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

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

Global wealth disparities drive adherence to COVID-safe pathways in head and neck cancer surgery

Peer reviewe

Clinical features and outcomes of elderly hospitalised patients with chronic obstructive pulmonary disease, heart failure or both

Background and objective: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) mutually increase the risk of being present in the same patient, especially if older. Whether or not this coexistence may be associated with a worse prognosis is debated. Therefore, employing data derived from the REPOSI register, we evaluated the clinical features and outcomes in a population of elderly patients admitted to internal medicine wards and having COPD, HF or COPD + HF. Methods: We measured socio-demographic and anthropometric characteristics, severity and prevalence of comorbidities, clinical and laboratory features during hospitalization, mood disorders, functional independence, drug prescriptions and discharge destination. The primary study outcome was the risk of death. Results: We considered 2,343 elderly hospitalized patients (median age 81 years), of whom 1,154 (49%) had COPD, 813 (35%) HF, and 376 (16%) COPD + HF. Patients with COPD + HF had different characteristics than those with COPD or HF, such as a higher prevalence of previous hospitalizations, comorbidities (especially chronic kidney disease), higher respiratory rate at admission and number of prescribed drugs. Patients with COPD + HF (hazard ratio HR 1.74, 95% confidence intervals CI 1.16-2.61) and patients with dementia (HR 1.75, 95% CI 1.06-2.90) had a higher risk of death at one year. The Kaplan-Meier curves showed a higher mortality risk in the group of patients with COPD + HF for all causes (p = 0.010), respiratory causes (p = 0.006), cardiovascular causes (p = 0.046) and respiratory plus cardiovascular causes (p = 0.009). Conclusion: In this real-life cohort of hospitalized elderly patients, the coexistence of COPD and HF significantly worsened prognosis at one year. This finding may help to better define the care needs of this population

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Elective cancer surgery in COVID-19-free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19–free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19–free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19–free surgical pathways. Patients who underwent surgery within COVID-19–free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19–free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score–matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19–free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19–free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Analysing and optimising Informed Consent in cooperation with ethics committees and medical researchers

Medical researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project (Informed Consent). Accordingly, information and consent represent a complex procedure, and the participant concerned “must receive comprehensible oral and written information” (Swiss legislation: Human Research Act (HRA) Art. 16). A triangle of stakeholders is involved in the procedure: ethics committees that review and approve research projects and Informed Consent (IC) documents, medical researchers who produce the documents and discuss enrolment with patients, and patients who have to be informed comprehensibly. From a linguistic point of view, the question arises as to which perceptions of comprehensibility form the basis of the IC process and how shared language can be established considering the complex relationship between these stakeholders. This contribution presents findings from two perspectives (ethics committees and researchers) while considering the needs of all three stakeholders. Firstly, the conceptualisation of comprehensibility among three ethic committees is presented, and steps toward harmonisation are outlined. Secondly, limitations of how researchers conduct oral IC information are analysed, and the measures that were implemented to improve patient information are discussed. A transdisciplinary approach is key in establishing these solutions because they do not stem from linguistic analysis alone but have been developed in close collaboration with members of ethics committees and medical researchers. Thus, the project shows how the expertise of applied linguistics in cooperation with practitioners can deliver an important impact in both academic analysis and optimisation of professional procedures