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. 2007 Nov 7;2007:0320.

Table.

GRADE Evaluation of interventions for Perinatal asphyxia.

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.