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

Sriram 2011.

Study characteristics
Methods Impact of pharmaceutical care on quality of life in patients with type 2 diabetes mellitus
Patient RCT, conducted in general medicine department of a multi specialty tertiary care teaching hospital located at Coimbatore, South of India, South India
Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm)
Participants Control arm N: 60
Intervention arm N: 60
Diabetes type: type 2
Mean age: NR ± NR
% Male: 50.0
Longest follow‐up: 8 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Facilitated relay of clinical information
3) Patient education
4) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SE)
Control arm: pre 9.0 (0.5), post 8.3 (0.2)
Intervention arm: pre 8.4 (0.3), post 6.7 (0.2)
Funding source This study was identified by the Tamil Nadu Pharmaceutical Sciences Welfare Trust as need of the hour and partial funding was provided to carry out the study.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…using random number table."
Allocation concealment (selection bias) Unclear risk Not described.
Patient's baseline characteristics (selection bias) Low risk In text, data are balanced.
Patient's baseline outcomes (selection bias) Low risk HbA1c (P > 0.05).
Incomplete outcome data (attrition bias) Low risk No losses indicated.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Blinding not described. HbA1c analysed using an ordinary calibrated biochemical auto analyser.
Selective reporting (reporting bias) Low risk < 2005 approach used since no protocol; methods match outcomes.
Risk of contamination (other bias) Low risk Information not available.
Other bias Low risk Information not available.