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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="author" content="Gerald Gartlehner, Andreea Dobrescu, Tammeka Swinson Evans, Kylie Thaler, Barbara Nussbaumer, Isolde Sommer, Kathleen N Lohr" /><meta name="citation_title" content="Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence" /><meta name="citation_publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="citation_date" content="2015/03" /><meta name="citation_author" content="Gerald Gartlehner" /><meta name="citation_author" content="Andreea Dobrescu" /><meta name="citation_author" content="Tammeka Swinson Evans" /><meta name="citation_author" content="Kylie Thaler" /><meta name="citation_author" content="Barbara Nussbaumer" /><meta name="citation_author" content="Isolde Sommer" /><meta name="citation_author" content="Kathleen N Lohr" /><meta name="citation_pmid" content="25927119" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK286188/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="DC.Contributor" content="Gerald Gartlehner" /><meta name="DC.Contributor" content="Andreea Dobrescu" /><meta name="DC.Contributor" content="Tammeka Swinson Evans" /><meta name="DC.Contributor" content="Kylie Thaler" /><meta name="DC.Contributor" content="Barbara Nussbaumer" /><meta name="DC.Contributor" content="Isolde Sommer" /><meta name="DC.Contributor" content="Kathleen N Lohr" /><meta name="DC.Date" content="2015/03" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK286188/" /><meta name="DC.Language" content="en" /><meta name="description" content="The objective of our methods project was to use a diverse sample of medical interventions to assess empirically whether first trials rendered substantially different treatment effect estimates than reliable, high-quality bodies of evidence." /><meta name="og:title" content="Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence" /><meta name="og:type" content="book" /><meta name="og:description" content="The objective of our methods project was to use a diverse sample of medical interventions to assess empirically whether first trials rendered substantially different treatment effect estimates than reliable, high-quality bodies of evidence." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK286188/" /><meta name="og:site_name" content="NCBI Bookshelf" /><meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-methreswpcoe-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/methreswpcoe/toc/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK286188/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_print.min.css" type="text/css" media="print" /><style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} </style><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript" src="/corehtml/pmc/js/large-obj-scrollbars.min.js"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/book-toc.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script><meta name="book-collection" content="methodscollect" />
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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/methreswpcoe/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-methreswpcoe-lrg.png" alt="Cover of Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence" /></a><div class="icnblk_cntnt"><h1 id="_NBK286188_"><span itemprop="name">Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence</span></h1><p><i>Research White Paper</i></p><p class="contrib-group">Investigators: <span itemprop="author">Gerald Gartlehner</span>, MD, MPH, <span itemprop="author">Andreea Dobrescu</span>, MD, <span itemprop="author">Tammeka Swinson Evans</span>, MOP, <span itemprop="author">Kylie Thaler</span>, MD, MPH, <span itemprop="author">Barbara Nussbaumer</span>, MSc, <span itemprop="author">Isolde Sommer</span>, PhD, MPH, and <span itemprop="author">Kathleen N Lohr</span>, PhD.</p><a data-jig="ncbitoggler" href="#__NBK286188_ai__" style="border:0;text-decoration:none">Author Information and Affiliations</a><div style="display:none" class="ui-widget" id="__NBK286188_ai__"><p class="contrib-group"><h4>Authors</h4>Investigators: <span itemprop="author">Gerald Gartlehner</span>, MD, MPH,<sup>1,2</sup> <span itemprop="author">Andreea Dobrescu</span>, MD,<sup>3</sup> <span itemprop="author">Tammeka Swinson Evans</span>, MOP,<sup>2</sup> <span itemprop="author">Kylie Thaler</span>, MD, MPH,<sup>1</sup> <span itemprop="author">Barbara Nussbaumer</span>, MSc,<sup>1</sup> <span itemprop="author">Isolde Sommer</span>, PhD, MPH,<sup>1</sup> and <span itemprop="author">Kathleen N Lohr</span>, PhD<sup>2</sup>.</p><h4>Affiliations</h4><div class="affiliation"><sup>1</sup> Austrian Cochrane Branch, Danube University, Krems, Austria</div><div class="affiliation"><sup>2</sup> RTI International, Research Triangle Park, NC</div><div class="affiliation"><sup>3</sup> Victor Babes University of Medicine and Pharmacy, Timisoara, Romania</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">2015 Mar</span>.<div class="small">Report No.: 15-EHC010-EF</div></div><div class="half_rhythm"><ul class="inline_list"><li><span class="label"><a data-jig="ncbidialog" href="#_ncbi_dlg_cpyrght_NBK286188" data-jigconfig="modal:true">Copyright and
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Permissions</a></span></li></ul></div><div id="_ncbi_dlg_cpyrght_NBK286188" 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/methreswpcoe/" 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>The objective of our methods project was to use a diverse sample of medical interventions to assess empirically whether first trials rendered substantially different treatment effect estimates than reliable, high-quality bodies of evidence.</p></div><div id="study_design_and_setting"><h4 class="inline">Study design and setting:</h4><p>We employed a meta-epidemiological study design using 100 bodies of evidence from Cochrane reports that had been graded as high quality of evidence. To determine the concordance of effect estimates between first and subsequent trials, we applied both quantitative and qualitative approaches. For quantitative assessment, we used Lin's concordance correlation and calculated z-scores; to determine the magnitude of differences of treatment effects, we calculated standardized mean differences (SMDs) and ratios of relative risks. We determined qualitative concordance based on a 2-tiered approach incorporating changes in statistical significance and magnitude of effect.</p></div><div id="results_1"><h4 class="inline">Results:</h4><p>First trials both over- and under-estimated the true treatment effects in no discernible pattern. Nevertheless, depending on the definition of concordance, effect estimates of first trials were concordant with pooled subsequent studies in at least 33 percent but up to 50 percent of comparisons. The pooled magnitude of change as bodies of evidence advanced from single trials to high-quality bodies of evidence was 0.16 SMD (95% confidence interval [CI], 0.12 to 0.21). In 80 percent of comparisons the difference in effect estimates was smaller than 0.5 SMDs. In first trials with large treatment effects (>0.5 SMD), however, estimates of effect substantially changed as new evidence accrued (mean change 0.68 SMD, 95% CI, .50 to 0.86)</p></div><div id="conclusion"><h4 class="inline">Conclusion:</h4><p>Results of first trials often change but the magnitude of change, on average, is small. Exceptions are first trials that present large treatment effects which often dissipate as new evidence accrues.</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_tllNBK286188_fm_s1" class="simple-list toc toc-toggle"><li class="half_rhythm" id="toc_itm_NBK286188_fm_s1"><a href="/books/n/methreswpcoe/fm.s1/" class="toc-item">Preface</a></li><li class="half_rhythm" id="toc_itm_NBK286188_fm_s2"><a href="/books/n/methreswpcoe/fm.s2/" class="toc-item">Peer Reviewers</a></li><li class="half_rhythm" id="toc_itm_NBK286188_introduction"><a href="/books/n/methreswpcoe/introduction/" class="toc-item">Introduction</a></li><li class="half_rhythm" id="toc_itm_NBK286188_methods"><a href="/books/n/methreswpcoe/methods/" class="toc-item">Methods</a><ul id="toc_lst_NBK286188_methods_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK286188_methods_s1"><a href="/books/n/methreswpcoe/methods/#methods.s1" class="toc-item">Empirical Data</a></li><li class="half_rhythm" id="toc_itm_NBK286188_methods_s2"><a href="/books/n/methreswpcoe/methods/#methods.s2" class="toc-item">Assessing Concordance in Effect Estimates</a></li><li class="half_rhythm" id="toc_itm_NBK286188_methods_s3"><a href="/books/n/methreswpcoe/methods/#methods.s3" class="toc-item">Qualitative Assessment of Concordance</a></li><li class="half_rhythm" id="toc_itm_NBK286188_methods_s4"><a href="/books/n/methreswpcoe/methods/#methods.s4" class="toc-item">Quantitative Assessment of Concordance</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK286188_results"><a href="/books/n/methreswpcoe/results/" class="toc-item">Results</a><ul id="toc_lst_NBK286188_results_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK286188_results_s1"><a href="/books/n/methreswpcoe/results/#results.s1" class="toc-item">Qualitative Concordance Analyses</a></li><li class="half_rhythm" id="toc_itm_NBK286188_results_s2"><a href="/books/n/methreswpcoe/results/#results.s2" class="toc-item">Quantitative Concordance and Differences in Magnitudes of Effect Estimates</a></li><li class="half_rhythm" id="toc_itm_NBK286188_results_s3"><a href="/books/n/methreswpcoe/results/#results.s3" class="toc-item">Stratified Analyses</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK286188_discussion"><a href="/books/n/methreswpcoe/discussion/" class="toc-item">Discussion</a></li><li class="half_rhythm" id="toc_itm_NBK286188_equations"><a href="/books/n/methreswpcoe/equations/" class="toc-item">Equations</a></li><li class="half_rhythm" id="toc_itm_NBK286188_references_rl1"><a href="/books/n/methreswpcoe/references.rl1/" class="toc-item">References</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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290-2012-00008-I. <b>Prepared by:</b>
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RTI International–University of North Carolina Evidence-based Practice Center, Research Triangle Park, NC</p></div><div><h4 class="inline">Suggested citation:</h4><p>Gartlehner G, Dobrescu A, Swinson Evans T, Thaler K, Nussbaumer B, Sommer I, Lohr KN. Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence. Research White Paper. (Prepared by the RTI–UNC Evidence-based Practice Center under Contract No. 290-2012-00008-I.) AHRQ Publication No. 15-EHC010-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2015. <a href="http://www.effectivehealthcare.ahrq.gov/reports/final.cfm" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">www.effectivehealthcare.ahrq.gov/reports/final.cfm</a>.</p></div><div><p>This report is based on work conducted by the Research Triangle Institute International – University of North Carolina Chapel Hill (RTI-UNC) Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00008-I). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and 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>AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies may not be stated or implied.</p><p>Drs. Gartlehner and Thaler are members of the GRADE Working Group. Drs. Gartlehner and Lohr are co-authors of the AHRQ guidance for grading the strength of evidence. None of the other authors have any affiliations or financial involvement disclosures to 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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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK286188/?report=reader">PubReader</a></li><li><a href="/books/NBK286188/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK286188" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK286188" style="display:none" title="Cite this Page"><div class="bk_tt">Gartlehner G, Dobrescu A, Evans TS, et al. Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence [Internet]. 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