Evidence map›Paper›PMID 41013678›Full record

ArticleHealth and quality of life outcomes2025

Design and selection of items for a new health-related quality of life instrument with infertility patients (Infertility-QoL): a national multicenter, four-phase, mixed-methods study.

Zhao Shi, Yu Zheng, Zhuxin Mao, Hongwei Nie, Gang Chen, Shunping Li

Abstract readMulticenter Study
In one paragraph

Article in Health and quality of life outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

6 authors.

Zhao ShiDepartment of Social Medicine and Health Management, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, China.
Yu ZhengBlood Center of Shandong Province, Jinan, China.
Zhuxin MaoCentre for Health Economics Research and Modelling Infectious Diseases (CHERMID), University of Antwerp, Antwerp, Belgium.
Hongwei NieState Key Laboratory of Reproductive Medicine and Offspring Health, Center for Reproductive Medicine, Institute of Women, Children and Reproductive Health, Shandong University, Jinan, China.
Gang ChenMelbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Shunping LiDepartment of Social Medicine and Health Management, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, China. lishunping@sdu.edu.cn.

Funding

Shandong Provincial Natural Science Foundation ZR2021MG010
6 · The paper itself

Abstract

backgroundInfertility is a global issue that significantly imposes physical and psychosocial burdens on both female and male patients, affecting their health-related quality of life (HRQoL) and family wellbeing. The aim of this study was to develop a de novo HRQoL instrument for male and female infertility patients in China, and describe the generation and selection of items for Infertility-QoL.

methodsThis study used a mixed methods design involving 4 steps. The items identified from the systematic review and qualitative interview analysis were used to construct draft candidate items (step 1). In order to ensure item relevance, comprehension, and acceptability, using cognitive interviews prior to quantifying psychometric testing (step 2). In the third step, we conducted a cross-sectional quantitative offline survey for item selection. Classical test theory (CTT) and item response theory (IRT) were used to assess dimensionality and performance of items. Finally, by conducting advisory committee consultations and thematic seminars, the items were further qualitatively evaluated, and developed a formal version of the Infertility-QoL (step 4).

resultsStep 1 resulted in the generation of 73 items. Based on CTT and IRT psychometric evidence, 36 items were deleted. Finally, according to the advisory committee consultations for qualitative evaluation, a formal version of the Infertility-QoL with 25 items was developed. The exploratory factor analysis results showed that the 6-factor model was appropriate. The newly developed instrument (Infertility-QoL) consisted of 25 items across six dimensions: physical health, sexual life, emotional status, self-efficacy, subjective wellbeing and social relations.

conclusionsThis study developed the new Infertility-QoL instrument for male and female infertility patients, and preliminarily verified its dimensions.

Indexed as

InfertilityInfertility, FemaleQuality of LifeAdultChinaCross-Sectional StudiesFemaleHumansMaleMiddle AgedPsychometricsReproducibility of ResultsSurveys and QuestionnairesHealth-related quality of lifeInfertilityItem selectionMixed-methodsPatient-reported outcome

Identifiers

PMID41013678
PMCPMC12465535

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