Evidence map›Paper›PMID 40626615›Full record

ArticleThe British journal of surgery2025

Information standards for innovative surgery: what patients need to know.

Christin Hoffmann, Daisy Elliott, Leila Rooshenas, Cynthia Ochieng, Barry Main, Pete Wheatstone, Samuel Lawday, Abigail Vallance, Jane M Blazeby, Angus G K McNair and 1 more

Abstract read
In one paragraph

Article in The British journal of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Christin HoffmannNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.ORCID 0000-0002-6293-3813
Daisy ElliottNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Leila RooshenasNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Cynthia OchiengNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Barry MainNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Pete WheatstonePatient Representative, Macmillan Cancer Support Research Advisory Panel, Cancer Research UK Patient Data Reference Panel, Selby, UK.
Samuel LawdayNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.ORCID 0000-0001-9165-4023
Abigail VallanceNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Jane M BlazebyNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.ORCID 0000-0002-3354-3330
Angus G K McNairNational Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.ORCID 0000-0002-2601-9258
wider study team

Funding

Biomedical Research CentreNational Institute for Health and Care Research CS-2017-17-010University Hospitals Bristol and Weston NHS Foundation TrustUniversity of Bristol BRC-1215-20011University of Bristol MR/S001751/1University of Bristol NIHR203315University of Bristol NIHR CS-2016-16-019
6 · The paper itself

Abstract

backgroundThere 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.

methodsThis 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.

resultsThe 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.

conclusionA 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.

Indexed as

Surgical Procedures, OperativeDecision Making, SharedHumansInformed ConsentQualitative Research

Identifiers

PMID40626615
PMCPMC12235506

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.