Cluster Randomization Trials
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Cluster Randomization Trials
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Author : Sin-Ho Jung
language : en
Publisher: CRC Press
Release Date : 2024-12-20
Cluster Randomization Trials written by Sin-Ho Jung and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-12-20 with Mathematics categories.
Oftentimes, small groups (called clusters) of individuals (called subunits) are randomized between treatment arms. Typically, clusters are families, classes, communities, surgeons operating patients, and so on. Such trials are called cluster randomization trials (CRTs). The subunits in each cluster share common frailties so that their outcomes tend to be positively correlated. Since clusters are independent, the data in two arms are independent in CRTs. In a clinical trial, multiple sites (such as teeth or ears) from each subject may be randomized between different treatment arms. In this case, the sites (subunits) of each subject (cluster) share common genetic, physiological, or environmental characteristics so that their observations tend to be positively correlated. This kind of trials are called subunit randomization trials (SRTs). In SRTs, dependency exists both within and between treatment arms. Individually randomized group treatment (IRGT) trials are composite of traditional independent subject randomization and CRTs. In an IRGT trial, the control arm is to treat patients individually, whereas the experimental arm is to treat patients using a group training, education, or treatment to increase the treatment effect by close interactions among patients. As a result, the outcome data of the control arm are independent as in traditional trials, but those in the experimental arm are correlated within each group (cluster) as in CRTs. Hence, two arms in IRGT trials have different dependency structures. Unlike standard CRTs, clusters of IRGT trials are usually organized after randomization. But statistically, they have identical statistical issues between the two types of trials, i.e., accounting for the dependency within each cluster. Although this book is entitled Cluster Randomization Trials, it covers all three types of trials (i.e., CRTs, SRTs, and IRGT trials) resulting in clustered data. For outcome variables of binary, continuous, and time-to-event types, we investigate generalized estimating equation type statistical tests and their sample size formulas. Also presented are random number generation algorithms for different types of outcome variables and randomization methods. The methods are discussed in terms of clinical trials, but can be used to design and analyze any types of experiments involving clustered data. This book also discusses statistical methods for various types of biomarker studies, including ROC methods, with clustered data. Key Features: Includes extensive statistical tests and their sample size formulas for various types of clinical trials resulting in clustered data. Handles different variable types of endpoints separately. Discusses algorithms to generate clustered binary and survival data that are useful for simulations. Covers statistical tests and sample size formulas for medical tests with clustered data.
Design And Analysis Of Cluster Randomization Trials In Health Research
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Author : Allan Donner
language : en
Publisher: Wiley
Release Date : 2010-05-17
Design And Analysis Of Cluster Randomization Trials In Health Research written by Allan Donner and has been published by Wiley this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-05-17 with Medical categories.
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.
Cluster Randomised Trials
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Author : Richard J. Hayes
language : en
Publisher: CRC Press
Release Date : 2017-07-06
Cluster Randomised Trials written by Richard J. Hayes and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-06 with Mathematics categories.
Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.
A Practical Guide To Cluster Randomised Trials In Health Services Research
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Author : Sandra Eldridge
language : en
Publisher: John Wiley & Sons
Release Date : 2012-01-09
A Practical Guide To Cluster Randomised Trials In Health Services Research written by Sandra Eldridge and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-09 with Medical categories.
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.
Cluster Randomised Trials
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Author : Richard J. Hayes
language : en
Publisher: CRC Press
Release Date : 2017-07-06
Cluster Randomised Trials written by Richard J. Hayes and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-06 with Mathematics categories.
Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.
Successful Randomized Trials
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Author : Michael J. Domanski
language : en
Publisher: Lippincott Williams & Wilkins
Release Date : 2009
Successful Randomized Trials written by Michael J. Domanski and has been published by Lippincott Williams & Wilkins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Medical categories.
This handbook is a ready reference on the theory and operation of modern large, multicenter randomized clinical trials, which have come to be the basis of evidence-based medicine. Written in a concise, engaging style geared to physicians, the book explains the rationale and theoretical foundations for clinical trials, the components of modern clinical trials including their functions and interactions, and practical considerations in the design and implementation of these studies including an introduction to the economics and business aspects.
How To Design Analyse And Report Cluster Randomised Trials In Medicine And Health Related Research
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Author : Michael J. Campbell
language : en
Publisher: John Wiley & Sons
Release Date : 2014-03-28
How To Design Analyse And Report Cluster Randomised Trials In Medicine And Health Related Research written by Michael J. Campbell and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-03-28 with Medical categories.
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.
Statistical Advances In The Biomedical Sciences
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Author : Atanu Biswas
language : en
Publisher: John Wiley & Sons
Release Date : 2007-12-14
Statistical Advances In The Biomedical Sciences written by Atanu Biswas and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-12-14 with Mathematics categories.
The Most Comprehensive and Cutting-Edge Guide to Statistical Applications in Biomedical Research With the increasing use of biotechnology in medical research and the sophisticated advances in computing, it has become essential for practitioners in the biomedical sciences to be fully educated on the role statistics plays in ensuring the accurate analysis of research findings. Statistical Advances in the Biomedical Sciences explores the growing value of statistical knowledge in the management and comprehension of medical research and, more specifically, provides an accessible introduction to the contemporary methodologies used to understand complex problems in the four major areas of modern-day biomedical science: clinical trials, epidemiology, survival analysis, and bioinformatics. Composed of contributions from eminent researchers in the field, this volume discusses the application of statistical techniques to various aspects of modern medical research and illustrates how these methods ultimately prove to be an indispensable part of proper data collection and analysis. A structural uniformity is maintained across all chapters, each beginning with an introduction that discusses general concepts and the biomedical problem under focus and is followed by specific details on the associated methods, algorithms, and applications. In addition, each chapter provides a summary of the main ideas and offers a concluding remarks section that presents novel ideas, approaches, and challenges for future research. Complete with detailed references and insight on the future directions of biomedical research, Statistical Advances in the Biomedical Sciences provides vital statistical guidance to practitioners in the biomedical sciences while also introducing statisticians to new, multidisciplinary frontiers of application. This text is an excellent reference for graduate- and PhD-level courses in various areas of biostatistics and the medical sciences and also serves as a valuable tool for medical researchers, statisticians, public health professionals, and biostatisticians.
Power Analysis Of Trials With Multilevel Data
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Author : Mirjam Moerbeek
language : en
Publisher: CRC Press
Release Date : 2015-07-01
Power Analysis Of Trials With Multilevel Data written by Mirjam Moerbeek and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-01 with Mathematics categories.
Power Analysis of Trials with Multilevel Data is a valuable reference for anyone who wants to perform power calculations on trials with hierarchical data. It provides a thorough overview of power analysis, familiarizing you with terminology and notation, outlining the key concepts of statistical power and power analysis, and covering all common hierarchical designs.
Randomization In Clinical Trials
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Author : William F. Rosenberger
language : en
Publisher: John Wiley & Sons
Release Date : 2015-11-23
Randomization In Clinical Trials written by William F. Rosenberger and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-23 with Mathematics categories.
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.