University of Bristol Leads Development of First Global Information Guide for Innovative Surgery

University of Bristol Leads Development of First Global Information Guide for Innovative Surgery

(IN BRIEF) University of Bristol researchers and partners have created the first international Core Information Set (CIS) for innovative surgical procedures, published in the British Journal of Surgery. Arising from the 2018 “First Do No Harm” review, the CIS comprises seven mandatory discussion points—ranging from the novelty of the procedure and conflicts of interest to governance and compensation—to ensure patients receive full transparency before consenting to new operations. Developed with multidisciplinary and patient input, the framework aims to standardise informed consent, prevent past oversights (such as mesh‐related harms), and guide implementation through shared decision‐making and clinician training.

(PRESS RELEASE) BRISTOL, 8-Jul-2025 — /EuropaWire/ — Experts from the University of Bristol, together with the NIHR Bristol Biomedical Research Centre (BRC) and international collaborators, have developed the first-ever Core Information Set (CIS) to guide surgeons in informing patients about novel surgical procedures. Published today in the British Journal of Surgery, this seven‐step framework responds directly to the 2018 “First Do No Harm” review and aims to ensure that patients contemplating innovative—but potentially high‐risk—operations receive clear, comprehensive, and consistent information.

Professor Angus McNair, co‐lead author and Consultant Colorectal Surgeon at North Bristol NHS Trust and the University of Bristol Medical School, explained: “We must learn from past harms and establish transparent processes so that patients understand what is truly new about a procedure, its possible risks and benefits, and any alternatives before consenting. This CIS represents a global consensus—built with input from surgeons, lawyers, ethicists, regulators, and over 130 patients—that could transform how innovative surgery is communicated.”

Key elements of the CIS require clinicians to discuss with their patients:

1. What distinguishes the new procedure from established techniques
2. Any conflicts of interest or commercial impacts
3. The rationale for recommending the innovation to that individual
4. All viable alternative treatments
5. Uncertainties regarding safety, efficacy, and the potential need to alter the technique mid‐operation
6. The surgeon’s personal experience and training with the new method
7. Governance structures, oversight mechanisms, and compensation pathways if complications occur

Dr. McNair noted that unlike new pharmaceuticals, surgical innovations often bypass rigorous pre‐approval trials, which has in the past led to serious patient harm—most notably with pelvic mesh implants. The CIS addresses these shortcomings by standardising pre‐ and post‐operative discussions, empowering patients to make truly informed decisions and know how to seek redress if necessary.

This work was supported by the NIHR Bristol BRC at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The authors have submitted their findings to MP Sharon Hodgson, Chair of the All-Party Parliamentary Group “First Do No Harm,” to inform future policy and practice. Next steps include integrating the CIS into shared decision‐making processes and embedding it within clinical governance and professional development frameworks.

Media Contact:

Tel: +44 (0)117 928 9000
Email: press-office@bristol.ac.uk

SOURCE: University of Bristol