Table 1.
Intervention compared with placebo or active control for preventing HAE attacks | ||||||
Patient or population: children or adults with type I HAE Settings: outpatient setting Intervention: intervention Comparison: placebo or active control | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of Participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Placebo/active control | Intervention | |||||
Number of attacks (per week, per month, per year; follow‐up) |
Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
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[value] per 1000 | [value] per 1000 ([value] to [value]) | RR [value] ([value] to [value]) | ||||
Mortality (per week, per month, per year; follow‐up) |
Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
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[value] per 1000 | [value] per 1000 ([value] to [value]) | RR [value] ([value] to [value]) | ||||
Incidence of serious adverse events (follow‐up) |
Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
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[value] per 1000 | [value] per 1000 ([value] to [value]) | RR [value] ([value] to [value]) | ||||
Quality of life [any validated scale] (follow‐up) | Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
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The mean change in quality of life ranged across control groups from [value][measure] | The mean change in quality of life in the intervention groups was [value] [lower/higher] [(value to value lower/higher)] | |||||
Measures of disability [any validated scale] (follow‐up) | Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
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The mean change in disability ranged across control groups from [value][measure] | The mean change in disability in the intervention groups was [value] [lower/higher] [(value to value lower/higher)] | |||||
Incidence of adverse events (follow‐up) | Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
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[value] per 1000 | [value] per 1000 ([value] to [value]) | RR [value] ([value] to [value]) | ||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; HAE: hereditary angioedema; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. |