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Table 2 Primary and key secondary study outcomes

From: SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout

  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
  1. ULT urate-lowering therapy, MPR Medication Possession Ratio, SATMED Satisfaction with Medications Questionnaire, HRQOL health-related quality of life, GAQ-GIS Gout Impact scale of the Gout assessment questionnaire