Background
Methods
Phase 1:Literature review
Phase 2: Qualitative interviews
Phase 3: Validation survey and analysis
Results
Phase 1
Phase 2
Have you – within the past three months – experienced the following symptoms? | ||||
---|---|---|---|---|
No, not at all | Yes, a bit | Yes, quite a bit | Yes, a lot | |
I have had hot flushes during the day | ||||
I have had hot flushes during the night |
Number | Number with/without BMS | Age (women with BMS) Mean (range) | Age (women without BMS) Mean (range) | |
---|---|---|---|---|
Group interviews | 9 | 9/0 | 52.89 (49–63) | – |
Single interviews | 4 | 4/0 | 50.75 (50–52) | – |
Pilot test | 4 | 2/2 | 52 (50–54) | 63 (62–64) |
Survey (cross sectional) | 1504 | 1073/431 | 51.97 (45–65) | 50.69 (45–65) |
Phase 3
Survey
Characteristics/exogenous variables | Total no. (% of total) | Bothersome menopausal symptoms No. (%) |
---|---|---|
Total | 1504 (100) | 1073 (71.34) |
Age (years): | ||
45–48 | 394 (26.20) | 209 (53.05) |
49–52 | 543 (36.10) | 417 (76.80) |
53–55 | 304 (20.21) | 264 (86.84) |
56–60 | 205 (13.63) | 154 (75.12) |
61–65 | 58 (3.86) | 29 (50.00) |
BMI | ||
0–18 | 10 (0.67) | 8 (80.00) |
19–24 | 682 (45.77) | 469 (68.77) |
25–29 | 518 (34.77) | 379 (73.17) |
≥ 30 | 280 (18.79) | 206 (73.57) |
Missing | 14 | |
Occupationa | ||
Yes | 1250 (83.11) | 893 (71.44) |
No | 75 (4.99) | 50 (66.67) |
Sick leave | 51 (3.39) | 34 (66.67) |
Retired or similar | 128 (8.51) | 96 (75.00) |
Education | ||
No education | 56 (3.73) | 41 (73.21) |
Skilled worker, apprentice, assistant nurse or likewise | 273 (18.16) | 206 (75.46) |
Short higher educationb < 3 years | 213 (14.17) | 167 (78.40) |
Medium higher education 3–4 years | 633 (42.12) | 449 (70.93) |
Long higher education > 4 years | 233 (15.50) | 141 (60.52) |
Other | 90 (5.99) | 63 (70.00) |
Do not know | 5 (0.33) | 5 (100) |
Missing | 1 | |
Living alone | ||
Yes | 310 (20.78) | 214 (69.03) |
No | 1182 (79.22) | 851 (72.00) |
Missing | 12 | |
Smoking | ||
Yes | 238 (15.82) | 179 (75.21) |
No | 1266 (84.18) | 894 (70.62) |
Gynecological history | ||
Hormonal intrauterine device | ||
Yes | 247 (16.42) | 144 (58.30) |
No | 1257 (83.58) | 929 (73.91) |
Bilateral ovariectomized | ||
Yes | 40 (2.66) | 32 (80.00) |
No | 1464 (97.34) | 1041 (71.11) |
Hysterectomized | ||
Yes | 121 (8.05) | 95 (78.51) |
No | 1383 (91.95) | 978 (70.72) |
Having menstruation within the past year | ||
Yes | 717 (47.67) | 464 (64.71) |
No | 787 (52.33) | 609 (77.38) |
Psychometric analysis
Item no. | Item wording | A priori domain | Final scale | Fit to Rasch model | Fit to log linear Rasch model | ||||
---|---|---|---|---|---|---|---|---|---|
Observed | Expected | P | Observed | Expected | P | ||||
4 | I have had hot flushes during the day | D2 - Vasomotor | HF | 0.824 | 0.823 | 0.9107 | 0.821 | 0.820 | 0.9157 |
5 | I have had hot flushes during the night | D2 - Vasomotor | HF | 0.824 | 0.823 | 0.9107 | 0.821 | 0.820 | 0.9157 |
6 | I have had bouts of sweating during the day | D2 - Vasomotor | DNS | 0.694 | 0.691 | 0.8768 | 0.694 | 0.691 | 0.8757 |
7 | I have had bouts of night sweats | D2 - Vasomotor | DNS | 0.694 | 0.691 | 0.8768 | 0.694 | 0.691 | 0.8757 |
8 | I have been sweating more than usual. | D2 - Vasomotor | GS | 0.632 | 0.633 | 0.9720 | 0.632 | 0.633 | 0.9628 |
9 | I have had cold sweats | D2 - Vasomotor | GS | 0.632 | 0.633 | 0.9720 | 0.632 | 0.633 | 0.9628 |
10 | I have not been able to sleep because of night sweats | D3 - Sleep | MSSP | 0.872 | 0.870 | 0.8853 | – | – | – |
11 | I have not been able to sleep because of hot flushes | D3 - Sleep | MSSP | 0.872 | 0.870 | 0.8853 | – | – | – |
22 | I have been depressed | D4 - Emotional | EM | 0.717 | 0.680 | 0.0360 | – | – | – |
27 | I have had mood swings | D4 - Emotional | EM | 0.646 | 0.677 | 0.0545 | – | – | – |
30 | I have felt anxiety | D4 - Emotional | EM | 0.690 | 0.693 | 0.9022 | – | – | – |
31 | I have felt nervous | D4 - Emotional | EM | 0.696 | 0.680 | 0.3557 | – | – | – |
33 | I have been needlessly worried | D4 - Emotional | EM | 0.667 | 0.678 | 0.5050 | – | – | – |
34 | I have been worried about having a nervous breakdown | D4 - Emotional | EM | 0.727 | 0.700 | 0.1399 | – | – | – |
40 | I have had less confidence | D4 - Emotional | EM | 0.677 | 0.687 | 0.5561 | – | – | – |
43 | I have not had the energy to socialize | D4 - Emotional | EM | 0.671 | 0.677 | 0.7186 | – | – | – |
45 | I have felt isolated | D4 - Emotional | EM | 0.689 | 0.693 | 0.7989 | – | – | – |
47 | I have done less than I would like | D4 - Emotional | EM | 0.694 | 0.681 | 0.3996 | – | – | – |
48 | I can accomplish less than I used to | D4 - Emotional | EM | 0.680 | 0.682 | 0.9221 | – | – | – |
53 | I have had difficulty concentrating | D4 - Emotional | EM | 0.682 | 0.683 | 0.9548 | – | – | – |
54 | My memory has been worse than usual | D4 - Emotional | MEM | 0.923 | 0.923 | 0.9841 | – | – | – |
55 | I have had problems with remembering everyday things | D4 - Emotional | MEM | 0.923 | 0.923 | 0.9841 | – | – | – |
58 | I have had dry skin | D5 - Skin, hair and mucosa | SH | 0.462 | 0.411 | 0.0273 | 0.462 | 0.351 | < 0.0001 |
62 | I have had a crawling feeling over the skin | D5 - Skin, hair and mucosa | SH | 0.411 | 0.418 | 0.8215 | 0.409 | 0.445 | 0.2133 |
63 | I have had itching of the scalp | D5 - Skin, hair and mucosa | SH | 0.436 | 0.405 | 0.2111 | 0.436 | 0.416 | 0.4045 |
64 | I have had vaginal dryness | D5 - Skin, hair and mucosa | SH | 0.418 | 0.431 | 0.5544 | 0.417 | 0.463 | 0.0378 |
65 | I have had vaginal itching | D5 - Skin, hair and mucosa | SH | 0.475 | 0.405 | 0.0131 | 0.474 | 0.478 | 0.8649 |
66 | I have shed more hair than usual | D5 - Skin, hair and mucosa | SH | 0.417 | 0.421 | 0.8541 | 0.417 | 0.418 | 0.9889 |
67 | My nails split more than usual | D5 - Skin, hair and mucosa | SH | 0.364 | 0.425 | 0.0128 | 0.371 | 0.423 | 0.0337 |
69 | I have more body hair growth | D5 - Skin, hair and mucosa | SH | 0.333 | 0.412 | 0.0062 | 0.333 | 0.346 | 0.6786 |
71 | I have had heart palpitations | D6 - Physical | PHY | 0.468 | 0.491 | 0.3039 | 0.468 | 0.491 | 0.3039 |
73 | I have had headache | D6 - Physical | PHY | 0.461 | 0.496 | 0.0934 | 0.461 | 0.496 | 0.0934 |
75 | I have had a blind spot in front of my eye | D6 - Physical | PHY | 0.510 | 0.510 | 0.9896 | 0.510 | 0.510 | 0.9896 |
76 | I have been dizzy | D6 - Physical | PHY | 0.533 | 0.485 | 0.0396 | 0.533 | 0.485 | 0.0396 |
80 | One or more of my joints has been sore | D6 - Physical | PHY | 0.528 | 0.513 | 0.4367 | 0.528 | 0.513 | 0.4367 |
84 | I have had neck pain | D6 - Physical | PHY | 0.530 | 0.518 | 0.5332 | 0.530 | 0.518 | 0.5332 |
86 | I have had pins and needles in my feet | D6 - Physical | PHY | 0.546 | 0.527 | 0.4502 | 0.546 | 0.527 | 0.4502 |
95 | I have been more clumsy than usual | D6 - Physical | PHY | 0.505 | 0.506 | 0.9606 | 0.505 | 0.506 | 0.9606 |
77 | I have had nausea | D6 - Physical | ABD | 0.421 | 0.464 | 0.1331 | 0.421 | 0.464 | 0.1331 |
96 | My stomach has tended to be bloated | D6 - Physical | ABD | 0.500 | 0.476 | 0.2837 | 0.500 | 0.476 | 0.2837 |
98 | I have had uncontrollable loss of gas | D6 - Physical | ABD | 0.507 | 0.472 | 0.1474 | 0.507 | 0.472 | 0.1474 |
102 | My stool has been loose | D6 - Physical | ABD | 0.453 | 0.466 | 0.6507 | 0.453 | 0.466 | 0.6507 |
106 | I need to pass urine more frequently than usual | D6 - Physical | URIN | 0.532 | 0.481 | 0.03241 | 0.532 | 0.492 | 0.0975 |
107 | I sometimes leak urine | D6 - Physical | URIN | 0.459 | 0.474 | 0.55320 | 0.459 | 0.489 | 0.2257 |
108 | My urine has smelled different | D6 - Physical | URIN | 0.511 | 0.482 | 0.28580 | 0.511 | 0.462 | 0.0770 |
110 | My vaginal discharge has been different | D6 - Physical | URIN | 0.419 | 0.483 | 0.03539 | 0.419 | 0.477 | 0.0569 |
115 | I have had pain during intercourse | D7 - Sexual | SEX | 0.701 | 0.629 | 0.0010 | 0.701 | 0.676 | 0.2232 |
116 | I have had bleeding after intercourse | D7 - Sexual | SEX | 0.714 | 0.699 | 0.5665 | 0.714 | 0.764 | 0.0222 |
117 | I have been too tired for sex | D7 - Sexual | SEX | 0.579 | 0.580 | 0.9703 | 0.579 | 0.550 | 0.1721 |
118 | I have had difficulty achieving an orgasm | D7 - Sexual | SEX | 0.535 | 0.576 | 0.0554 | 0.535 | 0.544 | 0.6740 |
91 | I have felt more tired than usual | D6 - Physical | Single item | – | – | – | – | – |
–
|
Vasomotor symptoms
Sleep
Emotional
Skin, hair and mucosa
Physical
Abdominal (ABD) scale
Urinary-vaginal (URIN) scale
Sexual
Work and spare time
Menstruation
Association (discrimination)
Scale | Number of items | Fit to Rasch model | Fit to log linear Rasch model | Cronbach’s alpha | discriminating abilitya | ||||
---|---|---|---|---|---|---|---|---|---|
χ2 | df | P | χ2 | df | P | ||||
Vaso-motor | 6 | 91.9 | 17 | < 0.0001 | – | – | – | 0.90 | |
1. HF | 2 | 6.1 | 5 | 0.2941 | 19.7 | 26 | 0.8057 | 0.85 | 30 |
2. DNS | 2 | 9.9 | 5 | 0.0778 | 21.6 | 25 | 0.6588 | 0.76 | 34 |
3. GS | 2 | 13.6 | 5 | 0.0183 | 13.2 | 17 | 0.7225 | 0.60 | 62 |
MSSP | 10 | 308.2 | 29 | < 0.0001 | – | – | – | 0.90 | |
4. MSSP | 2 | 6.0 | 5 | 0.3077 | – | – | – | 0.87 | 42 |
Emotional | 36 | 511.4 | 107 | < 0.0001 | – | – | – | 0.97 | |
5. EM | 12 | 45.1 | 35 | 0.1189 | – | – | – | 0.93 | 158 |
6. MEM | 2 | 2.9 | 5 | 0.7176 | – | – | – | 0.90 | 258 |
SH | 15 | 137.3 | 44 | < 0.0001 | 0.81 | ||||
7. SH | 8 | 27.7 | 23 | 0.2289 | 61.5 | 71 | 0.7828 | 0.71 | 300 |
Physical | 25 | 768.6 | 74 | < 0.0001 | 0.93 | ||||
8. PHY | 8 | 25.1 | 23 | 0.3433 | 87.2 | 73 | 0.1235 | 0.79 | 218 |
Abdominal | 10 | 219.0 | 29 | < 0.0001 | 0.81 | ||||
9. ABD | 4 | 13.2 | 11 | 0.2822 | 33.4 | 47 | 0.9260 | 0.63 | 522 |
Urinary | 6 | 65.8 | 17 | < 0.0001 | 0.74 | ||||
10. URIN | 4 | 18.7 | 11 | 0.0674 | 7.0 | 32 | 1.0000 | 0.67 | 1040 |
Sexual | 8 | 230.4 | 31 | < 0.0001 | 0.95 | ||||
11. SEX | 4 | 15.8 | 15 | 0.3981 | 37.6 | 58 | 0.9825 | 0.91 | 320 |