Nagy Ildiko, Szita Julia, Biczo Adam, Horvath-Szekely Laszlo, Koch Kristof, Lazary Aron
School of PhD Studies, Semmelweis University, Budapest, Hungary.
National Center for Spinal Disorders, Budapest, Hungary.
Eur Spine J. 2025 Aug 18. doi: 10.1007/s00586-025-09255-4.
The incidence of bone metastases is increasing due to advancements in cancer treatment, making it essential to monitor patients' health-related quality of life (HRQOL). Patients diagnosed with spinal metastases often experience persistent pain and functional decline. The use of specific patient-reported outcome measures in spinal tumors can help assess quality of life and treatment outcome.
This study aims to cross-culturally adapt and validate the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) into Hungarian to accurately assess the HRQOL of patients diagnosed with spinal metastases.
STUDY DESIGN/SETTING: A prospective study was conducted at a tertiary referral hospital among patients treated for spinal metastases.
50 patients with spinal metastases were included into the study. The median age of the study population was 52 years, ranging from 30 to 82 years. The gender distribution was 27 men and 33 women. The most common primary tumor was breast cancer, followed by lung cancer and prostate cancer.
SOSGOQ, EuroQol-5D index and EuroQol-VAS.
After translation and cross-cultural adaptation of SOSGOQ, the validity of the SOSGOQ was assessed by correlating it with the EQ-5D index and VAS using Spearman's rank correlation. Reliability was evaluated with the calculation of intraclass correlation coefficient (ICC) and standard error of measurement (SEM), from which the minimal detectable change (MDC95%) was calculated (2.77*SEM). Responsiveness was expressed by the change in group mean scores from pre-surgery to three months post-surgery and the effect size (Cohen's d). Receiver operating characteristic (ROC) analysis was also performed considering different dimensions of clinical outcome.
No significant floor or ceiling effect was observed for the total SOSGOQ score. The Spearman rank correlation between the SOSGOQ and the EQ-5D index showed a strong association (rho = 0.887, p < 0.001), as did the correlation between the SOSGOQ and the EQ-VAS (rho = 0.653, p < 0.001). Hungarian SOSGOQ proved to be a highly reliable PROM characterized by ICC = 0.95 SEM = 3.9 points, and MDC95 = 11 points. The responsiveness analysis indicates that the SOSGOQ can detect clinical changes in patients with spinal tumors performing better in this context than EQ-5D.
The Hungarian SOSGOQ is a reliable and valid tool for assessing the quality of life in patients diagnosed with spinal metastases. The outstanding responsiveness of this condition-specific PROM was also demonstrated in our study.
由于癌症治疗的进展,骨转移的发生率正在上升,因此监测患者的健康相关生活质量(HRQOL)至关重要。被诊断为脊柱转移瘤的患者经常经历持续疼痛和功能下降。在脊柱肿瘤中使用特定的患者报告结局指标有助于评估生活质量和治疗效果。
本研究旨在对脊柱肿瘤研究组结局问卷(SOSGOQ)进行跨文化改编并验证其匈牙利语版本,以准确评估被诊断为脊柱转移瘤患者的HRQOL。
研究设计/地点:在一家三级转诊医院对接受脊柱转移瘤治疗的患者进行了一项前瞻性研究。
50例脊柱转移瘤患者纳入研究。研究人群的中位年龄为52岁,范围从30岁到82岁。性别分布为27名男性和33名女性。最常见的原发肿瘤是乳腺癌,其次是肺癌和前列腺癌。
SOSGOQ、欧洲五维健康量表指数(EuroQol-5D index)和欧洲五维健康量表视觉模拟量表(EuroQol-VAS)。
在对SOSGOQ进行翻译和跨文化改编后,通过使用Spearman等级相关性将其与EQ-5D指数和VAS进行关联来评估SOSGOQ的有效性。通过计算组内相关系数(ICC)和测量标准误差(SEM)来评估可靠性,由此计算出最小可检测变化(MDC95%)(2.77×SEM)。反应性通过术前到术后三个月的组平均得分变化和效应量(Cohen's d)来表示。还考虑临床结局的不同维度进行了受试者工作特征(ROC)分析。
SOSGOQ总分未观察到明显的地板效应或天花板效应。SOSGOQ与EQ-5D指数之间的Spearman等级相关性显示出强关联(rho = 0.887,p < 0.001),SOSGOQ与EQ-VAS之间的相关性也如此(rho = 0.653,p < 0.001)。匈牙利语SOSGOQ被证明是一种高度可靠的患者报告结局指标,其ICC = 0.95,SEM = 3.9分,MDC95 = 11分。反应性分析表明,SOSGOQ能够检测脊柱肿瘤患者的临床变化,在这方面比EQ-5D表现更好。
匈牙利语SOSGOQ是评估被诊断为脊柱转移瘤患者生活质量的可靠且有效的工具。我们的研究还证明了这种针对特定疾病的患者报告结局指标具有出色的反应性。