Study on the Influencing Factors of Minimal Clinically Important Difference of the FACT-G Scale Based on Patients with Cervical Precancerous Lesions

doi:10.12114/j.issn.1007-9572.2022.0696

Abstract

Abstract:

Background

The minimum clinical importance difference (MCID) of the quality of life scale is an important parameter to explain and define the score changes of the scale, which can promote the clinical application of the quality of life scale as a tool to evaluate the effectiveness of treatment and intervention. MCID may be influenced by a variety of factors and there are few current studies on MCID of the Functional Assessment of Cancer Therapy-Generic Scale (FACT-G) .

Objective

To develop the MCID of FACT-G scale of patients with cervical precancerous lesions by a variety of methods and analyze the influence of patients' social demographic characteristics on the MCID of the FACT-G scale, so as to provide quantitative basis for clinicians to judge the clinical effectiveness of interventions.

Methods

A total of 66 patients with cervical precancerous lesions who received operation related to cervical precancerous lesions from October 2020 to November 2021 were included as study subjects in the First Affiliated Hospital of Shihezi University. The social demographic characteristics and disease-related information of the patients were collected, and the FACT-G scale was used to evaluate the quality of life of the patients before and 1 month after operation. The anchoring methods and distribution method were used to develop MCID for FACT-G scales. Multiple linear regression was used to analyze the influencing factors of MCID of the FACT-G scale.

Results

The four anchors including Global Rating of Change Questionnaire (GRCQ) , entry 10 of Global Rating of Change Questionnaire (SF-36 scale) , utility values (UI) of the Five-level EuroQol Five-dimensional Questionnaire (EQ-5D-5L scale) and EQ Visual Analogue Scale (EQ-VAS) were selected. The MCID of the total score of the FACT-G scale developed by the anchoring method ranged from 7.048 to 12.932, the MCID of the total scores of the FACT-G scale developed by the distribution method ranged from 3.696 to 10.243. The MCID developed by the anchoring method and distribution method were inconsistent. The MCID developed by the anchor-based GRCQ was considered as an example, there were 34 patients with slight improvement after operation were screened. The results of multiple linear regression analysis showed that that single (β=15.264, P<0.001) , obesity (β=-4.830, P=0.038) , and baseline scale total scores>89.5 (β=-7.600, P=0.001) were the influencing factors of MCID of the FACT-G total score in patients with cervical precancer lesions.

Conclusions

The MCIDs of FACT-G scale developed by different calculation methods are inconsistent. For patients with different characteristics of cervical precancerous lesions, MCIDs of the FACT-G scale should be selected to determine the effectiveness of clinical decisions and the clinical relevance of changes in quality of life after treatment.

Key words: Cervical intraepithelial neoplasia, Uterine diseases, FACT-G, Minimal clinically important difference, Root cause analysis, Linear models

摘要：

背景

生命质量量表的最小临床重要性差值（MCID）是解释和定义量表评分变化的重要参数，可促进生命质量量表作为治疗及干预效果评价工具在临床上的应用。MCID可能受多种因素的影响，目前关于癌症治疗功能评价系统-共性模块量表（FACT-G）MCID的研究较少。

目的

采用多种方法制订宫颈癌前病变患者FACT-G MCID，并分析患者社会人口学特征对FACT-G MCID的影响，为临床医生判断干预措施的临床有效性提供量化依据。

方法

纳入2020年10月至2021年11月于石河子大学第一附属医院接受宫颈癌前病变相关手术治疗的66例宫颈癌前病变患者为研究对象。收集患者社会人口学及疾病相关信息，并采用FACT-G对患者术前及术后1个月生命质量进行评估。利用锚定法和分布法制订MCID。采用多元线性回归分析探讨FACT-G MCID的影响因素。

结果

选择总体变化自评问卷（GRCQ）、36条目简明健康测量量表（SF-36量表）第10条目、五水平欧洲五维度健康量表（EQ-5D-5L）的效用值（UI）、视觉模拟尺度（EQ-VAS）四种锚，锚定法制订的FACT-G总分的MCID为7.048~12.932，分布法制订的FACT-G总分的MCID为3.696~10.243，锚定法和分布法制订的MCID不一致。以GRCQ为锚制订的MCID为例，筛选出术后轻微改善患者34例，多元线性回归分析结果表明，单身（β=15.264，P<0.001）、肥胖（β=-4.830，P=0.038）、基线FACT-G总分>89.5分（β=-7.600，P=0.001）是宫颈癌前病变患者FACT-G总分MCID的影响因素。

结论

不同计算方法制订的FACT-G MCID不同。对于不同特征的宫颈癌前病变患者，应选择不同的FACT-G MCID来判断临床决策的有效性及治疗后生命质量变化是否具有临床相关性。

关键词: 宫颈上皮内瘤样病变, 子宫疾病, 癌症治疗功能评价系统-共性模块量表, 最小临床重要性差值, 影响因素分析, 线性模型

YANG Yuli,JING Mingxia,HU Xin, et al. Study on the Influencing Factors of Minimal Clinically Important Difference of the FACT-G Scale Based on Patients with Cervical Precancerous Lesions[J]. Chinese General Practice, 2023, 26(17): 2108-2113. DOI: 10.12114/j.issn.1007-9572.2022.0696.
杨玉丽,井明霞,胡欣等. 基于宫颈癌前病变患者的癌症治疗功能评价系统-共性模块量表最小临床重要性差值的影响因素研究[J]. 中国全科医学, 2023, 26(17): 2108-2113. DOI: 10.12114/j.issn.1007-9572.2022.0696.

Figures/Tables 6

References 31

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FACT-G	ΔSF-36-10D		ΔUI		ΔEQ-VAS
FACT-G	r_s	P值	r_s	P值	r_s	P值
Δ总分	-0.30	0.017	0.51	<0.001	0.38	0.002
Δ生理状况	-0.43	<0.001	0.44	<0.001	0.28	0.021
Δ社会/家庭状况	-0.02	0.870	0.06	0.607	0.05	0.702
Δ情感状况	-0.22	0.072	0.48	<0.001	0.33	0.007
Δ功能状况	-0.20	0.111	0.40	0.001	0.32	0.009

FACT-G	ΔSF-36-10D		ΔUI		ΔEQ-VAS
FACT-G	r_s	P值	r_s	P值	r_s	P值
Δ总分	-0.30	0.017	0.51	<0.001	0.38	0.002
Δ生理状况	-0.43	<0.001	0.44	<0.001	0.28	0.021
Δ社会/家庭状况	-0.02	0.870	0.06	0.607	0.05	0.702
Δ情感状况	-0.22	0.072	0.48	<0.001	0.33	0.007
Δ功能状况	-0.20	0.111	0.40	0.001	0.32	0.009

维度	0.5SD	SEM	RCI	MDC_90%	MDC_95%
FACT-G总分	6.060	3.696	5.226	8.571	10.243
生理状况	1.603	1.049	1.483	2.432	2.906
社会/家庭状况	2.328	1.626	2.299	3.771	4.506
情感状况	2.123	1.395	1.973	3.236	3.867
功能状况	2.143	1.557	2.202	3.611	4.316

维度	0.5SD	SEM	RCI	MDC_90%	MDC_95%
FACT-G总分	6.060	3.696	5.226	8.571	10.243
生理状况	1.603	1.049	1.483	2.432	2.906
社会/家庭状况	2.328	1.626	2.299	3.771	4.506
情感状况	2.123	1.395	1.973	3.236	3.867
功能状况	2.143	1.557	2.202	3.611	4.316

特征	例数	差值（T1-T0）	检验统计量值	P值
年龄			-0.514^a	0.611
≤46岁	14	8.63±10.50
>46岁	20	10.33±8.77
婚姻状况〔M（P₂₅，P₇₅）〕			-2.941^b	0.003
在婚	30	5.83（2.17，10.08）
单身	4	29.17（20.58，30.25）
文化程度〔M（P₂₅，P₇₅）〕			-1.970^b	0.049
初中及以下	11	3.67（2.17，9.67）
高中及以上	23	9.50（4.83，19.00）
职业			-1.424^a	0.164
在职	12	12.69±10.36
无业	22	7.96±8.63
家庭人均月收入			-0.238^a	0.813
≤4 000元	16	9.22±8.05
>4 000元	18	10.00±10.68
医保类型〔M（P₂₅，P₇₅）〕			-0.945^b	0.345
城乡居民医保	10	7.33（3.58，23.21）
城镇职工医保	24	7.83（2.04，12.83）
家庭同住人口数			1.214^a	0.234
≤2人	20	11.26±9.30
≥3人	14	7.31±9.39
BMI			1.365^a	0.182
正常	24	11.03±8.56
肥胖	10	6.27±10.91
自评性格			-3.015^a	0.003
乐观	17	4.58±5.98
一般/悲观	17	14.69±9.61
病程〔M（P₂₅，P₇₅）〕			-0.577^b	0.564
≤30 d	22	9.25（2.29，18.63）
>30 d	12	5.83（2.42，12.83）
病理分期			0.879	0.425
Ⅰ级	5	14.57±11.27
Ⅱ级	11	9.67±6.69
Ⅲ级	18	8.24±10.30
治疗方式			-1.323^a	0.195
宫颈环形电切术	10	12.90±9.03
冷刀锥切/全子宫切除	24	8.27±9.40
高危HPV感染			0.891^a	0.448
是	22	10.55±9.42
否	12	7.94±9.55
基线FACT-G总分			-3.209^a	0.001
≤89.50分	19	14.30±9.74
>89.50分	15	3.72±4.41