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

Carter 2018.

Study characteristics
Methods Cluster‐randomized trial to evaluate a centralized clinical pharmacy service in private family medicine offices
Clustered RCT (12 clusters and NR providers), conducted in 1) 12 family medicine offices in Iowa, USA. 2) Clinical pharmacy specialists, providers. In United States of America.
2 arms: 1) Control (usual care) (control arm) and 2) Intervention (pharmacist management) (intervention arm)
Participants Control arm N: 125
Intervention arm N: 121, NA, NA
Diabetes type: 4
Mean age: 63.9 ± NR
% Male: 50.36
Longest follow‐up: 12 months
Interventions Control arm: (usual care)
Intervention arm: (pharmacist management)
1) Case management
2) Team change
3) Electronic patient registry
4) Clinician reminder
5) Facilitated relay of clinical information
6) Patient education
Outcomes Foot screening
Funding source Sources of Funding: NHLBI, R01HL116311.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were assigned to the pharmacists in the order they were enrolled into the study, independent of medical office. The biostatistician (JDD) randomised offices to avoid contamination that would occur if a physician had participants in both the intervention and control groups. All participants and physicians in a given office received either the intervention or usual care.
Allocation concealment (selection bias) Low risk Cluster‐RCT with randomisation occurring at one time.
Provider's baseline characteristics (selection bias) High risk Table 1. No P values provided. Some characteristics look unbalanced.
Patient's baseline characteristics (selection bias) High risk Table 2. No P values provided. Some characteristic values look unbalanced.
Patient's baseline outcomes (selection bias) High risk Table 2. No P values provided.  LDL showed a significant difference at baseline between the 2 groups, with a mean of 103.1 mg/dL in the control group and 90.6 mg/dL in the intervention group (P = 0.04). Similarly, baseline hyperlipidaemia was more common in the control group
(94.1%) than in the intervention group (86.6%) (P = 0.03).
Incomplete outcome data (attrition bias) Unclear risk Losses were even between groups and just over 13% in one metric. The greatest attrition for both groups was in Direct Measurement Forms: control (12.4%), intervention (14.1%).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Cluster‐randomised. Measurements taken objectively by medical professional.
Selective reporting (reporting bias) Low risk Prospectively registered protocol. Methods match outcomes.
Risk of contamination (other bias) Low risk The biostatistician (JDD) randomised offices to avoid contamination that would occur if a physician had participants in both the intervention and control groups. All participants and physicians in a given office received either the intervention or usual care.
Other bias Low risk … there is a possibility that selection bias occurred based on the strategy study co‐ordinators used to identify participants. However, we conducted a comprehensive analysis and found that the probability of selection bias was low.