Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease

Summary Background Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn’s disease (CD). However, there is no widely accepted luminal disease activity index. Aims To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and in...

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Veröffentlicht in:Alimentary pharmacology & therapeutics 2021-04, Vol.53 (8), p.873-886
Hauptverfasser: Goodsall, Thomas M., Jairath, Vipul, Feagan, Brian G., Parker, Claire E., Nguyen, Tran M., Guizzetti, Leonardo, Asthana, Anil K., Begun, Jakob, Christensen, Britt, Friedman, Antony B., Kucharzik, Torsten, Lee, Andrew, Lewindon, Peter J., Maaser, Christian, Novak, Kerri L., Rimola, Jordi, Taylor, Kirstin M., Taylor, Stuart A., White, Lauren S., Wilkens, Rune, Wilson, Stephanie R., Wright, Emily K., Bryant, Robert V., Ma, Christopher
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container_issue 8
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container_title Alimentary pharmacology & therapeutics
container_volume 53
creator Goodsall, Thomas M.
Jairath, Vipul
Feagan, Brian G.
Parker, Claire E.
Nguyen, Tran M.
Guizzetti, Leonardo
Asthana, Anil K.
Begun, Jakob
Christensen, Britt
Friedman, Antony B.
Kucharzik, Torsten
Lee, Andrew
Lewindon, Peter J.
Maaser, Christian
Novak, Kerri L.
Rimola, Jordi
Taylor, Kirstin M.
Taylor, Stuart A.
White, Lauren S.
Wilkens, Rune
Wilson, Stephanie R.
Wright, Emily K.
Bryant, Robert V.
Ma, Christopher
description Summary Background Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn’s disease (CD). However, there is no widely accepted luminal disease activity index. Aims To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. Methods An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1‐9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, >3.5 to
doi_str_mv 10.1111/apt.16288
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However, there is no widely accepted luminal disease activity index. Aims To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. Methods An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1‐9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, &gt;3.5 to &lt;6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting. Results A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions. Conclusions The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed. This study employed a modified RAND/UCLA appropriateness methodology to define an evidence‐based approach to standardise IUS assessment of luminal CD activity and determine areas of uncertainty and inconsistency of practice. These results will be used to inform future studies whose ultimate goals include the development and validation of an IUS‐based CD activity score for implementation in clinical trials and clinical practice.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/apt.16288</identifier><identifier>PMID: 33641221</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adult ; Child ; Clinical trials ; Crohn Disease - diagnostic imaging ; Crohn's disease ; Humans ; Inflammation ; Inflammatory bowel diseases ; Intestine ; Intestines ; Literature reviews ; Reference Standards ; Remission ; Ultrasonic imaging ; Ultrasonography ; Ultrasound</subject><ispartof>Alimentary pharmacology &amp; therapeutics, 2021-04, Vol.53 (8), p.873-886</ispartof><rights>2021 John Wiley &amp; Sons Ltd</rights><rights>2021 John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2021 John Wiley &amp; Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3538-c91f437a28ecebaab08dc63f4a9b6d79fba6108ed01a99d70c898d2b560650fe3</citedby><cites>FETCH-LOGICAL-c3538-c91f437a28ecebaab08dc63f4a9b6d79fba6108ed01a99d70c898d2b560650fe3</cites><orcidid>0000-0002-8587-5441 ; 0000-0001-8603-898X ; 0000-0003-3945-8134 ; 0000-0002-4928-4708 ; 0000-0002-8106-1280 ; 0000-0002-6914-3822 ; 0000-0002-4698-9948 ; 0000-0003-4164-7321 ; 0000-0002-8746-4275 ; 0000-0002-1814-4198</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fapt.16288$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapt.16288$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33641221$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Goodsall, Thomas M.</creatorcontrib><creatorcontrib>Jairath, Vipul</creatorcontrib><creatorcontrib>Feagan, Brian G.</creatorcontrib><creatorcontrib>Parker, Claire E.</creatorcontrib><creatorcontrib>Nguyen, Tran M.</creatorcontrib><creatorcontrib>Guizzetti, Leonardo</creatorcontrib><creatorcontrib>Asthana, Anil K.</creatorcontrib><creatorcontrib>Begun, Jakob</creatorcontrib><creatorcontrib>Christensen, Britt</creatorcontrib><creatorcontrib>Friedman, Antony B.</creatorcontrib><creatorcontrib>Kucharzik, Torsten</creatorcontrib><creatorcontrib>Lee, Andrew</creatorcontrib><creatorcontrib>Lewindon, Peter J.</creatorcontrib><creatorcontrib>Maaser, Christian</creatorcontrib><creatorcontrib>Novak, Kerri L.</creatorcontrib><creatorcontrib>Rimola, Jordi</creatorcontrib><creatorcontrib>Taylor, Kirstin M.</creatorcontrib><creatorcontrib>Taylor, Stuart A.</creatorcontrib><creatorcontrib>White, Lauren S.</creatorcontrib><creatorcontrib>Wilkens, Rune</creatorcontrib><creatorcontrib>Wilson, Stephanie R.</creatorcontrib><creatorcontrib>Wright, Emily K.</creatorcontrib><creatorcontrib>Bryant, Robert V.</creatorcontrib><creatorcontrib>Ma, Christopher</creatorcontrib><title>Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease</title><title>Alimentary pharmacology &amp; therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary Background Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn’s disease (CD). However, there is no widely accepted luminal disease activity index. Aims To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. Methods An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1‐9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, &gt;3.5 to &lt;6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting. Results A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions. Conclusions The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed. This study employed a modified RAND/UCLA appropriateness methodology to define an evidence‐based approach to standardise IUS assessment of luminal CD activity and determine areas of uncertainty and inconsistency of practice. These results will be used to inform future studies whose ultimate goals include the development and validation of an IUS‐based CD activity score for implementation in clinical trials and clinical practice.</description><subject>Adult</subject><subject>Child</subject><subject>Clinical trials</subject><subject>Crohn Disease - diagnostic imaging</subject><subject>Crohn's disease</subject><subject>Humans</subject><subject>Inflammation</subject><subject>Inflammatory bowel diseases</subject><subject>Intestine</subject><subject>Intestines</subject><subject>Literature reviews</subject><subject>Reference Standards</subject><subject>Remission</subject><subject>Ultrasonic imaging</subject><subject>Ultrasonography</subject><subject>Ultrasound</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10MtKAzEUBuAgiq3VhS8gA250MTaXmTRZSvEGgoJ1PZxJMhqZJjWZQbrzNXw9n8TYVheC2WRxvvzk_AgdEnxG0hnDojsjnAqxhYaE8TKnmPFtNMSUy5wKwgZoL8YXjDGfYLqLBozxglBKhggeOnAagrYROutd5pvMus7Ezjpos77tAkTfO51F5YN1T2maqdY6q9K4CxbamDU-ZG0_X72YBv_sPt8_YpYiDUSzj3aahMzB5h6hx8uL2fQ6v727upme3-aKlUzkSpKmYBOgwihTA9RYaMVZU4CsuZ7IpgZOsDAaE5BST7ASUmhalxzzEjeGjdDJOncR_GufFqjmNirTtuCM72NFC1kIUWIhEj3-Q198H9LvkyqxpExyViR1ulYq-BiDaapFsHMIy4rg6rv3KvVerXpP9miT2Ndzo3_lT9EJjNfgzbZm-X9SdX4_W0d-AX7yjo8</recordid><startdate>202104</startdate><enddate>202104</enddate><creator>Goodsall, Thomas M.</creator><creator>Jairath, Vipul</creator><creator>Feagan, Brian G.</creator><creator>Parker, Claire E.</creator><creator>Nguyen, Tran M.</creator><creator>Guizzetti, Leonardo</creator><creator>Asthana, Anil K.</creator><creator>Begun, Jakob</creator><creator>Christensen, Britt</creator><creator>Friedman, Antony B.</creator><creator>Kucharzik, Torsten</creator><creator>Lee, Andrew</creator><creator>Lewindon, Peter J.</creator><creator>Maaser, Christian</creator><creator>Novak, Kerri L.</creator><creator>Rimola, Jordi</creator><creator>Taylor, Kirstin M.</creator><creator>Taylor, Stuart A.</creator><creator>White, Lauren S.</creator><creator>Wilkens, Rune</creator><creator>Wilson, Stephanie R.</creator><creator>Wright, Emily K.</creator><creator>Bryant, Robert V.</creator><creator>Ma, Christopher</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>H94</scope><scope>M7N</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-8587-5441</orcidid><orcidid>https://orcid.org/0000-0001-8603-898X</orcidid><orcidid>https://orcid.org/0000-0003-3945-8134</orcidid><orcidid>https://orcid.org/0000-0002-4928-4708</orcidid><orcidid>https://orcid.org/0000-0002-8106-1280</orcidid><orcidid>https://orcid.org/0000-0002-6914-3822</orcidid><orcidid>https://orcid.org/0000-0002-4698-9948</orcidid><orcidid>https://orcid.org/0000-0003-4164-7321</orcidid><orcidid>https://orcid.org/0000-0002-8746-4275</orcidid><orcidid>https://orcid.org/0000-0002-1814-4198</orcidid></search><sort><creationdate>202104</creationdate><title>Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease</title><author>Goodsall, Thomas M. ; Jairath, Vipul ; Feagan, Brian G. ; Parker, Claire E. ; Nguyen, Tran M. ; Guizzetti, Leonardo ; Asthana, Anil K. ; Begun, Jakob ; Christensen, Britt ; Friedman, Antony B. ; Kucharzik, Torsten ; Lee, Andrew ; Lewindon, Peter J. ; Maaser, Christian ; Novak, Kerri L. ; Rimola, Jordi ; Taylor, Kirstin M. ; Taylor, Stuart A. ; White, Lauren S. ; Wilkens, Rune ; Wilson, Stephanie R. ; Wright, Emily K. ; Bryant, Robert V. ; Ma, Christopher</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3538-c91f437a28ecebaab08dc63f4a9b6d79fba6108ed01a99d70c898d2b560650fe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Child</topic><topic>Clinical trials</topic><topic>Crohn Disease - diagnostic imaging</topic><topic>Crohn's disease</topic><topic>Humans</topic><topic>Inflammation</topic><topic>Inflammatory bowel diseases</topic><topic>Intestine</topic><topic>Intestines</topic><topic>Literature reviews</topic><topic>Reference Standards</topic><topic>Remission</topic><topic>Ultrasonic imaging</topic><topic>Ultrasonography</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Goodsall, Thomas M.</creatorcontrib><creatorcontrib>Jairath, Vipul</creatorcontrib><creatorcontrib>Feagan, Brian G.</creatorcontrib><creatorcontrib>Parker, Claire E.</creatorcontrib><creatorcontrib>Nguyen, Tran M.</creatorcontrib><creatorcontrib>Guizzetti, Leonardo</creatorcontrib><creatorcontrib>Asthana, Anil K.</creatorcontrib><creatorcontrib>Begun, Jakob</creatorcontrib><creatorcontrib>Christensen, Britt</creatorcontrib><creatorcontrib>Friedman, Antony B.</creatorcontrib><creatorcontrib>Kucharzik, Torsten</creatorcontrib><creatorcontrib>Lee, Andrew</creatorcontrib><creatorcontrib>Lewindon, Peter J.</creatorcontrib><creatorcontrib>Maaser, Christian</creatorcontrib><creatorcontrib>Novak, Kerri L.</creatorcontrib><creatorcontrib>Rimola, Jordi</creatorcontrib><creatorcontrib>Taylor, Kirstin M.</creatorcontrib><creatorcontrib>Taylor, Stuart A.</creatorcontrib><creatorcontrib>White, Lauren S.</creatorcontrib><creatorcontrib>Wilkens, Rune</creatorcontrib><creatorcontrib>Wilson, Stephanie R.</creatorcontrib><creatorcontrib>Wright, Emily K.</creatorcontrib><creatorcontrib>Bryant, Robert V.</creatorcontrib><creatorcontrib>Ma, Christopher</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology &amp; therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Goodsall, Thomas M.</au><au>Jairath, Vipul</au><au>Feagan, Brian G.</au><au>Parker, Claire E.</au><au>Nguyen, Tran M.</au><au>Guizzetti, Leonardo</au><au>Asthana, Anil K.</au><au>Begun, Jakob</au><au>Christensen, Britt</au><au>Friedman, Antony B.</au><au>Kucharzik, Torsten</au><au>Lee, Andrew</au><au>Lewindon, Peter J.</au><au>Maaser, Christian</au><au>Novak, Kerri L.</au><au>Rimola, Jordi</au><au>Taylor, Kirstin M.</au><au>Taylor, Stuart A.</au><au>White, Lauren S.</au><au>Wilkens, Rune</au><au>Wilson, Stephanie R.</au><au>Wright, Emily K.</au><au>Bryant, Robert V.</au><au>Ma, Christopher</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease</atitle><jtitle>Alimentary pharmacology &amp; therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2021-04</date><risdate>2021</risdate><volume>53</volume><issue>8</issue><spage>873</spage><epage>886</epage><pages>873-886</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary Background Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn’s disease (CD). However, there is no widely accepted luminal disease activity index. Aims To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. Methods An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1‐9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, &gt;3.5 to &lt;6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting. Results A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions. Conclusions The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed. This study employed a modified RAND/UCLA appropriateness methodology to define an evidence‐based approach to standardise IUS assessment of luminal CD activity and determine areas of uncertainty and inconsistency of practice. These results will be used to inform future studies whose ultimate goals include the development and validation of an IUS‐based CD activity score for implementation in clinical trials and clinical practice.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>33641221</pmid><doi>10.1111/apt.16288</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0002-8587-5441</orcidid><orcidid>https://orcid.org/0000-0001-8603-898X</orcidid><orcidid>https://orcid.org/0000-0003-3945-8134</orcidid><orcidid>https://orcid.org/0000-0002-4928-4708</orcidid><orcidid>https://orcid.org/0000-0002-8106-1280</orcidid><orcidid>https://orcid.org/0000-0002-6914-3822</orcidid><orcidid>https://orcid.org/0000-0002-4698-9948</orcidid><orcidid>https://orcid.org/0000-0003-4164-7321</orcidid><orcidid>https://orcid.org/0000-0002-8746-4275</orcidid><orcidid>https://orcid.org/0000-0002-1814-4198</orcidid></addata></record>
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subjects Adult
Child
Clinical trials
Crohn Disease - diagnostic imaging
Crohn's disease
Humans
Inflammation
Inflammatory bowel diseases
Intestine
Intestines
Literature reviews
Reference Standards
Remission
Ultrasonic imaging
Ultrasonography
Ultrasound
title Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease
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