Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).
Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).
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DOI：
10.1161/strokeaha.109.571364
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发表时间：
2010-05
期刊：
影响因子：
8.3
通讯作者：
FAST-MAG Investigators and Coordinators
中科院分区：
文献类型：
--
作者：
Saver JL;Filip B;Hamilton S;Yanes A;Craig S;Cho M;Conwit R;Starkman S;FAST-MAG Investigators and Coordinators
改良兰金量表（mRS）对卒中后的总体残疾进行评分，是急性卒中试验中最全面和广泛使用的主要结局指标。然而，已报告了mRS评分的显著观察者间变异性。本研究旨在开发和验证一个简短，实用的结构化评估，将提高评分者之间的可靠性。兰金重点评估（RFA）是通过从先前的工具中选择和提炼元素而开发的。RFA只需3-5分钟即可应用，并提供明确的可操作标准来区分7个可分配的全球残疾级别。在III期NIH FAST-MAG试验入组的50例连续患者中，对卒中后3个月的RFA进行了前瞻性验证。在50例患者中，平均年龄71.5岁（范围43-93岁），48%为女性，24%的卒中亚型为出血性。在第90天，43名患者存活，7名患者死亡。mRS中位数为2.0，平均值为2.8。当成对的14名评估者评估所有入组患者时，一致率为94%，加权kappa为0.99（95% CI 0.99-1.0），未加权kappa为0.93（95% CI 0.85-1.00）。在43例存活患者中，一致率为93%，加权Kappa值为0.99（0.98-1.0），未加权Kappa值为0.91（0.82-1.00）。兰金集中评估在参与随机临床试验的连续脑卒中患者的最终总体残疾分级中产生了较高的评定者间可靠性。RFA简单实用，可用于多中心临床试验和质量改进活动。
The modified Rankin scale (mRS) rates global disability after stroke and is the most comprehensive and widely employed primary outcome measure in acute stroke trials. However, substantial inter observer variability in mRS scoring has been reported. This study sought to develop and validate a short, practicable structured assessment that would enhance inter-rater reliability. The Rankin Focused Assessment (RFA) was developed by selecting and refining elements from prior instruments. The RFA takes 3–5 minutes to apply and provides clear, operationalized criteria to distinguish the 7 assignable global disability levels. The RFA was prospectively validated 3 months poststroke among 50 consecutive patients enrolled in the phase 3 NIH FAST-MAG Trial. Among the 50 patients, mean age 71.5 (range 43–93), 48% were female, and stroke subtype was hemorrhagic in 24%. At day 90, 43 patients were alive and 7 had died. The mRS median was 2.0 and mean 2.8. When pairs of 14 raters assessed all enrolled patients, the percent agreement was 94%, the weighted kappa was 0.99 (95% CI 0.99–1.0), and the unweighted kappa was 0.93 (95% CI 0.85–1.00). Among the 43 surviving patients, the percent agreement was 93%, the weighted kappa was 0.99 (0.98–1.0), and the unweighted kappa was 0.91 (0.82–1.00). The Rankin Focused Assessment yields high inter-rater reliability in the grading of final global disability among consecutive stroke patients participating in a randomized clinical trial. The RFA is brief and practical for use in multicenter clinical trials and quality improvement activities.