Department of Clinical Research

Research Project  | 1 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  | 4 Project Members

Glucocorticoid therapy is an important component of the treatment regimen for childhood acute lymphoblastic leukaemia and lymphoblastic lymphoma by inducing apoptosis of lymphoblastic cells. However, the use of supraphysiological doses of glucocorticoids can lead to hypothalamic-pituitary-adrenal axis suppression. This suppression can result in a reduced cortisol response, leading to impaired stress response and inadequate host defence against infections, which can ultimately result in morbidity and mortality. To date, there is insufficient high-quality research to inform evidence-based guidelines for glucocorticoid replacement therapy in this populatioon.

Hence, in this prospective multicenter study, we aim to analyze the patterns of suppression of the hypothalamic-pituitary-adrenal axis suppression in children receiving glucocorticoid therapy for acute lymphoblastic leukaemia and lymphoblastic lymphoma.

Research Project  | 3 Project Members

Unspezifische untere Rückenschmerzen stellen ein komplexes Krankheitsbild dar, von welchen Patienten jeglicher Populationen weltweit betroffen sind. Etwa 5% aller Notfallkonsultationen sind mit Rückenschmerzen assoziiert.

Die Ätiologie sowie die optimale Behandlung dieser Erkrankung ist weiterhin unklar.

Die frühzeitige bildgebende Diagnostik wird aufgrund der hohen finanziellen Kosten und der Strahlenbelastung der Patienten in den ersten 6 Wochen nicht empfohlen, sofern keine Red Flags vorliegen. Ebenso sollte auf eine analgetische Therapie mit Opioiden bei akuter Symptomatik verzichtet werden. Hierbei sind insbesondere die unerwünschten Nebenwirkungen sowie gefährliche Überdosierungen von Bedeutung. Zusätzliche Konsequenzen können längere Arbeitsplatzabsenzen sowie Mehrfachkonsultationen sein. Im Spitalalltag bleibt es jedoch eine Herausforderung, die Diskrepanz zwischen Patientenanforderungen und den Empfehlungen der Guidelines zu meistern.

Wir planen eine retrospektive Single-Center-Beobachtungsstudie. Ziel der Studie ist die Analyse des Rückenschmerzenmanagements anhand von Fallserie-Analysen von Patientinnen und Patienten, welche in den Jahren zwischen 2018 und 2023 auf die Notfallstation mit Rückenschmerzen eingetreten sind. Aus den Erkenntnissen der Studie sollen weitere Massnahmen wie Patientenedukation und Mitarbeiterschulungen entstehen, um so die Versorgung und Sicherheit der Patienten zu verbessern. 

Research Project  | 12 Project Members

Introduction

The high prevalence of pain in the emergency department (ED) highlights the importance of an accurate assessments to provide effective interventions. However, common pain scales such as the numerical pain rating scale have shown limitations in assessing analgesic requirements and adequacy. The ideal outcome for evaluating a pain scale predicting analgesic requirements would be the “need for analgesia”, for which there is no universally accepted definition. Accordingly, the primary aim of this study is to define the “need for analgesia” using an interdisciplinary approach. The secondary aim is to define the “adequacy of analgesia”.

Methods and analysis

A two-stage modified Delphi process will be conducted by a core study group chosen for its expertise in ED pain management. A larger expert panel, identified through a comprehensive search in Scopus and CINAHL databases, will be invited to participate in the study and will be supplemented by patients recruited via International Patient Organizations. In Stage 1, the expert panel will complete a written survey to collect potential clinical variables for defining the “need for analgesia” and “adequacy of analgesia”. The core study group will elaborate these variables. In stage 2, the same participants will use a five-point Likert scale to achieve consensus defined as 80% of combined agreement on the proposed variables. The same process will be used to define the “adequacy of analgesia”.

Ethics and Dissemination

The Ethics Committee of Northwestern and Central Switzerland exempted the project from committee approval under the Human Research Act. Written consent will be obtained from all participants. Results will be disseminated through publication in peer-reviewed journals and conferences. 

Research Project  | 3 Project Members

Released in November 2022, ChatGPT gained over 100 million users in just two months to become the fastest growing application of all time. This Natural Language Processing Artificial Intelligence is capable of producing human-like responses on an incredibly large range of topics. It is inevitable that ordinary people will use it for medical diagnostic purposes, much as they do any other search engine. Although it, and other NLP tools like it, are comparable in diagnostic accuracy to human doctors, their use as substitutes to, or surrogates for, human doctors raises numerous ethical challenges. Not least of which is the impact this will have on vital doctor-patient relationships in under-served communities.

Current research focuses on quantitative research which does not take into consideration real-world patient experiences. The proposed project will provide an in-depth analysis of real-world patient experiences of using NLP tools in comparison to human doctors.

Following a scoping review, the project will use a novel qualitative research methodology. Real-world patients will be interviewed before a doctor’s consultation. They will then immediately engage in a similar mock consultation with an NLP tool. Data will be subjected to thematic analysis and recommendations produced for NLP tool developers and Swiss policy makers.   

Research Project  | 1 Project Members

Imported from Grants Tool 4694712