Williams 2012.
| Study characteristics | ||
| Methods |
A multifactorial intervention to improve blood pressure control in co‐existing diabetes and kidney disease: a feasibility randomized controlled trial Patient RCT, conducted in diabetes, renal, and diabetes and nephrology outpatient clinics at public tertiary metropolitan hospital in Melbourne and regional Victoria, Australia Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 41 Intervention arm N: 39 Diabetes type: type 1 and type 2 Mean age: 67.0 ± 9.6 % Male: 56.3 Longest follow‐up: 12 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1) HbA1c, median % (SD) Control arm: pre 7.5 (1.1), post 8.0 (1.5) Intervention arm: pre 7.5 (1.5), post 7.0 (1.5) 2) SBP, mean mmHg (SD) Control arm: pre 150.2 (NR), post 138.2 (NR) Intervention arm: pre 150.2 (NR), post 133.2 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 77.6 (NR), post 71.1 (NR) Intervention arm: pre 75.7 (NR), post 68.3 (NR) |
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| Funding source | This research was supported by an Australian Research Council (Linkage) Grant (LP0774989), Sigma Theta Tau International Small Grant, Nurses Memorial Centre Australian Legion of Ex‐ Servicemen and Women Scholarship, and the Mona Menzies Nurses Board of Victoria Grant | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "code numbers assigned prior to randomization by a statistician." How these code numbers were generated is unclear. Then used stratified block randomisation. |
| Allocation concealment (selection bias) | Unclear risk | Quote: "The identity of all participants who were enrolled and randomized to receive the intervention was kept in a locked cabinet". This doesn't mean it was concealed from those conducting the randomisation process. What about block size? if its too small one can predict next assignment. |
| Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
| Patient's baseline outcomes (selection bias) | Unclear risk | Not provided. |
| Incomplete outcome data (attrition bias) | Low risk | Lost to follow‐up reasons seem balanced. Quote: "The analysis was performed on an intention to treat basis." Also, number lost to attrition unlikely to alter results. Numbers lost to follow‐up similar and reasons are balanced. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: SBP measured using sphygmomanometer, outcome assessors were blinded. Not reported as secondary: HbA1c, no mention of how it was measured, but assessors were blinded. |
| Selective reporting (reporting bias) | Low risk | Checked protocol. |
| Risk of contamination (other bias) | Unclear risk | There were biases of patients showing the research assistant their group allocations; not sure if this constitutes contamination of interventions. |
| Other bias | Low risk | Information not available. |