Hart 2002.
Methods |
Design: parallel‐group randomised controlled trial; blinding not stated Duration: 13 weeks Setting: not reported. UK Trial registration: not reported |
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Participants |
Population: 83 'pre‐school' children with asthma randomised to an asthma education intervention or usual care (n for each group not given) Age: 'pre‐school children'; no further details reported Baseline asthma severity: not reported Inclusion criteria: 'asthmatic pre‐school children'; no further details reported Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported |
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Interventions |
Intervention summary: educational booklet about asthma and its treatment, and clinic consultation based on contents of booklet Control summary: usual care Complex intervention: yes |
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Outcomes |
Outcomes measured: adherence; beliefs and anxieties about adherence Adherence calculation: medication electronically monitored; details of adherence calculation not given |
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Notes |
Type of publication: conference abstract Funding: National Asthma Campaign, UK |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Children were "randomly allocated" ‐ 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 to blind participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No description of procedures to blind outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Drop‐out not reported, so unclear how many participants completed the study |
Selective reporting (reporting bias) | High risk | Conference abstract, so minimal details given. No prospective trial registration identified |
Other bias | Low risk | None noted |