基于分布法的癌症患者生命质量测定量表体系之白血病量表的最小临床重要性差值制定

Establishing minimal clinically important differences of Quality of Life Instruments for Cancer Patients-Leukemia based on the distribution-based approach

目的制定癌症患者生命质量测定量表体系之白血病量表(QLICP-LE)(V2.0)的最小临床重要性差值(MCID)。方法对昆明医科大学第一附属医院和云南省第一人民医院于2011年10月至2012年5月收治的101例白血病患者进行生命质量调查, 采用QLICP-LE(V2.0)进行数据收集, 使用分布法中的效应尺度、标准测量误差(SEM)、可靠变化指数、标准化反应均数以及反应度统计量等5种指标来计算量表的总分及各个领域得分的MCID, 并通过专家共识法, 确定MCID推荐值。结果上述5种指标制定的MCID分别为总量表1.4~9.3、躯体功能领域1.6~15.6、心理功能领域2.9~15.6、社会功能领域2.2~18.0、共性症状与不良反应领域1.7~17.1、共性模块1.8~10.0、特异性模块1.1~12.1。通过专家共识法, 推荐使用由1.96SEM计算出的MCID结果, 即总量表为4、躯体功能为8、心理功能为8、社会功能为9、共性症状与不良反应为9、共性模块为4、特异性模块为6。结论分布法中各种指标均有其优缺点, 可结合实际情况选用。当临床上为白血病患者治疗后QLICP-LE(V2.0)的得分分值改变超过所计算出的MCID时, 可以认为具有临床意义。

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.