Derick Mitchell SPHERE conference Jan 2018

January 11th, 2018

PATIENTS – SCIENCE – INDUSTRY

Structured & Sustainable Patient Involvement

SPHERE Conference 201811/1/2018 www.ipposi.ie

My talk

• IPPOSI

• How patient voices are changing health research + innovation?

• The power of patient-driven data & evidence

• Harnessing Patient Experience


Patients as Partners?


Collaborative sensemaking

“We are witnessing the collapse of expertise and the rise of

collaborative sensemaking”

David Holzmer


Evidence-based patient advocacy

In God We Trust…..…Everyone Else Bring Data!


IPPOSI? Who?IPPOSI

A patient-led organisation

that works with patients,

government, industry,

& science to put patients at

the heart of health innovation


IPPOSI Priorities + Members

20

Actively advocate for improved + equitable

patient access to Health Innovation

Promote meaningful patient involvement in

Health Research and Policy


PATIENT ORGANISATIONS

SCIENCE

INDUSTRY


Public Private Partnership

IPPOSI Board: Grant from Department of Health

(via Health Research Board)

Industry membership fee

Project Funding

8 Patient Organisations

6 Scientific Members

6 Industry Members

2016/2017 Board

FUNDINGLEADERSHIP


Patient-led activities

Health Hacks

Workshops

Consultations

Round-tables

Working Groups

Submissions

Conferences

Clinical Research

Health Information

Patient Data

Health Economics

Patient Registries

Access to Medicines

Data Protection

Patient Experience


What do patient advocates want re: health research?

That the patient voice is listened to

• To be involved as early as possible in research design, priority setting, policy

• To improve the quality of research - less wastage

• To ensure better use/reuse of research outputs and tools

• To generate impact and burden data to support the results of clinical trials

• To use online / ehealth / mobile health apps to generate patient-based evidence


What do we need to embed PPI in research + practice?

• Includes people, funding, networks, supports

• Education + Training for BOTH researchers and patients / public

• Evidence to inform practice

• High quality reporting to grow evidence base

• Understanding how PPI works in different contexts

ContextEvidence + Reporting

Resources + Infrastr.

Education

Demonstrate the impact & how it makes a difference


Incorporating the patient voice

• Hierarchical Rhetoric

• ‘Walking the walk’ at the highest possible level

Challenges:• Decision-makers never want to change their processes

• Patients are not trained in health policy, research, dialogue

• Many patient orgs are not focused on macro policy issues

“The perfect is the enemy of the good”


Wow!.....passionate and knowledgeable about PPI in research

Early Adopters

Constituency 2

Constituency 3“Hmm . . . show me the evidence that all this works and is helpful”

“Well …. PPI is a good idea but where on earth do I start?”


Current Challenges

• Research not (yet) embedded in Irish healthcare system?

• Support & Training for Patients for specific roles in research?

• Equality, Inclusiveness & Sustainability of current efforts?

• How to shift the power balance between researchers and patients?

• Qualitative research tends to be at bottom of research hierarchy?

• Evidence of the value and impact of PPI?

• An over-arching vision for PPI in Research?


2025 – a vision for PPI in Research in Ireland?

To begin this process:

• Develop a common understanding

• Share learning and ‘know how’

• Support organisations to develop robust PPI infrastructure

• Set standards and policies

• Embed the principles and inform the emerging practice

• Assess the impact of PPI in research

2018 - Where are we?

Research Leadership

5 PPI Ignite awards (€1.75m)University of Limerick – Prof Anne MacFarlane

University College Dublin - Prof Thilo Kroll

NUI Galway - Prof Sean Dinneen

Dublin City University - Dr Veronica Lambert

Trinity College Dublin - Prof Mary McCarron

Royal College of Surgeons, Ireland

University College Cork

Irish College of General Practitioners

Many other Irish researchers and research orgs

Health Agency Leadership

Dept. of Health

Muiris O’Connor, Head of Research & Analytics, Assistant National Director

HSE

Ana Terres – HSE Head of Research and Development, Assistant National Director

HRB

Anne Cody – Head of Pre-Award, Public Reviewers of proposals

2018- Where are we?

Patient / Patient Org. Leadership

• IPPOSI - Derick Mitchell, CEO

• MRCG - Avril Kennan, CEO

• Condition-specific patient orgs:

• Fighting Blindness

• Irish Cancer Society

• MS Ireland – Ava Battles, CEO

• CF Ireland – Philip Watt, CEO

• 9 Irish EUPATI Fellows (+4)

• Irish Health Research Forum

Links to International Leadership

• EUPATI

• European Patients Forum

• EURORDIS

• Several UK groups (NIHR, INVOLVE, James Lind, COMET, CRUK, etc.)

• PCORI (USA)

• CIHR (Canada)

• Cochrane

• EU Projects - H2020, IMI

2018- Where are we?

Public / Patient / Media Interest


Frameworks of Involvement

2008 - National Strategy for Service User Involvement in

Health and Social Services (DoHC & HSE)

---------------------------------------------------------------------------

2016 - Values in Action, QID Cultures of Person-centeredness (HSE)

2016 - Mental Health Local Recovery Groups (HSE)

2017 - National Patient Experience Survey - Hospitals (HIQA, HSE, DoH)

2017 - National Clinical Effectiveness Committee – PPI Values

(DoH, NCEC)

2017 – Personas for Electronic Health Records (eHealth Ireland)

2017/18 - Patient Narrative Project on Person-centered care

(CSPD-HSE, IPPOSI)


Metrics of Value of Involvement

• Anecdotal ----Qualitative----Quantitative

• Time / Cost savings

• Improved relationships

• Outcomes of relevance to patients


Assessing the Financial Value of PPI

From:

A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project. Levitan B et al., Drug Inf J : Therapeutic Innovation & Regulatory Science. Published: July 17, 2017. https://doi.org/10.1177/2168479017716715

https://doi.org/10.1177/2168479017716715


Tendering & Procurement impact

DOI: 10.1111/hae.12720


The Impact of Patient Education

Role Before EUPATI After

Member of patient organisation, not actively involved 17% 2%

Active role in a patient organisation 62% 71%

Leadership role in a patient organisation 62% 71%

Employee of a patient organisation 25% 23%

Volunteer role in a patient organisation 60% 67%

Presenting at conferences, workshops etc. 63% 83%

Advising a pharmaceutical company 13% 44%

Advising a regulatory agency 21% 42%

Advising a reimbursement agency 4% 8%

EUPATI Fellows are increasingly taking leadership roles and are engaging with pharma, regulators and HTA bodies. Role changes also imply identity shifts.


Pilot Irish Patient Education Programme

7 months – ends on March 21st, 2018

3 x 6-week Modules

• Understanding Clinical Trials

• Regulatory, Medicines Safety, PV

• HTA Principles + Practices

Irish Education Partners

2 Universities, 1 Regulator, 1 HTA Agency,

1 LMS website: www.patientsinvolved.ie

21 Students – Irish patients, carers, advocates

http://www.patientsinvolved.ie/


20142018 = Eighteen

Interest from:Brazil, Cyprus, Finland, Hungary, Israel, Russia, Serbia, Sweden and Turkey

EUPATI Countries

Legal Entity


EUPATI Countries 2018

Regional Groups


The power of patient-driven evidence + data


Generating patient-based evidence

• Health stakeholders take decisions based on evidence, not on (our) anecdotes

• Patient organisations are best-placed to generate patient-relevant data

• Cost-effectiveness is key. Prove that the informed patient is cost-effective…..!


Health Information / Patient Data


What we have learned…

• Trustworthiness is vital….• patients must believe that their data is secure and only used

for the purposes they consented to

• Equally….• create the situation where patients are the drivers of their

data, ensuring it is utilised to improve their health

Development of Electronic

Health Records

(10 years)

National Education / Training on EHRsFor clinicians, nurses and Patients By clinicians, nurses and Patients

Capacity Building / Empowerment of patients Link to self-management programmes

OPPORTUNITIES FOR PATIENT INVOLVEMENT TO ADDRESS THE FOLLOWING CHALLENGES

EHR Design + Roll-outPatient Portal

Other building blocks Decision-making boards

Promoting Partnerships Communication

Openness & Transparency

Advocating for essential building blocksReal-Time information

Informed Consent Bi-directional flow of information

Tracking patient outcomes

Public Trust + ConfidenceWho, When, Why?

Consent – How?Special Considerations for individual groups

Data Linkage & Sharing

TrustPatient Experience

Education and Training

CollaborationCommunication

TimingSharing

CommunityAccess

Consent

Data Quality


Access To Information

• Healthlink - National Message Broker

• Healthmail - National Secure Clinical Email Solution

• Integration with building blocks for national Electronic Health Record

• Innovation - development of MyHealthPortal


Patient Registries

• Evaluating new treatments in real-world settings (Pharmaco-vigilance)

• Rare Disease Reference Centres of Excellence

Slide courtesy of Abigeal Jackson, CF Registry of Ireland

Umotif, PatientslikeMe, Carenity

Graphically display charts, timelines and various representations of different measures


Harnessing Patient Experience


Patient Experience Survey - Hospitals


The Patient Narrative Project

Reference: Phelan A., Rohde D., Casey M., Fealy G., Felle P., Lloyd H. & O’Kelly G. (2017) Patient Narrative Project for Person-Centred Co-ordinated Care. UCD, IPPOSI & HSE, Dublin.

Phases 1 + 2 + 3:

Person-centered, co-ordinated care

Person centered co-ordinated care

Phase 1

What people in Ireland want to experienceduring their care when they require anumber of health services at one time orover time

Phase 2 + 3

A framework that will hear peoples’ experiences of using more than one health service at a time

11 Focus

Groups

2 Online

Surveys

4 Regional

Workshops

Output: Statements (19) + Definition (1)

Online Survey

+ System

Partnerships


Themes Emerging From Phase 1

My healthcare

experiences

Healthcare I am

confident in

My journey through

healthcare


My Journey through Healthcare

• My care includes issues that my health influences, such as finances, housing, employment, ability to travel and access to transport.

• I have services delivered by the most suitable healthcare staff in the correct setting and when I need them.

• I can have one person who will oversee and follow up on all my care.


Phase 2

• http://www.hse.ie/yourvoicematters

http://www.hse.ie/yourvoicematters


• Survey remains live• Proof-of-Concept• Producing data on patients’ experience of care when they use

more than one health service

• Target: • 1000 stories nationally, particularly in relation to older people and

people with chronic conditions

• Channel through Integrated Care Programmes HSE

By end of 2017… By end of 2018…

A ‘tried and tested’ framework

• To hear a high volume of patients’ experiences through the online survey

• To use data to influence service design, delivery and improvement of integrated care

• A qualitative and quantitative evaluation of POC within the context of the HSE;

Integration into ‘business as usual’

• Framework (incl. resource implications) to be integrated into a ‘business as usual’ model

• Quality and Patient Safety Structures at CHO level will be essential

• QID publication: ‘Quality and Safety Committees; Guidance and resources’


International Conference on Integrated Care

May 2017, UCD

https://patientsincluded.org

• 50 free admissions for IPPOSI patient members• 20 took up co-chair positions

https://patientsincluded.org/


PPI is now Global

• EUPATI - EU• PCORI - USA

• PFMD

• INVOLVE UK + Australia• ICHOM• ISPOR

• EU Projects• H2020, IMI• Joint Programmes• IMI – PARADIGM (2018-2021)


Practical “Roadmap” on patient involvement in medicines R&D

Research design

and Planning

Design of Protocol

Informed Consent Study reporting

Post-study communication

Patient Info

Leaflet

Trial steering committee

Investigators Meeting

Level of expertise in the disease area required:

mediumhigh

Data Monitoring Committee Practical

considerations

Health Technology Assessment

Protocol

Synopsis

Research

priorities

Setting

research

priorities:

Information to

trial participants

Research conduct and

operations

Regulatory affairs

Dissemination,

communication,

post-approval

Source: Geissler, Ryll, Leto, Uhlenhopp (2017) Therapeutic Innovation & Regulatory Science. (doi: 10.1177/2168479017706405)

Fundraisingfor research

Ethics Review


Focus: the three decision-making points

Research priority settingEarly dialogues with regulators

and HTA bodiesDesign of clinical trials


Where IPPOSI wants to get to…

INFORM ENGAGE EMPOWER

Thank you!

@IPPOSI

www.ipposi.ie

[email protected]

http://www.ipposi.ie/

mailto:[email protected]

Derick Mitchell SPHERE conference Jan 2018

Health & Medicine

Transcript of Derick Mitchell SPHERE conference Jan 2018