Holm 2002.
| Methods | Cluster‐randomised controlled trial Denmark |
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| Participants | 343 patients on oral anticoagulation therapy (OAT) (50% with atrial fibrillation; 18% with prosthetic heart valve; and 16% with thromboembolism); median age 70; 45% female 127 GPs 4 specialist physicians at a hospital outpatient clinic in Aarhis County, Denmark, covering population of 310,300 | |
| Interventions | Specialists' initial education programme for GPs; patient education; OAT telephone hotline for GPs; annual evaluation of all OAT patients; mailing of anonymised OAT quality reports to GPs GP referral of OAT patients to hospital clinics for evaluation of OAT; routine monitoring of OAT Comparison: usual care GPs monitoring OAT; no education or specialist support/evaluation | |
| Outcomes |
Health outcomes
Primary outcomes Median time spent within therapeutic interval of INR (optimal OAT control) Secondary outcomes Clinical outcomes: major and minor haemorrhage; recurrent thrombosis; death |
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| Notes | Study reports results for patients entering and leaving shared care service. This review includes only data related to patients maintained on OAT throughout the study period. Study duration 2 years with immediate follow‐up Study includes data on non‐randomised group (patients of non‐responder GPs) not included in this review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not reported |
| Allocation concealment (selection bias) | Low risk | 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 low risk due to cluster design |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up for participants maintained on oral anticoagulant therapy (OAT) throughout study period |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods reported |
| Protection against contamination | Low risk | Protection against contamination due to nature of the design |
| Other bias | Low risk | |