Qualitative cross-cultural exploration of breast symptoms and impacts associated with hormonal treatments for menopausal symptoms to inform the development of new patient-reported measurement tools

Lucy Abraham, Louise Humphrey, Rob Arbuckle, Lorraine Dennerstein, James A. Simon, Sebastian Mirkin, Nicola Bonner, Steven Walmsley, Sophi Tatlock, Tara Symonds

    Research output: Contribution to journalArticlepeer-review

    9 Citations (Scopus)

    Abstract

    To explore cross-cultural experiences of women taking estrogen plus progestin therapies (EPT) and develop a symptom-based electronic diary and impact questionnaire for EPT-related breast symptoms. (1) Concept elicitation interviews were conducted with women in the US (n = 14), Italy (n = 15), Mexico (n = 15) and China (n = 15) to explore breast symptoms associated with EPT. Patients completed the Breast Sensitivity Questionnaire (BSQ) to evaluate understanding and comprehensiveness. (2) Based on concept elicitation, a 6-item eDiary (Breast Pain/Tenderness Daily Diary - BPT-DD) was generated and the BSQ modified forming the 18-item Breast Sensations Impact Questionnaire (BSIQ). (3) The measures were pilot-tested and then cognitively debriefed with US women receiving EPT. All qualitative data was subject to thematic analysis. Concept elicitation identified breast pain/tenderness, swollen breasts and sensitivity to contact as important symptoms, impacting women's emotional well-being, relationships with family/friends, social life, sleep, ability to move freely, contact, clothing and sexual activity. Experiences were relatively consistent across the country samples. Based on pilot testing and cognitive debriefing, the BPT-DD was reduced to 4 items (and renamed the Breast Pain Daily Diary - BP-DD) and the BSIQ was reduced to 13 items due to conceptual redundancy. Women taking EPT in the US, China, Mexico and Italy reported breast sensations that have a detrimental impact on quality of life. Two new measures were developed to assess the severity and impact of breast pain specific to EPT. This work highlights that EPT-related symptoms should be part of treatment decision-making, and treatments with less burdensome side effects are needed.
    Original languageEnglish
    Pages (from-to)273-281
    Number of pages9
    JournalMaturitas
    Volume80
    Issue number3
    DOIs
    Publication statusPublished - 2015

    Keywords

    • abnormalities
    • breast
    • hormone replacement therapy
    • menopause
    • patient, reported outcomes

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