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 for standard breast-conserving surgery (the ANTHEM Feasibility Study)

Abstract

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 and the National Health Service.Methods and analysisMixed methods will be used to inform feasibility and design of a future large-scale study comparing the clinical effectiveness and cost-effectiveness of OPBCS and mastectomy±IBR. It will have four parts: (1) a National Practice Questionnaire to determine current practice and provision of oncoplastic breast and reconstructive surgery in the UK; (2) a pilot multicentre prospective cohort study to explore the proportion of patients choosing OPBCS versus mastectomy, the proportion in OPBCS is successful and clinical and patient-reported outcomes of different techniques at 3 and 12 months postsurgery; (3) a qualitative interview study to explore patients’ attitudes to different procedures, rationale for decision-making and perceptions of outcomes; and (4) design of the future study.All centres offering OPBCS and mastectomy in the UK will be invited to participate. Recruitment is planned to commence winter 2020 and continue for 12 months.Ethics and disseminationThe study has ethical approval from the Wales Research Ethics Committee 6 National Research Ethics Service (REC Ref 20/WA/0225). Results will be presented at national and international meetings and published in peer-reviewed journals. We will work with patients to develop lay summaries and share these through patient groups and breast cancer charities.Trial registration numberISRCTN18238549.

Current practice and provision of oncoplastic breast-conserving surgery in the UK: results of the ANTHEM national practice questionnaire

“…High-quality evidence is urgently needed to determine whether OPBCS is a better option than mastectomy (± IBR) for women not suitable for standard BCS. This survey is the first part of the ongoing ANTHEM study which will use mixed methods to inform the feasibility and design of a future large-scale study [ 12 ]. Phase 2, the prospective cohort study has recruited over 380 patients from 35 centres across the UK who have undergone either OPBCS or mastectomy (± IBR) and qualitative interviews will explore the experiences of this group.…”

“…The ANTHEM feasibility study [ 12 ] aims to inform the design of a future large-scale study. It has four parts: (1) National practice questionnaire (NPQ), (2) pilot prospective cohort study, (3) qualitative interview study and (4) design of future study [ 12 ].…”

“…The ANTHEM feasibility study [ 12 ] aims to inform the design of a future large-scale study. It has four parts: (1) National practice questionnaire (NPQ), (2) pilot prospective cohort study, (3) qualitative interview study and (4) design of future study [ 12 ]. We report here the results of the first part of the ANTHEM feasibility study, the NPQ which aimed to survey breast and plastic surgical units across the UK to comprehensively describe the current practice and provision of OPBCS (TM/LPF) to help inform future study design.…”

Understanding decision-making for and against oncoplastic breast-conserving surgery as an alternative to a mastectomy in early breast cancer: UK ANTHEM qualitative study

“…The ANTHEM study (ISRCTN18238549) explored the feasibility of undertaking a large-scale study comparing the clinical effectiveness and cost-effectiveness of OPBCS as an alternative to a mastectomy with or without IBR in women offered both options 19 . The qualitative phase of this study used semi-structured interviews to explore women’s perceptions of surgical choice and to understand factors influencing surgical decision-making for and against OPBCS.…”

A Machine Vision Anomaly Detection System to Industry 4.0 Based on Variational Fuzzy Autoencoder

“…The industrial environment consists of scattered heterogeneous nodes that exchange information through a common automated communication infrastructure. In this context, the complexity increases exponentially as the number of interconnected systems expands [ 10 ].…”