Corporate document

Content and process standards for patient decision aids

The tables in this section list the essential and enhanced standards, with notes on how to use them. There is also an assessment checklist and a self-assessment that you can download in Word files to record your notes on a patient decision aid (PDA):

  • The assessment checklist is for people using or delivering healthcare services to check the quality of individual PDAs.

  • The self-assessment is for commissioners and developers to check their PDAs and the processes they use to develop them. This includes space to record whether a standard is met, partially met or not met.

See the visual summary for an overview of the essential and enhanced standards supported with visual icons. Each of the standards have links to further information.

Section 1: essential content standards

Essential content standards

Health condition, decision and available options


The patient decision aid (PDA) states:

  • the symptom, condition, disease or illness the person is experiencing

  • that a decision about treatment or investigation is needed, and indicates which aspect of care this relates to

  • what evidence-based treatment or investigation options are available including all reasonable alternatives and the option of doing nothing.

The PDA should clearly outline:

  • the issue at hand for the patient in terms of their health state, that is their illness, condition or potential diagnosis

  • what decision needs to be taken by the patient in collaboration with their healthcare professional

  • what options are available to the patient, based on the best available evidence.

A good PDA will include all reasonable alternative courses of action available to the person making the choice, and will always include the option for them to choose no intervention.

Details of the available options


The PDA presents detailed information about the options to enable the person to make an informed decision in an unbiased way. This includes:

  • detailed information about the potential consequences, benefits and harms of each option

  • an even-handed approach to how the options are displayed and framed, for example, using the same sized font or neutral language

  • the option of doing nothing new or different, for example, what happens if the person chooses to continue with their current treatment, chooses not to have further treatment or chooses no treatment at all.

In presenting the options the PDA should include possible outcomes depending on the option chosen. This could include information about what will happen to the course of their illness or disease, what side effects they might experience, and what impact the choice might have on their quality of life.

A high-quality PDA will present the options in an unbiased way and will not attempt to influence the person making the decision. This can be shown by the use of font size, emboldening, colours, and the use of unbiased language.

Support for the person's values, circumstances and preferences


The PDA supports understanding by:

  • helping people to prioritise what matters most to them in terms of the positive and negative features of the available options

  • supporting people to communicate these priorities with others, such as health professionals.

A high-quality PDA will support people to identify the things that matter to them most in relation to their health state by providing them with a clear set of options for treatment or investigation.

In helping people to focus on their key priorities the PDA will help people shape the conversations they may choose to have with their healthcare professionals, their friends and family members about the choices they need to make.

Use of language and numbers


The PDA is written in the most accessible way, by:

  • using everyday language that is widely understood, or simpler language where necessary

  • using language equivalent to a reading age of 9 to 11 confirmed by a validated instrument such as the readability statistics within Word, or the Flesch Kincaid tool. Where this is not possible, and the PDA is intended to be explained by a healthcare professional, a reading age of 11 to 14 should be used

  • explaining information in a way that is meaningful to people without a background in health

  • explaining quantitative information about risks, benefits, chance and uncertainty in a way that is understandable to people with low levels of numeracy.

It is widely acknowledged that there are relatively low levels of health and general literacy among the UK population, and even lower levels of numeracy.

PDAs should be written in clear, straightforward, everyday language to enable the largest number of people to be able to benefit from them. This includes techniques such as using short sentences, simple words, using the 'active' voice.

This can be further enhanced if the PDA specifies that they have deployed a validated tool to determine the reading age of their content.

A high-quality PDA will use simple everyday language to explain concepts such as diagnostic tests, surgical interventions and medication regimens, with a minimal use of technical terms. Where technical terms are used these are explained.

Concepts such as risk probability and chance are also poorly understood, and a high-quality PDA will explain these in a comprehensible way.

For PDAs that include screening and diagnostic tests


If the PDA relates to screening and diagnostic tests, it provides details about:

  • what the test is designed to measure

  • how likely the test is to accurately identify what is being tested for

  • what (if any) intervention could follow from any result and the implications of that for example further investigations or treatments

  • the consequences of detecting a disease or condition that would not have caused any problems if the test had not been done.

Screening tests would include examples such as cervical smear, screening mammography. Diagnostic tests would include examples such as a polymerase chain reaction test for COVID-19, a sentinel node biopsy.

Diagnostic tests would include examples such as a polymerase chain reaction test for COVID-19, sentinel node biopsy.

High-quality PDAs will clearly define what the test is intended to be looking for, such as the likelihood of a fetus having a chromosomal anomaly. It will also be clear about how likely the test is to accurately give the person a definitive answer.

A high-quality PDA will also be clear about what (if any) interventions might follow the results of a test, and what these might mean for the person being tested.

Formats and availability of PDAs aimed at patients


Where the PDA is intended for a patient audience it addresses the needs of the patient through:

  • providing the PDA in a variety of sources such as websites, apps or by providing hard copies

  • providing a step-by-step guide to making a decision, and then explaining how to discuss that decision with family, friends, carers and healthcare professionals, if they wish.

To aid accessibility, an enhanced PDA should be made available in a variety of different formats and on a variety of different platforms. An enhanced PDA will also give people support in making a decision and in discussing this decision with their friends, family members and health professionals if they wish to do so.

Section 2 essential process standards

Essential process standards

Evidence sources


The patient decision aid (PDA) or supporting documentation provides information about:

  • how evidence was found, appraised and summarised

  • how certain the evidence is about the likelihood of the outcomes described

  • the sources of evidence – citing NICE guidance where applicable.

The importance of providing people with evidence-based options cannot be overstated. For assurance that a PDA is based on the best possible evidence, its supporting documentation needs to outline its evidence sourcing, appraising and summarising approaches.

It also needs to give an assessment of the certainty of the evidence and how reliable its findings can be considered.

The evidence that underpins a PDA needs to be cited and should always include relevant NICE guidance where appropriate.

Patient involvement and co-production


The supporting documentation demonstrates that the PDA focuses on the needs of the person. This is by confirming that:

  • a clear need for the PDA has been established through dialogue with people with lived experience of the condition

  • the PDA has been co-produced with professionals and a range of people with lived experience, to ensure the tone is acceptable to patients, and the information presented is balanced and easy to understand.

  • the PDA has been peer-reviewed by both people with lived experience and professionals.

The involvement of patients in the development of PDAs is essential. In any supporting material the PDA developers need to demonstrate how their tool meets patients' needs, possibly through a needs assessment.

The supporting materials also need to show how people with lived experience were involved in developing and coproducing the PDA. This needs to be in addition to any peer-review process before publication and should involve lay and professional contributors.

Neutral presentation of risks and benefits


The developers have considered the presentation of risks and benefits to ensure they are neutral, consistent and unbiased. They ensure this by:

  • using absolute risk rather than relative risk

  • using natural frequency

  • using data consistently

  • presenting risk over a defined period of time such as months or years, if appropriate

  • using numerical data, where possible, to describe risk, not terms such as rare, unusual, common as these are open to interpretation

  • inclusion of both positive and negative framing where possible.

Given that many people struggle with the concepts of risk and probability, as has already been stated, it is important that these are presented clearly and neutrally to remove any risk of bias. Absolute risk should be used rather than relative – for example the risk of an event increasing from 1 in 1,000 to 2 in 1,000, rather than the risk of the event doubling.

In addition, it is important that risk and probability data are presented in a consistent manner throughout the PDA – for example by using the same denominator when comparing risk: 7 in 100 for one risk and 20 in 100 for another, rather than 1 in 14 and 1 in 5.

Percentages are difficult for people and so natural frequencies are more suitable – for example 10 in 100 rather than a percentage such as 10%.

The use of a defined period of time can be helpful – for example, if 100 people are treated for 1 year, 10 will experience a given side effect.

Although numeracy can be a problem for some people, it is preferable and sometimes necessary to use numerical data, in a health literate way, rather than ambiguous terms or analogies.

The framing of the information is also important and should be presented both positively and negatively where possible. For example, treatment will be successful for 97 out of 100 people and unsuccessful for 3 out of 100 people.

Review cycle and declaration of interests


The PDA includes:

  • the date it was last updated and the nature of the updating process in the future, for example on a regular cycle or when new evidence emerges

  • a declaration of the source of funding to develop the PDA and any potential conflicts of interest

  • the authors' and developers' qualifications.

It is important that a PDA is kept up to date and aligned with the most recent evidence, so a high-quality PDA will include a publication date and an indication of when it will be reviewed.

It is also important that the organisations funding the development of the PDA are stated openly, particularly if the funding comes from outside of the public sector. Any conflicts of interest relating to the PDA's authors should also be declared.

The qualifications or the host organisation for the PDA's authors should be clearly stated.

Section 3 enhanced content standards

Enhanced content standards

Experience of treatments


The PDA describes what the person's experience might be depending on which option they choose.

An enhanced PDA might, as well as discussing the possible clinical consequences of each option available, describe the likely experience the person might expect, depending on the option they choose.

Section 4 enhanced process standards

Enhanced process standards

Presentation of data


The supporting documentation demonstrates that the patient decision aid (PDA) focuses on the needs of the person. It confirms that:

  • alternative formats are available, for example in audio or video format, as needed by the Accessible Information Standard

  • there is a mixed approach to displaying data and multiple descriptive methods such as words, numbers, diagrams, pictograms and icon arrays

  • risks and benefits are personalised where possible.

The people using the PDA will have different communication needs and so the supporting documentation needs to describe what alternative formats are available. A national standardised approach, such as the Accessible Information Standard, should be used where possible.

Where possible, developers should:

  • use data that can be converted into a variety of display formats to accommodate different learning and information gathering styles

  • enable personal data to be included so that risks and benefits can be tailored to the individual.

Field testing and validation with users


The supporting documentation verifies that through the use of the PDA, people can:

  • recognise the need for a decision

  • know what options are available to them

  • understand how their preferences, values and circumstances affect their decisions

  • identify what matters most to them in terms of outcomes, and can choose the option most aligned with this

  • discuss their values and preferences with their healthcare professionals

  • be involved in decision making to the extent that they wish to.

It is essential that any PDA delivers on its intention, which is to support people to make decisions about their treatment or other care options. Field testing and validating the PDA with people with lived experience are important aspects of the development process.

The supporting documentation should include details of how this was done and the extent to which the PDA delivers against the bullet points in the column to the left.

Equality, diversity and health inequalities


The developers have taken into consideration equality, diversity and health inequalities, through:

  • a thorough equality impact assessment looking at the protected characteristics in the Equality Act 2010, to avoid discrimination and promote equality

  • assessing whether the PDA could reduce health inequalities, or make them worse

  • a consideration of cultural diversity in terms of decision-making and risk analysis.

The Equality Act 2010 provides a legal framework to avoid discrimination and promote equality across the population. Those working in the public sector are also bound by the Public sector equality duty.

PDA developers need to demonstrate that they have undertaken some form of equality impact assessment. This should include an assessment of how likely the PDA is to address or compound health inequalities in the intended population.

Cultural aspects of decision making (such as whether to take medicine containing porcine products for Muslim or Jewish people) may also need to be taken into account, and the developers' sensitivities to these aspects should be documented.