Patient and Provider Assessment of Lipid Management Registry

The PALM registry is a multicenter, observational registry aimed at evaluating how cholesterol management is applied in current clinical practice. This registry will recruit approximately 175 sites in the United States to enroll 7,500 patients with cardiovascular risk factors warranting consideration of lipid-lowering therapies as well as those already on statin therapy. Enrolling clinicians will include primary care providers, internal medicine providers, family medicine providers, cardiologists, and endocrinologists. Site selection will also target geographic diversity to ensure representation from all regions of the U.S., including rural and urban areas, as well as from minority populations. This registry is unique featuring the use of a mobile tablet-based enrollment device. This tablet-based enrollment tool is designed to adapt to the workflow of an outpatient practice, allowing research procedures (including screening, informed consent and patient survey) to be carried out during the patient visit, and maximizes paper-less data entry. All patient management decisions (including the choice of cholesterol-lowering therapy) are completely at the discretion of the care providers. This registry will involve retrospective and prospective patient data collection. Baseline data from patients and physicians will be collected. There will be no patient follow-up.

The target sample size (n=7,500) in this registry is not determined based on statistical considerations, but is based upon a non-probabilistic sampling approach, in order to obtain sufficient exposure data in patients who are in the various atherosclerotic cardiovascular disease (ASCVD) risk groups. During the enrollment period, balance across groups will be maintained by frequent monitoring of enrollment. Adaptive enrollment and capping will be considered to ensure adequate exposure across groups, physician type, and geographic location. Data quality will be assured by web-based or application-based data collection tool queries and data quality reports . Data quality control measures will include: data entry missing and range checks, data validation checks; standard record level checks that are run on the database to identify suspected duplicate, blank, or missing records; and logic checks and data surveillance of trends in data entry and query processing. The tools will prompt user to correct any missing, out of range, or potentially incorrect data. There are no interventions, no outside monitoring of sites nor a DSMB with this registry.