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More and more frequently, clinical trials include the evaluation of Health-Related Quality of Life (HRQoL), yet many investigators remain unaware of the unique measurement and analysis issues associated with the assessment of HRQoL. At the end of a study, clinicians and statisticians often face challenging and sometimes insurmountable analytic problems. Design and Analysis of Quality of Life Studies in Clinical Trials details these issues and presents a range of solutions. Written from the author's extensive experience in the field, it focuses on the very specific features of QoL data: its longitudinal nature, multidimensionality, and the problem of missing data. The author uses three real clinical trials throughout her discussions to illustrate practical implementation of the strategies and analytic methods presented. As Quality of Life becomes an increasingly important aspect of clinical trials, it becomes essential for clinicians, statisticians, and designers of these studies to understand and meet the challenges this kind of data present. In this book, SAS and S-PLUS programs, checklists, numerous figures, and a clear, concise presentation combine to provide readers with the tools and skills they need to successfully design, conduct, analyze, and report their own studies.
As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.
This book provides research workers with the statistical background needed in order to collect and analyze data in an intelligent and critical manner. Key examples and case studies are used to illustrate commonly encountered research problems and to explain how they may be solved or even avoided altogether. Professor Manly also presents a clear understanding of the opportunities and limitations of different research designs, as well as an introduction to some new methods of analysis that are proving increasingly popular. Topics covered include: the differences between observational and experimental studies, the design of sample surveys, multiple regression, interrupted time series, computer intensive statistics, and the ethical considerations of research. In the final chapter, there is a discussion of how the various components of a research study come together.
Design Principles and Analysis Techniques for HRQoL Clinical TrialsSAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical meth
The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.
Novice and early career researchers often have difficulty with understanding how theory, data analysis and interpretation of findings “hang together” in a well-designed and theorized qualitative research investigation and with learning how to draw on such understanding to conduct rigorous data analysis and interpretation of their analytic results. Data Analysis, Interpretation, and Theory in Literacy Studies Research demonstrates how to design, conduct and analyze a well put together qualitative research project. Using their own successful studies, chapter authors spell out a problem area, research question, and theoretical framing, carefully explaining their choices and decisions. They then show in detail how they analyzed their data, and why they took this approach. Finally, they demonstrate how they interpreted the results of their analysis, to make them meaningful in research terms. Approaches include interactional sociolinguistics, microethnographic discourse analysis, multimodal analysis, iterative coding, conversation analysis, and multimediated discourse analysis, among others. This book will appeal to beginning researchers and to literacy researchers responsible for teaching qualitative literacy studies research design at undergraduate and graduate levels. Perfect for courses such as: Literacy Research Seminar | Introduction to Qualitative Research | Advanced Research Methods | Studying New Literacies and Media | Research Perspectives in Literacy | Discourse Analysis | Advanced Qualitative Data Analysis | Sociolinguistic Analysis | Classroom Language Research
Analysis in Nutrition Research: Principles of Statistical Methodology and Interpretation of the Results describes, in a comprehensive manner, the methodologies of quantitative analysis of data originating specifically from nutrition studies. The book summarizes various study designs in nutrition research, research hypotheses, the proper management of dietary data, and analytical methodologies, with a specific focus on how to interpret the results of any given study. In addition, it provides a comprehensive overview of the methodologies used in study design and the management and analysis of collected data, paying particular attention to all of the available, modern methodologies and techniques. Users will find an overview of the recent challenges and debates in the field of nutrition research that will define major research hypotheses for research in the next ten years. Nutrition scientists, researchers and undergraduate and postgraduate students will benefit from this thorough publication on the topic. - Provides a comprehensive presentation of the various study designs applied in nutrition research - Contains a parallel description of statistical methodologies used for each study design - Presents data management methodologies used specifically in nutrition research - Describes methodologies using both a theoretical and applied approach - Illustrates modern techniques in dietary pattern analysis - Summarizes current topics in the field of nutrition research that will define major research hypotheses for research in the next ten years
The National Children's Study (NCS) is planned to be the largest long-term study of environmental and genetic effects on children's health ever conducted in the United States. It proposes to examine the effects of environmental influences on the health and development of approximately 100,000 children across the United States, following them from before birth until age 21. By archiving all of the data collected, the NCS is intended to provide a valuable resource for analyses conducted many years into the future. This book evaluates the research plan for the NCS, by assessing the scientific rigor of the study and the extent to which it is being carried out with methods, measures, and collection of data and specimens to maximize the scientific yield of the study. The book concludes that if the NCS is conducted as proposed, the database derived from the study should be valuable for investigating hypotheses described in the research plan as well as additional hypotheses that will evolve. Nevertheless, there are important weaknesses and shortcomings in the research plan that diminish the study's expected value below what it might be.
The theory and practice of longitudinal studies; Sampling and design; The choice of measurement scales over time; The analysis of models for time related measurement; The analysis of models for relating measurements at differene occasions; Population standards or norms; Data processing.
This book constitutes a unique resource for advanced students and researchers in the behavioral and social sciences.