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Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study

Lookup NU author(s): Dr Gurdeep SagooORCiD

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


Abstract

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. INTRODUCTION: In a small percentage of patients, pulmonary nodules found on CT scans are early lung cancers. Lung cancer detected at an early stage has a much better prognosis. The British Thoracic Society guideline on managing pulmonary nodules recommends using multivariable malignancy risk prediction models to assist in management. While these guidelines seem to be effective in clinical practice, recent data suggest that artificial intelligence (AI)-based malignant-nodule prediction solutions might outperform existing models. METHODS AND ANALYSIS: This study is a prospective, observational multicentre study to assess the clinical utility of an AI-assisted CT-based lung cancer prediction tool (LCP) for managing incidental solid and part solid pulmonary nodule patients vs standard care. Two thousand patients will be recruited from 12 different UK hospitals. The primary outcome is the difference between standard care and LCP-guided care in terms of the rate of benign nodules and patients with cancer discharged straight after the assessment of the baseline CT scan. Secondary outcomes investigate adherence to clinical guidelines, other measures of changes to clinical management, patient outcomes and cost-effectiveness. ETHICS AND DISSEMINATION: This study has been reviewed and given a favourable opinion by the South Central-Oxford C Research Ethics Committee in UK (REC reference number: 22/SC/0142).Study results will be available publicly following peer-reviewed publication in open-access journals. A patient and public involvement group workshop is planned before the study results are available to discuss best methods to disseminate the results. Study results will also be fed back to participating organisations to inform training and procurement activities. TRIAL REGISTRATION NUMBER: NCT05389774.


Publication metadata

Author(s): O'Dowd E, Berovic M, Callister M, Chalitsios CV, Chopra D, Das I, Draper A, Garner JL, Gleeson F, Janes S, Kennedy M, Lee R, Mauri F, McKeever TM, McNulty W, Murray J, Nair A, Park J, Rawlinson J, Sagoo GS, Scarsbrook A, Shah P, Sudhir R, Talwar A, Thakrar R, Watkins J, Baldwin DR

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2024

Volume: 14

Issue: 1

Online publication date: 04/01/2024

Acceptance date: 28/11/2023

Date deposited: 15/01/2024

ISSN (print): 2044-6055

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjopen-2023-077747

DOI: 10.1136/bmjopen-2023-077747

PubMed id: 38176863


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Funding

Funder referenceFunder name
AI_AWARD02266
Nottingham University Hospitals NHS Trust
NHS Accelerated Access Collaborative

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