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The effect of acellular dermal matrix use on the outcomes of prosthetic breast reconstruction: A systematic review
472 Introduction: The need to perform axillary nodal clearance in the presence of nodal micrometastases is currently controversial. The literature quotes varying rates for the incidence of non sentinel node metastases in patients with sentinel lymph node (SLN) micrometastases. In our unit we routinely offer axillary node clearance to patients with micrometastases on SLN biopsy. The aim of this study was to assess the incidence of non-SLN metastases and identify any clinico-pathological parameters that would enable us to be more selective in offering axillary clearance. Methods: A retrospective analysis of a prospectively maintained database of patients undergoing intraoperative assessment of sentinel node biopsy was performed over the time period December 2007 to April 2012. The demographic information collated included patient age, tumour type, size, grade, ER status & LVI. Results: 471 patients had positive SLNs intraoperatively, with 66 patients (mean age 59.1) having confirmed micrometastases in a single sentinel node. All underwent axillary node clearance. 55 of these patients had no further positive nodes on clearance however 11 patients had further positive nodes (macrometastases). 9 of these patients had 1-3 positive nodes on clearance, whilst 2 patients had more than 3 further positive nodes. This study did not demonstrate any correlation between patient age, tumour size, grade, type, ER status, LVI and presence of non SLN disease. Conclusions: A 16.6% incidence of non-SLN macrometastases in patients with micrometastases on SLN biopsy raises the question whether we can justify omitting axillary clearance for these patients until further evidence is available. http://dx.doi.org/10.1016/j.ejso.2013.01.073
P038. The effect of acellular dermal matrix use on the outcomes of prosthetic breast reconstruction: A systematic review Shelley Pottera, Danielle Browningb, Jelena Savovica, Rob Warrc, Simon Cawthornc, Jane Blazebya a University of Bristol, Bristol, UK b Royal United Hospital, Bath, UK c North Bristol NHS Trust, Bristol, UK
Introduction: Acellular dermal matrix (ADM) may improve outcomes in prosthetic breast reconstruction (PBR) but there is conflicting evidence to support these benefits. Existing systematic reviews have major methodological limitations. The aim of this study was to critically appraise and evaluate the current evidence for ADM-assisted PBR. Methods: Comprehensive electronic searches identified complete papers published in English between January 2000 and October 2012, reporting any outcome of ADM-assisted PBR. All randomised trials (RCTs) and non-randomised studies (NRSs) with more than 50 ADM-recipients were included and critically appraised using the modified Cochrane Risk of Bias tool, adapted for NRSs. Characteristics and results of identified studies were summarised. Results: 23 papers; 1 RCT, 17 cohort studies and 5 case-series were identified, all of which were considered at high-risk of bias. The median ADM sample size was 124 (interquartile range 67-189). Most studies were single-centre (n¼21, 91.3%) and only half (n¼13) reported duration of follow-up. ADM was most commonly used for immediate (n¼16, 69.6%) two-stage PBR (n¼15, 65.2%) with few studies evaluating ADM-assisted single-stage procedures (n¼3, 13.0%). Most studies used AlloDerm (n¼22, 95.7%) with less than 10% (n¼2) assessing non-human ADMs (e.g.Strattice). All studies reported clinical outcomes and over half (n¼13,56.5%) assessed process outcomes but few evaluated cosmetic (n¼3, 13%) or patient-reported outcomes (n¼2, 8.7%). Heterogeneity between studies precluded meaningful cross-study comparison or data synthesis. Conclusions: There is currently a lack of high-quality evidence to support the use of ADM in PBR. Well-designed multi-centre RCTs are needed to evaluate whether ADM use may improve outcomes for patients choosing PBR.
ABSTRACTS http://dx.doi.org/10.1016/j.ejso.2013.01.074
P039. Raising the standards of outcome reporting in reconstructive breast surgery e Initial results of the BRAVO (Breast Reconstruction and Valid Outcomes) study, a multicentre consensus process to develop a core outcome set Shelley Pottera, Joseph Warda, Simon Cawthornb, Christopher Holcombec, Rob Warrb, Sherif Wilsonb, Rachel Tillettb, Eva Weiler-Mithoffd, Zoe Winterse, Jane Barkerb, Caroline Oatesb, Diana Harcourtf, Sara Brookesa, Jane Blazebya a University of Bristol, Bristol, UK b North Bristol NHS Trust, Bristol, UK c Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK d Canniesburn Plastic Surgical Unit, Glasgow, UK e University Hospitals Bristol NHS Foundation Trust, Bristol, UK f University of the West of England, Bristol, UK
Introduction: Careful selection of outcomes is important if research and audit are to inform clinical practice and direct policy-makers. Systematic reviews (SRs), however, demonstrate marked heterogeneity in the selection, definition and reporting of key outcomes in reconstructive breast surgery (RBS), limiting cross-study comparison and research synthesis. One solution is to develop and use core outcome sets (COS) e a scientifically agreed-upon minimum set of outcomes that should be measured and reported in all studies. We report the initial results of the BRAVO (Breast Reconstruction and Valid Outcomes) Study which aimed to develop a COS for RBS. Methods: A questionnaire was developed from a long-list of outcomes identified from SRs and qualitative work with key stakeholders and sent to a purposive sample of patients and professionals involved in the provision of specialist care. Participants were asked to prioritise outcomes on a scale of 1 (unimportant) to 9 (extremely important) and the proportion of respondents rating each outcome ‘very important’ (score of 7-9) was compared and contrasted between participant groups. Results: The response rate was 55.6% (151/274 patients; 88/156 professionals). There was agreement between seven out of 10 most-highly ranked outcomes including patient-reported cosmesis, cosmetic satisfaction and early complications. Patients, but not professionals rated generic complications including bleeding as important, whilst professionals rated psychosocial issues including self-esteem, more highly than patients. Conclusions: Patients and professionals prioritise similar outcomes, but areas of discrepancy exist. A further Delphi round in which outcomes are re-prioritised and stakeholder meetings to ratify the final decisions will be necessary to determine the final COS. http://dx.doi.org/10.1016/j.ejso.2013.01.075
P040. A prospective correlation of a single question linear analogue scale with the hospital anxiety and depression scale in breast outpatients Sa’ed Ramzi, Peter Cant Derriford Hospital, Plymouth, Devon, UK
Introduction: Referral to a breast outpatient clinic can be anxiety-provoking and this is frequently addressed in studies. Traditionally, long questionnaires are used with obvious practical difficulties. We wished to see if this could be simplified for practical use in our environment. Patients and methods: Patients attending our symptomatic breast clinic have their anxiety levels routinely assessed using a 5 point “in house” linear analogue scale (LAS); (1 “Really not worried” to 5 “Very anxious indeed”) This was prospectively correlated with the anxiety section of the Hospital Anxiety and Depression Scale (HADS), in 199 consecutive consented new patients.
P038. The effect of acellular dermal matrix use on the outcomes of prosthetic breast reconstruction: A systematic review Shelley Pottera, Danielle Browningb, Jelena Savovica, Rob Warrc, Simon Cawthornc, Jane Blazebya a University of Bristol, Bristol, UK b Royal United Hospital, Bath, UK c North Bristol NHS Trust, Bristol, UK
Introduction: Acellular dermal matrix (ADM) may improve outcomes in prosthetic breast reconstruction (PBR) but there is conflicting evidence to support these benefits. Existing systematic reviews have major methodological limitations. The aim of this study was to critically appraise and evaluate the current evidence for ADM-assisted PBR. Methods: Comprehensive electronic searches identified complete papers published in English between January 2000 and October 2012, reporting any outcome of ADM-assisted PBR. All randomised trials (RCTs) and non-randomised studies (NRSs) with more than 50 ADM-recipients were included and critically appraised using the modified Cochrane Risk of Bias tool, adapted for NRSs. Characteristics and results of identified studies were summarised. Results: 23 papers; 1 RCT, 17 cohort studies and 5 case-series were identified, all of which were considered at high-risk of bias. The median ADM sample size was 124 (interquartile range 67-189). Most studies were single-centre (n¼21, 91.3%) and only half (n¼13) reported duration of follow-up. ADM was most commonly used for immediate (n¼16, 69.6%) two-stage PBR (n¼15, 65.2%) with few studies evaluating ADM-assisted single-stage procedures (n¼3, 13.0%). Most studies used AlloDerm (n¼22, 95.7%) with less than 10% (n¼2) assessing non-human ADMs (e.g.Strattice). All studies reported clinical outcomes and over half (n¼13,56.5%) assessed process outcomes but few evaluated cosmetic (n¼3, 13%) or patient-reported outcomes (n¼2, 8.7%). Heterogeneity between studies precluded meaningful cross-study comparison or data synthesis. Conclusions: There is currently a lack of high-quality evidence to support the use of ADM in PBR. Well-designed multi-centre RCTs are needed to evaluate whether ADM use may improve outcomes for patients choosing PBR.
ABSTRACTS http://dx.doi.org/10.1016/j.ejso.2013.01.074
P039. Raising the standards of outcome reporting in reconstructive breast surgery e Initial results of the BRAVO (Breast Reconstruction and Valid Outcomes) study, a multicentre consensus process to develop a core outcome set Shelley Pottera, Joseph Warda, Simon Cawthornb, Christopher Holcombec, Rob Warrb, Sherif Wilsonb, Rachel Tillettb, Eva Weiler-Mithoffd, Zoe Winterse, Jane Barkerb, Caroline Oatesb, Diana Harcourtf, Sara Brookesa, Jane Blazebya a University of Bristol, Bristol, UK b North Bristol NHS Trust, Bristol, UK c Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK d Canniesburn Plastic Surgical Unit, Glasgow, UK e University Hospitals Bristol NHS Foundation Trust, Bristol, UK f University of the West of England, Bristol, UK
Introduction: Careful selection of outcomes is important if research and audit are to inform clinical practice and direct policy-makers. Systematic reviews (SRs), however, demonstrate marked heterogeneity in the selection, definition and reporting of key outcomes in reconstructive breast surgery (RBS), limiting cross-study comparison and research synthesis. One solution is to develop and use core outcome sets (COS) e a scientifically agreed-upon minimum set of outcomes that should be measured and reported in all studies. We report the initial results of the BRAVO (Breast Reconstruction and Valid Outcomes) Study which aimed to develop a COS for RBS. Methods: A questionnaire was developed from a long-list of outcomes identified from SRs and qualitative work with key stakeholders and sent to a purposive sample of patients and professionals involved in the provision of specialist care. Participants were asked to prioritise outcomes on a scale of 1 (unimportant) to 9 (extremely important) and the proportion of respondents rating each outcome ‘very important’ (score of 7-9) was compared and contrasted between participant groups. Results: The response rate was 55.6% (151/274 patients; 88/156 professionals). There was agreement between seven out of 10 most-highly ranked outcomes including patient-reported cosmesis, cosmetic satisfaction and early complications. Patients, but not professionals rated generic complications including bleeding as important, whilst professionals rated psychosocial issues including self-esteem, more highly than patients. Conclusions: Patients and professionals prioritise similar outcomes, but areas of discrepancy exist. A further Delphi round in which outcomes are re-prioritised and stakeholder meetings to ratify the final decisions will be necessary to determine the final COS. http://dx.doi.org/10.1016/j.ejso.2013.01.075
P040. A prospective correlation of a single question linear analogue scale with the hospital anxiety and depression scale in breast outpatients Sa’ed Ramzi, Peter Cant Derriford Hospital, Plymouth, Devon, UK
Introduction: Referral to a breast outpatient clinic can be anxiety-provoking and this is frequently addressed in studies. Traditionally, long questionnaires are used with obvious practical difficulties. We wished to see if this could be simplified for practical use in our environment. Patients and methods: Patients attending our symptomatic breast clinic have their anxiety levels routinely assessed using a 5 point “in house” linear analogue scale (LAS); (1 “Really not worried” to 5 “Very anxious indeed”) This was prospectively correlated with the anxiety section of the Hospital Anxiety and Depression Scale (HADS), in 199 consecutive consented new patients.