Catheter-associated urinary tract infections (CAUTIs) are the main cause of health care–associated infections, and they increase the disease burden, antibiotic usage, and hospital stay. Inappropriate placement and unnecessarily prolonged usage of a catheter lead to an elevated and preventable risk of infection. The smartphone app Participatient has been developed to involve hospitalized patients in communication and decision-making related to catheter use and to control unnecessary (long-term) catheter use to prevent CAUTIs. Sustained behavioral changes for infection prevention can be promoted by empowering patients through Participatient.The primary aim of our multicenter prospective interrupted time-series analysis is to reduce inappropriate catheter usage by 15%. We will evaluate the efficacy of Participatient in this quality improvement study in clinical wards. Our secondary endpoints are to reduce CAUTIs and to increase patient satisfaction, involvement, and trust with health care services.We will conduct a multicenter interrupted time-series analysis—a strong study design when randomization is not feasible—consisting of a pre- and postintervention point-prevalence survey distributed among participating wards to investigate the efficacy of Participatient in reducing the inappropriate usage of catheters. After customizing Participatient to the wards’ requirements, it will be implemented with a catheter indication checklist among clinical wards in 4 large hospitals in the Netherlands. We will collect clinical data every 2 weeks for 6 months in the pre- and postintervention periods. Simultaneously, we will assess the impact of Participatient on patient satisfaction with health care services and providers and the patients’ perceived involvement in health care through questionnaires, and the barriers and facilitators of eHealth implementation through interviews with health care workers.P<.05.To reduce the inappropriate use of approximately 40% of catheters (currently in use) by 15%, we aim to collect 9-12 data points from 70-100 patients per survey date per hospital. Thereafter, we will conduct an interrupted time-series analysis and present the difference between the unadjusted and adjusted rate ratios with a corresponding 95% CI. Differences will be considered significant when Our protocol may help reduce the inappropriate use of catheters and subsequent CAUTIs. By sharing reliable information and daily checklists with hospitalized patients via an app, we aim to provide them a tool to be involved in health care–related decision-making and to increase the quality of care.Netherlands Trial Register NL7178; https://www.trialregister.nl/trial/7178DERR1-10.2196/28314 Catheter-associated urinary tract infections (CAUTIs) are the main cause of health care–associated infections and lead to a higher disease burden, increased antibiotic usage, and prolonged hospital stay. Inappropriate placement and unnecessary prolongation of the use of a catheter lead to an elevated and preventable risk of infection.The smartphone app Participatient has been developed to involve patients in communication and decision-making related to catheter use with the aim to overcome unnecessary (long-term) catheter use and prevent CAUTIs. Participatient can potentially empower patients to bring about sustained behavioral changes and prevent infections.Participatient was developed at Dutch Hacking Health Leiden 2016 as a prototype smartphone app to prevent CAUTIs by involving patients in health care–related decision-making. The jury awarded the Participatient development team with the first prize nationwide for developing a patient involvement interface with an innovative design for infection prevention.Participatient engages patients by providing them with personalized information regarding the appropriateness of their catheter, along with other medical and admission-related information.The prototype was further developed in collaboration with patients, hospital staff, social scientists, engineers, eHealth experts, infection control professionals, and clinical microbiologists. We invited patients and staff in clinical wards to express their needs and concerns and to test, rate, and provide feedback on the initial versions of Participatient and its content.Through 3 rounds of improvements, based on 5-10 interviews with patients  based onThis led us to (1) generate iconic graphics to clarify text, (2) use visual feedback intermezzos containing motivational text or an explanation of the results, (3) use plain language adjusted to the level of understanding of patients in general, (4) develop clickable and thus optional instructions in the questionnaire, and (5) disseminate practical information, which was most valued by patients in the hospital wards. The patient information leaflet was digitized in the app.After the development phase, a proof-of-concept study was conducted at a clinical ward at Leiden University Medical Center (LUMC), in which the technical and interactive aspects of the app were tested. All patients admitted to this ward were invited to download the app for use during their hospital stay. The app was introduced to the patients by the nurse who managed patient admission. We actively supported app use and assessed and adjusted the app through feedback options and a questionnaire. Users expressed positive opinions about the app’s purpose and design. We received some valuable feedback regarding the app’s content, which was generated using the Catheter Check content module. Users scored the app with 5 out of 5 stars.During initial app use or “on-boarding,” the patient is asked to provide information regarding their ward of admission, gender, age group, and previous internet or app usage. This information is used to provide directed information regarding their admission. The app can be downloaded from the Apple App store and Google Play store on a patient’s smartphone or tablet device and comprises four content modules: Catheter Check, Admission Information, Pain Score, and Feedback. Finally, a Settings menu is included in the app .Catheter Check is the catheter module, in which the appropriateness of catheter use is assessed by answering 8 questions. This yields a score in accordance with nationwide and worldwide criteria ,6. The rThe Admission Information module comprises general medical information regarding infections, catheters, and the prevention of health care–associated infections for patients, but also practical information regarding the ward. From the patient feedback in the development phase, we learned that practical details including the visiting hours and telephone numbers of the ward were the most highly desired information. Participatient includes an information module with ward-specific information. In the proof-of-concept study, we used the patient information available in the ward’s paper-based records and digitized it in the app to include images and links.The Pain Score module yielded an adopted pain score that accounts for various factors including mobility, medication, and myths and facts on pain relief. This module motivated patients to ask for adequate pain medication and medication to combat side effects including nausea when needed. Pain score evaluation is not a part of this study proposal. Nonetheless, this module has been developed for better pain registration, advice and education on side effects, and motivation of patients to seek better pain management, leading to an enhanced health care experience. Through daily reminders, patients are motivated to regularly score their need for pain medication.The Feedback module contains an 8-question survey on patient satisfaction with the app and a link for email communication with the researchers.In the Settings module, the daily reminders can be adjusted or turned off, and basic demographic characteristics, including gender, age group, and specialty and ward of admission, can be visualized and modified.Participatient is available free of cost to all patients in the participating hospitals. The costs of adjustment and deployment are covered by the research team. App download and usage are limited by a code that is provided to the patients on admission.Through the Admission Information and Pain Score modules in the app, users can avail of information and advice on other useful topics in addition to the catheter. In the development and proof-of-concept phases, users appreciated the additional functions of the app and indicated that this further motivated them to continue using the app throughout their hospital stay.During the implementation study, we aim to investigate whether the involvement of patients in infection prevention through an eHealth tool is effective and sustainable. Our primary objective is to reduce catheters without an inappropriate indication in clinical wards by 15% by implementing Participatient.Our secondary objectives are as follows: (1) to reduce CAUTIs; (2) to increase patient satisfaction with health care, their involvement in health care, and their trust in physicians; (3) to measure patient satisfaction with the usefulness and ease of use of Participatient and to optimize the app on the basis of these outcomes; and (4) to obtain analytical information regarding the use of various modules of the app and feedback from users for its further development and to make it available for extended use in preventing health care–associated infections or CAUTIs in primary and long-term care.The app will be introduced in various clinical wards at 4 hospitals participating in the study. The app will be adjusted in accordance with the requirements of each medical center. Through a stepwise approach, we will launch the study at multiple locations.The study will be implemented at clinical wards with a training session for the nurses in each ward, which will include a “kick-off” day that involves a demonstration of the app and an interactive session with the research team. We will provide information and instructions for downloading and installing the app on leaflets, which are normally provided to patients upon admission. Posters and flyers with infographics elucidating the risk of nosocomial infections and the study are provided to the participating clinical wards.In each ward, we shall assess the willingness among and potential barriers to patients and health care workers. Before launching the app at each ward, it will be adjusted and extended to contain local information, protocols, and links to relevant websites of the 4 participating hospitals.At each ward, an ambassador, with an affinity for the study, is recruited from among the nursing staff to provide peer support. This has been tested and found to be very useful in the proof-of-concept phase of this study. For active engagement of the ward staff, we included a regular support day in the ward for technical and medical troubleshooting during the implementation phase and the postintervention phase.This is an interrupted time-series (ITS) analysis with the implementation phase between the pre- and postintervention survey. After the implementation phase, we will record feedback from the wards with regard to the prevalence and indication of catheters during the previous surveillance period. This “mirroring” technique is used in intervention studies and patient care to motivate subjects to facilitate further improvements. This would foster awareness and help reduce the use of catheters. Integration of an app in the health care routine is a complex intervention, with the implementation process itself also adding to the intervention. We will use the Trials of Intervention Principles Framework  to evaluThe Participatient website  containsThe following hospitals participated in this study: clinical wards of the LUMC , with the introduction of the app as main intervention; clinical wards of the Haaglanden Medical Center —a regional general hospital—with the introduction of the app as the main intervention; clinical wards of the department of internal medicine and neighboring specialties of the Amsterdam University Medical Center  and the Spaarne Gasthuis  as the second hospital from the Reduce the Inappropriate Use of Urinary and Intravenous Catheters study, with the app as an addition to the intervention bundle.All patients in the participating wards, aged ≥18 years, or their family members will be able to download the app from the Apple App store and Google Play store and use it on their personal smartphone or tablet device . The patients and staff are included in each step of the process in accordance with the Patients Included charters on patient information resources.All data are processed anonymously. The studies are and will be conducted in accordance with the tenets of the Declaration of Helsinki, and all procedures involving patients have been approved by the Medical Ethical and Institutional Review Board of the LUMC. Before conducting the interviews, distributing the questionnaires, or using the app, informed consent will be obtained, either in the verbal or written format in the case of interviews and paper-based questionnaires or in the digital format in the app before initial use, from all users to anonymize the data for analysis.For clinical data on the improvement of care quality, consent will be obtained as described previously . PatientWe will conduct a multicenter ITS consisting of a pre- and postintervention point-prevalence survey distributed among the participating wards to investigate the efficacy of the app in reducing the inappropriate use of catheters  10]..10].We will conduct the ITS as described previously . ClinicaAll admitted patients in the participating wards will be included in the point-prevalence survey regardless of app use, catheter presence, or urinary tract infection (UTI). A local study code will be generated for each patient for those with a catheter or a UTI. This code is a pseudonym to verify the collected data and rectify as required. This code will remain in the local hospital and only be used during the study.During the point-prevalence surveys, the following data will be collected: demographic factors including gender, department and specialty of admission, age in decennia, and the date of admission; catheter use including the date of insertion of the catheter, indication of the catheter on insertion, and the indication of the catheter at the time of the survey; and UTI episodes occurring at the time of the survey and if a catheter was associated with them.The presence and indications for catheter use will be extracted from the (electronic) medical records, nurses’ lists, and observations of the admitted patients. On the day of measurement, the indication of the catheter and the necessary patient variables will be collected.To investigate the secondary outcomes, namely the impact of the app on patient satisfaction with health care services and providers and the patients’ perceived involvement in health care, the following validated instruments will be included in the questionnaires. Paper-based questionnaires on satisfaction with care, trust in the physician, and communication will be distributed. These data will be collected along with additional data including gender, department and specialty, and age group. The questionnaire on patient satisfaction with the app will be administered through the app itself.Satisfaction with care will be measured using the items of the Quality of Care Through the Patient’s Eyes (QUOTE) questionnaire . In totaTrust in the physician will be measured using Trust in physicians_short form (TRIP_sf), which is based on the Cologne Patient Questionnaire scale to evaluate the patients’ trust in physicians, which measures different aspects of trust during physician-patient interactions .Self-efficacy during patient–health care provider communication will be measured with the 5-item version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) questionnaire, which assesses the subjective sense of patients’ confidence when interacting with their physicians and patient involvement in health care ,15.To assess patient satisfaction with the app, a short 8-item evaluation questionnaire on the ease of use, time investment, usefulness, and perceived effect of the app will be used. Patient feedback will be requested through leaflets, and there will be a dedicated button on the home screen in the app.Moreover, sociodemographic factors and general previous usage of eHealth or apps among patients will be measured ,4 to detWe will evaluate the health care workers’ experience with the implementation of shared eHealth-related decision-making on the wards before and after comparison interviews to detect barriers and facilitators  in the wData on app usage and data obtained from the end users will be collected via the app and accompanying questionnaires. Usage data  on the number of downloads, the page views, and continued app usage will be collected. These data are traced to the users per ward, gender, internet or app experience, and age group, although they are not traceable to an individual level (privacy by design). User-provided data comprise the responses to the catheter check, pain score, and the use of the Admission Information module.All data entered via the App will be stored with an anonymized ID in the app and on secure data management servers ADAS and ProMISe, which are located at the LUMC and managed by the Advanced Data Management section and are ISO 27001 certified. Data files used for analysis will be stored in the safe network storage facility DataSafe .Data will be collected by the research physician (RB) at the LUMC. Participants will respond to the questionnaires. After completion of a form, the app will contact the ADAS server of the LUMC and transmit the entered data, which is then stored as message files. These files are validated and transformed into requests for automatic data entry into the ProMISe server. The ProMISe server provides the functionality for data management, including data export to SPSS for statistical analysis, wherein an SPSS export will be performed, and these files will be stored in protected network storage (DataSafe) with access limited to the investigators.α of .05. We extracted data on the incidence of inappropriate catheter use from previous studies in similar health care systems, which was approximately 40% for catheters [The sample size is based on our objective of reducing inappropriate catheter use by 15%, with a power of 80% and a Cronbach atheters ,18. We aatheters ,20. On dWe will conduct an ITS analysis, similar to the one performed previously ,22. ITS P<.05. All analyses, including subgroup analyses, will be predefined in an analysis plan before their performance.We will use figures to visualize trends and the impact of the intervention. We will present the difference in unadjusted and adjusted rate ratios with a 95% CI. Differences will be considered significant when For questionnaire assessment, we will use descriptive statistics and compare patient satisfaction with health care, their involvement in care, and their trust in physicians, before and after implementing the app. Data on patient satisfaction regarding the usefulness and ease of use of Participatient will be analyzed using descriptive statistics and will be used for subsequent rounds of app improvement after the study.P<.05.Based on our objective of reducing the inappropriate use of approximately 40% of catheters by 15%, we aim to collect 9-12 data points from among 70-100 patients per survey date per hospital. We will conduct an ITS analysis, which is considered a strong study design when randomization is not feasible. We will present the difference in unadjusted and adjusted rate ratios with a 95% CI. Differences will be considered significant when This protocol describes the objectives, design, intervention, and survey methods for the “Patient Engagement Counter Catheter-associated urinary tract infections with an App” study and aims to prevent the inappropriate and prolonged use of catheters at acute care facilities.A potential limitation of an ITS analysis is the lack of a control group. However, this quasi-experimental design is considered to be among the most effective and powerful designs when randomization is not feasible. Another limitation of this protocol is its inability to evaluate the impact of app use on an individual level. However, the intervention stimulates communication and creates awareness regarding the risks of inappropriate catheter use among all ward staff through patient engagement, thus benefiting all patients in the ward.Thus far, patient involvement in infection prevention has been undervalued and unused as a means to improve the quality of care. By sharing reliable information and daily checklists to patients via an app, we can provide them a tool to involve them in the management of catheter use. Thus, inappropriate catheter use is expected to be better noticed and discouraged, and the risk of CAUTIs could be reduced.


An estimated 1 billion people with disabilities live in low and middle income countries, a population that includes people with communication disabilities (PwCD). PwCD are a heterogenous group with a wide range of abilities who may be underrepresented in research due to the communication demands involved in research participation.A critical analysis of 145 studies from a previously published systematic review was undertaken with the aim of documenting the opportunities for direct participation of PwCD in research on poverty and disability in low- and middle- income countries.The key finding was the high risk of underrepresentation of PwCD in research on poverty and disability in LMICs, despite low rates of explicit exclusion . A total of 366 uses of data collection tools were analysed (255 unique tools). The majority of data collection tools had high communication demands (92.9%), including those measuring disability (88.6%) and those assessing poverty (100%). Only 22 studies (15.2%) specifically included PwCD. A subset of these studies (n = 14) presented disaggregated data in a way that allowed for analysis of outcomes for PwCD, suggesting a clear intersection between poverty and communication disability, with findings related to general poverty indicators, reduced access to education, low levels of employment, and additional expenditure.The findings suggest a systematic underrepresentation of PwCD in research on poverty and disability with substantial implications for future policy and program planning, directly affecting the availability and provision of services and resources for this population. A failure to provide adequate opportunity for participation of PwCD in research risks leaving those with communication disabilities behind in the pursuit of global poverty eradication. A key recommendation by the World Report on Disability , and thenot included in the definition for the purposes of this paper for two reasons, the first being that hearing difficulties are categorised as distinct in the WGQs and although communication challenges may result these are not inevitable and secondly, in the case of sign language users, not relevant when the individual is using their preferred language. People who are Deaf , deaf  or hard of hearing also face difficulties in communicating and therefore, as an established body of research already shows, are frequently excluded from research . The underrepresentation of people with communication disabilities in research significantly impacts on the accuracy of data pertaining to their service , and theGlobal rates of communication disability are not known. Conservative projections indicate that there will be 190.5 million people with communication disabilities in LMICs by 2025. The existing data is largely geographically and historically framed, but suggests that among people with disabilities, as many as 28–49% have a communications impairment as a component of their disability . ReporteParticipation and inclusion of people with communication disabilities in research. The documented exclusion of PwCD from health research appears to be particularly pervasive for those with moderate to severe communication disabilities (e.g. in aphasia research ). This tThe inadequate representation of PwCD in research (including research based on census data) may be impacted by the fact that many disability measurement or screening tools do not specifically account for communication disability. This challenge is partly addressed by the adoption of the WGQs. In their short form, the WGQs are a set of six questions aiming to identify people with a disability, with the final question directly addressing communication difficulties. Although the WGQs (when administered as intended) should contribute to improved data disaggregation regarding the prevalence and severity of communication disability, true inclusion of this population is not guaranteed unless the relevant data collection processes (such as interview or surveys) are communicatively accessible.The extent of poverty experienced by PwCD in LMICs, is unknown, with limited data available. Research in HICs, in which resources and support are more readily available, indicates that those with communication disabilities may be economically disadvantaged. For example, in his analysis of epidemiological and economic data, Ruben  concludePoverty is generally accepted to be multidimensional, encompassing income, the ability to satisfy basic human needs such as shelter, education, employment or healthcare, and the capacity to contribute to family, social and political life , 29. ThiAn understanding of what disaggregated findings already exist and to what extent they are representative of PwCD and based on inclusive research practices, is an important first step in ensuring an inclusive evidence base which informs the specific needs of PwCD.The aim of this critical review is to document the opportunities for, and actual participation of, PwCD in research on poverty and disability in LMICs that met the criteria for inclusion in a previously published systematic review . SpecifiThe extent to which data collection tools and processes reported by primary studies addressing poverty and disability allowed for the direct participation of PwCD Where disaggregated data is available, to synthesise the findings on poverty and PwCD in LMICsA critical review approach was adopted, allowing for extension beyond description in order to analyse the primary studies in depth. A critical review approach differs from a systematic review in that it is typically not based on a structured systematic search of the literature, but is focused on a conceptual evaluative approach to the available literature . The focPoverty and Disability in Low- and Middle- Income Countries ll data collection exercises should include means for free, active and meaningful participation of relevant stakeholders, in particular the most marginalized population groups’ , p.3. PaThe second principle recognises that data disaggregation is required in order to identify patterns of inequalities. The findings of this study suggest that communication disability may be a contributing factor to inequalities and therefore disability data should allow for identification of PwCD. The Washington Group Short Question Set on Disability , when adAccountability is the final principle of a HRBAD and it is of direct relevance here. Even inclusive research and data collection processes do not automatically translate into policy and practice–in some contexts people with disability may be over-researched but remain marginalised . HoweverIn this study, direct participation of PwCD in research on poverty was explored–a complex phenomenon which is usually assessed at the household level. Other domains, such as quality of life, experiences of, and access to, education, health and justice, are domains where direct participation may be particularly important.reported about data collection tools and processes. Clearly it is possible, and even likely in some instances, that researchers or enumerators made adjustments ‘in the moment’. Informal visual analogue scales, or the use of supportive gesture may have been implemented but not reported. However, the vastly inconsistent prevalence findings, for example, indicate a need for transparency in reporting. The lack of detailed reporting on factors relating to method and study design warrant consideration. For transparency we suggest that issues of adjustment or communication support be clearly reported when used to allow for interpretation of the data.The main limitation for this critical review rest on the fact that analysis relied on what was Furthermore, the analysis was limited to consideration of communication disabilities as implicitly defined by the WGQs. The communication barriers experienced by people who are Deaf/deaf or hard of hearing were not explored in this study. The barriers to access intersect, but also have unique features and further exploration specific to the inclusion of Deaf / deaf and hard of hearing individuals in such research is warranted.Poverty and Disability in Low- and Middle- Income Countries: A Systematic Review [The use of c Review  as a proPeople with communication disability may be subject to subtle and unrecognised restrictions in their right to freedom of expression and opinion , pg.1. IS1 File(DOCX)Click here for additional data file.


The concept of internationalisation, when referring to the work of social scientists within academic institutions, takes on different meanings and involves different activities. This contribution aims to shed light on the international activities of political scientists across Europe and to investigate the various meanings and practices of internationalisation. The analysis relies on the PROSEPS survey, involving some 1,800 political scientists across 37 European countries. We identify three distinct profiles of international scholars: the networked researcher, the editorial manager, and the traveller. These profiles differ according to 1) the building of international research networks, 2) the involvement in the activities of the international publishing industry, 3) the research and teaching exchanges with foreign academic institutions. Determinants, such as gender, family status, career stage, availability of institutional and financial support, and geographical location, are considered as potential drivers or inhibitors of internationalisation. Our analysis shows that the internationalisation of academic practices follows contrasting paths according to the type of international profile. The idea that science is an intellectual enterprise overcoming national borders is something that we often take for granted, without requiring any further justification or specification. Although the international mobility of students and scholars is as old as universities themselves  list, Jane Knight : 6 mentiThe quest for a conceptual clarification is not just the result of the usual academic pedantry. The point is that each of these internationalising practices (and others that could be added) might appeal to different types of scholars and might require a different set of skills and resources. It is thus necessary to disentangle the meanings of internationalisation. To do so, we propose to draw on insights of existing practices rather than on a priori deliberation. The richness of the data of the PROSEPS survey allows us to investigate current practices of political scientists across Europe. Starting from self-reported scholarly activities, we look for different patterns of internationalisation and offer a parsimonious description of the actual meaning of internationalisation on the ground across European political science.The PROSEPS  project aims at building a network of scholars—mostly political scientists and political sociologists—to study the internationalisation and social impact of political science in Europe. It focuses on 1) the transformation of the academic subject, 2) the social and media visibility of its research outputs, 3) the international mobility and circulation of its researchers, 4) the applicability and concrete applications of the work of political scientists. Funded as a COST Action, the project ran between 2016 and 2020 and involved scholars from 40 European countries.2As far as internationalisation is concerned, the PROSEPS survey includes a large number of useful indicators 17), covering a broad range of internationalising activities related to teaching, research, and leadership. Table 7, coveriWe relied on a principal component analysis (PCA) with varimax rotation to identify the main types of international scholars across European political science. PCA is a statistical technique that is widely used to reduce dimensionality in cases of rich and complex information. In our analysis, PCA is useful for disentangling different dimensions of a concept while keeping as much information that is contained in the original set of the 17 indicators of internationalisation as possible. In other words, the goal of PCA is to maximise parsimony while preserving most of the richness of the original information. When several factors are considered, PCA allows to organise the maximum number of factors into the minimum number of underlying dimension(s). The first component retains the maximum possible information, the second component retains the maximum of the remaining information, and so forth.Published in a language (not English) other than the principal language of your academic system and Partner or subcontractor of a research project funded by international institutions) do not load sufficiently on either of the three components. It means that organising them together with other factors does not bring enough to any of the three main components. For this reason, they will not be considered in the following analyses.Table international networked researcher. Internationalised scholars belonging to this first type tend to publish in peer-reviewed international journals, and often with international co-authors , institutional support from the university of belonging, and career stage.For the purpose of this investigation, we identify three broad European regions: Northern Europe, the Mediterranean countries, and Central and Eastern Europe (CEE). In addition, we divide CEE into two sub-groups according to European Union membership.Family responsibilities are another source of contrasting propensity to build an international scholarly profile. Having children might be a particularly strong negative incentive in this sense. Gender is another key factor that may potentially affect international activities, and even more so when combined with family responsibilities. The PROSEPS survey provides information on both these aspects. Regarding family responsibilities, we have re-arranged the available information into four categories, integrating the family status with the presence of children in the same household. It seems reasonable to imagine four different situations, in order of increasing challenges posed to international mobility and activities. Scholars who are single, divorced, or widowed and without children are the least likely to have family responsibilities  and add another one, the career stage. This last variable is operationalised as a simple dichotomy that distinguishes between tenured and non-tenured scholars. As discussed above, family responsibilities can have differentiated effects on men’s and women’s career trajectories. To take this into account, we introduce an interaction term between gender and career stage in the modelling.Figure The first, quite surprising, insight is that neither gender nor family responsibilities seem to have any significant effect on the levels of internationalisation among the PROSEPS respondents. The interaction term is also statistically non-significant, and this for all the three types of international profiles. The only exception is represented by family responsibilities in the case of the international editorial manager. When compared to the absence of family responsibilities (scholars that are single/divorced/widowed and do not have children), the highest level of family burden (single/divorced/widowed with children living at home) has a negative impact on this specific set of activities. It does not exert any effect on the other two sets of activities. This result meets the 95% confidence interval statistical standard. As pointed out earlier, this may also be partially due to self-selection for responding to the survey. Scholars who are juggling between work and family commitments are probably among the least likely to answer a survey about the profession. While care responsibilities are unlikely to be the only driver for self-selection, it is certainly an important one. There are numerous accounts in the literature about how international activities are not always gender- or family-friendly. This said, a recent study from Norris  on the gfrom the three other areas.On the contrary, the variables capturing the career stage, the level of institutional support, and the regional location are all statistically relevant. Tenure is a strong predictor of internationalisation when this refers to editorial management activities. This most probably indicates that experienced scholars are more likely to take on (and to be offered) such responsibilities. International travellers are more commonly found among non-tenured (and often at an earlier career stage) scholars. This is also understandable. Tenured positions often imply teaching duties and institutional responsibilities that cannot be easily bypassed and normally require a physical presence at home university. Institutional support for international activities is also a significant predictor of internationalisation. This time, however, it is more relevant for networked researchers and travellers, and less so for editorial managers. This makes sense, as the four possible types of support included in the PROSEPS survey primarily refer to research activities to be carried out abroad, such as, participation in international conferences, teaching/research fellowships, and support for cooperation in international projects. This finding echoes the argument made by Norris  about thThis article aims at advancing our knowledge on the internationalisation of European political scientists. Drawing on the PROSPEPS survey, we have first disentangled three different and complementary set of practices regarding internationalisation and identified three ideal typical profiles: the networked researcher, the international editorial manager, and the traveller. Our investigation about the determinants of the propensity of European scholars to resemble one of the mentioned profiles reveals that some factors  exert differentiated directions for each type of international political scientist. While the PROSEPS survey covers the entire area of Europe and the response rate is satisfactory, we nevertheless have to keep in mind potential effects linked to self-selection and self-reporting. Our findings are thus best considered as illustrations of trends in practices rather than an iron law about any successful internationalisation of political science.Contrary to our expectation, gender and family responsibilities seem not to have a significant impact on internationalisation. Again, we should be careful in our phrasing. Gender and family responsibilities do not exert any significant impact among the PROSEPS respondents who were included in this specific set of analyses. A self-selection effect may blur the gender picture of international activities. Women academics are also more likely to be single or to have no children compared to men academics (for a recent overview of the gender barriers in European academia, see Engeli and Mügge Last but not least, geography matters too. The uneven distribution of resources between universities belonging to different European areas represents another obstacle for political scientists of southern and eastern countries to fully take part in the international debate, and even more so for countries outside the EU. The fact that scholars from the disadvantaged areas travel more than their colleagues from Northern European universities does not contradict this finding. There are certainly benefits from a circulation of political scientists for long-term visiting positions in foreign institutions. Nevertheless, problems arise for building a truly European Political Science when circulation goes one-way only (see also Norris


Copy number aberrations (CNA) are one of the most important classes of genomic mutations related to oncogenetic effects. In the past three decades, a vast amount of CNA data has been generated by molecular-cytogenetic and genome sequencing based methods. While this data has been instrumental in the identification of cancer-related genes and promoted research into the relation between CNA and histo-pathologically defined cancer types, the heterogeneity of source data and derived CNV profiles pose great challenges for data integration and comparative analysis. Furthermore, a majority of existing studies have been focused on the association of CNA to pre-selected “driver” genes with limited application to rare drivers and other genomic elements. In this study, we developed a bioinformatics pipeline to integrate a collection of 44,988 high-quality CNA profiles of high diversity. Using a hybrid model of neural networks and attention algorithm, we generated the CNA signatures of 31 cancer subtypes, depicting the uniqueness of their respective CNA landscapes. Finally, we constructed a multi-label classifier to identify the cancer type and the organ of origin from copy number profiling data. The investigation of the signatures suggested common patterns, not only of physiologically related cancer types but also of clinico-pathologically distant cancer types such as different cancers originating from the neural crest. Further experiments of classification models confirmed the effectiveness of the signatures in distinguishing different cancer types and demonstrated their potential in tumor classification. Copy number variations (CNV) are a class of structural genomic variants, in which the regional ploidy differs from the normal state of the corresponding chromosome. Germline copy number variations constitute a major part of genomic variability within and between populations and are an important contributor to genetic and inherited diseases , which presents a potential for early-stage and non-invasive cancer detection, attracts the attention of both the academia and the industry   represents an initiative from the International Cancer Genome Consortium (ICGC) for the uniform analysis of a representative set of cancer samples using Whole Genome Sequencing (WGS)  to perform a uniform normalization  using All copy number data can be represented in a platform-independent format of genomic segments, where each segment represents a continuous region on a chromosome. As the segments vary dramatically in platform-dependent resolution, reported size, and biologically supported thresholds  to perform a feature extraction, which generated a panel of cytobands with high separation power. In the second phase, the selected cytoband features were denormalized to the protein coding genes from each band. Finally, another iteration of the feature selection process was performed to arrive at a selection of genes that contribute to the distinctiveness of individual sample profiles.Another straightforward approach is to use the coverage of protein coding genes to represent each segment. This method provides inherent connections to genetic functions; however, direct mapping to protein coding genes overlooks the structural impact of CNA and also results in a large number of features, which are often difficult for machine learning methods to perform in optimal. In this study, we designed a two-phase approach to generate a refined gene panel as the feature representation, so that the noise and redundancy of the feature space could be reduced with consideration to functional significance. In the first phase, CNA segment data was mapped to cytobands, which represent “genomic phenotypes” correlated to gene density and chromosome structure and provided a good balance between feature number and genomic resolution. The cytobands features were then added to a hybrid model of An autoencoder is an unsupervised neural network that can derive abstracted representations from data. It usually consists of two parts, an encoder and a decoder, and both are also neural networks on their own. The input is first transformed to an encoding, then restored to its original by the decoder. The aim of an autoencoder is to reconstruct the input as exact as possible, and in the process, it learns a representation (encoding) of the input. It's typically used for dimensionality reduction and to remove noise from signals  were compared on their abilities of input reconstruction. The denoising and contractive autoencoders showed the best performance in the restoration of CNV data, and the denoising autoencoder was chosen for its efficiency in implementation. The details of the comparison are elaborated in Layer-wise Relevance Propagation (LRP) is a technique to scale the importance and contribution of input features in a deep neural network. It utilizes the network weights and activation functions to propagate the output backward until the input. The basic propagation rule is illustrated as the following:j and k are two neurons from two adjacent layers. a is the activation of a neuron, and w is the weight between two neurons. The initial R is known from the output, and this formula is iterated to compute R for each neuron in the previous layer until reaching the input layer. LRP provides a solution to the “black-box” problem of deep neural networks, and is especially useful in tracing the network attentions and understanding the network behavior. In our hybrid model, we exploited LRP's ability to quantify the importance of input features in distinguishing different samples. When an autoencoder can reconstruct a large number of inputs with high accuracy, it provides an encoding that carries the information to recognize the differences between samples. If we apply LRP to this encoding, we would be able to measure the importance of each feature in the encoding.Here, A primary goal of the research was to investigate the similarity and differences of CNA between cancers, through CNA feature dimension reduction toward an optimal representation of the uniqueness of each sample. In our hybrid model, we combined autoencoder's ability to recognize differences and the LRP's ability to scale feature relevance. First, the transformed feature matrix was used as the input data for the training of a denoising autoencoder. Then, the encoding generated by the autoencoder was used as the input of LRP to compute the weightings of each feature in the initial feature matrix. Next, the weightings of each feature were summed and normalized for all samples. Finally, by applying a threshold, we obtained a panel of high weighting features representing the uniqueness of each input sample.cytobands with high weighted CNA coverage; then, the hybrid model was utilized on the new feature matrix (CNA coverage on protein coding genes of the high-weighting cytobands), to calculate a panel of high-weighting genes as a representation of each sample's feature space. In the two-phased feature extraction, the hybrid model first returned a panel of Progenetix and arrayMap resources . In general, spatial and annotation analysis suggest that some feature genes reflect structural and functional alternations in samples; the signatures of different subtypes show high preference in several genomic regions that suffer frequent CNAs in many cancer types; and some subtypes, which have distinct disease codes, exhibit high similarity in their signatures.In the majority of copy number studies, analyses of tumor samples are focused on identifying the driver genes or the focal regions. However, in this study, the frequent drivers such as TP53 and PTEN, and the common aberrations such as CDKN2A/B and MYC are removed due to their prevalence. The genes in the signatures rather reflect the uniqueness of each sample or each cancer subtype. It is importance to note that the feature genes are not intended as the only nor the optimal representation. The fundamental objective of the study is to explore the potential driver mutations that are infrequent but relevant to specific cancer types. Although the signatures do not imply pathogenic causation, we can instead reveal their potential implications and correlations by investigating the signatures and the feature genes  The immunoglobulin heavy chains related genes showed the highest significance. Although the mutations of these genes are known to play causal roles in B-cell related malignancies  gene families are defined based on evolutional and functional homologies . High-level deletions are frequently observed and selected as features in many subtypes. Different studies have shown similar observations of frequent deletions on chromosome 22, however, the mechanism of the deletion is still obscure and the functional impact remains putative  were removed in the process. For future studies, complementary strategies should be developed to include these samples without detrimental effects on data normalization and quality. With respect to sample annotation for histologic and diagnostic classifications, extensive efforts went into the curation of the data with the aim to use a unified set of classifications. Here, future analyses may make use of emerging cancer specific ontologies for a better integration of varying annotation granularities using hierarchical terms and concepts. Currently, our research group is finishing a parallel study on ontology mappings of cancer samples, and we are expecting a considerable improvement in the disease annotation of samples in future studies.In summary, this study presents a systematic pipeline for integrative and comparative analyses of a large amount of copy number data. The resulting CNA signatures offer new perspectives on the understanding of common foundations in cancers and show promising potential in applications of tumor classification.https://www.progenetix.org;Data from TCGA is available at: https://portal.gdc.cancer.gov;Data from PCAWG is available at: https://dcc.icgc.org; Segmentation data and metadata of open-access samples used in the study are available at https://progenetix.org/progenetix-cohorts/gao-2021-signatures/.Data from Progenetix is available at: BG developed the method and implemented the analysis. MB conceived the original concept and supervised the project. All authors contributed to the writing and revisions of the manuscript.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Malnutrition is a major public health problem. It contributes to the high death rate among children in developing countries despite the various advocacies of institutions such as WHO and FAO and many other organisations. More research needs to be done in order to contribute to the achievement of the Sustainable Development Goals. The aim of this study was to explore socio-cultural practices and their influence on feeding practices of mothers and their children in Grand Popo, Benin.A qualitative research methodology was used with an inductive approach. A pretested discussion guide was used to conduct focus group discussions with participants in their local language. Four focus group discussions were held in 4 villages located in both the rural and the semi-urban areas with each focus group comprising seven to eight participants. The study protocol was approved by the Health Research Ethics Committee of Stellenbosch University. Focus group discussions were recorded, transcribed and translated to English. The data was analysed following the Creswell data analysis steps.All the children were breastfed, and 56.1% of children under 6 months received breast milk exclusively. Children were introduced to family foods at 5 months with very low consumption of animal protein and fruits. Mothers and children had monotonous diets with high consumption of vegetables and maize-based meals. Food taboos, particularly during pregnancy, were revealed. Those cultural beliefs were still followed by some mothers, and food rich in nutrients were pushed aside.There is a need for educational interventions to raise awareness of the negative impacts of some socio-cultural practices on the health of the mother and child. Malnutrition continues to be a major health burden in developing countries. Globally, it is the most important risk factor for illness and death. Every country is facing a serious public health challenge relating to malnutrition . AccordiPoor nutrition in the first 1000 days of a child’s life can also lead to stunted growth, which is irreversible and associated with impaired cognitive ability and reduced school and work performance . Rapid gExclusive breastfeeding is defined as the practice of only giving an infant breast milk for the first 6 months of life (no other food or water) and has the single largest potential impact on child mortality of any preventive intervention . Early iYoung children need adequate dietary intake  to support the rapid rate of growth that occurs in the first 2 years of life. Inadequate feeding and care practices often lead to a rapid decline in nutritional status after birth, and more prominently after 3 to 4 months of age .. Similarly, in rural Ethiopia, pregnant women avoid eating green leafy vegetables, yoghurt, cheese, sugarcane and green pepper as habitual in fear of obstetric complications associated with the delivery of a bigger infant [Different forms of taboos and cultural beliefs about food exist. They vary from one society to another and range from food for the adult and food fed to children. For example, snails and cane rat meat are taboo among pregnant women and eggs among children in Southeastern Nigeria . Similarr infant . A studyr infant . Anotherr infant . These br infant . It is nr infant .The study design was exploratory, descriptive and qualitative with an inductive approach . This meBenin is a French-speaking West African nation with an estimated population of 11.8 million inhabitants. The population of the community of Grand Popo is estimated at 57,636 inhabitants, 28,237 men and 29, 399 women, according to the national demography in 2013 . The comThe sample for this study was purposively recruited from participants of the related study from the same community which had 408 mother-child pairs from 24 villages. The children were under 5 years, and if the mother had more than one child, the youngest was preferred for the study. The inclusion criterion was parents living in the area for at least 6 months with children between 0 and 60 months, while the exclusion criteria were households not residing in the areas or those with no children in the 0 to 60 months age range.Focus groups were held in 4 villages selected from the 24, with eight to ten participants. A common guideline for focus group research is to conduct at least two focus groups for each demographic stratum in the study , 21. ForThe four focus group discussions (FGD) were held between February and April 2019. The discussion groups comprised seven to eight participants gathered in the public square or under the tree. Focus groups were conducted to establish the socio-cultural practices that influence children’s diets. The researcher welcomed the participants, asked each of them to introduce themselves and summarised the purpose of the discussion and informed the members that participation was voluntary. They were informed that the discussions were recorded, and confidentiality was assured to them. The researcher facilitated the focus group using the discussion guide which elaborated on specific topics identified to help manage the discussion. Themes were about healthy diet, breastfeeding, practice of exclusive breastfeeding, food usually given to a child in a day, foods necessary for child growth, first year feeding practices, care practices and feeding during illness, food distribution in the household (who is served first), foods taboos, restrictions during pregnancy and breastfeeding (women), foods eaten especially during pregnancy and lactation for mother and child good health, foods young children cannot eat and foods not eaten during illness. Two research assistants, who were students from the Department of Nutrition of the University of Abomey-Calavi, Benin, were selected to help the researcher with information recording. Assistants were observers during the discussions, who recorded and took notes. The researcher facilitated the sessions and allowed participants to express themselves freely.Mina) using the French guideline, since most mothers did not understand French nor English. Two research assistants assisted with the recording of information and the capturing of the socio-demographic characteristics of the mothers. The recording was in the local language while the notes were done in French and English.Quality control of the focus group guide was assured by choosing guidelines for the discussion from instruments that have been validated in preceding studies , 24. In Mina language before they were invited to participate in the study and informed consent obtained. The mothers were advised that their participation was voluntary and that they could withdraw at any time point without any explanation. Confidentiality was assured to them. The mothers of the children who agreed to participate in the study were presented with the consent form for signing.Ethical clearance was obtained from the Health Research Ethics Committee of Stellenbosch University (Reference no: S16/10/211). The study proposal was also submitted, and administrative authorisation obtained from the Departmental of Health of Mono-Couffo (Benin) to conduct the survey in the region. The recruitment of participants started with the researcher and assistants’ introduction to the chief of the village, where they explained the purpose of the study and sought permission. The chief helped the team to contact and recruit households. Prior to the interview, the mothers were informed of the goal of the study in the local Mina and French to English. The data collected was classified and organised into themes before generalisations were made. The analysis was done according to Creswell’s [The focus group data interviews recorded were transcribed and translated from eswell’s  five steFour focus group discussions were carried out with an average of 8 mothers per focus group  accompanied by local vegetable soup to the children who are on the family diet. Their diet is in most cases totally lacking in animal protein and fruit sources. Lack of funds and cultural believes limit the consumption of animal protein. Some mothers in focus group four said ‘Child can eat cowpea (vegetable) and jute sauce at 10 months’ another contradicted by saying ‘He couldn’t. He is too young for that’ and another backed the first statement by saying ‘He could. Just prepare it well and crush’. This is an indication that mothers have different perceptions and knowledge on what and how to prepare foods to give to the infant. On protein foods, one mother said ‘Give meat and fish occasionally. Eat eggs regularly, at least three times a week’. The main source of animal protein in Grand Popo, Benin, is fish. This is understandable considering that it is a fishing community, and fish is available permanently in the households. In low-income countries, meat and milk products are often lacking in the diets of children. Yet, the benefits of their consumption especially meat has been shown that it improved growth indicators, micronutrient status and cognitive performance [Social norms have a great impact on the quality of care provided to children by their mothers. There is a saying in West Africa that the whole family is responsible for supporting the child while growing up. The first year of a child’s life is a delicate time that all mothers recognise. They introduce the child to adult food from as early as 3 months, or later, 5 or 6 months. On the topic of first year diet, most mothers cited maize porridge as the first food followed by other foods or what the family eat  are often favoured with the best part . A motheFood taboos and misconceptions about food use contribute to the high levels of undernutrition. In fact, it plays a significant role in determining the diets of pregnant and lactating women, infants and young children. In the community studied, there are food taboos, but it is no longer respected by many. Some families or members of certain religions define some food items as appropriate for consumption and others less so . AccordiFurthermore, there are dietary restrictions during the period of pregnancy where women avoid nutritious foods for reasons such as avoiding having a big baby, facilitating labour and delivery, or not bearing a child which results in avoidance of certain foods. The study revealed that eggs, cane rat and wild meat were avoided during pregnancy. Long and hard labour was the reason given for avoiding it. They said ‘No eggs during pregnancy. We can eat but whole, we couldn’t share with someone else. A pregnant woman should not prepare eggs and give to someone. She must cook for herself and when she removes the shell it should not have any hurt otherwise, she should not eat because she might have birth complications’. Another group said, ‘When we are pregnant, we do not eat cane rat (giant rats)’. Ekwochi et al.  reportedMina  since most mothers did not understand French. For analysis, the data were first translated to French and then into English. Quality checks of the Mina and English were done by the researcher. However, it is known that the gist of words could have been lost in the progress of transcription and translation.The FGDs were conducted in The findings revealed that most mothers treated their ill children at home with self-prescribed tablets or herbal tea and only go to the hospital when the condition worsens. Socio-cultural influences were one of the determinants of the decisions that mothers made on child care and feeding practices. Many interventions are focused on the treatment of undernutrition, but it is necessary to raise awareness about the challenges brought by the influence of cultural practices in communities. On the basis of our findings, interventions should be focused on the household dynamics, as cultural norms are a barrier to child care. Educational interventions should be designed to raise awareness of the negative impacts of some socio-cultural practices on the health of the mother and child. It would be beneficial if the authorities organised nutrition education sessions in urban and peri-urban communities to improve the mothers’ knowledge on nutrition, food and child care practices based on local dietary practices. Involvement of men, religious and local authorities, as well as older women (grandmothers), would be an asset in adjusting diets all the while still respecting the culture of the environment.


Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki.For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed.The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible.The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements.Trial registration: Not applicable. Informed consent (IC) in biomedical studies can be defined as a process of communication involving both investigator and research participant that culminates in the authorization or refusal of participation in a research study . It is gToday, biomedical research, especially pharmaceutical research, is increasingly carried out by companies in offshoring mode. Countries in Central and Eastern Europe may constitute an inviting research environment due to centralized hospital systems and relatively fast patient recruitment. The ClinicalTrials.gov database of privately and publicly funded clinical studies lists 1.257 clinical trials that started in 2019 in Germany. These numbers for Poland and Russia are 552 and 372 respectively . Many ofThere is a risk that ethical compromises will occur in such contract studies . This isThe Declaration of Helsinki  is generThe aim of this research is to examine the requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. These three countries have been chosen as the focus of the investigation for several reasons. First, they are among the countries conducting a high number of clinical research each year. Second, they belong to supranational organizational structures, i.e. European Union (EU) and Eurasian Economic Union (EAEU), which require adaptation of national laws to common regulations. Third, we hypothesize that despite different historical developments these countries share sufficient socio-cultural values and orientations, to have enacted similar regulations on IC.This investigation is a comparative analysis of the regulations on informed consent in research on human beings in Germany, Poland, and Russia. The relevant regulations were searched in the national databases: “Gesetze im Internet” for Germany, “Internetowy System Aktów Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search in German and Russian databases was conducted with the use of pre-selected keywords: “informed consent” and “clinical research” . The search in the Polish database was conducted with the use of keywords provided by the database “research and certificates”, “health protection”, “pharmaceutical law”, “medical devices”, “pharmaceutical products” . In addition, examined were relevant scientific texts in English, Polish, and Russian, retrieved from the databases: Google Scholar, PubMed, the Polish National Library (PBN), and eLibrary.ru to provide contextual background and identify relevant documents not detected through our search in the legal databases.The investigation was designed as a documentary research with legal documents and professional guidelines as source materials. As official texts, they meet all of the four criteria for documentary analysis: authenticity, credibility, representativeness, and meaning . IdentifWe identified 21 documents with information pertaining to the research aim. These include binding legal acts, such as laws, regulations, or resolutions as well as legally non-binding guidelines on medical professional ethics. The documents were analyzed in their original language and in versions containing all amendments that occurred before August 1, 2020. An outline of the documents included in the analysis is provided in Table An analysis of the regulations concerning IC shows that in each country the subject is specified in several different documents, which may increase uncertainty regarding the proper conduct of clinical studies.In Germany, Poland, and Russia, the principle of IC for conducting studies on human subjects is written down in the fundamental state laws. The Polish Constitution provides in Art. 39 for voluntary consent for every medical experiment: “No one shall be subjected to scientific experimentation, including medical experimentation, without his voluntary consent” . SimilarThe normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Differences in the regulations on IC can be found in the areas of method and content of participant information, the form of consent and its withdrawal, consent in emergency situations, and obtaining approval for participants incapable of giving consent and minors Table .Table 2DConcerning the content of participant information, all three countries regulate the provision of information on aims, methods, conditions, as well as the scope and risks of the trial. Participants of a clinical trial need to also receive information on the purpose and scope of processing personal data. Moreover, participants should receive information that they have the right to withdraw from the study at any time. Such formulations follow the provisions of the Declaration of Helsinki. German legal regulations require a relatively short list of information items that should be provided to the participant. These should comprise the essence, meaning, and scope of the clinical trial –15, 18, The Declaration of Helsinki states that potential subjects must be adequately informed (§26). There are no specifications on whether the communication with the patient should occur in writing or verbally. Regulations in all three countries provide little specification on the method of participant information. In each country, the person responsible for providing information is the lead researcher or a member of the research team , 23, 29.In all three countries IC should preferably be documented in written form through the dated participant’s signature. This preference corresponds to the provisions of the Declaration of Helsinki. In special situations, when providing written consent is impossible, e.g. due to the inability to write, verbal consent is acceptable (§26). Verbal consent should be given in presence of one witness in Germany and Russia , 15, 29 Special precautions need to be taken to protect vulnerable groups during research. To this group belong participants who are physically or mentally incapable of giving consent, and children and adolescents before the legal age of consent. The Declaration of Helsinki includes ethical norms prescribing the process of IC with these particular subjects (§28–30). Regulations in all three countries explicitly address the issue. Participation in research of persons incapable of giving informed consent requires approval from their legal representative , 22, 29.The second vulnerable group expressly mentioned in context of IC in research in the normative framework of all three countries are minors. In Germany and Poland, the study information should be provided to legal representatives by a member of the research team. In Germany, in clinical studies with minors, the information needs to be communicated by a physician . The minIn emergency situations, participation can start immediately in research that can save life, restore good health, or alleviate the suffering of the person concerned. According to the Declaration of Helsinki, consent must be obtained as soon as possible (§30). In such a case, German law requires obtaining a subsequent IC as soon as it is possible and reasonable . ObtainiAlthough the Declaration of Helsinki is not legally binding in the context of international law, its impact on research practice, ethical reasoning and national legal regulations remains undisputed in Germany, Poland, and Russia. Through the inclusion in medical Codes of Ethics in all three countries, the Declaration gains binding character. The content of the Declaration constitutes therefore, beside ethical guidance, applicable regulation for medical researchers. It is also noticeable that many normative regulations regarding IC in all three countries adopt the ethical foundations provided by the Declaration without expressly mentioning it. However, the results of our comparative analysis show that provisions on IC vary among the countries, especially in the areas that are not explicitly covered by the Declaration. The differences range from the method of communication with participants, through the amount of information that they are required to receive, the form of providing consent or withdrawal, to the procedure of IC in research with vulnerable subjects.The Declaration of Helsinki lists the catalogue of information that should be provided to participants. However, it also expressly recognizes that information should be tailored to the individual needs of potential subjects. Clearly stated research objectives and methods presented by trained recruiters can positively influence participation in the study and decrease the level of uncertainty about the study’s aims and methods . None ofInadequate understanding of the information provided in the process of IC is a common phenomenon observed in research and other areas of medicine . TherefoEnsuring that the subject has understood the information is central for an autonomous decision and explicitly stated as a principle in the Declaration of Helsinki (§26). Despite this, regulations in all three countries do not provide a requirement for evaluating the level of comprehension of the provided information. Comprehension can be assessed through a questionnaire, interviews or, if study resources allow it, by a third party not affiliated with the project .To improve understanding, it is nowadays important to also pay attention to language barriers. Only German regulations explicitly state that translated information can be provided in the native language of potential subjects. This mirrors the progressing heterogeneity of the German society. However, for legal purposes, patients still need to sign the binding German text version. Considering the similar ethnic and cultural diversity within Russia and the changing societal composition in Poland, such omission is a risk for patient autonomy and can be a discriminating factor. It may lead to situations in which a proper processing of information is not guaranteed. In this respect, clear guidelines need to be adopted to face the communication challenges of a modern society.Regulations in all three countries follow the provisions of the Declaration of Helsinki regarding written or verbal form of consent. However, only Germany makes it possible to legally record in electronic form the provision or withdrawal of consent to participate in a study. Such flexibility gains importance with geographical distance between the research center and the research subject or under time pressure. Also during the ongoing pandemic, for instance, the possibility of recording the consent through means other than a handwritten signature becomes crucial to reduce the risk of contagion . AlternaAs mentioned, the Declaration of Helsinki provides guidelines for IC in research with vulnerable groups, i.e. participants incapable of giving consent, minors, and emergency patients. Here differences between national regulations become visible. German and Polish regulations foresee the involvement of incapacitated participants or minors in the process of IC through their assent to additionally support the decision of guardians. Russian norms request only consent from parents, legal representatives, or guardians, thus hardly involving vulnerable research participants in the IC process. This could indicate a certain paternalistic approach, observable also in the research process in other post-communist countries of Central and Eastern Europe . It alsoThe examination of norms pertaining to the question of IC shows that in each country this topic is repeatedly codified in several laws and regulations. A lack of coherent and transparent legislation can have a negative impact on the planning and implementation of clinical trials and creates legal uncertainty , 45. VarUniform binding IC regulations could expedite medical research. Such efforts for harmonization of national legislation have been attempted on the level of regional international organizations for example the European Union (EU) or the Eurasian Economic Union (EAEU). The introduction of the “EU Regulation No 536/2014 on clinical trials on medicinal products for human use” had the goal to harmonize and simplify procedures for clinical trials, especially in the case of multi-center international trials. . SimilarAlthough the normative framework for IC in all three countries generally adheres to the guiding principles of the Declaration of Helsinki, visible are differences between national regulations, especially regarding the method and content of information, the form of consent, and obtaining assent from subjects incapable of consent. The identified differences can negatively impact the conduct of international clinical studies and reveal the important directing role of international ethical guidelines. Due to cultural, political, and social differences, achieving global or even regional legislative harmonization might prove impossible—even within the closely interconnected Pan-European area. The lack of legal consensus reinforces the significance of the international ethical agreements. However, efforts for harmonization will remain unfulfilled if debates at the legal level are not complemented with an international discourse on ethical issues and an exchange of experiences among ethics committees.There is a need for improvement in national legal regulations. Special attention needs to be paid, so that flexibilities within national regulations are not misused to undermine protection of participants, especially regarding the questions of IC. We can expect in biomedical research a similar risk as with other areas with high financial stakes. Countries may be tempted to offer progressively laxer regulations in a competition to attract foreign capital or to grant regulatory approval through dubious means at the cost of individual autonomy and research integrity. An erosion of standards should be confronted for both ethical and epistemic reasons. Failure to follow protocols may not only discourage transparency over IC practices, but also over research processes themselves. Furthermore, these divergent standards make it more difficult to assess whether research carried out in countries with different value systems showed the same level of concern for respecting the principle of IC. An important role here falls on national and local Research Ethics Committees, to oversee that the guidelines of the Declaration of Helsinki are adequately interpreted in context of national norms and cultural values and orientations. Future research needs to assess whether ethics committees have indeed the power to assist the legal apparatus in making sure the principle of IC is respected.


Introduction: The successful treatment of a multitude of chronic diseases is largely dependent on effective interprofessional collaboration. In Germany, many healthcare employees feel unprepared for the challenges of interprofessional teamwork. Can a seminar designed by an interprofessional team for an interprofessional target group improve mutual understanding and provide the basis for successful interprofessional collaboration?Methodological approach: For the development of the seminar, Kern’s model for curriculum development was used, which includes the following six steps: problem identification, needs analysis, goal definition (learning objectives and learning content), educational strategies, implementation and evaluation. The all-day event brought together physiotherapists, pharmacists, medical assistants and doctors undergoing specialist training in family medicine. Representatives of the various professions were recruited through multiple channels . Practical examples and role-play were used to develop a better understanding of each other’s professions and to support goal-oriented and appreciative communication among them. The seminar belongs to the curriculum provided by the Hesse Competence Center for Specialist Training in General Practice and has so far taken place three times. The evaluation was carried out by means of a detailed, self-designed questionnaire with five open and 20 closed questions. The statistical analysis was mainly descriptive .Results: Overall, 29 persons have participated in the workshops . Overall, the seminar was rated very highly. Individual aspects of the seminar’s design, such as relevance and practice-orientation, as well as an assessment of whether the seminar contributed towards increasing participants’ ability to collaborate with other professionals, were rated positively. In addition, a pre-post comparison of self-assessed ability to collaborate interprofessionally showed significant improvement.Discussion: This highly interactive one-day seminar design contributed towards improving understanding for other professions and communication skills. In order to achieve a broad-based improvement in interprofessional collaboration over the long term, this or similar concepts should be employed more extensively.Conclusions: The results suggest that participants in interprofessional seminars consider them to improve interprofessional collaboration. As a result of demographic change and an associated increase in the overall number of multimorbid patients, successful interprofessional cooperation is being increasingly highlighted and called for  2014 . As treaPatients, family practitioners, and other healthcare professionals, are faced with the challenges involved in the provision of complex healthcare services for multimorbidity and polypharmacy on a daily basis . These pThe need for efficient, effective and economically viable personnel deployment has increasingly provided federal states with an argument to support interprofessional collaboration . HoweverIn the working group responsible for specialty training, the idea arose that colleagues from differing professions at the Institute of General Practice in Frankfurt am Main should develop, implement and evaluate an interprofessional seminar for physicians undergoing such training. The seminar was included in the Hesse Competence Center for Specialist Training’s education program, which was established as part of the “Hesse pact to safeguard the provision of healthcare” in 2012. The present paper describes the development, content and evaluation of the continuing seminar. When developing the content of the seminar, the following research question was posed: Can a seminar that is developed by an interprofessional team for an interprofessional target group achieve the following goals with the help of practical examples and role play:more intensive preparation for interprofessional collaboration,improvement in communication with other professional groups, improved comprehension of the particular competencies of other health professions.Kern’s model for curriculum development was used in the preparation of a seminar concept. This established method has proved its effectiveness and has been used in the health care systems of numerous countries for two decades. With the help of the Kern model, curriculum development, maintenance and improvement can be implemented in a structured manner .The individual development steps are presented below.The concept was developed for the Hessian Ministry for Social Affairs and Integration (HMSI) by an interprofessional team of two physicians undergoing specialty training in family medicine, a research assistant with a background in physiotherapy, an educational scientist, a pharmacist, a research employee with a healthcare assistant background, a specialist in family medicine, and experienced specialty training instructors.First of all, a survey of existing interprofessional teaching projects (ITP) was conducted on the basis of a literature search. Projects for the promotion of ITP among students, such as the projects supported by the Robert Bosch foundation were the first to be identified . We thenIn order to achieve appropriate access to the various professions and to ensure that they all began on an equal footing, interviews were conducted with two participants in existing ITP projects. Furthermore, information was shared and networking carried out with other instructors in the field under the umbrella of the Consortium of Institutes of Higher Education in Health and Rehabilitation in Europe (Cohehre) , 18]. T. T18]. TThe content of the preceding steps was then appraised, resulting in the following overlapping objectives, which reflect the principles of standard international ITP. These consist of: learning with one another: jointly develop and expand learning content, learning from one another: communicate one’s own professional competencies,learning about one another: gain knowledge of other professional groups . In order to create a basis, we wanted our seminar to achieve overarching learning objectives that improve communication between individual professions andbreak down role expectations and stereotypes of individual professions. One specific task was to try viewing patient-centered treatment objectives from the point of view of different professions within the interprofessional team, and jointly to develop and discuss these objectives. Based on the described analysis of differing ideas of ITP, and on interviews with experts, the implementation of specific learning objectives for the planned seminar were developed in a multi-stage process. Furthermore, the development team was interested from the beginning in providing the various professions with the opportunity to become acquainted with one another outside what are generally hierarchical settings at work. The focus thereby was on finding out more about the competencies and range of tasks performed by the other professions, and strengthening fundamental appreciation of one another. In a second step, the participants were asked to discuss the obstacles (e.g. lack of time) and possible solutions  that in their view affect communication with other professions. Key questions were: “What do I expect of other professions?” and “How can I contribute towards improving communication and collaboration with other professions?” In order to avoid taking a purely theoretical view, it was important to us that a large part of the seminar was spent conducting practical exercises, where possible with a (simulation) patient . Case exWe chose to involve seminar instructors from multiple professions and tried to ensure that all participating professions were represented. The seminar instructors rather adopted the role of observers, learning guides and moderators . The impBased on eight teaching units à 45 minutes, five key topics were defined. The seminar program, along with the various learning units, learning objectives and employed didactical methods are presented in table 1 In the morning, the focus was on getting to know the five unfamiliar professions, both personally and from a professional perspective. To achieve this, and after briefly introducing themselves, the participants were first divided into single-profession groups in which they prepared poster walks. They then presented first themselves as individuals and then their professional responsibilities and the everyday challenges they faced. At this point, there was time for questions and discussion. Afterwards, contributions could be made via structured communication channels (based on the SBAR tool) . After tOverall, all the elements of the seminar were structured interactively, using a wide range of methodologies. The implementation was part of the existing seminar program for physicians undergoing specialty training at the Competence Center for General Practice in the German state of Hesse. Up to now, the seminars have taken place at the Sankt-Elisabethen Hospital in Frankfurt am Main and at the Institute of General Practice at Goethe University, Frankfurt am Main, further seminars are planned. Thanks to the support of the HMSI, it was possible to provide the seminars at no cost to participants. In the seminars, ten places are available for physicians undergoing specialty training and five each for another three professional groups. As the three further professions are required to have as many points of contact with outpatient health care as possible, the team decided to begin by working with physiotherapists, pharmacists and either health care assistants (HCAs), specially qualified medical assistants, or non-physician practice assistants. Representatives of the various professions are recruited through multiple channels .As part of the seminar program, a detailed questionnaire was distributed for evaluation purposes. The questionnaire was adapted according to the specific seminar and included additional pre- and post-test surveys, and the validated, international evaluation questionnaire UWE-IP . The evaluation sheet for the seminar program for physicians in specialist training organized by the Hesse Competence Center was based on evaluation sheet recommendations made by the Specialist Training Department of the German College of General Practitioners and Family Physicians (DEGAM). It was therefore possible to compare evaluation results with those of other program seminars. The evaluation sheet, which consists of five open and 20 closed questions, was divided into two parts and contained additional self-assessment questions. Before the event began, participants filled in the first part, which consisted of demographic questions and three self-assessment questions relating to knowledge of the role played by the different healthcare professions, communication and interprofessional collaboration. Responses to the questions were given on a six-point Likert scale with defined endpoints . The second part was filled in after the seminar was over and consisted of an evaluation of the entire seminar and a further final self-assessment, based on the questions and response categories described above. As its psychometric data show good results, the interprofessional questionnaire UWE-IP, which was translated into German by the University of Heidelberg, is recommended for use in the evaluation of interprofessional entities. The number of available evaluation sheets is not yet sufficient for a detailed analysis, which we plan after completion of at least a further three seminars. It may then also be possible to assess effectiveness in terms of sustainability in particular. One limitation is, however, that the questionnaire has been very specifically designed for ITP in a university education setting, as this means it is only possible to draw conclusions on ITP in the context of specialty training and for a working population to a limited degree. Over the long term, the UWE-IP will nevertheless be able to provide a detailed picture of different professional groups, as it covers such topics as “communication and teamwork”, “interprofessional interactions” and “interprofessional relationships” . ® SPSS Statistics® (Version 20).The statistical analysis was mostly descriptive . We analyzed the participants’ demographic data and their assessment of the entire seminar, as well as differences in their self-assessment before and after completion of the seminar (Wilcoxon-W-Test). The questionnaires were analyzed using the statistical software IBMOverall, 29 persons took part in the first two seminars, of whom 11 were physicians in specialty training, six were physiotherapists, six pharmacists and six HCAs. Ninety percent of participants were women (N=26). The mean age of the participants was 40.0 years, whereby the physiotherapists (mean 43 years) and the HCAs (mean 42 years) were somewhat older than the physicians in specialty training (mean 37.8 years) and the pharmacists (mean 34.5 years). Most of the participants worked in a practice . Overall, the seminar was rated very highly . A detailed look at the results revealed that the seminar design , relevance and practical orientation  and the seminar’s contribution towards improving one’s own ability to collaborate with other professionals , were rated very positively. Particularly the opportunity for personal discussion/networking, becoming acquainted with other professional groups and the presentation of simple communication possibilities such as the SBAR model were highlighted positively in the free-text fields. The participants would like future interprofessional seminars to involve further professional groups, with psychotherapists (N=14), nursing occupations (n=10), occupational therapists (N=8) and speech therapists (N=3) being mentioned most frequently (multiple answers possible). A pre-post comparison of the self-assessment of ability to collaborate interprofessionally showed significant improvement  for one seminar day. The very good evaluation results reflect a successful and needs-oriented seminar design. The significant improvement shown in the pre-post self-assessment of ability to collaborate interprofessionally could also be followed up after a few weeks or months in order to evaluate the development more precisely and to investigate the influence of the seminar over the long term (see outlook). As participation in the seminar was voluntary, we assume that the interest of the participants in interprofessional collaboration was higher than average. Furthermore, it is impossible to draw general conclusions because of the relatively low number of 29 participants.Overall, the evaluation of the seminar was very positive. In the free text fields, participants expressed an interest in the integration of further professional groups  into a similar seminar format. In response to this wish, psychotherapists will be included in coming seminars. The inclusion of participants that are based locally is also an interesting idea and one that will, if possible, be considered in the planning of seminars in the future. We also plan to extend the evaluation to include a follow-up survey after six and 12 months. The results could contribute towards further improvement in the design and content of the seminar, as well as differentiation in the needs of the various professions in accordance with their employment situation (e.g. in inpatient or in outpatient care).Even if the small number of participants and the fact that the questionnaire was self-developed mean the results of this investigation only serve to indicate a trend and cannot be generally extrapolated to include further seminars, we would like to use the positive results to stress the usefulness of interprofessional seminars and encourage colleagues to establish similar courses as part of specialty training. After completing further seminars, a further publication is also planned, which will include a larger number of respondents, as well as explorative analyses of sub-groups.The first authorship is shared by Katharina Dippell and Maria-Sophie Brueckle. We would like to thank the Hessian Ministry for Social Affairs and Integration (HMSI) for the financial support without which the seminars could not have been provided to participants free of charge. Special thanks also go to Mrs. Andrea Schlicker and Prof. Dr. Mirjam Körner for supporting us with their experience of ITP events, and to the Department of General Practice and Health Services Research at the Heidelberg University Hospital (Germany) for the permission to use their translation of the UWE-IP for our seminar. Further cordial thanks go to the Hesse Chamber of Pharmacists, the Central Association of Physiotherapists, the Hesse Association of General Practitioners and the participating teaching practices of Goethe University Frankfurt am Main. Thank you to Mrs. PD Riphaus for providing facilities at St. Elisabethen Hospital. We would also like to thank all simulation patients for their acting performance and the simulation patient center of Faculty 16 of Goethe University Frankfurt am Main for preparatory training. Our special thanks also go to Phillip Elliot from Goethe University for translating our manuscript to English. And finally, we would like to express our gratitude to all participants in the seminars on interprofessional collaboration. The authors declare that they have no competing interests.