Clinical Research (eBook)

Claudia Witt, Klaus Linde (Autoren)

eBook Download: PDF | EPUB

2011 | 1. Auflage
200 Seiten
Elsevier Health Care - Major Reference Works (Verlag)
978-3-437-59652-0 (ISBN)

Infos

You want to conduct a CAM study but don't know how?  Problem solved - Clinical Research demonstrates all aspects of state-of-the-art study design in an understandable and practical way. You will get a comprehensive overview and instruction - step by step.

This practical training book:

• systematically introduces the key aspects of study design and basic statistics.
• helps you to develop, plan and execute your research project.
• combines established theoretical approaches with practical skills applicable to your own clinical study.
• is a step-by-step tutorial for a complete clinical study, which is illustrated in three case studies.
• includes additional training exercises, featuring different study conditions and environments, that will help you to practice and test your knowledge.

Clinical Research in Complementary and Integrative Medicine - the best way to understand clinical research and to plan and perform your own study!

Inhalt

Front Cover 1
Clinical Research in Complementary and Integrative Medicine 4
Copyright 5
Preface 6
We would like to thank 7
Glossary 8
Contents 12
KAPITEL 1 - Introduction 16
1.1 What do we mean by complementary medicine in this book? 16
1.2 The science behind clinical medicine 17
1.3 Why do we need research on complementary therapies? 18
1.4 Is research into complementary therapies special? 20
1.5 Aims, target audience and structure of this book 22
I - Theory – Things you should know before embarking on a clinical study 24
KAPITEL 2 - Basic study design 26
2.1 When is a treatment effective? 26
2.2 Bias – threats to internal validity 30
2.3 Clinical studies and the real world – external validity 33
2.4 What study design for what purpose? 37
2.5 Establishing an evidence picture 46
KAPITEL 3 - Basic statistics 48
3.1 Why statistics? 48
3.2 Types of variables and their distribution 48
3.3 Summarizing your data 49
3.4 Comparing two groups or two time points for one variable 53
3.5 Comparing more than two groups for one variable 59
3.6 Comparing two or more groups for more than one variable 60
3.7 Analysis populations 61
3.8 Dealing with missing values 61
3.9 Interval hypotheses: equivalence/non-inferiority and superiority 62
II - Practice – Planning, managing, analyzing and publishing a clinical study 64
KAPITEL 4 - Planning 66
4.1 Formulating the research question 66
4.2 Study Protocol 71
4.3 Interventions and Controls 74
4.4 Randomization 80
4.5 What to do if you do not randomize 86
4.6 Blinding 89
4.7 Study participants 96
4.8 Outcome measurement 100
4.9 Sample size calculation 108
4.10 Ethics and regulatory aspects 117
KAPITEL 5 - Study and data management 120
5.1 Project management 120
5.2 Guidelines for clinical trials 121
5.3 Study management 122
5.4 Data management 128
5.5 Case studies 136
KAPITEL 6 - Data analysis 138
6.1 Analysing your own data step by step 138
6.2 Case studies 142
KAPITEL 7 - Publication 148
7.1 General issues 148
7.2 Early preparatory work 149
7.3 Writing the manuscript 152
7.4 Getting your manuscript accepted 156
7.5 After acceptance 159
III - Putting a clinical study into context 160
KAPITEL 8 - Qualitative research 162
8.1 Research question and examples 162
8.2 Qualitative approaches 163
8.3 Qualitative methods and types of data 164
8.4 Qualitative data analysis 165
8.5 Quality assurance in qualitative research 166
8.6 Combining qualitative and quantitative research methods 166
KAPITEL 9 - Economic studies 168
9.1 Principles of economic analysis 168
9.2 Types of economic evaluations 171
9.3 Examples of economic analysis 173
9.4 Critical appraisal 174
KAPITEL 10 - Single-case research 178
10.1 Why case reports are not scientific 178
10.2 Why single-case research is important 178
10.3 Assessing causality in single cases 179
10.4 Experimental single-case studies 179
10.5 Observational single case studies 183
10.6 Cross-roads between research on single cases and groups of patients 184
KAPITEL 11 - A brief look at other study designs 188
11.1 Cross-sectional studies/surveys 188
11.2 Diagnostic studies 190
11.3 Etiological and prognostic studies 192
Appendix 196
Index 202

Produkt-Details

• Erscheint lt. Verlag: 1.11.2011
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Naturheilkunde
• ISBN-10: 3-437-59652-7 / 3437596527
• ISBN-13: 978-3-437-59652-0 / 9783437596520