Frank cue 08_june2012v4

Patient-Centered Outcomes Research Institute

PCORI Research on Engagement

Lori Frank, PhDDirector of Engagement ResearchJune 8, 2012

PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E

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Patient-Centered Outcomes Research (PCOR) Helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. This research answers patient-centered questions such as:

Expectations

• “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?”

• “What are my options and what are the potential benefits and harms of those options?”

• “What can I do to improve the outcomes that are most important to me?”

• “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and healthcare?”

Options Outcomes Decisions

Patient-Centered Outcomes Research


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To help people make informed health care decisions and improve 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

To define methodological best practices To identify gaps in methods knowledge To prioritize methodological areas of focus so that PCORI

can accomplish its PCOR agenda.

The Mission

PCORI

Methodology Committee


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Methodology Report

The Methodology Committee, in accordance with PCORI’s establishing legislation, submitted to the Board of Governors on May 10, 2012, the first draft PCORI Methodology Report

The draft report was accepted by the PCORI Board of Governors on May 21, 2012

A public comment period on the draft report will begin in July

Source: http://www.pcori.org/what-we-do/methodology/

http://www.pcori.org/what-we-do/methodology/


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Methodology Committee Awarded Contracts

Awarded RFP Topic/Type Contractor

Methods for Setting

Priorities in Research

(White Paper)

Topic Generation 1. Hayes Inc.Value of Information Analysis 2. NORC at The University of ChicagoValue of Information Analysis 3. Duke University, Evidence-Based Practice Center

Peer Review 4. University of Wisconsin, Medical College

Evidence for Eliciting the

Patient’s Perspective in

PCOR

Stakeholder Interview 5. Oregon Health & Science University, The Center for Evidence-Based Policy

Literature Review 6. Mayo Clinic, Knowledge and Evaluation Research Unit

Supplement to Stakeholder Interviews 7. University of Maryland School of Pharmacy, Pharmaceutical Health Services Research Department

Review of Guidance

Documents for Selected

Methods in PCOR

Standards in the Prevention and Handling of Missing Data in Observational and Experimental Patient Centered Outcomes Research.

8. Johns Hopkins Bloomberg School of Public Health

Standards in the Design and Selection of Patient-Reported Outcomes Measures (PROMs) for Use in Patient Centered Outcomes Research.

9. Northwestern University/UNC Chapel Hill

10. Oxford Outcomes

Standards in the Design, Conduct, and Evaluation of Adaptive Randomized Clinical Trials. 11. Berry Consultants

Standards in the Design, Conduct, and Evaluation of Research Evaluating Diagnostic Testing Strategies for Patient Centered Outcomes Research.

12. Brown University

Standards for Causal Inference Methods in Analyses of Data from Observational and Experimental Studies in Patient Centered Outcomes Research.

13. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School

Standards in the Conduct of Registry Studies for Patient Centered Outcomes Research. 14. Outcome Sciences, Inc. (A Quintiles Company)

Networks or Distributed Data Networks in Patient Centered Outcomes Research. 15. University of California and San Diego


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3.1.2 Identify Specific Populations and Health Decision(s) Affected by the Research

3.1.5 Measure Outcomes that People in the Population of Interest Notice and Care About

4.1.1 Engage Patient Informants, Persons Representative of the Population of Interest, in All Phases of Patient-centered Outcomes Research (PCOR)

4.1.2 Identify, Select, Recruit, and Retain Study Participants Representative of the Spectrum of the Population of Interest Facing the Health Decision of Interest and Ensure that Data Are Collected Thoroughly and Systematically from All Study Participants

4.1.3 Use Patient-Reported Outcomes When Patients or People at Risk of a Condition Are the Best Source of Information

4.1.4 Develop and Implement a Dissemination Assessment to Achieve Broad Awareness of Study Results

Standards for Patient-Centeredness and Engagement


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PCORI Research: Eliciting the Patient Perspective in PCOR A Meta Narrative Systematic Review

5551 Potentially relevant references identified by

electronic search

199 Studies at this level

194 Studies included in the Systematic review

Full text screening

Data extractionDuplicate

elimination

09 Potentially relevant references identified by manual search /

Expert contact

09 Studies included at this level

Abstract screening

Environmental Scan

11 Systematic Review

7 Randomized Controlled Trials

103 Qualitative 8 Single Cohort 7 Case report 9 Cross Sectional49 Non Systematic

Review

53 Included Documents

Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic.


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Study settings

0 5 10 15 20 25 30 35 40 45

General health research

Chronic diseases (i.e. TB, DM, etc.)

Social topics

Neoplastic diseases

Mental and neurological health

HIV

Physical disabilities

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In Which Therapeutic and Topic Areas Was Engagement Studied?


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Included Study Design

0

5

10

15

20

25

30

Agenda Setting Study Design &Procedures

Study Recruitment Data Collection Data Analysis Dissemination Implementation Evaluation

Preparation Execution Translation

N

Systematic Review Randomized Controlled Trail Qualitative Cross Sectional Case Report Literature Review Commentary


What Study Designs Were Used to Study Engagement?


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Used Methods to obtain informant's voice

0

2

4

6

8

10

12

14

16

18

Agenda Setting Study Design &Procedures

StudyRecruitment

Data Collection Data Analysis Dissemination Implementation Evaluation

Preparation Execution Translation

N

Focus Group Interview Survey Deliberation/Organizational participation


How Was Engagement Achieved?


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Conclusions From Reviewing the Literature

Methods not well described in most studies

Environmental scan:‒ Disease specific social networks‒ Networks designated for patient engagement (Europe/Canada)

We did not find comparative studies to determine the relative efficacy of a particular method of identifying patient representatives



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Next Step: Speaking to People About Engagement PCORI Expert Interviews Project

299 experts identified‒ Existing professional

networks‒ Environmental scan‒ Snowball technique

128 contacted

87 interviews completed‒ Phone‒ 30-60 minutes‒ December 12, 2011 –

February 15, 2012

Source: Curtis, P, Slaughter-Mason, S, Thielke, A, Gordon, C, Pettinari, C, Ryan, K, Church, B, King, V(2012). PCORI Expert Interviews Project: Final report. Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University.


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Los Angeles, CA

Austin, TX

Portland, OR

Athens, GA

Boston, MAOmaha, NE


PCORI Expert Interviews Project: Facilitated Discussions


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Respect

Communication

Dedicated Resources


PCORI Expert Interviews Project: Key Themes


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Using Patient-Reported Outcomes

Develop “Ideal” or “Best Practices” standards...‒ from conceptualization ‒ to development‒ through evaluating

psychometric properties ‒ in multiple diverse

populations.

Differentiate research use vs. healthcare use of PROs

Source: Butt, Z and Reeve, B (2012). Enhancing the Patient’s Voice: Standards in the Design and Selection of Patient-Reported Outcomes Measures (PROMs) for Use in Patient-Centered Outcomes Research: Methodology Committee Report. Evanston, IL: Northwestern University.


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Emerging Models of Engagement

Informant Selection

Co-learningResearchers Informants

Re-Assessment & Feedback

Building Reciprocal Partnerships

Source: 1Curtis, P, Slaughter-Mason, S, Thielke, A, Gordon, C, Pettinari, C, Ryan, K, Church, B, King, V(2012). PCORI Expert Interviews Project: Final report. Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University. 2Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic.


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Engagement Principles: From Thought to Action

Pre-Engagement with Target Population

Training: Patient and Participant

Evaluation of Comprehension over Time

Longitudinal Relationship Building/Maintenance

Require Elements for Proper Indexing –Permit Evaluation

Trust

Transparency

Co-learning

Reciprocal

relationships

Partnerships

Honesty

Ideal Practice: Engage “Early and Often”



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Patient-Centered Research Objectives

Outcomes

Outcomes are meaningful and important to patients

• And others: family, clinicians, policymakers, - ?

Stakeholder Input

Study design, outcomes and comparators have been informed by patients

Engagement

Engage patients iteratively

• From topic generation to research prioritization through dissemination

What Works for Whom…?

Assess disease course and treatment effect based on biomarker and “psychomarker” data


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• Who determined?– The research questions

– For database studies, the database to use

– The variables to examine: outcomes, comparators, covariates

– The analytic methods?

• Who is on the research team? – Patients or patient advocates?

– Other stakeholders?

• What will the research team do with the information?– How will results apply to health decisions?

• Is there a plan for interaction between researchers and the community?

Patient-Centered Perspective


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Connect with PCORI

Visit us at www.pcori.org

Subscribe to PCORI updates at

www.pcori.org/subscribe

Follow @PCORI on Twitter

Watch our YouTube channel –

PCORINews

http://www.pcori.org/

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Frank cue 08_june2012v4

Health & Medicine

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