NICE process and methods
12 Developing and wording guidance recommendations
12 Developing and wording guidance recommendations
Many users of good practice guidance (GPG) may not have time to read the guidance in full, and may want to focus only on the recommendations. It is therefore vital that recommendations are clear, can be understood by people who have not read the GPG in full, and are based on the best available evidence. This section addresses key areas in developing GPG recommendations:
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interpreting the evidence to make recommendations
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wording the recommendations
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formulating research recommendations.
These processes are at the heart of the work of the Guidance Development Group (GDG). However, they are not straightforward and it may not be easy for the GDG to reach agreement. Consensus techniques may need to be used within the GDG (see section 6.5).
12.1 Interpreting the evidence to make recommendations
The GDG must decide what the evidence means in the context of the review questions posed, and decide what recommendations can usefully be made to health and social care professionals. The aim of the GPG is to show clearly how the GDG moved from the evidence to the recommendation.
The 'strength' of a recommendation is agreed by the GDG. This takes into account the source and quality of the evidence. Some recommendations are 'strong' in that the GDG believes if others (including health and social care professionals and patients) considered the evidence in the same way they would agree with the recommendations.
The GRADE system (see appendix D) allocates labels or symbols to represent the strength of a recommendation. NICE has chosen not to do this, but instead to reflect the concept of strength in the wording of the recommendation (see section 12.2.4). The GDG's view of the strength of a recommendation should be clear from its discussions.
The following points are included in the discussions.
12.1.1 Relative value placed on the outcomes considered
For each review question, the GDG decides which outcomes are considered important for decision-making and what relative importance is given to them. This might be done informally or formally.
This discussion should be clearly separated from the discussion of the evidence, because there is a potential to introduce bias if outcomes are selected on the basis of the results.
It may be important to note outcomes that were not considered to be important for decision-making, and why.
12.1.2 Trade-off between benefits and resource use
There should be an explanation of how the GDG considered the cost and resource implications of following the recommendations. This will usually be informal.
12.1.3 Other trade-offs
Dependent on the GPG topic, the GDG also considers the trade-off between other factors, for example, time, service redesign and policy development. This discussion would be considered when wording the recommendation.
12.1.4 Quality of the evidence
There should be discussion of how the presence, likely magnitude and direction of potential biases and uncertainty in the evidence have influenced the recommendation, and why. This should reflect the judgement on the quality of the evidence as described in the GRADE profile. In principle, lower-quality evidence makes it more difficult to justify a strong recommendation in general, although there are likely to be exceptions to this.
The discussion may include whether the degree of uncertainty warrants delay in making a recommendation to await further research, considering any potential harm of failing to make a clear recommendation.
12.1.5 Extrapolation of evidence
Evidence identified for a specific cohort of patients may include principles that could be extrapolated to other patient populations. For example, medicines management systems in a care home for people with dementia may also be relevant and identify good practice that is relevant in other care home settings. The use of extrapolation must be considered carefully by the GDG, with explicit consideration of the features of the condition or interventions that allow extrapolation. This also applies when extrapolating findings from evidence in different healthcare settings. The GDG should comment on similarities in case mix, staffing, facilities and processes.
12.1.6 Other considerations
The GDG discusses any implications of the recommendations relating to equalities legislation and NICE's equality scheme. This covers inequalities related to age, disability, gender reassignment, marriage and civil partnership, race, religion or belief, sex and sexual orientation and socioeconomic status. The GDG needs to consider whether:
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the evidence review has addressed areas identified in the scope as needing specific attention with regard to equalities issues
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people with disabilities might find it impossible or unreasonably difficult to benefit from a recommendation being implemented
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guidance can be formulated so as to promote equalities.
Before the GPG is signed off, an equality impact assessment form is completed by the NICE project team and the GDG to show how equality issues have been identified and considered during development. The equality impact assessment form is signed by the project lead and GDG chair, and countersigned by the Centre for Clinical Practice Director, before being posted on the NICE website.
The GDG may need to discuss the implementation of a recommendation, particularly where this will involve a change in practice, for example, implementing training programmes.
12.1.7 Challenges in formulating recommendations
There are many reasons why it can be difficult for a GDG to reach a decision about a recommendation. The evidence base is always imperfect, and so there is always a degree of judgement by the GDG. There may be very little, or no, good-quality evidence that directly addresses the review question the GDG has posed. In this situation, there are several options to consider:
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The GDG may consider basing a recommendation on its view of current practice. Formal consensus techniques may be used to elicit opinions from the GDG, although NICE does not recommend a particular approach. Importantly, it is not usually appropriate to involve stakeholders from outside the GDG in this process, because they will be offering opinions on recommendations without having seen the evidence considered by the GDG; in addition, stakeholders will not have agreed to adhere to the principles underlying NICE's decisions on recommendations.
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The GDG may need to look at evidence that is likely to be more at risk of bias than the evidence it had hoped to find. This approach should be pursued only if there is reason to believe that it will help the GDG to formulate a recommendation.
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The GDG may wish to extrapolate from high-quality evidence in a related area, for example, in a largely similar patient group or setting. The GDG needs to make its approach explicit, stating the basis it has used for extrapolating from the data and the assumptions that have been made. This needs to include consideration of the plausibility of the assumptions. This approach is unlikely to be helpful if the evidence is derived from a question that is too different from the review question, or if the evidence is not of the highest quality.
When formulating recommendations, there are likely to be instances when members of the GDG disagree about the content of the final GPG. There should be a clear record of the proceedings and how areas of disagreement have been handled, for example, in the minutes of the GDG meeting (see section 6).
12.2 Wording the guidance recommendations
Writing the recommendations is one of the most important steps in developing the GPG. Many people read only the recommendations, so the wording must be concise, unambiguous and easy to translate into practice. Each recommendation, or bullet point within a recommendation, should contain only 1 main action.
The wording of recommendations should be agreed by the GDG, and should:
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focus on the action that needs to be taken
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include what readers need to know
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reflect the strength of the recommendation
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include the involvement of the patient (and/or their carers if needed) and/or stakeholders, as appropriate
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use plain English where possible and avoid vague language.
The rest of this section explains these points in more detail. The lead editor for the guidance from NICE's Publishing team advises on the wording of recommendations.
12.2.1 Who the recommendation is aimed at
When writing recommendations, the GDG aims to identify which individual person or organisation is responsible for implementing it. When this is possible, the recommendation clearly identifies this. When the individual or organisation responsible is not clearly identifiable, this is for commissioners or providers to consider and determine locally.
12.2.2 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 action being recommended and the group of people for whom it is recommended.
When a recommendation is aimed specifically at an individual person or organisation, this is clearly identifiable. However, the GDG may not be able to identify which individual person or organisation is responsible. In these circumstances, this will be for local consideration and determination
Use direct instructions because they are clearer and easier to follow. Most recommendations should be worded in this way. Assume you are talking to the person who will implement the recommendation.
Examples:
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Include a locally defined mix of members from partner organisations and key stakeholders, such as patients and the public.
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Hold meetings sufficiently frequently to ensure decision-making is robust and decisions are made in a reasonable and practical timeframe.
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Report to relevant corporate governance bodies for each partner organisation appropriately, and as a minimum annually, and by exception when needed.
Exceptions:
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Recommendations that a specific person 'should' carry out and is directed at a specific person. For example, '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'.
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Recommendations that a specific organisation 'should' carry out and is directed at the organisation. For example, 'For each PGD, the provider organisation should:
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identify a senior, responsible person from within the service to authorise named, registered health professionals to practise under the PGD
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ensure that authorised health professionals have signed the appropriate documentation.'
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Start with a verb describing what the reader should do, such as 'offer', 'include', 'advise', 'determine' or 'ask about' (see sections 12.2.3 and 12.2.4 for advice on the choice of verb).
Examples:
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Include horizon scanning as a standing agenda item on local formulary decision-making group meetings.
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Determine explicitly how local formulary decision-making groups reach final decisions.
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Identify the senior person in each profession who is responsible for ensuring that only fully competent, qualified and trained health professionals use PGDs.
Exceptions:
Sometimes it is clearer to start with other details, particularly if recommending different actions for slightly different circumstances or to make the sentence structure simpler. For example:
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When reviewing the PGD, conduct a literature search to identify new evidence. Ensure this evidence is evaluated to assess its relevance and validity.
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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.
12.2.3 Include what readers need to know
Recommendations should contain enough information to be understood without reference to the evidence or other supporting material. Unnecessary details should not be added, because recommendations are more likely to be followed if they are clear and concise.
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Define any specialised terminology that is used in the recommendations. Avoid using abbreviations unless your 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 and in a glossary.
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Define the target group or 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, for example, 'patients in care homes'.
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Include cross-references to other recommendations in the GPG if necessary to avoid the need to repeat information.
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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.
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Include only 1 main action in each recommendation or bullet point.
12.2.4 Reflect the strength of the recommendation
The description in section 12.1 indicates that some recommendations can be made with more certainty than others. This concept of the 'strength' of a recommendation should be reflected in the consistent wording of recommendations within and across good practice. There are 3 levels of certainty:
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recommendations for practice that must (or must not) be followed
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recommendations for practice that should (or should not) be followed
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recommendations for practice that could be followed.
12.2.4.1 Recommendations for practice that must or must not be followed
Recommendations for practice that 'must' or that 'must not' be followed are usually included only if there is a legal requirement to apply the recommendation, for example, to comply with medicines regulations. Reference to supporting documents should be included.
Occasionally, the consequences of not following a recommendation are so serious (for example, there is a high risk to patient safety) that using 'must' (or 'must not') is justified.
If using 'must', word the recommendation in the passive voice ('an intervention must be used') because the distinction between 'should' and 'must' is lost when the recommendation is turned into a direct instruction.
Examples:
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PGDs must be authorised only by an appropriate authorising body in line with legislation.
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All legally required information must be included in a PGD. Use a standard blank template to ensure that the format is consistent across the organisation.
12.2.4.2 Recommendations for practice that should or should not be followed – 'strong' recommendations
For recommendations for practice that 'should' be followed, the GDG is confident that, for majority of people and organisations, the benefits from the recommended practice will outweigh any harm, represent good practice and is cost effective (if cost effectiveness has been assessed). Recommendations using 'should' would normally be supported by 'strong' evidence, for example, randomised controlled trials, systematic reviews or NICE-accredited guidance.
Use direct instructions for recommendations of this type where possible (see section 12.2.1), rather than using the word 'should'. Use verbs such as 'ensure', 'establish', 'advise' and 'determine'.
Examples:
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Ensure resources are available to undertake all functions needed as determined by the scope and geographical coverage of the local formulary.
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Determine the expiry date for an individual PGD on a case-by-case basis, with patient safety paramount. Ensure that this date does not exceed 3 years from the date the PGD was authorised.
Use similar forms of words (for example, 'Do not use…') for recommendations for practice that should not be used because the GDG is confident that they will not be of sufficient benefit for most individual people.
Example:
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Do not use PGDs for managing long‑term conditions, such as hypertension or diabetes, or when uncertainty remains about the differential diagnosis.
12.2.4.3 Recommendations for practice that 'could' be followed
For recommendations that use 'could', the GDG is confident that the practice will be of benefit, represent good practice and will be cost effective (if cost effectiveness has been assessed) for most people and organisations.
However, some people or organisations may choose to practice differently with similar benefits to that of the recommended practice. This may be due limited resources and it is more practical to implement or it has been determined locally.
Use direct instructions for recommendations of this type where possible (see section 12.2.1), rather than using the word 'could'.
Examples:
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Consider investing in the training of additional non-medical prescribers to enable redesign of services if necessary, as part of a wider development or review of local medicines policy
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Consider collaborating with other organisations and sharing existing educational materials to ensure a comprehensive approach.
Recommendations using 'could' would normally be devised from evidence that would not be considered as 'must' or 'should'. The evidence is not a 'strong' as for recommendations using 'should'.
12.2.5 Emphasise the patient's involvement
To emphasise the patient's role in decision-making and the need for them to consent to treatment, generally use verbs such as 'offer', 'consider' and 'discuss' in recommendations, rather than 'prescribe' or 'give'. The term 'consider' is used for recommendations for good practice that could be used, and implies that more discussion will be needed (see section 12.2.4.3).
Use 'people' or 'patients' rather than 'individuals', 'cases' or 'subjects'. Where possible, use 'people' rather than 'patients' for people with mental health problems or chronic conditions. For guidance that has a social care remit, the term 'residents' can be used rather than 'patients'. 'Service users' can be used for people with mental health problems if 'patients' is the only alternative.
12.2.6 Recommendations on drugs, including 'off-label' use of licensed medicines
The NICE project team follows NICE's standard procedure when referring to drugs. This includes using standard wording when 'off-label' use of licensed medicines is recommended.
12.2.6.1 Use generic 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.
12.2.6.2 Do not give dosages
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 drug is often prescribed at the wrong dosage, or there is clear evidence about the effectiveness of different dose levels. If 'off-label' use of licensed medicines is being recommended and there is no relevant dosage information in the BNF, include details of the dosage regimen. SPCs can be found in the Electronic Medicines Compendium.
12.2.6.3 Off-label use of licensed medicines
Using a UK licensed medicine outside the terms of its marketing authorisation, is classed as 'off-label' use.
Off-label use of licensed medicines may be mentioned in a recommendation when it is relevant to the GPG topic. For example, 'ensure that off-label use of a licensed medicine is included in a PGD only when clearly justified by best clinical practice. Clearly state that the medicine is being used outside the terms of the marketing authorisation on the PGD. Consider informing the patient or their carer that the use is off-label, in line with General Medical Council guidance'.
If the recommendation includes off-label use of licensed medicines, the responsibilities of the prescriber and the need to follow relevant professional guidance should be included as given in the example above.
12.2.7 Using tables in recommendations
Do not use tables to summarise several actions in 1 recommendation. Such summaries make it more difficult to link the recommended actions to the summarised evidence from the literature review. A recommendation may include a small table to improve clarity; for example, to present information that should be shared with patients, or if the information is most easily understood when tabulated.
12.3 Formulating research recommendations
The GDG may identify areas in which there are uncertainties or where evidence is lacking. NICE has published a Research recommendations process and methods guide, which details the approach to be used across NICE's guidance-producing programmes to identify key uncertainties and associated research recommendations.