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Primary outcomes
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Hot flush/Night sweats problem rating
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HFRS
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▪ 3 items (subscale), 10 point scale
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▪ Score range: 0–10 (mean scores are used); higher scores indicate higher problem rating
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▪ Time frame: 1 week
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▪ Test-retest reliability 0.80
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Overall level of menopausal symptoms
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FACT-ES
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▪ 18 items, 4 point Likert scale
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▪ Score range: 0–72; higher scores indicate fewer menopausal symptoms
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▪ Time frame: 1 week
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▪ Cronbach’s alpha: >0.80
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Secondary outcomes
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Sexual functioning
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SAQ
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▪ 10 items, 4 point Likert scale
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▪ Subscales: pleasure; discomfort; habit
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▪ Score range: pleasure 0–18 higher scores indicate higher levels of pleasure; discomfort 0–6 lower scores indicates lower levels of discomfort; habit 0–3; single item (0 ‘less sexual activity than usual’ to 3 ‘much more sexual activity than usual’
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▪ Time frame: past month
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▪ Test-retest kappa: 0.50–0.76
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Sleep quality
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GSQS
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▪ 14 items, dichotomous (yes/no) scale
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▪ Score range: 0–14; higher scores indicate more sleep problems
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▪ Time frame: past month
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Hot flush frequency
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HFRS
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▪ 2 items (subscale); open-ended frequency scale
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▪ Score range: reported average of HF/NS per week
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▪ Time frame: past week
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▪ Test-retest reliability 0.80
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Psychological distress
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HADS
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▪ 14 items, 4-point Likert scale
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▪ Subscales: depression (HADS-D); anxiety (HADS-A)
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▪ Score range: total score 0–42; subscale scores 0–21 higher score indicates more psychological distress
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▪ Time frame: past week
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▪ Cronbach’s alpha: HADS-D 0.67–0.90; HADS-A 0.68–0.93
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Health-related quality of life
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SF-36
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▪ 36 items, dichotomous and 3- to 6-point Likert scales
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▪ Subscales: physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, general health perceptions
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▪ Score range: 0–100; higher score indicates higher levels of functioning/well-being
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▪ Time frame: past week
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▪ Cronbach’s alpha: 0.66–0.91 (mean 0.84)
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▪ For the cost-effectiveness analysis we will map the SF-36 onto the EuroQol5D to obtain utilities
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