Informed Consent : Literaturbericht, Verständlichkeitsmodell und Evaluation der swissethics-Templates

Der Bericht besteht aus vier Teilen: Teil I: Hintergrund: Begriffliche, ethische und juristische Problemlage Teil II: Forschungsstand: Literaturbericht aus pragmalinguistischer Perspektive Teil III: Verständlichkeitsmodell für Informed-Consent-Dokumente Teil IV: Evaluation der Informed-Consent-Templates von swissethic

Informed-Consent-Aufklärung aus Sicht der Forschenden

Dieser Bericht beschreibt den Status Quo der Informed-Consent-Aufklärungskonzepte von Forschenden in der Deutschschweiz in Form einer problemorientierten Auslegeordnung. Die klinisch Forschenden bezeichnen unisono das Aufklärungsgespräch als das Herzstück der Aufklärungspraxis. Instruktionen zur mündlichen Aufklärung fehlen jedoch weitgehend. Aufbauend auf diesen Beobachtungen legen wir aus linguistischer Sicht Good-Practice-Empfehlungen vor. Um der im HFG Art. 16 geforderten Kombination von schriftlicher und mündlicher Aufklärung zu entsprechen, ist aus unserer Sicht eine konzeptionelle Verschränkung von schriftlicher und mündlicher Aufklärung unabdingbar. Wir sehen darin eine effektive Massnahme zur Optimierung der künftigen IC-Aufklärungspraxis

Verständlichkeit von schriftlicher Aufklärung zur Forschungsteilnahme : die Auffassungen und Strategien von Ethikkommissionen und Forschenden

Das Ziel des Berichts ist, die Auffassungen und Strategien von Ethikkommissionen und Forschenden in Bezug auf die Verständlichkeit schriftlicher Einwilligungen für die Forschungsteilnahme zu untersuchen. Grundsätzlich kann festgehalten werden, dass in den untersuchten Ethikkommissionen unterschiedliche Verständlichkeitsauffassungen vorherrschen, welche die Prüfung der IC-Aufklärungsdokumente prägen. Bei der Analyse der Instruktionen in Leitfäden und Templates von swissethics hat sich gezeigt, dass diese vor allem die inhaltliche Ebene instruieren. Ausgehend von einem zweigeteilten Textkorpus mit IC-Aufklärungsdokumenten (IC-Korpus) und Studienzusammenfassungen (SNCTP-Korpus) konnten die Verständlichkeitsstrategien der Forschenden gezeigt werden. Unseres Erachtens ist es wichtig zu betonen, dass die Texte Strategien einsetzen, um fachliche Inhalte verständlich zu machen. Allerdings sind dies zu einem grossen Teil fachliche Definitions- und nicht alltagssprachliche Veranschaulichungsstrategie

Verständlichkeitsstudie Generalkonsent : Aufklärung und Einwilligung zur Weiterverwendung von biologischem Material und gesundheitsbezogenen Personendaten für die Forschung

Das Ziel des Berichtes ist, das Generalkonsent-Template 1/2017 empirisch auf Verständlichkeit hin zu untersuchen und Optimierungsmöglichkeiten aufzuzeigen. Im Usability-Testing wurde der GK1/2017_ORIG und eine für Testzwecke konstruierte Textalternative GK_ALTERN untersucht. Die Ergebnisse des vergleichenden Verfahrens zeigen text- und kontextgebundene Verständlichkeitsprobleme auf

Bioreactor-Based Bone Tissue Engineering

The aim of this chapter is to describe the main issues of bone tissue engineering. Bone transplants are widely used in orthopedic, plastic and reconstructive surgery. Current technologies like autologous and allogenic transplantation have several disadvantages making them relatively unsatisfactory, like donor site morbidity, chronic pain, and immunogenicity and risk hazard from infectious disease. Therefore, regenerative orthopedics seeks to establish a successful protocol for the healing of severe bone damage using engineered bone grafts. The optimization of protocols for bone graft production using autologous mesenchymal stem cells loaded on appropriate scaffolds, exposed to osteogenic inducers and mechanical force in bioreactor, should be able to solve the current limitations in managing bone injuries. We discuss mesenchymal stem cells as the most suitable cell type for bone tissue engineering. They can be isolated from a variety of mesenchymal tissues and can differentiate into osteoblasts when given appropriate mechanical support and osteoinductive signal. Mechanical support can be provided by different cell scaffolds based on natural or synthetic biomaterials, as well as combined composite materials. Three-dimensional support is enabled by bioreactor systems providing several advantages as mechanical loading, homogeneous distribution of cells and adequate nutrients/waste exchange. We also discuss the variety of osteoinductive signals that can be applied in bone tissue engineering. The near future of bone healing and regeneration is closely related to advances in tissue engineering. The optimization of protocols of bone graft production using autologous mesenchymal stem cells loaded on appropriate scaffolds, exposed to osteogenic inducers and mechanical force in bioreactor, should be able to solve the current limitations in managing bone injuries

Laien-Fachwortgebrauch für die Aufklärung nutzen : das Projekt eines digitalen Varianten-Fachwörterbuchs

This contribution addresses obstacles to comprehensibility of specialized vocabulary within informed consent information for laypeople and digital means of overcoming those obstacles. In specific, it is shown that basic concepts of research in information texts represent particular obstacles to comprehensibility. These basic concepts are highly frequent in information texts regarding participation in human research, and a lack of prior knowledge about these concepts can hardly be established textually. As a solution, this contribution focuses on a rarely considered part of expert-layperson communication: the layperson’s use of specialized vocabulary. The layperson's use of specialized vocabulary is introduced as a distinct variable and compared to the expert's use. An analysis of interactions in internet forums shows that laypeople have their own practices in using specialized vocabulary. To make information texts more comprehensible, we argue for replacing expert specialized vocabulary in favor of those variables that are closer to laypersons' everyday life. Finally, we present a digital dictionary of specialized variables that aims to show both expert and layperson variables of specialized vocabulary and to make them productive for information practice

Antipsychotics-induced hyperprolactinemia and screening for macroprolactin

Introduction: High prolactin (PRL) concentrations are found in laboratory test results of patients on majority of antipsychotic drugs. Prevalence rates and degrees of severity of hyperprolactinemia (HPRL) based on PRL concentration may depend on the presence of macroprolactin in the serum. The aim of the study was to investigate the difference between PRL concentrations before and after precipitation of macroprolactin and to examine if there were any changes in the categorization of HPRL between samples prior and after precipitation. Materials and methods: Total of 98 female patients (median age 33; range 19-47 years) diagnosed with a psychotic disorder, proscribed antipsychotic drugs, and with HPRL were included. Total PRL concentration and PRL concentration after macroprolactin precipitation with polyethylene glycol (postPEG-PRL) were determined by the chemiluminometric method on the Beckman Coulter Access2 analyser. Results: Total PRL concentrations (median 1471; IQC: 1064-2016 mlU/L) and postPEG-PRL concentrations (median 1453; IQC: 979-1955 mlU/L) were significantly correlated using intraclass correlation coefficient for single measurements (mean estimation 0.96; 95%CI 0.93-0.97) and average measurement (mean estimation 0.98; 95%CI 0.96-0.99), and all investigated female patient had HPRL according to PRL and postPEG-PRL concentration. The median PRL recovery following PEG precipitation was 95; IQC: 90-100%. There was substantial agreement (kappa test = 0.859, 95% CI: 0.764- 0.953) between the categories of HPRL severity based on total PRL concentrations and postPEG-PRL concentrations. Conclusion: The study demonstrated that HPRL was present in all subjects using the reference interval for total PRL concentration and postPEG-PRL concentration with no significant impact of macroprolactin presence in the serum on the categorization of patients according to severity of HPRL

Polymorphic expression of glutathione transferases A1, M1, P1 and T1 in epithelial ovarian cancer: a Serbian case-control study

PURPOSE: Since several studies have proposed that epithelial ovarian cancer should not be considered as a single disease entity and that it results from an accumulation of genetic changes, we aimed to assess the polymorphic expression of major cytosolic glutathione S-transferases (GSTM1, T1, A1 and P1) with respect to ovarian cancer susceptibility and aggressiveness. METHODS: This case-control study was conducted on 93 newly diagnosed epithelial ovarian cancer patients and 178 healthy matched controls. The multiplex polymerase chain reaction (PCR) was used to detect homozygous deletions of GSTM1 and GSTT1 genes. Analysis of the single nucleotide polymorphism (SNP) GSTA1 C69T was performed using PCR-restriction fragment length polymorphism (RFLP), while for SNP GSTP1 Ile105Val real-time PCR was used. RESULTS: No significant association to ovarian cancer risk was found for individual GSTM1, GSTA1 and GSTP1 genotypes (p>0.05). However, the carriers of GSTT1-active genotype were at 2-fold higher risk of ovarian cancer development (95%CI: 1.00-4.01, p=0.049), which was even more elevated in the subgroup of patients with positive family history of cancer. Moreover, the frequency of all three GST genotypes that might be associated to ovarian cancer risk (GSTT1-active, GSTA1-active and GSTP1-referent) was significantly higher in patients than in the control group (p=0.042). Even more, patients who were carriers of combination of these three genotypes represented over 64% of the total number of patients within any of the International Federation of Gynecology and Obstetrics (FIGO) stages of ovarian cancer. CONCLUSIONS: This study provides supportive evidence that GSTs might affect both susceptibility and progression of ovarian cance

Expression of OCT-4 and SOX-2 in Bone Marrow-Derived Human Mesenchymal Stem Cells during Osteogenic Differentiation

AIM: Determine the levels of expression of pluripotency genes OCT-4 and SOX-2 before and after osteogenic differentiation of human mesenchymal stem cells (hMSCs).METHODS: Human MSCs were derived from the bone marrow and differentiated into osteoblasts. The analyses were performed on days 0 and 14 of the cell culture. In vitro differentiation was evaluated due to bone markers – alkaline phosphatase (AP) activity and the messenger RNA (mRNA) expression of AP and bone sialoprotein (BSP). The OCT-4 and SOX-2 expression was evaluated at mRNA level by real-time qPCR and at protein level by immunocytochemistry.RESULTS: In vitro cultures on day 14 showed an increase in AP activity and upregulation of AP and BSP gene expression. OCT-4 and SOX-2 in undifferentiated hMSCs on day 0 is detectable and very low compared to tumor cell lines as a positive control. Immunocytochemistry detected OCT-4 in the cell nuclei prior (day 0) and post differentiation (day 14). On the same time points, cultures were negative for SOX-2 protein.CONCLUSION: Messenger RNA for pluripotency markers OCT-4 and SOX-2 isolated from hMSCs was less present, while OCT-4 protein was detected in cell nuclei prior and post differentiation into osteoblast lineage

Building consensus about eHealth in Slovene primary health care: Delphi study

<p>Abstract</p> <p>Background</p> <p>Slovenia's national eHealth strategy aims to develop an efficient, flexible and modern health care informatics framework that would be comparable to the most successful EU countries. To achieve this goal, the gap between availability and usage of information and communication technology by primary care physicians needs to be reduced.</p> <p>As recent efforts show, consensus on information and communication technology purpose and usage in primary care needs to be established before any national information and communication technology solutions are developed.</p> <p>The aim of this study was to identify the most appropriate measures in implementation of Slovene national eHealth strategy and to suggest an appropriate model for success by using the three round Delphi study.</p> <p>Methods</p> <p>An e-mail based, three-round Delphi study was undertaken to achieve consensus from a selected sample of nationally recognized experts from the fields of primary health care and medical informatics. The aim of this study was to identify the most appropriate measures and key obstacles in implementation of eHealth in Slovene primary health care by using the Delphi study.</p> <p>Results</p> <p>High levels of consensus on the majority of suggested measures were achieved among all study participants, as well as between the subgroups of experts from primary health care and medical informatics. All aims of the three-round Delphi study on eHealth implementation in Slovenian primary health care were achieved.</p> <p>Conclusions</p> <p>The three round decision Delphi process has proven to be effective for developing outcomes, ranking key priorities in primary care eHealth development, and achieving consensus among the most influential experts in that field. This consensus is an important contribution to future national eHealth strategies in the field of primary health care.</p