"University students' economic situation during the COVID-19 pandemic: A cross-sectional study in Germany".

The COVID-19 pandemic caused a major economic downturn that disproportionally affected university students. This empirical research investigated effects and risk factors of the pandemic on students' economic situation with focus on financial distress and financial limitations. Data was collected using an online survey in May and June 2020 from students (n = 917) enrolled at universities in Germany. 80.6% were enrolled in bachelor programs (n = 738), the mean semester was 3.8 (standard deviation (SD = 2.0) and students' mean age was 23.1 years (SD = 4.1). 51.8% (n = 472) were female and 47.4% (n = 432) male. 56.7% (n = 506) of students worked before the pandemic. More than one third reported a decrease in income (36.5%; n = 334) and an increase in financial constraints (38.7%; n = 354). A multivariate logistic regression analysis showed that students with regular income were less likely to experience financial distress compared to those without (odds ratio (OR) = 0.456; p = 0.014). Furthermore, working part-time as associated with a higher financial distress compared to those without part-time employment (OR = 1.811; p = 0.003). Students who worked part-time before the pandemic also had a higher probability of increased financial restriction (or constraint) compared to those who did not work part-time (OR = 2.094; p < 0.001). University students were disproportionally affected by the economic consequences of the COVID-19 pandemic, which increased students' economic uncertainty. To offset such problems, financial aid schemes for students need to be made available to alleviate distress and to allow students to focus on their studies but should not compound problems by leading to financial hardship at a later point in time.

A Comprehensive Comparison of Additional Benefit Assessment Methods Applied by Institute for Quality and Efficiency in Health Care and European Society for Medical Oncology for Time-to-Event Endpoints After Significant Phase III Trials-A Simulation Study.

OBJECTIVES: After a successful Marketing Authorization Application for clinical trials with time-to-event endpoints, the degree of the added benefit from new treatments remains unknown and needs to be assessed. Unfortunately, until now no clear definition for added benefit determination of a treatment exists. Nevertheless, European authorities / societies have developed 2 "additional benefit assessment" methods, which have up to now not been compared: the European Society for Medical Oncology (ESMO) developed a dual rule considering relative and absolute benefit. The German Institute for Quality and Efficiency in Health Care (IQWiG) developed a method using upper 95% hazard ratio confidence interval. METHODS: We evaluate and compare both methods in an extensive simulation study including different censoring rates, failure time distributions, and treatment effects for sample size calculation. The methods' performance is assessed via Receiver Operating Characteristic curves, Spearman correlation, and percentage of achieved maximal scores. RESULTS: The results show that IQWiG's method has in many situations a lower maximal scoring proportion than ESMO's rule, that is, up to 28.5% versus 94.7%. Various failure time distributions lead to strongly changed maximal scoring percentages for ESMO. High positive correlation between the methods is present for moderate treatment effects. CONCLUSIONS: IQWiG's method is usually more conservative than ESMO's. ESMO's rule tends to be more susceptible for various failure time distributions. Using the lower confidence interval limit seems to be a better solution resulting in a higher true-positive rate without increasing the false-positive rate. Thus, IQWiG's method might need to be adapted accordingly to achieve a better overall classification.

What do Germans really think about health-nudges?

BACKGROUND: In recent years, policymakers have increasingly used behaviourally informed policies, including 'nudges'. They have been implemented to produce desirable social outcomes such as healthier eating and physical activity. In Germany, a small research team at the Federal Chancellery acts as the central unit to promote the introduction of nudges in the design of public life. Despite this, the nudging concept itself as well as the understanding around it has not spread widely among German citizens. When reporting about the concept, German media is often very critical of the concept. METHODS: Using a for age, sex and educational level nationally representative online survey with 1000 participants, we investigate whether German citizens know about the concept of nudging. We also explore if they approve of the theoretical concept as well as a list of seven specific interventions regarding healthy eating and physical activity. A particular focus is placed on whether the level of approval is dependent on the target group of the intervention, as well as different intervention-initiators. RESULTS: We find that nearly 80% of the respondents have never heard of nudging. However when being provided with a definition, we find that a strong majority (90%) supports the concept of nudging as well as all the specific interventions. Acceptance rates are higher if interventions are targeted at the general population compared to only children. All initiators - statutory health insurers, the government, private companies, and independent experts - are accepted as nudge initiators. CONCLUSION: Amongst Germans nudges are an accepted method to promote health behaviours. Policy makers from various fields in Germany should take that into account to improve future health policy.

Children of Mentally III Parents at Risk Evaluation (COMPARE): Design and Methods of a Randomized Controlled Multicenter Study-Part I.

Objectives: Mental disorders are frequent, associated with disability-adjusted life years, societal, and economic costs. Children of parents with a mental illness (COPMI) are at an increased risk to develop disorders themselves. The transgenerational transmission of mental disorders has been conceptualized in a model that takes parental and family factors, the social environment (i.e., school, work, and social support), parent-child-interaction and possible child outcomes into account. The goal of the "Children of Mentally Ill Parents At Risk Evaluation" (COMPARE) study will thus be twofold: (1) to establish the efficacy and cost-effectiveness of a high-quality randomized controlled trial (RCT) with the aim of interrupting the intergenerational transmission of mental disorders in COPMI, (2) to test the components of the trans-generational transmission model of mental disorders. Methods: To implement a randomized controlled trial (RCT: comparison of parental cognitive behavioral therapy/CBT with CBT + Positive Parenting Program) that is flanked by four add-on projects that apply behavioral, psychophysiological, and neuro-imaging methods to examine potential moderators and mediators of risk transmission (projects COMPARE-emotion/-interaction/-work/-school). COMPARE-emotion targets emotion processing and regulation and its impact on the transgenerational disorder transmission; COMPARE-interaction focuses especially on the impact of maternal comorbid diagnoses of depression and anxiety disorders and will concentrate on different pathways of the impact of maternal disorders on socio-emotional and cognitive infant development, such as parent-infant interaction and the infant's stress regulation skills. COMPARE-work analyzes the transmission of strains a person experiences in one area of life to another (i.e., from family to work; spill-over), and how stress and strain are transmitted between individuals (i.e., from parent to child; cross-over). COMPARE-school focuses on the psychosocial adjustment, school performance, and subjective well-being in COPMI compared to an adequate control group of healthy children. Results: This study protocol reports on the interdisciplinary approach of COMPARE testing the model of the transgenerational transmission of mental disorders. Conclusion: The combination of applied basic with clinical research will facilitate the examination of specific risk transmission mechanisms, promotion, dissemination and implementation of results into a highly important but largely neglected field. Clinical Trial Registration: DRKS-ID: DRKS00013516 (German Clinical Trials Register, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013516).

Meeting the needs of multimorbid patients with Type 2 diabetes mellitus - A randomized controlled trial to assess the impact of a care management intervention aiming to improve self-care.

AIMS: This study explored the impact of a care management intervention aiming to improve self-care behavior in multimorbid individuals with Type 2 diabetes mellitus on health-related quality of life (HRQoL). METHODS: A patient-level randomized parallel-group superiority trial with 32 primary care practice teams, 11 care managers and 495 patients was conducted. The intervention was delivered as add-on to an already implemented disease management program and embedded in a network of primary care practices. Hierarchical linear modeling was used to analyze impacts of the care management approach on HRQoL. RESULTS: Small improvements of HRQoL in the intervention arm were found after nine months (r = 0.024; 95%CI = [0.000, 0.047]). However, compared to standard care no significant differences of HRQoL changes were observed (r = 0.022; 95%CI = [-0.011, 0.054]). Subgroup analyses showed effects for female participants favoring the intervention arm (r = 0.059; 95%CI = [0.010, 0.108]). No significant differences between intervention and control arm for several other subgroups were observed, including subgroups defined by comorbidities. CONCLUSION: Additional care management did not influence HRQoL over and above standard disease management. Improving diabetes patients' self-care behavior in the context of structured disease management programs may be difficult to achieve. Women might benefit from additional care management, but this finding needs to be confirmed in future research.

COMPARE Family (Children of Mentally Ill Parents at Risk Evaluation): A Study Protocol for a Preventive Intervention for Children of Mentally Ill Parents (Triple P, Evidence-Based Program That Enhances Parentings Skills, in Addition to Gold-Standard CBT With the Mentally Ill Parent) in a Multicenter RCT-Part II.

Background: Mental health problems are highly frequent, as well as being associated with enormous societal and economic costs and significant disability-adjusted life years. Children of parents with a mental illness (COPMI) are at a tremendously increased risk to develop disorders themselves. According to the literature, parental mental disorders launch a wave of risk factors that in turn predict the emergence of psychological problems in the offspring, and effective treatment of the parental disorder has been associated with reduced child psychopathology (launch and grow assumption). Furthermore, studies focusing on parent-child interaction demonstrate generally poorer parenting skills in parents with mental disorders, and the enhancement of such skills has been a significant mediator in improving child outcomes (parenting assumption). Objective: To implement a preventive intervention for COPMI with the aim of interrupting the transmission of mental disorders in children of a parent with mental disorders. An RCT will compare state-of-the-art cognitive behavioral therapy (CBT) for a parent with mental disorders to CBT plus the Positive Parenting Program (Triple-P), a well-established and evidence-based program that enhances parenting skills. Methods: A total of 634 patients seeking treatment in 8 outpatient clinics in Germany and their children will be included between January 2018 and April 2021 in the study. We use (clinical) interviews and self- as well as other-report questionnaires to assess the families at four main measurement points [T1: beginning of waiting period for psychotherapy treatment (duration of waiting period depends on usual waiting period in the study center: multiple baselines), T2: begin of parental psychotherapy, T3: post-assessment, T4: 6 months follow-up]. The total observation period will be 39 months. The patients will be randomly assigned to either the control condition (25 to 45 CBT sessions) or the experimental condition (25 to 45 CBT sessions + 10 Triple-P sessions). For evaluating the treatment process, the patients and clinicians will also be assessed after each treatment session. Furthermore, there will be a continuous assessment and report of adverse events during treatment. Discussion: This trial will be the first ever to address the launch and grow as well as the parenting assumption in one study and to establish effects of the two different interventions on children's health. Our study will also likely be the first one to provide data on the comparative cost-effectiveness and will therefore provide essential information relevant for the potential implementation of such programs. The structure of the RCT will allow us to establish effects of the parental disorder(s) with/without comorbidities on children's health, to test assumptions of the trans-generational transmission model of mental disorders and bi-directional influences of different treatments on the model and to analyze specific transmission mechanisms. A deeper understanding of risk mechanisms will reveal specific transmission profiles that will result in the early detection of and effective reduction in risk factors and thus improve the health of the children at risk. Ethics: The study is carried out according to the Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki and its later supplements and local legal requirements. The lead ethics committee at the department of psychology at Philipps-University Marburg approved the study procedure and all study documents. A positive ethics committee vote is required at a study site, before the inclusion of a first patient at the respective site. Dissemination: Via peer-reviewed publications in scientific journals, the results of this study will be made available to the scientific community. Using PsychData all primary data will be made available for re- and meta-analyses. Politicians, public health services, and stakeholders will be informed throughout the study and beyond, thus, improving public policy and health care decisions concerning preventive interventions and treatments for COPMI. Trial Registration: DRKS-ID: DRKS00013516 (German Clinical Trials Register, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013516).

Health, financial, and education gains of investing in preventive chemotherapy for schistosomiasis, soil-transmitted helminthiases, and lymphatic filariasis in Madagascar: A modeling study.

BACKGROUND: Neglected tropical diseases (NTDs) account for a large disease burden in sub-Saharan Africa. While the general cost-effectiveness of NTD interventions to improve health outcomes has been assessed, few studies have also accounted for the financial and education gains of investing in NTD control. METHODS: We built on extended cost-effectiveness analysis (ECEA) methods to assess the health gains (e.g. infections, disability-adjusted life years or DALYs averted), household financial gains (out-of-pocket expenditures averted), and education gains (cases of school absenteeism averted) for five NTD interventions that the government of Madagascar aims to roll out nationally. The five NTDs considered were schistosomiasis, lymphatic filariasis, and three soil-transmitted helminthiases (Ascaris lumbricoides, Trichuris trichiura, and hookworm infections). RESULTS: The estimated incremental cost-effectiveness for the roll-out of preventive chemotherapy for all NTDs jointly was USD125 per DALY averted (95% uncertainty range: 65-231), and its benefit-cost ratio could vary between 5 and 31. Our analysis estimated that, per dollar spent, schistosomiasis preventive chemotherapy, in particular, could avert a large number of infections (176,000 infections averted per $100,000 spent), DALYs (2,000 averted per $100,000 spent), and cases of school absenteeism (27,000 school years gained per $100,000 spent). CONCLUSION: This analysis incorporates financial and education gains into the economic evaluation of health interventions, and therefore provides information about the efficiency of attainment of three Sustainable Development Goals (SDGs). Our findings reveal how the national scale-up of NTD control in Madagascar can help address health (SDG3), economic (SDG1), and education (SDG4) goals. This study further highlights the potentially large societal benefits of investing in NTD control in low-resource settings.

Generation of a New Disease-specific Prognostic Score for Patients With Brain Metastases From Small-cell Lung Cancer Treated With Whole Brain Radiotherapy (BMS-Score) and Validation of Two Other Indices.

INTRODUCTION: Patients with small-cell lung cancer (SCLC) demonstrate an exception in the treatment of brain metastases (BM), because in patients with SCLC whole brain radiotherapy (WBRT) only is the preferred treatment modality. The purpose of this study was to develop a prognostic score for patients with brain metastases from SCLC treated with WBRT. PATIENTS AND METHODS: The present study was conducted utilizing a single-institution, previously described, retrospective database of patients with SCLC who were treated with WBRT (n = 221). Univariate and multivariate analyses were performed to generate the "brain metastases from SCLC score" (BMS score) based on favorable prognostic factors: Karnofsky performance status (KPS > 70), extracerebral disease status (stable disease/controlled), and time of appearance of BM (synchronous). Furthermore, the disease-specific graded prognostic assessment score as well as the recursive partitioning analysis (RPA) were performed and compared with the new BMS score by using the log-rank (Mantel-Cox) test. RESULTS: BMS score and RPA showed the most significant differences between classes (P < .001). BMS score revealed a mean overall survival (OS) of 2.62 months in group I (0-1 points), 6.61 months in group II (2-3 points), and 12.31 months in group III (4 points). The BMS score also identified the group with the shortest survival (2.62 months in group I), and the numbers of patients in each group were most equally distributed with the BMS score. CONCLUSION: The new BMS score was more prognostic than the RPA and disease-specific graded prognostic assessment scores. The BMS score is easy to use and reflects known prognostic factors in contemporary patients with SCLC treated with WBRT. Future studies are necessary to validate these findings.

Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial.

BACKGROUND: Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions. METHODS/DESIGN: The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios. DISCUSSION: We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014).