Holm Bente, Jacobsen Soren, Skjodt Henrik, Klarlund Mette, Jensen Trine, Hetland Merete Lund, Ostergaard Mikkel
Department of Physiotherapy, Copenhagen University Hospital at Hvidovre, Copenhagen, Denmark.
Phys Ther. 2008 May;88(5):664-78. doi: 10.2522/ptj.20070119. Epub 2008 Feb 14.
The purpose of this study was to translate the German Keitel Functional Test (KFT) into Danish and test it for reliability, concurrent and predictive validity, and responsiveness in patients with rheumatoid arthritis (RA).
Translation of the KFT was performed according to international recommendations, and the translated version was tested twice by 2 observers for intraobserver and interobserver reliability, with a 1-week interval between assessments, in 20 patients with RA with stable disease activity. Validity was investigated by studying 2 patient groups: (1) 15 patients with long-lasting (median=6 years) active RA, tested before and after 2, 6, and 14 weeks of anti-tumor necrosis factor alpha (TNF-alpha) inhibitor therapy, and (2) 35 patients with early (median=0.25 year) RA, tested at years 0, 0.5, 1, and 2. Twenty-three patients in the early RA group also were tested at year 7. KFT, conventional clinical and biochemical markers of disease activity, and Health Assessment Questionnaire (HAQ) were used.
The translated KFT showed good intraobserver reliability (intraclass correlation coefficients [ICC]=.90 and .95, coefficient of variation [CV]=3.5%) and interobserver reliability (ICC=.99 and .92, CV=3.5%), and the KFT correlated with several measures of disease activity and, most closely, with the HAQ. The KFT was, in contrast to clinical disease activity measures, not sensitive to changes over time. Only baseline KFT data were significantly related to functional changes over a long period of time as measured by the KFT, and only in the early RA group.
The Danish translation of the KFT showed good reliability, acceptable concurrent validity, very poor responsiveness, and inconclusive results concerning predictive validity. The results of this study do not support the use of the KFT for monitoring function in clinical practice, as an outcome measure in clinical trials, or as a predictor of functional changes.
本研究旨在将德国的凯特尔功能测试(KFT)翻译成丹麦语,并测试其在类风湿关节炎(RA)患者中的可靠性、同时效度和预测效度以及反应性。
根据国际推荐对KFT进行翻译,由2名观察者对20名疾病活动稳定的RA患者进行两次测试,以评估观察者内和观察者间的可靠性,两次评估间隔1周。通过研究2组患者来调查效度:(1)15名患有长期(中位数 = 6年)活动性RA的患者,在接受抗肿瘤坏死因子α(TNF-α)抑制剂治疗2、6和14周之前和之后进行测试;(2)35名早期(中位数 = 0.25年)RA患者,在第0、0.5、1和2年进行测试。早期RA组中的23名患者在第7年也进行了测试。使用了KFT、疾病活动的传统临床和生化指标以及健康评估问卷(HAQ)。
翻译后的KFT显示出良好的观察者内可靠性(组内相关系数[ICC]=0.90和0.95,变异系数[CV]=3.5%)和观察者间可靠性(ICC=0.99和0.92,CV=3.5%),并且KFT与多种疾病活动指标相关,与HAQ的相关性最为密切。与临床疾病活动指标不同,KFT对随时间的变化不敏感。只有基线KFT数据与KFT测量的长期功能变化显著相关,且仅在早期RA组中如此。
KFT的丹麦语翻译显示出良好的可靠性、可接受的同时效度、非常差的反应性以及关于预测效度的不确定结果。本研究结果不支持在临床实践中使用KFT来监测功能、作为临床试验的结局指标或作为功能变化的预测指标。