A Delphi consensus statement for digital surgery,npj Digital Medicine

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A Delphi consensus statement for digital surgery
npj Digital Medicine ( IF 12.4 ) Pub Date : 2022-07-19 , DOI: 10.1038/s41746-022-00641-6
Kyle Lam _{1,

2} , Michael D Abràmoff _{3,

4} , José M Balibrea _{5,

6} , Steven M Bishop ₇ , Richard R Brady _{8,

9} , Rachael A Callcut ₁₀ , Manish Chand ₁₁ , Justin W Collins _{7,

11} , Markus K Diener _{12,

13} , Matthias Eisenmann ₁₄ , Kelly Fermont ₁₅ , Manoel Galvao Neto _{16,

17} , Gregory D Hager _{18,

19} , Robert J Hinchliffe ₂₀ , Alan Horgan ₉ , Pierre Jannin ₂₁ , Alexander Langerman _{22,

23} , Kartik Logishetty ₁ , Amit Mahadik ₂₄ , Lena Maier-Hein _{14,

25,

26,

27} , Esteban Martín Antona ₂₈ , Pietro Mascagni _{29,

30,

31} , Ryan K Mathew _{32,

33} , Beat P Müller-Stich _{34,

35} , Thomas Neumuth ₃₆ , Felix Nickel ₃₄ , Adrian Park ₃₇ , Gianluca Pellino _{38,

39} , Frank Rudzicz _{40,

41,

42,

43} , Sam Shah ₄₄ , Mark Slack _{7,

45,

46} , Myles J Smith _{47,

48} , Naeem Soomro ₄₉ , Stefanie Speidel _{50,

51} , Danail Stoyanov ₅₂ , Henry S Tilney _{1,

53} , Martin Wagner _{34,

35} , Ara Darzi _{1,

2} , James M Kinross ₁ , Sanjay Purkayastha ₁

Affiliation

Department of Surgery and Cancer, Imperial College, London, UK.
Institute of Global Health Innovation, Imperial College London, London, UK.
Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA, USA.
Department of Electrical and Computer Engineering, University of Iowa, Iowa City, IA, USA.
Department of Gastrointestinal Surgery, Hospital Clínic de Barcelona, Barcelona, Spain.
Universitat de Barcelona, Barcelona, Spain.
CMR Surgical Limited, Cambridge, UK.
Newcastle Centre for Bowel Disease Research Hub, Newcastle University, Newcastle, UK.
Department of Colorectal Surgery, Newcastle Hospitals, Newcastle, UK.
Department of Surgery, University of California, Davis, CA, USA.
Department of Surgery and Interventional Sciences, University College London, London, UK.
Department of General and Visceral Surgery, University of Freiburg, Freiburg im Breisgau, Germany.
Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.
Division of Computer Assisted Medical Interventions (CAMI), German Cancer Research Center (DKFZ), Heidelberg, Germany.
Solicitor of the Senior Courts of England and Wales, Independent Researcher, Bristol, UK.
Endovitta Institute, Sao Paulo, Brazil.
FMABC Medical School, Santo Andre, Brazil.
The Malone Center for Engineering in Healthcare, The Johns Hopkins University, Baltimore, MD, USA.
Department of Computer Science, The Johns Hopkins University, Baltimore, MD, USA.
Department of Vascular Surgery, University of Bristol, Bristol, UK.
LTSI, Inserm UMR 1099, University of Rennes 1, Rennes, France.
Otolaryngology, Head & Neck Surgery and Radiology & Radiological Sciences, Vanderbilt University Medical Center, Nashville, TN, USA.
International Centre for Surgical Safety, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Stryker Corporation, Kalamazoo, MI, USA.
Faculty of Mathematics and Computer Science, Heidelberg University, Heidelberg, Germany.
Medical Faculty, Heidelberg University, Heidelberg, Germany.
LKSK Institute of St. Michael's Hospital, Toronto, ON, Canada.
Department of Surgery, Hospital Clínico San Carlos, Madrid, Spain.
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.
ICube, University of Strasbourg, Strasbourg, France.
School of Medicine, University of Leeds, Leeds, UK.
Department of Neurosurgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
National Center for Tumor Diseases, Heidelberg, Germany.
Innovation Center Computer Assisted Surgery (ICCAS), Universität Leipzig, Leipzig, Germany.
Department of Surgery, Anne Arundel Medical Center, School of Medicine, Johns Hopkins University, Annapolis, MD, USA.
Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania "Luigi Vanvitelli", Naples, Italy.
Colorectal Surgery, Vall d'Hebron University Hospital, Barcelona, Spain.
Department of Computer Science, University of Toronto, Toronto, ON, Canada.
Vector Institute for Artificial Intelligence, Toronto, ON, Canada.
Unity Health Toronto, Toronto, ON, Canada.
Surgical Safety Technologies Inc, Toronto, ON, Canada.
Faculty of Future Health, College of Medicine and Dentistry, Ulster University, Birmingham, UK.
Department of Urogynaecology, Addenbrooke's Hospital, Cambridge, UK.
University of Cambridge, Cambridge, UK.
The Royal Marsden Hospital, London, UK.
Institute of Cancer Research, London, UK.
Department of Urology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Division of Translational Surgical Oncology, National Center for Tumor Diseases (NCT/UCC), Dresden, Germany.
Centre for Tactile Internet with Human-in-the-Loop (CeTI), TU Dresden, Dresden, Germany.
Wellcome/ESPRC Centre for Interventional and Surgical Sciences, University College London, London, UK.
Department of Colorectal Surgery, Frimley Health NHS Foundation Trust, Frimley, UK.

The use of digital technology is increasing rapidly across surgical specialities, yet there is no consensus for the term ‘digital surgery’. This is critical as digital health technologies present technical, governance, and legal challenges which are unique to the surgeon and surgical patient. We aim to define the term digital surgery and the ethical issues surrounding its clinical application, and to identify barriers and research goals for future practice. 38 international experts, across the fields of surgery, AI, industry, law, ethics and policy, participated in a four-round Delphi exercise. Issues were generated by an expert panel and public panel through a scoping questionnaire around key themes identified from the literature and voted upon in two subsequent questionnaire rounds. Consensus was defined if >70% of the panel deemed the statement important and <30% unimportant. A final online meeting was held to discuss consensus statements. The definition of digital surgery as the use of technology for the enhancement of preoperative planning, surgical performance, therapeutic support, or training, to improve outcomes and reduce harm achieved 100% consensus agreement. We highlight key ethical issues concerning data, privacy, confidentiality and public trust, consent, law, litigation and liability, and commercial partnerships within digital surgery and identify barriers and research goals for future practice. Developers and users of digital surgery must not only have an awareness of the ethical issues surrounding digital applications in healthcare, but also the ethical considerations unique to digital surgery. Future research into these issues must involve all digital surgery stakeholders including patients.

中文翻译：

德尔福数字手术共识声明

数字技术的使用在外科专业中迅速增加，但对“数字手术”一词尚无共识。这一点至关重要，因为数字健康技术提出了外科医生和手术患者独有的技术、治理和法律挑战。我们的目标是定义数字手术这个术语以及围绕其临床应用的伦理问题，并确定未来实践的障碍和研究目标。来自外科、人工智能、工业、法律、伦理和政策等领域的 38 位国际专家参加了四轮德尔菲演习。问题由专家小组和公共小组通过围绕从文献中确定的关键主题的范围界定问卷产生，并在随后的两轮问卷调查中进行投票。如果 > 70% 的小组成员认为该陈述重要，而 <30% 的人认为该陈述不重要。举行了最后一次在线会议，讨论共识声明。数字化手术的定义是使用技术来增强术前计划、手术性能、治疗支持或培训，以改善结果和减少伤害，达成了 100% 的共识。我们强调有关数据、隐私、保密和公众信任、同意、法律、诉讼和责任以及数字手术中的商业伙伴关系的关键伦理问题，并确定未来实践的障碍和研究目标。数字手术的开发者和用户不仅要了解医疗保健中数字应用的伦理问题，还要了解数字手术特有的伦理问题。

更新日期：2022-07-19

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