Conflict of Interest and Disclosures Patient Engagement ... · • May be national/international, multi-disciplinary and multi-sectoral • Funders expect a high degree of knowledge

Monique A.M. Gignac, PhD Associate Scientific Director & Senior Scientist, Institute for Work and Health;

Affiliate Scientist, Toronto Western Research Institute, University Health Network;

Professor, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada

[email protected]

Patient Engagement from the

Researcher’s Perspective

Monique A.M. Gignac, PhD has none.

2

Conflict of Interest and Disclosures

Patient Engagement in Research from

the Researchers Perspective

...is the term “patient” appropriate?

3

Patient?

Consumers?

Citizens?

Citizen Engagement?

Research Ambassadors?

4

mailto:[email protected]

Presentation Objectives

1. Highlight the importance of researchers and people living with

arthritis negotiating their roles early in the research process and

regularly

2. Illustrate the diverse ways that people with arthritis and researchers

can work together.

3. Discuss the importance of:

a. A common agenda

b. Learning one another’s language

c. Understanding research timelines

5

Reports written, published;

may be presented

Conclusions Drawn

Research Themes

Focus Work

Specific research

questions posed

Studies Designed

Data collected

Data analyzed

Knowledge may be transferred

to specific audiences

Audiences/stakeholders may contribute to

design, data collection, analysis

Audiences/stakeholders

assist in translating research

knowledge for practice

Key Audiences/stakeholders identified;

relationships built for ongoing KTE

Audiences/stakeholders

input helps to focus

research questions

Knowledge transfer planned/delivered

with audiences/stakeholders

Courtesy of the Institute for Work & Health (IWH), Toronto, Canada, 2004

Networks & Research Teams

• Funding for large networks is becoming increasingly

common

• May be national/international, multi-disciplinary and

multi-sectoral

• Funders expect a high degree of knowledge translation

and relevance to stakeholders

7

Canadian Arthritis Network (CAN)

• Research and Training program

• Active from 1998 to 2012

• 2 years of legacy funding (2012-2014)

8


Research aimed at:

1. Better understanding the causes of arthritis

2. Developing and evaluating new treatments,

therapeutics and interventions

3. Population and community health research

9


Research aimed at:

1. Better understanding the causes of arthritis

2. Developing and evaluating new treatments,

therapeutics and interventions

3. Population and community health research

....involved nearly 200 researchers and ~ 1,000

collaborators and partners

10

Can Consumer Model

1. Governance of the Network (e.g., Consumer Advisory Council

(CAC); Research Management Committee; Board of Directors)

2. Strategic planning

3. Training with researchers

4. Creation of information and tools

5. Members of grant projects, grant review committees and

trainees/student review panels

6. Training the next generation of researchers

7. CAN Annual Conference

8. Outreach (e.g., “CAN Cares” public forums)

11

Lessons Learned

A successful relationship takes effort and

resources

12

Lessons Learned

• It’s critical to articulate a common agenda and vision

• Other stakeholders listen to patients (e.g., research

funders, industry, government, clinicians)

• Research and advocacy agendas don’t always mix

well

13

Lessons Learned

Take time to develop a shared language and messages

• The “tentative” language of research can create

frustration among researchers and consumers in

moving forward

14

Lessons Learned

Time: Why does is take sooooooo long to do

research?

15

Lessons Learned: Time

• The grant process is becoming increasingly long and

arduous

• It can be difficult for researchers and consumers to

sustain their interest in a research project over time

• The “honeymoon” period cools rapidly with the work and

time needed for data collection and analysis

• Publication needs can delay getting the messages out

• There’s always another study....

16

And yet…

The researcher-citizen relationship often works

extremely well

17

• Finding the right consumers isn’t always easy

• Need to make an effort to hear from diverse

groups of people with arthritis

• Need to include other types of stakeholders

18

Bringing people together is not the same as

keeping people together

Expect changes in your relationships

Thank you!

19

[email protected]

www.iwh.on.ca

Next Speaker – Amye L. Leong, MBA

www.rheumatology.org 20

mailto:[email protected]

http://www.rheumatology.org/

2016 ACR/ARHP Webinar

28 February 2016

Nothing About Us Without Us:

Engaging Patients in Rheumatology Research

Amye L. Leong, MBA President & CEO, Healthy Motivation;

Director of Strategic Relations, Bone and Joint Decade,

the Global Alliance for Musculoskeletal Health;

Chair, Leadership Board, Arthritis Foundation CA Central Coast;

OMERACT Patient Research Partner Leader

[email protected]

Amye Leong, MBA, has nothing to disclose.


Key References and Resources

1. Domecq, Juan et al. Patient engagement in research: a systematic review. BioMed Central Open Access, February 2014.

2. Bykerk V, Furst D, Leong A, et al. Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the

OMERACT 11 RA Flare Workshop. J Rheumatol: 2014, Mar; via online 131252.

3. de Wit, Maartin et al. Involving patient research partners has a significant impact on outcomes research: a responsive

evaluation of the international OMERACT conferences. BMJ Open 2013;3:e002241 doi:10.1136/bmjopen-2012-002241

4. Outcome Measures in Rheumatology. www.omeract.org.

5. Mullins, D. et al. Continuous patient engagement in comparative effectiveness research. JAMA. 2012;307(15):1587-1588

6. Canadian Foundation for Healthcare Improvement. Patient and family engagement. http://www.cfhi -

fcass.ca/whatwedo/PatientEngagement.aspx

7. Bingham CO 3rd, Alten R, Bartlett SJ, Bykerk VP, Brooks PM, Choy E, ChristensenR, Furst DE, Hewlett SE, Leong A,

May JE, Montie P, Pohl C, Sanderson TC, Strand V, Woodworth TG; OMERACT RA Flare Definition Working Group.

Identifying preliminary domains to detect and measure rheumatoid arthritis flares: report of the OMERACT 10 RA Flare

Workshop. J Rheumatol. 2011 Aug;38(8):1751-8.

8. Leong, A., Euller-Ziegler, L. Patient Advocacy and Arthritis: Moving Forward, Bulletin of the

World Health Organization. 2004 Feb; 82(2):115-20. E-pub 2004 Mar 16, 2004.

The Early Days: What Did Patient Engagement Look Like?

Rheumatology Patient Engagement 2002

Patient Engagement Today 2002 - 2016

International

•Cochrane Systematic Reviews

•OMERACT Patient Research Partners since 2002

Regional

•EULAR Guidelines & EULAR Network of PRPs

National

•INVOLVE: UK’s National Health Service

•Canadian Foundation for Healthcare Improvement

•USA: PCORI, NIH, AHRQ, FDA & C-PATH: PROMIS

Commercial

•Industry

. . . And growing . . .

OMERACT PRPs in Malaysia 2010

Common language = EXPERIENCE with Rheumatic Disease

Concordance – Discordance with HCPs EXPERTISE

The Experience of Patient Engagement

• Leadership Support



• Goals, Expectations




• Selection (geographical, diversity, disease duration, severity,

skills, etc.)





skills, etc.)

• Mutual training & preparation: Glossary for HPs and patients





skills, etc.)

• Mutual training & preparation: HPs and patients

• Logistics support: patient-to-patient, HP-patient





skills, etc.)



• Organizational support (recruitment, strategy, fundraising)





skills, etc.)



• Organizational support (recruitment, strategy, fundraising)

• Dissemination: authorship, presentations





skills, etc.)



• Organizational support (recruitment, strategy, fundraising, etc.)

• Dissemination, authorship, presentations

• Feedback, continuous improvement





skills, etc.)



• Organizational support (recruitment, funding, outreach, etc)

• Dissemination, authorship

• Feedback, continuous improvement

Patient Engagement: What It Looks Like

Focused Resources Online

• PCORI www.pcori.org

• OMERACT www.omeract.org

• CISCRP www.ciscrp.org

• Research Involvement and Engagement

www.researchinvolvement.com (open source)

RESOURCES 1. Domecq, Juan et al. Patient engagement in research: a systematic review. BioMed Central Open Access, February 2014.

2. Bykerk V, Furst D, Leong A, et al. Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the

OMERACT 11 RA Flare Workshop. J Rheumatol: 2014, Mar; via online 131252.

3. de Wit, Maartin et al. Involving patient research partners has a significant impact on outcomes research: a responsive

evaluation of the international OMERACT conferences. BMJ Open 2013;3:e002241 doi:10.1136/bmjopen-2012-002241

4. Outcome Measures in Rheumatology. www.omeract.org.

5. Mullins, D. et al. Continuous patient engagement in comparative effectiveness research. JAMA. 2012;307(15):1587-1588

6. Canadian Foundation for Healthcare Improvement. Patient and family engagement. http://www.cfhi -

fcass.ca/whatwedo/PatientEngagement.aspx

7. Bingham CO 3rd, Alten R, Bartlett SJ, Bykerk VP, Brooks PM, Choy E, ChristensenR, Furst DE, Hewlett SE, Leong A,

May JE, Montie P, Pohl C, Sanderson TC, Strand V, Woodworth TG; OMERACT RA Flare Definition Working Group.

Identifying preliminary domains to detect and measure rheumatoid arthritis flares: report of the OMERACT 10 RA Flare

Workshop. J Rheumatol. 2011 Aug;38(8):1751-8.

8. Leong, A., Euller-Ziegler, L. Patient Advocacy and Arthritis: Moving Forward, Bulletin of the

World Health Organization. 2004 Feb; 82(2):115-20. E-pub 2004 Mar 16, 2004.

T h a n k y o u ! ! !

Nothing About Us Without Us:

Engaging Patients in Rheumatology Research

Amye L. Leong, MBA President & CEO, Healthy Motivation;

Director of Strategic Relations, Bone and Joint Decade,

the Global Alliance for Musculoskeletal Health;

Chair, Leadership Board, Arthritis Foundation CA Central Coast;

OMERACT Patient Research Partner

[email protected]

40

Next Speaker – M. Suzanne Schrandt, JD

www.rheumatology.org

http://www.pcori.org/

http://www.omeract.org/

http://www.ciscrp.org

http://www.researchinvolvement.com/

http://www.rheumatology.org/

41

Patient Engagement Through all Stages

of Research

M. Suzanne Schrandt, JD

Deputy Director of Patient Engagement

42


M. Suzanne Schrandt, JD

Discloses activities with other organizations such as:

Arthritis Foundation, Rheumatoid Arthritis CME and Patient

Partners in Arthritis, 6

Our Mission

PCORI helps people make informed health care decisions, and improves health care delivery and outcomes, by producing and promoting high integrity, evidence-based information that comes from research guided by patients, caregivers and the broader health care community.

Our Review Criteria

Impact of the condition on health of individuals

and populations

Potential for improving care and outcomes

Technical merit

Patient-centeredness

Patient and stakeholder engagement

During a rigorous merit review process, proposals are evaluated to assess:

Study Design/ Implementation

Evaluation

Topic Selection and

Research

Prioritization

Merit Review

We Engage Patients and

Other Stakeholders at Every Step The Engagement Rubric

The rubric is intended to provide guidance to applicants, merit reviewers, awardees, and

engagement/program officers (for creating milestones and monitoring projects) regarding

patient and stakeholder engagement in the conduct of research. It is divided into four

segments:

Planning the Study

Conducting the Study

Disseminating the Study Results

PCOR Engagement Principles

Planning the Study

• Diabetes study: Clinicians who reviewed the initial study

design indicated that clinical practice is quite variable

and suggested that a three-arm approach would be more

appropriate for the study. The study design was revised

accordingly.

• Cancer study: Patient partners determine eligibility

requirements for study inclusion.

Conducting the Study

• Chronic pain study: The informed consent document

is developed with patient partners to make it

understandable to study participants.

• Chronic pain study: Patients and clinicians revise and

shorten survey tool.

• Preeclampsia study: Study team will recruit via a

national network of local health departments and

community health centers, as well as a preeclampsia

advocacy group’s website, and Facebook page.

Disseminating the Study Results

• Chronic Trauma study: The research team will convene

a policy summit with relevant professional societies

during the third year of the study to focus on identifying

ways to speed the implementation of findings into

practice.

• Neurology Study: Patient partners will co-present at

large patient advocacy organization summit.

• Chronic Sain Study: Patient partners co-author

manuscripts, present at scientific and lay conferences,

and share study findings through their networks.

Engagement Principles

• Compensation for patient partners is included in the

budget at an appropriate level.

• Meetings are held at a time and in a location that that

accommodates patient and stakeholder partners.

Compensation is provided for transportation and related

expenses.

• Training and educational opportunities are provided, for

patient, stakeholder, and researcher partners such as

training in human subjects protection.

Putting the Rubric to Work

Greater understanding of engagement

Stronger engagement in

proposals

Strong engagement

during research?

Engagement Officers: Role and

Responsibilities

Position that parallels the Program Officer role

Partners with Program Officers and research teams

to oversee and cultivate engagement throughout the

life of the project

Ensures robust engagement is integrated into

projects from time of contract formation

Participates in ongoing project management activities

Available for assistance and discussion

Gleans promising practices from projects to share

and replicate

Additional Resources

Compensation Framework, http://www.pcori.org/sites/default/files/PCORI-Compensation-Framework-for-

Engaged-Research-Partners.pdf

Sample Engagement Plans, http://www.pcori.org/sites/default/files/PCORI-Sample-Engagement-Plans.pdf

WE-Enact tool and data, http://www.pcori.org/sites/default/files/PCORI-PE-Advisory-Panel-Presentation-

WE-ENACT-Slides-011315.pdf

Find Us Online

www.pcori.org

Association of Rheumatology Health Professionals

www.rheumatology.org 55

Thank you for participating!

Questions: [email protected]

http://www.pcori.org/sites/default/files/PCORI-Compensation-Framework-for-Engaged-Research-Partners.pdf














http://www.pcori.org/sites/default/files/PCORI-Sample-Engagement-Plans.pdf








http://www.pcori.org/sites/default/files/PCORI-PE-Advisory-Panel-Presentation-WE-ENACT-Slides-011315.pdf


















Documents

Conflict of Interest and Disclosures Patient Engagement ... · • May be national/international, multi-disciplinary and multi-sectoral • Funders expect a high degree of knowledge