| No. of studies | Study design | Sample size | Effect size (95% CI) | Absolute risk: control * | Absolute risk: intervention (95% CI) | Estimated MID for MD | Risk of bias | Inconsistency | Indirectness | Imprecision | Quality |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Confirmed decline in Glasgow Coma Scale score to <14 - RR less than 1 favours 0.9% saline | |||||||||||
| Kuppermann 2018 | RCT | 1361 | 1.27 (0.72, 2.22) | 3 per 100 children and young people | 4 more per 100 children and young people (2 less, 7 more) | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Confirmed decline in Glasgow Coma Scale score to <14 - RR less than 1 favours 0.9% saline – fast rate | |||||||||||
| Kuppermann 2018 | RCT | 682 | 1.07 (0.46, 2.50) | 3 per 100 children and young people | 3 per 100 children and young people (1 less, 7 more) | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Confirmed decline in Glasgow Coma Scale score to <14 - RR less than 1 favours 0.9% saline– slow rate | |||||||||||
| Kuppermann 2018 | RCT | 679 | 1.44 (0.68, 3.06) | 3 per 100 children and young people | 5 more per 100 children and young people (2 less, 10 more) | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Confirmed decline in Glasgow Coma Scale score to <14 - RR less than 1 favours 0.9% saline - in children with severe DKA (defined as with initial pH in the lowest quartile of the study group (pH <7.0)) | |||||||||||
| Kuppermann 2018 | RCT | 282 | 1.66 (0.81, 3.38) | 8 per 100 children and young people | 13 more per 100 children and young people (6 less, 26 more) | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Confirmed decline in Glasgow Coma Scale score to <14 - RR less than 1 favours 0.9% saline - in children with severe DKA (defined as with initial pH in the lowest quartile of the study group (pH <7.0))- fast rate | |||||||||||
| Kuppermann 2018 | RCT | 131 | 1.62 (0.50, 5.27) | 6 per 100 children and young people | 10 more per 100 children and young people (3 less, 33 more) | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Confirmed decline in Glasgow Coma Scale score to <14 - RR less than 1 favours 0.9% saline - in children with severe DKA (defined as with initial pH in the lowest quartile of the study group (pH <7.0))- slow rate | |||||||||||
| Kuppermann 2018 | RCT | 151 | 1.68 (0.69, 4.10) | 9 per 100 children and young people | 15 more per 100 children and young people (6 less, 37 more) | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Clinically apparent brain injury - RR less than 1 favours 0.9% saline | |||||||||||
| Kuppermann 2018 | RCT | 1389 | 0.70 (0.22, 2.21) | 1 per 100 children and young people | 1 per 100 children and young people (0 less, 2 more) | - | No serious | NA1 | Serious3 | Serious2 | Low |
| Clinically apparent brain injury - RR less than 1 favours 0.9% saline – fast rate | |||||||||||
| Kuppermann 2018 | RCT | 695 | 0.98 (0.14, 6.92) | 1 per 100 children and young people | 1 per 100 children and young people (0 less, 4 more) | - | No serious | NA1 | Serious3 | Serious2 | Low |
| Clinically apparent brain injury - RR less than 1 favours 0.9% saline – slow rate | |||||||||||
| Kuppermann 2018 | RCT | 694 | 0.59 (0.14, 2.46) | 1 per 100 children and young people | 1 per 100 children and young people (0 less, 4 more) | - | No serious | NA1 | Serious3 | Serious2 | Low |
| Clinically apparent brain injury - RR less than 1 favours 0.9% saline - in children with severe DKA (defined as with initial pH in the lowest quartile of the study group (pH <7.0)) | |||||||||||
| Kuppermann 2018 | RCT | 303 | 1.03 (0.26, 4.02) | 3 per 100 children and young people | 3 per 100 children and young people (1 less, 11 more) | - | No serious | NA1 | Serious3 | Serious2 | Low |
| Clinically apparent brain injury - RR less than 1 favours 0.9% saline - in children with severe DKA (defined as with initial pH in the lowest quartile of the study group (pH <7.0))- fast rate | |||||||||||
| Kuppermann 2018 | RCT | 141 | 0.96 (0.06, 15.02) | 1 per 100 children and young people | 1 per 100 children and young people (0 less, 22 more) | - | No serious | NA1 | Serious3 | Serious2 | Low |
| Clinically apparent brain injury - RR less than 1 favours 0.9% saline - in children with severe DKA (defined as with initial pH in the lowest quartile of the study group (pH <7.0))- slow rate | |||||||||||
| Kuppermann 2018 | RCT | 162 | 1.05 (0.22, 5.05) | 4 per 100 children and young people | 4 per 100 children and young people (1 less, 18 more) | - | No serious | NA1 | Serious3 | Serious2 | Low |
| Mortality- RR less than 1 favours 0.9% saline | |||||||||||
| Kuppermann 2018 | RCT | 485 | 0.31 (0.01, 7.45) | 1 per 100 children and young people | Not estimable because of very low/zero event | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Mortality- RR less than 1 favours 0.9% saline – fast rate | |||||||||||
| Kuppermann 2018 | RCT | 238 | 0.31 (0.01, 7.45) | 1 per 100 children and young people | Not estimable because of very low/zero event | - | No serious | NA1 | No serious | Serious2 | Moderate |
| Mortality- RR less than 1 favours 0.9% saline – slow rate | |||||||||||
| Kuppermann 2018 | RCT | 247 | RR not estimable due to zero event in both arms | No serious | NA1 | No serious | Very serious4 | Low | |||
| Renal failure - RR less than 1 favours 0.9% saline | |||||||||||
| Kuppermann 2018 | RCT | 1389 | RR not estimable due to zero event in both arms | No serious | NA1 | No serious | Very serious4 | Low | |||
Inconsistency not applicable for single study.
Downgrade 1 level for serious imprecision. 95% confidence interval crosses the line of no effect.
Downgrade 1 level due to indirectness. Outcome was not specified in review protocol.
Downgrade 2 levels for very serious imprecision. Effect size could not be calculated.
Derived by taking the overall number of event/ total number of participants and multiplying by 100.
From: Evidence reviews for fluid therapy for the management of diabetic ketoacidosis
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