Cardiovascular Diseases
Conditions
Keywords
Cardiovascular diseases, Clinical prediction rule, Population projection, Risk stratification, Health behavior
Brief summary
The purpose of this study is to develop, evaluate, and apply a predictive algorithm for assessing CVD risk in the community setting: the Cardiovascular Disease Population Risk Tool (CVDPoRT).
Detailed description
This observational study will use the Ontario sample of the Canadian Community Health Survey (2001, 2003, 2005; 77,251 respondents) to assess risk factors - focusing on health behaviours (physical activity, diet, smoking, and alcohol use). Incident CVD outcomes will be assessed through linkage to administrative healthcare databases (619,886 person-years of follow-up until 31 December 2011). Socio-demographic factors (age, sex, immigrant status, education) and mediating factors such as presence of diabetes and hypertension will be included as predictors. Risk prediction models will be developed using competing risks survival analysis. The analysis plan adheres to published recommendations for the development of valid risk prediction models to limit the risk of over-fitting and improve the quality of predictions. Key considerations are fully pre-specifying the predictor variables; appropriate handling of missing data; use of flexible functions for continuous predictors; and avoiding data-driven variable selection procedures that increase the risk of type I error. The 2007 and 2009 surveys (approximately 50,000 respondents) will be used for validation. Calibration will be assessed overall and in predefined subgroups of importance to clinicians and policymakers.
Interventions
None listed
Sponsors
Canadian Institutes of Health Research (CIHR)
Institute for Clinical Evaluative Sciences
Statistics Canada
Ottawa Hospital Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Respondents to the Canadian Community Health Surveys
Exclusion criteria
* Not eligible for Ontario's universal health insurance program * Pregnant * Prior history of heart disease or stroke * Younger than age 20
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Disease Event | up to 12 years | The primary outcome of interest was a major CVD event resulting in hospitalization or sudden death from CVD. Respondents were followed from the survey administration date until the earliest of: incident event, death due to causes other than CVD (defined as a competing risk), loss to follow-up (defined as loss of health care eligibility), or end of study (31 December 2012). |
Other
| Measure | Time frame |
|---|---|
| Death Due to Causes Other Than CVD | up to 12 years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Derivation Cohort Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada. | 77 |
| Validation Cohort Eligible respondents to the 2007/2008 Canadian Community Health Survey. | 26 |
| Total | 103 |
Baseline characteristics
| Characteristic | Derivation Cohort | Validation Cohort | Total |
|---|---|---|---|
| Age, Continuous Female | 48.0 years | 51.0 years | 49.5 years |
| Age, Continuous Male | 46.0 years | 48.0 years | 47.0 years |
| Sex: Female, Male Female | 42185 Participants | 14801 Participants | 56986 Participants |
| Sex: Female, Male Male | 35066 Participants | 12167 Participants | 47233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Major Cardiovascular Disease Event
The primary outcome of interest was a major CVD event resulting in hospitalization or sudden death from CVD. Respondents were followed from the survey administration date until the earliest of: incident event, death due to causes other than CVD (defined as a competing risk), loss to follow-up (defined as loss of health care eligibility), or end of study (31 December 2012).
Time frame: up to 12 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Derivation Cohort | Major Cardiovascular Disease Event | 3182 Cardiovascular disease event |
| Validation Cohort | Major Cardiovascular Disease Event | 527 Cardiovascular disease event |
Other Pre-specified
Death Due to Causes Other Than CVD
Time frame: up to 12 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Derivation Cohort | Death Due to Causes Other Than CVD | 3538 deaths |
| Validation Cohort | Death Due to Causes Other Than CVD | 979 deaths |