| Human deoxyribonuclease versus placebo for primary (intrinsic) tracheomalacia in children |
| Patient or population: children with primary (intrinsic) tracheomalacia
Settings: outpatient
Intervention: human deoxyribonuclease Control: placebo |
| Clinical failure
Number of children with no significant improvement in cough diary scores at two weeks (average of day 13 to 14)
Follow‐up: 2 weeks | 57 per 100 | 65 per 100
(33 to 87) | OR 1.38
(0.37 to 5.14) | 38
(1 study) | ⊕⊕⊝⊝
Low quality1 | These results should be interpreted with caution given there is only one study |
| Daytime cough diary scores (change from baseline)
Follow‐up: 2 weeks On a scale of 0 to 5, 0 being no cough and 5 means unable to perform most usual activities due to coughing | ‐1.7 | 0.70 higher (‐0.19 to 1.59) | | 38
(1 study) | ⊕⊕⊝⊝
Low quality1 | There was no significant difference in daytime cough diary scores in two groups |
| Night time cough diary score (change from baseline)
Follow‐up: 2 weeks On a scale of 0 to 5, 0 being no cough and 5 means unable to perform most usual activities due to coughing | ‐1.7 | 1.00 higher (0.17 to 1.83) | | 38
(1 study) | ⊕⊕⊝⊝
Low quality1 | Night time cough diary scores significantly favoured the placebo group |
| Night time VAS (change from baseline) Follow‐up: 2 weeks VAS is a marked scale of 10 cm length, anchored by word descriptors at each end (e.g. 0 cm is absence of cough and 10 cm is continuous coughing). The child or parent places a mark on this line in the position that best represents their perception and the result is measured in mm from the anchor point i.e. scale of 0 to 100 | ‐36.7 | 23.00 higher (3.86 to 42.14) | | 38 (1 study) | ⊕⊕⊝⊝
Low quality1 | Night time VAS significantly favoured the placebo group |
| Difficulty expectorating sputum score (change from baseline) Follow‐up: 2 weeks VAS is a marked scale of 10 cm length, anchored by word descriptors at each end. On a scale of 0 to 100, 0 would mean no difficulty in expectoration and 100 would mean unable to expectorate | ‐35.6 | 0.46 higher (‐0.19 to 1.11) | | 38 (1 study) | ⊕⊕⊝⊝
Low quality1 | The data supported the placebo but the CI is too wide |
| Lung function: FVC % predicted (baseline to end point) Follow‐up: 2 weeks | ‐8.2% | 8.80% lower (‐0.05 to 17.65) | | 27 (1 study) | ⊕⊕⊝⊝
Low quality1 | The FVC % improved with placebo but worsened with rhDNase and the difference between two groups was of borderline significance |
| Lung function: FEV1 % predicted (baseline to end point) Follow‐up: 2 weeks | ‐10.8% | 9.20% lower (‐0.55 to 18.95) | | 27 (1 study) | ⊕⊕⊝⊝
Low quality1 | FEV1 % at end point improved more with placebo, but the CI was too wide to be of any significance |
| *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). The assumed risk for continuous data is the mean for the placebo group and corresponding risk is the mean difference. Since there was only one study in the review, assumed risk is not expressed as a range.
CI: confidence interval; FEV1 : forced expiratory volume in one second; FVC: forced vital capacity; OR: odds ratio; rhDNase: recombinant human deoxyribonuclease; VAS: visual analogue score. |
| 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. |
