Reliability and validity of a pattern identification diagnostic tool for climacteric and postmenopausal syndrome pattern identification: A clinical study of a newly developed questionnaire

Abstract

Abstract Introduction Traditional Korean Medicine (TKM) can be used to manage symptoms associated with the menopause, but effective treatment depends on diagnosis, which could be facilitated with an appropriate diagnostic tool. This study aimed to verify the reliability and validity of a diagnostic tool for climacteric and postmenopausal syndrome pattern identification (CaPSPI) by identifying seven major patterns and 10 syndrome elements. Methods This study was conducted between June and October 2018, in two University Korean Medicine Hospitals. To investigate the construct validity, 275 women aged 45–60 years experiencing menopausal symptoms (Kupperman index ≥20) answered a 75-item questionnaire regarding menopausal symptoms. To investigate the tool’s criterion validity, a previously developed pattern identification questionnaire (DSOM) was administered to 107 participants. Subsequent analysis examined construct validity using factor analysis, reliability using Cronbach’s alpha, and criterion validity using Pearson’s correlation. Results For construct validity, the factor loading of the seven patterns was ≥0.452, and Cronbach s coefficient was ≥0.759. For the 10 syndrome elements (證素), the factor loading of the four disease locations (病位) was ≥0.519, and the associated Cronbach s coefficient was ≥0.790, while the factor loading of the six disease natures (病性) was ≥0.468, and the associated Cronbach s coefficient was ≥0.700. The criterion validity of the DSOM was also verified (p\u2009 Conclusions The results confirmed the construct validity and reliability of the seven patterns and 10 syndrome elements proposed by the CaPSPI. The criterion validity of the DSOM was also verified. These results suggest that this may be an effective tool for diagnosing menopausal symptoms.