There is uncertainty whether current strategies for providing CVD risk scores  affect CVD events .
Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm .
BACKGROUND The current paradigm for cardiovascular disease ( CVD ) emphasises absolute risk assessment to guide treatment decisions in primary prevention .
Although the derivation and validation of multivariable risk assessment tools , or CVD risk scores , have attracted considerable attention , their effect on clinical outcomes is uncertain .
OBJECTIVES To assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes , risk factor levels , preventive medication prescribing , and health behaviours .
Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour
Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015
There is uncertainty whether current strategies for providing CVD risk scores  affect CVD events .
Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm .
BACKGROUND The current paradigm for cardiovascular disease ( CVD ) emphasises absolute risk assessment to guide treatment decisions in primary prevention .
Although the derivation and validation of multivariable risk assessment tools , or CVD risk scores , have attracted considerable attention , their effect on clinical outcomes is uncertain .
OBJECTIVES To assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes , risk factor levels , preventive medication prescribing , and health behaviours .