DEVELOPMENT AND PSYCHOMETRIC VALIDATION OF A NEW HEALTH-RELATED QUALITY OF LIFE INSTRUMENT FOR INFERTILITY PATIENTS (INFERTILITY-QOL):A NATIONAL MULTICENTER, FIVE-PHASE, MIXED-METHODS STUDY...
Author(s)
zhao shi, PhD1, Shunping Li, PhD2.
1Shandong University, jinan, China, 2Shandong University, Jinan, China.
1Shandong University, jinan, China, 2Shandong University, Jinan, China.
OBJECTIVES: Infertility 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 and evaluate its psychometric properties based on classical test theory (CTT) and item response theory (IRT).
METHODS: This study used a mixed methods design involving 5 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. Afterwards, by conducting advisory committee consultations, the items were further qualitatively evaluated, and developed a formal version of the Infertility-QoL (step 4). Finally, we evaluate the preliminary psychometric properties of the Infertility-QoL based on CTT and IRT.
RESULTS: Step 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 Cronbach’s α (0.800~0.950) and McDonald’s ω (0.798~0.951) were excellent (>0.70). The exploratory factor analysis results showed that the 6-factor model was appropriate. The newly developed Infertility-QoL consisted of 25 items across six dimensions: physical health, sexual life, emotional status, self-efficacy, subjective wellbeing and social relations.
CONCLUSIONS: This study developed the new Infertility-QoL instrument for male and female infertility patients, and demonstrated acceptable psychometric performance, suggesting that it can be considered a valid and reliable instrument to measure HRQoL for patients with infertility in China and Eastern clinical practice.
METHODS: This study used a mixed methods design involving 5 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. Afterwards, by conducting advisory committee consultations, the items were further qualitatively evaluated, and developed a formal version of the Infertility-QoL (step 4). Finally, we evaluate the preliminary psychometric properties of the Infertility-QoL based on CTT and IRT.
RESULTS: Step 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 Cronbach’s α (0.800~0.950) and McDonald’s ω (0.798~0.951) were excellent (>0.70). The exploratory factor analysis results showed that the 6-factor model was appropriate. The newly developed Infertility-QoL consisted of 25 items across six dimensions: physical health, sexual life, emotional status, self-efficacy, subjective wellbeing and social relations.
CONCLUSIONS: This study developed the new Infertility-QoL instrument for male and female infertility patients, and demonstrated acceptable psychometric performance, suggesting that it can be considered a valid and reliable instrument to measure HRQoL for patients with infertility in China and Eastern clinical practice.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
PCR9
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient Engagement, Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Reproductive & Sexual Health