Development of Menopause-related Oral Discomfort Questionnaire

Abstract

Objectives: The aim of this study is to develop a self-administrated questionnaire to evaluate the subjective menopause-related oral discomfort in women. Methods: The development stages of the menopause-related oral discomfort questionnaire included item generation, item selection and preliminary questionnaire validation. An initial literature review was carried out to identify menopause-associated oral symptoms to guide the semi-structured interviews. Chinese women aged 40-60 years old were interviewed to explore their self-perceived oral discomfort during menopause. The interview transcriptions were coded and analyzed in Nvivo.11 software to generate questionnaire domains and items. A further literature review for previous oral discomfort questionnaires was performed to identify any items missed in the interviews to generate a comprehensive question item pool. After this, 6 panel experts evaluated the question items using content validity ratio (CVR). Then the items were screened and reiteratively modified to generate the questionnaire. The questionnaire was further refined through target population interviews and face validity was determined by evaluating the clarity of question items. Results: 21 subjects participated in the interviews until data saturation and thematic analysis of the transcriptions generated 3 domains for the menopause-related oral discomfort questionnaire including oral dryness, taste and smell change, and oral discomfort sensation. Combined with questions from literature review, a question item pool of 43 items was generated and evaluated by the panel. The CVR of 43 items ranged from -0.67 to 1.00 and the ones lower than 0 were modified or excluded. A preliminary questionnaire of 3 domains consisting of 31 items was generated and face validity of each item ranged from 90.3% to 100%. Conclusions: A 31-item menopause-related oral discomfort questionnaire has been created with content and face validation and shown to be a suitable tool to evaluate oral discomfort in menopause women. Further reliability and validity tests are needed to better verify the questionnaire.