Mehuys 2011.
Methods | Design: cluster‐RT Groups: intervention group (self‐management of type 2 diabetes); control group (usual care) |
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Participants | Pharmacies: 66 Pharmacy worker: pharmacists ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user: 288 patients with type 2 diabetes (153 intervention; 135 control)
Setting: urban Country: Belgium |
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Interventions |
Pharmacy worker‐directed intervention: a training session about type 2 diabetes (pathophysiology), its non‐pharmacological and pharmacological management (current guidelines), and the study protocol
Pharmacy worker control: only received training on the study protocol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user‐directed intervention: patients received protocol‐defined intervention at start of the study and at each prescription refill visit (for hypoglycaemic medication) during the course of the study; received education on disease and medication management, lifestyle and annual reviews.
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: Ghent University |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The sequence of allocation to control or intervention group was predetermined by the investigators based on randomisation table generated using SPSS. |
Allocation concealment (selection bias) | Low risk | Sequence of allocation predetermined by randomisation table. |
Baseline outcome measures similar | Low risk | No differences between groups |
Baseline characteristics similar | Low risk | No differences between groups |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Minimal attrition |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objective primary outcome |
Protection against contamination | Low risk | Randomisation at 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 | Unclear risk | Unclear whether participants or pharmacists were aware of grouping, but likely. |