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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

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 ( or Dr. Kathleen Lohr ( 

Register to attend by clicking here or pasting the following link into your browser (

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

Kathleen N. Lohr, Ph.D
Distinguished Fellow
RTI International


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.


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,

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.


Comparative Effectiveness Research Methods:
Policy and Practice Applications and Implications

12.15 p.m.

Overview: Wade Aubry, MD, Moderator


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