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A Practical Guide to Cluster Randomised Trials in Health Services Research

A Practical Guide to Cluster Randomised Trials in Health Services Research

Wydawnictwo Blackwell Science
Data wydania 01/02/2012
Wydanie Pierwsze
Liczba stron 298
Forma publikacji książka w twardej oprawie
Poziom zaawansowania Dla profesjonalistów, specjalistów i badaczy naukowych
Język angielski
ISBN 9780470510476
Kategorie Badania medyczne, Epidemiologia i statystyka medyczna
296.07 PLN (z VAT)
$80.78 / €69.83 / £61.43 /
Produkt na zamówienie
Przesyłka w 3-4 tygodnie
Do schowka

Opis książki

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. There are several unique strengths to this book. In particular the authors are very experienced statisticians having worked for many years in the design and analysis of cluster randomized trials and have written excellent methodological articles many of which are cited in their book. (Journal of Biopharmaceutical Statistics, 2012)

A Practical Guide to Cluster Randomised Trials in Health Services Research

Spis treści

Preface xiii
Notation xv
Table of cases: Trials used as examples in more than one chapter in the book xviii
1 Introduction 1
1.1 Introduction to randomised trials 2
1.2 Explanatory or pragmatic trials 2
1.3 How does a cluster randomised trial differ from other trials? 3
1.4 Between-cluster variability 9
1.5 Why carry out cluster randomised trials? 10
1.6 Quality of evidence from cluster randomised trials 13
1.7 Historical perspectives 16
1.8 Summary 18
References 19
2 Recruitment and ethics 22
2.1 Selecting clusters and participants to enhance external validity 22
2.2 Ethics of cluster randomised trials 24
2.3 Selection and recruitment of participants to enhance internal validity 35
2.4 Retention of participants in the trial 41
2.5 Summary 41
References 41
3 Designing interventions 44
3.1 Lack of effectiveness of interventions evaluated in cluster randomised trials 45
3.2 What is a complex intervention? 46
3.3 Phases in the development of a complex intervention 50
3.4 Identifying evidence for potential intervention effect (pre-clinical phase) 50
3.5 Understanding more about intervention components (modelling phase) 53
3.6 Developing the optimum intervention and study design (exploratory trial phase) 55
3.7 What is the intervention? 57
3.8 Summary 58
References 58
4 Pilot and feasibility studies 60
4.1 What is a pilot study? 60
4.2 Reasons for conducting pilot and feasibility studies 63
4.3 Designing a pilot or feasibility study 69
4.4 Reporting and interpreting pilot studies 71
4.5 Summary 72
References 73
5 Design 74
5.1 Parallel designs with only two arms 75
5.2 Cohort versus cross-sectional designs 85
5.3 Parallel designs with more than two arms 88
5.4 Crossover designs 92
5.5 Further design considerations 95
5.6 Summary 96
References 96
6 Analysis 99
6.1 Data collection and management 99
6.2 Analysis an introduction 101
6.3 Analyses for two-arm, completely randomised, stratified or minimised designs 104
6.4 Analyses for other designs 124
6.5 Intention to treat and missing values 129
6.6 Analysis planning 131
6.7 Summary 132
References 133
7 Sample size calculations 137
7.1 Factors affecting sample size for cluster randomised designs 138
7.2 Calculating sample size using the intra-cluster correlation coeffi cient 142
7.3 Sample size calculations for rates 145
7.4 Restricted number of clusters 146
7.5 Trials with a small number of clusters 149
7.6 Variability in cluster size 150
7.7 Comparison of different measures of between-cluster variability 15

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