Risk scoring for the primary prevention of cardiovascular disease

Kunal N Karmali; Stephen D Persell; Pablo Perel; Donald M Lloyd-Jones; Mark A Berendsen; Mark D Huffman

doi:10.1002/14651858.CD006887.pub4

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Figure 1

Study flow diagram.

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Figure 2

Summary of CVD risk score interventions by included study.
Abbreviations: CHD: coronary heart disease; CVD: cardiovascular disease; FRS: Framingham risk score; MI: myocardial infarction; RF: risk factors, RR: risk ratio; UKPDS: United Kingdom Prospective Diabetes Study

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 5

Funnel plot of comparison: 1 CVD risk score versus no CVD risk score/usual care, outcome: 1.3 Total cholesterol (mmol/L).

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Figure 6

Funnel plot of comparison: 1 CVD risk score versus no CVD risk score/usual care, outcome: 1.5 Systolic blood pressure (mmHg).

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Figure 7

Funnel plot of comparison: 1 CVD risk score versus no CVD risk score/usual care, outcome: 1.7 Change in multivariable CVD risk.

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Analysis 1.1

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 1: CVD events

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Analysis 1.2

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 2: CVD events, excluding Bucher 2010

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Analysis 1.3

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 3: Total cholesterol

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Analysis 1.4

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 4: Low‐density lipoprotein cholesterol

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Analysis 1.5

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 5: Systolic blood pressure

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Analysis 1.6

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 6: Diastolic blood pressure

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Analysis 1.7

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 7: Change in multivariable CVD risk

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Analysis 1.8

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 8: Adverse events (investigator defined)

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Analysis 1.9

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 9: Anxiety

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Analysis 1.10

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 10: New/intensified lipid‐lowering medication

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Analysis 1.11

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 11: New/intensified antihypertensive medication

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Analysis 1.12

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 12: New aspirin

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Analysis 1.13

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 13: Medication adherence

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Analysis 1.14

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 14: Smoking cessation

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Analysis 1.15

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 15: Exercise

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Analysis 1.16

Comparison 1: CVD risk score versus no CVD risk score/usual care, Outcome 16: Decisional conflict

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Analysis 2.1

Comparison 2: CVD risk score versus no CVD risk score/usual care by decision support use, Outcome 1: Total cholesterol by decision support use

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Analysis 2.2

Comparison 2: CVD risk score versus no CVD risk score/usual care by decision support use, Outcome 2: Low‐density lipoprotein cholesterol by decision support

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Analysis 2.3

Comparison 2: CVD risk score versus no CVD risk score/usual care by decision support use, Outcome 3: Systolic blood pressure by decision support use

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Analysis 2.4

Comparison 2: CVD risk score versus no CVD risk score/usual care by decision support use, Outcome 4: Diastolic blood pressure by decision support use

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Analysis 2.5

Comparison 2: CVD risk score versus no CVD risk score/usual care by decision support use, Outcome 5: Change in multivariable CVD risk by decision support

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Analysis 3.1

Comparison 3: CVD risk score versus no CVD risk score/usual care by health IT use, Outcome 1: Total cholesterol by health IT use

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Analysis 3.2

Comparison 3: CVD risk score versus no CVD risk score/usual care by health IT use, Outcome 2: Low‐density lipoprotein cholesterol by health IT use

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Analysis 3.3

Comparison 3: CVD risk score versus no CVD risk score/usual care by health IT use, Outcome 3: Systolic blood pressure by health IT use

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Analysis 3.4

Comparison 3: CVD risk score versus no CVD risk score/usual care by health IT use, Outcome 4: Diastolic blood pressure by health IT use

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Analysis 3.5

Comparison 3: CVD risk score versus no CVD risk score/usual care by health IT use, Outcome 5: Change in multivariable CVD risk by health IT use

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Analysis 4.1

Comparison 4: CVD risk score versus no CVD risk score/usual care by risk status of participants, Outcome 1: Total cholesterol by risk status

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Analysis 4.2

Comparison 4: CVD risk score versus no CVD risk score/usual care by risk status of participants, Outcome 2: Low‐density lipoprotein cholesterol by risk status

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Analysis 4.3

Comparison 4: CVD risk score versus no CVD risk score/usual care by risk status of participants, Outcome 3: Systolic blood pressure by risk status

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Analysis 4.4

Comparison 4: CVD risk score versus no CVD risk score/usual care by risk status of participants, Outcome 4: Diastolic blood pressure by risk status

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Analysis 4.5

Comparison 4: CVD risk score versus no CVD risk score/usual care by risk status of participants, Outcome 5: Change in multivariable CVD risk by risk status

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Analysis 5.1

Comparison 5: Multivariable CVD risk, Outcome 1: Multivariable CVD risk

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Summary of findings 1. CVD risk scoring for the primary prevention of cardiovascular disease

Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	N of participants (studies)	Quality of the evidence (GRADE)	Comments
CVD risk scoring for the primary prevention of cardiovascular disease
Patient or population: adults without prevalent cardiovascular disease (primary cardiovascular disease prevention) Setting: outpatient Intervention: providing CVD risk scores Comparison: not providing CVD risk scores/usual care
Outcomes	Risk with not providing CVD risk scores/usual care	Risk with providing CVD risk scores	Relative effect (95% CI)	N of participants (studies)	Quality of the evidence (GRADE)	Comments
CVD events follow‐up: range 1‐10 years	Study population		RR 1.01 (0.95 to 1.08)	99,070 (3 RCTs)	⊕⊕⊝⊝ Low^a,b	—
CVD events follow‐up: range 1‐10 years	53 per 1000	54 per 1000 (51 to 58)	RR 1.01 (0.95 to 1.08)	99,070 (3 RCTs)	⊕⊕⊝⊝ Low^a,b	—
Total cholesterol (mmol/L) follow‐up: median 1 years	In the comparison group, the range of mean total cholesterol level was 5.1 to 6.6 mmol/L and the range of mean change from baseline in total cholesterol level was 0.09 lower to 0.14 mmol/L higher	The mean difference in total cholesterol in the intervention group was 0.10 mmol/L lower (0.20 lower to 0.00)	—	20,437 (12 RCTs)	⊕⊕⊝⊝ Low^c,d	—
Systolic blood pressure (mmHg) follow‐up: median 1 years	In the comparison group, the range of mean systolic blood pressure level was 124.1 to 159.0 mmHg and the range of mean change from baseline in systolic blood pressure level was 5.3 lower to 1.0 higher mmHg	The mean difference in systolic blood pressure in the intervention group was 2.77 mmHg lower (4.16 lower to 1.38 lower)	—	32,954 (16 RCTs)	⊕⊕⊝⊝ Low^c,d	—
Change in multivariable CVD risk (SD) follow‐up: median 1 years	In the comparison group, the range of mean change from baseline in multivariable CVD risk was 5.3 lower to 0.77 higher SDs	The mean difference in multivariable CVD risk in the intervention group was 0.21 SDs lower (0.39 lower to 0.02 lower)	—	9549 (9 RCTs)	⊕⊕⊝⊝ Low^c,d	Standardised mean differences were calculated for this outcome due to the use of different multivariable CVD risk scales. An effect size of ~0.20 SD units reflects a small effect.
Investigator‐defined adverse events follow‐up: range 1 month to 1 year	Study population		RR 0.72 (0.49 to 1.04)	4630 (4 RCTs)	⊕⊕⊝⊝ Low^e,f	Adverse events were defined heterogeneously by investigators and included some events that may have been due to newly prescribed medications rather than the provision of a CVD risk score itself.
	27 per 1000	19 per 1000 (13 to 28)	RR 0.72 (0.49 to 1.04)	4630 (4 RCTs)	⊕⊕⊝⊝ Low^e,f
New/intensified lipid‐lowering medication follow‐up: median 6 months	Study population		RR 1.47 (1.15 to 1.87)	14,175 (11 RCTs)	⊕⊕⊝⊝ Low^d,e	Prescribing rates in the comparison group varied among the included trials (range 4% to 22%). Median prescribing rate presented
	107 per 1000	157 per 1000 (123 to 200)	RR 1.47 (1.15 to 1.87)	14,175 (11 RCTs)	⊕⊕⊝⊝ Low^d,e
New/intensified antihypertensive medication follow‐up: median 1 years	Study population		RR 1.51 (1.08 to 2.11)	13,255 (8 RCTs)	⊕⊕⊝⊝ Low^d,e	Prescribing rates in the comparison group varied among the included trials (range 0% to 27%). Median prescribing rate presented
	114 per 1000	172 per 1000 (123 to 240)	RR 1.51 (1.08 to 2.11)	13,255 (8 RCTs)	⊕⊕⊝⊝ Low^d,e
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio; SD: standard deviation.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
^aDowngraded due to study limitations, primarily driven by high risk of selection bias in Holt 2010 and high risk of reporting bias in Bucher 2010 and Jorgensen 2014. ^bDowngraded due to imprecision; trials reported being underpowered for CVD events. ^cDowngraded due to study limitations, primarily in the domains of attrition bias (missing data for follow‐up risk factor levels) and other sources of bias (poor intervention fidelity, potential conflicts of interest). ^dDowngraded due to heterogeneity in pooled estimates. ^eDowngraded due to study limitations, primarily in the domains of attrition bias (missing data for medication prescribing in follow‐up) and other sources of bias (poor intervention fidelity, potential conflicts of interest). ^fDowngraded due to imprecision, because confidence interval includes 1 and sample size does not meet threshold for optimal information size.

Summary of findings 1. CVD risk scoring for the primary prevention of cardiovascular disease

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Comparison 1. CVD risk score versus no CVD risk score/usual care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 CVD events Show forest plot	3	99070	Risk Ratio (IV, Fixed, 95% CI)	1.01 [0.95, 1.08]

1.2 CVD events, excluding Bucher 2010 Show forest plot	2	95708	Risk Ratio (IV, Fixed, 95% CI)	1.01 [0.94, 1.08]

1.3 Total cholesterol Show forest plot	12	20437	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.20, 0.00]

1.4 Low‐density lipoprotein cholesterol Show forest plot	10	22122	Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.10, 0.04]

1.5 Systolic blood pressure Show forest plot	16	32954	Mean Difference (IV, Random, 95% CI)	‐2.77 [‐4.16, ‐1.38]

1.6 Diastolic blood pressure Show forest plot	14	22378	Mean Difference (IV, Random, 95% CI)	‐1.12 [‐2.11, ‐0.13]

1.7 Change in multivariable CVD risk Show forest plot	9	9549	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.39, ‐0.02]

1.8 Adverse events (investigator defined) Show forest plot	4	4630	Risk Ratio (IV, Fixed, 95% CI)	0.72 [0.49, 1.04]

1.9 Anxiety Show forest plot	2	388	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.07 [‐0.27, 0.13]

1.10 New/intensified lipid‐lowering medication Show forest plot	11	14175	Risk Ratio (IV, Random, 95% CI)	1.47 [1.15, 1.87]

1.11 New/intensified antihypertensive medication Show forest plot	8	13255	Risk Ratio (IV, Random, 95% CI)	1.51 [1.08, 2.11]

1.12 New aspirin Show forest plot	3	1614	Risk Ratio (IV, Fixed, 95% CI)	2.71 [1.24, 5.91]

1.13 Medication adherence Show forest plot	4	621	Risk Ratio (IV, Random, 95% CI)	1.14 [0.92, 1.40]

1.14 Smoking cessation Show forest plot	7	5346	Risk Ratio (IV, Fixed, 95% CI)	1.38 [1.13, 1.69]

1.15 Exercise Show forest plot	2	2595	Risk Ratio (IV, Fixed, 95% CI)	0.98 [0.90, 1.06]

1.16 Decisional conflict Show forest plot	4	1261	Std. Mean Difference (IV, Random, 95% CI)	‐0.29 [‐0.57, ‐0.01]

Comparison 1. CVD risk score versus no CVD risk score/usual care

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Comparison 2. CVD risk score versus no CVD risk score/usual care by decision support use

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Total cholesterol by decision support use Show forest plot	12	20437	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.20, 0.00]

2.1.1 Decision support use	8	9444	Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.20, 0.01]
2.1.2 No decision support use	4	10993	Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.27, 0.06]
2.2 Low‐density lipoprotein cholesterol by decision support Show forest plot	10	22122	Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.10, 0.04]

2.2.1 Decision support use	9	21739	Mean Difference (IV, Random, 95% CI)	‐0.02 [‐0.10, 0.06]
2.2.2 No decision support use	1	383	Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.25, 0.03]
2.3 Systolic blood pressure by decision support use Show forest plot	16	32954	Mean Difference (IV, Random, 95% CI)	‐2.77 [‐4.16, ‐1.38]

2.3.1 Decision support use	13	22457	Mean Difference (IV, Random, 95% CI)	‐2.17 [‐3.52, ‐0.82]
2.3.2 No decision support use	3	10497	Mean Difference (IV, Random, 95% CI)	‐4.57 [‐6.89, ‐2.25]
2.4 Diastolic blood pressure by decision support use Show forest plot	14	22378	Mean Difference (IV, Random, 95% CI)	‐1.12 [‐2.11, ‐0.13]

2.4.1 Decision support use	10	11385	Mean Difference (IV, Random, 95% CI)	‐0.76 [‐1.29, ‐0.23]
2.4.2 No decision support use	4	10993	Mean Difference (IV, Random, 95% CI)	‐2.09 [‐3.33, ‐0.85]
2.5 Change in multivariable CVD risk by decision support Show forest plot	9	9549	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.39, ‐0.02]

2.5.1 Decision support use	7	6209	Std. Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.27, ‐0.07]
2.5.2 No decision support use	2	3340	Std. Mean Difference (IV, Random, 95% CI)	‐0.26 [‐0.98, 0.46]

Comparison 2. CVD risk score versus no CVD risk score/usual care by decision support use

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Comparison 3. CVD risk score versus no CVD risk score/usual care by health IT use

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Total cholesterol by health IT use Show forest plot	12	20437	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.20, 0.00]

3.1.1 Health IT use	8	9444	Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.20, 0.01]
3.1.2 No health IT use	4	10993	Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.27, 0.06]
3.2 Low‐density lipoprotein cholesterol by health IT use Show forest plot	10	22122	Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.10, 0.04]

3.2.1 Health IT use	9	21739	Mean Difference (IV, Random, 95% CI)	‐0.02 [‐0.10, 0.06]
3.2.2 No health IT use	1	383	Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.25, 0.03]
3.3 Systolic blood pressure by health IT use Show forest plot	16	32954	Mean Difference (IV, Random, 95% CI)	‐2.77 [‐4.16, ‐1.38]

3.3.1 Health IT use	13	22457	Mean Difference (IV, Random, 95% CI)	‐2.17 [‐3.52, ‐0.82]
3.3.2 No health IT use	3	10497	Mean Difference (IV, Random, 95% CI)	‐4.57 [‐6.89, ‐2.25]
3.4 Diastolic blood pressure by health IT use Show forest plot	14	22378	Mean Difference (IV, Random, 95% CI)	‐1.12 [‐2.11, ‐0.13]

3.4.1 Health IT use	10	11385	Mean Difference (IV, Random, 95% CI)	‐0.76 [‐1.29, ‐0.23]
3.4.2 No health IT use	4	10993	Mean Difference (IV, Random, 95% CI)	‐2.09 [‐3.33, ‐0.85]
3.5 Change in multivariable CVD risk by health IT use Show forest plot	9	9549	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.39, ‐0.02]

3.5.1 Health IT use	6	5387	Std. Mean Difference (IV, Random, 95% CI)	‐0.19 [‐0.26, ‐0.12]
3.5.2 No health IT use	3	4162	Std. Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.69, 0.39]

Comparison 3. CVD risk score versus no CVD risk score/usual care by health IT use

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Comparison 4. CVD risk score versus no CVD risk score/usual care by risk status of participants

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Total cholesterol by risk status Show forest plot	12	20437	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.20, 0.00]

4.1.1 High‐risk participants only	3	4105	Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.22, ‐0.03]
4.1.2 Participants of all risk levels	9	16332	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.23, 0.03]
4.2 Low‐density lipoprotein cholesterol by risk status Show forest plot	10	22122	Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.10, 0.04]

4.2.1 High‐risk participants only	3	14219	Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.11, ‐0.03]
4.2.2 Participants of all risk levels	7	7903	Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.11, 0.09]
4.3 Systolic blood pressure by risk status Show forest plot	16	32954	Mean Difference (IV, Random, 95% CI)	‐2.77 [‐4.16, ‐1.38]

4.3.1 High‐risk participants only	5	18375	Mean Difference (IV, Random, 95% CI)	‐2.22 [‐4.04, ‐0.40]
4.3.2 Participants of all risk levels	11	14579	Mean Difference (IV, Random, 95% CI)	‐2.96 [‐4.68, ‐1.24]
4.4 Diastolic blood pressure by risk status Show forest plot	14	22378	Mean Difference (IV, Random, 95% CI)	‐1.12 [‐2.11, ‐0.13]

4.4.1 High‐risk participants only	3	4091	Mean Difference (IV, Random, 95% CI)	‐0.90 [‐2.42, 0.63]
4.4.2 Participants of all risk levels	11	18287	Mean Difference (IV, Random, 95% CI)	‐1.20 [‐2.26, ‐0.14]
4.5 Change in multivariable CVD risk by risk status Show forest plot	9	9549	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.39, ‐0.02]

4.5.1 High‐risk participants only	2	4038	Std. Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.21, ‐0.09]
4.5.2 Participants of all risk levels	7	5511	Std. Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.49, 0.05]

Comparison 4. CVD risk score versus no CVD risk score/usual care by risk status of participants

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Comparison 5. Multivariable CVD risk

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Multivariable CVD risk Show forest plot	5	1921	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.15 [‐0.25, ‐0.06]

Comparison 5. Multivariable CVD risk

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