9 Developing and wording recommendations and writing the guideline

The guideline contains the Committee's recommendations along with details of the methods used to develop them and the evidence they were based on. The way in which these are presented may vary but the information provided includes:

  • background and context for the guideline – such as the need for the guideline, epidemiology (if relevant), current practice and the policy context

  • the methods used during guideline development – highlighting the rationale for options taken, any deviations from the methods and processes described in this manual

  • the evidence – details of the evidence, any analysis and modelling, and any gaps in the evidence

  • the Committee's discussion – the rationale for the recommendations, their likely impact on practice, and how the Committee developed them, with links to the evidence

  • summaries of the evidence to support shared decision-making, if there are preference-sensitive decision points in the guideline

  • the recommendations

  • recommendations for future research

  • information about the guideline – including the scope, changes to published recommendations (if the guideline is an update), members of the Committee and declarations of interest.

The guideline recommendations are the distillation of the Committee's development work. They should be clear, understandable by the intended audience without reference to the evidence reviews, and based on the best available evidence. This chapter describes the key stages in developing guideline recommendations:

  • interpreting the evidence to make recommendations

  • wording the recommendations

  • prioritising recommendations for future consideration in quality standard development

  • formulating research recommendations.

It also summarises how the guideline recommendations are incorporated into NICE Pathways, which bring together everything NICE says on a topic in an interactive flowchart.

9.1 Interpreting the evidence to make recommendations

Recommendations are developed using a range of scientific evidence (see section 4.4) and other evidence – such as expert testimony, views of stakeholders, people using services and practitioners, Committee discussions and debate (see chapter 3).

The Committee must use its judgement to decide what the evidence means in the context of the guideline referral and decide what recommendations can be made to practitioners, commissioners of services and others. The evidence is assessed for validity, reliability and bias, but also requires interpretation, especially an assessment of its implicit and explicit value base. Evidence also needs to be assessed in light of any conceptual framework and theories relating to individual and organisational behaviour change.

The Committee should also take account of a range of issues (including any ethical issues, social value judgements (see the entry on social value judgements in our Glossary), equity considerations and inequalities in outcomes, particularly impacts on people sharing the characteristics protected by equality legislation) and policy imperatives (see chapter 1). This ensures that its recommendations are ethical, practical, specific and lawful.

Assessment and interpretation of the evidence to inform the guideline recommendations is at the heart of the work of the Committee.

The guideline should explain clearly how the Committee moved from the evidence to each recommendation, and should document how any issues influenced the decision‑making. It should describe the relative value placed on outcomes, benefits and harms, resource use, and the overall quality of the evidence, as well as other considerations of the Committee.

A summary of the Committee's discussions may also be used to integrate the findings from several evidence reviews that are related to the same recommendation or group of recommendations.

Quality of the evidence

The Committee is presented with evidence statements and, if used, GRADE tables that describe the number, type and quality of the studies for each review question and provide an overall rating of confidence (high, moderate, low or very low) in estimates of effect for each outcome. The Committee should agree that the evidence statements, and, if used, GRADE tables, are a fair summary of the evidence and should discuss any uncertainty in the evidence, including the presence, likely magnitude and direction of potential biases.

The evidence statements or, if used, GRADE tables summarise the applicability or indirectness of the evidence to people affected by the guideline and the setting. The Committee discusses the applicability of the evidence before making recommendations.

Trade‑off between benefits and harms of an intervention

A key stage in moving from evidence to recommendations is weighing up the magnitude and importance of the benefits and harms of an intervention, and the potential for unintended consequences. This may be done qualitatively (for example, 'the evidence of a reduction in medicines errors in care homes outweighed a small increase in staff workload and resources') or quantitatively using a decision model.

The Committee should assess the extent to which the available evidence is about efficacy (the extent to which an intervention produces a beneficial result under ideal conditions), effectiveness (the extent to which a specific intervention, when used under ordinary circumstances, does what it is intended to do) or both. Often the distinction between the 2 is not made clear; this may be of particular importance in reports of complex interventions, because these are often evaluated only in pragmatic studies.

If several possible interventions are being considered, it is useful to include discussion of the relative position of an intervention within a pathway of care or service model, based on effectiveness.

The Committee should also assess whether, when recommending an intervention, they are able to recommend stopping other interventions because they have been superseded by the new intervention.

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.

Trade‑off between economic considerations and resource use

As noted in section 7.7, the Committee should discuss cost effectiveness in parallel with general effectiveness when formulating recommendations.

The guideline should include an explanation of how the implications of costs, resource use and economic considerations were taken into account in determining the cost effectiveness of an intervention. Again, this may be informal, or may be more formal and include economic modelling (see chapter 7).

If several possible interventions are being considered, it is useful to include discussion of the relative position of an intervention within a pathway of care or service model, based on cost effectiveness.

Extrapolation of evidence

Sometimes evidence identified for a specific population or setting may include principles that could be extrapolated to other populations and/or settings. For example, a review of systems for managing medicines in care homes for people with dementia may identify good practice that is relevant in other care home settings. The use of extrapolation must be considered carefully by the Committee, with explicit consideration of the features of the condition or interventions that allow extrapolation. This also applies when extrapolating findings from evidence in different care settings. The Committee should consider and document any similarities in case mix, staffing, facilities and processes.

If GRADE is used, this would be accounted for in the overall quality assessment.

Availability of evidence to support implementation (including evidence from practice)

The Committee should also judge to what extent it will be possible to put the recommendations into practice. It can use expert oral or written testimony, the experience of Committee members or results from fieldwork or consultation with people using services, where this has been conducted. It may also be able to draw on qualitative studies or other forms of evidence relating to organisational and political processes.

The Committee should consider the extent of change in practice that will be needed to implement a recommendation, staff training needs, policy levers and funding streams, and the possible need for carefully controlled implementation with, for example, training programmes. This should be documented in the guideline and in any relevant resources which support implementation.

Size of effect and potential impact on population health

The Committee should consider whether it is possible to anticipate effect sizes at the population level, if this is appropriate for the topic. If this is the case, it is important to consider effect sizes along the whole causal chain, not just at the end points.

Wider basis for making recommendations

The Committee should take into account a range of issues (including any ethical issues, social value judgements, equity considerations and inequalities in outcomes) and policy imperatives, as well as equality legislation (see chapter 1) to ensure that the guideline recommendations are ethical, practical and specific. There are no hard‑and‑fast rules or mechanisms for doing this: the Committee should make conscious and explicit use of its members' skills and expertise. All evidence needs interpretation: evidence alone cannot determine the content of a recommendation. The development of evidence‑based recommendations involves inferential, inductive or deductive reasoning:

  • inferential because it involves moving from what is known (the evidence) to uncertainty about what is reasonably expected to happen as a consequence of implementing a recommendation

  • inductive when it is derived from evidence

  • deductive when it is drawn from theory or methodological principles.

NICE's principles on social value judgements explicitly acknowledge that non‑scientific values are brought to bear, and all of NICE's advisory Committees are encouraged to take account of (and to make explicit) the value judgments they make. The Committee may also draw upon the principles outlined in the report on ethical issues in public health by the Nuffield Council on Bioethics when making its judgements.

Conceptual framework or logic model

When the Committee is developing its recommendations, it should consider any conceptual framework or logic model/s that have been developed because they may help to identify any practical issues involved with a recommendation that will change practice (see appendix A).

Equality considerations

The guideline should also document how the Committee's responsibilities under equality legislation and NICE's equality policy have been discharged in reaching the recommendations (see section 1.4). The Committee needs to consider whether:

  • the evidence review has addressed areas identified in the scope as needing specific attention with regard to equality issues

  • criteria for access to an intervention might be discriminatory (for example, through membership of a particular group, or by using an assessment tool that might discriminate unlawfully)

  • disabled people might find it impossible or unreasonably difficult to receive an intervention

  • recommendations can be formulated to advance equality (for example, by making access more likely for certain groups, or by tailoring the intervention to specific groups).

Insufficient evidence

If evidence of effectiveness for an intervention is either lacking or too weak for firm conclusions to be reached, the Committee has several options. It may make recommendations based on the limited evidence (using expert opinion); or it make no recommendation; or it may recommend not to offer the intervention; or it may recommend that the intervention is used only in the context of research (see section 9.5).

Factors the Committee should consider before making a 'do not do' recommendation include:

  • The intervention should have no reasonable prospect of providing cost-effective benefits to people using services.

  • Stopping the intervention is not likely to reduce benefit for people currently receiving it.

Factors the Committee should consider before issuing 'only in research' recommendations include:

  • The intervention should have a reasonable prospect of providing cost‑effective benefits to people using services.

  • The necessary research can realistically be set up or is already planned, or people using services are already being recruited for a study.

  • There is a real prospect that the research will inform future NICE guidelines.

The same principles for wording recommendations should be used (see section 9.2), reflecting the strength of the evidence, and the considerations should be documented fully.

Strength of recommendations

As soon as the Committee has discussed the evidence, it should start drafting recommendations. The Committee should decide what it wants to recommend and, if possible and appropriate, which sectors (including which practitioners or commissioners within those sectors) should act on the recommendations.

The concept of the 'strength' of a recommendation (Schunemann et al. 2003) is key to translating evidence into recommendations. This takes into account the quality of the evidence but is conceptually different.

Some recommendations are 'strong' in that the Committee believes that the vast majority of practitioners or commissioners and people using services would choose a particular intervention if they considered the evidence in the same way as the Committee. This is generally the case if the benefits clearly outweigh the harms for most people and the intervention is likely to be cost effective. Similarly, if the Committee believes that the vast majority of practitioners or commissioners and people using services would not choose a particular intervention if they considered the evidence in the same way as the Committee, a negative recommendation can be made (that is, 'Do not offer'). This is generally the case if the harms clearly outweigh the benefits for most people, or the intervention is not likely to be cost effective.

However, there is often a closer balance between benefits and harms, and some people would not choose an intervention whereas others would. This may happen, for example, if some people are particularly likely to benefit and others are not, or people have different preferences and values. In these circumstances, the recommendation is generally weaker, although it may be possible to make stronger recommendations for specific groups of people. The Committee should also discuss making negative recommendations in such situations if they believe most people are particularly likely to experience no benefit or experience harm, but that there may be a benefit for some. Be as specific as possible about the circumstances (for example, 'Do not offer…, unless…') or population. If possible, avoid using vague phrases such as 'Do not routinely…'.

The GRADE system allocates labels or symbols to represent the strength of a recommendation. NICE has chosen not to do this, but to reflect the strength in the wording of the recommendation (see section 9.2). NICE uses 'offer' (or similar wording such as 'measure', 'advise', 'commission' or 'refer') to reflect a strong recommendation, usually where there is clear evidence of benefit. NICE uses 'consider' to reflect a recommendation for which the evidence of benefit is less certain.

For all recommendations, a general principle of NICE guidelines is that people using services and the wider public should be informed of their options and be involved in decisions about their care.

There might be little evidence of differences in cost effectiveness between interventions. However, interventions that are not considered cost effective should not usually be offered to people because the opportunity cost of that course of action has been judged to be too great (see chapter 7).

The Committee's view of the strength of a recommendation should be clear from its discussions, as reported in the guideline.

Some recommendations may be highlighted for possible use in the development of a quality standard (see section 9.4).

In most cases the Committee reaches decisions through a process of informal consensus, but sometimes formal voting procedures are used. The proceedings should be recorded and a clear statement made about the factors considered and the methods used to achieve consensus. This ensures that the process is as transparent as possible.

A summary of the generic and specific issues considered and the key deliberations should be included in the guideline.

Principles of person‑centred care

All NICE guidelines advocate the principles of person‑centred care; there are also 2 NICE guidelines specifically on the experience of people using services: Patient experience in adult NHS services and Service user experience in adult mental health. The recommendations from these guidelines and the general principles of patient‑centred care should not be re‑stated. However, any specific aspects of views and experiences that need addressing can be considered, and recommendations made. These might relate to communication, information and support needs, or the consequences of particular interventions.

9.2 Wording the recommendations

Writing the recommendations is one of the most important steps in developing a guideline. Many people read only the recommendations, so the wording must be concise, unambiguous and easy to translate into practice by the intended audience. As a general rule, each recommendation, or bullet point within a recommendation, should contain only 1 main action.

The Committee must take account of NICE's integrated approach to presenting recommendations across different areas, which includes using consistent language to avoid misunderstanding and to make the recommendations as accessible as possible to a wide audience.

The wording of recommendations should be agreed by the Committee, and should:

  • focus on the action that needs to be taken, and where appropriate, who needs to take this action

  • include what readers need to know

  • reflect the strength of the recommendation

  • emphasise the involvement of people using services, carers where appropriate, and the public in making decisions

  • be 'person‑centred'

  • use clear English and avoid vague language and jargon

  • use language and terms that NICE has agreed to ensure consistency across guidelines and other products

  • follow NICE's standard advice on recommendations about medicines.

The recommendations should (when possible and not obvious from the context of the guideline) clearly detail the intended audience for the recommendation (who is responsible for implementing it), the intended population, the setting (if relevant), what specifically should be done, and, where relevant, what the timeframe is for doing it.

The rest of this section explains these points in more detail. NICE's lead editor for the guideline can advise on the wording of recommendations.

Focus on the action

Recommendations should begin with what needs to be done. When writing recommendations, keep in mind a reader who is saying, 'What does this mean for me?' Recommendations should be as specific as possible about the exact intervention being recommended and the group of people for whom it is recommended.

Recommendations should use direct instructions wherever possible because they are clearer and easier to follow. They often start with a verb describing what the reader should do, for example, 'offer', 'consider', 'measure', 'advise', 'discuss', 'ask about', 'commission' (see box 9.1).

Box 9.1 Examples of guideline recommendations that start with a verb

  • Record the person's blood pressure every 6 months.

  • Discuss the transition to adult services and ensure that the young person feels fully involved. Start planning at least 6 months before the discharge from child and adolescent mental health services (CAMHS).

  • Advise pregnant women to limit their intake of oily fish to 2 portions a week.

  • Encourage staff who regularly come into contact with people whose health and wellbeing could be at risk to provide them with a brief intervention. (The risk could be due to current behaviours, sociodemographic characteristics or family history.)

Sometimes it is clearer to start with details of the population covered by the recommendation or other details, particularly if recommending different actions for slightly different circumstances or to make the sentence structure simpler (see box 9.2).

Box 9.2 Examples of guideline recommendations that don't start with a verb

  • If surgery is an option, refer the patient to a specialist surgeon to discuss the risks and benefits.

  • Within 4 weeks of initial diagnosis, identify the needs of people with dementia and their carers arising from ill health, physical disability, sensory impairment, communication difficulties, problems with nutrition, poor oral health and learning disabilities. Record all specific needs and how they will be addressed in the care plan.

  • As part of the local joint strategic needs assessment (JSNA), gather information on where, when and how often smokeless tobacco cessation services are promoted and provided to local South Asian communities – and by whom. Aim to get an overview of the services on offer.

  • If operating a local formulary covering a small population, consider sharing resources and establishing joint processes with neighbouring local formulary decision‑making groups to avoid duplicating work.

Recommendations about service organisation or if the audience is not the practitioner

  • Care should be provided by a multidisciplinary team.

Recommendations that specify that a specific type of practitioner, person or organisation should carry out an intervention or action

  • An occupational therapist should assess the patient's needs.

  • When acting as a doctor, dentist or pharmacist signatory, establish that the clinical and pharmaceutical content is accurate and supported by the best available evidence.

  • Providers of existing interventions should work with researchers to ensure they are rigorously evaluated.

  • For each patient group direction, the provider organisation should:

    • identify a senior, responsible person from within the service to authorise named, registered health professionals to practise under the patient group direction

    • ensure that authorised health professionals have signed the appropriate documentation

Recommendations that use 'must' or 'must not' should be worded in the passive voice (see below for more details)

Reflect the strength of the recommendation

Some recommendations can be made with more certainty than others (see the section on strength of recommendations). This concept of the 'strength' of a recommendation should be reflected in the consistent wording of recommendations within and across guidelines. There are 3 levels of certainty:

  • recommendations for activities or interventions that should (or should not) be used

  • recommendations for activities or interventions that could be used

  • recommendations for activities or interventions that must (or must not) be used.

Recommendations for activities or interventions that should (or should not) be used should use directive language such as 'offer' (or 'do not offer'), 'advise', 'ask about' or 'commission'.

Recommendations for which there is a closer balance between benefits and harms (activities or interventions that could be used) should use 'consider'. 'Consider' indicates that the recommendation is made with less certainty. To minimise confusion, 'consider' should only be used to indicate the strength of a recommendation. Other wording rather than 'consider' should be used for 'be aware of', 'explore' or similar. 'Take other factors into account' or similar should be used instead of 'consider other factors'. 'Assess' and 'think about' are other possible alternatives to 'consider'. 'Consider offering' should be avoided because of potential confusion with the wording of strong recommendations. Also, it might be misinterpreted to mean that a health or social care practitioner may consider offering an intervention without discussing it with the patient or person using services.

If there is a legal duty to apply a recommendation, or the consequences of not following a recommendation are extremely serious, the recommendation should use 'must' or 'must not' and be worded in the passive voice. When there is a legal duty to apply a recommendation, the recommendation should contain a reference to the supporting documents. Recommendations should not simply repeat what is set out in statutory guidance but should support and build on it.

Examples of recommendations made with the 3 different levels of certainty are given in box 9.3.

Box 9.3 Examples of recommendations made with 3 different levels of certainty

Recommendations for activities or interventions that must or must not be used

  • Ultra‑rapid detoxification under general anaesthesia or heavy sedation (where the airway needs to be supported) must not be used. This is because of the risk of serious adverse events, including death.

  • Patient group directions must be authorised only by an appropriate authorising body in line with legislation.

Recommendations for activities or interventions that should or should not be used

  • Offer a trial of supervised pelvic floor muscle training of at least 3 months' duration as first‑line treatment to women with stress or mixed urinary incontinence.

  • If a smoker's attempt to quit is unsuccessful using NRT, varenicline or bupropion, do not offer a repeat prescription within 6 months, unless special circumstances have hampered the person's initial attempt to stop smoking, when it may be reasonable to try again sooner.

  • Record the person's blood pressure every 6 months.

  • Do not offer lamotrigine to treat mania.

Recommendations for activities or interventions that could be used

  • Consider combination chemotherapy to treat advanced breast cancer in patients for whom a greater probability of response is important and who understand and are likely to tolerate the additional toxicity.

  • Consider collaborating with other organisations and sharing existing educational materials to ensure a comprehensive approach.

  • Do not offer tigecycline to treat diabetic foot infections, unless other antibiotics are unsuitable.

Include what readers need to know

Recommendations should contain enough information to be understood without reference to the evidence or other supporting material. But they should not include unnecessary details, because recommendations are more likely to be followed if they are clear and concise.

  • Define any specialised terminology that is used in the recommendations. Avoid using abbreviations unless the audience is likely to be more familiar with the abbreviation than with the term in full. If abbreviations are essential, define them at first mention. Do not use abbreviations for groups of people; for example, write 'people from black, Asian and minority ethnic backgrounds' rather than 'BAMEs' or 'BMEs'.

  • Define the intended audience for the recommendation (where possible and if it is not obvious from the context). For some guideline topics, it may be necessary to group recommendations for specific practitioner or professional groups (for example, care home staff or social care commissioners).

  • Define the population if it is not obvious from the context. Often it is necessary to define the group or population only in the first of a group of recommendations, if it is clear that the subsequent recommendations in that section relate to the same population.

  • Define the setting(s) where the intervention is to be delivered where necessary if it is not obvious from the context.

  • Include cross‑references to other recommendations in the guideline if necessary to avoid the need to repeat information such as treatment regimens or components of the intervention or service.

  • Do not include reasons justifying the recommendation unless this will increase the likelihood that it will be followed – for example, if it is required by legislation, involves a change in usual practice or needs particular emphasis.

  • Avoid trade names. Give the recommended international non‑proprietary name (rINN), as listed in the British national formulary (BNF). Usually, only the generic name is needed. Occasionally (for example, if referring to a specific preparation or device), the proprietary name may be given in parentheses at first mention. Do not give the manufacturer's name. Any reference to products (for example, pedometers or brand names of medicines) and services (for example, slimming clubs) should be made in general terms to avoid giving the impression that NICE endorses a particular brand.

  • Include only 1 main action in each recommendation or bullet point.

Emphasise the involvement of people using services

Recommendations should acknowledge the role of people who are directly affected by them, or the role of organisations or other people who are affected (for example, family members, carers or advocates), in any decision‑making.

To emphasise the role of people using services or the public in decision‑making (and, as appropriate, that of a family member, carer, or advocate of a person using services) and the need for them to consent to treatment or an intervention, generally use verbs such as 'offer' and 'discuss' in recommendations, rather than 'prescribe' or 'give'. As described above, 'consider' is used for recommendations on interventions that could be used, and implies that more discussion with the person will be needed.

Use 'people' (or 'patients', or 'people using services') rather than 'individuals', 'cases' or 'subjects'. Use 'people' rather than 'patients' for people with mental health problems or chronic conditions. 'Service users' can be used for people with mental health problems if 'patients' is the only alternative. Do not use 'patients' in relation to healthy pregnant women or in social care settings.

Use clear English and avoid jargon

Using clear, consistent wording is an important part of NICE's integrated approach to presenting guidelines and other products, and is in line with gov.uk style.

Follow the principles of effective writing as described in Writing for NICE and NICE's approach to consistency in language and terms across guidelines and other products. More information is available in the NICE style guide.

Avoid vague words and phrases, such as 'may' and 'can', or general statements such as 'is recommended', 'is useful/helpful', 'is needed' and 'service options include'. Instead, use an active verb that tells readers what they should do, and indicates the strength of the recommendation.

Examples
  • Instead of 'an intervention may be offered', say 'consider the intervention'.

  • Instead of 'an intervention is recommended', say 'offer the intervention'.

  • Instead of 'an intervention is helpful', say 'offer the intervention' or 'consider the intervention'.

'Appropriate' is often redundant: for example, 'give appropriate advice', because we would never recommend giving inappropriate advice.

Recommendations on medicines, including off‑label use of licensed medicines

The Developer should follow NICE's standard procedure when referring to medicines. This includes using standard wording when off‑label use of medicines is recommended.

Do not give dosages routinely

Readers are expected to refer to the summary of product characteristics (SPC) for details of dosages. Include dosage information only if there is evidence that a particular medicine is often prescribed at the wrong dosage, or there is clear evidence about the effectiveness of different dose levels. If off‑label use of a licensed medicine is being recommended and there is no relevant dosage information in the BNF, include details of the dosage regimen in the guideline. SPCs can be found in the Electronic Medicines Compendium.

Off‑label use of licensed medicines

Using a UK licensed medicine outside the terms of its marketing authorisation is classed as off‑label use. Make it clear in the recommendation if the recommended use of a medicine is outside its licensed indication.

Recommendations are usually about the uses of medicines (often referred to as the licensed indications) for which the regulatory authority has granted a marketing authorisation, either in the UK or under the European centralised authorisation procedure. However, there are clinical situations in which the off‑label use of a medicine may be judged by the prescriber to be in the best clinical interests of the patient. Off‑label use may be recommended if the clinical need cannot be met by a licensed product and there is sufficient evidence and/or experience of using the medicine to demonstrate its safety and efficacy to support this. Off‑label prescribing is particularly common in pregnant women and in children and young people (see below) because these groups have often been excluded from clinical trials during medicine development. When prescribing a medicine off‑label, the prescriber should follow relevant professional guidance (for example, the General Medical Council's Good practice in prescribing medicines – guidance for doctors) and make a clinical judgement, taking full responsibility for the decision for the patient under his or her direct care. In addition, the patient (or those with authority to give consent on their behalf) should be made fully aware of these factors and provide informed consent, which should be documented by the prescriber.

A licensed medicine is accompanied by an SPC, which includes the indications, cautions and contraindications for a medicine based on an assessment of safety, quality and efficacy by the regulatory authority. The guideline Developer and Committee should check recommended uses against the licensed indications listed in the SPC, and include the following standard information with the recommendation if the medicine does not have a UK marketing authorisation for the use being recommended:

At the time of publication ([month year]), [name of drug] did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines – guidance for doctors for further information.

Additional information can be added as needed. In cases where the SPC for a medicine specifically mentions a caution or contraindication for its use but the Committee wishes to recommend the medicine, this should be stated clearly in the recommendation. The evidence that the Committee has considered in reaching the conclusion that use in these circumstances can be justified should be clearly set out in the guideline.

If there is no information on dosage regimens available in a recognised source (such as the BNF), the guideline Developer should include dosage information in the guideline recommendations and alert NICE's medicines and prescribing team to ensure that this is disseminated to prescribers.

Prescribing medicines outside their licensed indications to children and young people

In certain circumstances medicines are prescribed outside their licensed indications (off‑label use) to children and young people because the clinical need cannot be met by licensed medicines; for example, for an indication not specified in the marketing authorisation, or administration of a different dose. The Standing Committee on Medicines (a joint committee of the Royal College of Paediatrics and Child Health and the Neonatal and Paediatric Pharmacists Group) has issued a policy statement on the use of unlicensed medicines and the use of licensed medicines for unlicensed indications in children and young people. This states clearly that such use is necessary in paediatric practice and that doctors are legally allowed to prescribe medicines outside their licensed indications where there are no suitable alternatives and where use is justified by a responsible body of professional opinion (Joint Royal College of Paediatrics and Child Health/Neonatal and Paediatric Pharmacists Group Standing Committee on Medicines 2013).

Therefore, if there is no alternative treatment and there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy, a guideline may recommend use of a medicine outside its licensed indications for treating a child or young person, in line with this policy. It is expected that prescribers will use the SPC to inform their prescribing decisions for individual patients, and they should be able to justify using a medicine outside its licensed indications. Informed consent should be obtained from the child and/or their parent or guardian as appropriate and should be documented.

Using tables in recommendations

Do not use tables to summarise several actions in 1 recommendation. Such tables make it more difficult to link the recommended actions to the evidence.

9.3 Supporting shared decision-making

Identify preference-sensitive decision points

Guidelines should include information to support shared decision-making between people and their health or social care practitioners (see NICE's recommendations about shared decision-making about medicines). The Committee should identify any recommendations where someone's values and preferences are likely to be particularly important in their decision about the best course of action for them.

These 'preference-sensitive decision points' occur when:

  • There are 2 or more effective options for investigation, treatment or care that deliver similar outcomes but:

    • they have different types of harms and benefits which people may value differently

    • the likelihood of the harms or benefits may differ

    • the practicalities of the options are different (for example, the choice is between medicine and surgery, or the requirements for monitoring differ)

    • people may consider the overall risks of harms for any of the options outweigh the overall benefits compared with no treatment.

  • The choice between an investigation, treatment or care option and the option of 'no treatment' is finely balanced.

When to identify preference-sensitive decision points

In some cases, preference-sensitive decision points might be apparent at the scoping stage of a guideline. In other cases, the Committee will identify them when reviewing the evidence. This is the same evidence used to make the recommendations, no additional evidence searches or syntheses are needed.

For updates, the Committee only needs to identify decision points in the areas of the guideline being updated.

Summarise information to support decisions

When a preference-sensitive decision point is identified, the Committee should create a summary of the evidence that makes it easy for professionals and practitioners to compare the options and discuss them with the person.

This summary should set out information about the options clearly and simply. It should usually include the option of no treatment or investigation. This could include brief information, for each option, about:

  • effectiveness: how well something is likely to work for particular outcomes or circumstances and for particular subgroups of people

  • safety: the risk of short- or long-term harms, and any contraindications

  • practical factors relevant to people using services: people's experience of treatment or care – for example, ease of use (route of administration for medicines), monitoring requirements, side effects, or impact on quality of life

  • quality and certainty of the evidence: an overall judgement about the quality of the underlying evidence base for each option.

The summary of evidence should include enough information for NICE or other organisations to use it to develop their own decision support tools or update existing ones.

Additional decision support

A 'patient decision aid' (PDA) is a tool that presents evidence-based estimates of the benefits and risks of available options simply but in sufficient detail for people to make an informed choice. PDAs make the choice explicit, describe the options available, and help people to understand these options as well as their possible benefits and harms. This helps people to consider the options from a personal view (for example, how important the possible benefits and harms are to them) and helps them to participate with their practitioner in making a decision.

PDAs are intended to supplement or support the discussion between the person and their health or care professional, rather than replace it. PDAs can also support the implementation of guidance and contribute to more effective use of resources.

If the Committee identifies a decision point where there is a particular need for a PDA, the Developers should alert NICE during guideline development. Reasons the Committee might do this include:

  • People need detailed information about a choice of treatment to work through before or after their appointment.

  • Graphical or pictorial representations of the data on risk and benefits would help people make the decision.

  • The decision is about taking a medicine for prevention (for example, if a person has no symptoms and needs to balance the potential for adverse events from the medicine against preventing a future event).

  • There are no existing PDAs about the decision.

NICE will decide whether to produce a PDA in house to support the guideline.

Updating evidence summaries to support shared decision-making

When a guideline is updated, summaries of evidence to support shared decision-making should be updated only if they are covered by a new evidence review.

9.4 Highlighting areas for future consideration in quality standard development

NICE guidelines can cover large areas of care and, as a result, often contain a considerable number of recommendations relevant to the many review questions. Where a linked quality standard is planned, the Committee may choose to discuss which recommendations might be suitable for consideration within the quality standard development process.

Recommendations that may be highlighted should:

  • be in areas in which there is evidence or consensus that there is variation in the delivery of care to people using services (in particular, aspects of care or services that are not widely provided and/or not considered to be standard practice, but that are feasible to provide)

  • focus on key requirements for high‑quality care or service provision that are expected to contribute to improving the effectiveness, safety and experience of care or services

  • be measurable and therefore suitable for development as quality measures.

Some members of the guideline Committee may be invited to apply to join the Quality Standards Advisory Committee that is developing a related quality standard, as specialist Committee members.

9.5 Formulating research recommendations

The Committee is likely to identify areas in which there are uncertainties or in which robust evidence is lacking. NICE has published a Research recommendations process and methods guide, which details the approach to be used to identify key uncertainties and associated research recommendations.

For guidelines where there could be many hundreds of uncertainties, it will not be possible to document every uncertainty in detail. Similarly, although Committees could write research recommendations for dealing with each uncertainty, this is not likely to be feasible. Therefore the Committee should select key research recommendations that are likely to inform future decision‑making (based on a systematic assessment of gaps in the current evidence base) for inclusion in the guideline. Methods such as value of information analyses can be useful in this process. Further information about how research recommendations should be derived can be found in the research recommendation process and methods guide.

9.6 Incorporating the guideline recommendations into NICE Pathways

The Committee and Developer should refer to both the guideline scope and the NICE Pathway outline when developing the guideline. This includes taking account of the links to other NICE Pathways and the guidance identified as related to the guideline topic at the scoping stage. The Committee and Developer should aim for the guideline structure to be compatible with NICE Pathways. They should also consider the links with existing pathways to help integrate the new topic into NICE Pathways.

The NICE Pathway is drafted by an editor in the NICE publishing team. Drafting begins when most of the draft recommendations are available for guideline consultation. Work continues during consultation on the draft guideline. The publishing team works with the Developer's lead(s) for the NICE Pathway, who may be members of the guideline Committee.

Further drafts of the NICE Pathway are prepared in the light of comments received.

When the recommendations are finalised, the editor checks the NICE Pathway against the final recommendations and makes changes if necessary.

9.7 References and further reading

Brown P, Brunnhuber K, Chalkidou K et al. (2006) How to formulate research recommendations. British Medical Journal 333: 804–6

Claxton K, Sculpher MJ (2006) Using value of information analysis to prioritise health research: some lessons from recent UK experience. Pharmacoeconomics 24: 1055–68

Glasziou P, Del Mar C, Salisbury J (2003) Evidence‑based medicine workbook. London: British Medical Journal Books

Joint Royal College of Paediatrics and Child Health/Neonatal and Paediatric Pharmacists Group Standing Committee on Medicines (2013) The use of unlicensed medicines or licensed medicines for unlicensed applications in paediatric practice

Kelly MP, Moore TA (2012) The judgement process in evidence-based medicine and health technology assessment. Social Theory and Health 10:1–19

Lord SJ, Irwig L, Simes RJ (2006) When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Annals of Internal Medicine 144: 850–5

Michie S, Johnston M (2004) Changing clinical behaviour by making guidelines specific. British Medical Journal 328: 343–5

Nuffield Council on Bioethics (2007) Public health: ethical issues. London: Nuffield Council on Bioethics

Sackett DL, Straus SE, Richardson WS (2000) Evidence‑based medicine: how to practice and teach EBM. Edinburgh: Churchill Livingstone

Schünemann HJ, Best D, Vist G et al. for the GRADE Working Group (2003) Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations. Canadian Medical Association Journal 169: 677–80

Scottish Intercollegiate Guidelines Network (2008) SIGN 50. A guideline developer's handbook, revised edition. Edinburgh: Scottish Intercollegiate Guidelines Network

Tannahill A (2008) Beyond evidence – to ethics: a decision making framework for health promotion, public health and health improvement. Health Promotion International 23: 380–90

Weightman A, Ellis S, Cullum A et al. (2005) Grading evidence and recommendations for public health interventions: developing and piloting a framework. London: Health Development Agency

Yale University (2011) Guideline Implementability Appraisal (GLIA)