Self 1983.
| Study characteristics | ||
| Methods |
Design: parallel‐group randomised controlled trial; blinding not stated Duration: 1 to 16 weeks (mean 6) but no training (control group); not followed up after initial assessment Setting: allergy clinic in Memphis, Tennessee, USA Trial registration: not reported |
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| Participants |
Population: 29 adults with asthma randomised to face‐to‐face pharmacist training (n = 9) or video training (n = 10) or no training (package insert) (n = 10) Age: mean age 39 years across all 3 groups Baseline asthma severity: 4 participants in each group had previously used the devices ‐ most were not taking/did not need MDIs Inclusion criteria: mildly asthmatic adults ‐ "mildly asthmatic" Exclusion criteria: not reported Percentage withdrawn: no drop‐out Other allowed medication: not reported |
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| Interventions |
Face‐to‐face training: personal instruction by 1 of 2 pharmacists on use of the inhaler while in the physician's office Video training: Participants watched a videotaped programme of instruction produced by investigators No training: received only an information sheet reflecting the manufacturer's direction and the current literature |
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| Outcomes |
Outcomes measured: inhaler technique/effectiveness of instruction Technique assessment method used: 10‐point checklist with equal weight items assessed by the physician |
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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 | "We randomly assigned 29 mildly asthmatic adults" ‐ 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 | Unclear risk | Inhaler technique was assessed by a "specially trained technician". This was not the person who delivered the intervention, but it is not clear if this person knew to which group each participant belonged |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐out |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. Only outcome described in Methods (inhaler technique) is clearly reported, although control group is not followed up |
| Other bias | Low risk | None noted |