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

Clifford 2002.

Study characteristics
Methods A randomised controlled trial of a pharmaceutical care programme in high‐risk diabetic patients in an outpatient clinic
Patient RCT, conducted in a diabetes clinic in Australia
Two arms: 1) Control (control arm) and 2) PCP ‐ pharmaceutical care programme (intervention arm)
Participants Control arm N: 25
Intervention arm N: 48
Diabetes type: type 1 and Type 2
Mean age: 60.5 ± 12.0
% Male: 55.0
Longest follow‐up: 6 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Team changes
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.5 (1.6), post 8.1 (1.6)
Intervention arm: pre 8.4 (1.4), post 8.2 (1.5)
Funding source This study was funded by The Society of Hospital Pharmacists of Australia, Pharmacia and Upjohn Contemporary Therapeutics Research Grant
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Information not available.
Allocation concealment (selection bias) Unclear risk Information not available.
Patient's baseline characteristics (selection bias) Low risk Information not available.
Patient's baseline outcomes (selection bias) Low risk Information not available.
Incomplete outcome data (attrition bias) Unclear risk Information not available.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Information not available.
Selective reporting (reporting bias) Unclear risk They report that "hypertension, dyslipidaemia and polypharmacy were inclusion criteria that did not apply to all patients, these data were not analysed further".
Risk of contamination (other bias) Unclear risk The doctors were aware of the allocation and could have treated the pharmaceutical care programme (PCP) group differently. Also, not sure if the pharmacist had exposure to the control group (it is not reported).
Other bias Unclear risk Information not available.