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Purpose: Timing of Deep Inferior Epigastric artery Perforator (DIEP)-flap breast reconstruction in the context of post-mastectomy radiotherapy for breast cancer patients is topic of debate. We compared the impact of immediate (before radiotherapy) versus delayed (after radiotherapy) DIEP-flap breast reconstruction (IBR versus DBR) on short- and long-term patient-reported outcomes (PROs)., Methods: Within the prospective, multicenter breast cancer cohort (UMBRELLA), we identified 88 women who underwent immediate or delayed DIEP-flap breast reconstruction and received PMRT. At 6 and 12 months post-mastectomy, as well as on long-term (≥ 12 months post-reconstruction) body image, breast symptoms, physical functioning, and pain were measured by EORTC-QLQ-30/BR23. Additionally, long-term evaluation included satisfaction with breast(s), physical well-being and self-reported adverse effects of radiation as measured by BREAST-Q, and late treatment toxicity. PROs were compared between groups using independent sample T-test., Results: IBR was performed in 56 patients (64%) and DBR in 32 patients (36%), with 15 months of median time to reconstruction. At 6 and 12 months post-mastectomy, better body image and physical functioning were observed after IBR. No statistically nor clinically relevant differences were observed in long-term EORTC and BREAST-Q outcomes (median follow-up 37-41 months for IBR vs. 42-46 months for DBR). Patients with IBR reported more fibrosis and movement restriction (median follow-up 29 vs. 61 months, resp.)., Conclusion: Long-term PROs were comparable for patients with IBR and DBR, despite more patient-reported fibrosis and movement restriction after IBR. Therefore, both treatment pathways can be considered when opting for autologous breast reconstruction in the setting of PMRT., Competing Interests: Declarations. Competing interests: The authors declare no competing interests. Ethical approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Medical Research Ethics Committee (MREC) Utrecht (NL52651.041.15, MEC15/165). Consent to participate: Informed consent was obtained from all individual participants included in the study., (© 2025. The Author(s).)

Background: Oncoplastic breast conserving surgery (OP-BCS) is becoming increasingly popular to avoid mastectomy or optimize cosmetic outcomes of breast conserving surgery (BCS). Few studies have compared clinical outcomes and patient-reported outcomes (PROs) of OP-BCS to conventional BCS (C-BCS). This study aims to compare clinical outcomes and short and long-term PROs after OP-BCS and C-BCS in a large prospective breast cancer cohort., Methods: Women in the prospective, multicenter UMBRELLA-breast cancer cohort who underwent OP-BCS or C-BCS were included. Clinical outcomes and PROs (measured by EORTC QLQ-C30/BR23) up to 24 months postoperatively were evaluated. Mixed-model analysis was performed to assess differences in PROs over time between groups., Results: 1628 (84.9%) patients received C-BCS and 290 (15.1%) OP-BCS. After C-BCS and OP-BCS, free resection margins were obtained in 84.2% (n = 1370) and 86.2% (n = 250), respectively, reoperation for re-exision of margins <3 months occurred in 5.3% (n = 86) and 4.8% (n = 14), median time interval from surgery until adjuvant systemic therapy was 66 and 63 days, and 36 and 41 days until radiotherapy. Shortly postoperative, OP-BCS was associated with statistically significant lower mean scores for physical functioning (83.6 vs 87.2) and body image (82.8 vs 89.4) and more pain (19.8 vs 26.5) and breast symptoms (22.7 vs 30.3) than C-BCS. Body image scores remained significantly less favorable after OP-BSC than C-BCS up to 24 months postoperatively (87.8 vs 92.2)., Conclusions: Oncoplastic surgery safely enables BCS, but may lead to less favorable long-term body image compared to C-BCS. These findings are important for patient education and shared decision-making., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Although deep inferior epigastric perforator (DIEP) flap breast reconstruction is the most widely used technique for autologous breast reconstruction, this technique leads to large scars in visible areas on breast and abdomen. So far, limited studies have thoroughly addressed the impact of breast and abdominal scars on satisfaction and Health-related Quality of Life (HR-QoL)., Objectives: This research aimed to determine whether women with no/minor scar symptoms after undergoing DIEP-flap breast reconstruction differ in satisfaction and perceived HR-QoL from women with symptomatic scars., Materials and Methods: In this cross-sectional survey study, women who had previously undergone DIEP-flap breast reconstruction completed an online survey. Patient-reported scar quality was assessed with the Patient and Observer Scar Assessment Scale (POSAS), and satisfaction and HR-QoL with BREAST-Q. Independent-samples t-tests were conducted to compare BREAST-Q scores between women with no/minor scar symptoms (POSAS overall opinion score 1-3) and women with symptomatic scars (POSAS overall opinion score 4-10)., Results: A total of 248 women completed the survey. Women with scar symptoms had significantly worse BREAST-Q scores on 'Satisfaction with breasts,' 'Physical well-being,' 'Psychosocial well-being' and, 'Sexual well-being' compared to women with no/minor scar symptoms (p ≤ 0.001)., Conclusion: After DIEP-flap breast reconstructions, women with symptomatic breast and abdominal scars had a clinically relevant and statistically significant lower degree of satisfaction and HR-QoL compared to women who had no/minor scar symptoms. We therefore recommend to explicitly and repeatedly address inevitability of visible scars after DIEP-flap breast reconstruction, aiming to improve preoperative patient selection and post-operative expectation management., Level of Evidence Iv: 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 ., (© 2024. The Author(s).)

Background: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation., Methods: Patient- and surgery-related characteristics of patients who underwent two-stage PMBR between 2017 and 2021 were collected from the Dutch Breast Implant Registry (DBIR). Unplanned reoperation was defined as TE explantation followed by either no replacement or replacement with the same or a different TE. Covariate-adjusted characteristics associated with unplanned reoperation were determined using backward stepwise selection and multivariable logistic regression analyses., Results: In total, 2529 patients (mean age, 50.2 years) were included. Unplanned reoperation occurred in 19.4% of all registered TEs ( n = 3190). Independent factors associated with unplanned reoperation were body mass index (BMI) greater than or equal to 25 kg/m 2 (adjusted OR [aOR], 1.63, 99% CI, 1.20 to 2.57 for BMI of 25 to 29.9 kg/m 2 ; aOR, 2.57, 99% CI, 1.74 to 3.78 for BMI ≥30 kg/m 2 ), low institutional volume (aOR, 1.51; 99% CI, 1.06 to 2.18), no drains (aOR, 2.06; 99% CI, 1.15 to 3.60), subcutaneous TE placement (aOR, 5.71; 99% CI, 3.59 to 9.10), and partial pectoralis major muscle coverage (aOR, 1.35; 99% CI, 1.02 to 1.79). Age younger than 40 years (aOR, 0.49; 99% CI, 0.32 to 0.74) and delayed PMBR (aOR, 0.35; 99% CI, 0.19 to 0.60) reduced the risk of unplanned reoperation. Median time until reoperation was 97 days for unplanned and 213 days for planned reoperation. Deep wound infections were most often registered as indication for unplanned reoperation (34.4%)., Conclusion: This study identified several risk factors for unplanned reoperation that may be used to reduce complications in expander-based PMBR., Clinical Question/level of Evidence: Risk, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Objectives: Open tibial fractures are relatively common injuries following traffic accidents. The vulnerability of the soft tissues surrounding the tibia increases the susceptibility to complications, including infection and nonunion. To minimize complications, a multidisciplinary, timely approach is crucial. To date, the Dutch incidence and level of hospital treatment remain unknown due to a lack of condition-specific nationwide registries. This study aimed to estimate the incidence and management of open tibial fractures in the Netherlands, providing essential information for public health policymaking and guideline development., Methods: The 2018 and 2019 Dutch National Hospital Care Basic Registration data, provided by the Dutch Hospital Data Foundation, were utilized to identify all patients admitted to Dutch hospitals with tibial fractures. Incidence rates, patient demographics, primary diagnoses, fracture classification, level of hospital, and length of hospital stays were analyzed using descriptive statistics., Results: 1,079 ICD-10 codes for closed and open tibial fractures were identified in patients that were admitted to a Dutch hospital. Thirty-four percent were classified as open tibial fractures, accounting for an estimated incidence rate of 1.1 per 100,000 person-years (95 % CI 0.97-1.12). When categorized by age, the calculated incidence rate was higher in males for all age categories up until the age of 70. Notably, the overall highest incidence rate was found for females aged 90 and above (6.6 per 100,000 person-years). Open tibial fractures were predominantly treated in general or top clinical hospitals (comprising 69 % of open all tibia fractures). Notably, the minority (31 %) presented at university medical centers, all Level-1 trauma centers, equipped with orthoplastic teams., Conclusion: This is the first study to report the nationwide incidence rate of open tibial fractures in the Netherlands; 34 % of tibial fractures were registered as open. Notably, a limited proportion of open tibial fractures underwent treatment within Level-1 trauma centers. Consequently, in the majority of cases, the implementation of an orthoplastic team approach was unattainable. This study underscores the need for more comprehensive data collection to assess and improve the current treatment landscape., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Purpose: Although peer support programs as a health resource have become increasingly popular, only limited studies evaluated the added value of one-on-one peer support for breast cancer patients. This study aims to bridge the knowledge gap by focusing on two related research topics. First, we evaluated emotional well-being and (unmet) needs regarding supportive care. Second, we evaluated patients' perspectives on their experiences after having one-on-one peer support., Methods: A quantitative analysis was conducted to provide insight in patients' symptoms of anxiety and depression (HADS), quality of life (EORTC-QLQ-C30), and supportive care needs (CaSUN-questionnaire). Furthermore, approximately 1 year after the implementation of a one-on-one peer support program, focus groups were conducted to evaluate patients' perspectives regarding one-on-one peer support., Results: Two hundred twenty-five of 537 patients diagnosed with breast cancer between 2019 and 2020 completed the questionnaires. Quantitative analysis showed increased symptoms of anxiety and depression among breast cancer patients and lower scores on all EORTC-QLQ-C30 domains compared to the Dutch normative population. Of all patients, 27.6% (95%CI = 0.22-0.34) reported to have unmet needs regarding emotional support and 23.1% (95%CI = 0.18-0.29) reported an unmet need to talk to someone who has experienced breast cancer. For the qualitative analysis, 19 breast cancer patients who were taking part in the one-on-one peer support program participated in three focus groups. Benefits, limitations, and wishes regarding the one-on-one peer support program were discussed., Conclusion: Breast cancer patients showed increased anxiety and depression and lower quality of life, physical, role, emotional, cognitive, and social functioning compared to the Dutch normative population. Almost one-third of breast cancer patients reported unmet needs regarding emotional support and a desire to talk to other breast cancer patients. These (unmet) needs can successfully be met by providing a low-threshold one-on-one peer support program., (© 2023. The Author(s).)

Background: Accurate tumour localization is crucial for precise surgical targeting and complete tumour removal. Indocyanine green fluorescence, an increasingly used technique in oncological surgery, has shown promise in localizing non-palpable breast tumours. The aim of this systematic review was to describe the efficacy of indocyanine green fluorescence for the identification of non-palpable breast tumours., Methods: A systematic literature search was performed in PubMed, Embase, and the Cochrane Library, including studies from 2012 to 2023. Studies reporting the proportion of breast tumours identified using indocyanine green fluorescence were included. The quality of the studies and their risk of bias were appraised using the Methodological Index for Non-Randomized Studies ('MINORS') tool. The following outcomes were collected: identification rate, clear resection margins, specimen volume, operative time, re-operation rate, adverse events, and complications., Results: In total, 2061 articles were screened for eligibility, resulting in 11 studies, with 366 patients included: two RCTs, three non-randomized comparative studies, four single-arm studies, and two case reports. All studies achieved a 100 per cent tumour identification rate with indocyanine green fluorescence, except for one study, with an identification rate of 87 per cent (13/15). Clear resection margins were found in 88-100 per cent of all patients. Reoperation rates ranged from 0.0 to 5.4 per cent and no complications or adverse events related to indocyanine green occurred., Conclusion: Indocyanine green fluorescence has substantial theoretical advantages compared with current routine localization methods. Although a limited number of studies were available, the current literature suggests that indocyanine green fluorescence is a useful, accurate, and safe technique for the intraoperative localization of non-palpable breast tumours, with equivalent efficacy compared with other localization techniques, potentially reducing tumour-positive margins., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)

Background: COVID-19 has impacted breast implant surgery for oncological and non-oncological patients worldwide. This population-based study aimed to evaluate the impact of the COVID-19 pandemic on access to reconstructive and cosmetic breast implant surgery in the Netherlands using real-world data to describe trends, and to identify lessons to prevent future capacity problems within (inter)national healthcare., Methods: This longitudinal study included patients undergoing breast implant surgery from the mandatory nationwide Dutch Breast Implant Registry. For 2020, the first COVID-19 wave, intermediate period, and second wave were defined. We compared data from during the pandemic to a pre-pandemic (2019) reference year, assessing differences in the number of registered breast implants, and patient and surgery-related characteristics., Results: A total of 34133 breast implants (17459 patients) were included. Compared to 2019, fewer implants were registered for post-cancer (n=484; -14.7%), cosmetic (n=480; -3.6%), and gender-affirming indications (n=104; -38.0%) during 2020. Fewer implants were registered in academic (n=196; -22.0%) and regional hospitals (n=1591; -16.5%), but more in private clinics (n=725; +10.1%). After the first wave, up to twice as many implants were registered in private clinics compared to 2019. No differences were found in characteristics of patients undergoing surgery in 2020 versus 2019., Conclusion: Hospital-based reconstructive and gender-affirming surgery were heavily impacted during the pandemic, while private-clinic-based cosmetic surgery quickly recovered. These outcomes are useful to fuel discussions about how healthcare could be reorganized in times of capacity problems. We suggest exploring options to deploy private clinics for ambulatory surgery aiming to keep hospital capacity available for acutely ill patients., Competing Interests: Declaration of competing interest None., (© 2023 Published by Elsevier Ltd.)

Purpose: During the first SARS-CoV-2-infection wave, a deterioration in emotional well-being and increased need for mental health care were observed among patients treated or being treated for breast cancer. In this follow-up study, we assessed patient-reported quality of life (QoL), physical functioning, and psychosocial well-being during the second SARS-CoV-2-infection wave in a large, representative cohort., Methods: This longitudinal cohort study was conducted within the prospective, multicenter UMBRELLA breast cancer cohort. To assess patient-reported QoL, physical functioning and psychosocial well-being, COVID-19-specific surveys were completed by patients during the first and second SARS-CoV-2-infection waves (April and November 2020, respectively). An identical survey was completed by a comparable reference population during the second SARS-CoV-2-infection waves. All surveys included the validated EORTC-QLQ-C30/BR23, HADS and "De Jong-Gierveld Loneliness" questionnaires. Pre-COVID-19 EORTC-QLQ-C30/BR23 and HADS outcomes were available from UMBRELLA. Response rates were 69.3% (n = 1106/1595) during the first SARS-CoV-2-infection wave and 50.9% (n = 822/1614) during the second wave. A total of 696 patients responded during both SARS-CoV-2-infection waves and were included in the analysis comparing patient-reported outcomes (PROs) during the second SARS-CoV-2-infection wave to PROs during the first wave. Moreover, PROs reported by all patients during the second SARS-CoV-2-infection wave (n = 822) were compared to PROs of a similar non-cancer reference population (n = 241) and to their pre-COVID-19 PROs., Results: Patient-reported QoL, physical functioning, and psychosocial well-being of patients treated or being treated for breast cancer remained stable or improved from the first to the second SARS-CoV-2-infection wave. The proportion of emotional loneliness reduced from 37.6 to 29.9% of patients. Compared to a similar non-cancer reference population, physical, emotional, and cognitive functioning, future perspectives and symptoms of dyspnea and insomnia were worse in patients treated or being treated for breast cancer during the second SARS-CoV-2-infection wave. PROs in the second wave were similar to pre-COVID-19 PROs., Conclusion: Although patients scored overall worse than individuals without breast cancer, QoL, physical functioning, and psychosocial well-being did not deteriorate between the first and second wave. During the second wave, PROs were similar to pre-COVID-19 values. Overall, current findings are cautiously reassuring for future mental health of patients treated or being treated for breast cancer., (© 2023. The Author(s).)

Objectives: Patients with head and neck cancer (HNC) are often highly affected by disease and treatment, resulting in impaired physical functioning and quality of life. Therefore, evaluation of patients' psychosocial and functional outcomes can be facilitated by patient-reported outcome measures (PROMs). By providing the patients' own perspectives, PROMs are crucial to improving patient-centered care. This study aimed to improve understanding of the perceived value of PROMs in HNC care and how to optimize their clinical value based on patients' and multidisciplinary healthcare professionals' (HCPs) perspectives., Methods: Population-based surveys among patients with HNC through their patient association and among HCPs nationwide through the Dutch Head and Neck Audit., Results: A total of 54 patients and 40 multidisciplinary HCPs from all 14 nationwide HNC centers (100%) responded. For patients, the most important element of patient-reported outcome collection systems was including a call to action for those with worse-than-average scores (28%), whereas clinicians found discussing scores during clinical visits the most important (39%). Although 16% of clinicians found short completion time the most important element, none of the patients selected completion time as most important. Additionally, 17% of patients stated completion time was not an issue, provided clinicians would use the outcomes for clinical purposes., Conclusions: Although patients and clinicians acknowledged the value of patient-reported outcomes, patients would like to be more involved in the clinical implications of their outcomes. Enhancing patients' involvement by a call to action and providing feedback on their scores during outpatient clinic visits may improve the clinical value of PROMs., (Copyright © 2023. Published by Elsevier Inc.)

Background: In immediate implant-based breast reconstruction (IBBR), large variation is observed in current practices between a direct-to-implant and a two-stage approach (insertion of a breast implant after a tissue expander). This population-based study aimed to compare unplanned short- and long-term revision incidence between direct-to-implant and two-stage IBBR in The Netherlands., Methods: All patients who underwent immediate IBBR following a mastectomy between 2015 and 2019 were selected from the nationwide Dutch Breast Implant Registry. Short- and long-term unplanned revision incidences were studied per immediate IBBR, including revision indications and the total number of additional operations. Confounding by indication was limited using propensity score matching., Results: A total of 4512 breast implants (3948 women) were included, of which 2100 (47%) were for direct-to-implant IBBR and 2412 (53%) were for two-stage IBBR. Median (IQR) follow-up was 29 months (range, 16 to 45 months) and 33 months (range, 21 to 47 months), respectively. Short-term revision incidence was 4.0% and 11.7%, respectively (conditional OR, 0.31; 95% CI, 0.23 to 0.42%). Long-term revision incidence was 10.6% (95% CI, 9.2 to 12.1%) and 16.4% (95% CI, 14.8 to 17.9%), respectively. In the propensity score-matched cohort, similar results were found. In the direct-to-implant group, more breasts were reconstructed within the planned number of operations than in the two-stage group., Conclusions: Unplanned revision surgery occurred less often after direct-to-implant IBBR, and more breasts were reconstructed within the planned number of operations compared to two-stage IBBR. These results, based on real-world data, are important for improving patient counseling and shared decision-making., Clinical Question/level of Evidence: Risk, II., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Objective: The aim was to compare the (sentinel) lymph node detection rate of indocyanine green (ICG)-fluorescent imaging versus standard-of-care 99m Tc-nanocoilloid for sentinel lymph node (SLN)-mapping., Background: The current gold standard for axillary staging in patients with breast cancer is sentinel lymph node biopsy (SLNB) using radio-guided surgery using radioisotope technetium ( 99m Tc), sometimes combined with blue dye. A promising alternative is fluorescent imaging using ICG., Methods: In this noninferiority trial, we enrolled 102 consecutive patients with invasive early-stage, clinically node-negative breast cancer. Patients were planned for breast conserving surgery and SLNB between August 2020 and June 2021. The day or morning before surgery, patients were injected with 99m Tc-nanocolloid. In each patient, SLNB was first performed using ICG-fluorescent imaging, after which excised lymph nodes were tested with the gamma-probe for 99m Tc-uptake ex vivo, and the axilla was checked for residual 99m Tc-activity. The detection rate was defined as the proportion of patients in whom at least 1 (S)LN was detected with either tracer., Results: In total, 103 SLNBs were analyzed. The detection rate of ICG-fluorescence was 96.1% [95% confidence interval (95% CI)=90.4%-98.9%] versus 86.4% (95% CI=78.3%-92.4%) for 99m Tc-nanocoilloid. The detection rate for pathological lymph nodes was 86.7% (95% CI=59.5%-98.3%) for both ICG and 99m Tc-nanocoilloid. A median of 2 lymph nodes were removed. ICG-fluorescent imaging did not increase detection time. No adverse events were observed., Conclusions: ICG-fluorescence showed a higher (S)LN detection rate than 99m Tc-nanocoilloid, and equal detection rate for pathological (S)LNs. ICG-fluorescence may be used as a safe and effective alternative to 99m Tc-nanocoilloid for SLNB in patients with early-stage breast cancer., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Peripheral vascular malformations (VMs) may lead to disfigurement of the body and face, potentially impairing aesthetic appearance. Yet, data on appearance in this population is limited. This study aimed to examine appearance-related concerns and their impact on health-related quality of life (HR-QoL) in patients with VMs., Methods: In this cross-sectional study, 384 adults and 194 children with VMs were invited to complete the Outcome Measures for VAscular MAlformations (OVAMA) questionnaire to evaluate potential appearance-related concerns on a five-point verbal-rating scale, with higher scores indicating more appearance-related concerns (e.g., colour-difference, facial-distortion, reduced self-esteem, and dissatisfaction with appearance). HR-QoL was evaluated using Patient-Reported Outcome Measurement Information System (PROMIS). Subgroups of patients reporting more appearance-related concerns were identified using univariate analysis. Associations between appearance-related concerns and various HR-QoL domains (e.g., anxiety and social participation) were assessed., Results: A total of 184 patients (32%) completed the questionnaires; 121 patients (66%) reported that one or more appearance outcome was severely affected (i.e., 4-5 out of 5). The following factors statistically significant associated with more appearance-related concerns: capillary/combined origin, facial localization, subcutaneous tissue involvement, larger size, overgrowth, and diagnosis of a syndrome. In adults, dissatisfaction with appearance and reduced self-esteem due to the appearance of the VM correlated with more anxiety and depression symptoms. Reduced self-esteem correlated with less social participation. In children, bodily distortion and being stared at were correlated with less peer relationships., Conclusion: Severe appearance-related concerns were present in two-thirds of patients with VMs, impairing their mental HR-QoL. Clinicians should acknowledge appearance-related aspects, monitor psychological well-being, and offer intervention aimed at improving satisfaction with appearance., Competing Interests: Declaration of Competing Interest The authors declare that there is no conflict of interest regarding the publication of this article., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: The use and effect of most infection control measures (ICMs) in breast implant surgery are still debated, likely resulting in undesired variation in current practices., Objectives: This study investigated the relationship between the number and combinations of ICMs used and the infection-related revision incidence after breast implant surgery. Additionally, national variation between Dutch healthcare institutions in ICM use was evaluated., Methods: For this multicentre, population-based study, all patients who received a primary breast implant or tissue expander for breast augmentation or reconstruction between 2015 and 2019 were identified from the Dutch Breast Implant Registry. Seven prospectively collected ICMs were investigated: preoperative antibiotics, implant and/or pocket irrigation, glove change, nipple guards, insertion sleeve, postoperative drains, and postoperative antibiotics., Results: This study included 52,415 implants (85% augmentation, 15% reconstruction).The median (IQR) number of ICMs used was 3 (3-4) for augmentation and 4 (4-5) for reconstruction. Median follow-up was 30 months for augmentation and 34 months for reconstruction. Infection-related revision incidence was 0.1% for augmentation and 2.1% for reconstruction. Most infection-related revisions occurred within 2 months for augmentation and 2.5 months for reconstruction. The impact of ICM use on infection-related revision incidence remained unclear, given its low incidence. A significant variation was observed between institutions in the use of postoperative antibiotics and drains., Conclusions: Although the use of different ICMs varied considerably between institutions, the infection-related revision incidence after breast implant surgery was generally low. Most surgeons used four ICMs for breast reconstruction and three ICMs for breast augmentation. Further studies on the causes and effects of the observed variation are needed., Competing Interests: None., (© 2022 The Author(s).)

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 I 2 -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., (© 2022 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Objectives: To evaluate patients' experience of having served as controls without a notification at the time of randomization in the context of the trial within cohorts (TwiCs) design., Methods: Patients were asked for their opinion on having served as controls in TwiCs, before and after having been provided the trial results. Patients had provided broad consent to randomization at cohort entry and had served as controls in one of two TwiCs (an exercise program after breast cancer treatment or radiotherapy dose-escalation for rectal cancer)., Results: Two to 6 years after cohort entry, 15% (n = 16) of all patients remembered having provided broad consent to randomization. Before disclosure of trial results, 47% (n = 52) of patients thought positively, 45% (n = 50) neutrally, and 2% (n = 2) negatively of having served as controls in one of the two trials. Seventeen percent (n = 18) of patients were positive, 65% (n = 71) neutral, and 11% (n = 12) negative about not having been notified when serving as controls. The survey results were comparable after disclosure of trial results., Conclusions: These results support the use of the TwiCs design with the staged-informed consent procedure. Keeping patients engaged and aware of the consents provided might further improve patients' experience of serving as controls in TwiCs., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

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., (© 2021 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Objective: Vascular malformations (VM) can negatively impact the patient's quality of life (QoL). Pain is a common problem in these patients. The aim of this study was to investigate risk factors associated with pain and to assess how pain affects QoL., Methods: This prospective cross-sectional study was conducted in a tertiary vascular anomaly expertise center. Between June and December 2020, all patients from our local database (334 adults and 189 children) with peripheral VMs were invited to complete the Outcome Measures for VAscular MAlformations questionnaire to evaluate the presence, frequency, and intensity of pain. Additionally, patients were asked to complete several Patient-Reported Outcome Measurement Information System scales to evaluate their QoL. Risk factors associated with pain were identified in bivariate analysis and multivariable logistic regression. QoL domains were compared between patients who experienced pain and patients who did not., Results: A total of 164 patients completed the questionnaire about pain and 133 patients completed all QoL questionnaires. Approximately one-half of the patients (52%) reported pain in the past four weeks and 57% of these patients reported pain daily or several times a week. Female sex (P = .009), lesions located in the upper extremity (P < .001) or lower extremity (P < .001), and intramuscular/intraosseous lesions (P = .004) were independently associated with the presence of pain. The following QoL domains were diminished in patients who experienced pain in comparison with patients who did not: pain interference (P < .001), physical functioning (P < .001), and social participation (P < .001) in adults, and pain interference (P = .001), mobility (P = .001), and anxiety (P = .024) in children., Conclusions: Pain is a frequently reported complaint in patients with VMs and is present in approximately one-half of the patients. Patients with lesions located in the upper or lower extremity, intramuscular/intraosseous lesions, and female patients are more likely to experience pain. The presence of pain negatively impacted patients' QoL. Although VM are a benign condition and expectative management is frequently applied, our study shows that pain is a serious concern and needs to be actively assessed. Pain is a sign of various etiologies and should be examined to properly treat the pain., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate perceived access to health care and preferences for health care provision among patients (being) treated for breast cancer during the COVID-19 pandemic., Methods: Longitudinal study within the prospective, multicenter UMBRELLA cohort of patients (being) treated for breast cancer. All cohort participants enrolled in UMBRELLA between October 2013 and November 2020 were sent a COVID-19-specific survey during the first and second wave of the COVID-19 pandemic, i.e., April 2020 and November 2020, respectively., Results: In total, 1106 (69.3%) and 822 (50.9%) cohort participants completed the survey in the first and second wave, respectively. The proportion of patients experiencing that their treatment or follow-up care was affected due to COVID-19 decreased from 28.4% (n = 198) in April 2020 to 14.8% (n = 103) in November 2020. Throughout the pandemic, one or more hospital consultations were postponed in 10.0% (n = 82) of all patients and changed into a teleconsultation in 23.1% (n = 190). The proportion of patients who experienced a higher threshold to contact their general practitioner due to COVID-19 decreased from 29.9% (n = 204) in the first wave to 20.8% (n = 145) in the second wave. In-person consultations remained most preferred in 35.2% (n = 289) of all patients. Nearly half of all patients (48.3%, n = 396) indicated that telehealth would be a useful alternative for in-person consultations in future., Conclusion: Perceived access to health care has improved substantially throughout the pandemic. Digital care is well received by patients (being) treated for breast cancer., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The symptoms and appearance of vascular malformations can severely harm a patient's quality of life. The aim of treatment of vascular malformations generally is to improve condition-specific symptoms and/or appearance. Therefore, it is highly important to start testing treatment effects in clinical studies from the patient's perspective., Objectives: To develop a patient-reported outcome measure for measuring symptoms and appearance in patients with vascular malformations., Methods: A first draft of the patient-reported outcome measure was based on the previously internationally developed core outcome set. The qualitative part of this study involved interviews with 14 patients, which led to a second draft. The second draft was field tested cross-sectionally, after which groups of items were evaluated for adequate internal consistency (Cronbach's alpha > 0·7) to form composite scores. Construct validity was evaluated by testing 13 predefined hypotheses on known-group differences., Results: The patient interviews ensured adequate content validity and resulted in a general symptom scale with six items, a head and neck symptom scale with eight items, and an appearance scale with nine items. Cronbach's alpha was adequate for two composite scores: a general symptom score (0·88) and an appearance score (0·85). Ten out of 13 hypotheses on known-group differences were confirmed, confirming adequate construct validity., Conclusions: With the development of the OVAMA questionnaire, outcomes of patients with vascular malformations can now be evaluated from the patient's perspective. This may help improve the development of evidence-based treatments and the overall care for patients with vascular malformations., (© 2021 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Purpose: To identify factors associated with (perceived) access to health care among (ex-)breast cancer patients during the COVID-19 pandemic., Methods: Cross-sectional study within a large prospective, multicenter cohort of (ex-)breast cancer patients, i.e., UMBRELLA. All participants enrolled in the UMBRELLA cohort between October 2013 and April 2020 were sent a COVID-19-specific survey, including the Hospital Anxiety and Depression Scale (HADS) questionnaire., Results: In total, 1051 (66.0%) participants completed the survey. During COVID-19, 284 (27.0%) participants reported clinically relevant increased levels of anxiety and/or depression, i.e., total HADS score ≥ 12. Participants with anxiety and/or depression reported statistically significant higher barriers to contact their general practitioner (47.5% vs. 25.0%, resp.) and breast cancer physicians (26.8% vs. 11.2%, resp.) compared to participants without these symptoms. In addition, a higher proportion of participants with anxiety and/or depression reported that their current treatment or (after)care was affected by COVID-19 compared to those without these symptoms (32.7% vs. 20.5%, resp.). Factors independently associated with symptoms of anxiety and/or depression during COVID-19 were pre-existent anxiety (OR 6.1, 95% CI 4.1-9.2) or depression (OR 6.0, 95% CI 3.5-10.2)., Conclusion: During the COVID-19 pandemic, (ex-)breast cancer patients with symptoms of anxiety and/or depression experience higher barriers to contact health care providers. Also, they more often report that their health care was affected by COVID-19. Risk factors for anxiety and/or depression during COVID-19 are pre-existent symptoms of anxiety or depression. Extra attention-including mental health support-is needed for this group.

Background and Objective: The Trials within Cohorts design aims to reduce recruitment difficulties and disappointment bias in pragmatic trials. On cohort enrollment, broad informed consent for randomization is asked, after which cohort participants can be randomized to interventions or serve as controls without further notification. We evaluated patients' recollection, understanding, and acceptance of broad consent in a clinical oncology setting., Methods: We surveyed 610 patients with cancer participating in ongoing TwiCs; 482 patients (79%) responded, of which 312 patients shortly after cohort enrollment, 108 patients after randomization to an intervention (12-18 months after cohort enrollment), and a random sample of 62 cohort participants who had not been selected for interventions (1-6 months after cohort enrollment)., Results: Shortly after providing cohort consent, 76% of patients (238/312) adequately remembered whether they had given broad consent for randomization. Of patients randomly offered interventions, 76% (82/108) remembered giving broad consent for randomization; 41% (44/108) understood they were randomly selected, 44% (48/108) were not interested in selection procedures, and 10% (11/108) did not understand selection was random. Among patients not selected for interventions, 42% (26/62) understood selection was random; 89% felt neutral regarding the scenario of "not being selected for an intervention while your data were being used in comparison with patients receiving interventions," 10% felt reassured (6/62) and 2% scared/insecure (2/62)., Conclusion: Patients adequately remember giving broad consent for randomization shortly after cohort enrollment and after being offered an intervention, but recollection is lower in those never selected for interventions. Patients are acceptant of serving as control without further notifications., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The coronavirus disease 2019 (COVID-19) pandemic (officially declared on the March 11, 2020), and the resulting measures, are impacting daily life and medical management of breast cancer patients and survivors. We evaluated to what extent these changes have affected quality of life, physical, and psychosocial well-being of patients previously or currently being treated for breast cancer., Methods: This study was conducted within a prospective, multicenter cohort of breast cancer patients and survivors (Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion). Shortly after the implementation of COVID-19 measures, an extra survey was sent to 1595 participants, including the validated European Organization for Research and Treatment of Cancer (EORTC) core (C30) and breast cancer-specific (BR23) Quality of Life Questionnaire (EORTC QLQ-C30/BR23) and Hospital Anxiety and Depression Scale (HADS) questionnaire. Patient-reported outcomes (PROs) were compared with the most recent PROs collected within UMBRELLA pre-COVID-19. The impact of COVID-19 on PROs was assessed using mixed model analysis, adjusting for potential confounders., Results: 1051 patients and survivors (65.9%) completed the survey; 31.1% (n = 327) reported a higher threshold to contact their general practitioner amid the COVID-19 pandemic. A statistically significant deterioration in emotional functioning was observed (mean = 82.6 [SD = 18.7] to 77.9 [SD = 17.3]; P  < .001), and 505 (48.0%, 95% confidence interval [CI] = 45.0% to 51.1%) patients and survivors reported moderate to severe loneliness. Small improvements were observed in quality of life and physical, social, and role functioning. In the subgroup of 51 patients under active treatment, social functioning strongly deteriorated (77.3 [95% CI = 69.4 to 85.2] to 61.3 [95% CI = 52.6 to 70.1]; P  = .002)., Conclusion: During the COVID-19 pandemic, breast cancer patients and survivors were less likely to contact physicians and experienced a deterioration in their emotional functioning. Patients undergoing active treatment reported a substantial drop in social functioning. One in 2 reported loneliness that was moderate or severe. Online interventions supporting mental health and social interaction are needed during times of social distancing and lockdowns., (© The Author(s) 2020. Published by Oxford University Press.)

Purpose: To improve shared decision making, clinical- and patient-reported outcomes between immediate implant-based and autologous breast reconstruction followed by postmastectomy radiotherapy (PMRT) were compared., Methods: All women with in situ and/or invasive breast cancer who underwent skin sparing mastectomy with immediate breast reconstruction (IBR) (autologous- or implant based, one- or two staged) followed by PMRT in the Utrecht region between 2012 and 2016 were selected from the Netherlands Cancer Registry, of which 112 (59%) agreed to participate. The primary outcome was reconstruction failure after the start of radiotherapy, and secondary outcomes were patient-reported outcomes measured with BREAST-Q., Results: 109 patients underwent skin-sparing mastectomy, of which 29 (27%) underwent immediate autologous reconstruction and 80 (73%) received immediate implant-based reconstruction. After PMRT, reconstruction failure occurred in 17 patients (21%) with implant-based reconstruction, while no failure was seen in the autologous group (p = 0.04). Mean patient-reported 'Satisfaction with Breasts' (50.9 vs. 63.7, p = 0.001) and 'Sexual Well-being' (46.0 vs. 55.5, p = 0.037) were lower after implant-based reconstruction compared to autologous reconstruction. Thirteen patients with autologous flaps underwent surgical cosmetic corrections compared to ten patients in the implant group (45 vs. 13%, p = 0.001). IBR and PMRT in this study resulted in a high rate of severe capsular contraction in implant-based reconstruction (16.9%) and fibrosis in autologous reconstruction (13.8%)., Conclusions: Patients treated with PMRT and one or two stage immediate implant-based reconstruction were at greater risk of developing reconstruction failure and were less satisfied when compared to one or two stage immediate autologous reconstruction. Since fairly high complication rates in both reconstruction methods after PMRT are observed, it raises the question whether immediate breast reconstruction should be considered at all when PMRT is indicated. Patients considering or potential candidates for IBR should be informed about the consequences of PMRT and especially when opting for autologous reconstruction one should possibly perform reconstruction in a secondary setting.

Background: Lymphedema of the breast/chest wall after breast cancer treatment is often associated with pain and reduced quality of life. We conducted a pilot study to evaluate whether the use of a compression vest reduced symptoms of breast/chest wall edema in breast cancer patients. Methods and Results: This single-center study included patients ( n  = 25) with symptomatic breast/chest wall edema with a pain score of ≥3 on the Numerical Rating Scales (range 1-10). The patients were instructed to wear a compression vest (Lymphatrex, Class II) for 6 months. Wilcoxon signed-rank tests were used to compare differences in patient-reported pain intensity/severity. Analyses included all patients with available data. In total, 17 (68%) continued to wear their vests for 6 months, whereas the other 8 withdrew prematurely. At baseline, median pain severity (4.9, interquartile range [IQR] 3.6-6.0) and pain interference (4.3, IQR 2.1-5.9) scores were significantly higher compared with pain scores after wearing the compression vest for 6 months (1.8 IQR 1.0-4.8 and 1.4 IQR 0.9-4.4, resp.). Patient-reported breast/chest wall swelling decreased from 92% ( n  = 22) at baseline to 71% ( n  = 12) at 6 months. The prevalence of moderate/severe patient-reported breast/chest wall pain declined from 63% ( n  = 15) at baseline to 18% ( n  = 3) at 6 months. Physical, emotional, and social functioning improved over time and was comparable to scores of the Dutch reference population. Conclusion: The results of this pilot study suggest that a compression vest could be an acceptable and effective treatment option for patients with painful breast/chest wall edema. In compliant patients, swelling and pain was significantly reduced.

Purpose: To evaluate patient-reported cosmetic satisfaction in women treated with radiation therapy for breast cancer and to determine the association between dissatisfaction and quality of life (QoL) and depression., Methods: Within the prospective UMBRELLA breast cancer cohort, all patients ≥ 1 year after breast conserving treatment or mastectomy with immediate reconstruction were selected. Self-reported cosmetic satisfaction was measured on a 5-point Likert scale. QoL, social functioning, and emotional functioning were measured using EORTC QLQ-C30 and BR23 at 1, 2, and 3 years after inclusion. Mixed model analysis was performed to assess the difference in different domains of QoL between patients with good versus poor self-reported cosmetic satisfaction over time after adjustment for potential confounders. Depression scores were collected by means of the HADS-NL questionnaire. Chi-square test or Fisher's exact test was used to assess the difference in proportions of HADS score ≥ 8, indicating increased depression risk, between satisfied and dissatisfied patients., Results: 808 patients were selected for analysis. Respectively one, two, and three years after surgery, 8% (63/808), 7% (45/626), and 8% (31/409) of patients were dissatisfied with their cosmetic outcome. Poor patient-reported cosmetic satisfaction was independently associated with impaired QoL, body image, and lower emotional and social functioning. Scores ≥ 8 on the HADS depression subscale were significantly more common in dissatisfied patients., Conclusions: Dissatisfaction with cosmetic outcome was low after breast cancer surgery followed by radiation therapy during 3 years follow-up. Knowing the association between dissatisfaction with cosmetic outcome and QoL and depression could help to improve the preoperative counseling of breast cancer patients.

Purpose: To evaluate patient-reported work ability of breast cancer patients, to compare scores with the Dutch general population, and to identify determinants of reduced work ability in breast cancer patients., Methods: In a prospective cohort study, we identified 939 patients <67 years. Employed patients filled out the Work Ability Index (WAI) questionnaire before the start of radiotherapy treatment (baseline) and at 6, 18, and 30 months. Work ability was compared with a matched Dutch cancer-free population (n=3,641). The association between (clinical) characteristics and work ability over time was assessed using mixed-effects models., Results: At baseline, 68% (n=641) of the respondents were employed and 64% (n=203) were employed at 30 months. Moderate or poor work ability was reported by 71% of patients at baseline, by 24% of the patients at 30 months and by 14% of the general population. Axillary lymph node dissection, (neo)adjuvant chemotherapy and locoregional radiotherapy were associated with reduced work ability. After 30 months, 18% of employed patients reported to have reduced their working hours, made substantial modifications to their work or were unable to work., Conclusion: Patient-reported work ability is strongly reduced during breast cancer treatment. Thirty months after treatment the proportion of women reporting poor or moderate work ability remains higher compared to the general population. Even though the proportion of women with paid employment is rather stable over time, substantial amendments in work are needed in 18% of patients. These findings emphasize the importance of informing patients on potential changes in work ability to allow shared decision making., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Although the use of breast implants is generally considered to be safe, breast implants are associated with short- and long-term complications. To evaluate and improve the quality of breast implant surgery, and increase our knowledge of implant performance, the national Dutch Breast Implant Registry (DBIR) was established in 2015. DBIR is one of the first up-and-running breast implant registries worldwide and follows an opt-out structure., Objective: This article provides an overview of the first outcomes and experiences of the DBIR., Methods: The national coverage of DBIR was studied using data from the Dutch Health and Youth Care Inspectorate. The incidence rate of breast implants was calculated for 2016 and 2017, and patient, device, and surgery characteristics were compared between cosmetic breast augmentations or reconstructive indications. Four infection control, measures were selected to demonstrate the variation in the Dutch clinical practice., Results: In 2016, 95% of the hospitals and 78% of the private clinics participated in DBIR. Between 2015 and 2017, a total of 15,049 patients and 30,541 breast implants were included. A minimum breast implant incidence rate of 1 per 1,691 women could be determined for 2017. The majority of devices were inserted for a cosmetic indication (85.2%). In general, patient, device, and surgery characteristics differed per indication group. Substantial variation was seen in the use of infection control measures (range 0-100%)., Conclusion: Preliminary results obtained from DBIR show high national participation rates and support further developments toward the improvement of breast implant surgery and patient safety., (Copyright © 2019. Published by Elsevier Ltd.)

Purpose: To evaluate the impact of chemotherapy on subjective cognitive functioning according to age in a large cohort of breast cancer patients., Methods: Within the UMBRELLA cohort, 715 patients with early-stage primary invasive breast cancer (T1-3N0-1M0) were selected. Subjective cognitive function was assessed by means of the EORTC QLQ-C30 up to 24 months and compared between patients treated with and without chemotherapy, for three different age strata (355 patients < 55 years, 240 patients aged 55-65 years, and 120 patients > 65 years). Differences between chemotherapy and non-chemotherapy patients by age at different time points were assessed by linear mixed-effect models correcting for age, tumor stage, educational level, endocrine therapy, anxiety, and depression., Results: In total, 979 patients from the UMBRELLA cohort were included, of which 715 (73%) responded to baseline and at least one follow-up questionnaire. Questionnaire response rates ranged between 92 and 70%. The proportion of patients treated with chemotherapy decreased with age: 64% (n = 277) in patients < 55 years, 45% (n = 107) in patients 55-65 years, and 23% (n = 27) in patients > 65 years. Chemotherapy was associated with reduced subjective cognitive functioning. The impact of chemotherapy on subjective cognitive function was most pronounced in patients < 55 years, followed by those between 55 and 65 years. In the youngest age groups, patients treated with chemotherapy had significantly lower cognitive functioning up to 24 months. In women over 65 years, subjective cognitive functioning was comparable between patients treated with and without chemotherapy., Conclusion: This study confirms that chemotherapy is associated with impaired subjective self-reported cognitive functioning in breast cancer patients, and the effect persists at least up to 2 years after diagnosis. The impact of chemotherapy on self-reported cognitive functioning in the first 24 months is most pronounced in younger patients, especially those under 55 years of age.

Background: The association between lymphedema of the arm and impaired health-related QoL (HR-QoL) has led to changes in clinical practice. However, data on lymphedema of the breast (ie, breast edema) are lacking. We prospectively evaluated patient-reported prevalence and determinants of breast edema and its effect on patient-reported HR-QoL and breast pain., Methods: We prospectively included 836 patients undergoing breast-conserving surgery followed by radiotherapy between October 2013 and October 2016 (UMBRELLA cohort). Patient-reported breast edema, HR-QoL, and breast pain were assessed by means of European Organisation for Research and Treatment of Cancer-C30/BR23 before starting radiotherapy and at 3, 6, 12, and 18 months thereafter. We assessed which patient, tumor, and treatment characteristics were associated with breast edema. With mixed-effects models, we assessed the impact of breast edema on patient-reported HR-QoL domains and breast pain over time, adjusting for confounders., Results: Within a median follow-up of 28 months (interquartile range [IQR] = 15), 207 (24.8%) patients reported breast edema at some point in time. Prevalence of breast edema was highest at 6 months (12.4%, 95% confidence interval [CI] = 10.0 to 14.7). Larger tumor size, oncoplastic surgery, axillary lymph node dissection, locoregional radiotherapy, radiotherapy boost on the tumor bed, and adjuvant chemotherapy were associated with breast edema. Breast edema was independently associated with more breast pain and with poorer QoL, physical functioning, and body image., Conclusions: Breast edema occurs frequently within the first year after breast-conserving surgery and radiotherapy and is independently associated with impaired HR-QoL and more breast pain. This information is important for use in clinical practice and should be discussed with patients during shared decision making.

Background: Existing patient-reported outcome measures (PROMs) used to assess patients with head and neck cancer have methodologic and content deficiencies. Herein, the development of a PROM that meets a range of clinical and research needs across head and neck oncology is described., Methods: After development of the conceptual framework, which involved a literature review, semistructured patient interviews, and expert input, patients with head and neck cancer who were treated at Memorial Sloan Kettering Cancer Center were recruited by their surgeon. The FACE-Q Head and Neck Cancer Module was completed by patients in the clinic or was sent by mail. Rasch measurement theory analysis was used for item selection for final scale development and to examine reliability and validity. Scale scores for surgical defect and adjuvant therapy were compared with the cohort average to assess clinical applicability., Results: The sample consisted of 219 patients who completed the draft scales. Fourteen independently functioning scales were analyzed. Item fit was good for all 102 items, and all items had ordered thresholds. Scale reliability was acceptable (person separation index was >0.75 for all scales; Cronbach α values were >.87 for all scales; test-retest ranged from 0.86 to 0.96). The scales performed well in a clinically predictable way, demonstrating functional and psychosocial differences across disease sites and with adjuvant therapy., Conclusions: The scales forming the FACE-Q Head and Neck Cancer Module were found to be clinically relevant and scientifically sound. This new PROM now is validated and ready for use in research and clinical care., (© 2018 American Cancer Society.)

Background: The BREAST-Q is a widely used patient-reported outcome instrument measuring health-related quality-of-life and patient satisfaction in breast surgery. Shorter assessment potentially increases patients' willingness to complete scales, but simply offering a shortened version leads to unacceptable loss in measurement precision. The authors aimed to develop a computerized adaptive test (CAT) to shorten the BREAST-Q's Satisfaction with Breasts scale while maintaining reliability of measurement., Methods: The authors created a CAT, which repetitively administered questions from the pool of 16 questions, until prespecified levels of reliability were reached [i.e., standard errors (SE) of 0.32 to 0.55]. In a simulation study, the authors tested the CAT's feasibility for all potential satisfaction scores. In a second study using actual patient data, 5000 breast reconstruction patients who had previously completed the full scale were randomly selected from a large database. Their full-scale satisfaction scores were compared with their CAT-derived scores., Results: In both studies, by applying CAT, the Satisfaction with Breasts scale could be reduced to an average of 10 questions when using the minimum level of measurement precision for individual-patient measurement (SE, 0.32), compared with four questions when using the minimum precision level for group-based research (SE, 0.55). Score estimates were highly correlated between the CAT assessment and the full scale (0.91 to 0.98 in the simulation study, and 0.89 to 0.98 in the patient data study)., Conclusions: Applying computerized adaptive testing to the BREAST-Q's Satisfaction with Breasts scale facilitates reliable assessment, with 38 to 75 percent fewer questions than the full version. The novel BREAST-Q CAT version may decrease response burden and help overcome barriers to implementation in routine care.

Purpose: To reduce arm morbidity, routine axillary lymph node dissection (ALND) is often omitted or replaced by axillary radiotherapy (AxRT) in patients with limited nodal involvement. We evaluated patient-reported arm morbidity and physical functioning in breast cancer patients undergoing modern-day axillary treatment., Methods: All patients within the UMBRELLA cohort undergoing local radiotherapy with sentinel lymph node biopsy (SLNB), ALND and/or AxRT were selected. Patient-reported arm morbidity and physical functioning were assessed with EORTC QLQ C30/BR23 questionnaires up to eighteen months after initiation of radiotherapy. Patient-reported outcomes were compared between patients with SLNB only, ALND only, AxRT (level I-II), AxRT (level I-IV) or AxRT plus ALND by means of mixed model analysis., Results: In total, 949 patients were identified; 641 (68%) SLNB only, 57 (6%) ALND only, 94 (10%) AxRT level I-II, 72 (8%) AxRT level I-IV and 85 (9%) ALND + AxRT. SLNB only resulted in the least arm morbidity scores. ALND + AxRT resulted in most arm morbidity, with clinically relevant differences at 18 months. AxRT (level I-II or level I-IV) resulted in significantly less arm symptoms in the first 3 months compared to ALND. Arm symptom scores between those receiving AxRT on levels I-II and I-IV were similar., Conclusion: Of all axillary management strategies, ALND plus AxRT is associated with worst patient-reported outcomes. AxRT resulted in less arm morbidity compared to ALND. Selective radiotherapy treatment of the axilla, i.e. radiotherapy of levels I-II only instead of levels I-IV, did not lead to clinically relevant reduced arm morbidity., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR., Methods: This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446., Findings: Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19)., Interpretation: Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis., Funding: Pink Ribbon, Nuts-Ohra, and LifeCell., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Autologous breast reconstructions are increasingly being performed. While increased risks for flap loss after free tissue transfer (FTT) in sickle cell patients are known to most plastic surgeons, risks for patients with sickle cell trait (SCT) are less known. Unfortunately, recommendations to prevent complications after FTT in SCT are still scarce. We present additional and novel surgical measures that we took aiming to enhance probabilities for successful FTT in a SCT patient undergoing autologous breast reconstruction. This is only the second case report describing a successful FTT without flap necrosis/loss in a patient with SCT, and the first successful report involving FTT in the breast., (© 2017 Wiley Periodicals, Inc.)

Little research has been done into cosmetic outcomes in non-Western breast cancer populations. We aimed to study the prevalence and determinants of dissatisfaction with cosmetic outcome after breast cancer surgery of Asian breast cancer survivors, and its association with patient-reported anxiety, depression, and quality of life. In a hospital-based cross-sectional study, 384 breast cancer survivors of at least 12 months after diagnosis completed questionnaires on satisfaction with cosmetic appearance, quality of life (EORTC-QLQ-C30) and anxiety and depression (HADS). Cumulative logit models were used to examine the adjusted association between dissatisfaction with cosmetic appearance and demographic and clinical characteristics. Kruskal-Wallis test was used to test for associations between dissatisfaction with cosmetic appearance and patient-reported outcomes. Overall, 20% of women reported to be (very) dissatisfied with cosmetic appearance. Survivors of Chinese ethnicity were more likely dissatisfied with cosmetic appearance compared to Malay survivors (22% and 14% respectively, adjusted OR = 2.4, 95%CI: 1.4-3.9). Women with DCIS (adjusted OR = 2.2, 95%CI: 1.3-3.7) or advanced stage disease (adjusted OR = 2.2, 95%CI: 1.2-3.9) had a higher risk of being dissatisfied with their cosmetic appearance. Women treated with mastectomy were at a higher risk of dissatisfaction with cosmetic appearance (adjusted OR = 1.7, 95%CI: 1.1-2.5). Dissatisfaction with cosmetic appearance was associated with increased depression scores. In this South-East Asian population, one in five breast cancer patients were (very) dissatisfied with the cosmetic outcome of treatment. Chinese women, women with larger tumors and women treated with mastectomy were most likely to report dissatisfaction with cosmetic appearance.

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

Purpose: Ductal carcinoma in situ (DCIS) is associated with an excellent prognosis; historical studies have shown similar levels of psychological distress in patients with DCIS and with early-stage invasive breast cancer (early-IBC). It is suggested that these results might have led to better patient education about prognosis after DCIS. This study reports the current levels of anxiety, depression, and health-related quality of life (HRQoL) in DCIS and early-IBC patients., Methods: DCIS (n = 89) and early-IBC patients, T1-2N0, (n = 361) were selected from the UMBRELLA breast cancer cohort. Patient-reported outcomes were prospectively collected before the start of adjuvant radiotherapy (baseline) and at 3, 6, 12, 18, and 24 months thereafter. Mixed models were used to compare differences in levels of anxiety, depression, and HRQoL between DCIS and early-IBC patients., Results: DCIS and early-IBC patients reported similar levels of anxiety, which were highest at baseline. Depression scores were comparable between groups, also after stratification by use of adjuvant chemotherapy. The proportion of patients reporting high-risk depression scores (i.e., Hospital Anxiety and Depression Sale score >8) was significantly higher among patients with DCIS at 6, 12 and 18 months, and this proportion increased over the first 18 months. Health-related quality of life was comparable between both groups., Conclusion: Severe depression scores are more common in DCIS patients, despite their excellent prognosis. These results suggest that further improvement of patient education and effective patient doctor communication about the prognostic differences between patients with DCIS and invasive breast cancer is still highly needed.

Purpose: In oncology, RCTs are often beset by slow recruitment, limited generalizability, and strong preferences for interventions by patients and physicians. The cohort multiple randomized controlled trial (cmRCT) is an innovative design with the potential to overcome those challenges. In cmRCT, a prospective cohort serves as an infrastructure for multiple RCTs. We implemented cmRCT in a clinical breast cancer setting by creating UMBRELLA-a large prospective cohort of breast cancer and DCIS patients/survivors., Methods: For all participants, clinical data and patient-reported outcomes (PROs, i.e., quality of life, fatigue, anxiety and depression, physical activity, work ability, and cosmetic satisfaction) are being collected at regular time-intervals for a period of 10 years. These data are being used both for observational and randomized studies. For each intervention to be tested against standard care, a subcohort of eligible patients is identified within UMBRELLA. From this subcohort, a random sample of patients is offered the intervention. Their outcomes are compared to the outcomes of patients receiving standard care., Results: So far, between October 2013 and July 2016, we have recruited 1308 participants. In this period, 1308/1486 (88%) patients who were invited for participation in UMBRELLA consented to cohort participation. Of these patients, 1138 (87%) gave broad consent for randomization to future interventions. Return rate for PROs at baseline were 80%, and varied from 67 to 74% during follow-up. Several observational studies-and the first randomized intervention study-are currently ongoing., Conclusions: Results from UMBRELLA show that this novel study design is feasible and acceptable to patients in a clinical breast cancer setting. We invite researchers who are interested in conducting randomized or observational studies within the UMBRELLA cohort to contact the UMBRELLA scientific advisory board.