Cluster Randomization Trials
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Design And Analysis Of Cluster Randomization Trials In Health Research
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Author : Allan Donner
language : en
Publisher: Wiley
Release Date : 2000-10-10
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 2000-10-10 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.
Designing Randomised Trials In Health Education And The Social Sciences
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Author : D. Torgerson
language : en
Publisher: Springer
Release Date : 2008-03-13
Designing Randomised Trials In Health Education And The Social Sciences written by D. Torgerson and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-13 with Social Science categories.
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.
Introduction To Randomized Controlled Clinical Trials
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Author : John N.S. Matthews
language : en
Publisher: CRC Press
Release Date : 2006-06-26
Introduction To Randomized Controlled Clinical Trials written by John N.S. Matthews and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-06-26 with Mathematics categories.
Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials prov
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.
Field Trials Of Health Interventions
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Author : Peter G. Smith
language : en
Publisher:
Release Date : 2015
Field Trials Of Health Interventions written by Peter G. Smith and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with Health & Fitness categories.
This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.
Handbook Of Statistical Methods For Randomized Controlled Trials
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Author : KyungMann Kim
language : en
Publisher: CRC Press
Release Date : 2021-08-23
Handbook Of Statistical Methods For Randomized Controlled Trials written by KyungMann Kim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-23 with Mathematics categories.
Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.
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.
Sample Sizes For Clinical Trials
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Author : Steven A. Julious
language : en
Publisher: CRC Press
Release Date : 2009-08-26
Sample Sizes For Clinical Trials written by Steven A. Julious and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-08-26 with Mathematics categories.
Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including su
Randomized Controlled Trials
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Author : Alejandro R. Jadad
language : en
Publisher:
Release Date : 2007
Randomized Controlled Trials written by Alejandro R. Jadad and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Clinical trials categories.
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.