Developing NICE guidelines: the manual

 

 

Process and methods guides

Developing NICE guidelines: the
manual

Developing NICE guidelines: the manual. October 2014

Contents

1

2

Introduction and overview ……………………………………………………………………….. 1
1.1 NICE guidelines ……………………………………………………………………………….. 1
1.2
Information about this manual …………………………………………………………….. 2
1.3 Choice of guideline topics ………………………………………………………………….. 4
1.4 Key principles for developing guidelines ………………………………………………. 4
1.5 Who is involved ………………………………………………………………………………… 7
1.6 Main stages of guideline development ……………………………………………….. 12
1.7 Publication and implementation of the guideline ………………………………….. 14
1.8 Updating this manual ………………………………………………………………………. 14
1.9 References and further reading…………………………………………………………. 15
The scope …………………………………………………………………………………………… 18
2.1 Purpose of the scope ………………………………………………………………………. 18
2.2 Who is involved in developing the scope ……………………………………………. 19
2.3 Stages of scope development …………………………………………………………… 19
2.4 Amending the final scope after publication on the NICE website ……………. 32
2.5 References and further reading…………………………………………………………. 32
3 Decision-making Committees…………………………………………………………………. 33
3.1
Introduction ……………………………………………………………………………………. 33
3.2 Forming the Committee ……………………………………………………………………. 35
3.3 Standing Committees ………………………………………………………………………. 36
3.4 Topic-specific Committees ……………………………………………………………….. 38
3.5 Other attendees at Committee meetings …………………………………………….. 40
3.6 Code of conduct and declaration of interests ………………………………………. 42
3.7
Identifying and meeting training needs of Committee members……………… 43
3.8 Committee meetings ……………………………………………………………………….. 45
3.9 Making group decisions and reaching consensus ………………………………… 49
3.10 References and further reading ……………………………………………………… 50
4 Developing review questions and planning the evidence review………………….. 52
4.1 Number of review questions ……………………………………………………………… 52
4.2 Developing review questions from the scope ………………………………………. 53
4.3 Formulating and structuring different review questions …………………………. 53
4.4 Evidence used to inform recommendations ………………………………………… 67
4.5 Planning the evidence review……………………………………………………………. 72
4.6 References and further reading…………………………………………………………. 74
Identifying the evidence: literature searching and evidence submission ……….. 77
5.1
Introduction ……………………………………………………………………………………. 77
5.2 Search protocols …………………………………………………………………………….. 78
5.3 Sources …………………………………………………………………………………………. 78
5.4 Developing search strategies ……………………………………………………………. 79
5.5 Calls for evidence from stakeholders …………………………………………………. 82
5.6 Health inequalities and equality and diversity ……………………………………… 85
5.7 Quality assurance …………………………………………………………………………… 85
5.8 Reference management …………………………………………………………………… 85
5.9 Documenting the search ………………………………………………………………….. 85
5.10 Re-running searches…………………………………………………………………….. 86
5.11 References and further reading ……………………………………………………… 86
6 Reviewing research evidence ………………………………………………………………… 89

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Developing NICE guidelines: the manual. October 2014

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181

6.1 Selecting relevant evidence ……………………………………………………………… 89
6.2 Assessing the quality of the evidence ………………………………………………… 92
6.3 Equality and diversity considerations …………………………………………………. 97
6.4 Presenting and summarising evidence ………………………………………………. 98
6.5 References and further reading……………………………………………………….. 114
Incorporating economic evaluation………………………………………………………… 120
7.1
Introduction ………………………………………………………………………………….. 120
7.2 The role of economics in guideline development ……………………………….. 120
7.3 The reference case ……………………………………………………………………….. 121
7.4 Reviewing economic evaluations …………………………………………………….. 127
7.5 Prioritising questions for further economic analysis ……………………………. 130
7.6 Approaches to bespoke economic evaluation ……………………………………. 131
7.7 Using economic evidence to formulate guideline recommendations ……… 144
7.8 References and further reading……………………………………………………….. 149
Linking to other guidance …………………………………………………………………….. 151
8.1 Linking to other NICE guidance……………………………………………………….. 151
8.2 Guidance from other developers ……………………………………………………… 162
8.3 References and further reading……………………………………………………….. 163
9 Developing and wording recommendations and writing the guideline …………. 164
9.1
Interpreting the evidence to make recommendations………………………….. 165
9.2 Wording the recommendations ……………………………………………………….. 172
9.3 Highlighting areas for future consideration in quality standard development

9.4 Highlighting recommendations for implementation support ………………….. 182
9.5 Formulating research recommendations …………………………………………… 182
9.6 References and further reading……………………………………………………….. 184
10
The validation process for draft guidelines, and dealing with stakeholder
comments ………………………………………………………………………………………………… 186
10.1 What happens during consultation ………………………………………………… 186
Principles of responding to stakeholder comments ………………………….. 189
10.2
10.3 When a second consultation may be needed …………………………………. 191
Finalising and publishing the guideline ……………………………………………….. 192
11.1 Quality assurance of the guideline ………………………………………………… 192
Signing off the guideline………………………………………………………………. 192
11.2
11.3 Releasing an advance copy to stakeholders…………………………………… 193
Publication ………………………………………………………………………………… 193
11.4
Launching and promoting the guideline …………………………………………. 193
11.5
Resources to support implementation ………………………………………………… 196
12.1
Introduction ……………………………………………………………………………….. 196
12.2 Routine guideline implementation tools …………………………………………. 196
Additional tools and activities in conjunction with partners………………… 197
12.3
12.4 Other NICE implementation support ……………………………………………… 198
12.5 References and further reading ……………………………………………………. 198
Ensuring that published guidelines are current and accurate …………………. 200
13.1 Checking that published guidelines are current ………………………………. 200
13.2 Deciding whether an update of a guideline is needed ……………………… 204
13.3
The ‘static list’ ……………………………………………………………………………. 207
13.4 Withdrawing the guideline ……………………………………………………………. 208
Exceptional updates……………………………………………………………………. 208
13.5
Updating guidelines …………………………………………………………………………. 209

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12

14

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Developing NICE guidelines: the manual. October 2014

Scheduling updates ……………………………………………………………………. 209
14.1
Full updates of guidelines ……………………………………………………………. 209
14.2
14.3
Partial updates of guidelines ………………………………………………………… 209
14.4 Refreshing the guideline ……………………………………………………………… 210
Presenting updates …………………………………………………………………….. 211
14.5
14.6
Post-publication changes …………………………………………………………….. 212
14.7 References and further reading ……………………………………………………. 213
Glossary ………………………………………………………………………………………………….. 215
About this manual……………………………………………………………………………………… 236

Developing NICE guidelines: the manual. October 2014

1

Introduction and overview

The National Institute for Health and Care Excellence (NICE) is an independent

public body that provides national guidance and advice to improve health and social

care in England. NICE guidance offers evidence-based recommendations made by

independent Committees on a broad range of topics. This manual explains the

processes and methods used to develop and update NICE guidelines. For more

information on the other types of NICE guidance and advice (including technology

appraisal guidance), see About NICE on the NICE website.

1.1

NICE guidelines

NICE guidelines make evidence-based recommendations on a wide range of topics,

from preventing and managing specific conditions, improving health, and managing

medicines in different settings, to providing social care and support to adults and

children, safe staffing, and planning broader services and interventions to improve

the health of communities. They aim to promote individualised care and integrated

care (for example, by covering transitions between children’s and adult services and

between health and social care).

Guideline recommendations set out:

 the care and services that are suitable for most people with a specific condition or

need

hospital)

 the care and services suitable for particular populations, groups or people in

particular circumstances or settings (for example, when being discharged from

 ways to promote and protect good health or prevent ill health

 the configuration, staffing and provision of health and social care services, and/or

 how national and local public sector organisations and partnerships can improve

the quality of care and services (for example, how the NHS and social care

services work together).

Many guideline recommendations are for individual health and social care

practitioners, who should use them in their work in conjunction with judgement and

discussion with people using services. Some recommendations are for local

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authorities, commissioners and managers, and cover planning, commissioning and

improving services; others are for providers (organisations providing services),

schools, and local and national organisations and partnerships in the public, private

and voluntary sectors. Guideline recommendations are also useful for people who

use health and social care services (including people who purchase their own social

care), their families and carers, and organisations representing their interests.

In addition to the recommendations, guidelines also summarise the evidence behind

the recommendations and explain how the recommendations were derived from the

evidence.

NICE guidelines cover health and care in England. Decisions on how they apply in

other UK countries are made by ministers in the Welsh Government, Scottish

Government, and Northern Ireland Executive.

1.2

Information about this manual

This manual explains the processes and methods NICE uses for developing,

maintaining and updating NICE guidelines. It is primarily for:

 NICE staff involved in developing guidelines

 NICE contractors (such as those doing evidence reviews, economic analysis and

fieldwork)

 members of the Committees that develop the guidelines (see section 1.5).

It is also likely to be of interest to a broader audience, including other developers of

guidance, stakeholders and users of NICE guidelines.

The processes and methods described in this manual are based on internationally

recognised guideline development methodology, and the experience and expertis e

of the teams at NICE, the contractors that work with NICE, NICE Committee

members and stakeholders. The processes and methods are based on

internationally accepted criteria of quality, as detailed in the Appraisal of Guidelines

for Research and Evaluation II (AGREE II) instrument, and primary methodological

research and evaluation undertaken by the NICE teams. They draw on the Guideline

Implementability Appraisal tool to ensure that recommendations are clear and

Developing NICE guidelines: the manual. October 2014

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unambiguous, making them easier to implement. They are also designed to fulfil the

requirements of the NICE accreditation scheme.

This manual describes the development of NICE guidelines from referral through to

publication, implementation, checking the need for an update and updating. The

guideline development process is summarised in section 1.6. There is also

information in chapter 12 on the support NICE provides to help organisations use

each guideline.

This is the first edition of the manual that covers all NICE guidelines. Previously,

guidelines were developed using 4 sets of processes and methods:

 The guidelines manual for clinical guidelines, including a slightly modified process

for ‘short’ guidelines, Interim methods guide for developing service guidance and

Interim clinical guideline surveillance process and methods guide and Interim

process and methods guide for the clinical guideline updates using standing

Committees pilot programme

 Methods for the development of NICE public health guidance and The NICE

public health guidance development process for public health topics

 Interim methods guide for developing medicines practice guidelines, and

Medicines practice guideline – Integrated process statement for medicines

practice topics

 The social care guidelines manual for social care topics.

These manuals were based on the same over-arching core principles common to all

NICE guidance. However, they had evolved to include some procedural and/or

methodological differences, depending on the areas and the evidence base that they

covered. This manual brings together methods and processes for developing

guidelines on the whole range of topics, with the aim of achieving consistency of

approach, and rationalising differences where appropriate. In some cases the best

approach may vary depending on the topic; this manual gives alternatives and

examples to help choose which approach to follow. Options should be considered

from the outset, and the approach discussed and agreed with NICE staff with

responsibility for quality assurance. The chosen approach should be documented in

the evidence review or guideline, together with the rationale for the choice. The use

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of, and rationale for, the approach agreed for each guideline will also be documented

by NICE staff with responsibility for quality assurance. Decisions will be reviewed for

consistency. In exceptional circumstances, significant deviations from the methods

and process described in this manual may be needed; in these cases, NICE’s Senior

Management Team must approve the approach before guideline development

begins.

All guidelines produced using this manual are known as NICE guidelines. In the

short term the Interim methods guide for developing service guidance will stand.

These interim methods will be incorporated in this manual at its next revision.

1.3

Choice of guideline topics

NICE guidelines are a key source for the development of NICE quality standards and

therefore new guidelines developed by NICE are usually chosen from a library of

topics for quality standards and then agreed with the relevant commissioning body

(NHS England or the Department of Health).

Decisions on which library topics to develop guidelines on, and in what order, are

based on factors such as:

 whether there is existing NICE-accredited guidance on which to base a quality

standard that encompasses the whole of the topic

 the priority given to the topic by commissioners and professional organisations,

and organisations for people using services, their families and carers.

A topic selection oversight group at NICE considers topics for guideline

development, taking these factors into account. NICE then discusses topics

identified in this way with NHS England, the Department of Health and Public Health

England, and a prioritised list is agreed by these 3 bodies.

Topics are then formally referred to NICE and scheduled into NICE’s guideline

development plans.

1.4

Key principles for developing guidelines

NICE develops guidelines according to the same core principles we use for all our

guidance:

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