exploring nice guidelines: from development to implementation · brief summary of effectiveness and...
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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!