Table 3

Timing and content of study assessments

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).

Mant et al. BMC Cardiovascular Disorders 2003 3:9   doi:10.1186/1471-2261-3-9