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Assessing Quality of Life in Clinical Trials by Peter M. Fayers,Ron D. Hays Pdf
Researchers in all clinical fields are fully aware of the importance of Quality of Life measurements in judging the efficacy of a given treatment. Psychological criteria play an important role in this evaluation. Assessment of Quality of Life in Clinical Trials: methods and practice explores the current state of the art and illustrates the benefits and potential of health related quality of life assessment in clinical trials. It covers a wide range of analytical issues, emphasizing new and innovative approaches that are of practical and clinical importance.
Author : Maurice J. Staquet,Ron D. Hays,Peter M. Fayers Publisher : Oxford University Press, USA Page : 360 pages File Size : 46,8 Mb Release : 1998 Category : Health & Fitness ISBN : 0192627856
Quality of Life Assessment in Clinical Trials by Maurice J. Staquet,Ron D. Hays,Peter M. Fayers Pdf
Researchers in all clinical fields are becoming increasingly aware of the importance of quality of life measurements in judging the efficacy of a given treatment, and it is becoming more common for psychological criteria to play an important role in the evaluation of therapies. In the past ten years a number of methods have been developed for carrying out such assessments. Quality of life research does however use special statistical methods which might well be unfamiliar to the clinician. Quality of life assessment in clinical trials: methods and practice explores these methods in a non-mathematical manner, comparing and contrasting the tools available to the clinician, and highlighting any potential pitfalls. It describes the methods used to collect and analyse quality of life data. The book will have widespread appeal to clinical trialists and researchers from a wide range of specialties.
Author : Peter F. Thall Publisher : Springer Science & Business Media Page : 263 pages File Size : 41,9 Mb Release : 2012-12-06 Category : Medical ISBN : 9781461520092
Recent Advances in Clinical Trial Design and Analysis by Peter F. Thall Pdf
Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.
Author : Peter M. Fayers,David Machin Publisher : John Wiley & Sons Page : 648 pages File Size : 41,5 Mb Release : 2016-01-19 Category : Medical ISBN : 9781444337952
Quality of Life by Peter M. Fayers,David Machin Pdf
The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies. The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis. This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.
Author : Peter M. Fayers,David Machin Publisher : John Wiley & Sons Page : 460 pages File Size : 43,5 Mb Release : 2013-05-23 Category : Medical ISBN : 9781118699454
Quality of Life by Peter M. Fayers,David Machin Pdf
Quality of life studies form an essential part of the evaluation of any treatment. Written by two authors who are well respected within this field, Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes, Second Edition lays down guidelines on assessing, analysing and interpreting quality of life data. The new edition of this standard book has been completely revised, updated and expanded to reflect many methodological developments emerged since the publication of the first edition. Covers the design of instruments, the practical aspects of implementing assessment, the analyses of the data, and the interpretation of the results Presents all essential information on Quality of Life Research in one comprehensive volume Explains the use of qualitative and quantitative methods, including the application of basic statistical methods Includes copious practical examples Fills a need in a rapidly growing area of interest New edition accommodates significant methodological developments, and includes chapters on computer adaptive testing and item banking, choosing an instrument, systematic reviews and meta analysis This book is of interest for everyone involved in quality of life research, and it is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and practitioners in the fields of cancer and other chronic diseases. Reviews of the First Edition – Winner of the first prize in the Basis of Medicine Category of the BMA Medical Book Competition 2001: “This book is highly recommended to clinicians who are actively involved in the planning, analysis and publication of QoL research.” CLINICAL ONCOLOGY “This book is highly recommended reading.” QUALITY OF LIFE RESEARCH
National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Publisher : National Academies Press Page : 163 pages File Size : 44,6 Mb Release : 2010-12-21 Category : Medical ISBN : 9780309186513
The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Charles Richard Boddington Joyce,Hannah M. McGee,Ciaran A. O'Boyle
Author : Charles Richard Boddington Joyce,Hannah M. McGee,Ciaran A. O'Boyle Publisher : Taylor & Francis Page : 258 pages File Size : 42,9 Mb Release : 1999 Category : Education ISBN : 905702425X
Individual Quality of Life by Charles Richard Boddington Joyce,Hannah M. McGee,Ciaran A. O'Boyle Pdf
The rubric "Quality of Life" first came to the explicit attention of the medical profession a little over thirty years ago. Despite the undoubted fact that each one of us has his or her own Quality of Life, be it good or bad, there is still no general agreement about its definition, or the manner in which it should be evaluated. Although much has been written about quality of life, this work has been largely concerned with population-based studies, especially in health policy & health economics. The importance of individual quality of life has been neglected, in part because of a failure to define quality of life itself with sufficient care, in part perhaps because of a belief that it is impossible to develop a meaningful method of measuring individual variables. It is a fundamental belief of the editors of this book that the primary focus of quality of life is & must continue to be the individual, who alone can define it & assess its changing personal significances. The individual perspective is of vital importance not only to patients but to their doctors too, & is more & more frequently proposed as the most meaningful measure of outcome in clinical research, especially in non-remitting or chronic conditions. Workers who wish to consider wider aspects of influences on the illnesses suffered by individuals & the health care that they receive will find much to stimulate them in the methods of documentation proposed in this book. Those mainly concerned with population samples rather than individuals may also find the sensitive methods of investigation proposed here not only to be applicable to their own areas of interest, but also rewarding in perhaps unexpected ways.
Quality of Life Assessment: Key Issues in the 1990s by S.R. Walker,Rachel M. Rosser Pdf
It was over five years ago that the Centre for Medicines Research organized a workshop entitled "Quality of Life: Assessment and Application". This workshop brought together a unique group of participants, some of whom had been involved in studies on quality of life for well over a decade, whilst others were meeting the subject for the first time. This blend of experienced researchers and enthusiastic newcomers was a great stimulus to the discus sions which followed individual presentations as well as that resulting from the study groups. In the ensuing publication, a balance was sought between a consideration of the complex principles underlying the assessment of quality of life and the application of such assessments to specific clinical conditions which necessitated this approach. The organization in 1991 of a second workshop entitled "Quality of Life Assessment: Key Issues in the 1990s" resulted in a further consideration of the quality of life philosophy, concepts and key instruments together with an update on assessing quality of life in a number of major disease areas. Of particular importance was an examination of various viewpoints concerned with ethical questions and their implications, and quality oflife from industry, regulatory and health care purchasers' perspectives. As a result of this second workshop, the editors of the original book referred to above decided to produce a second edition with a number of updates and additional chapters.
Quality of Life and Pharmacoeconomics in Clinical Trials by Bert Spilker Pdf
The Second Edition of this groundbreaking work refines the art and science of quality of life assessment and pharmacoeconomics and redefines the role of these evaluation parameters in clinical trials and health care decision-making. Dr. Spilker has assembled more than 200 experts from diverse clinical, research, and social science disciplines to provide a comprehensive reference on the methodology, interpretation, and use of quality of life and pharmacoeconomic studies. Expanded to four times its predecessor's size and scope, the Second Edition features: all-new sections on pharmacoeconomics and crucial health policy issues such as outcomes research a new, extensive section on cross-cultural and cross-national issues in quality of life assessment detailed information on specific tests and measures of quality of life comprehensive guidelines on choosing and administering tests and analyzing, interpreting, and presenting data many chapters on new topics such as phenomenology, assessment of spiritual status, and alternative/complementary medical treatments.
Effect of Cancer On Quality of Life by David Osoba Pdf
This book is comprised of extensive reviews and instructional chapters that discuss the quality of life in several aspects of cancer. The first six chapters deal with conceptual issues relating to measuring quality of life in adult and pediatric populations with cancer. The next five chapters provide practical information on how to select quality-of-life measures, the statistical analysis of trials, economic evaluations to be considered, and some possible abuses of quality-of-life measures. Five chapters review the results of studies using selected quality-of-life measures and provide recent information on their performance. These are followed by three chapters dealing with specific issues relating to nausea and vomiting associated with cancer therapy. Three chapters are devoted to the problems of assessing and controlling pain in patients who have cancer. There are also two chapters that deal with the quality of life in palliative care. Effect of Cancer on Quality of Life is intended for all who have an interest in measuring the quality of life in patients with cancer. This includes investigators who are just entering the field and can benefit from instructions on how to conduct quality-of-life research, as well as those who are experienced in conducting this kind of research.
Quality of Life and Pharmacoeconomics by Joyce A. Cramer,Bert Spilker Pdf
Based on Dr. Spilker's classic Quality of Life and Pharmacoeconomics in Clinical Trials, 2nd Edition, this streamlined sourcebook offers an easy-to-understand introduction to an increasingly critical aspect of health care. Seven succinct sections review key aspects of health-related quality of life and the essentials of pharmacoeconomics, providing expert answers to your most pressing questions: What generic HRQOL and disease-specific assessments are available? How are these scales chosen, used, and interpreted? What instruments do I need...and where can I find them? What is the relationship between pharmacoeconomics and quality of life? Between outcomes research and quality of life? Well-organized and easy to use, Quality of Life and Pharmacoeconomics: An Introduction will become a standard textbook for professionals and students in all areas of medical research and practice.
Fundamentals of Clinical Trials by Lawrence M. Friedman,Curt Furberg,David L. DeMets Pdf
This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Publisher : National Academies Press Page : 304 pages File Size : 46,8 Mb Release : 2015-04-20 Category : Medical ISBN : 9780309316323
Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Publisher : National Academies Press Page : 222 pages File Size : 48,5 Mb Release : 2001-01-01 Category : Medical ISBN : 0309171148
Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Measuring Health-Related Quality of Life in Children and Adolescents by Dennis Drotar Pdf
This volume's purpose is to describe concepts and methods concerning assessment of health-related quality of life (HRQOL) in children and adolescents with a special focus on chronic health conditions. The impetus for this book came from a recognition of the increasing importance of HRQOL assessments in the evaluation of treatment outcomes and the need to increase the utilization of HRQOL assessments in research and clinical applications with a range of pediatric populations. The need to develop a volume that describes new research and clinical applications concerning this topic stemmed from several recent developments. There is a continuing need for evaluations of the efficacy of medical treatments for children and adolescents, including those with chronic health conditions. To address these critical unmet needs in the field of HRQOL assessment, and to advance scientific methods and clinical applications in this field, a conference was held at Case Western Reserve University. The conference set out to summarize current information concerning the development and implementation of measures of HRQOL assessment, to identify and consider key conceptual and methodological issues in research concerning the measurement of HRQOL, and to recommend priorities to advance the state-of-the-art in research and clinical applications of QOL assessment in children and adolescents with chronic health conditions. This volume summarizes and synthesizes the information that was presented by the conference participants in a series of lively discussions and chapters that were based on the presentations.
