What proportion of people have a follow-up biopsy in randomized trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis
Trials of treatments for non-alcoholic steatohepatitis require endpoint assessment with liver biopsies. Previous large-scale trials have calculated their sample size expecting high retention but on average did not achieve this. We aimed to quantify the proportion of participants with a valid follow-...
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| Veröffentlicht in: | PloS one 2021-04, Vol.16 (4), p.e0250385-e0250385 |
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| creator | Koutoukidis, Dimitrios A Morris, Elizabeth Henry, John A Shammoon, Yusra Zimmerman, Matthew Michalopoulou, Moscho Jebb, Susan A Aveyard, Paul |
| description | Trials of treatments for non-alcoholic steatohepatitis require endpoint assessment with liver biopsies. Previous large-scale trials have calculated their sample size expecting high retention but on average did not achieve this. We aimed to quantify the proportion of participants with a valid follow-up biopsy.
We conducted a systematic review of MEDLINE and Embase until May 2020 and included randomized clinical trials of any intervention in non-alcoholic steatohepatitis with at least 1-year follow-up. We were guided by Cochrane methods to run a meta-analysis with generalized linear mixed models with random effects.
Forty-one trials (n = 6,695) were included. The proportion of participants with a valid follow-up biopsy was 82% (95%CI: 78%-86%, I2 = 92%). There was no evidence of a difference by location, trial length, or by allocated treatment group. Reasons for missing follow-up biopsies were, in ranked order, related to participants (95 per 1,000 participants (95%CI: 69-129, I2 = 92%), medical factors, protocol, trial conduct, and other/unclear. Biopsy-related serious adverse events occurred in 16 per 1,000 participants (95% CI: 8-33, I2 = 54%). No biopsy-related deaths were reported.
The proportion of participants with a valid follow-up biopsy in therapeutic trials in non-alcoholic steatohepatitis is on average 82%, with around 1 in 10 participants declining a follow-up biopsy. These findings can inform adequately-powered trials. |
| doi_str_mv | 10.1371/journal.pone.0250385 |
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We conducted a systematic review of MEDLINE and Embase until May 2020 and included randomized clinical trials of any intervention in non-alcoholic steatohepatitis with at least 1-year follow-up. We were guided by Cochrane methods to run a meta-analysis with generalized linear mixed models with random effects.
Forty-one trials (n = 6,695) were included. The proportion of participants with a valid follow-up biopsy was 82% (95%CI: 78%-86%, I2 = 92%). There was no evidence of a difference by location, trial length, or by allocated treatment group. Reasons for missing follow-up biopsies were, in ranked order, related to participants (95 per 1,000 participants (95%CI: 69-129, I2 = 92%), medical factors, protocol, trial conduct, and other/unclear. Biopsy-related serious adverse events occurred in 16 per 1,000 participants (95% CI: 8-33, I2 = 54%). No biopsy-related deaths were reported.
The proportion of participants with a valid follow-up biopsy in therapeutic trials in non-alcoholic steatohepatitis is on average 82%, with around 1 in 10 participants declining a follow-up biopsy. These findings can inform adequately-powered trials.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0250385</identifier><identifier>PMID: 33882107</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Bias ; Biology and Life Sciences ; Biomedical research ; Biopsy ; Care and treatment ; Clinical trials ; Confidence intervals ; Diet ; Dietary supplements ; Editing ; Fatty liver ; Fibrosis ; Funding ; Health care ; Health risks ; Health sciences ; Hospitals ; Liver ; Liver diseases ; Medical science ; Medicine and Health Sciences ; Meta-analysis ; Methodology ; Patients ; Physical Sciences ; Placebos ; Primary care ; Prognosis ; Reimbursement ; Research and Analysis Methods ; Research facilities ; Systematic review ; Weight control</subject><ispartof>PloS one, 2021-04, Vol.16 (4), p.e0250385-e0250385</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Koutoukidis et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Koutoukidis et al 2021 Koutoukidis et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-d95fd8f2c48ec8cc158cb9c674139c9441f176756754105195d92b769e6e62e23</citedby><cites>FETCH-LOGICAL-c692t-d95fd8f2c48ec8cc158cb9c674139c9441f176756754105195d92b769e6e62e23</cites><orcidid>0000-0002-1955-7234 ; 0000-0002-1802-4217 ; 0000-0002-7650-0963</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059856/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059856/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2100,2919,23857,27915,27916,53782,53784,79361,79362</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33882107$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Huang, Jee-Fu</contributor><creatorcontrib>Koutoukidis, Dimitrios A</creatorcontrib><creatorcontrib>Morris, Elizabeth</creatorcontrib><creatorcontrib>Henry, John A</creatorcontrib><creatorcontrib>Shammoon, Yusra</creatorcontrib><creatorcontrib>Zimmerman, Matthew</creatorcontrib><creatorcontrib>Michalopoulou, Moscho</creatorcontrib><creatorcontrib>Jebb, Susan A</creatorcontrib><creatorcontrib>Aveyard, Paul</creatorcontrib><title>What proportion of people have a follow-up biopsy in randomized trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Trials of treatments for non-alcoholic steatohepatitis require endpoint assessment with liver biopsies. Previous large-scale trials have calculated their sample size expecting high retention but on average did not achieve this. We aimed to quantify the proportion of participants with a valid follow-up biopsy.
We conducted a systematic review of MEDLINE and Embase until May 2020 and included randomized clinical trials of any intervention in non-alcoholic steatohepatitis with at least 1-year follow-up. We were guided by Cochrane methods to run a meta-analysis with generalized linear mixed models with random effects.
Forty-one trials (n = 6,695) were included. The proportion of participants with a valid follow-up biopsy was 82% (95%CI: 78%-86%, I2 = 92%). There was no evidence of a difference by location, trial length, or by allocated treatment group. Reasons for missing follow-up biopsies were, in ranked order, related to participants (95 per 1,000 participants (95%CI: 69-129, I2 = 92%), medical factors, protocol, trial conduct, and other/unclear. Biopsy-related serious adverse events occurred in 16 per 1,000 participants (95% CI: 8-33, I2 = 54%). No biopsy-related deaths were reported.
The proportion of participants with a valid follow-up biopsy in therapeutic trials in non-alcoholic steatohepatitis is on average 82%, with around 1 in 10 participants declining a follow-up biopsy. These findings can inform adequately-powered trials.</description><subject>Bias</subject><subject>Biology and Life Sciences</subject><subject>Biomedical research</subject><subject>Biopsy</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Diet</subject><subject>Dietary supplements</subject><subject>Editing</subject><subject>Fatty liver</subject><subject>Fibrosis</subject><subject>Funding</subject><subject>Health care</subject><subject>Health risks</subject><subject>Health sciences</subject><subject>Hospitals</subject><subject>Liver</subject><subject>Liver diseases</subject><subject>Medical science</subject><subject>Medicine and Health Sciences</subject><subject>Meta-analysis</subject><subject>Methodology</subject><subject>Patients</subject><subject>Physical Sciences</subject><subject>Placebos</subject><subject>Primary care</subject><subject>Prognosis</subject><subject>Reimbursement</subject><subject>Research 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proportion of people have a follow-up biopsy in randomized trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis</title><author>Koutoukidis, Dimitrios A ; Morris, Elizabeth ; Henry, John A ; Shammoon, Yusra ; Zimmerman, Matthew ; Michalopoulou, Moscho ; Jebb, Susan A ; Aveyard, Paul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-d95fd8f2c48ec8cc158cb9c674139c9441f176756754105195d92b769e6e62e23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Bias</topic><topic>Biology and Life Sciences</topic><topic>Biomedical research</topic><topic>Biopsy</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Diet</topic><topic>Dietary supplements</topic><topic>Editing</topic><topic>Fatty liver</topic><topic>Fibrosis</topic><topic>Funding</topic><topic>Health care</topic><topic>Health 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trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-04-21</date><risdate>2021</risdate><volume>16</volume><issue>4</issue><spage>e0250385</spage><epage>e0250385</epage><pages>e0250385-e0250385</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Trials of treatments for non-alcoholic steatohepatitis require endpoint assessment with liver biopsies. Previous large-scale trials have calculated their sample size expecting high retention but on average did not achieve this. We aimed to quantify the proportion of participants with a valid follow-up biopsy.
We conducted a systematic review of MEDLINE and Embase until May 2020 and included randomized clinical trials of any intervention in non-alcoholic steatohepatitis with at least 1-year follow-up. We were guided by Cochrane methods to run a meta-analysis with generalized linear mixed models with random effects.
Forty-one trials (n = 6,695) were included. The proportion of participants with a valid follow-up biopsy was 82% (95%CI: 78%-86%, I2 = 92%). There was no evidence of a difference by location, trial length, or by allocated treatment group. Reasons for missing follow-up biopsies were, in ranked order, related to participants (95 per 1,000 participants (95%CI: 69-129, I2 = 92%), medical factors, protocol, trial conduct, and other/unclear. Biopsy-related serious adverse events occurred in 16 per 1,000 participants (95% CI: 8-33, I2 = 54%). No biopsy-related deaths were reported.
The proportion of participants with a valid follow-up biopsy in therapeutic trials in non-alcoholic steatohepatitis is on average 82%, with around 1 in 10 participants declining a follow-up biopsy. These findings can inform adequately-powered trials.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33882107</pmid><doi>10.1371/journal.pone.0250385</doi><tpages>e0250385</tpages><orcidid>https://orcid.org/0000-0002-1955-7234</orcidid><orcidid>https://orcid.org/0000-0002-1802-4217</orcidid><orcidid>https://orcid.org/0000-0002-7650-0963</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Bias Biology and Life Sciences Biomedical research Biopsy Care and treatment Clinical trials Confidence intervals Diet Dietary supplements Editing Fatty liver Fibrosis Funding Health care Health risks Health sciences Hospitals Liver Liver diseases Medical science Medicine and Health Sciences Meta-analysis Methodology Patients Physical Sciences Placebos Primary care Prognosis Reimbursement Research and Analysis Methods Research facilities Systematic review Weight control |
| title | What proportion of people have a follow-up biopsy in randomized trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-14T20%3A39%3A14IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=What%20proportion%20of%20people%20have%20a%20follow-up%20biopsy%20in%20randomized%20trials%20of%20treatments%20for%20non-alcoholic%20steatohepatitis?:%20A%20systematic%20review%20and%20meta-analysis&rft.jtitle=PloS%20one&rft.au=Koutoukidis,%20Dimitrios%20A&rft.date=2021-04-21&rft.volume=16&rft.issue=4&rft.spage=e0250385&rft.epage=e0250385&rft.pages=e0250385-e0250385&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0250385&rft_dat=%3Cgale_plos_%3EA659212277%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2516205737&rft_id=info:pmid/33882107&rft_galeid=A659212277&rft_doaj_id=oai_doaj_org_article_770ec1e5787e42cdb147a45e5bc731e6&rfr_iscdi=true |