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

Obreli‐Neto 2015.

Study characteristics
Methods Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36‐month randomized controlled clinical trial
RCT (NA clusters and NA providers), conducted in 1) Clinical trial conducted in a Brazilian public Primary Health Care Unit (PHCU) located in the municipality of Salto Grande, Sao Paulo state. Brazil’s Sistema Único de Saúde (SUS) is a universal, publicly funded, rights‐based public healthcare system. 2) Intervention delivered by pharmacists. In Brazil.
2 arms: 1. Control (usual care) (control arm) and 2. Intervention (pharmaceutical care) (intervention arm)
Participants Control arm N: 100
Intervention arm N: 100, NA, NA
Diabetes type: 4
Mean age: 65.3 ± 6.48
% Male: 37.65
Longest follow‐up: 36 months
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
Outcomes Glycated haemoglobin
Funding source No separate funding was obtained for this study
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk JMP 8.0.1 software (SAS Institute, Inc., Cary, NC) provided computer‐generated random sequences (100 patients each in the intervention and control groups) according to the medical record numbers of the 200 patients selected.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. All characteristics have P values above 0.05. The intervention and control groups were well balanced at baseline with regard to sociodemographic, clinical and drug therapy characteristics.
Patient's baseline outcomes (selection bias) Low risk Table 1. All outcomes have P values above 0.05. The intervention and control groups were well balanced at baseline with regard to sociodemographic, clinical and drug therapy characteristics.
Incomplete outcome data (attrition bias) Low risk Only 6 lost to follow‐up out of 200 (3%). Numbers and reasons balanced.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Our outcome of interest is objective (HbA1c).
Selective reporting (reporting bias) Unclear risk No registered protocol or previously published protocol. Methods only mention cost‐effectiveness and economic costs. Nothing about HbA1c and blood pressure measures in the methods. They calculated their sample size based on LDL level.
Risk of contamination (other bias) Unclear risk Only the intervention arm had individual follow‐ups with pharmacists, education and special reminder pill packages. However, following suggestions by pharmacists to change medication for some intervention patients, it is not excluded that physicians changed their approach with patients in the usual care arm. Also, Quote: "The pharmacists also worked in association with other health care professionals for additional interventions, such as the adjustment of drug dosages, modification of drug therapy (addition or withdrawal), modification of diet plans, and practice of physical activities." It is unclear if the other health professionals were also working with the control group and may have changed their treatment based on meetings with pharmacists.
Other bias Low risk No evidence of other bias.