1. So You Want to Do Comparative Effectiveness Research? The Nuts and Bolts of CER

2. Introduction to Comparative Effectiveness Research Greg Cooper, MD

3. CER - ACA Definition Research evaluating and comparing health outcomes and the clinical effectiveness, risks and benefits of 2 or more medical treatments, services and items

4. Categories of CER Methods Systematic reviews of existing research Decision modeling, with or without cost information Retrospective analysis of existing clinical or administrative data Prospective, non-experimental studies, including registries Experimental studies, including RCT’s

5. Pragmatic Clinical Trials Compared to explanatory Decision maker viewpoint – should we provide intervention? Whether an intervention works in “real world” conditions Whether it works, not how or why

6. Pragmatic Clinical Trials Patient selection reflects routine practice –Exclude only if contraindicated Intervention to discretion of clinician –Dose adjustment Control routine practice (vs. placebo) Patient centered outcomes Always ITT analysis

7. Pragmatic Clinical Trials Identify prevalent condition –Often based on symptoms rather than explicit, verifiable diagnoses Evaluate common clinical dilemma in that condition Develop pragmatic study to understand health outcomes between competing management approaches

8. Primary Care Management of GERD Open label study of patients with symptomatic GERD despite H2RA or omeprazole Randomization at clinic level (n=226) Screened on basis of 5 item questionnaire Intervention esomeprazole at dose selected by clinician (20 or 40 mg) or continued care Measured HRQOL and utilities at 4 weeks Moayeddi, et al: Am J Gastroenterol 2010

9. Results InterventionControl None or minimal sx58%29% PPI baseline$1213 per QALM-------- H2RA baseline$648 per QALM--------

10. Patient Centered Outcomes Research Institute

11. PCORI Research Areas Prevention, Diagnosis and Treatment Options Improving Healthcare Systems Communication and Dissemination Research Addressing Disparities Accelerating Patient-Centered Outcomes Research and Methodological Research

12. PCORI Funding Up to 3 years, $500K/year (direct costs) –8/15, 12/15, 4/15 deadlines Letter of Intent Required (2 months prior) Must have key stakeholders engaged early and throughout research process Patient and stakeholder engagement plan –Involved in study design and monitoring conduct –Involved in dissemination of findings

13. Stakeholders Patients Caregivers Clinicians Patient advocacy groups Community groups Involved in advisory panels, teleconferences, focus groups

14. CER and the CTSA Develop a CTSA Consortium-wide framework for community-engaged and CER that will support improvement in healthcare access, quality, efficiency and patient-centered outcomes and will improve the health of diverse communities and the public CER Key Function Committee (KFC)

15. CER and Case CTSC Pilot projects 2010 Core Utilization Pilots Explorys Pilots Research symposium 2010 Three focal areas –Large database –Economic analysis –EHR

17. CER Services Assistance with study design –Pilots –Investigator initiated projects Grant preparation Facilitating referrals Through Request Management System (RMS)

18. Symposium Objectives Overview of CER Methodology –Electronic Health Records –Large Database Research –Systematic Review/Meta Analysis Practical Examples Panel Discussion Encourage Core Utilization Ideas for future talks, symposia