This document discusses improving how non-drug technologies are appraised in Ontario by revising the decision-making framework. It summarizes work done by various committees and working groups since 2007 to operationalize ethics and social values in the appraisal process. This includes identifying core social values, developing evaluative questions related to equity, patient-centered care and other domains, and proposing a methodology for systematic, evidence-based analysis of ethics and social values issues. The goal is to fully integrate such analyses into the technology appraisal process to make recommendations more responsive to patient and societal considerations.

1. Improving the Appraisal of Non-Drug Technologies:
Revising the Ontario Decision Framework
Ethics & Social Values: Patient Centred Care
Fiona A. Miller, PhD
Associate Professor, IHPME
Division of Health Policy & Ethics, THETA
CADTH, Saskatoon
April 14, 2015

2. Addressing Ethics & Social Values at OHTAC
2
Decision determinants Public engagement
PE #1
(2007-8)
PE #2
(2012-2014)

3. Addressing Ethics & Social Values at OHTAC
3
Decision determinants
DD #1
(2007-8)
• Johnson et al, Decision
Determinants Committee #1:
2007-2008/9
- Nancy Sikich, Gerald Evans,
William Evans, Mita
Giacomini, Les Levin,
Murray Krahn, Murray
Glendinning, Paul Oh,
Charmaine Perera

4. Ontario Health Technology Advisory Committee (OHTAC)
Decision Determinants

5. Addressing Ethics & Social Values at OHTAC
5
Decision determinants
DD #1
(2007-8)
Subcommittee on
social values & ethics
(2011-2012)
• Giacomini et al, Subcommittee on Social
Values & Ethics Evaluation: Identification
of core values relevant to OHTAC decision
making (2011-2012)
– Frank Wagner, Murray Krahn, Julia
Abelson, Nancy Sickich, Kellee
Kaulback

6. QualityEvidence-informed
policy
Effectiveness
Resource
stewardship
Resource
sufficiency
Equity
Solidarity
Collaboration
Patient-centred care
Shared responsibility
for health
Population health
OHTAC
• Mission Statement
• Terms of Reference
• Decision Determinants Framework
• Public Engagement Subcommittee, 2007
• External reviews, 2005, 2008
• Citizen’s Reference Panel, 2010
HTA (international ethics fwks)
• EUNetHTA Core Model
• INAHTA Working Group
• (“Hoffman’s list”, IJTAHC)
Canadian Health System
• Canada Health Act
• Romanow Commission
• First Ministers’ Accord on
Health Care Renewal
• Health Council of Canada
Ontario Health System
• (No MOHLTC strategic plan)
• Excellent Health Care for All
Act
• Ontario Health Plan for an
Infuenza Epidemic
• Ontario Health Quality
Council
Grounded in:
Established values frameworks
relevant to OHTAC’s jurisdiction
Human rights,
rule of law, etc.
Traditional
in HTA
Over-
arching
Economic
Clinical
Giacomini et al, 2012
NOT
Traditional
in HTA

7. Social values
7
Six domains of social value  20 social values statements
EQUITY#1: Access to health care should be universal among Canadians, and based on individual need.
EQUITY #2: Individuals should not face discrimination on the basis of factors other than need. These include but
are not limited to: ability to pay, wealth, province of residence, geographic location, origin, gender, or age.
COLLABORATION #1: Health care is complex. Success depends on
constructive collaboration between many providers, agencies,
organizations, professionals, patients, and their caregivers.
COLLABORATION #2: Mechanisms to support collaboration –
whether legal frameworks, economic incentives, organizational
structures, support technology, or others – should be regarded as
integral and important aspects of health services.
COLLABORATION #3: Health technologies should be analyzed in
context, including attention to both their integral components and how
they integrate with other aspects of health care.
COLLABORATION #4: Policy makers should understand and
consider health services’ (and technologies’) potential organizational,
economic, and social impacts, and how these affect constructive
collaborations.
SOLIDARITY #1: The principle of solidarity recognizes the importance of relationships and interdependence for
individual and societal flourishing.
SOLIDARITY #2 Solidarity is related to other values such as equity, justice, collaboration, and shared
responsibility for health. It also resonates with the familiar values of non-abandonment and compassion in clinical
bioethics.
SOLIDARITY #3: Solidarity entails sustaining strong, trusting, and compassionate relationships in the health
system. These include relationships between patients and providers, between citizens and their government
agencies, and others.
SOLIDARITY #4: Solidarity also implies that conflicts of interest and externalities should be transparent and
addressed.

8. Social values
8
Six domains of social value  20 social values statements
PATIENT-CENTRED CARE #1: Processes of care and positive patient experiences matter, in addition to health
outcomes.
PATIENT-CENTRED CARE #2: Patient burdens should be minimized and kept in proportion with benefits.
PATIENT-CENTRED CARE #3: Health care services should be responsive to patients’needs, values, and preferences.
PATIENT-CENTRED CARE #4: Diversity in patient values should be expected, and accommodated within legal and
pragmatic bounds
PATIENT-CENTRED CARE #5: The dignity, rights, liberty, autonomy, and privacy of patients must be respected
throughout the health care process.
PATIENT-CENTRED CARE #6: Patient-centred care also entails respect and support for the roles of family members
and other informal caregivers in generating the patient’s well-being.
POPULATION HEALTH #1: The health system should serve the health of the population as well as
the health of individuals.
POPULATION HEALTH #2: Policy makers should consider implications of decisions for
population health, prevention, and protection of the public from harm.
SHARED RESPONSIBILITY FOR HEALTH #1: The health system
holds partial responsibility for individual and population health.
Additional responsibility rests on social factors, the environment,
occupational settings, individual behaviours and lifestyle.
SHARED RESPONSIBILITY FOR HEALTH #2: Consideration should
be given to the role of not only the personal, but also the social
determinants of health.

9. Addressing Ethics & Social Values at OHTAC
9
Decision determinants
DD #1
(2007-8)
Subcommittee on
social values & ethics
(2011-2012)
DD #2
(2012-2014)
Clinical
Economic
E&SV
WorkingGroup
• Krahn et al, Decision Determinants
Committee #2: Revise decision
determinants framework (2012-2014)
- Mita Giacomini, Shawn Winsor, Frank
Wagner, Fiona Miller, Ahmed Bayoumi,
Ba Pham, Gabrielle Van Der Velde, Holger
Schunemann, Ron Goeree, Nancy Sikich
• Giacomini et al; Miller et al, Ethics &
Social Values Working Group:
Operationalize core values
- Frank Wagner, Shawn Winsor, Juliana
Yi, Celine Cressman (2014)

10. Equity Interests
Relationships
Patient-centred care
Population health
Operationalizing values as evaluative questions 1

11. Equity
Context-sensitive care
Patient-centred care
Operationalizing values as evaluative questions 2

12. Evaluative questions
Evaluative category Evaluative questions
Equity Are there differences among equity-relevant groups* with regard to
disease burden or access to care?
Patient-centred care Describe patient experiences and preferences regarding the condition,
as well as processes and outcomes of care?
Have particular issues been identified relevant to ethical principles and
rights in health care: autonomy and independence, vulnerability and
dignity, privacy and confidentiality?
Context-sensitive care Describe, if warranted, the potential effects on other health services or
systems, in the short or long term - Setting precedents, establishing or
diminishing clinical or organizational capacity, requiring new standards
of practice for regulated health professionals, etc?
Are there social or cultural pressures that affect the use of the
technology - Tensions between the individual and their community,
social stigma, or judgments of personal or social responsibility for poor
or improved health?
* Groups identified by MOHLTC HEIA Tool for equity considerations: Aboriginal peoples, Age-related groups, Disability,
Ethno-racial communities, Francophone, Homeless, Linguistic communities, Low income, Religious/faith communities,
Rural/remote or inner-urban populations, Sex/gender, Sexual orientation, “Other” 12

13. Test case for evidence-based E&SV analysis
• Uterine fibroids
– Benign tumors of the smooth muscle cells of the myometrium
– Common
• prevalence of 70% among white women in late 40s; 80% for black
women, though are asymptomatic in most women.
13
– Prevalence of clinically relevant tumors
increases with age
• 10-15% of white women in their 30’s and
35% of white women in their late 40’s.
• 2-3 fold higher incidence rates for black
women; earlier age of onset, over a greater
age span; more severe disease at
presentation and at surgery

14. Test case for evidence-based E&SV analysis
• A range of treatment alternatives
– Invasive
• surgical interventions (myomectomy and hysterectomy)
– Minimally invasive
• various embolic and ablative therapies (embolization,
radiofrequency, laser, microwave and cryoblation)
– Non-invasive thermal ablation technology - MRgHIFU
• magnetic resonance imaging (MR) for targeting and monitoring
• high-intensity focused ultrasound (HIFU) for treatment

15. Test case for evidence-based E&SV analysis
• Research questions
– What are patient values, preferences and expressed needs related to
uterine fibroids and treatments for it?
– What challenges exist in the provision of patient-centred care for uterine
fibroids and how might these be affected by the availability of MRgHIFU?
• Evidence review
– Comprehensive review of relevant literature – systematic scoping review
– 47 studies included in evidence synthesis
• Primary studies of patients and providers – qualitative & quantitative
• Epidemiologic and service utilization data (e.g., billing data, chart
review, disease registry)
• Findings across 4 thematic areas
– The burden of uterine fibroids
– The importance of values and preferences in treatment selection
– Challenges in delivering patient-centred care
– Challenges for health equity
15

16. Equity
Context-sensitive
care
Patient-
centred care
Reorganizing evaluative questions
Patient-centred
care

17. Patient-centred carePatient-CentredCare*
Patient &
public values
Equitable &
integrated
care systems
*Entwistle, V. A., & Watt, I. S. (2013). Treating patients as persons: A capabilities approach to support delivery of
person-centered care. The American Journal of Bioethics, 13(8), 29-39.

18. Patient-centred carePatient-CentredCare*
Patient &
public values
Treating patients as persons, recognizing the relational nature of our autonomy
• Not disease-centred
• Respectful and responsive to considered preferences, needs and values
• A positive and supportive respect, recognizing the social resources involved in
formulating and achieving valued ends
Equitable &
integrated
care systems
*Entwistle, V. A., & Watt, I. S. (2013). Treating patients as persons: A capabilities approach to support delivery of
person-centered care. The American Journal of Bioethics, 13(8), 29-39.

19. Patient-centred carePatient-CentredCare*
Patient &
public values
Treating patients as persons, recognizing the relational nature of our autonomy
• Not disease-centred
• Respectful and responsive to considered preferences, needs and values
• A positive and supportive respect, recognizing the social resources involved in
formulating and achieving valued ends
Equitable &
integrated
care systems
Ensuring that health systems work to fairly serve the needs of populations of patients
• Not staff or system-centred
• Integrated systems of responsive and respectful care
• Ensuring non-discrimination (not unfairly treating likes differently in the delivery of
healthcare services)
• Seeking to overcome health inequities (remediating, where possible, avoidable,
unfair and unjust differences in health outcomes)
*Entwistle, V. A., & Watt, I. S. (2013). Treating patients as persons: A capabilities approach to support delivery of
person-centered care. The American Journal of Bioethics, 13(8), 29-39.

20. AN EMERGING APPROACH
Ethics & Social Values at OHTAC
20

21. OHTAC Evidence Review Process
21

22. The stages of an HTA
Vignette:
Topic selection
& scoping
Evidence based
analysis
Appraisal:
OHTAC
Recommendations
Ethics &
Social
Values
Ethics &
Social
Values
Ethics &
Social
Values

23. Priority setting for HTA – Approach to E&SV
Domain Criteria Ranking Unknown RANK
A B C
Patient-
centred
care
Patient & public
values
Consistent with
patient values
& preferences
Limited impact
related to
patient
values/preferen
ces
Contrary to
patient values
and
preferences
Equitable &
integrated care
systems
Has the
potential to
improve the
delivery of
equitable and
integrated care
Limited impact
on the delivery
of equitable
and integrated
care
May worsen
the delivery of
equitable and
integrated care
23
• Incorporate the 2 main criteria proposed for the patient-centred care
domain
• Set at highest rank those technologies that promise to significantly
improve patient-centred care

24. • All mega-analyses should be accompanied by an evidence-based
E&SV analysis
• Review of a network of technologies provides excellent
opportunity for considering patient-centred system of care
• Evidence-based E&SV analysis to be triggered for other HTAs
(e.g., single technology appraisals) on a case by case basis
• Informed by: Institute of Health Economics, Edmonton, AB
Report: Assessing the Need for and Quality of Ethics
Analyses in HTA, October 18-26, 2013: 1-38.
Scoping – Triggering evidence-based E&SV analysis
24c

25. Trigger checklist
• Where use of priority setting tool identifies opportunities or
challenges in addressing patient-centred care
• Where treatments or outcomes are sensitive to patient
preferences, values or needs
• Where the patient population is vulnerable or marginalized
– For example, ill children, individuals with impaired cognitive capacity,
institutionalized persons, etc.
– Marginalized by unfair or unjust health differences
• Where the technology is proposed for use in healthy populations
– Population screening; prophylactic interventions
• Where the technology is ‘disruptive’ of existing services or systems
– Changing health care delivery and disease management processes
– Changing job prospects for health care providers
– Requiring new capital equipment and infrastructure
• Where the technology challenges legal or ethical commitments to
patient autonomy, privacy or confidentiality
25

26. The stages of an HTA
Vignette:
Topic selection
& scoping
Evidence based
analysis
Appraisal:
OHTAC
Recommendations
Ethics &
Social
Values
Ethics &
Social
Values
Ethics &
Social
Values

27. Evidence-based E&SV analysis
27
• Evidence-based E&SV analysis should involve a systematic review
of research evidence
• A consistent evidence-based approach to all relevant
decision criteria
• As appropriate, primary data collection or public engagement
• PE Subcommittee

28. Suggested methodology
• Suggested methodology for evidence review
– Scoping review
• Comprehensive and systematic search and selection
• Not specific to any one research methodology (i.e., including qualitative studies but
not only qualitative studies)
• Quality assessment through assessment of relevance; use of quality prompts and
exclusion for studies deemed critically flawed
– Addressing multiple domains of interest to E&SV analysis - drawing on 3 non traditional
approaches to research synthesis
• Qualitative research – To illuminate social phenomena commonly captured by
studies using qualitative methodologies: Patient (and other stakeholder) values,
preferences and experiences; also social and cultural beliefs, perceptions of
treatments and outcomes, implementation-relevant considerations
• Health equity – To identify “differences in health outcomes that are avoidable,
unfair and unjust.” (Welch et al, 2013, p2)
• Health ethics – To identify the moral issues arising in technologies, technology
appraisal, or technology use
– Search strategy – PICo - intermediate level of sensitivity/specificity
• Population, the phenomena of Interest, and the Context
– Data extraction and analysis using criteria for E&SV appraisal
28

29. The stages of an HTA
Vignette:
Topic selection
& scoping
Evidence based
analysis
Appraisal:
OHTAC
Recommendations
Ethics &
Social
Values
Ethics &
Social
Values
Ethics &
Social
Values

30. Appraisal – Integrating E&SV
30
• “Patient centred care” domain
• Not to be completed unless evidence-based E&SV analysis
undertaken
• Summative judgment includes consideration of relevance and
consistency of the evidence
• Role of evaluative criteria
• Influence decisions
• Give reason for favouring/ disfavouring adoption
• Inform implementation
• Give guidance related to education, training, service design

31. Patient Centred Care
✓
Check mark ("✓") indicates formal analysis completed. X mark ("✗") indicates no formal analysis
completed.
Patient-CentredCare
Patients:
Values &
Preferences
Aligned with patient values &
preferences
Do patients have specific values, preferences or needs
related to the condition, treatment or life impact that are
relevant to this assessment? (NB. Values and preferences of
family, informal caregivers or the public to be considered,
as appropriate)
Consistent with commitments
to autonomy, privacy,
confidentiality
Are there concerns regarding accepted ethical or legal
standards related to patient autonomy, privacy or
confidentiality that are relevant to this assessment?
Populations:
Equity &
Coordinated
Care
Enhances equity in access or
outcomes
Are there disadvantaged populations or populations in
need whose access to care or health outcomes might be
improved (or not worsened) that are relevant to this
assessment?
Coordinates care
Are there challenges in the coordination of care for patients
that might be improved (or not worsened) that are relevant
to this assessment?
SUMMARY
Taking account of these
considerations, select the
degree to which the evidence
supports the use of the
technology(ies)/ intervention.
Strongly
supports
Somewhat
supports
Neutral/
Unknown
Does not
support
Strongly
discourages

32. Conclusion, 1
• At OHTAC, many efforts to to integrate ethics & social values
into HTA:
– Public engagement subcommittees
– Decision Determinants subcommittees
• Ethics & Social Values Working Group
• Proposed methodology
– Across stages of HTA
– Based in set of social values
– Involving clear conceptual framework & evidence review
32

33. Conclusion, 2
• Many questions remain
– Evidence review
• Have we asked the right questions?
• Have we fairly and appropriately called attention to both
– The preferences and values of individual patients?
– The needs of populations of patients?
– Evidence review relative to direct engagement
• What is the value add?
– Technology appraisal
• What role does/ should these considerations play in HTA
decisions?
– Conducting evidence-based ethics & social values analysis
• Is this the right methodology?
• When should these reviews be done?
33

34. Acknowledgements
• Decision Determinants Subcommittee
– Murray Krahn, Chair
– Ahmed Bayoumi
– Ba Pham
– Gabrielle Van Der Velde
– Holger Schunemann
– Ron Goeree
– Nancy Sikich
– Mita Giacomini
– Frank Wagner
– Shawn Windsor
• Key HQO supports
– Corinne Holubowich
– Caroline Higgins
– Gaylene Pron
– Stephen Petersen
E&SV Evidence review team
Juliana Yi
Celine Cressman
Carolyn Barg
Sarah Patton
E&SV Working Group of DD
Mita Giacomini (2012-
2013)
Shawn Windsor
Frank Wagner
Juliana Yi
Celine Cressman (2014)