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. |