Solari Alessandra, Radice Davide, Manneschi Letizia, Motti Luisa, Montanari Enrico
Laboratory of Epidemiology, National Neurological Institute C. Besta, Milan, Italy.
J Neurol Sci. 2005 Jan 15;228(1):71-4. doi: 10.1016/j.jns.2004.09.033. Epub 2004 Nov 6.
The multiple sclerosis functional composite (MSFC) is a multidimensional, MS-specific outcome measure for use in clinical trials, comprising three tests: timed 25-foot walk (T25FW), paced auditory serial addition (PASAT), and 9-hole peg (9HP).
To assess interrater and intrarater reliability and practice/fatigue effects in the MSFC.
The MSFC was administered by two neurologists after a formal training session to 32 MS outpatients. Patients were assessed four times by one examiner and twice by the other. The six tests were administered in a single day, with at least 20 min of rest between them. The examiners were blinded to the results of previous assessments. Testing order was random.
Interrater reliability was excellent, with intraclass correlation coefficients (ICC) ranging from 0.93 for 9HP (95% confidence interval [CI] 0.84-0.96) to 0.99 for T25FW (95% CI 0.97-0.99). For intrarater reliability, ICC ranged from 0.93 for PASAT (95% CI 0.82-0.97) to 0.98 for T25FW (95% CI 0.93-1.00). We found no practice effect for T25FW after the first administration. However, performance improved with testing over the first three sessions for PASAT and over the first four sessions for 9HP.
The MSFC is characterised by excellent reliability. Practice effects for the three MSFC components differed, being negligible for T25FW and evident for PASAT and 9HP. To improve efficiency, we suggest one prebaseline administration of T25FW, three of PASAT and four of 9HP.
多发性硬化功能综合评分(MSFC)是一种用于临床试验的多维、针对多发性硬化的结局指标,包括三项测试:25英尺步行时间(T25FW)、听觉节律性加法测验(PASAT)和九孔插板试验(9HP)。
评估MSFC的评分者间信度、评分者内信度以及练习/疲劳效应。
在一次正式培训课程后,由两位神经科医生对32例多发性硬化门诊患者进行MSFC评估。一名检查者对患者进行四次评估,另一名检查者进行两次评估。六项测试在同一天进行,每次测试之间至少休息20分钟。检查者对先前评估的结果不知情。测试顺序是随机的。
评分者间信度极佳,组内相关系数(ICC)范围从9HP的0.93(95%置信区间[CI]0.84 - 0.96)到T25FW的0.99(95%CI 0.97 - 0.99)。对于评分者内信度,ICC范围从PASAT的0.93(95%CI 0.82 - 0.97)到T25FW的0.98(95%CI 0.93 - 1.00)。我们发现首次进行T25FW测试后没有练习效应。然而,PASAT在前三次测试以及9HP在前四次测试中,随着测试次数增加表现有所改善。
MSFC具有极佳的信度。MSFC三个组成部分的练习效应有所不同,T25FW可忽略不计,PASAT和9HP则较为明显。为提高效率,我们建议T25FW进行一次基线前测试,PASAT进行三次,9HP进行四次。