Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
National Center for Tumor Diseases (NCT), Fetscherstraße 74, 01307, Dresden, Germany.
BMC Cancer. 2021 Sep 23;21(1):1044. doi: 10.1186/s12885-021-08578-x.
The recently developed Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) was proven a valid and reliable instrument measuring health-related quality of life (HRQOL) for patients with spinal malignancies. A German version was not available.
A cross-cultural adaptation of the SOSGOQ2.0 to the German language and its multicenter evaluation.
In a multistep process, a cross-cultural adaptation of the SOSGOQ2.0 was conducted. Subsequently, a multicenter, prospective observational cohort study was initiated to assess the reliability and validity of the German adaptation. To assess external construct validity of the cross-cultural adapted questionnaire, a comparison to the established questionnaire QLQ-C30 from the European Organisation for Research and Treatment of Cancer was conducted. Mean-difference plots were used to measure the agreement between the questionnaires in total score and by domain (deviation from mean up to 10% allowed). Further reliability and validity tests were carried out. Change to baseline was analysed 3-16 weeks later after different interventions occurred. Clinically relevant thresholds in comparison to the EORTC QLQ-C30 questionnaire were evaluated by ROC curve analysis.
We could enroll 113 patients from four different university hospitals (58 females, 55 males). Mean age was 64.11 years (sd 11.9). 80 patients had an ECOG performance status of 2 or higher at baseline. External construct validity in comparison to the EORTC QLQ-C30 questionnaire in total score and by domain was confirmed (range of deviation 4.4 to 9.0%). Good responsiveness for the domains Physical Functioning (P < .001) and Pain (P < .001) could be shown. The group mean values also displayed a difference in the domains of Social Functioning (P = .331) and Mental Health (P = .130), but not significant. The minimum clinically relevant threshold values for the questionnaire ranged from 4.0 to 7.5 points.
According to our results, the cross-cultural adapted questionnaire is a reliable and valid tool to measure HRQOL in German speaking patients with spinal malignancies. Especially the domains Physical Functioning and Pain showed overall good psychometric characteristics. In this way, a generic questionnaire, such as the EORTC QLQ-C30, can be usefully supplemented by spine-specific questions to increase the overall accuracy measuring HRQOL in patients with spinal malignancies.
最近开发的脊柱肿瘤研究组结局问卷（SOSGOQ2.0）已被证明是一种有效的、可靠的测量脊柱恶性肿瘤患者健康相关生活质量（HRQOL）的工具。目前还没有德文版本。
将 SOSGOQ2.0 进行跨文化适应性改编为德文，并对其进行多中心评估。
采用多步过程对 SOSGOQ2.0 进行跨文化适应性改编。随后，开展了一项多中心前瞻性观察队列研究，以评估德文改编版的可靠性和有效性。为了评估跨文化适应问卷的外部结构效度，与欧洲癌症研究与治疗组织的既定问卷 QLQ-C30 进行了比较。均值差异图用于测量问卷总分和各领域的一致性（允许偏差在 10%以内）。进一步进行了可靠性和有效性测试。在不同干预发生后 3-16 周，分析与基线相比的变化。通过 ROC 曲线分析，评估与 EORTC QLQ-C30 问卷相比的临床相关阈值。
我们从 4 家不同的大学医院招募了 113 名患者（58 名女性，55 名男性）。平均年龄为 64.11 岁（标准差 11.9）。80 名患者在基线时的 ECOG 表现状态为 2 或更高。与 EORTC QLQ-C30 问卷相比，总分和各领域的外部结构效度得到了证实（偏差范围为 4.4 至 9.0%）。在身体功能（P<0.001）和疼痛（P<0.001）方面，良好的反应性可以得到证实。组平均值在社会功能（P=0.331）和心理健康（P=0.130）领域也存在差异，但无统计学意义。问卷的最小临床相关阈值范围为 4.0 至 7.5 分。
根据我们的结果，跨文化适应的问卷是一种可靠和有效的工具，可用于测量德语脊柱恶性肿瘤患者的 HRQOL。特别是身体功能和疼痛两个领域总体上具有良好的心理测量学特征。通过这种方式，EORTC QLQ-C30 等通用问卷可以通过脊柱特异性问题进行补充，从而提高测量脊柱恶性肿瘤患者 HRQOL 的整体准确性。
