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

doi:10.3760/cma.j.cn371439-20210420-00114

Abstract

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.

Key words: Leukemia, Quality of Life, Minimal clinically important difference

Li Weiqiang, Wu Yang, Wan Chonghua, Tan Jianfeng, He Zhengchun, Meng Qiong. Establishing minimal clinically important differences of Quality of Life Instruments for Cancer Patients-Leukemia based on the distribution-based approach[J]. Journal of International Oncology, 2021, 48(10): 577-582.

Figures/Tables 7

References 19

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项目	例数	构成比 (%)	项目	例数	构成比 (%)
性别			婚姻
男	56	55.4	未婚	20	19.8
女	45	44.6	已婚	76	75.2
年龄(岁)			离婚	4	4.0
20~40	53	52.4	丧偶	1	1.0
41~60	33	32.7	文化程度
>60	15	14.9	小学	16	15.8
民族			初中	41	40.6
汉族	81	80.2	高中或中专	20	19.8
少数民族	20	19.8	大专	9	8.9
			本科及以上	15	14.9

领域	治疗前	治疗后	t值	P值
总量表	70.2±11.6	73.7±11.6	-2.812	0.006
躯体功能领域	55.3±16.1	59.3±15.3	-2.101	0.038
心理功能领域	66.6±16.6	68.1±17.2	-0.786	0.434
社会功能领域	63.4±13.0	63.5±12.0	0.388	0.699
共性症状与不良反应领域	77.6±17.2	82.1±18.6	-3.201	0.001
共性模块	65.4±12.5	67.8±12.9	-1.561	0.122
特异性模块	79.9±11.8	85.5±10.1	-4.927	<0.001

领域	MCID
领域	弱效应	中等效应	强效应
总量表	2.3	5.8	9.3
躯体功能领域	3.2	8.1	12.9
心理功能领域	3.3	8.3	13.3
社会功能领域	2.6	6.5	10.4
共性症状与不良反应领域	3.5	8.6	13.8
共性模块	2.5	6.2	10.0
特异性模块	2.4	5.9	9.4

领域	基线标准差	信度r	MCID
领域	基线标准差	信度r	小效应	中等效应	大效应
总量表	11.6	0.975	1.8	3.6	5.1
躯体功能领域	16.1	0.939	4.0	7.8	11.0
心理功能领域	16.6	0.942	4.0	7.8	11.1
社会功能领域	13.0	0.874	4.6	9.0	12.7
共性症状与不良反应领域	17.2	0.936	4.4	8.6	12.1
共性模块	12.5	0.978	1.9	3.6	5.1
特异性模块	11.8	0.931	3.1	6.1	8.6

领域	基线标准差	信度r	MCID
领域	基线标准差	信度r	小效应	中等效应	大效应
总量表	11.6	0.975	2.6	5.1	7.2
躯体功能领域	16.1	0.939	5.6	11.0	15.6
心理功能领域	16.6	0.942	5.6	11.0	15.6
社会功能领域	13.0	0.874	6.5	12.7	18.0
共性症状与不良反应领域	17.2	0.936	6.2	12.1	17.1
共性模块	12.5	0.978	2.6	5.1	7.2
特异性模块	11.8	0.931	4.4	8.6	12.1