[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: 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.