Quality statement 4: Discussing risks and benefits of statins for primary prevention

Quality statement

Adults with a 10‑year risk of cardiovascular disease (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.

Rationale

People who are better informed and involved in decisions about their care are more likely to adhere to their chosen treatment plan, which improves patient experience and clinical outcomes.

Quality measures

Structure

Evidence of local arrangements to ensure that adults with a 10‑year risk of CVD of 10% or more, for whom lifestyle changes are ineffective or inappropriate, discuss with their healthcare professional the risks and benefits of starting statin therapy.

Data source: Local data collection.

Process

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.

Numerator – the number in the denominator who have a record of a discussion on the risks and benefits of starting statin therapy.

Denominator – the number of adults with a 10‑year risk of CVD of 10% or more for whom lifestyle changes have been ineffective or are inappropriate.

Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals, and commissioners

Service providers (primary care) ensure that adults with a 10‑year risk of CVD of 10% or more, for whom lifestyle changes are ineffective or inappropriate, have a documented discussion with their healthcare professional about the risks and benefits of starting statin therapy.

Healthcare professionals discuss the risks and benefits of starting statin therapy with adults who have a 10‑year risk of CVD of 10% or more for whom lifestyle changes have been ineffective or are inappropriate, and record details of the discussion and the person's decision.

Commissioners (NHS England area teams and clinical commissioning groups) ensure that adults with a 10‑year risk of CVD of 10% or more for whom lifestyle changes are ineffective or inappropriate have a documented discussion with their healthcare professional about the risks and benefits of starting statin therapy. Commissioners may do this by seeking evidence of practice, through clinical audits.

What the quality statement means for patients, service users and carers

Adults with a 1 in 10 or more chance of developing CVD in the next 10 years (a 10‑year risk of 10% or more) for whom lifestyle changes have not helped or are unsuitable, discuss with their doctor the risks and benefits of starting statin therapy. This should include information about how statin therapy may help to reduce their chances of having a heart attack or stroke in the future.

Source guidance

Definitions of terms used in this quality statement

Ineffective lifestyle changes

Lifestyle changes such as stopping smoking, increasing physical activity and changing diet that have not resulted in a reduction in CVD risk when QRISK2 is repeated are considered to have been ineffective. Use clinical judgement to determine how long to wait before lifestyle changes are considered ineffective, because this depends on the type of lifestyle changes and the person's wishes and needs. [Adapted from lipid modification (NICE guideline CG181) recommendation 1.3.16]

Discussion about the risks and benefits of statin therapy

The discussion should include information about a person's risk of CVD and about the benefits and harms of statin therapy over a 10‑year period. The discussion and the person's decision should be documented. This information should be in a form that:

  • presents individualised risk and benefit scenarios

  • presents the absolute risk of events numerically

  • uses appropriate diagrams and text.

[Adapted from lipid modification (NICE guideline CG181) recommendations 1.1.25 and 1.1.26]

The NICE patient decision aid (2014) can be used to help make decisions about treatment with statins.

Equality and diversity considerations

The statement includes adults with a 10‑year risk of CVD exceeding 10%, as determined by their QRISK2 score if they are aged under 85 years. Adults aged 85 years and older should be considered to be at high risk based on age alone, particularly those who smoke or have high blood pressure. Because QRISK2 calculates a person's CVD risk over the next 10 years, its risk scores may underestimate risk in younger people or women who have additional risk because of underlying medical conditions, such as serious mental health problems or severe obesity (body mass index greater than 40 kg/m2). When using a QRISK2 risk score to inform drug treatment decisions, particularly if it is near to the threshold for treatment, take into account other factors that may predispose the person to premature CVD that may not be included in calculated risk scores.

The discussion about the risks and benefits of starting statin therapy should be sensitive to people's culture and faith, and tailored to their needs. An interpreter should be consulted if it is not appropriate to use an English‑language‑based patient decision aid, for example, for people whose first language is not English.