Mehuys 2008.
Methods | Design: RT Groups: intervention group (asthma self‐management); control group (usual care) |
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Participants | Pharmacies: 66 Pharmacy worker: pharmacists ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user: 201 patients with asthma (107 intervention; 94 control)
Setting: urban Country: Belgium |
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Interventions |
Pharmacy worker‐directed intervention: a training session about asthma (pathophysiology), its non‐pharmacological and pharmacological treatment (Global Initiative for Asthma (GINA) guidelines), and about the use of the study protocol.
Pharmacy worker control: it appears that pharmacists saw both control and intervention participants. ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user‐directed intervention: intervention focused on ensuring correct use of drug therapy including inhaler use and good adherence
Pharmacy user control: usual treatment |
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Outcomes |
Pharmacy worker: not assessed ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user:
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Notes | Study/intervention name: none given Funding source: funded by Ghent Unviersity |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Predetermined by the investigators based on a randomisation table. Serially numbered, closed envelopes were made for each participating pharmacy. The envelope with the lowest number was opened by the pharmacist upon inclusion of a new patient. |
Allocation concealment (selection bias) | Low risk | See above |
Baseline outcome measures similar | Low risk | Baseline variables used as covariates in the analyses |
Baseline characteristics similar | Low risk | No significant differences |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Linear mixed model used with maximum‐likelihood method to handle missing data |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded assessment at 6 months |
Protection against contamination | High risk | Randomisation at patient level, not pharmacy level |
Selective reporting (reporting bias) | Low risk | Nothing noted |
Other bias | Unclear risk | Potential selection bias, as only regular clients recruited |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Pharmacists aware of patients' groups. |