Quality standard

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

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 treatment 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

The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.

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 treatment.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example, from local protocols.

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 treatment.

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

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: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example, from patient records.

Outcome

Proportion of adults with a 10‑year risk of CVD of 10% or more on high-intensity statin.

Numerator – the number in the denominator who have a record of high-intensity statin.

Denominator – the number of adults with a 10‑year risk of CVD of 10% or more.

Data source: CVD Prevent's indicator CVD006CHOL reports the percentage of patients aged 18 and over with no GP recorded CVD and a GP recorded QRISK score of 10% or more, on lipid lowering therapy.

What the quality statement means for different audiences

Service providers (primary care services) 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 treatment.

Healthcare professionals (such as GPs, nurse prescribers and pharmacists) discuss the risks and benefits of starting statin treatment 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 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 treatment. Commissioners may do this by seeking evidence of practice, through clinical audits.

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 treatment. This should include information about how statin therapy may help to reduce their chances of having a heart attack or stroke in the future.

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 QRISK3 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 NICE's guideline on cardiovascular disease, recommendation 1.6.4, and expert opinion]

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 treatment 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 NICE's guideline on cardiovascular disease, recommendations 1.1.14 and 1.1.15, and NICE's guideline on shared decision making, recommendations 1.4.1, 1.4.2 and 1.4.7]

The NICE patient decision aid for NICE's guideline on cardiovascular disease: Should I take a statin? (2023) 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 QRISK3 score if they are aged between 25 and 84 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. People aged under 25 are not at high risk for CVD unless they have a specific condition that increases risk.

Clinical judgement should inform interpretation of results from CVD risk tools when used in certain groups of people because tools may underestimate the risk (see NICE's guideline on cardiovascular disease, recommendation 1.1.10). When using a QRISK3 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 treatment 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. For people with additional needs related to a disability, impairment or sensory loss, information should be provided as set out in NHS England's Accessible Information Standard or the equivalent standards for the devolved nations.