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).
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).
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DOI：
10.1136/bmjopen-2020-046622
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发表时间：
2021-04-16
期刊：
影响因子：
2.9
通讯作者：
Potter S
中科院分区：
文献类型：
--
作者：
Davies C;Holcombe C;Skillman J;Whisker L;Hollingworth W;Conefrey C;Mills N;White P;Comins C;Macmillan D;Fairbrother P;Potter S
在英国，每年约有55000名女性被诊断患有乳腺癌，其中约有40%接受乳房切除术，因为由于肿瘤大小或多个肿瘤病灶，她们被认为不适合标准的保乳手术（BCS）。乳房切除术可以显着影响妇女的生活质量，目前只有四分之一的妇女接受立即乳房再造（IBR）。2级肿瘤整形保乳手术（OPBCS）将切除癌症与一系列整形外科体积置换（例如，局部穿支皮瓣）和体积置换技术（例如，治疗性乳房成形术）相结合，可以扩展BCS的作用，并可能使一些不适合标准BCS的女性避免乳房切除术。目前缺乏高质量的研究来确定OPBCS是否提供了乳房切除术±IBR的安全有效的替代方案。需要进行初步工作，以确保未来的大规模研究是可行的，设计良好，并解决对患者和国家卫生服务体系重要的问题。将使用混合方法为未来比较OPBCS和乳房切除术±IBR的临床有效性和成本效益的大规模研究的可行性和设计提供信息。它将有四个部分：（1）一项国家实践问卷调查，以确定英国目前的实践和乳房肿瘤整形和重建手术的提供情况;（2）一项试点多中心前瞻性队列研究，以探讨选择OPBCS与乳房切除术的患者比例，OPBCS的成功比例以及术后3个月和12个月不同技术的临床和患者报告结局;（3）定性访谈研究，探讨患者对不同手术的态度、决策依据和对结果的看法;（4）未来研究的设计。所有在英国提供OPBCS和乳房切除术的中心都将被邀请参加。招募计划于2020年冬季开始，持续12个月。本研究已获得威尔士研究伦理委员会6国家研究伦理服务的伦理批准（REC Ref 20/WA/0225）。研究结果将在国家和国际会议上发表，并发表在同行评审的期刊上。我们将与患者合作，制定非专业摘要，并通过患者团体和乳腺癌慈善机构分享这些摘要。ISRCTN18238549。
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. 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. 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. ISRCTN18238549.
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影响因子：
8.8
作者：
O'Connell, Rachel L.;Rattay, Tim;Balata, Safa Ahmed
通讯作者：
Balata, Safa Ahmed
影响因子：
3.9
作者：
Mansell, J.;Weiler-Mithoff, E.;Romics, L.
通讯作者：
Romics, L.
DOI：
10.4137/bcbcr.s41017
发表时间：
2016
期刊：
Breast cancer : basic and clinical research
影响因子：
--
作者：
Ho W;Stallard S;Doughty J;Mallon E;Romics L
通讯作者：
Romics L
影响因子：
9.6
作者：
Potter, S.;Holcombe, C.;Ward, J. A.;Blazeby, J. M.
通讯作者：
Blazeby, J. M.
影响因子：
3.8
作者：
Mennie, J. C.;Mohanna, P. -N.;Cromwell, D. A.
通讯作者：
Cromwell, D. A.