PMID- 35346222
OWN - NLM
STAT- MEDLINE
DCOM- 20220330
LR  - 20220401
IS  - 1477-7525 (Electronic)
IS  - 1477-7525 (Linking)
VI  - 20
IP  - 1
DP  - 2022 Mar 28
TI  - Development and validation of the health-related quality of life instrument for 
      Chinese infertile couples: a mixed-methods study protocol.
PG  - 54
LID - 10.1186/s12955-022-01957-3 [doi]
LID - 54
AB  - BACKGROUND: Infertility and its treatment have negative impacts on a couple's 
      marital relationship, sexual life, psychological state and interpersonal 
      relationships, causing personal distress. Health-related quality of life (HRQoL) 
      has become an important component of health outcomes. HRQoL instruments developed 
      in western culture are not always appropriate for use in China due to cultural 
      differences. Probably due to the unique concept of fertility in China, 
      infertility patients can be looked down upon and the family may  feel shameful. 
      This study aims to develop a HRQoL instrument for infertile couples based on the 
      Chinese social and cultural setting. METHODS: Complementary mixed methods will be 
      used to develop a new HRQoL instrument for Chinese infertile couples. The study 
      consists of four stages: the first stage will involve a systematic review and 
      qualitative interviews to construct draft candidate items. In the second stage, 
      quantitative research [e.g., exploratory factor analysis (EFA), item response 
      theory (IRT)] and cognitive interviews will be used for item selection. The third 
      stage will be instrument validation, in which classical test theory (CTT) and IRT 
      will be applied. In the final stage, the minimal clinically important difference 
      (MCID) will be calculated by using distribution-based methods and anchor-based 
      methods (e.g., logistic regression, receiver operating characteristic curve). 
      DISCUSSION: The new HRQoL instrument for Chinese infertile couples will be 
      developed, which will provide a standard and effective HRQoL instrument in 
      clinical outcome assessment and health outcome measurement.
CI  - (c) 2022. The Author(s).
FAU - Shi, Zhao
AU  - Shi Z
AD  - Centre for Health Management and Policy Research, School of Public Health, 
      Cheeloo College of Medicine, Shandong University, Jinan, 250012, China.
AD  - NHC Key Lab of Health Economics and Policy Research, Shandong University, Jinan, 
      250012, China.
AD  - Center for Health Preference Research, Shandong University, Jinan, 250012, China.
FAU - Mao, Zhuxin
AU  - Mao Z
AD  - School of Insurance, Southwestern University of Finance and Economics, Chengdu, 
      611130, China.
FAU - Nie, Hongwei
AU  - Nie H
AD  - Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong 
      University, Jinan, 250001, China.
FAU - Geng, Ling
AU  - Geng L
AD  - Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong 
      University, Jinan, 250001, China.
FAU - Chen, Gang
AU  - Chen G
AD  - Centre for Health Economics, Monash Business School, Monash University, 
      Melbourne, 3145, Australia.
FAU - Li, Shunping
AU  - Li S
AUID- ORCID: 0000-0001-8144-6220
AD  - Centre for Health Management and Policy Research, School of Public Health, 
      Cheeloo College of Medicine, Shandong University, Jinan, 250012, China. 
      lishunping@sdu.edu.cn.
AD  - NHC Key Lab of Health Economics and Policy Research, Shandong University, Jinan, 
      250012, China. lishunping@sdu.edu.cn.
AD  - Center for Health Preference Research, Shandong University, Jinan, 250012, China. 
      lishunping@sdu.edu.cn.
LA  - eng
GR  - ZR2021MG010/Shandong Provincial Natural Science Foundation/
PT  - Journal Article
DEP - 20220328
PL  - England
TA  - Health Qual Life Outcomes
JT  - Health and quality of life outcomes
JID - 101153626
SB  - IM
MH  - China
MH  - Factor Analysis, Statistical
MH  - Humans
MH  - *Infertility
MH  - *Quality of Life
MH  - Surveys and Questionnaires
MH  - Systematic Reviews as Topic
PMC - PMC8961984
OTO - NOTNLM
OT  - Chinese
OT  - Health-related quality of life
OT  - Infertile couples
OT  - Instrument
OT  - Protocol
OT  - Validation
COIS- The authors declare that they have no competing interests.
EDAT- 2022/03/30 06:00
MHDA- 2022/03/31 06:00
PMCR- 2022/03/28
CRDT- 2022/03/29 05:39
PHST- 2021/11/24 00:00 [received]
PHST- 2022/03/14 00:00 [accepted]
PHST- 2022/03/29 05:39 [entrez]
PHST- 2022/03/30 06:00 [pubmed]
PHST- 2022/03/31 06:00 [medline]
PHST- 2022/03/28 00:00 [pmc-release]
AID - 10.1186/s12955-022-01957-3 [pii]
AID - 1957 [pii]
AID - 10.1186/s12955-022-01957-3 [doi]
PST - epublish
SO  - Health Qual Life Outcomes. 2022 Mar 28;20(1):54. doi: 10.1186/s12955-022-01957-3.