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Practical Biostatistics

A Step-by-Step Approach for Evidence-Based Medicine

2nd Edition - June 4, 2021

Authors: Mendel Suchmacher, Mauro Geller

Paperback ISBN:

9 7 8 - 0 - 3 2 3 - 9 0 1 0 2 - 4

eBook ISBN:

9 7 8 - 0 - 3 2 3 - 8 9 8 9 7 - 3

Practical Biostatistics: A Step-by-Step Approach for Evidence-Based Medicine, Second Edition presents a complete resource of biostatistical knowledge meant for health sciences… Read more

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Practical Biostatistics: A Step-by-Step Approach for Evidence-Based Medicine, Second Edition presents a complete resource of biostatistical knowledge meant for health sciences students, researchers and health care professionals. The book's content covers the investigator’s hypothesis, collective health, observational studies, the biostatistics of intervention studies, clinical trials and additional concepts. Chapters are written in a didactic way, making them easier to comprehend by readers with little or no background on statistics. Evidence-based medicine aims to apply the best available evidence gained from the scientific method to medical decision-making using statistical analyses of scientific methods and outcomes to drive further experimentation and diagnosis.

With a detailed outline of implementation steps complemented by a review of important topics, this book can be used as a quick reference or hands-on guide on how to effectively incorporate biostatistics in clinical trials and research projects.

Cover image
Title page
Table of Contents
Copyright
About the authors
Part 1: The investigator's hypothesis
Part 1. The investigator's hypothesis
Chapter 1. Investigator’s hypothesis and expression of its corresponding outcome
Abstract
Part 2: Collective health
Part 2. Collective health
Chapter 2. Disease frequency measures
Abstract
2.1 Preamble
2.2 Simple count
2.3 Prevalence
2.4 Incidence
2.5 Relationship between prevalence and incidence
Chapter 3. Health indicators
Abstract
3.1 Preamble
3.2 Survival
3.3 Mortality
3.4 Life indicators
3.5 Morbidity indicators
Chapter 4. Epidemiological studies
Abstract
4.1 Ecological studies
4.2 Cross-sectional studies
4.3 Longitudinal studies
Chapter 5. Pharmacoeconomics
Abstract
5.1 Costs and benefits
5.2 Cost-oriented timing
5.3 Costs minimization analysis
5.4 Cost–efficacy analysis
5.5 Utility
5.6 Financial resources
5.7 Health-related life quality—using questionnaires
5.8 Decision analysis
Bibliography
Suggested reading
Part 3: Observational studies
Part 3. Observational studies
Chapter 6. Basic concepts in observational studies
Abstract
6.1 Case-control studies
6.2 Cohort studies
Chapter 7. Determination of association strength between an exposure factor and an event in observational studies
Abstract
7.1 Case-control studies
7.2 Cohort studies
Chapter 8. Increasing accuracy in observational studies
Abstract
8.1 Stratified analysis
8.2 Multivariable analysis
Bibliography
Suggested reading
Part 4: Biostatistics of intervention studies–The clinical trials
Part 4. Biostatistics of intervention studies–The clinical trials
Chapter 9. The intervention studies
Abstract
9.1 Reference standard
9.2 Relation between samples and of a sample with itself
9.3 Awareness of tested drug, vaccine, or exam
9.4 Study subject allocation method
9.5 Follow-up method
9.6 Subgroup analysis
Chapter 10. n Estimation and n assessment of a published trial
Abstract
10.1 Factors influencing n determination
10.2 n Estimate
10.3 Assessing n of a published trial
Chapter 11. Organization of variables and endpoints
Abstract
11.1 Qualitative variables
11.2 Quantitative variables
Chapter 12. Measures for results expression of a clinical trial
Abstract
12.1 Central tendency measures
12.2 Dispersal measures
12.3 Position measures: quantiles
Chapter 13. Determination of normality or nonnormality of data distribution
Abstract
Chapter 14. Hypothesis testing
Abstract
14.1 Parametric tests for independent and dependent samples
14.2 Nonparametric tests
Chapter 15. Correlating sample data with the general population—95% confidence interval
Abstract
15.1 Point estimation
15.2 Interval estimation (95% confidence interval)
Bibliography
Suggested reading
Part 5: Additional concepts in biostatistics
Part 5. Additional concepts in biostatistics
Chapter 16. Individual and collective benefit and risk indexes inferable from intervention studies
Abstract
16.1 Treatment effect indexes
16.2 Clinical decision analysis indexes
Chapter 17. Statistical assessment of diagnostic tests for the clinic
Abstract
17.1 Detection capacity indexes
17.2 Diagnostic significance indexes
Chapter 18. Systematic reviews and meta-analyses
Abstract
18.1 Systematic review
18.2 Meta-analysis
18.3 Options if meta-analysis performance is not possible
18.4 Systematic review/meta-analysis limitations
18.5 Summary of systematic review/meta-analysis stages
Chapter 19. Correlation and regression
Abstract
19.1 Correlation
19.2 Regression
19.3 Multiple linear regression
Chapter 20. Per-protocol analysis and intention-to-treat analysis
Abstract
20.1 Per-protocol analysis
20.2 Intention-to-treat analysis
Bibliography
Suggested reading
Appendix: Overview of study types for human health investigation
Glossary
Index

Mendel Suchmacher

Mendel Suchmacher, MD, MSc, graduated in Pharmaceutical Medicine at Federal University of the State of São Paulo, is Board Certified in Internal Medicine and Hematology-Hemotherapy and member of the American College of Physicians. He holds teaching and research positions at prestigious Brazilian institutions: Professor of Clinical Immunology at Carlos Chagas Institute of Medical Graduation; Professor & Chairman of Microbiology and Immunology, and Research Fellow at Teresopolis University Medical School - UNIFESO; Professor & Coordinator of the Genodermatoses Sector of the Clinical Genetics Service at Federal University of Rio de Janeiro. Additionally, he is member of the clinical staff of Hospital Israelita Albert Einstein.

Affiliations and expertise

Carlos Chagas Institute of Medical Graduation; Teresopolis University Medical School - UNIFESO; Genodermatoses Sector of the Clinical Genetics Service, Federal University of Rio de Janeiro, Brazil

Mauro Geller

Mauro Geller, MD, PhD, holds an MD degree from Teresopolis University Medical School, a PhD in Clinical Medicine from Federal University of Rio de Janeiro, and a Post-doc in Immunogenetics from Harvard University. He has extensive experience in the field of clinical immunology, especially in the areas of clinical medicine, tumoral immunology, genetics and immunodiagnostics. Dr. Geller is founding member and current medical director of the Brazilian National Neurofibromatosis Center; fellow of the American College of Physicians and of the Royal Society of Medicine; member of the European Society of Gene Therapy; and member of the Brazilian Societies of Immunology, Microbiology and Genetics. He is Board Certified in Internal Medicine, Immunology, Allergy and Public Health. Dr. Geller also has extensive experience with research in the areas of immunology, microbiology and genetics, as well as with clinical research, and has published 137 papers, 8 book chapters, and 4 books. He also serves as ad hoc advisor to the Brazilian National Institute of Health (ANVISA) and is member of the clinical staff of Hospital Israelita Albert Einstein.

Affiliations and expertise

MD degree, Teresopolis University Medical School PhD, Clinical Medicine, Federal University of Rio de Janeiro Post-doc, Immunogenetics, Harvard University