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

Smith 2004.

Study characteristics
Methods The North Dublin randomized controlled trial of structured diabetes shared care
Cluster‐RCT (30 clusters with 50 providers), conducted in general practices in Ireland
Two arms: 1. Control (control arm) and 2. Intervention (intervention arm)
Participants Control arm N: 87
Intervention arm N: 96
Diabetes type: type 2
Mean age: 65.1 ± 11.6
% Male: 55.5
Longest follow‐up: 18 months
Interventions Control arm:
None
Intervention arm:
1) Team changes
2) Clinician education
Outcomes 1) Aspirin, N users (%)
Control arm: pre 50 (57), post 44 (51)
Intervention arm: pre 45 (47), post 60 (63)
2) Statins, N users (%)
Control arm: pre 14 (16), post 30 (34)
Intervention arm: pre 21 (22), post 44 (46)
3) Retinopathy screening (fundoscopy), N screened (%)
Control arm: pre NR (NR), post 34 (39)
Intervention arm: pre NR (NR), post 58 (60)
4) Foot screening, N screened (%)
Control arm: pre 42 (48), post 45 (52)
Intervention arm: pre 44 (46), post 59 (61)
5a) Renal screening (microalbumin), N screened (%)
Control arm: pre NR (NR), post 10 (11)
Intervention arm: pre NR (NR), post 43 (45)
5b) Renal screening (creatinine), N screened (%)
Control arm: pre NR (NR), post 8 (9)
Intervention arm: pre NR (NR), post 44 (46)
6) HbA1c, mean % (SD)
Control arm: pre 6.6 (1.9), post 6.7 (NR)
Intervention arm: pre 6.9 (1.6), post 7.0 (NR)
7) SBP, mean mmHg (SD)
Control arm: pre 167.0 (28.0), post 163.4 (NR)
Intervention arm: pre 162.0 (26.0), post 157.7 (NR)
8) DBP, mean mmHg (SD)
Control arm: pre 92.0 (14.0), post 90.4 (NR)
Intervention arm: pre 88.0 (14.0), post 89.1 (NR)
Funding source NA
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table.
Allocation concealment (selection bias) Low risk Cluster‐RCT.
Provider's baseline characteristics (selection bias) High risk Not reported.
Patient's baseline characteristics (selection bias) Low risk See Table 1, P values > 0.05.
Patient's baseline outcomes (selection bias) Low risk See Table 1, P values > 0.05.
Incomplete outcome data (attrition bias) Low risk Information not available.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Information not available.
Selective reporting (reporting bias) Low risk Information not available.
Risk of contamination (other bias) Low risk Information not available.
Other bias Low risk Information not available.