Wishah 2015.
Study characteristics | ||
Methods |
Impact of pharmaceutical care interventions on glycemic control and other health‐related clinical outcomes in patients with type 2 diabetes: randomized controlled trial RCT (NA clusters and NA providers), conducted in 1) The study site was the outpatient diabetes clinic at Jordan University Hospital (JUH), a major teaching hospital in Amman, capital of Jordan. The diabetes clinic at JUH provides usual care services to more than 90 patients daily with regular follow‐up clinic visits every 1 to 3 months, depending on the glycaemic control for each patient. 2) The intervention group patients received pharmaceutical care interventions developed by the clinical pharmacist in collaboration with the physician. In Jordan. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (pharmaceutical care) (intervention arm) |
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Participants | Control arm N: 54 Intervention arm N: 52, NA, NA Diabetes type: 2 Mean age: 53.05 ± NR % Male: 43.39 Longest follow‐up: 6 months |
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Interventions |
Control arm: (usual care) Intervention arm: (pharmaceutical care) 1) Case management 2) Team change 3) Patient education 4) Promotion of self‐management 5) Patient reminders |
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Outcomes | Glycated haemoglobin Low‐density lipoprotein |
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Funding source | Not reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | At the time of recruitment, patients were randomised into the intervention group (n = 52) and the control group (n = 54) using a coin‐toss method. |
Allocation concealment (selection bias) | Low risk | Coin‐toss method. Not predictable. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. P values above 0.05. |
Patient's baseline outcomes (selection bias) | High risk | Table 1. HbA1c (P = 0.01) and serum triglycerides (P = 0.02) have significant P values and FBG is close to be significant (P = 0.06). Except for the baseline HbA1c values and serum triglycerides, statistical analyses indicated no significant differences between the 2 groups on the baseline measures. |
Incomplete outcome data (attrition bias) | Low risk | During the study period, 2/52 (3.8%) patients from the intervention group and 3/54 (5.6%) patients from the control group dropped out from the study. Therefore, a total of 101/106 patients (50 intervention group; 51 control group) completed the 6‐month study period. Low and balanced numbers. Reasons for lost not reported. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Our outcomes of interest were objectively measured (HbA1c and LDL). |
Selective reporting (reporting bias) | High risk | No registered or published protocol. Other clinical outcomes that were obtained during the course of the study were FBS, serum low‐density lipoprotein cholesterol (LDL‐C), high‐density lipoprotein cholesterol (HDL‐C), serum triglycerides, serum total cholesterol, weight, height, and blood pressure. No data reported for blood pressure. |
Risk of contamination (other bias) | High risk | Trial done in one clinic. Physicians were taking care of both control and intervention patients. They may have changed their care to control patients following pharmacist's recommendations for care of patients in the intervention group. |
Other bias | Low risk | None. |