Search results for "Clinical study design"
showing 10 items of 33 documents
Multidisciplinary strategies to improve treatment outcomes in hepatocellular carcinoma
2013
Hepatocellular carcinoma (HCC) is a complex disease with a poor prognosis. Incidence and mortality rates are increasing in many geographical regions, indicating a need for better management strategies. Among several risk factors for HCC, the most common are cirrhosis because of chronic hepatitis B virus or hepatitis C virus infection and alcohol consumption, obesity, and diabetes. In some patients, combined risk factors present additional challenges to the prevention and treatment of HCC. Screening and surveillance of high-risk populations varies widely by geographic regions, and access to optimal surveillance is critical for early diagnosis. The treatment choice for HCC depends on the canc…
Looking for a new panacea in ALK-rearranged NSCLC: may be Ceritinib?
2014
Abstract: In the past decade, the advent of targeted therapy led to a silent revolution in the war against lung cancer and a significant evolution on the concept of Phase I clinical trials design. Thanks to the specificity of their target, the new drugs have radically changed NSCLC treatment, leading to the development of personalized strategies. The accelerated approval of the first ALK-inhibitor, Crizotinib and more recently Ceritinib, without a Phase III randomized, clinical trial, has been an amazing success story in lung cancer research, marking the beginning of a new decade of targeted drugs development, characterized by modern, biomarker-driven, early clinical trial design and shorte…
A human factors intervention in a hospital - evaluating the outcome of a TeamSTEPPS program in a surgical ward
2021
AbstractBackgroundPatient safety in hospitals is being jeopardized, since too many patients experience adverse events. Most of these adverse events arise from human factors, such as inefficient teamwork and communication failures, and the incidence of adverse events is greatest in the surgical area. Previous research has shown the effect of team training on patient safety culture and on different areas of teamwork. Limited research has investigated teamwork in surgical wards. The aim of this study was to evaluate the professional and organizational outcomes of a team training intervention among healthcare professionals in a surgical ward after 6 and 12 months. Systems Engineering Initiative…
Strategies for Including Patients Recruited During Interim Analysis of Clinical Trials
2007
In clinical trials a periodical check of safety and efficacy data is often needed. For organizational reasons it is rarely desirable to stop a trial during such an interim analysis. Therefore, new study patients are included in the trial while the interim analysis is ongoing. Disregarding the additional information provided by these interim patients would be unsatisfactory, especially for an office of regulatory affairs. Consequently, the rules for group sequential or adaptive decisions must be adjusted to the recruitment of interim patients. In this paper, two strategies for modifying study designs to consider the analysis of interim patients are proposed.
Cost-effectiveness of psychotropic polypharmacy in routine schizophrenia care. Results of the ELAN prospective observational trial
2018
Abstract Aims To analyse the costs and cost-effectiveness of psychotropic polypharmacy in comparison to antipsychotic monotherapy in patients with schizophrenia and schizo-affective disorder under real-world treatment conditions. Methods A prospective observational study including 374 adult psychiatric in-patients with schizophrenia or schizo-affective disorder was conducted. Psychotropic regimen, clinical outcomes, and quality of life were assessed before discharge and after 6, 12, 18, and 24 months. Costs and outcomes of psychotropic polypharmacy in comparison to antipsychotic monotherapy were analysed by means of mixed-effects regression models adjusted for propensity scores. Net-benefit…
Designs and methods in school improvement research: a systematic review
2016
Purpose – The purpose of this paper is to focus on challenges faced by longitudinal quantitative analyses of school improvement processes and offers a systematic literature review of current papers that use longitudinal analyses. In this context, the authors assessed designs and methods that are used to analyze the relation between school improvement processes and student outcomes. Based on this the authors point out to what extent the papers consider different aspects of the complex nature of school improvement (e.g. multilevel structure, indirect and nonlinear effects, reciprocity). The choice of study designs and methods of analysis substantially determines which aspects of this complex…
Writing to Learn Programming? : A Single Case Pilot Study
2016
This paper explores the use of writing-to-learn techniques in the context of programming education. It presents a pilot study where a writing assignment is introduced with the purpose of strengthening students' conceptual understanding of a programming construct. The intervention is evaluated using a single case research design, which is augmented by qualitative interview data. Students participating in the study were mildly positive towards the intervention and the results encourage more work on the topic. This work sets directions for further investigations into how writing-to-learn can strengthen programming education and contributes with insights into what kinds of results can be obtain…
Peer Support for People Living With HIV: A Scoping Review
2021
Peer support for people living with HIV has gained increasing traction and is considered a way to take an active role in self-management. The existing research examining peer support interventions has reported promising evidence of the benefits of peer support. The purpose of our scoping review was to describe research on peer support for people living with HIV. We included 53 studies and sorted them into analytic categories and conducted descriptive analyses. The studies that were published between November/December 2000 and May 2021, had a range of study designs and heterogeneous priority groups, and included 20,657 participants from 16 countries. We identified 43 evaluations of the effe…
Systematic handling of missing data in complex study designs : experiences from the Health 2000 and 2011 Surveys
2016
We present a systematic approach to the practical and comprehensive handling of missing data motivated by our experiences of analyzing longitudinal survey data. We consider the Health 2000 and 2011 Surveys (BRIF8901) where increased non-response and non-participation from 2000 to 2011 was a major issue. The model assumptions involved in the complex sampling design, repeated measurements design, non-participation mechanisms and associations are presented graphically using methodology previously defined as a causal model with design, i.e. a functional causal model extended with the study design. This tool forces the statistician to make the study design and the missing-data mechanism explicit…
Intervention studies to foster resilience – A systematic review and proposal for a resilience framework in future intervention studies
2017
Psychological resilience refers to the phenomenon that many people are able to adapt to the challenges of life and maintain mental health despite exposure to adversity. This has stimulated research on training programs to foster psychological resilience. We evaluated concepts, methods and designs of 43 randomized controlled trials published between 1979 and 2014 which assessed the efficacy of such training programs and propose standards for future intervention research based on recent developments in the field. We found that concepts, methods and designs in current resilience intervention studies are of limited use to properly assess efficacy of interventions to foster resilience. Major pro…