Brodano Giovanni Barbanti, Pesce Eleonora, Griffoni Cristiana, Carretta Elisa, Noli Luigi Emanuele, Errani Costantino, Trentin Federica, Leopardi Martina Piccinni, Mavilla Loredana, Gasbarrini Alessandro
Department of Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Global Spine J. 2023 Oct;13(8):2367-2378. doi: 10.1177/21925682221083913. Epub 2022 Mar 28.
Prospective observational study.
The population of patients with advanced stages of cancer, including metastatic spinal disease, is growing because of better treatment options allowing for longer control of disease. The main goal of treatment for these patients is to improve or maintain their health-related quality of life (HRQOL). A spine oncology-specific outcome measure has been developed by the Spine Oncology Study Group and validated through international studies. We proposed to translate and validate the questionnaire in Italian language.
The cross-cultural adaptation of the questionnaire has been performed according to guidelines previously proposed. After this process, an observational prospective study has been conducted to validate the efficacy of SOSGOQ in Italian language. SOSGOQ has been compared to SF-36 (Short Form Health Survey-36), a generic validated questionnaire to assess HRQOL. Starting from January 2020, SOSGOQ and SF-36 questionnaires were auto-administered to 150 patients affected by spinal metastases who provided written informed consent for study participation.
The confirmatory factor analysis on the 4 domains examined showed a good model fit (comparative fit index, .95; RMSEA .07 (90% CI, .05-.09) and SRMR, .05), endorsing construct validity. The analysis of concurrent validity demonstrated strong correlation for physical function, pain and mental health domains with the corresponding domain scores of SF-36. The reliability across item was high with a Cronbach's alpha coefficient of .91.
The statistical analysis of the results will allow to accept the Italian version of SOSGOQ as a specific and efficient tool to measure HRQOL in Italian-speaking patients affected by spinal metastases.
前瞻性观察性研究。
由于有更好的治疗选择可实现对疾病的长期控制，包括转移性脊柱疾病在内的晚期癌症患者群体正在增加。这些患者的主要治疗目标是改善或维持其健康相关生活质量（HRQOL）。脊柱肿瘤学研究组已开发出一种针对脊柱肿瘤的结局测量方法，并通过国际研究进行了验证。我们提议将该问卷翻译成意大利语并进行验证。
已根据先前提出的指南对问卷进行了跨文化改编。在此过程之后，进行了一项观察性前瞻性研究，以验证意大利语版SOSGOQ的有效性。将SOSGOQ与SF-36（简短健康调查问卷-36）进行了比较，SF-36是一种经过验证的通用问卷，用于评估HRQOL。从2020年1月开始，将SOSGOQ和SF-36问卷自动发放给150名患有脊柱转移瘤的患者，这些患者已提供书面知情同意书参与研究。
对所检查的4个领域进行的验证性因素分析显示出良好的模型拟合度（比较拟合指数为0.95；RMSEA为0.07（90%置信区间为0.05-0.09），SRMR为0.05），支持结构效度。同时效度分析表明，身体功能、疼痛和心理健康领域与SF-36的相应领域得分具有很强的相关性。各项目间的信度较高，Cronbach's alpha系数为0.91。
对结果的统计分析将使意大利语版SOSGOQ被接受为一种测量受脊柱转移瘤影响的意大利语患者HRQOL的特定且有效的工具。
