COMET Initiative | Information standards for innovative surgery: what patients need to know

Information standards for innovative surgery: what patients need to know

Background
There are repeated and ongoing failures in shared decision-making and informed consent for innovative surgical procedures. Governments and regulatory bodies internationally recommend establishing information standards to support safe and transparent surgical innovation. The aim of this study was to develop a core information set (CIS) for surgical innovation.

Methods
This was a mixed-method study in three phases: a provisional CIS was generated from multiple data sources (interviews with patients/professionals (44), recorded consultations (34), policy documents (58), and published studies (213)) using qualitative content analysis; the CIS was refined, with input from key stakeholders (patient representatives, surgeon innovators, anaesthetists, lawyers, ethicists, medical directors, academic experts, and regulatory representatives) using a modified nominal group technique; and the CIS was finalized through public consultation.

Results
The final CIS comprised seven themes that included: what is ‘new’ about the procedure; potential conflicts of interest; reasons for the innovation (including why the innovation is believed to be appropriate for the patient); treatment alternatives; unknowns (including uncertain safety/efficacy and that the procedure may be abandoned/modified); expertise with the innovation; and governance, oversight, and accountability (including how safety will be monitored and recompense if anything goes wrong). Two themes require follow-up discussions after the procedure.

Conclusion
A seven-theme CIS for surgical innovation was co-developed, with input from key stakeholders. International implementation of these information standards may support safe and transparent surgical innovation.
Contributors

Contributors

Christin Hoffmann , Daisy Elliott , Leila Rooshenas , Cynthia Ochieng , Barry Main , Pete Wheatstone , Samuel Lawday , Abigail Vallance , Jane M Blazeby , Angus G K McNair

Publication

Journal: Br J Surg
Volume: 112
Issue: 7
Pages: -
Year: 2025
DOI: 10.1093/bjs/znaf140

Further Study Information

Current Stage: Completed
Date: October 2020 - March 2022
Funding source(s): This study is partly supported by an NIHR Clinician Scientists awarded to AM (CS-2017-17-010) and by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol.

Health Area

Disease Category: Other

Disease Name: N/A

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Ethicists
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Regulatory agency representatives
- Researchers

Study Type

- Core information set

Method(s)

- Consensus meeting
- Focus group(s)
- Interview
- Literature review
- Nominal group technique (NGT)
- Survey

Development of a CIS for surgical innovation adhered to established methods for developing core information sets (1) and used modified methods for establishing minimum standard set of outcomes (COMET, COS-STAD).

The study was conducted in three phases:
1) identify information items
2) create provisional CIS
3) refine and obtain endorsement for a final CIS
4) An additional phase which seeks UK national stakeholder opinions via public consultation survey.

(1) 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. Vol. 18, BMC Medical Ethics. BioMed Central Ltd.; 2017. p. 29.

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