Aguiar 2018.
Study characteristics | ||
Methods |
Pharmacist‐physician collaborative care model for patients with uncontrolled type 2 diabetes in Brazil: results from a randomized controlled trial RCT (NA clusters and NA providers), conducted in 1) This study was conducted at a university hospital‐affiliated secondary care clinic in São Paulo, Brazil. The metabolic disease clinic’s medical staff consists of 3 specialist physicians who follow patients with diabetes, hypertension or dyslipidaemia who have been referred by the primary care physician. Nurses and nutritionists also are part of the outpatient care team. 2) The intervention involved a pharmacist‐physician collaborative care model. In Brazil. 2 arms: 1) Control (usual care) (control arm) and 2) Intervention (clinical pharmacist service) (intervention arm) |
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Participants | Control arm N: 40 Intervention arm N: 40, NA, NA Diabetes type: 2 Mean age: 61.76 ± 9.2 % Male: 32.88 Longest follow‐up: 12 months |
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Interventions |
Control arm: (usual care) Intervention arm: (clinical pharmacist service) 1) Case management 2) Team change 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management |
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Outcomes | 1) Glycated haemoglobin 2) Systolic blood pressure 3) Diastolic blood pressure 4) Low‐density lipoprotein 5a) Hypertension control (SBP < 130 mmHg) 5b) Hypertension control (DBP < 80 mmHg) |
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Funding source | This project was supported by Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) – Grant Number 2011/11145‐4 and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Capes). The funders had no role in study design, data collection and analysis, writing of the report or decision to publish. | |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by pharmacist researcher using a computer‐generated randomised list from the research randomizer program (https://www.randomizer.org/), and followed the allocation sequence according to the referral of the physicians. |
Allocation concealment (selection bias) | Low risk | Randomisation was performed by pharmacist researcher using a computer‐generated randomised list from the research randomizer program (https://www.randomizer.org/), and followed the allocation sequence according to the referral of the physicians. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1) All P values above 0.05. Baseline characteristics were similar between the 2 study groups (P > 0.05 for all comparisons) (Table 1). |
Patient's baseline outcomes (selection bias) | Low risk | Table 1) All outcomes have P values above 0.05. Baseline characteristics were similar between the 2 study groups (P > 0.05 for all comparisons) (Table 1). |
Incomplete outcome data (attrition bias) | Low risk | 7 lost to follow‐up out of 80 (8.8%). Numbers and reasons reported and balanced. Quote: "Finally, only data of the patients who completed this study were analysed, but the lost to follow‐up was balanced between the groups and no difference was noted for the characteristics of patients and reasons for withdrawal. Some of the patients in this study had no laboratory tests of LDL cholesterol levels (52 available out of 80 = 65%)." |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | All of our outcomes of interest are objective (HbA1c, SBP, DBP and LDL). The outcome assessors were blinded and unaware to which group the patients had been assigned. |
Selective reporting (reporting bias) | Unclear risk | No registered protocol or previously published protocol. Results match methods. |
Risk of contamination (other bias) | High risk | Only the patients in the intervention arm received consultations from pharmacists but it is not excluded that physicians changed their care approach with their usual care patients following pharmacists' recommendations about intervention patients. Quote: "In addition, the physicians were not blinded to the clinical pharmacy service, which may have had some effect on the care of patients with diabetes in both study groups." |
Other bias | Low risk | No evidence of other bias. |