Developing NICE guidelines: the manual

Quality of the evidence

Evidence review documents summarise the evidence obtained from the results of evidence searches. Depending on the topic and type of evidence, they may include GRADE tables, GRADE-CERQual tables or (if GRADE or GRADE-CERQual are not used) evidence statements.

The committee should ensure that the reviews are a fair summary of the evidence and should discuss any uncertainty in the review findings (including limitations of individual studies and inconsistency across studies).

For details, see the chapter on reviewing evidence.

Trade‑off between benefits and harms of an intervention

A key stage in moving from evidence to recommendations is weighing up the size and importance of the benefits and harms of an intervention, compared with the alternatives specified in the review protocol, and the potential for unintended consequences. This may be done qualitatively or quantitatively.

The committee should discuss the extent to which the effects seen in the evidence are representative of what would happen in the real world.

The committee should also assess the extent to which the recommendations may impact on health inequalities. This needs to be made clear, regardless of whether the recommendation is aimed at the whole population, specific subgroups or a combination of both. If there is potential to increase health inequalities, the committee should consider whether they can do anything to prevent this from happening or reduce the impact.

Trade-off between economic considerations and resource use

The committee should discuss cost effectiveness at the same time as effectiveness when formulating recommendations. Interventions that are not considered cost effective should not usually be offered.

The evidence review document should explain how costs, resource use and economic considerations were taken into account in determining the cost effectiveness of an intervention. This may be informal, or may be more formal and include economic modelling (see the chapter on incorporating economic evaluation).

If several possible interventions are being considered, the committee should consider sequencing them in terms of their cost effectiveness. This usually means preferring the most cost-effective intervention first, although other factors such as availability and acceptability need to be considered.

Considerations about equity may also affect the decision whether to recommend the intervention (see the section on equity considerations in the chapter on incorporating economic evaluations).

Use of indirect evidence

Sometimes, when there is no evidence directly relevant to a specific population, indirect evidence from other populations may be considered. For example, evidence on treating absence seizures in children and young people was extrapolated to adults because the disease has a similar pathophysiology in all 3 populations.

This needs careful consideration by the committee, with discussion of the features of the condition or interventions that allow extrapolation to a different population.

This also applies when extrapolating findings from evidence in different care settings (for example, between primary and secondary care). The committee should consider the similarities and differences in case mix, staffing, facilities and processes between the settings before extrapolating evidence in this way.

Promoting equality and reducing health inequalities

The equality and health inequalities assessment (EHIA) form should document how the committee's responsibilities under equality legislation and our equality scheme have been discharged in reaching the recommendations (see the section on key principles for developing NICE guideline recommendations in the introduction chapter), and how the recommendations address equality issues and health inequalities.

The committee needs to consider whether:

Ideally, recommendations should be formulated to promote equality and reduce health inequalities (for example, by making access more likely for certain groups, or by tailoring the intervention to specific groups). If this is not possible, the committee should consider whether it is appropriate to make a research recommendation (for further details see the section on formulating recommendations for research).

Little evidence of difference between interventions

There might be little evidence of differences in effectiveness or cost effectiveness between interventions. In this case, all effective or cost-effective interventions may be recommended.

Insufficient evidence

If published evidence of efficacy or effectiveness for an intervention is lacking, too low quality, or too uncertain for firm conclusions to be reached, the committee may use its experience and knowledge to do 1 of the following:

The last option should be used sparingly on the basis that scoping will have shown that guidance was needed.

The principles in the section on wording the recommendations should be used.

Principles of person-centred care

All NICE guidelines advocate the principles of person-centred care: people using services and the wider public should be informed of their options and be involved in decisions about their care, as described in our webpage on making decisions about your care.

There are 5 guidelines specifically on the experience of people using services:

These include general recommendations on the principles of person-centred care, such as communication and providing information, which should not be restated in topic-specific guidelines (see table 1). Recommendations from these guidelines can be cross-referred to when needed.

Recommendations on person-centred care can be included in topic-specific guidelines if there is evidence of specific need for the topic.

Overprescribing

Overprescribing is when people are given medicines they do not need or want, or where the harm outweighs the benefits. In line with the Department of Health and Social Care's national overprescribing review, we should include recommendations for reviewing and stopping medicines if overprescribing is a concern. Also see NICE's guidelines on medicines optimisation and medicines associated with dependence or withdrawal symptoms.

National medicines safety advice

National medicines safety advice includes national patient safety alerts and the MHRA's drug safety updates. We do not usually include patient safety information in our recommendations though there are some exceptions to this. See table 1 for details.

Antimicrobials and antimicrobial stewardship

Recommendations on antimicrobials should:

Guidelines that cover antimicrobial prescribing may include prescribing tables that detail choice of antimicrobials, dosages, duration of treatment and routes of administration (for an example of an antimicrobial prescribing table, see the section on choice of antibiotic in NICE's guideline on Clostridioides difficile infection).

Off-label use of licensed medicines

Recommendations are usually about using medicines within their licensed indications. However, there are clinical situations in which recommending an off-label use of a licensed medicine may be in the best interests of the person, in line with the MHRA guidance (see appendix 2 of the MHRA guidance on the supply of unlicensed medicinal products). For example, this may happen if the clinical need cannot be met by using a licensed product within the terms of its marketing authorisation and there is enough evidence or experience of using the medicine to support its safety and efficacy.

Dosage information for off-label use of a licensed medicine is not usually included in the summary of product characteristics (SPC). If off-label use is being recommended, we will check whether there is any relevant dosage information in the BNF or BNF for Children. If there is none, we will work with the BNF to add the necessary information if needed. If we are recommending off-label use of a medicine, this will be clearly stated in the guideline.

Unlicensed medicines

The MHRA states that: If a UK licensed medicine can meet the person's clinical need (even if it is used off-label), it should be recommended instead of an unlicensed product. An unlicensed medicine should not be recommended if a product available and licensed within the UK could be used to meet the person's clinical need.

Committees should take account of the MHRA guidance (see appendix 2 of the MHRA guidance on the supply of unlicensed medicinal products) when making recommendations but consider each situation on its own merit.

Medical devices, including off-label use

Recommendations are usually about using devices within the terms of the instructions for their use. However, there are clinical situations in which the off-label use of a device may be in the best interests of the person. For example, when using a device outside the time period specified in the instructions for use.

Committees should take account of the MHRA guidance on the off-label use of medical devices.

Focus on the action and what readers need to know

Recommendations should be clear about what needs to be done, without the reader having to read the rationale or committee's discussion in the evidence review document. When writing recommendations, keep in mind the following:

Include only 1 action per recommendation or bullet point unless it is clearer to include a closely linked action in the same recommendation.

Be specific about actions and use direct instructions in recommendations wherever possible because these are easier to follow. Recommendations should start with a verb such as 'offer' (or 'do not'), 'consider', 'measure', 'advise', 'discuss', 'ask about'.

Exceptions to this principle include:

Think carefully about how much detail to include. Recommendations should be clear and concise. Including a lot of detail can reduce the impact and make them harder to understand.

Use 'person-centred', precise, concise, clear English

Key principles include using language that is person-centred, using clear and consistent wording, and using bullet lists and tables if they make recommendations easier to follow.

Language that is person-centred acknowledges the experience of people who are directly affected by the recommendations (and family members, carers or advocates), and their role in decision making. For more information, see the section on talking about people in the NICE style guide.