Clinical and psychometric validation of the quality of life assessment system for advanced gastric cancer based on traditional Chinese medicine.

OBJECTIVE: To establish questionnaire scaling and reliability and examine the clinical and psychometric validity of the quality of life assessment based on Traditional Chinese Medicine for advanced gastric cancer (QLASTCM-Ga). METHODS: The QLASTCM-Ga was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, pretesting and quantitative statistical procedures. The questionnaire was administered to 240 patients diagnosed with advanced gastric cancer before and after treatment. Structured group methods were employed to establish a general and a specifific module respectively. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness. RESULTS: The three identified scales of the QLASTCM-Ga and the total score demonstrated good psychometric properties. Test-retest reliability of the total scale and all domains ranged from 0.90 to 0.94, and internal consistency ranged from 0.86 to 0.93. Correlation and factor analysis demonstrated good construct validity. Signifificant difference in the subscales and the total score were found among groups differing in traditional Chinese medicine syndrome, supporting the clinical sensitivity of the QLASTCM-Ga. Statistically signifificant changes were found for each scale and the total score. Responsiveness was also good. CONCLUSIONS: The QLASTCM-Ga demonstrates good psychometric and clinical validity to assess quality of life in patients with advanced gastric cancer undergoing traditional Chinese medicine therapy. This study is an important fifirst step for future research in this area.

Psychometric properties of the coronary heart disease scale of the quality-of-life instruments for chronic diseases (QLICD-CHD): an application to Cantonese patients.

The purpose of this study was to validate the applicability of our proposed disease-specific questionnaire to Cantonese coronary heart disease (CHD) patients. During the investigation from August 2010 to March 2012, 1000 Cantonese inpatients were recruited. The reliability of the scale was judged by the internal consistency, and the content and construct validity were assessed by using Pearson correlation and confirmatory factor analysis, respectively. Results showed that the Cronbach's α coefficient for the whole scale and most domains/facets were larger than .70 (.59 to .93). Most items had moderate to strong Pearson correlations with their respective facets (r > 0.50). Confirmatory factor analysis showed that the indices for goodness of fit were nearly acceptable. Overall, the QLICD-CHD scale has adequate psychometric properties when applied to Cantonese CHD patients.

Measuring the burden of disease using disability-adjusted life years in Shilin County of Yunnan Province, China.

BACKGROUND: Few studies calculating burden of disease (BOD) have been carried out in China. Disability-adjusted life years (DALY) is one of the useful methods used to estimate BOD. This study aims to use DALY for evaluating BOD and to provide useful information for health planning for residents in Shilin Yi Nationality Autonomous County (Shilin County) of Yunnan Province, China. METHODS: Methods developed for the Global Burden of Disease (GBD) Study by the World Bank and World Health Organization (WHO) were adapted and applied to Shilin County population health data. DALY rate per 1,000 was calculated from medical death certificates in 2003 in Shilin County. The geographic coordinates of towns or townships were determined using the geocode function of R2.3.1 geographical information system (GIS) software. RESULTS: Respiratory diseases were by far the leading cause of years of life lost (YLL) in both males and females. The four other leading causes of YLL in descending order were: unintentional injuries, cardiovascular diseases, intentional injuries, and malignant neoplasms. However, the five leading causes of years lived with disability (YLD) were, in descending order: neuropsychiatric conditions, intentional injuries, respiratory diseases, unintentional injuries, and cardiovascular diseases. The leading cause of total disease burden (DALY) was neuropsychiatric conditions. Townships of Muzhuqing, Xijiekou, and Weize were the areas with most serious disease burden in Shilin County. CONCLUSIONS: Prevention and treatment of neuropsychiatric conditions and respiratory diseases for both females and males should be enhanced in Shilin County, so as to decrease injury. More preventive interventions for noninfectious chronic diseases should be emphasized in remote townships.

Clinical assessment of the efficacy of anti-cancer treatment: current status and perspectives.

With continued enhancements in cancer diagnosis and treatment, clinical assessments are deeper. More composite indicators are applied and evaluations are more "patient-centered", focusing on disease status and response to treatment, as well as the quality-of-life of patients as primary components, including the patients themselves, clinical staff, caregivers, and medical examinations, and other aspects of the evaluation. We reviewed the current research on the application and development of clinical assessment indicators for traditional Chinese medicine (TCM) and modern medicine, and explored its significance and the advancements in effective evaluations.

Assessing the disease burden of Yi people by years of life lost in Shilin county of Yunnan province, China.

BACKGROUND: Years of Life Lost (YLL) is one of the methods used to estimate the duration of time lost due to premature death. While previous studies of disease burden have been reported using YLL, there have been no studies investigating YLL of Yi people in rural China. Yunnan Province ranks first in terms of Yi people in China. This paper uses YLL to estimate the disease burden of Yi people in Shilin county of Yunnan Province. This study aims to address the differentials about YLL between Yi people and Han people for providing useful information for health planning. METHODS: We applied the Global Burden of Disease (GBD) method created by WHO. YLL rate per 1,000 were calculated from medical death certificates in 2003 in Shilin Yi Nationality Autonomous County (Shilin county). RESULTS: The male had greater YLL rate per 1,000 than did the female almost in each age group. It demonstrated a higher premature mortality burden due to injuries in Shilin county. Among the top non-communicable diseases, respiratory diseases are the most common mortality burden. Yi people are still suffering from maternal conditions, with two times the burden rates of Han people. For Yi people, while malignant neoplasm was one of the least burden of disease for male, it was the greatest for female, which is the opposite to Han people. CONCLUSION: Strategies of economic development should be reviewed to enhance the prevention and treatment of injuries, maternal conditions and respiratory diseases for Yi people.

[Development of the system of quality of life instruments for cancer patients: stomach cancer (QLICP-ST)].

BACKGROUND & OBJECTIVE: We have previously developed and reported the general module of the system of quality of life instruments for cancer patients (QLICP-GM). This study was to develop and evaluate the quality of life instrument for patients with stomach cancer (QLICP-ST). METHODS: The QLICP-ST was developed using the structured group methods applicable to Chinese populations. The system of QLICP-ST was evaluated by analyzing data from 86 stomach cancer patients using statistical description, Pearson's correlation, exploratory factor analysis, and paired student's t test. RESULTS: The test-retest reliability of the overall scale was 0.98 and that of each domain was greater than 0.90. The internal consistency coefficient alpha of the overall scale was 0.91 and that of each domain was higher than 0.65. Correlation analysis and the exploratory factor analysis revealed good construct validity of the QLICP-ST. Differences of the quality of life scores before and after the treatment in physical domain, psychological domain, common symptom and side effect domain, specific domain and the overall scale were significant. Moreover, the standardized response mean(SRM) of these domains were greater than 0.30. CONCLUSION: The system of QLICP-ST can be used in clinical evaluation of the quality of life for stomach cancer patients with sound validity, reliability and responsiveness.

[Development of the system of quality of life instruments for cancer patients: colorectal cancer (QLICP-CR)].

BACKGROUND & OBJECTIVE: Based on the development of the general module of the system of quality of life instruments for cancer patients (QLICP-GM), this study was to develop and evaluate a quality of life scale for patients with colorectal cancer (QLICP-CR). METHODS: A quality of life scale for colorectal cancer patients that associated with Chinese cultural background was developed. The data from 110 patients with colorectal cancer were analyzed using statistical description, Pearson Correlation, Cluster analysis, and paired t-student test to assess the instrument. RESULTS: The test-retest reliability for the scale and 5 domains were all above 0.78. Internal consistency alpha for each domain was higher than 0.85 except for the social domain (0.66) and the symptom and side effect domain (0.63). Most of the correlation coefficients between each item and its domains were above 0.6. The differences in the scores of overall scale, general module, special domain, psychological domain, and symptom and side effect domain between pre-treatment and post-treatment were significant. CONCLUSION: The QLICP-CR is reasonably valid, reliable, and responsible, and can be used to assess quality of life for the patients with colorectal cancer.

[Development of the system of quality of life instruments for patients with breast cancer (QLICP-BR)].

BACKGROUND & OBJECTIVE: The general module of the system of quality of life instruments for cancer patients, QLICP-GM, has been developed by us. Based on it, this study was to develop and evaluate the quality of life instrument for patients with breast cancer (QLICP-BR). METHODS: Using the structured group methods of instrument development, the instrument with Chinese cultural background was developed, and evaluated by analyzing the data from 186 breast cancer patients. RESULTS: The test-retest reliability for the overall scale and 5 domains were all above 0.75. The internal consistency alpha for each domain was higher than 0.65 except social domain (0.58). Most correlation coefficients between each item and the domain (that the item belongs to) were above 0.60. The differences between the scores before treatment and the scores after treatment for overall scale, general module, physical domain, psychologic domain, and social domain were significant. CONCLUSION: The QLICP-BR is of good validity, reliability and reasonable responsiveness, and can be used to assess quality of life for breast cancer patients.

[Development of the general module of the system of quality of life instruments for cancer patients: responsiveness analysis].

BACKGROUND & OBJECTIVE: The general module of the system of quality of life instruments for cancer patients, QLICP-GM, has been developed and its reliability and validity has been evaluated by us. This study was to analyze its responsiveness. METHODS: The quality of life of 600 patients with 5 kinds of cancer was measured using QLICP-GM before and after treatment. Traditional significance tests with some indices, such as effect size, standardized response mean and equivalence, were applied to evaluate responsiveness. RESULTS: The quality of life score changed significantly after treatment on 3 domains: physical function, psychologic function, and general symptoms and side effects. The standardized response mean of the overall instrument ranged from 0.16 to 0.67. Equivalence test showed no equivalence on quality of life score changes of these domains and the overall instrument. CONCLUSION: QLICP-GM possesses reasonable responsiveness and can be used in clinical measurement of quality of life for cancer patients.

[Development of the general module of the system of quality of life instruments for cancer patients: reliability and validity analysis].

BACKGROUND & OBJECTIVE: The general module of the system of quality of life instruments for cancer patients (QLICP-GM) has been developed by us, but its psychologic properties need to be evaluated. This study was to evaluate the reliability and validity of QLICP-GM. METHODS: The QOL data of 600 patients with lung cancer, breast cancer, colorectal cancer, gastric cancer, and head and neck cancer were analyzed by paired t-tests, correlation analysis, equivalence tests, and structural equation models to evaluate QLICP-GM. RESULTS: The test-retest reliability for all domains and the overall scale was above 0.85. Internal consistency alpha values for all domains except social function domain were above 0.70. The alpha value and split-half reliability of the overall scale were 0.88 and 0.93, respectively. Correlation analyses and structural equation models displayed good construction validity of the scale. It also showed good criterion-related validity when FACT-G was used as the criterion. CONCLUSION: QLICP-GM can be used to measure QOL for cancer patients with good reliability and validity.

[Development of the general module of the system of quality of life instruments for cancer patients: item selection and structure of the general module].

BACKGROUND & OBJECTIVE: The researches on quality of life (QOL) of cancer patients are concerned worldwide. Two QOL instrument systems for cancer patients, Functional Assessment of Cancer Therapy (FACT) and Quality of Life Questionnaires (QLQ), have been developed and used widely in the US and Europe, but no one has been developed in China. This study was to develop the general module of the system of quality of life instruments for cancer patients (QLICP-GM) used in China. METHODS: The structured group (nominal group and focus group) methods and the qualitative combined quantitative theory and methodology was used to develop rating scales. The items were preliminarily screened, evaluated, and modified. The QOL data of 448 cancer patients were analyzed by the methods of coefficient of variation, factor analysis, clustering analysis, and correlation analysis. RESULTS: QLICP-GM was developed and evaluated. The module, including 32 items, was consisted of 4 domains: physical function, psychologic function, social function, and general symptoms and side effects. CONCLUSION: QLICP-GM possesses a reasonable content validity because it reflects the WHO definition and connotation of QOL, and common issues of cancer patients as well.