Jane Cowl, Senior Public Involvement Adviser. Who is involved in making NICE guidance recommendations and what evidence do they look at?. Who decides what NICE will recommend?. Specialist staff employed by NICE . ID: 717659
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Student Champions Learning about NICE - 27 September 2017Jane Cowl, Senior Public Involvement Adviser
Who is involved in making NICE guidance recommendations and what evidence do they look at?
Slide2Who decides what NICE will recommend?
Specialist staff employed by NICE True
or False?
The Department of Health
True
or False?
NICE employed administration staff
True
or False?
NHS England
True
or False?
Clinical Commissioning Groups
True
or False?
NHS finance managers
True
or False?
Patients
True
or False?
Independent committees of NICE staff & experts
True
or False?
Independent committees of experts
True
or False?
Slide3Who decides what NICE will recommend?
Independent committees
Chair
At least 2 lay members
Health and other professionals
(specialists and generalists)SometimesTechnical experts e.g. health economist
2 types: standing committees and topic specific groupsStaff provide technical and administrative support
Slide4Evidence informing committee’s work
Reviews of research evidence (all NICE guidance)Stakeholder consultation (all NICE guidance)
Grey literature and unpublished data
Economic modelling
Manufacturers submissions
Expert testimony (patient and professional)
Occasional additional consultation with practitioners and patientsNICE recommendations based on best available evidence
Slide5The right evidence type for the question
Includes systematic reviews of studies when available
The question dictates the most appropriate study design
What is the cause of this disease?
Cohort, case-controlled study
What does it feel like?
What is important to you?What is your experience of care?
Qualitative researchWhat is the most clinically effective therapy?
Randomised controlled trial (RCT)
What works best in diagnosing the condition
Observational study or RCT
Slide6The nature of evidence
Acknowledgement: Dr Sophie Staniszewska, RCN Research Institute, University of Warwick
Relevant
Effective
Acceptable
Appropriate
Slide7Patient evidence
Slide8The value of patient evidence
What insights does patient evidence offer us?Personal impact of living with a condition and experience of care
People’s preferences and values
Outcomes that patients want from treatment or care
Impact of treatment or care on outcome, symptoms, physical and social functioning, quality of life
Risks, benefits and acceptability of a treatment or service
Equality issues and considerations for specific sub-groups
Slide9Evidence from experience of care
People who self-harm
Psoriasis
High dose rate brachytherapy for cervical carcinoma
Kidney dialysis
Slide10Patient perspectives: impact and challenges
Examples of positive influence of patient evidence on:
Scoping and review questions
Evidence reviews – how interpreted
Guidance recommendations
Research recommendations
ChallengesEnsuring patient voices are heardThe weighting of patient evidenceSynthesising with clinical and economic evidence
Slide11Ross Maconachie
Wednesday 27
th
Sept
2017
Health (Care) Economics
Slide12Why Consider Health Economics?
If the NHS spends more on one thing, it has to do less of something else (on the margin)Could we do more good by spending money in other ways?
The ‘
opportunity cost
’
is the value of the best alternative use of resources
Opportunity Cost
Slide13Which Mobile Phone Contract Would Choose?
i) for yourself
ii) if you had to decide for everyone on your course
Option A
Unlimited minutes
Unlimited textsUnlimited data£40 per monthOption B500 minutes500 texts
1.5 GB of data£20 per monthThinking about cost-effectiveness and opportunity costs – which contract do you pick?
Option C
0
minutes
0
texts
0
GB of data
£0 per month
Slide14There is more information that we would need here, ideally:
What is the budget/who is paying? This is our thresholdWho are we making the decision for (perspective)?How long for?
What benefits will the
person/people
get?
What is the opportunity cost?
the value of the best alternative use of that money
Slide15Economic Evaluation
What to Consider?
Slide16Economic Evaluation
Cost-effectiveness, not cost (or resource) impact“... the
comparative
analysis of alternative courses of action in terms of both their
costs and consequences
.”
Drummond, Stoddard & Torrance, 1987Current TreatmentNew Treatment
Consequences/
Outcome
Value of health gain for this patient group
Costs
Value of extra resources used (loss to other patients)
Slide17What Health Outcomes are Important?
What we want to know….
How much the intervention improves the health of the people involved?
What measure to use…..or to develop
What outcomes/factors should we be looking at?
Types of Outcome…..
Cure? ‘Progression-free’?Improved measurement? (e.g. growth; reduced blood pressureReduction of risk? (e.g. pre-term birth; falls in older people)Improved ‘quality of life’?
Additional years (or months) of life?Tools to measure quality of life (
QoL
)
were developed and are available in a wide range of areas of health.
At one point or another you will come across one, if not all of these outcomes – there is no one perfect outcome. However……
Slide18Examples of Measures
Generic (disease non-specific) – how we get a QALYEQ-5D –
EuroQol
5 Dimension
SF-6D and SF-36 – Short-Form
HUI – Health Utilities Index
Disease SpecificAQLQ- Asthma Quality of Life QuestionnaireMSQOL - Migraine Specific Quality of LifeEORTC QLQ-C30 -European Organization for Research and Treatment of Cancer Quality of Life QuestionnaireAdd-On ToolsEQ-5D+C – add on for cognitive factors18
Slide19Describing Health State Using EQ-5D
Mobility
I have no problems in walking about
I have some problems in walking about
I am confined to bed
Self-care
I have no problems with self care I have some problems washing or dressing myself
I am unable to wash or dress myself Usual activities (e.g. work, study, housework, family or leisure activities)
I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities
Pain/discomfort
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort
Anxiety/depression
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed
Slide20
Valuing Health States Using EQ-5D
EQ-5D defines 243 possible statesValues of states elicited from UK general population (n=3,395)
Has been developed in different countries for that specific population
Mean values can be used in economic evaluations
Values elicited using ‘time trade-off’ – so 1year in perfect health = 2 years in 0.5 health
Slide21
EQ-5D Exercise
Read the Vignette
describing a condition
Fill in the EQ-5D
form imagining you are that patient
Use the formula to
calculate your EQ-5D scoreDiscuss(NB: There is no ‘correct’ answer to this exercise)
Slide22Quality Adjusted Life Years -QALY
What is a QALY?
QALYs combine
both
quantity
and health-related quality of life (QoL) into a single measure
of health gainUse a self reported preference-based questionnaire score (like EQ-5D or SF-36) QoL
scores (utilities) should reflect people’s preferences over health
Utilities usually scored with ‘perfect health’=1 and death=0
22
Slide23Quality Adjusted Life Years
Why use QALYs?
Can weigh up net effect of treatment for patients
Survival vs
QoL
(e.g. for cancer chemotherapy)
Long-term QoL for chronic & recurrent conditions (e.g. arthritis)Benefits versus harms (e.g. COX II inhibitors)Allows broader comparisons between patient groups
The QALY is the preferred measure of NICE when conducting cost-effectiveness analysis (mostly in clinical and technology appraisals). However, not always possible for social care and public health so look to other methods.
23
Slide24"A QALY is a QALY is a QALY”
Usual value judgements used to calculate QALYs:
Allows the effectiveness of different technologies for different people to be compared
1 QALY:
One year of ‘perfectly’ health life for one person
OR two years of life with
QoL of 0.5 for one personOR one year of life with
QoL of 0.5 each for two peopleBUT – they do not incorporate an age weigh function – so 1 QALY at age 86 = 1 QALY at age 3
24
=
=
Slide25Quality Adjusted Life Year
Health-related quality of life
Length of life (years)
QALYs
gained
Current
treatment
New treatment
Initial QALY loss
due to side effects
0
1
Slide26Economic + Cost-Effectiveness Analysis
26
Slide27Types of Economic Evaluation
27
Warning – ‘cost-effectiveness’ often used as general term
for any analysis with non-monetary measure of health gain
Type of analysis
Value of resources
Value of health gain
Cost /
Cost impact
£
None
Cost-effectiveness
£
Single indicator:
Weight loss (kg),
blood glucose control (HbA1c)
deaths averted,
life years saved…
Cost-utility
£
Combined index
:
Quality
Adjusted Life Years
(QALY)
Cost-benefit
£
Monetary value:
Willingness to pay (£)
Slide28Treatment cost-effective
in shaded region
CE threshold
~£20-30K
Assessing Cost-Effectiveness
Cost (£)
Effect (QALYs)
New treatment
dominates
New treatment
dominated
Low extra cost
High QALY gain
High extra cost
Low QALY gain
£/QALY
Slide29The ThresholdIf one intervention does not ‘dominate’ then we use a threshold of £20-30k QALY to decide
Not set in stone – other considerations:-
Health gain not captured in the analysis
End of life criteria
Significant innovation
Certainty around the estimate
Theoretical basis - £20k/Q represents maximum WTP in a perfectly allocatively efficient NHS
Slide30Modelling – Why Do It?
Trials are of
limited duration
and so may not capture all costs and benefits
A single trial may not capture
all
the relevant informationNot all the relevant outcomes (e.g. adverse effects, quality of life, costs)Not all the relevant comparators [there may be several relevant options that are not feasible to examine concurrently in one single trial]
More than one study may addresses the clinical decisionTrials often report
intermediate outcomes
e.g. Blood pressure reduction
An intervention may have both positive and negative effects
There may not be a trial – social care and public health in particular
Trials can be very expensive
It may be unethical to carry out a trial in a particular area.
30
Slide3131
What is a model
MODEL
Resource use
GP visits, inpatient stays…
Preferences
QoL
weights
Unit costs
e.g
£ per GP visit
Epidemiology
Baseline risks,
sub-groups
Cost Effectiveness
£/QALY
Treatment effects
Survival, health status
Test accuracy
Sensitivity/specificity
A mathematical structure used to combines different sources of data
Slide32Cost-Effectiveness in NICE Guidelines
Principles set out in NICE’s Social Value Judgements:
Principle 2
- “Those developing clinical guidelines, technology appraisals or public health guidance
must
take into account the relative costs and benefits of interventions (their ‘cost effectiveness’) when deciding whether or not to recommend them.”BUTPrinciple 3
- “Decisions about whether to recommend interventions should not be based on evidence of their relative costs and benefits alone. NICE must consider other factors when developing its guidance, including the need to distribute health resources in the fairest way within society as a whole.”
Slide33Any Questions?
Slide34Student Champions Learning about NICE - 27 September 2017Jane Cowl, Senior Public Involvement Adviser
Making decisions in practice
Slide35Slide36Slide37What is shared d
ecision making?
“[shared decision making] is a
collaborative
process that allows patients and their providers to make health care
decisions together
, taking into account the best scientific evidence available, as well as the patient’s values and preferences” * *Angela Coulter and Alf Collins, The King’s Fund, 2011
Slide38www.nice.org.uk/shared-decision-making
Slide39SDM – Two sources of expertise
Clinician
’
s expertise
Patient
’
s expertise
Diagnosis
Experience of illness
Disease aetiology
Social circumstances
Prognosis
Attitude to risk
Treatment options
Values
Outcome probabilities
Preferences
Coulter A, Collins A, Kings Fund report 2011
Slide40Patient decision aids
105 studies involving 31,043 participantsDecision aids increased
Participants’ knowledge
Accuracy
o
f risk perceptions
Congruency between informed values and care choicesDecision aids decreasedDecisional conflict related to feeling uninformedIndecision about personal valuesThe proportion of people who were passive in decision-makingStacey D, Legare F, Lewis K, et al (2017) Cochrane database CD001431
Slide41NICE patient decision aids
www.nice.org.uk/shared-decision-making
Slide4242
Slide43Key components
InformationPatient goals or values
Meaningful involvement
Slide44What are the other common side effects?
What does the option involve
?
What difference will it make to my chance of developing breast cancer?
What difference will it make to my chance of a bone fracture?
What difference will it make to my chance of getting a blood clot such as deep vein thrombosis (DVT) or a blood clot in the lungs (pulmonary embolism)?
What difference will taking it make to my chance of getting endometrial cancer (cancer of the womb)?
Slide45Slide4646
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Slide55“… I believe that finding the sweet spot for shared decision making will require clinicians to work against their natural impulses to tell the patient what to do when they’re certain of what’s best, and to leave the patient to decide when they’re not
“
I’m not sure what the right answer is, so why don’t you decide”
can
be replaced
with:
“This is a really hard decision because we aren’t sure what will happen if you choose option x; let me show you how I think about this, and you can tell me whether it fits with what’s important to you.” And, equally important, “I’m recommending option x because it provides better outcomes than option y” can become “Let me tell you about the pros and cons of options x and y so that you can decide which one matches your priorities.”Perspective
: Shared Decision Making - Finding the Sweet Spot. nej.md/1nfA9nE
Slide56Move from:
“What's the matter with you?”
To:
“What matters to you?”
Slide57Next steps…for everyone
Get to know what decision aids are available
Try it out!
Spread the word!
Slide58
Any questions?
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