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多发性硬化症患者报告结局测量的比较。

Comparison of patient-reported outcome measures in multiple sclerosis.

机构信息

Department of Neurology, Institute of Neuroimmunology and Clinical MS Research (inims), University Medical Center, Hamburg, Germany.

出版信息

Acta Neurol Scand. 2013 Aug;128(2):114-21. doi: 10.1111/ane.12083. Epub 2013 Feb 7.

Abstract

BACKGROUND

Patient-reported outcome measurements (PROMS) have been proposed sensitive outcome parameters in multiple sclerosis (MS). In this study, we assessed a German version of the Multiple Sclerosis Impact Scale (MSIS-29) and a revised version of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) in comparison with rater- and physician-based tools.

METHODS

Consecutive MS patients (n = 117) of the MS outpatient unit were included. In addition to MSIS-29 and HAQUAMS, the following parameters were obtained: Expanded Disability Status Scale (EDSS) and modified Multiple Sclerosis Functional Composite (MSFC) [9-hole peg test (9HPT), 25-foot walk test and symbol digit modalities test]. We investigated validity, internal consistency and test-retest reliability as well as correlation between these measures.

RESULTS

Internal consistency (Cronbach's α ≤ 0.96) and test-retest coefficients (ICC ≤ 0.87) of both scales were high and satisfied psychometric standards. Convergent and discriminant validity was supported by direction, magnitude and pattern of correlation with other rater-based measures depending on the functional subdomain. Both MSIS-29 and HAQUAMS correlated with EDSS (ρ = 0.55 vs 0.62), but stronger correlation was found between MSIS-29 and HAQUAMS total score (ρ = 0.90). Both scales distinguished between patient groups of varied disease severity and cognitive impairment.

CONCLUSION

Patient-reported outcome measurements as MSIS-29 and HAQUAMS seem to be valid instruments to detect different impairment levels in comparison with traditional rater-based instruments like EDSS or MSFC.

摘要

背景

患者报告的结局测量(PROMs)已被提议作为多发性硬化症(MS)的敏感结局参数。在这项研究中,我们评估了德国多发性硬化症影响量表(MSIS-29)的版本和修订版汉堡多发性硬化症生活质量问卷(HAQUAMS),并将其与基于评定者和基于医生的工具进行比较。

方法

连续纳入 MS 门诊患者(n=117)。除了 MSIS-29 和 HAQUAMS 外,还获得了以下参数:扩展残疾状态量表(EDSS)和改良多发性硬化功能综合(MSFC)[9 孔钉测试(9HPT)、25 英尺步行测试和符号数字模式测试]。我们研究了这些措施的有效性、内部一致性和重测信度以及它们之间的相关性。

结果

两个量表的内部一致性(Cronbach's α≤0.96)和重测信度系数(ICC≤0.87)均较高,符合心理测量学标准。基于功能子域的相关性的方向、大小和模式支持了两种量表的收敛和判别有效性。MSIS-29 和 HAQUAMS 均与 EDSS 相关(ρ=0.55 与 0.62),但 MSIS-29 与 HAQUAMS 总分的相关性更强(ρ=0.90)。两种量表均能区分不同疾病严重程度和认知障碍的患者组。

结论

MSIS-29 和 HAQUAMS 等患者报告的结局测量似乎是有效的工具,可以与 EDSS 或 MSFC 等传统基于评定者的工具相比,检测不同的损伤水平。

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