Baumann Florian, Popp Daniel, Müller Karolina, Müller Michael, Schmitz Paul, Nerlich Michael, Fickert Stefan
Department of Trauma Surgery, Regensburg University Medical Center, Regensburg, Germany.
Center for Clinical Studies, Regensburg University Medical Center, Regensburg, Germany.
Health Qual Life Outcomes. 2016 Jan 8;14:3. doi: 10.1186/s12955-016-0407-9.
Patient Reported Outcome (PRO) measurements have become an important tool to evaluate disease-related quality of life. The "International Hip Outcome Tool" (iHOT12) is a self-administered patient-reported outcome tool, which includes questions on the patient's symptoms, functional and sports limitations as well as social, emotional, and occupational limitations. The purpose of this study was to adapt and validate a German version of the iHOT12 according to the COSMIN checklist.
In order to validate the German translation of the iHOT12, we conducted a prospective multicenter cohort study on patients with hip disorders and a score ≥4 on the modified Tegner Activity Scale (mTAS). The patients completed the German iHOT12 questionnaire and other functional scores (Hip Outcome Score, modified Tegner Activity Scale, EuroQol-5D) twice at intervals of at least two weeks. Evaluation of psychometric properties was conducted following the COSMIN checklist for validation of health status measurement instruments. The methodical testing for reliability included internal consistency, test-retest reliability, and measurement error. For testing of validity, we analyzed construct validity, hypotheses testing, interpretability and responsiveness.
Between December 2013 and December 2014, eighty-three consecutive patients completed both questionnaires and were available for data analysis. Cronbach's alpha was 0.94 (95 %-CI: 0.91, 0.95) confirming internal consistency and test-retest reliability of the iHOT-12 was high with an ICC = 0.94 (95 %-CI: 0.89, 0.97). All a priori hypotheses were confirmed. Further, no relevant floor- or ceiling effects occurred. The iHOT12 showed good responsiveness with a minimal important change (MIC) under 14 points.
The German translation of the iHOT-12 is a reliable, valid, and responsive tool for the evaluation of disease-related quality of life in active patients with a hip disorder. We could show that the minimal important change, a change of health condition the patient discerns, is less than 14 points in the iHOT12 scale.
患者报告结局(PRO)测量已成为评估疾病相关生活质量的重要工具。“国际髋关节结局工具”(iHOT12)是一种患者自我管理的报告结局工具,其中包括有关患者症状、功能和运动限制以及社会、情感和职业限制的问题。本研究的目的是根据COSMIN清单改编并验证iHOT12的德语版本。
为了验证iHOT12的德语翻译,我们对髋关节疾病患者且改良Tegner活动量表(mTAS)评分≥4的患者进行了一项前瞻性多中心队列研究。患者至少间隔两周两次完成德语iHOT12问卷和其他功能评分(髋关节结局评分、改良Tegner活动量表、欧洲五维健康量表)。按照用于验证健康状况测量工具的COSMIN清单进行心理测量特性评估。可靠性的方法学测试包括内部一致性、重测信度和测量误差。对于效度测试,我们分析了结构效度、假设检验、可解释性和反应性。
在2013年12月至2014年12月期间,83例连续患者完成了两份问卷并可用于数据分析。Cronbach's α为0.94(95%置信区间:0.91,0.95),证实了内部一致性,iHOT - 12的重测信度较高,组内相关系数(ICC)= 0.94(95%置信区间:0.89,0.97)。所有先验假设均得到证实。此外,未出现相关的地板效应或天花板效应。iHOT12显示出良好的反应性,最小重要变化(MIC)低于14分。
iHOT - 12的德语翻译是一种可靠、有效且具有反应性的工具,用于评估活跃的髋关节疾病患者的疾病相关生活质量。我们可以证明,在iHOT12量表中,患者能够察觉到的健康状况变化即最小重要变化小于14分。