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)
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 r...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/3/e065232.full |
| _version_ | 1797770845375954944 |
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| author | Gary A Abel John L Campbell Martin Pitt Sarah Gerard Dean Luke Mounce Fiona C Warren Emily Fletcher Anne Spencer Raff Calitri Antonieta Medina-Lara Elizabeth Shephard Marijke Shakespeare Adrian Mercer |
| author_facet | Gary A Abel John L Campbell Martin Pitt Sarah Gerard Dean Luke Mounce Fiona C Warren Emily Fletcher Anne Spencer Raff Calitri Antonieta Medina-Lara Elizabeth Shephard Marijke Shakespeare Adrian Mercer |
| author_sort | Gary A Abel |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T21:28:58Z |
| format | Article |
| id | doaj.art-c89773663fe0416ea4c455a5a01b29ac |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T21:28:58Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-c89773663fe0416ea4c455a5a01b29ac2023-07-28T00:50:07ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-065232Protocol 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)Gary A Abel0John L Campbell1Martin Pitt2Sarah Gerard Dean3Luke Mounce4Fiona C Warren5Emily Fletcher6Anne Spencer7Raff Calitri8Antonieta Medina-Lara9Elizabeth Shephard10Marijke Shakespeare11Adrian Mercer123 Primary Care, University of Exeter Medical School, Exeter, UKPrimary Care Research Group, University of Exeter Medical School, Exeter, UKMedical School, University of Exeter, Exeter, United Kingdom4 PenCLAHRC University of Exeter Medical School, Exeter, UKInstitute of Health Research, University of Exeter Medical School, Exeter, Devon, UK7 Collaboration for Academic Primary Care, University of Exeter, Exeter, UK1 Cambridge Institute for Medical Research, University of Cambridge, Cambridge, UKHealth Economics Group, University of Exeter Medical School, Exeter, UKCollege of Medicine and Health, University of Exeter, Exeter, Devon, UKHealth Economics Group, University of Exeter Medical School, Exeter, UK1Medical School, University of Exeter, College House, Exeter, UK11 Primary Care, University of Exeter Medical School, Exeter, UK11 Primary Care, University of Exeter Medical School, Exeter, UKIntroduction 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.https://bmjopen.bmj.com/content/13/3/e065232.full |
| spellingShingle | Gary A Abel John L Campbell Martin Pitt Sarah Gerard Dean Luke Mounce Fiona C Warren Emily Fletcher Anne Spencer Raff Calitri Antonieta Medina-Lara Elizabeth Shephard Marijke Shakespeare Adrian Mercer 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) BMJ Open |
| 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/3/e065232.full |
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