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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="author" content="Michelle B. Leavy, Claudia Schur, Ferhat Q. Kassamali, Margaret Edder Johnson, Raj Sabharwal, Paul Wallace, Richard E. Gliklich" /><meta name="citation_title" content="Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned" /><meta name="citation_publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="citation_date" content="2019/02" /><meta name="citation_author" content="Michelle B. Leavy" /><meta name="citation_author" content="Claudia Schur" /><meta name="citation_author" content="Ferhat Q. Kassamali" /><meta name="citation_author" content="Margaret Edder Johnson" /><meta name="citation_author" content="Raj Sabharwal" /><meta name="citation_author" content="Paul Wallace" /><meta name="citation_author" content="Richard E. Gliklich" /><meta name="citation_pmid" content="31573773" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK547134/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="Agency for Healthcare Research and Quality (US)" /><meta name="DC.Contributor" content="Michelle B. Leavy" /><meta name="DC.Contributor" content="Claudia Schur" /><meta name="DC.Contributor" content="Ferhat Q. Kassamali" /><meta name="DC.Contributor" content="Margaret Edder Johnson" /><meta name="DC.Contributor" content="Raj Sabharwal" /><meta name="DC.Contributor" content="Paul Wallace" /><meta name="DC.Contributor" content="Richard E. Gliklich" /><meta name="DC.Date" content="2019/02" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK547134/" /><meta name="description" content="Significant variation exists in both the types and definitions of outcome measures used in patient registries, even within the same clinical area. This variation, makes it difficult to compare, link, and aggregate data across a range of registries reflective of the spectrum of clinical care and reporting, thus reducing the potential utility of registry data. To address these limitations, the Agency for Healthcare Research and Quality (AHRQ) developed the Outcome Measures Framework (OMF), a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions; it is intended to serve as a content model for developing harmonized outcome measures for specific clinical areas." /><meta name="og:title" content="Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned" /><meta name="og:type" content="book" /><meta name="og:description" content="Significant variation exists in both the types and definitions of outcome measures used in patient registries, even within the same clinical area. This variation, makes it difficult to compare, link, and aggregate data across a range of registries reflective of the spectrum of clinical care and reporting, thus reducing the potential utility of registry data. To address these limitations, the Agency for Healthcare Research and Quality (AHRQ) developed the Outcome Measures Framework (OMF), a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions; it is intended to serve as a content model for developing harmonized outcome measures for specific clinical areas." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK547134/" /><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-methresharmonized-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/methresharmonized/toc/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK547134/" /><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/methresharmonized/preface1/" 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-methresharmonized-lrg.png" alt="Cover of Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned" /></a><div class="icnblk_cntnt"><h1 id="_NBK547134_"><span itemprop="name">Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned</span></h1><p><i>Research White Paper</i></p><p class="contrib-group">Investigators: <span itemprop="author">Michelle B. Leavy</span>, MPH, <span itemprop="author">Claudia Schur</span>, PhD, <span itemprop="author">Ferhat Q. Kassamali</span>, MSc, MPH, <span itemprop="author">Margaret Edder Johnson</span>, MBA, <span itemprop="author">Raj Sabharwal</span>, MPH, <span itemprop="author">Paul Wallace</span>, MD, and <span itemprop="author">Richard E. Gliklich</span>, MD.</p><a data-jig="ncbitoggler" href="#__NBK547134_ai__" style="border:0;text-decoration:none">Author Information and Affiliations</a><div style="display:none" class="ui-widget" id="__NBK547134_ai__"><p class="contrib-group"><h4>Authors</h4>Investigators: <span itemprop="author">Michelle B. Leavy</span>, MPH,<sup>1</sup> <span itemprop="author">Claudia Schur</span>, PhD,<sup>2</sup> <span itemprop="author">Ferhat Q. Kassamali</span>, MSc, MPH,<sup>2</sup> <span itemprop="author">Margaret Edder Johnson</span>, MBA,<sup>2</sup> <span itemprop="author">Raj Sabharwal</span>, MPH,<sup>3</sup> <span itemprop="author">Paul Wallace</span>, MD,<sup>3</sup> and <span itemprop="author">Richard E. Gliklich</span>, MD<sup>1</sup>.</p><h4>Affiliations</h4><div class="affiliation"><sup>1</sup> OM1, Inc.</div><div class="affiliation"><sup>2</sup> L&#x00026;M Policy Research, LLC</div><div class="affiliation"><sup>3</sup> AcademyHealth</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">2019 Feb</span>.<div class="small">Report No.: 19-EHC008-EF</div></div><div class="half_rhythm"><ul class="inline_list"><li><span class="label"><a data-jig="ncbidialog" href="#_ncbi_dlg_cpyrght_NBK547134" data-jigconfig="modal:true">Copyright and
Permissions</a></span></li></ul></div><div id="_ncbi_dlg_cpyrght_NBK547134" 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/methresharmonized/" 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"><p>Significant variation exists in both the types and definitions of outcome measures used in patient registries, even within the same clinical area. This variation, makes it difficult to compare, link, and aggregate data across a range of registries reflective of the spectrum of clinical care and reporting, thus reducing the potential utility of registry data. To address these limitations, the Agency for Healthcare Research and Quality (<a class="def" href="/books/n/methresharmonized/gl1/def-item/abb_DL1_DI1/">AHRQ</a>) developed the Outcome Measures Framework (<a class="def" href="/books/n/methresharmonized/gl1/def-item/abb_DL1_DI36/">OMF</a>), a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions; it is intended to serve as a content model for developing harmonized outcome measures for specific clinical areas.</p><p>This report describes the process developed and used by the project team to assess the overall feasibility of using the <a class="def" href="/books/n/methresharmonized/gl1/def-item/abb_DL1_DI36/">OMF</a> to develop standardized libraries of outcome measures, including the selection of clinical areas, recruitment of the registry and stakeholder workgroups, methodology for harmonizing outcome measures, and approach to creating standardized data definitions. The report also discusses the results from each clinical workgroup, as well as the lessons learned from each phase of the project. The final section of the report includes recommendations for future work to expand beyond the feasibility-testing stage.</p></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_tllNBK547134_toc_preface1" class="simple-list toc toc-toggle"><li class="half_rhythm" id="toc_itm_NBK547134_toc_preface1"><a class="toc-item" href="/books/n/methresharmonized/preface1/">Preface</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch1"><a class="toc-item" href="/books/n/methresharmonized/ch1/">Executive Summary</a><ul id="toc_lst_NBK547134_toc_ch1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch1_s1"><a class="toc-item" href="/books/n/methresharmonized/ch1/#ch1.s1">Challenges and Lessons Learned</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch1_s2"><a class="toc-item" href="/books/n/methresharmonized/ch1/#ch1.s2">Next Steps</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch2"><a class="toc-item" href="/books/n/methresharmonized/ch2/">Introduction</a><ul id="toc_lst_NBK547134_toc_ch2" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch2_s1"><a class="toc-item" href="/books/n/methresharmonized/ch2/#ch2.s1">Project Overview</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch2_s2"><a class="toc-item" href="/books/n/methresharmonized/ch2/#ch2.s2">Background and Rationale</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3"><a class="toc-item" href="/books/n/methresharmonized/ch3/">Key Project Activities</a><ul id="toc_lst_NBK547134_toc_ch3" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s1"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s1">Selection of Clinical Areas</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s2"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s2">Considerations for Selection</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s3"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s3">Compiling Information on Potential Clinical Areas</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s4"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s4">Identifying Registries Within Clinical Areas</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s5"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s5">Engaging Registries and Other Stakeholders</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s6"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s6">Convening Registry and Stakeholder Workgroups</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s7"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s7">Identification and Categorization of Outcome Measures</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s8"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s8">Collection of Outcome Measures</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s9"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s9">Comparison of Outcome Measures Across Sources</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s10"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s10">Refining Minimum Measure Sets and Harmonization</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s11"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s11">Defining Participant, Provider, and Disease Characteristics</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s12"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s12">Defining Treatments</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s13"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s13">Data Element Development: Measure Definitions and Data Element Descriptions</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s14"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s14">Development of Standardized Terminologies</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s15"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s15">Leveraging Existing Resources</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch3_s16"><a class="toc-item" href="/books/n/methresharmonized/ch3/#ch3.s16">Public Comment</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch4"><a class="toc-item" href="/books/n/methresharmonized/ch4/">Challenges and Lessons Learned</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch5"><a class="toc-item" href="/books/n/methresharmonized/ch5/">Next Steps</a><ul id="toc_lst_NBK547134_toc_ch5" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch5_s1"><a class="toc-item" href="/books/n/methresharmonized/ch5/#ch5.s1">Implementation</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch5_s2"><a class="toc-item" href="/books/n/methresharmonized/ch5/#ch5.s2">Dissemination</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch5_s3"><a class="toc-item" href="/books/n/methresharmonized/ch5/#ch5.s3">Ongoing Governance</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_ch5_s4"><a class="toc-item" href="/books/n/methresharmonized/ch5/#ch5.s4">Additional Clinical Areas</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_rl_r1"><a class="toc-item" href="/books/n/methresharmonized/rl.r1/">References</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_gl1"><a class="toc-item" href="/books/n/methresharmonized/gl1/">Abbreviations</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_appendixesappgroup1"><a class="toc-item" href="/books/n/methresharmonized/appendixesappgroup1/">Appendixes</a><ul id="toc_lst_NBK547134_toc_appendixesappgroup1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK547134_toc_appa"><a class="toc-item" href="/books/n/methresharmonized/appa/">Appendix A. Proposed Clinical Areas</a></li><li class="half_rhythm" id="toc_itm_NBK547134_toc_appb"><a class="toc-item" href="/books/n/methresharmonized/appb/">Appendix B. Registry and Stakeholder Participants</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><b>Prepared for:</b> Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857; <a href="http://www.ahrq.gov" ref="pagearea=meta&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">www.ahrq.gov</a>
<b>Contract No. 290-2014-0004-C Prepared by:</b> L&#x00026;M Policy Research, LLC, Washington, DC 20009; <i>With partners: OM1, AcademyHealth</i></div><div><h4 class="inline">Suggested citation:</h4><p>Leavy MB, Schur C, Kassamali FQ, Johnson ME, Sabharwal R, Wallace P, Gliklich RE. Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned. Final Report. (Prepared by L&#x00026;M Policy Research, LLC under Contract No. 290-2014-00004-C) AHRQ Publication No. 19-EHC008-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2019. Posted final reports are located on the Effective Health Care Program <a href="https://effectivehealthcare.ahrq.gov/search?f%5B0%5D=field_product_type%3Aresearch_report&#x00026;f%5B1%5D=field_product_type%3Asystematic_review&#x00026;f%5B2%5D=field_product_type%3Atechnical_brief&#x00026;f%5B3%5D=field_product_type%3Awhite_paper&#x00026;f%5B4%5D=field_product_type%3Amethods_guide_chapter&#x00026;sort_by=field_product_pub_date" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">search page</a>. DOI: https://doi.org/<a href="http://dx.crossref.org/10.23970/AHRQEPCLIBRARYFINALREPORT" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">10.23970/AHRQEPCLIBRARYFINALREPORT</a>.</p></div><div><p>This report is based on research conducted by the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers&#x02019; Methods Workgroup. This work was supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement #16-566R-16. The findings and conclusions in this document are those of the authors, 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><b>None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.</b></p><p>The information in this report is intended to help EPCs and AHRQ understand health-systems need and use of evidence to inform their decision making. 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 is made available to the public under the terms of a licensing agreement between the authors and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.</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>Persons using assistive technology may not be able to fully access information in this report. For assistance contact <a href="mailto:dev@null" data-email="vog.shh.qrha@cpe" class="oemail">vog.shh.qrha@cpe</a>.</p></div></div></div>
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Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned [Internet]. 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