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Protocol for a pragmatic cluster randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of Electronic RIsk-assessment for CAncer for patients in general practice (ERICA).
- Source :
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BMJ open [BMJ Open] 2023 Mar 20; Vol. 13 (3), pp. e065232. Date of Electronic Publication: 2023 Mar 20. - Publication Year :
- 2023
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Abstract
- Introduction: The UK has worse cancer outcomes than most comparable countries, with a large contribution attributed to diagnostic delay. Electronic risk assessment tools (eRATs) have been developed to identify primary care patients with a ≥2% risk of cancer using features recorded in the electronic record.<br />Methods and Analysis: This is a pragmatic cluster randomised controlled trial in English primary care. Individual general practices will be randomised in a 1:1 ratio to intervention (provision of eRATs for six common cancer sites) or to usual care. The primary outcome is cancer stage at diagnosis, dichotomised to stage 1 or 2 (early) or stage 3 or 4 (advanced) for these six cancers, assessed from National Cancer Registry data. Secondary outcomes include stage at diagnosis for a further six cancers without eRATs, use of urgent referral cancer pathways, total practice cancer diagnoses, routes to cancer diagnosis and 30-day and 1-year cancer survival. Economic and process evaluations will be performed along with service delivery modelling. The primary analysis explores the proportion of patients with early-stage cancer at diagnosis. The sample size calculation used an OR of 0.8 for a cancer being diagnosed at an advanced stage in the intervention arm compared with the control arm, equating to an absolute reduction of 4.8% as an incidence-weighted figure across the six cancers. This requires 530 practices overall, with the intervention active from April 2022 for 2 years.<br />Ethics and Dissemination: The trial has approval from London City and East Research Ethics Committee, reference number 19/LO/0615; protocol version 5.0, 9 May 2022. It is sponsored by the University of Exeter. Dissemination will be by journal publication, conferences, use of appropriate social media and direct sharing with cancer policymakers.<br />Trial Registration Number: ISRCTN22560297.<br />Competing Interests: Competing interests: WH owns background IP for the eRATs but will not use this for personal finacial benefit from any NHS use. All other authors declare no competing interests.<br /> (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 13
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 36940950
- Full Text :
- https://doi.org/10.1136/bmjopen-2022-065232