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在一个真实的卒中队列中,对德语版改良Rankin量表结构化电话访谈在3个月时的效度进行验证。

Validation of a German-language modified Rankin Scale structured telephone interview at 3 months in a real-life stroke cohort.

作者信息

Milles Lennart Steffen, Pommeranz Doreen, Chae Woon Hyung, Kühne Escolà Jordi, Kleinschnitz Christoph, Köhrmann Martin, Frank Benedikt

机构信息

Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.

出版信息

Neurol Res Pract. 2023 Nov 30;5(1):59. doi: 10.1186/s42466-023-00289-x.

Abstract

BACKGROUND

The modified Rankin scale (mRS) at 3 months is established as the primary outcome measure in clinical stroke trials. Traditionally, the mRS is assessed through an unstructured face-to-face interview. This approach can be labor-intensive and lead to suboptimal inter-rater reliability. Recently, the Covid-19 pandemic made face-to-face contact even more challenging. To address these issues, we developed and validated a structured German-language questionnaire for mRS testing by telephone.

METHODS

In this prospective cohort study, we compared the mRS testing results of the standard face-to-face interview with those obtained in a structured interview by telephone using Cohen's Kappa.

RESULTS

At our tertiary care stroke center, we included 108 patients who underwent both assessments. In 80.6% of cases (87/108) face-to-face and telephone interview reached identical scores. Linear weighted Kappa was 0.82 (p < 0.001). Unweighted Kappa for dichotomized mRS between fair (0-2) and poor (3-6) functional outcome was κ = 0.97 (p < 0.001).

CONCLUSIONS

Our study validates the use of the German-language structured telephone interview as a reliable instrument for the use in clinical trials. We encourage others to utilize the questionnaire. It is available as an Appendix (Additional file 1) to this publication.

摘要

背景

3个月时的改良Rankin量表(mRS)已被确立为临床中风试验的主要结局指标。传统上,mRS是通过非结构化的面对面访谈进行评估的。这种方法可能耗费人力,并且导致评分者间信度不理想。最近,新冠疫情使面对面接触变得更具挑战性。为了解决这些问题,我们开发并验证了一种用于通过电话进行mRS测试的德语结构化问卷。

方法

在这项前瞻性队列研究中,我们使用科恩kappa系数比较了标准面对面访谈与通过电话进行的结构化访谈获得的mRS测试结果。

结果

在我们的三级护理中风中心,我们纳入了108例接受了两种评估的患者。在80.6%的病例(87/108)中,面对面访谈和电话访谈的得分相同。线性加权kappa系数为0.82(p<0.001)。功能结局为中等(0-2)和差(3-6)的二分法mRS的非加权kappa系数为κ=0.97(p<0.001)。

结论

我们的研究验证了德语结构化电话访谈可作为一种可靠的工具用于临床试验。我们鼓励其他人使用该问卷。它作为本出版物的附录(附加文件1)提供。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81f7/10687899/22c08e1ab52b/42466_2023_289_Fig1_HTML.jpg

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