Baumann Florian, Weber Johannes, Zeman Florian, Müller Michael, Lahner Matthias, Nerlich Michael, Fickert Stefan
Department of Trauma Surgery, Regensburg University Medical Center, Regensburg, Germany.
Center for Clinical Studies, Regensburg University Medical Center, Regensburg, Germany.
Arch Orthop Trauma Surg. 2016 Jan;136(1):83-91. doi: 10.1007/s00402-015-2336-1. Epub 2015 Sep 29.
The evaluation of the subjective health-related quality of life is especially for young, active patients with hip joint disorders important. The MAHORN study group has recently developed the "International Hip Outcome Tool" (iHOT33), 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 iHOT33 according to the COSMIN checklist.
To validate the G-iHOT33, we conducted a prospective multicenter cohort study on patients with hip disorders and a score ≥4 on the modified Tegner Activity Scale. The patients completed the G-iHOT33 questionnaire twice at intervals of at least 2 weeks. In addition, we recorded the Hip Outcome Score (HOS), a modified Tegner Activity Scale (TAS), the EuroQol-5D (EQ5-D), and a subjective assessment of the limitations. 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 α was 0.97 (95% CI 0.96, 0.99) confirming internal consistency and test-retest reliability of the G-iHOT-33 was high with an ICC = 0.88 (95% CI 0.80, 0.99). All a priori hypotheses were confirmed, further, no floor- or ceiling-effects occurred. The G-iHOT33 showed good responsiveness with a minimal important change (MIC) of 10 points.
The German translation of the iHOT-33 (G-iHOT-33) is a viable tool for the evaluation of active patients with a hip disorder. Following the complete COSMIN checklist, we could prove that G-iHOT33 is a reliable, valid, and responsive PRO measurement tool. We could show that the minimal important change, a change of health condition the patient discerns is 10 points in the G-iHOT33 scale. This is the first study providing results on psychometric properties of the iHOT33 subscales. Level of evidence 1b validating cohort study.
对主观健康相关生活质量的评估对于年轻、活跃的髋关节疾病患者尤为重要。MAHORN研究小组最近开发了“国际髋关节结果工具”(iHOT33),这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清单对iHOT33的德文版本进行改编和验证。
为了验证G-iHOT33,我们对髋关节疾病患者且改良Tegner活动量表得分≥4分的患者进行了一项前瞻性多中心队列研究。患者至少间隔2周两次完成G-iHOT33问卷。此外,我们记录了髋关节结果评分(HOS)、改良Tegner活动量表(TAS)、欧洲五维度健康量表(EQ5-D)以及对限制的主观评估。心理测量特性的评估按照用于验证健康状况测量工具的COSMIN清单进行。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0.97(95%CI 0.96,0.99),证实了内部一致性,G-iHOT-33的重测信度较高,组内相关系数(ICC)=0.88(95%CI 0.80,0.99)。所有先验假设均得到证实,此外,未出现地板效应或天花板效应。G-iHOT33显示出良好的反应性,最小重要变化(MIC)为10分。
iHOT-33的德文翻译版本(G-iHOT-33)是评估活跃的髋关节疾病患者的可行工具。按照完整的COSMIN清单,我们可以证明G-iHOT33是一种可靠、有效且具有反应性的患者报告结局测量工具。我们可以表明,在G-iHOT33量表中,患者能够察觉的健康状况变化即最小重要变化为10分。这是第一项提供iHOT33子量表心理测量特性结果的研究。证据级别为1b级验证性队列研究。