eliciting societal values around complex ethical …...of observation and study.” (brown, 1986)...
TRANSCRIPT
Seminar presented to
Berman Institute of Bioethics
Johns Hopkins University, Baltimore, USA.
10th September 2012
Rachel Baker
Reader in Health Economics
Yunus Centre for Social Business & Health
Eliciting societal values around complex ethical issues:
Life-extending health technologies for people with terminal illness
Outline
• Setting the scene
– Scarcity, health economics and health care resource allocation
– UK NHS and NICE
– Evaluating medicines and difficult choices
– life-extending medicines at the end of life
• Eliciting societal views – Why do we want to elicit societal values?
– Methodological issues
• Ongoing research
• Q methodology and societal views
• Research in progress / Discussion points
Scarcity...
• ... and health care resource allocation in publicly funded health systems
Health care resource allocation
Economic evaluation
• Cost utility analysis
– Dominant form of economic evaluation in UK health economics
– Form of cost effectiveness analysis
– Outcomes are measured in terms of Quality-adjusted life years (QALYs)
Quality-adjusted life years (QALYs)
Measured on a 0-1 scale
0 = death
1 = full health
Duration Measured in years
QALY = q x t
q
t
Harris J (2005) It’s not NICE to discriminate J Med Ethics 2005 31: 373-375
Cost Utility Analyses and the Cost per QALY threshold
– Incremental cost effectiveness ratio (ICER)
– Additional cost per QALY gained of new technology compared to existing technology
– Cost per QALY threshold (£20,000-30,000)
Setting the Scene: UK NHS and NICE
• Fixed budget/ scarce resources
– >£100bn p.a.
• In 1999 NICE established
– National Institute for Health and Clinical Excellence
– http://www.nice.org.uk/
• NICE adopted CUA in their economic evaluation
• NICE reference case: – “An additional QALY has the
same weight regardless of the other characteristics of the individuals receiving the health benefit” (table 5.1 p 30)
• A QALY is a QALY is a QALY?
Setting the Scene
A QALY is a QALY is a QALY?
A QALY is sometimes a QALY
• Social value judgements
– NICE Citizens Council • Reports from meetings on various topics
• Social Value Judgements (SVJ) 2008
– Rawlins et al 2009 Br J Clin Pharma (70: 3) • “Social value judgements are concerned with what is
appropriate and acceptable for society in delivering healthcare across the NHS” p346
NICE End of life Supplementary guidance
Some QALYs are more valuable than others..
Specific criteria
• less than 2 years to live
• treatments would result in a gain of at least 3 months of increased life expectancy
• drug is licensed for a relatively small patient group
NICE review decisions invoking end of life supplementary guidance 2009
• first 4 months of implementation
• QALY weights based on the decisions invoking supplementary guidance.
• Committees had accepted an implicit QALY weight of 1.7
• Longson C, Littlejohns P. Update Report On The Application Of The ‘End-Of-Life’
Supplementary Advice In Health Technology Appraisals: National Institute for Health and Clinical Excellence 2009.
Update report continued..
• “The supplementary advice highlights that “the Institute intends to ensure that the supplementary advice is robust for the long-term and that it achieves its intended purpose” (see paragraph 1.2) therefore the Board is asked to agree that further research is required to test the assumptions of the EOL advice and to advise on the nature of that research.” p5.
• Longson C, Littlejohns P. Update Report On The Application Of The ‘End-Of-Life’ Supplementary Advice In Health Technology Appraisals: National Institute for Health and Clinical Excellence 2009.
The societal value of life extension for people with terminal illness
• There are claims that society places additional value on life extensions for terminally ill:
Departing from the Threshold report – NICE Citizens Council 2009 – page 14
Rawlins et al Brit j of Clinical Pharmacology 2009
• “The Institute recognises that the public, generally, places special value on treatments that prolong life – even for a few months – at the end of life, as long as that extension of life is of reasonable quality (at least pain-free if not disability-free). NICE has therefore provided its advisory bodies with supplementary advice about the circumstances under which they should consider advising, as cost-effective, treatments costing >£30,000 per QALY.” p 348
Evidence of societal values?
• Media?
• Politicians?
• Expensive life-extending technologies already funded?
• Little rigorous empirical research
Why do we want to elicit societal values
• There are other ways of making resource allocation decisions without incorporating societal values
• General move towards – Participation
– Public engagement
– Democratization
• Societal values as informing deliberative processes
What do we mean by societal values?
• “Values” has meanings for different disciplines.
• In economics terms it conveys something about strength of preference – Magnitude
– Measurable
• In this study: – Values/ perspectives/ subjectivities
– Perceived worth to society?
MRC Methodology panel
“Is ‘end-of-life’ care more valuable? Measuring societal views on health care resource allocation using the new Q2S
method.” Rachel Baker, Helen Mason, Cam Donaldson, Laura Williamson Jon Godwin (GCU) Job van Exel (Erasmus, Rotterdam) Cathy Hutchinson (Beatson Cancer Centre, NHS Greater Glasgow &Clyde) 1st Sept 2011, 3 year study
Objectives
i. To identify and describe societal perspectives on the
(relative) value of end of life technologies by eliciting
the views of both members of the public and experts
in relevant fields;
ii. To develop methods to investigate the distribution of
those views, including their association with other
characteristics, in a nationally representative sample
of the UK general public.
Objective i)
i. To identify and describe societal perspectives on the
(relative) value of end of life technologies by eliciting
the views of both members of the public and experts
in relevant fields;
– Qualitative, exploratory
– Perspectives, viewpoints
– Rich descriptions
– Relatively small sample size
– Purposive/ theoretical sampling
Objective ii)
ii. To develop methods to investigate the distribution
of those views, including their association with
other characteristics in a nationally representative
sample of the UK general public.
– Quantitative
– Frequency and distribution
– Strength of association
– Relatively large sample size
– Representative sampling
Methodological framework
i. To identify and describe societal perspectives on the
(relative) value of end of life technologies by eliciting
the views of both members of the public and experts
in relevant fields;
ii. To develop methods to investigate the distribution of
those views, including their association with other
characteristics, in a nationally representative sample
of the UK general public.
Q methodology
Q Survey methods
• Q methodology is a set of connected techniques designed to enable the study of ‘subjectivity’ (views, opinions, beliefs, values, tastes, …)
“Only subjective opinions are at issue in Q, and although they are typically unprovable, they can nonetheless be shown to have structure and form, and it is the task of Q technique to render this form manifest for purposes of observation and study.” (Brown, 1986) page 58
Two key aspects:
• Data collection - Card sort (Q-sort)
• Data Analysis - “inverted factor analysis” (William Stephenson - 1935 letter to Nature)
What is Q ?
Q sorting
http://www.yourviewonhealth.com/healthdecisions/index.html
Online Q sort – an example
The Q set
• Concourse: – The running or flocking together of people; the condition or state of being so
gathered together.
– The running, flowing together, or meeting of things (material or immaterial); confluence. (OED)
– universe of subjective viewpoints around a topic
• Q set:
– Representative of the concourse
Selection of respondents (the P set)
• Size of sample? – Cannot be predetermined ..but
– Typically a sample of between 40 and 60 respondents will be plenty. Often fewer.
• Who to sample? – Similar to qualitative approaches to sampling
– Theoretical sampling
– Purposive not representative
Overview of Q Analysis
• (By-person) factor analysis
• Factors represent clusters of individuals whose viewpoints on the subject are similar
• Aim to identify and describe subjectivities: the range of views on a topic (not to make a claim about percentage of people expressing them)
Correlation Matrix
• Each persons Q sort is correlated with every other Q sort
SORTS 1 2 3 4 5 6 7
1 Pil01 100 13 24 31 26 38 45
2 Pil02 13 100 25 14 12 38 30
3 Pil03 24 25 100 58 45 47 62
4 Pil04 31 14 58 100 36 47 58
5 Pil05 26 12 45 36 100 47 27
6 Pil06 38 38 47 47 47 100 54
7 Pil07 45 30 62 58 27 54 100
FACTOR A
FACTOR B
FACTOR C
Summing up Q
• What goes in: – people’s rank ordering of statements of opinion
– Their explanations of why
• What we do: – look for patterns between those orderings
– Interpret the patterns
• What comes out: – Rich descriptions of a small number of shared views/ subjectivities on a
subject.
– Distinguishing and consensus issues
Q methods – some potential advantages
• Respondents are presented with ‘the range’ of arguments to arrange rather than to articulate
• Consensus is examined through data analysis rather than required of respondents
• Once a small number of narratives/ shared perspectives have been identified, additional quantitative information may be useful: – ‘how much’ does each respondent associate with each
perspective (i.e. Factor)
– ‘how much’ does each statement contribute to and distinguish each perspective (i.e. Factor)
• Enables the design of quantitative survey
Research in progress
• Developed and refining the Q set based on statements taken from
– Media review (readers comments)
– Public consultation – NICE EoL policy
– 16 Interviews
– 3 Focus groups (20)
Interview and focus group participants
Interviews (16)
• Initial convenience sample (6)
• Friends/ family with relevant experience
• Health/ Medical professionals (4)
• 1 doctor; 1 cancer nurse; 1 medical director cancer research centre; 1 palliative care occupational therapist
• Academic (1)
• Health economist with interest in end of life
• Cancer charity/ patient groups (2)
• Pharmaceutical industry (2)
• Religious leader (1)
3 Focus groups (20)
• General population sample
• Recruited via Research Resource company
• 11f, 10m
• Age range 22-”70+”
Which resulted in..
• 200+ statements
• Which were then sifted for
– Relevance to the research question
– Duplication
– Sufficient similarity that statements could be merged
• 65 statements
– Process is ongoing
Examples of statements (against)
“These end of life treatments are not a cure. Those resources could be used to provide treatment to people who have a greater chance of survival and that ultimately could return to work so putting more money back into the system through their taxes.”
It is likely that there are other groups in very poor health who feel they have a similar claim. An equal case could be made for drugs which slow dementia or help to preserve eyesight
Treatments that provide a short life extension are not worth it, emotionally or financially. They only delay the inevitable and prolong the pain for those around the patient
People have the right to a decent end of life, but not the right to extend their life to the very last gasp at the expense of others.
Examples of statements
(against)
Real compassion isn’t always more drugs to get a few more weeks or months out of a very
sick body...
Examples of statements (in favour)
Failing to provide access to a life-extending medicine
for a person with a terminal illness is like
killing the person
People with a short life expectancy should be prioritised over others but it’s not appropriate to throw extra resources at a 90 year old just because they have less than 2 years to live
Treating people at the end of life is not going to result in big health gains but the system should be about improving health for society and looking after those in greatest need
Examples of statements (in favour)
If the means of helping someone live longer is available it is unfair to not allow the use of it
What price life? We all put a lot of
money into the NHS so we should have a right to treatment when we need it.
Next steps
• Pilot draft Q set in interviews with key respondents
• Phase I data collection (by end 2012) – 250 Q sorts from members of UK public
• Quota sample for representation according to age, gender, region and employment status...
– 50 Q sorts from ‘key informants’
• Health and health policy professionals, patients groups, charities, hospice volunteers, bereaved families, cancer research scientists, pharmaceutical industry, health economists, ethicists, religious leaders...
• Survey design and administration (2013-14)
Discussion points
• How might/should the information generated in this research be used in policy?
• What is the normative relevance of societal perspectives derived in this way?
• Empirical ethics, the generation of the Q set and factor interpretation
Acknowledgements
• Medical Research Council, UK
• MRC EoL project team: Cam Donaldson, Helen Mason, Laura Williamson, Job van Exel, Cathy Hutchison, Jon Godwin