{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T02:56:09Z","timestamp":1790823369296,"version":"4.1.0"},"reference-count":31,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2022,1,4]],"date-time":"2022-01-04T00:00:00Z","timestamp":1641254400000},"content-version":"unspecified","delay-in-days":3,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"MoleMap Ltd","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Victorian Medical Research Acceleration Fund, Department of Health and Human Services, State Government of Victoria","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Convolutional neural networks (CNNs) can diagnose skin cancers with impressive accuracy in experimental settings, however, their performance in the real-world clinical setting, including comparison to teledermatology services, has not been validated in prospective clinical studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>Participants will be recruited from dermatology clinics at the Alfred Hospital and Skin Health Institute, Melbourne. Skin lesions will be imaged using a proprietary dermoscopic camera. The artificial intelligence (AI) algorithm, a CNN developed by MoleMap Ltd and Monash eResearch, classifies lesions as benign, malignant or uncertain. This is a preintervention\/postintervention study. In the preintervention period, treating doctors are blinded to AI lesion assessment. In the postintervention period, treating doctors review the AI lesion assessment in real time, and have the opportunity to then change their diagnosis and management. Any skin lesions of concern and at least two benign lesions will be selected for imaging. Each participant\u2019s lesions will be examined by a registrar, the treating consultant dermatologist and later by a teledermatologist. At the conclusion of the preintervention period, the safety of the AI algorithm will be evaluated in a primary analysis by measuring its sensitivity, specificity and agreement with histopathology where available, or the treating consultant dermatologists\u2019 classification. At trial completion, AI classifications will be compared with those of the teledermatologist, registrar, treating dermatologist and histopathology. The impact of the AI algorithm on diagnostic and management decisions will be evaluated by: (1) comparing the initial management decision of the registrar with their AI-assisted decision and (2) comparing the benign to malignant ratio (for lesions biopsied) between the preintervention and postintervention periods.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>Human Research Ethics Committee (HREC) approval received from the Alfred Hospital Ethics Committee on 14 February 2019 (HREC\/48865\/Alfred-2018). Findings from this study will be disseminated through peer-reviewed publications, non-peer reviewed media and conferences.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04040114\">NCT04040114<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2021-050203","type":"journal-article","created":{"date-parts":[[2022,1,4]],"date-time":"2022-01-04T16:49:24Z","timestamp":1641314964000},"page":"e050203","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":29,"title":["Improving Skin cancer Management with ARTificial Intelligence (SMARTI): protocol for a preintervention\/postintervention trial of an artificial intelligence system used as a diagnostic aid for skin cancer management in a specialist dermatology setting"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04040114","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3443-8065","authenticated-orcid":false,"given":"Claire","family":"Felmingham","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"MacNamara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6368-5738","authenticated-orcid":false,"given":"William","family":"Cranwell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Narelle","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6337-3619","authenticated-orcid":false,"given":"Miki","family":"Wada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7972-9050","authenticated-orcid":false,"given":"Nikki R","family":"Adler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5880-8673","authenticated-orcid":false,"given":"Zongyuan","family":"Ge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alastair","family":"Sharfe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"Bowling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3357-5826","authenticated-orcid":false,"given":"Martin","family":"Haskett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2126-1045","authenticated-orcid":false,"given":"Rory","family":"Wolfe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9423-3435","authenticated-orcid":false,"given":"Victoria","family":"Mar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,1,4]]},"reference":[{"key":"2022063004200564000_12.1.e050203.1","doi-asserted-by":"publisher","DOI":"10.5826\/dpc.0701a01"},{"key":"2022063004200564000_12.1.e050203.2","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4939-0437-2_7"},{"key":"2022063004200564000_12.1.e050203.3","doi-asserted-by":"crossref","first-page":"971","DOI":"10.1016\/S0140-6736(18)31559-9","article-title":"Melanoma","volume":"392","author":"Schadendorf","year":"2018","journal-title":"Lancet"},{"key":"2022063004200564000_12.1.e050203.4","doi-asserted-by":"publisher","DOI":"10.1111\/ajd.12282"},{"key":"2022063004200564000_12.1.e050203.5","unstructured":"Australian Institute of Health and Welfare . Cancer in Australia, 2019. https:\/\/www.aihw.gov.au\/getmedia\/8c9fcf52-0055-41a0-96d9-f81b0feb98cf\/aihw-can-123.pdf.aspx?inline=true"},{"key":"2022063004200564000_12.1.e050203.6","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1016\/j.ijwd.2016.06.004","article-title":"Patient and practitioner satisfaction with tele-dermatology including Australia's Indigenous population: a systematic review of the literature","volume":"2","author":"Kozera","year":"2016","journal-title":"Int J Womens Dermatol"},{"key":"2022063004200564000_12.1.e050203.7","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21409"},{"key":"2022063004200564000_12.1.e050203.8","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0203459","article-title":"Automated decision support in melanocytic lesion management","volume":"13","author":"Gilmore","year":"2018","journal-title":"PLoS One"},{"key":"2022063004200564000_12.1.e050203.9","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-0942-0"},{"key":"2022063004200564000_12.1.e050203.10","doi-asserted-by":"crossref","first-page":"1625","DOI":"10.1093\/annonc\/mdy193","article-title":"Artificial intelligence for melanoma diagnosis: how can we deliver on the promise?","volume":"29","author":"Mar","year":"2018","journal-title":"Ann Oncol"},{"key":"2022063004200564000_12.1.e050203.11","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-018-0300-7"},{"key":"2022063004200564000_12.1.e050203.12","doi-asserted-by":"publisher","DOI":"10.1038\/nature21056"},{"key":"2022063004200564000_12.1.e050203.13","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy166"},{"key":"2022063004200564000_12.1.e050203.14","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1001\/jamadermatol.2018.4378","article-title":"Expert-level diagnosis of nonpigmented skin cancer by combined Convolutional neural networks","volume":"155","author":"Tschandl","year":"2019","journal-title":"JAMA Dermatol"},{"key":"2022063004200564000_12.1.e050203.15","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2017.08.016"},{"key":"2022063004200564000_12.1.e050203.16","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.16924"},{"key":"2022063004200564000_12.1.e050203.17","doi-asserted-by":"crossref","first-page":"1529","DOI":"10.1016\/j.jid.2018.01.028","article-title":"Classification of the clinical images for benign and malignant cutaneous tumors using a deep learning algorithm","volume":"138","author":"Han","year":"2018","journal-title":"J Invest Dermatol"},{"key":"2022063004200564000_12.1.e050203.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2019.05.023"},{"key":"2022063004200564000_12.1.e050203.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2019.02.005"},{"key":"2022063004200564000_12.1.e050203.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2019.04.001"},{"key":"2022063004200564000_12.1.e050203.21","article-title":"Acral melanoma detection using a convolutional neural network for Dermoscopy images","volume":"13","author":"Yu","year":"2018","journal-title":"PLoS One"},{"key":"2022063004200564000_12.1.e050203.22","doi-asserted-by":"crossref","unstructured":"Du-Harpur X , Watt FM , Luscombe NM , et al . What is AI? applications of artificial intelligence to dermatology. Br J Dermatol 2020.","DOI":"10.1111\/bjd.18880"},{"key":"2022063004200564000_12.1.e050203.23","doi-asserted-by":"crossref","first-page":"2277","DOI":"10.1016\/j.jid.2018.04.040","article-title":"Automated Dermatological Diagnosis: Hype or\u00a0Reality?","volume":"138","author":"Navarrete-Dechent","year":"2018","journal-title":"J Invest Dermatol"},{"key":"2022063004200564000_12.1.e050203.24","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30333-X"},{"key":"2022063004200564000_12.1.e050203.25","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1016\/j.annonc.2019.10.013","article-title":"Man against machine reloaded: performance of a market-approved convolutional neural network in classifying a broad spectrum of skin lesions in comparison with 96 dermatologists working under less artificial conditions","volume":"31","author":"Haenssle","year":"2020","journal-title":"Ann Oncol"},{"key":"2022063004200564000_12.1.e050203.26","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m689"},{"key":"2022063004200564000_12.1.e050203.27","first-page":"627","article-title":"Receiver operating characteristic (ROC) curve analysis for medical diagnostic test evaluation","volume":"4","author":"Hajian-Tilaki","year":"2013","journal-title":"Caspian J Intern Med"},{"key":"2022063004200564000_12.1.e050203.28","unstructured":"Cancer Council Australia Keratinocyte Cancers Guideline Working Party . Clinical practice guidelines for keratinocyte cancer. Sydney: Cancer Council Australia. https:\/\/wiki.cancer.org.au\/australia\/Guidelines:Keratinocyte_carcinoma"},{"key":"2022063004200564000_12.1.e050203.29","unstructured":"Cancer Council Australia Melanoma Guidelines Working Party . Clinical practice guidelines for the diagnosis and management of melanoma. Sydney: Cancer Council Australia, 2016. https:\/\/wiki.cancer.org.au\/australia\/Guidelines:Melanoma"},{"key":"2022063004200564000_12.1.e050203.30","doi-asserted-by":"crossref","first-page":"256","DOI":"10.5694\/mja2.50759","article-title":"Use of artificial intelligence in skin cancer diagnosis and management","volume":"213","author":"Wada","year":"2020","journal-title":"Med J Aust"},{"key":"2022063004200564000_12.1.e050203.31","doi-asserted-by":"publisher","DOI":"10.2307\/2529310"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-050203","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,6,30]],"date-time":"2022-06-30T11:20:40Z","timestamp":1656588040000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-050203"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1]]},"references-count":31,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,1,4]]},"published-print":{"date-parts":[[2022,1]]}},"alternative-id":["10.1136\/bmjopen-2021-050203"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-050203","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1]]}}}