Psychometric evaluation of electronic diaries assessing side-effects of hormone therapy

Climacteric. 2018 Dec;21(6):594-600. doi: 10.1080/13697137.2018.1517738. Epub 2018 Oct 29.


Objectives: Postmenopausal women (PMW) can experience side-effects (breast pain/tenderness and vaginal spotting/bleeding) associated with estrogen plus progestin therapies (EPTs). To assess these outcomes, the Breast Pain and Tenderness Daily Diary (BPT-DD) and the Vaginal Bleeding and Spotting Daily Diary (VBS-DD) were developed for electronic completion (eDiaries). This study evaluated the psychometric properties of the eDiaries.

Methods: The eDiaries were completed daily for 28 days by 202 PMW experiencing breast pain/tenderness and/or vaginal spotting/bleeding while on EPTs. Confirmatory factor analysis (CFA) investigated the BPT-DD structure. Response distributions, test-retest reliability (intraclass correlation coefficient [ICC]), internal consistency (BPT-DD only), and construct validity (via known groups and convergent validity analyses) were assessed.

Results: Completion rates were high: over 90% of women missed <3 daily entries. CFA supported the BPT-DD unidimensional structure (Bentler's Comparative Fit Index >0.98). BPT-DD inter-item correlations (r = 0.77-0.89) and internal consistency (Cronbach's alpha = 0.95-0.97) were high and good test-retest reliability was demonstrated (ICC ≥ 0.70). The eDiaries correlated moderately (>0.40), in a logical pattern with other instruments, supporting convergent validity. Known-groups analyses indicated both measures demonstrated significant differences between patients of differing severity (p < 0.001).

Conclusion: The study provides evidence of strong psychometric properties for the BPT-DD and VBS-DD to assess breast pain/tenderness and spotting/bleeding in PMW.

Keywords: Psychometric validation; health-related quality of life; impacts; postmenopause; questionnaire; symptoms.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Data Collection / instrumentation
  • Estrogen Replacement Therapy / adverse effects*
  • Female
  • Humans
  • Mastodynia / etiology*
  • Middle Aged
  • Postmenopause*
  • Psychometrics
  • Quality of Life*
  • Reproducibility of Results
  • Self Report
  • Surveys and Questionnaires
  • Uterine Hemorrhage / etiology*