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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

Autorzy
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
331.79 PLN (z VAT)
$87.57 / €81.59 / £59.33 /
Produkt na zamówienie
Przesyłka w 3-4 tygodnie
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Opis książki

Cluster randomised trials are trials in which groups (or clusters)of individuals are randomly allocated to different forms oftreatment. In health care, these trials often compare differentways of managing a disease or promoting healthy living, in contrastto conventional randomised trials which randomise individuals todifferent treatments, classically comparing new drugs with aplacebo. They are increasingly common in health services research.This book addresses the statistical, practical, and ethical issuesarising from allocating groups of individuals, or clusters, todifferent interventions.

Key features: * Guides readers through the stages of conducting a trial, fromrecruitment to reporting. * Presents a wide range of examples with particular emphasis ontrials in health services research and primary care, with bothprinciples and techniques explained. * Topics are specifically presented in the order in whichinvestigators think about issues when they are designing atrial. * Combines information on the latest developments in the fieldtogether with a practical guide to the design and implementation ofcluster randomised trials. * Explains principles and techniques through numerous examplesincluding many from the authors own experience. * Includes a wide range of references for those who wish to readfurther.

This book is intended as a practical guide, written forresearchers from the health professions including doctors,psychologists, and allied health professionals, as well asstatisticians involved in the design, execution, analysis andreporting of cluster randomised trials. Those with a more generalinterest will find the plentiful examples illuminating.

There are several unique strengths to this book. Inparticular the authors are very experienced statisticians havingworked for many years in the design and analysis of clusterrandomized trials and have written excellent methodologicalarticles 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 onechapter 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 othertrials? 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 externalvalidity 22

2.2 Ethics of cluster randomised trials 24

2.3 Selection and recruitment of participants to enhanceinternal 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 clusterrandomised 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 (modellingphase) 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 orminimised 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 designs138

7.2 Calculating sample size using the intra-cluster correlationcoeffi 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-clustervariability 154

7.8 Matched and stratifi ed designs 160

7.9 Sample size for other designs 166

7.10 Summary 169

References 169

8 The intra-cluster correlation coeffi cient 172

8.1 What is the ICC? 173

8.2 Sources of ICC estimates 175

8.3 Choosing the ICC for use in sample size calculations 179

8.4 Calculating ICC values 185

8.5 Uncertainty in ICCs 192

8.6 Summary 193

References 193

9 Other topics 196 Richard Grieve

9.1 Systematic reviews 197

9.2 Cost effectiveness analyses 207

9.3 Process evaluation 212

9.4 Monitoring 213

9.5 Summary 215

References 215

10 Trial reporting 218

10.1 Trial quality and reporting quality 218

10.2 Steps to improve trial reporting in the early stages of thetrial 227

10.3 Reporting randomised trials in journal and conferenceabstracts 230

10.4 Application of CONSORT statement to cluster randomisedtrials 232

10.5 Summary 262

References 263

Index 267

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