Evidence map›Paper›PMID 37104755›Full record

ArticleBJS open2023

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review.

Sina Hossaini, Christin Hoffmann, Sian Cousins, Natalie Blencowe, Angus G K McNair, Jane M Blazeby, Kerry N L Avery, Shelley Potter, Rhiannon Macefield

Abstract readScoping Review
In one paragraph

Article in BJS open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

9 authors.

Sina HossainiDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0001-8122-5321
Christin HoffmannDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-6293-3813
Sian CousinsDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0003-0088-841X
Natalie BlencoweDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.
Angus G K McNairDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-2601-9258
Jane M BlazebyDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-3354-3330
Kerry N L AveryDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.
Shelley PotterDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-6977-312X
Rhiannon MacefieldDepartment of Population Health Sciences, National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-6606-5427

Funding

Department of Health CS-2016-16-019Department of Health CS-2017-17-010Medical Research Council
6 · The paper itself

Abstract

backgroundInnovative surgical procedures and devices are often modified throughout their development and introduction into clinical practice. A systematic approach to reporting modifications may support shared learning and foster safe and transparent innovation. Definitions of 'modifications', and how they are conceptualized and classified so they can be reported and shared effectively, however, are lacking. This study aimed to explore and summarize existing definitions, perceptions, classifications and views on modification reporting to develop a conceptual framework for understanding and reporting modifications.

methodsA scoping review was conducted in accordance with PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. Targeted searches and two database searches were performed to identify relevant opinion pieces and review articles. Included were articles relating to modifications to surgical procedures/devices. Data regarding definitions, perceptions and classifications of modifications, and views on modification reporting were extracted verbatim. Thematic analysis was undertaken to identify themes, which informed development of the conceptual framework.

resultsForty-nine articles were included. Eight articles included systems for classifying modifications, but no articles reported an explicit definition of modifications. Some 13 themes relating to perception of modifications were identified. The derived conceptual framework comprises three overarching components: baseline data about modifications, details about modifications and impact/consequences of modifications.

conclusionA conceptual framework for understanding and reporting modifications that occur during surgical innovation has been developed. This is a first necessary step to support consistent and transparent reporting of modifications, to facilitate shared learning and incremental innovation of surgical procedures/devices. Testing and operationalization is now needed to realize the value of this framework.

Indexed as

General SurgeryInventionsResearch DesignHumans

Identifiers

PMID37104755
PMCPMC10139440

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.