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Co-Chairs, Tim Carey and Tom Concannon PI Liaison, Harry Selker NIH Coordinator, Rosemarie Filart

Comparative Effectiveness Research Key Function Committee (CER KFC) Monday, February 27, 2012, 11:00 AM-12:00 PM ET. Co-Chairs, Tim Carey and Tom Concannon PI Liaison, Harry Selker NIH Coordinator, Rosemarie Filart PM, Alecia Fair (C4).

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Co-Chairs, Tim Carey and Tom Concannon PI Liaison, Harry Selker NIH Coordinator, Rosemarie Filart

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  1. Comparative Effectiveness ResearchKey Function Committee(CER KFC)Monday, February 27, 2012, 11:00 AM-12:00 PM ET Co-Chairs, Tim Carey and Tom Concannon PI Liaison, Harry Selker NIH Coordinator, Rosemarie Filart PM, Alecia Fair (C4)

  2. CTSA CER Key Function Committee (KFC) Monthly Meeting AgendaMonday, February 27, 2012, 11:00 AM – 12:00 PM ET

  3. All Members invited to participate in any group

  4. ACTIVITY UPDATES • Steering Committee (CCSC), Executive Committee (CCEC), and SGC 4 Liaison News • CTSA Consortium C4 planning: Update on • In-Person Meeting Discussions • News impacting the CER KFC and members • Harry Selker • 11:02 AM

  5. Five Draft priorities in the PCORI document • 1) Assessment of Prevention, Diagnosis, and Treatment Options. Research should focus on 1) clinical options with emphasis on patient preferences and decision-making, 2) biological, • clinical, social, economic, and geographic factors that may affect patient outcomes. • 2) Improving Healthcare Systems. Research should focus on 1) ways to improve access to care, receipt of care, coordination of care, self-care, and decision-making, 2) use of non-physician • healthcare providers, such as nurses and physician assistants, and the impact on patient outcomes, 3) system-level changes affecting all populations, diseases, and health conditions. • 3) Communication and Dissemination. Research should focus on 1) strategies to improve patient and clinician knowledge about prevention, diagnosis and treatment options, 2) • methods to increase patient participation in care and decision-making and the impact on health outcomes, 3) communication tools that enhance decision-making and achieve desired • outcomes, 4) ways to use electronic data (“e-health records”) to support decision-making, 5) best practices for sharing research results. • 4) Addressing Disparities. Research should focus on 1) ways to reduce disparities in health outcomes, 2) benefits and risks of healthcare options across populations, 3) strategies to • address healthcare barriers that can affect patient preferences and outcomes. • 5) Accelerating Patient-Centered and Methodological Research. Research should focus on 1) ways to improve the quality and usefulness of clinical data in follow-up studies, 2) methods • to combine and analyze clinical data that follow patients over time, 3) use of registries and clinical data networks to support research about patient-centered outcomes, including rare • diseases, 4) strategies to train researchers and enable patients and caregivers to participate in patient-centered outcomes research

  6. NIH UpdatesLaunched www.ncats.nih.gov:Excerpt from the NIH CTSA/NCATS Integration Working Group Recommendations, 2011, Full document is at http://www.ncats.nih.gov/recommendations.pdf •Continue to provide infrastructure supporting the full spectrum of translational research while encouraging CTSA institutions to develop their unique strengths. •Strengthen CTSA consortia activities. •Strengthen mechanisms for enabling IC‐CTSA interactions.There are two Divisions: 1) Preclinical Innovation 2) Clinical Innovation. CTSAs are housed in the Division of Clinical Innovation. Rosemarie Filart 11:06 AM

  7. UPCOMING CER SCIENTIFIC PRESENTATION Monday, July 16th, 2012WELCOME VOLUNTEERS or SUGGESTIONS

  8. WORKGROUP REPORTS11:08 AM

  9. Education/Training/Workforce DevelopmentWorkgroup: Lead: Jodi Segal November 2011-January 2012 November 2011- November 2012 March 2012-July 2012 February 2012- June 2012 Understand education needs of patient advocacy groups  CER Video Project Learn about CER teaching in professional schools Review short courses in relevant organizations  Completed In Progress Cancelled To be Completed

  10. DIR Workgroup co-Leads: Paul Meissner and Jonathan Tobin October 2011 Fall –Winter 2011 2012 • Merged Collaboration and Dissemination and Implementation Workgroups launched into one WG: newly named as Dissemination and Implementation Research WG • White Paper on Stakeholder Engagement • - Working paper on CTSA wiki • - Submitted for peer review • 2. Best Practices in Translational Research • 7 interviews completed • Developed preliminary results • 15 interviews proposed & scheduled • Identification of variables of interest for D&I research from EHRs and other data sources. • 1. Stakeholder engagement demonstrations • Tufts EPC (5) • PPP KFC (1) • Other • 2. Best Practices in Translational Research • Manuscript on best practices • Variables of interest for D&I research • 4. Rapid D&I Network / Pilot DIR demonstrations • - Needs leadership Completed To be Completed

  11. Methods Workgroupco-Leads: Sean Tunis , Mark Helfand, Jerry Krishnan and Peter Neumann October 2011- Jan 2012 Feb 2012-Summer 2012 June – October 2011 Fall 2012 Develop and conduct an Methods WG Mini-Workshop of the October 2011 CER KFC Annual meeting with stakeholders. Focus on specific ways to advance methods research as detailed in the forthcoming CER Methods Agenda Paper. Discuss WG projects in light of the current CER/PCOR environment. • Dec 2011– Jan 2012:   • Key informant interviews on current consortium efforts to expand national infrastructure for conducting community-based PCTs • Jan 2012: Compile findings from key informant interviews Feb-March 2012: Create prioritized list of discrete projects related to overall workgroup focus, and for discussion at summer workshop. Establish planning committee. 2012: Workshop to convene individuals and groups from CTSA program and other initiatives with shared interest in expanding national infrastructure for community-based PCTs • Fall 2012:   Produce white paper with strategic plans for CTSA CER methods workgroup to contribute to expansion of national infrastructure for community based PCTs Completed To be Completed

  12. CER Informatics TaskforceTaskforce Charge: Follow-up Action Items of May and Dec. 2010 CER ForumsOpen Discussion:Current Draft Project ideas and Prioritizing Projects/Activities would you like to see for the CER Informatics TaskforceCo-Leads: Joel Saltz and Bill Hersh

  13. CER SCIENTIFIC PRESENTATIONChris Schmid11:32 AM

  14. N- of- 1 Trials in CER Chris Schmid, PhD Professor of Medicine Director of the Biostatistics Research Center Tufts University Medical Center

  15. Tx FU B • 1 week off meds for baseline • AM dose:25 mg; FL dose:20 mg • Pair randomized (block randomized for every 20 participants) • Each period is 6 weeks long • Outcomes measured at the end if each period: • FIQ (main), TPE, VAS1-5, GVAS1&2, SE/other meds used • Baseline &f/u measures:Outcomes, Beck, labs, demographics • Pre-trial expectations, Decision Making, End of Study (also at 3 mo)

  16. Visual Representation Baseline Statistical Analyses- Descriptive-Classic Mean score on: Drug A :51.0Drug B:38.3 Difference = 12.7 points (% of Baseline) (-15%) (-36%) [A-B] (21%) If the true effect of the treatments is the same, the chance of obtaining a difference of 12.7 points (as with your results) by “luck” alone is: 12% Based on your results, there is a 95% chance that the true difference in the average scores is between: -5 and +30

  17. Probability that: No prior assumptions (using only your data): Using historical info from previous studies: Drug B is more effective than Drug A: 95% 97% Drug A is more effective than baseline: 96% 98% Drug B is more effective than baseline: 99.9% 99.9% Statistical Analyses Bayesian

  18. population center center 1 2 Doctor Doctor Doctor Doctor 1 2 3 4 patient patient patient patient patient patient patient 7* 1* 2 3* 4 5 6* m m m m m m m m m m m m m m m m m m m m m Combining N of 1 Studies

  19. LIAISON REPORTS11:40AM

  20. Liaison Member Reports

  21. CER KFC Monthly Meeting: Monday, March 19thfrom 11 AM-12PM Education/Training/Workforce Development Workgroup: Wednesday, March 7thfrom 11 AM-12 PM EDT Dissemination and Implementation Research Workgroup: Tuesday, March 20thfrom 4-5 PM EDT Methods Workgroup: Thursday, March 22ndfrom 12-1 PM EDT Informatics Taskforce: Thursday, March 1stfrom 12 - 1 PM EDT Operations Group: Tuesday, February 28th3-4 PM EDT *attended by Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison SGC #4 Bi-Monthly Meeting : Monday, March 26thfrom 11 AM- 12 PM EDT *attended by CER and Comm. Eng. KFC Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison CER KFC Upcoming meeting schedule

  22. Membership Updates, Ideas, Suggestions, and NewsALL11:50 AM

  23. C4 UpdatesAlecia Fair, CER PM11:58 AM

  24. 1st Quarter deliverables • Authenticated space • Committee management and consortium targeted information • Collaborative space • A virtual sandbox for collaborative research activities

  25. APPENDIX

  26. CTSA Consortium Executive Committee Six Objectives for SGC #4 Objective 1: (Recognized as the Priority Objective by CCEC) Develop a CTSA Consortium-wide agenda for both community-engaged research and comparative effectiveness research that will support improvement in healthcare, such as access, quality, efficiency, and patient-centered outcomes and will improve the health of diverse communities and the public. Objective 2: Engage a wide range of stakeholders, including diverse communities, in the planning and implementation of both community-engaged and comparative effectiveness research. Objective 3: Facilitate collaboration among CTSAs, practice-based research networks, broad cross-section of practice settings, and other community-based networks, in an effort to facilitate more efficient clinical effectiveness trials in diverse settings in both community-engaged and comparative effectiveness research. Objective 4: Collaborate and create synergies between CTSAs and SGC4 goals with NIH Institutes and Centers and other DHHS Federal Partners in both community-engaged and comparative effectiveness research. Objective 5: Develop capacity and methods for the translation and dissemination of both community-engaged and comparative effectiveness research results into the full range of practice settings across the healthcare system. Objective 6: Enhance the translation and dissemination of SGC4 supported projects among the CTSA Consortium and stakeholders for both community-engaged and comparative effectiveness research.

  27. Mission Statement The Comparative Effectiveness Research (CER) Key Function Committee builds the field of comparative effectiveness research (CER) and patient-centered outcomes research by creating a learning community across CTSA institutions, spurring the development of methods, expanding training and education, promoting community and public engagement, applying CER findings and sharing successes and lessons learned. Vision Statement Through collaborative work products, the Comparative Effectiveness Research (CER) Key Function Committee facilitates the generation and synthesis of evidence about alternative interventions that results in actionable findings for policymakers, clinicians, patients, and purchasers to use in improving the quality and outcomes of patient-centered health care. CER KFC Mission and Vision Statements https://www.ctsawiki.org/wiki/display/CER/Comparative+Effectiveness+Research-+Home

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