Table 2 Primary and key secondary study outcomes
Gout storytelling N = 152 | Control N = 154 | Difference (95% CI) | p value | |
|---|---|---|---|---|
N (%) or estimate (95% CI) | N (%) or estimate (95% CI) | |||
Primary outcome; MEMSCap™ MPR | ||||
Baseline | 75.91 (71.71; 80.11) | 71.90 (67.75; 76.06) | 4.01 (−1.90; 9.91) | 0.18 |
3 months | 72.61 (67.88; 77.35) | 70.12 (65.49; 74.75) | 2.49 (−4.13; 9.12) | 0.46 |
6 months | 68.52 (63.40; 73.64) | 69.33 (64.36; 74.30) | -0.81 (−7.95; 6.33) | 0.82 |
9 months | 65.85 (60.14; 71.55) | 67.32 (61.84; 72.80) | −1.48 (−9.39; 6.44) | 0.72 |
12 months | 60.54 (54.29; 66.79) | 63.82 (57.83; 69.82) | −3.29 (−11.95; 5.38) | 0.46 |
Key secondary outcomes | ||||
1. Gout flares in last 1 month | ||||
Baseline | 1.38 (0.98; 1.77) | 1.42 (1.03; 1.81) | −0.044 (−0.60; 0.51) | 0.88 |
3 months | 1.29 (0.73; 1.85) | 1.53 (0.98; 2.07) | −0.24 (−1.02; 0.54) | 0.55 |
6 months | 1.32 (0.82; 1.83) | 1.55 (1.06; 2.03) | −0.23 (−0.93; 0.48) | 0.53 |
9 months | 0.74 (0.40; 1.08) | 1.27 (0.95; 1.59) | −0.53 (−0.99; −0.06) | 0.03 |
12 months | 0.74 (0.45; 1.02) | 0.99 (0.72; 1.26) | −0.26 (−0.65; 0.13) | 0.20 |
2. Voils self-reported ULT non-adherence | ||||
Baseline | 1.57 (1.46; 1.69) | 1.39 (1.28; 1.50) | 0.18 (0.02; 0.34) | 0.03 |
3 months | 1.49 (1.38; 1.61) | 1.46 (1.34; 1.57) | 0.04 (−0.13; 0.20) | 0.66 |
6 months | 1.45 (1.33; 1.57) | 1.45 (1.33; 1.57) | 0.01 (−0.16; 0.17) | 0.97 |
9 months | 1.40 (1.28; 1.52) | 1.48 (1.36; 1.59) | −0.08 (−0.24; 0.09) | 0.36 |
12 months | 1.46 (1.32; 1.59) | 1.46 (1.33; 1.60) | −0.01 (−0.20; 0.18) | 0.94 |
3. Total SATMED composite score (0–100) | ||||
Baseline | 79.98 (77.26; 82.71) | 78.29 (75.59; 81.00) | 1.69 (−2.16; 5.53) | 0.39 |
6 months | 63.74 (59.01; 68.47) | 66.28 (61.58; 70.98) | −2.54 (−9.21; 4.12) | 0.45 |
12 months | 62.16 (57.09; 67.23) | 67.43 (62.39; 72.47) | −5.27 (−12.42; 1.88) | 0.15 |
4. Serum urate, mg/dl | ||||
Baseline | 5.85 (5.56; 6.13) | 5.73 (5.45; 6.01) | 0.11 (−0.28; 0.51) | 0.57 |
6 months | 6.10 (5.64;6.56) | 5.79 (5.38; 6.20) | 0.31 (−0.30; 0.93) | 0.47 |
12 months | 5.94 (5.61; 6.27) | 5.72 (5.41; 6.04) | 0.22 (−0.23; 0.68) | 0.34 |
5. Serum urate, ≤ 6 mg/dl | ||||
Baseline | 88 (59.5%) | 91 (60.3%) | 0.97 (0.61; 1.54) | 0.89 |
6 months | 36 (52.9%) | 54 (63.5%) | 0.65 (0.34; 1.24) | 0.19 |
12 months | 67 (56.3%) | 79 (60.8%) | 0.83 (0.50; 1.38) | 0.47 |
6. Serum urate, ≤ 5 mg/dl | ||||
Baseline | 53 (35.8%) | 58 (38.4%) | 0.89 (0.56; 1.43) | 0.64 |
6 months | 20 (29.4%) | 30 (35.3%) | 0.76 (0.38; 1.52) | 0.44 |
12 months | 42 (35.3%) | 49 (37.7%) | 0.90 (0.54; 1.51) | 0.69 |
7. Gout-specific HRQOL on GAQ-GIS subscales | ||||
3 months | ||||
Gout concern overall | 47.40 (42.95; 51.86) | 46.52 (42.11; 50.92) | 0.89 (−5.38; 7.15) | 0.78 |
Gout medication side effects | 37.69 (33.29; 42.08) | 40.69 (36.35; 45.04) | −3.01 (−9.19; 3.17) | 0.34 |
Unmet gout treatment need | 30.85 (27.42; 34.27) | 38.20 (34.81; 41.59) | −7.35 (−12.17; −2.54) | 0.003 |
Well-being during attack | 49.85 (45.37; 54.32) | 40.06 (35.67; 44.45) | 9.79 (3.52; 16.05) | 0.002 |
Gout concern during attack | 51.60 (46.96; 56.25) | 45.67 (41.07; 50.26) | 5.94 (−0.60; 12.47) | 0.08 |
6 months | ||||
Gout concern overall | 44.44 (39.84; 49.05) | 44.21 (39.79; 48.62) | 0.24 (−6.14; 6.61) | 0.94 |
Gout medication side effects | 32.84 (28.62; 37.06) | 39.60 (35.55; 43.65) | −6.76 (−12.61; −0.91) | 0.02 |
Unmet gout treatment need | 29.50 (26.29; 32.71) | 34.52 (31.44; 37.60) | −5.02 (−9.47; −0.57) | 0.03 |
Well-being during attack | 42.35 (37.61; 47.09) | 41.47 (36.92; 46.02) | 0.88 (−5.69; 7.45) | 0.79 |
Gout concern during attack | 47.27 (42.96; 51.59) | 45.71 (41.57; 49.85) | 1.56 (−4.42; 7.54) | 0.61 |
9 months | ||||
Gout concern overall | 57.22 (52.83; 61.62) | 58.32 (54.16; 62.48) | −1.09 (−7.14; 4.96) | 0.72 |
Gout medication side effects | 52.15 (47.85; 56.46) | 51.10 (47.03; 55.18) | 1.05 (−4.88; 6.98) | 0.73 |
Unmet gout treatment need | 43.24 (39.08; 47.40) | 47.61 (43.67; 51.55) | −4.37 (−10.10; 1.36) | 0.14 |
Well-being during attack | 41.11 (36.05; 46.17) | 39.97 (35.24; 44.70) | 1.14 (−5.79; 8.07) | 0.75 |
Gout concern during attack | 51.59 (47.24; 55.94) | 51.62 (47.50; 55.74) | −0.036 (−6.03; 5.95) | 0.99 |
12 months | ||||
Gout concern overall | 40.97 (36.17; 45.76) | 42.43 (37.84; 47.02) | −1.47 (−8.10; 5.17) | 0.66 |
Gout medication side effects | 33.20 (28.87; 37.52) | 36.18 (32.04; 40.33) | −2.99 (−8.98; 3.00) | 0.33 |
Unmet gout treatment need | 28.55 (25.66; 31.44) | 31.83 (29.06; 34.60) | −3.28 (−7.28; 0.73) | 0.11 |
Well-being during attack | 44.32 (39.24; 49.40) | 38.34 (33.49; 43.18) | 5.99 (−1.03; 13.00) | 0.10 |
Gout concern during attack | 45.59 (41.03; 50.16) | 43.37 (39.01; 47.74) | 2.22 (−4.10; 8.54) | 0.49 |
% with current gout flare | ||||
Baseline | 27 (17.8%) | 30 (19.6%) | 0.89 (0.50; 1.58) | 0.68 |
1 month | 9 (6.5%) | 20 (13.4%) | 0.45 (0.20; 1.02) | 0.06 |
3 months | 19 (14.3%) | 27 (19.4%) | 0.69 (0.36; 1.31) | 0.26 |
6 months | 12 (9.5%) | 20 (14.5%) | 0.62 (0.29; 1.33) | 0.22 |
9 months | 14 (11.6%) | 18 (13.2%) | 0.86 (0.41; 1.81) | 0.69 |
12 months | 9 (7.4%) | 13 (9.8%) | 0.74 (0.30; 1.79) | 0.50 |