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)
Abstract 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...
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| Format: | Article |
| Language: | English |
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BMC
2020-06-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-020-07054-2 |
| _version_ | 1818299304853372928 |
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| author | David P. French Susan Astley Adam R. Brentnall Jack Cuzick Richard Dobrashian Stephen W. Duffy Louise S. Gorman Elaine F. Harkness Fiona Harrison Michelle Harvie Anthony Howell Andrew Jerrison Matthew Machin Anthony J. Maxwell Lorna McWilliams Katherine Payne Nadeem Qureshi Helen Ruane Sarah Sampson Paula Stavrinos Emma Thorpe Fiona Ulph Tjeerd van Staa Victoria Woof D. Gareth Evans |
| author_facet | David P. French Susan Astley Adam R. Brentnall Jack Cuzick Richard Dobrashian Stephen W. Duffy Louise S. Gorman Elaine F. Harkness Fiona Harrison Michelle Harvie Anthony Howell Andrew Jerrison Matthew Machin Anthony J. Maxwell Lorna McWilliams Katherine Payne Nadeem Qureshi Helen Ruane Sarah Sampson Paula Stavrinos Emma Thorpe Fiona Ulph Tjeerd van Staa Victoria Woof D. Gareth Evans |
| author_sort | David P. French |
| collection | DOAJ |
| description | Abstract 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 ). |
| first_indexed | 2024-12-13T04:49:06Z |
| format | Article |
| id | doaj.art-64fd976f49ac4a6bbd0473151527d0c6 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-13T04:49:06Z |
| publishDate | 2020-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-64fd976f49ac4a6bbd0473151527d0c62022-12-21T23:59:04ZengBMCBMC Cancer1471-24072020-06-0120111410.1186/s12885-020-07054-2What 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)David P. French0Susan Astley1Adam R. Brentnall2Jack Cuzick3Richard Dobrashian4Stephen W. Duffy5Louise S. Gorman6Elaine F. Harkness7Fiona Harrison8Michelle Harvie9Anthony Howell10Andrew Jerrison11Matthew Machin12Anthony J. Maxwell13Lorna McWilliams14Katherine Payne15Nadeem Qureshi16Helen Ruane17Sarah Sampson18Paula Stavrinos19Emma Thorpe20Fiona Ulph21Tjeerd van Staa22Victoria Woof23D. Gareth Evans24Manchester Centre of Health Psychology, Division of Psychology and Mental Health, School of Health Sciences, University of ManchesterNIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation TrustCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of LondonCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of LondonEast Lancashire Hospitals NHS Trust, Royal Blackburn HospitalCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of LondonThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation TrustNIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation TrustPatient representativeNIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation TrustNIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation TrustResearch IT, IT Services, University of ManchesterDivision of Informatics, Imaging and Data Sciences, School of Health Sciences, University of ManchesterNIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation TrustManchester Centre of Health Psychology, Division of Psychology and Mental Health, School of Health Sciences, University of ManchesterDivision of Population Health, Health Services Research & Primary Care, School of Health Sciences, University of ManchesterSchool of Medicine, University of Nottingham, University ParkThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation TrustThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation TrustThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation TrustNIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation TrustManchester Centre of Health Psychology, Division of Psychology and Mental Health, School of Health Sciences, University of ManchesterDivision of Informatics, Imaging and Data Sciences, School of Health Sciences, University of ManchesterManchester Centre of Health Psychology, Division of Psychology and Mental Health, School of Health Sciences, University of ManchesterNIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation TrustAbstract 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 ).http://link.springer.com/article/10.1186/s12885-020-07054-2ScreeningBreast cancerRisk stratificationHigh riskPsychological impactEarly detection |
| spellingShingle | David P. French Susan Astley Adam R. Brentnall Jack Cuzick Richard Dobrashian Stephen W. Duffy Louise S. Gorman Elaine F. Harkness Fiona Harrison Michelle Harvie Anthony Howell Andrew Jerrison Matthew Machin Anthony J. Maxwell Lorna McWilliams Katherine Payne Nadeem Qureshi Helen Ruane Sarah Sampson Paula Stavrinos Emma Thorpe Fiona Ulph Tjeerd van Staa Victoria Woof D. Gareth Evans 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) BMC Cancer Screening Breast cancer Risk stratification High risk Psychological impact Early detection |
| 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 | Screening Breast cancer Risk stratification High risk Psychological impact Early detection |
| url | http://link.springer.com/article/10.1186/s12885-020-07054-2 |
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