Nationwide study on open tibial fractures in the Netherlands: Incidence, demographics and level of hospital care.

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.

Appearance-related concerns and their impact on health-related quality of life in patients with peripheral vascular malformations.

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.

Towards evidence based plastic surgery; how a national research agenda can unite research.

We describe the development of the Research Agenda of the Dutch Society for Plastic Surgery, supported and democratically created by plastic surgeons, patients, and other stakeholders. The agenda contains the 10 most relevant knowledge gaps encountered in clinical practice, as prioritized by the abovementioned groups. The aim is to stimulate national collaborations and research networks to initiate trials to answer these knowledge gaps. The agenda will be renewed periodically to stay relevant. We encourage other national and international associations to develop a research agenda within their field, and intensify their research network and improve research quality.

Development of a condition-specific patient-reported outcome measure for measuring symptoms and appearance in vascular malformations: the OVAMA questionnaire.

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.

Higher reconstruction failure and less patient-reported satisfaction after post mastectomy radiotherapy with immediate implant-based breast reconstruction compared to immediate autologous breast reconstruction.

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.

Patient-reported cosmetic satisfaction and the long-term association with quality of life in irradiated breast cancer patients.

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.

Self-reported work ability in breast cancer survivors; a prospective cohort study in the Netherlands.

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.

How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015-2017).

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.

The effect of chemotherapy on subjective cognitive function in younger early-stage breast cancer survivors treated with chemotherapy compared to older patients.

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.

Severe depression more common in patients with ductal carcinoma in situ than early-stage invasive breast cancer patients.

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.

The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA): objectives, design, and baseline results.

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.