Jorgensen 2014.

Study characteristics
Methods	Randomised controlled trial, parallel group (1:1)
Participants	Danish residents aged 30‐60 years from 11 municipalities in suburban Copenhagen, Denmark 61,301 people originally randomised within the study but 59,993 people met the inclusion criteria at baseline for this analysis Total randomised: 59,993 (n = 11,708 intervention, n = 48,285 comparison) Mean age: not reported, 50% women, 88% Danish
Interventions	Intervention group: invited for screening, risk assessment, and lifestyle counselling up to 4 times over a 5‐year period; high‐risk individuals were offered additional lifestyle counselling on smoking cessation, diet, and physical activity Comparison group: not invited for screening; formal risk assessment not provided
Outcomes	Primary outcome: incident ischaemic heart disease Secondary outcome: incident stroke, incident combined ischaemic heart disease and stroke, mortality, and attendance rates Total analysed in follow‐up: 59,616 (n = 11,629 intervention, n = 47,987 comparison) Follow‐up: 10 years
Study funding sources	Public, private, and industry sources: Danish Research Councils, Health Foundation, Danish Centre for Evaluation and Health Technology Assessment, Copenhagen County, Danish Heart Foundation, Ministry of Health and Prevention, Association of Danish Pharmacies, Augustinus Foundation, Novo Nordisk, Velux Foundation, Becket Foundation, and Ib Henriksens Foundation
Notes	Trial powered for 70% participation rate in the intervention group but only 52% of people in the intervention group accepted the invitation and were examined at baseline Data for risk factor levels not available given the pragmatic study design
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The 61 301 people were randomised by computer generated random numbers with different randomisation ratios in the different age and sex groups …" *Note for this analysis, 59,313 people met the baseline inclusion criteria.
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Personnel and participants not blinded to intervention but "neither the control group nor their doctor knew that they formed a control group."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Use of data from central registers further blinded the assessment of endpoints in relation to randomisation group."
Incomplete outcome data (attrition bias) All outcomes	Low risk	< 1% loss to follow‐up of event data
Selective reporting (reporting bias)	High risk	Cardiovascular outcomes were not prespecified in the original trial protocol
Other bias	High risk	Potential for contamination bias because randomisation was at the participant level