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Background: Men make use of outpatient cancer counseling less commonly than women, even when they stand to benefit from it. Method: In a cluster-randomized trial (registered under DRKS00032181), we studied whether measures on multiple levels (information for referring physicians, public information, structural changes, offerings specifically for male patients) over a period of 12 months would be able to increase the percentage of men among patients seeking outpatient cancer counseling (primary endpoint, initial contact; secondary endpoint, all contacts). The intervention effect was quantified by the fitting of generalized linear mixed models to obtain an odds ratio, which was adjusted for cluster structure and for the percentages of first contacts and of all contacts during the 12 months before the start of the intervention. Results: In 12 regions of Germany (6 each in the intervention arm and the control arm), 11986 people had first contacts with outpatient cancer counseling, 6004 of them during the intervention phase. The percentage accounted for by men was 30.7% in the intervention arm and 25.7% in the control arm, corresponding to a statistically insignificant model-based adjusted odds ratio (OR) of 1.2 (95% confidence interval [1.0; 1.4], p =0.08) for the primary endpoint. There were a total of 51842 counseling sessions (both initial contacts and subsequent contacts), 26 651 of them in the intervention phase. The percentage of these that was accounted for by men was 27.6% in the intervention arm and 22.2% in the control arm; the adjusted OR for this secondary endpoint was 1.3 [1.1; 1.6], p =0.01). Conclusion: The targeted implementation of male-specific measures on multiple levels can increase, by a small amount, the percentage of men among persons seeking outpatient cancer counseling. [ABSTRACT FROM AUTHOR]

This work presents the materials selection process, the design and the dimensioning process of a latent heat storage tank that works between a high temperature heat pump and an Organic Rankine Cycle unit. The selected heat storage material is the S117 Phase Change Material that has a melting point at 117°C matches the operational temperature of the system at approximately 120°C. The tank configuration is selected for optimised heat transfer process, resulted from practical experience of the project partners and it is described in details in the document. The simulation results from the Computational Fluid Dynamic study of the tank are also presented here. This work should be useful for engineers designing compact heat storage tanks for medium temperature applications. [ABSTRACT FROM AUTHOR]

BACKGROUND/OBJECTIVES: Healthy eating behaviours, such as increasing fruit and vegetable consumption (FVC), are frequently used as a target or outcome measure in obesity prevention interventions. The goal of this study was to demonstrate replacement of high-caloric foods/drinks by FVC and changes in body mass index (BMI) z-score associated with FVC. SUBJECTS/METHODS: Anthropometric measurements of 1252 children (51.0% girls) were taken before school entrance (age 6 years) and repeated in the fourth grade (age 10 years). At the same time, parents were asked about their children's diet using a questionnaire. RESULTS: In longitudinal analysis, changes in FVC were not significantly correlated with changes of other nutritional habits, such as consumption of sweets and high-caloric drinks. BMI gain tended to be lower (nonsignificant) in children with increasing fruit consumption compared to those with decreasing fruit consumption. An opposite (nonsignificant) tendency was observed for vegetable consumption and BMI gain. CONCLUSIONS: Although beneficial for other health outcomes, the evidence for FVC replacing high-energy foods and thereby reducing BMI gain is weak and could not be substantiated in this study. This might be partially due to the limitation in dietary assessment. European Journal of Clinical Nutrition (2014) 68, 265-270; doi: 10.1038/ejcn.2013.139; published online 7 August 2013 Keywords: fruit; vegetable; diet; BMI; obesity; intervention; outcome; replacement; substitution; children, INTRODUCTION The World Health Organization (WHO) recommends high fruit and vegetable consumption (FVC). (1) Fruits and vegetables have high contents of vitamins, fibre and phytochemicals for which there is biological [...]

A liquid chromatographic-tandem mass spectrometric (LC-MS/MS) multi-residue method has been used for the simultaneous quantification and identification of 9 residues and metabolites of benzimidazole derivatives that the most widely used as anthelmintic veterinary drugs of animals. The modified QuEChERS method was used for sample preparation, which was initially developed for pesticide residue analysis. This paper highlights how quick, easy, cheap, effective and rugged the QuEChERS extraction method is. The method was successfully validated according to the 2002/657/EC guidelines. Recovery of analytes was in the range 99 - 110 %. The decission limits (CCα) were calculated at MRL level for analytes with an established permitted limit as next: 104.5 μg kg-1 (albendazole), 53.2 μg kg-1 (fenbendazole), 54.2 μg kg-1 (flubendazole), 12.1 μg kg-1 (levamisole), 53.9 μg kg-1 (cambendazole), 64.2 μg kg-1 (mebendazole), 52.5 μg kg-1 (parabendazole), 105.8 μg kg-1 (thiabendazole), 234.2 μg kg-1 (triclobendazole). The suitability of the assay has been assessed through InterVal Software by quo data GmbH (Germany). The method achieves high quality of the results, good recovery, repeatabilities, within-lab reproducibilities, and wide analytical scope and has practical benefits, low cost, high sample throughput, little labor used and few lab ware. [ABSTRACT FROM AUTHOR]

Introduction: Acute mesenteric ischemia is a rare but often fatal complication following cardiovascular surgery. Early suspicion may reduce overall mortality. This retrospective study aims to identify predictors and risk factors that may determine the onset and evolution of acute mesenteric ischemia.Methods: In a retrospective case-control study, we compared co-morbidities and peri-operative risk factors of patients with or without mesenteric ischemia following cardiac surgery using univariate and logistic regression analyses.Results: Of 9385 patients, 108 (1.15%) were diagnosed with acute mesenteric ischemia within two weeks after cardiac surgery. In-hospital mortality was 68% for this group. Patients with ischemia and controls were matched in regard to patient's age and type of surgical intervention and showed similar pre-operative parameters. Only liver cirrhosis (OR 13.3, CI95% 3.6-49.3), and emergency operation (OR 2.6, CI95% 1.3-5.2) remained independent pre-operative predictors for acute mesenteric ischemia in multivariate analysis. In contrast, early postoperative parameters revealed a higher correlation with the occurrence of mesenteric ischemia including the use of norepinephrine (OR 3.5 CI95% 1.6-7.8), epinephrine (OR 2.0, CI95% 1.1-3.7), and serum lactate levels >3 mmol/L (OR 2.9, CI95% 1.5-5.6). A set of key markers of regression analysis was evaluated in a ROC curve analysis. The area under curve was 0.835, which indicates moderate to good prognostic accuracy.Conclusion: Early identification of pre- and post-operative predictors including liver cirrhosis, emergency operation, serum lactate >3 mmol/L, and the use of norepinephrine and epinephrine may help facilitate early diagnosis of acute mesenteric ischemia following cardiac surgery, and thus may allow immediate adequate treatment, leading to a reduction in mortality rates. [ABSTRACT FROM AUTHOR]

Objective: To (i) validate a recently proposed questionnaire tool for the simple assessment of physical activity (PA) in pre-school children by comparison with accelerometry and heart-rate recordings; and (ii) extend the tool by adding more questions to improve validity and to refine the classification from two to three categories (PA low, medium, high).Setting: Baseline data of an intervention evaluation study.Subjects: Pre-school children.Design: Children were categorized as either physically active or non-active, based on their parents' answers to the five-item questionnaire. Activity and heart rate were recorded for 6 d (Actiheart device; CamNtech, Cambridge, UK). Nightly sleeping periods were removed and mean accelerometry counts (MACT), time spent in moderate-to-vigorous intensity physical activity (MVPA) and time spent in sedentary behaviour (SB) were computed. In a second step, additional questions that improved validity were added, resulting in an extended seven-item questionnaire.Results: For 748 (90·4 %) of the participating children aged 2·3-6·7 years, the questionnaires were filled out sufficiently for classification. Children classified as physically active showed 9·6 % higher MACT (P < 0·0003), spent more time in MVPA and insignificantly less time in SB. Using the extended questionnaire, children with PA classified as medium (reference: low) showed 11·0 % more MACT, spent 11·8 % more time in MVPA and 4·8 % less time in SB. Children with PA classified as high showed 16·9 % more MACT, spent 20·2 % more time in MVPA and 7·2 % less time in SB.Conclusions: With validated PA questionnaires for pre-school children lacking, the proposed questionnaire might be a reasonable option to include for PA assessment in epidemiological studies where more elaborate measurements are unavailable. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess shock reversal and required fluid volumes in patients with septic shock. DESIGN: Prospective before and after study comparing three different treatment periods. SETTING: Fifty-bed single-center surgical intensive care unit. PATIENTS: Consecutive patients with severe sepsis. INTERVENTIONS: Fluid therapy directed at preset hemodynamic goals with hydroxyethyl starch (predominantly 6% hydroxyethyl starch 130/0.4) in the first period, 4% gelatin in the second period, and only crystalloids in the third period. MEASUREMENTS AND MAIN RESULTS: Main outcome was time to shock reversal (serum lactate <2.2 mmol/L and discontinuation of vasopressor use). Hemodynamic goals were mean arterial pressure >70 mm Hg; ScvO2 <70%; central venous pressure >8 mm Hg. Safety outcomes were acute kidney injury defined by Risk, Injury, Failure, Loss, and End-stage kidney disease criteria and new need for renal replacement therapy. Hemodynamic measures, serum lactate, and creatinine were comparable at baseline in all study periods (hydroxyethyl starch n = 360, gelatin n = 352, only crystalloids n = 334). Severity scores, hospital length of stay, and intensive care unit or hospital mortality did not differ significantly among groups. All groups showed similar time to shock reversal. More fluid was needed over the first 4 days in the crystalloid group (fluid ratios 1.4:1 [crystalloids to hydroxyethyl starch] and 1.1:1 [crystalloids to gelatin]). After day 5, fluid balance was more negative in the crystalloid group. Hydroxyethyl starch and gelatin were independent risk factors for acute kidney injury (odds ratio, 95% confidence interval 2.55, 1.76-3.69 and 1.85, 1.31-2.62, respectively). Patients receiving synthetic colloids received significantly more allogeneic blood products. CONCLUSIONS: Shock reversal was achieved equally fast with synthetic colloids or crystalloids. Use of colloids resulted in only marginally lower required volumes of resuscitation fluid. Both low molecular weight hydroxyethyl starch and gelatin may impair renal function. [ABSTRACT FROM AUTHOR]

Unlabelled: Sleep duration has been identified as risk factor for obesity already in children. Besides investigating the role of fat mass (FM), this study addressed the question whether endocrine mechanisms act as intermediates in the association between sleep duration and overweight/obesity. Within the framework of the IDEFICS study, the present research was conducted in 609 German resident children aged 2-9 years with information on fasting insulin, C-reactive protein and cortisol levels next to anthropometric measurements and parental questionnaires. Emphasising methodological aspects, an age-specific measure of sleep duration was derived to account for alteration in sleep duration during childhood/period of growth. Multivariate linear regression and quantile regression models confirmed an inverse relationship between sleep duration and measures of overweight/obesity. The estimate for the association of sleep duration and body mass index (BMI) was approximately halved after adjustment for FM, but remained significant. The strength of this association was also markedly attenuated when adjusting for insulin mainly for the upper BMI quantiles (Q80, β = -0.36 vs. β = -0.26; Q95, β = -0.87 vs. β = -0.47). Adjustment for cortisol and CrP did not yield this attenuation.Conclusion: The inverse relationship between sleep duration and BMI is mainly explained by the association between sleep duration and FM. Insulin may explain part of this association, in particular at the upper tail of the BMI distribution. [ABSTRACT FROM AUTHOR]

Background Our purpose was to evaluate and compare the accuracy of the "Sequential Organ Failure Assessment" score (SOFA) and the "Cardiac Surgery Score" (CASUS) for the prediction of mortality after cardiac surgery. Methods Between January 1, 2007 and December 31, 2008 we prospectively included all consecutive adult patients admitted to our intensive care unit (ICU) after cardiac surgery. Both scoring systems were calculated daily from the 1st day in the ICU (day of operation) until the 7th ICU day. We evaluated the ICU mortality prediction of both models using calibration and discrimination statistics. Results 2801 patients (29.6% females) were included. Mean age was 66.9 ± 10.7 years. Intensive care unit mortality was 5.2%. The calibration of the "Sequential Organ Failure Assessment Score" and "Cardiac Surgery Score" was reliable for all days (p ≥ 0.05). CASUS was more accurate in predicting survival and mortality compared to SOFA for all days, as evidenced by the larger areas under the Receiver Operating Characteristic curves. Conclusions Both CASUS and SOFA are reliablemortality prediction tools after cardiac surgery. However, CASUS was more accurate in predicting the individual patient's risk of mortality. Thus, use of the CASUS in cardiac surgery intensive care units is recommended. [ABSTRACT FROM AUTHOR]

Analysis of 207 cases of subclavian steal syndrome- described in the literature shows 45 per cent cerebral symptoms only, 40 per cent cerebral and arm symptoms, 10 per cent arm symptoms only, and 6 per cent no symptoms at all. Most frequent cerebral symptoms are attacks of vertigo, headaches, disturbances of vision and short-lasting unconsciousness and these brachialic symptoms: paresthesias, a permanent weakness and feeling of coldness. Often, the symptoms appear in form of attacks and are mostly short-lived. Some of the cases could be induced or worsened through physical work, especially when performed with the affected arm. [ABSTRACT FROM AUTHOR]

Monastic vows have been a source of religious controversy at least since the Reformation. Today, new monastic movements recover many elements of the tradition (e.g., community life and prayer, material solidarity and poverty), but vows—understood as a lifelong or binding commitment to obedience, stability and conversion to the monastic way of life—do not appear to capture much enthusiasm. Even the Benedictine tradition in the Catholic Church appears, at least in certain regions, to struggle to attract young men and women to give themselves away through vows. In this context, I ask whether vows should belong to the "future of Christian monasticisms". I will look at Anselm of Canterbury for inspiration regarding their meaning. For him, monastic vows enact the "total" gift of self or the "total" belonging to God. I will suggest, following Anselm, that such vows enable an existential commitment that is in a unique way morally and intellectually enlivening, and that such vows should remain an element in any future monasticism wanting to stand in continuity with the "Christian monasticism" of the past. During my conclusion, I acknowledge that our imagination regarding the concrete forms the total gift could take may develop. [ABSTRACT FROM AUTHOR]

Abstract Background The original Logistic Organ Dysfunction Sore (LODS) excluded cardiac surgerypatients from its target population, and the suitability of this score in cardiac surgery patients has never been tested. We evaluated the accuracy of the LODS and the usefulness of its daily measurement in cardiac surgery patients. The LODS is not a true logistic scoring system, since it does not use β-coefficients. Methods This prospective study included all consecutive adult patients who were admitted tothe intensive care unit (ICU) after cardiac surgery between January 2007 and December 2008. The LODS was calculated daily from the first until the seventh postoperative day. Performance was assessed with Hosmer-Lemeshow (HL) goodness-of-fit test (calibration) and receiver operating characteristic (ROC) curves (discrimination) from ICU admission day until day 7. The outcome measure was ICU mortality. Results A total of 2801 patients (29.6% female) with a mean age of 66.4 ± 10.7 years wereincluded. The ICU mortality rate was 5.2% (n = 147). The mean stay on the ICU was 4.3 ± 6.8 days. Calibration of the LODS was good with no significant difference between expected and observed mortality rates on any day (p ≥ 0.05). The initial LODS had an area under the ROC curve (AUC) of 0.81. The AUC was best on ICU day 3 with a value of 0.93, and declined to 0.85 on ICU day 7. Conclusions Although the LODS has not previously been validated for cardiac surgerypatients it showed reasonable accuracy in prediction of ICU mortality in patients after cardiac surgery.

Abstract Background Outcome prediction scoring systems are increasingly used in intensive care medicine, but most were not developed for use in cardiac surgery patients. We compared the performance of four intensive care outcome prediction scoring systems (Acute Physiology and Chronic Health Evaluation II [APACHE II], Simplified Acute Physiology Score II [SAPS II], Sequential Organ Failure Assessment [SOFA], and Cardiac Surgery Score [CASUS]) in patients after open heart surgery. Methods We prospectively included all consecutive adult patients who underwent open heart surgery and were admitted to the intensive care unit (ICU) between January 1st 2007 and December 31st 2008. Scores were calculated daily from ICU admission until discharge. The outcome measure was ICU mortality. The performance of the four scores was assessed by calibration and discrimination statistics. Derived variables (Mean- and Max- scores) were also evaluated. Results During the study period, 2801 patients (29.6% female) were included. Mean age was 66.9 ± 10.7 years and the ICU mortality rate was 5.2%. Calibration tests for SOFA and CASUS were reliable throughout (p-value not < 0.05), but there were significant differences between predicted and observed outcome for SAPS II (days 1, 2, 3 and 5) and APACHE II (days 2 and 3). CASUS, and its mean- and maximum-derivatives, discriminated better between survivors and non-survivors than the other scores throughout the study (area under curve ≥ 0.90). In order of best discrimination, CASUS was followed by SOFA, then SAPS II, and finally APACHE II. SAPS II and APACHE II derivatives had discrimination results that were superior to those of the SOFA derivatives. Conclusions CASUS and SOFA are reliable ICU mortality risk stratification models for cardiac surgery patients. SAPS II and APACHE II did not perform well in terms of calibration and discrimination statistics.

Abstract Background Vertigo and dizziness are symptoms which are reported frequently in clinical practice. We aimed to develop diagnostic indices for four prevalent vertiginous diseases: benign paroxysmal positional vertigo (BPPV), Menière's disease (MD), vestibular migraine (VM), and phobic postural vertigo (PPV). Methods Based on a detailed questionnaire handed out to consecutive patients presenting for the first time in our dizziness clinic we preselected a set of seven questions with desirable diagnostic properties when compared with the final diagnosis after medical workup. Using exact logistic regression analysis diagnostic scores, each comprising of four to six items that can simply be added up, were built for each of the four diagnoses. Results Of 193 patients 131 questionnaires were left after excluding those with missing consent or data. Applying the suggested cut-off points, sensitivity and specificity were 87.5 and 93.5% for BPPV, 100 and 87.4% for MD, 92.3 and 83.7% for VM, 73.7 and 84.1% for PPV, respectively. By changing the cut-off points sensitivity and specificity can be adjusted to meet diagnostic needs. Conclusions The diagnostic indices showed promising diagnostic properties. Once further validated, they could provide an ease to use and yet flexible tool for screening vertigo in clinical practice and epidemiological research.

Abstract Background Co-morbidities of vertiginous diseases have so far not been investigated systematically. Thus, it is still unclear whether the different vertigo syndromes (e.g. benign paroxysmal positional vertigo (BPPV), Meniere's disease (MD), vestibular migraine and phobic vertigo (PPV)) have also different spectrums of co-morbidities. Methods All patients from a cohort of 131 participants were surveyed using a standardised questionnaire about the co-morbidities hypertension, diabetes mellitus, BMI (body mass index), migraine, other headache, and psychiatric diseases in general and the likelihood of a depression in particular. Results We noted hypertension in 29.0% of the cohort, diabetes mellitus in 6.1%, migraine in 8.4%, other headache in 32.1%, psychiatric diseases in 16.0%, overweight and obesity in 33.6% and 13.7% respectively, as well as a clinical indication for depression in 15.9%. Conclusion In general, we did not detect an increased prevalence of the co-morbidities diabetes mellitus, arterial hypertension, migraine, other headache and obesity compared to the general population. There was an increased prevalence of psychiatric co-morbidity in patients with PPV, and the prevalence of hypertension was elevated in patients with MD.

Monastic vows have been a source of religious controversy at least since the Reformation. Today, new monastic movements recover many elements of the tradition (e.g., community life and prayer, material solidarity and poverty), but vows—understood as a lifelong or binding commitment to obedience, stability and conversion to the monastic way of life—do not appear to capture much enthusiasm. Even the Benedictine tradition in the Catholic Church appears, at least in certain regions, to struggle to attract young men and women to give themselves away through vows. In this context, I ask whether vows should belong to the “future of Christian monasticisms”. I will look at Anselm of Canterbury for inspiration regarding their meaning. For him, monastic vows enact the “total” gift of self or the “total” belonging to God. I will suggest, following Anselm, that such vows enable an existential commitment that is in a unique way morally and intellectually enlivening, and that such vows should remain an element in any future monasticism wanting to stand in continuity with the “Christian monasticism” of the past. During my conclusion, I acknowledge that our imagination regarding the concrete forms the total gift could take may develop.

Importance: Questions remain concerning treatment efficacy for the common condition of benign paroxysmal positional vertigo (BPPV)., Objective: To compare the effectiveness of the Semont-plus maneuver (SM-plus) and the Epley maneuver (EM) for treatment of posterior canal benign paroxysmal positional vertigo (pcBPPV) canalolithiasis., Design, Setting, and Participants: This prospective randomized clinical trial was performed at 3 national referral centers (in Munich, Germany; Siena, Italy; and Bruges, Belgium) over 2 years, with a follow-up to 4 weeks after the initial examination. Recruitment took place from June 1, 2020, until March 10, 2022. Patients were selected randomly during routine outpatient care after being referred to 1 of the 3 centers. Two hundred fifty-three patients were assessed for eligibility. After consideration of the exclusion criteria as well as informed consent, 56 patients were excluded and 2 declined to participate, with 195 participants included in the final analysis. The analysis was prespecified and per-protocol., Interventions: After being randomized to the SM-plus or the EM group, patients received 1 initial maneuver from a physician, then subsequently performed self-maneuvers at home 3 times in the morning, 3 times at noon, and 3 times in the evening., Main Outcome and Measures: Patients had to document whether they could provoke positional vertigo every morning. The primary end point was the number of days until no positional vertigo could be induced on 3 consecutive mornings. The secondary end point was the effect of the single maneuver performed by the physician., Results: Of the 195 participants included in the analysis, the mean (SD) age was 62.6 (13.9) years, and 125 (64.1%) were women. The mean (SD) time until no positional vertigo attacks could be induced in the SM-plus group was 2.0 (1.6) days (median, 1 [range, 1-8] day; 95% CI, 1.64-2.28 days); in the EM group, 3.3 (3.6) days (median, 2 [range, 1-20] days; 95% CI, 2.62-4.06 days) (P = .01; α = .05, 2-tailed Mann-Whitney test). For the secondary end point (effect of a single maneuver), no significant difference was detected (67 of 98 [68.4%] vs 61 of 97 [62.9%]; P = .42; α = .05). No serious adverse event was detected with both maneuvers. Nineteen patients (19.6%) in the EM group and 24 (24.5%) in the SM-plus group experienced relevant nausea., Conclusions and Relevance: The SM-plus self-maneuver is superior to the EM self-maneuver in terms of the number of days until recovery in pcBPPV., Trial Registration: ClinicalTrials.gov Identifier: NCT05853328.

Purpose: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting., Methods: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach's α, and intra-class correlation coefficient)., Results: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68-0.92) and test-retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items., Conclusion: The Oslo COVID-19 QLQ-W61© is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed., (© 2022. The Author(s).)

Purpose: We conducted an international survey of bereaved relatives of cancer patients dying in hospitals in seven countries, with the aim to assess and improve the quality of care. The survey used the i-CODE (International Care of the Dying Evaluation) questionnaire. Here, we report findings from the free-text comments submitted with the questionnaires. We explored for topic areas which would potentially be important for improving the quality of care. Further, we examined who reported free-texts and in what way, to reduce bias without ignoring the function the free-texts may have for those contributing., Methods: We used a combined qualitative-quantitative approach: logistic regression analysis to study the effect of respondents' socio-demographic characteristics on the probability of free-texts contributions and thematic analysis to understand the free-text meaning. The primary survey outcomes, (1) how frequently the dying person was treated with dignity and respect and (2) support for the relative, were related to free-text content., Results: In total, 914 questionnaires were submitted; 457/914 (50%) contained free-text comments. We found no socio-demographic differences between the respondents providing free-texts and those who did not. We discovered different types of free-texts ("feedback," "narrative," "self-revelation") containing themes of which "continuity of care," "the one person who can make a difference," and "the importance of being a companion to the dying" represent care dimensions supplementing the questionnaire items. A free-text type of grateful feedback was associated with well perceived support for the relative., Conclusion: Bereaved relatives used the free-texts to report details related to i-CODE items and to dimensions otherwise not represented. They highlighted the importance of the perceived support from human interaction between staff and the dying patient and themselves; and that more than professional competence alone, personal, meaningful interactions have profound importance., (© 2022. The Author(s).)

Objective: We aimed at investigating the predictors of linguistic barriers among office-based haemato-oncologists during consultation with migrant cancer patients in Germany., Methods: Physicians from haemato-oncological practices were invited to participate in a cross-sectional study. Linguistic barriers and family factors were ascertained using a newly developed online-questionnaire with the scales "Overall linguistic barriers", "Self-perceived linguistic barriers" and "Family factors - antagonistic behaviour". Predictors of linguistic barriers were identified using multivariate ANOVA via step-wise backwards selection., Results: Fifty-five physicians participated in the study. Treating patients from Sub-Saharan Africa predicted higher overall and self-perceived linguistic barriers (F [2,46] = 4.51, p = .04; and F [3,45] = 5.44, p = .02, respectively). Working in an single practice (F [3,45] = 4.19; p = .05) predicted higher self-perceived linguistic barriers. Employees who could act as translators predicted lower barriers in form of antagonistic behaviour from relatives (F [2,48] = 6.12; p = .02)., Conclusions: The results indicate that linguistic barriers are affected by the level of linguistic concordance between patients and medical personnel. A temporary solution might be the presence of linguistically competent personnel in the practice. However, the results of this study highlight the need for greater availability of linguistic competent translators for consultations in haemato-oncological practices., (© 2022. The Author(s).)

Objective: This study aims to identify pathways patients and their relatives take to outpatient psychosocial cancer counselling centres. We had a special interest in how access for men can be eased., Methods: Cancer patients and relatives were purposively sampled in two regions in Germany. Participants were either outpatient cancer counselling centres (OCCCs) users or non-users and participated in qualitative face-to-face interviews. We used different guidelines for users and non-users. The interviews were analysed using content analysis., Results: One hundred and three people participated in the study. Important pathways to outpatient psychosocial cancer counselling centres for both men and women were: information about the service and its content, easy access (obtaining appointments quickly and without bureaucracy, close to home), and recommendations from another person, in particular from their treating physician. Pathways especially important for men are positive and repeated recommendations from their treating physician and other people they trust, organisation by others on the men's behalf, the Internet, the possibility to talk to a male counsellor, making it a routine in the hospital to refer distressed patients to the counselling services, and the emphasis on information sharing. Women reported more often than men that they discovered and accessed OCCCs via information material., Conclusions: Men in particular need recommendations from others, especially from their treating physician, in order to make use of psychosocial cancer counselling. In addition, stressing the provision of information instead of exploring and expressing emotions can ease access for men to cancer counselling., (© 2022 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.)

Introduction: Montelukast-induced neuropsychiatric adverse drug reactions (ADRs) have been reported in retrospective studies. This study aimed to reveal the neuropsychiatric ADRs triggered in patients taking montelukast due to asthma in real time, and to evaluate the effect of these ADRs on quality of life (QoL)., Methods: Patients, ages 3-18 years, taking montelukast for the first time and their parents were included. Ages 3-7 years were defined as the preschool and ages 8-18 years as the school-age group. At the beginning of the study and at the end of the second week of treatment, the neuropsychiatric complaint assessment questionnaire and the KINDL QoL scale were administered to patients and their parents. The effect of ADRs on the decrease in QoL was evaluated by multivariable logistic regression., Results: Neuropsychiatric ADRs were reported in 78 (62.4%) of 125 patients, who recovered when the drug was discontinued. Temperamental behavior, nightmares and sleep disorders occurred significantly more often in both groups compared with pretreatment ( p  < 0.001 for each). In both groups, except in the child-reported family relationships subscale in the school-age group, significant decreases were found in both child and parent proxy-reported QoL total/sub-scores compared with pretreatment ( p ˂0.001 for each). It was found in the evaluation that the overall QoL of those experiencing ADRs in both age groups was more affected. (Child-reported QoL OR preschool age =2.66, p  = 0.048; OR school-age =5.95, p  = 0.027; parent-proxy QoL OR preschool age =3.52, p  = 0.010, OR school-age =6.43, p  = 0.027)., Conclusions: Montelukast-induced neuropsychiatric ADRs are more frequent than reported in the literature and negatively impact children's QoL.

Objective: To compare the efficacy of the Sémont maneuver (SM) with the new "SémontPLUS maneuver" (SM+) in patients with posterior canal BPPV canalolithiasis (pcBPPVcan). Methods and Patients: In a prospective trinational (Germany, Italy, and Belgium) randomized trial, patients with pcBPPVcan were randomly assigned to SM or SM+; SM+ means overextension of the head by 60+° below earth horizontal line during the movement of the patient toward the affected side. The first maneuver was done by the physician, and the subsequent maneuvers by the patients 9 times/day on their own. Each morning the patient documented whether vertigo could be induced. The primary endpoints were: "How long (in days) does it take until no attacks can be induced?" and "What is the efficacy of a single SM/SM+?" Results: In the 194 patients analyzed (96 SM, 98 SM+), it took 2 days (median, range 1-21 days, mean 3.6 days) for recovery with SM and 1 day (median, range 1-8 days, mean 1.8 days) with SM+ ( p = 0.001, Mann-Whitney U -test). There was no difference in the second primary endpoint (chi 2 -test, p = 0.39). Interpretation: This prospective trial shows that SM+ is more effective than SM when repeated therapeutic maneuvers are performed but not when a single maneuver is performed. It also supports the hypothesis of the biophysical model: overextension of the head during step 2 brings the clot of otoconia beyond the vertex of the canal, which increases the effectivity. Classification of Evidence: This study provides Class I evidence that SM+ is superior to SM for multiple treatment maneuvers of pcBPPVcan., Competing Interests: MS has received speaker's honoraria from Abbott, Actelion, Auris Medical, Biogen, Eisai, Grünenthal, GSK, Henning Pharma, Interacoustics, MSD, Otometrics, Pierre-Fabre, TEVA, UCB, and Viatris. MS is a shareholder of IntraBio. MS is the distributor of M-glasses and the Positional vertigo App. MS acts as a consultant for Abbott, Actelion, AurisMedical, Heel, IntraBio, and Sensorion. NG received honoraria from IntraBio outside of this study. OB was employed by Relia Tec GmbH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Strupp, Goldschagg, Vinck, Bayer, Vandenbroeck, Salerni, Hennig, Obrist and Mandalà.)

Background: Vestibular migraine (VM) is the most frequent cause of recurrent spontaneous attacks of vertigo causally related to migraine. The objective of the Prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG) trial was to demonstrate that metoprolol succinate is superior to placebo in the prevention of episodic vertigo- and migraine-related symptoms in patients with VM., Methods: This phase III, two-arm, parallel-group, double-blind, randomized placebo-controlled trial was designed to be conducted at tertiary referral centres at neurology and ear, nose and throat departments of eight German university hospitals. The planned sample size was a total of 266 patients to be allocated. Adults aged 18 years or above diagnosed with probable or definitive VM according to the Neuhauser criteria 2001 were randomly assigned 1:1 to 6 months blinded metoprolol (maintenance dosage of 95 mg daily) or placebo. The primary efficacy outcome was the self-reported number of vertiginous attacks per 30 days documented by means of a paper-based daily symptom diary. The pre-specified time period of primary interest was defined as months 4 to 6. Secondary outcomes included the patient-reported number of migraine days and vertigo days, the Dizziness Handicap Inventory, and clinical assessments. Adverse events were reported throughout the whole 9-month study period., Results: At the time of trial termination, no evidence for a difference in the incidence of vertiginous attacks between groups was detected. For the full analysis set, the incidence rate ratio was 0.983 (95% confidence interval (CI) 0.902-1.071) for metoprolol versus placebo. In both groups, there was a significant decline over time in the overall monthly vertigo attacks by a factor of 0.830 (95% CI 0.776-0.887). Results were consistent for all subjective and objective key measures of efficacy. The treatment was well tolerated with no unexpected safety findings., Conclusions: After randomizing 130 patients PROVEMIG had to be discontinued because of poor participant accrual not related to the tolerability of the study medication or safety concerns; no treatment benefit of metoprolol over placebo could be established. Additional preparatory work is much needed in the development, psychometric evaluation and interpretation of clinically meaningful end points in trials on episodic syndromes like VM taking into consideration the complexity of this disease entity comprising two domains (vertigo- and headache-related disability)., Trial Registration: EudraCT, 2009-013701-34. Prospectively registered on 8 April 2011.

Background: Rotating several different WHO level III opioid drugs is a therapeutic option for patients with chronic cancer-related pain who suffer from inadequate analgesia and/or intolerable side effects. The evidence favoring opioid rotation is controversial, and the current guidelines in Germany and other countries contain only weak recommendations for it., Methods: This review is based on pertinent publications retrieved by a systematic review of the literature on opioid rotation for adult patients with chronic cancerrelated pain who are regularly taking WHO level III opioids by the oral or trans - dermal route., Results: 9 individual studies involving a total of 725 patients were included in the analysis, and 3 previous systematic reviews of studies involving a total of 2296 patients were also analyzed. Morphine, oxycodone, fentanyl, hydromorphone, and buprenorphine were used as first-line opioid drugs, and hydromorphone, bupre - norphine, tapentadol, fentanyl, morphine, oxymorphone, and methadone were used as second-line opioid drugs. In all of the studies, pain control was achieved for 14 days after each rotation. In most of them, the dose of the new drug introduced in each rotation needed to be increased above the dose initially calculated from a rotation ratio, with the exception of rotations to methadone. The frequency of side effects was only rarely lessened, but patients largely considered the result of opioid rotation to be positive. No particular opioid drug was found to be best., Conclusion: Opioid rotation can improve analgesia and patient satisfaction. The success of opioid rotation appears to depend on the magnitude of the initial dose, among other factors. Tables of equianalgesic doses should be considered no more than a rough guide for determining the dose of the new drug. Rotations to methadone should be carried out under clinical supervision in experienced hands.

Objective: Vestibular paroxysmia (VP) is characterized by short, often oligosymptomatic attacks of vertigo which occur spontaneously or are sometimes provoked by turning the head. Despite the description of the disease almost 40 years ago (first termed "disabling positional vertigo"), no controlled treatment trial has been published to date. The Vestparoxy trial was designed as a randomized, placebo-controlled, double-blind cross-over trial to examine the therapeutic effect of oxcarbazepine (OXA) in patients with definite or probable VP., Methods: Patients were recruited from August 2005 to December 2011 in the outpatient Dizziness Unit of the Department of Neurology of the Munich University Hospital, and randomized to receive OXA (first week: 300 mg once per day, second week: 300 mg b.i.d., third week: 300 mg t.i.d. until the end of the third month), followed by placebo or vice versa with a 1-month wash-out period in between. The primary endpoint was the number of days with one or more attacks. Secondary endpoints were the number of attacks during the observed days, and the median (for each day) duration of attacks. All these endpoints were assessed using standardized diaries collected at the end of each treatment phase., Results: Forty-three patients were randomized, 18 patients provided usable data (2525 patient days) for at least one treatment phase and were included in the main (intention-to-treat) analysis. The most common reasons for discontinuation documented were adverse events. The risk of experiencing a day with at least one attack was 0.41 under OXA, and 0.62 under placebo treatment, yielding a relative risk of 0.67 (95% CI 0.47-0.95, p = 0.025). The number of attacks during the observed days ratio was 0.53 (95% CI 0.42-0.68, p < 0.001) under OXA compared to placebo. Median attack duration was 4 s (Q25: 2 s, Q75: 120 s) under OXA, and 3 s (Q25: 2 s, Q75: 60 s) under placebo treatment. When days with no attacks, i.e., duration = 0, were included in the analysis, these figures changed to 0 (Q25: 0, Q75: 3 s), and 2 (Q25: 0, Q75: 6 s). No serious adverse events or new safety findings were identified during the trial., Conclusions: The Vestparoxy trial showed a significant reduction of VP attacks under OXA compared to placebo treatment, confirming the known and revealing no new side effects.

Background: Cerebellar ataxia (CA) is a frequent and often disabling condition that impairs motor functioning and impacts on quality of life (QoL). No medication has yet been proven effective for the symptomatic or even causative treatment of hereditary or non-hereditary, non-acquired CA. So far, the only treatment recommendation is physiotherapy. Therefore, new therapeutic options are needed. Based on three observational studies, the primary objective of the acetyl-DL-leucine on ataxia (ALCAT) trial is to examine the efficacy and tolerability of a symptomatic therapy with acetyl-DL-leucine compared to placebo on motor function measured by the Scale for the Assessment and Rating of Ataxia (SARA) in patients with CA., Methods/design: An investigator-initiated, multicenter, European, randomized, double-blind, placebo-controlled, 2-treatment 2-period crossover phase III trial will be carried out. In total, 108 adult patients who meet the clinical criteria of CA of different etiologies (hereditary or non-hereditary, non-acquired) presenting with a SARA total score of at least 3 points will be randomly assigned in a 1:1 ratio to one of two different treatment sequences, either acetyl-DL-leucine (up to 5 g per day) followed by placebo or vice versa. Each sequence consists of two 6-week treatment periods, separated by a 4-week wash-out period. A follow-up examination is scheduled 4 weeks after the end of treatment. The primary efficacy outcome is the absolute change in the SARA total score. Secondary objectives are to demonstrate that acetyl-DL-leucine is effective in improving (1) motor function measured by the Spinocerebellar Ataxia Functional Index (SCAFI) and SARA subscore items and (2) QoL (EuroQoL 5 dimensions and 5 level version, EQ-5D-5 L), depression (Beck Depression Inventory, BDI-II) and fatigue (Fatigue Severity Score, FSS). Furthermore, the incidence of adverse events will be investigated., Discussion: The results of this trial will inform whether symptomatic treatment with the modified amino-acid acetyl-DL-leucine is a worthy candidate for a new drug therapy to relieve ataxia symptoms and to improve patient care. If superiority of the experimental drug to placebo can be established it will also be re-purposing of an agent that has been previously used for the symptomatic treatment of dizziness., Trial Registration: The trial was prospectively registered at www.clinicaltrialsregister.eu (EudraCT no. 2015-000460-34) and at https://www.germanctr.de (DRKS-ID: DRKS00009733 ).

Objectives: The primary aim was to determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the bedside head-impulse test (bHIT) using the video HIT (vHIT) as the gold standard for quantifying the function of the vestibulo-ocular reflex (VOR). Secondary aims were to determine the bHIT inter-rater reliability and sensitivity in detecting unilateral and bilateral vestibulopathy., Methods: In this prospective study, 500 consecutive outpatients presenting to a tertiary neuro-otology clinic with vertigo or dizziness of various vestibular etiologies who did not have any of the pre-defined exclusion criteria were recruited. Bedside HITs were done by three experienced neuro-otology clinicians masked to the diagnosis, and the results were compared with the vHIT. The patients were likewise blinded to the bHIT and vHIT findings. Patients with VOR deficits were identified on the vHIT by referencing to the pre-selected "pathological" gain of <0.7. The data were then analyzed using standard statistical methods., Results: For the primary outcome (vHIT "pathological" VOR gain <0.7), the three-rater mean bHIT sensitivity = 66.0%, PPV = 44.3%, specificity = 86.2%, and NPV = 93.9%. Shifting the "pathological" threshold from 0.6 to 0.9 caused the bHIT sensitivity to decrease while the PPV increased. Specificity and NPV tended to remain stable. Inter-rater agreement was moderate (Krippendorff's alpha = 0.54). For unilateral vestibulopathy, overall bHIT sensitivity = 69.6%, reaching 86.67% for severely reduced unilateral gain. For VOR asymmetry <40% and >40%, the bHIT sensitivity = 51.7 and 83%, respectively. For bilateral vestibulopathy, overall bHIT sensitivity = 66.3%, reaching 86.84% for severely reduced bidirectional gains., Conclusion: For the primary outcome, the bHIT had moderate sensitivity and low PPV. While the study did not elucidate the best choice for vHIT reference, it demonstrated how the bHIT test properties varied with vHIT thresholds: selecting a lower threshold improved the sensitivity but diminished the PPV, while a higher threshold had the opposite effect. The VOR was most likely normal if the bHIT was negative due to its high NPV. The bHIT was moderately sensitive for detecting unilateral and bilateral vestibulopathy overall, but better for certain subgroups.