Essential Concepts in Clinical Research. Randomised Controlled Trials and Observational Epidemiology. Edition No. 2

  • ID: 4519583
  • Book
  • 272 Pages
  • Elsevier Health Science
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This practical guide speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials.

Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods.

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Introduction

1. An overview of clinical research: the lay of the land

Observational studies

2. Descriptive studies: what they can and cannot do

3. Bias and causal associations in observational research

4. Cohort studies: marching towards outcomes

5. Case-control studies: research in reverse

6. Finding controls for case-control studies: compared to what?

7. Limitations of observational epidemiology

Screening tests

8. Uses and abuses of screening tests

9. Refining clinical diagnosis with likelihood ratios

Randomized controlled trials

10. Boosting participant recruitment in trials

11. Sample size calculations in randomized trials: mandatory and mystical

12. Generation of allocation sequences in randomized trials: chance not choice

13. Generation of allocation sequences in non-double-blinded randomized trials: guarding against guessing

14. Allocation concealment in randomized trials: defending against deciphering

15. Exclusions and losses in randomized trials: sample size slippages

16. Blinding in randomized trials: hiding who got what

17. Implementing treatment blinding in randomized trials

18. Surrogate endpoints and composite outcomes: shortcuts to unknown destinations

19. Multiplicity in randomized trials I: endpoints and treatments

20. Multiplicity in randomized trials II: subgroup and interim analyses

21. Conducting randomized trials as part of a prospective meta-analysis

Publishing

22. Reporting studies in medical journals: CONSORT and other guidelines
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Schulz, Kenneth Distinguished Scientist, FHI360, Durham, North Carolina, USA; Clinical Professor, Department of Obstetrics & Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.

Grimes, David A. Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
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