可以减轻伦理问题并提供信息。关于 QOL 评估的值得沟通的大部分内容是由评估中使用的特定 QOL 工具及其管理方式决定的。在实践中,这些选择将由评估的目的驱动,但可以说,为了最大限度地理解,我们应该结合传统标准化 QOL 工具、个体化 QOL 评估以及最近提出的对话范式所获得的信息,其中 QOL 是通过关于文本解释的共享对话来确定的。虽然有些研究肯定可以使用简化的管理方法(例如,邮寄调查可能足以满足某些目的),但我们将重点关注涉及访谈者-受访者互动的管理方法。我们建议,在 QOL 收集过程中,访谈者和受访者应进行双向对话,以共同理解 QOL“问题”的“答案”,并最终共同解释个人的 QOL。