Estimating clinically significant differences in quality of life outcomes
Estimating clinically significant differences in quality of life outcomes
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DOI：
10.1007/s11136-004-0705-2
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发表时间：
2005-03-01
影响因子：
3.5
通讯作者：
Symonds, T
中科院分区：
文献类型：
--
作者：
Wyrwich, KW;Bullinger, M;Symonds, T
目的：本报告从30位国际专家在生活质量评估领域发表的6篇文章中提取确定和应用临床显著差异生活质量（QOL）指标的重要考虑因素。最初的六篇文章于2002年4月在梅奥诊所举行的癌症患者生活质量测量的临床意义研讨会上发表，随后发表在梅奥诊所学报上。主要发现：给出了基于锚点的方法的具体示例和公式，以及对应于已知或相关锚点的基于分布的方法，以确定生活质量指标的重要差异。提供了与仪器选择、反应性和QOL试验结果报告相关的临床意义的重要先决条件。我们还讨论了相对于临床显著阈值估计治疗所需的数量（NNT）。最后，我们提供了将群体衍生标准应用于个人评估的基本原理。结论：虽然没有一种确定临床意义的方法被单方面认可，但强烈鼓励研究和全面报告多种方法来建立临床意义变化水平，以衡量生活质量，并鼓励临床医生更直接地参与临床意义研究。
Objective: This report extracts important considerations for determining and applying clinically significant differences in quality of life (QOL) measures from six published articles written by 30 international experts in the field of QOL assessment and evaluation. The original six articles were presented at the Symposium on Clinical Significance of Quality of Life Measures in Cancer Patients at the Mayo Clinic in April 2002 and subsequently were published in Mayo Clinic Proceedings. Principal findings: Specific examples and formulas are given for anchor-based methods, as well as distribution-based methods that correspond to known or relevant anchors to determine important differences in QOL measures. Important prerequisites for clinical significance associated with instrument selection, responsiveness, and the reporting of QOL trial results are provided. We also discuss estimating the number needed to treat (NNT) relative to clinically significant thresholds. Finally, we provide a rationale for applying group-derived standards to individual assessments. Conclusions: While no single method for determining clinical significance is unilaterally endorsed, the investigation and full reporting of multiple methods for establishing clinically significant change levels for a QOL measure, and greater direct involvement of clinicians in clinical significance studies are strongly encouraged.