The Brighter study. Breast Reconstruction: Investigating long term clinical and cost-effectiveness in the National Mastectomy and Breast Reconstruction Audit cohort.

The Brighter study aims to address the lack of clinical and cost effectiveness evidence to guide patients and clinicians when choosing treatment options following a mastectomy for breast cancer. This application is the first part of the Brighter Study and as such is a first steps of the study and is not a standalone application.

The purpose of the study is to enable better informed, more evidence-based treatment decisions to be made, to improve clinical outcomes for the 55,000+ women who are diagnosed with breast cancer in the UK each year (though the impact of the study will be worldwide) and facilitate optimum health resource allocation in the NHS and beyond. The primary objective of Brighter is to compare the long term clinical and cost effectiveness of implant based and autologous (pedicled and free flap) breast reconstruction to help patients, health professionals and commissioners make more informed decisions about reconstructive breast surgery. Secondary objectives are to compare outcomes in patients undergoing immediate and delayed breast reconstruction and to explore long term outcomes in patients undergoing mastectomy. The study has three parts: a clinical outcomes cohort study including the use of HES, a patient reported outcomes cohort study, and a cost effectiveness analysis. This application relates a clinical outcomes cohort study including the use of HES.

The Brighter cohort will be women (age 16+) and whose sex is registered as female with NHS Digital and who have had a mastectomy for invasive breast cancer or preinvasive (ductal carcinoma in situ) disease, or a delayed breast reconstruction following a previous breast cancer diagnosis in an NHS England setting between 1 January 2008 and 31 March 2009. The cohort (estimated to number around 16,000) will necessarily be identified using routine sources (HES / Personal Demographics Service) rather than a direct approach from clinicians or the study team. The cohort will be supplied with fair processing materials when they are contacted and asked to consent to the patient reported outcomes cohort study. The Confidentiality Advisory Group (20/CAG/0021) agree that there is no alternative to identifying the study cohort using routine health records. This will be the second part of the study and not this application.

University of Bristol’s justification for processing is GDPR Article 6 (1) (e): The processing necessary to perform this task is in the public interest and the task has a clear basis in law. This is an issue of patients choosing treatment options following a mastectomy for breast cancer allowing them to be better.

GDPR Article 9 (2)(j): processing is necessary for scientific research purposes and shall be proportionate to the aim pursued, respect the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The data requested will allow the study team to replicate the eligibility criteria of the National Mastectomy and Breast Reconstruction Audit (NMBRA) (Royal College of Surgeons) carried out in the UK in 2008/9. The NMBRA cohort was drawn from independent as well as NHS hospitals, and some NHS trusts outside of England. The Brighter study cohort will be drawn solely from NHS England patients so although there will be overlap between the NMBRA and Brighter cohorts they will not be the same. The data requested will allow the Brighter study team to invite the cohort to participate in the study. Using HES and a range of Patient Reported Outcomes Questionnaires (BREAST Q, EQ5D, ICECAP-A), long term (10 year) clinical and cost-effectiveness of various reconstruction types following a mastectomy for breast cancer can be evaluated.

The National Institute for Health Research (NIHR) has funded the Brighter study. Although the study adopts the eligibility criteria of the NMBRA there is no merging of any other data. Brighter is a stand-alone project, separate from any other study, and the data can be deleted when analysis is complete.

The Chief Investigator of Brighter is an Oncoplastic Breast Surgeon who is a substantive employee of the University of Bristol in her capacity as a Consultant Senior Lecturer in Oncoplastic Breast Surgery in the Bristol Centre for Surgical Research at the Bristol Medical School, University of Bristol. The Brighter study team are all substantive employees of the University of Bristol. As such the University of Bristol is the data controller, and also the Data Processor. Members of the Royal College of Surgeons are part of the study’s steering committee and act in advisory capacity only. They are not involved in the processing, and as such only aggregated disclosure-controlled output will be shared with them. Similarly, a statistician from the University of the West of England is also on the study steering committee to provide statistical advice to the study team but will not have access to, or be involved in, processing of identifiable data. As with other members of steering committee the statistician will access only aggregated disclosure controlled output, to advise on the statistical analysis of HES. No record level data will be shared with the statistician. The University of Bristol are the only organisation making the decision about how the personal data will be processed under this agreement.

The National Institute for Health Research (Research for Patient Benefit) are funding the project but are not actively involved in carrying the project out and will not have access to any identifiable data. Only aggregated output with small numbers suppressed in line with HES analysis guidelines will be shared with them.

Admitted Patient Care data is requested from the year before eligibility (2007/8) to the most recent extract to derive a one-year Charlson Comorbidity Index and to allow for ten year follow up analysis. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. To describe comorbidity all diagnostic and operation codes need to be included in the HES data. Outpatients data is requested but this will be minimised to 3 years from the eligibility dates as adjuvant therapy is the key information that is required from these data sets, and 3 years should be sufficient to obtain this and the contact details of the cohort are required from the Personal Demographic Service to allow the study team to contact the cohort and provide fair processing materials. To achieve sufficient statistical power, and to match as closely as possible the National Mastectomy and Breast Reconstruction cohort, requesting national data (NHS England) is necessary.

Dissemination will include reports, submissions to peer reviewed journals, and presentations at conferences . All outputs will be aggregated and disclosure controlled with small numbers suppressed in line with HES analysis guide.

To be specific, submissions reporting the findings from the clinical and patient-reported outcomes studies are planned to high-impact factor journals including but not restricted to ‘JAMA Surgery’, ‘Annals of Surgery’, ‘British Journal of Surgery’ and the ‘British Medical Journal’. The cost-effectiveness findings will additionally be targeted to appropriate specialist journals including ‘Health Economics’ and ‘Value in Health’. At least 4 publications are planned. It is anticipated that these outputs will be generated and submissions made within 6-12 months of completing the planned analyses. Timelines for publication will be dependent on the process of editorial review. A paper describing the study protocol has already been published in BMJ Open (Johnson et al. Protocol for a national cohort study to explore the long-term clinical and patient-reported outcomes and cost-effectiveness of implant-based and autologous breast reconstruction after mastectomy for breast cancer: the brighter study BMJ Open. 2021 Aug 18;11(8):e054055. doi: 10.1136/bmjopen-2021-054055)

Conference presentations are planned for national and international meetings in 2022/23, including but not limited to, the Association of Breast Surgery meeting (2022 and 2023) and San Antonio Breast Cancer Symposium (December 2022). An abstract reporting a preliminary analysis of patient-reported outcome data from the immediate breast reconstruction cohort has been accepted for oral presentation at the May 2022 Association of Breast Surgery meeting and will be published in the European Journal of Surgical Oncology (EJSO). Further conference submissions are planned within the next 6-18 months as the analysis progresses. All conference presentations will be dependent on COVID19 restrictions.

Lay summaries will be produced in collaboration with our patient steering group members and shared with Independent Cancer Patients’ Voice (IPCV) and breast cancer charities including Breast Cancer Now. IPCV will help disseminate the summaries and we will liaise with other charities to also help disseminate the summaries.

Executive summaries of key findings will be prepared and shared with commissioners of healthcare services locally and nationally; the National Institute of Health and Care Excellence, the Breast Clinical Expert Group and the All Party Parliamentary Group on Breast Cancer (APPGBC). The APPGBC has previously highlighted inequalities in access to reconstructive surgery across the UK (June 2018). Long-term clinical and cost-effectiveness data generated from the Brighter study will allow commissioners of healthcare services to make evidence-based decisions on the provision of breast reconstruction services. It is anticipated that evidence-based decisions will be fairer and more transparent and promote equality of access to reconstructive services across the UK.

Brighter Steering Group members are active members of the professional associations with leadership roles. The study team will work with the Association of Breast Surgery (ABS) (Potter, Brighter Chief Investigator, ABS Academic and Research Committee Secretary; Holcombe ABS President-elect), the British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) (O’Donoghue), the Royal College of Nursing (RGN) (Gulliver Clarke) to produce updated patient materials informed by the study’s findings. This will include producing 1-2 page patient summaries, in collaboration with patients, to be hosted on the patient-facing breast reconstruction information sections of the association websites. This information will include a summary of the long-term clinical and patient-reported outcomes of different approaches to breast reconstruction for women considering surgery and will help them to them make more informed decisions about their reconstructive options.

All outputs are planned for within 6-12 months of completion of the analysis.

Findings will be further disseminated to clinical colleagues, commissioners, the study participants and the public via social media (Twitter account), and the study website. Dissemination via social media channels will occur throughout the study.

As there was a delay in receiving the data, analysis is currently ongoing prior to publication so there are no yielded benefits to date. (The published paper in (iBMJ Open. 2021 Aug 18;11(8):e054055. doi: 10.1136/bmjopen-2021-054055) is a protocol paper, and publication of results is anticipated to yield the benefits).

The Brighter study aims to address the lack of clinical and cost effectiveness evidence to guide patients and clinicians when choosing treatment options following a mastectomy for breast cancer. This application is the first part of the Brighter Study and as such is a first steps of the study and is not a standalone application.

The purpose of the study is to enable better informed, more evidence-based treatment decisions to be made, to improve clinical outcomes for the 55,000+ women who are diagnosed with breast cancer in the UK each year (though the impact of the study will be worldwide) and facilitate optimum health resource allocation in the NHS and beyond. The primary objective of Brighter is to compare the long term clinical and cost effectiveness of implant based and autologous (pedicled and free flap) breast reconstruction to help patients, health professionals and commissioners make more informed decisions about reconstructive breast surgery. Secondary objectives are to compare outcomes in patients undergoing immediate and delayed breast reconstruction and to explore long term outcomes in patients undergoing mastectomy. The study has three parts: a clinical outcomes cohort study including the use of HES, a patient reported outcomes cohort study, and a cost effectiveness analysis. This application relates a clinical outcomes cohort study including the use of HES.

The Brighter cohort will be women (age 16+) and whose sex is registered as female with NHS Digital and who have had a mastectomy for invasive breast cancer or preinvasive (ductal carcinoma in situ) disease, or a delayed breast reconstruction following a previous breast cancer diagnosis in an NHS England setting between 1 January 2008 and 31 March 2009. The cohort (estimated to number around 16,000) will necessarily be identified using routine sources (HES / Personal Demographics Service) rather than a direct approach from clinicians or the study team. The cohort will be supplied with fair processing materials when they are contacted and asked to consent to the patient reported outcomes cohort study. The Confidentiality Advisory Group (20/CAG/0021) agree that there is no alternative to identifying the study cohort using routine health records. This will be the second part of the study and not this application.

University of Bristol’s justification for processing is GDPR Article 6 (1) (e): The processing necessary to perform this task is in the public interest and the task has a clear basis in law. This is an issue of patients choosing treatment options following a mastectomy for breast cancer allowing them to be better.

GDPR Article 9 (2)(j): processing is necessary for scientific research purposes and shall be proportionate to the aim pursued, respect the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The data requested will allow the study team to replicate the eligibility criteria of the National Mastectomy and Breast Reconstruction Audit (NMBRA) (Royal College of Surgeons) carried out in the UK in 2008/9. The NMBRA cohort was drawn from independent as well as NHS hospitals, and some NHS trusts outside of England. The Brighter study cohort will be drawn solely from NHS England patients so although there will be overlap between the NMBRA and Brighter cohorts they will not be the same. The data requested will allow the Brighter study team to invite the cohort to participate in the study. Using HES and a range of Patient Reported Outcomes Questionnaires (BREAST Q, EQ5D, ICECAP-A), long term (10 year) clinical and cost-effectiveness of various reconstruction types following a mastectomy for breast cancer can be evaluated.

The National Institute for Health Research (NIHR) has funded the Brighter study. Although the study adopts the eligibility criteria of the NMBRA there is no merging of any other data. Brighter is a stand-alone project, separate from any other study, and the data can be deleted when analysis is complete.

The Chief Investigator of Brighter is an Oncoplastic Breast Surgeon who is a substantive employee of the University of Bristol in her capacity as a Consultant Senior Lecturer in Oncoplastic Breast Surgery in the Bristol Centre for Surgical Research at the Bristol Medical School, University of Bristol. The Brighter study team are all substantive employees of the University of Bristol. As such the University of Bristol is the data controller, and also the Data Processor. Members of the Royal College of Surgeons are part of the study’s steering committee and act in advisory capacity only. They are not involved in the processing, and as such only aggregated disclosure-controlled output will be shared with them. Similarly, a statistician from the University of the West of England is also on the study steering committee to provide statistical advice to the study team but will not have access to, or be involved in, processing of identifiable data. As with other members of steering committee the statistician will access only aggregated disclosure controlled output, to advise on the statistical analysis of HES. No record level data will be shared with the statistician. The University of Bristol are the only organisation making the decision about how the personal data will be processed under this agreement.

The National Institute for Health Research (Research for Patient Benefit) are funding the project but are not actively involved in carrying the project out and will not have access to any identifiable data. Only aggregated output with small numbers suppressed in line with HES analysis guidelines will be shared with them.

Admitted Patient Care data is requested from the year before eligibility (2007/8) to the most recent extract to derive a one-year Charlson Comorbidity Index and to allow for ten year follow up analysis. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. To describe comorbidity all diagnostic and operation codes need to be included in the HES data. Outpatients data is requested but this will be minimised to 3 years from the eligibility dates as adjuvant therapy is the key information that is required from these data sets, and 3 years should be sufficient to obtain this and the contact details of the cohort are required from the Personal Demographic Service to allow the study team to contact the cohort and provide fair processing materials. To achieve sufficient statistical power, and to match as closely as possible the National Mastectomy and Breast Reconstruction cohort, requesting national data (NHS England) is necessary.

Dissemination will include reports, submissions to peer reviewed journals, and presentations at conferences . All outputs will be aggregated and disclosure controlled with small numbers suppressed in line with HES analysis guide.

To be specific, submissions reporting the findings from the clinical and patient-reported outcomes studies are planned to high-impact factor journals including but not restricted to ‘JAMA Surgery’, ‘Annals of Surgery’, ‘British Journal of Surgery’ and the ‘British Medical Journal’. The cost-effectiveness findings will additionally be targeted to appropriate specialist journals including ‘Health Economics’ and ‘Value in Health’. At least 4 publications are planned. It is anticipated that these outputs will be generated and submissions made within 6-12 months of completing the planned analyses. Timelines for publication will be dependent on the process of editorial review.

Conference presentations are planned for national and international meetings, including but not limited to, the Association of Breast Surgery meeting (May 2021) and San Antonio Breast Cancer Symposium (December 2021). The timing of conference submission will depend on the timelines for delivery of data. It is anticipated that conferences in 2021/22 will be targeted. All conference presentations will be dependent on COVID19 restrictions.

Lay summaries will be produced in collaboration with our patient steering group members and shared with Independent Cancer Patients’ Voice (IPCV) and breast cancer charities including Breast Cancer Now. IPCV will help disseminate the summaries and we will liaise with other charities to also help disseminate the summaries.

Executive summaries of key findings will be prepared and shared with commissioners of healthcare services locally and nationally; the National Institute of Health and Care Excellence, the Breast Clinical Expert Group and the All Party Parliamentary Group on Breast Cancer (APPGBC). The APPGBC has previously highlighted inequalities in access to reconstructive surgery across the UK (June 2018). Long-term clinical and cost-effectiveness data generated from the Brighter study will allow commissioners of healthcare services to make evidence-based decisions on the provision of breast reconstruction services. It is anticipated that evidence-based decisions will be fairer and more transparent and promote equality of access to reconstructive services across the UK.

Brighter Steering Group members are active members of the professional associations with leadership roles. The study team will work with the Association of Breast Surgery (ABS) (Potter, Brighter Chief Investigator, ABS Academic and Research Committee Secretary; Holcombe ABS President-elect), the British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) (O’Donoghue), the Royal College of Nursing (RGN) (Gulliver Clarke) to produce updated patient materials informed by the study’s findings. This will include producing 1-2 page patient summaries, in collaboration with patients, to be hosted on the patient-facing breast reconstruction information sections of the association websites. This information will include a summary of the long-term clinical and patient-reported outcomes of different approaches to breast reconstruction for women considering surgery and will help them to them make more informed decisions about their reconstructive options.

All outputs are planned for within 6-12 months of completion of the analysis.

Findings will be further disseminated to clinical colleagues, commissioners, the study participants and the public via social media (Twitter account), and the study website. Dissemination via social media channels will occur throughout the study.

Yielded Benefits is not a requirement for new applications.