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1.
Int J Surg Protoc ; 28(1): 37-42, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38433870

RESUMO

Background: Breast pain accounts for 20-40% of new referrals to breast units in the UK and these patients have a very low risk of breast cancer. Patients have previously been assessed in resource-intensive, cancer-exclusion, one stop clinics, which are now failing to meet government targets due to excessive demand. UK Breast units are increasingly piloting Breast Pain-only Pathways (BPP) to assess these patients, and there is no consensus for the optimal pathway. The aim of this prospective multicentre study is to assess the safety and patient satisfaction of different BPPs to inform future BPP design and implementation. Methods: All UK breast units will be invited to join the ASPIRE study between January 2023 and December 2023. Units with a BPP are invited to submit their pathway for evaluation; and those without a BPP who see patients with breast pain-only in a one stop clinics setting are also invited to join the study to evaluate the traditional pathway model concurrently. Patient satisfaction assessments will be collected after their initial consultation and patient outcomes, including subsequent cancer diagnosis, will be followed up at 12 months to determine if they have cancer diagnosis after discharge to assess pathway safety.

2.
BMJ ; 383: 2273, 2023 10 04.
Artigo em Inglês | MEDLINE | ID: mdl-37793681
3.
Breast Cancer Res Treat ; 200(2): 163-170, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37213038

RESUMO

PURPOSE: Oncoplastic breast-conserving surgery (OPBCS) may be a better option than mastectomy ± immediate breast reconstruction (IBR) for women with breast cancer but studies directly comparing the techniques are lacking. We surveyed UK breast units to determine the current practice of OPBCS to inform the design of a future comparative study. METHODS: An electronic survey was developed to explore the current practice of OPBCS. This included the local availability of volume displacement and/or replacement techniques; number of cases performed; contraindications and approach to contralateral symmetrisation. Summary data for each survey item were calculated and overall provision of care examined. RESULTS: 58 UK centres completed the survey, including 43 (74%) stand-alone breast and 15 (26%) combined breast/plastics units. Over 40% of units (n = 24) treated more than 500 cancers/year. Most units offered volume displacement techniques (TMs) (97%). Over two-thirds (n = 39. 67%) of units offered local perforator flaps (LPF). Approximately a half of units (10/19) not performing LPF were planning to introduce them in the next 12-24 months. A third (n = 19, 33%) of units routinely performed simultaneous contralateral symmetrisation mostly with two-surgeon operating. There were limited oncological restrictions to OPBCS with no contraindications for multifocal cancers in most centres; 65% of units (36/55) offered OPBCS for multicentric disease. Extensive DCIS was a contraindication in a minority of units. CONCLUSIONS: OPBCS is widely available in the UK but contraindications and approaches to contralateral symmetrisation were variable. Work is now needed to prospectively evaluate the outcomes of OPBCS vs mastectomy ± IBR to support informed decision-making.


Assuntos
Neoplasias da Mama , Mamoplastia , Retalho Perfurante , Feminino , Humanos , Mastectomia Segmentar/métodos , Mastectomia/métodos , Neoplasias da Mama/cirurgia , Mamoplastia/métodos , Inquéritos e Questionários , Reino Unido/epidemiologia
6.
Br J Surg ; 109(6): 530-538, 2022 05 16.
Artigo em Inglês | MEDLINE | ID: mdl-35576373

RESUMO

BACKGROUND: Prepectoral breast reconstruction (PPBR) has recently been introduced to reduce postoperative pain and improve cosmetic outcomes in women having implant-based procedures. High-quality evidence to support the practice of PPBR, however, is lacking. Pre-BRA is an IDEAL stage 2a/2b study that aimed to establish the safety, effectiveness, and stability of PPBR before definitive evaluation in an RCT. The short-term safety endpoints at 3 months after surgery are reported here. METHODS: Consecutive patients electing to undergo immediate PPBR at participating UK centres between July 2019 and December 2020 were invited to participate. Demographic, operative, oncology, and complication data were collected. The primary outcome was implant loss at 3 months. Other outcomes of interest included readmission, reoperation, and infection. RESULTS: Some 347 women underwent 424 immediate implant-based reconstructions at 40 centres. Most were single-stage direct-to-implant (357, 84.2 per cent) biological mesh-assisted (341, 80.4 per cent) procedures. Conversion to subpectoral reconstruction was necessary in four patients (0.9 per cent) owing to poor skin-flap quality. Of the 343 women who underwent PPBR, 144 (42.0 per cent) experienced at least one postoperative complication. Implant loss occurred in 28 women (8.2 per cent), 67 (19.5 per cent) experienced an infection, 60 (17.5 per cent) were readmitted for a complication, and 55 (16.0 per cent) required reoperation within 3 months of reconstruction. CONCLUSION: Complication rates following PPBR are high and implant loss is comparable to that associated with subpectoral mesh-assisted implant-based techniques. These findings support the need for a well-designed RCT comparing prepectoral and subpectoral reconstruction to establish best practice for implant-based breast reconstruction.


Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Mamoplastia , Implante Mamário/efeitos adversos , Implante Mamário/métodos , Neoplasias da Mama/cirurgia , Feminino , Humanos , Mamoplastia/efeitos adversos , Mamoplastia/métodos , Mastectomia/métodos , Estudos Prospectivos , Estudos Retrospectivos
7.
BMJ Open ; 11(4): e046622, 2021 04 16.
Artigo em Inglês | MEDLINE | ID: mdl-33863715

RESUMO

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.


Assuntos
Neoplasias da Mama , Mamoplastia , Neoplasias da Mama/cirurgia , Estudos de Viabilidade , Feminino , Humanos , Mastectomia , Mastectomia Segmentar , Estudos Multicêntricos como Assunto , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Qualidade de Vida , Medicina Estatal , País de Gales
8.
BMJ Open ; 10(1): e035505, 2020 01 20.
Artigo em Inglês | MEDLINE | ID: mdl-31964677

RESUMO

INTRODUCTION: Outcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction. METHODS AND ANALYSIS: The CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) a modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; (4) strategies to promote dissemination and adoption of the CMS. ETHICS AND DISSEMINATION: Ethical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS.


Assuntos
Implantes de Mama , Auditoria Clínica , Consenso , Determinação de Ponto Final/métodos , Mamoplastia/métodos , Técnica Delphi , Feminino , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos
9.
BMJ Open ; 10(1): e033641, 2020 01 26.
Artigo em Inglês | MEDLINE | ID: mdl-31988232

RESUMO

INTRODUCTION: Implant-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 ANALYSIS: Pre-BRA is an IDEAL stage 2a/2b prospective multicentre cohort study with embedded qualitative research.Consecutive patients electing to undergo immediate PPBR at participating centres will be invited to participate. Demographic, operative, oncology and complication data will be collected and patient-reported outcomes will be assessed at baseline, 3 and 18 months postoperatively. The primary safety endpoint will be implant loss at 3 months.Surgeons performing PPBR will be asked to complete questionnaires regarding their practice and report any modifications made to the procedure or learning arising from complications via free-text response fields on electronic case-report forms. Semistructured will explore surgeons' experiences in detail to identify emerging best practice. This will be fed back to participating surgeons to promote shared learning.The Pre-BRA study will aim to recruit 341 patients from 30 to 40 UK centres over a 12-month period. Recruitment will commence Spring 2019. ETHICS AND DISSEMINATION: The study has full ethical approval from OXFORD-B South Central Committee Ref:19/SC/0129. Results will be presented at national and international meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN11898000; Pre-results.


Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama/cirurgia , Mamoplastia , Mastectomia , Adolescente , Adulto , Estudos de Viabilidade , Feminino , Humanos , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Qualidade de Vida , Projetos de Pesquisa , Inquéritos e Questionários , Reino Unido
10.
Patient Educ Couns ; 102(8): 1446-1451, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30922623

RESUMO

OBJECTIVE: Shared decision-making exists to reconcile healthcare practitioners' responsibilities to respect patients' autonomy whilst ensuring well-made decisions. Patients sometimes make unprompted requests for procedures that carry medical and other risks, such as risk-reducing mastectomy (RRM). Faced with pre-formed decisions into which they have had little input, it is unclear how practitioners can reconcile respecting autonomy with ensuring well-made decisions. METHODS: Qualitative study of linked patient-practitioner interviews in a breast unit in North-West England. We examined how 10 practitioners addressed 19 patients' unprompted requests for RRM. RESULTS: Practitioners empathised with patients' distress about cancer risk, regarded RRM as legitimate to help, but were wary of choices made 'emotionally'. Practitioners did not seek to establish whether choices were well-made but, instead, 'warranted' patients by satisfying themselves that patients were 'sensible' and 'informed' decision-makers, and thus their decisions could be trusted. Practitioners provided information, and tested patients' resolve by delaying decisions and presenting 'what if' scenarios depicting failure or harm from RRM. CONCLUSION: Patients who present emotionally and with resolution can receive RRM without evidence of a well-made decision. PRACTICE IMPLICATIONS: Argumentation theory proposes an ethically robust and clinically practicable approach, whereby practitioners elicit, examine and, where appropriate, challenge arguments underpinning patients' decisions.


Assuntos
Neoplasias da Mama/psicologia , Neoplasias da Mama/cirurgia , Tomada de Decisão Compartilhada , Mastectomia/psicologia , Participação do Paciente , Relações Médico-Paciente/ética , Adulto , Idoso , Emoções , Inglaterra , Feminino , Humanos , Pessoa de Meia-Idade , Autonomia Pessoal , Comportamento de Redução do Risco
11.
Breast ; 44: 94-100, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30703670

RESUMO

PURPOSE: The 21-gene recurrence score (Oncotype DX) (RS) informs systemic therapy decision making in ER-positive HER2-negative early breast cancer (BC). To date no study has described the more nuanced discussions that take place regarding systemic therapy or the impact of the RS on concordance in such decision making. Here we utilized a novel decision making tool to assess the impact of the RS on decision making as well as concordance of treatment recommendations. PATIENTS AND METHODS: The clinicopathological information (CPI) of 50 BCs without and with the RS were presented to a panel of breast oncologists in a simulated MDT. The Liverpool Adjuvant Systemic Therapy Decision Tool (LASTDT) was developed and used to categorize treatment recommendations. Outcome measures included the impact of the RS on decisiveness and concordance in decision making and its impact on treatment recommendations. RESULTS: Availability of the RS increased definitive decision making from 8% (4/50) to 56% (28/50) [χ2 = 79.35, p < 0.001] and altered the LASTDT category in 68% (34/50) of cases (p < 0.001), 74% of which were to forgo chemotherapy. With knowledge of RS, universal concordance rose from 14% to 64% [K = 0.328: K = 0.729]. CONCLUSIONS: The RS improves certainty of decision making as well as concordance amongst oncologists. This provides evidence that the availability of the RS can improve consistency of decision making amongst oncologists and thus helps to ensure patients are managed consistently. This is particularly important when patients are managed in a loco-regional, multidisciplinary team manner where heterogeneous decisions can lead to disparity in care.


Assuntos
Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Recidiva Local de Neoplasia/metabolismo , Recidiva Local de Neoplasia/patologia , Receptor ErbB-2/metabolismo , Adulto , Biomarcadores Tumorais/metabolismo , Neoplasias da Mama/terapia , Quimioterapia Adjuvante , Tomada de Decisão Clínica , Feminino , Humanos , Pessoa de Meia-Idade
12.
Eur J Surg Oncol ; 44(5): 708-716, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29472041

RESUMO

INTRODUCTION: The 2008 National Mastectomy and Breast Reconstruction Audit demonstrated marked variation in the practice and outcomes of breast reconstruction in the UK. To standardise practice and improve outcomes for patients, the British professional associations developed best-practice guidelines with specific guidance for newer mesh-assisted implant-based techniques. We explored the degree of uptake of best-practice guidelines within units performing implant-based reconstruction (IBBR) as the first phase of the implant Breast Reconstruction Evaluation (iBRA) study. METHODS: A questionnaire developed by the iBRA Steering Group was completed by trainee and consultant leads at breast and plastic surgical units across the UK. Simple summary statistics were calculated for each survey item to assess compliance with current best-practice guidelines. RESULTS: 81 units from 79 NHS Trusts completed the questionnaire. Marked variation was observed in adherence to guidelines, especially those relating to clinical governance and infection prevention strategies. Less than half (n = 28, 47%) of units obtained local clinical governance board approval prior to offering new mesh-based techniques and prospective audit of the clinical, cosmetic and patient-reported outcomes of surgery was infrequent. Most units screened for methicillin-resistant staphylococcus aureus prior to surgery but fewer than 1 in 3 screened for methicillin-sensitive strains. Laminar-flow theatres (recommended for IBBR) were not widely-available with less than 1 in 5 units having regular access. Peri-operative antibiotics were widely-used, but the type and duration were highly-variable. CONCLUSIONS: The iBRA national practice questionnaire has demonstrated variation in reported practice and adherence to IBBR guidelines. High-quality evidence is urgently required to inform best practice.


Assuntos
Antibioticoprofilaxia/estatística & dados numéricos , Implante Mamário/normas , Neoplasias da Mama/cirurgia , Fidelidade a Diretrizes/estatística & dados numéricos , Mastectomia , Padrões de Prática Médica/estatística & dados numéricos , Antibacterianos/uso terapêutico , Implantes de Mama , Feminino , Humanos , Mamoplastia/normas , Programas de Rastreamento , Staphylococcus aureus Resistente à Meticilina , Educação de Pacientes como Assunto/normas , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Assistência Perioperatória , Guias de Prática Clínica como Assunto , Infecções Relacionadas à Prótese/prevenção & controle , Infecções Estafilocócicas/diagnóstico , Staphylococcus aureus , Infecção da Ferida Cirúrgica/prevenção & controle , Inquéritos e Questionários , Reino Unido
13.
Breast ; 35: 182-190, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28768227

RESUMO

INTRODUCTION: The introduction of biological and synthetic meshes has revolutionised the practice of implant-based breast reconstruction (IBBR) but evidence for effectiveness is lacking. The iBRA (implant Breast Reconstruction evAluation) study is a national trainee-led project that aims to explore the practice and outcomes of IBBR to inform the design of a future trial. We report the results of the iBRA National Practice Questionnaire (NPQ) which aimed to comprehensively describe the provision and practice of IBBR across the UK. METHODS: A questionnaire investigating local practice and service provision of IBBR developed by the iBRA Steering Group was completed by trainee and consultant leads at breast and plastic surgical units across the UK. Summary data for each survey item were calculated and variation between centres and overall provision of care examined. RESULTS: 81 units within 79 NHS-hospitals completed the questionnaire. Units offered a range of reconstructive techniques, with IBBR accounting for 70% (IQR:50-80%) of participating units' immediate procedures. Units on average were staffed by 2.5 breast surgeons (IQR:2.0-3.0) and 2.0 plastic surgeons (IQR:1.0-3.0) performing 35 IBBR cases per year (IQR:20-50). Variation was demonstrated in the provision of novel different techniques for IBBR especially the use of biological (n = 62) and synthetic (n = 25) meshes and in patient selection for these procedures. CONCLUSIONS: The iBRA-NPQ has demonstrated marked variation in the provision and practice of IBBR in the UK. The prospective audit phase of the iBRA study will determine the safety and effectiveness of different approaches to IBBR and allow evidence-based best practice to be explored.


Assuntos
Implante Mamário/estatística & dados numéricos , Implantes de Mama/estatística & dados numéricos , Neoplasias da Mama/cirurgia , Mamoplastia/estatística & dados numéricos , Telas Cirúrgicas/estatística & dados numéricos , Feminino , Humanos , Centro Cirúrgico Hospitalar , Inquéritos e Questionários , Reino Unido
14.
PLoS One ; 12(5): e0178392, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28552971

RESUMO

OBJECTIVE: Contemporary approaches to medical decision-making advise that clinicians should respect patients' decisions. However, patients' decisions are often shaped by heuristics, such as being guided by emotion, rather than by objective risk and benefit. Risk-reducing mastectomy (RRM) decisions focus this dilemma sharply. RRM reduces breast cancer (BC) risk, but is invasive and can have iatrogenic consequences. Previous evidence suggests that emotion guides patients' decision-making about RRM. We interviewed patients to better understand how they made decisions about RRM, using findings to consider how clinicians could ethically respond to their decisions. METHODS: Qualitative face-to-face interviews with 34 patients listed for RRM surgery and two who had decided against RRM. RESULTS: Patients generally did not use objective risk estimates or, indeed, consider risks and benefits of RRM. Instead emotions guided their decisions: they chose RRM because they feared BC and wanted to do 'all they could' to prevent it. Most therefore perceived RRM to be the 'obvious' option and made the decision easily. However, many recounted extensive post-decisional deliberation, generally directed towards justifying the original decision. A few patients deliberated before the decision because fears of surgery counterbalanced those of BC. CONCLUSION: Patients seeking RRM were motivated by fear of BC, and the need to avoid potential regret for not doing all they could to prevent it. We suggest that choices such as that for RRM, which are made emotionally, can be respected as autonomous decisions, provided patients have considered risks and benefits. Drawing on psychological theory about how people do make decisions, as well as normative views of how they should, we propose that practitioners can guide consideration of risks and benefits even, where necessary, after patients have opted for surgery. This model of practice could be extended to other medical decisions that are influenced by patients' emotions.


Assuntos
Neoplasias da Mama/prevenção & controle , Tomada de Decisões , Emoções , Mastectomia , Participação do Paciente , Neoplasias da Mama/genética , Predisposição Genética para Doença , Humanos
15.
Artigo em Inglês | MEDLINE | ID: mdl-27965859

RESUMO

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:Phase 1 - a national practice questionnaire (NPQ) to survey current practicePhase 2 - a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and patient-reported outcomesPhase 3- an IBBR-RCT acceptability survey and qualitative work to explore patients' and surgeons' views of proposed trial designs and candidate outcomes.Phase 4 - phases 1 to 3 will inform the design and conduct of the future RCT All centres offering IBBR will be encouraged to participate by the breast and plastic surgical professional associations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons). Data collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues surrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria, trial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients and collect data. DISCUSSION: The preliminary work undertaken within the iBRA study will determine the feasibility, design and conduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an infrastructure of research-active breast and plastic surgeons which will facilitate future high-quality research that will ultimately improve outcomes for all women seeking reconstructive surgery. TRIAL REGISTRATION: ISRCTN37664281.

16.
Nat Commun ; 7: 13294, 2016 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-27827358

RESUMO

Pre-surgical studies allow study of the relationship between mutations and response of oestrogen receptor-positive (ER+) breast cancer to aromatase inhibitors (AIs) but have been limited to small biopsies. Here in phase I of this study, we perform exome sequencing on baseline, surgical core-cuts and blood from 60 patients (40 AI treated, 20 controls). In poor responders (based on Ki67 change), we find significantly more somatic mutations than good responders. Subclones exclusive to baseline or surgical cores occur in ∼30% of tumours. In phase II, we combine targeted sequencing on another 28 treated patients with phase I. We find six genes frequently mutated: PIK3CA, TP53, CDH1, MLL3, ABCA13 and FLG with 71% concordance between paired cores. TP53 mutations are associated with poor response. We conclude that multiple biopsies are essential for confident mutational profiling of ER+ breast cancer and TP53 mutations are associated with resistance to oestrogen deprivation therapy.


Assuntos
Antineoplásicos/farmacologia , Inibidores da Aromatase/farmacologia , Neoplasias da Mama/genética , Resistencia a Medicamentos Antineoplásicos/genética , Proteína Supressora de Tumor p53/genética , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Inibidores da Aromatase/uso terapêutico , Biópsia/métodos , Mama/patologia , Neoplasias da Mama/sangue , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Análise Mutacional de DNA/métodos , Estrogênios/metabolismo , Feminino , Proteínas Filagrinas , Humanos , Antígeno Ki-67/análise , Pessoa de Meia-Idade , Mutação , Receptores de Estrogênio/metabolismo , Resultado do Tratamento , Sequenciamento do Exoma/métodos
17.
Trials ; 17(1): 463, 2016 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-27664072

RESUMO

BACKGROUND: The development and use of core outcome sets (COSs) in trials may improve data synthesis and reduce outcome reporting bias. The selection of outcomes in COSs is informed by views of key stakeholders, yet little is known about the role and influence of different stakeholders' views during COS development. We report an exploratory case study examining how stakeholder selection and incorporation of stakeholders' views may influence the selection of outcomes for a COS in reconstructive breast surgery (RBS). We also make recommendations for future considerations. METHODS: Key stakeholder groups and subgroups were identified from the literature and expert opinion by the COS management group. They included health care professionals, subdivided by profession (breast and plastic surgeons, specialist nurses and psychologists) and patients, subdivided according to type of surgery received, timing of reconstruction, time since surgery and patient age. All participated in a survey in which they were asked to prioritise outcomes. Outcomes were prioritised using a 9-point scale from 1 (not important) to 9 (extremely important). The proportion of (1) all participants, ignoring stakeholder group (single heterogeneous panel analysis), (2) 'professional' and 'patient' groups separately (two heterogeneous panels), ignoring prespecified subgroups and (3) each participant subgroup separately (multiple homogeneous panel analysis) rating each item 'extremely important' was summarised and compared to explore how selection and integration of stakeholder views may influence outcome prioritisation. RESULTS: There were many overlaps between items rated as most important by all groups. Specific stakeholders, however, prioritised specific concerns and a broader range of outcomes were prioritised when the subgroups were considered separately. For example, two additional outcomes were prioritised when patient and professional groups were considered separately and eight additional outcomes were identified when the views of the individual subgroups were explored. In general, patient subgroups preferentially valued additional clinical outcomes, including unplanned surgery, whereas professional subgroups prioritised additional psychosocial issues including body image. CONCLUSION: Stakeholder groups value different outcomes. Selection of groups, therefore, is important. Our recommendations for robust and transparent stakeholder selection and integration of stakeholder views may aid future COS developers in the design and conduct of their studies and improve the validity and value of future COS.

18.
J Adv Nurs ; 71(10): 2305-14, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26037680

RESUMO

AIMS: The aim of this study was to ascertain if patients with breast cancer who have positive attachment models of 'self' and 'other' perceive higher levels of support from nurses than do patients with negative attachment models. BACKGROUND: Attachment models of 'self' and 'other' develop in childhood and affect relationships throughout life. People with negative attachment models tend to perceive themselves as unworthy of receiving support and to perceive others as incapable or unwilling to offer support. Attachment processes are activated when individuals feel threatened and seek support from those close to them. Breast cancer may represent such a threat and relationships between patients with breast cancer and nurses may therefore be influenced by patients' attachment models. DESIGN: A between-subjects cross-sectional design was used. Explanatory variables were indicators of patients' attachment models. Response variables were patient ratings of nurse support. Covariates were patient age and patient distress levels. METHOD: One hundred and fifty-three patients with breast cancer, diagnosed 1-3 years previously, were recruited when attending follow-up oncology appointments over 51 weeks in 2010-2011. Participants completed questionnaires assessing attachment models, distress and perceived support, from the nurse who was available to support them through their cancer. The hypotheses were tested by logistic regression analysis. RESULTS: Patients with more positive models of 'self' perceived more support from nurses. CONCLUSIONS: Patients' perceptions of nurses when being treated for breast cancer are influenced by patients' own models of attachment. Knowledge of this would help nurses further to individualize the emotional support they give patients.


Assuntos
Neoplasias da Mama/psicologia , Relações Enfermeiro-Paciente , Apego ao Objeto , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/enfermagem , Comunicação , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Percepção
19.
Med Educ ; 49(4): 408-16, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25800301

RESUMO

CONTEXT: Communication education has become integral to pre- and post-qualification clinical curricula, but it is not informed by research into how practitioners think that good communication arises. OBJECTIVES: This study was conducted to explore how surgeons conceptualise their communication with patients with breast cancer in order to inform the design and delivery of communication curricula. METHODS: We carried out 19 interviews with eight breast surgeons. Each interview centred on a specific consultation with a different patient. We analysed the transcripts of the surgeons' interviews qualitatively using a constant comparative approach. RESULTS: All of the surgeons described communication as central to their role. Communication could be learned to some extent, not from formal training, but by selectively incorporating practices they observed in other practitioners and by being mindful in consultations. Surgeons explained that their own values and character shaped how they communicated and what they wanted to achieve, and constrained what could be learned. CONCLUSIONS: These surgeons' understanding of communication is consistent with recent suggestions that communication education: (i) should place practitioners' goals at its centre, and (ii) might be enhanced by approaches that support 'mindful' practice. By contrast, surgeons' understanding diverged markedly from the current emphasis on 'communication skills'. Research that explores practitioners' perspectives might help educators to design communication curricula that engage practitioners by seeking to enhance their own ways of learning about communication.


Assuntos
Comunicação , Relações Médico-Paciente , Cirurgiões/psicologia , Neoplasias da Mama , Teoria Fundamentada , Humanos , Aprendizagem , Atenção Plena , Pesquisa Qualitativa
20.
Psychooncology ; 22(10): 2364-71, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23904068

RESUMO

OBJECTIVE: Cancer clinicians are routinely criticised for communicating information poorly to patients, but expert guidance is sometimes contradictory or impractical. We wanted to understand how, and how well, breast cancer surgeons in their normal practice balanced the competing tasks of informing patients while keeping them hopeful. METHOD: In a post-operative surgical outpatient clinic in a UK breast unit, we recruited 9 surgeons and 20 breast cancer patients with whom they consulted. We audio recorded and interviewed both patients and surgeons about their consultations, then analysed data qualitatively within and across cases taking a constant comparative approach. RESULTS: Every consultation contained biomedical factually explicit information, but the information that was most significant for patients was factually less explicit. Progressively less explicit forms, along a 'spectrum' of information, included: judgments about treatment implications; judgments about prognosis; evaluative comments; and clues about what information signified. Surgeons used the less explicit types of information to communicate hope. Where prognosis was poor, communication was confined to more explicit information. Surgeons' practice was closely aligned with what patients sought. CONCLUSION: Common criticisms of cancer clinicians for giving 'too little' information belie the complexity of their task in simultaneously managing information needs and hope. The 'information spectrum' could help educators and clinicians to understand this task.


Assuntos
Neoplasias da Mama/psicologia , Carcinoma/psicologia , Comunicação , Educação de Pacientes como Assunto , Relações Médico-Paciente , Cirurgiões , Revelação da Verdade , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/cirurgia , Carcinoma/cirurgia , Carcinoma Intraductal não Infiltrante/psicologia , Carcinoma Intraductal não Infiltrante/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Pesquisa Qualitativa
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