Post on 19-Dec-2014
description
Patient-Centered Outcomes Research Institute
PCORI Research on Engagement
Lori Frank, PhDDirector of Engagement ResearchJune 8, 2012
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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/
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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
N
Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic.
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
Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic.
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
Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic.
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
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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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
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.
PCORI Expert Interviews Project: Facilitated Discussions
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Respect
Communication
Dedicated Resources
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.
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”
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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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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