cadth 2015 e2 miller cadth-ohtac approach-april 14, 2015

Improving the Appraisal of Non-Drug Technologies: Revising the Ontario Decision Framework

Ethics & Social Values: Patient Centred Care

Fiona A. Miller, PhDAssociate Professor, IHPMEDivision of Health Policy & Ethics, THETACADTH, SaskatoonApril 14, 2015

Addressing Ethics & Social Values at OHTAC

2

Decision determinants Public engagement

PE #1(2007-8)

PE #2(2012-2014)


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

Ontario Health Technology Advisory Committee (OHTAC)Decision Determinants


5


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

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

CouncilGrounded in:Established values frameworksrelevant to OHTAC’s jurisdiction

Human rights, rule of law, etc.

Traditionalin HTA

Over-arching

Economic

Clinical

Giacomini et al, 2012

NOTTraditional

in HTA

7

Social valuesSix domains of social value 20 social

values statementsEQUITY#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 valuesSix domains of social value 20 social

values statementsPATIENT-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 boundsPATIENT-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


DD #1(2007-8)

Subcommittee on social values & ethics

(2011-2012)

DD #2(2012-2014)

Clin

ical

Econ

omic

E&SV

Wor

king

Gro

up

• 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)

Equity Interests

Relationships


Population health

Operationalizing values as evaluative questions 1

Equity

Context-sensitive 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”

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.

– 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

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

Equity

Context-sensitive care


Reorganizing evaluative questions



Patient-Centred Care*

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.




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






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


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)


20

AN EMERGING APPROACH

Ethics & Social Values at OHTAC

21

OHTAC Evidence Review Process

The stages of an HTA

Vignette:Topic selection

& scoping

Evidence based analysis

Appraisal: OHTAC

Recommendations

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/preferences

Contrary to patient values and preferences


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

• 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

• 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



& scoping


Appraisal: OHTAC

Recommendations




27

Evidence-based E&SV analysis

• 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



& scoping


Appraisal: OHTAC

Recommendations




30

Appraisal – Integrating E&SV

• “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

Patient Centred Care

✓ Check mark (" ") indicates formal analysis completed. X mark (" ") indicates no formal analysis ✓ ✗completed.

Patient-Centred

Care

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 careAre 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

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?

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 teamJuliana YiCeline CressmanCarolyn BargSarah Patton

E&SV Working Group of DDMita Giacomini (2012-2013)Shawn WindsorFrank WagnerJuliana YiCeline Cressman (2014)

cadth 2015 e2 miller cadth-ohtac approach-april 14, 2015

Health & Medicine

health technologies

aspects of health care

act ontario health plan

social impacts

decision determinants

constructive collaboration

domains of social value

patient centred care