Ah, but that’s not the pointRelevance and justification in the context of evaluating cochlear implants for deaf children

Prof. dr. G. J. van der WiltRadboud University Medical CentreDepartment of Epidemiology, Biostatistics & HTA

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)

The result of HTA:

Claims (and concerns) regarding the health care technology that has been studied, meant to support a judgment about its value.

Two questions about such claims and concerns:

Is it true?

Does it matter?

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

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)

“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.

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?

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

Moral principles or values that seem to be operative:

Respecting cultural diversityvs

Open future for (deaf) children

Basically, a hermeneutic stepInvolvement of stakeholders

Importance of Sign language to the cognitive and socio-emotional development of the deaf child

Critically important: Reinforcement modelvs

Unimportant or even adversive: Competition model

of the two linguistic modalities

Background theories

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

Wide reflective equilibrium

Judgment towards CI for deaf children:negativepositive

Background theory Moral principle

“open future”

respecting cultural diversity

competition model

reinforcement model

Relevance of perceived threat of pediatric CI to Deaf culture

Background theory seems to support respect for cultural diversity

Threat to Deaf culture should be considered relevant to the evaluation of pediatric CI

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

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.

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

Implications for HTA

Thank you for your attention!

Wide reflective equilibrium

Judgment towards CI for deaf children:negativepositive

Background theory Moral principle

“open future”

respecting cultural diversity

competition model

reinforcement model

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?

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

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.

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.

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?

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?

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

HTA

PlausibleRelevantAmenable to scientific research

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

HTA and beyond

Summative vs formative

Role of the HTA researcher

Required expertise