Karasawa Kumiko, Sasaki Takehito, Okawa Tomohiko, Takahashi Takeo, Hayakawa Kazushige, Ohizumi Yukio, Tamaki Yoshio, Makino Masaoki, Kobyashi Masao, Shibayama Chiaki, Saitou Tsutomu, Johnson Darlene J
QOL Research Group of Jastro.
J Oncol Manag. 2003 Mar-Apr;12(2):18-24.
To evaluate the reliability and validity of the Japanese translation of Quality of Life Radiation Therapy Instrument (QOL-RTI) and the head and neck module (H&N) for Japanese patients being treated with radiotherapy for head and neck malignancies.
MATERIALS & METHODS: The QOL-RTI/H&N was translated into Japanese by a preliminary QOL research working group of JASTRO and was used in this clinical trial. From 1998 to 2001, 70 patients with head and neck malignancies for whom radical radiotherapy was planned were entered into this study. Patients were requested to answer the questions before radiotherapy at baseline, twice during week 4 of therapy (for test-retest reliability), at the end of treatment, and 3 months, 6 months, 1 year and 2 years from the beginning of radiotherapy. Internal consistency was assessed by Cronbach's alpha coefficient. Validity was assessed by comparing the results with EORTC-QLQ-C30 and with QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ADC). Patient compliance and test sensitivity were also analyzed.
Cronbach's alpha coefficient was 0.79 to 0.93 depending on the time point for the evaluation. Test-retest reliability was acceptable, with a Pearson coefficient of 0.83 for QOL-RTI and 0.92 for H&N module. Compliance with this scheme was 98.2%. The QOL-RTI was sensitive enough to detect significant changes in the QOL score during and after the course of radiotherapy. Agreement with the EORTC-C30 was good with a high Pearson correlation coefficient of 0.648 and that with QOL-ADC was also good with a coefficient of 0.566. The factors analyzed consisted of 11 functional/health-oriented questions, 5 emotional/ psychological, 5 socio-economic/ family and 2 general.
The Japanese version of QOL-RTI with H&N module was found to be reliable and sensitive enough to evaluate variation of QOL in patients with head and neck malignancies during and after radiotherapy.
评估生活质量放射治疗仪器（QOL-RTI）及其头颈部模块（H&N）的日语翻译版对接受头颈部恶性肿瘤放射治疗的日本患者的可靠性和有效性。
QOL-RTI/H&N由日本放射肿瘤学会（JASTRO）的一个初步生活质量研究工作组翻译成日语，并用于本临床试验。1998年至2001年，70例计划接受根治性放射治疗的头颈部恶性肿瘤患者纳入本研究。要求患者在放疗前的基线期、治疗第4周期间回答两次问题（用于重测信度）、治疗结束时、放疗开始后3个月、6个月、1年和2年时回答问题。通过克朗巴哈α系数评估内部一致性。通过将结果与欧洲癌症研究与治疗组织核心生活质量问卷（EORTC-QLQ-C30）以及抗癌药物治疗癌症患者生活质量问卷（QOL-ADC）进行比较来评估效度。还分析了患者的依从性和测试敏感性。
根据评估时间点的不同，克朗巴哈α系数在0.79至0.93之间。重测信度可以接受，QOL-RTI的皮尔逊系数为0.83，H&N模块的皮尔逊系数为0.92。该方案的依从率为98.2%。QOL-RTI足够敏感，能够检测放疗期间及放疗后生活质量评分的显著变化。与EORTC-C30的一致性良好，皮尔逊相关系数较高，为0.648，与QOL-ADC的一致性也良好，系数为0.566。分析的因素包括11个功能/健康导向问题、5个情感/心理问题、5个社会经济/家庭问题和2个一般问题。
发现带有H&N模块的QOL-RTI日语版足够可靠且敏感，能够评估头颈部恶性肿瘤患者放疗期间及放疗后生活质量的变化。
