国内外不孕不育患者健康相关生命质量量表的系统综述与评价研究  

Health-related Quality of Life Instruments in Infertility Patients:a Systematic Review and Evaluation

作　　者：史钊 李顺平 吴小燕[1,2,3] 刘嘉琪 杜慧敏 SHI Zhao;LI Shunping;WU Xiaoyan;LIU Jiaqi;DU Huimin(Centre for Health Management and Policy Research,School of Public Health,Cheeloo College of Medicine,Shandong University,Jinan 250012,China;NHC Key Lab of Health Economics and Policy Research(Shandong University),Jinan 250012,China;Center for Health Preference Research,Shandong University,Jinan 250012,China)

机构地区：[1]山东大学齐鲁医学院公共卫生学院卫生管理与政策研究中心,山东省济南市250012 [2]国家卫生健康委员会卫生经济与政策研究重点实验室(山东大学),山东省济南市250012 [3]山东大学健康偏好研究中心,山东省济南市250012

出　　处：《中国全科医学》2022年第28期3579-3586,共8页Chinese General Practice

基　　金：山东省自然科学基金面上项目(ZR2021MG010)。

摘　　要：背景健康相关生命质量(HRQoL)是用于评价临床疗效的重要指标。目前,不孕不育患者HRQoL量表得到了广泛应用,但尚不确定这些量表应用于临床时是否具有良好的测量性能,缺乏对量表的质量评价。目的系统综述与评价不孕不育患者HRQoL量表,为合理选择健康结果测量工具提供参考。方法于2020年10月,计算机检索PubMed、Web of Science、the Cochrane Library、EmBase、中国知网、万方数据知识服务平台、维普中文科技期刊全文数据库和中国生物医学文献数据库,获取国内外公开发表的有关不孕不育患者HRQoL的研究,检索时限均为建库至2020-10-05。由两名研究者独立筛选文献和提取资料后,采用健康测量工具遴选标准(COSMIN)对不孕不育患者HRQoL特异性量表开发研究的方法学质量,以及量表的测量性能进行评价,采用描述分析法对评价结果进行汇总、分析。结果共纳入229篇文献,涉及19个不孕不育患者HRQoL量表,其中4个为不孕不育患者HRQoL特异性量表〔TLMK、生育生活质量量表(FertiQoL)、QOLICQ及中医肝郁型不孕症生命质量量表〕,4个为用于测评癌症及其他疾病患者HRQoL的特异性量表,11个为普适性HRQoL量表,FertiQoL量表在现有不孕不育患者HRQoL相关研究中被使用的频次最高〔39.1%(91/233)〕。PROMs开发方面,除FertiQoL量表开发的总体质量为“有问题的”外,其余3个量表开发的总体质量均为“不合格”。内容效度方面,FertiQoL、QOLICQ量表开发研究的方法学质量分别为“非常好”“有问题的”,TLMK、中医肝郁型不孕症生命质量量表开发研究的方法学质量均为“合格”。结构效度方面,除QOLICQ量表开发研究方法学质量为“有问题的”外,其余3个量表开发研究的方法学质量为“合格”;4个量表的结构效度均为“不确定”。内部一致性方面,4个量表开发研究的方法学质量均为“非常好”,4个量表的内部�Background Health-related quality of life(HRQoL)is a key indicator that is used for evaluating clinical outcomes.Infertility-specific HRQoL instruments have been widely used,but it is uncertain whether these instruments have good measurement properties in clinical application,and there is a lack of quality evaluation for them.Objective To perform a systematical review and evaluation of HRQoL instruments in infertility patients,offering a rational reference for the selection of these instruments.Methods In October 2020,PubMed,Web of Science,the Cochrane Library,EmBase,CNKI,WanFang Data,CQVIP,and SinoMed databases were searched from inception to October 5,2020 to identify studies on HRQoL instruments designed for or assess HRQoL for patients with infertility.Two reviewers independently implemented literature screening,data extraction,and methodological quality assessment of the included studies in terms of the process of developing infertility-specific HRQoL instruments and measurement properties of the instruments using the COnsensus-based Standards for the selection of health Measurement INstruments(COSMIN)checklist.Descriptive analysis was used to summarize and analyze the assessment results.Results We included 229 studies on 19 HRQoL instruments,including 4 infertility-specific HRQoL instruments〔TLMK(Tübinger Lebensqualitätsfragebogen für Männer mit Kinderwunsch),the Fertility Quality of Life(FertiQoL),Quality of Life in Infertile Couples Questionnaire(QOLICQ),Quality of Life in People with Infertility Induced by Liver Qi Stagnation Identified by Chinese Medicine Theory〕,4 cancer-specific or other disease-specific HRQoL instruments and 11 generic HRQoL instruments.The FertiQoL was the most frequently used in existing studies〔39.1%(91/233)〕.Regarding the development of PROMs,of the 4 infertility-specific HRQoL instruments,except for the FertiQoL instrument,whose overall development quality was considered"doubtful",the overall development quality of the other three instruments was considered"inadequat

关 键 词：不孕不育 健康相关生命质量 量表 系统评价 健康测量工具遴选标准 

分 类 号：R271.14[医药卫生—中医妇科学] R163[医药卫生—中医学]