Department of Clinical Research

Research Project  | 8 Project Members

Whether pelvic lymph node dissection offers an oncological benefit remains unknown. This study will compare extended pelvic lymph node dissection versus no dissection in PSMA PET-negative, T3, or Grade Group > 2 prostate cancer patients. The study will be conducted across all major urological clinics in Switzerland (KFS-5775-02-2023).

Research Project  | 1 Project Members

Imported from Grants Tool 4705002

Research Project  | 4 Project Members

Imported from Grants Tool 4705019

Research Project  | 4 Project Members

This project develops and enhances G-methods to improve causal inference in clinical research by combining longitudinal data with advanced statistical techniques, addressing time-varying treatments, confounders, and spatial correlations.

Research Project  | 4 Project Members

Brain death is the irreversible loss of brain function necessary to sustain life. Its diagnosis is based on the absence of brainstem reflexes, unresponsiveness to endo- or exogenous stimuli, apnea, and the exclusion of factors confounding the clinical presentation(4). While other organ functions may be preserved, the identification of brain death raises the question of whether viable organs can and should be transplanted to save the lives of critically ill patients in need of organ support.

 

With advancements in critical care techniques enabling the maintenance of organ function beyond brain death, as well as the intricate legal and regulatory frameworks surrounding organ donation, healthcare professionals in intensive care units are increasingly faced with complex clinical scenarios, considerations, and challenges related to the concept and diagnosis of brain death and ethical and legal aspects associated with organ donation. Studies investigating the individual conceptual understanding of brain death and organ donation of health care professionals on Intensive Care Units (ICUs) as well as their experiences and opinions related to these topics, are scarce(5-8).

 

The study aims to gather information regarding the individual perceptions, opinions, beliefs, and conceptual understanding of healthcare professionals working in the intensive care units at the University Hospital Basel and to determine associations of individual beliefs, personal, educational, and professional experiences with individual perceptions, opinions, and conceptual understanding regarding brain death and organ donation. 

To achieve the study objectives, we will employ a questionnaire-based survey administered to the consenting/participating nurses and physicians. The questionnaire will address various aspects related to personal background, religious affiliation, beliefs about life after death, the conceptual understanding of brain death and organ donation, as well as experiences and opinions related to these topics.

Participating in this study will create no additional risk or burden for patients and is therefore classified under category A according to HRO Art. 7.(1)

Hypothesis and primary objective

The primary objective of this study is to gather insights into the individual perceptions, opinions, beliefs, and conceptual understanding regarding brain death and organ donation of healthcare professionals working in the ICU at the University Hospital Basel in Switzerland. 

The following hypotheses will be tested: Individual perceptions, opinions, beliefs, and conceptual understanding regarding brain death and organ donation vary between the different professions and in dependence of specific aspects regarding personal, educational and professional experiences.

Primary and secondary endpoints

The primary endpoints of this study will be information on individual perceptions, opinions, beliefs, and conceptual understanding of healthcare professionals in the ICU regarding brain death and organ donation and the identification ofinterprofessional variations.

The secondary endpoints will be associations of specific demographics, beliefs, personal, educational, social and professional experiences with individual perceptions, opinions, and conceptual understanding regarding brain death and organ donation.

References

1.         Council TSF. Ordinance on Human Research with the Exception of Clinical Trials (HRO)2013.

2.         Council TSF. Ordinance on Clinical Trials in Human Research (HRA)2013.

3.         World Medical A. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama. 2013;310(20):2191-4.

4.         Wijdicks EF. The diagnosis of brain death. N Engl J Med. 2001;344(16):1215-21.

5.         Ferhatoglu SY, Ferhatoglu MF, Gurkan A. Approach of the Clinicians Practicing in Intensive Care Units to Brain Death Diagnosis and Training Expectations in Turkey: A Web-Based Survey. Transplant Proc. 2020;52(10):2916-22.

6.         Al-Mousawi M, Abdul-Razzak M, Samhan M. Attitude of ICU staff in Kuwait regarding organ donation and brain death. Transplant Proc. 2001;33(5):2634-5.

7.         Ong JS, James Foong W, Oo WL, Vallapil MK, Hossain MM, Hossain H, et al. Does knowledge and attitude of healthcare professionals working in critical care areas affect their willingness to offer the option of organ donation? results of a tertiary hospital survey. Med J Malaysia. 2022;77(3):347-56.

8.         Camut S, Baumann A, Dubois V, Ducrocq X, Audibert G. Non-therapeutic intensive care for organ donation: A healthcare professionals' opinion survey. Nurs Ethics. 2016;23(2):191-202.

Research Project  | 6 Project Members

Background:

In cancer patients with incurable disease pain is one of the most debilitating symptoms with a prevalence of about 70% (1). Many of these patients need opioids, which are the mainstay in managing cancer pain. Initiation of opioid therapy is frequently hindered by opioid induced nausea and vomiting (OINV) in up to 40% of patients (2). Nausea is highly distressing symptom that may occur with or without vomiting and can affect overall outcome and quality of life (3). To avoid discontinuation of the opioid therapy 50-80% of doctors prescribe prophylactic or on-demand antiemetics to reduce OINV (4), although evidence for this practice is scarce or not supported by randomised controlled trials (RCTs) (5). However, the medications used to prevent OINV, e.g. dopamine antagonists can trigger adverse events in the central nervous system (headaches, drowsiness) or even parkinsonism-like symptoms.

 Aims / Methods:

To better inform physicians, guidelines and patients, we propose a Cochrane systematic review and meta-analysis of RCTs concerning the benefits and harms of antiemetic drug therapy for the prevention and treatment of OINV in patients treated with opioids for cancer pain therapy.

Benefit for patients and / or public

The numbers of affected patients are expected to increase during the decades to come due to the medical progress in oncology and the demographic change (9,10).

Research Project  | 5 Project Members

INPUT is a nationwide survey of people taking part in clinical trials (INPUT survey). This project is funded by the Federal Office of Public Health. The aim is to find out which experiences trial participants make. The findings from the survey can be used to review and improve legal regulations and their recommendations for implementation of human research in the interests of study participants.

Research Project  | 1 Project Members

A stroke is a life-threatening condition that occurs when the blood supply to part of the brain is cut off by either a blood clot (85% of cases) or a burst blood vessel. Strokes affect some 15-17 million people a year, and they are a leading cause of death and disability. Urgent treatment is therefore essential to save the patient’s life and prevent further damage to the brain. Due to the potential for long-lasting consequences, stroke care involves a lengthy, complex pathway requiring coordination among multiple healthcare professionals. Unfortunately, many patients experience impaired care due to poor coordination between their healthcare providers.

The UMBRELLA project aims to revolutionise the way we manage strokes by implementing a comprehensive approach that addresses gaps along the whole stroke care pathway, from diagnosis and emergency treatment, right through to rehabilitation and the prevention of further strokes.

At the heart of UMBRELLA is a federated data platform dubbed the ‘U-platform’. The project will harmonise real world stroke data from participating clinical centres to a common data model. These datasets will then be used to locally create and validate artificial intelligence (AI) algorithms designed to advance stroke diagnosis, risk prediction, and decision-making at different points in the stroke care pathway.

The new AI algorithms will undergo further training and testing on other datasets via a federated learning framework. This approach ensures the AI models benefit from being trained on multiple datasets, but because the data is not shared or pooled, security and privacy are ensured.

The project also aims to create standardised stroke management protocols and procedures and implement them across the participating clinical centres. These protocols will include the use of digital technologies to collect and visualise data, engage patients, and facilitate decision making at all stages of stroke care.

Finally, the project will develop a regulatory roadmap to secure the approvals needed to implement the project outputs in patient care. They will also establish a sustainability plan to ensure the continued existence of resources like the U-Platform beyond the end of the project.

Research Project  | 2 Project Members

CASCADE is a Swiss, multicenter, family-based, open-ended, prospective cohort established in 2017 by contacting individuals with pathogenic variants (PV) associated with hereditary breast and ovarian cancer (HBOC) or Lynch syndrome (LS) and their biological relatives. The cohort includes individuals with PV who are either affected or unaffected by cancer, relatives without the familial PV (true negatives), and relatives who did not have genetic testing (cascade screening). Self-administered questionnaires collect information on epidemiological factors (e.g., cancer status) and risk management behaviors (e.g., risk reducing surgeries) approximately 18-24 months apart.

Since the initiation of the cohort we have examined rates of cascade screening among relatives and family communication of genetic risk (CASCADE I); and guideline-concordant cancer surveillance and risk reducing practices (CASCADE II). CASCADE III will focus on individuals from HBOC and LS families whose cancer surveillance and risk management behaviors do not correspond to the expectations of the healthcare system (discordant behaviors). We hypothesize that discordant behaviors may be related to the characteristics of the healthcare system and/or its responses to the needs of these individuals.

CASCADE III will: Aim 1: Examine the influence of individual domain clusters (e.g., cancer status), interpersonal domain clusters (e.g., partner status), and healthcare system domain clusters (e.g., provider specialty) on cancer risk management behaviors, and explore how changes in these clusters impact changes in risk management. Aim 1 will be addressed with two (additional) questionnaires approximately 24 months apart. Combined data will cover a period of close to 10 years and 6 data collection points for participants who have been in the cohort since its initiation - currently 461 carriers of pathogenic variants (index cases and relatives), and 86 untested or ‘true negative’ individuals. Newly-identified carriers and their biological relatives will also be recruited. Risk management behaviors will be analyzed longitudinally, in light of the trajectory of the person, using survival analyses.

Aim 2: Explore decision-making processes and the perceived role of providers and the healthcare system among individuals from HBOC and LS families with discordant cancer surveillance, risk management, and genetic testing behaviors. Aim 2 will be addressed with questionnaire and narrative data. Subgroups of individuals with discordant risk management behaviors (e.g., female, over 45 years old, without risk-reducing salpingo-oophorectomy) will be invited to participate either in in-depth interviews or in focus groups. Data will be analyzed with thematic analysis.

Aim 3: Design improvements in the healthcare system based on risk-stratified “survivorship care” models for families harboring HBOC or LS pathogenic variants. Aim 3 will be addressed with a Delphi survey of a panel with international and national experts and patient representatives. The panel will explore models of risk-stratified survivorship care for HBOC and LS families. Delphi methodology is based on the principle that decisions of an expert panel are more accurate than those of unstructured groups, given adequate diversity and representativeness of panel members.