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[FG] Briel Matthias

Projects & Collaborations

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Pharmacological antiemetic prophylaxis and treatment for opioid induced nausea and vomiting (OINV) in patients treated for cancer pain: Cochrane systematic review

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).


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RETUNE

Research Project  | 7 Project Members

Reduce Tobacco Use in People Living with HIV in Switzerland (RETUNE)


Tobacco smoking represents a leading health burden in the aging population of people living with HIV in Switzerland. New tools for smoking cessation like electronic cigarettes or nicotine pouches are promising to reduce the harm caused by tobacco smoking. However, high quality evidence of their effectiveness among people living with HIV and outside of explanatory randomized trials is missing. 


RETUNE is a highly pragmatic randomized trial, fully embedded in the Swiss HIV Cohort Study (SHCS), using the “Trials within Cohorts” (TwiCs) design. 

In the TwiCs design, participants are recruited within a prospective cohort study and can consent not only to regular data collection at cohort visits, but also to be randomized in future low-risk pragmatic trials (“randomization consent”). Participants are informed that only participants randomized to the intervention arm are approached and may then accept or decline the offered intervention. Participants in the intervention who accept the intervention, are asked to sign an “intervention consent”, that only covers additional data collection in this group and the safety/side-effects of the intervention – similar to a routine clinical consent (e.g. consent for a lumbar puncture in clinical care). 


RETUNE aims to assess the effectiveness of the offer of a menu including different tobacco cigarettes substitutional products (e-cigarettes, nicotine pouches, nicotine patches) to quit smoking. People with HIV in the SHCS who smoke tobacco cigarettes and who signed the randomization consent will be randomized in a 1:1 ratio to the offer of the menu or to usual care. People are included regardless of their willingness to quit smoking. The primary endpoint is tobacco abstinence after 6 months. RETUNE is a multicenter trial which will include centers in Basel, Bern, Geneva, Lausanne, St. Gallen, and Zurich. 


RETUNE is funded by the Tobacco Prevention Fund, the Novartis foundation for medical-biological research, and the Swiss National Science Foundation.



Involved partner:

Swiss HIV Cohort Study

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MARTA: Making clinical trials more affordable - systematic investigation of trial costs and tool development

Research Project  | 1 Project Members

Randomized clinical trials (RCTs) are an essential method of evaluating health care interventions and a cornerstone for evidence-based health care. Their conduct, in particular for investigator-initiated RCTs, has long involved many practical challenges, challenges that have become increasingly complex and costly. Efforts to render RCTs more cost-effective are, therefore, urgently needed. Identifying lever-points for cost reductions requires knowledge of cost structures and cost drivers (e.g. recruitment duration, sample size, therapeutic area, number of trial sites). The medical literature, however, currently lacks detailed empirical data addressing costs and resource use of investigator-initiated RCTs as well as information about current practices of budget planning and cost monitoring, attitudes, needs, and preferences of trial investigators, trial support organizations (e.g. Clinical Trial Units), and funding agencies. Academic investigators usually depend on scarce financial resources; user-friendly and reliable tools to effectively limit costs of RCTs through optimized budget planning and cost monitoring during the conduct of an RCT are currently unavailable and sorely needed. We therefore propose three complementary projects using mixed-methods to render investigator-initiated RCTs more affordable and efficient through evidence-based budget planning, stakeholder consensus regarding relevant budget items, and the development of suitable tools. In Project A we will gather empirical resource use and cost data from 180 investigator-initiated RCTs in Switzerland, Germany, Canada, and the United Kingdom to investigate cost patterns, empirically identify major cost drivers and lever-points for cost savings, examine planned versus actual RCT costs, and explore heterogeneity of costs across medical fields and countries. Project B will consist of semi-structured interviews to explore current practices, attitudes, needs, and preferences of trial investigators, trial funders, and trial support organizations with respect to budget planning, funding acquisition for RCTs, managing costs during RCT conduct, and supporting tools in Switzerland. In Project C we will develop reliable and user-friendly budget calculation and cost monitoring tools for RCTs with stakeholder consensus based on systematically collected evidence from the literature/internet and informed by user needs and preferences (as elicited in Project B). We will formally user-test and evaluate the reliability and accuracy of developed tools using the generated database of empirical RCT cost data from Project A. The results of the proposed mixed-methods work will have immediate impact on the research practice of trial investigators, trial support organizations, and funders of RCTs in Switzerland and abroad. Given the increasing costs and complexity of RCTs, our project is timely and should shift the discussion from "rough guesses" to "analysing transparent and valid data" so that costs of clinical trials can be assessed, cost drivers identified, and costs effectively limited so that RCTs, critical to advancing clinical science, become more affordable.

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Generalizability, applicability and pragmatism of clinical trials and their impact on treatment effect estimates: a meta-epidemiological study

Research Project  | 2 Project Members

It is often claimed that results from some randomized clinical trials (RCT) are difficult to transfer into real life situations. Pragmatic RCTs provide decision-oriented, real world evidence that is perceived as highly applicable and generalizable to routine care. Conversely, explanatory RCTs conducted in highly controlled research settings are often considered little or not applicable and generalizable. Pragmatic and explanatory RCTs are the extremes of a continuum measurable using the PRECIS-2 tool, which is increasingly being used to design and assess clinical trials. It is widely assumed that treatment effects provided by more pragmatic trials differ from those given by more explanatory trials. However, it is unknown how they differ and which features determine pragmatism, generalizability and applicability. Our goal is to provide empirical evidence on the strengths, weaknesses and the impact on treatment effect estimates of pragmatism, applicability and generalizability beyond the theoretical expectations of their value in the decision-making process of patient care.Objectives: (1) To set up the PragMeta database, which will include trials investigating the same clinical questions but having different aspects of generalizability, applicability and pragmatism; (2) to descriptively characterize those aspects using the PRECIS-2 score and specific trial population- and setting-related determinants of generalizability (for example strict or broad eligibility criteria) and applicability (for example highly controlled environment versus routine care); and (3) to determine their impact on the treatment effect estimatesDesign and Methods: This is a meta-epidemiological study of published trials. We will work in a large international research collaboration, with key experts in the field, to incorporate and share in the PragMeta database large already available datasets of pragmatic trials, supplemented by specific systematic searches of pragmatic and explanatory trials on the same clinical questions. Standard methods of systematic reviewing, meta-analysis and meta-epidemiology will be used. We will compare treatment effects from pragmatic versus explanatory trials and from trials with versus without specific determinants of pragmatism, generalizability, and applicability using meta- regressions and the ratio of odds ratio method. We plan to include over 2000 trials that will be representative of the pragmatic-explanatory continuum.Relevance of the project: The cornerstone of real world evidence is that treatment effects under real world conditions in routine care may differ from that in highly controlled research settings, such as in drug approval trials. The PragMeta project aims to provide a better understanding of the pragmatic-explanatory continuum, and the generation and interpretation of real world evidence. It will give practical guidance for clinicians, researchers, regulators, health insurers and health-care policy makers, developers of reporting guidelines, and other stakeholders who develop, fund, conduct, assess or otherwise use clinical trials. Ultimately it may help to generate, report and use evidence that is more relevant for patients, clinicians and other key health care decision-makers.

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Functional Aging in Health and Disease - the COmPLETE Project

Research Project  | 5 Project Members

The increasing prevalence of chronic non-communicable diseases and associated risk factors contribute to earlier disability and frailty onset over the course of life in industrialized western countries. This process applies also to diseases of the cardiovascular system, including heart failure, which is a widespread syndrome in middle-aged and older people. Although life expectancy has steadily increased in past decades, the traditional curative way of thinking in medicine is unlikely to compress the disease phase to the final stage of life and thus increase the health span, which is defined as a period of relatively disease-free aging followed by a period of age-related diseases and disabilities. In the period of healthy aging, the function of the organs, including the cardiovascular system, is already deteriorating. To counteract this process and to increase the health span, the preservation or improvement of components of physical fitness (endurance capacity, muscle strength, and neuromuscular function) is thought to be an essential element. The proven, independently predictive value of the single physical fitness components for total and cardiovascular mortality confirms this assumption. However, comprehensive data regarding individual physical fitness characteristics over the course of life are not yet available. Such data is necessary for any targeted prevention program with physical activity and exercise training as crucial pillars. Furthermore, healthy reference values could be used to estimate the adaptive capacity in healthy individuals compared to patients. Therefore, the aims of the COmPLETE project are:1.To determine the trajectories of physical fitness components of healthy aging by measurement of endurance capacity, muscular strength and neuromuscular coordination in a healthy population sample between 20 and 100 years (COmPLETE-Health) and 2.To determine the health distance between healthy individuals (COmPLETE-Health) and heart failure patients (COmPLETE-Heart) on the basis of different physical fitness components (endurance capacity, muscular strength and neuromuscular coordination). We anticipate that, for the first time, a basis for targeted prevention programs will be created through better and comprehensive knowledge of the individual physical fitness to improve the health span. In addition, we are convinced that by calculating the health distance between healthy and heart failure patients, we are laying the foundation for more individual exercise therapy. The COmPLETE project could be the starting point for strengthening the in-depth diagnostics of physical fitness as a component of preventative health care.

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INSPIRE: Einführung eines gemeindebasierten Versorgungsprogramms für ältere Menschen im Kanton Basel-Landschaft (Implementation of a Community-based Care Program for Senior Citizens in Canton BL)

Research Project  | 14 Project Members

In der Schweiz steigt die Lebenserwartung. Somit wird auch der Anteil von älteren Menschen mit Unterstützungsbedarf grösser. Die Unterstützung wird dabei von verschiedenen Anbietern zur Verfügung gestellt. Ältere Menschen brauchen oft eine Kombination von Dienstleistungen, diese sind jedoch weder zentralisiert noch koordiniert, so dass ältere Menschen dem Risiko einer fragmentierten Versorgung ausgesetzt sind. Negative Folgen sind die Mehrfachnutzung von Diensten, Lücken in der Informationsbereitstellung, unpassende oder widersprüchliche Empfehlungen und Medikationsfehler. Dies führt zu Unsicherheit, Stress und Belastung bei älteren Personen und ihren Angehörigen. Dazu kommen höhere Pflegekosten durch unnötige Spitalaufenthalte, das Aufsuchen von Notfallabteilungen und andere unnötige Inanspruchnahme von Dienstleistungen. Solche unerwünschten Prozesse und Auswirkungen können durch Investitionen in integrierte Versorgungsmodelle verhindert werden. INSPIRE geht diesen drängenden Fragen nach und zeigt, wie neue Versorgungsmodelle in der Praxis mit hoher Nachhaltigkeit umgesetzt werden können. Angesichts der demografischen Entwicklung der Bevölkerung im Kanton Basel-Landschaft (BL) und des bevorstehenden Mangels an Hausärzten und Betreuungspersonen wurde die Organisation der Gesundheitsversorgung für ältere Personen im Kanton überdacht. Am 16. Nov. 2017 wurde im Landrat das neue Altersbetreuungs- und Pflegegesetz (APG) verabschiedet. Dieses schreibt eine Reorganisation des Kantons BL in Versorgungsregionen vor, was eine Zusammenarbeit auf Gemeindeebene erfordert. In den Versorgungsregionen werden Informations- und Beratungsstellen zu Fragen der Betreuung und Pflege im Alter eingerichtet. Diese stellen den Bewohnerinnen und Bewohnern einer Versorgungsregion Informationen zum Thema Alter(n) und Altersfragen zur Verfügung, und ermöglichen Beratung und Bedarfsabklärung durch eine Pflegefachperson, insbesondere vor dem Eintritt in ein Pflegeheim. Eine zentrale Aufgabe der Versorgungsregionen ist es, ein Versorgungskonzept zu erstellen, um eine angemessene ambulante, intermediäre und stationäre Versorgung sicherzustellen. Das Ziel von INSPIRE besteht darin, ein effizientes und nachhaltiges gemeindebasiertes Versorgungskonzept für ältere Menschen mit neuen Methoden der Public Health- und Implementierungsforschung im Kanton BL zu entwickeln und umzusetzen. Das Projekt wird in folgenden Schritten durchgeführt: Organisation einer kantonalen Steuergruppe und eines lokalen Stakeholder-Gremiums, die sich aktiv für die Entwicklung und Umsetzung des gemeindebasierten Versorgungsmodelles einsetzen. Ermittlung bestehender gemeindebasierter Versorgungsprogramme, und Analyse der Wirksamkeit und Nachhaltigkeit (Literaturrecherche, gute Praxisbeispiele in der Schweiz inklusiv lokalen Beispielen im Kanton BL). Kontextanalyse: Erfassung der aktuellen gemeindebasierten Gesundheitsversorgung im Kanton BL. Evidenzbasierte Entwicklung eines gemeindebasierten Versorgungsmodells, das dem Gesundheitswesen von BL entspricht und aus der Sicht der Stakeholder passt und umsetzbar ist. Entwicklung eines Monitoring-Systems, das die Umsetzung und Auswirkungen des gemeindebasierten Programmes auf ältere Menschen, Anbieter und Gesundheitssystem laufend evaluiert. Als Resultat der oben beschriebenen Arbeitspakete liegt ein auf die lokalen Gegebenheiten von BL angepasstes Versorgungsmodell mit geplantem Monitoring-System vor. Dies wird in einem weiteren Schritt in einer Versorgungsregion von BL umgesetzt und evaluiert.