Crasto 2011.
| Study characteristics | ||
| Methods |
Multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: The Microalbuminuria Education and Medication Optimisation (MEMO) Study Patient RCT, conducted in primary care practices and specialist diabetes clinics in Leicestershire, United Kingdom Two arms: 1) Control group (control arm) and 2) Education Medication Optimisation ‐ EMO (intervention arm) |
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| Participants | Control arm N: 95 Intervention arm N: 94 Diabetes type: type 2 Mean age: 61.5 ± 10.5 % Male: NR Longest follow‐up: 18 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) Aspirin, N users (%) Control arm: pre 65 (68), post 58 (69) Intervention arm: pre 80 (85), post 82 (95) 2) Statins, N users (%) Control arm: pre 74 (78), post 74 (88) Intervention arm: pre 77 (82), post 80 (93) 3) Antihypertensives (ACE inhibitor or angiotensin II receptor blockers), N users (%) Control arm: pre 84 (88), post 77 (92) Intervention arm: pre 89 (95), post 86 (100) 4) HbA1c, mean % (SD) Control arm: pre 8.0 (1.6), post 7.9 (NR) Intervention arm: pre 7.9 (1.4), post 7.2 (NR) 5) SBP, mean mmHg (SD) Control arm: pre 136.0 (16.0), post 138.1 (NR) Intervention arm: pre 139.0 (16.0), post 130.0 (NR) 6) DBP, mean mmHg (SD) Control arm: pre 77.0 (12.0), post 76.4 (NR) Intervention arm: pre 76.0 (12.0), post 69.9 (NR) 7) LDL, mean mg/dL (SD) Control arm: pre 85.1 (30.9), post 83.9 (NR) Intervention arm: pre 81.2 (23.2), post 64.6 (NR) 8a) Harms (hypoglycaemic events, grade 1: mild), N (%) Control arm: pre NR (NR), post 31 (35) Intervention arm: pre NR (NR), post 39 (44) 8b) Harms (hypoglycaemic events, grade 2: moderate), N (%) Control arm: pre NR (NR), post 27 (30) Intervention arm: pre NR (NR), post 11 (12) 8c) Harms (hypoglycaemic events, grade 3: severe), N (%) Control arm: pre NR (NR), post 6 (7) Intervention arm: pre NR (NR), post 0 (0) |
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| Funding source | The MEMO study was funded by a fellowship grant provided by Kidney Research, UK. The study is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for Leicestershire, Northamptonshire & Rutland, University Hospitals of Leicester. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Patient's baseline characteristics (selection bias) | Unclear risk | No P values provided. |
| Patient's baseline outcomes (selection bias) | Unclear risk | P values not provided and no in‐text description. |
| Incomplete outcome data (attrition bias) | Low risk | Per‐protocol analysis, baseline based on those randomised. Numbers and reasons for loss to follow‐up provided and seem balanced. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Outcome assessors were blinded. HbA1c measured using liquid chromatography, LDL by Friedwald formula. |
| Selective reporting (reporting bias) | Unclear risk | No data on outcomes. |
| Risk of contamination (other bias) | High risk | Quote: "Since some participants were also recruited from specialist clinic settings, it is conceivable that some participants in the control group would have received aggressive treatment." |
| Other bias | Low risk | Information not available. |