Table 2.
Study outcome measures and corresponding questionnaires
| Variable | Questionnaire | Details |
|---|---|---|
| Primary outcomes | ||
| Hot flush/Night sweats problem rating | HFRS | ▪ 3 items (subscale), 10 point scale |
| ▪ Score range: 0–10 (mean scores are used); higher scores indicate higher problem rating | ||
| ▪ Time frame: 1 week | ||
| ▪ Test-retest reliability 0.80 | ||
| Overall level of menopausal symptoms | FACT-ES | ▪ 18 items, 4 point Likert scale |
| ▪ Score range: 0–72; higher scores indicate fewer menopausal symptoms | ||
| ▪ Time frame: 1 week | ||
| ▪ Cronbach’s alpha: >0.80 | ||
| Secondary outcomes | ||
| Sexual functioning | SAQ | ▪ 10 items, 4 point Likert scale |
| ▪ Subscales: pleasure; discomfort; habit | ||
| ▪ 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’ | ||
| ▪ Time frame: past month | ||
| ▪ Test-retest kappa: 0.50–0.76 | ||
| Sleep quality | GSQS | ▪ 14 items, dichotomous (yes/no) scale |
| ▪ Score range: 0–14; higher scores indicate more sleep problems | ||
| ▪ Time frame: past month | ||
| Hot flush frequency | HFRS | ▪ 2 items (subscale); open-ended frequency scale |
| ▪ Score range: reported average of HF/NS per week | ||
| ▪ Time frame: past week | ||
| ▪ Test-retest reliability 0.80 | ||
| Psychological distress | HADS | ▪ 14 items, 4-point Likert scale |
| ▪ Subscales: depression (HADS-D); anxiety (HADS-A) | ||
| ▪ Score range: total score 0–42; subscale scores 0–21 higher score indicates more psychological distress | ||
| ▪ Time frame: past week | ||
| ▪ Cronbach’s alpha: HADS-D 0.67–0.90; HADS-A 0.68–0.93 | ||
| Health-related quality of life | SF-36 | ▪ 36 items, dichotomous and 3- to 6-point Likert scales |
| ▪ 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 | ||
| ▪ Score range: 0–100; higher score indicates higher levels of functioning/well-being | ||
| ▪ Time frame: past week | ||
| ▪ Cronbach’s alpha: 0.66–0.91 (mean 0.84) | ||
| ▪ For the cost-effectiveness analysis we will map the SF-36 onto the EuroQol5D to obtain utilities | ||