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Objective Women considering reconstructive breast surgery (RBS) require adequate information to make informed treatment decisions. This study explored patients' and health professionals' (HPs) perceptions of the adequacy of information provided for decision-making in RBS. Methods Semi-structured interviews with a purposive sample of patients who had undergone RBS and HPs providing specialist care explored participants' experiences of information provision prior to RBS. Results Professionals reported providing standardised verbal, written and photographic information about the process and outcomes of surgery. Women, by contrast, reported varying levels of information provision. Some felt fully-informed but others perceived they had received insufficient information about available treatment options or possible outcomes of surgery to make an informed decision. Conclusions Women need adequate information to make informed decisions about RBS and current practice may not meet women's needs. Minimum agreed standards of information provision, especially about alternative types of reconstruction, are recommended to improve decision-making in RBS.

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© 2018 Elsevier Ltd The 2013 Breast Cancer Campaign gap analysis established breast cancer research priorities without a specific focus on surgical research or the role of surgeons on breast cancer research. This Review aims to identify opportunities and priorities for research in breast surgery to complement the 2013 gap analysis. To identify these goals, research-active breast surgeons met and identified areas for breast surgery research that mapped to the patient pathway. Areas included diagnosis, neoadjuvant treatment, surgery, adjuvant therapy, and attention to special groups (eg, those receiving risk-reducing surgery). Section leads were identified based on research interests, with invited input from experts in specific areas, supported by consultation with members of the Association of Breast Surgery and Independent Cancer Patients' Voice groups. The document was iteratively modified until participants were satisfied that key priorities for surgical research were clear. Key research gaps included issues surrounding overdiagnosis and treatment; optimising treatment options and their selection for neoadjuvant therapies and subsequent surgery; reducing rates of re-operations for breast-conserving surgery; generating evidence for clinical effectiveness and cost-effectiveness of breast reconstruction, and mechanisms for assessing novel interventions; establishing optimal axillary management, especially post-neoadjuvant treatment; and defining and standardising indications for risk-reducing surgery. We propose strategies for resolving these knowledge gaps. Surgeons are ideally placed for a central role in breast cancer research and should foster a culture of engagement and participation in research to benefit patients and health-care systems. Development of infrastructure and surgical research capacity, together with appropriate allocation of research funding, is needed to successfully address the key clinical and translational research gaps that are highlighted in this Review within the next two decades.

What you need to know Of the 55 000 women diagnosed with breast cancer1 each year in the UK, more than 40% require a mastectomy2 as primary surgical treatment. To optimise quality of life and outcomes, the National Institute for Health and Care Excellence (NICE) recommends offering immediate breast reconstruction.3 In the UK4 and US,5 implant based breast reconstruction (IBBR) is the most commonly performed technique. The implant is usually placed in a pocket under the pectoralis major muscle. This generally requires a two-stage approach as the pocket is not large enough to accommodate a fixed volume implant. A tissue expander is placed as a first stage and it is expanded by injecting fluid percutaneously until the desired size is achieved. The expander is then replaced by a fixed volume implant at a second operation. This technique is safe,6 but time consuming and uncomfortable. It is possible to use combined expander implants (“permanent expanders”) as a one-stage approach to avoid a second operation, but the results may be unsatisfactory.7 The introduction of biological and synthetic meshes in the early 2000s to augment the submuscular pocket has had a major impact on the practice of IBBR. The mesh can be used as a sling between the lower …

Introduction Mallet injuries are common, and usually treated conservatively. Various systematic reviews have found a lack of evidence regarding best management and it is unclear whether this uncertainty is reflected in current UK practice. Methods An online survey was developed to determine current practice for the conservative treatment of mallet injury amongst specialist hand clinicians in the UK, including physiotherapists, occupational therapists and surgeons. Clinician’s views of study outcome selection were also explored to improve future trials. Results 336 professionals completed the survey. Inconsistency in overall practice was observed in splint type choice, time to discharge to GP, and the assessment of adherence. Greater consistency was observed for recommended duration of continuous immobilisation. Bony injuries were most commonly splinted for six weeks (n=228, 78%) and soft tissue injuries for either eight weeks (n=172, 56%) or six weeks (n=119, 39%). Postimmobilisation splinting was frequently recommended, but duration varied between two and 10 weeks. The outcome rated as most important by all clinicians was patient satisfaction. Discussion There is overall variation in the current UK conservative management of mallet injuries, and the development of a standardised, evidence based protocol is required. Clinicians’ opinions may be used to develop a core set of outcome measures, which will improve standardisation and comparability of future trials.

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.

Introduction Acellular dermal matrix (ADM) may improve outcomes in implant-based breast reconstruction, but recent evidence suggests complication rates may be higher when ADM is used. We retrospectively compared early complications and implant loss in implant-based breast reconstruction (BR) with and without ADM to evaluate the safety of the procedure in our centre. Methods Case-notes of consecutive women undergoing implant-based BR from May 2011 to November 2012 were retrospectively reviewed. Data were extracted using a standardised pro-forma and the rate of early complications, major complications and implant loss compared between procedure groups. Results Forty-six implant-based reconstructions were performed for malignancy ( n = 31, 67.4%) or prophylaxis ( n = 15, 32.6%) in 31 women over the 18-month study period. ADM (Tecnoss Protexa ® , Tecnoss S.r.l.) was used in 31 (67.4%) cases. There were no differences in patient age, BMI, co-morbidities, smoking or chemotherapy between groups, but patients receiving ADM were more likely to have received radiotherapy prior to their reconstruction ( n = 6, 30% vs. n = 0, 0%, p = 0.043). The overall rate of early complications was 26.1% ( n = 12) but there was no significant difference between procedure groups (standard- n = 4, 27.7% vs. ADM- n = 8, 25.8%; p = 0.950). There were 2 (4.3%) major complications none of which were associated with ADM use (standard- n = 2, 13.3% vs. ADM- n = 0, 0.0%; p = 0.038). There were 6 (13.0%) implant losses of which 4 were in the ADM group (standard- n = 2, 13.3% vs. ADM- n = 4, 12.9%; p = 0.968). All of these were associated with pre-reconstruction radiotherapy. Conclusions ADM-assisted implant-based reconstruction with Tecnoss Protexa ® is safe and may improve outcomes for women by facilitating a single-stage procedure. Robust prospective evaluation is now needed to definitively evaluate the role of ADM in implant-based BR.

Background The IDEAL framework (Idea, Development, Exploration, Assessment, Long-term study) proposes a staged assessment of surgical innovation, but whether it can be used in practice is uncertain. This study aimed to review the reporting of a surgical innovation according to the IDEAL framework. Methods Systematic literature searches identified articles reporting laparoendoscopic excision for benign colonic polyps. Using the IDEAL stage recommendations, data were collected on: patient selection, surgeon and unit expertise, description of the intervention and modifications, outcome reporting, and research governance. Studies were categorized by IDEAL stages: 0/1, simple technical preclinical/clinical reports; 2a, technique modifications with rationale and safety data; 2b, expanded patient selection and reporting of both innovation and standard care outcomes; 3, formal randomized controlled trials; and 4, long-term audit and registry studies. Each stage has specific requirements for reporting of surgeon expertise, governance details and outcome reporting. Results Of 615 abstracts screened, 16 papers reporting outcomes of 550 patients were included. Only two studies could be put into IDEAL categories. One animal study was classified as stage 0 and one clinical study as stage 2a through prospective ethical approval, protocol registration and data collection. Studies could not be classified according to IDEAL for insufficient reporting details of patient selection, relevant surgeon expertise, and how and why the technique was modified or adapted. Conclusion The reporting of innovation in the context of laparoendoscopic colonic polyp excision would benefit from standardized methods.

We support the consensus recommendations from Lineberry and colleagues for improving the credibility and transparency of the reporting of adverse events in publications of research sponsored by industry.1 We also support a similar process for the development of standards and consensus for the reporting of benefit and harm outcomes in surgical trials, including early phase surgical studies. Recent reviews have …

Background Resident surgeons have been identified as a risk factor for worse outcome after appendectomy. The context of grade of resident and impact of supervision require further investigation. The objective of this study was to determine whether grade and supervision level of resident-performed appendectomy affects patient outcome. Methods A multicenter, prospective cohort study was performed for consecutive patients undergoing appendectomy during May and June 2013. The primary endpoint for this analysis was the 30-day adverse event rate. Supervision was defined as resident-performed appendectomy with an attending scrubbed. Multivariable binary logistic regression was used to take into account case mix and produce adjusted odds ratios (OR). Results From 2,867 appendectomies, 87% were performed by residents, and 72% were performed unsupervised. Residents operated on significantly younger patients with lower American Society of Anesthesiologists scores. Although wound infection rates were similar between attendings, and senior and junior residents (4.1%, 3.8%, 3.4% respectively; P = .486), pelvic abscess rate was greater for attendings (5.2%, 2.7%, 2.4%; P = .045). In adjusted models, supervised senior, supervised junior, and unsupervised junior residents showed no difference in 30-day adverse event rates compared with attendings (OR, 1.07 [P = .834], 0.93 [P = .773], and 0.83 [P = .264] respectively); unsupervised senior residents had a lesser rate of adverse events (OR, 0.71; P = .045). All resident groups showed no difference for rates of histopathologically normal appendectomy compared with attendings. Conclusion Resident-performed appendectomy does not worsen patient outcomes. These findings support independent resident operating rights for selected cases. The system relies on mutual credentialing of competency between residents and supervising attendings.

Objective To determine safety of short in-hospital delays before appendicectomy. Background Short organizational delays before appendicectomy may safely improve provision of acute surgical services. Methods The primary endpoint was the rate of complex appendicitis (perforation, gangrene, and/or abscess). The main explanatory variable was timing of surgery, using less than 12 hours from admission as the reference. The first part of this study analyzed primary data from a multicentre study on appendicectomy from 95 centers. The second part combined this data with a systematic review and meta-analysis of published data. Results The cohort study included 2510 patients with acute appendicitis, of whom 812 (32.4%) had complex findings. Adjusted multivariable binary regression modelling showed that timing of operation was not related to risk of complex appendicitis [12-24 hours odds ratio (OR) 0.98 (P = 0.869); 24-48 hours OR 0.88 (P = 0.329); 48+ hours OR 0.82 (P = 0.317)]. However, after 48 hours, the risk of surgical site infection and 30-day adverse events both increased [adjusted ORs 2.24 (P = 0.039) and 1.71 (P = 0.024), respectively]. Meta-analysis of 11 nonrandomized studies (8858 patients) revealed that delay of 12 to 24 hours after admission did not increase the risk of complex appendicitis (OR 0.97, P = 0.750). Conclusions Short delays of less than 24 hours before appendicectomy were not associated with increased rates of complex pathology in selected patients. These organizational delays may aid service provision, but planned delay beyond this should be avoided. However, where optimal surgical systems allow for expeditious surgery, prompt appendicectomy will still aid fastest resolution of pain for the individual patient.

IntroductionRigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation.Methods and analysisA COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases:1. Generation of a list of relevant outcome domains and reporting items identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items.2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome.3. A consensus meeting with key stakeholders will discuss and agree the final content of the reporting guidance and COS(s).Ethics and disseminationEthical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events.

Background: Breast reconstruction (BR) may improve psychosocial and cosmetic outcomes after mastectomy for breast cancer but currently, few women opt for surgery. Reasons for this are unclear. The aim of this qualitative study was to explore access to care and the provision of procedure choice to women seeking reconstructive surgery. Methods: Semi-structured interviews with a purposive sample of patients who had undergone BR and professionals providing specialist care explored participants' experiences of information provision before BR. Interviews were transcribed verbatim and analysed using the constant comparative technique of grounded theory. Sampling, data collection and analysis were performed concurrently and iteratively until data saturation was achieved. Results: Both patients and professionals expressed concerns about the provision of adequate procedure choice and access to care. Lack of information and/or time, involvement in decision making and issues relating to the evolution and organisation of reconstructive services, emerged as potential explanations for the inequalities seen. Interventions to improve cross-speciality collaboration were proposed to address these issues. Conclusion: Inequalities in the provision of choice in BR exist, which may be explained by a lack of integration between surgical specialities. Pathway restructuring, service reorganisation and standardisation of training may enhance cross-speciality collaboration and improve the patient experience.

Background Identification of variation in practice is a key step towards standardization of service and determination of reliable quality markers. This study aimed to investigate variation in provision and outcome of emergency appendicectomy. Methods A multicentre, trainee-led, protocol-driven, prospective observational cohort study was performed during May and June 2012. The main outcome of interest was the normal histopathology rate; secondary outcomes were laparoscopy and 30-day adverse event rates. Analysis included funnel plots and binary logistic regression models to identify patient- and hospital-related predictors of outcome. Results A total of 3326 patients from 95 centres were included. An initial laparoscopic approach was performed in 66·3 per cent of patients (range in centres performing more than 25 appendicectomies over the study period: 8·7–100 per cent). A histologically normal appendix was removed in 20·6 per cent of patients (range in centres performing more than 25 procedures: 3·3–36·8 per cent). Funnel plot analysis revealed that 22 centres fell below three standard deviations of the mean for laparoscopy rates. Higher centre volume, consultant presence in theatre and daytime surgery were independently associated with an increased use of laparoscopy, which in turn was associated with a reduction in 30-day morbidity (adjusted for disease severity). Daytime surgery further reduced normal appendicectomy rates. Increasing volume came at the cost of higher negative rates, and low negative rates came at the cost of higher perforation rates. Conclusion This study reveals the extremely wide variation in practice patterns and outcomes among hospitals. Organizational factors leading to this variation have been identified and should be addressed to improve performance.

Introduction: Appropriate outcome selection is essential if research is to guide decision-making for patients, professionals and policy makers. Systematic reviews evaluating the clinical, cosmetic and patient-reported outcomes of breast reconstruction, however, have demonstrated marked heterogeneity of outcome reporting such that results from individual studies cannot be compared or combined. Standardising end-points by developing and using core outcome sets - an agreed minimum set of outcomes that should be measured and reported in all research and audit studies – is one way by which outcome reporting may be improved. We therefore report the initial results of the BRAVO (Breast Reconstruction and Valid Outcomes) Study which aims to use a scientifically rigorous Delphi consensus process to develop a core outcome set for reconstructive breast surgery. Methods: The Delphi process involves the sequential completion of questionnaires to allow stakeholder opinions to be synthesised using item responses to prioritise outcome domains. The questionnaire was developed from a long list of 148 outcomes generated from literature reviews and qualitative work with stakeholders. The outcomes were categorised into 34 domains in six categories (short-term complications; late complications; symptoms; psychosocial issues; practical issues and cosmesis) and each domain operationalised. Key stakeholders were identified as patients, surgeons, specialist nurses and psychologists and participants were sampled purposively to ensure a breadth of perspectives. Each participant was sent a questionnaire and asked to prioritise the outcomes on a nine-point likert scale from 1(not important) to 9(extremely important). The number of respondents in each group rating each outcome as not important(scores 1–3); equivocal(scores 4–6) or very important(score 7–9) were calculated for each item and compared between groups. The proportions of respondents rating each item as very important(score 7–9) was used to rank the items. Results: 213 of the 430 questionnaires were returned(126/274 patients and 87/156 professionals) giving a response rate of 49.5%. Patient participants had a median age of 53.4 years(range 34–76) and had undergone a full range of reconstructive procedures. The professional group included 39 breast surgeons, 20 plastic surgeons and 18 clinical nurse specialists. There was agreement between 7 of the 10 outcomes that each group rated most highly. Items with consensus included patient-reported cosmesis, cosmetic satisfaction and early complications. Patients, but not professionals, considered generic complications such as bleeding to be important while professionals valued psychosocial issues such as self-esteem more highly than patients. Conclusions: Patients and professionals prioritise similar outcomes, but areas of discrepancy with regard to complications and psychosocial outcomes remain. A further Delphi round asking participants to re-prioritise outcomes and a consensus meeting to ratify the final decisions will be necessary to determine a final core outcome set for reconstructive breast surgery. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P4-17-03.

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IntroductionImmediate breast reconstruction (IBR) is routinely offered to improve quality of life for women with breast cancer requiring a mastectomy, but there are concerns that more complex surgery may delay the delivery of adjuvant oncological treatments and compromise long-term oncological outcomes. High-quality evidence, however, is lacking. iBRA-2 is a national prospective multicentre cohort study that aims to investigate the effect of IBR on the delivery of adjuvant therapy. Methods and analysisBreast and plastic surgery centres in the UK performing mastectomy with or without (+/-) IBR will be invited to participate in the study through the trainee research collaborative network. All women undergoing mastectomy+/-IBR for breast cancer between 1st July and 31st December 2016 will be included. Patient demographics, operative, oncological and complication data will be collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy+/-IBR will be compared to determine the impact that IBR has on the time of delivery of adjuvant therapy. Prospective data on 3000 patients from approximately 50 centres is anticipated. Ethics and disseminationResearch ethics approval is not required for this study. This has been confirmed using the on-line Health Research Authority (HRA) decision tool. This novel study will explore whether IBR impacts the time to delivery of adjuvant therapy. The study will provide valuable information to help patients and surgeons make more informed decisions about their surgical options. Dissemination of the study protocol will be via the Mammary Fold Academic and Research Collaborative (MFAC) and the Reconstructive Surgery Trials Network (RSTN), the Association of Breast Surgery (ABS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). Participating units will have access to their own data and collective results will be presented at relevant surgical conferences and published in appropriate peer-reviewed journals.

Background Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders. Methods Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria. Results Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3–22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65–82 % agreement for peer-only feedback versus 74–94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group. Conclusions In the development of a core outcome or information set, providing feedback within Delphi questionnaires from all stakeholder groups separately may influence the final core set and improve consensus between the groups. Further work is needed to better understand how participants rate and re-rate items within a Delphi process. Trial registration The three randomized controlled trials reported here were each nested within the development of a core information or outcome set to investigate processes in core outcome and information set development. Outcomes were not health-related and therefore trial registration was not applicable. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1479-x) contains supplementary material, which is available to authorized users.

Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

IntroductionDuctal carcinoma in situ (DCIS) accounts for approximately 10% of all newly-diagnosed breast cancers in the UK. The latest national guidelines were published in 2009 and may not reflect current best practice. We aimed to explore variation in the current management of DCIS to support the need for updated guidelines. MethodsA national practice questionnaire was developed by the Mammary Fold Academic Committee (MFAC) focusing on the pre, intra and post-operative management of DCIS. Trainees at UK breast units were invited to complete the questionnaire at their multidisciplinary team meeting to provide a comprehensive picture of current national practice.Results76 of 144 UK breast units (52.8%) participated in the survey. Variation was observed in radiological pre-operative assessment with only 33/76 units (43.4%) performing routine ultrasound assessment of the tumour or axilla. There was no clear consensus regarding indications for mastectomy; multifocality (38.2%) and extensive microcalcifications (34.2%) were the most frequent indications. 34/76 units (44.7%) offered nipple sparing mastectomy. 33/76 units (43.3 %) perform sentinel node biopsy in the presence of a palpable/mass lesion and 51/76 (67.1 %) at the time of mastectomy. The most widely accepted pathological radial margin remained 2mm (36.8%). The commonest factors in decision-making for radiotherapy were tumour grade (51.3%) and size (35.5%). Only 12 units (15.8 %) routinely used the Van Nuys prognostic index. Approximately half of all breast units offer clinical long-term follow-up. DiscussionThere is marked variation in the management of DCIS in the UK. Updated evidence-based guidelines may standardise practice and improve outcomes for patients.

Breast reconstruction (BR) is undertaken to improve cosmetic outcomes, but how this is optimally assessed is uncertain. This review summarises current methods for assessing cosmesis after reconstructive surgery and makes recommendations for future practice.A comprehensive systematic review identified all studies with 20 or more participants that evaluated the cosmetic outcome of BR. Four evaluation criteria (reporting of study inclusion criteria, type and timing of BR and timing of assessment) were used to assess study quality. Articles reporting at least three of the four criteria were considered robust and further summarised to report methods of cosmetic assessment, assessor details and the scoring systems used.122 primary papers assessed cosmesis in 11,308 women with median follow-up of 28.8 months (range 18.0-42.9 months). Cosmesis was assessed by either healthcare professionals or patients in 33 (27.1%) and 37 studies (30.3%), respectively, and by both professionals and patients in 52 (42.6%). Professional assessments included 43 (40.2%) clinical, 49 (45.8%) photographic and 13 (12.1%) geometric assessments conducted by between 1 and 26 observers. Surgeons were most frequently involved in assessments (n = 71, 67.6%), but in 38 (36.1%) papers the assessor's profession was not reported. Twenty-seven (25.7%) papers used previously published assessment scale. Patients' views were assessed in 89 studies, using questionnaires (n = 63) or interviews (n = 12); 14 (15.7%) did not report how patients' views were obtained.Current methods for assessing the cosmetic outcome of BR vary widely. A valid patient-centred assessment method is required to fully understand the outcomes of BR and to inform decision-making.

Background Health-related quality of life (HRQL) is an important outcome following breast reconstruction. This study evaluated current methods of HRQL assessment in patients undergoing latissimus dorsi breast reconstruction, hypothesizing that early surgical morbidity would be reflected by poorer HRQL scores. Methods Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and breast module (QLQ-BR23), the Functional Assessment of Cancer Therapy (FACT) general measure, and breast module and arm subscale (FACT-B + 4), and the Body Image Scale and Hospital Anxiety and Depression Scale (HADS) 3 months after surgery. They also reported additional HRQL problems not included in the questionnaires. HRQL scores were compared between patients with and without early surgical morbidity. Results Sixty women completed the questionnaires, of whom 25 (42 per cent) experienced complications. All EORTC and FACT subscale and HADS scores were similar in patients with or without morbidity. Women with complications were twice as likely to report feeling less feminine and dissatisfied with the appearance of their scar than those without problems. Thirty-two women (53 per cent) complained of problems not covered by the questionnaires, most commonly donor-site morbidity. Conclusion Existing HRQL instruments are not sufficiently sensitive to detect clinically relevant problems following breast reconstruction.

The National Breast Screening Programme had dramatically impacted surgical practice. Up to 50% of all newly diagnosed cancers are now impalpable creating increased demand for image-guided localisation. Wire-guided localisation (WGL) is the current gold standard, but USS-guided localisation by radiologists is a well-documented and effective technique. Increasing numbers of surgeons are proficient in using ultrasound and may be as accurate as radiologists in localising lesions intra-operatively. Of 68 patients with screen-detected impalpable lesions referred to one surgeon in our unit between January 2005 and February 2006, 32 had mass lesions, which were well seen on ultrasound and underwent intra-operative USS-guided localisation performed by a surgeon. All lesions were correctly identified and 87.5% (n=28) were fully excised. Those lesions not fully excised were lobular cancers. Intra-operative sonographic localisation performed by surgeons is an accurate and effective technique. It may produce less patient anxiety and discomfort than WGL and allow more effective and efficient use of resources and theatre time.

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 revolutionalised the procedure, but there is a lack of high-quality outcome data to support the safety or efficacy 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 of conducting a pragmatic-RCT to examine the effectiveness of new approaches to IBBR.

Background Evidence-based interventions may reduce mortality in surgical patients. This study documented the prevalence of sepsis, adherence to guidelines in its management, and timing of source control in general surgical patients presenting as an emergency. Methods Patients aged 16 years or more presenting with emergency general surgery problems were identified over a 7-day period and then screened for sepsis compliance (using the Sepsis Six standards, devised for severe sepsis) and the timing of source control (whether radiological or surgical). Exploratory analyses examined associations between the mode (emergency department or general practitioner) and time of admission, adherence to the sepsis guidelines, and outcomes (complications or death within 30 days). Results Of a total of 5067 patients from 97 hospitals across the UK, 911 (18·0 per cent) fulfilled the criteria for sepsis, 165 (3·3 per cent) for severe sepsis and 24 (0·5 per cent) for septic shock. Timely delivery of all Sepsis Six guidelines for patients with severe sepsis was achieved in four patients. For patients with severe sepsis, 17·6–94·5 per cent of individual guidelines within the Sepsis Six were delivered. Oxygen was the criterion most likely to be missed, followed by blood cultures in all sepsis severity categories. Surgery for source control occurred a median of 19·8 (i.q.r. 10·0–35·4) h after diagnosis. Omission of Sepsis Six parameters did not appear to be associated with an increase in morbidity or mortality. Conclusion Although sepsis was common in general surgical patients presenting as an emergency, adherence to severe sepsis guidelines was incomplete in the majority. Despite this, no evidence of harm was apparent.

Background Acellular dermal matrix (ADM) may improve outcomes in implant-based breast reconstruction (IBBR). The aim of this study was critically to appraise and evaluate the current evidence for ADM-assisted IBBR. Methods Comprehensive electronic searches identified complete papers published in English between January 2000 and August 2013, reporting any outcome of ADM-assisted IBBR. All systematic reviews, randomized clinical trials (RCTs) and non-randomized studies (NRSs) with more than 20 ADM recipients were included. Studies were critically appraised using AMSTAR for systematic reviews, the Cochrane risk-of-bias tool for RCTs and its adaptation for NRSs. Characteristics and results of identified studies were summarized. Results A total of 69 papers (8 systematic reviews, 1 RCT, 40 comparative studies and 20 case series) were identified, all of which were considered at high risk of bias, mostly due to patient selection and selective outcome reporting. The median ADM group sample size was 51.0 (i.q.r. 33.0–127.0). Most studies were single-centre (54), and they were often single-surgeon (16). ADM was most commonly used for immediate (40) two-stage IBBR (36) using human ADM (47), with few studies evaluating ADM-assisted single-stage procedures (10). All reported clinical outcomes (for example implant loss) and more than half of the papers (33) assessed process outcomes, but few evaluated cosmesis (16) or patient-reported outcomes (10). Heterogeneity between study design and, especially, outcome measurement precluded meaningful data synthesis. Conclusion Current evidence for the value of ADMs in IBBR is limited. Use in practice should therefore be considered experimental, and evaluation within registries or well designed and conducted studies, ideally RCTs, is recommended to prevent widespread adoption of a potentially inferior intervention.

Background Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. Methods We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ 2 tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. Results Surgical complications following breast reconstruction in 42146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. Conclusions The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

Screening is an important strategy for reducing cancer-related mortality in developed countries. Programmes for breast and cervical cancer screening are well established, while protocols for prostate, colorectal and ovarian cancer are still being developed [1–7]. Population screening programmes help to detect both invasive cancers and pre-malignant disease. Prompt treatment of those identified with ca­ncer can reduce mortality, although screening trials do not consistently improve survival [8–12]. Diagnosing cancer early may mean that less invasive treatments with better clinical outcomes can be offered to patients [13, 14].

INTRODUCTION The UK National Institute for Health and Clinical Excellence (NICE) recommends that breast cancer follow-up should be limited to 2–3 years stating this will ‘release resources’ making it ‘possible for all women with breast symptoms to be seen within 2 weeks’. In 2000, breast cancer follow-up services in North Bristol were redesigned to reflect evidence-based best practice. The aim of this paper is to assess the impact of this policy on numbers of follow-ups, clinic capacity and waiting times. PATIENTS AND METHODS Data regarding the numbers of new and follow-up patients seen in breast clinic between January 2000 and December 2005 were collected from the hospital Patient Administration System. New patients were categorised as either ‘routine’ or ‘urgent’ according to ‘2-week wait’ rule guidelines. Median waiting times were calculated for each group and nominal appointment times assigned in an attempt to assess the effect of any changes on clinic capacity. RESULTS The number of follow-ups decreased by 33% as a result of the new policy. Numbers of referrals over the same period, however, increased by 14%. Routine referrals declined, but there was a 27% increase in ‘2-week wait’ patients. Waiting times for routine appointments initially decreased in response to reduced follow-up, but then rose as the number of ‘2-week wait’ referrals increased. CONCLUSIONS Reducing long-term follow-up is a simple and effective method of increasing clinic capacity but its effects are inadequate and transient in the face of increasing service demand. Additional innovative and creative strategies will be required if all breast patients are to be seen within 2 weeks.