Abstract
BackgroundThe experience of menopausal symptoms is common and an adequate patient-reported outcome measure is crucial in studies where women are treated for these symptoms. The aims of this study were to identify a patient-reported outcome measure for bothersome menopausal symptoms and, in the absence of an adequate tool, to develop a new measure with high content validity, and to validate it using modern psychometric methods.MethodsThe literature was reviewed for existing questionnaires and checklists for bothersome menopausal symptoms. Relevant items were extracted and subsequently tested in group interviews, single interviews, and pilot tests. A patient-reported outcome measure was drafted and completed by 1504 women. Data was collected and psychometrically validated using item-response theory Rasch Models.ResultsAll questionnaires identified in the literature lacked content validity regarding bothersome menopausal symptoms and none were validated using item-response theory. Our content validation resulted in a draft measurement encompassing 122 items across eight domains. Following psychometrical validation, the final version of our patient-reported outcome measure, named the MenoScores Questionnaire, encompassed 51 items, including one single item, covering 11 scales.ConclusionMenopausal symptoms are multidimensional with some symptoms unquestionably related to the menopausal transition. We identified four constructs of importance: hot flushes, day-and-night sweats, general sweating, and menopausal-specific sleeping problems. The MenoScores Questionnaire is condition-specific with high content validity and adequate psychometrical properties. It is designed to measure bothersome menopausal symptoms and all scales are developed and psychometrically validated using item-response theory Rasch Models.Trial registrationApproved by the Danish Data Agency (J.nr. 2015–41-4057). Ethics Committee approval was not required.
Highlights
The experience of menopausal symptoms is common and an adequate patient-reported outcome measure is crucial in studies where women are treated for these symptoms
Phase 1 We identified 15 questionnaires written in English or Danish in the literature search, many of which referred to each other: Kupperman index [31, 32], Modified Blatt-Kupperman index [33, 34], Greene (1976) [35], Greene climacteric scale (GCS) [36], WHQ [37, 38], MENQOL [39], MENQOL-intervention [40], Menopause symptom list (MSL) [41], Menopause rating scale (MRS) [42], 10-items Cervantes scale (CS-10) [43], Menopause health state classification [44], Menopause health questionnaire [4], Neugarten and Kraines [45], Hvas et al [46], MQOL [47]
We found that all existing questionnaires lacked content validity regarding bothersome menopausal symptoms and none were validated using Item response theory (IRT)
Summary
The experience of menopausal symptoms is common and an adequate patient-reported outcome measure is crucial in studies where women are treated for these symptoms. The aims of this study were to identify a patient-reported outcome measure for bothersome menopausal symptoms and, in the absence of an adequate tool, to develop a new measure with high content validity, and to validate it using modern psychometric methods. The aims of this study are threefold: 1) To review existing questionnaires and symptoms checklists (which we refer to as questionnaires) measuring bothersome menopausal symptoms, and, if we cannot identify an adequate existing questionnaire from the literature search : 2) To develop a patient-reported outcome measure (PROM) for bothersome menopausal symptoms with high content validity, and: 3) To validate this new PROM for dimensionality, invariance, known-groups validity, and reliability using modern psychometric methods
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