Development and psychometric properties of the Reproductive Health Assessment in Systemic Lupus Erythematosus: Mixed-Methods study

Objectives Systemic lupus erythematosus (SLE) with a high morbidity rate (7% in general and 325/100.000 in reproductive period) was known as "the mother of autoimmune diseases." But healthcare providers hadn't reliable scales to measure the effectiveness of interventions to improve reproductive health. Women with systemic lupus erythematosus (SLE) express concern about a significant gap in their reproductive and sexual health during medical care due to the lack of a specific scale to measure this concept. This study developed psychometrically specific scale to evaluate this concept in Iranian women. Methods The study utilized a sequential-exploratory mixed-methods design, wherein the concept of reproductive health was clarified during the qualitative phase using conventional content analysis (inductive-deductive) to create a pool of RHASLE (Reproductive Health Assessment in SLE) items. During the psychometric process, the face, content, and construct validities of the RHASLE were checked with 650 individuals (320 using exploratory factor analysis [EFA] and 330 using confirmatory factor analysis [CFA]) through interviews and completion of the questionnaire. Convergent and divergent validities were then checked, and the reliability was assessed through stability and internal consistency. Finally, the measurement error, responsiveness, and interpretability of the scale were evaluated and confirmed. Results The study's findings revealed that the RHASLE consisted of 5 factors (33 items): physical-psychological disorder (13 items), relaxing feeling (6 items), spirituality (3 items), high-risk pregnancies (5 items), and sexual satisfaction (6 items). These factors explained a total of 99.97% of the variance in the concept of reproductive health. Confirmatory factor analysis confirmed the good model fit, and its validity and reliability were deemed acceptable. Conclusion The RHASLE consisted of 27 items with high internal consistency, stability, responsiveness, and interpretability. That was able to get approval of Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. Based on the results, RHASLE is a valid and reliable multidimensional scale that encompasses various aspects of reproductive health (physical, sexual, psychological, social, and spiritual).