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).
dc.contributor.author | Hamilton, W | |
dc.contributor.author | Mounce, L | |
dc.contributor.author | Abel, GA | |
dc.contributor.author | Dean, SG | |
dc.contributor.author | Campbell, JL | |
dc.contributor.author | Warren, FC | |
dc.contributor.author | Spencer, A | |
dc.contributor.author | Medina-Lara, A | |
dc.contributor.author | Pitt, M | |
dc.contributor.author | Shephard, E | |
dc.contributor.author | Shakespeare, M | |
dc.contributor.author | Fletcher, E | |
dc.contributor.author | Mercer, A | |
dc.contributor.author | Calitri, R | |
dc.date.accessioned | 2023-04-19T12:15:32Z | |
dc.date.issued | 2023-03-20 | |
dc.date.updated | 2023-04-19T10:35:18Z | |
dc.description.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. 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. 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. TRIAL REGISTRATION NUMBER: ISRCTN22560297. | en_GB |
dc.description.sponsorship | Cancer Research UK | en_GB |
dc.description.sponsorship | Dennis and Mireille Gillings Foundation | en_GB |
dc.format.extent | e065232- | |
dc.format.medium | Electronic | |
dc.identifier.citation | Vol. 32, article e065232 | en_GB |
dc.identifier.doi | https://doi.org/10.1136/bmjopen-2022-065232 | |
dc.identifier.grantnumber | C8640/A23385 | en_GB |
dc.identifier.uri | http://hdl.handle.net/10871/132945 | |
dc.identifier | ORCID: 0000-0003-1611-1373 (Hamilton, Willie) | |
dc.identifier | ScopusID: 55031252700 | 57209301809 (Hamilton, Willie) | |
dc.identifier | ResearcherID: G-8612-2014 (Hamilton, Willie) | |
dc.identifier | ORCID: 0000-0002-6089-0661 (Mounce, Luke) | |
dc.identifier | ORCID: 0000-0003-2231-5161 (Abel, Gary A) | |
dc.identifier | ScopusID: 57202757335 (Abel, Gary A) | |
dc.identifier | ORCID: 0000-0002-3682-5149 (Dean, Sarah Gerard) | |
dc.identifier | ScopusID: 12804309300 | 56654882600 | 56844769700 | 57192416272 | 8583848900 (Dean, Sarah Gerard) | |
dc.identifier | ORCID: 0000-0002-6752-3493 (Campbell, John L) | |
dc.identifier | ScopusID: 55323494700 | 55470023300 (Campbell, John L) | |
dc.identifier | ResearcherID: A-5792-2011 (Campbell, John L) | |
dc.identifier | ORCID: 0000-0002-3833-0182 (Warren, Fiona C) | |
dc.identifier | ORCID: 0000-0002-8163-3103 (Spencer, Anne) | |
dc.identifier | ORCID: 0000-0001-7325-8246 (Medina-Lara, Antonieta) | |
dc.identifier | ORCID: 0000-0003-4026-8346 (Pitt, Martin) | |
dc.identifier | ORCID: 0000-0002-3610-3680 (Shephard, Elizabeth) | |
dc.identifier | ORCID: 0000-0003-0889-4670 (Calitri, Raff) | |
dc.identifier | ScopusID: 24168014000 (Calitri, Raff) | |
dc.language.iso | en | en_GB |
dc.publisher | BMJ Publishing Group | en_GB |
dc.relation.url | https://www.ncbi.nlm.nih.gov/pubmed/36940950 | en_GB |
dc.rights | © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. Open access This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/. | en_GB |
dc.subject | Clinical trials | en_GB |
dc.subject | Risk management | en_GB |
dc.subject | Cost-Benefit Analysis | en_GB |
dc.subject | Delayed Diagnosis | en_GB |
dc.subject | General Practice | en_GB |
dc.subject | Treatment Outcome | en_GB |
dc.subject | Risk Assessment | en_GB |
dc.subject | Neoplasms | en_GB |
dc.subject | Randomized Controlled Trials as Topic | en_GB |
dc.title | 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). | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2023-04-19T12:15:32Z | |
dc.identifier.issn | 2044-6055 | |
exeter.location | England | |
dc.description | This is the final version. Available from [BMJ Publishing via the DOI in this record. | en_GB |
dc.description | Data availability statement: Data sharing not applicable as no datasets generated and/or analysed for this study. Data sharing not applicable as no datasets generated and/or analysed for this Protocol paper. | en_GB |
dc.identifier.journal | BMJ Open | en_GB |
dc.relation.ispartof | BMJ Open, 13(3) | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_GB |
dcterms.dateAccepted | 2023-02-28 | |
dc.rights.license | CC BY | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2023-03-20 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2023-04-19T12:12:17Z | |
refterms.versionFCD | VoR | |
refterms.dateFOA | 2023-04-19T12:15:33Z | |
refterms.panel | A | en_GB |
refterms.dateFirstOnline | 2023-03-20 |
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