What do Germans really think about health-nudges?

Peer reviewedPublisher PD

Translation and psychometric properties of the German version of the University of the West of England Interprofessional Questionnaire (UWE-IP)

© 2017 Taylor & Francis. The implementation of a bachelor degree in Interprofessional Health Care at the University of Heidelberg, Germany, has fostered the need to evaluate the impact of this innovative programme. The University of the West of England Interprofessional Questionnaire (UWE-IP) was developed for longitudinal evaluation of an interprofessional curriculum. The UWE-IP consists of 35 items in four scales: “Communication and Teamwork Scale,” “Interprofessional Learning Scale,” “Interprofessional Interaction Scale,” and “Interprofessional Relationships Scale.” The UWE-IP was translated to German according to international guidelines. Psychometrics were assessed: reliability of the four scales was tested with Cronbach‘s alpha and confirmatory factor analysis was performed to examine the underlying factor structure. The sample consisted of 326 datasets. Reliability for the scales was between 0.75 and 0.90. The underlying factor structure showed a good fit. We conclude that the German UWE-IP shows good psychometrics and recommend its use for evaluation of interprofessional learning activities. These results add to the body of knowledge on evaluation instruments in interprofessional education

Risk factors associated with the recent cholera outbreak in Yemen: a case-control study

OBJECTIVES The cholera outbreak in Yemen has become the largest in the recent history of cholera records, having reached more than 1.4 million cases since it started in late 2016. This study aimed to identify risk factors for cholera in this outbreak. METHODS A case-control study was conducted in Aden in 2018 to investigate risk factors for cholera in this still-ongoing outbreak. In total, 59 cholera cases and 118 community controls were studied. RESULTS The following risk factors were associated with being a cholera case in the bivariate analysis: a history of travelling and having had visitors from outside Aden Province; eating outside the house; not washing fruit, vegetables, and khat (a local herbal stimulant) before consumption; using common-source water; and not using chlorine or soap in the household. In the multivariate analysis, not washing khat and the use of common-source water remained significant risk factors for being a cholera case. CONCLUSIONS Behavioural factors and unsafe water appear to be the major risk factors in the recent cholera outbreak in Yemen. In order to reduce the risk of cholera, hygiene practices for washing khat and vegetables and the use and accessibility of safe drinking water should be promoted at the community level

Prospective phase-II-study evaluating postoperative radiotherapy of cervical and endometrial cancer patients using protons – the APROVE-trial

Background: The prognosis for patients with cervical or endometrial cancer has improved over the last decades. Thus, reducing therapy-related toxicity and impact on quality of life have become more and more important. With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy) the incidence of acute and chronic toxicities has already been reduced. Nevertheless, rates of complications requiring medical treatment range from 0.7–8% according to literature. 7.7% of patients develop severe complications after 5 years with an increasing risk for complications of 0.3%/year. Particularly, the volume of the small and large bowel receiving low doses (15 Gy) has been shown to be a predictive factor for the development of higher bowel toxicity. With the introduction of proton therapy into clinical practice, there are new opportunities for optimization of organ at risk-sparing thus possibly reducing toxicity. Methods/design: The APROVE study is a prospective single-center one-arm phase-II-study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. A total of 25 patients will be included in this trial. Patients will receive a dose of 45–50.4 GyE in 1.8 GyE fractions 5–6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. For treatment planning, rectum, sigma, large and small bowel, bladder and femoral heads are defined as organs at risk. The CTV is defined according to the RTOG consensus guidelines. Discussion: The primary endpoint of the study is the evaluation of safety and treatment tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4 toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and progression-free survival. The aim is to explore the potential of proton therapy as a new method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder thus reducing acute and chronic toxicity and improving quality of life. Trial registration: Registered at https://clinicaltrials.gov , ClinicalTrials.gov Identifier: NCT03184350 , registered 09 June 2017, enrolment of the first participant 19 June 2017

Assessing self-management in patients with diabetes mellitus type 2 in Germany: validation of a German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G)

Kamradt M, Bozorgmehr K, Krisam J, et al. Assessing self-management in patients with diabetes mellitus type 2 in Germany: validation of a German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G). Health and Quality of Life Outcomes. 2014;12(1): 185

Diphtheria outbreak in Yemen: the impact of conflict on a fragile health system

Background: War in Yemen started three years ago, and continues unabated with a steadily rising number of direct and indirect victims thus leaving the majority of Yemen’s population in dire need of humanitarian assistance. The conflict adversely affects basic socioeconomic and health conditions across the country. Methods: This study analyzed the recent ongoing diphtheria outbreak in Yemen and in particular, the health system’s failure to ensure immunization coverage and respond to this outbreak. Data from the weekly bulletins of the national electronic Disease Early Warning System’s (eDEWS) daily diphtheria reports and district immunization coverage were analyzed. The number of diphtheria cases and deaths, and immunization coverage (DPT) were reviewed by district including the degree to which a district was affected by conflict using a simple scoring system. A logistic regression and bivariate correlation were applied using the annual immunization coverage per district to determine if there was an association between diphtheria, immunization coverage and conflict. Results: The study results confirm the association between the increasing cases of diphtheria, immunization coverage and ongoing conflict. A total of 1294 probable cases of diphtheria were reported from 177 districts with an overall case fatality rate of 5.6%. Approximately 65% of the patients were children under 15 years, and 46% of the cases had never been vaccinated against diphtheria. The risk of an outbreak increased by 11-fold if the district was experiencing ongoing conflict p < 0.05. In the presence of conflict (whether past or ongoing), the risk of an outbreak decreased by 0.98 if immunization coverage was high p > 0.05. Conclusion: The conflict is continuously devastating the health system in Yemen with serious consequences on morbidity and mortality. Therefore, the humanitarian response should focus on strengthening health services including routine immunization procedures to avoid further outbreaks of life-threatening infectious diseases, such as diphtheria

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)

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

Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19.

The COVID-19 pandemic has led to an unprecedented response in terms of clinical research activity. An important part of this research has been focused on randomized controlled clinical trials to evaluate potential therapies for COVID-19. The results from this research need to be obtained as rapidly as possible. This presents a number of challenges associated with considerable uncertainty over the natural history of the disease and the number and characteristics of patients affected, and the emergence of new potential therapies. These challenges make adaptive designs for clinical trials a particularly attractive option. Such designs allow a trial to be modified on the basis of interim analysis data or stopped as soon as sufficiently strong evidence has been observed to answer the research question, without compromising the trial's scientific validity or integrity. In this article, we describe some of the adaptive design approaches that are available and discuss particular issues and challenges associated with their use in the pandemic setting. Our discussion is illustrated by details of four ongoing COVID-19 trials that have used adaptive designs