Hinotsu A, Niimi M, Akaza H, Miyanaga N, Takeshima H, Eremenco S, Cella D
Graduate School of Medicine, University of Tsukuba Dept. of Urology.
Gan To Kagaku Ryoho. 1999 Apr;26(5):657-66.
Quality of life (QOL) has been known to be a prognostic factor as well as the endpoint of treatment efficacy in many clinical fields. We have begun a US-Japan collaborative project introducing a QOL questionnaire, the FACT (Functional Assessment of Cancer Therapy), into Japan. We report on the translation process, results of the pilot study, and future plans for translating the Japanese version of the FACT subscales, FACT-Bl (for bladder cancer) and FACT-P (for prostate cancer).
The FACT translation procedure, which is quite rigorous, follows a four-step methodology. After completing the translations, we tested the translated FACT-G (general questionnaire) and subscales for bladder and prostate cancer patients. The questionnaires were tested on 30 outpatients at Tsukuba University Hospital (15 bladder, 15 prostate). The only eligibility requirement to participate in the study was a confirmed diagnosis of cancer of the bladder or prostate.
There was satisfactorily high internal consistency of FACT-G of both bladder and prostate cancer patients. FACT-Bl study included patients having undergone radical cystectomy as well as those who had not. Because not all items were answered by all patients, the Cronbach's alpha coefficient for the FACT-Bl subscale could not be computed. Further evaluation of the FACT-Bl concerning the surgical procedures affecting QOL is needed. We are currently planning to make the further refinement of the questionnaire in order to make it more suitable for bladder cancer patients. FACT-P subscale had an alpha coefficient of 0.82 and was determined to be useful in its present form.
在许多临床领域,生活质量(QOL)一直被认为是一个预后因素以及治疗效果的终点。我们已经启动了一个美日合作项目,将一份生活质量问卷——癌症治疗功能评估(FACT)引入日本。我们报告翻译过程、初步研究结果以及翻译FACT子量表日语版(用于膀胱癌的FACT-Bl和用于前列腺癌的FACT-P)的未来计划。
FACT的翻译程序非常严格,遵循四步法。完成翻译后,我们对翻译后的FACT-G(通用问卷)以及膀胱癌和前列腺癌患者的子量表进行了测试。问卷在筑波大学医院的30名门诊患者中进行了测试(15名膀胱癌患者,15名前列腺癌患者)。参与该研究的唯一资格要求是确诊为膀胱癌或前列腺癌。
膀胱癌和前列腺癌患者的FACT-G内部一致性都令人满意地高。FACT-Bl研究纳入了接受根治性膀胱切除术的患者以及未接受该手术的患者。由于并非所有患者都回答了所有项目,因此无法计算FACT-Bl子量表的克朗巴哈α系数。需要进一步评估FACT-Bl中影响生活质量的手术程序。我们目前正计划对问卷进行进一步完善,使其更适合膀胱癌患者。FACT-P子量表的α系数为0.82,并且确定其目前形式是有用的。