Department of Reconstructive Surgery and Arthroscopy of the Knee Joint, Faculty of Health Sciences, Medical University, Radliński Hospital, Drewnowska 75, 91-002 Łódź, Poland.
Health Qual Life Outcomes. 2013 Jun 27;11:107. doi: 10.1186/1477-7525-11-107.
Knee Injury and Osteoarthritis Outcome Score (KOOS) is available in over 30 languages and a commonly used Patient-Reported Outcome (PRO) for assessment of treatment effects following knee surgery. The aim of the study was to report the linguistic translational process and evaluate the psychometric properties of the Polish version of the KOOS questionnaire.
We translated and culturally adapted the KOOS according to current guidelines for use in Poland. Patients who had undergone anterior cruciate ligament reconstruction (ACLR) completed the KOOS and Short Form 36 Health Survey (SF-36). We evaluated floor/ceiling effects, reliability (using Cronbach's alpha, intraclass correlation coefficients (ICC) and measurement error), convergent and divergent construct validity (using four a priori stated hypotheses) and responsiveness (using data obtained prior to and one year after ACLR and described by both effect size (ES) and standardized response mean (SRM)).
The clinical study population consisted of 72 subjects (mean age 29.8, 28% women). We did not observe floor effects in any KOOS subscales neither pre- nor postoperatively. As expected, ceiling effects were found postoperatively for the subscales Pain and ADL in this cohort assessed on average 1.3 year after surgery as more than 15% reported no pain or limitations in daily activities. The Cronbach's alpha was above 0.9 for all subscales indicating excellent internal consistency. The test-retest reliability of all KOOS subscales at one-year postoperatively was excellent with ICCs exceeding 0.86 for all subscales. The minimal detectable change on group level ranged from 1.3 to 2.4, and on an individual level from 10.9 to 20.2. Responsiveness was demonstrated since the expected pattern of effect sizes between subscales following ACLR was found.
We found the Polish version of the KOOS to be a valid and reliable instrument for use in patient groups having ACLR. We caution against monitoring individual patients since the smallest change considered clinically relevant cannot reliably be detected.
膝关节损伤和骨关节炎结局评分(KOOS)有 30 多种语言版本,是一种常用于评估膝关节手术后治疗效果的患者报告结局(PRO)。本研究旨在报告 KOOS 问卷波兰语版本的翻译和文化调适过程,并评估其心理测量学特性。
我们根据在波兰使用的最新指南对 KOOS 进行了翻译和文化调适。接受前交叉韧带重建(ACLR)的患者完成了 KOOS 和简明 36 健康调查(SF-36)。我们评估了地板/天花板效应、可靠性(使用 Cronbach's alpha、组内相关系数(ICC)和测量误差)、收敛和发散结构有效性(使用四个预先设定的假设)以及反应度(使用 ACLR 前后获得的数据,并分别用效应量(ES)和标准化反应均值(SRM)来描述)。
临床研究人群由 72 名患者组成(平均年龄 29.8 岁,28%为女性)。我们在任何 KOOS 子量表中均未观察到术前或术后的地板效应。正如预期的那样,在接受 ACLR 平均 1.3 年后评估的该队列中,术后疼痛和 ADL 子量表出现了天花板效应,因为超过 15%的患者报告没有疼痛或日常活动受限。所有子量表的 Cronbach's alpha 均高于 0.9,表明内部一致性极好。所有 KOOS 子量表的术后一年时的重测信度均极佳,ICC 均超过 0.86。组内的最小可检测变化范围为 1.3 至 2.4,个体内的最小可检测变化范围为 10.9 至 20.2。反应度得到了证明,因为在 ACLR 后,预期的子量表之间的效应量模式出现了。
我们发现,波兰语版的 KOOS 是一种用于接受 ACLR 的患者群体的有效和可靠的工具。我们警告说,由于无法可靠地检测到被认为具有临床意义的最小变化,因此不建议对个体患者进行监测。