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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p></div><div class="pagination bk_noprnt"><span class="inactive page_link prev">< Prev</span><a class="active page_link next" href="/books/n/methresequiv/fm.s1/" title="Next page in this title">Next ></a></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/Book"><div class="meta-content fm-sec"><div class="iconblock whole_rhythm clearfix no_top_margin"><a href="https://effectivehealthcare.ahrq.gov" title="Agency for Healthcare Research and Quality (US)" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-methresequiv-lrg.png" alt="Cover of Assessing Equivalence and Noninferiority" /></a><div class="icnblk_cntnt"><h1 id="_NBK98979_"><span itemprop="name">Assessing Equivalence and Noninferiority</span></h1><p><i>Methods Research Reports</i></p><p class="contrib-group">Investigators: <span itemprop="author">Jonathan Treadwell</span>, PhD, <span itemprop="author">Stacey Uhl</span>, MSS, <span itemprop="author">Kelley Tipton</span>, MPH, <span itemprop="author">Sonal Singh</span>, MD, MPH, <span itemprop="author">Lina Santaguida</span>, PhD, <span itemprop="author">Xin Sun</span>, PhD, <span itemprop="author">Nancy Berkman</span>, PhD, <span itemprop="author">Meera Viswanathan</span>, PhD, <span itemprop="author">Craig Coleman</span>, PhD, <span itemprop="author">Tatyana Shamliyan</span>, MD, <span itemprop="author">Shi-Yi Wang</span>, MD, <span itemprop="author">Rema Ramakrishnan</span>, and <span itemprop="author">Adam Elshaug</span>, MPH, PhD.</p><a data-jig="ncbitoggler" href="#__NBK98979_ai__" style="border:0;text-decoration:none">Author Information and Affiliations</a><div style="display:none" class="ui-widget" id="__NBK98979_ai__"><p class="contrib-group"><h4>Authors</h4>Investigators: <span itemprop="author">Jonathan Treadwell</span>, PhD,<sup>a</sup> <span itemprop="author">Stacey Uhl</span>, MSS,<sup>a</sup> <span itemprop="author">Kelley Tipton</span>, MPH,<sup>a</sup> <span itemprop="author">Sonal Singh</span>, MD, MPH,<sup>b</sup> <span itemprop="author">Lina Santaguida</span>, PhD,<sup>c</sup> <span itemprop="author">Xin Sun</span>, PhD,<sup>d</sup> <span itemprop="author">Nancy Berkman</span>, PhD,<sup>e</sup> <span itemprop="author">Meera Viswanathan</span>, PhD,<sup>e</sup> <span itemprop="author">Craig Coleman</span>, PhD,<sup>f</sup> <span itemprop="author">Tatyana Shamliyan</span>, MD,<sup>g</sup> <span itemprop="author">Shi-Yi Wang</span>, MD,<sup>g</sup> <span itemprop="author">Rema Ramakrishnan</span>,<sup>g</sup> and <span itemprop="author">Adam Elshaug</span>, MPH, PhD<sup>h</sup>.</p><h4>Affiliations</h4><div class="affiliation"><sup>a</sup>
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ECRI Institute Evidence-based Practice Center (Lead EPC), Plymouth Meeting, PA</div><div class="affiliation"><sup>b</sup> Johns Hopkins University Evidence-based Practice Center, Baltimore, MD</div><div class="affiliation"><sup>c</sup> McMaster University Evidence-based Practice Center, Hamilton, Ontario, Canada</div><div class="affiliation"><sup>d</sup> Oregon Evidence-based Practice Center, Portland, OR</div><div class="affiliation"><sup>e</sup> Research Triangle Institute Evidence-based Practice Center, Research Triangle Park, NC</div><div class="affiliation"><sup>f</sup> University of Connecticut Evidence-based Practice Center, Hartford, CT</div><div class="affiliation"><sup>g</sup> University of Minnesota Evidence-based Practice Center, Minneapolis, MN</div><div class="affiliation"><sup>h</sup> Agency for Healthcare Research and Quality, Rockville, MD, and The University of Adelaide, Australia</div></div><div class="half_rhythm">Rockville (MD): <a href="https://effectivehealthcare.ahrq.gov" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">Agency for Healthcare Research and Quality (US)</span></a>; <span itemprop="datePublished">2012 Jun</span>.<div class="small">Report No.: 12-EHC045-EF</div></div><div class="half_rhythm"><ul class="inline_list"><li><span class="label"><a data-jig="ncbidialog" href="#_ncbi_dlg_cpyrght_NBK98979" data-jigconfig="modal:true">Copyright and
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Permissions</a></span></li></ul></div><div id="_ncbi_dlg_cpyrght_NBK98979" style="display:none" title="Copyright and Permissions"><div>This publication is in the public domain. For more information, see the <a href="/books/about/copyright/">Bookshelf Copyright Notice</a>.</div></div><div class="bk_noprnt"><form method="get" action="/books/n/methresequiv/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div></div></div><div class="body-content whole_rhythm" itemprop="text"><div itemprop="description"><h2>Structured Abstract</h2><div id="objective"><h4 class="inline">Objective:</h4><p>To provide guidance on how to manage the concepts of equivalence and noninferiority in the context of systematic reviews.</p></div><div id="methods1"><h4 class="inline">Methods:</h4><p>This guidance was developed by a workgroup consisting of 13 individuals from seven Evidence-based Practice Centers (EPCs) and the Agency for Healthcare Research and Quality, under the leadership of the ECRI EPC. Prior to developing any guidance, the lead EPC also performed two methods projects intended to assist the workgroup. The first was a review of 12 existing guidance documents pertaining to equivalence and noninferiority, all of which were intended for primary researchers. The second project assessed the methodology used for a random sample of 50 recent systematic reviews that concluded equivalence or noninferiority between two or more treatments. Based on the previous experience and knowledge of the workgroup members, as well as insights from the two methods projects, guidance was developed and underwent posting for public comment and peer review.</p></div><div id="results"><h4 class="inline">Results:</h4><p>No guidance documents specifically addressing equivalence and noninferiority in the context of systematic review were identified. The workgroup developed a list of recommendations for four areas. First, how to assess the unique risk of bias for trials self-identifying as equivalence or noninferiority trials. Second, how to set Minimum Important Difference for a systematic review. Third, the analytic foundations for concluding equivalence or noninferiority in a systematic review. Fourth, language considerations when concluding equivalence or noninferiority in a systematic review.</p></div><div id="conclusions"><h4 class="inline">Conclusions:</h4><p>Systematic reviewers need to adopt a consistent and conceptually sound approach to interpreting, concluding, and expressing equivalence or noninferiority in the context of systematic reviews. This paper provides preliminary guidance in that endeavor.</p></div></div><div><h2>Contents</h2><div class="bktoc_all_cntnr top align_right" style="display:none"><ul class="inline_list_right"><li><a class="bktoc_all_exp" href="#">Expand All</a></li><li style="margin-left:.8em"><a class="bktoc_all_clps" href="#">Collapse All</a></li></ul></div><ul id="toc_tllNBK98979_fm_s1" class="simple-list toc toc-toggle"><li class="half_rhythm" id="toc_itm_NBK98979_fm_s1"><a href="/books/n/methresequiv/fm.s1/" class="toc-item">Preface</a></li><li class="half_rhythm" id="toc_itm_NBK98979_ack"><a href="/books/n/methresequiv/ack/" class="toc-item">Acknowledgements</a></li><li class="half_rhythm" id="toc_itm_NBK98979_fm_s3"><a href="/books/n/methresequiv/fm.s3/" class="toc-item">Peer Reviewers</a></li><li class="half_rhythm" id="toc_itm_NBK98979_introduction"><a href="/books/n/methresequiv/introduction/" class="toc-item">Introduction</a></li><li class="half_rhythm" id="toc_itm_NBK98979_methods"><a href="/books/n/methresequiv/methods/" class="toc-item">Methods</a><ul id="toc_lst_NBK98979_methods_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK98979_methods_s1"><a href="/books/n/methresequiv/methods/#methods.s1" class="toc-item">Workgroup Composition</a></li><li class="half_rhythm" id="toc_itm_NBK98979_methods_s2"><a href="/books/n/methresequiv/methods/#methods.s2" class="toc-item">Methods Projects</a></li><li class="half_rhythm" id="toc_itm_NBK98979_methods_s3"><a href="/books/n/methresequiv/methods/#methods.s3" class="toc-item">Guidance Development</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK98979_guidance"><a href="/books/n/methresequiv/guidance/" class="toc-item">Guidance</a><ul id="toc_lst_NBK98979_guidance_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK98979_guidance_s1"><a href="/books/n/methresequiv/guidance/#guidance.s1" class="toc-item">Section 1 Unique Risk of Bias Issues for Trials Self-Identifying as EQ-NI</a></li><li class="half_rhythm" id="toc_itm_NBK98979_guidance_s14"><a href="/books/n/methresequiv/guidance/#guidance.s14" class="toc-item">Section 2 Setting the Reviewer’s Minimum Important Difference</a></li><li class="half_rhythm" id="toc_itm_NBK98979_guidance_s18"><a href="/books/n/methresequiv/guidance/#guidance.s18" class="toc-item">Section 3 Analytic Foundations for Concluding EQ or NI</a></li><li class="half_rhythm" id="toc_itm_NBK98979_guidance_s27"><a href="/books/n/methresequiv/guidance/#guidance.s27" class="toc-item">Section 4 Language Considerations When Concluding EQ or NI</a></li><li class="half_rhythm" id="toc_itm_NBK98979_guidance_s28"><a href="/books/n/methresequiv/guidance/#guidance.s28" class="toc-item">Examples</a></li><li class="half_rhythm" id="toc_itm_NBK98979_guidance_s29"><a href="/books/n/methresequiv/guidance/#guidance.s29" class="toc-item">Summary of Recommendations</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK98979_references_rl1"><a href="/books/n/methresequiv/references.rl1/" class="toc-item">References</a></li><li class="half_rhythm" id="toc_itm_NBK98979_appa"><a href="/books/n/methresequiv/appa/" class="toc-item">Appendix A Example MIDs for Specific Clinical Topics</a></li><li class="half_rhythm" id="toc_itm_NBK98979_appb"><a href="/books/n/methresequiv/appb/" class="toc-item">Appendix B Methods Project 1: Existing Guidance for Individual Trials</a></li><li class="half_rhythm" id="toc_itm_NBK98979_appc"><a href="/books/n/methresequiv/appc/" class="toc-item">Appendix C Methods Project 2: Review of Recent Systematic Reviews That Concluded Equivalence or Noninferiority</a></li></ul><div class="bktoc_all_cntnr align_right" style="display:none"><ul class="inline_list_right"><li><a class="bktoc_all_exp" href="#">Expand All</a></li><li style="margin-left:.8em"><a class="bktoc_all_clps" href="#">Collapse All</a></li></ul></div></div><div><p><b>Prepared for:</b>
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Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services<a class="bk_pop" href="#address1"><sup>1</sup></a>,
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<b>Contract No.</b>
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<b>290-2007-10063</b>, <b>Prepared by:</b>
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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</p></div><div><h4 class="inline">Suggested citation:</h4><p>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. <a href="http://www.effectivehealthcare.ahrq.gov" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">www.effectivehealthcare.ahrq.gov</a>.</p></div><div><p>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.</p><p>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.</p><p>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.</p><p>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.</p></div><div><dl class="temp-labeled-list small"><dt>1</dt><dd><div id="address1"><p class="no_top_margin">540 Gaither Road, Rockville, MD 20850; <a href="http://www.ahrq.gov" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">www<wbr style="display:inline-block"></wbr>.ahrq.gov</a></p></div></dd></dl></div></div></div>
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