NICE process and methods

1 Introduction

This is not the current manual. From January 2015, guidelines were developed using Developing NICE guidelines: the manual.

The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and advice on promoting good health and preventing and treating ill health.

From 2013, NICE has an expanded remit to produce guidance and set quality standards for social care.

Further details about NICE and its work programmes are available from What we do.

1.1 NICE guidance

NICE develops guidance across several areas and on a range of topics. NICE social care guidance:

  • sets out the care and services that are suitable for most people with a specific condition or need in England

  • sets out the care and services suitable for particular groups or people in particular circumstances (for example, when being discharged from hospital)

  • aims to improve the quality of care and services

  • assesses the effectiveness and cost effectiveness of care and services to address the needs of service users

  • is developed using a process that takes account of the views of people who might be affected by the guidance[1]

  • is based on the best available evidence and expert consensus when necessary

  • is developed using recognised methods that are robust and transparent

  • is used to help develop NICE quality standards.

All types of NICE guidance are developed using the best available evidence and by involving stakeholders in a transparent and collaborative manner. Stakeholders include:

  • organisations that represent the interests of service users and carers

  • social care and health practitioner organisations

  • providers and commissioners of social care services (including service users that purchase their own care)

  • organisations that fund or carry out research in social care

  • voluntary organisations (including both those that provide services and those that represent the interests of specific populations)

  • companies that have an interest in the guidance being developed.

More information for registered stakeholders can be seen on the NICE website.

NICE operates the Social Care Guidance Programme according to its core principles. These include:

  • input from experts, service users and carers

  • transparent process and decision-making

  • consultation

  • effective dissemination and implementation

  • regular review.

1.2 Equality and social value judgements

NICE is committed to promoting equality, eliminating unlawful discrimination and actively considering the implications of its guidance for human rights. It aims to comply fully with all legal obligations to:

  • promote race and disability equality and good relations, and equality of opportunity between men and women and

  • eliminate unlawful discrimination on the grounds of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, family origin, religion or belief, gender, sex or sexual orientation in the way it carries out its functions and in its employment policies and practices.

NICE's equality scheme sets out how it is meeting its obligations on equality and discrimination. Currently, NICE's work in this area extends beyond the legal requirements: socio-economic status and specific disadvantaged or vulnerable groups are listed in recommendations, where appropriate. (For example, this could include looked-after children, asylum seekers and people who are homeless.)

All NICE guidance, and the procedures NICE uses to develop its guidance, follow the principles set out in Social value judgements: principles for the development of NICE guidance (second edition, 2008). (This publication is currently being updated to incorporate NICE's new remit for social care.)

1.3 Who this manual is for

This guidance manual explains how NICE develops and updates social care guidance. It provides advice on the technical aspects of guidance development and the methods used. It is aimed primarily at staff at the NICE Collaborating Centre for Social Care (NCCSC) and at members of the Guidance Development Groups (GDGs) that develop the individual guidance (see section 1.8.1). It is also likely to be useful and of interest to a broader audience, including developers of other guidance, such as NICE clinical guidelines or NICE public health guidance.

The advice in this manual draws on international guideline development methodology, and the experience and expertise of the teams in the Centre for Public Health Excellence and the Centre for Clinical Practice at NICE, and the National Collaborating Centres that work with NICE. It is based on internationally acceptable criteria of quality, as detailed in the appraisal of guidelines research and evaluation II (AGREE II) instrument, and adapted for use in social care guidance development. It is designed to fulfil the requirements of the NICE accreditation scheme.

The structure of this manual follows the development of NICE social care guidance from inception through to publication. The guidance development process is summarised in section 1.8.2. There is also information in section 13 on the support NICE and the NCCSC provide to help organisations use the guidance.

1.4 NICE social care guidance

There is no agreed definition of social care. However, it generally refers to all forms of personal care and other practical assistance for children, young people and adults who need extra support. This includes:

  • vulnerable children and young people (those who are at risk of, or who are already experiencing social and emotional problems)

  • children, young people and adults with learning or physical disabilities or mental health problems

  • people who misuse drugs or alcohol

  • older people.

NICE social care guidance provides a set of action-oriented recommendations, based on the best available evidence, for social care or social care services. The recommendations are relevant to service users, their families and carers, and communities. They are also relevant to social care providers, social care managers and commissioners.

Effective social care guidance will improve outcomes for service users and carers, change the process of social care provision and planning, improve social care practice and ensure efficient use of public resources. Specifically, it can be used to:

  • let service users and carers know what they should be able to expect from social care services

  • ensure that care commissioned and provided has been shown to work and be cost effective

  • increase the national consistency of social care provision

  • support the development of inter-agency and inter-professional working

  • support professional decision-making and continued professional development

  • develop standards for assessing the practice of social care practitioners and providers

  • educate and train people working in the social care sector to help service users and their carers make informed decisions

  • improve communication between service users, social care practitioners and providers.

1.4.1 Service guidance

Sometimes, social care guidance may need to focus on or include specific recommendations on, service provision. Service guidance is developed primarily for service providers and commissioners, rather than social care practitioners. It focuses on the broad configuration and provision of social care services. Generally, service guidance recommendations will fall into the following categories:

  • effectiveness of particular service models

  • timing of an intervention and referral

  • access to the service

  • competencies needed to achieve safe, effective and person-centred interventions.

1.4.2 Quality standards

Topics for new social care guidance are likely to inform the development of subsequent quality standards.

NICE quality standards are a concise set of statements designed to drive and measure priority quality improvements within a particular area of care. NICE quality standards are derived from the best available evidence, such as NICE guidance and other evidence sources accredited by NICE. They are developed independently by NICE, in collaboration with NHS and social care professionals, their partners and service users. Effectiveness, cost effectiveness, people's experience of using services, safety issues, equality and cost impact are considered during the development process.

1.5 Types of knowledge and evidence

NICE social care guidance draws on evidence and knowledge from across a spectrum of sources that use different methods and approaches. Sources include:

  • organisations

  • practitioners

  • policy makers and the wider policy context

  • research, gathered systematically with a planned design

  • service users and carers.

NICE social care guidance needs to be based on a wide variety of evidence and other forms of information (Lomas et al. 2005) (see section 4). This includes knowledge gathered using explicit, systematic and replicable research and social research methods. It also includes models, theories, expert testimony, mapping, practice reviews, consultation and practice.

NICE social care guidance is developed using methods and processes that can incorporate these different types of knowledge and evidence at various stages.

1.5.1 Best available evidence

Evidence is drawn from a range of disciplines and research models. Evidence is selected and appraised according to well-defined criteria. It is summarised according to general principles developed by NICE and using methods that are appropriate for a range of research evidence types.

The core issues are:

  • What is the most appropriate type of evidence to answer the question (see below and section 4 for further information)?

  • How can the most relevant evidence (published and unpublished) be identified (see sections 5.2-5.3)?

  • How can the quality of evidence be assessed (see section 6.2)?

  • How can evidence from different kinds of research be combined, in particular, quantitative and qualitative data (see section 6.3)?

A randomised controlled trial is normally the most appropriate study design for judging the efficacy or effectiveness of interventions. However, such studies may not always be available when evaluating the effectiveness of approaches and aspects of service delivery, and may not always report all important outcomes. In addition, because of the complexity of social care provision and the context of its delivery, the findings often have to be supplemented by data from other study designs.

To assess factors that affect effectiveness, such as acceptability to service users, it may also be necessary to consider other types of evidence, such as qualitative studies of user or practitioner views and experience.

Other evidence, including clinical and epidemiological evidence, can be used to examine outcomes, context, process and adoption (implementation), as well as barriers to and facilitators of interventions. There is little academic consensus about how best to synthesise information from different study designs or research models or about how to use the evidence synthesis to develop guidance.

It may therefore be important to consider:

  • evidence as an adjunct to studies of service effectiveness, to explore issues such as acceptability

  • evidence about the impact of context and process on effectiveness

  • underlying theories and models that may provide insight into variation in effectiveness.

For each of these, different methods of appraisal and synthesis will be appropriate.

1.6 Stakeholders

Stakeholders are central to the development of NICE social care guidance. Guidance is subject to scrutiny and validation by stakeholders throughout development to ensure the recommendations are realistic and appropriate (see sections 2.5, 2.6 and 11.1).

1.7 Quality assurance principles

In addition to the broader values outlined above, NICE social care guidance is produced in accordance with NICE's quality assurance principles, which are designed to ensure that guidance is credible, robust and relevant:

  • Guidance development processes are governed by clear, published statements of methods and process, including a standard timeline. These processes are updated at regular, predetermined intervals.

  • Guidance publications are authorised for publication by the Guidance Executive, on behalf of the NICE Board.

1.8 The development process for social care guidance

The development time for NICE social care guidance is usually around 18–24 months (from the start of scoping to publication) for standard guidance. However, there will be flexibility, depending on the size and scope of the topic.

1.8.1 Who is involved?

The key groups and individuals involved in developing social care guidance are the NCCSC, the GDG for the topic, NICE and registered stakeholders. The GDG will include social care practitioners, other professionals, service users and/or carers. The various groups are involved at different points in the process and have different responsibilities. These are described in this manual.

1.8.2 Summary of the social care guidance development process

Social care guidance topics are referred from the Department of Health, and the Department for Education for topics related to children or young people. The key stages in the development of NICE social care guidance are summarised in figure 1.

Figure 1 Key stages in the development of NICE social care guidance

Figure 1 Key stages in the development of NICE social care guidance

1.8.3 Publication and adoption of social care guidance

Social care guidance is published in a range of digital formats, including the web format and NICE Pathways.

The web format contains links to the background and evidence for the guidance.

Social care guidance will also appear in many NICE Pathways. This practical online resource brings together all relevant NICE guidance on a given topic, with links to adoption tools and to related NICE guidance and other pathways.

The tools produced by NICE and the NCCSC are intended to help people put the guidance into practice. This may include communities, service users and their families and carers, as well as social care providers, social care managers and commissioners. (See section 13 for information about the support available to help adopt the recommendations.)

All versions of social care guidance, and the associated adoption tools, are published on the NICE website.

1.8.4 Practical information

As it becomes available, the following information about each piece of social care guidance is published on the NICE website:

  • a list of registered stakeholders

  • contact details of the NCCSC

  • details of the NICE project team

  • members of the GDG

  • a schedule for development of the guidance

  • the consultation draft of the scope

  • the final scope

  • the Equality Impact Assessment forms for the guidance (completed at the scoping stage and before the guidance is signed off by NICE)

  • a table of stakeholder comments on the consultation draft of the scope and responses

  • project history and information on progress of the guidance

  • economics plan, review protocols and search strategies

  • the consultation draft of the guidance

  • a table of stakeholder comments on the consultation draft of the guidance and responses

  • the published guidance and pathway

  • details of related NICE guidance

  • tools to support adoption of the guidance.

1.9 Updating the social care guidance manual

The social care guidance manual will be reviewed by NICE in accordance with internal processes and timescales. This includes the planned development of an integrated manual for all guidance development across NICE (scheduled for late 2013/14). The processes for social care guidance will need to be updated in line with any changes to the interim manual or the future integrated manual.

We welcome comments on the content of this manual and suggested subjects for inclusion. These should be addressed to:

1.9.1 Interim updates

In some situations, it may be necessary to make small changes to the social care guidance development process before a formal update is due. These may be either minor insubstantial changes ('bug fixes') or more significant changes for which formal consultation with stakeholders is necessary. For small changes to be put in place without stakeholder consultation, they must fulfil all of the following criteria:

  • no fundamental stage in the process is added or removed

  • no fundamental method, technique or step is either added or removed

  • no stakeholders will obviously be disadvantaged

  • the efficiency, clarity or fairness of the process or methodology will be improved.

Changes that meet all of these criteria will be published on the NICE website. The manual will be updated, and changes from the previous version of the manual will be listed. Stakeholders in social care guidance under development at the time of the change will be notified if they are affected by the change. Stakeholders in newly commissioned guidance will be advised to consult the website at the start of the project to familiarise themselves with the updated development process.

1.10 References and further reading

Lomas J, Culyer T, McCutcheon C et al. (2005) Conceptualizing and combining evidence for health system guidance: final report. Ottawa: Canadian Health Services Research Foundation

Pawson R (2006) Evidence based policy: a realist perspective. London: Sage

[1] People who might be affected by the guidance include social care practitioners and providers, healthcare and other professionals, service users and their carers and families, social care service managers, local authorities, the public, government bodies and suppliers of social care services, including voluntary and commercial organisations.