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      Establishing key research questions for the implementation of artificial intelligence in colonoscopy: a modified Delphi method

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          Abstract

          Background  Artificial intelligence (AI) research in colonoscopy is progressing rapidly but widespread clinical implementation is not yet a reality. We aimed to identify the top implementation research priorities.

          Methods  An established modified Delphi approach for research priority setting was used. Fifteen international experts, including endoscopists and translational computer scientists/engineers, from nine countries participated in an online survey over 9 months. Questions related to AI implementation in colonoscopy were generated as a long-list in the first round, and then scored in two subsequent rounds to identify the top 10 research questions.

          Results  The top 10 ranked questions were categorized into five themes. Theme 1: clinical trial design/end points (4 questions), related to optimum trial designs for polyp detection and characterization, determining the optimal end points for evaluation of AI, and demonstrating impact on interval cancer rates. Theme 2: technological developments (3 questions), including improving detection of more challenging and advanced lesions, reduction of false-positive rates, and minimizing latency. Theme 3: clinical adoption/integration (1 question), concerning the effective combination of detection and characterization into one workflow. Theme 4: data access/annotation (1 question), concerning more efficient or automated data annotation methods to reduce the burden on human experts. Theme 5: regulatory approval (1 question), related to making regulatory approval processes more efficient.

          Conclusions  This is the first reported international research priority setting exercise for AI in colonoscopy. The study findings should be used as a framework to guide future research with key stakeholders to accelerate the clinical implementation of AI in endoscopy.

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          Most cited references35

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          The practical implementation of artificial intelligence technologies in medicine

          The development of artificial intelligence (AI)-based technologies in medicine is advancing rapidly, but real-world clinical implementation has not yet become a reality. Here we review some of the key practical issues surrounding the implementation of AI into existing clinical workflows, including data sharing and privacy, transparency of algorithms, data standardization, and interoperability across multiple platforms, and concern for patient safety. We summarize the current regulatory environment in the United States and highlight comparisons with other regions in the world, notably Europe and China.
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            Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled study

            Objective The effect of colonoscopy on colorectal cancer mortality is limited by several factors, among them a certain miss rate, leading to limited adenoma detection rates (ADRs). We investigated the effect of an automatic polyp detection system based on deep learning on polyp detection rate and ADR. Design In an open, non-blinded trial, consecutive patients were prospectively randomised to undergo diagnostic colonoscopy with or without assistance of a real-time automatic polyp detection system providing a simultaneous visual notice and sound alarm on polyp detection. The primary outcome was ADR. Results Of 1058 patients included, 536 were randomised to standard colonoscopy, and 522 were randomised to colonoscopy with computer-aided diagnosis. The artificial intelligence (AI) system significantly increased ADR (29.1%vs20.3%, p<0.001) and the mean number of adenomas per patient (0.53vs0.31, p<0.001). This was due to a higher number of diminutive adenomas found (185vs102; p<0.001), while there was no statistical difference in larger adenomas (77vs58, p=0.075). In addition, the number of hyperplastic polyps was also significantly increased (114vs52, p<0.001). Conclusions In a low prevalent ADR population, an automatic polyp detection system during colonoscopy resulted in a significant increase in the number of diminutive adenomas detected, as well as an increase in the rate of hyperplastic polyps. The cost–benefit ratio of such effects has to be determined further. Trial registration number ChiCTR-DDD-17012221; Results.
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              Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension

              The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human–AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.
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                Author and article information

                Journal
                Endoscopy
                Endoscopy
                10.1055/s-00000012
                Endoscopy
                Georg Thieme Verlag KG (Rüdigerstraße 14, 70469 Stuttgart, Germany )
                0013-726X
                1438-8812
                September 2021
                09 November 2020
                1 September 2021
                : 53
                : 9
                : 893-901
                Affiliations
                [ 1 ]Wellcome/EPSRC Centre for Interventional & Surgical Sciences, University College London, London, UK
                [ 2 ]Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
                [ 3 ]Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway
                [ 4 ]Department of Gastroenterology, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK
                [ 5 ]Computer Science Department, Universitat Autonoma de Barcelona and Computer Vision Center, Barcelona, Spain
                [ 6 ]Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
                [ 7 ]Department of Gastroenterology and Hepatology, University Hospitals Leuven, TARGID KU Leuven, Leuven, Belgium
                [ 8 ]Division of Gastroenterology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada
                [ 9 ]Division of Gastroenterology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan
                [10 ]Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK
                [11 ]Oxford NIHR Biomedical Research Centre, University of Oxford, Oxford, UK
                [12 ]Medical Imaging Research Center, ESAT/PSI, KU Leuven, Leuven, Belgium
                [13 ]Hamlyn Centre for Robotic Surgery, Institute of Global Health Innovation, Imperial College London, London, UK
                [14 ]Department of Surgery and Cancer, Imperial College London, London, UK
                [15 ]Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
                [16 ]ETIS, Universite de Cergy-Pointoise, ENSEA, CNRS, Cergy-Pointoise Cedex, France
                [17 ]H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology & Hepatology, Department of Medicine, University of California, Irvine, California, USA
                [18 ]Department of Gastroenterology, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy
                [19 ]Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy
                [20 ]Department of Gastroenterology and Hepatology, Lyell McEwan Hospital, Adelaide, South Australia, Australia
                [21 ]School of Electronics and Electrical Engineering, University of Leeds, Leeds, UK
                [22 ]Division of Gastroenterology & Hepatology, Mayo Clinic, Jacksonville, Florida, USA
                [23 ]Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, Chengdu, China
                [24 ]Gastrointestinal Services, University College London Hospital, London, UK
                Author notes
                Corresponding author Omer F. Ahmad, MB BS Wellcome/EPSRC Centre for Interventional & Surgical Sciences Charles Bell House 43–45 Foley StreetLondonW1W 7TSUnited Kingdom ofahmad123@ 123456gmail.com
                Author information
                http://orcid.org/0000-0001-6498-481X
                http://orcid.org/0000-0003-2262-0334
                http://orcid.org/0000-0002-2953-9603
                http://orcid.org/0000-0002-6625-114X
                http://orcid.org/0000-0002-9994-8226
                http://orcid.org/0000-0001-5400-905X
                http://orcid.org/0000-0001-8035-3700
                http://orcid.org/0000-0002-3029-4412
                http://orcid.org/0000-0002-6446-5785
                http://orcid.org/0000-0002-1234-309X
                Article
                10.1055/a-1306-7590
                8390295
                33167043
                14290eee-b6b9-404d-bd7e-dcf65f610349
                © 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 June 2020
                : 09 November 2020
                Funding
                Funded by: Wellcome Trust
                Award ID: 203145Z/16/Z
                Funded by: Engineering and Physical Sciences Research Council
                Award ID: 203145Z/16/Z
                Funded by: Engineering and Physical Sciences Research Council
                Award ID: EP/P027938/1
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