Tomaszewski Krzysztof A, Henry Brandon Michael, Paradowski Jan, Kłosiński Michał, Walocha Ewa, Golec Joanna, Kucharska Ewa, Dudkiewicz Zbigniew
Department of Anatomy, Jagiellonian University Medical College, 12 Kopernika St, 31-034, Krakow, Poland.
Department of Orthopaedics and Trauma Surgery, 5th Military Hospital, Krakow, Poland.
Health Qual Life Outcomes. 2015 Sep 29;13:158. doi: 10.1186/s12955-015-0354-x.
A distal radius fracture (DRF) is a common injury that can cause significant pain and lead to a prolonged decrease in physical, emotional, and social functioning. In modern randomized clinical trials, assessing outcomes after a DRF, health-related quality-of-life (HRQoL) is a "must-be" endpoint. Additionally, HRQoL assessments are essential in the clinical decision-making process. The aim of this study to cross-culturally adapt the International Osteoporosis Foundation Quality of Life Questionnaire (IOF QLQ) for patients with a DRF to Polish.
A standard forward-backward translation procedure and pilot-testing were used to prepare the Polish version of the IOF QLQ for use in this case-control study. Patients were eligible if they were between 18-80 years and were within 1-3 days after a non-comminuted DRF. The study group was gender and aged matched with healthy controls. All DRF patients filled out the Polish version of the IOF QLQ, the SF-36 and a demographic questionnaire. Assessment points were set as soon as possible after the fracture, 7 days, 6 weeks, 3, 6, 12, and 18 months after the fracture. Standard validity and reliability analyses were performed.
Ninety-seven patients (73 women - 75.3%) with a mean age of 62.4 ± 7.1 years agreed to take part in the study. The control group consisted of 81 patients (60 women - 74.1%) with a mean age 63.9 ± 8.2 years. No significant differences were found between the mean age of patients and controls (p = 0.19). Cronbach's alpha coefficients showed positive internal consistency (0.79-0.89). The interclass correlations for the IOF QLQ domains and the overall score ranged from 0.85 to 0.92. Satisfactory convergent and discriminant validity of the IOF QLQ was seen.
The Polish version of the IOF QLQ for patients with a DRF is a reliable and valid tool for measuring HRQoL. It can be fully recommended for use in clinical settings in the Polish population. When combined with the SF-36 the IOF QLQ allows to obtain a comprehensive HRQoL assessment in patients with a DRF.
桡骨远端骨折(DRF)是一种常见损伤,可导致严重疼痛,并致使身体、情感和社会功能长期下降。在现代随机临床试验中,评估DRF后的结果时,健康相关生活质量(HRQoL)是一个“必须具备”的终点指标。此外,HRQoL评估在临床决策过程中至关重要。本研究的目的是对国际骨质疏松基金会生活质量问卷(IOF QLQ)进行跨文化改编,使其适用于波兰的DRF患者。
采用标准的前后翻译程序和预测试来准备用于本病例对照研究的IOF QLQ波兰语版本。年龄在18 - 80岁之间且在非粉碎性DRF后1 - 3天内的患者符合入选条件。研究组在性别和年龄上与健康对照组相匹配。所有DRF患者填写IOF QLQ波兰语版本、SF - 36和一份人口统计学问卷。评估时间点设定为骨折后尽快、骨折后7天、6周、3个月、6个月、12个月和18个月。进行了标准的效度和信度分析。
97例患者(73名女性 - 75.3%)同意参与研究,平均年龄为62.4±7.1岁。对照组由81例患者(60名女性 - 74.1%)组成,平均年龄为63.9±8.2岁。患者和对照组的平均年龄之间未发现显著差异(p = 0.19)。克朗巴哈系数显示出良好的内部一致性(0.79 - 0.89)。IOF QLQ各领域与总分的组内相关性在0.85至0.92之间。IOF QLQ具有令人满意的收敛效度和区分效度。
用于DRF患者的IOF QLQ波兰语版本是一种可靠且有效的测量HRQoL的工具。完全推荐在波兰人群的临床环境中使用。当与SF - 36结合使用时,IOF QLQ能够对DRF患者进行全面的HRQoL评估。