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Structured Abstract
Background:
The Institute of Medicine appointed an independent committee of experts to assess and to recommend a set of methodological standards that would assure objective, transparent, and scientifically valid systematic reviews of comparative effectiveness research. Following the release of these standards in March 2011, the EPC program established a collaborative process to comparatively examine the standards with respect to general EPC practice and guidance.
Purpose:
The purpose of this process was to assess which elements of the IOM standards should be adopted into EPC methods guidance and how to best implement these changes, and which elements require further empirical evidence.
Methods:
A two-phase approach is adopted, where in phase one, 13 EPC directors, in consultation with their respective staff, identified areas where general agreement exist and where further deliberation was necessary, and in phase two, workgroups, consisting of EPC investigators, were tasked to further deliberate and provide a disposition of each of those elements. These elements were categorized into one of four topic groups: program policies or procedures, protocol elements, searching/screening/reporting biases, and synthesis of evidence. Based on current practices and through discussions, four workgroups determined whether there was “agreement,” “agreement with modifications,” or “disagreement” for each element. Where there were modifications recommended, each workgroup provided a description of the differences between EPC practice or methods guidance and IOM guidelines, summarized the deliberative discussion, and made recommendations for further action.
Results:
EPC directors identified 34 elements across the 21 standards that required remediation and assignment to one of the four workgroups. Workgroups described general agreement with the majority of these 34 elements in principle. There were three elements with which the EPCs were in disagreement, and were not recommended for routine practice as currently stated. Discussion on the remaining 31 elements pointed out inconsistency of practice and need for clearer guidance, the need for more empiric evidence in some cases, the difficulty in balancing benefits and the required resources for implementation of elements, and in some cases, specific suggestions on how to implement particular elements.
Conclusions/Recommendations:
This process engaged the EPCs in a productive, collaborative evaluation and response to the work of the IOM committee for systematic review standards. Recommendations for further research or development, for updating of EPC guidance, and specific recommendations for practical implementation were itemized. Principally, this process will result in improvements in EPC practice.
Contents
- Preface
- Acknowledgments
- Introduction
- Methods
- Results
- Discussion
- References
- Appendix A Workgroups
- Appendix B EPC Directors’ Summary of Responses to IOM Standards for Systematic Reviews
- Appendix C Summary of Decisions and Protocol for Resolution in the Event of Difference of Opinion Between EPC Report Authors and AHRQ Officer
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10055-I, Prepared by: Tufts Evidence-based Practice Center, Tufts Medical Center, Boston, MA
Suggested citation:
Lau J, Chang S, Berkman N, Ratichek SJ, Balshem H, Brasure M, Moher D. EPC Response to IOM Standards for Systematic Reviews. Research White Paper (Prepared by the Tufts Evidence-based Practice Center, Tufts Medical Center under Contract No. 290-2007-10055-I). AHRQ Publication No. 13-EHC006-EF. Rockville, MD: Agency for Healthcare Research and Quality; April 2013. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Tufts Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10055-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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