Identifying eligible patients: Baseline data |
---|
ECG clinic: practice nurse interview-administered schedule |
• Socio-demographic characteristics: |
Age, sex and ethnicity. |
• Medical history: |
Previous history of hypertension, stroke, transient ischaemic attack, diabetes, myocardial infarction, heart failure, angina, rheumatic fever, valvular heart disease, oesophageal varices, peptic ulcer disease or intra-cranial haemorrhage. Current prescription medications. Smoking status and alcohol intake. |
• Clinical measures: |
Blood pressure and a 12 lead ECG. |
Receipt of ECG results: practice nurse & GP review of the medical record |
• Medical history (for patients in atrial fibrillation only): |
Previous history of hypertension, stroke, transient ischaemic attack, diabetes; myocardial infarction, heart failure, angina, rheumatic fever, valvular heart disease, oesophageal varices, peptic ulcer disease or intra-cranial haemorrhage. Current prescription medications. |
Randomisation clinic |
Patient schedule: self-completion |
• Disability assessed by the Rankin Score [3]. |
• Health related quality of life assessed by the SF-12 [41] and EQ-5D. [38]. |
Practice nurse schedule: interview |
• Blood pressure, current prescription medications and the Short-Orientation Memory Concentration test [37]. |
GP schedule: interview |
• Review of inclusion and exclusion criteria and record outcome of consent process. |
Patient follow-up procedures: for an average of three years |
Obtaining information on patients who died |
• Records flagged at NHS central register. |
GP interviews at 3 months post-randomisation, then six monthly intervals there afterward |
• Major extra-cranial haemorrhage (fatal, or one that requires transfusion or surgery). |
• Death – all cause, all vascular and stroke. |
• Admission to hospital – all cause, all vascular, stroke. |
• Cognition assessed by Mini-Mental State Exam [42]. at (9, 21, and 33 month follow-ups only). |
• Disability assessed by the patient using the Rankin Score [3]. |
• Blood pressure and apical pulse rate. |
• Drop out/withdrawal from allocated medication. |
Researcher case note review at 6 months post-randomisation, then six monthly intervals there afterward |
• Major extra-cranial haemorrhage (fatal, or one that requires transfusion or surgery). |
• Death – all cause, all vascular and stroke. |
• Admission to hospital – all cause, all vascular, stroke. |
• Drop out/withdrawal from allocated medication. |
Patient self-completed postal questionnaire at 12 months post-randomisation, then annually there afterwards |
• Disability assessed by the Rankin Score [3]. |
• Health related quality of life assessed by the SF-12 [41] and EQ-5D [38]. |
• Patient costs questionnaire (warfarin patients only, at 12 months). |