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Abstract
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.
Conflict of interest
Sophi Tatlock, Nicola Williamson, and Rob Arbuckle are employees of Adelphi Values who were consultants paid by Pfizer in connection with this study and the writing of this manuscript. Lucy Abraham, Andrew Bushmakin, and Maggie Moffat are employees and shareholders of Pfizer. Cheryl Coon was an employee of Adelphi Values at the time the study was conducted. All authors reviewed and approved the final manuscript.
