A Delphi consensus statement for digital surgery

Kyle Lam; Michael D Abràmoff; José M Balibrea; Steven M Bishop; Richard R Brady; Rachael A Callcut; Manish Chand; Justin W Collins; Markus K Diener; Matthias Eisenmann; Kelly Fermont; Manoel Galvao Neto; Gregory D Hager; Robert J Hinchliffe; Alan Horgan; Pierre Jannin; Alexander Langerman; Kartik Logishetty; Amit Mahadik; Lena Maier-Hein; Esteban Martín Antona; Pietro Mascagni; Ryan K Mathew; Beat P Müller-Stich; Thomas Neumuth; Felix Nickel; Adrian Park; Gianluca Pellino; Frank Rudzicz; Sam Shah; Mark Slack; Myles J Smith; Naeem Soomro; Stefanie Speidel; Danail Stoyanov; Henry S Tilney; Martin Wagner; Ara Darzi; James M Kinross; Sanjay Purkayastha

doi:10.1038/s41746-022-00641-6

A Delphi consensus statement for digital surgery

NPJ Digit Med. 2022 Jul 19;5(1):100. doi: 10.1038/s41746-022-00641-6.

Authors

Kyle Lam^{1

2}, Michael D Abràmoff^{3

4}, José M Balibrea^{5

6}, Steven M Bishop⁷, Richard R Brady^{8

9}, Rachael A Callcut¹⁰, Manish Chand¹¹, Justin W Collins^{7

11}, Markus K Diener^{12

13}, Matthias Eisenmann¹⁴, Kelly Fermont¹⁵, Manoel Galvao Neto^{16

17}, Gregory D Hager^{18

19}, Robert J Hinchliffe²⁰, Alan Horgan⁹, Pierre Jannin²¹, Alexander Langerman^{22

23}, Kartik Logishetty¹, Amit Mahadik²⁴, Lena Maier-Hein^{14

25

26

27}, Esteban Martín Antona²⁸, Pietro Mascagni^{29

30

31}, Ryan K Mathew^{32

33}, Beat P Müller-Stich^{34

35}, Thomas Neumuth³⁶, Felix Nickel³⁴, Adrian Park³⁷, Gianluca Pellino^{38

39}, Frank Rudzicz^{40

41

42

43}, Sam Shah⁴⁴, Mark Slack^{7

45

46}, Myles J Smith^{47

48}, Naeem Soomro⁴⁹, Stefanie Speidel^{50

51}, Danail Stoyanov⁵², Henry S Tilney^{1

53}, Martin Wagner^{34

35}, Ara Darzi^{1

2}, James M Kinross⁵⁴, Sanjay Purkayastha¹

Affiliations

¹ Department of Surgery and Cancer, Imperial College, London, UK.
² Institute of Global Health Innovation, Imperial College London, London, UK.
³ Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA, USA.
⁴ Department of Electrical and Computer Engineering, University of Iowa, Iowa City, IA, USA.
⁵ Department of Gastrointestinal Surgery, Hospital Clínic de Barcelona, Barcelona, Spain.
⁶ Universitat de Barcelona, Barcelona, Spain.
⁷ CMR Surgical Limited, Cambridge, UK.
⁸ Newcastle Centre for Bowel Disease Research Hub, Newcastle University, Newcastle, UK.
⁹ Department of Colorectal Surgery, Newcastle Hospitals, Newcastle, UK.
¹⁰ Department of Surgery, University of California, Davis, CA, USA.
¹¹ Department of Surgery and Interventional Sciences, University College London, London, UK.
¹² Department of General and Visceral Surgery, University of Freiburg, Freiburg im Breisgau, Germany.
¹³ Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.
¹⁴ Division of Computer Assisted Medical Interventions (CAMI), German Cancer Research Center (DKFZ), Heidelberg, Germany.
¹⁵ Solicitor of the Senior Courts of England and Wales, Independent Researcher, Bristol, UK.
¹⁶ Endovitta Institute, Sao Paulo, Brazil.
¹⁷ FMABC Medical School, Santo Andre, Brazil.
¹⁸ The Malone Center for Engineering in Healthcare, The Johns Hopkins University, Baltimore, MD, USA.
¹⁹ Department of Computer Science, The Johns Hopkins University, Baltimore, MD, USA.
²⁰ Department of Vascular Surgery, University of Bristol, Bristol, UK.
²¹ LTSI, Inserm UMR 1099, University of Rennes 1, Rennes, France.
²² Otolaryngology, Head & Neck Surgery and Radiology & Radiological Sciences, Vanderbilt University Medical Center, Nashville, TN, USA.
²³ International Centre for Surgical Safety, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
²⁴ Stryker Corporation, Kalamazoo, MI, USA.
²⁵ Faculty of Mathematics and Computer Science, Heidelberg University, Heidelberg, Germany.
²⁶ Medical Faculty, Heidelberg University, Heidelberg, Germany.
²⁷ LKSK Institute of St. Michael's Hospital, Toronto, ON, Canada.
²⁸ Department of Surgery, Hospital Clínico San Carlos, Madrid, Spain.
²⁹ Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
³⁰ IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.
³¹ ICube, University of Strasbourg, Strasbourg, France.
³² School of Medicine, University of Leeds, Leeds, UK.
³³ Department of Neurosurgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
³⁴ Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
³⁵ National Center for Tumor Diseases, Heidelberg, Germany.
³⁶ Innovation Center Computer Assisted Surgery (ICCAS), Universität Leipzig, Leipzig, Germany.
³⁷ Department of Surgery, Anne Arundel Medical Center, School of Medicine, Johns Hopkins University, Annapolis, MD, USA.
³⁸ Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania "Luigi Vanvitelli", Naples, Italy.
³⁹ Colorectal Surgery, Vall d'Hebron University Hospital, Barcelona, Spain.
⁴⁰ Department of Computer Science, University of Toronto, Toronto, ON, Canada.
⁴¹ Vector Institute for Artificial Intelligence, Toronto, ON, Canada.
⁴² Unity Health Toronto, Toronto, ON, Canada.
⁴³ Surgical Safety Technologies Inc, Toronto, ON, Canada.
⁴⁴ Faculty of Future Health, College of Medicine and Dentistry, Ulster University, Birmingham, UK.
⁴⁵ Department of Urogynaecology, Addenbrooke's Hospital, Cambridge, UK.
⁴⁶ University of Cambridge, Cambridge, UK.
⁴⁷ The Royal Marsden Hospital, London, UK.
⁴⁸ Institute of Cancer Research, London, UK.
⁴⁹ Department of Urology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
⁵⁰ Division of Translational Surgical Oncology, National Center for Tumor Diseases (NCT/UCC), Dresden, Germany.
⁵¹ Centre for Tactile Internet with Human-in-the-Loop (CeTI), TU Dresden, Dresden, Germany.
⁵² Wellcome/ESPRC Centre for Interventional and Surgical Sciences, University College London, London, UK.
⁵³ Department of Colorectal Surgery, Frimley Health NHS Foundation Trust, Frimley, UK.
⁵⁴ Department of Surgery and Cancer, Imperial College, London, UK. [email protected].

Abstract

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.