Evidence map›Paper›PMID 41073949›Full record

SynthesisBMC surgery2025

Continuity of outcome assessment throughout the lifecycle of surgical research: mapping core outcome domains measured in early phase and late phase studies.

Christin Hoffmann, Emma Sewart, Susanna Dodd, Sarah L Gorst, Jane M Blazeby, Kerry N L Avery, Shelley Potter, Rhiannon C Macefield

Abstract readSystematic Review
In one paragraph

Synthesis in BMC surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Christin HoffmannBristol Medical School: Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, University of Bristol, Bristol, UK. c.hoffmann@bristol.ac.uk.ORCID http://orcid.org/0000-0002-6293-3813
Emma SewartBristol Medical School, Translational Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-1214-0356
Susanna DoddDepartment of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK.ORCID http://orcid.org/0000-0003-2851-3337
Sarah L GorstDepartment of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK.ORCID http://orcid.org/0000-0002-7818-9646
Jane M BlazebyBristol Medical School: Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-3354-3330
Kerry N L Avery *Bristol Medical School: Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0001-5477-2418
Shelley Potter *Bristol Medical School, Translational Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-6977-312X
Rhiannon C Macefield *Bristol Medical School: Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-6606-5427

Funding

National Institute for Health and Care Research NIHR203315
6 · The paper itself

Abstract

backgroundConsistent outcome assessment in surgical research, from early phase studies (during introduction and refinement of new procedures) to late phase studies (to establish comparative effectiveness) needs improvement to ensure efficient and safe surgical care. This study explored the potential continuity of outcome domain assessment throughout the evaluation lifecycle of surgical interventions.

methodsCore outcome sets (COS) for late phase studies of surgical interventions were identified through COMET database searches. Core outcomes/outcome domains were extracted and mapped to core domains of a COS developed specifically for evaluating surgical innovation (COHESIVE COS). Outcomes/domains were categorised as "definite match" (clear similarity), "possible match" (potential similarity) and "no match" (no similarity) COHESIVE domain based on similarity in wording or meaning.

resultsA total of 54 COS studies were included, yielding 573 core outcomes/domains. Most late phase core outcomes/domains (N = 519, 91%) showed clear or possible similarity. All late phase COS studies recommended measurement of COHESIVE domains 'Intended benefits' and 'Expected and unexpected disadvantages'. Some late phase outcomes/domains also showed similarity with early phase COHESIVE domains, including 'Problems with the device working', 'Patients' experience' and 'Operators'/surgeons' experience'. A minority of late phase outcomes/domains showed no similarity with COHESIVE domains (n = 54, 9%).

conclusionHigh similarity between outcome domains recommended in early and late phase evaluations of surgical interventions demonstrates continuity of outcome domain assessment throughout the surgical innovation lifecycle is possible. Harmonising outcome measurement throughout the research pathway can streamline evaluation, enhancing access to beneficial treatment and improving early detection of harms.

Indexed as

Biomedical ResearchOutcome Assessment, Health CareSurgical Procedures, OperativeHumansComplex intervention evaluationCore outcome setOutcomesSurgerySurgical innovation

Identifiers

PMID41073949
PMCPMC12512511

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Registered trials

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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.