Medical Specialist Care Utilization Prior to the Explantation of Cosmetic Silicone Breast Implants: A Nationwide Retrospective Data Linkage Study.

BACKGROUND: Explantation is the proposed treatment for breast implant illness (BII). Little is known about which medical specialists are visited and what diagnoses are made before explantation is provided as the treatment. OBJECTIVES: This study investigated medical specialist care utilization in women with cosmetic breast implants who underwent explantation compared to women who chose breast implant replacement surgery and to women without breast implants. METHODS: Retrospective cohort study using data linkage with the Dutch Breast Implant Registry and the Dutch health insurance claims database. Visits to medical specialists were examined over the 3 years before explantation. A total of 832 explantation patients were matched and compared to 1463 breast implant replacement patients and 1664 women without breast implants. RESULTS: Explantation patients were more likely to have visited > 5 different medical specialties compared to both replacement patients (12.3% vs. 5.7%; p < 0.001) and women without breast implants (12.3% vs. 3.7%; p < 0.001). Among explantation patients, women who underwent explantation because of BII were more likely to have visited > 5 different medical specialties compared to women who underwent explantation because of other reasons (25.0% vs. 11.0%; p < 0.001). CONCLUSIONS: Women who underwent explantation of breast implants had higher utilization of medical specialist care in the years before explantation compared to women who underwent breast implant replacement surgery and women without breast implants. Medical specialist care use was especially high among women for whom BII was the registered reason for explantation. These findings suggest further research is needed into the link between BII and the use of medical specialist care. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Comparing quality of breast cancer care in the Netherlands and Norway by federated propensity score analytics.

PURPOSE: The aim of the study was to benchmark and compare breast cancer care quality indicators (QIs) between Norway and the Netherlands using federated analytics preventing transfer of patient-level data. METHODS: Breast cancer patients (2017-2018) were retrieved from the Netherlands Cancer Registry and the Cancer Registry of Norway. Five European Society of Breast Cancer Specialists (EUSOMA) QIs were assessed: two on magnetic resonance imaging (MRI), two on surgical approaches, and one on postoperative radiotherapy. The QI outcomes were calculated using 'Vantage 6' federated Propensity Score Stratification (PSS). Likelihood of receiving a treatment was expressed in odds ratios (OR). RESULTS: In total, 39,163 patients were included (32,786 from the Netherlands and 6377 from Norway). PSS scores were comparable to the crude outcomes of the QIs. The Netherlands scored higher on the QI 'proportions of patients preoperatively examined with breast MRI' [37% vs.17.5%; OR 2.8 (95% CI 2.7-2.9)], the 'proportions of patients receiving primary systemic therapy examined with breast MRI' [83.3% vs. 70.8%; OR 2.3 (95% CI 1.3-3.3)], and 'proportion of patients receiving a single breast operation' [95.2% vs. 91.5%; OR 1.8 (95% CI 1.4-2.2)]. Country scores for 'immediate breast reconstruction' and 'postoperative radiotherapy after breast-conserving surgery' were comparable. The EUSOMA standard was achieved in both countries for 4/5 indicators. CONCLUSION: Both countries achieved high scores on the QIs. Differences were observed in the use of MRI and proportion of patients receiving single surgery. The federated approach supports future possibilities on benchmark QIs without transfer of privacy-sensitive data.

Changes in breast cancer treatment during the COVID-19 pandemic: a Dutch population-based study.

PURPOSE: We aimed to compare (1) treatments and time intervals between treatments of breast cancer patients diagnosed during and before the COVID-19 pandemic, and (2) the number of treatments started during and before the pandemic. METHODS: Women were selected from the Netherlands Cancer Registry. For aim one, odds ratios (OR) and 95% confidence intervals (95%CI) were calculated to compare the treatment of women diagnosed within four periods of 2020: pre-COVID (weeks 1-8), transition (weeks 9-12), lockdown (weeks 13-17), and care restart (weeks 18-26), with data from 2018/2019 as reference. Wilcoxon rank-sums test was used to compare treatment intervals, using a two-sided p-value < 0.05. For aim two, number of treatments started per week in 2020 was compared with 2018/2019. RESULTS: We selected 34,097 women for aim one. Compared to 2018/2019, neo-adjuvant chemotherapy was less likely for stage I (OR 0.24, 95%CI 0.11-0.53), stage II (OR 0.63, 95%CI 0.47-0.86), and hormone receptor+/HER2- tumors (OR 0.55, 95%CI 0.41-0.75) diagnosed during transition. Time between diagnosis and first treatment decreased for patients diagnosed during lockdown with a stage I (p < 0.01), II (p < 0.01) or III tumor (p = 0.01). We selected 30,002 women for aim two. The number of neo-adjuvant endocrine therapies and surgeries starting in week 14, 2020, increased by 339% and 18%, respectively. The number of adjuvant chemotherapies decreased by 42% in week 15 and increased by 44% in week 22. CONCLUSION: The pandemic and subsequently altered treatment recommendations affected multiple aspects of the breast cancer treatment strategy and the number of treatments started per week.

Preservation of the Pectoral Fascia in Mastectomy With Immediate Reconstruction: A Nationwide Survey.

INTRODUCTION: Pectoral fascia (PF) removal during mastectomy still seems to be the standard procedure. However, preservation of the PF might improve postoperative and cosmetic outcomes, without compromising oncological safety. Here, we report on a national survey among Dutch plastic surgeons and oncological breast surgeons to evaluate their techniques and opinions regarding the PF. MATERIALS AND METHODS: A survey based study was performed in the Netherlands, in which both plastic surgeons and oncological breast surgeons were included, each receiving a different version of the survey. The surveys were distributed to 460 and 150 e-mail addresses, respectively. RESULTS: A total of 68 responses were included from more than half of all Dutch medical centers. The results of this study indicate that circa one in five plastic surgeons and breast surgeons routinely preserve the PF during mastectomies and even more surgeons preserve the PF in specific cases. The surgical techniques and opinions regarding PF preservation widely differ between surgeons. CONCLUSIONS: Preservation of the PF does occur in a substantial part of the Dutch medical centers and techniques and opinions are contradictory. Future studies on this topic should clarify the effect of PF preservation on oncological safety, complication rates, postoperative pain, cosmetic outcomes, and patient satisfaction.

Trends in emotional functioning and psychosocial wellbeing in breast cancer survivors: a prospective cohort study using patient-reported outcome measures.

BACKGROUND: A breast cancer diagnosis can threaten every aspect of a woman's wellbeing, including her mental health. With the growing number of breast cancer survivors, studies addressing mental health in this population are of increasing importance now more than ever. Therefore, the current study investigated trends in emotional functioning and psychosocial wellbeing of breast cancer survivors, and the demographic and treatment characteristics that may influence these trends. METHODS: Prospectively collected data of women treated for breast cancer at the Erasmus MC were analyzed in this study using a cohort study design. Emotional functioning was measured using the EORTC-QLQ-C30, while psychosocial wellbeing was measured using the BREAST-Q. Type of surgery, age, family status and employment status of study participants were retrieved, and multilevel analyses were performed to identify trends in emotional functioning and psychosocial wellbeing and to determine the relationship between aforementioned characteristics and these outcomes. RESULTS: Three hundred thirty-four cancer survivors were analyzed. Psychosocial wellbeing declined, but emotional functioning showed a steady improvement over time. Women who underwent breast reconstruction showed a steeper increase in their emotional functioning, and women with no partner or children showed a marginal decline in psychosocial wellbeing between baseline and 12 months after surgery. CONCLUSIONS: These findings can be utilized by healthcare teams to identify breast cancer patients at risk for emotional problems and to provide adequate psychological support to those women who need help dealing with their emotions and self-concept in order to optimize clinical treatment.

Long-term outcomes, quality of life, and costs of treatment modalities for T1-T2 lip carcinomas.

PURPOSE: Early stage lip squamous cell carcinoma (lip SCC) can be treated with conventional excision, Mohs micrographic surgery (MMS), or brachytherapy. The aim of this retrospective study was to describe the medical outcomes, patient-reported outcomes, and costs of these treatments. METHODS: A retrospective cohort study of T1-T2 lip SSCs treated between 1996 and 2019. Medical outcomes, recurrences, and survival were retrieved from medical records. Facial appearance, facial function, and Quality of Life (QoL) were measured with the Face-Q H&N and EQ-5D-5L questionnaires. Costs were also calculated. RESULTS: Of the 336 lip SCCs, 122 were treated with excision, 139 with MMS, and 75 with brachytherapy. Locally, the recurrence rate was 2.7% and regionally 4.8%. There were 2% disease-related deaths. T2-stage and poor tumor differentiation were associated with recurrences. Posttreatment QoL, facial function, and appearance were rated as good. Brachytherapy was the most expensive treatment modality. CONCLUSION: Early-stage lip SCC has a good prognosis, with a disease-specific survival of 98.2% after a median follow-up of 36 months, there was a high QoL and satisfaction at long-term follow-up. Based on the costs and the risk of locoregional recurrences, we believe that, for most noncomplex lip SCCs, MMS would be the most logical treatment option.

Breast cancer recurrence after immediate and delayed postmastectomy breast reconstruction-A systematic review and meta-analysis.

BACKGROUND: Oncological safety of different types and timings of PMBR after breast cancer remains controversial. Lack of stratified risk assessment in literature makes current clinical and shared decision-making complex. This is the first systematic review and meta-analysis to evaluate differences in oncological outcomes after immediate versus delayed postmastectomy breast reconstruction (PMBR) for autologous and implant-based PMBR separately. METHODS: A systematic literature search was performed in MEDLINE, Cochrane Library, and Embase. The Cochrane Collaboration Handbook and Meta-analysis Of Observational Studies in Epidemiology checklist were followed for data abstraction. Variability in point estimates attributable to heterogeneity was assessed using I2 -statistic. (Loco)regional breast cancer recurrence rates, distant metastasis rates, and overall breast cancer recurrence rates were pooled in generalized linear mixed models using random effects. RESULTS: Fifty-five studies, evaluating 14,217 patients, were included. When comparing immediate versus delayed autologous PMBR, weighted average proportions were: 0.03 (95% confidence interval [CI], 0.02-0.03) versus 0.02 (95% CI, 0.01-0.04), respectively, for local recurrences, 0.02 (95% CI, 0.01-0.03) versus 0.02 (95% CI, 0.01-0.03) for regional recurrences, and 0.04 (95% CI, 0.03-0.06) versus 0.01 (95% CI, 0.00-0.03) for locoregional recurrences. No statistically significant differences in weighted average proportions for local, regional and locoregional recurrence rates were observed between immediate and delayed autologous PMBR. Data did not allow comparing weighted average proportions of distant metastases and total breast cancer recurrences after autologous PMBR, and of all outcome measures after implant-based PMBR. CONCLUSIONS: Delayed autologous PMBR leads to similar (loco)regional breast cancer recurrence rates compared to immediate autologous PMBR. This study highlights the paucity of strong evidence on breast cancer recurrence after specific types and timings of PMBR. LAY SUMMERY: Oncologic safety of different types and timings of postmastectomy breast reconstruction (PMBR) remains controversial. Lack of stratified risk assessment in literature makes clinical and shared decision-making complex. This meta-analysis showed that delayed autologous PMBR leads to similar (loco)regional recurrence rates as immediate autologous PMBR. Data did not allow comparing weighted average proportions of distant metastases and total breast cancer recurrence after autologous PMBR, and of all outcome measures after implant-based PMBR. Based on current evidence, oncological concerns do not seem a valid reason to withhold patients from certain reconstructive timings or techniques, and patients should equally be offered all reconstructive options they technically qualify for.

Using a Digital Implant Catalog Improves Data Quality and Reduces Administrative Burden in the Dutch Breast Implant Registry.

BACKGROUND: Correct registration of implant characteristics is essential to monitor implant safety within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR), these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry. OBJECTIVES: This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden. METHODS: Manually entered implant characteristics (fill, shape, coating, texture) of newly inserted breast implants in the DBIR, from 2015 to 2019, were compared with the corresponding implant characteristics in the DIC. Reference numbers were employed to match characteristics between the 2 databases. The DIC was based on manufacturers' product catalogs and set as the gold standard. RESULTS: A total of 57,361 DBIR records could be matched with the DIC. Accuracy of implant characteristics varied from 70.6% to 98.0%, depending on the implant characteristic. The largest discrepancy was observed for "texture" and the smallest for "coating." All manually registered implant characteristics resulted in different conclusions about implant performance compared with the DIC (P < 0.01). Implementation of the DIC reduced the administrative burden from 14 to 7 variables (50%). CONCLUSIONS: Implementation of a DIC increases data quality in the DBIR and reduces the administrative burden. However, correct registration of reference numbers in the registry by plastic surgeons remains key for adequate matching. Furthermore, all implant manufacturers should be involved, and regular updates of the DIC are required.

Beauty Is in the Eye of the Beholder: Esthetic Outcome Assessment in Smile Reanimation Surgery in Patients With Facial Palsy.

ABSTRACT: Layperson assessments are becoming increasingly important in the evaluation of surgical procedures of the face, including smile reanimation. In this study, the authors set out to answer 3 questions: (1) are esthetic scores more dependent on the assessor or the person that is being assessed, (2) how does smile reanimation change esthetic scores, (3) do sex and age of the patient and assessor explain some of the esthetic outcomes?Thirty-five assessors scored pre and postoperative photographs of 21 facial palsy patients undergoing smile reanimation. Linear mixed-effect models were used to investigate the effects of assessor and patient factors on esthetic outcome assessments, to examine changes after smile reanimation, and to determine whether sex and age explained part of the esthetic outcomes.Fifty-eight percent of variation in the esthetic scores can be explained by some assessors being more positive in their esthetic scoring compared to other assessors. Twenty-nine percent was attributed to patient baseline esthetic scores. Overall esthetic scores improved after smile reanimation. Sex and age of the patient and assessor could not explain variation in the esthetic scores.Esthetic appearance highly depends on "who is looking." These findings are important for preoperative counseling, and for those treating and educating patients with facial palsy.

Telehealth: Could It Be an Avenue to Microvascular Breast Reconstruction for Patients with Geographical Barriers?

BACKGROUND: All women undergoing a mastectomy have the right to reconstruction. However, many women do not receive reconstruction and many more are not aware of all the reconstructive options available to them. Travel distance to a center that provides reconstruction and subsequent follow-up may be a contributing factor to this disparity especially among those who seek microsurgical options. Telehealth, which provides patients with remote video consultations and decreases the travel burden, may be a solution to optimize the accessibility of breast reconstruction for these patients. The purpose of this study was to discuss the efficacy and reliability of telehealth to overcome geographic barriers. METHODS: Patients who received breast reconstruction and participated in video telehealth visits between February and May 2020 were included in this study. Patient demographics, comorbidities, and clinical outcomes were collected. Video telehealth encounters were reviewed to determine specific concerns and questions discussed during these encounters. RESULTS: A total of 235 breast reconstruction surgery patient encounters were recorded for 4 plastic surgeons who offer microsurgical breast reconstruction. Eighty-eight patients (37.4%) were seen as telehealth visits, 20 (22.7%) of which were new patient visits. Eight (9.09%) patients were microsurgical breast reconstruction candidates and 25 (28.4%) were following-up after microsurgical breast reconstruction. The majority of telehealth visits included normally healing wounds in the postoperative patient. CONCLUSION: Telehealth provides an avenue for premastectomy consultation, second opinion visits, and postoperative follow-up for patients who have geographical barriers precluding them from reaching plastic surgeons who perform all types of breast reconstruction.

Predictors of women's sexual outcomes after implant-based breast reconstruction.

OBJECTIVE: Although breast reconstruction has become an important treatment modality following mastectomy, few studies assessed predictors of postoperative sexual outcomes after breast reconstruction. Therefore, we aimed to study three sexual outcomes following implant-based breast reconstruction (IBBR), and associate multiple biopsychosocial factors with these outcomes. METHODS: Data collection was part of a multicenter prospective study on IBBR. A predictive model was tested including medical, background and psychological predictors, partner relationship factors and physical sexual function. Data collection included clinical and questionnaire data (preoperatively and 1 year following reconstruction) using the BREAST-Q Sexual well-being scale (BQ5), and questions regarding sexual dysfunction and sexual satisfaction questions (Female Sexual Function Index). RESULTS: The study sample consisted of 88 women who underwent mastectomy and IBBR. Mean postoperative BQ5 scores were lower than before surgery (M = 58 [SD = 18] vs 65 [SD = 20]; P = .01, Wilks' Lamdba = .88). Sexual dysfunctions were related strongest to orgasm inability and vaginal lubrication issues. The tested models predicted 37%-46% of the sexual outcomes: sexual outcomes were mostly predicted by psychosocial well-being, physical sexual function and partner support. Preoperative sexual and psychosocial well-being were positively associated with postoperative sexual well-being (r = 0.45 and r = 0.47). CONCLUSIONS: Although moderately positive sexual outcomes were reported after IBBR, some women reported issues with vaginal lubrication, breast sensation and orgasm. Sexual dysfunctions were predicted by vaginal lubrication and medical treatments, while sexual well-being and satisfaction were more predicted by psychosocial well-being and partner support. We advocate supportive care that includes partners and psychosocial functioning to optimize sexual outcomes after IBBR.

Long-Term Quality of Life after Free Flap Upper Extremity Reconstruction for Traumatic Injuries.

BACKGROUND: Microsurgical reconstruction of upper extremity injuries is often challenging, and the resulting impact on the quality of life (QoL) may be significant. However, there is a lack of knowledge on long-term patient-reported QoL. METHODS: In a retrospective long-term follow-up study, all consecutive patients with an upper extremity injury who had undergone a free flap reconstruction were identified and categorized into three groups based on the type of injury. Patient-reported upper extremity function and QoL were assessed using three validated questionnaires: the 36-item Short Form Health Survey (SF-36), the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and the Michigan Hand Outcomes Questionnaire (MHQ). RESULTS: A total of 61 patients were identified, of whom 10% had undergone a free flap reconstruction for soft tissue loss only, 62% for an injury accompanied by a fracture, and 28% for a (sub) total amputation. Twenty-one (44%) patients responded to the questionnaires, with a mean follow-up time of 9.7 ± 6.2 years. Patients, on average, reported poorer SF-36 "physical component score" and "role limitations due to physical health" scores compared with Dutch norms. Also, they reported poorer mean DASH scores compared with the general population, indicating worse upper extremity function. Mean MQH scores were lower for the injured side compared with the noninjured side. Pain correlated negatively with the total scores of DASH, MHQ, and SF-36. CONCLUSION: Free flap upper extremity reconstruction is challenging. At 10 years of follow-up, the injury and its treatment continued to have a significant impact on the upper extremity function and daily QoL, with chronic pain being an important factor negatively affecting these outcomes.

Dermatofibrosarcoma Protuberans Re-excision and Recurrence Rates in the Netherlands Between 1989 and 2016.

Dermatofibrosarcoma protuberans is a rare soft tissue tumour with a very low (p < 0.5%) rate of metastasis. Rates of re-excision and recurrence were determined using data from the Netherlands Cancer Registry between 1989 and 2016. Of the 1,890 instances of dermatofibrosarcoma protuberans included, 87% were treated with excision, 4% with Mohs micrographic surgery, and 9% otherwise or unknown. Linked pathology data were retrieved for 1,677 patients. Half of all excisions (847/1,644) were incomplete and 29% (192/622) of all re-excisions were incomplete. The cumulative incidence of a recurrence was 7% (95% confidence interval (95% CI) 6-8) during a median follow-up of 11 years (interquartile range (IQR) 6-17). After Mohs micrographic surgery (n = 34), there were no recurrences during a median follow-up of 4 years (IQR 3-6). Due to the high rate of incomplete excisions and recurrences after excision, this study supports the European guideline, which recommends treating dermatofibrosarcoma protuberans with Mohs micrographic surgery in order to decrease the rate of recurrence.

Reconstruction of Mohs Defects Located in the Head and Neck.

BACKGROUND: Defects following Mohs micrographic surgery (MMS) can range in size from small defects requiring linear closure to large defects needing flap coverage. Reconstruction is dependent on defect size and facial aesthetic unit involvement. The aim of this study was to review the types of facial reconstruction per aesthetic unit involvement and describe their outcomes. METHODS: All data were retrieved for patients ≥18 years who underwent multidisciplinary treatment including dermatological MMS and plastic surgical reconstruction at a single tertiary hospital center (2001-2017). Patient characteristics, tumor pathology, surgical specifics, reconstructive modalities, and surgical outcomes were analyzed. RESULTS: A total of 418 patients were included. Patients were predominantly White, non-Hispanic (97%) and female (58%) with a mean age of 60 ±â€Š13.9 years. Tumor pathology was predominantly basal cell carcinoma in 73% of all cases followed by squamous cell carcinoma in 14%. The nasal aesthetic unit was mostly affected (50%). Local advancement flaps and different types of grafts were used in 51% and 25% of reconstructions, respectively. Complications were observed in 3% and local cancer recurrence in 4% of the patients. Scar revision was needed in 6% of the patients. CONCLUSION: Reconstruction of facial defects after Mohs micrographic surgery can be challenging due to its technical complexity and aesthetic implications. There were differences in complications in reconstructions performed within the same day versus 1 week, with a majority of complications occurring within same-day Mohs reconstructions. A multidisciplinary structured approach, which incorporates patient-reported outcomes, may be needed to optimize surgical results.

Long-Term Outcomes after Double Free Flap Reconstruction for Locally Advanced Head and Neck Cancer.

BACKGROUND: The use of simultaneous, multiple free flaps has become a reliable reconstructive option in patients with extensive composite defects after resection of locally advanced head and neck cancer. However, some reluctance remains among reconstructive surgeons with concerns regarding flap outcomes and limited patient survival. Therefore, we evaluated complications, long-term patient survival, and patient-reported outcomes following these extensive head and neck reconstructions. METHODS: All consecutive patients treated with multiple free flaps for reconstruction of extensive composite defects after resection of locally advanced head and neck cancer between 1999 and 2014 were retrospectively reviewed. Patient charts were evaluated for demographics, treatment details, complications, and patient survival. In addition, all patients alive at the start of the study were asked to complete the 10-item Eat Assessment Tool (EAT-10) and the Intelligibility Rating Scale (IRS). RESULTS: Eighty-four simultaneous, multiple free flaps were performed in 42 patients. The predominant free flap combination consisted of a fibula with either an anterolateral thigh (n = 22) or a radial forearm flap (n = 14). Complete flap survival was 95%. Nineteen patients were still alive with a mean follow-up of 55 months. Five-year patient survival was 46.3%. Mean EAT-10 score was 8.4 (range: 0-29), with only one patient reporting problematic swallowing. Ninety percent of the patients had moderate to good speech intelligibility with the IRS. CONCLUSION: Multiple, simultaneous free flaps can be performed safely, leading to acceptable long-term patient survival and patient-reported functional outcomes. Our study demonstrates that it is worthwhile to perform these challenging microvascular reconstructions in patients with locally advanced head and neck cancer.

Discrepancies Between Surgical Oncologists and Plastic Surgeons in Patient Information Provision and Personal Opinions Towards Immediate Breast Reconstruction.

BACKGROUND: Immediate breast reconstruction (IBR) may improve quality of life of patients receiving mastectomy. However, a significant hospital variation exists in the use of IBR due to various reasons. To better understand this variation, the present study investigated preoperative information provision to patients and personal opinions of surgical oncologists and plastic surgeons towards potential contra-indications for IBR. METHODS: An online survey (35 questions) was developed including questions on respondent demographics, information provision to the patient about IBR and potential contra-indications by IBR technique. RESULTS: One-hundred-eighty-nine physicians participated: 118 surgical oncologists and 71 plastic surgeons. All clinicians discussed the possibility of IBR with their patients. Complications (79% versus 100%, P < 0.001) and aesthetic outcomes (83% versus 99%, P = 0.001) were discussed less frequently by surgical oncologists than by plastic surgeons.Patient age >75 years, breast size >D-cup, BMI >40 kg/m, smoking (for implant reconstruction), pulmonary/cardiac comorbidities (for autologous reconstruction) and radiotherapy were considered a contra-indication more frequently by plastic surgeons. In contrast, surgical oncologists reported tumor stage (≥cT3), nodal stage (≥cN2) and chemotherapy more frequently to be a contra-indication for IBR. CONCLUSION: We observed that all respondents discussed the possibility of IBR with their patients, whereas patient-tailored information was given more frequently by plastic surgeons. Physicians differed in their opinions towards contra-indications for IBR, with plastic surgeons reporting patient-related risk factors for wound healing problems and surgical oncologists reporting oncological contra-indications more frequently. Consensus between physicians regarding contra-indications for IBR may optimize patient counseling and shared decision-making.

Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial.

BACKGROUND: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. METHODS: We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. FINDINGS: 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. INTERPRETATION: Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.

Clinical auditing as an instrument for quality improvement in breast cancer care in the Netherlands: The national NABON Breast Cancer Audit.

BACKGROUND: In 2011, the NABON Breast Cancer Audit (NBCA) was instituted as a nation-wide audit to address quality of breast cancer care and guideline adherence in the Netherlands. The development of the NBCA and the results of 4 years of auditing are described. METHODS: Clinical and pathological characteristics of patients diagnosed with invasive breast cancer or in situ carcinoma (DCIS) and information regarding diagnosis and treatment are collected in all hospitals (n = 92) in the Netherlands. Thirty-two quality indicators measuring care structure, processes and outcomes were evaluated over time and compared between hospitals. RESULTS: The NBCA contains data of 56,927 patients (7,649 DCIS and 49,073 invasive cancers). Patients being discussed in pre- and post-operative multidisciplinary team meetings improved (2011: 83% and 91%; 2014: 98% and 99%, respectively) over the years. Tumour margin positivity rates after breast-conserving surgery for invasive cancer requiring re-operation were consistently low (∼5%). Other indicators, for example, the use of an MRI-scan prior to surgery or immediate breast reconstruction following mastectomy showed considerable hospital variation. CONCLUSIONS: Results shown an overall high quality of breast cancer care in all hospitals in the Netherlands. For most quality indicators improvement was seen over time, while some indicators showed yet unexplained variation. J. Surg. Oncol. 2017;115:243-249. © 2016 Wiley Periodicals, Inc.

Burden of Keloid Disease: A Cross-sectional Health-related Quality of Life Assessment.

Keloid scars may be painful, itch severely and be cosmetically disturbing. The burden of keloid disease, however, has not yet been determined. This study evaluated the association of keloid disease with health-related quality of life (HRQL) and identified indicators of burden using a cross-sectional survey study, with one disease-specific HRQL measure (Skindex-29) and 2 generic HRQL measures (SF-36 and EQ-5D-5L). A total of 106 keloid patients with no other skin diseases participated in the study. Having keloid disease was associated with a considerable impairment of emotional wellbeing, with most impairment on the emotional and mental HRQL. Pain and itch were the strongest indicators of HRQL impairment in keloid patients. Having painful or itchy keloids was related to low mental and emotional HRQL, implying that patients with keloids require access to effective treatment aimed at alleviating physical symptoms.