Smith 2004.
| Methods | Cluster‐randomised controlled trial Ireland |
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| Participants | Adults with type 2 diabetes identified by diabetes registers of participating general practices; mean age 65 years; 45% female; mean 6 years diagnosed; mean HbA1c 6.7%; 30 participating general practices (50 GPs), 43% single‐handed; 23% with practice nurse One specialist centre | |
| Interventions | Education for GPs and practice nurses (6‐week distance learning course and 3 skills sessions); community diabetes nurse to support practices and co‐ordinate care; locally agreed clinical and referral guidelines; 3‐monthly general practice reviews; annual specialist review generating individualised management plans; structured record care that moved between sectors; fast‐track re‐referral to specialist if indicated Comparison: usual care. 76% of participants undergoing annual specialist review; no structured GP care | |
| Outcomes |
Health outcomes
Primary outcomes HbA1c Secondary outcomes BP; cholesterol; BMI; diabetes well‐being scores; treatment satisfaction; smoking status Information exchange between sectors (shared care group only); default from care Process outcomes Measures of diabetes care delivery in specialist and GP clinics; recording of risk factors; numbers of specialist and GP visits; information exchange between sectors (shared care group only) Costs Direct costs (data from study author) |
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| Notes | Study duration 18 months Good glycaemic control at baseline |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table used by independent researcher |
| Allocation concealment (selection bias) | Low risk | Done (cluster allocation) |
| Baseline characteristics | Low risk | Reported and similar |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not possible owing to nature of the intervention but unlikely owing to design |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Automated test |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 93% follow‐up |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods reported |
| Protection against contamination | Low risk | Contamination unlikely owing to design |
| Other bias | Low risk | |