描述
Clinical Trials in Psychiatry, 2nd Edition
Brian Everitt, Simon Wessely
ISBN: 978-0-470-51302-6
Hardcover
248 pages
March 2008
At last – a new edition of the highly claimed book Clinical Trials in Psychiatry
This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding:
Recent important psychiatric trials
More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration)
An extended chapter on meta-analysis
Further discussion of sub-group analysis
Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section.
From the reviews of the First Edition:
“Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read…it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY
“The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications… an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE
Preface to the first edition
Preface to the second edition
1. Treatments, good, bad or worthless – and how do we tell?
Treatments worthless – and worse
A brief history of treating the mentally ill
Summary
2. The randomized clinical trial
Introduction
The clinical trial
Ethical issues in clinical trials
Informed consent
Compliance
Summary
3. Design issues in clinical trials
Introduction
Clinical trial designs
Methods of randomization
Methods of masking treatments
The size of a clinical trial
Interim analysis
Summary
4. Special problems of trials in psychiatry
Introduction
Explanatory versus pragmatic trials
Complex interventions
Outcome measures in psychiatry
Summary
5. Some statistical issues in the analysis of psychiatric trials
Introduction
P-values and confidence intervals
Using baseline data
Longitudinal data
Missing values and dropouts in longitudinal data
Multiple outcome measures
Intention-to-treat
Economic evaluation of trials
Number needed to treat
6. Analysing data from a psychiatric trial: an example
Introduction
Beating the Blues
Analysis of the post-treatment BDI scores
Graphical displays and summary measure analysis of longitudinal data
Random effects models for the BtB data
The dropout problem in the BtB data
Summary
7. Systematic reviews and meta-analysis
Introduction
Study selection
Publication bias
The statistics of meta-analysis
Some examples of meta-analysis of psychiatric trials
Summary
8. RCTs in psychiatry: threats, challenges and the future
Introduction
Can randomized clinical trials in psychiatry be justified?
Are randomized clinical trials really necessary?
Conflicts of interest
Scandals, trials and tribulations
The future of psychiatric trials
Defending the clinical trial
Summary
Appendix A Issues in the management of clinical trials- ‘how to do it’
Introduction
Clinical trial protocols
Getting the costs right
Collecting and managing the data
Writing the patient information sheet
Getting informed consent
Maintaining recruitment
Useful web sites
Appendix B Writing a trial report
Introduction
Appendix C Useful software for clinical trials
Introduction
Data management
Design
Analysis
Bibliography
Index
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