PRO Instrument | Baseline (n = 89) | Longitudinal phase1 (n = 38) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FACIT-Fatigue | β | 95% CI | Wald Chi-square | *p | Time points | FACIT-Fatigue | Model Effects Test | |||||||
Score < 34 | Score ≥ 34 | Lower | Upper | Score < 34 | Score ≥ 34 | Effects | Df | **p | ||||||
HADS-A | 10.94 ± 0.98a | 7.16 ± 0.86b | -3.779 | -5.498 | -2.059 | 18.546 |  < 0.001 |  |  | 8.21 ± 1.11a | 6.57 ± 0.89b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 9.33 ± 1.15a | 10.43 ± 1.25 | 8.22 ± 1.17a | Time points | 2 | 0.035 |
 |  |  |  |  |  |  | T1 | 6.91 ± 0.96b | 7.56 ± 1.22 | 6.26 ± 0.90b | FACIT-Fatigue | 1 | 0.028 | |
 |  |  |  |  |  |  | T2 | 5.94 ± 1.38a,b | 6.63 ± 1.72 | 5.25 ± 1.31a,b | Interaction2 | 2 | 0.602 | |
HADS-D | 10.15 ± 1.00a | 5.35 ± 0.88b | -4.799 | -6.559 | -3.038 | 28.544 |  < 0.001 |  |  | 8.22 ± 1.19a | 6.61 ± 0.98b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 7.50 ± 1.29 | 8.59 ± 1.40 | 6.42 ± 1.32 | Time points | 2 | 0.697 |
 |  |  |  |  |  |  | T1 | 7.15 ± 1.06 | 7.79 ± 1.31 | 6.50 ± 1.00 | FACIT-Fatigue | 1 | 0.027 | |
 |  |  |  |  |  |  | T2 | 7.60 ± 1.47 | 8.30 ± 1.72 | 6.91 ± 1.41 | Interaction2 | 2 | 0.676 | |
HAQ | 1.39 ± 0.14a | 0.83 ± 0.12b | -0.554 | -0.803 | -0.304 | 18.947 |  < 0.001 |  |  | 1.02 ± 0.16a | 0.76 ± 0.13b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 0.81 ± 0.17 | 0.95 ± 0.19 | 0.68 ± 0.18 | Time points | 2 | 0.614 |
 |  |  |  |  |  |  | T1 | 0.86 ± 0.14 | 1.00 ± 0.18 | 0.71 ± 0.13 | FACIT-Fatigue | 1 | 0.022 | |
 |  |  |  |  |  |  | T2 | 0.99 ± 0.20 | 1.10 ± 0.24 | 0.89 ± 0.18 | Interaction2 | 2 | 0.907 | |
CS-31 Total Score | 94.20 ± 5.88a | 59.87 ± 4.86b | -34.337 | -45.278 | -23.397 | 37.839 |  < 0.001 |  |  | 72.10 ± 8.33a | 57.24 ± 6.88b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 65.76 ± 9.17 | 76.13 ± 10.02 | 55.38 ± 9.36 | Time points | 2 | 0.545 |
 |  |  |  |  |  |  |  | T1 | 62.05 ± 7.21 | 65.61 ± 9.01 | 58.49 ± 6.94 | FACIT-Fatigue | 1 | 0.007 |
 |  |  |  |  |  |  |  | T2 | 66.21 ± 9.94 | 74.57 ± 11.66 | 57.84 ± 9.61 | Interaction2 | 2 | 0.219 |
CS-31 Menopause and Health Domain | 50.00 ± 3.08a | 32.86 ± 2.55b | -17.143 | -22.882 | -11.405 | 34.284 |  < 0.001 |  |  | 35.17 ± 4.08a | 29.25 ± 3.21b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 30.45 ± 4.19 | 33.76 ± 4.72 | 27.14 ± 4.35 | Time points | 2 | 0.771 |
 |  |  |  |  |  |  | T1 | 31.83 ± 3.40 | 32.98 ± 4.44 | 30.69 ± 3.26 | FACIT-Fatigue | 1 | 0.042 | |
 |  |  |  |  |  |  | T2 | 34.36 ± 4.95 | 38.78 ± 6.08 | 29.93 ± 4.70 | Interaction2 | 2 | 0.385 | |
CS-31 Psychological Domain | 26.25 ± 2.46a | 10.03 ± 2.03b | -16.214 | -20.792 | -11.636 | 48.180 |  < 0.001 |  |  | 15.89 ± 3.41a | 9.60 ± 2.76b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 17.52 ± 3.68 | 24.11 ± 4.05a | 10.94 ± 3.78 | Time points | 2 | 0.060 |
 |  |  |  |  |  |  | T1 | 10.60 ± 2.92 | 11.48 ± 3.81b | 9.71 ± 2.79 | FACIT-Fatigue | 1 | 0.008 | |
 |  |  |  |  |  |  | T2 | 10.11 ± 3.94 | 12.09 ± 4.74a,b | 8.14 ± 3.78 | Interaction2 | 2 | 0.004 | |
CS-31 Sexuality Domain | 12.78 ± 1.58 | 12.53 ± 1.30 | -0.250 | -3.183 | 2.683 | 0.028 | 0.867 |  |  | 13.27 ± 2.29 | 12.29 ± 1.84 |  |  |  |
 |  |  |  |  |  |  |  | T0 | 11.82 ± 2.46 | 11.69 ± 2.73 | 11.95 ± 2.53 | Time points | 2 | 0.541 |
 |  |  |  |  |  |  | T1 | 12.20 ± 1.95 | 12.45 ± 2.51 | 11.96 ± 1.87 | FACIT-Fatigue | 1 | 0.530 | |
 |  |  |  |  |  |  | T2 | 14.32 ± 2.68 | 15.66 ± 3.24 | 12.98 ± 2.56 | Interaction2 | 2 | 0.494 | |
CS-31 Couple Relations Domain | 5.08 ± 1.46 | 4.49 ± 1.20 | -0.591 | -3.302 | 2.120 | 0.182 | 0.669 |  |  | 9.27 ± 1.79a | 6.17 ± 1.48b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 6.31 ± 1.96 | 7.52 ± 2.13 | 5.10 ± 2.01 | Time points | 2 | 0.355 |
 |  |  |  |  |  |  | T1 | 8.47 ± 1.56 | 10.34 ± 2.06 | 6.59 ± 1.50 | FACIT-Fatigue | 1 | 0.008 | |
 |  |  |  |  |  |  | T2 | 8.38 ± 2.05 | 9.95 ± 2.40 | 6.81 ± 1.99 | Interaction2 | 2 | 0.766 | |
CS-31 Vasomotor Subdomain | 11.02 ± 1.20a | 8.74 ± 0.99b | -2.279 | -4.509 | -0.050 | 4.015 | 0.045 |  |  | 7.28 ± 1.68a | 6.80 ± 1.33b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 6.59 ± 1.78 | 6.56 ± 1.99 | 6.63 ± 1.85 | Time points | 2 | 0.922 |
 |  |  |  |  |  |  | T1 | 7.15 ± 1.42 | 7.11 ± 1.92 | 7.19 ± 1.36 | FACIT-Fatigue | 1 | 0.684 | |
 |  |  |  |  |  |  | T2 | 7.37 ± 1.90 | 8.16 ± 2.36 | 6.58 ± 1.81 | Interaction2 | 2 | 0.647 | |
CS-31 Health Subdomain | 16.75 ± 1.17a | 10.42 ± 0.97b | -6.325 | -8.513 | -4.138 | 32.115 |  < 0.001 |  |  | 11.30 ± 1.92a | 7.91 ± 1.47b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 9.87 ± 1.98 | 12.36 ± 2.26 | 7.40 ± 2.06 | Time points | 2 | 0.502 |
 |  |  |  |  |  |  | T1 | 8.83 ± 1.58 | 9.07 ± 2.12 | 8.59 ± 1.51 | FACIT-Fatigue | 1 | 0.019 | |
 |  |  |  |  |  |  | T2 | 10.12 ± 2.20 | 12.48 ± 2.84 | 7.76 ± 2.06 | Interaction2 | 2 | 0.097 | |
CS-31 Aging Subdomain | 22.24 ± 1.74a | 13.70 ± 1.44b | -8.539 | -11.777 | -5.301 | 26.721 |  < 0.001 |  |  | 17.19 ± 2.25a | 14.09 ± 1.85b |  |  |  |
 |  |  |  |  |  |  |  | T0 | 14.29 ± 2.47 | 15.40 ± 2.71 | 13.19 ± 2.52 | Time points | 2 | 0.727 |
 |  |  |  |  |  |  | T1 | 15.66 ± 1.94 | 17.26 ± 2.39 | 14.07 ± 1.87 | FACIT-Fatigue | 1 | 0.036 | |
 |  |  |  |  |  |  | T2 | 16.97 ± 2.72 | 18.92 ± 3.22 | 15.02 ± 2.62 | Interaction2 | 2 | 0.765 | |
CS-31 Aching in muscles and/or joints | 4.19 ± 0.35a | 3.41 ± 0.31b | -0.779 | -1.394 | -0.165 | 6.176 | 0.013 |  |  | 3.79 ± 0.49 | 3.29 ± 0.39 |  |  |  |
 |  |  |  |  |  |  |  | T0 | 3.33 ± 0.51 | 3.25 ± 0.56 | 3.41 ± 0.52 | Time points | 2 | 0.502 |
 |  |  |  |  |  |  | T1 | 3.40 ± 0.44 | 3.73 ± 0.60 | 3.07 ± 0.41 | FACIT-Fatigue | 1 | 0.110 | |
 |  |  |  |  |  |  | T2 | 3.89 ± 0.56 | 4.40 ± 0.67 | 3.39 ± 0.53 | Interaction2 | 2 | 0.057 |