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) |
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| 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 |
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| 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 |
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| Outcomes | 1) Glycated haemoglobin 2) Harms (hypoglycaemic episodes) |
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| 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 |