Structured Abstract

Contents

• Preface
• Acknowledgements
• Peer Reviewers
• Introduction
• Methods
  • Workgroup Composition
  • Methods Projects
  • Guidance Development
• Guidance
  • Section 1 Unique Risk of Bias Issues for Trials Self-Identifying as EQ-NI
  • Section 2 Setting the Reviewer’s Minimum Important Difference
  • Section 3 Analytic Foundations for Concluding EQ or NI
  • Section 4 Language Considerations When Concluding EQ or NI
  • Examples
  • Summary of Recommendations
• References
• Appendix A Example MIDs for Specific Clinical Topics
• Appendix B Methods Project 1: Existing Guidance for Individual Trials
• Appendix C Methods Project 2: Review of Recent Systematic Reviews That Concluded Equivalence or Noninferiority

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services¹, Contract No. 290-2007-10063, Prepared by: EPC Workgroup: ECRI Institute Evidence-based Practice Center, Plymouth Meeting, PA; Johns Hopkins University Evidence-based Practice Center, Baltimore, MD; McMaster University Evidence-based Practice Center, Hamilton, Ontario, Canada; Oregon Evidence-based Practice Center, Portland, OR; Research Triangle Institute Evidence-based Practice Center, Research Triangle Park, NC; University of Connecticut Evidence-based Practice Center, Hartford, CT; University of Minnesota Evidence-based Practice Center, Minneapolis, MN; The University of Adelaide, Australia; Agency for Healthcare Research and Quality, Rockville, MD

Suggested citation:

Treadwell J, Uhl S, Tipton K, Singh S, Santaguida L, Sun X, Berkman N, Viswanathan M, Coleman C, Shamliyan T, Wang S, Ramakrishnan R, Elshaug A. Assessing Equivalence and Noninferiority. Methods Research Report. (Prepared by the EPC Workgroup under Contract No. 290-2007-10063.) AHRQ Publication No. 12-EHC045-EF. Rockville, MD: Agency for Healthcare Research and Quality; June 2012. www.effectivehealthcare.ahrq.gov.

This report is based on research conducted by the EPC Workgroup under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10063). The findings and conclusions in this document are those of the author(s), 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.

The investigators have no relevant financial interests in the report. The investigators have no employment, consultancies, honoraria, or stock ownership or options, or royalties from any organization or entity with a financial interest or financial conflict with the subject matter discussed in the report.

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