Table 4.
KQ1. What is the efficacy and effectiveness of MPSS compared with no pharmacologic treatment? | Effect Size | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Outcome | No. of Studies; Sample Size | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Overall Quality of Evidence | Mean Difference (95% CI, P Value) | ||
Motor scores | 6 months 2 RCTs (N = 414)23,24 12 months 2 RCTs (N = 335)22,25 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 6 months 1.19 (−2.34, 4.72); P = .51 12 months −1.17 (−4.80, 2.47); P = .53 | ||
Pinprick | 6 months 1 RCTs (N = 296)23 12 months 2 RCTs (N = 334)22,25 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 6 months 3.37 (0.75, 5.99); P = .01 12 months 0.18 (−2.66, 3.02); P = .90 | ||
Light touch | 6 months 1 RCTs (N = 294) 23 12 months 2 RCTs (N = 334) 22,25 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 6 months 2.88 (0.10, 5.66); P = .04 12 months 0.74 (−2.12, 3.61); P = .61 | ||
KQ2. What is the safety profile of MPSS compared with no pharmacologic treatment? | MPSS % | Control % | ||||||||
Death | 3 RCTs (N = 530)22–24,27 1 non RCT (N = 88)26 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 2.58% (8/310) | 4.87% (15/308) | −1.51 (−4.13, 1.12); P = .26 |
Wound infection | 3 RCTs (N = 434)22,23,25,27 1 Non-RCT (N = 88)26 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 4.26% (11/258) | 2.27% (6/264) | 0.98 (−1.70, 3.66); P = .47 |
GI hemorrhage | 3 RCTs (N = 434)22,23,25,27 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 6.07% (13/214) | 2.27% (5/20) | 4.51 (−1.92, 10.94); P = 17 |
Sepsis | 3 RCTs (N = 434)22,23,25,27 1 Non-RCT (N = 88)26 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 5.81% (15/258) | 4.92% (13/264) | 0.74 (−2.88, 4.35); P = .69 |
PE | 2 RCTs (N = 238)22,23,25 1 Non-RCT (N = 88)26 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 8.09% (19/235) | 4.592% (111/241) | 2.94 (−0.15, 6.03); P = .06 |
Urinary infection | 3 RCTs (N = 434)22,23,25,27 1 Non-RCT (N = 88) | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 35.27% (91/258) | 34.47% (1/264) | 1.73 (−5.04, 8.49); P = .62 |
Pneumonia | 1 RCT (N = 156) 1 Non-RCT (N = 88)26 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 25.50% (51/200) | 21.33% (45/211) | 4.69 (−3.19, 12.57); P = .24 |
Decubitis | 2 RCTs (N = 238)22,23,27 1 Non-RCT (N = 88)26 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | 15.7% (35/223) | 14.96% (35/234) | 20.99 (−6.01, 7.98); P = .78 |
One or more complications | 1 Non- RCT28 (N = 411) | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Very low | 33.48% (78/233) | 46.07% (82/178) | −12.59 (−22.10, −3.09); P = .009 |
KQ3. What is the evidence that MPSS has differential efficacy or safety in subpopulations? | ||||||||||
MPSS administered within 8 hours | ||||||||||
Motor scores | Final follow-up (6-12 months) 3 RCTs (N = 300)22,24,25 Median time 3 months 1 Non-RCT (N = 88)26 | No serious risk of bias | No serious inconsistency | No serious indirectness | Serious risk of imprecision | Undetected | Moderate | RCTs: 3.88 (0.50, 7.27); P = .02 RCTs + Prospective cohort: 3.21 (0.10, 6.33); P = .04 |
Abbreviations: CI, confidence interval; GI, gastrointestinal; MPSS, methylprednisolone sodium succinate; PE, pulmonary embolism; RCT, randomized controlled trial.