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Table 2 Timing and content of study assessments.

From: Protocol for Past BP: a randomised controlled trial of different blood pressure targets for people with a history of stroke of transient ischaemic attack (TIA) in primary care

Baseline data: research nurse administered

Socio-demographic characteristics:

   Age; Ethnicity; Gender; Postcode

Validation of stroke/transient ischaemic attack:

   Review of medical records with patient history

Clinical measures:

   Six blood pressure (BP) measurements, calculating mean of 2nd and 3rd measurements and recording details of: arm used; arm circumference; BP cuff size; and time BP measurement started

   24 hour ambulatory BP recording

Medical history

   Previous history of angina, myocardial infarction, heart failure, atrial fibrillation, CABG/angioplasty (balloon)/or stent, peripheral vascular disease, diabetes, chronic kidney disease. Current prescription medications. Smoking status and alcohol intake

Patient questionnaires - self-completion

   Health related quality of life assessed by the SF-36 [20] and EQ-5 D [19]

   Disability assessed by the Modified Rankin Scale [26]

   Medication Adherence Report Schedule (MARS) for BP treatment [27]

   Symptoms/side effects questionnaire

Patient questionnaire - research nurse completion

   Cognitive function assessed by the Mini Mental State [21]

Eligibility and consent

   Review inclusion and exclusion criteria and record outcome of consent process

Patient follow up for BP control

GP appointment at any time patient BP medication review required

   Action taken to treat/monitor side effects

   Action taken to treat BP above target using study algorithm (see figure 1)

   Make appointment with practice nurse at appropriate interval (see figure 2)

Practice nurse follow up - 1-3 month intervals

   Six BP readings, as per baseline data collection

   Side effects of BP medication

   Refer patient to GP or make further appointment with practice nurse (see figure 2)

Patient follow up by research team

Research nurse follow up - 6 and 12 months post randomisation

   Six BP readings, as per baseline data collection

   24 hour ambulatory BP recording (12 month f/u only)

   Check details of patient visits to GP and practice nurse

   Diagnosis of key medical conditions (as per baseline data collection) since baseline or the previous research nurse follow up

   All hospital admissions or outpatient visits since baseline or the previous research nurse follow up

   Record of medications introduced since baseline or the previous research nurse follow up

   Monitor compliance with repeat medication since baseline or previous research nurse follow up

   Completion of patient questionnaires, as per baseline data collection.

Obtaining information on patients who died

   Records flagged at NHS central register