Sarayani 2018.
Study characteristics | ||
Methods |
Efficacy of a telephone‐based intervention among patients with type‐2 diabetes; a randomized controlled trial in pharmacy practice RCT (NA clusters and NA providers), conducted in 1) facilities of a referral pharmacy affiliated with the College of Pharmacy, Tehran University of Medical Sciences (conference hall and the drug information call centre). This pharmacy is in the midtown area of Tehran, the capital city of Iran 2) Intervention delivered by pharmacists in Iran 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (pharmacist telephone consultation) (intervention arm) |
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Participants | Control arm N: 50 Intervention arm N: 50, NA, NA Diabetes type: 2 Mean age: 55.05 ± 8.8 % Male: 58.45 Longest follow‐up: 9 months |
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Interventions |
Control arm: (usual care) 1) Patient education 2) Promotion of self‐management Intervention arm: (pharmacist telephone consultation) 1) Case management 2) Patient education 3) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Low‐density lipoprotein Smoking status |
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Funding source | This study was supported by a research grant from Research Deputy of Tehran University of Medical Sciences (ID: 91‐03‐156‐19496) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | One of the authors who was not involved in eligibility confirmation, diabetes education or telephone intervention generated and concealed the allocation sequence. Not clear how allocation was concealed. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1, P values > 0.05. |
Patient's baseline outcomes (selection bias) | Low risk | Table 1. Moreover, there were no significant differences between groups regarding the duration of diabetes, number or type of diabetes medications and the baseline HbA1c. |
Incomplete outcome data (attrition bias) | High risk | 14 lost in intervention group (28%), 7 lost in control group (14%). |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Objective outcomes: HbA1c, LDL; subjective: smoking. |
Selective reporting (reporting bias) | Low risk | Prospectively registered ("during recruitment") protocol with outcomes that match those reported in manuscript. |
Risk of contamination (other bias) | High risk | One of the control group participants insisted on receiving tele‐intervention (Figure 1). The risk of contamination between intervention and control group could not be fully ruled out as we did not document patients’ social ties to other participants in the study. However, the risk of contamination must be low because the study participants were mostly recruited by advertisement in the community pharmacies. |
Other bias | Low risk | No evidence of other bias. |