Co-Chairs, Tim Carey and Tom Concannon PI Liaison, Harry Selker

1. Comparative Effectiveness ResearchKey Function Committee(CER KFC)Monday, June 18 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, June 18, 2012, 11:00 AM – 12:00 PM ETTeleconference Only Dial-in: 1 877 568 4109 Access Code: 271-247-588Go To Meeting Registration (only) link https://student.gototraining.com/r/1271356837225888256

3. All Members invited to participate in any group

4. Identify current activities and collaborations with CER KFC members with NIH I/Cs NIH Updates Rosemarie Filart 11:02 AM

5. Identifying and Prioritizing Research Gaps CER SCIENTIFIC PRESENTATION Presented by: TIM CAREY, MD, MPHUNIVERSITY OF North Carolina at chapel hill11:08AM

6. Identifying and Prioritizing Research Gaps Tim Carey, M.D., M.P.H.

7. Importance: Why We Need to Identify and Prioritize Research Gaps from Systematic Reviews • Systematic reviews are the standard for evaluating the current state of scientific knowledge regarding a specific clinical or policy question. • Identification and prioritization of research gaps has the potential to lead to more rapid generation of subsequent research, informed by input from stakeholders • Audiences including researchers, funders, clinicians, advocates, and patients could use information about prioritized research gaps to understand areas of uncertainty and more quickly initiate studies. Primary Research Systematic Review Assessment of Gaps Funding Opportunities Prioritization of New Research Conduct New Research Systematic Review Update

8. Existing Methods to Identify and Prioritize Research Gaps • Identification of research gaps from and within systematic reviews is common, but often very general. • Criteria used to date have been variable and often unclear. • Prioritization of research gaps arising out of systematic reviews is not common at present. • Only half of the systematic reviews in major journals discussed future research needs at all, one-fifth described study designs that would address research gaps. • Text devoted to future research generally less than a paragraph.

9. Existing Methods to Identify and Prioritize Research Gaps • A scan of reports published within the past two years by the Drug Effectiveness Review Project (N = 4), NIH Consensus Conferences (N=5), and the Cochrane Collaboration (N = 19) showed no standardized methods for identifying or prioritizing research gaps. • Cochrane Collaboration reviews generally included ‘implications for future research’ but the discussions were often nonspecific. • Global Evidence Mapping (GEM) describes gap analysis as part of planning for future research after a systematic review is completed with stakeholder engagement. • The James Lind Alliance (UK) supports the development of partnerships of clinicians, patients, and advocacy groups in the prioritization of areas of uncertainty in clinical medicine.

10. Existing Methods to Identify and Prioritize Research Gaps Agency for Healthcare Research and Quality Future Research Needs • AHRQ piloted 8 Future Research Needs (FRNs) Projects in 2010 to extract research gaps from a systematic review, transforming them into prioritized research questions with aided by diverse stakeholder groups. • AHRQ EPCs have published multiple FRN methods papers to date. • 7 steps common to AHRQ FRN projects.

11. Example: AHRQ FRN on ADHD Identify Research Gap: For children less than 6 years of age with disruptive behavior disorder or ADHD, limited data are available about the efficacy and effectiveness of psychosocial treatment programs (e.g., parent training and summer behavior treatment programs), alone or in combination with pharmacological interventions, compared with other psychosocial treatment programs, alone or in combination with pharmacological interventions. (KQ 1) After One Round of Prioritization Apply PICOTS and Develop Research Question: Research Question: For children less than 6 years of age with disruptive behavior disorder or ADHD, what is the comparative efficacy and effectiveness of specific psychosocial treatments alone compared with pharmacological treatments alone or in combination with psychosocial treatments for patient outcomes?

12. Example: AHRQ ADHD FRN After Second Round of Prioritization Develop Study Design Considerations: • Randomized controlled trials • Randomized trials could be designed to test various components in a 2x2 matrix of psychosocial treatment variants (parent training, school-based intervention, combination, or pharmacological). • Advantages of study design for producing a valid result • Allows isolation of causal inferences related to the intervention being tested. Multiple-armed trials would allow testing of several hypotheses regarding relative efficacy of singular or combination treatment components. • Ability to recruit/availability of data • Common condition in this age group with uncertainty regarding treatment choice; all arms receive some treatment. • Resource use, size, and duration • Large sample size (N = 840; n = 210 per treatment arm) needed. Key outcomes such as school achievement will require follow-up of several years. • Ethical, legal, and social issues • Vulnerable population, careful informed consent will need to occur.

13. How can we conduct these activities better? • Work with funders, advocates, and others regarding the optimal format and presentation of future research needs documents. • Evaluate different stakeholder panel sizes and compositions in prioritization. • Evaluate the reliability of stakeholder prioritization through replication studies. • Test different methods of prioritization to assess for transparency, reproducibility and efficiency. • Clarify role of gap identification and prioritization with other methods such as value of information analysis. • Investigators working in this area should collaborate in order to harmonize terminology.

14. UPCOMING CER SCIENTIFIC PRESENTATIONThe FuRTHeR PlatformJuly 16thPresented by: Ram GouripeddiUniversity of UtahWELCOME VOLUNTEERS or SUGGESTIONS

15. WORKGROUP REPORTS11:16AM

16. 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

17. Methods Workgroupco-Leads: Sean Tunis , Mark Helfand, Jerry Krishnan and Peter Neumann October 2011- Jan 2012 Feb 2012-October 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-May 2012: Create prioritized list of projects/ topics for discussion at CTSA PCTi workshop. Establish a planning committee with CER and CE KFC workgroup leaders. October 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 (CTSA PCTi) Completed To be Completed

18. CER Informatics TaskforceOpen Discussion:*Projects*In-person CER KFC Informatics Taskforce meeting with the CER KFCCo-Leads: Joel Saltz and Bill Hersh

19. CER Capacity and Needs AssessmentOpen Discussion:*3rd Needs Assessment *Co-Leads: Harold Pincus and Dan Ford

20. LIAISON REPORTS11:40AM

21. Liaison Member Reports

22. The Ohio State UniversityComparative Effectiveness ResearchOnline Learning Centerhttp://www.cph.osu.edu/hopes/cer/home The Ohio State University Center for Clinical and Translational Science College of Public Health Nationwide Children’s Hospital

23. OSU CER Online Learning Center • Created through an NIH ARRA Workforce Development Grant • Training program to clinician researchers interested in enhancing their analysis skills • Online modules • In-person, weeklong Summer Program course • Capstone mentored project • Online Learning Center created to house online modules, Summer Program recordings and additional resources

24. Goals of the program • Create a dynamic curriculum that provides instruction at foundational and more advanced levels • Provide these materials on an on-going basis, at no cost • Stimulate CER work at OSU and beyond

26. CER Topics • Causality and effect identification • CER Research design • Propensity Score Theory • Propensity Score Application • Instrumental Variables • Economic Evaluation • Decision Modeling • Working with Health Care Claims and Complex Surveys • Linear Regression • Survival Analysis • Systematic Reviews • Meta-analysis • Translation of CER (2) • Pragmatic Clinical Trials (2)

30. Summer Program • Weeklong, in-person course taught by Paul Hebert and Matt Maciejewski through the OSU Center for Public Health Practice’s Summer Program • Addresses similar topics to online modules but in greater depth • Provides hands-on experience of data analysis • Offered again this summer, July 16th to 20th http://cph.osu.edu/practice/summerprogram

31. Instructors • Ralph Gonzales and Henry Lee, UCSF • Christopher Granger, Duke • Paul Hebert, Sean Sullivan, and David Veenstra, University of Washington • Matthew L. Maciejewski, Duke • Brook Martin, Darmouth • Leif Nelin, Nationwide Childrens Hospital • Susan L. Norris, Oregon Health and Science University • J. Michael Oakes, University of Minnesota • John P. Vavalle, UNC Chapel Hill

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

33. C4 UpdatesAlecia Fair, CER PM11:58 AM

34. CER KFC Monthly Meeting: Monday, July 16th from 11 AM-12PM Dissemination and Implementation Research Workgroup: Tuesday, June 19th from 4-5 PM EDT Methods Workgroup: Thursday, June 28th from 12-1 PM EDT Informatics Taskforce: Thursday, July 5th from 12 - 1 PM EDT Operations Group: Tuesday, June 26th3-4 PM EDT *attended by Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison SGC #4 Bi-Monthly Meeting : Monday, July 23rdfrom 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

35. APPENDIX (Proceed If needed)

36. CTSA Consortium Executive Committee Three Objectives for SGC #4 Objective 1: (Recognized as the Priority Objective by CCEC) :Develop a CTSA Consortium-wide strategy for community-engaged and comparative effectiveness research that leads to improvements in the access, quality, and efficiency of healthcare delivery and the health of diverse communities and the public. (*Metric followed by CCEC). Objective 2: Collaborate and create synergies with a wide range of stakeholders (i.e., communities, health departments, CTSA and other academic medical centers, NIH Institutes and Centers and other DHHS Federal Partners) in planning and implementing community-engaged and comparative effectiveness research and in disseminating the research findings. Objective 3: Facilitate collaborations across CTSA institutions, PBRNs, and a broad cross-section of practice settings that increase the nation’s capacity for innovative community-engaged and comparative effectiveness research leading to the development of novel methodologies for both conducting research and for implementing and disseminating the findings of that research.

37. 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