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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Kirwin 2010.

Study characteristics
Methods Pharmacist recommendations to improve the quality of diabetes care: a randomized controlled trial
Cluster‐RCT (8 clusters with 72 providers), conducted in 8 suites within a hospital‐based primary care practice on the main campus of a large academic teaching hospital in Boston, Massachusetts, USA
Two arms: 1. Usual care group (control arm) and 2. Intervention group (intervention arm)
Participants Control arm N: 175
Intervention arm N: 171
Diabetes type: type 1 and type 2
Mean age: 63.0 ± NR
% Male: 34.2
Longest follow‐up: 12 months
Interventions Control arm:
None
Intervention arm:
1) Team changes
2) Electronic patient registry
3) Clinician reminders
Outcomes 1) Retinopathy screening (eye exam), N screened (%)
Control arm: pre 56 (37), post 76 (50)
Intervention arm: pre 57 (38), post 90 (60)
2) Renal screening (microalbumin), N screened (%)
Control arm: pre 71 (47), post 87 (58)
Intervention arm: pre 69 (46), post 94 (63)
3) Controlled hypertension (< 130/80 mmHg), N under control (%)
Control arm: pre 68 (45), post 62 (41)
Intervention arm: pre 71 (47), post 66 (44)
Funding source This project received no external funding
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…random number generator".
Allocation concealment (selection bias) Low risk Allocation concealment not described. Cluster.
Provider's baseline characteristics (selection bias) High risk Information not available.
Patient's baseline characteristics (selection bias) High risk Annual lipid profiles (P = 0.015).
Patient's baseline outcomes (selection bias) Low risk Annual eye exam (P = 0.870); annual urine microalbumin exam (P = 0.859); HTN‐C (< 130/80) (P = 0.769).
Incomplete outcome data (attrition bias) High risk Per‐protocol analysis, baseline based on those analysed. Numbers provided for loss to follow‐up (balanced), but reasons not provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Blinding (and of outcome assessors) not described.
Objective outcome methods not described.
Selective reporting (reporting bias) High risk Does not match protocol for secondary outcomes listed in protocol.
Risk of contamination (other bias) Low risk Quote: "This randomization unit minimized the potential for contamination of the intervention that might occur if …."cluster"".
Other bias Low risk Information not available.