ACTRN12607000489493.
Methods |
Design: open‐label, parallel‐group randomised controlled trial Duration: 4 months Setting: 1 paediatric asthma clinic within an outer metropolitan general hospital in Australia Trial registration: not reported |
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Participants |
Population: 26 children with asthma randomised to receive adherence feedback (n = 14) or usual care (n = 12) Age: 6 to 14 years; mean age in the adherence feedback group 9.1 years and in the control group 9.3 years Baseline asthma severity: intervention group: FEV1 % predicted = 72.9, mean fluticasone dose (mcg/d) 300; number with symptoms or reliever use 3 or more times per week = 10. Control group: FEV1 % predicted = 77.5, mean fluticasone dose (mcg/d) 250, number with symptoms or reliever use 3 or more times per week = 8 Inclusion criteria: Children given a diagnosis of asthma at between 6 and 14 years of age (inclusive) were eligible for enrolment if their asthma was not well controlled despite prescribed preventive medication. Suboptimal control was based on reported history of asthma symptoms (wheeze or limitation of activity) occurring more than twice a week and requiring reliever medication and/or reduced lung function (reproducible FEV1 < 80% predicted) Exclusion criteria: not reported Percentage withdrawn: no withdrawal from trial Other allowed medication: not reported |
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Interventions |
Intervention summary: Adherence data collected via Smartinhaler were shared with the child, parent and physician during consultation for those allocated to the intervention group. These data were incorporated in the management plan for the coming month. Reviews were performed monthly with the child's usual physician Control summary: Children in the control group had their Smartinhaler collected and were given a new device. Their adherence remained unknown to parent, child and respiratory physician. Reviews were performed monthly with the child's usual physician Complex intervention: yes |
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Outcomes |
Outcomes measured: adherence, symptoms (via questionnaire), lung function Adherence calculation: Adherence was calculated as a percentage of prescribed doses registered by the Smartinhaler, between midnight and midday or between midday and midnight for morning and evening doses, respectively, or at any time during the day for once‐daily dosing |
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Notes |
Type of publication: single peer‐reviewed full‐text 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 | "After providing informed written consent, children were randomly allocated to either the intervention or control group through the use of sealed opaque envelopes" Not clear how the order of sealed envelopes was generated |
Allocation concealment (selection bias) | Low risk | "After providing informed written consent, children were randomly allocated to either the intervention or control group through the use of sealed opaque envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel described. Although primary outcome ‐ adherence ‐ was measured by an electronic counter, other outcomes (such as SABA use) may be subject to performance bias |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors described. Main outcome ‐ adherence ‐ objectively measured, but other outcomes (such as reported SABA use) subject to detection bias as the unblinded parent is the outcome assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study |
Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified; symptoms measured but not reported so could not be included in meta‐analysis. No measure of variance is given for the adherence outcome, nor for the secondary outcomes of FEV1 and controller medication use. P values are not exact (1 decimal place). Other outcomes reported appropriately |
Other bias | Low risk | None noted |