Keogh 2011.
| Study characteristics | ||
| Methods |
Psychological family intervention for poorly controlled type 2 diabetes Patient RCT, conducted in a specialist diabetes clinic at a large suburban hospital, Ireland Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
|
| Participants | Control arm N: 61 Intervention arm N: 60 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 6 months |
|
| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Promotion of self‐management |
|
| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 9.3 (1.1), post 8.8 (1.4) Intervention arm: pre 9.1 (1.0), post 8.4 (1.0) 2) SBP, mean mmHg (SD) Control arm: pre 138.0 (17.9), post 135.9 (16.5) Intervention arm: pre 139.5 (19.2), post 139.7 (20.8) 3) DBP, mean mmHg (SD) Control arm: pre 77.7 (10.6), post 77.0 (9.9) Intervention arm: pre 76.0 (9.7), post 75.4 (10.3) 4) Smoking cessation, N smokers (%) Control arm: pre 13 (28), post 12 (27) Intervention arm: pre 5 (12), post 3 (7) |
|
| Funding source | This study was funded by the Irish Health Research Board, project grant RP/2005/178 | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "…remote computer‐generated random number sequence." |
| Allocation concealment (selection bias) | Unclear risk | They talk about concealment but only the fact that the participants did not know their allocation until they began the study. However, the actual process of concealment was not described. |
| Patient's baseline characteristics (selection bias) | Unclear risk | In text not in table. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | High risk | Per‐protocol analysis, baseline based on those randomised, but numbers and reasons for loss to follow‐up not balanced. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Quote: "Outcome assessors were blinded to group allocation." Primary outcome: HbA1c, secondary: SBP. |
| 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 | None identified. |