Free University Medical Center, Amsterdam, The Netherlands.
Mult Scler. 2013 Mar;19(3):326-33. doi: 10.1177/1352458512454346. Epub 2012 Aug 20.
To study the relationships between 1-2 year changes in well-known physician-rated measurements (Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9HPT)) and the long-term (≥ 5 years) outcome in patient-reported outcome (PRO) measures (Multiple Sclerosis Impact Scale (MSIS-29), Multiple Sclerosis Walking Scale (MSWS-12)) that reflect the patient-perceived impact of disease, in progressive MS.
We selected all progressive patients having at least two complete visits within 1-2 years, from a larger cohort of prospectively-followed MS patients. These were invited for another visit, at least 5 years later, consisting of another series of similar examinations, plus 2 PRO scales: the MSIS-29 and MSWS-12. We explored associations between early changes in physician-rated measurements and the long-term outcome as per the PRO measures.
In this study,134 patients fulfilled the selection criteria. We found that early change in T25FW was the only physician-rated change that was significantly related to long-term physical impact experienced by the patient, as was assessed by MSIS-29 (Kruskal-Wallis test: χ(2)=7.8, p=0.020). Early T25FW change, and to a lesser degree early 9HPT change, were significantly related to the reported long-term walking limitations, as assessed by MSWS-12 (Kruskal-Wallis test: χ(2)=13.8 and p=0.001 for T25FW, χ(2)=6.5 and p=0.038 for 9HPT). None of the early physician-rated changes were related to the long-term psychological impact experienced by the patient.
Early changes on physician-rated scales do have long-term impact in terms of potentially predictive value of outcomes for groups of patients in progressive MS, regarding walking limitations and more global physical impact. Surprisingly, early change in T25FW, rather than early change in EDSS, was significantly associated with longer-term patient-reported disease impact. Our study data support the value of using early physician-rated examinations in clinical trials in progressive MS.
研究知名医师评估测量(扩展残疾状况量表(EDSS)、定时 25 英尺步行测试(T25FW)、九孔插栓测试(9HPT))在 1-2 年内的变化与反映疾病对患者影响的长期(≥5 年)患者报告结局(PRO)测量(多发性硬化影响量表(MSIS-29)、多发性硬化步行量表(MSWS-12))之间的关系,这些测量反映了进展性多发性硬化症患者的疾病感知影响。
我们从前瞻性随访的 MS 患者的较大队列中选择了至少有两次 1-2 年内完整就诊的所有进展性患者。邀请他们在至少 5 年后再次就诊,进行另一系列类似检查,并添加 2 个 PRO 量表:MSIS-29 和 MSWS-12。我们探索了早期医师评估测量的变化与长期 PRO 测量结果之间的关联。
在这项研究中,134 名患者符合选择标准。我们发现,T25FW 的早期变化是唯一与患者长期身体影响显著相关的医师评估变化,正如 MSIS-29 评估的那样(Kruskal-Wallis 检验:χ²=7.8,p=0.020)。早期 T25FW 变化,以及在较小程度上早期 9HPT 变化,与 MSWS-12 评估的长期行走受限显著相关(Kruskal-Wallis 检验:T25FW 的 χ²=13.8,p=0.001;9HPT 的 χ²=6.5,p=0.038)。早期医师评估的变化均与患者长期心理影响无关。
在进展性多发性硬化症患者中,早期的医师评估量表变化在潜在的预后价值方面具有长期影响,与行走受限和更全面的身体影响有关。令人惊讶的是,T25FW 的早期变化而不是 EDSS 的早期变化与患者报告的疾病影响的长期变化显著相关。我们的研究数据支持在进展性多发性硬化症的临床试验中使用早期医师评估检查的价值。