Download or read book A Practical Guide to Cluster Randomised Trials in Health Services Research written by Sandra Eldridge and published by John Wiley & Sons. This book was released on 2012-02-20 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cluster randomised trials are trials in which groups (or clusters) of individuals are randomly allocated to different forms of treatment. In health care, these trials often compare different ways of managing a disease or promoting healthy living, in contrast to conventional randomised trials which randomise individuals to different treatments, classically comparing new drugs with a placebo. They are increasingly common in health services research. This book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions. Key features: Guides readers through the stages of conducting a trial, from recruitment to reporting. Presents a wide range of examples with particular emphasis on trials in health services research and primary care, with both principles and techniques explained. Topics are specifically presented in the order in which investigators think about issues when they are designing a trial. Combines information on the latest developments in the field together with a practical guide to the design and implementation of cluster randomised trials. Explains principles and techniques through numerous examples including many from the authors own experience. Includes a wide range of references for those who wish to read further. This book is intended as a practical guide, written for researchers from the health professions including doctors, psychologists, and allied health professionals, as well as statisticians involved in the design, execution, analysis and reporting of cluster randomised trials. Those with a more general interest will find the plentiful examples illuminating.

Download or read book Design and Analysis of Group randomized Trials written by David M. Murray and published by Monographs in Epidemiology and. This book was released on 1998 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Community or group-randomized trials, which are usually done to evaluate the effect of health promotion effors. It reviews the underlying issues, describes the most widely used research design, and presents the many approaches to analysis that are now available.

Download or read book Bayesian Evaluation of Informative Hypotheses written by Herbert Hoijtink and published by Springer. This book was released on 2008-10-06 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the developments in the area of Bayesian evaluation of informative hypotheses that took place since the publication of the ?rst paper on this topic in 2001 [Hoijtink, H. Con?rmatory latent class analysis, model selection using Bayes factors and (pseudo) likelihood ratio statistics. Multivariate Behavioral Research, 36, 563–588]. The current state of a?airs was presented and discussed by the authors of this book during a workshop in Utrecht in June 2007. Here we would like to thank all authors for their participation, ideas, and contributions. We would also like to thank Sophie van der Zee for her editorial e?orts during the construction of this book. Another word of thanks is due to John Kimmel of Springer for his con?dence in the editors and authors. Finally, we would like to thank the Netherlands Organization for Scienti?c Research (NWO) whose VICI grant (453-05-002) awarded to the ?rst author enabled the organization of the workshop, the writing of this book, and continuation of the research with respect to Bayesian evaluation of informative hypotheses.

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Bayesian Data Analysis Third Edition written by Andrew Gelman and published by CRC Press. This book was released on 2013-11-01 with total page 677 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its third edition, this classic book is widely considered the leading text on Bayesian methods, lauded for its accessible, practical approach to analyzing data and solving research problems. Bayesian Data Analysis, Third Edition continues to take an applied approach to analysis using up-to-date Bayesian methods. The authors—all leaders in the statistics community—introduce basic concepts from a data-analytic perspective before presenting advanced methods. Throughout the text, numerous worked examples drawn from real applications and research emphasize the use of Bayesian inference in practice. New to the Third Edition Four new chapters on nonparametric modeling Coverage of weakly informative priors and boundary-avoiding priors Updated discussion of cross-validation and predictive information criteria Improved convergence monitoring and effective sample size calculations for iterative simulation Presentations of Hamiltonian Monte Carlo, variational Bayes, and expectation propagation New and revised software code The book can be used in three different ways. For undergraduate students, it introduces Bayesian inference starting from first principles. For graduate students, the text presents effective current approaches to Bayesian modeling and computation in statistics and related fields. For researchers, it provides an assortment of Bayesian methods in applied statistics. Additional materials, including data sets used in the examples, solutions to selected exercises, and software instructions, are available on the book’s web page.

Download or read book Design and Analysis of Cluster Randomization Trials in Health Research written by Allan Donner and published by Wiley. This book was released on 2010-05-17 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A cluster randomization trial is one in which intact social units, or clusters of individuals, are randomized to different intervention groups. Trials randomizing clusters have become particularly widespread in the evaluation of non-therapeutic interventions, including lifestyle modification, educational programmes and innovations in the provision of health care. The increasing popularity of this design among health researchers over the past two decades has led to an extensive body of methodology on the subject. This is the first book to present a systematic and united treatment of this topic; it contains distinctive chapters on the history of cluster randomized trials, ethical issues and reporting guidelines.

Download or read book How to Design Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research written by Michael J. Campbell and published by John Wiley & Sons. This book was released on 2014-05-27 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to understanding cluster randomised trials Written by two researchers with extensive experience in the field, this book presents a complete guide to the design, analysis and reporting of cluster randomised trials. It spans a wide range of applications: trials in developing countries, trials in primary care, trials in the health services. A key feature is the use of R code and code from other popular packages to plan and analyse cluster trials, using data from actual trials. The book contains clear technical descriptions of the models used, and considers in detail the ethics involved in such trials and the problems in planning them. For readers and students who do not intend to run a trial but wish to be a critical reader of the literature, there are sections on the CONSORT statement, and exercises in reading published trials. Written in a clear, accessible style Features real examples taken from the authors’ extensive practitioner experience of designing and analysing clinical trials Demonstrates the use of R, Stata and SPSS for statistical analysis Includes computer code so the reader can replicate all the analyses Discusses neglected areas such as ethics and practical issues in running cluster randomised trials How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research provides an excellent reference tool and can be read with profit by statisticians, health services researchers, systematic reviewers and critical readers of cluster randomised trials.

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Download or read book Informative Hypotheses written by Herbert Hoijtink and published by CRC Press. This book was released on 2011-10-26 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: When scientists formulate their theories, expectations, and hypotheses, they often use statements like: ``I expect mean A to be bigger than means B and C"; ``I expect that the relation between Y and both X1 and X2 is positive"; and ``I expect the relation between Y and X1 to be stronger than the relation between Y and X2". Stated otherwise, they formulate their expectations in terms of inequality constraints among the parameters in which they are interested, that is, they formulate Informative Hypotheses. There is currently a sound theoretical foundation for the evaluation of informative hypotheses using Bayes factors, p-values and the generalized order restricted information criterion. Furthermore, software that is often free is available to enable researchers to evaluate the informative hypotheses using their own data. The road is open to challenge the dominance of the null hypothesis for contemporary research in behavioral, social, and other sciences.

Download or read book Randomized Clinical Trials written by David Machin and published by John Wiley & Sons. This book was released on 2010-05-20 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level. Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

Download or read book Designing Randomised Trials in Health Education and the Social Sciences written by D. Torgerson and published by Springer. This book was released on 2008-03-13 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book focuses on the design of rigorous trials rather than their statistical underpinnings, with chapters on: pragmatic designs; placebo designs; preference approaches; unequal allocation; economics; analytical approaches; randomization methods. It also includes a detailed description of randomization procedures and different trial designs.

Download or read book Bayesian Designs for Phase I II Clinical Trials written by Ying Yuan and published by CRC Press. This book was released on 2017-12-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

Download or read book Design and Analysis of Experiments in the Health Sciences written by Gerald van Belle and published by John Wiley & Sons. This book was released on 2012-07-24 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: An accessible and practical approach to the design and analysis of experiments in the health sciences Design and Analysis of Experiments in the Health Sciences provides a balanced presentation of design and analysis issues relating to data in the health sciences and emphasizes new research areas, the crucial topic of clinical trials, and state-of-the- art applications. Advancing the idea that design drives analysis and analysis reveals the design, the book clearly explains how to apply design and analysis principles in animal, human, and laboratory experiments while illustrating topics with applications and examples from randomized clinical trials and the modern topic of microarrays. The authors outline the following five types of designs that form the basis of most experimental structures: Completely randomized designs Randomized block designs Factorial designs Multilevel experiments Repeated measures designs A related website features a wealth of data sets that are used throughout the book, allowing readers to work hands-on with the material. In addition, an extensive bibliography outlines additional resources for further study of the presented topics. Requiring only a basic background in statistics, Design and Analysis of Experiments in the Health Sciences is an excellent book for introductory courses on experimental design and analysis at the graduate level. The book also serves as a valuable resource for researchers in medicine, dentistry, nursing, epidemiology, statistical genetics, and public health.

Download or read book Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research written by Chul Ahn and published by CRC Press. This book was released on 2014-12-09 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

Download or read book Applying Quantitative Bias Analysis to Epidemiologic Data written by Timothy L. Lash and published by Springer Science & Business Media. This book was released on 2011-04-14 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bias analysis quantifies the influence of systematic error on an epidemiology study’s estimate of association. The fundamental methods of bias analysis in epi- miology have been well described for decades, yet are seldom applied in published presentations of epidemiologic research. More recent advances in bias analysis, such as probabilistic bias analysis, appear even more rarely. We suspect that there are both supply-side and demand-side explanations for the scarcity of bias analysis. On the demand side, journal reviewers and editors seldom request that authors address systematic error aside from listing them as limitations of their particular study. This listing is often accompanied by explanations for why the limitations should not pose much concern. On the supply side, methods for bias analysis receive little attention in most epidemiology curriculums, are often scattered throughout textbooks or absent from them altogether, and cannot be implemented easily using standard statistical computing software. Our objective in this text is to reduce these supply-side barriers, with the hope that demand for quantitative bias analysis will follow.

Download or read book WHO CVD risk Management Package for Low and Medium resource Settings written by World Health Organization. Cardiovascular Disease Programme and published by World Health Organization. This book was released on 2002 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: The WHO CVD-Risk Management package contains a variety of components to guide healthcare providers and health systems, even those with very minimal resources, to more effective CVD risk management through easy-to-follow risk-assessment and risk-management algorithms; lifestyle counselling protocols; drug treatment protocols; referral pathways, and follow-up schedules.