Table.
GRADE Evaluation of interventions for Malaria: fluid therapy in severe disease.
| Important outcomes | Coma recovery time, Hypotensive shock, Mortality, Neurological sequelae at follow-up | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What is the optimal method of fluid resuscitation in patients with severe malaria? | |||||||||
| 3 (1288) | Mortality | Human albumin (bolus) versus usual care (no bolus) | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for methodological flaws (open-label nature of studies and subgroup analysis in largest RCT); directness point deducted for uncertainty about generalisability of population (evidence in children only) |
| 1 (63) | Neurological sequelae at follow-up | Human albumin (bolus) versus usual care (no bolus) | 4 | –3 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, methodological flaws (open-label nature of study), and incomplete reporting of results (lack of statistical assessment); directness points deducted for uncertainty about generalisability of population (includes moderate acidosis only) and evidence in children only |
| 3 (1372) | Mortality | Human albumin (bolus) versus intravenous saline (bolus) | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for methodological flaws (open-label nature of studies and subgroup analysis in largest RCT); directness point deducted for uncertainty about generalisability of population evidence (in children only) |
| 1 (63) | Neurological sequelae at follow-up | Human albumin (bolus) versus intravenous saline (bolus) | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, methodological flaws (open-label nature of study), and incomplete reporting of results (lack of statistical assessment); directness point deducted for uncertainty about generalisability of population evidence (in children only) |
| 3 (1309) | Mortality | Intravenous fluids (bolus) versus usual care (no bolus, maintenance fluids only) | 4 | –1 | 0 | –1 | 0 | Low | Quality points deducted for methodological flaws (open-label nature of studies and subgroup analysis in largest RCT); directness point deducted for uncertainty about generalisability of population (evidence in children only) |
| 1 (68) | Neurological sequelae at follow-up | Intravenous fluids (bolus) versus usual care (no bolus, maintenance fluids only) | 4 | –3 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, methodological flaws (open-label nature of study), and incomplete reporting of results (lack of statistical assessment); directness points deducted for uncertainty about generalisability of population (includes moderate acidosis only) and evidence in children only |
| 2 (230) | Mortality | Blood transfusion versus usual care (no blood transfusion) | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for methodological flaws (open-label nature of studies) and for uncertainty about result due to low event rate; directness point deducted for uncertainty about generalisability of population (evidence in children only) |
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.