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105 Optimising shared decision making for surgical innovation: development of a core information set
  1. Christin Hoffmann1,
  2. Daisy Elliott1,
  3. Cynthia Ochieng1,
  4. Samuel Lawday1,2,
  5. Abigail Vallance1,2,
  6. Leila Rooshenas1,
  7. Barry Main3,4,
  8. Jane M Blazeby1,3,
  9. Pete Wheatstone5,
  10. Angus GK Mcnair1,2
  1. 1National Institute for Health Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
  2. 2North Bristol NHS Trust, Bristol, UK
  3. 3Bristol Royal Infirmary, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
  4. 4Bristol Dental School, University of Bristol, Bristol,UK
  5. 5Patient representative, Macmillan Cancer Support Research Advisory Panel, Cancer Research UK Patient Data Reference Panel,UK

Abstract

Introduction Surgical innovation is important to advance care for patients. There are, however, challenges for high- quality patient-centred communication due to inconsistent and incomplete information disclosure during consultations involving surgical innovation.1 There is a need to support shared decision making(SDM) and optimise informed consent in this context. This study developed a core information set(CIS) that will facilitate consultations between health professionals and patients offered novel surgical procedures/devices.

Methods This study adhered to guidance for CIS development2 and core outcome set development (COS- STAD).3 There were three phases: (1) generation of a provisional core information set from multiple data sources (44 interviews with patients/professionals, 34 recorded consultations, 213 published studies, 58 policy documents) applying thematic content analysis, (2) refinement and agreement of the CIS with stakeholders (patient representatives, surgeon innovators, anaesthetists, lawyers, ethicists, medical directors, academic experts in SDM, regulatory body representatives) using modified nominal group technique, (3) public consultation in the United Kingdom.

Results Phase 1: Eight initial themes and 28 subthemes were generated from the 349 data sources. Phase 2: 25 stakeholders refined and agreed seven themes in the final CIS to cover what is ‘new’ about the procedure, conflicts of interest, reasons for the innovation, treatment alternatives, unknowns, expertise with the innovation, and governance, oversight, and accountability. Phase 3: 136 public consultation participants endorsed all themes.

Discussion The CIS provides baseline information for consultations between health professionals and patients being offered novel surgical procedures/devices to achieve transparent/consistent information provision.

It can be applied flexibly within established processes of SDM to catalyse personalised discussions and address current deficiencies in informed consent.

Conclusion(s) An evidence-based CIS has been co-developed with key stakeholders and is the recommend standard to optimise SDM and informed consent for surgical innovation.

References

  1. Elliott D, Ochieng CA, Zahra J, McNair AGK, Main BG, Skilton A, et al. What are patients told about innovative surgical procedures? A Qualitative Synthesis of 7 Case Studies in the United Kingdom. Ann Surg. 2023;278:E482–90.

  2. Main BG, McNair AGK, Huxtable R, Donovan JL, Thomas SJ, Kinnersley P, et al. Core information sets for informed consent to surgical interventions: Baseline information of importance to patients and clinicians. BMC Med. Ethics. BioMed Central Ltd. 2017:29.

  3. Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core outcome set-STAndards for development: the COS-STAD recommendations. PLOS Med. 2017;14:e1002447.

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