To develop a questionnaire with high content validity measuring menopausal symptoms and validate this questionnaire using Rasch analysis.
Menopause is not a disease, but many women experience the period as very stressful. Hot flushes and night sweats as very common symptoms, but also problems such as emotional vulnerability, sleeping problems, fatigue, vaginal dryness and loss of sexual desire may be linked to menopause. Hormone replacement therapy (HRT) has in many years been an effective treatment for menopausal symptoms. However, research has shown that women treated with long-time HRT have an increased risk of breast cancer and thromboembolic disorders. Therefore, alternative effective treatment with few side effects is desired. Acupuncture has in several studies shown an effect on hot flushes. Many of these studies have been criticized for methodological errors and flaws and larger randomized controlled trials (RCTs) are recommended.
A PhD project is currently planning an RCT within general practice in order to determine the effect of acupuncture on menopausal symptoms. The present subproject includes development and validation of a Danish questionnaire measuring menopausal symptoms, which later can be used as the primary outcome measure in the abovementioned RCT.
Preliminary results: 15 questionnaires were identified, including 356 items in total, of which 129 items encompassed unique meaning content covering 5 domains. After the first focus group 68 items were endorsed, 18 new items were generated and 61 items needed further testing. A second focus group is planned and interviews will continue until Data saturation occurs.
A literature search was conducted in order to identify existing questionnaire encompassing menopausal symptoms. From those questionnaires, the meaningful content of relevant items was extracted and assessed for redundancy. The content matter of these items was translated into Danish. The content relevance and content coverage (content validity) of these unique items will be tested in single- and focus group interviews with women suffering from menopausal symptoms. Items not relevant will be deleted. If there is lack of content coverage new items will be generated from the interviews. Thereby a new draft version of a Danish questionnaire measuring menopausal symptoms will be developed. This draft version will be psychometrically validated using data collected cross sectional. Rasch analysis will be used at the primary psychometric analysis, but also classical test theory will be used.
The unique items, the domains and the results from interviews and psychometric analyses will be presented at the conference.