Supplementary Material for: Validation of the Simplified Modified Rankin Scale Questionnaire

<b><i>Introduction:</i></b> 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. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> 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 (<i>p</i> &lt; 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. <b><i>Discussion/Conclusion:</i></b> 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.

<b><i>引言：</i></b> 改良Rankin量表（modified Rankin Scale, mRS）是卒中研究中评估整体功能结局最常用的评估工具。传统的面对面mRS评估方式既耗时又耗成本。本研究旨在验证简化版改良Rankin量表问卷（simplified modified Rankin Scale questionnaire, smRSq）的瑞典语译本的效度，并与卒中发病6个月后的面对面mRS评估结果进行对比。<b><i>方法：</i></b> 在正在进行的EFFECTS试验中，研究人员向108名发病6个月后的连续性卒中患者邮寄了smRSq问卷。其中90%（97/108）的患者自行完成了问卷；剩余10%的问卷由患者的近亲代为填写。由瑞典4家卒中中心的7名认证医护人员对所有患者进行面对面的mRS评估。主要结局采用科恩kappa系数和加权kappa系数进行评估。<b><i>结果：</i></b> 患者自行填写的邮寄版smRSq与面对面mRS评估结果具有良好的一致性：科恩kappa系数为0.43（95%置信区间0.31~0.55），加权kappa系数为0.64（95%置信区间0.55~0.73），斯皮尔曼等级相关系数为0.82（*p* < 0.0001）。55%（59/108）的患者结果完全一致；在49名结果未完全一致的患者中，44名的评分相差1个等级，5名的评分相差2个等级。<b><i>讨论/结论：</i></b> 本研究结果显示，卒中发病6个月后由患者自行填写的邮寄版smRSq具有良好的效度，与面对面mRS评估结果一致性较好。该结果可为未来的试验研究者简化研究设计提供帮助，使纳入大量患者的多中心试验及质量登记研究更具可行性且更节省时间与成本。