Improving patient involvement in the lifecycle of medicines : insights from the EUPATI BE survey

EUPATI Belgium (EUPATI.be) is an informal gathering of local partners who are interested in improving patient involvement in healthcare innovation and medicines research and development. EUPATI.be brings together various stakeholders from different areas related to healthcare including patients, academia and industry. In doing so, we create an innovative collaborative approach where actors from different backgrounds work toward improving patient involvement in medical research, and putting the patient at the center of the Belgian healthcare system. Previously, we performed in-depth interviews with a small group of stakeholders on patient involvement. Here, we elaborate on our previous findings by using a nation-wide survey to inquire into Belgian stakeholders' perception on patient involvement. To this end, an electronic survey was available in French, Dutch and English, and accessible for 11 months. Twelve questions were asked, including 11 multiple choice questions and 1 open question. The latter was thematically analyzed according to the framework method. A total of 117 responses were registered and descriptive statistics were performed. The majority of respondents could be categorized into patient, academia and industry, whereas policy makers, payers, and healthcare professionals were underrepresented. We identified several barriers that hamper patient involvement, which were sometimes more reported by specific stakeholder groups. Next, we found that various stakeholders still consider patient involvement as a passive role, i.e., medical subject in a clinical trial. Respondents also reported that the role of the various stakeholders needed more clarification; this was also confirmed by the level of trust amongst the various stakeholders. Existing and the wish for more collaboration with the various stakeholders was reported by almost all respondents. Based on this survey, we can define the potential of involving patients in the medical research and development in the Belgian landscape. Our results will help to understand and tackle the various barriers that currently hamper patient involvement, whilst highlighting the need for a collaborative landscape from the multi-stakeholder perspective

Effects of chronic stress on the brain – the evidence from morphological examinations of hippocampus in a chronic unpredictable stress (CUS) model in rats

Sekita-Krzak Joanna, Żebrowska-Łupina Iwona, Łupina Tomasz, Czajkowski Leszek, Cichacz-Kwiatkowska Beata, Robaczewska Joanna. Effects of chronic stress on the brain – the evidence from morphological examinations of hippocampus in a chronic unpredictable stress (CUS) model in rats. Journal of Education, Health and Sport. 2016;6(12):384-399. eISSN 2391-8306. DOI http://dx.doi.org/10.5281/zenodo.203269 http://ojs.ukw.edu.pl/index.php/johs/article/view/4068 The journal has had 7 points in Ministry of Science and Higher Education parametric evaluation. Part B item 754 (09.12.2016). 754 Journal of Education, Health and Sport eISSN 2391-8306 7 © The Author (s) 2016; This article is published with open access at Licensee Open Journal Systems of Kazimierz Wielki University in Bydgoszcz, Poland Open Access. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. This is an open access article licensed under the terms of the Creative Commons Attribution Non Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted, non commercial use, distribution and reproduction in any medium, provided the work is properly cited. This is an open access article licensed under the terms of the Creative Commons Attribution Non Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted, non commercial use, distribution and reproduction in any medium, provided the work is properly cited. The authors declare that there is no conflict of interests regarding the publication of this paper. Received: 01.12.2016. Revised 12.12.2016. Accepted: 14.12.2016. Effects of chronic stress on the brain – the evidence from morphological examinations of hippocampus in a chronic unpredictable stress (CUS) model in rats Joanna Sekita-Krzak1, Iwona Żebrowska-Łupina2, Tomasz Łupina3, Leszek Czajkowski2, Beata Cichacz-Kwiatkowska1, Joanna Robaczewska4 1 Department of Histology and Embryology with the Lab of Experimental Cytology, Medical University, Lublin, Poland 2 Department of Clinical Pharmacology, Medical University, Lublin, Poland 3 Department of Pulmonology, Oncology and Allergology, Medical University, Lublin, Poland 4 Department of Public Health, Collegium Medicum UMK, Poland Abstract Background. Chronic stress exposure deteriorates memory and increases the risk of psychiatric disorders, including depression. Objectives. The objective of this study was to perform morphological studies in experimental model of neuropsychiatric disorder and to assess histologically the effect of chronic unpredictable stress procedure (CUS) influence on hippocampus. Material and methods. Chronic unpredictable stress procedure (CUS) was applied for 8 weeks in rats by the modified method described by Katz et al. Experimental model of neuropsychiatric disorder was used based on morphological studies of hippocampal formation. Results. Stress-induced alterations were observed in the hippocampus. Nerve cell changes included neuron shrinkage and dendritic remodeling. The most vulnerable hippocampal cells to chronic stress were CA3 and CA4 pyramidal neurons. In dentate gyrus chronic stress led to granule neuron shrinkage and slight exacerbation of apoptosis in the polygonal cell layer. CUS led to statistically significant changes in quantitative characteristics of the CA3 and CA4 neuron size and nuclei diameter. Conclusions. Chronic stress induces degeneration of hippocampal neurons. The observed neuronal changes indicate the damage of the neurons did not involve neither apoptosis nor necrosis Similarity between histological changes obtained in 8-week long CUS procedure applied in our research and morphological changes described in depressed patients confirms the usefulness of the applied stress procedure as the experimental model of depression. Key words: stress, depression, hippocampus, chronic unpredictable stress procedure (CUS), animal model, morphology

Inhibition of hepadnaviral replication by polyethylenimine-based intravenous delivery of antisense phosphodiester oligodeoxynucleotides to the liver

Antisense oligodeoxynucleotides (ODNs) appear as attractive anti-hepatitis B virus (HBV) agents. We investigated in vivo, in the duck HBV (DHBV) infection model, whether linear polyethylenimine (lPEI)-based intravenous delivery of the natural antisense phosphodiester ODNs (O-ODNs) can prevent their degradation and allow viral replication inhibition in the liver. DHBV-infected Pekin ducklings were injected with antisense O-ODNs covering the initiation codon of the DHBV large envelope protein, either in free form (O-ODN-AS2) or coupled to lPEI (lPEI/O-ODN-AS2). Following optimization of lPEI/O-ODN complex formulation, complete O-ODN condensation into a homogenous population of small (20–60 nm) spherical particles was achieved. Flow cytometry analysis showed that lPEI-mediated transfer allowed the intrahepatic delivery of lPEI/O-ODN-AS2 to increase three-fold as compared with the O-ODN-AS2. Following 9-day therapy the intrahepatic levels of both DHBV DNA and RNA were significantly decreased in the lPEI/O-ODN-AS2-treated group as compared with the O-ODN-AS2-treated, control lPEI/O-ODN-treated, and untreated controls. In addition, inhibition of intrahepatic viral replication by lPEI/O-ODN-AS2 was not associated with toxicity and was comparable with that induced by the phosphorothioate S-ODN-AS2 at a five-fold higher dose. Taken together, our results demonstrate that phosphodiester antisense lPEI/O-ODN complexes specifically inhibit hepadnaviral replication. Therefore we provide here the first in vivo evidence that intravenous treatment with antisense phosphodiester ODNs coupled to lPEI can selectively block a viral disease-causing gene in the liver

Multiomics modeling of the immunome, transcriptome, microbiome, proteome and metabolome adaptations during human pregnancy.

MotivationMultiple biological clocks govern a healthy pregnancy. These biological mechanisms produce immunologic, metabolomic, proteomic, genomic and microbiomic adaptations during the course of pregnancy. Modeling the chronology of these adaptations during full-term pregnancy provides the frameworks for future studies examining deviations implicated in pregnancy-related pathologies including preterm birth and preeclampsia.ResultsWe performed a multiomics analysis of 51 samples from 17 pregnant women, delivering at term. The datasets included measurements from the immunome, transcriptome, microbiome, proteome and metabolome of samples obtained simultaneously from the same patients. Multivariate predictive modeling using the Elastic Net (EN) algorithm was used to measure the ability of each dataset to predict gestational age. Using stacked generalization, these datasets were combined into a single model. This model not only significantly increased predictive power by combining all datasets, but also revealed novel interactions between different biological modalities. Future work includes expansion of the cohort to preterm-enriched populations and in vivo analysis of immune-modulating interventions based on the mechanisms identified.Availability and implementationDatasets and scripts for reproduction of results are available through: https://nalab.stanford.edu/multiomics-pregnancy/.Supplementary informationSupplementary data are available at Bioinformatics online

Multiomics modeling of the immunome, transcriptome, microbiome, proteome and metabolome adaptations during human pregnancy

Motivation Multiple biological clocks govern a healthy pregnancy. These biological mechanisms produce immunologic, metabolomic, proteomic, genomic and microbiomic adaptations during the course of pregnancy. Modeling the chronology of these adaptations during full-term pregnancy provides the frameworks for future studies examining deviations implicated in pregnancy-related pathologies including preterm birth and preeclampsia. Results We performed a multiomics analysis of 51 samples from 17 pregnant women, delivering at term. The datasets included measurements from the immunome, transcriptome, microbiome, proteome and metabolome of samples obtained simultaneously from the same patients. Multivariate predictive modeling using the Elastic Net (EN) algorithm was used to measure the ability of each dataset to predict gestational age. Using stacked generalization, these datasets were combined into a single model. This model not only significantly increased predictive power by combining all datasets, but also revealed novel interactions between different biological modalities. Future work includes expansion of the cohort to preterm-enriched populations and in vivo analysis of immune-modulating interventions based on the mechanisms identified. Availability and implementation Datasets and scripts for reproduction of results are available through: Https://nalab.stanford.edu/multiomics-pregnancy/

Monograph Social Welfare Home in Piekary Śląskie

Streszczenie pracyW mojej naukowej pracy badawczej Monografia DOM POMOCY SPOŁECZNEJw Piekarach Śląskich przedstawiłam genezę, rozwój i zadania badanej instytucji naprzestrzeni 83lat. Instytucja ta została założona w 1928 roku i pełniła funkcję Centralnego Ośrodka Opieki Społecznej pomagając i wspierając osoby samotne i nieuleczalnie chore.Obecnie jest to instytucja pomocy społecznej zgodnie z ustawą o pomocy społecznejz 2004 roku przeznaczona dla osób przewlekle psychicznie chorych. Celem moich badań była analiza jej działalności w oparciu o metodę monografii pedagogicznej. Wykorzystałam następujące techniki badawcze: analizę dokumentów, obserwacje uczestniczącą oraz wywiady z mieszkańcami Domu Pomocy Społecznej, z ich opiekunami i terapeutami. Posłużyłam się również metodą indywidualnych przypadków w celu dokładniejszego poznania biografii trzech mieszkańców. Badania moje potwierdziły, iż Dom Pomocy Społecznej w Piekarach Śląskich jest instytucją społeczną, która wypełnia wszystkie zakładane funkcje.W kompleksowy sposób podejmuje działania w sferze bytowej mieszkańców, opiekuńczej,wspomagającej i edukacyjnej. Metoda monografii pedagogicznej pozwoliła więc ustalić,iż w badanej placówce realizuje się potrzeby mieszkańców i pracowników wskazanew ustawie o pomocy społecznej z 2004 roku.In my research work Monograph Social Welfare Home in Piekary Śląskie,I presented function on the institution for over 83 years.Social Welfare Act of 2004 states that nursing homes are institutions which are designedto meet the following requirements:· need for household· need for care· need for support· educational need· medical need.The first part of my research work shows the history, development and tasks of the SocialWelfare Home. The second part of my work describes the object of my research - SocialWelfare Home for the chronically mentally ill in Piekary Śląskie. The activities of care andcultural and educational Social Welfare Home.The third part contains:1. Examining documents Social Welfare Home.2. Interviews with residents and staff3. Observation of therapeutic activities.4. Analysis of individual cases.Conclusion:On the basis of studies I can say that Social Welfare Home in Piekary Śląskie realizes theneeds of the Social Welfare Act

Applying open innovation strategies in the context of a regional innovation ecosystem: The case of Janssen Pharmaceuticals

Open innovation strategies in large firms have been changing considerably during the last 15 years. Some multinationals are now taking a long-term, strategic approach to Open innovation, thereby actively developing a regionally bounded innovation ecosystem. This approach goes beyond the tradition of open innovation, which emphasized the opening of firms’ boundaries for inbound and outbound knowledge flows. In the new approach, multinationals actively shape their innovation environment to better exploit external talent and expertise, share public infrastructure, raise funds and influence public policies - the key enablers for establishing a vibrant, world-class research and development (R&D) environment. We examine one such regionally embedded innovation ecosystem set up by Janssen Pharmaceuticals at its global R&D centre in Beerse, Belgium.We develop a conceptual framework by integrating Open innovation, Innovation Ecosystems and Regional Economics literature streams. This combination of the three distinct theoretical approaches is required to explain the benefits and working of Janssen Pharmaceuticals’ regionally embedded innovation ecosystem.•Some multinationals are taking strategic approach to Open Innovation (OI) by shaping the regional innovation ecosystem.•Regional innovation ecosystem strategy brings together key enablers for developing R&D environment conductive to innovation.•Benefits and working of regionally-embedded innovation ecosystem at Janssen Pharmaceuticals are explained in this study.•Open Innovation theory alone is not enough to understand the structure and functioning of such OI ecosystems.•We propose a framework based on contributions from Open Innovation, Innovation Ecosystems and Regional Economics

Przydatność testu Lepidium do oceny toksyczności odcieków ze składowiska odpadów komunalnych

Sealing of landfill and treatment of leachate is a very important issue in the operation of the landfill, part of which is monitoring of leachate. In addition to the assessment of quantitative and qualitative characteristics, monitoring of leachate should also involve the assessment of leachate phytotoxicity. This is particularly important in the case of migration of leachate and its impact on the soil and water environment. The aim of this study was to determine phytotoxicity of leachate from a municipal landfill based on the plant stress test (the Lepidium test). The Lepidium test was considered as useful in the assessment of toxicity of landfill leachate, resulting from changes in the plant growth depending on leachate concentration in the solution. The use of the Lepidium test allowed for the determination of an approximate threshold volume of leachate which leads to the inhibition of test plant growth. Undisturbed plant development was achieved in the environment with leachate concentrations below 1÷2%. It is also suggested that the test methodology should be extended in order to measure protein concentration. The usefulness of measuring peroxidase was not demonstrated. Based on the values of physico-chemical indicators of leachate and the content of metals, no significant toxic factors were found to inhibit the growth of the test plant.Wody odciekowe ze składowisk odpadów komunalnych charakteryzują się wysoką koncentracją składników organicznych i nieorganicznych, w tym metali ciężkich i wielu niebezpiecznych substancji organicznych. Wody odciekowe są również uważane za potencjalne źródło mikroorganizmów chorobotwórczych. Uszczelnienie składowiska oraz oczyszczanie wód odciekowych stanowi bardzo istotne zagadnienie eksploatacyjne składowiska odpadów, którego częścią jest monitoring odcieków. Monitoring wód odciekowych, oprócz charakterystyki ilościowo-jakościowej, powinien opierać się również na ocenie fitotoksyczności odcieków. Ma to szczególne znaczenie w przypadku migracji wód odciekowych i ich wpływu na środowisko gruntowo-wodne. Celem przeprowadzonych badań było ustalenie fitotoksyczności wód odciekowych ze składowiska odpadów komunalnych na podstawie roślinnych testów stresowych. W pracy przedstawiono wyniki badań uzyskanych w teście Lepidium oraz zawartości białek i peroksydazy występujących w roślinie testowej. Badania określały możliwość rozwoju bądź zahamowania wzrostu rośliny, która została poddana czynnikowi stresowemu, jakim były różne dawki wód odciekowych. Test Lepidium został uznany za przydatny test w ustalaniu toksyczności odcieków ze składowisk odpadów. Zastosowanie tego testu pozwoliło ustalić przybliżoną progową objętość odcieku, która wpłynęła na hamowanie rozwoju roślin testowych. Niezakłócony rozwój roślin osiągnięto w środowisku o stężeniu odcieków nieprzekraczającym 1÷2%. W celu pełniejszego badania toksyczności odcieków proponuje się zastosowanie testu Lepidium wraz z równoległym pomiarem stężenia białek. Nie stwierdzono przydatności pomiaru peroksydaz. Na podstawie wartości wskaźników fizykochemicznych odcieków i zawartości metali nie stwierdzono istotnych czynników toksycznych hamujących rozwój badanej rośliny

Hepatitis G virus: Molecular organization, methods of detection, prevalence, and disease association

AbstractThis article reviews data on hepatitis G virus (HGV) prevalence and possible disease associations in various groups of patients. An important fraction of acute or chronic hepatitis cases probably have a viral etiology and are not attributable to known hepatitis viruses. Therefore, researchers continually are looking for new hepatitis viruses. Among the agents found are members of GB hepatitis viruses, including GB-C virus, or HGV. This review presents the history of the discovery of HGV, its molecular biology and some methods of detection; results of clinical and molecular studies of HGV infection also are discussed