Establishing minimal clinically important differences of Quality of Life Instruments for Cancer Patients-Leukemia based on the distribution-based approach / 国际肿瘤学杂志

ABSTRACT

Objective:To develop the minimal clinically important difference (MCID) of Quality of Life Instruments for Cancer Patients-Leukemia (QLICP-LE) (V2.0).Methods:The quality of life of 101 patients with leukemia in First Affiliated Hospital of Kunming Medical University and First People′s Hospital of Yunnan Province from October 2011 to May 2012 were measured. The QLICP-LE (V2.0) was used for data collection, and the MCID for the overall score and scores of various domains of QLICP-LE (V2.0) were established by using the distribution-based approach including indexes of effect size, standard error of measurement (SEM), reliable change index, standardized response mean and responsiveness statistic, and the recommended values of MCID were determined through the consensus method.Results:The MCID formulated by the above five indexes were as follows: the total scale 1.4-9.3, physical functional domain 1.6-15.6, psychological functional domain 2.9-15.6, social functional domain 2.2-18.0, common symptoms and side-effects domain 1.7-17.1, common module 1.8-10.0, and the specific module 1.1-12.1. Through the expert consensus method, it was recommended to use the MCID results calculated by 1.96SEM: the total scale was 4, physical domain was 8, psychological domain was 8, social domain was 9, common symptoms and side-effects domain was 9, common module was 4, and the specific module was 6.Conclusion:Each index of distribution-based approach has its own advantages and disadvantages, which can be selected based on actual conditions. There is clinical significance when the score change of QLICP-LE (V2.0) of leukemia patients after treatment exceeds its MCID.