for the main comparison.
Bronchodilators delivered by nebuliser versus pMDI with spacer for exacerbations of COPD | ||||||
Patient or population: participants with an exacerbation of COPD; people with asthma excluded from our analysis Settings: treatment was allowed at home or in the clinic or hospital. Intervention: nebuliser Comparison: pMDI with spacer | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
pMDI with spacer | Nebuliser | |||||
Change in FEV1 1 h after dosing in ml | The mean change in FEV1 1 h after dosing in the pMDI group was 103 ml | The mean change in FEV1 1 h after dosing in the nebuliser group was 36 ml more (from 38 ml fewer to 110 ml more) | — | 40 (1) | ⊕⊝⊝⊝ Very lowa | — |
Serious adverse events | 88 per 1000 | 88 per 1000 (17 to 348) | OR 1.00 ( 0.18 to 5.53) | 70 (2) | ⊕⊕⊝⊝ Lowb | — |
Change in FEV1 closest to 1 h after dosing in ml | The mean change in FEV1 closest to 1 h after dosing in the pMDI group is93 ml | The mean change in FEV1 closest to 1 h after dosing in the nebuliser groups was 83 ml more (10 to 156 ml more) | — | 126 (4) | ⊕⊕⊝⊝ Lowb | — |
Change in dyspnoea score during the first 24 h after dosing | The mean change in dyspnoea score during the first 24 h after dosing−1.28 points on the Borg scale (lower score indicates reduced dyspnoea) | The mean change in dyspnoea score during the first 24 h after dosing was 0.12 points worse (0.56 better to 0.79 worse) on the Borg scale in the nebuliser groups | — | 74 (2) | ⊕⊕⊝⊝ Lowb | A lower Borg score indicates reduced dyspnoea |
Adverse events/side effects | 56 per 1000 | 89 per 1000 (24 to 278) |
OR 1.65 ( 0.42 to 6.48) |
110 (3) | ⊕⊕⊝⊝ Lowb | — |
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; OR: odds ratio; ml: millilitres; FEV1 : forced expiratory volume in 1 second; pMDI: pressurised metered dose inhaler. | ||||||
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. |
aDowngraded for sample size (only one small study included in the analysis) (−2) and indirectness (e.g. older trials, so devices used may not be relevant to clinical practice today, and heterogeneity in dose between the groups) (−1) bDowngraded for sample size of the included trials (−1) and indirectness (e.g.older trials, so devices used may not be relevant to clinical practice today and heterogeneity in dose between the groups) (−1)