PCORI Board of Governors Meeting September 2012

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Slide presentations from the PCORI Board of Governors meeting held Monday, September 24, 2012.

Slide presentations from the PCORI Board of Governors meeting held Monday, September 24, 2012.

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  • Talking Points: LF text:Criterion 5: Rigorous Research MethodsDoes the application include methods appropriate for comparative research on clinical questions?Does the applicant propose use of methods that are appropriate for the research question? Are there better methods that should have been selected or at least mentioned?How likely is it that the proposed study population, study design and available sample size will yield generalizable information with sufficient precision to be useful and reliable for patients, their caregivers, and clinicians?We encourage applicants to refer to the first draft of the PCORI Methodology Report, which is available on the PCORI website. Please note, however, that this draft has not yet had the benefit of public comment and public comment and revision in response to public comment will not be complete before the July 31 2012 application deadlines. Therefore, adherence to the contents of the report is not required for this funding cycle. Original text:You must use appropriate methods for the research at hand that your application suggest.Refer to the first draft of the PCORI methodology report. This report is not finalized, not required element for this funding cycle. Adherence to the final Methodology standards will be required in future funding cycles.Emphasize that we are expecting studies that are comparative and involve clinical outcomesNote: Stay close to wording on 2nd bullet.
  • ANNE BEAL
  • SUSAN
  • SUSANBuild community – use examples of meetingsPlug community into research community
  • SUE
  • SUE
  • SUSAN WILL DO
  • SUESay that 1/3 of each study section will be comprised of patients, caregivers and other stakeholders.
  • SUE WILL DO*Notes:Patient includes Patient, Patient Advocate/Family Members, and Patient or Caregiver Association Representative Other Stakeholders include Health Insurance Issuer, Hospital Representative, Pharmaceutical, Device, and Diagnostic Manufacturer or Developer, Policy Maker, Caregiver, etc.
  • SUE
  • SUE AND SUSANSUSAN WILL START WITH FIRST TWO CLOUDSSUE WILL DO LAST TWO CLOUDS
  • SUSAN WILL DOMake clear that we are still developing this area/best practices for dissemination.
  • SUSAN
  • SUE WILL DOMake clear that we are still developing this area – feedback – and looking for best practices.
  • SUEDescribe details of “thought piece”
  • SUE
  • SUSAN
  • SUSAN
  • SUSANWe are very excited to be responsible for PCORI’s engagement activities and are eager to discuss our work with you,and you will be hearing from us.
  • ANNE BEAL
  • This presentation will describe PCORI”s proposed topic generation and research prioritization process.
  • PCORI’s board approved in May 2012 the national Priorities for Research and Research Agenda. Five priorities were identified in this process: addressing disparities, communication and dissemination, Assessment of options for prevention, diagnosis, and treatment, improving health care system. The final priority included the improvement of PCOR methods and the development of infrastructure.
  • PCORI has embarked on two complimentary ways to develop its research portfolio under the National Priorities. The first is a more traditional path that is investigator led, although patients and stakeholders are involved each step of the way. [Read pyramid]
  • The second approach is unique to PCORI and involves reaching out to the wider community to ask patients and stakeholders about the questions that matter to them, and what information would help them make better informed health decisions. [Read the slide]
  • PCORI has embarked on this second approach and I am going to talk in a more detail in the rest of this presentation about how PCORI is . PCORI is building on existing knowledge about the science of this process and the practical experience with the process from other organizations. The science in this area is fairly recent but there is some literature on the methods. We will also build on the recommendations from PCORI’s Methodology Committee. In terms of practical experience with engaging patients and stakeholders in this process, other agencies have had experience with this and we will draw upon what they have done, what they have learned and what challenges they have encountered along the way.
  • This slide provides a broad overview of the 4 main phases that make up this process. I will be speaking in more detail about each of these phases over the next few slides. The first step, which we call topic generation, involves identifying research questions that matter and have not been answered. There is no one way to do this and PCORI is working on many fronts to elicit these questions: by reaching out to the wider community of patients and stakeholders, and asking through a variety of means, including a web portal which I will show you on the next slide, but also workshops, social media. We will also be continuously monitoring our own portfolio of research to identify gaps that need to be addressed, and then finally we will be collaborating with other organizations and funding agencies such as AHRQ and NIH to keep identifying known gaps in the field. I will say more about this in a couple of slides. 2. In the second phase, called gap confirmation, PCORI confirms that the research question is truly a gap in knowledge and that no research currently answers this question or that no research is currently underway to answer this question, to avoid any duplication of efforts. 3. In the third phase, the research questions that constitute true gaps in knowledge will be given to advisory groups made up of patients and stakeholders to prioritize and rank according to how highly the research is needed. 4. Finally in a last step, PCORI’s Board of Governors will consider this advice and make final decision on which questions should be the subject of a funding announcement.
  • As I mentioned previously, our first phase in this process involves setting up many ways for the wider community of patients and stakeholders to generate and share the questions that are important to them for PCORI to consider. PCORI is reaching out to patients and the wider health care community in many different ways: the web page which I have just shown you, Workshops such as the ones that will take place this FallUsing social media and general outreach to patients, stakeholders and their organizations to let them know of our efforts and our requests for these topics We are also engaging with other funding agencies who work everyday on identifying current knowledge gaps in our evidence base, such as AHRQ and NIH, and we will build upon existing work to identify priorities, such as the IOM 100 list of priorities for comparative effectiveness research. The questions will be examined and reviewed by PCORI to make sure they meet our basic requirements. This means that the question must be related to a health care decision, it needs to be comparative and relate to several options, it must not be about costs or cost-effectiveness, and it must align with our National Priorities for Research. These questions will then be examined to confirm whether they are true gaps in evidence.
  • This is a snapshot of PCORi’s webpage where patients and stakeholders can send us in their question.
  • In this second phase, the questions will undergo a “gap confirmation”. Contracting with AHRQ, the questions will be examined to ensure that existing research does not already answer the question and to ensure that no existing research is underway so that we avoid any duplication. After examining the question, several possible recommendations will be possible. In some cases, there will be existing knowledge in various studies but this needs to be pulled together and synthesized and so the recommendation will be for a systematic review and evidence synthesis. In other cases, new primary research will be needed. In both these cases, the questions will be put to the Advisory Boards for prioritization. In cases where we determine that that evidence already exists or that research is underway, dissemination efforts will be required.
  • This slides reviews the actual research prioritization process that we are envisaging. It starts with the research questions that need prioritization. These questions will go to advisory panels comprised of patients and stakeholders. We will be discussing the composition and role of advisory panels in the next hour. We are envisaging that each of our national priorities would have a distinct Advisory Panel to reflect the different expertise needed. We also envisage that an Advisory Panel on rare diseases will be formed. These groups will go through prioritization processes and propose a final ranking to the Board. The Board will select from the prioritized list and PCORI will issue funding announcements. Note from Dry-Run: Advisory panels – Advise – Board takes their advice but makes final decisions. In the context of prioritization, they advise the Board. First ones: disparities, CER, health systems and patient engagement.
  • PCORI is working on developing a rigorous and transparent process for prioritizing research questions. It makes sense to start with our already established criteria in our funding announcements and to adapt these to our prioritization process. We propose to use the following criteria: [Read the criteria]
  • This is an example of a topic brief that would be part of the package that the patient and stakeholder advisory groups would receive in order to conduct prioritization.
  • Our immediate plans are to finalize our proposed process with our Technical Working Group comprised of Board members, MC members expert in the area of prioritization, outside experts, and that also includes patient and stakeholder representatives. [READ SLIDE]
  • This is our timeline.
  • To summarize: we have embarked on a unique approach to reach out to the wider community and to prioritize research questions.
  • Clinical Trials-- The Institute shall appoint expert advisory panels in carrying out randomized clinical trials under the research project agenda under paragraph (2)(A)(ii). Such expert advisory panels shall advise the Institute and the agency, instrumentality, or entity conducting the research on the research question involved and the research design or protocol, including important patient subgroups and other parameters of the research. Such panels shall be available as a resource for technical questions that may arise during the conduct of such research.Rare Diseases-- In the case of a research study for rare disease, the Institute shall appoint an expert advisory panel for purposes of assisting in the design of the research study and determining the relative value and feasibility of conducting the research study.
  • I will briefly discuss the development of the funding announcement related to improving methods in PCOR. Because we are limited in what can be said on a funding announcement prior to its release, this will be brief presentation mainly designed to inform you on the process of its development as well as its progress.
  • PCORI’s board approved in May the national Priorities for Research and Research Agenda. Five priorities were identified in this process: addressing disparities, communication and dissemination, Assessment of options for prevention, diagnosis, and treatment, improving health care system. The final priority included the improvement of PCOR methods and the development of infrastructure. This presentation addresses the development of the PFA associated with improving methods for PCOR.
  • A working group has been set up to review and finalize the PFA. This working group is comprised of members of the Board and members of the MC as well as PCORI staff. The working group has been set up so as to keep a strict firewall between the MC members who wish to be eligible to respond to this PFA and those who do not. MC members of the working group will not be eligible to respond to the PFA.
  • The PFA was developed using various sources of information. First and foremost, the research gaps identified in the draft Methodology Report were reviewed in great detail. As part of this process, we also combed through the 18 standards that were not deemed to have sufficient evidence to be included in the first draft report to identify potential gaps there. We also reviewed the 17 contractor reports that are available on the website. These were reports commissioned by the MC in 2012 in a number of research areas. Each of these specialized reports reported gaps in evidence in their specific topic areas. We also combed through the summaries of the methodology workshops held in march 2012 in baltimore and finally we looked at the ARRA funding announcements to glean any further information that could be helpful to craft the PFA.
  • The PFA captures 4 broad areas of interest: patient centeredness, research prioritization, general analytic methods and design specific analytic methods. Here are some of the specific areas of interest. [READ]
  • This slide describes some of the major milestones ahead for the release of the PFA.
  • Approved by the Board on June 19th, 2012 (via teleconference and webinar)
  • Implementation efforts focused first on the Methodology CommitteeTime-sensitive
  • Allows most Methodology Committee (MC) members to apply for PFAs; they have no unfair advantage in competition (due to firewalls explained in the following slides)
  • This subcommittee will work directly with the Board, Executive Director and PCORI staff in developing research priorities and a research agendaIn general, functions unique to this subcommittee include:Participate in preparation of funding announcementsParticipate in closed PCORI calls/sessions where non-public confidential information is presented and discussedInvolved in funding decisionsThis subcommittee will be ineligible for research funding
  • The Methodology Committee aims to:Serve as Methodological Consultants to the Board and StaffRecommend standards and provide guidance about the appropriate use of methods for patient-centered outcomes researchRecommend priorities to address gaps in research methods or their application Recommend actions to support standards Map research methods to specific research questions (Translation Table)
  • Confidentiality IndicatorsAll confidential information will be marked confidentialA statement will be made prior to initiating closed meetings to indicate that the meeting will include discussion of confidential and sensitive topics Non-Disclosure Agreements (NDAs/Mentoring)All MC members must acknowledge and sign the PCORI non-disclosure agreementMC Recusal and DisclosureMC Members will be required to recuse themselves from closed discussions or sessions where a conflict, whether real or perceived, emergesRecusal may be required if conflicts arise with offerors responding to RFPs (i.e., during RFP proposal reviews). A standardized disclosure process will be used during closed MC sessions involving voting on standards.
  • How will access to information be controlled?Controlaccess to PCORI’s restricted internal IT systems Limit distribution of confidential emails and non-public informationRestrict access to closed meetings
  • IT GovernanceMC members and external parties will have restricted access to Evidence and future IT systems that contain documents related to activities that they are firewalled fromA designated PCORI staff person (or persons) will be responsible for identifying and establishing access levels to IT systemsMitigating Time/Knowledge AdvantagePCORI shall provide PFA applicants at least 6 months time to interpret and/or incorporate Board-adopted MC recommendations/standards into their PFA applications prior to their application due datesAll contracted research supporting Methodology Report standards development will be posted on the PCORI website in as timely a manner as possibleDistribution Controls (E-mail)Staff shall be responsible for controlling email communicationsSpecifically in the case of PFA development, a unique distribution list will be created to include ONLY those involved in development of the PFAClosed Meeting ControlsStaff (or designees) shall be responsible for controlling access to closed Board-, committees-, MC-PFA Development Subcommittee-, or staff – face-to-face meetings and teleconferences. (Confirm meeting invitees; monitor attendance)Agendas, meeting minutes or any other materials for closed meetings where the MC is prohibited from attending, will not be accessible to the MC, unless they are also made available to the public
  • The SCCOI held a conference call on September 7.Supportive of the plans to operationalize the policy.
  • Staff will develop and execute a plan for implementing these firewall strategies. Key Steps in COI implementation checklist:Collect non-disclosure agreements from all MC membersAssign firewall implementation, monitoring, and reporting responsibilities to staffConduct training on maintaining firewallsLearn from other organizations, e.g. the revised NIH COI regulationsDevelop and incorporate confidentiality indicators and procedures into all non-public emails, documents, and closed meetings
  • Sherine or Bill or LoriAs you know the MC delivered its legislatively mandated Standards to the BoG on May 10 of this year. The public comment period opened July 23 and closed September 14. The MC is actively revising the Standards in response to comments from the public and from the Board, and from the MC itself and will deliver a revised set of Standards and Report to the Board later this Fall.
  • Goal of presentation:Acknowledge the call for a detailed strategic plan, agree with that and look forward to the dialogue and input that will guide our producing thatAs we do that, make clear that we know we have ongoing, and growing, daily communications and outreach needs, opportunities and challenges.So this is an attempt to set a framework for the development of the strategic communications plan while providing an overview of our nascent but growing and, we think, coherent and integrated, set of communications and outreach activitiesClose with a set of suggested next steps for both strategic and operational activities and initiatives
  • Key pointCommunications is both strategic and supportive in its role – ie, it provides a series of tools and platforms to support the advancement of PCORI’s objectives and goals
  • Platforms, tools and channelsWeb site; e-mail tools; multimedia; news media; social media; convening Staffing and resourcesSufficient to effectively manage growing operations and leverage future opportunitiesProcess and proceduresContent development, quality assurance, distribution, branding, Partnerships and relationshipsExtend PCORI’s efforts while building trust and “pull” for and use of research results; includes media
  • Goal of presentation:Acknowledge the call for a detailed strategic plan, agree with that and look forward to the dialogue and input that will guide our producing thatAs we do that, make clear that we know we have ongoing, and growing, daily communications and outreach needs, opportunities and challenges.So this is an attempt to set a framework for the development of the strategic communications plan while providing an overview of our nascent but growing and, we think, coherent and integrated, set of communications and outreach activitiesClose with a set of suggested next steps for both strategic and operational activities and initiatives
  • Goal of presentation:Acknowledge the call for a detailed strategic plan, agree with that and look forward to the dialogue and input that will guide our producing thatAs we do that, make clear that we know we have ongoing, and growing, daily communications and outreach needs, opportunities and challenges.So this is an attempt to set a framework for the development of the strategic communications plan while providing an overview of our nascent but growing and, we think, coherent and integrated, set of communications and outreach activitiesClose with a set of suggested next steps for both strategic and operational activities and initiatives
  • Key pointThe subcommittee is charged with coordinating and facilitating publication of PCORI-associated papers; the process should be widely used
  • OpportunitiesSupporting/proposing theme issuesSeeking/considering opportunities for standing columnsSupporting journal-branded multimedia opportunities

Transcript

  • 1. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Patient-Centered Outcomes Research Institute Executive Director’s Welcome Joe V. Selby, MD, MPH, Executive Director PCORI Board of Governors Meeting Washington, DC September 24, 2012
  • 2. New PCORI Staff – since May 2012 P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Kelton Chapman Katie Wilson Gregory Martin Orlando Gonzales Ayodola Anise Assistant Manager, Project Associate Deputy Director, Chief of Staff Project Associate Meetings and Special Events June 11, 2012 Stakeholder Engagement August 1, 2012 August 13, 2012 May 29, 2012 July 23, 2012 Michele Orza Marla Bolotsky James Hulbert Kara Odom-Walker Senior Advisor Associate Director, Contracts Administrator Scientist to the Executive Director Digital Media September 10, 2012 August 13, 2012 September 4, 2012 September 5, 2012 Not Shown: Lorraine Bell, Senior Program Associate – May 29, 2012 Desiree Frank, Executive Assistant to the Executive Director – June 19, 2012 Kimberly Holloway, Senior Administrative Assistant – August 27, 2012 David Hickam, Scientific Program Leader, Health System Research – September 17, 2012 Jordan Elliker, Project Events Coordinator – September 19, 2012
  • 3. PCORI PILOT PROJECTS (PPP)• 50 projects funded (of 856); mostly 2-years in length• $31 million total funding
  • 4. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEFunded PCORI Pilot Projects in 25 States and DC 4
  • 5. PCORI Pilot Projects Areas of Interest P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Area of Interest Submitted Funded Informing PCORI national priorities 21 2 Bringing together patients, caregivers, and other stakeholders in all stages of a research process 80 1 Translating evidence into health care practice in ways that account for individual patient preferences for various outcomes, including decision-support tools 180 19 Collecting and assessing patient- and provider-perceived gaps in evidence 26 0 Identifying, testing, and/or evaluating patient-centered outcomes instruments 214 11 Assessing the patient perspective when researching behaviors, lifestyles, and choices 31 5 Studying patient care team interactions in situations where multiple options exist 45 6 Analytical methods for CER 170 6
  • 6. Types of Organization Overview: All Applications P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Type Primes Subs Funded Academic 561 235 38 Hospitals 80 98 4 Primes Research organizations 55 49 3 Non-profit health systems 28 54 2 Community-based health 20 46 0 centers Consultants 18 32 1 Provider associations 16 19 0 Patient associations 10 40 1 Subcontractors Non-profit foundations 9 24 1 Technology organizations 7 25 0 Government 5 16 0 For-profit health benefits 2 0 0 For-profit pharmaceutical 1 2 0 6 Other 0 52 0
  • 7. Target Populations – Applicants & Awardees P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Percent of Total Applications Total Applications by Target 60% Population 50% Population All Funded 40% 30% Underserved 453 30 20% Specific Ethnic 243 21 10% or Cultural 0% Disabled 163 12 Urban & Rural 383 28 Only Urban 188 14 Only Rural 22 1 Unspecified 224 8
  • 8. Monitoring the Pilot Projects P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Two-year competitive contract awarded to AcademyHealth (A Rein, PI) to do the following:  Work closely with PCORI to monitor the 50 pilot projects for achievement of specific aims  Assess learnings on patient engagement in research from all 50 projects  Identify 5 subgroups with common themes, convene and create joint products within each thematic area 8
  • 9. PCORI FUNDINGANNOUNCEMENT APPLICATIONS• 483 applications received• Review process underway• ~ 100 awards expected in December 2012
  • 10. Description of Applications Received 483 applications received P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Applications by PFA Top 15 States Applying IA 71, 15% OH GA 109, 22% IL MI MD NC FL WA 92, 19% TX 211, 44% MN NY MA PA Addressing Disparities CA Assessment of Prevention, Diagnosis, and Treatment Options 0 10 20 30 40 50 60 Communication and Dissemination Research Improving Healthcare Systems
  • 11. Mention of Specific Conditions P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE 300Number of Applications 250 200 150 100 50 0 Multiple conditions and study designs may
  • 12. Study Designs Noted in Applications P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Priority #1: Assessment of Prevention, Diagnosis, and Treatment Options (n=211 applications) 90 80 70 60 50 40 30 20 10 0
  • 13. Study Populations Noted in Applications P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Priority #1: Assessment of Prevention, Diagnosis, and Treatment Options (n=211 applications) 80 70 Number of Applications 60 50 40 30 20 10 0 Disabled Elderly Other Pediatric Racial or Rural Urban Veterans Women Persons Ethnic Group
  • 14. Reviewers P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Total First Second Volunteers Applicants Round Round Technical Reviewers 800+ 483* 75-100 Patient Reviewers 225 -- 25 Stakeholder Reviewers 225 25 Committee Chairs -- 10
  • 15. PCORI’s 8 Review Criteria P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE 1. Impact of the Condition 2. Innovation and Potential for Improvement 3. Impact on Healthcare Performance 4. Patient-Centeredness 5. Rigorous Research Methods 6. Inclusiveness of Different Populations 7. Team and Environment 8. Efficient Use of Resources 15
  • 16. Agenda for Today’s Meeting P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Patient and Stakeholder Engagement Prioritization of Research Topics Advisory Panels Conflict of Interest Policy and Plan for Methodology Committee PCORI Funding Announcement 5A - Methods Methodology Committee Public Comment 2012 Budget Communications Update
  • 17. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Engagement Update Sue Sheridan, Acting Director, Patient Engagement Susan Hildebrandt, Director, Stakeholder Engagement Anne Beal, MD, MPH, Chief Operating Officer Sharon Levine, MD, Chair, COEC PCORI Board of Governors Meeting Washington, DC September 24, 2012
  • 18. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEEngagement: Questions to Consider • What recommendations does the Board have for reaching stakeholders who may not be part of established networks and are more difficult to reach?1 • What are the measures of success in engaging patients, caregivers, and stakeholders that the Board would like to see in the next 12 months?2 • How do we demonstrate and lead “research done differently” for patients, caregivers, stakeholders, and the research community?3 18
  • 19. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPresentation Outline• Review of Strategic Priorities• Engagement “Touch Points” in the PCOR Process• Workshops 19
  • 20. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEEngagement Priorities1. To invite, value, and use the wisdom and experience of patients, caregivers, and other stakeholders nationwide in the PCORI research enterprise; eliminate barriers to participation2. Establish a community of trained and informed patients and caregivers as valued partners who participate in all stages of the research enterprise3. Communicate transparently and regularly about PCORI’s approach and methods for prioritization, decision making, and funding to all stakeholders to create trust4. Evaluate and refine patient engagement processes to continuously learn and incorporate best practices and methods for developing a robust and engaged community of stakeholders in PCORI work• PCORI Strategic Plan 20
  • 21. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Patient and Stakeholder Engagement in Patient-Centered Outcomes Research Advise Us as to What PCORI Review Proposals and Should Study: Partner in ResearchWhat questions are most important? Review research proposals for impact(research prioritization) and patient-centerednessWhat outcomes should be studied? (topic Participate in conducting research Patientsgeneration) and Stakeholders Tell Us How We Are Doing Help Us Share the FindingsHow can we improve on what we are doing and How do we best communicatehow we are doing it? important research findings? 21
  • 22. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Patient View on Engagement in Research 22
  • 23. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Tell Us What PCORI Should Study• Conduct patient and stakeholder testing of content and language on topic generation Web page• Solicit research topics in patient and stakeholder meetings and PCORI roundtables• Host workshops • Patient Workshop (October 27-28) • Stakeholder Workshop (December 4) • Prioritization Workshop (December 5) 23
  • 24. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Review Proposals and Partner in Research• Revamped pilot projects reviewer recruitment process • Created a user-friendly application and process • Reached out to extensive lists of key stakeholders • Vetted reviewer applications in-house • Contracted with expert vendor to develop merit review training specifically for patients and other stakeholders • Will engage patients and stakeholders in process improvement cycle 24
  • 25. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPatient and Stakeholder Reviewers• Patients and stakeholders will be one-third of review panels• 350 total applicants• 242 with prior grant review Other Stakeholders,16 experience Patient, 25 • 102 from patient community • 140 from stakeholder community• 58 selected in final vetting Researcher, 5 • Based on balanced criteria• Goal is to build a database of lay reviewers of PCORI funding Clinician or Nurse, Provider 3 applications Association Physician, 5 Rep, 4 25
  • 26. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPatient and Stakeholder Reviewers 8 7 6 4 3 2 1 26
  • 27. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE What We Heard From Reviewers “First time patient’s voice is being“This is exciting formalized.” “Need to find ways “17-year breast cancerand will to optimize survivor and want tolead to positive healthcare system.” see an end to theoutcomes.” disease.” "Its about “Need to get “Need for more research time this is patients to meet current needs of happening perspective and patients.” “Served as a PCORI in find ways to get reviewer and experience healthcare.” them involved.” was fascinating."“Want to give back "I want do my part as aExpertise, and this “Stakeholder engagement is essential to patient, and I will beis a great learning relevant and useful research and honored with thisopportunity.” evaluation: from identification of study opportunity.” questions to dissemination and utilization of findings.” 27 Source: Patient and Stakeholder Interviews. August 2012
  • 28. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Help Us Spread the Word Share and Create Engage Adopt Latest Communities Meaningfully Information 28
  • 29. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Stakeholder View on Dissemination 29
  • 30. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Tell Us How We Are Doing Patients 30
  • 31. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPatient Workshop: ObjectivesTransforming Patient-Centered Research:Building Partnerships and Promising Models(October 27-28: Washington, DC)• Launch the creation of an informed and engaged community• Create consensus recommendations for patient engagement in – Generating and prioritizing research questions – Reviewing research proposals and the conduct of research – Disseminating and implementing research findings – Evaluating the success of PCORI’s engagement efforts• Write a “thought piece” on promising practices in patient engagement in research 31
  • 32. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPatient Workshop: Selection Criteria• Invitation list developed with the goal of inclusiveness• Balance sought between and among disease incidence, prevalence, burden, and disparities in the United States (with emphasis on chronic conditions)• Total attendance will be limited to 150 participants – 75% of participants will be patients, patient advocates, caregivers, and individuals from patient/caregiver advocacy organizations – 25% of participants will be a mix of PCORI’s other stakeholders 32
  • 33. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEStakeholder Workshop: ObjectivesWhat Should PCORI Study?A Call for Topics From Patients and Stakeholders(December 4: Washington, DC)• Solicit research topics for specific funding announcements using breakout sessions on PCORI’s priority areas and generate list• Report on draft prioritization process (topic of December 5 workshop), allow participants to experiment with applying it to their topics, and solicit feedback on the process• Report on Patient Engagement Workshop participants’ reactions to PCORI’s engagement strategies and to seek additional input 33
  • 34. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEStakeholder Workshop: Other CriteriaSpecific Experience With:• Research or work in PCORI Priority Areas• Leadership in PCORI Priority Areas• The health policy or research communities• Broad membership or responsibility for health care delivery 34
  • 35. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEWhat’s Next• Advisory Panels• Additional Workshops• State-Based Events 35
  • 36. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEEngagement: Questions to Consider • What recommendations does the Board have for reaching stakeholders who may not be part of established networks and are more difficult to reach?1 • What are the measures of success in engaging patients, caregivers, and stakeholders that the Board would like to see in the next 12 months?2 • How do we demonstrate and lead “research done differently” for patients, caregivers, stakeholders, and the research community?3 36
  • 37. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Topic Generation and Research Prioritization Joe V. Selby, MD, MPH, Executive Director Rachael Fleurence, PhD, Scientist Rick Kuntz, MD, MSc, Chair, PDC PCORI Board of Governors Meeting Washington, DC 20008 September 24, 2012,
  • 38. Strategic Questions to Consider P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE• Strategic questions to consider • Does the research prioritization process engage patients and stakeholders at the appropriate level? Is the process transparent and rigorous? • Will the process enable PCORI to develop a balanced portfolio in line with its mission? • Does the process enable the optimal level of engagement between the Board of Governors and Advisory Panels? 38
  • 39. PCORI’s Research Agenda P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Five Board-Approved Priority Areas 1. Addressing Disparities 2. Communication and Dissemination 3. Assessment of Prevention, Diagnosis, and Treatment Options 4. Improving Healthcare Systems 5. Infrastructure and Methods 39
  • 40. 2 Complementary Approaches for Developing PCORI’s National Research Agenda P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Investigator-Generated Research Just One Part of the Process PCORI issues broad funding announcements Researchers partner with stakeholders to generate questions Researchers, stakeholders apply review criteria in their applications Peer review prioritizes applications by level of alignment with criteria Diverse Research Portfolio answering key questions for patients and clinicians 40
  • 41. Patient/Stakeholder-Led Approach Unique to PCORI P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Patient/Stakeholder-Led Approach PCORI and stakeholders generate and prioritize questions based on review criteria PCORI issues specific, funding announcements for highest priority topics Researchers and stakeholders develop responsive proposals Peer review prioritizes applications by level of alignment with criteria Diverse Research Portfolio answering key questions for patients and clinicians 41
  • 42. Building on the Existing Evidence Base and Prior Experience P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Existing Scientific Methodology Committee Experience of Work and Literature and Methodology Report Other Agencies 42
  • 43. PCORI’s Process Transparent, Rigorous P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Final Selection for Topic Generation Gap Research Specific PFAs (Through Multiple Modes) Confirmation Prioritization (PCORI Board)Patients & Stakeholders:• Web Page• Social Media• WorkshopsPCORI:• Continuous Portfolio ReviewOther agencies:• AHRQ gaps• NIH gaps Research Opportunities 43
  • 44. Phase 1: Topic Generation P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Topic PCORI “Filter”—All Nomination Nominated Topics Must: Process Begins with Patients and Stakeholders • Web page • Social media/marketing • In-person workshops, focus groups  Answer a clinical question around a • Topic generation discussed at health care decision Patient and Stakeholder  Be comparative Workshops in the Fall  Not be related to cost/cost Gap effectiveness Confirmation • AHRQ: Future Research Needs (FRNs)  Align with at least one of PCORI’s Reports, Systematic Gap Review National Priorities for Research • Other guidelines development processes (such as NQF) • Gaps identified by NIH, other funding agencies • Building on existing work or other organizations, prioritization exercises (eg, IOM 100) 44
  • 45. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE 45
  • 46. Phase 2: Gap Confirmation P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Topics Provided to Potential Next AHRQ for Gap Determinations Steps Confirmation Evidence Synthesis Needed Research Prioritization AHRQ Topic Review and New Primary Disposition Research Needed Answer already Dissemination known, or research underway In collaboration with AHRQ; contract under development 46
  • 47. Phase 3: Research Prioritization P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Advisory Panels Board of Patients and Stakeholders Governors Prevention, Diagnosis, Research Questions Prioritized List Selected From Creation Treatment OptionsNeeding Prioritization of Topics Prioritized List of PFAs Communication and Dissemination 1. D 11. D ✔  2. D 12. D   ✔  Research 3. D 13. D ✔ ✔ Disparities 4. D 14. D  ✔ Prioritization 5. D 15. D Process Using 6. D 16. D Improving Health PCORI Criteria 7. D 17. D Care Systems 8. D 18. D 9. D 19. D 10. d 20. d Infrastructure and Methods Rare Diseases 47
  • 48. Five Prioritization Criteria Adapted From PCORI Funding Criteria P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE 1 Patient centeredness 2 Impact of the condition on the health of individuals and populations (prevalence, incidence, and other measures of burden of disease) 3 Potential for improvement: • Are the differences in benefits between the interventions sufficient to warrant conducting a research study? • Will the study reduce the uncertainty around the effect of the interventions? • How likely are the findings to change practice? • How long will the information be valid? 4 Potential for impact on health care performance 5 Potential for inclusiveness of different populations 48
  • 49. Developing Topic Briefs forPrioritization of Questions P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Sample PCORI Topic Brief Each Topic Brief explores a research question for which a gap has been identified Topic Brief addresses PCORI’s criteria: patient centeredness, impact of disease, potential for improvement, etc. 49
  • 50. Piloting the Process with Patientsand Stakeholders P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Patients and stakeholders will participate in a pilot 1 prioritization exercise using topic briefs and online tools. Participation will be by open application. 2 The pilot group will convene via several teleconferences to discuss topic briefs and results of initial ranking exercises. The pilot group will meet in person to reach 3 consensus on a final prioritized list, and to provide feedback to PCORI. The group will present at the December 5th workshop. 4 The revised process will be used by Advisory Panels in Winter 2013 with topics generated from patients and stakeholders across the country. 50
  • 51. Research Prioritization Timeline P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Aug Sep Oct Nov Dec Jan Feb Mar PCORI Science Team proposes initial RP Process Technical Working Group tests/provides feedback on RP Process; supports development of PCORI RP Process Patients, Stakeholders pilot RP process Revised Prioritization Process presented at PCORI Methods Workshop December 5th Patient/Stakeholder Advisory Panel training on Research Prioritization Methods Advisory Panels conduct Research Prioritization Process for nominated topics and submit to the Board 51
  • 52. PCORI’s Research Prioritization Team PCORI Staff and Leadership: P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE • Joe Selby, Executive Director • Rachael Fleurence, Scientist • Katie Wilson, Project Management • Natalie Wegener, Project Coordination Technical Working Group: • Arnie Epstein (BoG) • Gail Hunt (BoG) • Neil Kirschner (Stakeholder Representative) • David Meltzer (Methodology Committee) • Linda Morgan, RPh, MBA (Patient Representative) • Jean Slutsky (Methodology Committee) • Clyde Yancy (Methodology Committee) Pilot Workshop Participants: • Approximately 15-20 patients, stakeholders, researchers, and experts trained and prepared in PCORI’s research prioritization process 52
  • 53. Summarizing PCORI’s Unique Approach to Research Prioritization P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Patients and stakeholders engaged in each step of a transparent process: • Patients and stakeholders involved in developing the process, providing feedback, and members of the future Advisory Panels PCORI criteria for research prioritization: • Criteria developed to achieve research that will improve patient’s health outcomes, is impactful, and has a high probability of changing clinical practice Transparency/visibility embedded in the process: • Process shared with public for input and comment • Pilot group open to applications • Research prioritization methods workshop on December 5th broadcast via Web cast 53
  • 54. Revisiting the Strategic Questions P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE • Does the research prioritization process engage patients and stakeholders at the appropriate level? Is the process transparent and rigorous? • Will the process enable PCORI to develop a balanced portfolio in line with its mission? • Does the process enable the optimal level of engagement between the Board of Governors and Advisory Panels? 54
  • 55. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORI Advisory Panels Anne Beal, MD, MPH, Chief Operating Officer Sue Sheridan, Acting Director, Patient Engagement Susan Hildebrandt, Director, Stakeholder Engagement Sharon Levine, Chair, COEC PCORI Board of Governors Meeting Washington, DC September 24, 2012
  • 56. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEQuestions for Board Consideration Is this the right scope for advisory panel activities?1 Please comment on the proposed number and type of panels.2 56
  • 57. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEAdvisory Panels: What the Law Says • The Institute may appoint permanent or ad hoc expert advisory panels as determined appropriate to assist in identifying research priorities and establishing the research project agenda • The Institute shall appoint expert advisory panels in carrying out randomized clinical trials under the research project agenda • In the case of a research study for rare disease, the Institute shall appoint an expert advisory panel 57
  • 58. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEAdvisory Panels: Purpose• Advisory Panels will assist PCORI staff and Board in: – Modeling robust patient and stakeholder engagement efforts, – Refining and prioritizing specific research questions, – Providing other scientific or technical expertise – Addressing other questions that may arise relevant to PCORI’s mission and work 58
  • 59. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEAdvisory Panels: Framework• Each Advisory Panel will have – A unique charter and duration – Clearly defined scope of work• Membership on each Advisory Panel will be based on ensuring those with appropriate expertise are selected to satisfy the scope of work established in its charter – We are developing a plan for compensation of members 59
  • 60. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Proposed Advisory Panels • Patient Engagement • Assessment of Prevention, Diagnosis and Treatment Options • Health Disparities • Improving Healthcare Systems • Communication and Dissemination • Infrastructure* • Randomized Clinical Trials* • Rare Diseases 60*in collaboration with MC
  • 61. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEFirst Panels: First Half of 2013 Patient Engagement Assessment of Prevention, Diagnosis, and Treatment Options Health Disparities Improving Health Care Systems 61
  • 62. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Future Panels: Second Half of 2013 Communication and Dissemination Infrastructure Randomized Clinical Trials* Rare Diseases**Required by statute 62
  • 63. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEAdvisory Panels: What the Law SaysAn expert advisory panel shall include representatives ofpracticing and research clinicians, patients, and experts inscientific and health services research, health servicesdelivery, and evidence-based medicine who have experiencein the relevant topic and, as appropriate, experts in integrativehealth and primary prevention strategies. 63
  • 64. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEComposition• Advisory Panel size will be 10-21 panel members, depending on the panel’s purpose• Membership of each Advisory Panel will be selected based on the scope of work established in the charter 64
  • 65. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEComposition (continued)• Panel may have a non-voting liaison from the PCORI Board of Governors or Methodology Committee as appropriate• An Advisory Panel Chairperson will be selected from among the Panel members by the PCORI Board of Governors• Members will be appointed for 1-year terms, with an opportunity for reappointment 65
  • 66. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEConflict of Interest• PCORI will consider implications for panel members’ eligibility for future PCORI funding in creating Advisory Panels – The role will be advisory and participation will not affect eligibility for funding – We will have firewalls similar to those surrounding the Methodology Committee regarding access to information – Advise members before appointment about potential impact on eligibility for PCORI funding if they might receive non-public information – Explore options to promote transparency of proceedings• We will clarify that Advisory Panels’ roles are to provide input to the Board and staff, not to make decisions 66
  • 67. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEAdvisory Panel Establishment Process1 2 3 Staff Activates 4 Staff Draft and Board Reviews the Nomination and Board Approves Submit Charter for Proposed Advisory Selection of Panel Panel Participants an Advisory Panel Panel Charter Participants • Board, MC, and/or • Board may authorize • Staff initiates open • Staff selects and PCORI staff identify charter (proceed to call for proposes a panel the need to establish step 3) nominations, via the roster to the Board an Advisory Panel PCORI Web site and • Board may request other • Board authorizes • Staff initiates request revisions to the communications and approves the for an advisory panel charter (return to • Nominees submit an panel roster by submitting a step 1) expression of panel-specific charter interest, via the PCORI Web site • Staff evaluates nominees, per evaluation criteria unique to the panel charter 67 Staff Phase Board Phase
  • 68. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEFirst Panels: First Half of 2013 Patient Engagement Assessment of Prevention, Diagnosis, and Treatment Options Health Disparities Improving Health Care Systems 68
  • 69. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEProposed Panel: Patient Engagement• Purpose: Assure the highest patient engagement standards and patient-centeredness in all aspects of PCORI’s work• Term: 1 year• Membership: Between 10–21 members with 75% patients, caregivers, and advocacy organizations and 25% researchers and other stakeholders• Advisory Panels will provide advice and make recommendations to PCORI and help inform decisions of the Board of Governors, the Methodology Committee, and Institute staff, as requested 69
  • 70. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Proposed Panel: Patient Engagement • Patients and caregivers who can represent the collective voice of their communities/networks • Online communities and organizations with extensive reach into high priority populationsSelection • Represent underserved/disparate populations and Criteria those with rare diseases • Experience in patient-centered research/proposal review • Involvement in systems improvement • Community- or state-based 70
  • 71. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEQuestions for Board Consideration Is this the right scope for advisory panel activities?1 Please comment on the proposed number and type of panels.2 71
  • 72. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE BOARD VOTE: Recommend Approval to Develop Advisory Panels • Patient Engagement • Assessment of Prevention, Diagnosis and Treatment Options • Health Disparities • Improving Health Care Systems
  • 73. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORI Funding Announcement 5A: Methods Rachael Fleurence, PhD, Scientist Sherine Gabriel, MD, MSc, Chair, Methodology Committee PCORI Board of Governors Meeting Washington, DC September 24, 2012
  • 74. PCORI’s Research Agenda P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Five Board-Approved Priority Areas 1. Addressing Disparities 2. Communication and Dissemination 3. Assessment of Prevention, Diagnosis, a nd Treatment Options 4. Improving Health care Systems 5. Infrastructure and Methods
  • 75. Structure of Priority #5A/Methods Working Group P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Working Group Structure Enables MC Feedback While Protecting Members From COI • PFA Development Subcommittee of the Methodology Committee -Naomi Aronson -Al Berg -Sherine Gabriel Methodology Committee -Michael Lauer Members and Subgroups Unidirectional -Jean Slutsky Input • Patient Engagement -Clyde Yancy • Research Prioritization • PDC/Board • Research Methods Representation: -Rick Kuntz • PCORI Staff: -Executive Leadership: Joe Selby -Scientific Staff: Rachael PCORI Sr. Advisor and Staff to advise on Fleurence firewall/COI issues as needed -Project Management
  • 76. Combing Existing Sources for Research Questions, Comments, Gaps P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE • Methodology Report: -Research recommendations -Recommended actions -Text of the report -Review of 18 standards that were not included in the first draft of the report • Review of the 17 Contractor Reports commissioned by the MC to develop the Report • Summaries from Methodology Workshops held in March 2012, Baltimore
  • 77. Areas of Interest P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE • Methods for Patient Centeredness • Methods for Research Prioritization • General and Design-Specific Analytic methods
  • 78. Major Milestones Ahead for #5A Work P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PFA Development First Draft of Adapt existing PCORI Subcommittee of the Methods PFA review criteria from Methodology (PCORI Science Staff, in current PFAs to meet Committee progress) Methods needs reviews, revises first draft of Methods PFA Distill, incorporate Announce and Post public comments to Share with PDC and Methods PFA to PCORI Methodology Report Full Board for Web site as needed, as Comments (anticipated Nov., 2012) available (comments due 9/15)
  • 79. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Standing Committee on Conflict of Interest (SCCOI) Larry Becker, Chair, SCCOI and Member, Board of Governors Board of Governor’s Meeting Washington, DC September 24, 2012
  • 80. Today’s Agenda P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Agenda 1. Introduction – COI Rules Approved by the Board on June 19, 2012 2. Operationalizing the COI Rules for the Methodology Committee 3. Next Steps 4. Discussion 80
  • 81. Introduction P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE COI Rules Approved by the Board on June 19, 2012  Intended to “safeguard the integrity and public trust in the process for funding patient- centered outcomes research (PCOR)” 81 Full text available at www.pcori.org
  • 82. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORI FUNDING OPERATIONALIZING THE COI ANNOUNCEMENT RULES FOR THE METHODOLOGY•APPLICATIONS 483 applications received COMMITTEE (MC)• Review process underway• ~ 100 awards expected in December 2012
  • 83. Operationalizing the COI Rules for the MC P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE COI Rules Pertaining to the MC Methodology  Creates the MC-PFA Committee Development Subcommittee* (MC) to function as a liaison to PCORI’s Board and staff − These MC members will not be eligible to apply for PFA MC-PFA funding Development Subcommittee * Previously referred to as the Methodology Executive Subcommittee in Patient-Centered Outcomes Research 83 Institute (PCORI) Draft Conflict of Interest Rules for Research Funding, June 19, 2012
  • 84. Operationalizing the COI Rules for the MC P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE MC-PFA Development Subcommittee Naomi Aronson, PhD Mike Lauer, MD Alfred Berg, MD, MPH Jean Slutsky, PA, MSPH Sherine Gabriel, MD Clyde Yancy, MD (MC Chair)
  • 85. Operationalizing the COI Rules for the MC P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE The Methodology Committee will remain united in its mission to provide scientific guidance to PCORI… …the new operating model will not change this 85
  • 86. Operationalizing the COI Rules for the MC P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Elements of PCORI’s COI Policy Regarding the Methodology Committee MC Recusal Protect against COI when awarding funding for non – and COI Disclosure PFA research (RFPs) Non- Require all members of PCORI community Disclosure (e.g., MC, Board, staff) to preserve confidentiality Agreements of non-public information Firewalls for Create firewalls to preserve Methodology PFAs Committee eligibility for PFA funding 86
  • 87. Operationalizing the COI Rules for the MC P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Firewalls will be implemented to preserve eligibility of most MC members for PFAs Firewall Goals:  Avoid an unfair advantage for MC members  Control access to information 87
  • 88. Operationalizing the COI Rules for the MC P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE MC Firewall Implementation Strategies Mitigating IT Time Governance Advantage Distribution Meeting Controls Controls 88
  • 89. Operationalizing the COI Rules for the MC P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE SCCOI Guidance • Importance of IT solutions to maintain firewalls • Emphasis on policy training for the Board, Methodology Committee, and staff • Encouragement of preparation of public-facing document that reinforces the significance of guarding against COI as a core PCORI value Operationalizing the COI Rules for the MC 89
  • 90. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORISTEPS NEXT FUNDING ANNOUNCEMENT•APPLICATIONS 483 applications received• Review process underway• ~ 100 awards expected in December 2012
  • 91. Next Steps P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Next Steps  Develop and adopt the COI policy regarding external parties (e.g., advisory panels, consultants)  Implement the firewalls for the Methodology Committee  Monitor and regularly review COI compliance Operationalizing the COI Rules for the MC 91
  • 92. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORI FUNDING DISCUSSION ANNOUNCEMENT•APPLICATIONS 483 applications received• Review process underway• ~ 100 awards expected in December 2012
  • 93. Discussion P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Questions or Comments? Operationalizing the COI Rules for the MC 93
  • 94. Update on Public CommentP A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Period for Draft Methodology Report Jean Slutsky, Methodology Committee Lori Frank, PhD, Director, Engagement Research Bill Silberg, Director, Communications PCORI Board of Governors Meeting Washington, DC September 24, 2012
  • 95. Methodology Report P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE  Submitted to the PCORI Board of Governors on May 10, 2012  Approved for posting by the PCORI Board of Governors on May 21, 2012  Public comment period: July 23, 2012 through September 14, 2012  Revised draft standards to be submitted to the Board of Governors November 2012
  • 96. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORI FUNDING AND PUBLIC COMMENT ANNOUNCEMENT ONGOING OUTREACH•APPLICATIONS 483 applications received• Review process underway• ~ 100 awards expected in December 2012
  • 97. Outreach efforts for MC report P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEcomment period Professional Journal Article “Why Methods Matter” Webinars and Ads Social Media Targeted Outreach News Release
  • 98. “Why Methods Matter” P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORI blog columns and associated videos pushed to targeted email lists
  • 99. Professional Journal Article and Ads P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Digital Ads released in Annals of Internal Medicine; Science Translational Medicine; JAMA; NEJM; Nature; and Health Affairs
  • 100. Measures of Reach P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE •>850,000 total anticipated •Three blog posts •Two webinars impressions •671 total blog views •>650 total attendees •Exposure to nearly 13,000 subscribers •150 total video views •Strong audience interest indicated by through a Health Affairs e-alert low fall-off rate 6,500 Professional “Why Methods page views Journal Articles Webinars Matter” and Ads 1,600 •PCORI mentioned 5,753 times in •Three e-mail blasts to opt-in •News release republished 244 times Twitter and social media stakeholder list (~4,600 names)report downloads conversations over the last six •Open and click-through rates above •Coverage included: The Pink Sheet; Medical Device Daily; Government months (mid-April through mid- industry norms: Health IT; Inside Health Policy; September) •First alert: 43.8% and 50.3% BioCentury; and CQ Healthbeat •Estimated 7.4 million impressions •Second alert: 35.2% and 37.3% , reaching individuals through a •Third alert: 26.2% and 22.2% variety of online media. •Additional alert to 3,143 researchers through PCORI’s contracts platform.* As of 9/19/2012 Targeted Social Media News Release Outreach
  • 101. Webinars P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE• Two webinars Rate your understanding of the process the MC used to generate standards – Setting Standards for 100% Research Methods, August 3 80% – Setting Standards for 60% Patient-Centeredness and Before 40% Patient Engagement in After Research, August 14 20% 0% I do not understand I understand I have good somewhat understanding * Actual responses from both webinars combined
  • 102. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
  • 103. Collecting, Analyzing, &Transparently CommunicatingPublic Comments P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE MC Standards and Report• Public Comment Contractor: Public Comment Process American Institutes for Research (AIR) PCORI• Criteria: AIR Conducts Collects Public Analysis of Comments – Patient panel to review and Public Comments refine comment analysis – Extensive patient and Results Vetted by stakeholder engagement Patient Panel experience – Expertise in qualitative research methodology – Significant experience with Deliverables public comment process Public Comment Analysis Delivered to MC Transparent Comment Disposition Table
  • 104. Public Comment Results P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTECumulative Comments Received, by Week 140 124 Respondents by Stakeholder Category 120 100 Policymaker, 1 Caregiver, 1% Patient # of comments % Advocate, 1% 80 Patient, 2% Organizational Clinician, 5% 60 Provider, 4% Caregiver / 40 23 Patient 16 20 20 8 9 10 11 Advocacy Organization, 8 0 % Researchers, 33 % Unspecified, 12 % Industry, 16% Other, 17%
  • 105. Public Comment Results P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEComments by Stakeholder Category450 414 400400350300 Comments by Type250 227 227 Related to a specific200 175 standard 8%150 125100 55 48 Unrelated to Related to a 50 25 the report 12 6 specific 17% chapter 0 39% Related to report as a whole 36% 105
  • 106. MC Report Public Comment - Themes P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE • Role of standards in PCOR • Feasibility of standards implementation • Document accessibility • Interest in training and resources to support PCOR and standards implementation • Interest in more specific details regarding research methods
  • 107. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE PCORI FUNDING COMMITTEE METHODOLOGY ANNOUNCEMENT•APPLICATIONS of Standards/Recommended Actio •483 applications received Review and Revisions• •Review process underway Future Directions• ~ 100 awards expected in December 2012
  • 108. Review and Revision of StandardsThe MC will provide revisions tomethodologic standards andrecommended actions across each of P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEthe eleven research domains Systematic Patient Review Centeredness Research Dissemination Prioritization Heterogeneity Causal Missing of Treatment Inference Data Effects Data Trial Translation T able/ Diagnostic Networks Methodologies Registries Testing
  • 109. Review and Revision of Standards P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Methodology Committee Goals 1. Propose revisions to the standards and recommended actions based on public and Board comments (with justification) 2. Provide summary of MC responses to public and Board comments 3. Offer additional suggestions for methodological research gaps gleaned from public and board comment
  • 110. Review and Revision of Standards P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Start Should the Standard Provide strong justification continue as is? Yes why comments should not be addressed. No Can the substance of the standard be subsumed by Yes Provide specific revisions other existing Standards with modest revision? No Can the substance of the standard be framed as a Provide specific language Yes recommended Action to for Draft PCORI Policy inform PCORI policy? Propose revisions to the standard that fully address No comments (from board and public) in a meaningful No and substantive manner.
  • 111. Review and Revision of Translation Table P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE 1. Review and propose responses and revisions to relevant Board and Public Comments. Include justification if no response/no change is recommended 2. Discuss and propose next steps for translation table. Options include: • No further changes. Maintain the translation table as it currently stands • Propose RFP to develop v2 of Translation Tool which expands on current tool and creates additional versions for different audiences, e.g. Researchers, students, general public, policy makers etc.
  • 112. Review and Revision of Standards Timeline P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE 11/19 – Board Vote to 5/21 – 9/14 – Public Comment Accept FinalApproved for Period Ends Posting Update Revise Standards/ Standards/ Draft Report Public Analysis of Recommended Submission to Recommende Posted Comment Public Actions/ Board d Actions Period Comment Comment based on Disposition analysis Table 7/23 – Public Comment 10/31 –MC Consensus on Period Begins Proposed Revisions May-Jul 2012 Aug-Sep 2012 Oct-Nov 2012
  • 113. Future Direction P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Priorities • Select Standards for further research in 2013 • Develop a detailed Standards implementation and dissemination plan • Incorporate standards into PFAs • Incorporate principles of research prioritization into evaluation of the impact of standards on improving research quality and advancing PCORI mission • Enhance methods for use of patient-reported outcomes • Create PCOR methods training programs for patients and other stakeholders
  • 114. Future Direction P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Methods Leadership • Contribute to PCORI patient engagement workshop • Contribute to PCORI methods workshop • Participate in PFA development (subset of MC members) • Advise on methods-relevant dissemination (subset of MC members)
  • 115. Future Direction P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Moving toward Standards 2.0 • Ongoing outreach planned for Standards following completion of revision in November 2012 • Further Standards development to be evaluated based on additional review by MC, Board, and patients and other stakeholders throughout the planned ongoing outreach and dissemination
  • 116. Thank You P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE To those who provided comment on the MC Standards and Report: Thank you for your thoughtful input! To the Methodology Committee: Thank you for all your hard work in the development and revision of these document!
  • 117. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Finance, Audit, and Administrative Committee (FAAC) Report Kerry Barnett, JD, Chair Anne Beal, MD, MPH, COO Pamela Goodnow, Director of Finance PCORI Board of Governors Washington, DC September 24, 2012
  • 118. Agenda P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE • Unaudited Financial Statements ~ Results of Operations • Revised 2012 Budget • Budget Assumptions • Cash Flow Appendix • Financial Statements • CBO Updated Estimate for the Insurance Coverage Provisions of the Affordable Care Act
  • 119. Unaudited Financial Statements Results of Operations P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE The GFY 2013 Appropriation of $150 million will be received on October 1, 2012, and will be taken into Operating Revenue at that time. UNAUDITED JUNE 30, 2012 OPERATING REVENUE $0 Program Expenses Communication and Engagement 1,435,365 Research 1,888,897 Methodology 3,054,947 Total Program Expenses 6,379,209 Administrative Expenses Board 739,262 Management and General 3,312,271 Total Administrative Expenses 4,051,533 Non-operating Interest Income 35,190 NET INCOME (LOSS) ($10,395,552)
  • 120. Revised 2012 Budget Unaudited June 30, 2012 P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE The Board approved the 2012 budget subject to mid-year corrections. UNAUDITED PROJECTED REVISED JUNE 30, 2012 3Q/4Q BUDGET OPERATING REVENUE $0 $120,000,000 $120,000,000 Program Expenses Communication and Engagement 1,435,365 4,347,026 5,782,391 Research 1,888,897 7,701,268 9,590,165 Methodology 3,054,947 3,002,344 6,057,291 Total Program Expenses 6,379,209 15,050,637 21,429,846 Administrative Expenses Board 739,262 1,414,026 2,153,288 Management and General 3,312,271 3,274,663 6,586,934 Total Administrative Expenses 4,051,533 4,688,689 8,740,222 Non-operating Interest Income 35,190 37,500 72,690 [1] NET INCOME (LOSS) ($10,395,552) $100,298,174 $89,902,622 [1] There will be $96 million awarded for research in November 2012.
  • 121. Budget Assumptions Revenue Projections P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE $320 million estimated for GFY 2013 less HHS/AHRQ PCORI receives $120 million in direct appropriation Partial year collected on covered lives for PCOR fee on health plan providers and the self-insured IRS will collect the fee annually on the Quarterly Federal Excise Tax Return Form 720 due July 31 of the following year PCORI receives $28 million between August 15, and October 15, 2013 Partial year collected on covered lives for PCOR fee on Medicare/Medicaid/CHIP PCORI receives $6 million on July 31, 2013; actual timing unknown
  • 122. Cash Flow Net Revenue (Dollars in -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE P A T IENT millions) 2012 2013 CASH BALANCE $162 $241 Appropriation $150 $150 PCOR Fee 0 34 Subtotal 150 184 Less AHRQ/HHS (30) (37) Less Program and Operating Expenses (30) (41) Net Revenue $90 $106 Research Contract Commitments $127 $300 Research Outflows 2012 ($11) ($21) 2013 (139) Total Outflows ($11) ($160) CASH BALANCE $241 $188
  • 123. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Communications Update Bill Silberg, Director of Communications Sharon Levine, MD, Chair, COEC PCORI Board of Governors Meeting Washington, DC September 24, 2012
  • 124. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Communications Update• A communications framework that advances our goals• Building infrastructure• Building awareness• Promoting our milestones• Key metrics• Future opportunities to consider and discuss 124
  • 125. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEQuestions to Consider• How can we best refine our messaging as we build our research portfolio?• What critical lessons do we want to impart from our research to date?• What kinds of “stories” might we use to make our work “real” to our stakeholders and show how “research done differently” benefits them?• How can we best collaborate with and leverage the work of others in the CER/PCOR space to advance our communications goals? 125
  • 126. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE A Communications Framework That Advances Our Goals• Define organizational messages, stakeholder audiences and goals• Develop and implement a comprehensive plan that delivers those messages to key stakeholder audiences• Refine and update the plan over time based on key performance indicators• Continue close collaboration with COEC and other leadership to refine strategic and operational objectives• Ensure support of PCORI’s foundational pillars and the implementation of its strategic plan 126
  • 127. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE A Communications Framework That Advances Our GoalsPCORI’s Key Messages• To improve the quality and effectiveness of care, patients and those who care for them need evidence-based information that they trust and use in making better- informed clinical decisions.• PCORI funds research that provides such trusted, high-quality information by requiring meaningful patient engagement in all aspects of the research process.• PCORI advances its mission by convening, partnering, and soliciting the input and guidance of all stakeholders in the health and health care community. 127
  • 128. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEA Communications Framework That Advances Our GoalsPCORI’s Key Audiences• Multiple stakeholders, but particularly patients, caregivers, researchers, clinicians, public and private payers and policymakersPCORI’s Key Goals• Reshape research to meaningfully include patients’ concerns, with patients and caregivers as true partners• Establish stakeholder partnerships that will advance our research and dissemination efforts• Promote the adoption of rigorous methods and robust infrastructure to sustain PCOR over time• Establish PCORI as a trusted “must-have” source of patient-centered outcomes 128 research and information that will be widely used
  • 129. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEA Communications Framework That Advances Our GoalsCommunications Plan Goals• Provide a consistent stream of high-quality content and activities that support and advance PCORI’s strategic imperatives and goals in ways that build trust with stakeholders• Be proactive in identifying communications opportunities and assessing and addressing challenges• Be transparent in showing how PCORI is meeting its statutory obligations and delivering on its research agenda• Establish and maintain a robust infrastructure that facilitates two-way communication and engagement with key stakeholder audiences• Develop and track metrics that assess progress toward communications goals, refining activities as needed 129
  • 130. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEA Communications Framework That Advances Our GoalsOur Opportunities• Telling the story of building a research institute and “brand” from scratch• Creating a new approach to traditional research• Convening multiple stakeholder groups to pursue a shared agendaOur Challenges• Telling the story of building a research institute and “brand” from scratch• Creating a new approach to traditional research• Convening multiple stakeholder groups to pursue a shared agenda 130
  • 131. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEBuilding Infrastructure• Platforms, tools, and channels• Staffing and resources• Process and procedures• Partnerships and relationships 131
  • 132. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEBuilding Awareness• We are a new organization building a track record of research• Our story to date has been largely aspirational, organizational, and “stage- setting” but is evolving as our work continues• We are measuring our progress in milestones• We are building relationships with those who will help tell our story and 132 advance our research and dissemination efforts
  • 133. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPromoting Our MilestonesNational Priorities for Research and Research Agenda• 503 comments received via web site, e-mail, or mail• Hosted National Patient and Stakeholder Dialogue, PCORI’s largest stakeholder engagement event to datePCORI Pilot Projects• Covered by Modern Healthcare, Politico, Kaiser Health News• Special Board webinar to approve revisions to priorities and agenda and approve Pilot Projects attended by 421 stakeholders 133
  • 134. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Promoting Our MilestonesPCORI Funding Announcements (PFAs)• PCORI’s PFA web page has received an average of >15,000 page views per month• Secured >400,000 impressions through advertising in NEJM, JAMA, and Health AffairsDraft Methodology Report• Two webinars for patients and stakeholders combined to draw >650 attendees• Three columns and videos published explaining “Why Methods Matter” from the researcher, patients and industry perspective• Social media hashtag: #WhyMethodsMatter 134
  • 135. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPromoting Our MilestonesPatient/Stakeholder Engagement InitiativeThree workshops designed to engage patients andstakeholders in refining PCORI’s research agenda:• Transforming Patient-Centered Research: Building Partnerships and Promising Models • October 27-28• What Should PCORI Study? A Call for Topics From Patients and Stakeholders • December 4• PCORI Methodology Workshop for Prioritizing Specific Research Topics • December 5Promotion through web site, e-mail, webcasts, media outreach, video 135
  • 136. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEWebsite Metrics Site Traffic 60,000 50,000 40,000 30,000 20,000 Visits 10,000 0 6-Month Snapshot• >195,000 site visits, including > 98,000 unique visits• The average site visitor spends nearly four minutes per visit 136• May 23: PFAs announced; 4,200 new visitors logged on to the site
  • 137. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEGrowing Our E-mail List 9/19/2012 4,800 Subscribers 5000 4000 3000 2000 2/1/2011 Subscribers 1000 283 Subscribers 0 Nov-11 Apr-11 Apr-12 Aug-11 Aug-12 May-11 May-12 Mar-11 Jan-12 Mar-12 Jul-11 Sep-11 Jul-12 Sep-12 Feb-11 Dec-11 Feb-12 Jun-11 Oct-11 Jun-12 • 15 e-mail alerts sent to stakeholders • Average alert open rate is 40% (industry standard is 19%) • Goal: Grow opt-in e-mail list to 10,000 by end of 2012 137
  • 138. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEConvening: PCORI Events National Patient and Stakeholder Dialogue Attended by 850 people in person or by webcast and teleconference; 46 public comments provided at event by representatives of diverse stakeholder segment. National Workshop to Advance Use of Electronic Data Convened a select group of researchers and thought leaders to develop ideas for how PCORI can facilitate the creation or function of a national data infrastructure to support high quality patient- centered outcomes research; 300+ attendees live and via webcast. 138
  • 139. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTECommunicating Through New Platforms PCORI Channel on YouTube • Videos of Board meetings, workshops, webinars • >9,000 views of 49 videos uploaded 139
  • 140. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTETelling Our Story PCORI’s work has been featured in dozens of reports in health policy and top national news outlets, as well as major journals
  • 141. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTETracking Growth of @PCORITotal PCORI Twitter Impressions (Feb-Aug): 7.6 Million Twitter follower volume (six-month snapshot) Tweets by month (via tweetstats.com) 141
  • 142. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEFuture Opportunities• Refine our messaging as we build our research portfolio• Develop a plan and structure in partnership with AHRQ for research dissemination efforts• Mine programmatic efforts to show what we are learning; use more effective storytelling to make that work meaningful and “real”• Continue to upgrade our infrastructure• Review the CER/PCOR landscape to assess opportunities for collaboration in advancing our communications goals, focusing on our leadership in “research done differently”• Take a strategic approach to speaking/publishing opportunities 142
  • 143. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEQuestions to Consider• How can we best refine our messaging as we build our research portfolio?• What critical lessons do we want to impart from our research to date?• What kinds of “stories” might we use to make our work “real” to our stakeholders and show how “research done differently” benefits them?• How can we best collaborate with and leverage the work of others in the CER/PCOR space to advance our communications goals? 143
  • 144. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Scientific Publications Subcommittee Update Debra J. Barksdale, PhD,RN, Chair, SPC Bill Silberg, Director of Communications PCORI Board of Governors Meeting Washington, DC September 24, 2012
  • 145. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEPlanning and Managing Our Publishing Opportunities• Subcommittee activities, policies, and procedures• Tracking the pipeline• Coordination with COEC and AHRQ• Strategic publishing plan• Next steps• Questions to consider 145
  • 146. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTESubcommittee Members• Debra J. Barksdale, Chair• Harlan Krumholz• Sharon-Lise Normand• Alfred O. Berg• Michael Lauer• Anne Beal• Joe Selby 146
  • 147. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEQuestions to Consider• How can we more strategically generate ideas for PCORI- associated papers and other scientific communication opportunities?• How might we improve our processes for helping to turn those ideas into realities?• How should we develop and support policies designed to make our supported research as widely available as possible? 147
  • 148. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Activities, Policies and Procedures• Facilitate the process of publication of papers written on behalf of PCORI o Consider and approve manuscript ideas initiated by Board or MC members or staff and identify appropriate authors o Review article requests from outside entities (ie, solicited by journals) o Ensure no overlap with papers already in development.• Manage courtesy review of papers not written on behalf of PCORI and apply disclaimer 148
  • 149. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTETracking the pipeline• Four PCORI-related papers published, one in review and one more cleared for submission• Improvements to consider o Prioritizing papers to improve turnaround time and follow-up o More effective means of notifying the subcommittee of article ideas o Plan for informing Board, MC and staff of published papers, tied to PCORI document delivery system to ensure broad access 149
  • 150. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTETracking the Pipeline Recent publications of note 150
  • 151. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTECoordination With COEC and AHRQ• Coordination with COEC is critical to see that scientific publishing activities are appropriately aligned with PCORI’s broader communications, outreach, and engagement goals• Coordination with AHRQ is critical to meet statutory requirements for dissemination of primary research results o Develop plan for coordinating dissemination efforts o Assess how best to interpret and meet “90-day rule” o Determine how to best serve multiple audiences 151
  • 152. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEStrategic Publishing Plan• Proactively assess and take advantage of opportunities to pursue publishing activities that advance our goals• Build relationships with key influencers – journal editors – to assist in dissemination, use, and impact of PCOR• Seek ways to support new forms of scientific publishing and communication (blogs, multimedia) that will tell the story of our mission and supported research• Support polices that provide broad and open access to PCORI-supported work• Consider how subcommittee’s work might apply to consumer media 152
  • 153. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Next Steps• Improve process for soliciting ideas for papers and other opportunities• Address authorship issues (eg, “corporate authorship”)• Assess subcommittee’s role in helping manage PCORI-related content other than scientific articles (eg, white papers, reports, blog posts)• Consider how the subcommittee’s work might apply to consumer media• Consider ways to better support workflow and prioritize/track articles• Advise on PCORI policy on open access issues• Formalize strategic publishing plan 153
  • 154. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEQuestions to Consider• How can we more strategically generate ideas for PCORI-related papers and other scientific communication opportunities?• How might we improve our processes for helping to turn those ideas into realities?• How should we develop and support policies designed to make our supported research as widely available as possible? 154
  • 155. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTEThank You For more information about PCORI, Board meetings and events visit www.pcori.org.