Table 3.
Changes in patient-reported outcomes (PRO) scores from mixed model1 (N = 185)
Measure | Stable Group | Exacerbation Group | Difference in Differences | F-statistic | P-value | f2 Effect Sizec | 95% CI | ||
---|---|---|---|---|---|---|---|---|---|
Baseline Meanb | 12 week Meanb | Baseline Meanb | 12 week Meanb | ||||||
PROMIS Short Forms | |||||||||
Anger | 51.41 | 50.24 | 50.96 | 49.86 | 0.07 | 0.00 | 0.96 | 0.000 | [−0.001, 0.001] |
Anxiety | 53.99 | 51.25 | 58.11 | 54.30 | −1.06 | 3.18 | < 0.001 | 0.023 | [0.022, 0.024] |
Depression | 51.84 | 50.51 | 54.63 | 53.16 | −0.13 | 2.38 | < 0.05 | 0.018 | [0.017, 0.019] |
Fatigue | 55.37 | 54.75 | 61.63 | 56.97 | −4.04 | 4.89 | < 0.0001 | 0.036 | [0.035, 0.037] |
Pain Behavior | 53.63 | 52.12 | 55.54 | 53.63 | −0.39 | 0.06 | 0.80 | 0.000 | [−0.001, 0.001] |
Pain Interference | 57.29 | 55.66 | 59.43 | 57.26 | −0.53 | 0.15 | 0.70 | 0.001 | [0.000, 0.002] |
Physical Function | 36.97 | 37.29 | 34.50 | 35.35 | 0.54 | 1.41 | 0.17 | 0.011 | [0.011, 0.011] |
Discretionary Social Activities | 45.18 | 45.93 | 42.74 | 45.27 | 1.79 | 1.45 | 0.21 | 0.011 | [0.010, 0.012] |
Social Roles | 43.26 | 42.51 | 39.38 | 42.27 | 3.64 | 4.73 | < 0.001 | 0.035 | [0.034, 0.036] |
Dyspnea Severity | 51.15 | 50.69 | 56.70 | 54.22 | −2.01 | 2.68 | 0.10 | 0.017 | [0.015, 0.019] |
Functional Limitations | 50.36 | 50.33 | 53.86 | 52.14 | −1.69 | 1.77 | 0.18 | 0.015 | [0.013, 0.017] |
Global Physical | 39.20 | 39.56 | 35.98 | 37.60 | 1.26 | 1.86 | 0.17 | 0.008 | [0.007, 0.009] |
Global Mental | 43.75 | 43.07 | 45.02 | 44.71 | 0.37 | 0.12 | 0.73 | 0.001 | [0.000, 0.002] |
PROMIS CATs | |||||||||
Anger | 52.11 | 50.86 | 51.46 | 50.21 | 0.01 | 0.00 | 0.99 | 0.000 | [−0.001, 0.001] |
Anxiety | 54.99 | 52.13 | 59.64 | 55.42 | −1.36 | 2.75 | < 0.01 | 0.021 | [0.021, 0.021] |
Depression | 51.98 | 50.32 | 55.27 | 53.50 | −0.12 | 1.62 | 0.17 | 0.012 | [0.011, 0.013] |
Fatigue | 56.80 | 54.53 | 63.24 | 57.08 | −3.89 | 6.26 | < 0.0001 | 0.047 | [0.046, 0.048] |
Pain Behavior | 53.98 | 52.43 | 55.90 | 54.43 | 0.08 | 0.00 | 0.96 | 0.000 | [−0.001, 0.001] |
Pain Interference | 57.53 | 55.51 | 60.72 | 58.18 | −0.51 | 0.10 | 0.76 | 0.001 | [0.000, 0.002] |
Physical Function | 37.11 | 37.34 | 35.26 | 35.78 | 0.29 | 0.98 | 0.46 | 0.007 | [0.007, 0.007] |
Discretionary Social Activities | 44.33 | 45.57 | 41.99 | 44.91 | 1.68 | 1.19 | 0.31 | 0.009 | [0.008, 0.010] |
Social Roles | 42.89 | 42.61 | 39.54 | 42.31 | 3.05 | 3.03 | 0.02 | 0.024 | [0.023, 0.025] |
SGRQ | |||||||||
SGRQ Symptoms | 57.24 | 58.30 | 71.74 | 58.36 | −14.44 | 24.54 | < 0.0001 | 0.133 | [0.129, 0.137] |
SGRQ Activities | 68.61 | 67.09 | 77.35 | 72.26 | −3.57 | 2.03 | 0.15 | 0.011 | [0.009, 0.013] |
SGRQ Impacts | 40.66 | 40.15 | 53.25 | 43.18 | −9.56 | 15.31 | < 0.001 | 0.094 | [0.090, 0.098] |
SGRQ Total | 51.84 | 51.30 | 63.66 | 54.50 | −8.62 | 18.98 | < 0.0001 | 0.118 | [0.114, 0.122] |
MMRC | 41.28 | 37.85 | 53.04 | 48.95 | −0.66 | 0.02 | 0.89 | 0.000 | [−0.001, 0.001] |
aResults in this table come from a mixed-effects model that included age, number of exacerbations in past year, group (fixed effect; i.e., stable or exacerbation), time (fixed effect; i.e., baseline or 12 weeks) and group-by-time interaction; bleast square means; cCohen f2, ≥0.02 = small, ≥0.15 = medium, ≥0.35 large; CAT Computer adaptive test, SGRQ St. George’s Respiratory Questionnaire, MMRC Modified Medical Research Council dyspnea scale