Institute of Cardiovascular and Medical Sciences, Undergraduate Medical School, University of Glasgow, and Department of Academic Geriatric Medicine, Walton Bldg, Glasgow Royal Infirmary, Glasgow, UK G4 0SF.
Stroke. 2012 Dec;43(12):3184-8. doi: 10.1161/STROKEAHA.112.670422. Epub 2012 Nov 13.
The modified Rankin Scale (mRS) is the recommended functional outcome assessment in stroke trials. Utility of mRS may be limited by interobserver variability. prestroke function, described using mRS, is often used as trial entry criterion. We assessed the reliability and validity of prestroke mRS in acute stroke.
We present two complementary analyses of the properties of prestroke mRS: (1) Paired interviewers (trained in mRS) performed independently a blinded assessment of mRS and prestroke mRS. Interobserver variability was described using percentage agreement and weighted (kw) κ statistics with 95% confidence interval (95% CI). Validity was assessed by comparing prestroke mRS with other markers of function (comorbidity; medication count; need for carers). (2) We further assessed validity using a larger retrospective dataset. We compared prestroke mRS with Charlson comorbidity index (CCI) and the Rockwood frailty index. Rank correlation coefficient or Fisher exact test were used as appropriate.
Paired interviewers assessed 74 stroke survivors. Median standard mRS was 4 (interquartile range [IQR], 2-4), median prestroke mRS was 1 (IQR, 0-3; range, 0-4). Reliability for standard mRS interview was 56% agreement, kw=0.55 (95% CI, 0.39-0.71). Reliability for prestroke mRS was 70%, kw=0.70 (95% CI, 0.53-0.87). The retrospective dataset described 231 subjects. In this data set, Spearman Rho for prestroke mRS and frailty index was J. 0.82 (95% CI, 0.78-0.86); CCI 0.50 (95% CI, 0.40-0.59); patient age 0.45 (95% CI, 0.34-0.54); medication count 0.28 (95% CI, 0.15-0.40). There was no association between need for carers and prestroke mRS (p=0.10).
Interobserver reliability of prestroke mRS is limited but comparable with standard mRS. Poor correlation of prestroke mRS with certain markers of function suggests limited validity. Our data would suggest that relying on mRS alone may be a suboptimal measure of prestroke function and could potentially bias trial samples.
改良 Rankin 量表(mRS)是中风试验中推荐的功能结局评估方法。mRS 的使用可能受到观察者间变异性的限制。mRS 描述的发病前功能通常用作试验纳入标准。我们评估了急性中风发病前 mRS 的可靠性和有效性。
我们对发病前 mRS 的性质进行了两项互补分析:(1)经过 mRS 培训的配对评估员独立进行了 mRS 和发病前 mRS 的盲法评估。使用百分比一致性和加权(kw)κ统计量(95%置信区间[95%CI])描述观察者间变异性。通过将发病前 mRS 与其他功能标志物(合并症;药物计数;需要照顾者)进行比较来评估有效性。(2)我们使用更大的回顾性数据集进一步评估了有效性。我们将发病前 mRS 与 Charlson 合并症指数(CCI)和 Rockwood 虚弱指数进行了比较。使用适当的秩相关系数或 Fisher 确切检验。
配对评估员评估了 74 例中风幸存者。中位数标准 mRS 为 4(四分位距[IQR],2-4),中位数发病前 mRS 为 1(IQR,0-3;范围,0-4)。标准 mRS 访谈的可靠性为 56%的一致性,kw=0.55(95%CI,0.39-0.71)。发病前 mRS 的可靠性为 70%,kw=0.70(95%CI,0.53-0.87)。回顾性数据集描述了 231 例患者。在该数据集中,发病前 mRS 和虚弱指数的 Spearman Rho 为 J. 0.82(95%CI,0.78-0.86);CCI 为 0.50(95%CI,0.40-0.59);患者年龄为 0.45(95%CI,0.34-0.54);药物计数为 0.28(95%CI,0.15-0.40)。需要照顾者与发病前 mRS 之间无关联(p=0.10)。
发病前 mRS 的观察者间可靠性有限,但与标准 mRS 相当。发病前 mRS 与某些功能标志物的相关性较差表明其有效性有限。我们的数据表明,仅依赖 mRS 可能不是发病前功能的最佳测量方法,并且可能会对试验样本产生偏差。