Isaksson Eva, Wester Per, Laska Ann Charlotte, Näsman Per, Lundström Erik
Department of Neurology, Danderyd Hospital, Stockholm, Sweden and Department of Clinical Neuroscience, Neurology, Karolinska Institutet, Stockholm, Sweden,
Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm and Department of Public Health & Clinical Medicine, Umeå University, Umeå, Sweden.
Eur Neurol. 2020;83(5):493-499. doi: 10.1159/000510721. Epub 2020 Oct 7.
The modified Rankin scale (mRS) is the most common assessment tool for measuring overall functional outcome in stroke studies. The traditional way of using mRS face-to-face is time- and cost-consuming. The aim of this study was to test the validity of the Swedish translation of the simplified modified Rankin scale questionnaire (smRSq) as compared with the mRS assessed face-to-face 6 months after a stroke.
Within the ongoing EFFECTS trial, smRSq was sent out to 108 consecutive stroke patients 6 months after a stroke. The majority, 90% (97/108), of the patients answered the questionnaire; for the remaining 10%, it was answered by the next of kin. The patients were assessed by face-to-face mRS by 7 certified healthcare professionals at 4 Swedish stroke centres. The primary outcome was assessed by Cohen's kappa and weighted kappa.
There was good agreement between postal smRSq, answered by the patients, and the mRS face-to-face; Cohen's kappa was 0.43 (CI 95% 0.31-0.55), weighted kappa was 0.64 (CI 95% 0.55-0.73), and Spearman rank correlation was 0.82 (p < 0.0001). In 55% (59/108), there was full agreement, and of the 49 patients not showing exact agreement, 44 patients differed by 1 grade and 5 patients had a difference of 2 grades.
DISCUSSION/CONCLUSION: Our results show good validity of the postal smRSq, answered by the patients, compared with the mRS carried out face-to-face at 6 months after a stroke. This result could help trialists in the future simplify study design and make multicentre trials and quality registers with a large number of patients more feasible and time-saving.
改良Rankin量表（mRS）是卒中研究中测量整体功能结局最常用的评估工具。传统的面对面使用mRS的方式既耗时又费钱。本研究的目的是检验简化改良Rankin量表问卷（smRSq）瑞典语翻译版与卒中后6个月面对面评估的mRS相比的有效性。
在正在进行的EFFECTS试验中，卒中后6个月向108例连续的卒中患者发放smRSq。大多数患者，即90%（97/108）回答了问卷；其余10%由其近亲回答。4个瑞典卒中中心的7名认证医疗保健专业人员对患者进行面对面的mRS评估。主要结局通过Cohen卡方检验和加权卡方检验进行评估。
患者回答的邮寄smRSq与面对面的mRS之间有良好的一致性；Cohen卡方值为0.43（95%CI 0.31 - 0.55），加权卡方值为0.64（95%CI 0.55 - 0.73），Spearman等级相关性为0.82（p < 0.0001）。55%（59/108）的结果完全一致，在49例结果不完全一致的患者中，44例相差1个等级，5例相差2个等级。
讨论/结论：我们的结果表明，与卒中后6个月面对面进行的mRS相比，患者回答的邮寄smRSq具有良好的有效性。这一结果未来可帮助试验者简化研究设计，使针对大量患者的多中心试验和质量登记更可行、更节省时间。
