Symonds Tara, Berzon Rick, Marquis Patrick, Rummans Teresa A
Outcomes Research Department, Pfizer Ltd, Sandwich, Kent, United Kingdom.
Mayo Clin Proc. 2002 Jun;77(6):572-83. doi: 10.4065/77.6.572.
This is the sixth article in a series intended to summarize the state of the science for assessing the clinical significance of quality-of-life (QOL) assessments. The previous 5 articles dealt with specific methodological issues, whereas this article addresses practical considerations in implementing the methods and presenting the results to various audiences with differing perspectives. Proposals for how to interpret the "clinical significance" or "clinical meaningfulness" of changes in QOL scores were addressed in previous articles within this series. Within this article, 4 audiences-patients and physicians, clinical researchers, health policymakers, and private- and public-sector employees who work in health-related fields-are examined because each is a unique stakeholder with a distinct vantage point and each can interpret QOL outcomes differently. A clinician may attempt to explain to a patient potential treatment alternatives for his or her QOL; a health policymaker may try to describe to elected officials the financial impact on a patient population with reduced QOL; a researcher may try to obtain the vital messages from a clinical trial that included QOL end points; and a regulatory agency and/or pharmaceutical company may try to ascertain the appropriate level of evidence required for a successful research study. For each of the 4 audiences, concrete examples and practical guidelines are offered by which changes in QOL outcomes can be interpreted meaningfully. Ultimately, both determining and disseminating the meaning of clinical significance are functions of the outlook of the audience because the perspective of the audience determines its ability to comprehend, evaluate, and convey the context within which such outcomes appear meaningful. Among the audiences described within this article, a commonality of interests exist that mandates a careful exposition of the scientific rigor involved in describing the clinical significance of QOL assessments. Collectively, this series attempts to provide methods and means for making such determinations.
这是一个系列文章中的第六篇，旨在总结评估生活质量（QOL）评估临床意义的科学现状。前5篇文章讨论了具体的方法学问题，而本文则探讨了在实施这些方法并向不同视角的各类受众呈现结果时的实际考量。本系列之前的文章讨论了如何解读QOL评分变化的“临床意义”或“临床重要性”。在本文中，将审视四类受众——患者和医生、临床研究人员、卫生政策制定者以及从事健康相关领域工作的私营和公共部门员工，因为每一类都是具有独特优势视角的利益相关者，且对QOL结果的解读可能各不相同。临床医生可能会向患者解释针对其生活质量的潜在治疗选择；卫生政策制定者可能会向当选官员描述生活质量下降对患者群体的财务影响；研究人员可能会试图从包含生活质量终点的临床试验中获取关键信息；而监管机构和/或制药公司可能会试图确定成功的研究所需的适当证据水平。针对这四类受众中的每一类，都提供了具体示例和实用指南，以便能够有意义地解读生活质量结果的变化。最终，确定和传播临床意义的含义都是受众视角的功能，因为受众的视角决定了其理解、评估和传达这些结果有意义的背景的能力。在本文所描述的受众中，存在共同利益，这就要求仔细阐述描述生活质量评估临床意义所涉及的科学严谨性。总体而言，本系列试图提供做出此类判定的方法和手段。
