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Assessing Relevance in Health Technology Assessments
1. Ah, but that’s not the point
Relevance and justification in the context of
evaluating cochlear implants for deaf children
Prof. dr. G. J. van der Wilt
Radboud University Medical Centre
Department of Epidemiology, Biostatistics & HTA
2. The objective of HTA:
Assembling evidence which allows us
to judge the value of a health care
technology, to support (policy)
decisions (e.g., reimbursement)
3. The result of HTA:
Claims (and concerns) regarding the
health care technology that has
been studied, meant to support a
judgment about its value.
5. Considerable progress has been made
in scrutinizing the first –validity-
claim: identifying potential sources
of bias, estimating the risk of bias,
etc.
This is not true in case of scrutinizing
the second – relevance- claim: how
do we establish what is, and what is
not relevant when assessing the
value of a health care technology?
Objective: Explore methods for
assessing relevance
6. Case study: pediatric cochlear
implantation
“…demeans Deaf people, belittles
their culture and language, and
makes no acknowledgment of the
diversity of lives Deaf people lead,
or their may achievements.”
Deaf Australia, , Policy on Cochlear
Implants. (www.deafau.org.au
accessed on June 16th 2012)
7. “But if Deafness is a culture rather
than a disability, it is an
exceedingly narrow one.”
DS Davis, Hastings Center Report
1997; 27 (2): 7 – 15.
8. How can we establish relevance?
Poses a dilemma to the HTA
researcher: which claims and
concerns seem to be sufficiently
relevant to warrant further inquiry
into their validity?
Is there a way of doing this in a more
systematic way, justifying
selections and conclusions to a
wider public?
9. Approach: Wide Reflective
Equilibrium
1. What are the moral principles or
values that seem to guide our
judgment?
2. Is there any background theory
that lends differential to support to
either of these principles?
3. Try to achieve optimal coherence
10. Moral principles or values that seem
to be operative:
Respecting cultural diversity
vs
Open future for (deaf) children
Basically, a hermeneutic step
Involvement of stakeholders
11. Background theories
Importance of Sign language to the
cognitive and socio-emotional
development of the deaf child
Critically important: Reinforcement
model
vs
Unimportant or even adversive:
Competition model
of the two linguistic modalities
12. Is there any evidence favoring either
the competition model or the
reinforcement model (of Sign and
spoken language)?
Yes there is: children who have
highest proficiency in Sign language
before implantation benefit most
from CI (in terms of development of
spoken language). Preisler et al, 2002
13. Wide reflective equilibrium
Judgment towards CI for deaf children:
negative
positive Relevance of perceived threat
of pediatric CI to Deaf culture
competition model “open future”
reinforcement model respecting cultural diversity
Background theory Moral principle
14. Background theory seems to support
respect for cultural diversity
Threat to Deaf culture should be
considered relevant to the
evaluation of pediatric CI
15. Judgment of pediatric CI may change
if provision of CI is conditional on
offering and uptake of Sign
language to / by (parents of) deaf
children (as is the case in Sweden)
Practice would then be consistent with
both values, respecting cultural
diversity and creating an open
future for the child
Dependent on (provisional)
acceptance of mutual reinforcement
model of the two linguistic
modalities
16. HTA: claims and concerns about a health care
technology as a basis for a value judgment
Is it true?
Does it matter?
Unless good reasons can be given in support of
both of these claims, a value judgment and
associated coverage decision cannot be
justified
Methods have been developed in the field of
ethics that may be used to do this in a more
systematic way.
17. Implications for HTA
Quality of an HTA partly depends on whether
we have been sufficiently comprehensive in
producing claims and concerns related to the
health care technology
Stakeholder consultation may be crucially
important to achieve this
Important task of the HTA researcher is to
address both, empirical adequacy and
relevance of the various claims and concerns
HTA researchers may decide to take one step
further, and not only conduct a summative,
but also a formative evaluation
This could greatly enhance legitimacy of HTA
and ensuing decisions
19. Wide reflective equilibrium
Judgment towards CI for deaf children:
negative
positive
competition model “open future”
reinforcement model respecting cultural diversity
Background theory Moral principle
20. Approach 2: Specifying norms
What are the general norms that are
in conflict and that explain why we
are uncertain as to how we should
proceed?
Can these general norms be specified
in such a way, that the conflict is
resolved and the original rationale
of the unqualified norm is still
captured in what we propose to do?
21. Specifying norms
Generally speaking, one should raise a child in a
way that leaves open a wide range of future
options (capability approach)
Generally speaking, one should respect choices
that parents make for their children that reflect
key elements of their culture
22. Specifying norms
Generally speaking, one should raise a child in a
way that leaves open a wide range of future
options (capability approach), and that does not
lead to alienation* of the child from its roots
(* ‘to make unfriendly, hostile, or indifferent,
especially where attachment formerly existed’,
Webster)
Generally speaking, one should respect choices
that parents make for their children that reflect
key elements of their culture, as long as such
choices are consistent with full inclusion in
existing institutions.
23. Specification (qualifying our moral
commitments in specific cases) may
resolve the conflict, favoring CI,
provided that it is associated with
offering Sign language to parents of
deaf children.
24. Approach 3: casuistry
Reasoning by analogy
What are typical (paradigmatic) cases
where cultural identity should (not)
be respected?
What are the differences and
commonalities with the case under
investigation?
25. Exploring relevance: In exceptional
cases only?
No. The issue of relevance is always
at stake.
We calculate incremental cost-utility
ratios. Why, what is the value which
renders such data relevant?
We generally do not explore whether
the introduction of a health care
technology either mitigates or
reinforces existing inequalities in
health. Why not?
26. Ah, but that’s not the point
Were the right options examined?
Were the appropriate dimensions
explored?
Many controversies can probably best
be understood in terms of
disagreements regarding relevance,
rather than validity
28. Reconstructing the argument
1. The acquisition of proficiency in
Sign language and in spoken
language interfere with each other
(‘competition model’)
2. Early development of SL will
negatively affect the impact of CI
3. If an ‘open future’ for the deaf
child is preferred (Davis), then SL
should not be developed
4. This would constitute a threat to
Deaf culture
What evidence is considered necessary and sufficient to draw conclusions regarding the value of the health care technology under study?
Typically: “The results of our study show that [the technology] is safe and effective in [controlling pain, restoring function, lowering blood pressure, etc] and constitutes an efficient way of spending resources to improve longevity and / or quality of life.”
Implicitly, then, it is claimed that the collected evidence is (internally and externally) valid, and that it is relevant (necessary and sufficient?) to the assessment of the value of the health care technology under study
Or what is more and what is less relevant (relevance not being an all-or-none property). Could there also be something as ‘nomative bias’?
“ CI is a threat to Deaf culture.” Is it true? Does it matter?
Challenging the relevance of the concern (based on a judgment of the value of Deaf culture)
Viewed most generally, a “reflective equilibrium” is the end-point of a deliberative process in which we reflect on and revise our beliefs about an area of inquiry, moral or non-moral. The inquiry might be as specific as the moral question, “What is the right thing to do in this case?” or the logical question, “Is this the correct inference to make?” Alternatively, the inquiry might be much more general, asking which theory or account of justice or right action we should accept, or which principles of inductive reasoning we should use. (Daniels, Reflective equilibrium. Stanford Encyclopedia of Philosophy, 2011.
Viewed most generally, a “reflective equilibrium” is the end-point of a deliberative process in which we reflect on and revise our beliefs about an area of inquiry, moral or non-moral. The inquiry might be as specific as the moral question, “What is the right thing to do in this case?” or the logical question, “Is this the correct inference to make?” Alternatively, the inquiry might be much more general, asking which theory or account of justice or right action we should accept, or which principles of inductive reasoning we should use. (Daniels, Reflective equilibrium. Stanford Encyclopedia of Philosophy, 2011.
Viewed most generally, a “reflective equilibrium” is the end-point of a deliberative process in which we reflect on and revise our beliefs about an area of inquiry, moral or non-moral. The inquiry might be as specific as the moral question, “What is the right thing to do in this case?” or the logical question, “Is this the correct inference to make?” Alternatively, the inquiry might be much more general, asking which theory or account of justice or right action we should accept, or which principles of inductive reasoning we should use. (Daniels, Reflective equilibrium. Stanford Encyclopedia of Philosophy, 2011.
Here: observation by Paul Feyerabend, on the selection of research programmes for funding.
A positive judgement towards CI for deaf children coheres with an emphasis on an open future for deaf children and with a competition model regarding Sign and spoken language. A more negative judegment towards CI in deaf children coheres with an emphasis on respect for cultural diversity and a reinforcement model regarding Sign and spoken language.
Which is practice in Sweden
Which is practice in Sweden
A positive judgement towards CI for deaf children coheres with an emphasis on an open future for deaf children and with a competition model regarding Sign and spoken language. A more negative judegment towards CI in deaf children coheres with an emphasis on respect for cultural diversity and a reinforcement model regarding Sign and spoken language.