Table 2.
Mixed-effect linear regression model estimated means and change in means from pre-injection to approximate 3-month, 6-month, 1-year, and 2-year post-injection follow-up, and responder and worst-case responder analysis. The worst-case responder analysis was conducted under the assumption that patients who were missing data at the pre- and/or post-injection time point did not improve by the MCID.
| Time | N | Estimated Mean (95 % CI) | Estimated Mean Change From Pre-Injection (95 % CI) |
P-value | Responder (Improved by MCID) Proportion (%) |
Worst-Case Responder Analysis |
|
|---|---|---|---|---|---|---|---|
| NRS Arm (MCID = 2) | Pre-Injection | 217 | 6.89 (6.57, 7.22) | ||||
| 3-month | 163 | 3.21 (2.81, 3.60) | −3.68 (−4.10, −3.27) | <0.001 | 117/163 (71.8 %) | 117/219 (53.4 %) | |
| 6-month | 38 | 3.25 (2.50, 4.02) | −3.64 (−4.40, −2.89) | <0.001 | 27/38 (71.1 %) | 27/219 (12.3 %) | |
| 1-year | 36 | 2.65 (1.92, 3.43) | −4.24 (−5.02, −3.47) | <0.001 | 29/36 (80.6 %) | 29/219 (13.2 %) | |
| 2-year | 17 | 2.30 (1.14, 3.33) | −4.60 (−5.69, −3.50) | <0.001 | 15/17 (88.2 %) | 15/219 (6.8 %) | |
| PHQ-9 (MCID = 5) | Pre-Injection | 97 | 9.01 (7.81, 10.32) | ||||
| 3-month | 77 | 7.01 (5.65, 8.31) | −2.00 (−3.39, −0.62) | 0.005 | 20/71 (28.2 %) | 20/219 (9.1 %) | |
| 6-month | 43 | 6.66 (4.92, 8.21) | −2.35 (−4.07, −0.64) | 0.007 | 9/39 (23.1 %) | 9/219 (4.1 %) | |
| 1-year | 51 | 7.66 (6.15, 9.32) | −1.35 (−2.96, 0.26) | 0.101 | 13/46 (28.3 %) | 13/219 (5.9 %) | |
| 2-year | 29 | 6.95 (5.22, 9.02) | −2.06 (−4.08, −0.04) | 0.046 | 6/25 (24.0 %) | 6/219 (2.7 %) | |
| PROMIS-GH Physical (MCID = 5) | Pre-Injection | 82 | 38.17 (36.43, 39.78) | ||||
| 3-month | 68 | 40.87 (39.25, 42.60) | 2.70 (1.24, 4.16) | <0.001 | 22/63 (34.9 %) | 22/219 (10.0 %) | |
| 6-month | 42 | 40.86 (38.89, 42.73) | 2.69 (0.95, 4.43) | 0.003 | 10/38 (26.3 %) | 10/219 (4.6 %) | |
| 1-year | 51 | 41.69 (39.78, 43.53) | 3.52 (1.90, 5.13) | <0.001 | 18/48 (37.5 %) | 18/219 (8.2 %) | |
| 2-year | 28 | 41.77 (39.44, 44.13) | 3.60 (1.55, 5.64) | <0.001 | 8/25 (32.0 %) | 8/219 (3.7 %) | |
| PROMIS-GH Mental (MCID = 5) | Pre-Injection | 80 | 45.62 (43.60, 47.71) | ||||
| 3-month | 69 | 46.01 (43.91, 48.17) | 0.39 (−1.23, 2.01) | 0.636 | 16/63 (25.4 %) | 16/219 (7.3 %) | |
| 6-month | 43 | 46.39 (44.16, 48.77) | 0.77 (−1.16, 2.71) | 0.432 | 8/38 (21.1 %) | 8/219 (3.7 %) | |
| 1-year | 50 | 45.15 (42.83, 47.30) | −0.47 (−2.30, 1.37) | 0.616 | 8/45 (17.8 %) | 8/219 (3.7 %) | |
| 2-year | 28 | 48.31 (45.78, 50.74) | 2.69 (0.41, 4.97) | 0.021 | 12/25 (48.0 %) | 12/219 (5.5 %) |
CI – confidence interval; MCID – minimal clinically important difference.