Table 3.
Baseline and 12-week estimated outcome metrics following an ITT and PP analysis for each of the racial and ethnic groups (outcomes filtered at baseline as explained in the table)a.
| Outcome and time | Asian | Black | Hispanic | Non-Hispanic White | Other | Entire cohort | ||||||||||||||||||||||||
|
|
ITTb | PPc | ITT | PP | ITT | PP | ITT | PP | ITT | PP | ITT | PP | ||||||||||||||||||
| Pain level, mean (95% CI) | ||||||||||||||||||||||||||||||
|
|
Baseline | 4.6 (4.5-4.8) | 4.6 (4.5-4.8) | 5.6 (5.4-5.7) | 5.5 (85.4-5.7) | 5.3 (5.1-5.4) | 5.3 (5.1-5.5) | 4.8 (4.7-4.8) | 4.7 (4.6-4.7) | 4.8 (4.6-5.0) | 4.7 (4.5-4.9) | 4.9 (4.8-4.9) | 4.8 (4.8-4.9) | |||||||||||||||||
|
|
12 weeks | 2.6 (2.4-2.8) | 2.6 (2.4-2.8) | 3.2 (3.0-3.5) | 3.2 (2.9-3.5) | 2.7 (2.5-3.0) | 2.7 (2.4-2.9) | 2.8 (2.8-2.9) | 2.8 (2.7-2.9) | 2.9 (2.6-3.2) | 2.8 (2.5-3.1) | 2.9 (2.8-2.9) | 2.8 (2.7-2.9) | |||||||||||||||||
|
|
P value | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | |||||||||||||||||
|
|
Mean change, OR (95% CI) | 2.02 (1.80- 2.25) | 2.00 (1.77- 2.24) | 2.35 (2.10- 2.61) | 2.35 (2.1- 2.6) | 2.55 (2.30- 2.81) | 2.63 (2.37- 2.88) | 1.91 (1.82- 1.99) | 1.88 (1.79- 1.97) | 1.88 (1.56- 2.21) | 1.90 (1.58- 2.22) | 2.0 (1.9-2.1) | 2.0 (1.9- 2.1) | |||||||||||||||||
| Surgery intent>0, mean (95% CI) | ||||||||||||||||||||||||||||||
|
|
Baseline | 18.6 (16.6- 20.7) | 17.4 (15.1- 19.6) | 28.8 (26.3- 31.3) | 27.7 (24.8- 30.6) | 25.9 (23.4- 28.4) | 25.6 (22.6- 28.7) | 24.1 (23.1- 25.0) | 22.8 (21.8- 23.9) | 21.5 (18.1- 25.0) | 21.1 (17.2- 25.0) | 24.2 (23.4- 24.9) | 23.1 (22.2- 24.0) | |||||||||||||||||
|
|
12 weeks | 9.1 (6.0- 12.2) | 8.6 (5.4- 11.8) | 15.0 (11.0- 19.0) | 14.1 (10.0- 18.2) | 11.8 (8.5- 15.0) | 11.1 (7.8- 14.4) | 13.5 (12.1- 14.9) | 12.3 (10.9- 13.7) | 10.0 (5.6- 14.4) | 9.9 (5.2- 14.6) | 13.0 (11.9- 14.2) | 12.0 (10.9- 13.2) | |||||||||||||||||
|
|
P value | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | |||||||||||||||||
|
|
Mean change | 9.54 (6.14- 12.93) | 8.79 (5.28- 12.29) | 13.85 (9.80- 17.91) | 13.62 (9.48- 17.75) | 14.16 (10.85- 17.46) | 14.46 (11.14- 17.98) | 10.54 (9.22- 11.85) | 10.51 (9.20- 11.83) | 11.56 (7.46- 15.65) | 11.18 (6.89- 15.47) | 11.1 (10.0- 12.3) | 11.1 (9.9- 12.2) | |||||||||||||||||
| GAD-7d ≥5, mean (95% CI) | ||||||||||||||||||||||||||||||
|
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Baseline | 8.1 (7.6- 8.5) | 8.0 (7.5- 8.5) | 9.2 (8.8- 9.7) | 9.0 (8.4- 9.6) | 9.9 (9.4- 10.4) | 9.8 (9.1- 10.4) | 8.8 (8.6- 9.0) | 8.6 (8.4- 8.8) | 9.5 (8.8- 10.2) | 9.1 (8.3- 9.9) | 8.9 (8.8-9.1) | 8.7 (8.5- 8.9) | |||||||||||||||||
|
|
12 weeks | 3.6 (2.9- 4.3) | 3.7 (2.9- 4.4) | 4.3 (3.5- 5.1) | 4.1 (3.3- 4.9) | 4.9 (3.8- 6.1) | 4.9 (3.7- 6.1) | 4.9 (4.6- 5.3) | 4.8 (4.4- 5.2) | 5.2 (3.6- 6.8) | 5.0 (3.3- 6.7) | 4.8 (4.5-5.1) | 4.7 (4.4- 5.0) | |||||||||||||||||
|
|
P value | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | |||||||||||||||||
|
|
Mean change | 4.44 (3.62- 5.26) | 4.37 (3.51- 5.22) | 4.92 (4.18- 5.66) | 4.91 (4.17- 6.65) | 4.93 (3.78- 6.08) | 4.86 (3.68- 6.04) | 3.87 (3.55- 4.20) | 3.77 (3.44- 4.10) | 4.30 (2.65- 5.95) | 4.07 (2.33- 5.81) | 4.1 (3.8- 4.4) | 4.0 (3.7- 4.3) | |||||||||||||||||
| PHQ-9e ≥5, mean (95% CI) | ||||||||||||||||||||||||||||||
|
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Baseline | 8.2 (7.7- 8.8) | 8.0 (7.4- 8.7) | 9.5 (8.9- 10.0) | 9.0 (8.4- 3.2) | 10.0 (9.4- 10.7) | 9.6 (8.8- 10.4) | 9.5 (9.2- 9.7) | 9.2 (9.0- 9.5) | 10.0 (9.1- 10.9) | 9.5 (8.4- 10.5) | 9.5 (9.3-9.7) | 9.1 (8.9- 9.4) | |||||||||||||||||
|
|
12 weeks | 3.8 (2.7- 4.8) | 3.6 (2.5- 4.7) | 4.7 (3.5- 5.9) | 4.4 (3.2- 5.5) | 6.4 (4.9- 7.9) | 6.2 (4.7- 7.8) | 5.2 (4.8- 5.7) | 5.0 (4.5- 5.4) | 6.6 (4.7- 8.4) | 6.2 (4.3- 8.1) | 5.2 (4.9-5.6) | 5.0 (4.6- 5.4) | |||||||||||||||||
|
|
P value | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | 0.001 | <.001 | <.001 | |||||||||||||||||
|
|
Mean change | 4.49 (3.47- 5.52) | 4.41 (3.36- 5.46) | 4.80 (3.63- 5.96) | 4.66 (3.48- 5.83) | 3.68 (2.19- 5.16) | 3.38 (1.86- 4.89) | 4.30 (3.86- 4.74) | 4.24 (3.80- 4.68) | 3.41 (1.54- 5.29) | 3.29 (1.33- 5.26) | 4.3 (4.6-3.9) | 4.2 (3.8- 4.5) | |||||||||||||||||
| WPAI overall work impairmentf >0, mean (95% CI) | ||||||||||||||||||||||||||||||
|
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Baseline | 27.5 (25.8-29.1) | 27.1 (25.2- 29.0) | 35.6 (33.6- 37.6) | 35.0 (32.7- 37.3) | 33.5 (31.4- 35.6) | 33.1 (30.5- 35.6) | 29.0 (28.3- 29.7) | 28.3 (27.5- 29.2) | 29.4 (26.8- 32.0) | 28.9 (26.0- 31.8) | 29.9 (29.4- 30.5) | 29.4 (28.7- 30.0) | |||||||||||||||||
|
|
12 weeks | 13.3 (10.1- 16.5) | 12.7 (9.5- 15.9) | 15.9 (12.3- 19.6) | 15.9 (12.2- 19.6) | 18.3 (13.6- 23.1) | 18.3 (13.5- 23.1) | 16.0 (14.7- 17.4) | 15.5 (14.1- 16.8) | 17.8 (13.3- 22.4) | 17.8 (13.1- 22.5) | 16.1 (15.0- 17.3) | 15.7 (14.5- 18.8) | |||||||||||||||||
|
|
P value | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | |||||||||||||||||
|
|
Mean change | 14.12 (10.83- 17.40) | 14.41 (11.08- 17.74) | 19.64 (15.91- 23.37) | 19.14 (15.30- 22.97) | 15.18 (10.25- 20.10) | 14.80 (9.78- 19.83) | 12.96 (11.61- 14.31) | 12.86 (11.49- 14.22) | 11.55 (6.93- 16.17) | 11.11 (6.32- 15.90) | 13.8 (12.6- 15.0) | 13.7 (12.5- 14.9) | |||||||||||||||||
| WPAI work impairment>0, mean (95% CI) | ||||||||||||||||||||||||||||||
|
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Baseline | 26.3 (24.7- 27.9) | 25.9 (24.1- 27.7) | 34.2 (32.3- 36.1) | 33.7 (31.5- 36.0) | 32.1 (30.1- 34.1) | 31.3 (28.9- 33.7) | 28.0 (27.4- 28.7) | 27.3 (26.5- 28.1) | 28.2 (25.7- 30.6) | 27.5 (24.8- 30.2) | 28.8 (28.3-29.4) | 28.2 (27.5- 28.8) | |||||||||||||||||
|
|
12 weeks | 11.7 (9.0- 14.4) | 11.1 (8.4- 13.8) | 14.8 (11.4- 18.3) | 14.8 (11.2- 18.3) | 17.2 (12.6- 21.7) | 17.0 (12.4- 21.6) | 14.8 (13.6- 16.1) | 14.3 (13.0- 15.5) | 16.2 (12.2- 20.3) | 16.2 (12.0- 20.4) | 14.8 (13.8-15.9) | 14.4 (13.3- 15.5) | |||||||||||||||||
|
|
P value | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | |||||||||||||||||
|
|
Mean change | 14.57 (11.75- 17.38) | 14.80 (11.96- 17.65) | 19.35 (15.74- 22.96) | 18.97 (15.24-22.70) | 14.91 (10.20- 19.62) | 14.35 (9.55- 19.15) | 13.21 (11.95- 14.46) | 13.03 (11.76- 14.31) | 11.92 87.76- 16.08) | 11.35 (7.05- 15.66) | 14.0 (12.9- 15.1) | 13.8 (12.7- 14.9) | |||||||||||||||||
| WPAI work time missed>0, mean (95% CI) | ||||||||||||||||||||||||||||||
|
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Baseline | 19.0 (14.0- 24.0) | 20.2 (14.1- 26.4) | 37.4 (30.5- 44.4) | 33.0 (25.2- 40.8 | 28.5 (22.1- 35.0) | 26.8 (19.9- 33.7) | 23.0 (20.5- 25.4) | 21.6 (19.0- 24.3) | 29.5 (20.9- 38.1) | 26.8 (17.0- 36.5) | 25.5 (23.4- 27.5) | 23.9 (21.7- 26.2) | |||||||||||||||||
|
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12 weeks | 7.7 (0- 17.0) | 7.1 (0- 16.3) | 13.2 (4.0- 22.4) | 13.2 (4.1- 22.2) | 7.3 (3.0- 11.5) | 7.4 (2.8- 12.0) | 8.4 (5.5- 11.3) | 8.2 (5.3- 11.1) | 5.6 (0- 14.24) | 16.2 (12.0- 20.4) | 8.7 (6.1- 11.2) | 8.5 (6.1- 11.0) | |||||||||||||||||
|
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P value | 0.04 | 0.03 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | 0.001 | <.001 | <.001 | |||||||||||||||||
|
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Mean change | 11.27 (0.36- 22.17) | 13.08 (1.55- 24.61) | 24.20 (14.83- 33.58) | 19.81 (10.84- 28.78) | 21.15 (15.02- 27.48) | 19.42 (13.04- 25.81) | 14.55 (11.06- 18.03) | 13.44 (9.88- 17.00) | 23.92 (11.47- 36.37) | 21.70 (8.51- 34.88) | 16.8 (19.8- 13.8) | 15.4 (12.5- 18.4) | |||||||||||||||||
| WPAI activity impairment>0, mean (95% CI) | ||||||||||||||||||||||||||||||
|
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Baseline | 32.8 (31.1- 34.4) | 33.2 (31.3- 35.1) | 42.0 (40.3- 43.8) | 41.9 (39.9- 43.9) | 39.5 (37.7- 41.3) | 38.4 (36.2- 40.5) | 37.1 (36.5- 37.7) | 36.2 (35.5- 37.0) | 37.7 (35.4- 40.1) | 37.6 (34.9- 40.4) | 37.4 (36.9- 38.0) | 36.8 (36.2- 37.4) | |||||||||||||||||
|
|
12 weeks | 15.7 (13.3 -18.2) | 15.7 (13.1- 18.2) | 21.6 (18.3- 24.8) | 21.6 (18.3- 24.9) | 18.5 (15.4- 21.5) | 17.9 (14.8- 21.0) | 20.2 (19.2- 21.3) | 19.6 (18.5- 20.6) | 23.2 (19.2- 27.5) | 22.3 (18.3- 26.4) | 20.1 (19.2- 20.9) | 19.5 (18.6-20.4) | |||||||||||||||||
|
|
P value | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | <.001 | |||||||||||||||||
|
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Mean changes | 17.05 (14.39-19.71) | 17.53 (14.76-20.31) | 20.49 (17.13-23.84) | 20.34 (16.87-23.80) | 21.03 (17.89-24.18) | 20.50 (17.27-23.73) | 16.85 (15.82-17.88) | 16.67 (15.62-17.72) | 14.40 (10.1-18.7) | 15.26 (10.95-19.57) | 17.4 (16.5-18.3) | 17.3 (16.4-18.2) | |||||||||||||||||
aData represent the mean (95% CI). P values represent comparisons between 12-week and baseline means with statistically significant P values italicized.
bITT: intention-to-treat analysis.
cPP: per-protocol analysis.
dGAD-7: Generalized Anxiety Disorder 7-item scale.
ePHQ-9: Patient Health 9-item questionnaire.
fWPAI: Work Productivity and Activity Impairment Questionnaire.