Methods | RCT. Parallel design. Location: single centre in UK. Duration: 12 months. |
|
Participants | 30 participants (20 girls, 10 boys matched). Age range 6 ‐ 15 years; mean age 11.5 years. 15 to each treatment arm. BMI, LCI and FEV₁ were well matched. One from each group withdrew because either they preferred their previous device, or they found it too fiddly to clean. | |
Interventions | PEP versus cornet. The treatment was used as their main ACT for 12 months. | |
Outcomes | FEV₁; LCI; pulmonary exacerbations; health perception; quality of life. FEV₁ and LCI were measured at start 6 months and 12 months. Quality of Well‐Being Scale, health perception and frequency of exacerbations measured at beginning and end. | |
Notes | Abstracts only, no full paper published as yet. Blinding not possible. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was stratified for age, sex and FEV₁, further details not given. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not possible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One child from each group dropped out after randomisation, reason given. |
Selective reporting (reporting bias) | High risk | Ongoing study which spanned 3 abstracts, but no full paper as yet identified. |
Other bias | High risk | The authors themselves questioned whether quality of life measures were reliable in children as they may be unable to accurately compare current health to that experienced the previous year. |