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Background: Although current guidelines advocate early integration of palliative care, symptom burden and palliative care needs of patients at diagnosis of incurable cancer and along the disease trajectory are understudied. Material and Methods: We assessed distress, symptom burden, quality of life, and supportive care needs in patients with newly diagnosed incurable cancer in a prospective longitudinal observational multicenter study. Patients were evaluated using validated self‐report measures (National Comprehensive Cancer Network Distress Thermometer [DT], Functional Assessment of Cancer Therapy [FACT], Schedule for the Evaluation of Individual Quality of Life [SEIQoL‐Q], Patients Health Questionnaire‐4 [PHQ‐4], modified Supportive Care Needs Survey [SCNS‐SF‐34]) at baseline (T0) and at 3 (T1), 6 (T2), and 12 months (T3) follow‐up. Results: From October 2014 to October 2016, 500 patients (219 women, 281 men; mean age 64.2 years) were recruited at 20 study sites in Germany following diagnosis of incurable metastatic, locally advanced, or recurrent lung (217), gastrointestinal (156), head and neck (55), gynecological (57), and skin (15) cancer. Patients reported significant distress (DT score ≥ 5) after diagnosis, which significantly decreased over time (T0: 67.2%, T1: 51.7%, T2: 47.9%, T3: 48.7%). The spectrum of reported symptoms was broad, with considerable variety between and within the cancer groups. Anxiety and depressiveness were most prevalent early in the disease course (T0: 30.8%, T1: 20.1%, T2: 14.7%, T3: 16.9%). The number of patients reporting unmet supportive care needs decreased over time (T0: 71.8 %, T1: 61.6%, T2: 58.1%, T3: 55.3%). Conclusion: Our study confirms a variable and mostly high symptom burden at the time of diagnosis of incurable cancer, suggesting early screening by using standardized tools and underlining the usefulness of early palliative care. Implications for Practice: A better understanding of symptom burden and palliative care needs of patients with newly diagnosed incurable cancer may guide clinical practice and help to improve the quality of palliative care services. The results of this study provide important information for establishing palliative care programs and related guidelines. Distress, symptom burden, and the need for support vary and are often high at the time of diagnosis. These findings underscore the need for implementation of symptom screening as well as early palliative care services, starting at the time of diagnosis of incurable cancer and tailored according to patients' needs. Guidelines recommend early integration of palliative care in the treatment of patients with advanced cancer. This study assessed distress, symptom burden, quality of life, and supportive care needs in patients with newly diagnosed incurable cancer to facilitate future implementation of more effective palliative care services. [ABSTRACT FROM AUTHOR]

Study Question: What is willingness, preference and decision-making about planning for the possibility of needing multiple cycles of IVF/ICSI treatment among patients consulting for a first or repeat stimulated IVF/ICSI cycle?Summary Answer: The majority of patients seem to value the opportunity to plan for multiple cycles of treatment while acknowledging both possible challenges and benefits of doing so and decisions that might need to be made in advance.What Is Known Already: Patients have strong intentions to do treatment to achieve pregnancy and approximately 48-54% continue treatment when confronted with a failed cycle, undergoing at least three complete cycles of treatment. However, there is inconsistency between this apparent willingness to do multiple cycles of treatment and the way treatment is currently planned on a cycle-by-cycle basis with patients.Study Design, Size, Duration: The study was of cross-sectional design, comprising a mixed-methods English online survey posted between November 2019 and March 2020. Eligibility criteria were being a patient who had had a consultation to start a stimulated cycle of IVF/ICSI for the first time or for a repeat stimulated cycle after an unsuccessful cycle in the eight weeks prior to survey completion. Individuals were also required to be aged 18 or older (upper age limit of 42 years for women) and able to respond in English. In total 881 clicked on the survey link, 118 did not consent, 41 were excluded after data screening, 57 did not meet the inclusion criteria, 331 started the survey but did not complete it, 28 had missing data on critical variables (e.g., age) and 306 completed the survey (40.1% completion, 57 men, 249 women).Participants/materials, Setting, Methods: Participants were allocated to either the willing or unwilling to plan for multiple cycles of treatment group based on their responses to three variables: willingness to plan for three complete cycles, whether they would choose to have another cycle of IVF and whether they would continue treatment after an unsuccessful cycle. Quantitative questions gathered data on preferences towards planning for multiple cycles (i.e., attitudes, subjective norms and perceived behavioural control), challenges, benefits of planning for multiple cycles, decisional conflict experienced and treatment decisions involved in planning for multiple cycles. Demographic, fertility and fertility treatment information were also collected. Qualitative questions gathered textual data on other perceived benefits and challenges of planning for multiple cycles and solutions to the challenges. Descriptive and inferential statistics were used on quantitative data. Thematic analysis (inductive coding) was performed on the textual data.Main Results and the Role Of Chance: Overall, 73.2% (n = 224) of participants had had a consultation to start a first cycle of IVF/ICSI. Participants were on average 33 years of age and had been trying to conceive for three years. A total of 63.07% (n = 193) were university educated. A total of 56% (n = 172) of participants were willing to plan for multiple cycles of IVF/ICSI in advance of treatment. Repeated measures ANOVA, t-tests and chi-square analysis showed the willing group to be significantly more likely to have been in a relationship for longer (p<.05), have higher education (p<.05) and be resident in the United Kingdom (p<.05). The willing group had positive attitudes towards planning for multiple cycles (p<.001) and stronger agreement with subjective norms (p<.001), perceived behavioural control (p<.001), benefits of planning for multiple cycles (p<.01) and felt able and attached more importance to making treatment decisions in advance of treatment (p<.05). Data saturation was achieved for the thematic analysis of textual data which revealed a total of four other challenges (e.g., less decisional freedom) and six other benefits (e.g., having a realistic view of treatment) to planning for multiple cycles. Qualitative analysis also revealed that most patients could anticipate and provide solutions for the nine challenges of planning for multiple cycles (e.g., using flexible working for the negative effect of treatment on work).Limitations, Reasons For Caution: Limitations included the outcome measure being willingness to plan for multiple cycles rather than actual multi-cycle planning behaviour. The unwilling group represented a heterogeneous group with possibly unknown motivational coherence (e.g., definitely against planning, ambivalent about planning). Other limitations included the cross-sectional nature of the survey and the recruitment source.Wider Implications Of the Findings: Treatment consultations about undergoing fertility treatment could re-frame treatment to be a multi-cycle process in line with patient's willingness, preference and decision-making. This multi-cycle approach could empower patients and clinicians to discuss treatment expectations realistically and formulate fully informed treatment plans that take account of the high likelihood of cycle failure in addition to the treatment decisions that may need to be made during treatment when a cycle fails. This multi-cycle approach could help us support patients in adhering to their treatment plans even when faced with challenges, and help ascertain the level of treatment engagement possible to achieve parenthood goals.Study Funding/competing Interest(s): This project is funded by an Investigator-Sponsor Non-interventional Study from Merck Serono Ltd (MS200059_0010). Professor Boivin reports personal fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, Ferring Pharmaceuticals A/S, grant from Merck Serono Ltd, outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app. Dr. Gameiro reports consultancy fees from Ferring Pharmaceuticals A/S, Access Fertility and SONA-Pharm LLC, and grants from Merck Serono Ltd. Dr. Harrison declares no conflicts of interest.Trial Registration Number: n/a. [ABSTRACT FROM AUTHOR]

Background: For the European Prospective Investigation into Cancer and Nutrition (EPIC) study Germany, a self-administered food frequency questionnaire (FFQ) was developed and tested for its relative validity and reproducibility in 1991/1992. Study participants were 92 potential cohort members. This paper reports results regarding retinol, carotenoids, tocopherols and ascorbic acid.Methods: Study participants were invited to the study centre in Heidelberg once a month over one year. At each visit, a 24 hour recall was obtained. The FFQ was filled in twice with a 6-month interval (FFQ1, FFQ2). In addition, a questionnaire on general consumption frequencies of 14 broad food groups was completed. This information was combined with estimates derived from FFQ2 and frequency-corrected food and nutrient intakes were calculated (FFQcorr). Blood specimens were taken in winter and summer 1992.Results: The intraclass correlation of the FFQ ranged from 0.65 to 0.67 for retinol, tocopherols, carotenoids, and ascorbic acid. Intake of carotenoids by FFQcorr showed de-attenuated Pearson correlation coefficients with blood values in the order of 0.37, and with recall data of 0.44. Respective correlations for retinol were 0.21 and 0.29, for tocopherols 0.18 and 0.52, and for ascorbic acid 0.36 and 0.69. Errors of FFQcorr and 24-hour diet recalls were not correlated.Conclusions: In general, it was demonstrated that the FFQ was able to rank participants into biologically meaningful categories of intake or blood concentrations for carotenoids and ascorbic acid, but misclassification was higher for tocopherol and retinol. [ABSTRACT FROM AUTHOR]

Background: For use in the German part of the European Prospective Investigation into Cancer and Nutrition (EPIC) a self-administered, optically readable food frequency questionnaire (FFQ) was developed to assess individuals' usual food and nutrient intake over the past year. The food list comprised 158 food items for which the typical portion size, the consumption frequency (1-6 times) and the time period (day, week, month, or year) were requested. This paper reports the results of the reproducibility and relative validity of nutrient intakes obtained by this instrument.Methods: The study was carried out from October 1991 to October 1992. During this period, 104 men and women, aged 35-64 years, completed a 24-hour recall once a month, and the FFQ in the middle and at the end of this study. A short questionnaire on global consumption patterns was used to adjust the food consumption frequency given in the FFQ.Results: Reproducibility correlations varied from 0.59 for saturated fat to 0.88 for alcohol, with most values falling between 0.60 and 0.70. Energy-adjustment decreased the observed correlations for all nutrients. Correlations between nutrient intake values from the 12-day average of dietary recalls and the FFQ corrected for food consumption frequency ranged from 0.42 for polyunsaturated fat to 0.88 for alcohol, followed by 0.65 for dietary fibres. After de-attenuation and energy-adjustment the range of correlations was somewhat wider (0.43-0.75, without alcohol). With regard to classification, on average, 36% of subjects fell into the same quintile, and 75% into within-one quintile when classified by the frequency-corrected FFQ compared to the quintiles based on recalled data.Conclusions: In summary, the newly developed FFQ showed fairly good reproducibility and relative validity for most evaluated nutrients. The between-subject variation of nutrients in the German cohort (including the participants from East Germany) is likely to be greater than that among the subjects of the pilot phase. A revised version of the FFQ corrected for food consumption frequency is used in the EPIC study. [ABSTRACT FROM AUTHOR]

Study Question: Can the Endometriosis Fertility Index (EFI) be estimated accurately before surgery?Summary Answer: The EFI can be estimated accurately based on mere clinical/ultrasound information, with some improvement after adding data from diagnostic laparoscopy.What Is Known Already: The EFI is a validated clinical instrument predicting the probability of pregnancy after endometriosis surgery without the use of ART. Being an end-of-surgery-score, it implies the decision for operative laparoscopy to be made in advance-hence, its role in the pre-surgical decision-making process remains to be established.Study Design, Size, Duration: Single-cohort prospective observational study in 82 patients undergoing complete endometriosis excision (between June and December 2016). Two methods were used to estimate the final EFI: type A based on non-surgical clinical/ultrasound findings only, and type B based on the combination of non-surgical clinical/ultrasound findings and diagnostic laparoscopy data. To calculate EFI type A, an algorithm was created to translate non-surgical clinical/imaging information into rASRM (revised American Society of Reproductive Medicine)-and EFI points. EFI type A and type B estimates were assessed for their clinical and numerical agreement with the final EFI score. Agreement was defined as clinical if EFI scores were within the same range (0-4, 5-6, 7-10), and numerical if their difference was ≤1.Participants/materials, Setting, Methods: All 82 patients underwent complete laparoscopic CO2-laser excision of any rASRM stage of endometriosis in the Leuven University Fertility Centre (LUFC) of University Hospitals Leuven, a tertiary referral centre for both endometriosis and infertility. An anonymized clinical research file was created. For each patient, three different data sets were created, in order to allow the estimation of the (surgical part) EFI and of the rASRM scores, defined as follows: 'Estimated type A' contained only non-surgical clinical/imaging data, 'Estimated type B' included type A information plus the information of the diagnostic laparoscopy and 'Final EFI' included information of type A, type B and all intra-operative information required to calculate the final EFI. To calculate EFI type A without surgical information, a set of rules was used to translate pre-surgical clinical/imaging information into (rASRM and EFI points). Scoring was done by one person (C.T.), with a time interval of 4 weeks between sessions for each EFI type. Next to the EFI, also rASRM score and stage were calculated.Main Results and the Role Of Chance: Agreement rate between estimated EFI type A and final EFI was high for both the clinical (0.915; 95% CI 0.832-0.965) and numerical definition (0.878; 95% CI 0.787-0.940). Agreement rates between estimated EFI type B and final EFI were even higher (clinical (0.988; 95% CI 0.934-1.000), numerical (0.963; 95% CI 0.897-0.992)).Limitations, Reasons For Caution: Type A estimation is dependent on high-level gynaecological ultrasound expertise, which may not be available in all clinics. A small number of patients had no prior clinical, ultrasound (hard markers) or surgical confirmation of the diagnosis of endometriosis. When applying the estimated EFI type A in clinical practice, a priori assumptions of the presence or absence of endometriosis will need to be made in adjunct to the estimation of the estimated type A EFI when counselling patients on the potential benefit of an (at least diagnostic) laparoscopy. The level of agreement for type A or B should also be taken into account when counselling patients on the type of efforts undertaken to attempt to diagnose or rule out endometriosis.Wider Implications Of the Findings: As this study reports, the EFI can be estimated accurately based on clinical/ultrasound data only without the need for any surgical data. This means that the EFI could be used as an instrument to guide joint physician-patient decision-making between surgery, ART or other fertility management options for the individualized treatment of women with endometriosis-related infertility.Study Funding/competing Interest(s): During this study period, C.T. was supported by FWO (Research Fund Flanders, Grant number 1700816N) and UZ Leuven KOF (University Hospitals Leuven, Klinisch Onderzoeksfonds).The LUFC received unrestricted research grants from Ferring Pharmaceuticals and Merck SA. Gedeon Richter and MSD sponsored travel to and attendance at scientific meetings. C.M. received consultancy fees from Lumenis (paid to KU Leuven, no private revenue). T.D. has been vice-president and head of global medical affairs infertility for the multinational pharmaceutical company Merck (Darmstadt, Germany) since 1 October 2015. He continues his academic appointment on a part-time basis as Professor of Reproductive Medicine at the University of Leuven (KU Leuven). T.D. has been vice-president and head of global medical affairs infertility for the multinational pharmaceutical company Merck (Darmstadt, Germany) since October 2015. He is also a Guest Professor in Reproductive Medicine and Biology at the Department of Development and Regeneration, Group Biomedical Sciences, KU Leuven (University of Leuven), Belgium, and an Adjunct Professor at the Department of Obstetrics and Gynecology in the University of Yale, New Haven, USA. This work was initiated before he joined Merck KGaA in October 2015, and completed during the subsequent years.Trial Registration Number: study registration number at UZ Leuven Clinical Trial Centre: S59221. [ABSTRACT FROM AUTHOR]

Background: Estimating infectious disease parameters such as the serial interval (time between symptom onset in primary and secondary cases) and reproductive number (average number of secondary cases produced by a primary case) are important in understanding infectious disease dynamics. Many estimation methods require linking cases by direct transmission, a difficult task for most diseases.Methods: Using a subset of cases with detailed genetic and/or contact investigation data to develop a training set of probable transmission events, we build a model to estimate the relative transmission probability for all case-pairs from demographic, spatial and clinical data. Our method is based on naive Bayes, a machine learning classification algorithm which uses the observed frequencies in the training dataset to estimate the probability that a pair is linked given a set of covariates.Results: In simulations, we find that the probabilities estimated using genetic distance between cases to define training transmission events are able to distinguish between truly linked and unlinked pairs with high accuracy (area under the receiver operating curve value of 95%). Additionally, only a subset of the cases, 10-50% depending on sample size, need to have detailed genetic data for our method to perform well. We show how these probabilities can be used to estimate the average effective reproductive number and apply our method to a tuberculosis outbreak in Hamburg, Germany.Conclusions: Our method is a novel way to infer transmission dynamics in any dataset when only a subset of cases has rich contact investigation and/or genetic data. [ABSTRACT FROM AUTHOR]

Purpose: This article reports on the long‐term impact of radiotherapy adapted to stage, histology, and previous resection in a large cohort of patients with intestinal lymphoma (iL) treated with definitive or adjuvant curative‐intent radiation therapy (RT) ± chemotherapy (CHOP, MCP, or COP). Patients and Methods: In two consecutive prospective study designs, 134 patients with indolent (stage IE–IIE) or aggressive (stage IE–IVE) iL were referred to 61 radiotherapeutic institutions between 1992 and 2003. Patients with indolent iL received extended field (EF) 30 Gy (+10 Gy boost in definitive treatment); patients with aggressive iL received involved field (IF) (EF) 40 Gy by means of stage‐, histology‐, and operation‐adapted radiation fields. Results: The patients had median age 58 years and were predominantly male (2:1). Histology showed aggressive prevalence (1.6:1), stage IE–to–stage IIE ratio of iL 1.04:1, and localized stages–to–advanced stages ratio of aggressive lymphoma 23:1. Median follow‐up was in total 11.7 years: 10.0 years in the first study, GIT (GastroIntestinal‐Tract) 1992, and 11.8 years in the second study, GIT 1996. Lymphoma involvement was predominantly a single intestinal lesion (82.1%). Decrease of radiation field size from EF to IF in stage I aggressive iL from GIT 1992 to GIT 1996 resulted in a nonsignificant partial reduction of chronic toxicity while maintaining comparable survival rates (5‐year overall survival 87.9 vs. 86.7%, 10‐year overall survival 77.4 vs. 71.5%) with nonsignificant difference in event‐free survival (5‐year event‐free survival 82.6 vs. 86.7%, 10‐year event‐free survival 69.7 vs. 71.5%) and lymphoma‐specific survival (5‐year lymphoma‐specific survival 90.1 vs. 91.9%, 10‐year lymphoma‐specific survival 87.6% vs. 91.9%). Comparative dose calculation of two still available indolent duodenal lymphoma computed tomography scans revealed lower radiation exposure to normal tissues from applying current standard involved site RT (ISRT) 30 Gy in both cases. Conclusion: RT adapted to stage, histology, and resection in multimodal treatment of iL, despite partially decreasing field size (EF to IF), achieves excellent local tumor control and survival rates. The use of modern RT technique and target volume with ISRT offers the option of further reduction of normal tissue complication probability. Implications for Practice: Although patients with intestinal lymphoma (iL) are heterogeneous according to histology and subtype, they benefit from radiotherapy. Prospective study data from 134 patients with indolent iL (stage IE–IIE) or aggressive iL (stage IE–IVE) show 100% tumor control after definitive or adjuvant curative‐intent radiation therapy ± chemotherapy. Radiation treatment was applied between 1992 and 2003. Median follow‐up in total was 11.7 years. No radiotherapy‐associated death occurred. Relapse developed in 15.7% of the entire cohort; distant failure was more frequent than local (4:1). Normal tissue complication probability can be further improved using modern involved site radiation therapy techniques. This article reports the details of radiation therapy in the therapeutic multimodality approach for treatment of patients with intestinal lymphoma. [ABSTRACT FROM AUTHOR]

Background: Low response rates do not indicate poor representativeness of study populations if non-response occurs completely at random. A non-response analysis can help to investigate whether non-response is a potential source for bias within a study.Methods: A cross-sectional survey among a random sample of a health insurance population with diabetes (n = 3642, 58.9% male, mean age 65.7 years), assessing depression in diabetes, was conducted in 2013 in Germany. Health insurance data were available for responders and non-responders to assess non-response bias. The response rate was 51.1%. Odds ratios (ORs) for responses to the survey were calculated using logistic regression taking into consideration the depression diagnosis as well as age, sex, antihyperglycaemic medication, medication utilization, hospital admission and other comorbidities (from health insurance data).Results: Responders and non-responders did not differ in the depression diagnosis [OR 0.99, confidence interval (CI) 0.82-1.2]. Regardless of age and sex, treatment with insulin only (OR 1.73, CI 1.36-2.21), treatment with oral antihyperglycaemic drugs (OAD) only (OR 1.77, CI 1.49-2.09), treatment with both insulin and OAD (OR 1.91, CI 1.51-2.43) and higher general medication utilization (1.29, 1.10-1.51) were associated with responding to the survey.Conclusion: We found differences in age, sex, diabetes treatment and medication utilization between responders and non-responders, which might bias the results. However, responders and non-responders did not differ in their depression status, which is the focus of the DiaDec study. Our analysis may serve as an example for conducting non-response analyses using health insurance data. [ABSTRACT FROM AUTHOR]

Background: Key recommendations for the management of patients with polypharmacy are structured medication counselling (SMC), medication lists and systematic medication reviews.Objective: The aim of this study was to identify determinants (hindering and facilitating factors) for the implementation of the recommendations in general practice.Methods: This study was linked to a tailored intervention aimed at improving the implementation of the recommendations in German general practice. Interviews and focus groups with different healthcare professionals were carried out in the design phase and after delivery of the intervention. The material from both data collections was analysed separately in a content analytical approach resulting in two sets of categories. For this study, the subcategories of both sets were assigned to the Tailoring Interventions for Chronic Diseases (TICD) checklist, a comprehensive framework of determinants of practice.Results: Interviews with 24 general practitioners (GPs), 4 other medical specialists, 1 pharmacist, 3 nurses and 6 medical assistants as well as 2 mixed focus groups with 17 professionals were conducted. We identified 93 determinants: 29 referred to medication counselling, 21 to the use of medication lists, 20 to medications reviews and 23 to all recommendations. The determinants were related to all 7 main domains and to 25 of the 57 subdomains on the TICD checklist including guideline factors, patient factors, individual healthcare professional factors, social, political and legal factors, incentives and resources, and capacity for organizational change.Conclusion: While many interventions to improve polypharmacy focus on the provision of pharmacological knowledge, a much wider range of domains need to be addressed, such as communication skills, patient involvement and practice organization. [ABSTRACT FROM AUTHOR]

Aims: The early repolarization pattern (ERP) has been shown to be associated with arrhythmias in patients with short QT syndrome, Brugada syndrome, and ischaemic heart disease. Catecholaminergic polymorphic ventricular tachycardia (CPVT) is an inherited arrhythmia syndrome and related to malignant ventricular tachyarrhythmias in a structurally normal heart. The aim of this study was to evaluate the prevalence of ERP and clinical events in patients with CPVT.Methods and Results: Digitalized resting 12-lead ECGs of patients were analysed for ERP and for repolarization markers (QT and Tpeak-Tend interval). The ERP was diagnosed as 'notching' or 'slurring' at the terminal portion of QRS with ≥0.1 mV elevation in at least two consecutive inferior (II, III, aVF) and/or lateral leads (V4-V6, I, aVL). Among 51 CPVT patients (mean age 36 ± 15 years, 11 males), the ERP was present in 23 (45%): strictly in the inferior leads in 9 (18%) patients, in the lateral leads in 9 (18%) patients, and in infero-lateral leads in 5 (10%) patients. All patients with ERP were symptomatic at presentation (23 of 23 patients with ERP vs. 19 of 28 patients without ERP, P = 0.003). Syncope was also more frequent in patients with ERP (18 of 23 patients with ERP vs. 11 of 28 patients without ERP, P = 0.005).Conclusion: A pathologic ERP is present in an unexpected large proportion (45%) of patients and is associated with an increased frequency of syncope. In patients with unexplained syncope and ERP at baseline, exercise testing should be performed to detect CPVT. [ABSTRACT FROM AUTHOR]

Background. International associations admit that specialized palliative care (SPC) is an obvious component of excellent cancer care. Nevertheless, gaps in integration at the international level have been identified. Recommendations for integrating SPC in clinical care, research, and education are needed, which are subject of the present study. Materials and Methods. A Delphi study, with three written Delphi rounds, including a face-to-face-meeting with a multi-professional expert panel (n = 52) working in SPC in 15 German Comprehensive Cancer Centers (CCCs) funded by the German Cancer Aid was initiated. Initial recommendations are built on evidence-based literature. Consensus was defined in advance with ≥80% agreement based on the question of whether each recommendation was unambiguously formulated, relevant, and realizable for a CCC. Results. A total of 38 experts (73.1%) from 15 CCCs performed all three Delphi rounds. Consensus was achieved for 29 of 30 recommendations. High agreement related to having an organizationally and spatially independent palliative care unit (≥6 beds), a mobile multiprofessional SPC team, and cooperation with community-based SPC. Until round 3, an ongoing discussion was registered on hospice volunteers, a chair of palliative care, education in SPC among staff in emergency departments, and integration of SPC in decision-making processes such as tumor boards or consultation hours. Integration of SPC in decision-making processes was not consented by a low-rated feasibility (76.3%) due to staff shortage. Conclusion. Recommendations should be considered when developing standards for cancer center of excellence in Germany. Definition and implementation of indicators of integration of SPC in CCCs and evaluation of its effectiveness are current and future challenges. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the tolerability, effectiveness and utilization of tocilizumab for the treatment of RA in a usual care setting. Methods. ROUTINE was a prospective, non-interventional, observational 52-week study performed at 174 sites throughout Germany. RA patients were selected and treated according to label. Study objectives included the targeted documentation of infections, other adverse events, and various effectiveness out-comes (e.g. DAS28, clinical disease activity). Statistical analyses were performed primarily based on the data as observed. Results. A total of 850 patients (75% women, mean age: 56 ±13 years, mean RA duration: 10.3 ±8.6 years) were enrolled. Most patients (79%) were pretreated with TNF-inhibitors, whereas 21% were pre-treated with conventional DMARDs only. Most common DMARD pretreatments were MTX (79%), LEF (68%), adalimumab (53%) and etanercept (50%). At baseline, 60.5% of patients received tocilizumab in combination with any other RA drugs, while 39.5% were treated in monotherapy. Mean baseline DAS28 was 5.5 ±1.3, and this decreased to 2.6 ±1.6 at week 52. At week 52, good EULAR response was achieved in 62.3%, low disease activity state in 66.4%, and DAS28 remission in 55.1 % of patients (ad-justed relative frequencies). 35.3% of patients discontinued the study prematurely; common reasons were lack of effectiveness (10.5%) and intolerability (7.3%). Any infections and severe infections occurred in 37.6% and 7.2% of patients, respectively (N = 836); serious infections were seen in 5.3% (N = 850). Event rates of any, severe and serious infections were 70.3, 9.8 and 4.4 events/100 patient-years, respectively. Conclusion. Tocilizumab administered in a real-life setting showed clinically meaningful improvements and a safety profile that was consistent with data reported from pre-approval Phase III studies. [ABSTRACT FROM AUTHOR]