Table 2 |
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|
Comparison of Treatment Groups on Primary and Secondary MOPSE Outcomes |
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|
Primary Outcomes |
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|
|
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|
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 |
|
|
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|
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. |
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|
Noll et al. Osteopathic Medicine and Primary Care 2010 4:2 doi:10.1186/1750-4732-4-2 |
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