Evidence map›Paper›PMID 40588381›Full record

SynthesisBMJ open2025

Identifying and reporting modifications to surgical innovation: a systematic review of IDEAL/IDEAL-D studies.

James Olivier, Daisy Elliott, Kerry Avery, Natalie S Blencowe, Rhiannon Macefield

Abstract readSystematic Review
In one paragraph

Synthesis in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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. Article
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

5 authors.

James OlivierNIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, Bristol, UK james.olivier@nhs.net.ORCID http://orcid.org/0000-0003-3082-8426
Daisy ElliottNIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, Bristol, UK.ORCID http://orcid.org/0000-0001-8143-9549
Kerry AveryNIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, Bristol, UK.ORCID http://orcid.org/0000-0001-5477-2418
Natalie S BlencoweNIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-6111-2175
Rhiannon MacefieldNIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-6606-5427

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

designSystematic review and thematic synthesis of studies reporting surgical innovation. DATA SOURCES: Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers). ELIGIBILITY CRITERIA: Primary research studies of any design that involved invasive innovative devices or procedures. DATA EXTRACTION AND SYNTHESIS: Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

resultsOf 1071 records screened, 104 studies published between 2011-2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

conclusionReporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety. PROSPERO REGISTRATION NUMBER: CRD42023427704.

Indexed as

InventionsResearch DesignSurgical Procedures, OperativeHumansQUALITATIVE RESEARCHResearch DesignSURGERYSystematic Review

Identifiers

PMID40588381
PMCPMC12211834

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.