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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="author" content="Meera Viswanathan, Nancy D Berkman" /><meta name="citation_title" content="Development of the RTI Item Bank on Risk of Bias and Precision of Observational Studies" /><meta name="citation_publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="citation_date" content="2011/09" /><meta name="citation_author" content="Meera Viswanathan" /><meta name="citation_author" content="Nancy D Berkman" /><meta name="citation_pmid" content="22191112" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK82258/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Development of the RTI Item Bank on Risk of Bias and Precision of Observational Studies" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="DC.Contributor" content="Meera Viswanathan" /><meta name="DC.Contributor" content="Nancy D Berkman" /><meta name="DC.Date" content="2011/09" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK82258/" /><meta name="DC.Language" content="en" /><meta name="description" content="To create a practical and validated item bank for evaluating the risk of bias and precision of observational studies of interventions or exposures included in systematic evidence reviews." /><meta name="og:title" content="Development of the RTI Item Bank on Risk of Bias and Precision of Observational Studies" /><meta name="og:type" content="book" /><meta name="og:description" content="To create a practical and validated item bank for evaluating the risk of bias and precision of observational studies of interventions or exposures included in systematic evidence reviews." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK82258/" /><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-methresobsbias-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/methresobsbias/toc/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK82258/" /><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/methresobsbias/methresobsbias.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-methresobsbias-lrg.png" alt="Cover of Development of the RTI Item Bank on Risk of Bias and Precision of Observational Studies" /></a><div class="icnblk_cntnt"><h1 id="_NBK82258_"><span itemprop="name">Development of the RTI Item Bank on Risk of Bias and Precision of Observational Studies</span></h1><p><i>Methods Research Reports</i></p><p class="contrib-group">Investigators: <span itemprop="author">Meera Viswanathan</span>, PhD and <span itemprop="author">Nancy D Berkman</span>, PhD.</p><a data-jig="ncbitoggler" href="#__NBK82258_ai__" style="border:0;text-decoration:none">Author Information and Affiliations</a><div style="display:none" class="ui-widget" id="__NBK82258_ai__"><p class="contrib-group"><h4>Authors</h4>Investigators: <span itemprop="author">Meera Viswanathan</span>, PhD and <span itemprop="author">Nancy D Berkman</span>, PhD.</p><h4>Affiliations</h4><div class="affiliation"><sup>1</sup> RTI International&#x02013;University of North Carolina 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">2011 Sep</span>.<div class="small">Report No.: 11-EHC028-EF</div></div><div class="half_rhythm"><ul class="inline_list"><li><span class="label"><a data-jig="ncbidialog" href="#_ncbi_dlg_cpyrght_NBK82258" data-jigconfig="modal:true">Copyright and
Permissions</a></span></li></ul></div><div id="_ncbi_dlg_cpyrght_NBK82258" 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/methresobsbias/" 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 create a practical and validated item bank for evaluating the risk of bias and precision of observational studies of interventions or exposures included in systematic evidence reviews.</p></div><div id="study_design_and_setting"><h4 class="inline">Study Design and Setting:</h4><p>The item bank was created based on 1,492 questions included in earlier instruments, organized by the quality domains identified by Deeks and colleagues. Items were eliminated and refined through face validity, cognitive, content validity, and interrater reliability testing.</p></div><div id="result"><h4 class="inline">Results:</h4><p>The resulting RTI item bank, consisting of 29 questions for evaluating the risk of bias and precision of observational studies of interventions or exposures: (1) captures all of the domains critical for evaluating this type of research; (2) is comprehensive and can be easily lifted &#x0201c;off the shelf&#x0201d; by different researchers; (3) can be adapted to different topic areas and study types (e.g., cohort, case control, cross-sectional and case series studies); and (4) provides sufficient instruction to apply the tool to varied topics.</p></div><div id="conclusions"><h4 class="inline">Conclusions:</h4><p>One bank of items, with specific instructions for focusing abstractor evaluations, can be created to judge the risk of bias and precision of the variety of observational studies that may be used in systematic and comparative effectiveness 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_tllNBK82258_methresobsbias_fm_s1" class="simple-list toc toc-toggle"><li class="half_rhythm" id="toc_itm_NBK82258_methresobsbias_fm_s1"><a href="/books/n/methresobsbias/methresobsbias.fm.s1/" class="toc-item">Preface</a></li><li class="half_rhythm" id="toc_itm_NBK82258_acknowledgments"><a href="/books/n/methresobsbias/acknowledgments/" class="toc-item">Acknowledgments</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methresobsbias_fm_s2"><a href="/books/n/methresobsbias/methresobsbias.fm.s2/" class="toc-item">Technical Expert Panel</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methresobsbias_fm_s3"><a href="/books/n/methresobsbias/methresobsbias.fm.s3/" class="toc-item">Peer Reviewers</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methresobsbias_fm_s4"><a href="/books/n/methresobsbias/methresobsbias.fm.s4/" class="toc-item">Cognitive Testing Respondents</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methresobsbias_fm_s5"><a href="/books/n/methresobsbias/methresobsbias.fm.s5/" class="toc-item">Content Validity Experts</a></li><li class="half_rhythm" id="toc_itm_NBK82258_introduction"><a href="/books/n/methresobsbias/introduction/" class="toc-item">Introduction</a><ul id="toc_lst_NBK82258_introduction_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK82258_introduction_s1"><a href="/books/n/methresobsbias/introduction/#introduction.s1" class="toc-item">Approaches To Assessing the Risk of Bias and Precision of Studies</a></li><li class="half_rhythm" id="toc_itm_NBK82258_introduction_s2"><a href="/books/n/methresobsbias/introduction/#introduction.s2" class="toc-item">Organization of the Manuscript</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK82258_methods"><a href="/books/n/methresobsbias/methods/" class="toc-item">Methods</a><ul id="toc_lst_NBK82258_methods_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK82258_methods_s1"><a href="/books/n/methresobsbias/methods/#methods.s1" class="toc-item">Compilation of Potential Questions for Item Bank</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methods_s3"><a href="/books/n/methresobsbias/methods/#methods.s3" class="toc-item">Cognitive Testing and Experienced Reviewer Review</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methods_s4"><a href="/books/n/methresobsbias/methods/#methods.s4" class="toc-item">Content Validity Testing</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methods_s5"><a href="/books/n/methresobsbias/methods/#methods.s5" class="toc-item">Interrater Reliability</a></li><li class="half_rhythm" id="toc_itm_NBK82258_methods_s6"><a href="/books/n/methresobsbias/methods/#methods.s6" class="toc-item">Post-Test Revisions</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK82258_results"><a href="/books/n/methresobsbias/results/" class="toc-item">Results</a><ul id="toc_lst_NBK82258_results_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK82258_results_s1"><a href="/books/n/methresobsbias/results/#results.s1" class="toc-item">Compilation of Potential Questions for Item Bank</a></li><li class="half_rhythm" id="toc_itm_NBK82258_results_s5"><a href="/books/n/methresobsbias/results/#results.s5" class="toc-item">Interrater Reliability</a></li><li class="half_rhythm" id="toc_itm_NBK82258_results_s6"><a href="/books/n/methresobsbias/results/#results.s6" class="toc-item">Post-Test Revisions</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK82258_discussion"><a href="/books/n/methresobsbias/discussion/" class="toc-item">Discussion</a></li><li class="half_rhythm" id="toc_itm_NBK82258_references_rl1"><a href="/books/n/methresobsbias/references.rl1/" class="toc-item">References</a></li><li class="half_rhythm" id="toc_itm_NBK82258_appendixes_appgroup1"><a href="/books/n/methresobsbias/appendixes.appgroup1/" class="toc-item">Appendixes</a><ul id="toc_lst_NBK82258_appendixes_app1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK82258_appendixes_app1"><a href="/books/n/methresobsbias/appendixes.app1/" class="toc-item">Appendix A AC1 Statistic</a></li><li class="half_rhythm" id="toc_itm_NBK82258_appendixes_app2"><a href="/books/n/methresobsbias/appendixes.app2/" class="toc-item">Appendix B Item Bank for Assessment of Risk of Bias and Precision for Observational Studies of Interventions or Exposures</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>
<b>290-2007-10056-I</b>. <b>Prepared by:</b>
RTI International&#x02013;University of North Carolina Evidence-based Practice Center, Research Triangle Park, NC</p></div><div><h4 class="inline">Suggested citation:</h4><p>Viswanathan M, Berkman ND. Development of the RTI Item Bank on Risk of Bias and Precision of Observational Studies. Methods Research Report. (Prepared by the RTI International&#x02013;University of North Carolina Evidence-based Practice Center under Contract No. 290-2007-0056-I.) AHRQ Publication No. 11-EHC028-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2011. Available at: <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 RTI International&#x02013;University of North Carolina Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-0056-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. 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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