Interpreting clinically significant changes in patient-reported outcomes
Interpreting clinically significant changes in patient-reported outcomes
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DOI：
10.1002/cncr.22799
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发表时间：
2007-07-01
期刊：
影响因子：
6.2
通讯作者：
Redelmeier, Donald A.
中科院分区：
文献类型：
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作者：
Ringash, Jolie;O'Sullivan, Brian;Redelmeier, Donald A.
背景。本研究的目的是确定患者报告的结果评分的变化幅度在临床上有意义，因此当无法获得经验估计时，可以为临床医生提供最小重要差异（MID）的估计指南。连续喉癌患者（n = 98）相对于其他患者评价其生活质量（QOL）。这些比较与癌症治疗-头颈部功能评估（FACT-H&N）量表、癌症治疗功能评估（FACT-G）量表、2项效用测量（时间权衡[TTO]和每日活跃时间交换[DATE]）和表现状态（Karnofsky）评分的算术差异进行对比。FACT-H&N评分需要相差4%，一般患者才会认为自己相对于其他患者“好一点”（95% CI, 1%-8%），并且需要相差9%，才会认为自己相对于其他患者“差一点”（950X， CI, 4%-13%）。其他测量的相应值为FACT-G 4%（1% - 7%）和8% (95% CI, 5%-11%)；TTO为5% （95% CI, 0%-11%）和6% (95% CI, 0%- 10%)；日期5% （95%CI, 2%-9%）和14% (95%CI, 0%-5%)；Karnofsky 4%(95%可信区间,1% - -6%)和10%(95%可信区间,7% -13%)。在每种情况下，最小重要差异（MID）约为仪器范围的5%至10%。解释生活质量评分差异的一个经验法则是，基准值约为仪器范围的10%。患者似乎对有利的差异更敏感，所以5%的改善可能是有意义的。这个简单的基准可以作为有意义的更改的粗略指南。
BACKGROUND. The goal of this study was to determine what magnitude of change in a patient- reported outcome score is clinically meaningful, so a clinicians' guide may be provided for estimating the minimal important difference (MID) when empiric estimates are not available.METHODS. Consecutive laryngeal cancer patients (n = 98) rated their quality of life (QOL) relative to other patients. These comparisons were contrasted with arithmetic differences in scores on the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) scale, Functional Assessment of Cancer Therapy-General (FACT-G) scale, 2 utility measures (the time tradeoff [TTO] and Daily Active Time Exchange [DATE]), and performance status (Karnofsky) scores.RESULTS. The FACT-H&N score needed to differ by 4% for average patients to rate themselves as "a little bit better" relative to other patients (95% CI, 1%-8%) and by 9% to rate themselves as "a little bit worse" relative to others (950X, CI, 4%-13%). The corresponding values for other measures were FACT-G 4% (1%7%) and 8% (95% CI, 5%-11%); TTO 5% (95% CI, 0%-11%) and 6% (95% CI, 0%10%); DATE 5% (95%CI, 2%-9%) and 14% (95% CI, 0%-5%); Karnofsky 4% (95% CI, 1%-6%) and 10% (95% CI, 7%-13%). In each case, the minimal important difference (MID) was about 5% to 10% of the instrument range.CONCLUSIONS. One rule of thumb for interpreting a difference in QOL scores is a benchmark of about 10% of the instrument range. Patients appear to be more sensitive to favorable differences, so an improvement of 5% may be meaningful. This simple benchmark may be useful as a rough guide to meaningful change.