RESUMO
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.
Assuntos
Doenças Mamárias/etnologia , Terapia de Reposição de Estrogênios , Menopausa , Dor Intratável/etnologia , Doenças Mamárias/psicologia , China , Comparação Transcultural , Etnicidade , Feminino , Humanos , Itália , México , Pessoa de Meia-Idade , Dor Intratável/psicologia , Índice de Gravidade de Doença , Inquéritos e Questionários , Estados UnidosRESUMO
OBJECTIVES: To understand the vaginal bleeding/spotting experiences of postmenopausal (PM) women taking estrogen plus progestin therapies (EPT) and develop measures to assess these symptoms and their impact on women's daily lives in four countries. DESIGN: (1) Concept elicitation interviews were conducted with PM women in the US (n=14), Italy (n=15), Mexico (n=15) and China (n=15) to explore vaginal bleeding/spotting symptoms associated with EPT. The Post-Menopausal Bleeding Questionnaire (PMBQ) was also debriefed to evaluate understanding and comprehensiveness. (2) Based on concept elicitation, a single item electronic daily diary was developed and the PMBQ modified to form a 12-item impact measure. (3) The measures were pilot-tested and then cognitively debriefed with US women receiving EPT. All qualitative data was subject to thematic analysis. MAIN OUTCOME MEASURES: The Vaginal Bleeding/Spotting Daily Diary, (VBS-DD) and Post-Menopausal Bleeding Impact Questionnaire (PMBIQ) were developed in this study. RESULTS: Concept elicitation identified vaginal bleeding and spotting as important symptoms for women taking EPT, impacting their emotional wellbeing, social life, ability to move freely, clothing and sexual activity. Based on pilot testing and cognitive debriefing, women demonstrated good understanding of the VBS-DD and the PMBQ was reduced to 10 items due to conceptual redundancy. CONCLUSIONS: Women taking EPT in the US, China, Mexico and Italy reported vaginal bleeding/spotting symptoms that have a detrimental impact on their quality of life. Two new measures were developed to assess the severity and impact of vaginal bleeding/spotting specific to EPT. This work highlights the need for EPT-related symptoms to be a part of treatment decision-making.
Assuntos
Terapia de Reposição de Estrogênios/efeitos adversos , Metrorragia/etiologia , Pós-Menopausa , Qualidade de Vida , Inquéritos e Questionários , Hemorragia Uterina/etiologia , Adulto , China , Cultura , Estrogênios/farmacologia , Feminino , Humanos , Entrevistas como Assunto , Itália , México , Pessoa de Meia-Idade , Pesquisa Qualitativa , Estados Unidos , Vagina/efeitos dos fármacosRESUMO
OBJECTIVES: Determine women's experiences of premenstrual symptoms. STUDY DESIGN: Cross-sectional survey. Sample In all, 4085 women aged 14-49 years recruited by random telephone digit dialing in France, Germany, Hungary, Italy, Spain, UK, Brazil and Mexico. Main outcome measures Telephone interview checklist of 23 premenstrual symptoms, sociodemographic variables and lifestyle variables. RESULTS: The most prevalent symptoms were abdominal bloating, cramps or abdominal pain, breast tenderness, irritability and mood swings. Severity of symptoms is directly proportional to duration (R = 0.79). Hierarchical clustering found the following mental and physical domains and a typology: 'Mild' type (40.8%) with minimal symptoms; 'Moderate M' type (28.7%) with moderately severe, mostly mental symptoms; 'Moderate P' type (21.9%) with moderately severe, mostly physical symptoms; and 'Severe' type (8.6%) with severe intensity of both mental and physical symptoms. Multiple stepwise regression found significant effects on symptom duration severity index of age (linear and quadratic effects), current smoking and country. CONCLUSIONS: Further research is needed on the impact of premenstrual symptoms on quality of life, and whether a brief symptom list could be developed as a valid and reliable tool globally.