Engaging Patients and Other Stakeholders in Clinical Research Kim Bailey Engagement Officer Health Action 2015 1/24/2015

Objectives for Today What is PCORI? What is PCOR? Why patients and family members should be engaged in research? How we engage patients, family members, and other stakeholders in research? To learn more about PCORI, please see: www.pcori.org/about

About PCORI We are an independent research institute that was authorized by Congress in 2010 We fund comparative clinical effectiveness research (CER) that engages patients and other stakeholders throughout the research process We seek answers to real-world questions about what works best for patients based on their circumstances and concerns To learn more about PCORI, please see: www.pcori.org/about

Why PCORI? For all the advances it produces, research still has not answered many questions patients face People want to know which treatment is best for them Patients and their clinicians need information they can understand and use

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 Broad and Complex Mandate “The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis... … and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services...” -- from PCORI’s authorizing legislation

What is Patient-Centered Outcomes Research? Helps people and their families communicate and make better-informed healthcare decisions Actively engages patients and other key stakeholders throughout the research process Compares the effectiveness of important clinical management options Evaluates the outcomes that are the most important to patients and families Addresses implementation of findings in real life clinical environments

Snapshot of Funded Projects Number of projects: 360 Amount awarded: $671 million Number of states where we are funding research: 39 (plus the District of Columbia and Quebec) As of September 30, 2014

The Research We Fund is Guided by Our National Priorities for Research Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication & Dissemination Research Addressing Disparities Accelerating PCOR and Methodological Research

We Focus Attention On… Conditions Conditions that affect large numbers of people across a range of populations Conditions that place a heavy burden on individuals, families, specific populations, and society Rare diseases, which are difficult to study Populations Racial and ethnic minorities Older adults Low-income and rural populations Children For more background on the research PCORI supports, see: www.pcori.org/research-we-support

We Follow a Unique Proposal Review Process Applications are reviewed against five criteria: Applications are reviewed by a panel of two scientists, one patient, and one other stakeholder PCORI’s Board of Governors makes funding decisions based on merit review and staff recommendations Impact of the condition on the health of individuals/populations Potential for the study to improve healthcare and outcomes Technical merit Patient-centeredness Patient and stakeholder engagement

We Require Patient-Centeredness and Patient and Stakeholder Engagement Does the project aim to answer questions or examine outcomes that matter to patients within the context of patient preferences? Research questions and outcomes should reflect what is important to patients and caregivers Patient and Stakeholder Engagement Patients are partners in research, not just “subjects” Active and meaningful engagement between scientists, patients, and other stakeholders Community, patient, and caregiver involvement already in existence or a well-thought out plan

Engagement as a Path To Useful, High-Quality Research Proposal Review; Design and Conduct of Research Topic Selection and Research Prioritization ENGAGEMENT Dissemination and Implementation of Results Evaluation

Who Are Our Stakeholders? PCORI Community Patient/ Consumer Caregiver/Family Member of Patient Clinician Patient/ Caregiver Advocacy Org Hospital/ Health System Training Institution Policy Maker Industry Payer Purchaser

Engagement Goals Build a patient-centered outcomes research, or PCOR, community Engage the PCOR community in research Promote dissemination and implementation of PCOR research findings

Engagement in Research PCORI encourages awardees to engage patients and other stakeholders at every stage of their project Planning the study Conducting the study Disseminating study results PCORI encourages creativity and innovation in engagement Spectrum of engagement: from subject to co-PI Engagement should fit the project aims and objectives

The 5 Ws & H of Engagement Why engage? Who to engage? What to engage around? When to engage? Where to find patients and stakeholders to engage? How to engage?

Engagement Rubric PCORI has developed a four-part Engagement Rubric to provide guidance to applicants, merit reviewers, awardees, and engagement/ program officers regarding engagement in the conduct of research Planning the Study: How patient and stakeholder partners will participate in study planning and design Conducting the Study: How patient and stakeholder partners will participate in the study conduct Disseminating the Study Results: How patient and stakeholder partners will be involved in plans to disseminate study findings, and ensure that findings are communicated in understandable, usable ways PCOR Engagement Principles: Reciprocal Relationships; Co-learning; Partnership; Trust, Transparency, Honesty

Find Us Online www.pcori.org

Thank You Kim Bailey Engagement Officer kbailey@pcori.org