Page 132 - 2022-28-中国全科医学
P. 132
http://www.chinagp.net E-mail:zgqkyx@chinagp.net.cn ·3585·
表 5 不孕不育患者 HRQoL 特异性量表测量性能评价 https://www.fda.gov/regulatory-information/search-fda-guidance-
Table 5 Quality of measurement properties of infertility-specific HRQoL documents/patient-reported-outcome-measures-use-medical-
instruments
product-development-support-labeling-claims.
结构 内部 聚合效度 / 反应度 /
量表 重测信度 效标效度 [7]周星宇,冯淑娴,李雪兰,等 . 40 岁以上妇女行体外受精 - 胚
效度 一致性 区分效度 灵敏度
胎移植治疗的结局分析[J]. 南方医科大学学报,2016,36(12):
TLMK [20] ? a + 0 0 + 0
1632-1637. DOI:10.3969/j.issn.1673-4254.2016.12.08.
FertiQoL [21-22] ? a + 0 0 0 +
[8]季静娟,刘雨生,骆丽华,等 . 两种促卵泡生长激素三种使用
[23]
b
a
QOLICQ ? + ? 0 0 0
方法在体外受精 - 胚胎移植中疗效比较和经济学分析[J]. 生
中医肝郁型不孕症 ? a + 0 + 0 0
生命质量量表 [24] 殖医学杂志,2012,21(4):329-333.
a
注:+ 表示足够,? 表示不确定,0 表示未提及; 表示仅进行了 [9]CHAMBERS G M,SULLIVAN E A,ISHIHARA O,et al. The
b
探索性因子分析, 表示未报告具体统计分析方法 economic impact of assisted reproductive technology:a review of selected
developed countries[J]. Fertil Steril,2009,91(6):2281-2294.
典测量理论等多种理论为指导进行量表条目筛选与测量性能 [10]NI Y,TONG C,HUANG L,et al. The analysis of fertility
评价,量表研制时需要尽可能设置回忆期,以为量表反应性 quality of life and the influencing factors of patients with repeated
implantation failure[J]. Health Qual Life Out,2021,19(1):
评估提供相关参照,保证测评的一致性与准确性。同时,也
32. DOI:10.1186/s12955-021-01666-3.
须注重对MCID的探讨,旨在为量表结果的解释提供相应参考。
[11]单伟超,杨娜,单伟颖 . 不孕症相关量表的研究现状[J]. 中
本研究存在一定的局限性:首先,本研究采用了 COSMIN
国计划生育学杂志,2015,23(8):573-576.
作为不孕不育患者 HRQoL 特异性量表评价工具,COSMIN 中
[12]杨娜,李青,单伟颖 . 不孕症专用量表的研究现状[J]. 中国
部分评价标准主观性较强,可能会导致评价结果的偏倚;其
实用护理杂志,2015,31(2):150-153.
次本研究仅对不孕不育患者 HRQoL 特异性量表开发研究的方 [13]CHACHAMOVICH J R,CHACHAMOVICH E,EZER H,et al.
法学质量及原版量表的测量性能进行了评价,未来在进行量 Investigating quality of life and health-related quality of life in
表的测量性能评价时可将不同语言版本的量表均纳入研究, infertility:a systematic review[J]. J Psychosom Obst Gyn,
从而使评价结果更加全面、完善。也可运用 COSMIN 改良 2010,31(2):101. DOI:10.3109/0167482X.2010.481337.
GRADE [53] 综合评定不孕不育患者 HRQoL 特异性量表各测量 [14]MOUSAVI S A,MASOUMI S Z,KERAMAT A,et al. Assessment of
性能的证据等级,并形成对于量表的最终推荐意见。 questionnaires measuring quality of life in infertile couples:a systematic
作者贡献:史钊、李顺平进行文章的构思与设计,史钊、 review[J]. J Reprod Infertil,2013,14(3):110-119.
吴小燕、刘嘉琪、杜慧敏负责文献筛选及质量控制与审校; [15]LUK B H,LOKE A Y. The impact of infertility on the psychological
well-being,marital relationships,sexual relationships,and
史钊、吴小燕、刘嘉琪进行数据收集及整理;史钊、李顺平
quality of life of couples:a systematic review[J]. J Sex Marital
负责结果的分析与解释,撰写论文;史钊、李顺平、吴小燕、
Ther,2015,41(6):610-625.
刘嘉琪、杜慧敏进行论文的修订;李顺平负责文章的可行性
[16]KITCHEN H,ALDHOUSE N,TRIGG A,et al. A review of
分析,对文章整体负责,监督管理。
patient-reported outcome measures to assess female infertility-
本文无利益冲突。
related quality of life[J]. Health Qual Life Out,2017,15(1):
参考文献 86. DOI:10.1186/s12955-017-0666-0.
[1]ZEGERS-HOCHSCHILD F,ADAMSON G D,DYER S,et al. [17]HUBENS K,ARONS A,KROL M. Measurement and evaluation
The international glossary on infertility and fertility care,2017[J]. of quality of life and well-being in individuals having or having had
Hum Reprod,2017,32(9):1786-1801. fertility problems:a systematic review[J]. Eur J Contracept
[2]GURUNATH S,PANDIAN Z,ANDERSON R A,et al. Defining Reprod Health Care,2018,23(6):441-450.
infertility:a systematic review of prevalence studies[J]. Hum Reprod [18]PRINSEN C,MOKKINK L B,BOUTER L M,et al. COSMIN
Update,2011,17(5):575-588. DOI:10.1093/humupd/dmr015. guideline for systematic reviews of patient-reported outcome
[3]QIAO J,WANG Y,LI X,et al. A Lancet Commission on 70 measures[J]. Qual Life Res,2018,27(5):1147-1157.
years of women's reproductive,maternal,newborn,child,and [19]COSMIN. Guideline for systematic reviews of outcome measurement
adolescent health in China[J]. Lancet,2021,397(10293): instruments[EB/OL]. [2022-05-30]. https://www.cosmin.nl/
2497-2536. DOI:10.1016/S0140-6736(20)32708-2. tools/guideline-conducting-systematic-review-outcome-measures/.
[4]ZHOU Z,ZHENG D,WU H,et al. Epidemiology of infertility in [20]SCHANZ S,BAECKERT-SIFEDDINE I T,BRAEUNLICH C,et
China:a population-based study[J]. BJOG,2018,125(4): al. A new quality-of-life measure for men experiencing involuntary
432-441. DOI:10.1111/1471-0528.14966. childlessness[J]. Hum Reprod,2005,20(10):2858-2865.
[5]新京报 . 我国不孕不育率达 12%~15%[N]. 新京报,2018-10- [21]BOIVIN J,TAKEFMAN J,BRAVERMAN A. The Fertility Quality
30(D03). of Life(FertiQoL)tool:development and general psychometric
[6]U.S. Food and Drug Administration(FDA). Guidance for industry properties[J]. Hum Reprod,2011,26(8):2084-2091.
patient-reported outcome measures:use in medical product [22]BOIVIN J,TAKEFMAN J,BRAVERMAN A. The Fertility Quality
development to support labeling claims[EB/OL]. [2022-05-30]. of Life(FertiQoL)tool:development and general psychometric