Methodological guidance documents for evaluation of ethical considerations in health technology assessment: a systematic review

Methodological guidancedocuments for evaluation ofethical considerations inhealth technologyassessment: a systematicreviewExpert Rev. Pharmacoecon. Outcomes Res. 14(2), 203–220 (2014)

Nazila Assasi*1,2,Lisa Schwartz2,3,Jean-Eric Tarride2,Kaitryn Campbell1,2

and Ron Goeree1,2

1Programs for Assessment of

Technology in Health (PATH) Research

Institute, McMaster University,

Hamilton, ON, Canada2Department of Clinical Epidemiology

and Biostatistics, McMaster University,

Hamilton, ON, Canada3Centre for Health Economics and

Policy Analysis, McMaster University,

Hamilton, ON, Canada

*Author for correspondence:

Tel.: +1 905 523 7284

Fax: +1 905 522 0568

[email protected]

Despite the advances made in the development of ethical frameworks for health technologyassessment (HTA), there is no clear agreement on the scope and details of a practicalapproach to address ethical aspects in HTA. This systematic review aimed to identify existingguidance documents for incorporation of ethics in HTA to provide an overview of theirmethodological features. The review identified 43 conceptual frameworks or practicalguidelines, varying in their philosophical approach, structure, and comprehensiveness. Theywere designed for different purposes throughout the HTA process, ranging from helpingHTA-producers in identification, appraisal and analysis of ethical data to supporting decision-makers in making value-sensitive decisions. They frequently promoted using analyticalmethods that combined normative reflection with participatory approaches. The choice of amethod for collection and analysis of ethical data seems to depend on the context in whichtechnology is being assessed, the purpose of analysis, and availability of required resources.

KEYWORDS: ethics • frameworks • health technology assessment • methodology • systeamtic review

Health technology assessment (HTA) isdefined as a multidisciplinary process ofstudying the medical, social, ethical and eco-nomic implications of development, diffusionand use of a particular health technology [1].Although there is a general consensus on theimportance of ethical assessment as a part ofHTA [2–4], the evaluation of ethical issues isfrequently neglected in the development ofthe majority of HTA reports. An analysis of680 HTA reports produced by six Canadianagencies between 1997 and 2006 showsthat only 17% addressed ethical issues [5]. Asurvey of 223 HTA reports, publishedbetween 2003 and 2006, by nine differentagencies (five in Canada, two in the UK, onein Denmark and one in the USA) showedthat only 5% reports were considered asethical, social and organizational issues

in addition to clinical and economic evalua-tions [6].

Given the different nature and goals of eth-ical evaluation, its scarcity in mainstreamHTA is understandable [4]. Unlike clinicaland economic assessments, which seek to cor-rectly explain and predict outcomes of a tech-nology using empirical data, ethical analysistends to look for ethical values and use philo-sophical theories to justify certain reasons forimplementation of a technology or otherwise.Therefore, different approaches must be usedto tackle ethical issues in HTA, in whichHTA practitioners may not necessarily havespecialized knowledge and skills. The currentliterature recognizes insufficient methodologyas one of the challenges related to lackof incorporation of ethics in HTA andhighlights the need to improve methods of

informahealthcare.com 10.1586/14737167.2014.894464 � 2014 Informa UK Ltd ISSN 1473-7167 203

Review

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identifying and analyzing ethical concerns raised by healthcaretechnologies [2,3].

While advances have been made in the development of ethi-cal frameworks for HTA, there is no clear agreement on themost useful and practical approach to address ethical aspects [7].Moreover, uncertainty remains about appropriate scope andlevel of details regarding ethical frameworks for HTA [8–11].A number of studies have been conducted to evaluate ethicalanalysis methods applied in HTA reports [11,12,8,9]. These studieshave described frequently used methodological approaches foraddressing ethical issues, but none of them has critically evalu-ated characteristics of such methodologies.

The purpose of this article is to systematically review the lit-erature to identify existing guidance documents for incorpo-ration of ethics in HTA in order to provide a comprehensiveoverview of their methodologies and to gain a better under-standing of the areas of commonality and divergence betweendifferent frameworks or guidelines.

Systematic review of the literatureMethods

Data sources & study selection

A systematic search of literature was undertaken, without limitsof time and language, to identify methodological frameworkspublished up to 1 October 2013. The following bibliographicdatabases were searched through the Ovid interface: Medline,EMBASE and PsycINFO. Parallel searches were run inPubMed, Wiley’s Cochrane Library and the Centre for Reviewsand Dissemination’s HTA database. The search strategyincluded a combination of text words and Medical SubjectHeadings terms and synonyms of ethics, HTA and methodol-ogy. Suggestions made by Droste [13] and Niederstadt [14] wereused as a guide for the selection of ethics-related search terms.The details of the search strategy are presented in SUPPLEMENTARY

APPENDIX 1 (supplementary material can be found online at www.informahealthcare.com/suppl/10.1586/14737167.2014.894464).Additionally, gray literature was identified by searching the web-sites of selected HTA agencies (SUPPLEMENTARY APPENDIX 1) and review-ing the bibliographies of key articles and through contacts withappropriate experts.

Articles were included if they were methodological papersproviding formal conceptual or practical frameworks, models ortools for dealing with ethical aspects of health technologies; orHTA guidelines containing instructional guidance for address-ing ethical issues. Both generic and technology-sensitive guid-ance documents were deemed relevant for inclusion. Citationsthat primarily offered a theoretical discussion or comments onif and why ethics should be included in HTA were excludedfrom this review. Ethical frameworks developed for assessmentof nonhealthcare technologies (e.g., information technology) orfor purposes other than HTA were also excluded.

Titles and abstracts of all articles were screened by two inde-pendent reviewers to exclude the articles that clearly did notmatch the inclusion criteria. The remaining articles wereretrieved and assessed for eligibility by one reviewer and

checked by the other. Disagreements were resolved byconsensus.

Data abstraction & synthesis

The included papers were grouped into: scholarly methodologi-cal articles presenting ethical frameworks, models or tools forHTA, from here on referred to as ‘frameworks’; and methodo-logical guidance for incorporation of ethics in HTA, publishedby HTA-related organizations, from here on referred to as‘guidelines’. Guidelines could be published as manuals, hand-books or online guidance documents. The articles were thor-oughly scrutinized to get a sense of common themes ormethodological considerations. All articles with a normativeanalysis component were read thoroughly to identify the ethicaltheories they utilized as lenses to understand different issuesaround healthcare technologies and as foundations to buildtheir frameworks or models such as: utilitarianism (which pro-motes maximization of benefits for the greatest number of peo-ple), deontological ethics (which focuses on duties, rules andobligations), virtue ethics (which emphasizes moral characterand virtues of individuals) or feminist perspectives (which areconcerned with context, power balance in decision-making andindividual situations) [15]. The guidance documents were fur-ther evaluated for their areas of focus, and methodologicalapproaches through which the users are instructed to collect,appraise, synthesize or interpret ethical data. Data were alsoabstracted on practical tools provided to help address ethicalissues, case studies presented to facilitate understanding of thesuggested approach or model in practice, level of stakeholderengagement and required expertise. The results were summa-rized in both text and tabular forms.

Results

A total of 1474 potential citations were identified through thesystematic search, of which 1346 citations were excluded aftertitle and abstract review, leaving 128 citations for the full-textassessment. Of these 128 citations, 85 were eliminated becausethey did not meet the eligibility criteria, leaving a total of21 methodological articles and 22 HTA guidelines for inclusionin this review. FIGURE 1 shows the detailed study selection process.

Frameworks published as scholarly articles

All of the included frameworks were published in Englishbetween 1999 and 2012. Seventeen of the 21 frameworks sug-gested a generic approach applicable to all health technologies[13,16–18,19–31], whereas the remaining 4 provided a methodologi-cal approach or model that could be used in the context of aspecific group of technologies [32–35]. A general summary of theincluded articles is shown in TABLE 1.

Theoretical foundation

None of the proposed frameworks or models was based on a sin-gle moral theory. The majority of authors either implicitly orexplicitly pursued a pluralistic approach to explain their concep-tual or procedural frameworks. Moral pluralism, also referred to

Review Assasi, Schwartz, Tarride, Campbell & Goeree

204 Expert Rev. Pharmacoecon. Outcomes Res. 14(2), (2014)

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https://www.researchgate.net/publication/6781596_Just_Another_Reproductive_Technology_The_Ethics_of_Human_Reproductive_Cloning_as_an_Experimental_Procedure?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==

https://www.researchgate.net/publication/28364686_Ethical_evaluation_in_health_technology_assessment_reports_An_eclectic_approach?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==

as an ‘eclectic’ approach by some authors[23,16,31], emphasizes examining a technol-ogy and its consequences from multipleethical perspectives in order to arrive at arobust judgment, to address the complex-ity of ethical dilemmas and uncertaintiesaround healthcare technologies and to bet-ter justify HTA decisions [16–27,35].

Areas of focus

The authors of the included frameworksidentified a wide range of ethical areasthat might be relevant in HTA. Hof-mann [23] listed a set of questions relatedto: fundamental moral issues such asbenefits and risks, autonomy, humanrights, integrity, dignity, obligations,social and cultural values, legal issuesand justice; stakeholders; technology;methodological choices in HTA; andthe HTA process. The main ethicaldomains that were suggested by theremaining frameworks included: bene-fit and harm (safety) [13,18,28,32–34],autonomy [13,28,32–34], equity (fairness ordistributive justice) [13,16,18,22,31], stake-holder values [21,22,25–29,31,35], utility [18],acceptability [20,34,31], psychological im-pact [20,31], impact on family and caregivers [31,33], quality of life [33,13], effi-ciency [18], opportunity cost [31,18] andethical issues related to appropriatenessof methods chosen for economicevaluations [17].

Procedural guidance

We classified the included frameworks to four general catego-ries based on the procedural approaches they took: reflectionthrough ethical principles and theories (classical methods); sup-plementing classical methods with participatory and interactiveapproaches; providing pragmatic tools for obtaining and syn-thesizing ethical data; and frameworks for discussion of ethicaldata for making HTA decisions.

Frameworks proposing classical methods for ethical reasoning

Principlism [28,32–34] justifies action through adherence to ethicalprinciples. HTA, like most health related literature, generallypromotes the use of Beauchamp and Childress’ four fundamen-tal principles of bioethics including beneficence (responsibilityto maximize benefits), nonmaleficence (to avoid causing harm),respect for autonomy (respecting the decision-making capacityof individuals) and justice (equitable distribution of benefitsand costs) [36].

Casuistry [24,29] is presented as a case-based reasoningmethod, which starts from the description of a particular case

and compares ethical dilemmas around this case with examplesof ethical dilemmas related to similar cases to identify the para-digm that best fits the case.

Coherence analysis [26] attempts to reflect on the consistencyof various ethical components that are generally used in ethicalreasoning, such as theories, principles and value judgments,without being directive in terms of which argument is morerelevant.

Frameworks proposing classical methods supplemented by

participatory approaches

Wide reflective equilibrium (WRE) [27] is described as a delib-erative method for establishing a decisional balance through abroad social reflective process. In WRE, stakeholders and citi-zens discuss the normative justification for a HTA decisionuntil a state of balance is achieved within a wide set of moralvalues and beliefs.

Axiology-based value analysis [17,22] is a reasoning modelthat is concerned about values (beliefs and social attitudes aswell as monetary values), their origins, inter-relationships and

Records identified throughdatabase search

(n = 1931)

Additional records identifiedthrough other sources

(n = 31)

Records after duplicatesremoved

(n = 1474)

Titles and abstractsscreened(n = 1474)

Records excluded(n = 1346)

Full-text articles assessedfor eligibility

(n = 128)

Full-text articles excluded(n = 85)

Reasons for exclusion: – Academic discussion papers on ethics and HTA (39) − HTA-related frameworks or guidelines with no ethics component (24) − Ethical frameworks not related to HTA (7) − Systematic or qualitative reviews (9) − Duplicate publications (4) − Unable to translate (2)

Articles included (n = 43)Scholarly articles (21)HTA guidelines (22)

Figure 1. Study selection flow diagram.HTA: Health technology assessment.

Methods for evaluation of ethics in HTA Review

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https://www.researchgate.net/publication/43493712_The_Principles_of_Biomedical_Ethics?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==

Table

1.Overview

oftheincludedmethodologicalscholarlyarticlesto

address

ethicalissu

esin

healthtech

nologyassessment.

Study

(year)

Countryof

origin

Methodological

approach

Description

Ethicalanalysis

tools

Case

study

Ref.

Culyeran

d

Bombard

(2012)

Canad

aAneclecticapproach

forconsiderationof

equityissues

Thisframework

forHTA

lists

13eq

uitydomains

tobetakenconsideredin

HTAproceduresand

decisions.These

include:‘equityvs

equality,

adequacy

ofdomainsofequity,

legalobligations,

generalprinciples,em

bed

ded

inequity,

institutionalbias,im

plicitstereotyping,contexts

andcircumstances,processes

inHTA,hidden

opportunitycosts,processesin

deliveryofcare,

specialclaim

sandcumulative

effects’

Achecklistconsisting

ofsets

ofquestionsfor

variousdomainsof

framew

ork

None

[16]

Burlsetal.

(2011)

Multinational

Ethicalreflectionatthe

axiologicallevel

Thiscontext-sensitive

framew

ork,whichconsists

oftargetedquestionsaboutthecharacteristicsof

aselected

technologyandethicalissuesaround

itsim

plementationanduse,has

beendeveloped

basedontherecommendationsofagroupof

expertsfrom

16INAHTAmemberag

encies

Asetof13questions

None

[17]

Goetghebeur

etal.(2010)

Canad

aMCDA

Thefram

ework

includesfourquan

tifiab

le(quality

ofevidence,disease,interventionandeconomics)

andsixnonquantifiable

(threeethicalandthree

healthcare

system

related)elements

tofacilitate

decisionmakingab

outhealthtechnologies.The

ethicalcomponentsuggeststheprinciplesof

utility,

efficiency

andfairness

tobeconsideredin

combinationwiththegoalofhealthcare,

opportunitycostsan

dpopulationpriorities

MCDAvaluematrix

consistingofquestions

relatedto

15

quan

titative

andsix

ethicalandsystem-

relatedcomponents.

Growth

horm

onefor

turnersyndrome

[18]

Drosteetal.

(2010)

Germ

any

Systematicretrievalof

inform

ation

Thearticle

recognizestheneedforaseparately

perform

edsystematicsearchofinform

ation

relatedto

ethicalaspectsofhealthtechnologies

andproposesamultistepmethodologyfor

identificationan

dselectionofavailable

inform

ationsources,designingandexecutionof

searchstrategies,retrievalofinform

ation,

reportingthesearchresultsandrelevantquality

check

practices

Searchterm

sand

strategiestailoredto

relevantinform

ation

sources

None

[13]

Sacchinietal.

(2009)

Italy

Triangularmodel

for

integratingethicsin

HTA

Thismodelseeksto

relate

biomedical,

anthropologicalandethicalaspectsofhealth

technologiesthroughthreestep

s:collectionof

factualdata

aboutthetechnology;

anthropologicalanalysisto

understandvaluesan

d

justifyfacts;an

dethical

evaluationat

a

norm

ativelevelto

guidedecisionmaking

None

None

[19]

BRACAgen

es:Tu

morsuppressorgen

es,also

knownas

thebreastcancergen

es;CHD:Coronaryheartdisease;CP:Cereb

ralpalsy;HTA

:Healthtechnologyassessmen

t;IVF:Invitrofertilization;MCDA:Multicriteriadecisionan

alysis.



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Table

1.Overview


address

ethicalissu

esin

healthtech

nologyassessment(cont.).

Study

(year)

Countryof

origin

Methodological

approach

Description

Ethicalanalysis

tools

Case

study

Ref.

Johnsonetal.

(2009)

Can

ada

Amulticriteria

fram

ework

forHTA

decisions

Theframew

ork

suggeststhefollowingdecision

determ

inants

beconsideredin

HTA

:clinical

benefit,consistency

withsocietalan

dethical

values

(relatedto

thetechnologyandits

consequences),valueformoneyandfeasibility

of

adoptioninto

thehealthsystem,as

decision

determ

inants

thatshould

beconsideredin

HTA

None

None

[30]

Autti-Ramo

andMakela

(2007)

Finland

Eclecticapproach

Thearticle

suggestsan

eclecticapproach

for

evaluationofethicalaspectsrelatedto

the

technologyandconsequencesofits

implemen

tationbeevaluatedcontinuously

throughouttheHTAprocess

(withthehelp

ofan

ethicalexpert,ifneeded).Theauthors

emphasis

ontheidentificationofrelatedstakeholders

and

repeatingtheethicalappraisalafew

times

duringtheHTAprocess.Ethicalconsiderations

are

recommendedto

bepresentedin

aseparate

chapter

None

None

[31]

Doumaet

al.

(2007)

The

Netherlan

ds

Constructive

technologyassessment

Themethodfocusesondynam

icsoftechnology

anditsinteractionswiththeenvironment/society

andsuggests

thatdepen

dingondynam

icsof

developmentandim

plementationoftechnology,

theassessm

entshould

address

acombinationof

clinical,economicandpatient-related(social/

environmentalim

pact,ethics,acceptability,

psychologicalreactions,patientcenteredness,

etc.)andorganizationalaspects

None

Microarrayanalysisfor

breastcancer

[20]

Lessard

(2007)

Can

ada

Complexadaptive

systems(complexity)

theory

Thisconceptualframework

recognizesthe

complexity

ofassessmentofhealthcare

technologiesandtheim

portance

ofreflexivity

andconsiderationofcontextual

elements

(individualandsocietal)andmultiple

perspectives

ineconomicevaluationsofhealthtechnologies

None

None

[21]

Hofm

ann

(2005)

Norw

ay

Valuean

alysis/axiology

Thearticlepresentsaconceptualframework

for

thinkingaboutvalue-laden

nessoftechnologyand

variousaspectsofHTA

(e.g.,scientific,economic,

professionalan

dmoral)andemphasizesonthe

importance

ofiden

tifyingvaluesinvolvedin

development,im

plementationandutilizationof

thetechnologyanddiscussingtheinterrelation

betw

eendifferenttypesofvalues

None

None

[22]

BRACAgen

es:Tu

morsuppressorgen

es,also

knownas

thebreastcancergen


ralpalsy;HTA



alysis.



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Table

1.Overview


address

ethicalissu

esin

healthtech


Study

(year)

Countryof

origin

Methodological

approach

Description

Ethicalanalysis

tools

Case

study

Ref.

Hofm

ann

(2005)

Norw

ayMoralpluralism

Thearticle

seeksto

introduce

apracticaleclectic

approach

toaddress

moralissuesin

HTAand

providesalistofquestionsconcerningawide

rangeofmoralissuesrelatedto

thetechnology,

thestakeholdersandtheHTAmethodologyand

process.Variousquestionsin

thischecklist

presentdifferentmoraltheories,forexample,

utilitarian,deontological,principlism,social

shapingoftechnology,

casuistry,

virtueethics

andcriticaltheory

Achecklistof

33moralquestions

None

[23]

Giacomini

(2005)

Canad

aCasuistry

Casuistican

alysis(case–basedecisionmakingby

analogicalreasoning)issuggestedto

be

perform

edthroughappraisalofthetechnology

andresourcesrequiredforitsim

plementation,

throughidentificationofprecedenttechnologies

(paradigmaticcases)similarto

thetechnologyof

interest,comparisonbyanalogyandintegrating

theresultsto

thedecision-m

akingcycle

None

IVF,

Viagra

and

predictive

gen

etic

testing

[24]

Clausenand

Yoshinaka

(2004)

Denmark

Social

shapingof

technology

Thisan

alyticalapproach

isconcernedwiththe

mutual

influen

ceoftechnologyandsociety

on

shapingoftechnology.

Themethodregards

technological(content)andsocietal(context)

aspectsofthetechnologyequally

importantand

suggeststhatethicalanalysisshould

address

the

rolesandvaluesofdifferentactors

andtheir

interactionsin

thecourseofdevelopmentand

assessmentoftechnology,

throughinteractive

methodssuch

asconsensusconferences

None

Laparoscopic

cholecystectomy

[25]

Grunwald

(2004)

Germ

any

Social

shapingof

technologyand

coherence

analysis

Thisan

alyticalapproach

realizesthat

ethical

arguments

should

bejustifiedbytheircoherence

withdiverseethicaltheoriesandprinciples,and

themoralbeliefs

held

insocietywithout

justifyingthebeliefs

asrightorwrong.The

followingareasare

encouragedto

be

addressed:society’scurrentnorm

ative

fram

ework;society’sexpectationsofthe

technologyanditsim

pact;objectivesandvisions

ofsociety;andanalysisofsociety’spresent

nature

andcapacity

None

None

[26]

BRACAgen

es:Tu

morsuppressorgen

es,also

knownas

thebreastcancergen


ralpalsy;HTA



alysis.



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Table

1.Overview


address

ethicalissu

esin

healthtech


Study

(year)

Countryof

origin

Methodological

approach

Description

Ethicalanalysis

tools

Case

study

Ref.

Reuzelet

al.

(2001)

Netherlands

Widereflective

equilibrium

through

interactivetechnology

assessment

Theframework

requiresa‘newlyestablished’and

‘inter-subjective’ag

reementachievedthrough

participationofvariousstakeholders

inan

interactiveassessm

entofthetechnology.

Thisis

aprocess

bywhichstakeholdersandcitizens

arriveatawideandfullreflectiveeq

uilibrium

afterexaminingtheirvaluesthroughanextensive

deliberation

None

None

[27]

VanDer

Wilt

etal.

(2000)

Netherlands

Interactivetechnology

assessment

Theframework

proposesa‘circleof

conversations’withallpotentialstakeholders

to

evaluate

theirperspectives

(concerns,norm

san

d

values)throughinterviewsandotherinteractive

researchmethodssuch

asDelphitechnique

None

Cochlear

pediatric

implants

[28]

Reuzelet

al.

(1999)

Netherlands

Casuistryim

bed

ded

in

interactivetechnology

assessment

Thisfram

ework

proposesa‘circleofinterviews’

toevaluate

stakeholdersperspectivesaboutthe

technology.

Casuistry(analysisofmoralissuesby

analogy)

issuggested

tobeusedduringthis

interactiveevaluationto

compare

differentcases

andclarify

ethicalconcerns

None

Cochlear

pediatric

implants

[29]

Tech

nology-specificframeworksormodels

Tech

nologyfocu

s

Kidholm

etal.

(2012)

Multinational

Ethicalprinciples

(human

dignity,

access,eq

uity)

Thisstructuralmodel

forapplicationsof

telemedicinehasbeen

developedbasedon

domainsan

delements

oftheHTACore

model[38]classifiessociocultural,ethicaland

legalaspectsin

onecategory

andrequires

considerationofallethicalquestionsraisedby

thetechnologyan

dtheconsequen

cesofits

implementationin

theassessmen

t

None

Telemedicine

[32]

Mah

oney

etal.(2007)

USA

Ethicalreasoning

basedonevidence

and

moralprinciples

Themodelpositionshumanisticissues

(e.g.,

disability,autonomy,

qualityoflife,respectfor

family

caregivers

andfamily

relationships)in

the

centeras‘core

priority’concerns.Research

needs

andsocietalissuesaroundthetechnologyform

theouterlayers

ofthemodel.

Alistofethical

principlesand

guidelinesfor

gerontechnology

research

Telehealthforpersons

withdem

entia

[33]

BRACAgen

es:Tu

morsuppressorgen

es,also

knownas

thebreastcancergen


ralpalsy;HTA



alysis.



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ert R

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dynamics. Value analysis is presented as an approach formapping values held by individuals or the society andstudying their interactions or conflicts.

The triangular model [19] is a human-centered model forevaluation of healthcare technologies recommends combin-ing factual, anthropological and ethical data and synthesiz-ing through a normative reflection process.

Based on the conceptual framework of the complexitytheory [21], a large number of inter-related technologicaland environmental factors should be taken into account inthe evaluation of healthcare technologies. The frameworkseeks to involve stakeholders in the assessment and takeinto account the uncertainty due to complex and unpredict-able interactions between technology and its environmentincluding ethical and social dimensions.

Similar to the complexity framework, the Actor–networktheory [35] approach recognizes the need for considerationof a complex network of scientific, technical, social andpolitical actors in HTA and describes potential inter-relationships between actors, interactions with the environ-ment and technological change due to time- and context-dependent changes in attitudes and behaviors of the actorstoward the technology.

The social shaping of technology [20,25,26] frameworkemphasizes coshaping of technology and society and pro-motes deliberation on social and ethical issues around tech-nology earlier on in the technology development processwhen such considerations can influence the design and useof the technology.

Frameworks providing pragmatic tools for obtaining &

synthesizing ethical data

Droste et al. proposed a framework for the identificationand retrieval of ethical data for HTA. They recognized theneed for a systematic search of ethical information using aprocedure similar to the one used for the assessment ofclinical benefits [13]. The authors suggested specific searchterms, databases and examples of ethics-related search strat-egies and, however, emphasized that other data sourcessuch as expert advice might also be needed.

Some frameworks provided practical tools for HTA pro-cedures to evaluate and report ethical aspects of healthcaretechnologies in a structured manner. These tools mainlyincluded eclectic checklists consisting of generic or context-sensitive ethical questions as road maps for ethical reflec-tion [23,33,16]. The authors of these articles believed that nosingle ethical theory can cover all of ethical concernsaround a health technology. They suggested that evaluationof ethical issues in HTA should include a variety of ques-tions reflecting different perspectives and normative theo-ries, and the information related to all of the relevantquestions should be synthesized in the process of ethicalreasoning. For example, Hoffman [23] presented a series of33 ethical questions related to the development and use ofhealthcare technologies. Mahoney et al. [33] recommendedT

able

1.Overview


address

ethicalissu

esin

healthtech


Study

(year)

Countryof

origin

Methodological

approach

Description

Ethicalanalysis

tools

Case

study

Ref.

Tech

nology-specificframeworksormodels

(cont.)

Tech

nologyfocu

s

Elsner(2006)

Australia

Ethicalprinciples

Themodel

identifiespossible

risk

categories

relatedto

childrenborn

throughreproductive

cloningorotherassistedreproductive

technologiesanddeterm

ineswhetheritis

acceptable

touse

such

technologiesbybalancing

reproductivefreedom

andsafety

concerns

(autonomyversusnonmaleficence).

None

Assistedreproductive

technologies

[34]

Williams-

Jonesand

Graham

(2003)

UK

Actor–netw

ork

theory

Thisan

alyticalapproach

considers

thepotential

moral,social

andeconomicdilemmasofvarious

stakeholders

inHTA

throughthefollowing

concepts:actor–netw

orks:humanand

nonhumanactors

(institutions,groupsand

technologies);tran

slation:theprocess

of

negotiationofcommoninterestsbetw

een

human

andnonhumanactors;anddrift:the

tran

sform

ationofatechnologyas

aresultofits

use

innew

socialandtechnologicalcontexts.

None

Commercialgenetic

testing(BRACA)

[35]

BRACAgen

es:Tu

morsuppressorgen

es,also

knownas

thebreastcancergen


ralpalsy;HTA



alysis.



Exp

ert R

evie

w o

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es R

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from

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onal

use

onl

y.

the question-based checklist of ethical principles and guidelinesfor gerontechnology research and development as a modelframework for the analysis of ethical considerations related tohome monitoring. The equity framework proposed by Culyeret al. [16] provided comprehensive checklist of questions thatcould be used in various phases of a HTA process from selec-tion of a candidate technology to discussion of equity consider-ations by advisory committees during the assessment anddecision-making phases.

Frameworks & models proposed for combining ethical evidence

with other types of evidence in HTA

Two Canadian frameworks introduced multicriteria methodolo-gies that explicitly included ethical considerations as an elementthat decision makers should consider when choosing betweenhealthcare technologies [18,30]. Johnson et al. recommended fourdeterminant criteria to be included in HTA decision-makingprocesses: clinical benefit, consistency with ethical and socialvalues, cost–effectiveness and feasibility of implementation [30].They required the evidence on the proposed criteria to beobtained through a systematic literature review and discussed ina deliberative public engagement process before HTA professio-nals and decision-makers could make their recommendationson the new health technologies. A decision support tool usingthe multicriteria decision analysis framework was provided byGoetghebeur et al. [18] to facilitate a structured decision-makingprocess based on HTA. The tool focused on quality of evi-dence, disease severity and efficacy of interventions, cost–effec-tiveness, as well as ethical principles of utility, efficiency andfairness. The authors exemplified their proposed frameworkwith the help of a case study, where they demonstrated howthe information from the literature and stakeholder opinionscan be converted to a multicriteria decision analysis matrix andhow the information in the matrix should be processed andscored with the help of experts in order to rank the alternativehealthcare technologies.

Stakeholder engagement

Fourteen frameworks emphasized on the need for assessment ofethical aspects through stakeholder involvement or a broadersocial discourse [17,19–23,25–31,35]. The proposed participatorymodels were categorized thematically, based on the level ofstakeholder engagement, to the following types: consultativemodels [17,19,21–23,30,31,35] in which a range of relevant stakehold-ers are contacted in order to learn about their personal andsocietal values and to obtain their concerns about the technol-ogy, alternatives and the impact of potential decisions; interac-tive models [26–29] that involve experts, stakeholders and citizensin a deliberative process in order to identify, discuss and reflecton the ethical aspects of a technology; and constructive mod-els [20,25] that emphasize a mutual influence of technology andsociety and argue that in order to have an impact on the designof the technology, public engagement should take place earlyin the development process. Consultative methods seek infor-mation from stakeholders as inputs for ethical analysis or a

decision-making process, whereas interactive or constructivemodels is more participative and is based on argumentation,public reasoning and agreement.

The included frameworks suggested a number of participa-tory techniques in order to collect primary data on stake-holders’ values and behaviors. These included: awarenessinitiatives [20], social controlled experiments [20,25], circle ofconversations [26,28,29], focus group discussions [28], dialogworkshops [20], Delphi technique and consensus conferen-ces [20,25,26]. Some frameworks stressed the integration of quan-titative and qualitative data for the purpose of ethicalanalysis [21,24,28].

Need for ethical expertise

Although the necessity of ethical knowledge was implied in allof the included frameworks, six of the included frameworkshighlighted the role of ethical expertise in providing inputsfor preparing the search strategy [13], making normativejudgments [26,31] and providing ethical knowledge requiredfor deliberative ethical analysis or decision-making processes[16,22,26].

Guidelines published by HTA organizations

Twenty-two guidelines were included in this review. Six of theguidelines were developed by international/multinational organ-izations such as the WHO [37], the European Network forHealth Technology Assessment (EUnetHTA) [38], the Interna-tional Network of Agencies for Health Technology Assess-ment [39,40] or the EU [41,42]; while the remaining 16 guidelinesoriginated in European countries (n = 14), particularly Aus-tria [43], Belgium [44], Denmark [45], Germany [46,47], Ireland [48],Norway [49], Poland [50], Spain [51], Sweden [52], Switzerland [53]

and the UK [54–56] followed by Canada (n = 2) [57,56] andThailand (n = 1) [58]. More than half of the guidelineswere published in or after 2006 (n = 15) [39,38,43–46,48–56].Documents’ publication language was either English (n = 16)[37–42,44,45,48,50,53–58], German (n = 3) [43,47,46], Spanish(n = 1) [51], Swedish (n = 1) [52] or Norwegian [49]. Two guide-lines intended to offer guidance for preparation of HTAreports [39,57], 15 provided a generic procedural framework forHTA with ethical analysis included as a part of the HTAmethodology [37,38,41–46,48,50,52,53,55,56,58] and 5 explicitly focusedon methodology for addressing ethical issues in HTA[40,47,49,51,54]. The guidelines differed in terms of their compre-hensiveness and practicality. Two guidelines emphasized oninclusion of ethical issues in HTA with little instructions to fol-low [39,46], but the remaining guidelines provided instructions atvarious levels of details for the collection, analysis and reportingethical data. A general summary of the included guidelines isshown in TABLE 2.

The HTA Core Model, developed by EUnetHTA [38], pro-vided structured guidance for developing HTA reports alongwith frameworks for application of the core model for theassessments of medical and surgical [59], diagnostic [60] andscreening technologies [61], as well as rapid relative effectiveness



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https://www.researchgate.net/publication/14025630_EUR-ASSESS_Project_Subgroup_Report_on_Methodology_Methodological_Guidance_for_the_Conduct_of_Health_Technology_Assessment?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==



https://www.researchgate.net/publication/24169930_Health_System_and_Equity_Perspectives_in_Health_Technology_Assessment?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==





Table

2.Summary

ofguidelinesofhealthtech

nologyassessmentorganizationsforinclusionofethicalissu

esin

HTA.

Country/organization

publicationtype

Year

Description

Tools/instruments

Ref.

International/WHO

Equity-basedHTAtoolkit

(online)

2004

Thetoolkitintegratesequity-orientedcomponen

ts(e.g.,genderequity,

socialjusticeandcommunityparticipation)afourstep

need-basedHTA

-

toolkitthatfocusesburdenofillness,communityeffectiven

ess,

economicevaluationandknowledgetranslationandim

plementation

Weblinksto

commonlyused

toolsforeach

ofthesuggested

foursteps

[37]

International/INAHTA

ChecklistforHTAreports

2007

Thechecklistcategorizesethical,social,legal,economicand

organizationalissuesunderacontext-specificquestionthatmaynotbe

addressedin

allHTAreports.Theboxrelatedto

ethicalaspectsshould

becheckedifethicalissues

includingaccess,equityandinform

ed

consenthavebeen

consideredandtherelatedmethodologyforethical

analysishas

beendescribed

None

[39]

Reportofworkinggroupon

handlingethicalissues

2005

Theguidan

cedocumentsuggestsacontext-sensitive

integrationofa

widerangeofethicalconsiderationrelatedto

thetechnologyitselfand

itsconsequencesbasedonbasicmoralprinciples,society’sunderlying

valuesan

dstakeh

olders’valuesan

dpreferences.Thisshould

be

perform

edas

anongoingprocess

inallphasesofHTA

Hoffman’s33questions

[40]

Multinational/EUnetH

TA

HTAcore

model

2008

Theethicaldomain

oftheCore

modelincludes18questionscovering

eighttopics:principalquestions,autonomy,

human

dignity,

beneficence/

nonmaleficence,justiceandequity,

rights,legislationandeffectiveness/

accuracy.Themodelalsoprovidesabriefexplanationofmethodsthat

havebeencommonlyusedto

answ

erthese

typesofquestionsan

da

discussionaboutintegratingethical

reflectionin

allphasesoftheHTA

process

Tab

leofethicalassessment

elements

Matrixofstakeholder–ethical

consequen

ces

[38]

Multinational/EU

ECHTA’sHTApractice

guidelines

2002

Thisfram

ework

suggestsasystematicreview

ofavailable

literature

(includingqualitative

research)an

dethicsexpertconsultationasthe

primary

approachesforcollectionandap

praisalofdata

on

psychological,socialandethicalissues.In

case

oflack

ofeviden

ce,

primary

data

collectionisrecommendedthroughindividualinterviews,

focusgroupdiscussions,Delphitechnique,

consensusworkshopsor

patientsatisfaction/acceptance

survey

questionnaires

None

[41]

AHTAPol:

Agen

cyforHealth

Technology

Assessm

entPoland;CADTH:Can

adian

Agen

cyforDrugsan

dTechnologiesin

Health;DACEH

TA:Danish

Centre

forEvaluation

and

Health

Technology

Assessm

ent;

DAHTA:GermanAgency

forHTA;DIM

DI:Germ

anInstitute

forMed

ical

DocumentationandInform

ation;ECHTA:EuropeanCollaborationforHealthTechnologyAssessment;EU

netHTA:TheEuropeanNetw

ork

forHealth

TechnologyAssessmen

t;GmbH:GesundheitOsterreich;HIQA:HealthInform

ationandQualityAuthority;HITAP:HealthInterventionandTechnologyAssessm

entProgram

(Thailand);HTA

:Healthtechnologyassessm

ent;

iHPP:

International

HealthPolicyProgram

(Thailand);INAHTA:International

Netw

ork

ofAgenciesforHealth

TechnologyAssessm

ent;INNOVAL:

Institute

forinnovationan

dvaluationin

healthcare;KCE:BelgianHealth

CareKnowledgeCentre;NOKC:Norw

egianKnowledgeCen

trefortheHealthServices;SB

U:Swed

ishCouncilonTechnologyAssessmen

tin

Health

Care;SWOT:

Strengths,weaknesses,opportunitiesan

dthreatsanalysis;

UETS:Unidad

deEvaluaciondeTecnologiasSan

itarias.



Exp

ert R

evie

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f Ph

arm

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mic

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onal

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onl

y.

Table

2.Summary



esin

HTA

(cont.).


publicationtype

Year

Description

Tools/instruments

Ref.

Multinational/EU

(cont.)

EUR-ASSESS’

methodological

guidance

forHTA

1997

Theguidan

cedocumentencouragesinteractivetechnologyassessment

throughthefollowingstep

s:

Identificationofallstakeh

olders

(potential

agents,beneficiariesan

d

victim

s)andinquiringab

outtheirexpectationsandconcerns,

constructingananalyticalmodelto

includetheabove

inform

ation,

recheckingthemodelwiththestakeholders

andreachingto

an

agreemen

tthroughnegotiations

Documentationoftheabove

process,theexpectationsandconcerns

andsuggestionsforfuture

activities,should

beapartoftheHTAreport

None

[42]

Austria/GmbH

HTAhandbook

2011

Theguidelines

grouppsychosocial,ethical,legalan

dorgan

izational

aspectsundersocioculturalconsiderationsandsuggest

aperspective-

orientedanalysisbasedona2Dmatrixwithstakeholders

alongoneaxis

andsocioculturalaspectsalongtheother

axis

Socioculturalmatrix

[43]

Belgium/KCE

HTAProcess

Notes

2007

Theguidelines

emphasizeonthecollectionandappraisalofethical

evidence

atpatientandsocietallevels.Variousmethodological

approachesare

proposedforthesearch

ofethicalandsocial

inform

ation

aroundthetechnology

None

[44]

Canada/CADTH

Guidelinesforeconomic

evaluationsofhealth

technologies

2006

Theguidelines

suggest

thateq

uityconsiderationsshould

betakeninto

accountbymakingim

plicitandexplicitequityassumptions,identifying

equity-relatedsubgroupsoftechnologybeneficiaries,andanalysisofthe

distributionalim

pact

ofthetechnologyacross

theequity-related

subgroups.Incorporationofeq

uityweights

inthebase–case

analysisis

notrecommended

Matrixofeq

uity-related

subgroupsanddistributionalor

cost–effectiveness

impact

[56]

Guidelinesforau

thors

of

HTAreports

2001

Theguidan

cedocumentgroupsethical,equityandpsychologicalissues

inonecategory

andencouragesHTAproducers

tobalance

efficiency

(cost–effectiveness)against

equity.

Theconsiderationofprocedural

issues(preferencesandchoices,confidentiality)

andpsychologicalfactors

(patientsatisfaction,acceptance,family

concerns)isalso

suggested

[57]

AHTAPol:

Agen

cyforHealth

Technology

Assessm

entPoland;CADTH:Can

adian

Agen

cyforDrugsand

Technologiesin

Health;DACEH

TA:Danish

Centre

forEvaluation

and

Health

Technology

Assessm

ent;

DAHTA:GermanAgen

cyforHTA;DIM

DI:Germ

anInstitute

forMed

ical

DocumentationandInform

ation;ECHTA:EuropeanCollaborationforHealthTechnologyAssessment;EU

netHTA

:TheEuropeanNetw

ork

forHealth

TechnologyAssessm

ent;GmbH:GesundheitOsterreich;HIQA:HealthInform

ationandQualityAuthority;HITAP:HealthInterventionandTechnologyAssessm

entProgram

(Thailand);HTA

:Healthtechnologyassessm

ent;

iHPP:

International

HealthPolicyProgram


Netw

ork

ofAgen

ciesforHealthTechnologyAssessm

ent;INNOVAL:

Institute

forinnovationandvaluationin


CareKnowledgeCentre;NOKC:Norw

egianKnowledgeCen

trefortheHealthServices;SB

U:SwedishCouncilonTechnologyAssessm

entin

Health

Care;SWOT:

Strengths,weaknesses,opportunitiesandthreatsanalysis;

UETS:Unidad

deEvaluaciondeTecnologiasSan

itarias.



Exp

ert R

evie

w o

f Ph

arm

acoe

cono

mic

s &

Out

com

es R

esea

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nloa

ded

from

info

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ealth

care

.com

by

McM

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rsity

on

03/1

3/14

For

pers

onal

use

onl

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Table

2.Summary



esin

HTA

(cont.).


publicationtype

Year

Description

Tools/instruments

Ref.

Denmark/DACEHTA

Dan

ishHTA

model

2007

Themain

elements

ofthisHTAmodelare

listedastechnology,

organ

ization,patien

tandeconomy.

Ethicshave

beenincludedunderthe

elementof‘thepatient’.Explorationofthepatientaspectsofahealth

technologyincludingethicalconsiderations,ethicalchoices

andethical

dilemmas

isrecommended.Ethicalanalysisissuggestedto

includeall

aspects

ofHTA,notjust

thepatientaspect,basedonthefourbasic

ethical

principles

None

[45]

Germ

any/DAHTA-D

IMDI

HTA

han

dbook

2008

Thedocumentrecognizesnecessityofaddressingethical,socialand

legal

aspectsin

HTAwithoutprovidingadetailedmethodological

guidance.Theabove

aspectsare

encouraged

tobeaddressedin

the

‘Discussion’section,iftheycannotbead

dressedduringtheHTAprocess

None

[46]

Methodologicalguidance

for

ethicsin

mini-HTAreports

2003

Theguidance

documen

tsuggestsanextensive

literature

review

to

identify

ethicalissues,aqualitativeanalysisto

examineandcategorize

ethical

issuesto

medical,psychological,social,etc.,followedbyan

ethical

analysisin

each

category

basedonbasicethicalprinciplesand

furthercontext-specificcriteria,ifneeded

None

[13]

Ireland/HIQ

A

HTA

guidelines

2010

Theguidelinessuggest

that

equityconsiderationsshould

beincludedin

HTAreportsthroughaddressing‘unmetneeds’ofdisadvantaged

populations.However,eq

uityweights

should

notbeincorporatedin

economicanalysis

None

[48]

Norw

ay/NOKC


for

ethicsin

HTA

2008

Thedocumentsuggestsasix-stepprocedure

toaddress

moralissues

in

HTA,consistingofidentificationofmoralchallenges,iden

tificationof

stakeh

olders,selectionofrelevantmoralquestions,literature

search,

analysisofmoralquestionsbasedonliterature

search,stakeholder

hearingsandsummarizingtheprocess.Alistof32moralquestions

(relatedto

healthtechnology,

stakeholders,methodologicalchoicesan

d

HTAitself)isprovidedto

guidetheethicalan

alysis.Differentapproaches

forethicalanalysisare

describedandthebasicstep

sforeachmethod

are

provided

Achecklistconsistingof

32ethicalquestions

[49]

AHTAPol:

Agen

cyforHealth

Technology

Assessmen

tPoland;CADTH:Canadian

Agen

cyforDrugsand

Technologiesin

Health;DACEHTA:Danish

Centre

forEvaluation

and

Health

Technology

Assessment;

DAHTA

:Germ

anAgency

forHTA

;DIM

DI:GermanInstitute

forMed

icalDocumentationandInform

ation;EC

HTA:European

CollaborationforHealthTechnologyAssessm

ent;EUnetHTA:TheEuropeanNetw

ork

forHealth

TechnologyAssessment;GmbH:GesundheitOsterreich;HIQA:HealthInform

ationandQualityAuthority;HITAP:Health

InterventionandTechnologyAssessmentProgram

(Thailand);HTA:Healthtechnologyassessment;

iHPP:International

Health

PolicyProgram


Network

ofAgen

ciesforHealthTechnologyAssessmen

t;INNOVAL:

Institute


healthcare;KCE:

BelgianHealth

Care

KnowledgeCentre;

NOKC:Norw

egianKnowledgeCentrefortheHealthServices;SBU:SwedishCouncilonTechnologyAssessmentin

HealthCare;SWOT:Strengths,weaknesses,opportunitiesandthreats

analysis;

UETS:

Unidad

deEvaluaciondeTecnologiasSanitarias.



Exp

ert R

evie

w o

f Ph

arm

acoe

cono

mic

s &

Out

com

es R

esea

rch

Dow

nloa

ded

from

info

rmah

ealth

care

.com

by

McM

aste

r U

nive

rsity

on

03/1

3/14

For

pers

onal

use

onl

y.

Table

2.Summary



esin

HTA

(cont.).


publicationtype

Year

Description

Tools/instruments

Ref.

Poland/AHTAPol

HTA

guidelines

2009

Theguidelinesencouragetheassessmentofim

pactofim

plementation

ofthetechnologyonvariousstakeholders,eq

ualityandeq

uityissues,

patien

tsatisfaction,socialaccep

tance

andpsychologicalconsequen

ces

ofthetechnology.

Theidentified

ethicalandsocialissues

are

suggested

tobeincludedin

aSWOTanalysisalongwitheconomicaspects

None

[50]

Spain/UETS


for

ethicsin

HTA

2010

Theguidance

documen

tprovidesamethodologicaltool(checklist)to

guidetheethicalanalysisthroughadaptationandmodificationofthe

EUnetHTA’score

model[38]andHoffman’ssuggestedmoral

questions[23].Differentapproachesforethicalanalysisaredescribed

andthebasicstepsforeachmethodare

provided

Achecklistconsistingof

31ethicalquestions+5

questionsspecificto

diagnostic

technologies

Stakeh

older–ethical

consequencesmatrix

Searchstrategy(proposedby

Droste)[13]forstructuredethics-

relatedlistsearch

[51]

Sweden/SBU

HTA

han

dbook

2013

Thedocumentemphasizesontheuse

ofbasicethical

principlesin

all

phasesofHTAwithafocusonpatientperspective,stakeholder

engagementandiden

tificationofethicalissuesaroundthecurren

t

practice(effectiven

ess,safety

andcost–effectivenessvs

equity).Amatrix

ofvaluationoftechnologyconsequencesfordifferentstakeholders

is

suggestedforconductionofethicalanalysis

Matrixofstakeholder–ethical

consequences

[52]

Switze

rland/INNOVAL

HTA

consensusdocumen

t2012

ThedocumentdescribesHTA

asanorm

ative

process

focusedonhuman

rights

andtheconcepts

ofpersonality,

integrity

andself-determ

ination

ofindividuals.Evaluationoftheappropriateness

ofthetechnology

throughinvolvementofstakeholders

inallphasesofHTA(social

desirability)isconsideredas

oneofthemaincomponents

ofHTA

None

[53]

Thailand/HiTAP,iHPP

ThaiHTAguidelines

2008

Theguidelinessuggest

considerationofequityissuesan

dtheir

integrationwithresultsofeconomicevaluationbychoosingappropriate

evaluationtechniquesandusingethicalcriteriaan

dsocial

preferencesin

healthresourceallocationdecisionsandpriority

setting

None

[58]

AHTAPol:

Agen

cyforHealth

Technology

Assessmen

tPoland;CADTH:Canadian

Agen

cyforDrugsand

Technologiesin


Centre

forEvaluation

and

Health

Technology

Assessment;

DAHTA

:Germ

anAgency

forHTA;DIM

DI:GermanInstitute

forMed

icalDocumentationandInform

ation;EC

HTA:Eu

ropeanCollaborationforHealthTechnologyAssessm

ent;EUnetHTA:TheEuropeanNetw

ork

forHealth

TechnologyAssessment;GmbH:GesundheitOsterreich;HIQA:Health

Inform


InterventionandTechnologyAssessmentProgram


iHPP:International

Health

PolicyProgram


Network

ofAgen

ciesforHealthTechnologyAssessmen

t;INNOVAL:

Institute


healthcare;KCE:

BelgianHealth

Care

KnowledgeCentre;

NOKC:Norw

egianKnowledgeCentrefortheHealthServices;SBU:SwedishCouncilonTechnologyAssessmentin

HealthCare;SWOT:Strengths,weaknesses,opportunitiesandthreats

analysis;

UETS:

Unidad




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assessment of pharmaceuticals [62]. The model included ninedomains: health problem and current use, description and tech-nical characteristics, safety, effectiveness, costs and economicevaluation, ethical, organizational, social and legal aspects. Eachdomain consisted of a number of topics and each topic coveredseveral issues. The ethical domain of the Core Model includeda checklist of questions covering ethical issues related to thetechnology and the HTA process, along with a brief descriptionof commonly used methods to answer the questions, and theways through which ethical evaluations should be integratedinto HTA (TABLE 2).

Guidelines developed by the European HTA agencies whoparticipated in the development of the HTA Core Modelseemed to follow a similar methodological approach with somebetween-country variations. Country-specific guidelines pub-lished by the Swedish [52], Norwegian [49], Spanish [51], Dan-ish [45], Austrian [43] and German [47] agencies suggested similarsystematic approaches to guide ethical evaluation providing setsof steps associated with preanalysis planning, identification ofethical issues, stakeholder involvement, ethical analysis andsummarizing the ethical information. Similar to EUnetHTA’sCore Model, these guidelines allowed using different proce-dural approaches for ethical analysis. Four of the guidelinessuggested using checklists with questions drawn fromHofmann’s question list [23] to help identify ethical issues[51,49,38,40].

The majority of the above-mentioned guidelines describedavailable methodologies for ethical analysis. However, someexpressed no preference for the choice of method, while othersfocused their instructions on a specific approach. For example,Swedish guidelines promoted the use of an ‘actor model’ thatconsiders ethical concerns related to various structural andindividual actors based on basic ethical principles [52]. Three ofthe guidelines introduced an ‘ethical matrix’ as a tool for ana-lyzing ethical issues related to different stakeholders based onethical principles [52], stakeholders’ values and perspectives [43]

or consequences of implementation of the technology orotherwise [51].

As can be seen in TABLE 2, the included guidelines also variedin specifying the types of ethical issues that should be incorpo-rated in HTA. Some focused on integration of ethical and eco-nomic analyses by balancing cost–effectiveness against equity[54–58,50,48], while others encouraged consideration of basic ethi-cal principles [63,45,47,52,54], patient rights [44,45,53] or stakeholdervalues [40–44,49–51].

The NICE’s social value judgments (SVJs) document recom-mended that a combination of scientific and social values ofheath technologies should be taken into account in the healthtechnology appraisal process [54]. The document provided adescription of the principles that should be considered in mak-ing SVJs and guidance on how SVJs should be used byNICE’s advisory bodies to make HTA decisions. However,NICE did not recommend weighting cost–effectiveness esti-mates based on social values [55]. Similarly, the guidelinesdeveloped by the national HTA agencies in Canada [56,57],T

able

2.Summary



esin

HTA

(cont.).


publicationtype

Year

Description

Tools/instruments

Ref.

UK/NICE

Socialvaluejudgments

for

HTAguidance

2008

Thedocumentincludesboth

generalandcase-specificsocialvalue

judgments

andasksNICE’sad

visory

bodiesto

takeinto

accountethical

principlesofrespect

forautonomy,

nonmaleficence,beneficence

and

justice(distributionalan

dprocedural),

fundamentaloperatingprinciples

(leg

alandprocedural)in

appraisinghealth

care

technologies

None

[54]

Guideto

methodsof

technologyap

praisal

2008

Inadditionto

appraisalofevidence

onclinical-andcost–effectiveness,

theguidelinesencourageconsiderationofevidence

relatedto

acceptability,ap

propriateness,preference,equityan

dequality

None

[55]

AHTAPol:

Agency

forHealth

Technology

AssessmentPoland;CADTH:Canadian

Agen

cyforDrugsand

Technologiesin


Cen

tre

forEvaluation

and

Health

Technology

Assessment;

DAHTA:Germ

anAgen

cyforHTA;DIM

DI:Germ

anInstitute

forMed

icalDocumen

tationan

dInform

ation;ECHTA:EuropeanCollaborationforHealth

TechnologyAssessmen

t;EUnetHTA

:TheEu

ropeanNetwork

forHealth

TechnologyAssessm

ent;GmbH:GesundheitOsterreich;HIQA:HealthInform


InterventionandTechnologyAssessmen

tProgram


iHPP:International

HealthPolicyProgram

(Thailand);INAHTA

:International

Netw

ork

ofAgen

cies

forHealthTechnologyAssessment;INNOVAL:

Institute



Care

KnowledgeCen

tre;NOKC:Norw

egianKnowledgeCentrefortheHealth

Services;SBU:SwedishCouncilonTechnologyAssessm

entin

HealthCare;SWOT:Strengths,weakn

esses,opportunitiesandthreats

analysis;

UETS:Unidad




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https://www.researchgate.net/publication/228496204_Recognizing_biotechnology_as_a_tool_for_sustainable_development?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==

Ireland [48], Poland [50] and Thailand [58], which included rec-ommendations regarding incorporation of equity issues andsocial preferences in economic evaluations, did not allow equityweights to be applied to the results of cost–effectiveness analy-ses (TABLE 2).

Expert commentaryOur systematic review identified multiple guidance documentsfor incorporation of ethical considerations in HTA, varying intheir philosophical approach, structure and comprehensiveness.We also found that ethical guidance documents have beendesigned for different purposes throughout the HTA process.These purposes range from helping HTA producers in identifi-cation, appraisal and analysis of ethical data to supportingdecision makers in making better informed, value-sensitivedecisions.

Some of the identified frameworks were designed for use ina particular context, while others were generic. Although theincluded frameworks seemed to have originated from slightlydifferent lines of thinking, the majority of them supported uti-lization of multiple ethical principles and theories to addressethical issues from different perspectives. They frequently pro-moted combining normative reflection with descriptiveapproaches to the analysis of values and preferences of potentialstakeholders and other societal or technical actors. The natureof the proposed procedural approaches differed widely. Theyvaried from the approaches that basically gave a general way ofthinking about how to approach the assessment of ethical issuesin HTA to those that provided analytical tools or case studiesto aid the users’ understanding of a particular ethical analysismethod. However, there were limited guidelines provided onhow to perform such analyses.

Our findings are similar to those of Saarni et al. whoreported the results of a survey on methodologies used byHTA organizations for the assessment of ethical considera-tions [11]. They listed casuistry, coherence analysis, principl-ism, participatory HTA approaches, social shaping oftechnology and WRE as the commonly used methods byHTA producers up to the time of publication of their paperin 2008. Further approaches used by individual EuropeanHTA organizations were also referenced in this article suchas value analysis, triangular model and eclectic or context-specific integrated approaches. Potter et al., who performeda review of HTA and policy evaluation frameworks in thefield of genetic screening and public health genomics, iden-tified three general approaches recommended for integrationof ethical, social and legal aspects in HTA including: syn-thesis of literature, expert advice and consideration ofstakeholder values [12]. The reviewed frameworks includeda number of ethical issues related to genetic testing suchas human rights, equity, autonomy, stigmatization anddiscrimination, psychological consequences, acceptability,confidentiality and intellectual property. The authors recog-nized the lack of methodological guidance for evaluation ofethical and social consideration as an important challenge

for HTA producers. Similarly, through content analysis ofpublished HTA reports, Lehoux and Williams-Jones identi-fied three main mechanisms for evaluation of ethical issuesin HTA reports: expert advice, primary or secondaryresearch and participatory approaches [8]. They found theo-retical approaches that were relevant to bioethics and socialsciences prevalent in evaluation of ethical issues in HTAreports.

Our review differs from the above studies in several aspects.First, we used a systematic approach to identify formal frame-works for ethical considerations in HTA. Second, the potentialsources for data were broader, and no limitations of languageand year of publication were applied. Third, our reviewprovides a structured summary of the ethical frameworksand guidelines for a better understanding of differentmethodologies.

Choosing between frameworks

Our review found no common approach that could be usedfor ethical analysis in HTA. Additionally, we found limitedguidance on specific circumstances in which each analyticalapproach could be appropriate. Thus, it seems difficult tochoose a procedural approach that allows for optimum integra-tion of ethical issues in HTA. When deciding which frame-work to use, it is important to consider the appropriateness ofthe framework for a given context, the objective of ethicalanalysis and the way in which the framework addresses prob-lems within its target application domain (e.g., genetictechnologies).

Prior to the utilization of a framework, it is also importantto consider its potential weaknesses and limitations. In general,normative approaches require an adequate knowledge of ethicsand ethical theories, which may not be available within mostof HTA organizations. In addition, most of the analyticalmethods in this category are prone to subjective bias, that is,the assessment may vary between different assessors or con-texts [28]. Theoretical frameworks may also have some limita-tions with respect to the validity and generalizability of theirresults. For example, in using ethical principles, there might bea conflict between two or more of the principles. A classic typeof conflict is between the principles of respect for autonomyand beneficence [36]. Since the principlist approach does notweigh the principles, researches might need to prioritize theconflicting principles, a judgment that is often decided byintuition alone, although evaluation, debate and consensus aremuch sounder and more generalizable (in Canada, e.g., princi-ples could be derived from consensus about the values in theCanada Health Act). Casuistry is another commonly used nor-mative method that suffers the potential limitations of relyingon subjective analogic arguments and intuitive judgment abouta particular case [24]. On the other hand, the descriptiveapproaches (value research) that frequently employ publicinvolvement methods also appear to have a number of limita-tions. They might be costly, time-consuming and complex toperform. Other possible challenges to consider are willingness



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https://www.researchgate.net/publication/6568689_Mapping_the_integration_of_social_and_ethical_issues_in_health_technology_assessment?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==



of stakeholders to participate, representativeness of participatingpublic groups, complexity of the collection and processing ofqualitative data, the institutional barriers related to the atti-tudes of researchers and the availability of competentexpertise [64].

Currently available evidence on how different methods mightbe effectively used for ethical evaluation in HTA is limited.Saarni et al. compared the results of four analytical methods(axiology, casuistry, principlism and EUnetHTA Core Model)in evaluation of ethical issues related to bariatric surgery [10].The authors who obtained similar results with all four methodsconcluded that the results produced by a given ethical analysisapproach could be ‘transferable between methods’. Furtherresearch is needed to compare different frameworks when theyare applied to different types of technologies or to differentcontexts.

Diversity of guidelines

One of the notable findings of this review was the diversity inthe scope and depth of ethical assessment methods recom-mended by different HTA agencies. Some agencies recom-mended a systematic approach to guide different steps of anethical evaluation from identification of ethical issues to analy-sis and reporting, while others concentrated their recommenda-tions on addressing societal values or equity issues in HTA.This variation seems to reflect differences in healthcare systemsin which the HTA agencies operate and the degree of theagencies’ connection to decision making [65]. Further researchis required to better understand how institutional aspects ofHTA organizations and their relation to policy decisionscan influence their approach to the assessment of ethicalconsiderations.

Role of experts

Although not explicitly recommended, in all of the reviewedframeworks, ethical expertise was deemed implicitly necessaryfor conducting an ethical analysis.

In the literature, it has been argued that the role of ethicistsis important in the incorporation of ethical considerations inHTA [26,8,11,9]. However, in discussion surrounding the expertrole, a distinction should be made between the top–down andbottom–up approaches for ethical analysis. In classical methods(e.g., principlism, casuistry or coherence analysis), the norma-tive assessment of ethical aspects is generally performed withthe help of experts with knowledge of ethics in a top–downmanner. On the contrary, in participatory approaches, stake-holders and citizens are involved in a bottom–up process oftechnology appraisal and decision making. In conducting par-ticipatory assessments, HTA practitioners and ethicists can playan active role in public and political debates by providing sci-entific and theoretical inputs and assisting stakeholders in

reaching a consensus [26]. They also might act in an advisorycapacity to justify and provide rationale for differentapproaches for ethical analysis [26]. Further research is neededto determine the relative weight that should be given to expertand democratic inputs in the assessment of ethical aspects ofhealthcare technologies.

Five-year viewOur systematic review identified a range of approaches toaid consideration of ethical issues throughout the HTA pro-cess; yet, no generally accepted way was found. The choiceof a method for collection and analysis of ethical data seemsto depend on the context in which technology is beingassessed, the purpose of analysis and availability of requiredresources.

The identified methodologies predominantly use participa-tory methods as complementary methods to classicalapproaches of normative ethical analysis. It is evident that theformal HTA has been undergoing a shift from being a largelyscience-oriented expert-driven tool for guiding policy decisionsto being a method for the assessment of scientific, technologicaland wider ethical and social aspects of healthcare technologiesthrough a social communicative process between HTA profes-sionals, technical experts and stakeholders. However, in somejurisdictions, this transition may need organizational and socialtransformations to occur.

It is important to note that the scope of this systematicreview was limited to identification and description of existingframeworks for ethical assessment in HTA, rather than compar-ing methodological features of different frameworks. We sug-gest that future research should not only focus on comparisonof alternative methods of addressing ethical issues in HTA, butalso assess their practicality, applicability to various contextsand impact of their results on decision-making processes. Inaddition, we focused our review on frameworks and guidelinesdeveloped specifically for ethical analysis in HTA. Other ethicalframeworks might exist which have primarily been developedfor the assessment of nonhealth technologies, but which mightalso be useful in HTA. Future researchers are encouraged toextend this work to include literature from other technologyareas.

Financial & competing interests disclosure

This research was supported in part by the Canadian Centre for Ethics

and Corporate Policy’ s Graduate Award. The authors have no other

relevant affiliations or financial involvement with any organization or

entity with a financial interest in or financial conflict with the subject

matter or materials discussed in the manuscript apart from those

disclosed.

No writing assistance was utilized in the production of this

manuscript.



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https://www.researchgate.net/publication/49780874_Improving_ethics_analysis_in_health_technology_assessment?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==

https://www.researchgate.net/publication/5100002_Deliberations_About_Deliberative_Methods_Issues_in_the_Design_and_Evaluation_of_Public_Consultation_Processes?el=1_x_8&enrichId=rgreq-1580f6e52960f3727126eec39ac687ab-XXX&enrichSource=Y292ZXJQYWdlOzI2MDgwODA5MTtBUzoxMDQ4NTkwODQ3ODc3MThAMTQwMjAxMTc2MjQ2Ng==

Key issues

• The current guidance documents for ethical considerations in health technology assessment (HTA) are designed for different purposes

throughout the HTA process such as helping HTA producers in identification, appraisal and analysis of ethical data, and supporting deci-

sion makers in making better informed value-sensitive decisions.

• The existing guidelines seem to vary in terms of their focus and recommendations across different HTA agencies based on the type of

organization and its decision-making process.

• Four general procedural approaches are proposed for ethical analysis in HTA: reflection through ethical principles and theories,

supplementing classical methods with participatory approaches, providing pragmatic tools for obtaining and synthesis of ethical data

and integrating ethics in multicriteria HTA decision-making tools.

• Ethical frameworks frequently use analytical methods that combine normative reflection with participatory approaches, where

stakeholders and citizens share and discuss different viewpoints and arguments.

• Existing methods are generally meant to be used by professional ethicists or HTA practitioners with a knowledge and skill in ethical analysis.

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