Mehuys 2011.
| Study characteristics | ||
| Methods |
Effectiveness of a community pharmacist intervention in diabetes care: a randomized controlled trial Cluster‐RCT (66 clusters with 66 providers), conducted in 66 community pharmacies in Flanders (Dutch speaking area), Belgium Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm) |
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| Participants | Control arm N: 135 Intervention arm N: 153 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 24 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Patient education 3) Patient reminders |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.3 (1.2), post 7.2 (1.0) Intervention arm: pre 7.7 (1.7), post 7.1 (1.1) 2) Smoking cessation, N smokers (%) Control arm: pre 29 (21), post 28 (21) Intervention arm: pre 28 (18), post 27 (18) |
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| Funding source | This study was funded by Ghent University | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The sequence of allocation to control or intervention group was predetermined by the investigators based on randomization schedule generated using SPSS." |
| Allocation concealment (selection bias) | Low risk | Cluster. |
| Provider's baseline characteristics (selection bias) | High risk | Information not available. |
| Patient's baseline characteristics (selection bias) | Low risk | Quote: "Values did not differ significantly among both groups, according to independent sample t‐test for continuous variables and chi‐square test for categorical variables." |
| Patient's baseline outcomes (selection bias) | Low risk | HbA1c (P = 0.08). |
| Incomplete outcome data (attrition bias) | High risk | Per‐protocol analysis, baseline based on those randomised. Although very low attrition. numbers and reasons for loss to follow‐up provided. Numbers provided for each arm, but reasons were provided overall, so we do not know if there were significant differences in reasons for both arms. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | HbA1c, methods not described. Blinding not described. |
| Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match outcomes. |
| Risk of contamination (other bias) | Low risk | Cluster. |
| Other bias | Low risk | No evidence of other bias |