Kaufmann Petra, Levy Gilbero, Montes Jacquelina, Buchsbaum Richard, Barsdorf Alexandra I, Battista Vanessa, Arbing Rachel, Gordon Paul H, Mitsumoto Hiroshi, Levin Bruce, Thompson John L P
Department of Neurology, The Eleanor and Lou Gehrig MDA/ALS Research Center, College of Physicians and Surgeons, New York, NY, USA.
Amyotroph Lateral Scler. 2007 Feb;8(1):42-6. doi: 10.1080/17482960600888156.
We wished to determine whether the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) is reliable when used as primary outcome measure in a multicenter clinical trial. To establish inter-rater reliability, we randomly assigned 19 primary raters and 11 back-up raters to score nine amyotrophic lateral sclerosis (ALS) patients using the ALSFRS-R. To assess intra-rater reliability and reliability of telephone administration, we randomly assigned consecutive participants of the Clinical Trial of High Dose Coenzyme Q10 in ALS (QALS) to have in-person ALSFRS-R interviews at both screening and baseline visits (n=41 patients) or to have the ALSFRS-R interview by telephone at screening and in person at the baseline visit (n=27). An intraclass correlation coefficient (ICC) of reliability was calculated using a one-way random effects analysis of variance model. In the inter-rater reliability assessment, the primary raters performed 54 ratings on nine patients with ICC=0.93 (95% CI 0.84-0.98). For back-up raters, 32 ratings on nine patients resulted in ICC=0.93 (95% CI 0.82-0.98). The intra-rater reliability for in-person interviews was ICC = 0.95 (95% CI 0.92-0.98). The reliability of telephone administration compared to in-person interviews was ICC=0.97 (95% CI 0.93-0.98). We conclude that the ALSFRS-R shows excellent inter- and intra-rater reliability, and reliability of telephone administration when used as primary outcome measure in a multicenter ALS trial.
我们希望确定修订后的肌萎缩侧索硬化功能评定量表（ALSFRS-R）在多中心临床试验中用作主要结局指标时是否可靠。为了建立评分者间信度，我们随机分配了19名主要评分者和11名备用评分者，使用ALSFRS-R对9例肌萎缩侧索硬化（ALS）患者进行评分。为了评估评分者内信度和电话施测的信度，我们将ALS高剂量辅酶Q10临床试验（QALS）的连续参与者随机分配，使其在筛查和基线访视时均接受面对面的ALSFRS-R访谈（n = 41例患者），或在筛查时接受电话ALSFRS-R访谈，在基线访视时接受面对面访谈（n = 27例）。使用单向随机效应方差分析模型计算信度的组内相关系数（ICC）。在评分者间信度评估中，主要评分者对9例患者进行了54次评分，ICC = 0.93（95%CI 0.84 - 0.98）。对于备用评分者，对9例患者进行的32次评分得出ICC = 0.93（95%CI 0.82 - 0.98）。面对面访谈的评分者内信度为ICC = 0.95（95%CI 0.92 - 0.98）。与面对面访谈相比，电话施测的信度为ICC = 0.97（95%CI 0.93 - 0.98）。我们得出结论，当在多中心ALS试验中用作主要结局指标时，ALSFRS-R显示出优异的评分者间和评分者内信度以及电话施测的信度。
