Introduction

Abstract

This supplement to The American Journal of Medicine focuses on comparative effectiveness research (CER) and lessons learned in the long history of contributions by the US Department of Veterans Affairs (VA). A report by the Institute of Medicine recently defined CER as both the generation and synthesis of evidence that examines “benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care.”1Sox H.C. Greenfield S. Comparative effectiveness research: a report from the Institute of Medicine.Ann Intern Med. 2009; 151: 203-205Crossref PubMed Scopus (416) Google Scholar The definition provided by the Federal Coordinating Council on CER has similar elements.2US Department of Health and Human Services, Federal Coordinating Council for Comparative Effectiveness ResearchReport to the President and the Congress.http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdfDate: June 30, 2009Google Scholar The supplement begins with an article by Drs. Joel Kupersmith and Alexander K. Ommaya who discuss the challenges facing healthcare providers and patients in choosing the most appropriate therapeutic approach. This is particularly difficult when the relative benefits and risks of competing treatments are not uniformly available from the existing scientific information. The goal of CER is to generate more of this information. In order to understand recent VA contributions, the authors review publications by VA coauthors in 2 major medical journals, and identify that 25% of the published articles were CER studies. In addition, in a review of all CER articles published in the same journals, 26% had VA coauthors. In the second article, Dr. Peter Peduzzi and colleagues review comparative effectiveness clinical trials and the contributions of the VA Cooperative Studies Program (CSP). The authors identify lessons learned, including the importance of managing risk factors, patient preferences, considering evolving technology, and issues in use of usual care as a comparator. In the design of CER studies, important considerations include appropriate management of comorbid conditions and dealing with changing treatment practices over time. Next, Dr. John Concato and associates review observational study design and identify its use in regard to CER. They assess the evidence supporting how observational studies can provide accurate and comparable results to clinical trials, and also identify strategies and new methods for conducting these trials. The contribution by Dr. Grant D. Huang and coworkers reviews the VA CSP as a model for CER. The program has a long history of addressing scientific, structural, and operational issues in conducting large-scale clinical research. The CSP has an established and longstanding approach to identifying and framing clinically relevant scientific questions, and, in addition, developing the appropriate study design to efficiently answer the questions. In their review, Dr. Leonard W. D'Avolio and colleagues examine the challenges of the data deluge in medical care and medical research, highlighting the VA's data resources and informatics efforts to generate knowledge from the VA's electronic health record and biological data including genomic information. In the final article, Dr. David Atkins and Joel Kupersmith review implementation research and lessons learned from the VA's Quality Enhancement Research Initiative. They point out that we must go beyond simple dissemination and education efforts to promote lasting practice change. Lasting change will be harder to argue for and achieve when the evidence is only from nonrandomized studies. Patient preferences, time pressures, historical practice patterns, and other factors also will play a role in implementation. Tools such as the electronic health record, evidence synthesis, and performance measures can play a significant role in facilitating implementation. The theme that is emphasized throughout this supplement is that appropriate scientific infrastructure—including human capital, procedures for question refinement, appropriate methods, implementation tools, and implementation plans—are required for effective CER. Appropriate attention to all of these efforts is necessary to generate results that have the potential to change practice. The enhanced interest in CER will influence how clinicians and healthcare system managers interact and assist the research enterprise in identifying promising research. To achieve the goal of CER, the need for research efficiency will enhance consideration of observational methodologies to address these questions. The author of this article has disclosed the following industry relationships: Joel Kupersmith, MD, reports no relationships to disclose with any manufacturer of a product or device discussed in this supplement.