Wallymahmed 2011.
Study characteristics | ||
Methods |
Nurse‐led cardiovascular risk factor intervention leads to improvements in cardiovascular risk targets and glycaemic control in people with type 1 diabetes when compared with routine diabetes clinic attendance Patient RCT, conducted in a Diabetes Centre at Aintree University Hospitals, Liverpool, United Kingdom Two arms: 1. Routine group (control arm) and 2. Nurse‐led group (intervention arm) |
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Participants | Control arm N: 41 Intervention arm N: 40 Diabetes type: type 1 Mean age: 34.6 ± 9.0 % Male: 55.6 Longest follow‐up: 24 months |
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Interventions |
Control arm: None Intervention arm: 1) Case management 2) Team changes 3) Patient education |
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Outcomes | 1) Statins, N users (%) Control arm: pre 9 (22), post 24 (62) Intervention arm: pre 16 (40), post 37 (95) 2) Antihypertensives (any), N users (%) Control arm: pre 9 (22), post 11 (28) Intervention arm: pre 12 (30), post 18 (46) 3) HbA1c, mean % (SD) Control arm: pre 9.9 (1.4), post 9.4 (1.5) Intervention arm: pre 10.1 (1.4), post 9.2 (1.6) 4) SBP, mean mmHg (SD) Control arm: pre 119.0 (17.0), post 124.0 (16.0) Intervention arm: pre 127.0 (22.0), post 120.0 (15.0) 5) DBP, mean mmHg (SD) Control arm: pre 69.0 (10.0), post 70.0 (8.0) Intervention arm: pre 71.0 (13.0), post 68.0 (7.0) 6) LDL, mean mg/dL (SD) Control arm: pre 127.6 (23.2), post 100.5 (30.9) Intervention arm: pre 131.5 (34.8), post 85.1 (34.8) |
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Funding source | Not reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer generated". |
Allocation concealment (selection bias) | Unclear risk | Quote: "blind‐envelope system". Sealed? Opaque? |
Patient's baseline characteristics (selection bias) | Low risk | Quote: "The baseline data showed that the groups were well matched". Also provide non‐significant values for baseline characteristics. |
Patient's baseline outcomes (selection bias) | Low risk | All outcome assessed were not significant at baseline between both groups. |
Incomplete outcome data (attrition bias) | High risk | Two were lost to follow‐up in reference group and 1 lost to follow‐up in intervention group. Study states that they failed to attend and were discharged back to general practice, but did not provide reasons for why they were discharged. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Blinding not described. Objective laboratory methods not described. |
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. |