Page 127 - 2022-28-中国全科医学

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【Abstract】 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 "inadequate". In terms of the content
validity，the methodological quality of the studies on FertiQoL and QOLICQ development was rated "very good" and "doubtful"，
respectively，while that of the study on the TLMK or Quality of Life in People with Infertility Induced by Liver Qi Stagnation
Identified by Chinese Medicine Theory scale development was rated "adequate". In terms of the construct validity，except for
the study on QOLICQ development，which was of "doubtful" methodological quality，the methodological quality of studies on
the other three instruments development was considered "adequate". And the construct validity was rated "indeterminate" for
all these 4 instruments. In terms of the internal consistency，the methodological quality of studies on the development of the 4
instruments was rated "very good"，and the internal consistency of the 4 instruments was rated "sufficient". Regarding the test-
retest reliability，the methodological quality of the study on QOLICQ development was considered "doubtful" and the test-retest
reliability of the instrument was rated "indeterminate". The methodological quality of studies on the Quality of Life in People with
Infertility Induced by Liver Qi Stagnation Identified by Chinese Medicine Theory scale development was rated "very good" in terms
of criterion validity，and the criterion validity of the instrument was rated "sufficient". The methodological quality of the study on
TLMK instrument development was rated "very good" in terms of criterion validity，and the criterion validity of this instrument was
rated "sufficient". As for responsiveness/sensitivity，the methodological quality of the study on FertiQoL development was rated
"very good"，and the responsiveness/sensitivity of the instrument was rated "sufficient". Conclusion The methodological quality
of the study on the development of FertiQoL and the measurement properties of the instrument were much higher. The number of
Chinese infertility-specific HRQoL instruments is insufficient and needs more relevant studies.
【Key words】 Infertility；Health-related quality of life；Instruments；Systematic review；COSMIN

不孕症是指 1 对配偶未采取避孕措施，有规律性生活至 者出现疼痛、失眠、焦虑等症状，尤其是在“不孝有三，无
少 12 个月未能获得临床妊娠 ［1-2］ 。由于环境污染问题严峻， 后为大”的观念和“传宗接代”的思想影响下，不孕不育患
以及受睡眠不足、生活节奏加快等因素的影响，我国育龄夫 者更是承受着较大的社会、心理压力 ［10］ 。因此，临床客观指
妇的不孕不育率从 20 年前的 2.5%~3% 攀升至近年的 15% 左 标并不能全面反映患者的健康状况。
右 ［3-5］ 。不孕不育严重影响着个人健康和家庭幸福，已经成 目前，已有研究者对国内外不孕不育患者 HRQoL 量表
为重要的公共卫生问题，同时随着我国人口老龄化趋势加剧， 进行了详细介绍 ［11-12］ 和系统综述 ［13-17］ ，并且不孕不育患者
不孕不育也已成为日益突出的社会性问题。健康相关生命质 HRQoL 量表已在临床上得到了广泛的应用，但尚不确定这些
量（HRQoL）是患者基于自身健康状况和治疗对其日常生活 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
影响做出的自我评价，是从生理、心理和社会适应方面综合 质量评价。健康测量工具遴选标准（COSMIN）是用于评价患
评价健康的一种模式，能比较全面地反映患者的主观与客观 者报告结局测量量表（PROMs）的测量性能及研究方法学质
健康状况 ［6］ 。同时，HRQoL 是患者报告结局（PRO）测量的 量的工具，适用于 PROMs 的系统评价，可用于形成 PROMs
核心内容之一。目前在不孕不育患者临床效果评估中多将受 开发与利用相关推荐意见 ［18］ 。本研究通过全面梳理国内外不
精率、胚胎着床率、妊娠率等临床客观指标作为健康结局指 孕不育患者 HRQoL 量表相关研究，采用 COSMIN 对不孕不育
标 ［7-9］ ，但不孕不育的治疗过程复杂、周期较长，可导致患 患者 HRQoL 特异性量表进行系统评价，旨在为健康结局测量