Cella David, Choi Seung, Garcia Sofia, Cook Karon F, Rosenbloom Sarah, Lai Jin-Shei, Tatum Donna Surges, Gershon Richard
Department of Medical Social Sciences, Northwestern University, 633 N. St. Clair, 19th Floor, Chicago, IL, 60611, USA,
Qual Life Res. 2014 Dec;23(10):2651-61. doi: 10.1007/s11136-014-0732-6. Epub 2014 Jun 18.
Although the use of patient-reported outcome measures (PROs) has increased markedly, clinical interpretation of scores remains lacking. We developed a method to identify clinical severity thresholds for pain, fatigue, depression, and anxiety in people with cancer.
Using available Patient-Reported Outcomes Measurement Information System (PROMIS) item bank response data collected on 840 cancer patients, symptom vignettes across a range of symptom severity were developed and placed on index cards. Cards represented symptom severity at five-point intervals differences on the T score metric [mean = 50; standard deviation (SD) = 10]. Symptom vignettes for each symptom were anchored on these standardized scores at 0.5 SD increments across the full range of severity. Clinical experts, blind to the PROMIS score associated with each vignette, rank-ordered the vignettes by severity, then arrived at consensus regarding which two vignettes were at the upper and lower boundaries of normal and mildly symptomatic for each symptom. The procedure was repeated to identify cut scores separating mildly from moderately symptomatic, and moderately from severely symptomatic scores. Clinician severity rankings were then compared to the T scores upon which the vignettes were based.
For each of the targeted PROs, the severity rankings reached by clinician consensus perfectly matched the numerical rankings of their associated T scores. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70.
The study results provide empirically generated PROMIS T score thresholds that differentiate levels of symptom severity for pain interference, fatigue, anxiety, and depression. The convergence of clinical judgment with self-reported patient severity scores supports the validity of this methodology to derive clinically relevant symptom severity levels for PROMIS symptom measures in other settings.
尽管患者报告结局测量指标（PROs）的使用显著增加，但对其分数的临床解读仍然缺乏。我们开发了一种方法来确定癌症患者疼痛、疲劳、抑郁和焦虑的临床严重程度阈值。
利用收集到的840例癌症患者的患者报告结局测量信息系统（PROMIS）项目库应答数据，制定了一系列症状严重程度的症状 vignettes，并将其放在索引卡上。卡片代表了T分数度量上五点间隔差异的症状严重程度[平均值 = 50；标准差（SD）= 10]。每种症状的症状 vignettes 在整个严重程度范围内以0.5 SD的增量锚定在这些标准化分数上。临床专家在不知道每个 vignette 所关联的PROMIS分数的情况下，按严重程度对 vignettes 进行排序，然后就每种症状的正常和轻度症状的上下边界分别是哪两个 vignettes 达成共识。重复该过程以确定区分轻度与中度症状、中度与重度症状分数的临界分数。然后将临床医生的严重程度排名与其所基于的T分数进行比较。
对于每个目标PROs，临床医生通过共识达成的严重程度排名与它们相关联的T分数的数值排名完全匹配。在所有症状中，区分正常与轻度症状的阈值（临界分数）接近T分数50。区分轻度与中度症状的临界分数在60或接近60，而区分中度与重度症状的临界分数在70或接近70。
研究结果提供了根据经验得出的PROMIS T分数阈值，可区分疼痛干扰、疲劳、焦虑和抑郁的症状严重程度水平。临床判断与患者自我报告的严重程度分数的一致性支持了该方法在其他环境中得出PROMIS症状测量的临床相关症状严重程度水平的有效性。
