Sample Size Calculations For Clustered And Longitudinal Outcomes In Clinical Research

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Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research

Author : Chul Ahn
Publisher : CRC Press
ISBN 13 : 1466556269
Total Pages : 262 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research by : Chul Ahn

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.

Sample Size Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1351727125
Total Pages : 510 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Sample Size Calculations in Clinical Research by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2017-08-15 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Sample Size Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1351727117
Total Pages : 825 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Sample Size Calculations in Clinical Research by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2017-08-15 with total page 825 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Sample Size Calculations in Clinical Research, Second Edition

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1439870934
Total Pages : 481 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Sample Size Calculations in Clinical Research, Second Edition by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research, Second Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2007-08-22 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence. A comprehensive and unified presentation of statistical concepts and practical applications, this book highlights the interactions between clinicians and biostatisticians, includes a well-balanced summary of current and emerging clinical issues, and explores recently developed statistical methodologies for sample size calculation. Whenever possible, each chapter provides a brief history or background, regulatory requirements, statistical designs and methods for data analysis, real-world examples, future research developments, and related references. One of the few books to systematically summarize clinical research procedures, this edition contains new chapters that focus on three key areas of this field. Incorporating the material of this book in your work will help ensure the validity and, ultimately, the success of your clinical studies.

Sample Sizes for Clinical Trials

Author : Steven A. Julious
Publisher : CRC Press
ISBN 13 : 0429994540
Total Pages : 643 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Sample Sizes for Clinical Trials by : Steven A. Julious

Download or read book Sample Sizes for Clinical Trials written by Steven A. Julious and published by CRC Press. This book was released on 2023-06-21 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sample Sizes for Clinical Trials, Second Edition is a practical book that assists researchers in their estimation of the sample size for clinical trials. Throughout the book there are detailed worked examples to illustrate both how to do the calculations and how to present them to colleagues or in protocols. The book also highlights some of the pitfalls in calculations as well as the key steps that lead to the final sample size calculation. Features: Comprehensive coverage of sample size calculations, including Normal, binary, ordinal, and survival outcome data Covers superiority, equivalence, non-inferiority, bioequivalence and precision objectives for both parallel group and crossover designs Highlights how trial objectives impact the study design with respect to both the derivation of sample formulae and the size of the study Motivated with examples of real-life clinical trials showing how the calculations can be applied New edition is extended with all chapters revised, some substantially, and four completely new chapters on multiplicity, cluster trials, pilot studies, and single arm trials The book is primarily aimed at researchers and practitioners of clinical trials and biostatistics, and could be used to teach a course on sample size calculations. The importance of a sample size calculation when designing a clinical trial is highlighted in the book. It enables readers to quickly find an appropriate sample size formula, with an associated worked example, complemented by tables to assist in the calculations.

Sample Size Tables for Clinical Studies

Author : David Machin
Publisher : John Wiley & Sons
ISBN 13 : 1444357964
Total Pages : 319 pages
Book Rating : 4.4/5 (443 download)

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Book Synopsis Sample Size Tables for Clinical Studies by : David Machin

Download or read book Sample Size Tables for Clinical Studies written by David Machin and published by John Wiley & Sons. This book was released on 2011-08-26 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides statisticians and researchers with the statistical tools - equations, formulae and numerical tables - to design and plan clinical studies and carry out accurate, reliable and reproducible analysis of the data so obtained. There is no way around this as incorrect procedure in clinical studies means that the researcher's paper will not be accepted by a peer-reviewed journal. Planning and analysing clinical studies is a very complicated business and this book provides indispensible factual information. Please go to http://booksupport.wiley.com and enter 9781405146500 to easily download the supporting materials.

Sample Sizes for Clinical, Laboratory and Epidemiology Studies

Author : David Machin
Publisher : John Wiley & Sons
ISBN 13 : 1118874935
Total Pages : 666 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Sample Sizes for Clinical, Laboratory and Epidemiology Studies by : David Machin

Download or read book Sample Sizes for Clinical, Laboratory and Epidemiology Studies written by David Machin and published by John Wiley & Sons. This book was released on 2018-05-29 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ein fundiertes Referenzwerk zu den statistischen Instrumenten und Softwareprogrammen, die für das Design und die Planung klinischer Studien erforderlich sind. Die erweiterte 4. Auflage von Sample Sizes for Clinical, Laboratory and Epidemiology Studies beinhaltet eine Sample-Size-Software (SSS), Formeln und nummerische Tabellen für die Gestaltung valider klinischer Studien. Das Fachbuch behandelt ebenfalls Labor- und epidemiologische Studien und stellt die Informationen zur Verfügung, damit Studien einen wesentlichen Beitrag zur medizinischen Forschung leisten. Die Autoren, allesamt anerkannte Experten des Fachgebiets, erläutern und untersuchen Schritt für Schritt die vielfältigen Überlegungen bei der Festlegung geeigneter Stichprobengrößen und helfen so bei der Planung von Studien. Bereitgestellt werden ebenfalls Stichprobentabellen mit Erläuterungen und aussagekräftige Beispiele auf der Basis von Echtdaten. Darüber hinaus enthält das Fachbuch ein Literaturverweise und Angaben zu weiterführenden Referenzen zur Unterstützung der vorgestellten Prinzipien. Diese überarbeitete 4. Auflage - ist das bislang einzige Referenzwerk mit einem Softwareprogramm für die Gestaltung und Planung klinischer Studien. - enthält neue und erweiterte Kapitel mit einer Vielzahl neuer und aktualisierter Beispiele. - erläutert verständlich die angewandten Prinzipien und Methoden anhand von Beispielen aus der Praxis. - präsentiert auf nachvollziehbare Weise ein komplexes und dennoch wichtiges Thema, damit die richtigen Methoden verwendet werden und fundierte Ergebnisse veröffentlicht werden können. - bietet Hilfestellung von einem Team international anerkannter Statistikexperten im medizinischen Bereich. Sample Sizes for Clinical, Laboratory and Epidemiology Studies richtet sich an medizinische Forscher aller Disziplinen sowie an Medizinstatistiker. Die aktualisierte 4. Auflage ist ein wichtiges Referenzwerk für die Gestaltung und Planung verlässlicher, evidenzbasierter klinischer Studien.

Textbook of Clinical Trials in Oncology

Author : Susan Halabi
Publisher : CRC Press
ISBN 13 : 1351620975
Total Pages : 626 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Textbook of Clinical Trials in Oncology by : Susan Halabi

Download or read book Textbook of Clinical Trials in Oncology written by Susan Halabi and published by CRC Press. This book was released on 2019-04-24 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Design and Analysis of Pragmatic Trials

Author : Song Zhang
Publisher : CRC Press
ISBN 13 : 1000873552
Total Pages : 215 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Design and Analysis of Pragmatic Trials by : Song Zhang

Download or read book Design and Analysis of Pragmatic Trials written by Song Zhang and published by CRC Press. This book was released on 2023-05-16 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.

Cluster Randomised Trials

Author : Richard J. Hayes
Publisher : CRC Press
ISBN 13 : 1498728235
Total Pages : 398 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Cluster Randomised Trials by : Richard J. Hayes

Download or read book Cluster Randomised Trials written by Richard J. Hayes and published by CRC Press. This book was released on 2017-07-06 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Design and Analysis of Group-randomized Trials

Author : David M. Murray
Publisher : Monographs in Epidemiology and
ISBN 13 : 0195120361
Total Pages : 481 pages
Book Rating : 4.1/5 (951 download)

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Book Synopsis Design and Analysis of Group-randomized Trials by : David M. Murray

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.

Multiregional Clinical Trials for Simultaneous Global New Drug Development

Author : Joshua Chen
Publisher : CRC Press
ISBN 13 : 1498701485
Total Pages : 367 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Multiregional Clinical Trials for Simultaneous Global New Drug Development by : Joshua Chen

Download or read book Multiregional Clinical Trials for Simultaneous Global New Drug Development written by Joshua Chen and published by CRC Press. This book was released on 2016-04-21 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in

Methods in Comparative Effectiveness Research

Author : Constantine Gatsonis
Publisher : CRC Press
ISBN 13 : 1466511974
Total Pages : 575 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Methods in Comparative Effectiveness Research by : Constantine Gatsonis

Download or read book Methods in Comparative Effectiveness Research written by Constantine Gatsonis and published by CRC Press. This book was released on 2017-02-24 with total page 575 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies—experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.

Sample Size Determination in Clinical Trials with Multiple Endpoints

Author : Takashi Sozu
Publisher : Springer
ISBN 13 : 3319220055
Total Pages : 98 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Sample Size Determination in Clinical Trials with Multiple Endpoints by : Takashi Sozu

Download or read book Sample Size Determination in Clinical Trials with Multiple Endpoints written by Takashi Sozu and published by Springer. This book was released on 2015-08-20 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints.

Blinded Sample Size Re-estimation for Longitudinal Overdispersed Count Data in Randomized Clinical Trials with an Application in Multiple Sclerosis

Download Blinded Sample Size Re-estimation for Longitudinal Overdispersed Count Data in Randomized Clinical Trials with an Application in Multiple Sclerosis PDF Online Free

Author : Thomas Asendorf
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (123 download)

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Book Synopsis Blinded Sample Size Re-estimation for Longitudinal Overdispersed Count Data in Randomized Clinical Trials with an Application in Multiple Sclerosis by : Thomas Asendorf

Download or read book Blinded Sample Size Re-estimation for Longitudinal Overdispersed Count Data in Randomized Clinical Trials with an Application in Multiple Sclerosis written by Thomas Asendorf and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In many clinical experiments, particularly in randomized clinical trials, the sample size required needs to be assessed and justified. For calculating a clinical trial's sample size, assumptions have to be made regarding the clinical trial's outcome data. These assumptions are based on prior clinical trials or merely on expert knowledge and always subject to some degree of uncertainty. To cope with this uncertainty in sample size estimation, adaptive designs were developed to re-estimate the sample size within a running trial. Especially adaptive designs for blinded sample size re-estimatio...

A Comparison of Sample Size Calculations for Cluster Randomized Crossover Trials with a Binary Outcome

Author : Erin Case
Publisher :
ISBN 13 :
Total Pages : 52 pages
Book Rating : 4.:/5 (898 download)

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Book Synopsis A Comparison of Sample Size Calculations for Cluster Randomized Crossover Trials with a Binary Outcome by : Erin Case

Download or read book A Comparison of Sample Size Calculations for Cluster Randomized Crossover Trials with a Binary Outcome written by Erin Case and published by . This book was released on 2014 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: A simplified sample size calculation for a cluster randomized crossover trial with a binary survival outcome (the "T-BOSS" method) was compared to the closed form equation and simulation methods currently available from Connolly, et. al. (2013, Canadian Journal of Cardiology, 29, p.652) and Reich, et. al. (2012, PLoS ONE, 7(4), p.E35564), respectively. When there was no period effect present, the T-BOSS method was consistently conservative with a sample size that is 11.4%, 14.8%, and 37.8% larger than the closed form sample size for intracluster correlations of 0.01, 0.04, and 0.20, respectively. When there was a period effect present, T-BOSS was nearly always anti-conservative unless the period effect was small or the average cluster size was very small (less than 20 patients at most for the settings we explored). The simulations were fairly close to the closed form equation, though showed more variability.

How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research

Author : Michael J. Campbell
Publisher : John Wiley & Sons
ISBN 13 : 1118763602
Total Pages : 266 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research by : Michael J. Campbell

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 2014-03-28 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.