Table 2.
Comparison of Treatment Groups on Primary and Secondary MOPSE Outcomes
| Primary Outcomes | ||||
|---|---|---|---|---|
| OMT | LT | CCO | p valuea | |
| Hospital Length of Stay (days) | ||||
| ITT Analysis | (n = 130) | (n = 124) | (n = 133) | |
| mean (SD) | 4.5 (2.7) | 4.9 (2.7) | 4.5 (2.6) | |
| median (95% CI) | 3.9 (3.4-4.7) | 4.5 (3.8-4.9) | 4.3 (3.9-4.9) | 0.53 |
| PP Analysis | (n = 96) | (n = 95) | (n = 127) | |
| mean (SD) | 4.0 (2.0) | 4.4 (2.4) | 4.5 (2.6) | |
| median (95% CI) | 3.5 (3.2-4.0) | 3.9 (3.5-4.8) | 4.5 (3.9-4.9) | 0.01 (OMT<CCO) |
| Time to Clinical Stability (days) | ||||
| ITT Analysis | (n = 121) | (n = 118) | (n = 130) | |
| mean (SD) | 2.5 (1.6) | 2.5 (1.4) | 2.6 (1.6) | |
| median (95% CI) | 2.0 (2.0-2.0) | 2.0 (2.0-3.0) | 2.0 (2.0-2.0) | 0.97 |
| PP Analysis | (n = 90) | (n = 90) | (n = 124) | |
| mean (SD) | 2.3 (1.4) | 2.5 (1.5) | 2.6 (1.6) | |
| median (95% CI) | 2.0 (2.0-2.0) | 2.0 (2.0-2.0) | 2.0 (2.0-2.0) | 0.47 |
| Symptomatic and Functional RecoveryScore | ||||
| ITT Analysis - mean (SD) | (n = 99) | (n = 102) | (n = 99) | |
| - Admission | 11.9 (4.6) | 11.6 (4.4) | 10.6 (4.6) | |
| - 14-day | 5.8 (4.5) | 5.0 (4.0) | 4.4 (3.7) | Interaction (GroupxTime) |
| - 30-day | 4.1 (4.4) | 4.2 (3.6) | 4.4 (3.7) | p = 0.24 |
| - 60-day | 4.0 (4.7) | 4.0 (4.1) | 3.4 (3.6) | Group p = 0.47 |
| PP Analysis - mean (SD) | (n = 80) | (n = 80) | (n = 91) | |
| - Admission | 11.6 (4.5) | 11.6 (4.4) | 10.5 (4.6) | |
| - 14-day | 5.1 (3.9) | 4.6 (3.8) | 4.1 (3.4) | Interaction (GroupxTime) |
| - 30-day | 3.8 (4.3) | 4.0 (3.8) | 4.2 (3.7) | p = 0.24 |
| - 60-day | 3.6 (4.9) | 3.9 (4.2) | 3.2 (3.6) | Group p = 0.73 |
| Secondary Outcomes | ||||
| Duration of Intravenous Antibiotic Use(days) | ||||
| ITT Analysis | (n = 130) | (n = 124) | (n = 133) | |
| mean (SD) | 3.7 (2.6) | 3.9 (2.5) | 3.9 (2.5) | |
| median (95% CI) | 3.3 (2.9-3.7) | 3.7 (2.9-3.9) | 3.5 (3.1-3.9) | 0.44 |
| PP Analysis | (n = 96) | (n = 95) | (n = 127) | |
| mean (SD) | 3.4 (1.9) | 3.7 (2.5) | 3.9 (2.5) | |
| median (95% CI) | 3.0 (2.7-3.5) | 3.3 (2.7-3.8) | 3.5 (3.2-3.9) | 0.05 (OMT<CCO) |
| Duration of Total (Intravenous+Oral) Antibiotic Use (days) | ||||
| ITT Analysis | (n = 130) | (n = 124) | (n = 133) | |
| mean (SD) | 4.2 (2.7) | 4.6 (2.5) | 4.5 (2.5) | |
| median (95% CI) | 3.6 (3.2-4.3) | 4.1 (3.7-4.8) | 4.0 (3.6-4.8) | 0.43 |
| PP Analysis | (n = 96) | (n = 95) | (n = 127) | |
| mean (SD) | 4.0 (2.0) | 4.4 (2.4) | 4.5 (2.5) | |
| median (95% CI) | 3.5 (3.0-3.9) | 3.7 (3.1-4.6) | 4.0 (3.6-4.8) | 0.08 |
| Treatment Endpoint | ||||
| ITT Analysis | (n = 124) | (n = 124) | (n = 132) | |
| n (%) Death | 2 (2) | 3 (3) | 8 (6) | 0.08 |
| n (%) Respiratory Failure | 4 (3) | 4 (3) | 10 (8) | |
| n (%) Discharge | 118 (95) | 117 (94) | 114 (86) | |
| PP Analysis | (n = 96) | (n = 95) | (n = 127) | |
| n (%) Death | 0 (0) | 3 (3) | 8 (6) | 0.006b |
| n (%) Respiratory Failure | 1 (1) | 2 (2) | 9 (7) | |
| n (%) Discharge | 95 (99) | 90 (95) | 110 (87) | |
| 60-day Hospital ReadmissionRate | ||||
| ITT Analysis | (n = 93) | (n = 96) | (n = 96) | |
| n (%) Readmission | 16 (17) | 20 (21) | 21 (22) | 0.64 |
| PP Analysis | (n = 80) | (n = 79) | (n = 92) | |
| n (%) Readmission | 9 (11) | 16 (20) | 19 (21) | 0.16 |
ITT = intention-to-treat, PP = per-protocol, OMT = osteopathic manipulative treatment, LT = light-touch treatment, CCO = conventional care only, CI = confidence interval.
a P values are for overall comparisons across three groups. Results from multiple comparisons are reported in parentheses.
b Death and respiratory failure were less common in the OMT group compared to the CCO group.