Methods
The Guidelines Oriented Approach to Lipid lowering (GOAL) Canada(11) was an
interventional program supported by Amgen Canada. It was an
investigator-initiated study started in 2015 and coordinated by the
Canadian Heart Research Centre, an academic research and education
physician organization. The intervention studied was physician
education/lipid management reminders applied at the end of each of three
visits based on data entry in the electronic case report form (eCRF).
Participating physicians received fair market value compensation for
completing the electronic case report form. The study was approved by
central and institutional research ethics boards where appropriate and
all enrolled patients provided informed consent.
Invitations to participate were sent to 750 Canadian physicians across
Canada from a proprietary (CASL Regulation) Canadian Heart Research
Centre list of physicians who participated in prior cholesterol-oriented
data collection studies (12,13) and 248 were activated
to enrol their patients for whom the participating physicians had the
primary role for cholesterol lowering management. These physicians were
asked to consecutively enrol at least 12 of their patients with either
(1) clinical vascular disease such as coronary artery disease (CAD),
cerebrovascular disease, abdominal aortic aneurysm, or peripheral
arterial disease; or, (2) familial hypercholesterolemia (FH), as defined
in the Canadian guidelines. (2). In addition, all
patients had to have an LDL-C > 2.0 mmol/L despite
maximally tolerated statin therapy (defined as having tried at least two
statins, each at least on two reduced doses) for at least three months
prior to enrolment. Patient outcomes for lipid lowering were assessed at
baseline and twice more approximately 4-6 months apart. Physicians were
asked to provide a single most important reason for each patient as to
why the guidelines were not followed.