| Objective To develop and validate the second version of the Quality of Life Instrument for Cancer Patients-Liver Cancer (QLICP-LI V2.0) and to discuss preliminary applications of the instrument.Methods Based on the modular approach (a general modules plus specific modules), literature review and Chinese culture, and also the programmed decision procedure including in-depth interview, nominal group and focus group discussion, pilot tests, pre-tests and the statistical procedures for item selection, a specific QOL instrument for patients with liver cancer (QLICP-LI V2.0) beta version had been developed. In the aspect of instrument development:Two instruments (QLICP-LI, the Chinese version of FACT-Hep) were used to a sample of114patients with liver cancer at the time of their admission to the hospital so that the psychometric properties (validity, reliability and responsiveness) can be evaluated. In the aspect of instrument applications:the relationship between quality of life scores and the clinical objective indicators were analyzed by multiple linear regression and canonical correlation analysis, then discussed the influence factors of quality of life in patients with liver cancer. In addition, the minimal important difference (MID) through anchor-based and distribution-based methods for different domains of QLICP-LI (V2.0) and total instrument were computed. The statistic methods used in this study included statistic description, t-test, variance analysis, exploratory factor analysis, generalizebility theory (GT), multiple linear regression and canonical correlation.Results 1. After pilot study,18-item specific module was formed by combining the results of five kinds of statistic analysis methods with the experts’ opinion.2. By the survey data of beta instrument, items of specific module were screened again, and thus13-item specific module was developed finally.3. Results on psychometrics of QLICP-LI (V2.0) beta version showed test-retest reliability of the instrument was0.95, Cronbach’s Alpha was0.89, split-half reliability was0.90. Generalizability theory research results showed that the item number of physical domain(10), psychological domain(13), specific module(18) were appropriate, but the item number of social domain(10) and common symptom and side effect domain can be appropriately increased. Correlation analysis, factor analysis and criterion validity analysis showed that the instrument structure of the validity was tolerable. After treatments, the score changes of physical domain, social domain and total instrument were statistically significant (P<0.05). but psychological domain, common symptom and side effect domain, specific module were not statistically significant compared to that of the pre-treatments (P>0.05). For the specific module, differences of complications after treatments were statistically significant (P<0.05), showing the instrument can reflect QOL for patients with liver cancer after treatment basicallly.4. The analysis on influence factors of quality of life showed that sex, educational level, family economic status, globulin, aspertate aminotransferase, platelet, sodium might be influenced the quality of life in patients with liver cancer. the educational level impacted on the quality of life in patients with liver cancer was more clear.5. Minimal important difference:the results of anchor-based method in this study were for reference only, We tended to the results distribution-based method, so the final results were psychological domain6.84, physical domain6.84, social domain5.07, common symptom and side effect domain6.21, general module4.55, specific module4.85, total instrument4.25.Conclusion QLICP-LI (V2.0) beta version showed good validity, reliability and responsiveness, and can be used to measure QOL for Chinese patients with liver cancer, at the same time, it can be used as the tool to evaluate clinical effect. |
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