Nicola Mills - Academia.edu (original) (raw)

Papers by Nicola Mills

Research paper thumbnail of #11 The Pre-Bra Study (oral presentation)

International Journal of Surgery, Nov 1, 2018

Background: There are a number of ethical concerns when discussing surgical innovation including ... more Background: There are a number of ethical concerns when discussing surgical innovation including accountability, harms to patients and conflicts of interest. Whilst some preliminary research has been undertaken to conceptualise surgical innovation, and its identifiable ethical issues, and some discussion has arisen as a result of new surgical procedures going wrong, it is unclear if innovation has been discussed in sufficient detail. Aim: To explore how the regulation of innovation within surgery has been discussed within the literature. Methods: A critical interpretative synthesis was conducted. Four databases (PubMed, Westlaw, JSTOR and HeinOnline) were searched to identify literature on the topic. The literature was screened in four stages, and the principles of theoretical sampling used to select literature for review from the screened results. Key extracts were highlighted and coded, and then aggregated into themes. Results: The search yielded 54 documents for review. Four main themes were identified: criticisms of current regulation, the driving factors behind innovation, what reform must do (should the current regulatory system change), and further examination of proposed alternative regulatory models (which include responsive regulation, meta-regulation, triple-loop learning and detailed reporting). The review also identified a gap in the literature, with the views of patients not being voiced. These opinions should be explored in more detail. Conclusion: The regulation, governance and associated ethical issues pertaining to surgical innovation have not been discussed in sufficient detail, and more discussion regarding regulatory reform is necessary.

Research paper thumbnail of The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction

BMJ Open, 2020

, et al. The Pre-BRA (prepectoral Breast Reconstruction EvAluation) feasibility study: protocol f... more , et al. The Pre-BRA (prepectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction. BMJ Open 2020;10:e033641.

Research paper thumbnail of Exploring information provision in reconstructive breast surgery: A qualitative study

The Breast, Dec 1, 2015

Women considering reconstructive breast surgery (RBS) require adequate information to make inform... more Women considering reconstructive breast surgery (RBS) require adequate information to make informed treatment decisions. This study explored patients' and health professionals' (HPs) perceptions of the adequacy of information provided for decision-making in RBS. Semi-structured interviews with a purposive sample of patients who had undergone RBS and HPs providing specialist care explored participants' experiences of information provision prior to RBS. Professionals reported providing standardised verbal, written and photographic information about the process and outcomes of surgery. Women, by contrast, reported varying levels of information provision. Some felt fully-informed but others perceived they had received insufficient information about available treatment options or possible outcomes of surgery to make an informed decision. Women need adequate information to make informed decisions about RBS and current practice may not meet women's needs. Minimum agreed standards of information provision, especially about alternative types of reconstruction, are recommended to improve decision-making in RBS.

Research paper thumbnail of Exploring inequalities in access to care and the provision of choice to women seeking breast reconstruction surgery: a qualitative study

British Journal of Cancer, Aug 8, 2013

Background: Breast reconstruction (BR) may improve psychosocial and cosmetic outcomes after maste... more Background: Breast reconstruction (BR) may improve psychosocial and cosmetic outcomes after mastectomy for breast cancer but currently, few women opt for surgery. Reasons for this are unclear. The aim of this qualitative study was to explore access to care and the provision of procedure choice to women seeking reconstructive surgery. Methods: Semi-structured interviews with a purposive sample of patients who had undergone BR and professionals providing specialist care explored participants' experiences of information provision before BR. Interviews were transcribed verbatim and analysed using the constant comparative technique of grounded theory. Sampling, data collection and analysis were performed concurrently and iteratively until data saturation was achieved. Results: Both patients and professionals expressed concerns about the provision of adequate procedure choice and access to care. Lack of information and/or time, involvement in decision making and issues relating to the evolution and organisation of reconstructive services, emerged as potential explanations for the inequalities seen. Interventions to improve cross-speciality collaboration were proposed to address these issues. Conclusion: Inequalities in the provision of choice in BR exist, which may be explained by a lack of integration between surgical specialities. Pathway restructuring, service reorganisation and standardisation of training may enhance cross-speciality collaboration and improve the patient experience.

Research paper thumbnail of Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

Trials, Mar 14, 2014

Background: Well-designed randomised clinical trials (RCTs) provide the best evidence to inform d... more Background: Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons' preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons' views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons' preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Methods: Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Results: Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel 'in equipoise', they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. Conclusion: There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required.

Research paper thumbnail of 26. Early results from the Pre-BRA IDEAL 2a/2b prospective multicentre cohort study to evaluate the safety and effectiveness of prepectoral breast reconstruction

Research paper thumbnail of P119. Designing a definitive randomised clinical trial in implant-based breast reconstruction: A qualitative study

Ejso, May 1, 2019

surgery is known to lead to low self-esteem and poor body image. The aim of this study is to iden... more surgery is known to lead to low self-esteem and poor body image. The aim of this study is to identify if lipofilling improves patient satisfaction. Methods: This retrospective study included all patients undergoing lipofilling at a single institution between September 2014 and February 2018 (n¼76). Patients received two validated questionnaires (Breast-Q and Sexual Adjustment and Body Image Scale) to measure health-related quality of life and patient satisfaction before and after lipofilling. Data was summarized with simple descriptive statistics. Differences between the scores were tested for statistical significance using the Wilcoxon test for paired samples. Appropriate divisional ethical approval was obtained to undertake study. Results: 101 procedures were performed in 76 patients. 32 completed questionnaires returned; a response rate of 42%. Lipofilling improves psychosocial wellbeing significantly across multiple areas including patients level of confidence (p¼0.0001), feeling of normality (p¼0.0002) and femininity (p¼0.0002). Reported outcomes concentrating on satisfaction with breasts highlights improved satisfaction when looking in the mirror clothed (p¼0.0001) and unclothed (p¼0.0001). Our patients report that they feel more satisfied in their clothes following lipofilling (p¼<0.0001), that they are able to wear more fitted clothes (p¼0.004) and an improved softness of the breast is enhanced (p¼0.0002). Conclusion: Lipofilling significantly improves a patient's psychosocial wellbeing and satisfaction with their breasts following surgery. Lipofilling is a useful tool to help improve low self-esteem in breast cancer patients.

Research paper thumbnail of Patient-reported outcomes of prepectoral implant-based breast reconstruction: Early results from the pre-bra prospective multi-centre cohort study

Research paper thumbnail of Improving the patient journey in breast reconstruction: A qualitative study

Ejso, May 1, 2012

Introduction: We audited length of stay (LofS) after breast surgery [breast conserving surgery (B... more Introduction: We audited length of stay (LofS) after breast surgery [breast conserving surgery (BCT) or mastectomy (Mx)] for three consecutive years and implemented interventions to reduce the LofS in our hospital in line with national policy. Methods: Data were collected from the electronic patient record and interviews with nursing staff and patients. The first audit identified the existing LofS and triggers for prolonged hospital stay. Between the first and second audits, education sessions were held with ward, pre-operative assessment, district and breast care nurses. Further education sessions to reiterate the benefits of reduced LofS were delivered after the second audit. During the third audit, patients were interviewed about their views on discharge and community care, and patient factors correlating with increased hospital stay were identified.

Research paper thumbnail of Understanding decision-making for reconstructive breast surgery: A qualitative study

Research paper thumbnail of Investigation of the feasibility of clinical trials in breast reconstruction

The Lancet, Feb 1, 2013

ABSTRACT Breast cancer affects one in eight women and approximately 40% will require a mastectomy... more ABSTRACT Breast cancer affects one in eight women and approximately 40% will require a mastectomy. The loss of a breast can dramatically impact upon quality of life. Breast reconstruction is offered to improve outcomes. Making decisions about reconstructive surgery, however, is challenging, and women and health-care professionals need to assess the likely benefits of surgery against the risks of adverse outcomes. Decisions are informed by published outcomes and surgeon and patient preferences. Well-designed studies, such as multicentre, randomised, controlled trials (RCTs) provide the best evidence, but few RCTs have been undertaken in breast reconstruction. The aim of this study was therefore to explore the need for and the feasibility of RCTs in breast reconstruction.

Research paper thumbnail of 26. Early results from the Pre-BRA IDEAL 2a/2b prospective multicentre cohort study to evaluate the safety and effectiveness of prepectoral breast reconstruction

European Journal of Surgical Oncology, 2021

Research paper thumbnail of Protocol for a mixed-method study to inform the feasibility of undertaking a large-scale multicentre study comparing the clinical and patient-reported outcomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction in women unsuitable fo...

BMJ Open, 2021

IntroductionApproximately 40% of the 55 000 women diagnosed with breast cancer each year in the U... more IntroductionApproximately 40% of the 55 000 women diagnosed with breast cancer each year in the UK undergo mastectomy because they are considered unsuitable for standard breast-conserving surgery (BCS) due to tumour size or multiple tumour foci. Mastectomy can significantly impact women’s quality of life, and only one in four women currently undergo immediate breast reconstruction (IBR).Level 2 oncoplastic breast-conserving surgery (OPBCS) combines removing the cancer with a range of plastic surgical volume replacement (eg, local perforator flaps) and volume displacement techniques (eg, therapeutic mammaplasty) that can extend the role of BCS and may allow some women not suitable for standard BCS to avoid mastectomy. High-quality research to determine whether OPBCS offers a safe and effective alternative to mastectomy±IBR is currently lacking. Preliminary work is needed to ensure a future large-scale study is feasible and well designed and addresses questions important to patients a...

Research paper thumbnail of Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy

BMJ Open, 2021

BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructiv... more BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to d...

Research paper thumbnail of Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study

Trials, 2020

Background Implant-based breast reconstruction (IBBR) is the most commonly performed breast recon... more Background Implant-based breast reconstruction (IBBR) is the most commonly performed breast reconstruction technique worldwide but the technique is evolving rapidly. High-quality evidence is needed to support practice. Randomised controlled trials (RCTs) provide the best evidence but can be challenging to conduct. iBRA is a four-phased study which aimed to inform the feasibility, design and conduct of an RCT in IBBR. In phase 3, the randomisation acceptability study, an electronic survey and qualitative interviews were conducted to explore professionals’ perceptions of future trials in IBBR. Findings from the interviews are presented here. Methods Semi-structured qualitative interviews were undertaken with a purposive sample of 31 health professionals (HPs) who completed the survey to explore their attitudes to the feasibility of potential RCTs in more detail. All interviews were transcribed verbatim and data were analysed thematically using constant comparative techniques. Sampling...

Research paper thumbnail of The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction

BMJ Open, 2020

IntroductionImplant-based breast reconstruction is the most commonly performed reconstructive tec... more IntroductionImplant-based breast reconstruction is the most commonly performed reconstructive technique worldwide. Subpectoral reconstruction with mesh is the current standard of care but new prepectoral techniques have recently been introduced. Prepectoral breast reconstruction (PPBR) may improve outcomes for patients but robust evaluation is required. Randomised clinical trials (RCTs) are ideally needed but the short-term safety of PPBR is yet to be established; the technique and its indications are evolving and it has yet to be adopted by a sufficient number of surgeons for an RCT to be feasible.The Pre-BRA study aims to determine the feasibility of using mixed-methods within an IDEAL 2a/2b (IDEAL, Idea-Development-Exploration-Assessment-Long-term) study to explore the short-term safety of PPBR and determine when the technique is sufficiently stable for evaluation in a pragmatic RCT.Methods and analysisPre-BRA is an IDEAL stage 2a/2b prospective multicentre cohort study with embe...

Research paper thumbnail of Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study

The Lancet Oncology, 2019

Background Use of biological or synthetic mesh might improve outcomes of immediate implant-based ... more Background Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques. Methods In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281.

Research paper thumbnail of The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction

Pilot and Feasibility Studies, 2016

Background: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstruct... more Background: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR. Methods/design: The iBRA study is a trainee-led research collaborative project with four phases:

Research paper thumbnail of The IBRA (implant breast reconstruction evaluation) study: a prospective multicentre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new approaches to implant-based breast reconstruction

Trials, 2015

Potter and Blazeby: The IBRA (implant breast reconstruction evaluation) study: a prospective mult... more Potter and Blazeby: The IBRA (implant breast reconstruction evaluation) study: a prospective multicentre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new approaches to implant-based breast reconstruction. Trials 2015 16(Suppl 2):P12.

Research paper thumbnail of Exploring information provision in reconstructive breast surgery: A qualitative study

The Breast, 2015

Women considering reconstructive breast surgery (RBS) require adequate information to make inform... more Women considering reconstructive breast surgery (RBS) require adequate information to make informed treatment decisions. This study explored patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; and health professionals&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; (HPs) perceptions of the adequacy of information provided for decision-making in RBS. Semi-structured interviews with a purposive sample of patients who had undergone RBS and HPs providing specialist care explored participants&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; experiences of information provision prior to RBS. Professionals reported providing standardised verbal, written and photographic information about the process and outcomes of surgery. Women, by contrast, reported varying levels of information provision. Some felt fully-informed but others perceived they had received insufficient information about available treatment options or possible outcomes of surgery to make an informed decision. Women need adequate information to make informed decisions about RBS and current practice may not meet women&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s needs. Minimum agreed standards of information provision, especially about alternative types of reconstruction, are recommended to improve decision-making in RBS.

Research paper thumbnail of #11 The Pre-Bra Study (oral presentation)

International Journal of Surgery, Nov 1, 2018

Background: There are a number of ethical concerns when discussing surgical innovation including ... more Background: There are a number of ethical concerns when discussing surgical innovation including accountability, harms to patients and conflicts of interest. Whilst some preliminary research has been undertaken to conceptualise surgical innovation, and its identifiable ethical issues, and some discussion has arisen as a result of new surgical procedures going wrong, it is unclear if innovation has been discussed in sufficient detail. Aim: To explore how the regulation of innovation within surgery has been discussed within the literature. Methods: A critical interpretative synthesis was conducted. Four databases (PubMed, Westlaw, JSTOR and HeinOnline) were searched to identify literature on the topic. The literature was screened in four stages, and the principles of theoretical sampling used to select literature for review from the screened results. Key extracts were highlighted and coded, and then aggregated into themes. Results: The search yielded 54 documents for review. Four main themes were identified: criticisms of current regulation, the driving factors behind innovation, what reform must do (should the current regulatory system change), and further examination of proposed alternative regulatory models (which include responsive regulation, meta-regulation, triple-loop learning and detailed reporting). The review also identified a gap in the literature, with the views of patients not being voiced. These opinions should be explored in more detail. Conclusion: The regulation, governance and associated ethical issues pertaining to surgical innovation have not been discussed in sufficient detail, and more discussion regarding regulatory reform is necessary.

Research paper thumbnail of The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction

BMJ Open, 2020

, et al. The Pre-BRA (prepectoral Breast Reconstruction EvAluation) feasibility study: protocol f... more , et al. The Pre-BRA (prepectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction. BMJ Open 2020;10:e033641.

Research paper thumbnail of Exploring information provision in reconstructive breast surgery: A qualitative study

The Breast, Dec 1, 2015

Women considering reconstructive breast surgery (RBS) require adequate information to make inform... more Women considering reconstructive breast surgery (RBS) require adequate information to make informed treatment decisions. This study explored patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; and health professionals&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; (HPs) perceptions of the adequacy of information provided for decision-making in RBS. Semi-structured interviews with a purposive sample of patients who had undergone RBS and HPs providing specialist care explored participants&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; experiences of information provision prior to RBS. Professionals reported providing standardised verbal, written and photographic information about the process and outcomes of surgery. Women, by contrast, reported varying levels of information provision. Some felt fully-informed but others perceived they had received insufficient information about available treatment options or possible outcomes of surgery to make an informed decision. Women need adequate information to make informed decisions about RBS and current practice may not meet women&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s needs. Minimum agreed standards of information provision, especially about alternative types of reconstruction, are recommended to improve decision-making in RBS.

Research paper thumbnail of Exploring inequalities in access to care and the provision of choice to women seeking breast reconstruction surgery: a qualitative study

British Journal of Cancer, Aug 8, 2013

Background: Breast reconstruction (BR) may improve psychosocial and cosmetic outcomes after maste... more Background: Breast reconstruction (BR) may improve psychosocial and cosmetic outcomes after mastectomy for breast cancer but currently, few women opt for surgery. Reasons for this are unclear. The aim of this qualitative study was to explore access to care and the provision of procedure choice to women seeking reconstructive surgery. Methods: Semi-structured interviews with a purposive sample of patients who had undergone BR and professionals providing specialist care explored participants' experiences of information provision before BR. Interviews were transcribed verbatim and analysed using the constant comparative technique of grounded theory. Sampling, data collection and analysis were performed concurrently and iteratively until data saturation was achieved. Results: Both patients and professionals expressed concerns about the provision of adequate procedure choice and access to care. Lack of information and/or time, involvement in decision making and issues relating to the evolution and organisation of reconstructive services, emerged as potential explanations for the inequalities seen. Interventions to improve cross-speciality collaboration were proposed to address these issues. Conclusion: Inequalities in the provision of choice in BR exist, which may be explained by a lack of integration between surgical specialities. Pathway restructuring, service reorganisation and standardisation of training may enhance cross-speciality collaboration and improve the patient experience.

Research paper thumbnail of Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

Trials, Mar 14, 2014

Background: Well-designed randomised clinical trials (RCTs) provide the best evidence to inform d... more Background: Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons' preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons' views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons' preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Methods: Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Results: Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel 'in equipoise', they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. Conclusion: There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required.

Research paper thumbnail of 26. Early results from the Pre-BRA IDEAL 2a/2b prospective multicentre cohort study to evaluate the safety and effectiveness of prepectoral breast reconstruction

Research paper thumbnail of P119. Designing a definitive randomised clinical trial in implant-based breast reconstruction: A qualitative study

Ejso, May 1, 2019

surgery is known to lead to low self-esteem and poor body image. The aim of this study is to iden... more surgery is known to lead to low self-esteem and poor body image. The aim of this study is to identify if lipofilling improves patient satisfaction. Methods: This retrospective study included all patients undergoing lipofilling at a single institution between September 2014 and February 2018 (n¼76). Patients received two validated questionnaires (Breast-Q and Sexual Adjustment and Body Image Scale) to measure health-related quality of life and patient satisfaction before and after lipofilling. Data was summarized with simple descriptive statistics. Differences between the scores were tested for statistical significance using the Wilcoxon test for paired samples. Appropriate divisional ethical approval was obtained to undertake study. Results: 101 procedures were performed in 76 patients. 32 completed questionnaires returned; a response rate of 42%. Lipofilling improves psychosocial wellbeing significantly across multiple areas including patients level of confidence (p¼0.0001), feeling of normality (p¼0.0002) and femininity (p¼0.0002). Reported outcomes concentrating on satisfaction with breasts highlights improved satisfaction when looking in the mirror clothed (p¼0.0001) and unclothed (p¼0.0001). Our patients report that they feel more satisfied in their clothes following lipofilling (p¼<0.0001), that they are able to wear more fitted clothes (p¼0.004) and an improved softness of the breast is enhanced (p¼0.0002). Conclusion: Lipofilling significantly improves a patient's psychosocial wellbeing and satisfaction with their breasts following surgery. Lipofilling is a useful tool to help improve low self-esteem in breast cancer patients.

Research paper thumbnail of Patient-reported outcomes of prepectoral implant-based breast reconstruction: Early results from the pre-bra prospective multi-centre cohort study

Research paper thumbnail of Improving the patient journey in breast reconstruction: A qualitative study

Ejso, May 1, 2012

Introduction: We audited length of stay (LofS) after breast surgery [breast conserving surgery (B... more Introduction: We audited length of stay (LofS) after breast surgery [breast conserving surgery (BCT) or mastectomy (Mx)] for three consecutive years and implemented interventions to reduce the LofS in our hospital in line with national policy. Methods: Data were collected from the electronic patient record and interviews with nursing staff and patients. The first audit identified the existing LofS and triggers for prolonged hospital stay. Between the first and second audits, education sessions were held with ward, pre-operative assessment, district and breast care nurses. Further education sessions to reiterate the benefits of reduced LofS were delivered after the second audit. During the third audit, patients were interviewed about their views on discharge and community care, and patient factors correlating with increased hospital stay were identified.

Research paper thumbnail of Understanding decision-making for reconstructive breast surgery: A qualitative study

Research paper thumbnail of Investigation of the feasibility of clinical trials in breast reconstruction

The Lancet, Feb 1, 2013

ABSTRACT Breast cancer affects one in eight women and approximately 40% will require a mastectomy... more ABSTRACT Breast cancer affects one in eight women and approximately 40% will require a mastectomy. The loss of a breast can dramatically impact upon quality of life. Breast reconstruction is offered to improve outcomes. Making decisions about reconstructive surgery, however, is challenging, and women and health-care professionals need to assess the likely benefits of surgery against the risks of adverse outcomes. Decisions are informed by published outcomes and surgeon and patient preferences. Well-designed studies, such as multicentre, randomised, controlled trials (RCTs) provide the best evidence, but few RCTs have been undertaken in breast reconstruction. The aim of this study was therefore to explore the need for and the feasibility of RCTs in breast reconstruction.

Research paper thumbnail of 26. Early results from the Pre-BRA IDEAL 2a/2b prospective multicentre cohort study to evaluate the safety and effectiveness of prepectoral breast reconstruction

European Journal of Surgical Oncology, 2021

Research paper thumbnail of Protocol for a mixed-method study to inform the feasibility of undertaking a large-scale multicentre study comparing the clinical and patient-reported outcomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction in women unsuitable fo...

BMJ Open, 2021

IntroductionApproximately 40% of the 55 000 women diagnosed with breast cancer each year in the U... more IntroductionApproximately 40% of the 55 000 women diagnosed with breast cancer each year in the UK undergo mastectomy because they are considered unsuitable for standard breast-conserving surgery (BCS) due to tumour size or multiple tumour foci. Mastectomy can significantly impact women’s quality of life, and only one in four women currently undergo immediate breast reconstruction (IBR).Level 2 oncoplastic breast-conserving surgery (OPBCS) combines removing the cancer with a range of plastic surgical volume replacement (eg, local perforator flaps) and volume displacement techniques (eg, therapeutic mammaplasty) that can extend the role of BCS and may allow some women not suitable for standard BCS to avoid mastectomy. High-quality research to determine whether OPBCS offers a safe and effective alternative to mastectomy±IBR is currently lacking. Preliminary work is needed to ensure a future large-scale study is feasible and well designed and addresses questions important to patients a...

Research paper thumbnail of Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy

BMJ Open, 2021

BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructiv... more BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to d...

Research paper thumbnail of Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study

Trials, 2020

Background Implant-based breast reconstruction (IBBR) is the most commonly performed breast recon... more Background Implant-based breast reconstruction (IBBR) is the most commonly performed breast reconstruction technique worldwide but the technique is evolving rapidly. High-quality evidence is needed to support practice. Randomised controlled trials (RCTs) provide the best evidence but can be challenging to conduct. iBRA is a four-phased study which aimed to inform the feasibility, design and conduct of an RCT in IBBR. In phase 3, the randomisation acceptability study, an electronic survey and qualitative interviews were conducted to explore professionals’ perceptions of future trials in IBBR. Findings from the interviews are presented here. Methods Semi-structured qualitative interviews were undertaken with a purposive sample of 31 health professionals (HPs) who completed the survey to explore their attitudes to the feasibility of potential RCTs in more detail. All interviews were transcribed verbatim and data were analysed thematically using constant comparative techniques. Sampling...

Research paper thumbnail of The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction

BMJ Open, 2020

IntroductionImplant-based breast reconstruction is the most commonly performed reconstructive tec... more IntroductionImplant-based breast reconstruction is the most commonly performed reconstructive technique worldwide. Subpectoral reconstruction with mesh is the current standard of care but new prepectoral techniques have recently been introduced. Prepectoral breast reconstruction (PPBR) may improve outcomes for patients but robust evaluation is required. Randomised clinical trials (RCTs) are ideally needed but the short-term safety of PPBR is yet to be established; the technique and its indications are evolving and it has yet to be adopted by a sufficient number of surgeons for an RCT to be feasible.The Pre-BRA study aims to determine the feasibility of using mixed-methods within an IDEAL 2a/2b (IDEAL, Idea-Development-Exploration-Assessment-Long-term) study to explore the short-term safety of PPBR and determine when the technique is sufficiently stable for evaluation in a pragmatic RCT.Methods and analysisPre-BRA is an IDEAL stage 2a/2b prospective multicentre cohort study with embe...

Research paper thumbnail of Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study

The Lancet Oncology, 2019

Background Use of biological or synthetic mesh might improve outcomes of immediate implant-based ... more Background Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques. Methods In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281.

Research paper thumbnail of The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction

Pilot and Feasibility Studies, 2016

Background: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstruct... more Background: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR. Methods/design: The iBRA study is a trainee-led research collaborative project with four phases:

Research paper thumbnail of The IBRA (implant breast reconstruction evaluation) study: a prospective multicentre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new approaches to implant-based breast reconstruction

Trials, 2015

Potter and Blazeby: The IBRA (implant breast reconstruction evaluation) study: a prospective mult... more Potter and Blazeby: The IBRA (implant breast reconstruction evaluation) study: a prospective multicentre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new approaches to implant-based breast reconstruction. Trials 2015 16(Suppl 2):P12.

Research paper thumbnail of Exploring information provision in reconstructive breast surgery: A qualitative study

The Breast, 2015

Women considering reconstructive breast surgery (RBS) require adequate information to make inform... more Women considering reconstructive breast surgery (RBS) require adequate information to make informed treatment decisions. This study explored patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; and health professionals&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; (HPs) perceptions of the adequacy of information provided for decision-making in RBS. Semi-structured interviews with a purposive sample of patients who had undergone RBS and HPs providing specialist care explored participants&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; experiences of information provision prior to RBS. Professionals reported providing standardised verbal, written and photographic information about the process and outcomes of surgery. Women, by contrast, reported varying levels of information provision. Some felt fully-informed but others perceived they had received insufficient information about available treatment options or possible outcomes of surgery to make an informed decision. Women need adequate information to make informed decisions about RBS and current practice may not meet women&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s needs. Minimum agreed standards of information provision, especially about alternative types of reconstruction, are recommended to improve decision-making in RBS.