Design and analysis of cluster randomization trials in health research:
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
London
Arnold
2000
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | X, 178 S. |
| ISBN: | 0340691530 |
Internformat
MARC
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Datensatz im Suchindex
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|---|---|
| adam_text | Contents
Acknowledgements viii
Preface ix
1 Introduction 1
1.1 Why randomize clusters? 1
1.2 What is the impact of cluster randomization on the design and
analysis of a trial? 6
1.3 Quantifying the effect of clustering 7
1.4 Randomized versus non randomized comparisons 11
1.5 The unit of inference 13
1.6 Terminology: what s in a name? 14
2 The historical development of cluster randomized trials 16
2.1 Randomized trials before 1950 16
2.2 Cluster randomized trials between 1950 and 1978 18
2.3 Cluster randomized trials since 1978 22
3 Issues arising in the planning of cluster randomization trials 24
3.1 Selecting interventions 24
3.2 Setting eligibility criteria 26
3.3 Measuring subject response 28
3.4 The most commonly used experimental designs 31
3.5 Factorial and crossover designs 34
3.6 Selecting an experimental design 36
3.7 The importance of cluster level replication 40
3.8 Strategies for conducting successful trials 41
4 The role of informed consent and other ethical issues 43
4.1 The risk of harm 44
4.2 Informed consent 45
4.3 Subject blindness and informed consent 48
4.4 Randomized consent designs 49
4.5 Ethical issues and trial monitoring 50
vi Contents
5 Sample size estimation for cluster randomization designs 52
5.1 General issues of sample size estimation 53
5.2 The completely randomized design 56
5.2.1 Comparison of means 56
5.2.2 Subsample size and statistical efficiency 60
5.2.3 Comparison of proportions 62
5.2.4 Comparison of incidence rates 64
5.3 The matched pair design 65
5.3.1 Comparison of means 66
5.3.2 Comparison of proportions 67
5.3.3 Comparison of incidence rates 69
5.4 The stratified design 70
5.4.1 Comparison of means 70
5.4.2 Comparison of proportions 70
5.5 Issues involving losses to follow up 74
5.6 Strategies for achieving desired power 76
6 Analysis of binary outcomes 79
6.1 Selecting the unit of analysis 80
6.2 The completely randomized design 84
6.2.1 Comparison of proportions 84
6.2.1.1 Standard Pearson chi square test 85
6.2.1.2 Cluster level analyses 87
Two sample Mest comparing average values of the
event rates 87
Non parametric approaches 88
6.2.1.3 Individual level analyses 90
Adjusted chi square approach 90
Ratio estimator approach 91
Parametric modelling 92
Generalized estimating equations approach 93
6.2.1.4 Summary of results 95
6.2.2 Confidence interval construction 96
6.2.3 Adjusting for covariates 97
6.2.4 Analysis strategies for trials with a small number of clusters
per group 100
6.3 The matched pair design 100
6.3.1 Comparison of proportions 100
6.3.1.1 Standard Mantel Haenszel chi square test 102
6.3.1.2 Liang s test procedure 102
6.3.1.3 Paired t test 102
6.3.1.4 Non parametric approaches 104
6.3.1.5 Summary of results 105
6.3.2 Confidence interval construction 106
6.3.3 Adjusting for covariates 107
6.4 The stratified design 108
Contents vii
7 Analysis of quantitative outcomes 111
7.1 The completely randomized design 111
7.1.1 Comparison of two means 111
7.1.1.1 Standard two sample f test 113
7.1.1.2 Cluster level analyses 114
7.1.1.3 Individual level analyses 114
Adjusted two sample f test 114
Mixed effects linear regression models 116
7.1.2 Adjusting for covariates 120
7.2 The matched pair design 122
7.2.1 Comparison of means 122
7.2.2 Adjusting for covariates 123
7.3 The stratified design 125
8 Analysis of count, time to event and categorical outcomes 128
8.1 Count and time to event data 129
8.1.1 The completely randomized design 129
8.1.1.1 Standard methods of analysis 129
8.1.1.2 Cluster level analyses 132
8.1.1.3 Extensions of Poisson regression 132
Ratio estimator approach 132
Parametric models 133
Generalized estimating equations approach 134
8.1.1.4 Extensions of the Cox proportional hazards model 13 5
8.1.2 Matched pair and stratified designs 138
8.2 Categorical data 139
9 Reporting of cluster randomization trials 141
9.1 Reporting of study design 141
9.2 Reporting of study results I45
References 152
Index 175
|
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| indexdate | 2024-07-09T18:49:00Z |
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| isbn | 0340691530 |
| language | English |
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| spelling | Donner, Allan 19XX- Verfasser (DE-588)1249408326 aut Design and analysis of cluster randomization trials in health research Allan Donner ; Neil KLar London Arnold 2000 X, 178 S. txt rdacontent n rdamedia nc rdacarrier Clinical trials gtt Medizin Cluster Analysis Group-randomized trials Medicine Research Methodology Randomized Controlled Trials as Topic methods Research Design Klar, Neil 19XX- Verfasser (DE-588)1249408474 aut Äquivalent Chichester: John Wiley, [2000] Druck-Ausgabe, hardback 978-0-470-71100-2 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009302032&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Donner, Allan 19XX- Klar, Neil 19XX- Design and analysis of cluster randomization trials in health research Clinical trials gtt Medizin Cluster Analysis Group-randomized trials Medicine Research Methodology Randomized Controlled Trials as Topic methods Research Design |
| title | Design and analysis of cluster randomization trials in health research |
| title_auth | Design and analysis of cluster randomization trials in health research |
| title_exact_search | Design and analysis of cluster randomization trials in health research |
| title_full | Design and analysis of cluster randomization trials in health research Allan Donner ; Neil KLar |
| title_fullStr | Design and analysis of cluster randomization trials in health research Allan Donner ; Neil KLar |
| title_full_unstemmed | Design and analysis of cluster randomization trials in health research Allan Donner ; Neil KLar |
| title_short | Design and analysis of cluster randomization trials in health research |
| title_sort | design and analysis of cluster randomization trials in health research |
| topic | Clinical trials gtt Medizin Cluster Analysis Group-randomized trials Medicine Research Methodology Randomized Controlled Trials as Topic methods Research Design |
| topic_facet | Clinical trials Medizin Cluster Analysis Group-randomized trials Medicine Research Methodology Randomized Controlled Trials as Topic methods Research Design |
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