Püsküllüoğlu Mirosława, Tomaszewski Krzysztof A, Bottomley Andrew, Holden Lori, Tomaszewska Iwona M, Głowacki Roman, Bereza Krzysztof, Golec Edward B, Chow Edward, Krzemieniecki Krzysztof
Department of Clinical Oncology, University Hospital in Krakow, Krakow, Poland.
Qual Life Res. 2014 Mar;23(2):527-32. doi: 10.1007/s11136-013-0486-6. Epub 2013 Aug 3.
The aim of our study was to undertake a prospective validation study of the Polish version of the European Organization for Research and Treatment of Cancer (EORTC) bone metastases (QLQ-BM22) module used alongside the EORTC core measure.
The translated module was pilot-tested according to the established EORTC guidelines. Patients with histological confirmation of malignancy and bone metastases, diagnosed by imaging studies, were eligible for the study. All patients filled out the Polish version of the QLQ-BM22 module in addition to QLQ-C30 and a demographic questionnaire. Standard validity and reliability analyses were performed.
One hundred and fifty-five patients were enrolled into the study, including 94 women (60.7 %) and 61 men (mean age ± SD; 59.1 ± 12.1). Cronbach's alpha coefficients, range 0.68-0.93, showed positive internal consistency. Re-test was undertaken with fifty patients (32.3 %). Interclass correlations for the EORTC QLQ-BM22 ranged from 0.91 to 0.93 and proved sufficient test-retest reliability. Satisfactory convergent and discriminant validity in multi-trait scaling analyses was seen.
Our study provides new and robust evidence which shows that the Polish version of the QLQ-BM22 module is a valid and reliable instrument for measuring health-related quality of life in patients with bone metastases. It is suitable for use in clinical trials and in research.
我们研究的目的是对与欧洲癌症研究与治疗组织（EORTC）核心测量指标一起使用的波兰语版EORTC骨转移（QLQ-BM22）模块进行前瞻性验证研究。
根据既定的EORTC指南对翻译后的模块进行预试验。经组织学证实为恶性肿瘤且经影像学检查诊断为骨转移的患者符合研究条件。所有患者除填写QLQ-C30和一份人口统计学问卷外，还填写了波兰语版的QLQ-BM22模块。进行了标准的效度和信度分析。
155例患者纳入研究，其中94例女性（60.7%），61例男性（平均年龄±标准差；59.1±12.1）。克朗巴哈系数范围为0.68 - 0.93，显示出良好的内部一致性。对50例患者（32.3%）进行了重测。EORTC QLQ-BM22的组内相关性范围为0.91至0.93，证明具有足够的重测信度。在多特质量表分析中观察到了令人满意的收敛效度和区分效度。
我们的研究提供了新的有力证据，表明波兰语版的QLQ-BM22模块是测量骨转移患者健康相关生活质量的有效且可靠的工具。它适用于临床试验和研究。
