NICE process and methods

7 Developing recommendations

7.1 Introduction

Developing recommendations is at the heart of the work of the public health advisory committees (PHAC). It is not a straightforward task and it may not always be easy to reach agreement.

It is vital to ensure the recommendations:

  • are informed by the most appropriate and available evidence (both scientific and other evidence)

  • are set in a framework that acknowledges a range of social value judgements (see Social value judgements: principles for the development of NICE guidance)

  • take account of relevant theories of public health and behaviour change

  • reflect the views and experiences of both those being advised to take action (for example, healthcare professionals or teachers) and the people who might be affected by that action (the target population and their families or carers)

  • are clear

  • are practical (that is, they can be implemented).

This chapter describes the stages involved in creating clear, practical recommendations:

  • Considering the evidence and other factors.

  • Creating the format and wording of recommendations.

  • Revising the recommendations following consultation with stakeholders.

  • Developing considerations.

  • Equality and diversity.

  • Formulating research recommendations.

7.2 Considering the evidence and other issues

Recommendations are developed using a range of scientific evidence (section 3.2.1) and other evidence – such as expert testimony, stakeholder and practitioner views, committee discussions and debate (see chapter 3).

The evidence may be assessed for validity, reliability and bias, however evidence is not the sole determinant of the content of recommendations. It requires interpretation, especially an assessment of its implicit and explicit value base. It also needs to be assessed in light of the conceptual framework for public health (appendix A) and theories relating to individual and organisational behaviour change.

The PHAC's 'considered judgement' should take account of a range of issues (including any ethical issues and social value judgements) and policy imperatives, as well as equality and diversity legislation (see chapter 1) to ensure the recommendations are ethical, practical and specific. There are no hard-and-fast rules or mechanisms for doing this: the PHAC should make conscious and explicit use of its members' skills and expertise to make assumptions and apply inductive and deductive reasoning.

The PHAC, with support from the Centre for Public Health Excellence (CPHE) project team, should examine the evidence and related documents and discuss whether or not they address the issues under consideration. They should focus on the decision which needs to be made and the recommendations that are required, as well as the research questions used for the NICE evidence reviews and the key questions from the scope. (This should be documented in the minutes – see The NICE public health guidance development process [third edition, 2012]. for more detail on minutes.) To do this, it should consider the following issues (these are not in hierarchal order).

7.2.1 Strength (type, quality, quantity and consistency) of the evidence

Statistical and methodological issues and the study types available should all be taken into account, along with the degree of bias in the findings. The evidence statements (see section 5.5) will describe the number, type and quality of studies and summarise the strength of evidence. The PHAC should agree that this is a fair summary of the evidence and be mindful that the strongest available evidence does not necessarily translate to important areas for action. The impact of the potential benefits and harms also needs to be taken into account (see sections 7.2.4 to 7.2.6).

Members may want to discuss any inconsistencies in the findings (different studies may relate to slightly different interventions, populations or settings). In addition, they should use the NICE conceptual framework for public health (appendix A) to identify which causation vectors are applicable. (See also chapter 2.)

7.2.2 Applicability of evidence to the target populations and settings

The evidence statements conclude with a summary statement on applicability. This describes the evidence as 'directly', 'partially' or 'not applicable' and why. The PHAC should reach its own conclusion, based on its members knowledge, experience and understanding of the target populations. They may choose to make a recommendation on evidence that is weaker, but more applicable, than stronger evidence from another context. (For more detail on the assessing applicability, see section 5.6.)

7.2.3 Availability of evidence to support implementation – including evidence from practice

The PHAC should assess the extent to which the available evidence is about efficacy, effectiveness or both. Often the distinction between the 2 is not made clear in reports of public health interventions, not least because the number of efficacy studies is relatively small (compared to clinical studies).

The PHAC should also judge whether or not it will be possible to put the recommendations into practice. They can decide by using expert testimony, by drawing on their own experience or on information from fieldwork in cases where this has been conducted. They may also be able to draw on qualitative studies from the reviews or other forms of evidence relating to organisational and political processes.

In addition, the PHAC should assess the degree of change in practice required, staff training needs, policy levers and funding streams.

7.2.4 Relative value of the outcomes (including impact on inequalities)

The PHAC should 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. As discussed in chapter 1, NICE has a duty to comply with current Equality legislation (Equality Act 2010) in addition to taking into account additional important considerations about health inequalities.

7.2.5 Trade-off between harms and benefits

Where possible, the PHAC should assess any potentially negative effects and whether these are offset by the anticipated benefits.

7.2.6 Size of effect and potential impact on individual and population health (if applicable)

The PHAC should consider whether it is possible to anticipate effect sizes at individual or population-level. If this is the case, it will be important to consider effect sizes along the whole causal chain, not just at the end points. This may be difficult because of the current state of the evidence.

7.2.7 Cost effectiveness

The PHAC should consider cost-effectiveness evidence and the economic models (see chapter 6).

7.2.8 Target groups

The PHAC should assess the particular characteristics of the target group, paying attention to social differences (including class, gender, ethnicity, disability, culture and sexual orientation). It should assess how these characteristics will impact on the effectiveness of interventions. For specific information relating to equality and diversity, see section 7.7.

7.2.9 Philosophical basis for making recommendations

All evidence requires interpretation, based on past experience, as 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 Social value judgements: principles for the development of NICE guidance explicitly acknowledges 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 advisory committee may also draw upon the principles outlined in the Nuffield Committee on Bioethics report on public health when making its judgements[9].

The PHAC should make explicit the kinds of interpretive methods they are using during the inferential and judgemental process (Kelly and Moore 2012).

7.2.10 Conceptual framework and logic model

When the advisory committee is developing its recommendations, it should keep in mind the overarching conceptual framework, how it applies to the topic in question and the resulting logic models. This will help to clarify the practical issues involved in bridging the gaps between the evidence and producing a recommendation. It will also demonstrate how evidence drawn from the organisational and political sciences can help inform the decision- making process. (See appendix A.)

7.2.11 Additional documents

In addition to the NICE evidence review(s) (particularly the evidence statements and the economic analysis and modelling), other documents available to help the PHAC develop recommendations include (not in hierarchical order):

  • the scope

  • related NICE guidance

  • policy reports and guidance produced by other organisations

  • position papers on current practice

  • evidence (including practice-based evidence) and opinions from expert witnesses

  • evidence reviews about the views and experiences of the target population

  • stakeholder comments on the draft recommendations

  • fieldwork report (if fieldwork was required)

  • any documents that help members consider equity issues – such as NICE's documentation on its responsibilities in relation to equalities legislation (The equality scheme and action plan for implementation).

7.2.12 Challenges

Table 7.1 summarises the challenges that may arise during the deliberations – and possible approaches to overcoming them. In each case, the PHAC will need to make its approach explicit in the 'Considerations' section of the guidance, stating the basis for its decision(s) and the assumption(s) made (see section 7.6).

Table 7.1 Interpreting the evidence: possible challenges and ways to overcome them


Possible approach

No evidence, weak evidence or it is only partially applicable

Consider the 'direction of travel' of the evidence available. Make a tentative recommendation and develop a 'consideration' that explains why weak or partially applicable evidence has been used.

Consider evidence from practice (see below).

Only evidence of a similar type and quality is available and the findings conflict (inconsistent or mixed evidence)

Consider the reasons for conflict. For example, if this is because different groups of people might respond differently to an intervention or programme, consider making recommendations for specific groups.

Identify studies that are most applicable to the target population and setting and, where appropriate, use them as a basis for recommendations.

Evidence not directly applicable to the target population (for example, it covers a different age group)

Consider the degree to which the findings can be extrapolated to the target population. For example, this may be possible if it is high quality evidence drawn from a largely similar but different population group.

Evidence conflicts with existing government policy or NICE guidance

Consider the reason(s) for conflict. For example, was the policy or guidance evidence-based? Has the evidence changed substantially since the policy or guidance was developed? Were the goals or intentions of the policy or guidance different?

The CPHE project team may be able to discuss the conflict(s) with the relevant policy guidance team, as necessary, to help resolve this issue. However, be mindful that this latest NICE guidance might directly inform changes in government policy or supersede previous NICE guidance.

Limited information on cost effectiveness

For recommendations that are likely to have a significant resource impact,

consider using economic modelling to develop an estimate of cost effectiveness.

Unclear how to make best use of the different types of evidence from practice (including evidence provided by committee members, expert witnesses, stakeholders and the target population)

Consider how evidence from practice can help answer the key questions.

Consider what weight should be given to evidence from practice compared to evidence from the NICE evidence reviews.

Consider how evidence from practice can:

1) support the NICE evidence reviews of effectiveness and cost effectiveness and
2) address gaps in the evidence on effectiveness and cost effectiveness.

Consider whether it is possible to record the conclusions drawn from practice in a consistent and transparent way. Specifically, can the conclusions be developed into evidence statements and discussed in the considerations section of the guidance?

7.2.13 The process in practice

As soon as members have discussed the findings of a NICE evidence review (or any expert testimony), the PHAC should start drafting recommendations. This is an iterative process; the recommendations are likely to be revised on a number of occasions before the wording is finalised.

First, the PHAC should decide what they want to recommend and which sectors (including which professionals in those sectors) should act on the recommendations. (As an example, the recommendations could be aimed at practitioners in the NHS, schools, workplaces or local authorities.)

In the early stages, it can be helpful to work in small groups, supported by the CPHE project team and using sample templates. It may also help if the CPHE project team develops a first draft of the recommendations as a starting point for discussion, based on the PHAC's initial deliberations as a group. However they are developed, the CPHE project team should ensure the draft recommendations are clearly linked to evidence statements.

Between the PHAC meetings, the nuances of the words can be refined via email discussions among members (again, supported by the CPHE project team). (See The NICE public health guidance development process third edition 2012, for terms of reference and the standing orders that define quoracy for advisory committees.)

The recommendations may be prioritised (see section 7.8).

Where evidence on effectiveness or cost effectiveness is lacking or conflicting, the PHAC may decide that further research should be a condition for implementation.

Decisions can be made using a variety of approaches: discussion, informal or formal consensus or formal voting (for example, in instances when 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 'Considerations' section of the guidance (see section 7.5).

7.3 Format and wording of recommendations

Writing the recommendations is 1 of the most important and difficult steps in developing guidance. Great care should be taken. Each recommendation should answer the reader's main question: 'What does this mean for me?' In addition, it should clearly specify the intervention or action to be taken (what, how often and for how long?) and the context or circumstances (where and when?).

The wording must be concise and unambiguous so that the target audience knows what to do in practice and the public know what is being recommended. The CPHE project team should ensure that the PHAC is supplied with a copy of the booklet 'Writing for NICE'.

7.3.1 Format of recommendations

The recommendations are grouped under 3 main headings as below.

Whose health will benefit from the recommendation?

All those who will be affected by the recommendation. This may include:

  • individuals

  • communities or families

  • larger population groups defined by a range of factors (for example, by age, gender, ethnicity, setting).

Who should take action?

The professionals and others who should take action, these may be:

  • practitioners

  • commissioners

  • policy makers

  • researchers.

They may be subdivided by sector and setting, for example:

  • NHS

  • other public sector bodies (government, government agencies and local government, arm's length bodies, armed forces, prisons, police service, education)

  • private and voluntary organisations (large, medium and small).

They may refer to specific job titles, such as:

  • teachers

  • GPs.

Ensure those taking action are listed by type of organisation or by job title, do not mix organisations and job titles in the same list.

What action should they take?

Actions should be as specific as possible, although how prescriptive they are will be decided on a case-by-case basis and will depend on the evidence available. They may cover:

  • strategy, policy and planning

  • service management and delivery

  • individual practice

  • research priorities.

7.3.2 Wording of recommendations

Each recommendation should:

  • Stand alone and be understood without reference to supporting material (supporting information can be included in the 'Considerations' section of the guidance or as part of the implementation materials).

  • Be as specific as possible about the action and who should take it (the ability to check whether it is being implemented properly [audit] should be considered when finalising the wording).

  • Only contain 1 main action in each bullet point.

  • Provide a clear link to the supporting evidence statements and evidence reviews, preferably with a numeric reference (to review number and evidence statement number).

  • Avoid, wherever possible, terminology and jargon – where this is not possible, it needs to be clearly defined and unambiguous (NICE can advise on this and also give you a copy of the 'Writing for NICE' guide).

  • Avoid trade names. Any reference to products (for example, pedometers) and services (for example, slimming clubs) should be made in general terms to avoid giving the impression that NICE endorses a particular brand.

  • Avoid implying that interventions or actions should be 'done' to people (that is, use 'offer' and 'discuss' rather than 'prescribe' or 'give', also avoid 'subjects' and 'cases' – use 'people', 'patients', 'clients' or 'service users' instead).

  • Avoid labelling people (that is, don't describe someone as a 'drug user' or 'smoker', use instead, 'someone who takes drugs or who smokes').

  • Acknowledge the role of individuals, service users, clients or members of the public who are directly affected by the recommendations or the organisations that represent them in any decision-making.

  • Include cross-references to recommendations from other NICE guidance to avoid the need to repeat information. It should be clear where the recommendations come from (refer to the guidance template for instructions). Recommendations from other NICE guidance or NHS policy can be quoted verbatim (as appropriate).

  • Recommendations from other (non-NICE) guidance should not be quoted verbatim.

7.3.3 Reflecting the strength of recommendations

NICE's public health recommendations are not graded, but the PHAC's view of how important they are should be clear from the wording (see table 7.2). The importance of a recommendation should not necessarily reflect the strength of the evidence available to support it. Other important factors (for example, ethics, principles, potential outcomes and equality issues) all need to be considered by the PHAC (see sections 7.2.1 to 7.2.11).

Table 7.2 Reflecting the strength of recommendations

Level of certainty


Actions that must be taken

Use 'must' only if the recommendation links to enforceable legislation (such as health and safety regulations), or there will be serious repercussions if the recommendation is not followed. In such a case, a clear rationale for using 'must' should be set out and discussed with the CPHE director.

Actions that should be taken

Use this type of wording if the action will do more good than harm and is likely to be cost effective.

Word recommendations of this type as direct instructions using verbs such as 'offer', 'assess', 'refer'.

If these recommendations refer to all people and situations (where the evidence is clear and uncontested) they should be worded, 'always do this'. They can include caveats (where the evidence is less clear or mixed) such as, 'do this when'.

Example (from Skin cancer prevention: information, resources and environmental changes [Public health guidance, NICE 2011]):

  • Commissioners, organisers and planners of national, mass-media skin cancer prevention campaigns should:

    • continue to develop, deliver and sustain these campaigns to raise awareness of the risk of UV exposure and ways of protecting against it

    • try to integrate campaign messages within existing national health promotion programmes or services to keep costs as low as possible (Sure Start is an example of an initiative where they could be integrated)

    • evaluate the impact using a range of knowledge, attitudes, awareness and behavioural measures.

Actions that could be taken

Use this type of wording if the action is effective or cost effective, but other options may be similarly effective or cost effective. Or the choice of action (or the decision whether to act at all) is likely to vary depending on the client's values and preferences.

Word recommendations of this type as direct instructions (if possible), but add 'consider' or 'could'– for example, 'consider referring'.

Example (from Prevention of sexually transmitted infections and under 18 conceptions [Public health guidance, NICE 2007]):

Identify individuals at high risk of STIs using their sexual history. Opportunities for risk assessment may arise during consultations on contraception, pregnancy or abortion, and when carrying out a cervical smear test, offering an STI test or providing travel immunisation. Risk assessment could also be carried out during routine care or when a new patient registers.

In exceptional circumstances, the committee or group may consider making 'only in research' recommendations.

Actions that should not be taken

State explicitly if a particular action should not be carried out or should be stopped (because, for example, it is ineffective or not cost effective).

Example (from Smoking cessation services [Public health guidance, NICE 2008]):

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.

7.4 NICE documents

The public health guidance issued by NICE will take 2 formats:

  • The guidance: Available online in web format, the NICE guidance lists all the recommendations, with details of how they were developed and evidence statements. It contains clear links to other NICE products to support the implementation of the recommendation.

  • NICE pathways: NICE pathways are a practical online resource for healthcare professionals to use on a day-to-day basis. A pathway presents recommendations from the guidance in a set of interactive topic-based diagrams. It contains all the recommendations from and links to related NICE guidance and other NICE products (for example, relevant quality standards and implementation tools).

7.5 Revisions following stakeholder consultation

Once the PHAC has agreed the content of the guidance and draft recommendations have been constructed, a stakeholder consultation is conducted on the full draft guidance. The stakeholder consultation is described in The NICE public health guidance development process (third edition 2012). Stakeholders will review and comment on the full draft guidance. Registered stakeholders normally include professional organisations and statutory agencies representing practitioners, as well as voluntary organisations run by, or representing the interests of, the target populations. The CPHE project team should prepare a summary of stakeholder responses.

7.5.1 Fieldwork

In addition to stakeholder consultation, draft recommendations may, on occasion, be tested with key groups of practitioners or policy makers. This activity is referred to as 'Fieldwork'. Fieldwork is carried out on an exceptional basis for public health guidance in new or sensitive areas, and not as a matter of routine on all guidance. Often, particularly for those topics where there is already related NICE guidance, fieldwork findings add little to the insights generated by the consultation with stakeholders. Nevertheless, for areas where NICE does not yet have good links with key practitioners and stakeholder groups it can be a valuable part of the process. Exceptions would include occasions when NICE develops public health guidance in a new or (scientifically or politically) controversial topic area. For an exception to be made, the CPHE team will need to put the case for fieldwork to the centre director for approval.

During fieldwork, the draft recommendations are tested with policy makers, commissioners and practitioners to see how easy they are to implement. Appendix M provides a detailed overview of the fieldwork methods and process.

If fieldwork has been conducted (see appendix M), a summary of the information collected and any key implications for the recommendations are presented as a fieldwork report to the PHAC.

The CPHE project team may also occasionally commission separate work to test out the draft recommendations directly with the target population (see chapter 3 for details).

7.5.2 PHAC meeting following stakeholder consultation

The PHAC meets to review the evidence in light of stakeholder responses, revise the recommendations (if necessary) and finalise the guidance. It uses the following documents:

  • summary of stakeholder responses to the guidance consultation

  • summary of how stakeholder responses impact on the draft recommendations (as necessary)

  • report on direct consultation with the target population (if conducted)

  • equality and diversity assessment carried out on the draft recommendations (see section 7.7)

  • fieldwork report (if applicable) including any impact on the draft recommendations.

If it appears from the consultation (or fieldwork) that professionals or others (as appropriate) do not endorse a recommendation, the PHAC should consider:

  • the possible reason(s) (for example, they may have concerns over training issues or capacity)

  • whether to amend the recommendation or associated recommendations to support implementation.

7.6 Considerations

The 'Considerations' section of the guidance should clearly illustrate the range of issues the PHAC has considered in developing the recommendations. It should also make explicit the criteria used to create and prioritise them.

This section can be developed using the issues and documents listed in section 7.2, the minutes from all its meetings (including any subgroup meetings) and records of any email discussions.

The following information may be included:

  • How the evidence statements were developed into recommendations – such as detail on the decisions made in relation to issues raised in table 7.1 and, in particular, on the strength and applicability of the evidence available.

  • How recommendations were prioritised – for example, whether this was based on the strength of evidence or policy imperatives.

  • The rationale for making recommendations that do not answer the key questions in the scope.

  • The rationale for making recommendations where there is a lack of evidence of effectiveness or cost effectiveness.

  • How evidence from practice was defined and the relative weight it was given compared to the evidence of effectiveness or cost effectiveness.

  • Testimony from expert witnesses.

  • Key facts for example, in relation to legislation, policy, funding and organisational issues.

  • Issues outside the remit of the guidance – to re-emphasise them.

  • Evidence not considered due to its quality or focus or due to time constraints.

  • The 'Considerations' section should not include any text that could be construed as a recommendation. However, where considerations correspond directly with groups of recommendations they should be grouped under the same sub-headings.

The considerations section may be used to point out where the PHAC would have liked to have made a recommendation but felt that there was insufficient evidence or lack of a rationale for doing so.

7.7 Equality and diversity

The following 2 questions should be addressed when assessing recommendations in line with equality and diversity legislation:

  • Does the guidance avoid unlawful discrimination?

  • Are there ways in which the guidance could better promote equality?

Equality issues are considered during the standard guidance development process and it is likely that many will have been considered during the PHAC's deliberations. These should be recorded in the 'Considerations' section of the guidance. (Where a direction suggested by the evidence has been altered in the interests of promoting equality, this should also be recorded.)

Recommendations should be formally assessed against equality considerations after the draft guidance has been issued for consultation. The findings should be considered by the PHAC when it reviews stakeholder comments (and fieldwork, if applicable).

To avoid unlawful discrimination, 4 issues are considered:

  • whether specific groups may be denied access to an intervention

  • whether specific groups will, in practice, find it more or less easy to access the intervention

  • whether any assessment needed to access the intervention will make it more or less difficult for specific groups to gain access

  • whether any features make it impossible or unreasonably difficult for people with disabilities to access the intervention.

In addition, the assessment checks whether stakeholders have raised any areas of possible discrimination.

Ideally, opportunities to promote equality will have been maximised during development of the draft recommendations. Nevertheless, after the consultation the PHAC should reconsider the draft recommendations specifically from this perspective: would, for example, changes to the wording (or the deletion of a recommendation or inclusion of new ones) further promote equality?

Suggested changes to the recommendations should be recorded and presented to the PHAC, together with stakeholder comments (and fieldwork, if applicable) on the draft guidance. Decisions on these issues should also be noted in the minutes of the relevant committee meetings.

7.8 Formulating research recommendations

Research recommendations provide an opportunity to highlight how the public health evidence base can be improved. More important, they ensure CPHE has access to the best possible evidence when the relevant guidance is being revised.

Research recommendations are a set of specific questions that aim to gather new evidence or strengthen the existing knowledge base, where it was previously equivocal. Recommendations to conduct both primary and secondary research (for example, systematic reviews) can be made.

The recommendations are drawn from a broader set of 'gaps in the evidence' and areas for further research that should be listed in an appendix to the guidance. These may have arisen out of the original evidence reviews or through general discussion at meetings.

This section provides a framework for formulating and prioritising research recommendations.

7.8.1 Principles for formulating research recommendations

There will probably be a large number of potential research recommendations. They can cover questions about effectiveness, implementation, acceptability, feasibility and costs.

Each research recommendation should be formulated as 1 question or as a set of closely related questions. It should consider the importance of issues relating to equality and diversity (for example, gender, ethnicity and people with special needs) and take into account the criteria set out in table 7.3 Each recommendation should also be evaluated and prioritised according to these criteria and this information should be presented as an appendix.

Only high-priority research recommendations should be included in the guidance.

7.8.2 Developing research recommendations

The PHACs should develop a maximum of 6 research recommendations. A research recommendation has 2 components: a well-formulated, answerable question (see below) and where appropriate a statement about the importance of the recommended research (see table 7.4).

It should comprise a question with explanatory text of not more than 150 words. See below for an example from Brief interventions and referral for smoking cessation in primary care and other settings (Public health guidance, NICE 2006).


Which brief interventions are most cost effective for increasing smoking cessation among lower socioeconomic and vulnerable groups?

Explanatory paragraph:

Smoking remains the leading cause of preventable morbidity and premature mortality in England, causing an estimated annual average of 86,500 deaths between 1998 and 2002. There is a clear social class gradient in smoking and it accounts for over half of the difference in risk of premature death between social classes. Smoking prevalence remains worryingly high in some groups. Vulnerable groups in society are the groups most likely to bear the burden of ill health and have the fewest resources with which to cope.

Alternatively, it may take the form of a recommendation that will answer: 'who should take action?' (for example, the Medical Research Council); and 'what action should they take?' (for example, to ensure certain outcome measures are used in studies that it funds in a particular topic area). If more than 1 organisation and 1 action is involved, these should be broken down into a bullet point list under the 2 headings.

Table 7.3 Checklist for formulating research questions about interventions using the population, intervention, comparison and outcome (PICO) model

PICO is a widely used mnemonic summarising the 4 major components of a research question about an intervention: patient (population), intervention, comparison and outcome (see table below).

Population or problem

What is the primary problem, disease or condition you are interested in? What are the most important characteristics of the population to be studied?


  • determinants of health, health status

  • gender, age, ethnic group, specific exclusions

  • setting.

Intervention or indicator

Which main intervention are you considering? What determinants of risk are important?


  • type, frequency, duration (for intervention or exposure).

Comparison or control

What is the main alternative(s) or control to compare with the intervention?


  • all the parameters mentioned above, where applicable.


What will the researcher need to measure, improve, influence or accomplish? What intervention outcomes should be measured?


  • outcomes to be measured (for example, mortality, morbidity, quality of life, intermediate outcomes, health promotion)

  • method of measurement (type, frequency or timing)

  • the need for blinding of target populations, provider or outcome assessor.

7.8.3 Why is this question important?

The PHAC should draft a paragraph explaining the need for research following the process set out in the NICE research recommendations process and methods guide to ensure that: the process of developing the research recommendations is robust, transparent and that significant research priorities are identified

The NICE research recommendations process and methods guide describes a step-by-step approach to identifying uncertainties, formulating research recommendations and research questions, prioritising them and communicating them to the NICE Research and Development (R&D) team and researchers and funders.

Table 7.4 Research priorities

1. Relevance to NICE

How would the research change future NICE guidance?

2. Importance to the population

What would be the impact of any new or amended guidance? (For example, on quality of life, morbidity or disease prevalence, severity or mortality).

3. Relevance to the NHS and the public sector

What would be the impact of any new or amended guidance – on the NHS and the public sector? (For example, financial advantages, effect on staff, impact on strategic planning or service delivery).

4. National priorities

Is the question relevant to a national public health priority area (such as Public Health Outcomes Framework 2012 or Healthy Lives Healthy People [Department of Health DH 2011])? Specify the relevant document.

5. Lack of evidence

How much research has been carried out in this area? What are the problems, if any, with previous research? Provide details of any previous systematic review.

6. Feasibility

Can it be carried out in a realistic timescale and at an acceptable cost?

7. Other comments

Mention any other important issues, such as potential funders, or the outcome of previous attempts to address this issue. However, remember that this is not a research protocol.

All proposed research recommendations should be included in the draft guidance that is made available for stakeholder consultation. Following consultation, the PHAC will take account of any concerns raised by stakeholders and they will be amended as appropriate. Draft research recommendations will be finalised post consultation. All the research recommendations contained in the guidance are added to a database on the NICE website. Those classed as high priority are highlighted. High-priority research recommendations are put through a second prioritisation process at NICE.

7.8.4 Other research recommendations

Important research recommendations that fall outside the scope of the guidance are communicated to research and development funders such as:

  • National Institute for Health Research (NIHR) Public Health Research Programme

  • NIHR Health Technology Assessment Programme

  • NIHR Health Services and Delivery Research Programme

  • Medical Research Council (MRC)

  • Economic and Social Research Council (ESRC)

  • DH Policy Research Programme (PRP).

7.8.5 Equality and diversity

Research recommendations should aim to address any gaps in the evidence base in relation to the groups identified in the Equality Act (2010) (or groups who are particularly disadvantaged with respect to the topic under consideration).

7.9 Further reading

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

Kelly MP,Moore TA (2012) The judgement process in evidence-based medicine and health technology assessment. Social Theory and Health, 10:1-19.i:10.1057/sth.2011.21

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

Research recommendation manual, National Institute for Clinical Excellence (2011)

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

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

Schunemann HJ, Best D, Vist G et al. (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 (2002) SIGN 50. A guideline developer's handbook. 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 (4): 380–90

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