. 2021 Aug 13;43:24–30. doi: 10.1016/j.athplu.2021.08.003

Table 1.

Parameters recorded during the observation period and at follow-up.

Parameters documented at baseline (if available)	Parameters to be documented at 12-month follow-up (if available)
• Eligibility • Demographic and sociodemographic variables • Vital signs • Medical history, including CVD risk status-related medical history: o CV risk assessment with or without utilization of risk score o History/diagnosis and current status of elevated LDL-C o Heterozygous familial hypercholesterolemia (HeFH), as documented by investigator o Documented ASCVD either clinical or unequivocal on imaging^a • Concomitant diseases • For diabetic patients o Disease type and date of diagnosis o Treatment o Microvascular complications • Current concomitant medication for CVD, as documented by investigator • Previous/current dietary restrictions • Previous/current use of lipid-lowering treatment including details of dose, dose modification, switching, combination therapy, drug intolerance, insufficient responsiveness, investigators and patient's assessment on adherence o Statin(s) o Bile acid sequestrant(s) o Cholesterol absorption inhibitor (Ezetimibe) o PCSK9 inhibitor(s) o Nicotinic acid o Drug combinations o Other • Laboratory parameters o Lipid variables - LDL-C - HDL-C, non-HDL-C, TC, Apo B, TG, Lp(a) o Diabetes-related parameters - Fasting glucose - HbA1c o Inflammatory status - hsCRP o Renal function parameters (GFR, serum creatinine, blood urea nitrogen (BUN)) o Other laboratory parameters (liver function, serum chemistry, hematology) • HEOR parameters o Hospital admissions o Length of hospital stay o Number of days in ICU o Interventions o Other HEOR parameters o Adherence to former and current treatment o Patient reported outcomes (EQ-5D-5L^b, PAM-13^c)	• Vital signs • CVD risk status: o CV risk assessment with or without utilization of risk score o History/diagnosis and current status of elevated LDL-C o Heterozygous familial hypercholesterolemia (HeFH) o Documented ASCVD either clinical or unequivocal on imaging • Concomitant diseases o Pre-specified and other CVD newly diagnosed/worsened from baseline o Time to disease onset/first event o Pre-specified and other symptomatic CVD newly diagnosed/symptomatic since baseline o Time to disease stopped being symptomatic o Pre-specified CV procedures since baseline o Time to last CV procedure • Deaths o Time to death and cause of death • For diabetic patients o Disease type and date of diagnosis o Treatment o Microvascular complications • Current concomitant medication for CVD • Previous/current dietary restrictions • Previous/current use of lipid-lowering treatment including details of dose, dose modification, switching, combination therapy, drug intolerance, insufficient responsiveness, investigators and patient's assessment on adherence o Statin(s) o Bile acid sequestrant(s) o Cholesterol absorption inhibitor (Ezetimibe) o PCSK9 inhibitor(s) o Nicotinic acid o Drug combinations o Other • Clinical events associated with the lipid-lowering therapies: o Insufficient lipid lowering efficacy o Muscle-associated symptoms (taken from patient chart) o New-onset diabetes mellitus o Drug-drug interaction o Laboratory abnormalities o Other • Neurocognitive impairment • Non-adherence to lipid-lowering therapies, as assessed by investigator • Laboratory parameters, as measured and provided by individual study sites o Lipid variables - LDL-C - HDL-C, non-HDL-C, TC, Apo B, TG, Lp(a) o Diabetes-related parameters - Fasting glucose - HbA1c o Inflammatory status - hsCRP o Renal function parameters (GFR, serum creatinine, blood urea nitrogen (BUN)) o Other laboratory parameters (liver function, serum chemistry, hematology) • HEOR parameters o Hospital admissions o Length of hospital stay o Number of days in ICU o Interventions o Other HEOR parameters (e.g. insurance status, employment status, education) o Patient reported outcomes (EQ-5D-5L^b, PAM-13^c)

Parameters documented at baseline (if available)

Parameters to be documented at 12-month follow-up (if available)

•
Eligibility
•
Demographic and sociodemographic variables
•
Vital signs
•
Medical history, including CVD risk status-related medical history:
- o
  CV risk assessment with or without utilization of risk score
- o
  History/diagnosis and current status of elevated LDL-C
- o
  Heterozygous familial hypercholesterolemia (HeFH), as documented by investigator
- o
  Documented ASCVD either clinical or unequivocal on imaging^a
•
Concomitant diseases
•
For diabetic patients
- o
  Disease type and date of diagnosis
- o
  Treatment
- o
  Microvascular complications
•
Current concomitant medication for CVD, as documented by investigator
•
Previous/current dietary restrictions
•
Previous/current use of lipid-lowering treatment including details of dose, dose modification, switching, combination therapy, drug intolerance, insufficient responsiveness, investigators and patient's assessment on adherence
- o
  Statin(s)
- o
  Bile acid sequestrant(s)
- o
  Cholesterol absorption inhibitor (Ezetimibe)
- o
  PCSK9 inhibitor(s)
- o
  Nicotinic acid
- o
  Drug combinations
- o
  Other
•
Laboratory parameters
- o
  Lipid variables
- -
  LDL-C
- -
  HDL-C, non-HDL-C, TC, Apo B, TG, Lp(a)
- o
  Diabetes-related parameters
- -
  Fasting glucose
- -
  HbA1c
- o
  Inflammatory status
- -
  hsCRP
- o
  Renal function parameters (GFR, serum creatinine, blood urea nitrogen (BUN))
- o
  Other laboratory parameters (liver function, serum chemistry, hematology)
•
HEOR parameters
- o
  Hospital admissions
- o
  Length of hospital stay
- o
  Number of days in ICU
- o
  Interventions
- o
  Other HEOR parameters
- o
  Adherence to former and current treatment
- o
  Patient reported outcomes (EQ-5D-5L^b, PAM-13^c)

•
Vital signs
•
CVD risk status:
- o
  CV risk assessment with or without utilization of risk score
- o
  History/diagnosis and current status of elevated LDL-C
- o
  Heterozygous familial hypercholesterolemia (HeFH)
- o
  Documented ASCVD either clinical or unequivocal on imaging
•
Concomitant diseases
- o
  Pre-specified and other CVD newly diagnosed/worsened from baseline
- o
  Time to disease onset/first event
- o
  Pre-specified and other symptomatic CVD newly diagnosed/symptomatic since baseline
- o
  Time to disease stopped being symptomatic
- o
  Pre-specified CV procedures since baseline
- o
  Time to last CV procedure
•
Deaths
- o
  Time to death and cause of death
•
For diabetic patients
- o
  Disease type and date of diagnosis
- o
  Treatment
- o
  Microvascular complications
•
Current concomitant medication for CVD
•
Previous/current dietary restrictions
•
Previous/current use of lipid-lowering treatment including details of dose, dose modification, switching, combination therapy, drug intolerance, insufficient responsiveness, investigators and patient's assessment on adherence
- o
  Statin(s)
- o
  Bile acid sequestrant(s)
- o
  Cholesterol absorption inhibitor (Ezetimibe)
- o
  PCSK9 inhibitor(s)
- o
  Nicotinic acid
- o
  Drug combinations
- o
  Other
•
Clinical events associated with the lipid-lowering therapies:
- o
  Insufficient lipid lowering efficacy
- o
  Muscle-associated symptoms (taken from patient chart)
- o
  New-onset diabetes mellitus
- o
  Drug-drug interaction
- o
  Laboratory abnormalities
- o
  Other
•
Neurocognitive impairment
•
Non-adherence to lipid-lowering therapies, as assessed by investigator
•
Laboratory parameters, as measured and provided by individual study sites
- o
  Lipid variables
- -
  LDL-C
- -
  HDL-C, non-HDL-C, TC, Apo B, TG, Lp(a)
- o
  Diabetes-related parameters
- -
  Fasting glucose
- -
  HbA1c
- o
  Inflammatory status
- -
  hsCRP
- o
  Renal function parameters (GFR, serum creatinine, blood urea nitrogen (BUN))
- o
  Other laboratory parameters (liver function, serum chemistry, hematology)
•
HEOR parameters
- o
  Hospital admissions
- o
  Length of hospital stay
- o
  Number of days in ICU
- o
  Interventions
- o
  Other HEOR parameters (e.g. insurance status, employment status, education)
- o
  Patient reported outcomes (EQ-5D-5L^b, PAM-13^c)

ACS, acute coronary syndrome; Apo B, apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; BUN, blood urea nitrogen; CABG, coronary artery bypass graft surgery; CT, computed tomography; CV, cardiovascular; GFR, glomerular filtration rate; HDL-C, high-density lipoprotein cholesterol; HEOR, health economics outcome research; hsCRP, high-sensitivity C-reactive protein; ICU, intensive care unit; Lp(a), lipoprotein (a); MI, myocardial infarction; PCI, percutaneous coronary intervention; PCSK9, proprotein convertase subtilisin/kexin type 9; TC, total cholesterol; TG, triglycerides; TIA, transient ischaemic attack.

Documented ASCVD includes previous ACS (MI or unstable angina), stable angina, coronary revascularization (PCI, CABG, and other arterial revascularization procedures), stroke and TIA, and peripheral arterial disease. Unequivocally documented ASCVD on imaging includes those findings that are known to be predictive of clinical events, such as significant plaque on coronary angiography or CT scan (multivessel coronary disease with two major epicardial arteries having >50% stenosis), or on carotid ultrasound [2].

The EuroQol (EQ-5D-5L) consists of five domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) and a visual analogue scale (VAS). The scores range from 0 to 100 based on the level of health for each domain given by participants. A score of 100 indicates current health is equivalent to full health; a score of 0 indicates that the current health is equivalent to death. According to the scores of the five domains, a sum utility score is calculated ranging from 0 to 1. A score of 1 represents a perfect state. In addition, patients rate their current health on a 20-cm vertical VAS scored from 0 to 100 reflecting the continuum from a best imaginable to the worst imaginable health state.

PAM-13 assesses patient knowledge, skills, and confidence for self-management based on 13 items. Individuals are segmented into one of four activation levels along an empirically derived 100-point scale. Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals in the lowest activation level do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self-management skills, and are resilient in times of stress or change.