NICE’s role in establishing guidelines and Quality

standards

Dr Françoise Cluzeau, Associate Director, NICE International

Dr Ryan Li, Adviser, NICE International
 Overview
• NICE, its role, structure, funding &
governance
• Guidelines & Quality Standards process and
methods
• Enhancing guidance implementation and pay
for performance
• How does the work of NICE improve care
quality?
• Learning from other countries
 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
NICE as an organisation
Roles of NICE
 Range & products
• medicines, treatments, procedures, diagnostics &
devices
• clinical guidelines & pathways
• Quality Standards, performance metrics and a range of
information services for those providing commissioning
and managing services across the spectrum of health
and social care.

Shared
Learning
Awards
 Centres & support services
Health Health &
Clinical Practice Technology
Evaluation Social Care

Technology
Clinical Appraisals Quality Standards
Guidelines

Surgical Implementation
interventions
Medicines and NICE pathways
Prescribing
Centre
Devices and
Diagnostics
Business, Planning
Social Care
Safe staffing
guidelines
& resources
PASL

Prevention
Scientific Advice

R&D
NICE International
Accreditation

Communication Evidence Resources

Public involvement
 Funding & expenditure

Funding Expenditure

National Institute for Health and Care Excellence Annual Report and Accounts 2013/14
 NICE’s core principles
Scientific
Rigour

Timeliness Inclusiveness

Accountability
Support for Transparency
implementation for
reasonableness

Review Independence
Challenge
NICE GUIDELINES AND
QUALITY STANDARDS

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 Why NICE clinical guidelines
and quality standards?
• Variation in care and health outcomes across
the country – “postcode lottery”
– “Different organisations set different standards, using different
methods [and] evidence… not clear which standards must be
followed and which are optional” Sir Liam Donaldson, previous
Chief Medical Officer
• NICE given responsibility to develop guidance:
– To promote cost-effective use of NHS resources
– Based on best available evidence and participatory process

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 What are NICE Clinical Guidelines?
• Broad guidance covering
management of a particular
condition
• Considers clinical and cost-
effectiveness, and patient/carer
perspective
• Incorporates other relevant NICE
guidance (e.g. Technology
Appraisals for specific drugs)
• Recommendations are advisory,
not mandatory… but can be used to
develop quality standards
What are NICE guidelines and
quality standards?
A comprehensive set of recommendations for a particular
disease or condition

Evidence
(e.g. clinical trials, Evidence-based Quality
health economic Clinical Guidelines Standards
studies)

A prioritised, concise set of statements (usually 6-8) with associated

measurable indicators, chosen and adapted from the Clinical Guideline
recommendations
 NICE quality standards define best
practice, not minimum standards
NICE quality standards
CQC- Registration
requirements

Proportion of
services
Standard of
services Unsafe Sub- Adequate Good Excellent
standard

Quality standards complement regulatory or other minimum requirements

Example: Quality standard for stroke developed from
NICE guideline
NICE clinical guideline recommendation (2008)
Brain imaging should be performed immediately*
for people with acute stroke if any of the
[indications] apply. Indications for immediate brain
*’Immediately’ is defined as ‘ideally the next slot and definitely imaging:
within 1 hour, whichever is sooner’ • Indications for thrombolysis or
early anticoagulation
treatment
• On anticoagulant treatment
• Known bleeding tendency
• Depressed level of
consciousness (Glasgow Coma
Score < 13)
Quality standard (NICE 2010) • Unexplained progressive or
fluctuating symptoms
Patients with acute stroke receive brain imaging
• Papilloedema, neck stiffness or
within 1 hour of admission if they meet any of the fever
indications for immediate imaging. • Severe headache at onset of
stroke symptoms.

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 NICE guideline development brings together many
different stakeholders
NICE
• Define process and methods
• Quality assure NCCs’ work Stakeholders
• Manage stakeholder consultation and dissemination
• Accountable for the final guideline

National Collaborating

NCC Mental
NICE NCC Women
& Children’s
Centres
•
•
Convene GDGs
Provide technical input
Health Health to facilitate GDG
• Draft the guideline

Guideline
Development Guideline development
National Group groups (GDG)
Clinical • Review evidence base
NCC Cancer and make
Guidelines Guideline recommendations
Centre Development • Respond to consultation
Group
comments
Guideline development is a systematic process
with stakeholder participation throughout

Draft scope
4 months Stakeholder comments
Final scope
Scoping

13-16 months GDG develops guideline

Development

Consultation on draft guideline

Stakeholder comments
Consultation on draft guideline

9 months Revise guideline after comments

Pre-publication check

Prepare and publish guideline

Validation

Final guideline published

Publication and dissemination
 The Guideline Development Group
(GDG) is crucial to each guideline
• Multi-disciplinary committee consisting of
– Chair: usually highly experienced and respected
clinical leader
– Clinical and academic experts
– Patients, carers and lay members
– NCC technical team
• GDG members bring their own expertise from
different perspectives, but do not represent
particular organisations
• All members have equal status
 Key role of the GDG is to make
judgements based on the evidence
Effectiveness Extent of
uncertainty &
Cost-
Irreversibility of
effectiveness
decision

NICE
Legal and DECISIONS
policy
constraints
Other social
values: ethics,
equity, rights
Practicalities of
implementation
 Developing guidelines –
some challenges….
• Scope
– What to include/exclude?
• Timeliness
• Taking into account cost-effectiveness
– Selecting topics for economic modelling
– When to rely on published data
• Keeping guidelines up to date
Helping compliance /implementation

– Baseline assessment/audit tools

– Cost impact tools
– Online educational tools Shared
Learning
Awards

– Local practice improvement

– Financial incentives
– Do they work?
– What is the impact of NICE guidance
 Baseline assessment tool
• Used to evaluate current practice and plan activity to meet NICE
recommendations
• Can serve to audit practice
• Always used in conjunction with the guidelines they relate to
 Cost Impact Statement
Advise pregnant women with type 2 diabetes or
gestational diabetes who are on a multiple daily insulin
injection regimen to test their fasting, pre-meal, 1-hour
post-meal and bedtime blood glucose levels daily
during pregnancy. (recommendation 1.3.2)

Expert clinical opinion: recommendation could potentially

double the number of testing strips being used by pregnant
women with type 2 or gestational diabetes

box of 50 testing strips costs £2.29 (NHS electronic Drug

Tariff). Expert clinical opinion suggests approximately 80%
to 90% (1,400) of women with type 2 diabetes and 20%
(5,600) of women with gestational diabetes are on a
multiple daily insulin injection regimen
Local Practice improvement
case studies_shared learning
• Antibiotic prescribing for coughs
reduced from 54.5% to 37.7% over 3
months
• Antibiotic prescribing for URTI reduced
from 32.6% to 19.7% over 3 months
• In January alone, 67 patients avoided
unnecessary prescription of antibiotics
(over 700 fewer prescriptions in 1 year)
Lessons
• Buy-in of staff from across the practice
• reinforcing the message to clinicians
• Involving reception staff from the early
stages as first contact with patients on
the phone.
 Pay for Performance in Primary Care
Quality Outcomes Framework (QOF)

• Introduced in 2004 – voluntary annual incentive scheme

that rewards family doctors in the UK for improving care.
• GPs get achievement points for:
- Managing common diseases (asthma/diabetes)
- Implementing preventative measures (blood pressure checks)
- Targeting hard to reach / at risk groups (vaccinations and
screening)
• There are 75 indicators across 25 disease areas
• NICE develops indicators, based on NICE
guidelines/Quality Standards
 How does the QOF work?

• Point system: GP practices

are scored against indicators
across various domains
• Higher score  Higher GP
income (adjusted for caseload
and casemix)

Significant expenditure and a significant incentive:

£670 Million per year
15% of NHS primary care costs
15% of GP practice income
 Does QOF improve outcomes?
• Recording? – definitely
• Process? – mostly yes
• Intermediate/proxy outcomes? – yes for some but
not for others
• Clinical outcomes? – unclear
– Strong evidence of initially improved health outcomes for a
limited number of conditions but subsequently fell to the
pre-existing trend; “limited impact on improving health
outcomes due to its focus on process-based
indicators...” (Langdown et al. 2014, J Pub Health)
– Some evidence that the poorest performing practices have
improved the most with narrowing of inequalities in care
(Gillam et al. 2012, Annals Fam Med)
 Preventing VTEs

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.
 VTE impact assessment: mandatory quarterly
data collection by all acute care providers

The documentation of risk assessment improved

following the implementation of NICE guidance; it is
NICE guidance

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

• 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.
 NICE International is NICE’s non-profit
programme since 2008
• Supporting foreign governments to make better
policy decisions for better health
o Technical support: HTA, guidelines and quality
standards
o Advice on process and governance: transparency,
public and stakeholder involvement
• Practical support projects (clinical pathways,
quality standards) with country partners,
including: China, India, Vietnam
Vietnam: QS for Stroke developed over 14 month, country-
owned process
Undertake situation analysis

Define the topic for the QS

Recruit a QS Committee

Select relevant clinical guideline/pathway

Develop the QS (3 workshops)

Approve final draft and publish

MOH policymakers and clinicians across Vietnam
engaged in deliberative process
• Selected relevant recommendations to
address high-priority clinical areas
• Developed quality statements and
measures, appropriate to Vietnamese
context
• Final product approved by Vice Minister

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 QS: a model of national/international
partnership?
• Effective partnership
– Convened policymakers and stroke clinicians for the first time
with direct policy impact
• Stronger institutions
– MoH incorporated QS in Hospital Quality Criteria
– Pilot QS implementation funded through World Bank project
• Better decisions
– Focus on low cost, high impact interventions: prevention,
joint working across disciplines, early diagnosis and
rehabilitation
– Full implementation could lead to improved care for 115,000
patients, and net savings of US$2.8m per year

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