Exploring NICE guidelines: from

development to implementation

Dr. Francoise Cluzeau

Associate Director, Global Health & Development Group,

Imperial College London

NICE….what is it ?

The National Institute for Health & Care

Excellence (NICE) is the independent

organisation responsible for providing

national guidance and advice to improve

health and social care

• Produces evidence-based guidance

• Develops quality standards and performance metrics

• Provides a range of information services

NICE is not a regulator

Centre for Clinical Practice

Clinical Guidelines

Medicines and Prescribing

Centre

Centre for Health Technology Evaluation

Technology Appraisals

Surgical interventions

Devices and Diagnostics

Health and Social Care

Quality Standards

Quality Indicators

Social Care

Centre for Public Health

Excellence

Programmes

Interventions

R&D (part of CHTE)

Implementation

(H & SC)

Public

Involvement

NHS Evidence

Communications

NICE structure

What are (NICE) clinical guidelines?

• Broad guidance covering all or specific aspects of the

management of a particular condition

• For the NHS, local governments, private & voluntary

sectors

• Methods & processes based on international quality

criteria (AGREE II instrument) & primary methodological

research & evaluation by the NICE teams.

• Recommendations are advisory only but can be used to

develop Quality Standards to assess clinical practice

and inform commissioning

• Updated every 3 years

Guidelines & the patient pathway

Linking across NICE guidance

Hypertension

Lung cancer guideline _related NICE guidance

Who develops NICE guidelines

Internal Clinical Guidelines

GDG

GDG

GDG

GDGGDG

GDGNICE

GuidelinesTeam

GDG

National GuidelinesAlliance

GDG

GDG

GDG

GDG

GDG

GDG

GDG

GDGGDG

GDG

GDG

GDG

National Clinical Guidelines

Centre

GDG

GDG

GDG

GDG

GDG

GDG

GDG

GDGGDG

GDG

GDG

A mixed model

Working to the same methods

• Contains details of

NICE methods &

processes

• Developed

collaboratively

• Updated every 3 years

• Ranging from minor

updates to

• major updates

• Major updates

consulted on

The GDG: a multidisciplinary Group

• Clinicians

• Researchers/method

ologists

• Service managers

• Health economists

• Patients/carers

• Topic specific Group

• Recruited through an open & rigorous process

• Provided with training by NICE

Declarations of interest

The NICE Guideline Development process

2

ye

ars

• GDG meets every

2 months

• One day meeting

Referral and scoping

Topic is referred to NICE by NHS England; the Department

of Health or the Department for Education.

The referral is translated into the scope though

consultation with stakeholders.

The scope provides a framework. It describes

the need for the guideline, epidemiology/condition

The review questions

the aspects of care that the guideline will and will not cover

A search of key sources (previous guidelines, HTAs, key

systematic reviews, RCTs & economic evaluations

The scope is consulted on publicly

The review protocol

Outlines the background, objectives and planned methods

for an evidence review. Agreed with NICE

It details:

Objectives of the review question, for example: ‘to estimate the

effectiveness and cost effectiveness of…' or ‘to describe the

views of…‘

Criteria for considering studies – using relevant framework (for

example, PICO)

How the information will be searched – sources to be searched

and any limits to be applied (e.g. publication date, language,

study design)

Review strategy - the methods that will be used to review the

evidence and how evidence will be synthesised

Review questions

• Up to 20 questions for a standard guideline (fewer for

an update)

• Review questions (in PICO) typically discussed and

agreed at the 1st/2nd committee meetings

• Include health economics considerations

• Once agreed, the NCC technical team develops the

evidence review

• Health Economics Plan developed

Bladder cancer guideline_Endoscoping

assessment

Review question: What are the most effective

endoscopic techniques for diagnosing bladder cancer

(for example white light, blue light, narrow band

cystoscopy)?

• Search carried out by information scientists, consulting with

Systematic reviewers & Health economists

• Identifies the best available evidence to address review question

• Includes clinical and cost-effectiveness evidence

• Includes a mix of core databases,

• The GDG reviews and advises on search strategies or unpublished

research

• Calls for evidence can also be made - where information is

believed to exist but has not been found using standard searches

• GRADE approach used for assessing evidence

Evidence search & Assessing evidence

Cost effectiveness analysis

What is the optimal first-line chemotherapy regimen for patients with incurable locally advanced or metastatic bladder cancer?

What is presented to the GDG?

• Search strategies (and/or questions on these)

• Lists of references – excluded and included

• Quality assessment checklists

• Evidence tables

• Evidence syntheses (forest plots, where possible)

• Narrative description of evidence

• GRADE evidence profiles, summarising quality of the

evidence by outcome ( 7 to 9 outcomes per research

question)

GRADE - profile and evidence statements

PREGABALIN – (as monotherapy – placebo-controlled trials) for neuropathic pain

No. of studies

Design Treatment Placebo Relative risk (95%CI)

[ARR]

[NNTB, 95%CI]

Lim

itati

on

s

Inco

nsis

ten

cy

Ind

irectn

ess

Imp

recis

ion

Oth

er

co

nsid

era

tio

n

s

Quality

PRIMARY Outcome: Patient- reported 30% pain reduction

6 RCT 554/955 (58.0%)

126/462 (27.3)

2.08 (1.78, 2.44) ARR = 30.7% NNTB = 3.2 (2.8, 3.9)

N N N N N High

PRIMARY Outcome: No. of withdrawals due to adverse effects

11 RCT 239/1742 (13.7%)

53/843 (6.3%)

2.32 (1.73, 3.11) ARI = 7.4% NNTH = 13.5 (10.3, 19.5)

N N N N N High

Evidence statements

• There was high-quality evidence that patients receiving pregabalin were

significantly more likely to report at least 30% pain reduction (with NNTB = 3.2)

compared with those receiving placebo.

• There was also high-quality evidence that patients receiving pregabalin were

significantly more likely to withdraw from treatment because of adverse effects

(with NNTH = 13.5) compared with those receiving placebo.

Presentation of modified GRADE profiles

GRADE profile: Bladder cancer

Strength of recommendations

NICE use elements of GRADE

• No ‘summary grades’

for quality of the

evidence or strength

of a recommendation

• Uses wording to

denote certainty

• Integrates a review of

the quality of cost-

effectiveness studies

• Selects priority

recommendations for

implementation

Making decisions

NICEDECISIONS

Other socialvalues: ethics, equity, rights

Legal and policy

constraints

Practicalities of implementation

Extent of uncertainty &

Irreversibility of decision

Cost-effectiveness

Effectiveness

Making Judgements

Evidence sections structure

Reflects the systematic approach taken to recommendation

development

• Review question(s)

• Summary of the quality of the evidence

GRADE Evidence profile [more on GRADE next], if used

Links to evidence tables in appendices

Including summary of effectiveness and economic evidence

• Evidence statement(s)

Brief summary of effectiveness and economic evidence

• Evidence to recommendations

• The GDG’s interpretation of the evidence

• Recommendation(s)

Research recommendations

Considered by the National Institute for Health Research

(NIHR)

What gets published

GUIDANCE

• Recommendations

• Pathways (electronic)

EVIDENCE

• Full guideline

• Evidence tables, profiles etc.

INFORMATION FOR THE PUBLIC

TOOLS & RESOURCES

• Baseline assessment tool

• Resource impact tool & report

IMPLEMENTATION

• Audit tools

LEARNING RESOURCES

From evidence to improvement_the linking process

Research GuidelinesQuality

Standards & indicators

• Medical education and professional training

• Performance management

• Financial incentive (QOF, CQUINs)

• Audit & governance

• provider benchmarking

• Provider regulation (CQC)

• accreditation

HTA & economics

Six key components to successful local

implementation of national guidelines:

1. Board support and clear leadership

2. Provision of a dedicated resource (a NICE

manager)

3. Support from a multidisciplinary team

4. A systematic approach to financial planning

5. A systematic approach to implementing

guidance

6. A process to evaluate uptake and feedback.

The NICE implementation strategy

Four principles:

Raise awareness

• Disseminate and communicate effectively

Motivate and encourage change

• Use ‘levers for change’

Provide practical support

• To remove some of the practical barriers

Evaluate impact and uptake

• To determine effectiveness of the strategy

Using tools to help implementation

• Baseline assessment

• Audit support

• Cost impact tools

• NICE Field Team

• Online educational tools

• Local practice improvement

• Scholars/fellows & Students champions

Shared Learning Awards

Quality Standards : the law

The Secretary of State’s duty as to improvement in

quality of services:

"In discharging the duty [of securing continuous

improvement in the quality of services provided to

individuals for or in connection with the prevention,

diagnosis or treatment of illness, or the protection or

improvement of public health] the Secretary of State

must have regard to the quality standards prepared

by NICE under section 218 of the Health and Social

Care Act 2011.”

Health and Social Care Bill, Jan 2011, Page 1

Example of NICE standards & indicators

Quality and Outcomes Framework (QOF)

Voluntary, pay-for-performance scheme introduced in 2004 as

part of new contract for Primary Care practitioners

• Rewards GP practices for implementing systematic improvements in quality

of care

• Point system: GP practices are

scored against indicators across

various domains

• Higher score Higher GP income

(adjusted for caseload and casemix)

• Using QS developed by NICE

• Significant expenditure and a

significant incentive: £1bn per year

– 25% of GP practice income

An estimated 25,000 people die from DVT each year.

Ministers said trusts that fail to act on the guidelines

are likely to face financial penalties.

Hospitals that fail to screen at least 90% of their

patients will be penalised by withholding payments.

From 1 April 2010, a hospital could stand to lose

0.3% of its income through the new Department of

Health commissioning for quality and innovation

framework.

Preventing VTEs

VTE impact assessment

There has been a steady increase in the proportion of adult admissions risked

assessed for VTE in all providers of NHS funded acute care, from 47% in

July 2010 to 94% in December 2012.

NIC

E g

uid

an

ce

mandatory quarterly data collection by all acute care providers

The documentation of risk assessment improved following the implementation

of NICE guidance; it is questionable, however, whether this led to improved

patient safety with respect to prescribing appropriate

prophylaxis.

Bateman et al. The implementation of nice guidance on venous thromboembolism risk assessment and prophylaxis: a before-

after observational study to assess the impact on patient safety across four hospitals in England BMC Health Services Research

2013, 13:203

Tracking adherence to NICE QS_Sepsis

Sepsis: recognition, diagnosis and early management

Source: National Confidential Enquiry into Patient Outcome and Death. Just Say Sepsis! A

review of the process of care received by patients with sepsis. May 2014

Endocarditis and antibiotic use

After the introduction of the guideline a large (78.6%) and rapid decrease occurred in

prescribing of antibiotic prophylaxis. However, we did not detect a significant increase

in the number of infective endocarditis cases above the long term baseline trend over

this period. Thornhill et al., BMJ, 2011

Challenges. Updating NICE guidelines

• Almost 200 guidelines

published

• Most reviewed every 2

years

• Some on static list

• Surveillance review

triggered if major new

findings published.

Keeping up to date with new evidence

Challenges_Increasing demand

• Large programme (about 30

guidelines/year )

• NICE is asked to do more and

more ‘rapid reaction’

guidelines to address specific

clinical problems

• New programme of service

delivery guidelines

• Budget cuts

Further information on NICE guidelines is available at:

https://www.nice.org.uk/

Thank you!