鼻咽癌患者生存质量简短版量表的研制和评价

Development and evaluation of the short quality of life scales for nasopharyngeal carcinoma

目的鼻咽癌患者生存质量量表从研制以来,在临床得到了广泛的应用。本研究采用国际标准化的程序,研制该量表的简短版量表(quality of life scale for nasopharyngeal carcinoma,QOL-NPC13)。方法研究步骤包括成立核心讨论组、确定理论模型、语言调试、筛选条目、预实验和现场调查。采用横断面调查的方法开展现场调查。选择2014-06-01-2014-10-31在中山大学肿瘤防治中心接受治疗并经病理确诊的鼻咽癌患者为研究对象,调查患者的人口学资料、QOL-NPC13和FACT量表,1周左右用QOL-NPC13量表再次调查。评价QOL-NPC13的信度和效度。结果共纳入206例患者,平均年龄(43.8±11.6)岁,中位年龄为43.0岁。男性占74.3%,已婚占90.8%,74.8%患者来自广东。QOL-NPC13包括身体机能、心理精神状况、社会关系和毒副作用4个领域。所有条目都只有低比例的缺失。条目与自己领域得分的相关系数>0.6,差异有统计学意义,P<0.001。整个量表的α系数和分半信度系数>0.8,所有领域的组内相关系数≥0.9。模型的近似误差均方根为0.080,范拟和指数、非范拟和指数及相对拟和指数均>0.9。除了毒副作用领域(0.48),其他领域的校标系数均>0.7。不同放疗阶段患者的领域得分差异均有统计学意义,P<0.05。结论QOL-NPC13量表的内容效度能较好反映量表所要测量的内容,具有良好的信度和效度,可用于评价鼻咽癌患者的生存质量。

OBJECTIVE The quality of life scale for nasopharyngeal carcinoma（QOL-NPC）was developed and used widely.The object of the study was to develop the short scales of QOL-NPC（QOL-NPC13）according to the standard procedure.METHODS The research included the establishment of the focus group,the determination of theoretical model,language testing,screening items,pilot study and field study.The cross-sectional study was used.The nasopharyngeal carcinoma（NPC）patients were enrolled from June 2014 to October 2014,in Cancer Centre of Sun Yat-sen University.The data about the characteristics,QOL-NPC13 and FACT scales were collected.The validity and reliability of the QOL-NPC13 were evaluated.RESULTS A total of 206 patients were enrolled.The average age of the patients was（43.8 ±11.6）years old,with median age 43 years old.74.3% of the patients were male,and 74.8% of the patients were from Guangdong province.The QOL-NPC13 included 4domains：Physical（PH）,psychological（PS）,social relations（SO）and side effects（SE）domains.The correlation between each item and its domain were great than 0.6（statistically significant）.The Cronbach＇s coefficients and split-half reliability were above 0.80.The intra-class correlation coefficients for the domains were≥0.9.The root mean square error of approximation was 0.080.Other indexes were all greater than 0.9.The criterion coefficients were greater than 0.7,except the SE domain.The domain scores of the patients among different radiotherapy were statistically significant（P〈0.05）.CONCLUSIONS The content validity of the QOL-NPC13 can reflect the contents of the measurement,and have good reliability and validity.It can be used as a tool to evaluate the QOL of NPC patients.