Description
Book SynopsisFocusing on improving the diagnosis, prognosis, and management of human disease, this book takes on the issues of research design, measurement, and evaluation which are critical to clinical epidemiology. This second edition of Clinical Epidemiology: Practice and Methods opens with how best to frame a clinical research question, the ethics associated with doing a research project in humans, and the definition of various biases that occur in clinical research. From there, it continues by examining issues of design, measurement, and analysis associated with various research designs, including determination of risk in longitudinal studies, assessment of therapy in randomized controlled clinical trials, and evaluation of diagnostic tests, and then delves into the more specialized area of clinical genetic research, before concluding with basic methods used in evidence-based decision making including critical appraisal, aggregation of multiple studies using meta-analysis, health technology as
Table of ContentsPart I: Introduction
1. On Framing the Research Question and Choosing the Appropriate Research Design
Patrick S. Parfrey and Pietro Ravani
2. Research Ethics for Clinical Researchers
John D. Harnett and Richard Neuman
3. Definitions of Bias in Clinical Research
Geoffrey Warden
Part II: Longitudinal Studies
4. Longitudinal Studies 1: Determination of Risk
Sean W. Murphy
5. Longitudinal Studies 2: Modeling Data Using Multivariate Analysis
Pietro Ravani, Brendan J. Barrett, and Patrick S. Parfrey
6. Longitudinal Studies 3: Data Modeling Using Standard Regression Models and Extensions
Pietro Ravani, Brendan J. Barrett, and Patrick S. Parfrey
7. Longitudinal Studies 4: Matching Strategies to Evaluate Risk
Matthew T. James
8. Longitudinal Studies 5: Development of Risk Prediction Models for Patients with Chronic Disease
Navdeep Tangri and Claudio Rigatto
Part III: Randomized Controlled Clinical Trials
9. Randomized Controlled Trials 1: Design
Bryan M. Curtis, Brendan J. Barrett, and Patrick S. Parfrey
10. Randomized Controlled Trials 2: Analysis
Robert N. Foley
11. Randomized Controlled Trials 3: Measurement and Analysis of Patient-Reported Outcomes
Michelle M. Richardson, Megan E. Grobert, and Klemens B. Meyer
12. Randomized Controlled Trials 4: Biomarkers and Surrogate Outcomes
Claudio Rigatto and Brendan J. Barrett
13. Randomized Controlled Trials 5: Determining the Sample Size and Power for Clinical Trials and Cohort Studies
Tom Greene
14. Randomized Controlled Trials 6: On Contamination and Estimating the Actual Treatment Effect
Patrick S. Parfrey
15. Randomized Controlled Trials 7: Analysis and Interpretation of Quality of Life Scores
Robert N. Foley and Patrick S. Parfrey
16. Randomized Controlled Trials 8: Planning, Monitoring, and Execution
Elizabeth Hatfield, Elizabeth Dicks, and Patrick S. Parfrey
Part IV: The Basics for Other Clinical Epidemiology Methods
17. Evaluation of Diagnostic Tests
John M. Fardy and Brendan J. Barrett
18. Qualitative Research in Clinical Epidemiology
Deborah M. Gregory and Christine Y. Way
19. Health Economics in Clinical Research
Braden J. Manns
Part V: Clinical Genetic Research
20. Clinical Genetic Research 1: Bias
Susan Stuckless and Patrick S. Parfrey
21. Clinical Genetic Research 2: Genetic Epidemiology of Complex Phenotypes
Darren D. O’Rielly and Proton Rahman
22. Clinical Genetic Research 3: Genetics ELSI (Ethical, Legal and Social Issues) Research
Daryl Pullman and Holly Etchegary
Part VI: Methods in Evidence–Based Decision Making
23. Evidence-Based Decision Making 1: Critical Appraisal
Laurie K. Twells
24. Evidence-Based Decision Making 2: Systematic Reviews and Meta-Analysis
Aminu Bello, Natasha Wiebe, Amit Garg, and Marcello Tonelli
25. Evidence-Based Decision Making 3: Health Technology Assessment
Daria O’Reilly, Kaitryn Campbell, Meredith Vanstone, James M. Bowen, Lisa Schwartz, Nazila Assasi, and Ron Goeree
26. Evidence-Based Decision Making 4: Development and Limitations of Clinical Practice Guidelines
Bruce Culleton
27. Evidence-Based Decision-Making 5: Translational Research
Deborah M. Gregory and Laurie K. Twells
28. Evidence-Based Decision Making 6: Utilization of Administrative Databases for Health Services Research
Turin Chowdury and Brenda Hemmelgarn
29. Evidence-Based Decision Making 7: Knowledge Translation
Braden J. Manns
30. Evidence-Based Decision Making 8: Health Policy, A Primer for Researchers
Victor Maddalena
