title: 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.
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.
authors.affiliation: Pfizer Ltd., Dorking Road, Tadworth, Kent KT20 7NS, UK. Electronic address: Lucy.Abraham@pfizer.com.
authors.forename: Lucy
authors.initials: L
authors.lastname: Abraham
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, UK. Electronic address: lhumphrey@abacusint.com.
authors.forename: Louise
authors.initials: L
authors.lastname: Humphrey
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, UK. Electronic address: rob.arbuckle@adelphivalues.com.
authors.forename: Rob
authors.initials: R
authors.lastname: Arbuckle
authors.affiliation: University of Melbourne, Australia. Electronic address: lorrdenn@aol.com.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Dennerstein
authors.affiliation: George Washington University, Washington, DC, USA. Electronic address: jsimon@JamesASimonMD.com.
authors.forename: James A
authors.initials: JA
authors.lastname: Simon
authors.affiliation: Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: mirkin.sebastian@gmail.com.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Mirkin
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, UK. Electronic address: nicola.bonner@adelphivalues.com.
authors.forename: Nicola
authors.initials: N
authors.lastname: Bonner
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, UK. Electronic address: S.Walmsley@uws.edu.au.
authors.forename: Steven
authors.initials: S
authors.lastname: Walmsley
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, UK. Electronic address: sophi.tatlock@adelphivalues.com.
authors.forename: Sophi
authors.initials: S
authors.lastname: Tatlock
authors.affiliation: Pfizer Ltd., Dorking Road, Tadworth, Kent KT20 7NS, UK. Electronic address: tara.symonds@clinoutsolutions.com.
authors.forename: Tara
authors.initials: T
authors.lastname: Symonds
mesh_terms: D001941:Breast Diseases / Q000208:ethnology* / Q000523:psychology; D002681:China; D003431:Cross-Cultural Comparison; D015914:Estrogen Replacement Therapy; D005006:Ethnicity; D005260:Female; D006801:Humans; D007558:Italy; D008593:Menopause; D008800:Mexico; D008875:Middle Aged; D010148:Intractable Pain / Q000208:ethnology* / Q000523:psychology; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014481:United States
keywords: Instrument development; Patient-reported outcomes; Qualitative