{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T20:52:47Z","timestamp":1792011167425,"version":"4.4.0"},"reference-count":35,"publisher":"Elsevier BV","issue":"9","license":[{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T00:00:00Z","timestamp":1776988800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100018952","name":"National Institute for Health and Care Research Birmingham Biomedical Research Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100018952","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","thelancet.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["The Lancet Digital Health"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1016\/j.landig.2026.101033","type":"journal-article","created":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T19:39:33Z","timestamp":1783539573000},"page":"101033","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of a target product profile for artificial intelligence in diabetic eye screening in England: a modified Delphi consensus study"],"prefix":"10.1016","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8561-0718","authenticated-orcid":false,"given":"Trystan B","family":"Macdonald","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1343-7335","authenticated-orcid":false,"given":"Jacqueline","family":"Dinnes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Maniatopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ameenat L","family":"Solebo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H D Jeffry","family":"Hogg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph E","family":"Alderman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Engelmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rhys","family":"Owen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaswath","family":"Ganapathi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Ng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1100-3049","authenticated-orcid":false,"given":"Jaspret","family":"Gill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adnan","family":"Tufail","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0369-8574","authenticated-orcid":false,"given":"Alicja","family":"Rudnicka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bethany","family":"Shinkins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6095-1639","authenticated-orcid":false,"given":"Michael","family":"Pogose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell","family":"Pearson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3198-7808","authenticated-orcid":false,"given":"Carl","family":"Macrae","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ros","family":"Given-Wilson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J Kevin","family":"Dunbar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Sutton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Attwood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Greaves","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Stratton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2355-9742","authenticated-orcid":false,"given":"John","family":"Anderson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Combes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raz","family":"Edwards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiri","family":"Fajtl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moritz","family":"Flockenhaus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Galsworthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Glocker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Holloway","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gareth","family":"Hopkin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phil","family":"Huggins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Jordan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3034-1602","authenticated-orcid":false,"given":"Alasdair","family":"McLay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Meredith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Owens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Perks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6265-0381","authenticated-orcid":false,"given":"Tunde","family":"Peto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Berit","family":"Reglar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Scanlon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-6591-6157","authenticated-orcid":false,"given":"Mark","family":"Simkin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Styles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Tongue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Wilkinson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4714-5533","authenticated-orcid":false,"given":"Gavin","family":"Quigley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sian","family":"Taylor-Philips","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoxuan","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alastair K","family":"Denniston","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.landig.2026.101033_bib1","series-title":"Fit for the future: 10 year health plan for England","year":"2025"},{"key":"10.1016\/j.landig.2026.101033_bib2","doi-asserted-by":"crossref","DOI":"10.1016\/j.eclinm.2025.103481","article-title":"Procurement and early deployment of artificial intelligence tools for chest diagnostics in NHS services in England: a rapid, mixed method evaluation","volume":"89","author":"Ramsay","year":"2025","journal-title":"EClinicalMedicine"},{"key":"10.1016\/j.landig.2026.101033_bib4","doi-asserted-by":"crossref","DOI":"10.2196\/39742","article-title":"Stakeholder perspectives of clinical artificial intelligence implementation: systematic review of qualitative evidence","volume":"25","author":"Hogg","year":"2023","journal-title":"J Med Internet Res"},{"key":"10.1016\/j.landig.2026.101033_bib5","doi-asserted-by":"crossref","DOI":"10.3389\/frhs.2025.1537016","article-title":"Target product profiles for digital health technologies including those with artificial intelligence: a systematic review","volume":"5","author":"Macdonald","year":"2025","journal-title":"Front Health Serv"},{"key":"10.1016\/j.landig.2026.101033_bib6","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1186\/s12916-020-01582-1","article-title":"Target Product Profiles for medical tests: a systematic review of current methods","volume":"18","author":"Cocco","year":"2020","journal-title":"BMC Med"},{"key":"10.1016\/j.landig.2026.101033_bib9","series-title":"Service specification no.22 - NHS Diabetic Eye Screening Programme","year":"2019"},{"key":"10.1016\/j.landig.2026.101033_bib10","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2013-004015","article-title":"A comparison of the causes of blindness certifications in England and Wales in working age adults (16\u201364 years), 1999\u20132000 with 2009\u20132010","volume":"4","author":"Liew","year":"2014","journal-title":"BMJ Open"},{"key":"10.1016\/j.landig.2026.101033_bib11","doi-asserted-by":"crossref","first-page":"515","DOI":"10.1007\/s00592-017-0974-1","article-title":"The English National Screening Programme for diabetic retinopathy 2003\u20132016","volume":"54","author":"Scanlon","year":"2017","journal-title":"Acta Diabetol"},{"key":"10.1016\/j.landig.2026.101033_bib12","doi-asserted-by":"crossref","first-page":"776","DOI":"10.1111\/j.1464-5491.2011.03504.x","article-title":"External quality assurance for image grading in the Scottish Diabetic Retinopathy Screening Programme","volume":"29","author":"Goatman","year":"2012","journal-title":"Diabet Med"},{"key":"10.1016\/j.landig.2026.101033_bib13","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3310\/hta20920","article-title":"An observational study to assess if automated diabetic retinopathy image assessment software can replace one or more steps of manual imaging grading and to determine their cost-effectiveness","volume":"20","author":"Tufail","year":"2016","journal-title":"Health Technol Assess"},{"key":"10.1016\/j.landig.2026.101033_bib14","series-title":"Automated grading in the diabetic eye screening programme","author":"Zhelev","year":"2021"},{"key":"10.1016\/j.landig.2026.101033_bib15","article-title":"Automated retinal image analysis systems to triage for grading of diabetic retinopathy: a large-scale, open-label, national screening programme in England","volume":"7","author":"Rudnicka","year":"2025","journal-title":"Lancet Digit Health"},{"key":"10.1016\/j.landig.2026.101033_bib18","doi-asserted-by":"crossref","DOI":"10.2196\/50568","article-title":"Target product profile for a machine learning-automated retinal imaging analysis software for use in English diabetic eye screening: protocol for a mixed methods study","volume":"13","author":"Macdonald","year":"2024","journal-title":"JMIR Res Protoc"},{"key":"10.1016\/j.landig.2026.101033_bib19","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1004326","article-title":"ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi","volume":"21","author":"Gattrell","year":"2024","journal-title":"PLoS Med"},{"key":"10.1016\/j.landig.2026.101033_bib20","doi-asserted-by":"crossref","DOI":"10.1016\/j.jclinepi.2024.111485","article-title":"Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilize?","volume":"174","author":"Manyara","year":"2024","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.landig.2026.101033_bib21","doi-asserted-by":"crossref","first-page":"e64","DOI":"10.1016\/S2589-7500(24)00224-3","article-title":"Tackling algorithmic bias and promoting transparency in health datasets: the STANDING Together consensus recommendations","volume":"7","author":"Alderman","year":"2025","journal-title":"Lancet Digit Health"},{"key":"10.1016\/j.landig.2026.101033_bib22","doi-asserted-by":"crossref","first-page":"e537","DOI":"10.1016\/S2589-7500(20)30218-1","article-title":"Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension","volume":"2","author":"Liu","year":"2020","journal-title":"Lancet Digit Health"},{"key":"10.1016\/j.landig.2026.101033_bib23","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1038\/s41746-025-01726-8","article-title":"A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America","volume":"8","author":"Ong","year":"2025","journal-title":"NPJ Digit Med"},{"key":"10.1016\/j.landig.2026.101033_bib26","doi-asserted-by":"crossref","DOI":"10.1016\/j.xops.2023.100293","article-title":"A datasheet for the Insight Birmingham, Solihull, and Black country diabetic retinopathy screening dataset","volume":"3","author":"Kale","year":"2023","journal-title":"Ophthalmol Sci"},{"key":"10.1016\/j.landig.2026.101033_bib28","series-title":"Medical devices: Application of usability engineering to medical devices (BS EN 62366-1:2015+A1:2020)","year":"2015"},{"key":"10.1016\/j.landig.2026.101033_bib35","doi-asserted-by":"crossref","first-page":"1168","DOI":"10.2337\/dc20-1877","article-title":"Multicenter, head-to-head, real-world validation study of seven automated artificial intelligence diabetic retinopathy screening systems","volume":"44","author":"Lee","year":"2021","journal-title":"Diabetes Care"},{"key":"10.1016\/j.landig.2026.101033_bib37","doi-asserted-by":"crossref","first-page":"3283","DOI":"10.1038\/s41591-025-03953-8","article-title":"The STARD-AI reporting guideline for diagnostic accuracy studies using artificial intelligence","volume":"31","author":"Sounderajah","year":"2025","journal-title":"Nat Med"},{"key":"10.1016\/j.landig.2026.101033_bib38","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1017\/S0266462311000717","article-title":"Linking the evidence: intermediate outcomes in medical test assessments","volume":"28","author":"Staub","year":"2012","journal-title":"Int J Technol Assess Health Care"},{"key":"10.1016\/j.landig.2026.101033_bib53","doi-asserted-by":"crossref","first-page":"1196","DOI":"10.1016\/j.jval.2024.05.006","article-title":"Consolidated Health Economic Evaluation Reporting Standards for interventions that use artificial intelligence (CHEERS-AI)","volume":"27","author":"Elvidge","year":"2024","journal-title":"Value Health"},{"key":"10.1016\/j.landig.2026.101033_bib57","article-title":"Green algorithms: quantifying the carbon footprint of computation","volume":"8","author":"Lannelongue","year":"2021","journal-title":"Adv Sci (Weinh)"},{"key":"10.1016\/j.landig.2026.101033_bib58","author":"Hooker"},{"key":"10.1016\/j.landig.2026.101033_bib65","series-title":"Regulation (EE) 2017\/745 of the European Parliament and of the Council on Medical Devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC","year":"2017"},{"key":"10.1016\/j.landig.2026.101033_bib67","author":"Clark"},{"key":"10.1016\/j.landig.2026.101033_bib73","author":"Taylor"},{"key":"10.1016\/j.landig.2026.101033_bib75","doi-asserted-by":"crossref","DOI":"10.1148\/ryai.220146","article-title":"Impact of different mammography systems on artificial intelligence performance in breast cancer screening","volume":"5","author":"de Vries","year":"2023","journal-title":"Radiol Artif Intell"},{"key":"10.1016\/j.landig.2026.101033_bib76","doi-asserted-by":"crossref","first-page":"e351","DOI":"10.1016\/S2589-7500(22)00004-8","article-title":"Validation and algorithmic audit of a deep learning system for the detection of proximal femoral fractures in patients in the emergency department: a diagnostic accuracy study","volume":"4","author":"Oakden-Rayner","year":"2022","journal-title":"Lancet Digit Health"},{"key":"10.1016\/j.landig.2026.101033_bib77","series-title":"Artificial Intelligence: how to get it right","author":"Joshi","year":"2022"},{"key":"10.1016\/j.landig.2026.101033_bib78","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1038\/s41746-020-0253-3","article-title":"Presenting machine learning model information to clinical end users with model facts labels","volume":"3","author":"Sendak","year":"2020","journal-title":"NPJ Digit Med"},{"key":"10.1016\/j.landig.2026.101033_bib86","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1016\/j.techfore.2016.01.021","article-title":"Biases in future-oriented Delphi studies: a cognitive perspective","volume":"105","author":"Winkler","year":"2016","journal-title":"Technol Forecasting Soc Change"},{"key":"10.1016\/j.landig.2026.101033_bib87","doi-asserted-by":"crossref","DOI":"10.1111\/dme.14425","article-title":"Trends in diabetic retinopathy screening attendance and associations with vision impairment attributable to diabetes in a large nationwide cohort","volume":"38","author":"Lawrenson","year":"2021","journal-title":"Diabet Med"}],"container-title":["The Lancet Digital Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589750026000567?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589750026000567?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T20:33:57Z","timestamp":1792010037000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2589750026000567"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":35,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["S2589750026000567"],"URL":"https:\/\/doi.org\/10.1016\/j.landig.2026.101033","relation":{},"ISSN":["2589-7500"],"issn-type":[{"value":"2589-7500","type":"print"}],"subject":[],"published":{"date-parts":[[2026,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Development of a target product profile for artificial intelligence in diabetic eye screening in England: a modified Delphi consensus study","name":"articletitle","label":"Article Title"},{"value":"The Lancet Digital Health","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.landig.2026.101033","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Author(s). Published by Elsevier Ltd.","name":"copyright","label":"Copyright"}],"article-number":"101033"}}