Patient-reported outcome and cost implication of acute salvage of infected implant-based breast reconstruction with negative pressure wound therapy with Instillation (NPWTi) compared to standard care.

INTRODUCTION: Implant loss due to infection is the most devastating complication of implant-based breast reconstruction. The use of negative pressure wound therapy with instillation(NPWTi) for salvage of infected implant-based breast reconstructions has shown promising results allowing early reinsertion of a new implant as an alternative to the current management with delayed reinsertion. This study compares the patient-reported outcome and cost implication of NPWTi to the current management. METHODS: Twenty cases of infected breast implants treated with NPWTi(V.A.C. VERAFLO™ Therapy), followed by early reinsertion of new implants were compared to 20 cases that had delayed reinsertion(non-NPWTi). Patient satisfaction was evaluated using the BREAST-Q questionnaire. The average cost per patient was calculated using total operative expense, cost of inpatient stay, investigations, antibiotics, and outpatient visits. RESULTS: Treatment with NPWTi allowed earlier reinsertion of a new implant (NPWTi: 10.3 ± 2.77days vs. non-NPWTi: 247.45±111.28days, p<0.001). Patients in the NPWTi group reported higher satisfaction. The average cost per patient for NPWTi and non-NPWTi was £14,343.13±£2,786.70 and £8,920.31±£3,005.73, respectively(p<0.001). All patients treated with NPWTi had one admission and spent 11.9 ± 4.1days as inpatients, while non-NPWTi patients had 2.1 ± 0.3 admissions(p<0.001) and spent 7.1 ± 5.8days(p<0.004) as inpatients. Patients treated with NPWTi had more procedures (NPWTi:3.35±0.81 Vs. non-NPWTi:2.2 ± 0.41, p = 0.006); however, three non-NPWTi cases required flap reconstruction. CONCLUSION: Patients treated with NPWTi reported higher satisfaction, received a new and earlier implant, and had fewer admissions and outpatient visits; however, they incurred higher average costs, longer inpatient stays, and underwent more procedures. Early implant reinsertion preserves skin envelope; hence avoiding additional cost and stress related to further major autologous reconstruction.

Radiation-induced fibrosis in breast cancer: A protocol for an observational cross-sectional pilot study for personalised risk estimation and objective assessment.

INTRODUCTION: About 30% of patients request breast reconstruction following surgery for breast cancer, but radiation therapy negatively influences the outcome. Post-reconstruction radiotherapy is associated with more complications, including more severe capsular contracture and inferior cosmetic results. In general, less fibrosis is seen if autologous reconstruction is performed after radiotherapy, so surgeons will often delay reconstruction until after radiotherapy is complete. Drawbacks to this approach include additional surgery, recuperation, cost, and an extended reconstructive process. Randomised clinical trials are required to determine the best approach. METHODS AND ANALYSIS: The aim of this cross-sectional pilot study is to see if it is feasible to recruit women, and gather the required data. This information will be used to design a subsequent, larger study whose aim is to identify factors that increase the risk of radiation-induced fibrosis, and use these to develop a personalised risk-prediction tool, to enable the clinician and patient to have a more informed discussion when treatment for breast cancer is being discussed. Identification of the risk factors will also enable the development of methods to minimise the risk, which would have applications in other medical conditions where fibrosis is a problem. In addition, the project will develop objective methods of assessing fibrosis, and will determine the psychological and economic impacts that fibrosis has affected individuals. A better understanding of the long-term effects of radiotherapy on normal tissues such as the heart and lungs may also have applications in other medical conditions where fibrosis is a problem. ETHICS AND DISSEMINATION: The study has been submitted for ethical approval (REC reference). Findings will be made available to patients and clinicians through presentations at national and international meetings, peer-reviewed publications, social media and patient support groups. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (after REC approval).

A Meta-analysis of Clinical, Patient-Reported Outcomes and Cost of DIEP versus Implant-based Breast Reconstruction.

INTRODUCTION: Comparative data on clinical outcomes and cost of deep inferior epigastric perforator (DIEP) and implant-based reconstruction (IBR) are limited. We conducted a Preferred Reporting Items for Systematic Review and Meta-analysis-compliant systematic review and meta-analysis to compare clinical, patient-reported outcomes (PROs) and cost. METHODS: The protocol was published a priori on PROSPERO (CRD42017072557). EMBASE, MEDLINE, Google Scholar, Cochrane Controlled Register of Trials, Science Citation Index, and ClinicalTrials.gov were searched from January 1994 to August 2018. Two independent reviewers evaluated the articles for inclusion. Study quality was assessed using Grading of Recommendations Assessment, Development, and Evaluation, and risk of bias (RoB) was assessed using Cochrane's RoB in Nonrandomized Studies of Interventions tool. RESULTS: Out of 6,381 articles screened, 16 were included [unilateral 782 DIEPs, 376 implants; mean age 49 years, follow-up (months): DIEP 29.9; IBR 35.5]. Mean flap loss and fat necrosis rates were 3.97% (SD 4.90) and 9.67% (SD 17.0), respectively. There was no difference in mean length of stay {standard mean difference 0.63 [confidence interval (CI) -9.17 to 10.43]; P =0.90}. The number of reoperations for complications was significantly lower in DIEP versus IBR [SMD -0.29 (CI -0.48 to -0.09); P < 0.01]. There were no randomized controlled trials. Study quality was low with high RoB. One study reported $11,941/Quality-adjusted Life Year incremental cost-effectiveness ratio for DIEP, with higher breast Quality-adjusted Life Year (DIEP 19.5; IBR 17.7) using Breast Questionnaire; 3 studies evaluated cost, favoring DIEP. Two comparative studies evaluating PROs favored DIEP. CONCLUSIONS: DIEP reconstruction maybe more cost-effective and yield superior PROs. However, poor-quality, bias-ridden studies limit the findings. Adequate reporting of core outcome measures is required to minimize reporting bias and facilitate evidence synthesis. Prospective, multicenter, cohort studies using robust patient-reported outcome measures (PROMs) tools, evaluating cost-effectiveness and contributing to national/international registries, will facilitate national-level policy and shared decision-making.

Protocol for a systematic review and meta-analysis on the clinical outcomes and cost of deep inferior epigastric perforator (DIEP) flap versus implants for breast reconstruction.

BACKGROUND: Mastectomy in the context of breast malignancy can have a profoundly negative impact on a woman's self-image, impairing personal, sexual and social relationships. The deep inferior epigastric perforator (DIEP) flap and implants are the two commonest reconstructive modalities that can potentially overcome this psychological trauma. The comparative data on clinical outcomes and costs of the two modalities is limited. We aim to synthesise the current evidence on DIEP versus implants to establish which is the superior technique for breast reconstruction, in terms of clinical outcomes and cost-effectiveness. METHODS: A comprehensive search will be undertaken of EMBASE, MEDLINE, Google Scholar, CENTRAL and Science citation index databases (1994 up to August 2017) to identify studies relevant for the review. Primary human studies evaluating clinical outcomes and cost of DIEP and implant-based reconstruction in context of breast malignancy will be included. Primary outcomes will be patient satisfaction and cosmetic outcome from patient-reported outcome measures (scores from validated tools, e.g. BREAST-Q tool), complications and cost-analysis. The secondary outcomes will be duration of surgery, number of surgical revisions, length of stay, availability of procedures and total number of clinic visits. DISCUSSION: This will be the first systematic review and meta-analysis in available literature comparing the clinical outcomes and cost-effectiveness of DIEP and implants for breast reconstruction. This review is expected to guide worldwide clinical practice for breast reconstruction. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017072557 .

Assessing the effects of changes in care commissioning guidelines at a tertiary centre in London on the provision of NHS-funded procedures of limited clinical effectiveness: an 11-year retrospective database analysis.

OBJECTIVES: The main objective of this study was to assess the impact of changes in care commissioning policies on National Health Service (NHS)-funded cosmetic procedures over an 11-year period at our centre. SETTING: The setting was a tertiary care hospital in London regulated by the North Central London Hospitals NHS Trust care commissioning group. PARTICIPANTS: We included all patients logged on to our database at the time of the study which was 2087 but later excluded 61 from analysis due to insufficient information. PRIMARY AND SECONDARY OUTCOME MEASURES: The main outcome measures were the results of tribunal assessment for different cosmetic surgeries which were either accepted, rejected or inconclusive based on the panel meeting. RESULTS: There were a total of 2087 patient requests considered between 2004 and 2015, of which 715 (34%) were accepted, 1311 (63%) were declined and 61 (3%) had inconclusive results. The implementation of local care commissioning guidelines has reduced access to cosmetic surgeries. Within this period, the proportion of procedures accepted has fallen from 36% in 2004 to 21% in 2015 (χ2; p<0.05, 95% CI). CONCLUSION: Local guidance on procedures of limited clinical effectiveness is a useful, although not evidence-based selection process to reduce access to cosmetic surgery in line with increasing financial constraints. However, patients with a physical impairment may not receive treatment in comparison to previous years, and this can have a negative impact on their quality of life.

Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial.

BACKGROUND: Split-thickness skin grafting (SSG) is an important modality for wound closure. However, the donor site becomes a second, often painful wound, which may take more time to heal than the graft site itself and holds the risk of infection and scarring. Epidermal grafting (EG) is an alternative method of autologous skin grafting that harvests only the epidermal layer of the skin by applying continuous negative pressure on the normal skin to raise blisters. This procedure has minimal donor site morbidity and is relatively pain-free, allowing autologous skin grafting in an outpatient setting. We plan to compare EG to SSG and to further investigate the cellular mechanism by which each technique achieves wound healing. METHODS/DESIGN: EPIGRAAFT is a multicentre, randomised, controlled trial that compares the efficacy and wound-healing mechanism of EG with SSG for wound healing. The primary outcome measures are the proportion of wounds healed in 6 weeks and the donor site healing time. The secondary outcome measures include the mean time for complete wound healing, pain score, patient satisfaction, health care utilisation, cost analysis, and incidence of adverse events. DISCUSSION: This study is expected to define the efficacy of EG and promote further understanding of the mechanism of wound healing by EG compared to SSG. The results of this study can be used to inform the current best practise for wound care. TRIAL REGISTRATION: Clinicaltrials.gov identifier, NCT02535481 . Registered on 11 August 2015.