Addressing ethical issues of complex interventions in HTA - PowerPoint Presentation

Slide1

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 Hofmannaa University of Oslo b University of Sheffield c ECORYS Rotterdam, d University of Bremen e Università Cattolica del Sacro Cuore, Romef Radboud University Medical Center

This project is co-funded by the European Union under the Seventh Framework Programme (Grant Agreement No.

306141)

<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.>Slide2

Framework for ethical analyses in HTA of complex technologies

INTEGRATE-HTASlide3

Assessing complexity of the technology (step 1

)- the characteristics toolINTEGRATE-HTACharacteristic Short explanation1. Multiple and changing perspectivesMany components (social, material, theoretical, and procedural), actors, stakeholders, and organisa­tional levels involved, which are interconnected and interacting, and exposed to changes2. Indeterminate phenomenaThe technologies or condition cannot be strictly defined or delimited due to characteristics like flexibility, tailoring, self-organization, adaptivity and evolution over time3. 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 outcome4. Unpredictable outcomesThe outcomes of the technology may be many, variable, new, emerging and unexpected5. Ethical complexityEspecially ethically complex due to contradicting basic ethical principles or because fundamental moral or sociocultural values are at stakeSlide4

(step 1) -

sources of informationINTEGRATE-HTAStakeholder involvement Stakeholder Advisory Panels, traditional qualitative interviews of individuals, or focus groups etc.Reflective thoughts’ drawing on assessor’s existing knowledge LiteratureIntegrated scoping exercisethe INTEGRATE-HTA Model by Wahlster et al.Slide5

(step 1) - examples from (r)HBPC

INTEGRATE-HTACharacteristic Examples from r(HBPC)1. Multiple and changing perspectives- physical, psychological, social and spiritual components- multiple interacting actors  changes in the actors perspectives2. 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

ba

sic ethical principles embedded in HBPC

-

f

undamental moral values potentially at stake:

dignity in a vulnerable situation. Potential public controversy, e.g. if people

perceive a

pressure towards

rHBPC

(partly) economically

motivatedSlide6

Framework for ethical analyses in HTA of complex technologies

INTEGRATE-HTASlide7

Selecting

ethical approach (step 2)INTEGRATE-HTASlide8

(step 2)

a) how do the ethical approaches fit the complexity profile of the technology?INTEGRATE-HTAMultiple and changing perspectivesIndeterminate 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 addressed.

Data required by the approach, indicates that 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 perspectives into account, but may not be suitable for joining/synthesizing/com-promising perspectives, or to address interconnect­ed­ness/interactions.

Analogues can provide potential conceptions of indefinite phenomena, but there is a threat of over-simplification.

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

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 technology is a fundamental under­standing in SST, which paves the way for addressing ethical challenges related to these uncertainties.

Moral challenges related to HTA methods can be addressed due to the interactive nature of SST.

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.

Interactive, participatory

HTA

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 process facilitates addressing ethical challenges in methodological choices.

The approach is likely to increase the range of outcomes taken into account, which indicate 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.

The triangular model

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 directly, and methodological challenges thereof with moral implications. Takes into account the social context of the human person.

Unpredictability of outcomes is not addressed directly, but may be issued as part of the ethical analyses (i.e. the therapeutic principle).

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 methodo­logical choices are addressed in the introduction 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.Outcome uncertainties are addressed in the “Beneficence/ nonmaleficence” issue, and in some other part of the model.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 approachIdentifies 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 are well addressed, which can contribute to improvement in taking causal pathway uncertainties into account.Variety in outcome not specifically addressed, but rather a series of moral question about different potential outcomes.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.Ethical guidance of local HTA- agency Fill inFill inFill inFill inFill in

Outcome uncertainties are addressed in the “Beneficence/ nonmaleficence” issue …

The

approach is by principal not focused on

outcomes …Slide9

(step 2)

b) how do the ethical approaches fit the integration perspective of the HTA agency/- commissionerINTEGRATE-HTA Subsume/Combine CoordinateInteractive

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 to and adjusting to the other parts of the HTA process

Casuistry is a conservative method, in that it bases the handling new cases on solved solutions. Hence, 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 result in a separate chapter in the HTA report. They identify ethical issues and provide moral judgments in a separate and top-down manner

The principles are fixed and hierarchical and may be difficult to coordinate with other issues

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

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

Presently being implemented this way, results are uncertain due to limited stakeholder involvement

Based on social involvement, which is challenging in a subsumed/ combined

mode

…

identify ethical issues and provide moral judgments in a separate and top-down

mannerSlide10

(step 2)

c) how do the ethical approaches fit the local HTA policy of aims for assessment vs. appraisal?INTEGRATE-HTA AssessmentAppraisal Principlism

Highlights a range of ethical issues.

Aims at resolving moral conflicts

Casuistry

Will normally direct towards specific solutions, and may be less suitable for Assessment.

Aims at resolving moral conflicts

Wide Reflective Equilibrium

Will normally direct towards specific solutions, and may be less suitable for Assessment.

Aims at resolving moral conflicts

Social Shaping of Technology

Aims at framing and forming technology in accordance with ethical values. May be less suitable for assessment in the traditional sense.

Aims at resolving moral conflicts

Interactive techno-logy assessment (

iHTA

)

May be less suitable for assessment in the traditional sense (limited to highlighting normative issues).

Aims at developing consensus

The triangular model

Highlights ethical issues related to human dignity and human rights

Aims at decision making based on the primacy of dignity of human person

Axiological (Socratic, the HTA Core model)

Aims at exploring ethical issues

Does not direct the decision making process.

Will normally direct towards specific

solutions

…

Aims

at exploring ethical

issuesSlide11

(step 2) –

examples from (r)HBPCINTEGRATE-HTA(r)HBPC was considered complex in terms of all five characteristicsAn Interactive technology approach (iHTA) appeared to be ‘best fit’, close followed by Social Shaping of Technology (SST)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)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 assessmentBalancing 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 Slide12

Framework for ethical analyses in HTA of complex technologies

INTEGRATE-HTASlide13

Confirming and modifying ethical approach (step 3)

INTEGRATE-HTAPossible 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 informationimportant features of the ethical approaches in general to be aware of and consider, presented in table toolSlide14

INTEGRATE-

HTAPrinciplismthe stakeholder involvement process, … broaden the scope of ethical analysesCasuistryuse in an interactive way, to overcome some of the shortcomings in addressing uncertainty, unpredictable outcomes, and ethical complexity

Wide reflective equilibrium

ensuring

that minority groups are considered. Improving the decision making when principles are

conflicting

Social Shaping of Technology

how

to handle unplanned/unintended use of the technology. Acknowledge organisation and institutional limits of the

approach

Interactive, participatory

HTA

ensuring

representative participation of all involved parties

Triangular model

the

stakeholder involvement process,

… broaden

the scope of ethical

analyses

The HTA Core Model

addressing

the many complexity aspect in a more systematic way, and clarification of the link between the methodological approaches and assessment

tables

The Socratic approach

addressing

questions of decision making and responsibility, and the moral impact of indeterminacy and uncertain of

outcome

(

step 3

) - features to considerSlide15

(

step 3) - examples from (r)HBPC and the Socratic approachINTEGRATE-HTAIn (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 responsibilitiesUncertainty of outcomes may relate to (in)adequacy of professional and lay carer training:Address the moral implications: quality of care, safety and trust in servicesSlide16

Framework for ethical analyses in HTA of complex technologies

INTEGRATE-HTASlide17

Applying the ethical approach (step 4

)INTEGRATE-HTAa short introduction to the different approaches is provided with reference to further readingconsult ethicist if neededexplore 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 processSlide18

Framework for ethical analyses in HTA of complex technologies

INTEGRATE-HTASlide19

Outcome of

the ethical assessment (step 5)INTEGRATE-HTAvalidation of outcome of the assessment by the different relevant stakeholdersan 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 technologiesThank you for your attention