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

Mahwi 2013.

Study characteristics
Methods Role of the pharmaceutical care in the management of patients with type 2 diabetes mellitus
RCT (NA clusters and NA providers), conducted in 1) Study was conducted at Diabetic Center in Sulaimani, Kurdistan‐Iraq. 2) Intervention provided by pharmacists. In Iraq.
2 arms: 1. Control (usual medical care) (control arm) and 2. Intervention (pharmaceutical care) (intervention arm)
Participants Control arm N: 65
Intervention arm N: 65, NA, NA
Diabetes type: 2
Mean age: 52.69 ± 10.1
% Male: 30.88
Longest follow‐up: 3 months
Interventions Control arm: (usual medical care)
Intervention arm: (pharmaceutical care)
1) Case management
2) Team change
Outcomes Glycated haemoglobin
Funding source This study was funded by an American Diabetes Association Core Research Award
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk In this study, patients were divided into 2 groups by simple randomisation technique; the first group is the intervention group, who received pharmaceutical care, while the second one is the control group who only received traditional medical care.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Unclear risk There are more hyperlipidaemic patients in intervention than control (33% vs 24%). Duration of diabetes seems shorter for the intervention group. No P values calculated for all baseline characteristics.
Patient's baseline outcomes (selection bias) High risk At baseline, FPG value were 211 ± 70.3 vs 249 ± 88.9 in the control and intervention groups. At baseline, HbA1c value were 9.97 ± 2.75 vs 11.53 ± 1.83 in the control and intervention groups. No P values reported.
Incomplete outcome data (attrition bias) Low risk 7 lost to follow‐up out of 130 (5.4%). The 7 patients were excluded because they came too late after first or second visits.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective outcome (HbA1c).
Selective reporting (reporting bias) Unclear risk No registered protocol or previously published protocol. Results match methods.
Risk of contamination (other bias) Low risk Given the intervention is case management, contamination is not a concern. Patients individually met a pharmacist or they were called by him. Patients do not see each other.
Other bias Low risk No evidence of other bias.