Patient Management Tip - The success of ANBP2 will depend primarily on two aspects of the monitoring phase of the trial. Firstly, the identification of study end-points and secondly the adherence of patients to the randomisation group to which they have been allocated. This second aspect of keeping patients on the right track is one which is becoming a major focus of the ANBP2 research staff. Some new initiatives to assist practitioners in keeping patients on track will commence during 1997 and include the following:
a) A clearly identified ACE or diuretic group sticker on patient case notes, and
b) An antihypertensive drug record sheet which will indicate the initial group to which the patient was randomised and identify the appropriate recommended treatment steps. Also the research nurses conducting the three month reviews where they have identified a cross-over or a breaking of randomisation protocol, will ask the practitioner to complete a drug cross-over form. It is likely that in many instances that the cross-over will be appropriate management strategy and the purpose of the sheet is to gain an indication as to why patients have moved between groups. The monitoring of patients is clearly focussed on their stepping down through the randomisation arms and not across between treatment groups as in the following table.
STEP DOWN -- NOT ACROSS
ACE INHIBITOR GROUP STEP 1 ACE inhibitor (enalapril)
STEP 1 Diuretic STEP 2 Beta-blocker or calcium channel antagonist or alpha blocker STEP 2 Beta-blocker or calcium channel antagonist or alpha blocker STEP 3
Drug from a class not used in STEP 2 or a diuretic
STEP 3 Drug from a class not used in STEP 2 STEP 4 Drug from a class not used in STEPS 2 or 3
STEP 4 Drug from a class not used in STEPS 2 or 3
Keeping Patients on the Right Track
After Randomisation
DIURETIC GROUP
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