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Background Patient safety is a key target in public health, health services and medicine. Communication between all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their partners, close relatives or friends providing social support) should be improved to ensure patient safety, including the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in this project through a participatory approach integrating two theoretical models. The interventions will be designed to support participants in their communication with each other and to overcome difficulties in everyday hospital life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is improved, clinical staff should show an increase in work satisfaction and patients should show an increase in patient satisfaction. Methods The study will take place in two maternity clinics in Germany. In line with previous studies of complex interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase 1: Needs assessment and a training for staff ( n  = 140) tested in a pre-experimental study with a pre/post-design. Phase 2: Assessment of communication training for patients and their social support providers ( n  = 423) in a randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff, patients, and their social support providers ( n  = 423) in a case-control study. The primary outcome is improvement of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs, patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes). Discussion This is the first large intervention study on communication and patient safety in gynecology and obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the interventions, including the app, will improve communication practice which is linked to a lower probability of pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of users’ motivation. Insights gained from this study can inform other patient safety interventions and health policy developments. Trial registration ClinicalTrials.gov Identifier: NCT03855735 ; date of registration: February 27, 2019.

Influenza encephalopathy, a rare manifestation of influenza infection in the adult population which is not widely recognised, can present with confusion and focal neurological symptoms, including aphasia. The aim of this report is to illustrate the unique presentation of influenza encephalopathy and discuss the need for close attention to and monitoring of this rare but highly fatal disease.A 28-year-old woman was admitted with acute-onset confusion and incoherent speech. CT of the head was unremarkable. Cerebrospinal fluid analysis showed elevation of protein, but was otherwise unremarkable. A detailed history revealed recent upper respiratory symptoms which prompted a rapid influenza test which was positive and oseltamivir was started. The patient’s confusion and aphasia gradually improved and her speech was back to her baseline by the next day.

Die Komplexität und Vielfalt an plastisch-operativen und rekonstruktiven Eingriffsmöglichkeiten an der Mamma erfordert eine operative Spezialisierung des chirurgisch tätigen Gynäkologen auf diesem Gebiet. Eine gute und fächerübergreifende Zusammenarbeit mit der plastischen Chirurgie ist zwingende Voraussetzung, um den Wünschen und Bedürfnissen der Patientinnen gerecht werden zu können. Ein Schwerpunkt der operativen Therapiemöglichkeiten liegt heute in der onkoplastischen Mammachirurgie, die neben der onkologisch sicheren In-sano-Resektion des Karzinoms eine ästhetisch für die Patientin zufriedenstellende Wiederherstellung der Brust zum Ziel hat. Von verschiedenen brusterhaltenden Ansätzen kommen hier u. a. Verfahren mit auto- und heterologen Rekonstruktionsmöglichkeiten nach Mastektomie zum Einsatz. In diesem Zusammenhang ist auch die prophylaktische Mastektomie bei Hochrisikopatientinnen (BRCA-Mutationsträgerinnen) zu nennen. Weitere Indikationen für plastisch-operative Eingriffe sind angeborene oder erworbene Fehlbildungen, z. B. Aplasie/Hypoplasie, eine tubuläre Brust oder eine deutliche Makromastie mit entsprechenden körperlichen Beschwerden. Besonders bei rekonstruktiven und plastisch-ästhetischen Operationen muss vorher umfassend über den Eingriff, mögliche Komplikationen und Alternativen aufgeklärt werden.

Human papillomavirus-related (HPV+) oropharyngeal cancer is a rapidly emerging disease with generally good prognosis. Many prognostic algorithms for oropharyngeal cancer incorporate HPV status as a stratification factor, rather than recognising the uniqueness of HPV+ disease. The International Collaboration on Oropharyngeal cancer Network for Staging (ICON-S) aimed to develop a TNM classification specific to HPV+ oropharyngeal cancer. The ICON-S study included patients with non-metastatic oropharyngeal cancer from seven cancer centres located across Europe and North America; one centre comprised the training cohort and six formed the validation cohorts. We ascertained patients' HPV status with p16 staining or in-situ hybridisation. We compared overall survival at 5 years between training and validation cohorts according to 7th edition TNM classifications and HPV status. We used recursive partitioning analysis (RPA) and adjusted hazard ratio (AHR) modelling methods to derive new staging classifications for HPV+ oropharyngeal cancer. Recent hypotheses concerning the effect of lower neck lymph nodes and number of lymph nodes were also investigated in an exploratory training cohort to assess relevance within the ICON-S classification. Of 1907 patients with HPV+ oropharyngeal cancer, 661 (35%) were recruited at the training centre and 1246 (65%) were enrolled at the validation centres. 5-year overall survival was similar for 7th edition TNM stage I, II, III, and IVA (respectively; 88% [95% CI 74–100]; 82% [71–95]; 84% [79–89]; and 81% [79–83]; global p=0·25) but was lower for stage IVB (60% [53–68]; p<0·0001). 5-year overall survival did not differ among N0 (80% [95% CI 73–87]), N1–N2a (87% [83–90]), and N2b (83% [80–86]) subsets, but was significantly lower for those with N3 disease (59% [51–69]; p<0·0001). Stage classifications derived by RPA and AHR models were ranked according to survival performance, and AHR-New was ranked first, followed by AHR-Orig, RPA, and 7th edition TNM. AHR-New was selected as the proposed ICON-S stage classification. Because 5-year overall survival was similar for patients classed as T4a and T4b, T4 is no longer subdivided in the re-termed ICON-S T categories. Since 5-year overall survival was similar among N1, N2a, and N2b, we re-termed the 7th edition N categories as follows: ICON-S N0, no lymph nodes; ICON-S N1, ipsilateral lymph nodes; ICON-S N2, bilateral or contralateral lymph nodes; and ICON-S N3, lymph nodes larger than 6 cm. This resembles the N classification of nasopharyngeal carcinoma but without a lower neck lymph node variable. The proposed ICON-S classification is stage I (T1–T2N0–N1), stage II (T1–T2N2 or T3N0–N2), and stage III (T4 or N3). Metastatic disease (M1) is classified as ICON-S stage IV. In an exploratory training cohort (n=702), lower lymph node neck involvement had a significant effect on survival in ICON-S stage III but had no effect in ICON-S stage I and II and was not significant as an independent factor. Overall survival was similar for patients with fewer than five lymph nodes and those with five or more lymph nodes, within all ICON-S stages. Our proposed ICON-S staging system for HPV+ oropharyngeal cancer is suitable for the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer TNM classification. Future work is needed to ascertain whether T and N categories should be further refined and whether non-anatomical factors might augment the full classification. None.

In the member countries of the Organization for Economic Co-operation and Development (OECD), overweight and obesity affect the majority of the population. The use of environmental chemicals, such as the plasticizer DEHP, has largely increased simultaneously with this development. DEHP is an \"obesogen\" that interferes with normal adipocyte differentiation and energy homeostasis. Obesity in turn is accompanied by chronic low-grade adipose tissue inflammation, leading to metabolic disorders such as type II diabetes. The main actors in adipose tissue inflammation are adipocytes and macrophages. However, the impact of DEHP on adipose tissue inflammation and the crosstalk between adipocytes and macrophages are unknown and the subjects of the current study. The influence of DEHP on inflammation was investigated in human Simpson–Golabi–Behmel syndrome (SGBS)-derived adipocytes and human THP-1 macrophages. The proinflammatory markers IL8, MCP1, IL1β, TNFα and others were measured (qRT-PCR, ELISA) in SGBS-derived adipocytes treated with DEHP [day 0 (d0)–d4; 50 µg/ml] and THP-1 macrophages cultured with conditioned medium (CM) from DEHP-treated adipocytes (SGBS-CM) (from d4 and d8). DEHP exposure led to a proinflammatory state in SGBS-derived adipocytes (e.g., increased secretion of IL8 and MCP1). Surprisingly, exposure of THP-1 macrophages to SGBS-CM did not show DEHP-induced effects. However, we demonstrated that medium containing (pre)adipocyte-secreted factors had a significant impact on the expression and secretion of macrophage and inflammatory markers in THP-1 macrophages in general and led to the significantly increased accumulation of intracellular lipid droplets.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for selenium. Systematic reviews of the literature were conducted to identify evidence regarding excess selenium intake and clinical effects and potential biomarkers of effect, risk of chronic diseases and impaired neuropsychological development in humans. Alopecia, as an early observable feature and a well‐established adverse effect of excess selenium exposure, is selected as the critical endpoint on which to base a UL for selenium. A lowest‐observed‐adverse‐effect‐level (LOAEL) of 330 μg/day is identified from a large randomised controlled trial in humans (the Selenium and Vitamin E Cancer Prevention Trial (SELECT)), to which an uncertainty factor of 1.3 is applied. A UL of 255 μg/day is established for adult men and women (including pregnant and lactating women). ULs for children are derived from the UL for adults using allometric scaling (body weight0.75). Based on available intake data, adult consumers are unlikely to exceed the UL, except for regular users of food supplements containing high daily doses of selenium or regular consumers of Brazil nuts. No risk has been reported with the current levels of selenium intake in European countries from food (excluding food supplements) in toddlers and children, and selenium intake arising from the natural content of foods does not raise reasons for concern. Selenium‐containing supplements in toddlers and children should be used with caution, based on individual needs.

Alexander Schramm, Johannes Schulte and colleagues characterize 16 paired samples from patients with neuroblastoma at diagnosis and relapse using whole-exome sequencing, mRNA expression profiling, array CGH and DNA methylation analysis. Their data show the frequency, identity and evolution of genetic alterations in neuroblastoma. Neuroblastoma is a malignancy of the developing sympathetic nervous system that is often lethal when relapse occurs. We here used whole-exome sequencing, mRNA expression profiling, array CGH and DNA methylation analysis to characterize 16 paired samples at diagnosis and relapse from individuals with neuroblastoma. The mutational burden significantly increased in relapsing tumors, accompanied by altered mutational signatures and reduced subclonal heterogeneity. Global allele frequencies at relapse indicated clonal mutation selection during disease progression. Promoter methylation patterns were consistent over disease course and were patient specific. Recurrent alterations at relapse included mutations in the putative CHD5 neuroblastoma tumor suppressor, chromosome 9p losses, DOCK8 mutations, inactivating mutations in PTPN14 and a relapse-specific activity pattern for the PTPN14 target YAP. Recurrent new mutations in HRAS , KRAS and genes mediating cell-cell interaction in 13 of 16 relapse tumors indicate disturbances in signaling pathways mediating mesenchymal transition. Our data shed light on genetic alteration frequency, identity and evolution in neuroblastoma.

Purpose The aims of this examination were to compare cancer patients’ fatigue burden with that of the general population, to identify clinical factors that are associated with fatigue, and to test psychometric properties of the fatigue questionnaire MFI-20 including the short-form MFI-10. Methods A sample of 1818 German cancer patients was tested with the MFI-20. Results The study confirmed that the cancer patients demonstrate a high level of burden from fatigue. The effect size for the comparison between the cancer patients and a sample of the general population ( n  = 1993) was d  = 0.58 based on MFI-20 total scores. In the cancer patients’ sample, females reported slightly higher levels of fatigue than males did ( p  < 0.05). There was no significant effect of age on fatigue. Advanced tumor stage, the presence of metastases, and a “poorer” Eastern Cooperative Oncology Group (ECOG) performance status were significantly associated with fatigue. The results of the confirmatory factor analyses (CFAs) only partly confirmed the factorial structure of the MFI-20. Conclusion Despite the insufficient CFA indices, we believe that the scale structure of the MFI-20 should not be changed and that calculating a total fatigue score is justifiable. For those seeking a shorter questionnaire, the MFI-10, which only contains those 10 items which positively indicate fatigue, is a good alternative.