Development and Psychometric Evaluation of the Sexual and Reproductive Health Questionnaire for Women With Type 1 Diabetes Mellitus: A Study Protocol for a Sequential Exploratory Mixed-Methods Study

Objectives: Type 1 diabetes mellitus (T1DM) can profoundly influence different dimension of health such as sexual and reproductive health (SRH). The aim of this study is to develop and evaluate the psychometric properties of the Sexual and Reproductive Health Questionnaire for Women with Type 1 Diabetes Mellitus (SRHQ-WT1DM).Materials and Methods: This protocol for a sequential exploratory mixed-methods study has two phases. Conducting a literature review, the first phase of the study will develop the items of SRHQ-WT1DM. Data analysis in this phase will be performed using directed content analysis and according to the framework proposed by the United Nations Population Fund (UNFPA) and the World Health Organization (WHO) for SRH in women. The second phase will evaluate the psychometric properties of SRHQWT1DM through a methodological study. Face and content validity will be evaluated both qualitatively and quantitatively, and construct validity will be done by exploratory factor analysis and convergent validity. The questionnaire's reliability and stability will be examined using internal consistency (by Cronbach's alpha calculation) and test-retest method (by Intra class correlation coefficient calculation), respectively. Descriptive statistics, Pearson correlation coefficient, and independent t-test will also be used. Women with T1DM who are of childbearing age and have unknown mental disorders will be selected as participants in the study from the Iranian Diabetes Society.Discussion: Development and psychometric evaluation of a specific tool for SRH assessment in women will help identify and fulfill their SRH-related needs and improve dimensions of their SRH.