Table.
Important outcomes | Mortality, Neurological impairment | ||||||||
Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
What are the effects of interventions in term or near-term newborns with perinatal asphyxia? | |||||||||
3 (114) | Mortality | Allopurinol versus placebo or no drug treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for composite outcome in one RCT |
1 (60) | Neurological impairment | Allopurinol versus placebo or no drug treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
1 (63) | Mortality | Miltiorrhizae versus citicoline (cytidine diphosphate choline) | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, and for allocation, blinding, and randomisation flaws. Directness point deducted for composite outcome |
4 (559) | Mortality | Head, and whole-body, hypothermia versus normothermia | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for the use of composite outcome in three RCTs |
2 (231) | Neurological impairment | Head, and whole-body, hypothermia versus normothermia | 4 | 0 | 0 | 0 | 0 | High | |
7 (675) | Mortality | Hyperbaric oxygen treatment | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for poor follow-up, and for allocation, blinding, and randomisation flaws |
7 (649) | Neurological impairment | Hyperbaric oxygen treatment | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for poor follow-up, and for allocation, blinding, and randomisation flaws |
1 (33) | Mortality | Magnesium sulphate plus inotrope support versus no drug treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for composite outcome |
1 (25) | Mortality | Mannitol versus no drug treatment | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and wide confidence intervals |
5 (1737) | Mortality | Resuscitation in air versus pure oxygen | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for poor follow-up, and for allocation, blinding, and randomisation flaws |
4 (155) | Mortality | Prophylactic anticonvulsants versus no drug treatment | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, allocation and blinding flaws, and lack of placebo control |
2 (155) | Neurological impairment | Prophylactic anticonvulsants versus no drug treatment | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data; methodological, allocation, and blinding flaws; and lack of placebo control |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.