Blinded, randomized trial of sonographer versus AI cardiac function assessment
Artificial intelligence (AI) has been developed for echocardiography 1 – 3 , although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer in...
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| Veröffentlicht in: | Nature (London) 2023-04, Vol.616 (7957), p.520-524 |
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| creator | He, Bryan Kwan, Alan C. Cho, Jae Hyung Yuan, Neal Pollick, Charles Shiota, Takahiro Ebinger, Joseph Bello, Natalie A. Wei, Janet Josan, Kiranbir Duffy, Grant Jujjavarapu, Melvin Siegel, Robert Cheng, Susan Zou, James Y. Ouyang, David |
| description | Artificial intelligence (AI) has been developed for echocardiography
1
–
3
, although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer initial assessment of left ventricular ejection fraction (LVEF) to evaluate the impact of AI in the interpretation workflow. The primary end point was the change in the LVEF between initial AI or sonographer assessment and final cardiologist assessment, evaluated by the proportion of studies with substantial change (more than 5% change). From 3,769 echocardiographic studies screened, 274 studies were excluded owing to poor image quality. The proportion of studies substantially changed was 16.8% in the AI group and 27.2% in the sonographer group (difference of −10.4%, 95% confidence interval: −13.2% to −7.7%,
P
|
| doi_str_mv | 10.1038/s41586-023-05947-3 |
| format | Article |
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1
–
3
, although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer initial assessment of left ventricular ejection fraction (LVEF) to evaluate the impact of AI in the interpretation workflow. The primary end point was the change in the LVEF between initial AI or sonographer assessment and final cardiologist assessment, evaluated by the proportion of studies with substantial change (more than 5% change). From 3,769 echocardiographic studies screened, 274 studies were excluded owing to poor image quality. The proportion of studies substantially changed was 16.8% in the AI group and 27.2% in the sonographer group (difference of −10.4%, 95% confidence interval: −13.2% to −7.7%,
P
< 0.001 for non-inferiority,
P
< 0.001 for superiority). The mean absolute difference between final cardiologist assessment and independent previous cardiologist assessment was 6.29% in the AI group and 7.23% in the sonographer group (difference of −0.96%, 95% confidence interval: −1.34% to −0.54%,
P
< 0.001 for superiority). The AI-guided workflow saved time for both sonographers and cardiologists, and cardiologists were not able to distinguish between the initial assessments by AI versus the sonographer (blinding index of 0.088). For patients undergoing echocardiographic quantification of cardiac function, initial assessment of LVEF by AI was non-inferior to assessment by sonographers.
The impact of artificial intelligence in cardiac function assessment is evaluated by a blinded, randomized non-inferiority trial of artificial intelligence versus sonographer initial assessment of the left ventricular ejection fraction.</description><identifier>ISSN: 0028-0836</identifier><identifier>ISSN: 1476-4687</identifier><identifier>EISSN: 1476-4687</identifier><identifier>DOI: 10.1038/s41586-023-05947-3</identifier><identifier>PMID: 37020027</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308/2779/777 ; 692/700/1421/1860/1445 ; Algorithms ; Artificial intelligence ; Artificial Intelligence - standards ; Cardiac function ; Cardiologists ; Cardiology ; Clinical medicine ; Clinical trials ; Confidence intervals ; Echocardiography - methods ; Echocardiography - standards ; Evaluation ; Heart ; Heart Function Tests - methods ; Heart Function Tests - standards ; Humanities and Social Sciences ; Humans ; Image quality ; multidisciplinary ; Randomization ; Reproducibility of Results ; Science ; Science (multidisciplinary) ; Single-Blind Method ; Stroke Volume ; Ultrasonic imaging ; Ventricle ; Ventricular Function, Left ; Workflow</subject><ispartof>Nature (London), 2023-04, Vol.616 (7957), p.520-524</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><rights>Copyright Nature Publishing Group Apr 20, 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-9bc2c469c3925acc297ad98ac856bcf841390ab29eb05f96940f63b38b0a463f3</citedby><cites>FETCH-LOGICAL-c475t-9bc2c469c3925acc297ad98ac856bcf841390ab29eb05f96940f63b38b0a463f3</cites><orcidid>0000-0002-4393-1011 ; 0000-0001-8880-4764 ; 0000-0001-5782-7437 ; 0000-0002-3813-7518 ; 0000-0002-6150-761X ; 0000-0002-4977-036X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41586-023-05947-3$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41586-023-05947-3$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37020027$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>He, Bryan</creatorcontrib><creatorcontrib>Kwan, Alan C.</creatorcontrib><creatorcontrib>Cho, Jae Hyung</creatorcontrib><creatorcontrib>Yuan, Neal</creatorcontrib><creatorcontrib>Pollick, Charles</creatorcontrib><creatorcontrib>Shiota, Takahiro</creatorcontrib><creatorcontrib>Ebinger, Joseph</creatorcontrib><creatorcontrib>Bello, Natalie A.</creatorcontrib><creatorcontrib>Wei, Janet</creatorcontrib><creatorcontrib>Josan, Kiranbir</creatorcontrib><creatorcontrib>Duffy, Grant</creatorcontrib><creatorcontrib>Jujjavarapu, Melvin</creatorcontrib><creatorcontrib>Siegel, Robert</creatorcontrib><creatorcontrib>Cheng, Susan</creatorcontrib><creatorcontrib>Zou, James Y.</creatorcontrib><creatorcontrib>Ouyang, David</creatorcontrib><title>Blinded, randomized trial of sonographer versus AI cardiac function assessment</title><title>Nature (London)</title><addtitle>Nature</addtitle><addtitle>Nature</addtitle><description>Artificial intelligence (AI) has been developed for echocardiography
1
–
3
, although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer initial assessment of left ventricular ejection fraction (LVEF) to evaluate the impact of AI in the interpretation workflow. The primary end point was the change in the LVEF between initial AI or sonographer assessment and final cardiologist assessment, evaluated by the proportion of studies with substantial change (more than 5% change). From 3,769 echocardiographic studies screened, 274 studies were excluded owing to poor image quality. The proportion of studies substantially changed was 16.8% in the AI group and 27.2% in the sonographer group (difference of −10.4%, 95% confidence interval: −13.2% to −7.7%,
P
< 0.001 for non-inferiority,
P
< 0.001 for superiority). The mean absolute difference between final cardiologist assessment and independent previous cardiologist assessment was 6.29% in the AI group and 7.23% in the sonographer group (difference of −0.96%, 95% confidence interval: −1.34% to −0.54%,
P
< 0.001 for superiority). The AI-guided workflow saved time for both sonographers and cardiologists, and cardiologists were not able to distinguish between the initial assessments by AI versus the sonographer (blinding index of 0.088). For patients undergoing echocardiographic quantification of cardiac function, initial assessment of LVEF by AI was non-inferior to assessment by sonographers.
The impact of artificial intelligence in cardiac function assessment is evaluated by a blinded, randomized non-inferiority trial of artificial intelligence versus sonographer initial assessment of the left ventricular ejection fraction.</description><subject>692/308/2779/777</subject><subject>692/700/1421/1860/1445</subject><subject>Algorithms</subject><subject>Artificial intelligence</subject><subject>Artificial Intelligence - standards</subject><subject>Cardiac function</subject><subject>Cardiologists</subject><subject>Cardiology</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Echocardiography - methods</subject><subject>Echocardiography - standards</subject><subject>Evaluation</subject><subject>Heart</subject><subject>Heart Function Tests - methods</subject><subject>Heart Function Tests - standards</subject><subject>Humanities and Social Sciences</subject><subject>Humans</subject><subject>Image quality</subject><subject>multidisciplinary</subject><subject>Randomization</subject><subject>Reproducibility of Results</subject><subject>Science</subject><subject>Science (multidisciplinary)</subject><subject>Single-Blind Method</subject><subject>Stroke Volume</subject><subject>Ultrasonic imaging</subject><subject>Ventricle</subject><subject>Ventricular Function, 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randomized trial of sonographer versus AI cardiac function assessment</title><author>He, Bryan ; Kwan, Alan C. ; Cho, Jae Hyung ; Yuan, Neal ; Pollick, Charles ; Shiota, Takahiro ; Ebinger, Joseph ; Bello, Natalie A. ; Wei, Janet ; Josan, Kiranbir ; Duffy, Grant ; Jujjavarapu, Melvin ; Siegel, Robert ; Cheng, Susan ; Zou, James Y. ; Ouyang, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-9bc2c469c3925acc297ad98ac856bcf841390ab29eb05f96940f63b38b0a463f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>692/308/2779/777</topic><topic>692/700/1421/1860/1445</topic><topic>Algorithms</topic><topic>Artificial intelligence</topic><topic>Artificial Intelligence - standards</topic><topic>Cardiac function</topic><topic>Cardiologists</topic><topic>Cardiology</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Echocardiography - methods</topic><topic>Echocardiography - standards</topic><topic>Evaluation</topic><topic>Heart</topic><topic>Heart Function Tests - methods</topic><topic>Heart Function Tests - standards</topic><topic>Humanities and Social Sciences</topic><topic>Humans</topic><topic>Image quality</topic><topic>multidisciplinary</topic><topic>Randomization</topic><topic>Reproducibility of Results</topic><topic>Science</topic><topic>Science (multidisciplinary)</topic><topic>Single-Blind Method</topic><topic>Stroke Volume</topic><topic>Ultrasonic imaging</topic><topic>Ventricle</topic><topic>Ventricular Function, Left</topic><topic>Workflow</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>He, Bryan</creatorcontrib><creatorcontrib>Kwan, Alan C.</creatorcontrib><creatorcontrib>Cho, Jae Hyung</creatorcontrib><creatorcontrib>Yuan, Neal</creatorcontrib><creatorcontrib>Pollick, 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Nature (London)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>He, Bryan</au><au>Kwan, Alan C.</au><au>Cho, Jae Hyung</au><au>Yuan, Neal</au><au>Pollick, Charles</au><au>Shiota, Takahiro</au><au>Ebinger, Joseph</au><au>Bello, Natalie A.</au><au>Wei, Janet</au><au>Josan, Kiranbir</au><au>Duffy, Grant</au><au>Jujjavarapu, Melvin</au><au>Siegel, Robert</au><au>Cheng, Susan</au><au>Zou, James Y.</au><au>Ouyang, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Blinded, randomized trial of sonographer versus AI cardiac function assessment</atitle><jtitle>Nature (London)</jtitle><stitle>Nature</stitle><addtitle>Nature</addtitle><date>2023-04-20</date><risdate>2023</risdate><volume>616</volume><issue>7957</issue><spage>520</spage><epage>524</epage><pages>520-524</pages><issn>0028-0836</issn><issn>1476-4687</issn><eissn>1476-4687</eissn><abstract>Artificial intelligence (AI) has been developed for echocardiography
1
–
3
, although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer initial assessment of left ventricular ejection fraction (LVEF) to evaluate the impact of AI in the interpretation workflow. The primary end point was the change in the LVEF between initial AI or sonographer assessment and final cardiologist assessment, evaluated by the proportion of studies with substantial change (more than 5% change). From 3,769 echocardiographic studies screened, 274 studies were excluded owing to poor image quality. The proportion of studies substantially changed was 16.8% in the AI group and 27.2% in the sonographer group (difference of −10.4%, 95% confidence interval: −13.2% to −7.7%,
P
< 0.001 for non-inferiority,
P
< 0.001 for superiority). The mean absolute difference between final cardiologist assessment and independent previous cardiologist assessment was 6.29% in the AI group and 7.23% in the sonographer group (difference of −0.96%, 95% confidence interval: −1.34% to −0.54%,
P
< 0.001 for superiority). The AI-guided workflow saved time for both sonographers and cardiologists, and cardiologists were not able to distinguish between the initial assessments by AI versus the sonographer (blinding index of 0.088). For patients undergoing echocardiographic quantification of cardiac function, initial assessment of LVEF by AI was non-inferior to assessment by sonographers.
The impact of artificial intelligence in cardiac function assessment is evaluated by a blinded, randomized non-inferiority trial of artificial intelligence versus sonographer initial assessment of the left ventricular ejection fraction.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>37020027</pmid><doi>10.1038/s41586-023-05947-3</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-4393-1011</orcidid><orcidid>https://orcid.org/0000-0001-8880-4764</orcidid><orcidid>https://orcid.org/0000-0001-5782-7437</orcidid><orcidid>https://orcid.org/0000-0002-3813-7518</orcidid><orcidid>https://orcid.org/0000-0002-6150-761X</orcidid><orcidid>https://orcid.org/0000-0002-4977-036X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0028-0836 |
| ispartof | Nature (London), 2023-04, Vol.616 (7957), p.520-524 |
| issn | 0028-0836 1476-4687 1476-4687 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10115627 |
| source | MEDLINE; Nature Journals Online; SpringerLink Journals - AutoHoldings |
| subjects | 692/308/2779/777 692/700/1421/1860/1445 Algorithms Artificial intelligence Artificial Intelligence - standards Cardiac function Cardiologists Cardiology Clinical medicine Clinical trials Confidence intervals Echocardiography - methods Echocardiography - standards Evaluation Heart Heart Function Tests - methods Heart Function Tests - standards Humanities and Social Sciences Humans Image quality multidisciplinary Randomization Reproducibility of Results Science Science (multidisciplinary) Single-Blind Method Stroke Volume Ultrasonic imaging Ventricle Ventricular Function, Left Workflow |
| title | Blinded, randomized trial of sonographer versus AI cardiac function assessment |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-06T13%3A29%3A00IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Blinded,%20randomized%20trial%20of%20sonographer%20versus%20AI%20cardiac%20function%20assessment&rft.jtitle=Nature%20(London)&rft.au=He,%20Bryan&rft.date=2023-04-20&rft.volume=616&rft.issue=7957&rft.spage=520&rft.epage=524&rft.pages=520-524&rft.issn=0028-0836&rft.eissn=1476-4687&rft_id=info:doi/10.1038/s41586-023-05947-3&rft_dat=%3Cproquest_pubme%3E2797144526%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2805591029&rft_id=info:pmid/37020027&rfr_iscdi=true |