9. Sensitivity analysis: Random‐effects versus fixed‐effect model.
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Sensitivity analysis: Random‐effects versus fixed‐effect model |
Statistical method | Random‐effects model | Fixed‐effect model |
Impact on robustness (95% CI) (fixed‐effect model) |
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| n | Effect estimate | n | Effect estimate | ||||
| 1. Remifentanil (PCA) versus another opioid (IV/IM) | |||||||
| 1.1 Satisfaction with pain relief | SMD (IV), 95% CI | 4 | 2.11 [0.72, 3.49] | 4 | 1.85 [1.51, 2.19] | Yes (CI decreased, large effect) | |
| 1.3 Oxygen desaturation (SpO2 < 95%) | RR (MH), 95% CI | 2 | 0.48 [0.00, 47.37] | 2 | 0.66 [0.28, 1.57] | Yes (CI decreased) | |
| 1.4 Nausea (and vomiting) | RR (MH), 95% CI | 4 | 0.54 [0.29, 0.99] | 4 | 0.51 [0.28, 0.95] | No | |
| 1.6 Pruritus | RR (IV), 95% CI, 0/0 cell counts |
2 | 1.02 [0.00, 1.1E12] | 2 | 1.02 [0.00, 1.1E12] | No | |
| 1.10 FHR/CTG abnormalities, non‐reassuring fetal status | RR (MH), 95% CI | 2 | 0.30 [0.10, 0.90] | 2 | 0.30 [0.10, 0.85] | No | |
| 1.11 Pain intensity 'early' (30 min/1 h) | SMD (IV), 95% CI | 3 | ‐1.58 [‐2.69, ‐0.48] | 3 | ‐1.35 [‐1.68, ‐1.01] | Yes (CI decreased, large effect) | |
| 1.13 Additional analgesia required (escape analgesia) | RR (MH), 95% CI | 3 | 0.57 [0.40, 0.81] | 3 | 0.53 [0.39, 0.71] | No | |
| 1.14 Rate of caesarean delivery | RR (MH), 95% CI | 4 | 0.70 [0.34, 1.41] | 4 | 0.77 [0.39, 1.49] | No | |
| 2. Remifentanil (PCA) versus another opioid (PCA) | |||||||
| 2.2 Oxygen desaturation (SpO2 < 95%) | RR (MH), 95% CI | 2 | 1.28 [0.49, 3.30] | 2 | 1.39 [1.16, 1.67] | Yes (CI > 1: favours opioid) | |
| 2.10 Need for naloxone | RR (IV,), 95% CI, 0/0 cell counts |
2 | 0.03 [0.00, 1.8E8] | 2 | 0.01 [0.00, 2.4E6] | No | |
| 2.12 NACS at 15/30 min | MD (IV), 95% CI | 2 | 1.11 [‐0.65, 2.87] | 2 | 1.15 [0.38, 1.93] | Yes (CI > 0: favours RPCA) | |
| 2.13 Pain intensity 'early' (30 min/1 h) | SMD (IV), 95% CI | 3 | ‐0.51 [‐1.01, ‐0.00] | 3 | ‐0.57 [‐0.86, ‐0.29] | Yes (CI < 0: favours RPCA) | |
| 2.15 Additional analgesia required (escape analgesia) | RR (MH), 95% CI | 3 | 0.76 [0.45, 1.28] | 3 | 0.74 [0.55, 1.00] | No | |
| 2.16 Rate of caesarean delivery | RR (MH), 95% CI | 2 | 2.78 [0.99, 7.82] | 2 | 2.78 [0.99, 7.77] | No | |
| 3. Remifentanil (PCA) versus epidural/combined spinal‐epidural analgesia (CSE) | |||||||
| 3.1 Satisfaction with pain relief | SMD (IV), 95% CI | 7 | ‐0.22 [‐0.40, ‐0.04] | 7 | ‐0.29 [‐0.38, ‐0.20] | No | |
| 3.3 Respiratory depression (< 9, < 8 breaths/min) | RR (IV), 95% CI, 0/0 cell counts |
3 | 0.91 [0.51, 1.62] | 3 | 1.2 [0.67, 2.17] | No | |
| 3.4 Oxygen desaturation (SpO2 < 92%) | RR (MH), 95% CI | 3 | 3.24 [1.66, 6.32] | 3 | 3.46 [2.32, 5.16] | No | |
| 3.5 Oxygen desaturation (SpO2 < 95%) | RR (MH), 95% CI | 3 | 3.27 [2.32, 4.61] | 3 | 3.30 [2.43, 4.49] | No | |
| 3.6 Hypotension | RR (IV,), 95% CI, 0/0 cell counts |
4 | 0.59 [0.37, 0.94] | 4 | 0.57 [0.36, 0.89] | No | |
| 3.7 Bradycardia | RR (IV,), 95% CI, 0/0 cell counts |
2 | 1.0 [0.00, 1.0E12] | 2 | 1.0 [0.00, 1.0E12] | No | |
| 3.8 Nausea | RR (MH), 95% CI | 8 | 1.49 [1.19, 1.86] | 8 | 1.53 [1.22, 1.91] | No | |
| 3.9 Vomiting | RR (MH), 95% CI | 6 | 1.63 [1.25, 2.13] | 6 | 1.62 [1.24, 2.10] | No | |
| 3.10 Pruritus | RR (MH), 95% CI | 7 | 0.75 [0.48, 1.18] | 7 | 0.76 [0.54, 1.07] | No | |
| 3.11 Sedation (1 h) | MD (IV), 95% CI | 3 | 0.71 [0.03, 1.39] | 3 | 0.91 [0.57, 1.25] | No | |
| 3.12 Apgarscore ≤ 7 (< 7) at 5 min | RR (IV,), 95% CI, 0/0 cell counts |
5 | 1.26 [0.62, 2.57] | 5 | 1.22 [0.67, 2.62] | No | |
| 3.13 Apgarscore at 5 min | MD (IV,), 95% CI | 3 | 0.06 [‐0.27, 0.39] | 3 | 0.06 [‐0.27, 0.39] | No | |
| 3.14 Need for naloxone | RR (IV,), 95% CI, 0/0 cell counts |
2 | 0.02 [0.00, 1.6E8] | 2 | 0.01 [0.00, 4.6E5] | No | |
| 3.15 FHR/CTG abnormalities, non‐reassuring fetal status | RR (MH), 95% CI | 5 | 1.55 [0.49, 4.92] | 5 | 1.38 [0.84, 2.25] | No | |
| 3.16 Pain intensity 'early' (1 h) | SMD (IV), 95% CI | 6 | 0.57 [0.31, 0.84] | 6 | 0.57 [0.31, 0.84] | No | |
| 3.18 Additional analgesia required | RR (IV,), 95% CI, 0/0 cell counts |
6 | 9.27 [3.73, 23.03] | 6 | 10.86 [4.37, 26.95] | No | |
| 3.19 Rate of caesarean delivery | RR (MH), 95% CI | 9 | 0.99 [0.81, 1.21] | 9 | 0.96 [0.79, 1.18] | No | |
| 4. Remifentanil (PCA) versus remifentanil (continuous IV) | |||||||
| 4.1 Respiratory depression (< 8 breaths/min) | RR (IV,), 95% CI, 0/0 cell counts |
2 | 0.98 [0.00, 1.0E12] | 2 | 0.98 [0.00, 1.0E12]] | No | |
| 4.3 Hypotension | RR (IV,), 95% CI, 0/0 cell counts |
2 | 0.98 [0.00, 1.0E12] | 2 | 0.98 [0.00, 1.0E12] | No | |
| 4.4 Bradycardia | RR (IV,), 95% CI, 0/0 cell counts |
2 | 0.98 [0.00, 1.0E12] | 2 | 0.98 [0.00, 1.0E12] | No | |
| 4.5 Nausea (and vomiting) | RR (MH), 95% CI | 2 | 0.85 [0.28, 2.54] | 2 | 0.81 [0.38, 1.73] | No | |
| 4.8 Need for naloxone | RR (IV,), 95% CI, 0/0 cell counts |
2 | 0.98 [0.00, 1.0E12] | 2 | 0.98 [0.00, 1.0E12] | No | |
All RR for outcomes including 0/0 cell counts (zero/zero event trials) were calculated using TSA (constant continuity correction, 0.01). Review Manager 5 produces computational errors when both the intervention and control group have zero events. By using TSA there is no possibility to choose the MH method (only IV) which may cause small deviations within results.
Abbreviations:
[95% CI]: 95% confidence interval; IV: Inverse Variance; MD: mean difference; MH: Mantel‐Haenszel; n: number of participants; RPCA: Remifentanil PCA; RR: risk ratio; SMD: standardised mean difference