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

Abuloha 2016.

Study characteristics
Methods The role of clinical pharmacist in initiation and/or dose adjustment of insulin therapy in diabetic patients in outpatient clinic in Jordan
RCT (NA clusters and NA providers), conducted in 1) Study carried out in the endocrine‐outpatient clinic in Jordan University Hospital (JUH), 2) Clinical pharmacists collaborated with physician in the management of insulin therapy in the intervention group
2 arms: 1) Control (usual care and SMBG) (control arm) and 2) Intervention (pharmacist management and SMBG) (intervention arm)
Participants Control arm N: 50
Intervention arm N: 50, NA, NA
Diabetes type: 3
Mean age: 55.59 ± 8.02
% Male: 42
Longest follow‐up: 3 months
Interventions Control arm: (usual care and SMBG)
1) Promotion of self‐management
Intervention arm: (pharmacist management and SMBG)
1) Case management
2) Team change
3) Patient education
4) Promotion of self‐management
Outcomes 1) Glycated haemoglobin
2) Harms (hypoglycaemic episodes)
Funding source This research was supported by a grant from the Deanship of Academic Research, The University of Jordan, Amman, Jordan
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was carried out by asking the patients to draw from a closed envelope of equal even and odd numbers.
Allocation concealment (selection bias) Unclear risk Opaque envelopes?
Patient's baseline characteristics (selection bias) Low risk Table 1. All P values above 0.05.
Patient's baseline outcomes (selection bias) Low risk Table 2. All P values are above 0.05.
Incomplete outcome data (attrition bias) Low risk 12 patients (out of 100, 12%) were lost from follow‐up (7 from the control group and 5 from the intervention group) as they did not return back to their clinic visits. Numbers and reasons balanced.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Objective outcome (HbA1c) and subjective outcome (hypoglycaemia). Patients were asked to record hypoglycaemic episodes if any. Patients were aware of their allocated group. Limitation: Some of the outcomes which were measured are based on patients reporting.
Selective reporting (reporting bias) Unclear risk No registered protocol or previously published protocol. Methods match results.
Risk of contamination (other bias) Unclear risk Both arms received SMBG device. However, only the intervention arm had pharmacist management. It is not excluded that pharmacists' recommendations to physicians changed their approach in managing insulin therapy initiation for the control arm patients as well.
Other bias Low risk No evidence of other bias