Ensuring access to post-cancer breast reconstructions: COVID-19 lessons from the Dutch Breast Implant Registry.

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.

Risk factors for unplanned reoperation during the expansion phase in two-stage breast reconstruction in the Dutch Breast Implant Registry.

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. Co-variate 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 percent of all registered TEs (n=3190). Independent factors associated with unplanned reoperation were BMI≥25 kg/m 2 (adjusted Odds Ratio [aOR]=1.63;99% Confidence Interval [99%CI]=1.20-2.57 for BMI 25-29.9 kg/m2, aOR=2.57;99%CI=1.74-3.78 for BMI≥30 kg/m 2), low institutional volume (aOR=1.51;99%CI=1.06-2.18), no drains (aOR=2.06;99%CI=1.15-3.60), subcutaneous TE placement (aOR=5.71;99%CI=3.59-9.10), and partial pectoralis major muscle coverage (aOR=1.35;99%CI=1.02-1.79). Age<40 years (aOR=0.49;99%CI=0.32-0.74) and delayed PMBR (aOR=0.35;99%CI=0.19-0.60) 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 percent). CONCLUSION: This study identified several risk factors for unplanned reoperation which may be used to reduce complications in expander-based PMBR.

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.

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.

Impact of 70-Gene Signature Use on Adjuvant Chemotherapy Decisions in Patients With Estrogen Receptor-Positive Early Breast Cancer: Results of a Prospective Cohort Study.

Purpose Gene-expression profiles increasingly are used in addition to conventional prognostic factors to guide adjuvant chemotherapy (CT) decisions. The Dutch guideline suggests use of validated gene-expression profiles in patients with estrogen receptor (ER) -positive, early-stage breast cancer without overt lymph node metastases. We aimed to assess the impact of a 70-gene signature (70-GS) test on CT decisions in patients with ER-positive, early-stage breast cancer. Patients and Methods In a prospective, observational, multicenter study in patients younger than 70 years old who had undergone surgery for ER-positive, early-stage breast cancer, physicians were asked whether they intended to administer adjuvant CT before deployment of the 70-GS test and after the test result was available. Results Between October 1, 2013, and December 31, 2015, 660 patients, treated in 33 hospitals, were enrolled. Fifty-one percent of patients had pT1cN0, BRII, HER2-Neu-negative breast cancer. On the basis of conventional clinicopathological characteristics, physicians recommended CT in 270 (41%) of the 660 patients and recommended withholding CT in 107 (16%) of the 660 patients. For the remaining 43% of patients, the physicians were unsure and unable to give advice before 70-GS testing. In patients for whom CT was initially recommended or not recommended, 56% and 59%, respectively, were assigned to a low-risk profile by the 70-GS (κ, 0.02; 95% CI, -0.08 to 0.11). After disclosure of the 70-GS test result, the preliminary advice was changed in 51% of patients who received a recommendation before testing; the definitive CT recommendation of the physician was in line with the 70-GS result in 96% of patients. Conclusion In this prospective, multicenter study in a selection of patients with ER-positive, early-stage breast cancer, 70-GS use changed the physician-intended recommendation to administer CT in half of the patients.

Breast magnetic resonance imaging use in patients undergoing neoadjuvant chemotherapy is associated with less mastectomies in large ductal cancers but not in lobular cancers.

BACKGROUND: To assess the impact of breast magnetic resonance imaging (MRI) use on surgical outcome per histological breast cancer subtype in patients treated with neoadjuvant chemotherapy. PATIENTS AND METHODS: All patients aged 18-70 years who underwent neoadjuvant chemotherapy for stage I-III invasive breast cancer in the Netherlands in the years 2011-2013 were identified from the Netherlands Cancer Registry. Patients with cT4 tumours were excluded from the analysis. Use of breast MRI and impact on surgical treatment, resection margins and detection of contralateral breast cancer were analysed by multivariable analyses. RESULTS: Breast MRI was performed in 2879 (83.9%) out of 3433 patients treated with neoadjuvant chemotherapy. Younger age (odds ratio [OR] 1.42; 95% confidence interval [CI] 1.17-1.71 for 18-50 years compared with 50-70 years), larger tumour stage (OR 1.46 [95% CI 1.15-1.86] for cT3, compared to cT1-2 tumours) and multifocality (OR 1.30; 95% CI 1.04-1.61, versus unifocality) were associated with increased breast MRI use. In ductal breast cancer, after stratification for cT-status, breast MRI use is associated with a significant lower OR for mastectomy as final surgery in cT3 tumours (OR 0.45, 95% CI 0.21-0.99). Resection margin involvement and detection of contralateral breast cancer were not associated with breast MRI use. CONCLUSION: In patients treated with neoadjuvant chemotherapy, the use of breast MRI was associated with a reduced mastectomy rate, particularly in patients with large invasive ductal breast tumours but not in patients with lobular breast cancer.

An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer.

IMPORTANCE: Global health systems are shifting toward value-based care in an effort to drive better outcomes in the setting of rising health care costs. This shift requires a common definition of value, starting with the outcomes that matter most to patients. OBJECTIVE: The International Consortium for Health Outcomes Measurement (ICHOM), a nonprofit initiative, was formed to define standard sets of outcomes by medical condition. In this article, we report the efforts of ICHOM's working group in colorectal cancer. EVIDENCE REVIEW: The working group was composed of multidisciplinary oncology specialists in medicine, surgery, radiation therapy, palliative care, nursing, and pathology, along with patient representatives. Through a modified Delphi process during 8 months (July 8, 2015 to February 29, 2016), ICHOM led the working group to a consensus on a final recommended standard set. The process was supported by a systematic PubMed literature review (1042 randomized clinical trials and guidelines from June 3, 2005, to June 3, 2015), a patient focus group (11 patients with early and metastatic colorectal cancer convened during a teleconference in August 2015), and a patient validation survey (among 276 patients with and survivors of colorectal cancer between October 15, 2015, and November 4, 2015). FINDINGS: After consolidating findings of the literature review and focus group meeting, a list of 40 outcomes was presented to the WG and underwent voting. The final recommendation includes outcomes in the following categories: survival and disease control, disutility of care, degree of health, and quality of death. Selected case-mix factors were recommended to be collected at baseline to facilitate comparison of results across treatments and health care professionals. CONCLUSIONS: A standardized set of patient-centered outcome measures to inform value-based health care in colorectal cancer was developed. Pilot efforts are under way to measure the standard set among members of the working group.

Breast MRI increases the number of mastectomies for ductal cancers, but decreases them for lobular cancers.

PURPOSE: In this retrospective population-based cohort study, we analyzed breast MRI use and its impact on type of surgery, surgical margin involvement, and the diagnosis of contralateral breast cancer. METHODS: All Dutch patients with cT1-4N0-3M0 breast cancer diagnosed in 2011-2013 and treated with primary surgery were eligible for inclusion. Using multivariable analyses, we analyzed in different categories whether MRI use was related to surgery type, margin involvement, and diagnosis of contralateral breast cancer (CBC). RESULTS: MRI was performed in 10,740 out of 36,050 patients (29.8%). Patients with invasive ductal cancer undergoing MRI were more likely to undergo primary mastectomy than those without MRI (OR 1.30, 95% confidence interval (CI) 1.22-1.39, p < 0.0001). Patients with invasive lobular cancer undergoing MRI were less likely to undergo primary mastectomy than those without MRI (OR 0.86, 95% CI 0.76-0.99, p = 0.0303). A significantly lower risk of positive surgical margins after breast-conserving surgery was only seen in patients with lobular cancer who had undergone MRI as compared to those without MRI (OR 0.59, 95% CI 0.44-0.79, p = 0.0003) and, consequently, a lower risk of secondary mastectomy (OR 0.61, 95% CI 0.42-0.88, p = 0.0088). Patients who underwent MRI were almost four times more likely to be diagnosed with CBC (OR 3.55, 95% CI 3.01-4.17, p < 0.0001). CONCLUSIONS: Breast MRI use was associated with a reduced number of mastectomies and less positive surgical margins in invasive lobular cancer, but with an increased number of mastectomies in ductal cancers. Breast MRI use was associated with a fourfold higher incidence of CBC.

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.

A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative.

A major challenge in value-based health care is the lack of standardized health outcomes measurements, hindering optimal monitoring and comparison of the quality of health care across different settings globally. The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary international working group, comprised of 26 health care providers and patient advocates, to develop a standard set of value-based patient-centered outcomes for breast cancer (BC). The working group convened via 8 teleconferences and completed a follow-up survey after each meeting. A modified 2-round Delphi method was used to achieve consensus on the outcomes and case-mix variables to be included. Patient focus group meetings (8 early or metastatic BC patients) and online anonymized surveys of 1225 multinational BC patients and survivors were also conducted to obtain patients' input. The standard set encompasses survival and cancer control, and disutility of care (eg, acute treatment complications) outcomes, to be collected through administrative data and/or clinical records. A combination of multiple patient-reported outcomes measurement (PROM) tools is recommended to capture long-term degree of health outcomes. Selected case-mix factors were recommended to be collected at baseline. The ICHOM will endeavor to achieve wide buy-in of this set and facilitate its implementation in routine clinical practice in various settings and institutions worldwide.

Defining a standard set of patient-centred outcomes for lung cancer.

In lung cancer, outcome measurement has been mostly limited to survival. Proper assessment of the value of lung cancer treatments, and the performance of institutions delivering care, requires more comprehensive measurement of standardised outcomes.The International Consortium for Health Outcomes Measurement convened an international, multidisciplinary working group of patient representatives, medical oncologists, surgeons, radiation oncologists, pulmonologists, palliative care specialists, registry experts and specialist nurses to review existing data and practices. Using a modified Delphi method, the group developed a consensus recommendation ("the set") on the outcomes most essential to track for patients with lung cancer, along with baseline demographic, clinical and tumour characteristics (case-mix variables) for risk adjustment.The set applies to patients diagnosed with nonsmall cell lung cancer and small cell lung cancer. Our working group recommends the collection of the following outcomes: survival, complications during or within 6 months of treatment and patient-reported domains of health-related quality of life including pain, fatigue, cough and dyspnoea. Case-mix variables were defined to improve interpretation of comparisons.We defined an international consensus recommendation of the most important outcomes for lung cancer patients, along with relevant case-mix variables, and are working to support adoption and reporting of these measures globally.

Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach.

BACKGROUND: There are no universally monitored outcomes relevant to men with advanced prostate cancer, making it challenging to compare health outcomes between populations. OBJECTIVE: We sought to develop a standard set of outcomes relevant to men with advanced prostate cancer to follow during routine clinical care. DESIGN, SETTING, AND PARTICIPANTS: The International Consortium for Health Outcomes Measurement assembled a multidisciplinary working group to develop the set. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used a modified Delphi method to achieve consensus regarding the outcomes, measures, and case mix factors included. RESULTS AND LIMITATIONS: The 25 members of the multidisciplinary international working group represented academic and nonacademic centers, registries, and patients. Recognizing the heterogeneity of men with advanced prostate cancer, the group defined the scope as men with all stages of incurable prostate cancer (metastatic and biochemical recurrence ineligible for further curative therapy). We defined outcomes important to all men, such as overall survival, and measures specific to subgroups, such as time to metastasis. Measures gathered from clinical data include measures of disease control. We also identified patient-reported outcome measures (PROMs), such as degree of urinary, bowel, and erectile dysfunction, mood symptoms, and pain control. CONCLUSIONS: The international multidisciplinary group identified clinical data and PROMs that serve as a basis for international health outcome comparisons and quality-of-care assessments. The set will be revised annually. PATIENT SUMMARY: Our international group has recommended a standardized set of patient-centered outcomes to be followed during routine care for all men with advanced prostate cancer.

The additional cancer yield of clinical breast examination in screening of women at hereditary increased risk of breast cancer: a systematic review.

Women at hereditary increased risk of breast cancer are subjected to frequent clinical breast examination (CBE) and radiological evaluation of the breasts. This review appraises the additional cancer yield by CBE in screening of women at increased risk of breast cancer who are also subjected to frequent radiological evaluation. A literature search was conducted to identify all prospective studies on the additional value of CBE in screening of women at increased risk of breast cancer. Quality appraisal of included studies was performed using the QUADAS-2 tool. A total of 514 citations were identified. Relevant literature was scarce and highly heterogeneous. Seven prospective studies were included for review of which two studies reported additional cancer yield of CBE (3 and 5 % of total cancer cases). These two studies reported lower screen detection (77 and 80 %) compared to the studies in which no additional cases were detected by CBE (screen detection ≥94 %). Current literature on CBE in screening of women at increased risk of breast cancer is insufficient. However, it suggests that the additional cancer yield by performing CBE is minimal or absent. Reconsideration of the role of CBE in intensified screening might be warranted.

Ranking and rankability of hospital postoperative mortality rates in colorectal cancer surgery.

OBJECTIVES: To examine to what extent random variation and variation in case-mix influence hospital rankings on the basis of mortality rates and to determine the suitability of mortality for ranking hospitals in colorectal surgery. BACKGROUND: Comparing and ranking postoperative mortality rates between hospitals becomes increasingly popular. Differences in hospital case-mix, and chance variation related to caseload, may influence rankings. The suitability of mortality for rankings remains unclear. METHODS: Data were derived from the Dutch Surgical Colorectal Audit. Hospital rankings based on fixed- and random-effects logistic regression models, unadjusted and adjusted for case-mix were compared with the percentile based on expected ranks (the chance that a hospital performs better than a random hospital). Rankability, measuring which part of variation between hospitals is not due to chance, was calculated. RESULTS: Some 25,591 patients undergoing colorectal resections in 92 hospitals were evaluated. Postoperative mortality rates ranged between 0% and 8.8%. Adjustment for case-mix with a fixed-effects model caused large changes in rankings. A smaller additional effect on changes in rankings occurred after adjusting with a random-effects model, with lower volume hospitals moving toward the mean. Percentile based on expected ranks ranged between 10% and 85%. Rankability was 38%, meaning that 62% of hospital variation in mortality was due to chance. CONCLUSIONS: Hospital ranks changed after case-mix adjustment and random-effects models, compared with unadjusted analysis. A large proportion of hospital variation in mortality was due to chance. Caution should be warranted when interpreting hospital rankings on the basis of postoperative mortality. Percentiles of expected ranks may help identify hospitals with exceptional performance.

Subjective and Objective Assessment of Hand Function in Mucopolysaccharidosis IVa Patients.

INTRODUCTION: Morquio A is classically described as a skeletal dysplasia, but the impact of the abnormalities on the upper limb has not been described. AIM: The aim of our study is to assess the level of subjective and objective functions of the hand and upper limb in Morquio A patients in order to advance understanding as this may change future management for this complex group of patients. METHOD: We have evaluated a series of ten patients with Morquio syndrome who are currently part of the enzyme replacement therapy trials in our unit. To establish functional levels, we developed a questionnaire based on the principles of the World Health Organization International Classification of Functioning, Disability and Health (WHO ICF). Furthermore, we measured patients' grip function and range of motion. RESULTS: All patients showed hypermobility and limited control of the wrist. Their grip strength was reduced and they showed higher difficulty levels for activities involving strength. It is feasible that the wrist abnormalities may be the major cause of functional loss for Morquio patients. CONCLUSION: Our findings suggest the wrist itself represents an area that we should focus on to be able to improve the patients' functional abilities and hence their level of independence on day-to-day basis.

Vulva reconstruction after pelvic exenteration, using a unique combination of two flaps.

A 64-year-old woman with recurrence of carcinoma of the vulva in an irradiated area received an en-bloc total pelvic exenteration. Reconstruction of the pelvic defect was performed with an anterolateral thigh (ALT) flap and a rectus abdominis muscle (RAM) flap (PM/RAM). This combination of flaps is unique, with excellent results. In a large defect, often irradiated in advance, well-vascularised tissue should be placed. Multiple flaps can be used to reconstruct these large pelvic defects, each with their own advantages and disadvantages. The combination of flaps used in this case uses the good properties of both flaps: the reliable and well-vascularised PM/RAM in combination with the ALT flap to provide much bulk in extreme large defects.