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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.

Title: 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.
Authors: O'Dowd, E.; Berovic, M.; Callister, M.; Chalitsios, C.V.; Chopra, D.; Das, I.; Draper, A.; Garner, J.L.; Gleeson, F.; Janes, S.; Kennedy, M.; Lee, R.; Mauri, F.; McKeever, T.M.; McNulty, W.; Murray, J.; Nair, A.; Park, J.; Rawlinson, J.; Sagoo, G.S.; Scarsbrook, A.; Shah, P.; Sudhir, R.; Talwar, A.; Thakrar, R.; Watkins, J.; Baldwin, D.R.
Publisher Information: BMJ Publishing Group
Publication Year: 2024
Collection: White Rose Research Online (Universities of Leeds, Sheffield & York)
Description: 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.
Document Type: article in journal/newspaper
File Description: text
Language: English
ISSN: 2044-6055
Relation: https://eprints.whiterose.ac.uk/id/eprint/207379/1/e077747.full.pdf; O'Dowd, E. orcid.org/0000-0001-6904-1327 , Berovic, M., Callister, M. et al. (24 more authors) (2024) 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. BMJ Open, 14. e077747. ISSN: 2044-6055
Availability: https://eprints.whiterose.ac.uk/id/eprint/207379/; https://eprints.whiterose.ac.uk/id/eprint/207379/1/e077747.full.pdf
Rights: cc_by_nc_4
Accession Number: edsbas.BFA48C1
Database: BASE