Transcript Addressing ethical issues of complex - INTEGRATE-HTA

Addressing ethical issues of complex
interventions in HTA
Kristin Bakke Lysdahla , Louise Breretonb , Wija Ortwijnc, Kati Mozygembad Pietro Refoloe, Dario
Sacchinie, Jan Brönneked, Gert Jan van der Wiltf, Ansgar Gerhardusd, Bjørn Hofmanna
a University of Oslo
b University of Sheffield
c ECORYS Rotterdam,
d University of Bremen
e Università Cattolica del Sacro Cuore, Rome
f Radboud University Medical Center
<DISCLAIMER: The sole responsibility for the content of this presentation lies with the authors. It does not necessarily reflect the opinion of the European Union. The European
Commission is not responsible for any use that may be made of the information contained therein.>
This project is co-funded by the European
Union under the Seventh Framework
Programme (Grant Agreement No. 306141)
Framework for ethical analyses in HTA of
complex technologies
INTEGRATE-HTA
Assessing complexity of the technology (step 1)
- the characteristics tool
Characteristic
Short explanation
1. Multiple and
changing
perspectives
Many components (social, material, theoretical, and procedural), actors,
stakeholders, and organisational levels involved, which are interconnected
and interacting, and exposed to changes
2. Indeterminate
phenomena
The technologies or condition cannot be strictly defined or delimited due
to characteristics like flexibility, tailoring, self-organization, adaptivity and
evolution over time
3. Uncertain
causality
Synergy between components, feedback loops, moderators and mediators
of effect, context, symbolic value of the technology lead to uncertain causal
pathways between intervention and outcome
4. Unpredictable
outcomes
The outcomes of the technology may be many, variable, new, emerging and
unexpected
5. Ethical
complexity
Especially ethically complex due to contradicting basic ethical principles or
because fundamental moral or sociocultural values are at stake
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(step 1) - sources of information
• Stakeholder involvement
– Stakeholder Advisory Panels, traditional qualitative
interviews of individuals, or focus groups etc.
• Reflective thoughts’ drawing on assessor’s existing knowledge
• Literature
• Integrated scoping exercise
– the INTEGRATE-HTA Model by Wahlster et al.
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(step 1) - examples from (r)HBPC
Characteristic
Examples from r(HBPC)
1. Multiple and
changing
perspectives
- physical, psychological, social and spiritual components
- multiple interacting actors  changes in the actors perspectives
2. Indeterminate
phenomena
- range of HBPC models
- unclear target population: type of disease and timeliness
3. Uncertain
causality
- HBPC aims at being sensitive to preferences and adaptive to context: change in
interactions and relationship between patient, relatives, and providers  change the
course of care and outcome
4. Unpredictable
outcomes
- different individual needs in target populations  a range of outcomes
- continuously evolvement of HBPC  new / unexpected outcome
5. Ethical
complexity
- hardly any contradicting basic ethical principles embedded in HBPC
- fundamental moral values potentially at stake: dignity in a vulnerable situation.
Potential public controversy, e.g. if people perceive a pressure towards rHBPC
(partly) economically motivated
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Framework for ethical analyses in HTA of
complex technologies
INTEGRATE-HTA
Selecting ethical approach (step 2)
INTEGRATE-HTA
(step 2)
a) how do the ethical approaches fit the complexity profile
of the technology?
Multiple and
changing
perspectives
Indeterminate
phenomena
Uncertain
causality
Unpredictable
outcomes
Ethical
complexity
Principlism
Limited number of perspectives are included,
implication of interactions between agents are
partially included.
Questions related to indeterminacy are not Data required by the approach, indicates that
addressed.
methodological choices in the HTA process
may be partially addressed.
Ethical issues of outcomes are addressed, but
not the uncertainties in outcomes as such.
Resolvability conflicting of principles can be
illuminated, but not always overcome.
Casuistry
Analogues can provide solutions taking different
Analogues can provide potential
perspectives into account, but may not be suitable
conceptions of indefinite phenomena, but
for joining/synthesizing/com-promising perspectives, there is a threat of over-simplification.
or to address interconnectedness/interactions.
Analogues may address uncertainties.
However, whether the analogues will handle
relevant potential uncertainties cannot be
predicted.
Analogues may address un-predictability, but it
may also cloak basic or dynamic challenges,
such as unpredictable outcomes.
Casuistry is excellent for finding solutions to
morally challenging problems. However,
casuistry does not provide solutions to genuine
paradoxes and aporias. It may be useful to
highlight them, though.
Wide reflective
equilibrium
WRE can take into account multiple perspectives
and differences in judgement of moral properties.
Interaction between components may be addressed
in the WRE process. Control and decision-making is
issued by the aim of providing a coherent base for
this.
The moral implication of indeterminacy of
the technology or condition can be
revealed and explored in discussions
towards equilibrium.
Do not address moral issues related to
methodological choices in HTA in general, but
recognise the uncertainties from context
dependency and the importance of taking this in
to account.
Can accommodate different views of what
constitute relevant end points. Unexpected
outcomes may be interpreted as disruption of
the equilibrium, calling for a renewed debate.
WRE can reveal fundamental values at stake,
take value conflicts into account, elucidate
contractions and inform about their resolvability.
The aim of WRE is clear, but quality of reporting
is not explicitly addressed.
Social Shaping
of Technology
Interactive,
participatory
HTA
The triangular
model
SST aims at taking into account the perspectives of
various actors involved in the development and use
of a technology. Interactions between technology
and society are the main issue.
A level of indeterminacy of the health
Moral challenges related to HTA methods can
technology is a fundamental understanding be addressed due to the interactive nature of
SST.
in SST, which paves the way for
addressing ethical challenges related to
these uncertainties.
The approach is by principal not focused on
outcomes, but can contribute in identification of
unpredictable outcomes.
Fundamental values at stake should be
revealed, and the resolvability of possible
contradicting principles/values may be
elucidated.
iHTA is pre-eminently suited to take into account a
variety of perspectives, and interaction between
actors.
Indeterminacy of a technology and its use
is acknowledged.
Stakeholder involvement in the assessment
The approach is likely to increase the range of
process facilitates addressing ethical challenges outcomes taken into account, which indicate
in methodological choices.
that ethical challenges of this unpredictability
are also addressed.
Stakeholders may reveal fundamental moral or
socio-cultural values involved, and may
elucidate the resolvability of possible
contradicting principles/values.
A top-down (ethicist based) approach, different
perspectives can in the data collection step.
Alterative interpretation of the technology /
condition can be thematised when
considering available data in the ethical
analyses.
Do not address uncertainty in causal pathway
Unpredictability of outcomes is not addressed
directly, and methodological challenges thereof directly, but may be issued as part of the ethical
with moral implications. Takes into account the analyses (i.e. the therapeutic principle).
social context of the human person.
The approach tries to verify the solvability of
conflicting values in the light of personalist
framework, clarifies aim and scope of the
ethical analyses and contributes to
comprehensiveness and transparency of
reporting.
The HTA Core
Model
Different perspectives are included through
stakeholder involvements and cooperation with
experts in other HTA-areas. Interactions /
interrelations are not specified or related to ethical
implications.
Defining the technology and target group is
addressed in another domain of the model.
Ethical implications of indeterminacy of
technology / condition, are not addressed,
but an illustration of ethical relevance of
defining the target group is given.
Morally relevant issues related to methodoOutcome uncertainties are addressed in the
logical choices are addressed in the introduction “Beneficence/ nonmaleficence” issue, and in
some other part of the model.
to the core model, and to some extent in the
ethics domain. Factors contributing to uncertain
causality is no specifically included, but context
are indirectly though context dependent values.
Some fundamental values are directly
addresses, others may be revealed by
stakeholder involvement, which also may reveal
contradicting principles/ values. Whereas the
contribution to handling conflicting concerns is
limited. The (common) reporting structure
contributes to transparency.
The Socratic
approach
Ethical
guidance of
local HTAagency
Identifies actors and stakeholders, and their
perspectives, interest etc. Normative implications of
interactions between agents (and components in
general) are partly covered. Decision-making and
responsibilities are also touched upon.
Provides means for exploring various
definitions / under-standing of the
technologies. Moral impact of indeterminacy is not directly addressed, but may
be illuminated through related questions.
Morally relevant methodological choices in HTA Variety in outcome not specifically addressed,
are well addressed, which can contribute to
but rather a series of moral question about
different potential outcomes.
improvement in taking causal pathway
uncertainties into account.
Reveals fundamental values, and contribute to
elucidate contradictions. The clear descriptive
aim limits the contribution to handling conflicting
concern and contractions. Comprehensiveness
and transparency in reporting is emphasised.
Fill in
Fill in
Fill in
Fill in
Outcome
uncertainties are
addressed in the
“Beneficence/
nonmaleficence”
issue …
Fill in
The approach is
by principal not
focused on
outcomes …
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(step 2)
b) how do the ethical approaches fit the integration
perspective of the HTA agency/- commissioner
Subsume/Combine
Coordinate
Interactive
Principlism
Ethical assessments adopting Principlism are
generally performed in a top–down manner (a priori
principles where ethical assessments result in a
separate chapter in the HTA report and is limited to
identifying ethical issues
The principles are fixed and may be difficult to
coordinate with other issues
As the principles are fixed, it may be difficult to apply
in an interactive manner
Casuistry
Casuistry can be used subsumed or combined, as it
may be organized alongside other inquiries of
effectiveness, safety, and cost-effectiveness
Casuistry can be used in a coordinated way, adjusted Casuistry is a conservative method, in that it bases
to and adjusting to the other parts of the HTA
the handling new cases on solved solutions. Hence,
process
the background values and principles may not be
challenged
Wide Reflective
Equilibrium
Reflected equilibrium is not obtained in isolation
Equilibrium can result from coordinated parts
As the reflective process can also alter principles,
values, and background theories, WRE could be
used interactively
Social Shaping
of Technology
Based on social involvement, which is challenging in
a subsumed/ combined mode
SST can be used for coordination, but it will not be
the most efficient way to apply it
SST is interactive by nature
Interactive
technology
assessment
Based on social involvement, which is challenging in
a subsumed/ combined mode
Coordination is ok for iTA
iTA is interactive by nature
The triangular
model
Ethical analyses adopting triangular model generally The principles are fixed and hierarchical and may be
difficult to coordinate with other issues
result in a separate chapter in the HTA report. They
identify ethical issues and provide moral judgments in
a separate and top-down manner
As the principles are fixed and hierarchical, it may be
difficult to apply in an interactive manner
Axiological
(Socratic, the
HTA Core
model)
Ethical issues can be addressed independent of and
isolated from the other parts of the HTA process,
usually resulting in a separate chapter in the HTA
report
Presently being implemented this way, results are
uncertain due to limited stakeholder involvement
Ethics assessment has been co-ordinated with other
parts of the HTA process, and has played a
significant role in the HTA process as well as the
forming of the report and its conclusions
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(step 2)
c) how do the ethical approaches fit the local HTA policy of
aims for assessment vs. appraisal?
Principlism
Casuistry
Wide Reflective
Equilibrium
Social Shaping of
Technology
Interactive techno-logy
assessment (iHTA)
The triangular model
Axiological (Socratic,
the HTA Core model)
Assessment
Appraisal
Highlights a range of ethical issues.
Aims at resolving moral conflicts
Will normally direct towards specific solutions, and
may be less suitable for Assessment.
Will normally direct towards specific solutions, and
may be less suitable for Assessment.
Aims at resolving moral conflicts
Aims at framing and forming technology in
accordance with ethical values. May be less
suitable for assessment in the traditional sense.
May be less suitable for assessment in the
traditional sense (limited to highlighting normative
issues).
Highlights ethical issues related to human dignity
and human rights
Aims at exploring ethical issues
Aims at resolving moral conflicts
AimsWill
at resolving
moral
conflicts
normally
direct
towards
specific
solutions …
Aims at developing consensus
Aims at decision making based on the primacy of
dignity of human person
Does not direct the decision making process.
Aims at exploring ethical issues
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(step 2) – examples from (r)HBPC
a)
(r)HBPC was considered complex in terms of all five characteristics
 An Interactive technology approach (iHTA) appeared to be ‘best fit’, close
followed by Social Shaping of Technology (SST)
b)
According to the integration perspective on NICE (UK) the ethical
analysis is a subsumed part of the HTA, which favoured
 Principlism, Casuistry, the Triangular model and Axiological approaches
(Socratic, EUnetHTA)
c)
In the local HTA context policy in UK, the HTA is separated from the work
of the appraisal committee.
 an Axiological approach is most applicable when the aim of the HTA is
assessment
 Balancing these assessments against each other led to the selection of the
Socratic approach as the most suitable for assessing ethical aspects of
(r)HBPC in the local context
INTEGRATE-HTA
Framework for ethical analyses in HTA of
complex technologies
INTEGRATE-HTA
Confirming and modifying ethical approach (step 3)
• Possible shortcoming, and accompanied amendments, when
applying the approach to the specific complex technology can
be identify from:
– ethical relevant objectives and issues of the technology
extracted from the stakeholders information
– important features of the ethical approaches in general to
be aware of and consider, presented in table tool
INTEGRATE-HTA
(step 3) - features to consider
Principlism
Casuistry
Wide reflective
equilibrium
Social Shaping of
Technology
Interactive,
participatory HTA
Triangular model
The HTA Core
Model
The Socratic
approach
the stakeholder involvement process, … broaden the scope of
ethical analyses
use in an interactive way, to overcome some of the shortcomings
in addressing uncertainty, unpredictable outcomes, and ethical
complexity
ensuring that minority groups are considered. Improving the
decision making when principles are conflicting
how to handle unplanned/unintended use of the technology.
Acknowledge organisation and institutional limits of the approach
ensuring representative participation of all involved parties
the stakeholder involvement process, … broaden the scope of
ethical analyses
addressing the many complexity aspect in a more systematic
way, and clarification of the link between the methodological
approaches and assessment tables
addressing questions of decision making and responsibility, and
the moral impact of indeterminacy and uncertain of outcome
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(step 3) - examples from (r)HBPC and
the Socratic approach
• In (r)HBPC decisions need to be made throughout the illness
trajectory by various (professional and lay) stakeholders with
different perspectives and changing roles:
 Address moral questions re. decision making and
responsibilities
• Uncertainty of outcomes may relate to (in)adequacy of
professional and lay carer training:
 Address the moral implications: quality of care, safety and
trust in services
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Framework for ethical analyses in HTA of
complex technologies
INTEGRATE-HTA
Applying the ethical approach (step 4)
• a short introduction to the different approaches is provided
with reference to further reading
• consult ethicist if needed
• explore possible shared objectives with socio-cultural and/or
legal approaches - for quality and labour-saving purposes
• bilateral need for integration between aspects of the HTA
process
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Framework for ethical analyses in HTA of
complex technologies
INTEGRATE-HTA
Outcome of the ethical assessment (step 5)
• validation of outcome of the assessment by the different
relevant stakeholders
• an integrated approach should be considered
• supplemental analysis, as an iterative element, in the ethical
framework is important because of the many uncertainties in
complex health technologies
Thank you for your attention
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