Chinese General Practice ›› 2023, Vol. 26 ›› Issue (20): 2488-2495.DOI: 10.12114/j.issn.1007-9572.2022.0728

• Original Research • Previous Articles     Next Articles

A Nephrotic Syndrome-specific Quality of Life Scale: Development Based on the Quality of Life Instruments for Chronic Diseases, and Verification Using the Classical Test Theory

  

  1. 1. Department of Epidemiology and Health Statistics, Guangdong Medical University, Dongguan 523808, China
    2. School of Humanities and Management, Guangdong Medical University, Dongguan 523808, China
  • Received:2022-07-23 Revised:2022-11-11 Published:2023-07-15 Online:2022-11-23
  • Contact: PAN Haiyan

基于慢性病患者生命质量测定量表的肾病综合征生命质量量表编制及经典测量理论评价

  

  1. 1.523808 广东省东莞市,广东医科大学流行病与卫生统计学教研室
    2.523808 广东省东莞市,广东医科大学人文与管理学院
  • 通讯作者: 潘海燕
  • 作者简介:
    作者贡献:张杏珊负责病例资料的收集、整理与数据分析,并撰写论文初稿;林悦负责病例资料的复核与论文的修订;万崇华负责研究选题的确定以及指导;宋爱峰负责数据核对与论文修订;潘海燕负责资料收集的督导,以及文章的质量控制及审校。所有作者确认了论文的最终稿。
  • 基金资助:
    广东省自然科学基金资助项目(2019A1515010875); 广东省普通高校重点领域专项(2020ZDZX3007)

Abstract:

Background

The quality of life of patients with nephrotic syndrome requires a lot of focus, and improvements. A relevant scale can be used to measure it, but there is no nephrotic syndrome-specific quality of scale.

Objective

To develop a Quality of Life Instruments for Chronic Diseases-Nephrotic Syndrome〔QLICD-NS (V2.0) 〕 combined with QLICD-GM (V2.0), then verify it using the classical test theory.

Methods

From 2017 to 2021, an item pool was established according to literature review and the results of a semi-structured questionnaire, then the items were screened in accordance with a pre-test and importance score rated by physicians and patients, after that, the draft of the QLICD-NS (V2.0) was developed. The draft version was tested using onsite interview and questionnaire survey in nephrotic syndrome patients treated in Department of Nephrology, the Affiliated Hospital of Guangdong Medical University from March to November 2021. The first measurement was conducted on the day of admission, the second measurement was conducted with some of the patients, and the third measurement was conducted on the day of discharge. The coefficient of variation, correlation coefficient and Cronbach's α, factor analysis and classical test theory were used to evaluate QLICD-NS (V2.0) .

Results

The QLICD-NS (V2.0) contains 15 items, belonging to three domains of clinical symptoms, adverse drug reactions and psychological effects. The Cronbach's α measuring the split-half reliability was greater than 0.7 for the scale and each of the three domains. With the Chinese version of SF-36 as the calibration standard, the domains of the QLICD-NS (V2.0) were highly correlated with their counterpart domains of the Chinese version of SF-36. The standardized response mean was greater than 0.80 for all domains and items (except for the cognition and social support items), indicating that the responsiveness of the QLICD-NS (V2.0) was good. Scanning the QR code in the text can obtain the detailed evaluation of the scale.

Conclusion

The QLICD-NS (V2.0) compiled by us includes 15 items, and has proven with good reliability, validity and responsiveness.

Key words: Nephrotic syndrome, Quality of life, Classical measurement theory, Chronic disease, Scale, Reliability, Validity, Development and validation

摘要:

背景

肾病综合征患者的生命质量需要得到关注和提升,通过量表可测量其生命质量,但暂未在国内外文献中找到关于肾病综合征的特异性量表。

目的

结合慢性病患者生命质量量表系列第二版共性模块,构成慢性病患者生命质量测定量表的肾病综合征生命质量量表第二版〔QLICD-NS(V2.0)〕,并对其进行经典测量理论评价。

方法

2017—2021年,在文献分析的基础上开展半结构化问卷调查并初步拟定量表初始条目,通过预调查、医生和患者重要性评分进行筛选形成预成QLICD-NS(V2.0)。选取2021年3—11月于广东医科大学附属医院肾病内科就诊的肾病综合征患者为调查对象,采用现场访谈和问卷调查,患者入院当天完成第1次测量,选择部分患者进行第2次测定,出院当天完成第3次测量。采用变异度法、相关系数法、信度分析法、因子分析法并运用经典测量理论评价法评价QLICD-NS(V2.0)。

结果

QLICD-NS(V2.0)特异模块包含15个条目,各领域和总量表的Cronbach's α系数和分半信度均>0.7。条目内容包括临床症状、药物不良反应和心理影响3个方面。以中文版健康调查简表(SF-36)为校标,QLICD-NS(V2.0)各领域与其类似领域的相关性较高。除认知、社会支持条目外,其余领域或条目标准反应均数(SRM)均>0.80,尚可认为QLICD-NS(V2.0)量表的反应度良好。QLICD-NS(V2.0)具体评价条目见正文二维码。

结论

本研究编制的QLICD-NS(V2.0)的特异模块包括15个条目,其信度、效度、反应度良好。

关键词: 肾病综合征, 生命质量, 经典测量理论, 慢性病, 量表, 信效, 效度, 开发与验证