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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).

作者信息

Davies Charlotte, Holcombe Christopher, Skillman Joanna, Whisker Lisa, Hollingworth William, Conefrey Carmel, Mills Nicola, White Paul, Comins Charles, Macmillan Douglas, Fairbrother Patricia, Potter Shelley

机构信息

Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, UK

Linda McCartney Breast Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.

出版信息

BMJ Open. 2021 Apr 16;11(4):e046622. doi: 10.1136/bmjopen-2020-046622.


DOI:10.1136/bmjopen-2020-046622
PMID:33863715
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8055121/
Abstract

INTRODUCTION: Approximately 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 ANALYSIS: Mixed 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 DISSEMINATION: The 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 NUMBER: ISRCTN18238549.

摘要

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[2]
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[3]
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Br J Surg. 2024-6-12

[4]
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本文引用的文献

[1]
Six-year experience of oncoplastic volume replacement using local perforator flaps.

J Plast Reconstr Aesthet Surg. 2021-9

[2]
Therapeutic mammaplasty is a safe and effective alternative to mastectomy with or without immediate breast reconstruction.

Br J Surg. 2020-6

[3]
The use of micro-costing in economic analyses of surgical interventions: a systematic review.

Health Econ Rev. 2020-1-29

[4]
Development and Validation of the BREAST-Q Breast-Conserving Therapy Module.

Ann Surg Oncol. 2020-7

[5]
Oncoplastic Volume Replacement for Breast Cancer: Latissimus Dorsi Flap versus Thoracodorsal Artery Perforator Flap.

Plast Reconstr Surg Glob Open. 2019-10-30

[6]
The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study.

Br J Cancer. 2019-3-29

[7]
A cost-utility analysis comparing large volume displacement oncoplastic surgery to mastectomy with free flap reconstruction in the treatment of breast cancer.

Am J Surg. 2019-1-31

[8]
Opportunities and priorities for breast surgical research.

Lancet Oncol. 2018-10-1

[9]
Current practice and short-term outcomes of therapeutic mammaplasty in the international TeaM multicentre prospective cohort study.

Br J Surg. 2018-8-22

[10]
A cost-utility analysis comparing large volume displacement oncoplastic surgery to mastectomy with single stage implant reconstruction in the treatment of breast cancer.

Breast. 2018-8-3

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