|
Timing and content of study assessments |
| Identifying eligible patients: Baseline data |
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| 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. |
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| Patient follow-up procedures: for an average of three years |
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| 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). |
Mant et al. BMC Cardiovascular Disorders 2003 3:9 doi:10.1186/1471-2261-3-9 |