Process and methods
9 Developing and wording guidance recommendations
Many users of social care guidance do not have time to read the full document 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 evidence reviews, and are based on the best available evidence. This section addresses key areas in developing guidance recommendations:
interpreting the evidence to make recommendations
wording the recommendations
prioritising recommendations for future consideration in quality standard development
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 (see section 3.5).
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:
The GDG may wish to look at evidence that is likely to be more at risk of bias than the evidence they 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.
The GDG may wish to consider high-quality evidence in a related area, for example, in a largely similar service user group or for a closely related intervention. The GDG needs to make its approach explicit, stating the basis it has used for reviewing 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.
The GDG may consider basing a recommendation on its view of current most cost-effective 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 have not agreed to adhere to the principles underlying NICE's decisions on recommendations. This approach would also allow some stakeholders input to the decision-making process that other stakeholders do not have. GDGs should therefore be particularly cautious about using and interpreting the results of such exercises involving stakeholders outside the GDG, and should talk with NICE about any proposed use. NICE makes the final decision on whether such work with external stakeholders is warranted.
When formulating recommendations, there are likely to be instances when members of the GDG disagree about the content of the final guidance. Formal consensus methods can be used for agreeing the final recommendations (see section 3.5). Whatever the approach used, there should be a clear record of the proceedings and how areas of disagreement have been handled. This may be summarised in the guidance.
The GDG must decide what the evidence means in the context of the review questions and economic questions posed, and decide what recommendations can usefully be made to social care practitioners and other professionals.
The guidance should show clearly how the GDG moved from the evidence to the recommendation. This is done in a section called 'evidence to recommendations' so that it can be easily identified. A simple table can be used to show how the evidence was used to develop the recommendations, and should describe the relative value placed on outcomes, benefits and harms, net benefits and resource use, and the overall quality of the evidence, as well as other considerations of the GDG.
This section may also be a useful way to integrate the findings from several evidence reviews that are related to the same recommendation or group of recommendations.
Underpinning this section is the concept of the 'strength' of a recommendation (Schunemann et al. 2003). This takes into account the quality of the evidence but is conceptually different.
Some recommendations are 'strong' in that the GDG believes that the vast majority of social care practitioners and other professionals and service users would choose a particular intervention if they considered the evidence in the same way as the GDG has. This is generally the case if the benefits clearly outweigh the harms for most people and the intervention is likely to be cost effective.
However, there is often a closer balance between benefits and harms, and some service users would not choose an intervention whereas others would. This may happen, for example, if some service users are particularly likely to benefit and others are not. In these circumstances, the recommendation is generally weaker, although it may be possible to make stronger recommendations for specific groups of service users.
For all recommendations, a general principle of NICE social care guidance is that service users should be informed of their options and be involved in decisions about their care. Service users may choose not to accept the advice to have the most cost-effective intervention. Or they may opt for an intervention that has the same or lower long-term benefits and personal social service costs if, for example, they feel that its associated harms are more tolerable.
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 service users (see section 7.3) because the opportunity cost of that course of action has been judged to be too great (see section 7.1.2).
The concept of strength is reflected in the wording of the recommendation (see section 9.6.4). The GDG's view of the strength of a recommendation should be clear from its discussions, as reported in the guidance.
The following points need to be covered in the discussions and can also be used as a framework for reporting those discussions.
Often, more outcome data are available than are actually used in decision-making. It is therefore important to have explicit discussion of which outcomes are considered important for decision-making (including considering the perspective of the decision-makers) when developing review protocols (see section 4.4), and of what relative importance was given to them. This might be done informally (for example, 'capacity was considered the most important outcome') or formally (for example, by the use of utility weights).
This discussion should be clearly separated from discussion of how this will play out when the evidence is reviewed, because there is potential to introduce bias if outcomes are selected on the basis of the results. An example of this would be choosing only outcomes for which there were statistically significant results.
It may be important to note outcomes that were not considered to be important for decision-making, and why (such as surrogate outcomes if longer-term, more relevant outcomes are available). If the same set of outcomes is used for a number of review questions, it might be more efficient to record this information once and then refer back to it.
A key stage in moving from evidence to recommendations is weighing up the magnitude and importance of the benefits and harms of an intervention. 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.
If there are net benefits from an intervention, there should be an explanation of how the implications of resource use were considered in determining cost effectiveness. Again, this may be informal, or may be more formal and include economic modelling. If there is no clear evidence of net benefit, cost and resource use could be discussed here.
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. Lower-quality evidence generally makes it more difficult to justify a strong recommendation, although there may be exceptions to this.
The discussion of uncertainty may include considering whether the uncertainty is sufficient to justify delaying making a recommendation to await further research, taking into account the potential harm of failing to make a clear recommendation.
If the 'evidence to recommendations' section combines consideration of several possible interventions, it may be useful to include discussion of the position of an intervention within a pathway of care or service model.
This section is also the appropriate place to note how the GDG's responsibilities under equalities legislation and NICE's equality scheme have been discharged in reaching the recommendations (see section 1.2). The GDG needs to consider whether:
the evidence review has addressed areas identified in the scope as needing specific attention with regard to equalities 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
people with disabilities might find it impossible or unreasonably difficult to receive an intervention
guidance can be formulated to promote equalities, for example, by making access more likely for certain groups, or by tailoring the intervention to specific groups.
It may be useful to briefly talk about the extent of change in practice that will be needed to implement a recommendation, and the possible need for carefully controlled adoption with, for example, training programmes or demonstration projects.
If evidence of effectiveness is either lacking or too weak for reasonable conclusions to be reached, the GDG may recommend that particular interventions are used only in the context of research. Factors to be considered before issuing 'only in research' recommendations include the following:
The intervention should have a reasonable prospect of providing benefits to service users in a cost-effective way.
The necessary research can realistically be set up or is already planned, or service users are already being recruited.
There is a real prospect that the research will be used when developing future NICE guidance.
The GDG should ensure that effective interventions strongly supported by the evidence are clearly identifiable. This will be fed into a future database.
As soon as members have discussed the findings of a NICE evidence review (or any expert testimony), the GDG should start drafting recommendations. This is an iterative process; the recommendations are likely to be revised several times before the wording is finalised.
First, the GDG should decide what it wants to recommend and which sectors (including which professionals within those sectors) should act on the recommendations.
In the early stages, it can be helpful to work in small groups. It may also help if a first draft of the recommendations is used as a starting point for discussion, based on the GDG's initial deliberations as a group. However they are developed, the draft recommendations should be clearly linked to evidence statements.
Some recommendations may be prioritised (see section 9.7).
If evidence on effectiveness or cost effectiveness is lacking or conflicting, the GDG may decide that further research should be a condition for adoption.
Decisions can be made using a variety of approaches: discussion, informal or formal consensus or formal voting (for example, if members disagree). The proceedings should be recorded and a clear statement made about the factors that have been considered and the methods used to achieve consensus. This ensures the process is as transparent as possible.
A summary of the generic and specific issues considered and the key deliberations should be given in the 'Evidence to recommendations' section of the guidance (see section 9.2).
Writing the recommendations is one of the most important steps in developing social care guidance. 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 one main action.
The wording of recommendations should be agreed by the GDG and should:
focus on the action that needs to be taken (action-oriented)
include what readers need to know
reflect the strength of the recommendation
emphasise the involvement of the service user (and/or their carers if needed) in decisions
use plain English where possible and avoid vague language
follow NICE's standard advice on recommendations about waiting times and ineffective interventions.
The rest of this section explains these points in more detail. The lead editor for the guidance from NICE will advise on the wording of recommendations.
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 (see also section 9.6.3).
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 social care practitioner who is working with the service user or carer at the time.
Sometimes, it is clearer to start with details of the service user group or other details, particularly if recommending different actions for slightly different circumstances or to make the sentence structure simpler.
Recommendations should contain enough information to be understood without reference to the evidence or other supporting material. But do not add 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 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. Do not use abbreviations for groups of people; for example, write 'people from black and minority ethnic backgrounds' rather than 'BMEs'.
Define the intended audience for the recommendation. For some guidance 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 target population if it is not obvious from the context. Often, it is necessary to define the 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 if it is not obvious from the context.
Include cross-references to other recommendations in the guidance if necessary to avoid the need to repeat information, such as 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 involves a change in usual practice or needs particular emphasis.
The description of the process of moving from evidence to recommendations in section 9.2 shows 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 social care guidance. There are 3 levels of certainty:
recommendations for interventions that must (or must not) be used
recommendations for interventions that should (or should not) be used
recommendations for interventions that could be used.
The guidance document includes a standard section about how wording reflects the strength of recommendations.
Recommendations that an intervention must or must not be used are usually included only if there is a legal duty to apply the recommendation, for example, to comply with health and safety regulations. In these instances, give a reference to supporting documents.
Occasionally, the consequences of not following a recommendation are so serious (for example, there is a high risk that the service user could be placed at significant risk) that using 'must' (or 'must not') is justified even if a legal requirement is not involved. Talk about this with the programme manager at NICE, and explain in the recommendation the reason for the use of 'must'.
If using 'must', word the recommendation in the passive voice ('an intervention must be used') because the distinction between 'should' and 'must' is lost if the recommendation is turned into a direct instruction.
For recommendations on interventions that 'should' be used, the GDG is confident that, for most people, the intervention (or interventions) will do more good than harm, and will be cost effective.
Use direct instructions for recommendations of this type where possible, rather than using the word 'should'. Use verbs such as 'offer', 'refer', 'advise' and 'discuss'.
Use similar forms of words (for example, 'Do not offer…') for recommendations on interventions that should not be used because the GDG is confident that they will not be of sufficient benefit for most service users.
If an intervention is strongly recommended but there are 2 or more options with similar cost effectiveness, and the choice will depend on the service user's values and preferences, a 'should' recommendation can be:
combined with a 'could' recommendation (see 'Recommendations for interventions that could be used), for example, by using wording such as 'Offer a choice of service A or service B' or
followed by a 'could' recommendation, for example 'Offer rehabilitation. Consider service A or service B.'
For recommendations on interventions that 'could' be used, the GDG is confident that the intervention will do more good than harm for most service users, and will be cost effective. However, other options may be similarly cost effective, or some service users may opt for a less effective but cheaper intervention.
The choice of intervention, and whether to have the intervention at all, is therefore more likely to vary depending on a person's values and preferences, and so the social care practitioner should spend more time considering and discussing the options with the service user. It may be possible to make 'strong' recommendations for subgroups of people with different values and preferences.
Use direct instructions for recommendations of this type where possible (see section 9.6.2), rather than using the word 'could'.
Use 'consider' to show that the recommendation is less strong than a 'should' recommendation.
Do not use 'consider offering', because of potential confusion with the wording of strong recommendations. Also, it might be misinterpreted to mean that a social care practitioner may consider offering an intervention without discussing it with the service user.
To minimise confusion, use 'consider' only to show the strength of a recommendation. Avoid other possible uses of 'consider'. For example, use 'be aware of', 'explore' or similar, rather than 'consider'. Use 'take other factors into account' or similar, instead of 'consider other factors'. 'Assess' and 'think about' are other possible alternatives to 'consider'.
To emphasise the service user's role in decision-making (and, where appropriate, that of the carer, parent, guardian or advocate) and the need for them to consent to intervention, generally use verbs such as 'offer' and 'discuss' in recommendations, rather than 'prescribe' or 'give'. As described above, 'consider' is used for weaker recommendations; this implies that more discussion with the service user will be needed than a recommendation that uses, for example, 'offer'.
Use 'people' or 'service users' rather than 'individuals', 'cases' or 'subjects'. Where possible, use 'people' rather than 'patients' for people with mental health problems or chronic conditions.
The guidance document includes a standard section on person-centred care that covers informed consent and taking into account the service user's individual needs. Specific recommendations should not be made on points covered in this standard section guidance unless there are particular reasons to do so that relate to the guidance topic; for example, if there are issues relating to providing information, or to support needs, that are specific to the condition or needs covered by the guidance.
In general, follow the principles of effective writing as described in the 'Writing for NICE' booklet, available from Sola Odutola.
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 shows the strength of the recommendation.
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' (see section 9.6.4).
Avoid giving targets for the timeliness of care or services. In some cases, a recommendation will need to specify a waiting time, referral time or time of intervention because this relates to the safety or effectiveness of an intervention. In this case, ensure that the evidence and reason for specifying the time is made clear in the evidence to recommendations section of the guidance.
Do not use tables to summarise several actions in 1 recommendation. Such summaries make it more difficult to link the recommended actions to the evidence summaries.
Recommendations for social care should meet the key principles expected by NICE. They should (wherever possible) clearly detail: the intended audience for the recommendation; the intended population; the setting (if relevant); what specifically should be done; and, where relevant, what the time-frame is for doing it.
Examples are provided below of social care recommendations from a variety of sources and after these, we have suggested rewording to ensure that the recommendations meet the key principles expected by NICE for social care guidance. The reworded recommendations are solely to illustrate the principles and are not NICE guidance.
The NICE clinical guideline Dementia: supporting people with dementia and their carers in health and social care recommends:
'Health and social care staff should identify the specific 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. Care plans should record and address these needs.' [Recommendation 22.214.171.124]
To meet the requirements for NICE social care recommendations, this could be reworded as:
'Within 4 weeks of initial diagnosis, identify the specific 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.'
All recommendations for health and social care staff could then be presented together.
The Social Care Institute for Excellence's guide on Mental health service transitions for young people (accredited by NICE) states:
'It is vital that young people are fully involved in planning their transition. Planning should start in good time – at least six months in advance.'
To meet the requirements for NICE social care recommendations, this could be reworded as:
'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).'
NICE's social care guidance may cover large areas of social care. The GDG identifies a subset of these recommendations as priorities to consider for quality standard development.
Prioritised recommendations are usually those that are likely to do at least 1 of the following:
have a large effect on outcomes that are important to service users
have a large effect on reducing variation in care and outcomes
set challenging but achievable expectations of social care services
focus on key areas for quality improvement
include actions that are measurable
lead to more efficient use of public resources
promote service user choice
In addition, the GDG should try to identify recommendations that are particularly likely to benefit from adoption support. Criteria overlap with those above, but include whether a recommendation:
relates to an intervention that is not part of routine service provision
will need changes in service delivery
will need retraining of staff or the development of new skills and competencies
highlights the need for practice to change
affects, and needs to be implemented across, a number of agencies or settings (complex interactions)
may be viewed as contentious, or difficult to implement for other reasons.
There should be a clear record of which criteria were considered particularly important by the GDG for each prioritised recommendation. This should be reported in a short paragraph in the guidance.
The GDG is likely to identify areas in which there are uncertainties or specific gaps in the evidence base, or for which robust 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.
For standard social care guidance in which there may be many hundreds of uncertainties or gaps, it is not possible to document each in detail. Although GDGs could write research recommendations for dealing with each uncertainty or gap, this is not likely to be feasible. Therefore, the GDG should select key research recommendations to include in the guidance. Further information about how these should be derived can be found in the Research recommendation process and methods guide.