Dr Ivan Benett shows how NICE has prioritised guidance on cardiovascular risk assessment and lipid modification into a quality standard to improve patient outcomes and experience
Read this article to learn more about:
- using QRISK®2 to assess CVD risk
- lifestyle advice for people at risk of CVD
- when to offer a statin.
Although mortality from cardiovascular disease (CVD) in the UK is falling, CVD is still the leading cause of death in England and Wales, accounting for almost one-third of all deaths. In 2010, 180,000 people died from CVD, 80,000 from coronary heart disease, and 49,000 from strokes. Of these 180,000 deaths, 46,000 occurred in people aged 75 years or younger, of whom 70% were men. Cardiovascular disease was estimated to cost the NHS in England almost £6940 million in 2003, rising to £7880 million in 2010.1 There continues to be a need to optimise primary and secondary evidence-based interventions at a population level in order to improve health outcomes.
NICE quality standards
NICE quality standards aim to improve health and social care outcomes in the complete care pathway by driving quality improvement within priority areas. They take the form of aspirational but achievable statements and are based on NICE guidance or other NICE-accredited evidence sources.2 The NICE quality standards advisory committees consider guideline recommendations and prioritise them according to how much they are likely to impact on the quality of care and delivery of improved outcomes. A narrative that includes the rationale accompanies each quality statement. The outcomes are usually about mortality benefit, patient experience, and improved safety or reduced avoidable hospital activity.
This NICE guidance is part of the NICE Cardiovascular disease prevention pathway, available at: pathways.nice.org.uk/pathways/cardiovascular-disease-prevention
NICE Quality Standard (QS) 100 for Cardiovascular risk assessment and lipid modification,3 published in September 2015, was developed from NICE Clinical Guideline (CG) 181: Cardiovascular disease: risk assessment and reduction, including lipid modification (2014), which updated and replaced NICE CG67.1
The updated NICE CG1811 makes 28 recommendations for identifying, assessing, and communicating CVD risk; for example, it advises that if a person’s CVD risk is at a level where intervention is recommended, but they decline the offer of treatment, they are advised to have their CVD risk reassessed in the future. It also gives advice about how to encourage the person to participate in reducing their CVD risk.1,4 See Box 1, below.
Box 1: How to encourage the person to participate in reducing their cardiovascular disease risk1
- Find out what, if anything, the person has already been told about their CVD risk and how they feel about it
- Explore the person's beliefs about what determines future health (this may affect their attitude to changing risk)
- Assess their readiness to make changes to their lifestyle (diet, physical activity, smoking, and alcohol consumption), to undergo investigations, and to take long-term medication
- Assess their confidence in making changes to their lifestyle, undergoing investigations, and taking medication
- Inform them of potential future management based on current evidence and best practice
- Involve them in developing a shared management plan
- Check with them that they have understood what has been discussed.
NICE (2014) CG181. Cardiovascular disease: risk assessment and reduction, including lipid modification. NICE, 2014. Available at: www.nice.org.uk/guidance/cg181
Reproduced with permission
NICE CG1811 focuses on identifying and assessing CVD risk and on lifestyle and lipid-lowering drug interventions for those identified as being at highest risk. For the primary prevention of CVD in primary care, it recommends adopting a systematic strategy to identify people who are likely to be at high risk, using CVD risk factors already recorded in primary care electronic medical records. These people are then invited for a more precise measure of CVD risk using the QRISK® 2 score.5
People older than 40 years should have their estimate of CVD risk reviewed on an ongoing basis (approximately every 5 years), and people should have a full formal risk assessment using QRISK® 2 if their estimated 10-year risk of CVD is 10% or more.1
The process of risk assessment should be discussed with the person identified as being at risk, including the option of declining any formal risk assessment. Identification strategy is further discussed later in the article NICE explicitly says, 'Do not use opportunistic assessment as the main strategy in primary care to identify CVD risk in unselected people.'1
Full formal risk assessment
As mentioned above, NICE recommends using the QRISK® 2 risk assessment tool5 to assess CVD risk for the primary prevention of CVD in people aged up to and including 84 years, and in those with type 2 diabetes.1
Who is already at sufficient risk of cardiovascular disease without the need for assessment?
People with type 1 diabetes and individuals with an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2 and/or albuminuria should be excluded from risk assessment as they are already at sufficient risk of CVD to intervene. This includes offering statin treatment.
Similarly, people with pre-existing CVD, or those who are at high risk of developing CVD because of familial hypercholesterolaemia or other inherited disorders of lipid metabolism, need not have a formal risk assessment.1 For these people, a full formal assessment does not provide any additional information and could underestimate their risk of CVD, leading to inappropriate treatment. Detailed guidance about the management of CVD risk factors for individuals with these conditions can be found in other relevant NICE guidelines:
- Type 1 diabetes in adults: diagnosis and management (NICE Guideline [NG] 17)6
- Chronic kidney disease in adults: assessment and management (CG182)7
- Myocardial infarction: cardiac rehabilitation and prevention of further MI (CG172)8
- Familial hypercholesterolaemia: identification and management (CG71)9
- Stroke and transient ischaemic attack in over 16s: diagnosis and initial management (CG68).10
Standard CVD risk scores underestimate risk in people who have additional risk because of underlying medical conditions or treatments. These groups include people:1
- treated for HIV
- with serious mental health problems
- taking medicines that can cause dyslipidaemia (e.g. antipsychotic medication, corticosteroids, or immunosuppressant drugs)
- with autoimmune disorders (e.g. systemic lupus erythematosus) and systemic inflammatory disorders.
CVD risk will also be underestimated in people who are already taking antihypertensive or lipid modification therapy, or who have recently stopped smoking. NICE recommends using clinical judgment to decide on further treatment of risk factors in people who are below the CVD risk threshold for treatment.1
Severe obesity (body mass index greater than 40 kg/m2) also increases CVD risk.
People aged 85 years or older should be considered to be at increased risk of CVD because of age alone, particularly if they smoke or have raised blood pressure.1
|Table 1: NICE quality standard for cardiovascular risk assessment and lipid modification—list of quality statements3|
|1||Adults under 85 years with an estimated increased risk of cardiovascular disease (CVD) are offered a full formal risk assessment using the QRISK® 2 tool.|
|2||Adults with a 10-year risk of CVD of 10% or more are assessed for secondary causes before any offer of statin therapy.|
|3||Adults with a 10-year risk of CVD of 10% or more receive advice on lifestyle changes before any offer of statin therapy.|
|4||Adults with a 10-year risk of CVD of 10% or more for whom lifestyle changes are ineffective or inappropriate, discuss the risks and benefits of starting statin therapy with their healthcare professional.|
|5||Adults choosing statin therapy for the primary prevention of CVD are offered atorvastatin 20 mg.|
|6||Adults with newly diagnosed CVD are offered atorvastatin 80 mg.|
|7||Adults on a high-intensity statin who have side-effects are offered a lower dose or an alternative statin.|
|8||Adults on a high-intensity statin have a repeat measurement of lipids and liver transaminases after 3 months of treatment.|
|9||(placeholder) Identifying people with an estimated increased risk.
A placeholder statement is an area of care that has been prioritised by the Quality Standards Advisory Committee but for which no source guidance is currently available. A placeholder statement indicates the need for evidence-based guidance to be developed in this area.
NICE (2015) QS100. Cardiovascular risk assessment and lipid modification. Available at: www.nice.org.uk/guidance/qs100
NICE Quality Standard 100 for cardiovascular risk assessment and lipid modification
See Table 1, above, for a list of the nine quality statements in this quality standard.3 Note: a placeholder statement (i.e. statement 9) is an area of care prioritised by the Quality Standards Advisory Committee, but for which no source guidance is currently available. It signals the need for evidence-based guidance to be developed in that area.
Full formal risk assessment using QRISK® 2—statement 1
NICE states that:3'A full formal risk assessment for adults who have been identified to have an estimated increased risk of CVD is the most accurate method of targeting prevention strategies to improve clinical outcomes.'
NICE recommends the use of QRISK® 25 as the formal risk assessment tool to assess CVD risk for primary prevention of CVD in people from the age of 18 years up to and including 84 years. QRISK® 2 is an online assessment tool, which estimates the 10-year risk of a cardiovascular event occurring in people who do not already have heart disease. A person's 10-year risk of CVD can inform treatment decisions, for example lifestyle advice or drug treatment.3
As stated above, adults aged 85 years and over and people with existing CVD, type 1 diabetes, chronic kidney disease, or familial hypercholesterolaemia should be considered to be at an increased risk of CVD events without using QRISK® 2.
Excluding secondary causes—statement 2
Several secondary conditions may increase the risk of CVD or dyslipidaemia, including:3
- uncontrolled diabetes
- liver disease
- nephrotic syndrome.
It is important that these conditions are identified before statin therapy is started so that the underlying condition can be managed, which may impact on lipid status without resorting to lipid lowering agents.
Lifestyle advice for primary prevention—statement 3
Lifestyle changes (e.g. smoking cessation, increasing physical activity, a healthy diet, managing weight, reducing alcohol intake) can reduce the risk of CVD.3 NICE guidance is available on exercise and smoking interventions.12,13 Lifestyle changes can reduce the risk of CVD without the need for drug treatment, so these should be made before statin treatment is offered, if possible. The benefits of lifestyle changes for primary prevention should be discussed with people at risk of CVD, to encourage them to make the changes before statin therapy is offered.3
There has been some controversy over the use of statins at the 10% threshold. As the threshold for intervention decreases, more people will receive statin therapy and so more people will benefit from decreased CVD risk; however, the number of people who will not benefit from decreased CVD risk and who will develop side-effects will also increase. The intervention also becomes more costly, financially but also in terms of GP/nurse time, and in the medicalisation of people who do not currently have an 'illness'. Some GPs and lay people feel that the balance is too far in the direction of intervention and medicalisation. Others, such as in the American Guidelines, have lowered the threshold for intervention even further to 7.5%.14 For many, especially older people without other risk factors, lifestyle advice may be all that is necessary.
Discussing risks and benefits of statins for primary prevention—statement 4
People are more likely to keep to their treatment plan when they are well informed and involved in decisions regarding their care.3,11 Patients (or their carers) may prefer to make an informed decision not to take statins. NICE has developed a patient decision aid for patients to work through, with the help of their healthcare professional. The decision aid provides information to help the patient decide whether statin therapy is appropriate for them. See: www.nice.org.uk/guidance/cg181/resources/patient-decision-aid-243780157.
Statins for primary prevention—statement 5
High-intensity statins are the most clinically effective treatment option for the primary prevention of CVD. These should be offered after a discussion of the possible risk and potential benefits for that person. Atorvastatin 20 mg is recommended because it is clinically and cost effective for the primary prevention of CVD.
Statins for secondary prevention—statement 6
For secondary prevention it is recommended to use high-intensity statins as the most effective way to prevent further events.3 For this, atorvastatin 80 mg is the most cost-effective high-intensity statin.3
Side-effects of high-intensity statins—statement 7
High-intensity statins can cause side-effects including muscle aches and elevated liver enzymes, but it is important that practitioners try alternative strategies rather than stopping treatment, because any statin at any dose reduces the risk of CVD.3
Three-month statin review—statement 8
It is important that a person who takes a high-intensity statin has a repeat measurement of lipids and liver transaminases after 3 months of treatment. A repeat lipid profile can be used to determine whether the expected 40% reduction in non-high-density lipoprotein (non-HDL) cholesterol has been achieved. If not, then poor adherence should be suspected.15 A repeat measurement of liver transaminases is important in detecting any increased levels of these enzymes, which may indicate liver function problems.3
Identifying people with an estimated increased risk (placeholder)—statement 9
NICE CG1811 recommends that primary care adopts a systematic strategy, using electronic records to identify people with an estimated increased risk of CVD, before using the QRISK® 2 tool. As stated earlier in this article, no clarification in guideline recommendations has so far been given as to what this systematic strategy should be. Further guidance is therefore needed on methods to use across the healthcare pathway to identify people with an estimated increased risk of CVD, how frequently this identification should be carried out, and by whom.
Any of the quality statements for NICE QS100 (see Table 1, above) could be used as audit criteria for measurement by individual practices or aggregated into CCG standards. The purpose of setting standards against each of these criteria is in order to judge improvement, or to make changes to improve performance. The author suggests prioritising audit points for Statements 3–8 from NICE QS1003; see the audit points box above.
Cardiovascular disease remains a major cause of premature mortality. A healthy lifestyle and management
of reversible risk factors, such as smoking and blood pressure, are still the mainstay of active management; however, it is also important to identify those individuals where pharmacological intervention to reduce lipid levels is more likely to provide benefit than harm. This quality standard is intended to support identification of those individuals.
Introduction of statins, whether for primary or secondary prevention, should be done only after a full discussion of the possible benefits and harms. If it is jointly decided to use a statin then it is recommended to use atorvastatin, a high-intensity statin that balances benefit with cost. Atorvastatin 20 mg should be used for primary prevention, and 80 mg for secondary prevention. The impact on lipid levels and side-effects should be monitored and adjustments made accordingly. Lack of impact may result from non-compliance.
- Identify people at potential high risk of CVD and calculate their 10-year risk of a CVD event using QRISK®2
- If their risk of a CVD event is greater than 10%, offer lifestyle advice and risk-factor modification
- Always take into account the patient’s views, ideas, and health beliefs in shared decision-making
- If lifestyle changes on their own fail to improve risk sufficiently, consider having a discussion with the patient about the benefits and risks of using statins for primary prevention
- Use atorvastatin 20 mg for the primary prevention of CVD if:
- there is a greater than 10% risk of a CVD event
- if the person has type 1 diabetes, or chronic kidney disease stage 3 or more
- If a person already has CVD, use atorvastatin 80 mg
- Monitor the effectiveness of intervention, and side-effects or complications
- If one statin is not effective or not tolerated, try another
- a lower dose of the currently prescribed statin may also help reduce side-effects
- Always accept that a patient may take an informed decision not to adhere to the prescribed intervention—this decision should be recorded in their medical notes
- Audit the effectiveness of your care, and seek to improve performance if necessary.
- Statement 1: Proportion of adults under 85 years with an estimated increased risk of CVD who have a full formal risk assessment using the QRISK2 tool
- Statement 2: Proportion of adults with a 10-year risk of CVD of 10% or more who are assessed for secondary causes before any offer of statin therapy
- Statement 3: Proportion of adults with a 10-year risk of CVD of 10% or more who receive advice on lifestyle changes before any offer of statin therapy
- Statement 4: Proportion of adults with a 10-year risk of CVD of 10% or more, for whom lifestyle changes are ineffective or inappropriate, with a recorded discussion on the risks and benefits of starting statin therapy
- Statement 5: Proportion of adults choosing statin therapy for primary prevention of CVD who are prescribed atorvastatin 20 mg
- Statement 6: Proportion of adults with newly diagnosed CVD who are prescribed atorvastatin 80 mg
- Statement 7: Proportion of adults reporting side effects from a high-intensity statin who are given a lower dose or alternative statin
- Statement 8: Proportion of adults on high-intensity statins who have had a repeat measurement of lipids and liver transaminases after 3 months of treatment
NICE (2015) QS100. Cardiovascular risk assessment and lipid modification. NICE, 2015. Available at: www.nice.org.uk/guidance/qs100
Reproduced with permission
GP commissioning messages
written by Dr David Jenner, NHS Alliance GMS contract/PBC Lead
- NICE recommends that primary care providers adopt a systematic, strategic approach to identifying individuals at high risk of CVD; however, this is not specified in detail and thus is rarely happening
- The NHS Health Check programme, commissioned by Public Health England for those aged 40–74 years, can be used to screen for CVD risk though evidence of its effectiveness is inconsistent (see NHS Health Check programme: literature review at: bit.ly/1RMiHm7)
- Health checks could be targeted within the target group to those likely to have higher CVD risk (e.g. males, older persons, and those who smoke or are overweight)
- Local commissioners of primary care now include Public Health England, NHS England, and CCGs; it would be prudent for them to agree the systematic approach to be used locally and defined within Health and Wellbeing Plan
- There is a scepticism among both patients and GPs about the benefits of intensive statin therapy at 10% 10-year risk thresholds, which is now subject to national debate. This has compromised the implementation of this guidance and seems to have prevented 10% risk thresholds being added to the QOF.
- NICE. Cardiovascular disease: risk assessment and reduction, including lipid modification. NICE Clinical Guideline 181. NICE, 2014. Available at: www.nice.org.uk/guidance/cg181
- NICE. Standards and indicators. www.nice.org.uk/standards-and-indicators (accessed 1 November 2015).
- NICE. Cardiovascular risk assessment and lipid modification. NICE Quality Standard 100. NICE, 2015. Available at: www.nice.org.uk/guidance/qs100
- NICE. Behaviour change: individual approaches. NICE Public Health Guideline 49. NICE, 2014. Available at: www.nice.org.uk/guidance/ph49
- QRISK website. www.qrisk.org (accessed 1 November 2015)
- NICE. Type 1 diabetes in adults: diagnosis and management. NICE Guideline 17. NICE, 2015. Available at: www.nice.org.uk/guidance/ng17
- NICE. Chronic kidney disease in adults: assessment and management. NICE Clinical Guideline 182. NICE, 2014. Available at: www.nice.org.uk/guidance/cg182
- NICE. Myocardial infarction: cardiac rehabilitation and prevention of further MI. NICE Clinical Guideline 172. NICE, 2013. Available at: www.nice.org.uk/guidance/cg172
- NICE. Familial hypercholesterolaemia: identification and management. NICE Clinical Guideline 71. NICE, 2008. Available at: www.nice.org.uk/guidance/cg71
- NICE. Stroke and transient ischaemic attack in over 16s: diagnosis and initial management. NICE Clinical Guideline 68. NICE, 2008. Available at: www.nice.org.uk/guidance/cg68
- NICE. Patient experience in adult NHS services: improving the experience of care for people using adult NHS services. NICE Clinical Guideline 138. NICE, 2012. Available at: www.nice.org.uk/guidance/cg138
- NICE. Physical activity: brief advice for adults in primary care. NICE guideline PH44. NICE, 2013. Available at: www.nice.org.uk/guidance/ph44
- NICE. Smoking: brief interventions and referrals. NICE Public Health Guideline 1. NICE, 2006. Available at: www.nice.org.uk/guidance/ph1
- Stone N, Robinson J, Lichtenstein A et al. ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circ 2013; 63 (25B): 2889–2934.
- NICE. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. NICE Clinical Guideline 76. NICE, 2009. Available at: www.nice.org.uk/guidance/cg76G