Chonghua Wan

Quality of life (QOL) research in diabetes has long been a concern with many specific instruments being developed, but no scale for diabetes has been developed based on the modular approach. This study aimed to develop and validate the Diabetes Mellitus Scale of the System of Quality of Life Instruments for Chronic Diseases QLICD-DM (V2.0) by a modular approach and mixed methods. The Scale was developed based on procedural decision-making methods and by combining the general module and the specific module. The instrument was used to assess the quality of life of 242 diabetic patients both before and after treatments. Under Classical Test Theory (CTT), the psychometric properties of the scale were assessed with regard to validity, reliability and responsiveness by correlation analyses, structural equation modeling, as well as t-tests. In addition, G-study and D-study in Generalizability Theory (GT) were used to validate the scale further. The QLICD-DM (V2.0) was developed with a 14-item specific module and a 28-item general module in the final scale. For all domains, Cronbach's α values were greater than 0.70 with the exception of physical function (0.68), the test-retest reliability correlations r and ICCs were greater than 0.80 with the exception of physical and social function (0.65,0.64). The theoretical construct was supported by correlation analyses and confirmatory factor analysis using structural equation modeling, which demonstrated good construct validity. There were significant differences (P < 0.05) in the domains of physical function, specific module and the total scale before and after treatments. The standardized response means (SRMs) of the physical, psychological, social, and the specific module were 0.36, 0.14, 0.11 and 0.28 respectively. All G-coefficients were all greater than 0.70 with the exception of the physical domain (0.683), further confirming the reliability of the scale further. The overall error was found to be small in the G-study and in the D-study, indicating a high level of accuracy. The QLICD-DM (V2.0) not only integrated characteristics of generic and disease-specific instruments but also demonstrated good reliability, validity, and moderate responsiveness, and it could serve as a quality of life assessment tool for diabetes patients.

The minimal clinically important difference (MCID) is an important phrase with big appeal in the interpretation of quality of life (QOL), and a bridge between statistical inference and clinical implication. This study aimed to explore multiple MCIDs of the QLICP-ES(V2.0), an esophageal cancer scale in Quality of Life Instruments system for Cancer Patients. The MCID were established by anchor-based and distribution-based methods. The item Q29 in EORTC QLQ-C30 was selected as an anchor, and Standard A (improves one level after treatment) and standard B (improves at least one level after treatment) were used to define effects in the anchor-based method, whereas methods of effect size (ES), standard error of measurement (SEM), and reliable change index (RCI) were used in the distribution-based method. A total of 232 esophageal cancer patients completed the QLICP-ES (V2.0) assessment. Under criterion A, 102 patients were included and the MCID values for the physical, psychological, social, common symptoms and side effects domains, the general module, the specific module, and the overall score were 15.1, 4.4, 3.1, 6.7, 4.8, 8.5, and 6.0, respectively. Under criterion B, 165 patients were included and the MCID values for the aforementioned domains and overall score were 19.3, 4.2, 4.8, 7.7, 6.5, 9.5, and 7.5, respectively. The MCID values using three approaches of effect size, standard error of measurement and reliable change index were ranged from 1.1 to 13.3. Although the threshold values of anchor-based method and 1.96SEM were recommended to establish the MCID of QLICP-ES(V2.0) in patients with ES, several MCID values have been presented by different methods and standards so that users may select according to different situations.

The quality of life(QoL) of patients with chronic diseases is a greater concern for both patients and clinicians. This study was aimed to develop and evalu

Background: The purpose of this study was to develop and validate the prostate cancer scale among the system of quality-of-life instruments for patients with cancer (QLICP-PR V2.0) to provide a reliable tool for assessing quality of life changes and clinical outcomes. Patients and Methods: Application of programmed decision procedures, including multiple qualitative and quantitative analyses with general module and specific module combination pattern, were utilized to develop the QLICP-PR V2.0. On the basis of the data from 115 admitted and discharged patients with prostate cancer, the reliability, validity, and responsiveness of the QLICP-PR V2.0 scale were evaluated using correlation analysis, multi-trait scaling analysis, factor analysis, structural equation model, and paired t -tests, as well as combined with generalizability theory. Results: Cronbach’s alpha, test–retest reliability, and intra-class correlation coefficient of the total scale were 0.886, 0.896, and 0.889, respectively. Correlation analysis and factor analysis confirmed good construct validity and criterion-related validity. The score differences at all five domains and the total scale before and after the treatment were statistically significant ( P < 0.05), with the SRM value ranging from − 1.152 to − 0.408, and the total scale was − 1.152. Generalizability theory results showed that the generalization coefficient of the five domains of the scale range from 0.575 to 0.764, and the reliability index between 0.529 and 0.748. Conclusions: The QLICP-PR V2.0 has good psychometric properties in reliability, validity, and responsiveness, and can be used to evaluate the quality of life of patients with prostate cancer.

Background: Health-related Quality of life (HRQOL) is now concerned worldwide in cancer clinical fields, with the specific scales for patients with hepatocellular carcinoma in China being seldom and no formal validation of Chinese Version of the FACT-Hep. This study was aimed to validate the Chinese FACT-Hep based on both Classical Test Theory and Generalizability Theory to rationalize its use in the Chinese population. Methods: One hundred and fourteen in-patients with hepatocellular carcinoma were measured three times before and after treatments using the FACT-Hep. The FACT-Hep was evaluated by Cronbach α, Pearson correlation, intra-class correlation (ICC), and paired-t tests with standardized response mean. The Generalizability Theory was also applied to addresses the dependability of measurements deeply by estimation of multiple sources of variance. Results: The Cronbach’s α coefficients were greater than 0.70 for all domains, and test-retest reliability coefficients were all greater than 0.80 exception of EWB 0.74 with the range of 0.81– 0.96. The domains of PWB, FWB and the overall scale had significant changes after treatments with SRM ranging from 0.40 to 0.69. G-coefficients and Ф-coefficients confirmed the reliability of the scale further with exact variance components. Conclusion: The Chinese version of FACT-Hep can be used to measure HRQOL for patients with hepatocellular carcinoma in China with being of good psychometric properties.

The importance of quality of life (QoL) in cancer care has gained increasing recognition, but no scale for renal cancer was developed based on the modular approach. This paper is aimed to develop and validate a renal cancer-specific assessment tool, QLICP-RE (V2.0), to provide a scientific basis for evaluating the QoL of kidney cancer patients and informing relevant policy development. The QLICP-RE (V2.0) was developed based on procedural decision-making methods and combining the general module and the specific module. Based on the data from 179 admitted and discharged renal cancer patients, the psychometric properties of the scale were evaluated. Reliability of the QLICP-RE (V2.0) was evaluated using Cronbach’s α and Test-retest reliability correlation. The construct validity and criteria-related validity was assessed through correlation analysis and structural equation modeling. The responsiveness was evaluated by comparing the differences in scores of the scale before and after treatment using paired t-tests, and computing the Standard Response Mean (SRM). The QLICP-RE(V2.0) was developed with a 32 items general module and a 11 items specific module. Regarding the Cronbach’s α coefficients for each domain of the QLICP-RE (V2.0), all domains showed satisfactory reliability (α ≥ 0.7), except for the social functioning domain (α = 0.34). The test-retest reliability coefficients demonstrated good stability, with values exceeding 0.80 for all domains except the social functioning domain (r = 0.50). The correlation analysis and structural equation modeling confirmed good construct validity and criterion-related validity. There were significant differences (P < 0.05) for all domains exception of psychological function and common symptoms and side effects, and also specific module and the total scale before and after treatments, with standardized response mean (SRM) values ranged from − 2.54 to 0.23. QLICP-RE(V2.0) has good validity, reliability and moderate responsiveness. In the future, more patients should be enrolled and the sample size should be expanded to continuously optimize the scale and evaluate the quality of life of patients with renal cancer more scientifically.