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What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420)
BACKGROUND: In principle, risk-stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE-approved more frequent screening and/ or chemoprevention for women who are at increased risk, bu...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7302349/ https://www.ncbi.nlm.nih.gov/pubmed/32552763 http://dx.doi.org/10.1186/s12885-020-07054-2 |
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author | French, David P. Astley, Susan Brentnall, Adam R. Cuzick, Jack Dobrashian, Richard Duffy, Stephen W. Gorman, Louise S. Harkness, Elaine F. Harrison, Fiona Harvie, Michelle Howell, Anthony Jerrison, Andrew Machin, Matthew Maxwell, Anthony J. McWilliams, Lorna Payne, Katherine Qureshi, Nadeem Ruane, Helen Sampson, Sarah Stavrinos, Paula Thorpe, Emma Ulph, Fiona van Staa, Tjeerd Woof, Victoria Evans, D. Gareth |
author_facet | French, David P. Astley, Susan Brentnall, Adam R. Cuzick, Jack Dobrashian, Richard Duffy, Stephen W. Gorman, Louise S. Harkness, Elaine F. Harrison, Fiona Harvie, Michelle Howell, Anthony Jerrison, Andrew Machin, Matthew Maxwell, Anthony J. McWilliams, Lorna Payne, Katherine Qureshi, Nadeem Ruane, Helen Sampson, Sarah Stavrinos, Paula Thorpe, Emma Ulph, Fiona van Staa, Tjeerd Woof, Victoria Evans, D. Gareth |
author_sort | French, David P. |
collection | PubMed |
description | BACKGROUND: In principle, risk-stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE-approved more frequent screening and/ or chemoprevention for women who are at increased risk, but are unaware of this. We have developed BC-Predict, to be offered to women when invited to NHSBSP which collects information on risk factors (self-reported information on family history and hormone-related factors via questionnaire; mammographic density; and in a sub-sample, Single Nucleotide Polymorphisms). BC-Predict produces risk feedback letters, inviting women at high risk (≥8% 10-year) or moderate risk (≥5 to < 8% 10-year) to have discussion of prevention and early detection options at Family History, Risk and Prevention Clinics. Despite the promise of systems such as BC-Predict, there are still too many uncertainties for a fully-powered definitive trial to be appropriate or ethical. The present research aims to identify these key uncertainties regarding the feasibility of integrating BC-Predict into the NHSBSP. Key objectives of the present research are to quantify important potential benefits and harms, and identify key drivers of the relative cost-effectiveness of embedding BC-Predict into NHSBSP. METHODS: A non-randomised fully counterbalanced study design will be used, to include approximately equal numbers of women offered NHSBSP (n = 18,700) and BC-Predict (n = 18,700) from selected screening sites (n = 7). In the initial 8-month time period, women eligible for NHSBSP will be offered BC-Predict in four screening sites. Three screening sites will offer women usual NHSBSP. In the following 8-months the study sites offering usual NHSBSP switch to BC-Predict and vice versa. Key potential benefits including uptake of risk consultations, chemoprevention and additional screening will be obtained for both groups. Key potential harms such as increased anxiety will be obtained via self-report questionnaires, with embedded qualitative process analysis. A decision-analytic model-based cost-effectiveness analysis will identify the key uncertainties underpinning the relative cost-effectiveness of embedding BC-Predict into NHSBSP. DISCUSSION: We will assess the feasibility of integrating BC-Predict into the NHSBSP, and identify the main uncertainties for a definitive evaluation of the clinical and cost-effectiveness of BC-Predict. TRIAL REGISTRATION: Retrospectively registered with clinicaltrials.gov (NCT04359420). |
format | Online Article Text |
id | pubmed-7302349 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-73023492020-06-19 What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420) French, David P. Astley, Susan Brentnall, Adam R. Cuzick, Jack Dobrashian, Richard Duffy, Stephen W. Gorman, Louise S. Harkness, Elaine F. Harrison, Fiona Harvie, Michelle Howell, Anthony Jerrison, Andrew Machin, Matthew Maxwell, Anthony J. McWilliams, Lorna Payne, Katherine Qureshi, Nadeem Ruane, Helen Sampson, Sarah Stavrinos, Paula Thorpe, Emma Ulph, Fiona van Staa, Tjeerd Woof, Victoria Evans, D. Gareth BMC Cancer Study Protocol BACKGROUND: In principle, risk-stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE-approved more frequent screening and/ or chemoprevention for women who are at increased risk, but are unaware of this. We have developed BC-Predict, to be offered to women when invited to NHSBSP which collects information on risk factors (self-reported information on family history and hormone-related factors via questionnaire; mammographic density; and in a sub-sample, Single Nucleotide Polymorphisms). BC-Predict produces risk feedback letters, inviting women at high risk (≥8% 10-year) or moderate risk (≥5 to < 8% 10-year) to have discussion of prevention and early detection options at Family History, Risk and Prevention Clinics. Despite the promise of systems such as BC-Predict, there are still too many uncertainties for a fully-powered definitive trial to be appropriate or ethical. The present research aims to identify these key uncertainties regarding the feasibility of integrating BC-Predict into the NHSBSP. Key objectives of the present research are to quantify important potential benefits and harms, and identify key drivers of the relative cost-effectiveness of embedding BC-Predict into NHSBSP. METHODS: A non-randomised fully counterbalanced study design will be used, to include approximately equal numbers of women offered NHSBSP (n = 18,700) and BC-Predict (n = 18,700) from selected screening sites (n = 7). In the initial 8-month time period, women eligible for NHSBSP will be offered BC-Predict in four screening sites. Three screening sites will offer women usual NHSBSP. In the following 8-months the study sites offering usual NHSBSP switch to BC-Predict and vice versa. Key potential benefits including uptake of risk consultations, chemoprevention and additional screening will be obtained for both groups. Key potential harms such as increased anxiety will be obtained via self-report questionnaires, with embedded qualitative process analysis. A decision-analytic model-based cost-effectiveness analysis will identify the key uncertainties underpinning the relative cost-effectiveness of embedding BC-Predict into NHSBSP. DISCUSSION: We will assess the feasibility of integrating BC-Predict into the NHSBSP, and identify the main uncertainties for a definitive evaluation of the clinical and cost-effectiveness of BC-Predict. TRIAL REGISTRATION: Retrospectively registered with clinicaltrials.gov (NCT04359420). BioMed Central 2020-06-18 /pmc/articles/PMC7302349/ /pubmed/32552763 http://dx.doi.org/10.1186/s12885-020-07054-2 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol French, David P. Astley, Susan Brentnall, Adam R. Cuzick, Jack Dobrashian, Richard Duffy, Stephen W. Gorman, Louise S. Harkness, Elaine F. Harrison, Fiona Harvie, Michelle Howell, Anthony Jerrison, Andrew Machin, Matthew Maxwell, Anthony J. McWilliams, Lorna Payne, Katherine Qureshi, Nadeem Ruane, Helen Sampson, Sarah Stavrinos, Paula Thorpe, Emma Ulph, Fiona van Staa, Tjeerd Woof, Victoria Evans, D. Gareth What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420) |
title | What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420) |
title_full | What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420) |
title_fullStr | What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420) |
title_full_unstemmed | What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420) |
title_short | What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420) |
title_sort | what are the benefits and harms of risk stratified screening as part of the nhs breast screening programme? study protocol for a multi-site non-randomised comparison of bc-predict versus usual screening (nct04359420) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7302349/ https://www.ncbi.nlm.nih.gov/pubmed/32552763 http://dx.doi.org/10.1186/s12885-020-07054-2 |
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