Ozkaya 2010.
Study characteristics | ||
Methods |
Design: single‐blind parallel‐group randomised controlled trial Duration: 12 weeks Setting: allergy outpatient clinic in the urban area of Istanbul, Turkey Trial registration: not reported |
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Participants |
Population: 130 children with asthma randomised to face‐to‐face nurse training (n = 66 completed) or no training (package insert) (n = 54 completed). NB: n randomised to each arm not reported Age: mean (SD) age in intervention group 8.2 (1.7) years, and in control group 7.7 (0.9) years Baseline asthma severity: in the intervention group 51 classified as mild asthma, 15 as moderate; in the control group 42 classified as mild asthma; 12 as moderate Inclusion criteria: mild to moderate asthma and attending outpatient allergy clinic. Diagnosis and severity of asthma defined according to GINA 2005 Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: Participants were permitted to take salbutamol or terbutaline as needed for relief of symptoms."None of the patients had previously received an MDI with spacer, and none had taken oral steroids in the past 1‐month" |
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Interventions |
Intervention summary: At the beginning of the study, the active group was educated at home on correct use of the MDI spacer by 2 paediatric nurse specialists certified in allergy‐pulmonology. All of the children in this study group received instruction. All participants were prescribed fluticasone propionate 125 mg 1 puff by an MDI with a small‐volume Aerochamber spacer twice daily for 12 weeks. Educational pamphlets, such as those on asthma management, prophylactic measures and trigger avoidance, were also distributed to both groups Control summary: The control group was left as a baseline, meaning that group members did not receive any formal education on correct use of the MDI spacer. However, all study participants received the Aerochamber package insert, which includes information on how to use the device. All participants were prescribed fluticasone propionate 125 mg 1 puff by an MDI with a small‐volume Aerochamber spacer twice daily for 12 weeks. Educational pamphlets, such as those on asthma management, prophylactic measures and trigger avoidance, were also distributed to both groups |
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Outcomes |
Outcomes measured: inhalation skill, health‐related quality of life (PAQLQ), spirometry. All participants were asked to keep an asthma diary on the presence of asthma symptoms and on the use of main and additional antiasthmatic drugs Technique assessment method used: Inhalation skill scoring was done using the standardised MDI spacer checklist. Summation of 10 item scores not weighted equally |
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Notes |
Type of publication: single peer‐reviewed journal article Funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Our subjects were randomly classified into study and control groups at the beginning of therapy" ‐ no further details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No description of procedures intended to blind participants or personnel to group assignment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "At the end of the 12 weeks, a paediatric allergist blinded to the results of the pulmonary function parameters (PFPs), rated each child’s MDI spacer skills after asking the child to demonstrate how he or she used the MDI spacer at home". However, it is not clear if this outcome assessor was blinded to group allocation, and for patient‐reported outcomes, such as AQLQ, the un‐blinded participant was the outcome assessor |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Drop‐out not clearly reported (130 children were randomised and 120 are included in the analyses because 10 dropped out. eAlthough this represents fairly low drop‐out overall of 7.7%, it is not clear to which groups the drop‐outs were randomised) |
Selective reporting (reporting bias) | High risk | No prospective trial registration identified, and the PAQLQ is reported only as a correlation with the MDI checklist, not as means per group |
Other bias | Low risk | None noted |