Clinical and Comparative Effectiveness
Research Methods: II

June 1-2, 2009
John M. Eisenberg Building – Agency for Healthcare Research and Quality
AHRQ Conference Center - Rockville, Maryland

Invitation to Scientists and Others Interested in Research Methods for Conducting Comparative Effectiveness Studies

AHRQ is hosting an invitational symposium on potential methods for conducting comparative effectiveness research (CER) on June 1 and 2, 2009. The symposium aims to provide a forum for scholarly deliberation of new and emerging research methods by scientists working in different disciplines and across settings. The symposium will feature presentations by more than 20 authors whose abstracts were selected through a blinded peer-review process. In addition to the scientific presentations, AHRQ’s Director, Dr. Carolyn Clancy, and the Chair of the Institute of Medicine committee on CER priorities, Dr. Harold Sox, will offer introductory remarks on opportunities and challenges facing this field.

To expand access to the symposium proceedings, AHRQ will provide a live broadcast of the authors’ slides and audio presentations via the internet. If you are interested in viewing this broadcast, we invite you to register through the website listed below. Although there is no charge for registration, seats are limited and we ask that you register only when you are sure you can attend the full meeting on June 1 and/or June 2. Insofar as possible, we ask that individuals from the same organization gather together at one location for the broadcast to conserve seating, which will allow as many people as possible to view the presentations. Registration is on a first-come, first-served basis, so it is recommended that you commit early to ensure a reserved seat.

Here's the provisional agenda for the symposium and a listing of the Planning Committee members. The symposium is sponsored by AHRQ’s Effective Health Care program, through its DEcIDE research network. Proceedings from this symposium will be published in 2010 as an open-access journal supplement and on AHRQ’s website as we did for the first such symposium in Medical Care, October 2007 (available at http://tinyurl.com/decide-ehc).

This symposium will be a unique opportunity to hear about innovative research methods proposed for conducting comparative effectiveness studies. Should you have any questions regarding the event, please feel free to contact me (Scott.Smith@ahrq.hhs.gov) or Dr. Kathleen Lohr (klohr@rti.org).

Register to attend by clicking here or pasting the following link into your browser (https://hhs-ahrq500.webex.com/hhs-ahrq500/onstage/g.php?p=0&t=m).

Thank you and best regards,

Scott R. Smith and Kathleen N. Lohr
EHC DEcIDE Symposium Planning Committee Co-Chairs

Scott R. Smith, Ph.D. Center for Outcomes & Evidence Agency for Healthcare Research and Quality email: Scott.Smith@ahrq.hhs.gov	Kathleen N. Lohr, Ph.D Distinguished Fellow RTI International email: klohr@rti.org

Provisional Symposium Agenda

Day 1, 2009
8:00 a.m.	Continental Breakfast in Conference Room
8:30 a.m.	Welcome, Housekeeping, Goals for the Day Kathleen N. Lohr, PhD, RTI International
8:45 a.m.	AHRQ's Role in Advancing Methods for Comparative Effectiveness Research Scott Smith, PhD, Agency for Healthcare Research and Quality. Moderator
9:00 a.m.	Background: Challenges for the Comparative Effectiveness Agenda Carolyn Clancy, MD, Agency for Healthcare Research and Quality
9:15 a.m.	Comparative Effectiveness Research: Future Directions Harold Sox, MD, Co-Chair, Institute of Medicine Committee
*Optimizing Clinical Heterogeneity and Longitudinal Outcomes—* *The Role of Study Design and Methods*
9:30 a.m.	Overview: Jean-Paul Gagnon, PhD, Moderator
9:40 a.m.	Heterogeneity of treatment response: using patient-reported comorbidity in am a priori design of clinical trials Sheldon Greenfield, MD, University of California, Irvine
10:00 a.m.	Designs and Methods for Assessing Medication Exposures in the Frail Elderly Stephen Crystal, Ph.D., Rutgers University
10:20 a.m.	Break
10:40 a.m.	Cluster Randomized Trials of Comparative Effectiveness in a Multi-Hospital System: A Case Study of MRSA Infection Prevention. Richard Platt, MD, MS, Harvard Pilgrim Health Care
11:00 a.m.	Practice-based Evidence: Study Design that Incorporates Clinical Heterogeneity and Patient-Reported Outcomes Susan D. Horn, PhD, Institute for Clinical Outcomes Research
11:20 a.m.	Discussion and Audience Participation
12:00 noon:	Lunch (Conference Room Foyer and Conference Room)

*Optimizing Clinical Heterogeneity and Longitudinal Outcomes—* *The Role of Study Design and Data Collection Methods (continued)*
1:30 p.m.	Overview: Mitchell Sugarman, MBA, and Sue West, PhD, moderators
1:40 p.m.	Comparative Effectiveness and Safety of Depression Treatments in DARTNet Primary Care Practices Anne Libby, PhD, and Robert Valuck, PhD, University of Colorado, Denver
2:00 p.m.	Building and Evaluating a Distributed Data Network Proof-of-Principle to Demonstrate Selected Functions of a Distributed Research Network Jeffrey S. Brown, PhD, Harvard Pilgrim Health Care
2:20 p.m.	Identifying Hypertension in Electronic Health Records: A Comparison of Various Approaches Nirav R. Shah, MD, MPH, Geisinger Health
2:40 p.m.	Discussion and Audience Participation and Break
3:10 p.m.	Electronic Patient-Reported Data Capture as the Foundation of a Learning Cancer Clinic Amy P. Abernethy, MD, Duke University
3:30 p.m.	Statistical Surveillance Techniques for Hip Arthoplasty: Integrating Data Sources of post-market information. Sharon-Lise Normand, PhD, Harvard Medical School/School of Public Health
3:50 p.m.	Mitigating Systematic Measurement Error in Comparative Effectiveness Research in Heterogeneous Populations Adam C. Carle, PhD, University of North Florida
4:10 p.m.	Innovative Multi-Media Methods To Measure Patient-Reported Outcomes in People with Low Reading Ability. Elizabeth A. Hahn, MA, Northwestern University
4:30 p.m.	Discussion and Audience Participation
5:00 p.m.	Adjourn for Free Time
	Dinner on one’s own

Day 2, 2009
8:00 a.m.	Continental Breakfast in Conference Room
8:25 a.m.	Welcome for Day 2 Kathleen N. Lohr, RTI International
Optimizing Clinical Heterogeneity and Longitudinal Outcomes: The Role of Statistical Techniques and Analytic Models
8:30 a.m.	Overview: Thomas Trikalinos, MD, and Eric Johnson, PhD, Moderators
8:40 a.m.	Secure Propensity-Score-based Pooling of Multiple Databases in a Study of the Safety of Biologics. Jeremy A. Rassen, Harvard Medical School
9:00 a.m.	Using Mechanistic Models to Estimate Long-Term Outcomes in HIV Care and Simulate Comparative Effectiveness Trials of Therapy. Mark S. Roberts, MD, MPP, University of Pittsburgh
9.20 a.m.	Methodologic Approaches for Predicting Disease Onset from Electronic Health Record Data: A Heart Failure Case Study Jason A. Roy, PhD., Geisinger Health System
9.40 a.m.	Break (or use the time for Discussion and Audience Participation?)
10.00 a.m.	Methods to Evaluate Benefits in the Presence of Competing Risks of Death or Adverse Events Ravi Varadhan, PhD, Johns Hopkins University
10.20 a.m.	Variable Selection in the Presence of Uncontrolled Confounding Alan Brookhart, Partners.org
10:40 a.m.	Comprehensive Risk Calculator for Type 2 Diabetes Using Electronic Medical Records Michael W. Kattan, PhD, Cleveland Clinic and Case Western Reserve University
11.00 a.m.	Discussion and Audience Participation
11.30 a.m.	Lunch
*Comparative Effectiveness Research Methods:* *Policy and Practice Applications and Implications*
12.15 p.m.	Overview: Wade Aubry, MD, Moderator
12.25p.m.	Developing a Framework for Implantable Device Evaluation and Approaches to Improve the Methodology of Clinical Studies Art Sedrakyan, MD, PhD, Agency for Healthcare Research and Quality, Food and Drug Administration.
12.45 p.m.	Framing Comparative Effectiveness Results to Support Innovative Coverage and Reimbursement Policies Steven D. Pearson, MD, MSc, Institute for Clinical and Economic Review
1:05 p.m.	Spinal Cord Stimulation for Failed Back Surgery Syndrome: A Coverage with Evidence Development Study in the Washington State Workers’ Compensation System Judith Turner, PhD, University of Washington
1:25 p.m.	Bayesian Meta-Analysis for Policy Decisionmaking: Application to Implantable Cardioverter Defibrillators Scott Berry, PhD, Berry Consultants
1:45 p.m.	Translating Information about Comparative Effectiveness into Practice: The Case of Diabetes Medications Nilay D. Shah, PhD, Mayo Clinic
2:05 p.m.	Discussion and Audience Participation
2:30 p.m.	Closing Remarks and Conference Adjournment

DEcIDE EHC Symposium Planning Committee

Kathleen N. Lohr, PhD	Co-Chair and Distinguished Fellow, RTI International
Scott R. Smith, PhD	Co-Chair and Program Director, Center for Outcomes & Evidence, AHRQ

Wade Aubry, MD	Associate Clinical Professor of Medicine, Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco Senior Clinical and Policy Advisor, Center for Medical Technology Policy and Senior Medical Advisor to the California Technology Assessment Forum
Jean Paul Gagnon, PhD	Director of Public Policy, Sanofi-aventis Pharmaceuticals Inc.
Eric Johnson, PhD	Epidemiologist, Kaiser Permanente Northwest, Center for Health Research
Malcolm Maclure, PhD	Manager of Research, Pharmaceutical Services Division, British Columbia Ministry of Health & Adjunct Associate Professor, Harvard University
Sharon-Lise Normand, PhD	Professor of Health Policy (Biostatistics) Department of Health Care Policy, Harvard Medical School Department of Biostatistics, Harvard School of Public Health
Jean Slutsky, MSPH	Director, Center for Outcomes and Evidence, AHRQ
Mitchell Sugarman, MBA	Senior Director. Health Economics, Policy and Payment, Medtronic
Thomas Trikalinos, MD, PhD	Assistant Director, Center for Clinical Evidence Synthesis, Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center, Assistant Professor of Medicine, Tufts University

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Clinical and Comparative Effectiveness Research Methods: II

Provisional Symposium Agenda

DEcIDE EHC Symposium Planning Committee

Clinical and Comparative Effectiveness
Research Methods: II