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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="author" content="Lisa Hartling, Michele Hamm, Andrea Milne, Ben Vandermeer, P Lina Santaguida, Mohammed Ansari, Alexander Tsertsvadze, Susanne Hempel, Paul Shekelle, Donna M Dryden" /><meta name="citation_title" content="Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments" /><meta name="citation_publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="citation_date" content="2012/03" /><meta name="citation_author" content="Lisa Hartling" /><meta name="citation_author" content="Michele Hamm" /><meta name="citation_author" content="Andrea Milne" /><meta name="citation_author" content="Ben Vandermeer" /><meta name="citation_author" content="P Lina Santaguida" /><meta name="citation_author" content="Mohammed Ansari" /><meta name="citation_author" content="Alexander Tsertsvadze" /><meta name="citation_author" content="Susanne Hempel" /><meta name="citation_author" content="Paul Shekelle" /><meta name="citation_author" content="Donna M Dryden" /><meta name="citation_pmid" content="22536612" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK92293/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="DC.Contributor" content="Lisa Hartling" /><meta name="DC.Contributor" content="Michele Hamm" /><meta name="DC.Contributor" content="Andrea Milne" /><meta name="DC.Contributor" content="Ben Vandermeer" /><meta name="DC.Contributor" content="P Lina Santaguida" /><meta name="DC.Contributor" content="Mohammed Ansari" /><meta name="DC.Contributor" content="Alexander Tsertsvadze" /><meta name="DC.Contributor" content="Susanne Hempel" /><meta name="DC.Contributor" content="Paul Shekelle" /><meta name="DC.Contributor" content="Donna M Dryden" /><meta name="DC.Date" content="2012/03" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK92293/" /><meta name="DC.Language" content="en" /><meta name="description" content="Numerous tools exist to assess methodological quality, or risk of bias in systematic reviews; however, few have undergone extensive reliability or validity testing." /><meta name="og:title" content="Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments" /><meta name="og:type" content="book" /><meta name="og:description" content="Numerous tools exist to assess methodological quality, or risk of bias in systematic reviews; however, few have undergone extensive reliability or validity testing." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK92293/" /><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-methresvalid-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/methresvalid/toc/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK92293/" /><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">&lt; Prev</span><a class="active page_link next" href="/books/n/methresvalid/fm.s1/" title="Next page in this title">Next &gt;</a></div></div></div>
<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&amp;targetsite=external&amp;targetcat=link&amp;targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-methresvalid-lrg.png" alt="Cover of Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments" /></a><div class="icnblk_cntnt"><h1 id="_NBK92293_"><span itemprop="name">Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments</span></h1><p><i>Methods Research Reports</i></p><p class="contrib-group">Investigators: <span itemprop="author">Lisa Hartling</span>, PhD, <span itemprop="author">Michele Hamm</span>, MSc, <span itemprop="author">Andrea Milne</span>, MLIS, <span itemprop="author">Ben Vandermeer</span>, MSc, <span itemprop="author">P Lina Santaguida</span>, PhD, <span itemprop="author">Mohammed Ansari</span>, MBBS, MMedSc, MPhil, <span itemprop="author">Alexander Tsertsvadze</span>, MD, MSc, <span itemprop="author">Susanne Hempel</span>, PhD, <span itemprop="author">Paul Shekelle</span>, MD, PhD, and <span itemprop="author">Donna M Dryden</span>, PhD.</p><a data-jig="ncbitoggler" href="#__NBK92293_ai__" style="border:0;text-decoration:none">Author Information and Affiliations</a><div style="display:none" class="ui-widget" id="__NBK92293_ai__"><p class="contrib-group"><h4>Authors</h4>Investigators: <span itemprop="author">Lisa Hartling</span>, PhD, <span itemprop="author">Michele Hamm</span>, MSc, <span itemprop="author">Andrea Milne</span>, MLIS, <span itemprop="author">Ben Vandermeer</span>, MSc, <span itemprop="author">P Lina Santaguida</span>, PhD, <span itemprop="author">Mohammed Ansari</span>, MBBS, MMedSc, MPhil, <span itemprop="author">Alexander Tsertsvadze</span>, MD, MSc, <span itemprop="author">Susanne Hempel</span>, PhD, <span itemprop="author">Paul Shekelle</span>, MD, PhD, and <span itemprop="author">Donna M Dryden</span>, PhD.</p><h4>Affiliations</h4><div class="affiliation"><sup>1</sup> University of Alberta Evidence-based Practice Center</div></div><div class="half_rhythm">Rockville (MD): <a href="https://effectivehealthcare.ahrq.gov" ref="pagearea=meta&amp;targetsite=external&amp;targetcat=link&amp;targettype=publisher"><span itemprop="publisher">Agency for Healthcare Research and Quality (US)</span></a>; <span itemprop="datePublished">2012 Mar</span>.<div class="small">Report No.: 12-EHC039-EF</div></div><div class="half_rhythm"><ul class="inline_list"><li><span class="label"><a data-jig="ncbidialog" href="#_ncbi_dlg_cpyrght_NBK92293" data-jigconfig="modal:true">Copyright and
Permissions</a></span></li></ul></div><div id="_ncbi_dlg_cpyrght_NBK92293" style="display:none" title="Copyright and&#10; 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/methresvalid/" 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="background"><h4 class="inline">Background:</h4><p>Numerous tools exist to assess methodological quality, or risk of bias in systematic reviews; however, few have undergone extensive reliability or validity testing.</p></div><div id="objectives"><h4 class="inline">Objectives:</h4><p>(1) assess the reliability of the Cochrane Risk of Bias (ROB) tool for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale (NOS) for cohort studies between individual raters, and between consensus agreements of individual raters for the ROB tool; (2) assess the validity of the Cochrane ROB tool and NOS by examining the association between study quality and treatment effect size (ES); (3) examine the impact of study-level factors on reliability and validity.</p></div><div id="method"><h4 class="inline">Methods:</h4><p>Two reviewers independently assessed risk of bias for 154 RCTs. For a subset of 30 RCTs, two reviewers from each of four Evidence-based Practice Centers assessed risk of bias and reached consensus. Inter-rater agreement was assessed using kappa statistics. We assessed the association between ES and risk of bias using meta-regression. We examined the impact of study-level factors on the association between risk of bias and ES using subgroup analyses. Two reviewers independently applied the NOS to 131 cohort studies from 8 meta-analyses. Inter-rater agreement was calculated using kappa statistics. Within each meta-analysis, we generated a ratio of pooled estimates for each quality domain. The ratios were combined to give an overall estimate of differences in effect estimates with inverse-variance weighting and a random effects model.</p></div><div id="result"><h4 class="inline">Results:</h4><p>Inter-rater reliability between two reviewers was considered fair for most domains (&#x003ba; ranging from 0.24 to 0.37), except for sequence generation (&#x003ba;=0.79, substantial). Inter-rater reliability of consensus assessments across four reviewer pairs was moderate for sequence generation (&#x003ba;=0.60), fair for allocation concealment and &#x0201c;other sources of bias&#x0201d; (&#x003ba;=0.37, 0.27), and slight for the remaining domains (&#x003ba; ranging from 0.05 to 0.09). Inter-rater variability was influenced by study-level factors including nature of outcome, nature of intervention, study design, trial hypothesis, and funding source. Inter-rater variability resulted more often from different interpretation of the tool rather than different information identified in the study reports. No statistically significant differences were found in ES when comparing studies categorized as high, unclear or low risk of bias. Inter-rater reliability of the NOS varied from substantial for length of followup to poor for selection of non-exposed cohort and demonstration that the outcome was not present at outset of study. We found no association between individual NOS items or overall NOS score and effect estimates.</p></div><div id="conclusion"><h4 class="inline">Conclusion:</h4><p>More specific guidance is needed to apply risk of bias/quality tools. Study-level factors that were shown to influence agreement provide direction for detailed guidance. Low agreement across pairs of reviewers has implications for incorporation of risk of bias into results and grading the strength of evidence. Variable agreement for the NOS, and lack of evidence that it discriminates studies that may provide biased results, underscores the need for more detailed guidance to apply the tool in systematic reviews.</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_tllNBK92293_fm_s1" class="simple-list toc toc-toggle"><li class="half_rhythm" id="toc_itm_NBK92293_fm_s1"><a href="/books/n/methresvalid/fm.s1/" class="toc-item">Preface</a></li><li class="half_rhythm" id="toc_itm_NBK92293_ack"><a href="/books/n/methresvalid/ack/" class="toc-item">Acknowledgments</a></li><li class="half_rhythm" id="toc_itm_NBK92293_fm_s2"><a href="/books/n/methresvalid/fm.s2/" class="toc-item">Steering Committee</a></li><li class="half_rhythm" id="toc_itm_NBK92293_fm_s3"><a href="/books/n/methresvalid/fm.s3/" class="toc-item">Peer Reviewers</a></li><li class="half_rhythm" id="toc_itm_NBK92293_executivesummary"><a href="/books/n/methresvalid/executivesummary/" class="toc-item">Executive Summary</a></li><li class="half_rhythm" id="toc_itm_NBK92293_introduction"><a href="/books/n/methresvalid/introduction/" class="toc-item">Introduction</a><ul id="toc_lst_NBK92293_introduction_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK92293_introduction_s1"><a href="/books/n/methresvalid/introduction/#introduction.s1" class="toc-item">Quality and Risk of Bias Assessment in Systematic Reviews</a></li><li class="half_rhythm" id="toc_itm_NBK92293_introduction_s4"><a href="/books/n/methresvalid/introduction/#introduction.s4" class="toc-item">Goal and Objective</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK92293_methods"><a href="/books/n/methresvalid/methods/" class="toc-item">Methods</a><ul id="toc_lst_NBK92293_methods_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK92293_methods_s1"><a href="/books/n/methresvalid/methods/#methods.s1" class="toc-item">Steering Committee</a></li><li class="half_rhythm" id="toc_itm_NBK92293_methods_s2"><a href="/books/n/methresvalid/methods/#methods.s2" class="toc-item">General Approach</a></li><li class="half_rhythm" id="toc_itm_NBK92293_methods_s3"><a href="/books/n/methresvalid/methods/#methods.s3" class="toc-item">Risk of Bias and Randomized Controlled Trials</a></li><li class="half_rhythm" id="toc_itm_NBK92293_methods_s8"><a href="/books/n/methresvalid/methods/#methods.s8" class="toc-item">Newcastle-Ottawa Scale and Cohort Studies</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK92293_results"><a href="/books/n/methresvalid/results/" class="toc-item">Results</a><ul id="toc_lst_NBK92293_results_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK92293_results_s1"><a href="/books/n/methresvalid/results/#results.s1" class="toc-item">Overview</a></li><li class="half_rhythm" id="toc_itm_NBK92293_results_s2"><a href="/books/n/methresvalid/results/#results.s2" class="toc-item">Risk of Bias and Randomized Controlled Trials</a></li><li class="half_rhythm" id="toc_itm_NBK92293_results_s8"><a href="/books/n/methresvalid/results/#results.s8" class="toc-item">Newcastle-Ottawa Scale and Cohort Studies</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK92293_summary"><a href="/books/n/methresvalid/summary/" class="toc-item">Summary and Discussion</a><ul id="toc_lst_NBK92293_summary_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK92293_summary_s1"><a href="/books/n/methresvalid/summary/#summary.s1" class="toc-item">Key Points</a></li><li class="half_rhythm" id="toc_itm_NBK92293_summary_s4"><a href="/books/n/methresvalid/summary/#summary.s4" class="toc-item">Discussion</a></li><li class="half_rhythm" id="toc_itm_NBK92293_summary_s7"><a href="/books/n/methresvalid/summary/#summary.s7" class="toc-item">Implications for Practice</a></li><li class="half_rhythm" id="toc_itm_NBK92293_summary_s8"><a href="/books/n/methresvalid/summary/#summary.s8" class="toc-item">Future Directions</a></li><li class="half_rhythm" id="toc_itm_NBK92293_summary_s9"><a href="/books/n/methresvalid/summary/#summary.s9" class="toc-item">Strengths and Limitations</a></li><li class="half_rhythm" id="toc_itm_NBK92293_summary_s10"><a href="/books/n/methresvalid/summary/#summary.s10" class="toc-item">Conclusions</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK92293_references_rl1"><a href="/books/n/methresvalid/references.rl1/" class="toc-item">References</a></li><li class="half_rhythm" id="toc_itm_NBK92293_abbreviations"><a href="/books/n/methresvalid/abbreviations/" class="toc-item">Abbreviations</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_appgroup1"><a href="/books/n/methresvalid/appendixes.appgroup1/" class="toc-item">Appendixes</a><ul id="toc_lst_NBK92293_appendixes_app1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app1"><a href="/books/n/methresvalid/appendixes.app1/" class="toc-item">Appendix A Sample of Randomized Controlled Trials</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app2"><a href="/books/n/methresvalid/appendixes.app2/" class="toc-item">Appendix B Guidelines for Risk of Bias Assessments</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app3"><a href="/books/n/methresvalid/appendixes.app3/" class="toc-item">Appendix C Variables for Data Extraction from Randomized Controlled Trials</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app4"><a href="/books/n/methresvalid/appendixes.app4/" class="toc-item">Appendix D Meta-Analyses and Cohort Studies Used for NOS Assessments</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app5"><a href="/books/n/methresvalid/appendixes.app5/" class="toc-item">Appendix E Decision Rules for Application of the Newcastle-Ottawa Scale</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app6"><a href="/books/n/methresvalid/appendixes.app6/" class="toc-item">Appendix F Supplementary Information for NOS Assessments</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app7"><a href="/books/n/methresvalid/appendixes.app7/" class="toc-item">Appendix G Description of Randomized Controlled Trials</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app8"><a href="/books/n/methresvalid/appendixes.app8/" class="toc-item">Appendix H Data Used for Kappa Calculations</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app9"><a href="/books/n/methresvalid/appendixes.app9/" class="toc-item">Appendix I Inter-rater Reliability on Risk of Bias Assessments, by Domain and Study-level Variable With Confidence Intervals</a></li><li class="half_rhythm" id="toc_itm_NBK92293_appendixes_app10"><a href="/books/n/methresvalid/appendixes.app10/" class="toc-item">Appendix J Sources of Disagreement Across Consensus Assessments Using the Risk of Bias Tool</a></li></ul></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>
Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services<a class="bk_pop" href="#address1"><sup>1</sup></a>, . <b>Contract No.</b>
290-2007-10021-I. <b>Prepared by:</b>
University of Alberta Evidence-based Practice Center, Edmonton, Alberta, Canada</p></div><div><h4 class="inline">Suggested citation:</h4><p>Hartling L, Hamm M, Milne A, Vandermeer B, Santaguida PL, Ansari M, Tsertsvadze A, Hempel S, Shekelle P, Dryden DM. Validity and inter-rater reliability testing of quality assessment instruments. (Prepared by the University of Alberta Evidence-based Practice Center under Contract No. 290-2007-10021-I.) AHRQ Publication No. 12-EHC039-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2012. <a href="http://www.effectivehealthcare.ahrq.gov/reports/final.cfm" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">www.effectivehealthcare.ahrq.gov/reports/final.cfm</a>.</p></div><div><p>This report is based on research conducted by the University of Alberta Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10021-1). 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. 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 clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.</p><p>This report may be used, in whole or in part, as the basis for the 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 or actions may not be stated or implied.</p><p>None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this 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&amp;targetsite=external&amp;targetcat=link&amp;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/NBK92293/?report=reader">PubReader</a></li><li><a href="/books/NBK92293/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK92293" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK92293" style="display:none" title="Cite this Page"><div class="bk_tt">Hartling L, Hamm M, Milne A, et al. Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Mar. <span class="bk_cite_avail"></span></div></div></li><li><a href="/books/n/methresvalid/pdf/">PDF version of this title</a> (1.2M)</li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Other titles in these collections</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" 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/n/methodscollect/">AHRQ Methods for Effective Health Care</a></li><li><a href="/books/n/hstatcollect/">Health Services/Technology Assessment Texts
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