Data quality assessment of the Dutch Breast Implant Registry by automated data verification using medical billing data.

BACKGROUND: The Dutch Breast Implant Registry (DBIR) provides real-time population-based data to monitor and improve the quality and safety of breast implants and to trace patients in the event of an (inter)national recall. To serve these main goals, the capture rate and percentage of implants that are actually registered should be known and data should be complete. This study aimed to describe an automated verification process for capture rates and data completeness using medical billing data as the external source. METHODS: DBIR-data on reconstructive permanent breast implants and tissue expanders (TEs) from 2019 were compared to medical billing data. At the hospital level, the capture rate of DBIR and accuracy of the selected data points were assessed. RESULTS: In total, 2389 implants (1420 patients) were included from 12 participating hospitals (11% of all healthcare institutions registering in DBIR). DBIR had capture rates of 99% to 114% for inserted permanent implants and TEs and 49% for explanted permanent implants and TEs. Among the 9015 data points analyzed in DBIR, 8861 (98%) matched the medical billing data. Mastopexy had the highest matching percentage (100%) and capsulectomy the lowest (86%). CONCLUSION: This study showed varying capture rates in DBIR depending on the intervention group, indicating that registration of DBIR-data and medical billing codes could be further optimized. Data accuracy was high as only 2% of data points did not correspond to medical billing data. For future data verification, other external data sources could be explored, including sources that enable verification of cosmetic implants.

Associations between hypopharyngeal defect closure and quality of life in long-term total laryngectomy survivors.

BACKGROUND: Few studies have examined health-related quality of life (HRQOL) outcomes in long-term total laryngectomy survivors in relation to the type of hypopharyngeal defect. METHODS: A cross-sectional study was performed in long-term total laryngectomy survivors, treated between 2000 and 2020. The primary outcome was HRQOL, assessed using the FACE-Q Head and Neck Cancer Module, in relation to the type of hypopharyngeal closure (primary closure, partial or circumferential reconstruction). RESULTS: Seventy-nine survivors were included with a median follow-up of 92.1 months (IQR 75.6-140.2 months). Patients requiring partial hypopharyngeal reconstruction (n = 18) scored significantly worse than patients with primary closure (n = 51) on 4 of 13 FACE-Q domains: functional domains of eating (p = 0.03), speech (p = 0.05), and swallowing (p = 0.03), and the psychological domain of speaking-related distress (p = 0.02). No statistically significant differences were found between the circumferential hypopharyngeal defect reconstruction group (n = 10). Stricture occurrence was the only clinical factor associated with worse eating, speaking, swallowing, eating-related distress, and cancer worry in multivariable analyses. CONCLUSION: Several functional and psychological domains were significantly worse following partial hypopharyngeal reconstruction than in patients who received primary closure. Efforts to reduce stricture rates to enhance reconstructive outcomes following total laryngectomy merit further research.

Surgical Outcomes after Full Thickness Chest Wall Resection Followed by Immediate Reconstruction: A 7-Year Observational Study of 42 Cases.

Introduction: Reconstruction of full thickness chest wall defects is challenging and is associated with a considerable risk of complications. Therefore, the aim of this study was to investigate the surgical outcomes and their associations with patient and treatment characteristics following full thickness chest wall reconstruction. Patients and methods: A retrospective observational study was performed by including patients who underwent reconstruction of full thickness chest wall defect at the Erasmus MC between January 2014 and December 2020. The type of reconstruction was categorized into skeletal and soft tissue reconstructions. For skeletal reconstruction, only non-rigid prosthetic materials were used. Patient and surgical characteristics were retrieved and analyzed for associations with postoperative complications. Results: Thirty-two women and 10 men with a mean age of 60 years were included. In 26 patients (61.9%), the reconstruction was performed using prosthetic material and a soft tissue flap, in nine cases (21.4%) only a soft tissue flap was used, and in seven other patients (16.7%) only the prosthetic material was used. Pedicled musculocutaneous latissimus dorsi flaps were used most often (n=17), followed by pectoralis major flaps (n=8) and free flaps (n=8). Twenty-two patients (52.4%) developed at least one postoperative complication. Wounds (21.4%) and pulmonary (19.0%) complications occurred most frequently. Five (11.9%) patients required reoperation. There were no associations between patient and treatment characteristics and the occurrence of major complications. There was no mortality. Conclusions: Reconstruction of full thickness chest wall defects using only non-rigid prosthetic material for skeletal reconstruction appears safe with an acceptable reoperation rate and low mortality, questioning the need for rigid fixation techniques.

Recurrence of breast cancer after reconstruction with macro-textured silicone breast implants: A retrospective cohort study.

BACKGROUND: Recently, old concerns linking silicone breast implants (SBIs) with breast cancer have resurfaced. These concerns apply specifically to the risk of breast cancer recurrence in patients who received breast reconstructions with macro-textured SBIs. In this study, we investigated the effect of breast reconstruction with macro-textured SBIs on long-term oncologic outcomes of breast cancer patients. MATERIALS AND METHODS: We conducted a retrospective cohort study in two large cancer centres in the Netherlands. Patients who had been treated for primary breast cancer between January 1st 2000 and December 31st 2015 were included. Data on treatment and oncologic outcomes were obtained from prospectively maintained institutional and nationwide registries. Patient files were reviewed manually to complement missing information. Missing data was accounted for by multiple imputation by chained equations (MICE). Reconstruction with a macro-textured SBI was analysed as a time-dependent variable. The main outcomes of interest were locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS). Hazard Ratios (HRs) were estimated using multivariable Cox proportional hazard models. RESULTS: Of the 4,695 women who were eligible for inclusion, 2,393 had undergone mastectomy. Of these women, 1,187 (25%) had received breast reconstruction with a macro-textured SBI. Mean follow-up time was 11.5 (SD, 5.0) years. Compared with women who had undergone a simple mastectomy or autologous breast reconstruction, women with an implant-based reconstruction did not differ significantly in LRRFS or DMFS after accounting for various confounding factors (HR 1.27 [95% CI 0.93 - 1.72] and HR 0.94 [95% CI 0.74 - 1.20], respectively). Sensitivity analysis in complete cases of patients and varies subgroup analyses yielded similar results. CONCLUSION: Reassuringly, in this multi-centre cohort study no difference was found in long-term oncologic outcomes between women who had received breast reconstruction with a macro-textured SBI and women who had undergone a simple mastectomy or autologous breast reconstruction.

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

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

Reconstruction of Partial Hypopharyngeal Defects following Total Laryngectomy: A Systematic Review and Meta-Analysis.

BACKGROUND: Various operative techniques exist to reconstruct partial hypopharyngeal defects following total laryngectomy. The current study aimed to investigate and compare complications and functional results following commonly used reconstructive techniques. METHODS: A systematic review and meta-analysis were performed using studies that investigated outcomes after the reconstruction of a partial hypopharyngeal defect. The outcomes of interest were fistulas, strictures, flap failure, swallowing function and postoperative speech. RESULTS: Of the 4035 studies identified, 23 were included in this review. Four common reconstructive techniques were reported, with a total of 794 patients: (1) pectoralis major myocutaneous and (2) myofascial flap, (3) anterolateral thigh free flap and (4) radial forearm free flap. Fistulas occurred significantly more often than pectoralis major myocutaneous flaps (34%, 95% CI 23-47%) compared with other flaps (p < 0.001). No significant differences in the rates of strictures or flap failure were observed. Pectoralis major myofascial flaps were non-inferior to free-flap reconstructions. Insufficient data were available to assess speech results between flap types. CONCLUSION: Pectoralis myocutaneous flaps should not be the preferred method of reconstruction for most patients, considering their significantly higher rate of fistulas. In contrast, pectoralis major myofascial flaps yield promising results compared to free-flap reconstructions, warranting further investigation.

Quality of life in 583 head and neck cancer survivors assessed with the FACE-Q head and neck cancer module.

OBJECTIVES: Long-term health-related quality of life (HRQOL) is frequently affected in head and neck cancer (HNC) survivors. Due to the shortage of studies investigating long-term patient-reported outcomes, we investigated long-term HRQOL using the novel FACE-Q HNC Module. METHODS: A retrospective cross-sectional single-center study was performed, including all patients who underwent curative treatment for HNC between 2006 and 2013. All eligible patients (n = 863) were invited to participate of whom 540 completed the questionnaires. Additionally, a prospective longitudinal cohort of 43 HNC patients treated between 2020 and 2022 was included who preoperatively filled in the FACE-Q, and at three, six, and 12 months postoperatively. HRQOL domain scores were analyzed to visualize group characteristics by tumor site and type of surgical resection. RESULTS: Both surgical and non-surgical HNC treatments predominantly affected long-term functional HRQOL domains (eating, salivation, speech, and swallowing), eating distress, and speaking distress, with distinct profiles depending on tumor site and type of treatment. In contrast, few long-term intergroup differences between HNC patients were observed for appearance, smiling, drooling distress, and smiling distress. Longitudinal data showed significant deterioration across all functional HRQOL domains in the short-term following treatment. Patients predominantly reported long-lasting negative treatment effects at 12 months follow-up for functional domains, whereas psychological domains showed near-complete recovery at group level. CONCLUSIONS: At long-term, various function-related and psychosocial HRQOL domains still are affected in head and neck cancer survivors. The results may serve to better inform patients with regard to specific treatments and highlight HRQOL domains which may potentially be optimized.

Quality of life after surgical treatments for facial palsy: A systematic review and meta-analysis.

BACKGROUND: Facial palsy profoundly affects patients' quality of life (QoL). We evaluated the effect of various surgical procedures on QoL using patient-reported outcome measures (PROMs) to provide evidence-based recommendations for improved care. METHODS: Embase, Medline, Web of Science, Cochrane, and CINAHL were searched for studies on QoL in patients with facial palsy who had undergone reconstructive surgery with preoperative and postoperative data from validated PROMs. After conducting the quality assessment, data were subtracted from the articles. Meta-analyses of subgroups were performed when study outcomes where compatible. RESULTS: Incorporating 24 studies (522 patients), our systematic review revealed consistent and significant QoL improvements following diverse reconstructive surgical procedures. CONCLUSIONS: Our systematic review and meta-analysis showed the positive effects of different reconstructive surgical procedures on QoL of patients with facial palsy. These results support clinicians to better inform patients about their potential outcomes, optimizing informed and shared decision-making and ultimately improving overall QoL in patients with facial palsy.

The clinical applicability of sensor technology with body position detection to combat pressure ulcers in bedridden patients.

INTRODUCTION: Pressure Ulcers (PUs) are a major healthcare issue leading to prolonged hospital stays and decreased quality of life. Monitoring body position changes using sensors could reduce workload, improve turn compliance and decrease PU incidence. METHOD: This systematic review assessed the clinical applicability of different sensor types capable of in-bed body position detection. RESULTS: We included 39 articles. Inertial sensors were most commonly used (n = 14). This sensor type has high accuracy and is equipped with a 2-4 hour turn-interval warning system increasing turn compliance. The second-largest group were piezoresistive (pressure) sensors (n = 12), followed by load sensors (n = 4), piezoelectric sensors (n = 3), radio wave-based sensors (n = 3) and capacitive sensors (n = 3). All sensor types except inertial sensors showed a large variety in the type and number of detected body positions. However, clinically relevant position changes such as trunk rotation and head of bed elevation were not detected or tested. CONCLUSION: Inertial sensors are the benchmark sensor type regarding accuracy and clinical applicability but these sensors have direct patient contact and (re)applying the sensors requires the effort of a nurse. Other sensor types without these disadvantages should be further investigated and developed. We propose the Pressure Ulcer Position System (PUPS) guideline to facilitate this.

Mental health is strongly associated with capability after lower extremity injury treated with free flap limb salvage or amputation.

BACKGROUND: Knowledge about factors associated with long-term outcomes, after severe traumatic injury to the lower extremity, can aid with the difficult decision whether to salvage or amputate the leg and improve outcome. We therefore studied factors independently associated with capability at a minimum of 1 year after amputation or free flap limb salvage. METHODS: We included 135 subjects with a free flap lower extremity reconstruction and 41 subjects with amputation, between 1991 and 2021 at two urban-level 1 trauma centers with a mean follow-up of 11 ± 7 years. Long-term physical functioning was assessed using the Physical Component Score (PCS) of the Short-Form 36 (SF36) and the Lower Extremity Functional Scale (LEFS) questionnaires. Independent variables included demographics, injury characteristics, and the Mental Component Score (MCS) of the SF36. RESULTS: Greater mental health was independently and strongly associated with greater capability, independent of amputation or limb reconstruction. Mental health explained 33% of the variation in PCS and 57% of the variation in LEFS. Injury location at the knee or leg was associated with greater capability, compared to the foot or ankle. Amputation or limb reconstruction was not associated with capability. DISCUSSION: This study adds to the growing body of knowledge that physical health is best regarded through the lens of the bio-psycho-social model in which mental health is a strong determinant. This study supports making mental health an important aspect of rehabilitation after major lower extremity injury, regardless of amputation or limb salvage.

Fasciocutaneous and jejunal free flaps for circumferential hypopharyngeal defect reconstruction: A 22-year multicenter cohort study.

BACKGROUND: It remains unclear whether a tubed fasciocutaneous or jejunal free flap (FCFF and JFF) is preferable for reconstruction of circumferential pharyngolaryngoesophageal defects. METHODS: All consecutive patients with circumferential pharyngolaryngoesophageal defects reconstructed with an FCFF or JFF between 2000 and 2022 were included. Outcomes of interest were rates of fistulas, strictures, and donor-site complications. RESULTS: In total, 112 patients were included (35 FCFFs and 77 JFFs). Fistula and stricture rates were significantly lower following JFF compared to FCFF reconstructions, with 12% versus 34% (p = 0.008) and 29% versus 49% (p = 0.04), respectively. Severe donor-site complications leading to surgical intervention or ICU admittance only occurred after JFF reconstructions (18%, p = 0.007). CONCLUSIONS: The high fistula and stricture rates in FCFF reconstructions and the rate of severe abdominal complications in JFF reconstructions illustrate inherent procedure-specific advantages and disadvantages. Relative pros and cons should be carefully weighed when tailoring treatments to the individual needs of patients.

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.

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

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

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.

Reconstruction of partial hypopharyngeal defects following total laryngectomy: Pectoralis major myofascial versus myocutaneous flaps.

BACKGROUND: To date, few comparative studies exist for partial hypopharyngeal defect reconstruction following total laryngectomy. In the absence of objective evidence from comparative studies, the ideal flap choice remains controversial, leading to heterogeneity in institutional treatment protocols. Comparative studies between different reconstructive techniques are required. Therefore, this study compared postoperative outcomes of pectoralis major myocutaneous (PMMC) and myofascial (PMMF) flaps. METHODS: A single-center retrospective cohort study was performed between 2000 and 2022, which included all consecutive patients who underwent a PMMC or PMMF flap reconstruction following total laryngectomy and partial hypopharyngectomy. Primary outcomes were suture line leakages (conservative management), fistulas (surgical management), and strictures. Secondary outcomes included flap failure, donor-site morbidity, and the start of oral intake. RESULTS: In total, 122 patients were included (109 PMMC and 13 PMMF flap reconstructions). The incidence of suture line leakage was significantly higher (p = 0.007) after PMMC flaps (57%) compared with PMMF flaps (15%). Between PMMC and PMMF flaps, fistula (19% vs. 0%) and stricture rates (22% vs. 15%) did not differ significantly. No differences in flap failure, donor-site morbidity, or start of oral intake were observed. CONCLUSIONS: PMMF flaps have inherent advantages (e.g., reduced bulk, increased pliability) over conventional PMMC flaps and have non-inferior results compared to the latter in terms of postoperative complications. Although the final choice for reconstruction should be patient-tailored, a PMMF flap can be considered a reliable primary choice that is feasible in most patients.

Long-term patient-reported outcomes after reconstructive surgery for head and neck cancer: A systematic review.

Current literature on reconstruction after head and neck cancer (HNC) focusses on short-term patient-reported outcomes (PROs), while there is a need for knowledge on long-term consequences. Embase, Medline, Web of Science, and Cochrane were searched for studies on health-related quality of life (HRQoL) after HNC reconstruction, using validated PROMs in at least 50 patients, and a follow-up of more than 1 year. Thirty studies were included, comprising 2358 patients with a follow-up between one and 10 years. The most used questionnaire was the UW-QoL v4. Reconstructive surgery was generally followed by diminished oral function, worsened by radiotherapy. Patients experienced anxiety and fear of cancer recurrence. However, there was a progressive decrease in pain over time with some flaps having more favorable HRQoL outcomes. Age and bony tumor involvement were not related to postoperative HRQoL. These results may lead to better patient counseling and expectation management of HNC patients.

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

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

Surgical outcomes following breast reconstruction in patients with and without a history of chest radiotherapy for Hodgkin lymphoma: a multicentre, matched cohort study.

BACKGROUND: Breast cancer is the most common treatment-related second malignancy among women with previous chest radiotherapy for Hodgkin lymphoma (HL). Little is known about the effects of this kind of radiotherapy on the outcomes of postmastectomy breast reconstruction (BR). This study compared adverse outcomes of BR after HL-related chest radiotherapy to matched controls. METHODS: The authors conducted a retrospective, matched cohort study in two expert cancer centres in the Netherlands. BRs after therapeutic or prophylactic mastectomy in HL survivors who received chest radiotherapy were matched with BRs in nonirradiated patients without HL on age at mastectomy date, date of BR, and type of BR. The primary outcome was complication-related BR failure or conversion and secondary outcomes were complication-related re-operation, capsular contracture, major donor-site complications, and complication-related ICU admission. The authors analyzed all outcomes univariably using Fisher's exact tests and the authors assessed reconstruction failure, complication-related re-operation, and capsular contracture with multivariable Cox regression analysis adjusting for confounding and data clustering. RESULTS: Seventy BRs in 41 patients who received chest radiotherapy for HL were matched to 121 BRs in 110 nonirradiated patients. Reconstruction failure did not differ between HL survivors (12.9%) and controls (12.4%). The comparison groups showed no differences in number of reoperations, major donor-site complications, or capsular contractures. BR in HL survivors more often let to ICU admission due to complications compared with controls ( P =0.048). CONCLUSIONS: We observed no increased risk of adverse outcomes following BR after previous chest radiotherapy for HL. This is important information for counselling these patients and may improve shared decision-making.

The Areola study: design and rationale of a cohort study on long-term health outcomes in women with implant-based breast reconstructions.

BACKGROUND: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of silicone breast implants in the development of so-called "breast implant illness" (BII) and autoimmune diseases in breast cancer survivors with implant-based reconstructions. BII is a constellation of non-specific symptoms reported by a small group of women with silicone breast implants. METHODS: The Areola study is a multicenter retrospective cohort study with prospective follow-up aiming to assess the risk of BII and autoimmune diseases in female breast cancer survivors with and without silicone breast implants. In this report, we set out the rationale, study design, and methodology of this cohort study. The cohort consists of breast cancer survivors who received surgical treatment with implant-based reconstruction in six major hospitals across the Netherlands in the period between 2000 and 2015. As a comparison group, a frequency-matched sample of breast cancer survivors without breast implants will be selected. An additional group of women who received breast augmentation surgery in the same years will be selected to compare their characteristics and health outcomes with those of breast cancer patients with implants. All women who are still alive will be invited to complete a web-based questionnaire covering health-related topics. The entire cohort including deceased women will be linked to population-based databases of Statistics Netherlands. These include a registry of hospital diagnostic codes, a medicines prescription registry, and a cause-of-death registry, through which diagnoses of autoimmune diseases will be identified. Outcomes of interest are the prevalence and incidence of BII and autoimmune diseases. In addition, risk factors for the development of BII and autoimmune disorders will be assessed among women with implants. DISCUSSION: The Areola study will contribute to the availability of reliable information on the risks of BII and autoimmune diseases in Dutch breast cancer survivors with silicone breast implants. This will inform breast cancer survivors and aid future breast cancer patients and their treating physicians to make informed decisions about reconstructive strategies after mastectomy. REGISTRATION: This study is registered at ClinicalTrials.gov on June 2, 2022 (NCT05400954).

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

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