Search

Objective: The goal of the present paper is to provide evidence on the behavior of physician practice cost functions.Data Sources: Our study is based on the data of 3686 physician practices in Germany for the years 2006 to 2008.Study Design: We apply a translog functional form and include a comprehensive set of variables that have not been previously used in this context. A system of four equations using three-stage least squares is estimated.Principal Findings: We find that a higher degree of specialization leads to a decrease in costs, whereas quality certification increases costs. Costs of group practices are higher than of solo practices. The latter finding can be explained by the existence of indivisibilities of expensive technical equipment. Smaller practices do not reach the critical mass to invest in certain technologies, which leads to differences in the type of health care services provided by different practice types.Conclusions: This is the first study to use physician practices as the unit of observation and to consider the endogenous character of physician input. Our results suggest that identifying factors that influence physician practice costs is important for providing evidence-based physician payment systems and to enable decision-makers to set incentives effectively. [ABSTRACT FROM AUTHOR]

In response to the growing burden of obesity, public primary prevention programs against obesity have been widely recommended. Several studies have estimated the cost-effectiveness of diabetes-prevention trials for different countries. Nevertheless, it is still controversial if prevention conducted in more real-world settings and among people with increased risk but not yet exhibiting increased glucose tolerance can be a cost-saving strategy to cope with the obesity epidemic. We examine this question in a simulation model based on the results of the M.O.B.I.L.I.S program, a German lifestyle intervention to reduce obesity, which is directed on the high-risk group of people who are already obese. The contribution of this paper is the use of 4-year follow-up data on the intervention group and a comparison with a control group formed by SOEP respondents as inputs in a Markov model of the long-term cost savings through this intervention due to the prevention of type 2 diabetes. We show that from the point of view of a health insurer, these programs can pay for themselves. [ABSTRACT FROM AUTHOR]

Objective: The clinical symptoms of schizophrenia are associated with serious social, quality of life and functioning alterations. Typically, data on health utilities are not available in clinical studies in schizophrenia. This makes the economic evaluation of schizophrenia treatments challenging. The purpose of this article was to provide a mapping function to predict unobserved utility values in patients with schizophrenia from the available clinical and socio-demographic information.Methods: The analysis was performed using data from EuroSC, a 2-year, multi-centre, cohort study conducted in France (N = 288), Germany (N = 618), and the UK (N = 302), totalling 1208 patients. Utility was calculated based on the EQ-5D questionnaire. The relationships between the utility values and the patients' socio-demographic and clinical characteristics (Positive and Negative Syndrome Scale--PANSS, Calgary Depression Scale for Schizophrenia--CDSS, Global Assessment of Functioning--GAF, extra-pyramidal symptoms measured by Barnes Akathisia Scale-BAS, age, sex, country, antipsychotic type) were modelled using a random and a fixed individual effects panel linear model.Results: The analysis demonstrated the prediction ability of the used parameters for estimating utility measures in patients with schizophrenia. Although there are small variations between countries, the same variables appear to be the key predictors. From a clinical perspective, age, gender, psychopathology, and depression were the most important predictors associated with the EQ-5D.Conclusion: This paper proposed a reliable, robust and easy-to-apply mapping method to estimate EQ-5D utilities based on demographic and clinical measures in schizophrenia. [ABSTRACT FROM AUTHOR]

The large difference in the level and variance of student performance in the 2000 PISA study between Finland and Germany motivates this paper. It analyses why Finnish students showed a significantly higher performance by estimating educational production functions for both countries, using a unique micro-level dataset with imputed data and added school type information. The difference in reading proficiency scores is assigned to different effects, using Oaxaca–Blinder and Juhn–Murphy–Pierce decomposition methods. The analysis shows that German students and schools have on average more favorable characteristics except for the lowest deciles, but experience much lower returns to these characteristics in terms of test scores than Finnish students. The role of school types remains ambiguous. Overall, the observable characteristics explain more of the variation in test scores in Germany than in Finland. [ABSTRACT FROM AUTHOR]

The continued growth in the economic evaluation of healthcare over the past 25 years has led to a shortage of trained health economists globally, leading to a number of universities and/or national governments developing specialised health economics programmes to train more health economists. One of the common problems with many of these training programmes is that they only educate new health economists to the Masters level, and as such they are unable to cover the many skills needed by a successful health economist. Furthermore, government and industry interests have ensured that economic evaluation is a heavily regulated environment that gives little incentive to seek further education. These two related factors (under-education and over-regulation) have lead to a situation where economic evaluation methods may adversely limit innovation of therapeutics and devices in clinical areas that perform badly when evaluated on the cost per QALY scale. The good news, however, is that the tide is turning and theoretically sound adjustments (such as risk adjustments and stated preferences) to the current paradigm are now being considered. This, of cause, is just the tip of the iceberg with other important issues such as time preference and the endogeneity of preference remaining very much under-researched areas in health. This paper concludes that many of these real-world issues, such as patient preferences, can be avoided by using artificial objective functions such as cost per QALY, but this comes at the cost of irrelevance and the misallocation of resources. If we are to meet all of the future challenges in economic evaluation in healthcare then we must focus more on advanced education and far less on the regulation of health economists. [ABSTRACT FROM AUTHOR]

Unlabelled: Deaths in temporal association with vaccination of hexavalent vaccines have been recently reported. The objective of this paper is to assess whether these temporal associations can be attributed to chance. Standardised mortality ratios (SMR) for deaths within 1 to 28 days after administration of either of the two hexavalent vaccines in the 1st and 2nd year of life were determined using the respective annual rates for sudden unexpected deaths (SUDs) from the national vital statistics. The distribution of SUD cases and the vaccination uptake by month were estimated from surveys and sales figures for the individual vaccines. Sensitivity analyses were performed to account for limitations in the data sources. For one of the vaccines, Vaccine B, all SMRs were well below one. For the other, Vaccine A, SMRs exceeded one insignificantly on the 1st day after vaccination in the 1st year of life. In the 2nd year of life, however, the SMRs for SUD cases within 1 day of vaccination with vaccine A were 31.3 (95% CI 3.8-113.1; two cases observed; 0.06 cases expected) and 23.5 (95% CI 4.8-68,6) for within 2 days after vaccination (three cases observed; 0.13 cases expected). Extensive sensitivity analyses could not attribute these findings to limitations of the data sources.Conclusion: These findings based on spontaneous reporting do not prove a causal relationship between vaccination and sudden unexpected deaths. However, they constitute a signal for one of the two hexavalent vaccines which should prompt intensified surveillance for unexpected deaths after vaccination. [ABSTRACT FROM AUTHOR]

Background: Schizophrenia has a variety of clinical profiles, disabilities and outcomes requiring responsive management and the devotion of considerable resources. The primary objective of the European Schizophrenia Cohort (EuroSC) is to relate the types of treatment and methods of care to clinical outcome. Secondary objectives include the assessment of treatment needs in relation to outcome, the calculation of resource consumption associated with different methods of care, and the identification of prognostic factors.Method: EuroSC is a naturalistic follow-up of a cohort of people aged 18 to 64 years, suffering from schizophrenia and in contact with secondary psychiatric services. The study was done in nine European centres, in France (N = 288), Germany (N = 618), and Britain (N = 302). Participants were interviewed at 6-monthly intervals for a total of 2 years. This initial paper describes the methods used and presents clinical and social baseline data.Results: The clinical and socio-demographic differences between patients from the different countries were small. However, patients from Britain were considerably more likely than their continental counterparts to have a history of homelessness, rooflessness or imprisonment, even when social and clinical differences between the samples were controlled.Conclusions: The samples were largely similar in clinical terms. Thus, the social differences between the samples seem likely to be due more to the societal context and may reflect relatively benign situations in the continental locations of our study. [ABSTRACT FROM AUTHOR]

This paper presents two studies (one single case and one comparative study) examining change processes within individual therapy sessions as well as during the course of treatment. The Therapeutic Cycle Model (TCM), developed for general psychotherapy to objectify change events in the course of psychotherapies, is applied to transcribed tape recordings of therapy sessions with sexual offenders. The TCM focuses on emotional experience and cognitive mastery and uses computer assisted text analysis. In addition to the TCM approach clinical ratings are used as independent criteria. The predicted relationship between the phases of the TCM and scores on the respective scales of the clinical ratings were supported. [ABSTRACT FROM AUTHOR]

This study examined the prevalence of sexual aggression perpetration and victimization in a sample of 1,172 students (755 female, 417 male) from four universities in Germany. All participants were asked about both victimization by, and perpetration of, sexual aggression since the age of 14 years, using the Sexual Aggression and Victimization Scale (SAV-S). Prevalence rates were established for different coercive strategies, sexual acts, and victim-perpetrator relationships. Both same-sex and opposite-sex victim-perpetrator constellations were examined. The overall victimization rate was 62.1% for women and 37.5% for men. The overall perpetration rate was 17.7% for men and 9.4% for women. Prevalence rates of both victimization and perpetration were higher for participants who had sexual contacts with both opposite-sex and same-sex partners than for participants with exclusively opposite-sex partners. Significant overlap was found between victim and perpetrator status for men and women as well as for participants with only opposite-sex and both opposite-sex and same-sex partners. A disparity between (higher) victimization and (lower) perpetration reports was found for both men and women, suggesting a general underreporting of perpetration rather than a gendered explanation in terms of social desirability or the perception of consent cues. The findings are placed in the international research literature on the prevalence of sexual aggression before and after the #metoo campaign, and their implications for prevention efforts are discussed. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the work situation of lung cancer survivors and to identify the factors associated with their returning to work.Methods: Descriptive analysis and logistic regression were used to evaluate study population characteristics and independent factors of subsequently returning to work. To analyze time to return to work, Cox regression was used.Results: The study sample included 232 lung cancer survivors of working age from 717 enrolled participants in the multi-center cross-sectional LARIS (Quality of Life and Psychosocial Rehabilitation in Lung Cancer Survivors) study. About 67% of the survivors were not employed during the survey. More than 51% of the survivors who were employed before their illness did not return to their work. The survivors who had returned to their careers were younger, associated with higher household income, lower fatigue score, and stable relationship and vocational training. Patients who received social service counseling showed a higher chance of regaining their career.Conclusions: Lung cancer survivors were found to be associated with a high risk of unemployment and very low professional reintegration after interruption due to illness. More comprehensive studies are needed to support lung cancer survivors and targeting of patients in need of special attention in rehabilitation that would benefit from the findings in the present study. [ABSTRACT FROM AUTHOR]

Mantle cell lymphoma (MCL) is a non-Hodgkin's lymphoma with an often aggressive course, incurable by chemotherapy. Consolidation with high-dose therapy and autologous stem cell transplantation (autoSCT) has a low transplant-related mortality but does not lead to a survival plateau. Allogeneic stem cell transplantation (alloSCT) is associated with a higher early mortality, but can cure MCL. To investigate alloSCT for therapy of MCL, we conducted two prospective trials for de novo MCL (OSHO#74) and for relapsed or refractory MCL (OSHO#60). Fifteen and 24 patients were recruited, respectively. Induction was mainly R-DHAP alternating with R-CHOP. Conditioning was either Busulfan/Cyclophosphamide or Treosulfan/Fludarabin. Either HLA-identical siblings or matched-unrelated donors with not more than one mismatch were allowed. ATG was mandatory in mismatched or unrelated transplantation. Progression-free survival (PFS) was 62% and overall survival (OS) was 68% after 16.5-year follow-up. Significant differences in PFS and OS between both trials were not observed. Patients below 56 years and patients after myeloablative conditioning had a better outcome compared to patients of the corresponding groups. Nine patients have died between day +8 and 5.9 years after SCT. Data from 7 long-term surviving patients showed an excellent Quality-of-life (QoL) after alloSCT. AlloSCT for MCL delivers excellent long-term survival data. The early mortality is higher than after autoSCT; however, the survival curves after alloSCT indicate the curative potential of this therapy. AlloSCT is a standard of care for all feasible patients with refractory or relapsed MCL and should offer to selected patients with de novo MCL and a poor risk profile. For defining the position of alloSCT in the therapeutic algorithm of MCL therapy, a randomized comparison of autoSCT and alloSCT is mandatory. [ABSTRACT FROM AUTHOR]

Background: Primary biliary cholangitis (PBC) is a chronic, cholestatic liver disease that can lead to end-stage liver disease and impairs the quality of life. At current, most data come from few large cohorts.Aim: This cross-sectional study evaluated treatment response and symptom burden in patients with PBC in Germany to expand the available data.Methods: A total of 140 PBC patients were prospectively enrolled at the outpatient liver clinic of the University Medical Center in Mainz starting in June 2016. Historic and current response rates of UDCA treatment were determined using published binary models. Symptom burden was assessed using the PBC-40 questionnaire.Results: The primary treatment response ranged between 73 and 86% depending on the definition used. Importantly, this response rate was maintained over a median time of 5 years in follow-up. The highest symptom burden was observed for fatigue and emotional (2.4 ± 1; 2.3 ± 1.1 of 5), while pruritus (1.1 ± 1.1 of 5) had the lowest scores. IgG correlated with the PBC-40 domain social (r = 0.211, p = 0.032), while HDL inversely correlated with the symptom burden of pruritus (r = - 0.236; p = 0.018).Conclusion: In this tertiary care cohort, 75% of the patients showed biochemical response after 1 year according to the acknowledged Paris II criteria. Patients reported a significant symptom burden, and the domain fatigue of the PBC-40 was most prominently impaired. [ABSTRACT FROM AUTHOR]

Clinical research has resulted in an improvement of treatment options for patients with immune thrombocytopenia (ITP) over the last years. However, only few data exist on the real-life management of patients with ITP. To expand the knowledge, a multicenter, national survey was undertaken in 26 hematology practices distributed all over Germany. All patients with a diagnosis of ITP were documented using questionnaires, irrespective of the diagnosis date over a period of 2 years. Overall, data of 1023 patients were evaluated with 56% of patients being older than 60 years. Seventy-nine percent of the patients had chronic (> 12 months), 16% persistent (> 3-12 months), and 5% newly diagnosed (0-3 months) ITP. In 61% of cases, the disease lasted 3 or more years before survey documentation started. Main strategies applied as first-line therapy consisted of steroids in 45% and a "watch and wait" approach in 41% of patients. During second- and third-line strategies, treatment with steroids decreased (36% and 28%, respectively), while treatment modalities such as TPO-RAs increased (19% and 26%, respectively). As expected, patients with a low platelet count and thus a higher risk for bleeding and mortality received treatment (esp. steroids) more frequently during first line than those with a higher platelet count. Up to a third of patients were treated with steroids for more than a year. Overall, our study provides a cross-section overview about the current therapeutic treatment landscape in German ITP patients. The results will help to improve therapeutic management of ITP patients. [ABSTRACT FROM AUTHOR]

Background: Patients with NAFLD are considered at a high risk of cardiovascular events due to underlying metabolic risk factors. Currently, data related to the impact of NAFLD on cardiovascular risk in the general population are lacking.Aims: The aim of this study was to investigate the role of NAFLD on risk of myocardial infarction (MI), coronary heart disease (CHD), atrial fibrillation (AF), and stroke in primary care in Germany.Methods: The study included patients diagnosed with NAFLD in primary care between 2010 and 2015. NAFLD cases (n = 22,048) were matched to a cohort without NAFLD (n = 22,048) based on age, sex, treating physician, type 2 diabetes, arterial hypertension, and hyperlipidemia. The primary outcome of the study was the incidence of MI, CHD, AF, and stroke.Results: Within 10 years of the index date, 12.8% of patients with NAFLD and 10.0% of controls were diagnosed with CHD (p < 0.001). Additionally, frequency of MI was significantly higher in NAFLD (2.9% vs. 2.3%, p < 0.001). On regression analysis, HR for incidence of MI was 1.34 (p = 0.003) in all NAFLD patients and 1.35 (p = 0.013) for men. Incidence of AF was significantly higher in patients with NAFLD. On regression analysis, HR for incidence of AF was 1.15 (p = 0.005). NAFLD was not associated with a higher incidence of stroke (HR 1.09, p = 0.243).Conclusions: NAFLD constitutes an independent risk factor for CHD, MI, and AF in primary care in Germany. Identification of patients with NAFLD in primary care will allow specifically managing and modifying underlying risk factors to improve the overall prognosis. [ABSTRACT FROM AUTHOR]

Introduction: Sublingual immunotherapy (SLIT) with birch pollen extract has been shown to be an efficacious treatment of allergic rhinitis (AR). An as-yet unanswered question is whether and how clinical benefit translates into patient benefit, i.e. what benefit patients derive from this treatment.Methods: This 1-year, open, prospective, multicenter, non-interventional study conducted in 75 German centers measured patient-relevant benefit of birch pollen SLIT (Staloral® Birch) using the questionnaire "Patient Benefit Index for Allergic Rhinitis (PBI-AR)". At treatment onset, patients rated the importance of 25 treatment needs; after the first birch pollen season on treatment, goal achievement was evaluated. A preference-weighted benefit index was calculated and its association with gender, asthma, allergy status, and severity of AR symptoms was determined.Results: Mean age of the 291 adult patients was 38.8 years; 58.4% were female. The most important treatment goals were to "be able to stay outdoors without symptoms" (87.3% quite or very important), "no longer have a runny or stuffed-up nose" (86.9%), and "be able to breathe through your nose more freely" (86.9%). The treatment goals with the highest benefit ratings (referring to those patients to whom the respective goal applied) were to "have confidence in the therapy" (60.5% has helped "quite" or "very much"), "have an easily applicable treatment" (55.6%), and "be able to breathe through my nose more freely" (51.7%). The average PBI-AR global score was 2.19 (SD 1.04) (0-4; with 4 indicating maximum benefit). No significant differences in PBI-AR global score or subscales were found between men and women, poly- and monoallergic patients, or patients with severe versus mild rhinoconjunctivitis. Patients with asthma reported relevant but lower benefit than patients without asthma.Conclusion: After 1 year of birch pollen SLIT treatment, patients reported considerable benefit, mainly due to a reduction of physical symptoms and treatment burden. [ABSTRACT FROM AUTHOR]

Introduction: Disease-modifying therapies (DMTs) in multiple sclerosis (MS) are chronic therapies, and patients are likely to face challenges in adhering to DMT dosing regimens over time. DMT manufacturers offer patient support programs (PSPs) to increase adherence. PSPs are managed offerings typically encompassing nurse services, phone services, online resources, or mobile offerings. This study evaluated whether PSPs have a positive impact on adherence to DMTs among patients with mild-to-moderate relapsing-remitting multiple sclerosis (RRMS) in Germany, independent of the treatment duration on DMT.Methods: This was a non-interventional, prospective, cross-sectional, multi-center study with patient-reported outcomes. Patients reported their DMT adherence using patient adherence questionnaires at four visits during an observation period of 24 weeks; PSP participation for this period was reported at the last visit. The primary objective was to evaluate the impact of PSPs on adherence across different DMTs by comparing patients with PSP participation versus no participation; adherence was defined as not missing a single dose of DMT.Results: One hundred eighty-four patients were analyzed (mean age: 44.6 years; 73.4% female; mean time on DMT: 7.2 years). Adherence across DMTs was significantly higher for PSP participants (92.9%) compared with non-participants (61.8%) (P = 0.0197). The observed rate of PSP participation (7.6%) was significantly lower than reported in earlier studies (P < 0.0001); PSP awareness among patients analyzed was low (22.3%).Conclusion: We consider this study to have shown that PSPs have a positive impact on adherence to DMTs in MS, independent of the treatment duration on DMT. The majority of PSP participants also believe in this positive effect. PSP participation and patient awareness were low, and real-world adherence levels were found to be higher with self-injectable DMTs than with oral DMTs. In summary, physicians should actively advise patients with MS to participate in PSPs and, together with their patients, consider achievable real-world adherence under different DMTs when deciding MS treatment strategies. [ABSTRACT FROM AUTHOR]

Low stakes assessment without grading the performance of students in educational systems has received increasing attention in recent years. It is used in formative assessments to guide the learning process as well as in large-scales assessments to monitor educational programs. Yet, such assessments suffer from high variation in students' test-taking effort. We aimed to identify institutional strategies related to serious test-taking behavior in low stakes assessment to provide medical schools with practical recommendations on how test-taking effort might be increased. First, we identified strategies that were already used by medical schools to increase the serious test-taking behavior on the low stakes Berlin Progress Test (BPT). Strategies which could be assigned to self-determination theory of Ryan and Deci were chosen for analysis. We conducted the study at nine medical schools in Germany and Austria with a total of 108,140 observations in an established low stakes assessment. A generalized linear-mixed effects model was used to assess the association between institutional strategies and the odds that students will take the BPT seriously. Overall, two institutional strategies were found to be positively related to more serious test-taking behavior: discussing low test performance with the mentor and consequences for not participating. Giving choice was negatively related to more serious test-taking behavior. At medical schools that presented the BPT as evaluation, this effect was larger in comparison to medical schools that presented the BPT as assessment. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to answer the questions where breast cancer patients in Germany receive follow-up care (with what types of doctors) and what are the long-term problems and treatment regrets of breast cancer patients.Methods: In the prospective multicenter cohort study BRENDA II ("Breast Cancer under Evidence-Based Guidelines"), 456 patients with primary breast cancer were sampled consecutively over a period of 4 years (2009-2012) and contacted again 5 years after surgery. Long-term problems were elicited on a 4-point Likert scale ranging from 0 ('not at all') to 3 ('very much').Results: 82% of the patients receive follow-up (FU) at the private practice gynecologist. In 22%, the initial treating hospital is involved in the FU, and in 20% the general practitioner does this (multiple answers possible). Long-term problems attributed to the treatment were most often related to endocrine therapy (mean 1.29) and to chemotherapy (mean 0.94). Most of the patients were happy to have had radiotherapy (95%). For chemotherapy, endocrine therapy, and antibody therapy, the satisfaction for the treatment decision was 87%, 87%, and 84% respectively. Among patients who reported they regretted having undergone a recommended treatment, it was most often for endocrine therapy (5%) and chemotherapy (4%).Conclusion: In Germany, different specialists are involved in the patients' FU care for BC. The detection of long-term problems due to BC treatment is an essential part of FU care. [ABSTRACT FROM AUTHOR]

The aim of this study was to correlate ventricular size and volumes of deep gray matter (DGM) in MRI at term equivalent age (TEA) with outcome at a corrected age of 24 months in preterm infants and with handedness. Seventy-three infants born before 32 weeks of gestation or with birth weight < 1500 g  were included in this retrospective analysis and measurement of lateral ventricles, and DGM was performed on MRI scans. The left lateral ventricle was significantly larger than the right lateral ventricle (p = 0.001). There was no correlation between volumes of the right and left ventricles and the DGM volume (p = 0.207 and p = 0.597, respectively), nor with the head circumference at TEA (p = 0.177 and p = 0.976, respectively). The total volume of both lateral ventricles did not correlate with Mental Develomental Index (MDI, p = 0.336) or Psychomotor Developmental Index (PDI, p = 0.650) score (Bayley Scales of Infant Development, BSID II). However, a correlation of total DGM volume with birth weight (p = 0.0001; r = 0.437), head circumference at TEA (p < 0.0001; r = 0.640), MDI (p = 0.029; r = 0.310), and PDI (p = 0.002; r = 0.456) was observed. No significant difference between right- and left-handed infants was seen in relation to volumes of both lateral ventricles and of DGM.Conclusion: DGM volume at TEA was significantly associated with the outcome at a corrected age of 24 months. Handedness did not correlate with DGM or lateral ventricle size.What is Known:• White matter injury as well as altered development of deep gray matter is associated with neurodevelopmental disability in preterm infants.• No study analyzed the association between deep gray matter volume or volumes of lateral ventricle and handedness in former preterm infants so far.What is New:• Volume of deep gray matter, but not lateral ventricular size was significantly associated with outcome at a corrected age of 24 months in preterm infants.• There was no correlation of handedness with volumes of lateral ventricular size or with deep gray matter volumes. [ABSTRACT FROM AUTHOR]

Objectives: Treatment switching adjustment methods are often used to adjust for switching in oncology randomized controlled trials (RCTs). In this exploratory analysis, we apply these methods to adjust for treatment changes in the setting of an RCT followed by an extension study in relapsing-remitting multiple sclerosis.Methods: The CLARITY trial evaluated cladribine tablets versus placebo over 96 weeks. In the 96-week CLARITY Extension, patients who received placebo in CLARITY received cladribine tablets; patients who received cladribine tablets in CLARITY were re-randomized to placebo or cladribine tablets. End points were time to first qualifying relapse (FQR) and time to 3- and 6-month confirmed disability progression (3mCDP, 6mCDP). We aimed to compare the effectiveness of cladribine tablets with placebo over CLARITY and the extension. The rank-preserving structural failure time model (RPSFTM) and iterative parameter estimation (IPE) were used to estimate what would have happened if patients had received placebo in CLARITY and the extension versus patients that received cladribine tablets and switched to placebo. To gauge whether treatment effect waned after the 96 weeks of CLARITY, we compared hazard ratios (HRs) from the adjustment analysis with HRs from CLARITY.Results: The RPSFTM resulted in an HR of 0.48 [95% confidence interval (CI) 0.36-0.62] for FQR, 0.62 (95% CI 0.46-0.84) for 3mCDP and 0.62 (95% CI 0.44-0.88) for 6mCDP. IPE algorithm results were similar. CLARITY HRs were 0.44 (95% CI 0.34-0.58), 0.60 (95% CI 0.41-0.87) and 0.58 (95% CI 0.40-0.83) for FQR, 3mCDP and 6mCDP, respectively.Conclusions: Treatment switching adjustment methods are applicable in non-oncology settings. Adjusted CLARITY plus CLARITY Extension HRs were similar to the CLARITY HRs, demonstrating significant treatment benefits associated with cladribine tablets versus placebo.Funding: EMD Serono, Inc. (a business of Merck KGaA, Darmstadt, Germany). [ABSTRACT FROM AUTHOR]

Purpose: To determine the impact of depression, epilepsy and drug abuse during pregnancy on delivery and fetal outcome. Due to the worldwide increasing prevalence of neurological and psychiatric diseases and drug abuse, the number of affected pregnant women is increasing.Methods: A large-scale retrospective case-control analysis of pregnancies affected by depression, epilepsy or drug abuse with and without medication was conducted in two German perinatal centres between 2013 and 2017. The case group consisted of 706 pregnant women who had a diagnosis of depression, epilepsy or drug abuse vs. 12,574 pregnant women without neuropsychiatric diagnosis (control group). The analysis included the rate of intrauterine growth restriction, birth weight and length, neonatal head circumference.Results: Significant differences in the subgroups were found in the parameters intrauterine growth restriction, birth weight, length and head circumference. Women with epilepsy were affected less often than women with depression and substance abuse. Major differences were found in the group of women with substance abuse. Negative associations were found within the non-pharmacologically managed disease group itself compared to women exposed to medication.Conclusion: The present results demonstrated a negative association between maternal neurological or psychiatric disease and pregnancy outcome in the examined parameters. However, the non-pharmacologically treated maternal disease was identified as a risk factor itself. [ABSTRACT FROM AUTHOR]

Background/objectives: The aim of the study was to describe a novel dietary assessment strategy based on two instruments complemented by information from an external population applied to estimate usual food intake in the large-scale multicenter German National Cohort (GNC). As proof of concept, we applied the assessment strategy to data from a pretest study (2012-2013) to assess the feasibility of the novel assessment strategy.Subjects/methods: First, the consumption probability for each individual was modeled using three 24 h food lists (24h-FLs) and frequencies from one food frequency questionnaire (FFQ). Second, daily consumed food amounts were estimated from the representative German National Nutrition Survey II (NVS II) taking the characteristics of the participants into account. Usual food intake was estimated using the product of consumption probability and amounts.Results: We estimated usual intake of 41 food groups in 318 men and 377 women. The participation proportion was 100, 84.4, and 68.5% for the first, second, and third 24h-FL, respectively. We observed no associations between the probability of participating and lifestyle factors. The estimated distributions of usual food intakes were plausible and total energy was estimated to be 2707 kcal/day for men and 2103 kcal/day for women. The estimated consumption frequencies did not differ substantially between men and women with only few exceptions. The differences in energy intake between men and women were mostly due to differences in estimated daily amounts.Conclusions: The combination of repeated 24h-FLs, a FFQ, and consumption-day amounts from a reference population represents a user-friendly dietary assessment approach having generated plausible, but not yet validated, food intake values in the pretest study. [ABSTRACT FROM AUTHOR]

Purpose: The Scored Patient-Generated Subjective Global Assessment (PG-SGA) is the only malnutrition (risk) assessment tool that combines patient-generated measures with professional-generated (medical) factors. We aimed to apply international standards to produce a high quality, validated, translation and cultural adaptation of the original PG-SGA for the Austrian, German, and Swiss setting.Methods: Analogue to methodology used for the Dutch, Portuguese, and Thai versions of PG-SGA, the ten steps of the International Society for Pharmacoeconomics and Outcomes Research's principles of good practice for translation and cultural adaptation were followed. Comprehensibility and difficulty of the translation were assessed in 103 patients and 104 healthcare professionals recruited from all three German-speaking countries. Content validity of the translation was assessed among healthcare professionals (HCP). Item and scale indices were calculated for content validity (I-CVI; S-CVI), comprehensibility (I-CI; S-CI), and difficulty (I-DI; S-DI).Results: Patients' perceived comprehensibility and difficulty of the PG-SGA fell within the range considered to be excellent (S-CI = 0.90, S-DI = 0.90), HCP-perceived content validity (S-CVI = 0.90) was also excellent, while HCP-perceived comprehensibility fell within the high range of acceptable (S-CI = 0.87). The professional component of the PG-SGA was perceived as below acceptable (S-DI = 0.72) with the physical exam being rated the most difficult (I-DI=0.29-0.75).Conclusions: The systematic approach resulted in a high-quality validation of the German language version of the PG-SGA, that is internationally comparable, comprehensible, easy to complete, and considered relevant for use in Austria, Germany and Switzerland. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the humanistic burden on caregivers of patients with advanced non-small cell lung cancer (aNSCLC) as the disease progresses.Methods: Data were drawn from a cross-sectional study of patients with aNSCLC and their caregivers conducted in France, Germany, and Italy between 2015 and 2016. Data were collected by medical chart review and patient and caregiver questionnaires. The EuroQol five-dimension three-level (EQ-5D-3L) was used to evaluate patient and caregiver health status. Caregivers also completed the Work Productivity and Activity Impairment (WPAI) questionnaire and Zarit Burden Interview (ZBI).Results: The population for the analysis consisted of 427 caregivers (mean age 53.5 years; 72.6% female; 54.9% spouse; 36.2% in full-time employment) and 427 matched patients (mean age 66.2 years; 68.6% male). Most (69.5%) patients were receiving first-line therapy for advanced disease. Patients' caregivers provided a mean of 29.5 h of support per week. Significant differences in EQ-5D-3L scores were observed between caregivers of patients receiving first and later lines of therapy in France (0.87 vs. 0.78; p = 0.0055). Among employed caregivers, overall work impairment was considerable and ranged from 21.1% in Germany to 30.4% in France and 29.7% in Italy. Caregivers of patients receiving later lines of therapy in France rated their own health status as significantly worse than did those caring for patients receiving first-line therapy (82.7 vs. 72.9; p = 0.0039).Conclusions: Informal caregivers provided the majority of support for patients with advanced NSCLC and their caregiving activities impose a significant humanistic burden. [ABSTRACT FROM AUTHOR]

Objectives: To assess undergraduate medical students' attitudes towards artificial intelligence (AI) in radiology and medicine.Materials and Methods: A web-based questionnaire was designed using SurveyMonkey, and was sent out to students at three major medical schools. It consisted of various sections aiming to evaluate the students' prior knowledge of AI in radiology and beyond, as well as their attitude towards AI in radiology specifically and in medicine in general. Respondents' anonymity was ensured.Results: A total of 263 students (166 female, 94 male, median age 23 years) responded to the questionnaire. Around 52% were aware of the ongoing discussion about AI in radiology and 68% stated that they were unaware of the technologies involved. Respondents agreed that AI could potentially detect pathologies in radiological examinations (83%) but felt that AI would not be able to establish a definite diagnosis (56%). The majority agreed that AI will revolutionise and improve radiology (77% and 86%), while disagreeing with statements that human radiologists will be replaced (83%). Over two-thirds agreed on the need for AI to be included in medical training (71%). In sub-group analyses male and tech-savvy respondents were more confident on the benefits of AI and less fearful of these technologies.Conclusion: Contrary to anecdotes published in the media, undergraduate medical students do not worry that AI will replace human radiologists, and are aware of the potential applications and implications of AI on radiology and medicine. Radiology should take the lead in educating students about these emerging technologies.Key Points: • Medical students are aware of the potential applications and implications of AI in radiology and medicine in general. • Medical students do not worry that the human radiologist or physician will be replaced. • Artificial intelligence should be included in medical training. [ABSTRACT FROM AUTHOR]

Introduction: Various treatment options are available for metastatic hormone-sensitive prostate cancer. This study aimed to quantify how men with prostate cancer in the United Kingdom (UK), Germany, and Spain perceive the risks and benefits of hypothetical abiraterone acetate plus prednisone treatment and docetaxel-based chemotherapy treatment options.Methods: A targeted literature review, exploratory interviews with prostate cancer patients and oncologists, and pre-test interviews were used to develop a discrete choice experiments (DCE). The final DCE included 32 choice sets, selected using a main-effects orthogonal design, divided into two survey blocks. Paired profiles presented hypothetical treatments for prostate cancer through six attributes that could be presented at two or four levels each. Preference estimates were estimated using a conditional logit regression model. Preference results were stratified by cancer stage.Results: A total of 152 participants (mean age 69 years) completed the DCE in the UK, Germany, and Spain. Treatment effectiveness was the main concern for the patients (difference in preference estimates between 8 and 32 months 1.443). Participants wanted to avoid pain that was not well controlled (preference dummy coding estimate - 1.157). Participants valued a change from an oral medication to an intravenous treatment (change in preference estimate - 0.416) more negatively than a change from a 1% to a 5% risk of infection (change in preference estimate - 0.313).Conclusions: This study shows that treatment effectiveness and pain control were the most important attributes for patients with prostate cancer. These two attributes influenced more than 50% of their decision-making in this study. The risk of fatigue and mode of administration were least prioritised by patients. This study highlights the relative importance that Spanish, German, and British patients place on various aspects of treatment options for prostate cancer. Understanding patient preference and taking them into consideration shall help physicians when developing their treatment strategies for their patients.Funding: Janssen. [ABSTRACT FROM AUTHOR]

Background/objectives: Assessing fatty acid (FA) composition in relation to inflammatory markers can shed light on the role of different FA and their metabolism in low-grade inflammation. Existing exploratory studies in children are scarce, and findings inconsistent. We hence aim to analyse associations of FA with common inflammatory markers, high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6), in 10-year-old children.Subjects/methods: Complete data were available for 958 participants from the 10-year follow-up of the LISAplus (Influence of Lifestyle-Related Factors on the Immune System and the Development of Allergies in Childhood plus the Influence of Traffic Emissions and Genetics) birth cohort study. FA composition was assessed in serum glycerophospholipids. Hs-CRP and IL-6 were categorised into three levels. Associations of FA with inflammatory markers were assessed using multinomial logistic regression, adjusting for potential confounders. Additionally, sex-stratified analyses were carried out.Results: FA exposures associated with significantly higher low-grade inflammation, as indicated by higher hs-CRP or IL-6 levels, included: palmitic acid (PA) (IL-6: P<0.001, 95% confidence interval: 1.30; 2.43), arachidonic acid (AA) (hs-CRP: P=0.002, 1.07; 1.31), n-6 highly unsaturated FA (HUFA) (hs-CRP: P=0.002, 1.06; 1.27), ratio of AA to linoleic acid (AA/LA) (hs-CRP: P<0.001, 1.16; 1.62) and total saturated FA (SFA) (IL-6: P<0.001, 1.77; 3.15). FA exposures associated with reduced levels of inflammatory markers included LA (hs-CRP: P=0.001, 0.84; 0.96; IL-6: P<0.001, 0.69; 0.90) and total polyunsaturated FA (PUFA) (IL-6: P<0.001, 0.57; 0.78).Conclusions: These findings suggest that higher SFA and minor n-6 HUFA, namely PA and AA, are associated with increased low-grade inflammation in children, whereas the major dietary n-6 PUFA and total PUFA are associated with reduced inflammation. Elevated desaturase activity, estimated by the ratio AA/LA, may be associated with higher inflammation, particularly in boys. [ABSTRACT FROM AUTHOR]

Introduction: The objective of this study was to investigate the nature, management, and outcome of major injuries related to equestrian sports and to define the at-risk groups for serious and life-threatening injuries.Methods: We analyzed demographic, pre-hospital, clinical, and outcome data from an international population-based prospective trauma database (TraumaRegister DGU®). Patients with major injuries (Injury Severity Score [ISS] ≥9 points) related to equestrian sports activities were included (January 1, 1993, to December 31, 2012). Clinical and outcome parameters were stratified for four different types of injury mechanisms: fall from horse (FFH), horse-kick (HK), horse crush (HC), and carriage-related accidents (CRA). Participating countries included Germany, Austria, Switzerland, Finland, Slovenia, Belgium, Luxembourg, and The Netherlands. Statistical analyses were performed with SPSS (Version 22, IBM Inc., Armonk, NY).Results: The Database identified 122,000 documented patients, of whom 679 were equestrian incidents. Among these, the four major injury mechanisms were: FFH (n = 427), HK (n = 188), HC (n = 34), and the CRA (n = 30). Females were more likely to sustain FFH (75.5%, p < 0.001), leading to head injuries (n = 204, 47.8%) and spinal fractures (n = 109, 25.5%). HK injuries often resulted in facial fractures (29.3%, p < 0.001). Individuals sustaining HC injuries had a high risk for pelvic (32.4%, p < 0.001) and abdominal injuries (35.2%, p < 0.001). In contrast to the FFH cohort, the CRA cohort involved older males (57 ± 13 years), with chest (63.3% p = 0.001), and extremity injuries, resulting in significant injury severity (ISS 20.7 ± 10.6). In the CRA cohort, 16% were in haemorrhagic shock on scene, and also the highest in-hospital mortality (14.8%, p = 0.006) was observed.Conclusions: Young female riders are at risk from falling, horse-kicks, and crush-injuries. Older males in carriage-related accidents sustained the highest injury severity and mortality rate, and must specifically be targeted by future prevention initiatives. Level of evidence Descriptive Epidemiologic Study, Level II. [ABSTRACT FROM AUTHOR]

Postoperative junctional ectopic tachycardia (JET) is a frequent complication after pediatric cardiac surgery. Current recommendations on how and when to treat JET are inconsistent. We evaluated the management strategies of postoperative JET in German-speaking countries. We sent an online survey to 30 centers of pediatric cardiology that perform surgery for congenital heart defects in Germany (24), Austria (4), and Switzerland (2). The survey asked 18 questions about how and in what treatment sequence postoperative JET was managed. All 30 centers completed the survey (100% return rate). There was general agreement that the management of JET is based on administration of antiarrhythmic drugs, body surface cooling, and temporary pacing. Many centers presented treatment algorithms based on published literature, all centers named amiodarone as the first drug of choice. Significant disagreement was found concerning the timing and sequential order of additional therapeutic measures and particularly about the dosing of amiodarone and the role of R-wave synchronized atrial pacing.Conclusion: This survey reveals that from center to center, the treatment of postoperative JET may vary substantially. Future work should focus on those treatment modalities where a high rate of variation is found. Such studies may be of value to achieve commonly adopted treatment recommendations. What is known: • Treatment of postoperative junctional ectopic tachycardia is predominantly based on administration of antiarrhythmic drugs, therapeutic cooling, and temporary pacing. • Amiodarone is the antiarrhythmic drug of choice in this context. What is new: • Dosing and duration of administration of amiodarone differ relevantly from center to center. • The sequential order of drug administration, therapeutic cooling, and pacing is not consistent. [ABSTRACT FROM AUTHOR]

Copyright of Strahlentherapie und Onkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Transfusion-dependent patients with low- or intermediate-1-risk myelodysplastic syndrome, <5% bone marrow (BM) blasts and isolated 5q-deletion received lenalidomide within the German MDS study group phase-II clinical trial LE-MON-5 (EudraCT:2008-001866-10) of the University of Duesseldorf, Germany. Cytogenetic monitoring was performed by chromosome banding analyses (CBA) of BM cells and fluorescence in situ hybridization (FISH) analyses of peripheral blood (PB) mononuclear CD34+ cells using extended probe panels. Out of 144 patients screened for study enrollment, 24% failed to meet inclusion criteria due to cytogenetic findings. Eighty-seven patients were followed with a median observation time of 30 months. Cytogenetic response detected by FISH and CBA in 74 and 66% of patients, respectively, was predictive for hematologic response as well as of high prognostic relevance. After 2 years, AML rate was 8% for all patients. Karyotype evolution was detected in 21 (FISH)-34% (CBA) of patients associated with significantly shorter AML-free survival. Disease progression was first detectable on the cytogenetic level on average 5-6 months before recurrence of transfusion dependence. Our data show for the first time in a prospective setting that a cytogenetic monitoring from the PB helps to early identify treatment failure and progressive disease in lenalidomide-treated patients to improve clinical management.Trial Registration: EudraCT:2008-001866-10. [ABSTRACT FROM AUTHOR]

Introduction: Most asthma patients have mild disease, although the burden of mild asthma is not well understood nor studied. Some evidence suggests that many patients with mild asthma experience suboptimal symptom control and exacerbations. This study characterizes the burden of illness and treatment patterns among patients with a confirmed diagnosis of mild asthma, defined as GINA Step 1 or Step 2, and residing in China, France, Germany, Italy, Japan, Spain, the United Kingdom, or the United States.Methods: The Respiratory Disease-Specific Programme prospective cross-sectional survey was conducted with primary care and specialty physicians in each of the eight countries. Physician and patient surveys assessed demographic and clinical characteristics, frequency and timing of asthma symptoms, exacerbations, and rescue inhaler usage, the most recent FEV1% predicted, and healthcare utilization. GINA Step was determined by prescribed treatment regimen. GINA Step 1 patients were prescribed as-needed reliever medication and Step 2 required treatment with a low-dose inhaled corticosteroid, leukotriene receptor antagonist, or theophylline. Treatment adherence was assessed with the Morisky Medication Adherence scale, disease control with the Asthma Control Test, and work and activity impairments with the Work Productivity and Activity Impairment scale.Results: The sample included 1115 GINA Step 1 and 2 patients, with 53% classified as Step 2. Overall asthma control was suboptimal, with reports of nocturnal symptoms (40.6%), symptom worsening (10.5%), and rescue inhaler usage in the last 4 weeks (33.6%). 25% of patients were uncontrolled. The overall mean number of exacerbations in the last 12 months was 0.4, with a higher frequency of exacerbations in Step 2 patients who also experienced more exacerbations requiring treatment intensification, an emergency department visit, or hospitalization.Conclusion: Mild asthma imposes a substantial burden on patients, establishing the need for comprehensive management plans and ongoing support for treatment adherence.Funding: AstraZeneca. [ABSTRACT FROM AUTHOR]

Purpose: Many patients with schizophrenia have a desire for shared decision-making (SDM). However, in clinical practice SDM often does not take place. One cause might be that many patients behave passively in the medical encounter, therefore not facilitating SDM. It was the aim of the study to evaluate the effects of a patient directed SDM-training on patients' communicative behavior in the consultation, their attitudes towards decision-making and their long-term adherence.Methods: Randomized-controlled trial comparing a five-session SDM-training for inpatients with schizophrenia with five sessions of non-specific group training. The SDM-training sessions included motivational (e.g. prospects of participation, patient rights) and behavioral aspects (e.g. role plays) and addressed important aspects of the patient-doctor interaction such as question asking or giving feedback.Results: N = 264 patients were recruited in four psychiatric hospitals in Germany. The SDM-training yielded no group differences regarding the main outcome measure (treatment adherence) at 6 and 12 months after discharge. However, there were short-term effects on patients' participation preferences, their wish to take over more responsibility for medical decisions and (according to their psychiatrists' estimate) their behavior in psychiatric consultations.Conclusions: While there was no effect regarding treatment adherence, the shared decision-making training for inpatients with schizophrenia has been shown to increase patients' active behavior in psychiatric consultations during their inpatient treatment. When implemented it should be combined with complementary SDM interventions (decision support tools and communication training for professionals) to yield maximum effects. [ABSTRACT FROM AUTHOR]

Copyright of Strahlentherapie und Onkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The aim of this study was to evaluate the effects of low-level laser irradiation on the rate of orthodontic tooth movement (OTM) and the interleukin-6 (IL-6) concentration in gingival crevicular fluid (GCF) during orthodontic treatment. In this randomized split-mouth double blind clinical trial, 11 female patients aged 14 to 25 years (mean 19 ± 4.21 year), who required canine retraction following four first premolars extraction, were selected. The GaAlAs laser diode laser (A.R.C. Laser GmbH, Nürnberg, Germany) (980 nm, 100 mW, 5.6 J/cm2, three points from the buccal side and three from lingual side of the tooth, 56 s, running in continuous mode) was used for canine retraction in only one maxillary quadrant (LG). The irradiation time for each cervical and middle third of the tooth was 10 s, and 8 s for the apical third of the tooth. The other maxillary quadrant served as the control group (CG) using the laser pseudo-application in this side. The laser irradiation was applied on days 0, 7, 14, 21, and 28 of each month during the canine retraction phase. Canine retraction was done using closed coil spring with 150 g force on rectangular wires after the alignment and leveling. This study was done in 11 months. Dental casts were made at different time points during the treatment, and the amount of tooth movement was measured. To evaluate the levels of IL-6, GCF samples were collected from the distal side of the maxillary canine teeth on both quadrants at the beginning of the trial, the end of aligning phase, and on day 21 of each month during canine retraction. Although the mean rate of canine retraction was higher in the LG (0.013) than the CG (0.012) and there was definitely a tendency for more canine retraction in the LLLI, but the results failed to show any significant difference between the mean rate of canine retraction of both groups (P = 0.068). A paired t test showed that there was no significant difference in the mean concentration of IL-6 at various stages of the treatment between the groups during canine distalization (P > 0.05). Therefore, conclusive evidence could not be provided to support the efficacy of the diode laser (980 nm) in accelerating OTM in female subject. [ABSTRACT FROM AUTHOR]

Background: Previous studies comparing restraint data from different countries had to rely on randomly published data and showed wide variance in the prevalence of restraint between countries.Aim: To systematically compare datasets from four similar European countries with regard to restraint prevalence.Methods: We analysed whole country or area datasets on restraint from Wales, Ireland, Germany and the Netherlands systematically, thus excluding selection, patient and setting bias. Learning disability (LD) and forensic settings were analysed separately. Differences in proportions between countries were tested by means of Chi square, with number of admissions, admission days and catchment area as denominator and counts of restraint as numerators.Results: Full datasets were obtained allowing calculations of total admissions, total restraint numbers, numbers of patients involved and total occupied bed days. Data for Ireland is from 2012 and from 2013 for the other three countries. The percentage of patients exposed to restraint varies between 4.5 and 9.4 %. The average number of restraints per patient is stable at around 3 in all countries. Patient numbers affected by restraint per 100 occupied bed days per month vary between 0.095 and 0.200. The Netherlands have the highest use of seclusion (79 %), the longest restraint times and low use of enforced medication. Wales the lowest use of seclusion (2 %), followed by Ireland (29 %) and Germany (49 %). Events per 100 admissions per month vary between 17 and 21. Patients affected by restraint per 100 admissions per month vary between 5.4 and 7.5. LD services account for a disproportionately high number of restraint events.Conclusion: Patient related restraint data are remarkably similar between countries. Type and length of restraint still vary significantly. [ABSTRACT FROM AUTHOR]

Purpose: Pelvic organ prolapse (POP) impairs quality of life (QoL) due to vaginal bulge symptoms and changes in bladder/bowel and sexual function. The effect of alloplastic meshes on QoL is still being discussed. The purpose of this study was to prospectively evaluate the effect of mesh implantation on QoL and sexual function over 1 year.Methods: 289 women with cystocele > stage I were included in this prospective multicenter study, with nine hospitals participating (ClinicalTrials.gov NCT01084889). Mesh exposures rates and pelvic floor-related QoL using the validated German version of the p-QoL questionnaire were evaluated as the primary endpoints. Based on a single-sided binominal test with α = 0.05 and a power of 0.80, a sample size of 225 for the mesh exposures was calculated. The mesh used was a 6-arm mesh with titanium coating (TILOOP(®) Total 6, sponsor pfm medical ag, Germany). Preoperative data were compared to 6 and 12 months postoperative data, using Wilcoxon test.Results: The mean age of the patients was 67 years (min 43, max 87). All domains of QoL improved significantly compared after surgery: mean prolapse score dropped from 73.7 to 19.4 after 6 and 16.2 after 12 months (p < 0.001). Sexual function also improved significantly. The rate of dyspareunia was lower at follow-up.Conclusions: In this prospective trial, a significant positive effect of mesh implantation on pelvic floor-related QoL was observed. These findings remained stable 1 year after surgery with further improvement. This trial adds further data to the ongoing discussion on the role and risk of meshes in POP surgery. [ABSTRACT FROM AUTHOR]

Purpose: Osteoarthritis (OA) has been shown to be associated with decreased physical function, which may impact upon a person's self-rated health (SRH). Only a few studies have examined the association between OA and SRH in the general population, but to date none have used a clinical definition of OA. The objectives are: (1) To examine the cross-sectional association between clinical OA and fair-to-poor SRH in the general population; (2) To examine whether this association differs between countries; (3) To examine whether physical function is a mediator in the association between clinical OA and SRH.Methods: Baseline data of the European Project on OSteoArthritis (EPOSA) were used, which includes pre-harmonized data from six European cohort studies (n = 2709). Clinical OA was defined according to the American College of Rheumatology criteria. SRH was assessed using one question: How is your health in general? Physical function was assessed using the Western Ontario and McMaster Universities OA Index and Australian/Canadian OA Hand Index.Results: The prevalence of fair-to-poor SRH ranged from 19.8 % in the United Kingdom to 63.5 % in Italy. Although country differences in the strength of the associations were observed, clinical OA of the hip, knee and hand were significantly associated with fair-to-poor SRH in five out of six European countries. In most countries and at most sites, the association between clinical OA and fair-to-poor SRH was partly or fully mediated by physical function.Conclusions: Clinical OA at different sites was related to fair-to-poor SRH in the general population. Most associations were (partly) mediated by physical functioning, indicating that deteriorating physical function in patients with OA should be a point of attention in patient care. [ABSTRACT FROM AUTHOR]

A widely discussed shortcoming of long-term care in nursing homes for the elderly is the inappropriate or suboptimal drug utilization, particularly of psychotropic drugs. Using administrative data from the largest sickness fund in Germany, this study was designed to estimate the effect of institutionalization on the drug intake of the frail elderly. Difference-in-differences propensity score matching techniques were used to compare drug prescriptions for the frail elderly who entered a nursing home with those who remained in the outpatient care system; findings suggest that nursing home residents receive more doses of antipsychotics, antidepressants, and analgesics. The potential overprescription correlates with estimated drug costs of about €87 million per year. [ABSTRACT FROM AUTHOR]

Despite the increasing availability of routine data, no analysis method has yet been presented for cost-of-illness (COI) studies based on massive data. We aim, first, to present such a method and, second, to assess the relevance of the associated gain in numerical efficiency. We propose a prevalence-based, top-down regression approach consisting of five steps: aggregating the data; fitting a generalized additive model (GAM); predicting costs via the fitted GAM; comparing predicted costs between prevalent and non-prevalent subjects; and quantifying the stochastic uncertainty via error propagation. To demonstrate the method, it was applied to aggregated data in the context of chronic lung disease to German sickness funds data (from 1999), covering over 7.3 million insured. To assess the gain in numerical efficiency, the computational time of the innovative approach has been compared with corresponding GAMs applied to simulated individual-level data. Furthermore, the probability of model failure was modeled via logistic regression. Applying the innovative method was reasonably fast (19 min). In contrast, regarding patient-level data, computational time increased disproportionately by sample size. Furthermore, using patient-level data was accompanied by a substantial risk of model failure (about 80 % for 6 million subjects). The gain in computational efficiency of the innovative COI method seems to be of practical relevance. Furthermore, it may yield more precise cost estimates. [ABSTRACT FROM AUTHOR]

Purpose: To describe the implementation process of a computer-adaptive test (CAT) for measuring health-related quality of life (HRQoL) of children and adolescents in two pediatric clinics in Germany. The study focuses on the feasibility and user experience with the Kids-CAT, particularly the patients' experience with the tool and the pediatricians' experience with the Kids-CAT Report.Methods: The Kids-CAT was completed by 312 children and adolescents with asthma, diabetes or rheumatoid arthritis. The test was applied during four clinical visits over a 1-year period. A feedback report with the test results was made available to the pediatricians. To assess both feasibility and acceptability, a multimethod research design was used. To assess the patients' experience with the tool, the children and adolescents completed a questionnaire. To assess the clinicians' experience, two focus groups were conducted with eight pediatricians.Results: The children and adolescents indicated that the Kids-CAT was easy to complete. All pediatricians reported that the Kids-CAT was straightforward and easy to understand and integrate into clinical practice; they also expressed that routine implementation of the tool would be desirable and that the report was a valuable source of information, facilitating the assessment of self-reported HRQoL of their patients.Conclusions: The Kids-CAT was considered an efficient and valuable tool for assessing HRQoL in children and adolescents. The Kids-CAT Report promises to be a useful adjunct to standard clinical care with the potential to improve patient-physician communication, enabling pediatricians to evaluate and monitor their young patients' self-reported HRQoL. [ABSTRACT FROM AUTHOR]

Dysfunctional trauma-related cognitions are associated with posttraumatic stress disorder (PTSD). The psychometric properties of the German version of the Child Post-Traumatic Cognitions Inventory (CPTCI-GER) were assessed in a sample of 223 children and adolescents (7-16 years) with a history of different traumatic events. Confirmatory factor analyses supported the original two-factor structure--permanent and disturbing change (CPTCI-PC) and fragile person in a scary world (CPTCI-SW). The total scale and both subscales showed good internal consistency. Participants with PTSD had significantly more dysfunctional trauma-related cognitions than those without PTSD. Dysfunctional posttraumatic cognitions correlated significantly with posttraumatic stress symptoms (PTSS; r = .62), depression (r = .71), and anxiety (r = .67). The CPTCI-GER has good psychometric properties and may facilitate evaluation of treatments and further research on the function of trauma-related cognitions in children and adolescents. (Partial) correlations provide empirical support for the combined DSM-5 symptom cluster negative alterations in cognitions and mood. [ABSTRACT FROM AUTHOR]

Purpose: Obstructive sleep apnea (OSA) can lead to severe health consequences. Drivers of motor vehicles with untreated or undiagnosed OSA have a greater risk of traffic accidents. Use of self-reported questionnaires is the first step in OSA diagnosis. The main aim of this study was to perform the translation and validation of Berlin Questionnaire in a sample of commercial drivers.Methods: After formal translation, validation was performed on a sample of commercial drivers and included evaluation of internal consistency, test-retest reliability, construct and criterion validity. Full-night attended polysomnography or cardiorespiratory polygraphy was used for OSA diagnosis.Results: One hundred male participants, 24-62 years old, were included. Berlin Questionnaire classified 35 % subjects as potential OSA patients. Polysomnography confirmed OSA in 58 % of the subjects. Berlin Questionnaire showed good internal consistency (Cronbach's alpha 0.82-first category, 0.73-0.95-second category). Test-retest reliability (Cohen's kappa 0.78) was adequate. Berlin score was significantly correlated with OSA category and apnea-hypopnea index (AHI). Sensitivity of Berlin Questionnaire was from 50.9 (AHI ≥ 5) to 75 % (AHI ≥ 30), while specificity ranged from 86 to 70.5 %.Conclusions: Berlin Questionnaire (Serbian version) showed good measurement properties, creating basis for further research of its usefulness as OSA screening tool in populations of interest. [ABSTRACT FROM AUTHOR]

Purpose: Recognizing patients at risk of developing chronic low back pain is essential for targeted interventions. One of the best researched screening instruments for this purpose is the Örebro Musculoskeletal Pain Questionnaire (ÖMSPQ). This work addresses psychometric properties of the German ÖMSPQ short form and its construct and prognostic validity.Methods: Analyses are based on a cluster-randomized trial assessing a risk tailored intervention for patients consulting for low back pain in 35 general practices. A total of 360 patients consulting for acute and sub-acute back pain, aged 20-60 years, were included. All patients received a 10-item German short version of the ÖMSPQ, and other generic instruments (Graded Chronic Pain Scale, Patient Health Questionnaire-Depression, Hannover Functional Ability Questionnaire, Fear-Avoidance Beliefs Questionnaire). The construct validity was assessed based on the factorial structure of the items and correlations with generic instruments. The area under the curve (AUC), sensitivity and specificity were calculated as measures of prognostic validity.Results: ÖMSPQ items belonging to the same subscale correlated highest among each other. The internal consistency of the ÖMSPQ items was 0.80 (Cronbach's α). The factorial structure corresponds with theoretic expectations. ÖMSPQ subscales on pain related disability, depression, and fear-avoidance beliefs correlated highest with their counterpart generic scales. The AUC for three ÖMSPQ-based prediction models ranged from 0.77 to 0.81.Conclusions: Our results support a satisfactory factorial and prognostic validity of the German short ÖMSPQ. The instrument may guide the provision of targeted interventions. Further research should link it to targeted treatments. [ABSTRACT FROM AUTHOR]

Empirical studies considering the location and relocation of emergency medical service (EMS) vehicles in an urban region provide important insight into dynamic changes during the day. Within a 24-hour cycle, the demand, travel time, speed of ambulances and areas of coverage change. Nevertheless, most existing approaches in literature ignore these variations and require a (temporally and spatially) fixed (double) coverage of the planning area. Neglecting these variations and fixation of the coverage could lead to an inaccurate estimation of the time-dependent fleet size and individual positioning of ambulances. Through extensive data collection, now it is possible to precisely determine the required coverage of demand areas. Based on data-driven optimization, a new approach is presented, maximizing the flexible, empirically determined required coverage, which has been adjusted for variations due to day-time and site. This coverage prevents the EMS system from unavailability of ambulances due to parallel operations to ensure an improved coverage of the planning area closer to realistic demand. An integer linear programming model is formulated in order to locate and relocate ambulances. The use of such a programming model is supported by a comprehensive case study, which strongly suggests that through such a model, these objectives can be achieved and lead to greater cost-effectiveness and quality of emergency care. [ABSTRACT FROM AUTHOR]

Background: Physical activity (PA) is recommended for stable patients with advanced heart failure (HF). Purpose: We evaluated expected health benefits of PA and social support as facilitators of PA, and physical symptom distress and psychological distress (depression, anxiety) as barriers to PA. Additionally, we investigated if facilitators of PA are of particular importance for patients who report barriers. Method: We analyzed data assessed at time of waitlisting in 231 ambulatory patients (53.4 ± 10.3 years, 18 % women) who were enrolled in the multisite Waiting for a New Heart Study in 1 Austrian and 16 German hospitals. Self-reported everyday PA scores (number of activities, duration of activities) was regressed on demographic characteristics and indicators of disease severity (ejection fraction, peak oxygen consumption), facilitators (expected health benefits of PA, perceived emotional support, perceived support for PA), and barriers to PA (physical symptom distress, psychological distress). Interaction terms of facilitators with barriers were also examined. Results: PA was positively associated with higher peak oxygen consumption, validating self-reported PA. Regarding facilitators, expected health benefits of PA were independently associated with higher PA ( p values < 0.001). There were no main effects for social support on PA. Regarding barriers, depression tended to be associated with fewer activities ( p = 0.068). However, in the presence of barriers (depression, physical symptoms), feeling supported for being physically active was positively associated with PA ( p values < 0.05). Conclusion: Interventions to improve PA may benefit from strengthening positive expectations of health outcomes associated with everyday PA and fostering PA-specific social support for those distressed by HF symptoms or depression. [ABSTRACT FROM AUTHOR]

Aim: The study evaluates a community-based intervention programme, using a peer approach. The programme's objective is to improve life opportunities for children from disadvantaged families in a poor district of Berlin by empowering their mothers. Women of varying cultural backgrounds-most of them from immigrant families-are educated in subjects like child development, early education and health in order to work as community mothers (CMs). Their major task is to obtain access to the families, strengthen the mothers' parenting and personal skills, and promote early nursery school attendance and access to social support systems. Community settings are integrated in the programme through the establishment of family cafés in nursery and primary schools. Methods: The evaluation analyses the organisational structure and process determinants of the programme, and its impact on the CMs as well as on the visited family mothers (FMs), identifying the supporting and inhibiting factors. To match the comprehensive programme design, a mixed method approach was chosen, combining primarily qualitative methods with quantitative methods and participatory observation. Target groups for the investigation are the CMs, the FMs, and professionals directly or indirectly involved in the programme. Results: According to preliminary results, the programme has been successful in recruiting women from the community for training as CMs ( n = 67) and in reaching disadvantaged families of German and migrant backgrounds through home visits ( n = 86) as well as in single contacts in various settings ( n = 170). Access to families by home visits and sometimes in family cafés, however, has turned out to be more difficult than expected. The FMs interviewed qualitatively ( n = 15) within the first year after the start of home visits and with a semi-structured questionnaire ( n = 44) after 2.5 years, report increased self-esteem, improved relationships with their children, better access to public services, emotional support and practical assistance. The results also demonstrate a significant gain for the CMs themselves as part of the target group. Professionals ( n = 42) assess the project primarily positively; co-operation with the CMs sometimes presents barriers. Conclusion: Peer-based home visitation programmes are successful in reaching otherwise hard-to-reach populations but also have limits in access to some of the families. The combination of home visits with other forms of activities located in various settings seems promising. [ABSTRACT FROM AUTHOR]

Aim: This investigation aimed to determine whether socially disadvantaged elementary school children profit health-wise from their participation in the mentoring program 'Balu und Du' in which their basic competencies are strengthened and their health-related quality of life is improved. Subjects and methods: For the evaluation study we compared an intervention group of 141 children, or so-called "Mowglis" (treatment group), with a stratified control group of 158 children. The children in both the treatment and control groups were 6 to 10 years old and visited 38 different elementary schools at 12 participating locations in Lower Saxony, Germany. Children were recommended for 'Balu und Du' by their teachers who were worried about their pupils' disadvantaged family backgrounds and their personal and developmental problems. The control group children were also selected by the Mowglis' teachers and were supposed to match the participants closely in the mentioned attributes. With their parents' consents they participated in the evaluation study. Results: The children in the treatment group (Mowglis) can profit from their participation in the project "Balu und Du" in the areas of health-related quality of life. Scholastic achievement and motivation increased in comparison to the control group and the willingness of the children to acquire knowledge and skills that are necessary for current and future problem-solving capacity grew. Conclusion: The project 'Balu und Du' was able to reach elementary school children from socially disadvantaged families and, by strengthening important basic competencies and their health-related quality of life, can prevent hazardous health characteristics. [ABSTRACT FROM AUTHOR]

Copyright of HeilberufeSCIENCE is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objectives: The aim of the 'Motorik-Modul' (MoMo Basiserhebung, www.motorik-modul.de ) was to establish prevalence measurements on physical fitness and physical activity in German children and adolescents and to identify differences between age groups and genders. A total of 4,529 children and adolescents between the ages of 4-17 years from 167 cities across all states of the German Federation participated in this study. Sociodemographic parameters were recorded. Physical fitness was measured using endurance, strength, coordination and flexibility tests. Physical activity was assessed using a validated questionnaire, including aspects of physical activity participation (school/club/non-club), intensity of physical activity and type of activity. Chi-square tests and ANOVAS were used to compare groups and to detect age and gender effects, and data were compared with criterion-related guidelines by the WHO. For parameters describing physical fitness, age was the dominant influencing parameter. Many parameters showed increasing performance until the onset of puberty. Boys generally performed better than girls except in fine motor coordination during precision tasks and in flexibility. Physical activity was greater in older subjects with a greater intensity for adolescents who were physically active. The general activity level was similar to the data reported in the HBSC study by the WHO but lower than the recommended activity levels.Conclusion: With the results of this study, nationwide representative prevalence data on physical fitness and physical activity are available. These data contribute to the scientific knowledge on the prevalence and conditions of physical fitness and physical activity. [ABSTRACT FROM AUTHOR]