Practical Biostatistics: A Friendly Step-by-Step Approach for Evidence-based Medicine

by Mendel Suchmacher, Mauro Geller

Overview

Evidence-based medicine aims to apply the best available evidence gained from the scientific method to medical decision making. It is a practice that uses statistical analysis of scientific methods and outcomes to drive further experimentation and diagnosis. The profusion of evidence-based medicine in medical practice and clinical research has produced a need for life scientists and clinical researchers to assimilate biostatistics into their work to meet efficacy and practical standards. Practical Biostatistics provides researchers, medical professionals, and students with a friendly, practical guide to biostatistics. With a detailed outline of implementation steps complemented by a review of important topics, this book can be used as a quick reference or a hands-on guide to effectively incorporate biostatistics in clinical trials.

• Customized presentation forbiological investigators with examples taken from current clinical trials in multiple disciplines
• Clear and concise definitions and examples provide a pragmatic guide to bring clarity to the applications of statistics in improving human health
• Addresses the challenge of assimilation of mathematical concepts to better interpret literature, to build stronger studies, to present research effectively, and to improve communication with supporting biostatisticians

Product Details

ISBN-13:	9780124157941
Publisher:	Elsevier Science
Publication date:	08/09/2012
Pages:	248
Product dimensions:	5.90(w) x 8.90(h) x 0.50(d)

About the Author

* Board Certification in Internal Medicine and Hematology-Hemotherapy

* Post-graduation in Pharmaceutical Medicine (Universidade Federal do Estado de Sao Paulo)

* Clinical Research Dpt. (Gross Pharmaceuticals)

* Member of the American College of Physicians

* Professor of Clinical Immunology - Carlos Chagas Institute of Medical Post-graduation (Rio de Janeiro) - Brazil

* Professor of Microbiology and Immunology at Teresopolis University Medical School (Rio de Janeiro State)

* Research Fellow - Fundacao Educacional Serra dos Orgaos (Rio de Janeiro)

* Professor & Chairman of Immunology & Microbiology - Teresópolis Medical School (Centro Universitário Serra dos Órgãos - UNIFESO. Rio de Janeiro, Brazil)

* Professor & Coordinator of the Genodermatoses Sector of the Clinical Genetics Service (Instituto de Puericultura e Pediatria Martagão Gesteira - UFRJ. Rio de Janeiro, Brazil)

* Professor and Chairman of Clinical Immunology (Instituto de Pós-Graduação Médica Carlos Chagas. Rio de Janeiro, Brazil)

* Member of the clinical staff of Hospital Israelita Albert Einstein (HIAE - São Paulo, Brasil)

Mauro Geller MD, PhD holds an MD degree from Teresopolis University Medical School, a PhD in Clinical Medicine from Universidade Federal do Rio de Janeiro, and a Post-PhD in Immunogentics from Harvard University. He has extensive experience in the area of clinical immunology, especially in the areas of clinical medicine, tumoral immunology, genetics and immunodiagnostics. Dr. Geller is a founding member of the Brazilian National Neurofibromatosis Center (Centro Nacional de Neurofibromatose - CNNF), where he also serves as Scientific Director. He is a two-time recipient of the Moção de Louvor of the Assembléia Legislativa do Estado do Rio de Janeiro; in 1994 he received the Título de Benmerito do Estado do Rio de Janeiro, and he has received several awards of recognition from UNIFESO, from both the faculty and students. In 1996, he was awarded the Public Service Award from the National Neurofibromatosis Foundation and in 1997 he was named Honorary Chairperson of the same institution. IN 2006, he received the Prêmio de Incentivo Científico Hilton souchois from the Brazilian Society of Odontology. He 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 an ad hoc advisor to the Brazilian National Institute of Health (ANVISA).

Table of Contents

PART 1 - STUDY TYPE DETERMINATION 1. Epidemiological studies 2. Analytical studies 3. Summary

PART 2 - OBSERVATIONAL STUDIES 4. Determination of association strength between an exposure factor and an event in observational studies 5. Increasing accuracy in observational studies

PART 3 - STEP-BY-STEP BIOSTATISTICS OF A CLINICAL TRIAL 6. STEP 1: Investigator's hypothesis and expression of its corresponding outcome 7. STEP 2: n estimation and n assessment of a published trial 8. STEP 3: Organization of variables and endpoints 9. STEP 4: Measures for results expression of a clinical trial 10. STEP 5: Determination of normality or non-normality of data distribution 11. STEP 6: Hypothesis testing 12. STEP 7: Correlating sample data with the general population - 95% confidence Interval

PART 4 - ADDITIONAL CONCEPTS IN BIOSTATISTICS 13. Individual and collective benefit and risk indexes inferable from intervention cohort studies 14. Statistical assessment of diagnostic tests for the clinic 15. Systematic reviews and meta-analyses 16. Correlation and regression 17. Per protocol analysis and intention to treat analysis

Editorial Reviews

"...strongly recommended as a practical guide for readers interested in applied biostatistics. Each chapter of the book is accompanied by practical examples and a huge set of reflection questions and answers." --Zentralblatt MATH, Practical Biostatistics

"With a detailed outline of implementation steps complemented by a review of important topics, this book can be used as a quick reference or a hands-on guide to effectively incorporate biostatistics in clinical trials." --Doody.com, April 2013

"Practical Biostatistics is destined to be a companion book for health professionals and graduation students who face the challenge of assimilating concepts on statistics." --Mauri Carakushansky, MD, Pediatric Endocrinologist - Nemours Children's Clinic Orlando, Assistant Professor of Pediatrics - Florida State University, Assistant Professor of Pediatrics - University of Central Florida

"This work by Dr. Suchmacher and Dr. Geller is bound to become a classic and should be readily available on the desk, shelf and on line." --Salin Dahlben, Harvard University, Clinical Assistant Professor in Psychiatry, Tufts University

"Dr. Suchmacher and Dr. Geller are experienced researchers and writers in the clinical research field, who were able to fathom the often confusing realm of Statistics applied to biological sciences, and to come back with a pragmatic study proposal for interested medical students and healthcare professionals […] In my opinion, 'Practical Biostatistics' will undoubtedly be welcomed as one of the books designed to bring medical students and healthcare professionals alike, closer to a better understanding of this inescapable issue." --Spyros G.E. Mezitis, Assistant Professor of Clinical Medicine, The New York Presbyterian Hospital Weill, Cornell Medical Center

"I believe the result of [Drs. Suchmacher and Geller’s] efforts will prove useful for many medical students and researchers, who must thrive in an era when Biostatistics is destined to be an ever present matter." --Allan E. Rubenstein, Clinical Professor of Neurology, The Stephen D. Hassenfeld Children's Center for Cancer and Blood Disorders, Langone Medical Center, School of Medicine, New York University

"Practical Biostatistics is destined to be a companion book for health professionals and graduation students who face the challenge of assimilating concepts on statistics." --Mauri Carakushansky, MD, Pediatric Endocrinologist - Nemours Children's Clinic Orlando, Assistant Professor of Pediatrics - Florida State University, Assistant Professor of Pediatrics - University of Central Florida

From the Publisher

Reviewer: James C. Torner, PhD, MS (University of Iowa College of Public Health)
Description: This book is intended to provide an easy, accessible approach to biostatistics in the clinical setting. In brief descriptions, the book covers study design, analytical methods, and the use of biostatistics in applications relevant in clinical medicine.
Purpose: The authors' purpose is to provide a resource to help clinicians understand what design and analytical methods are applicable in clinical medicine. It is based upon their perception of the areas that are important for clinicians to know, but who have limited time to acquire the knowledge. Their goal is to create an "approachable" book to increase understanding of statistical principles. The acceptance of the book's contents depends on the readers need for a brief overview rather than an in-depth understanding of the foundations of the methods.
Audience: It is intended for clinicians who need a resource to apply to professional development, clinical data, and clinical reading, covering topics most relevant to the use of biostatistics. The depth of the design and analysis limits its appeal for researchers. The authors are clinicians who as investigators and teachers have experience in clinical research.
Features: The book is divided into parts that include an overview, the design of observational studies, statistical methods, biostatistical methods in clinical trials, and use of biostatistics in risk assessment, diagnostic test evaluation, systematic reviews, and association studies. The unique feature of this book is the demonstration of analytical methods through Microsoft Excel. Examples appear throughout the book, which also includes a section of Reader Resources along with self-evaluation and readings at the end of each part.
Assessment: The book is divided into parts that include an overview, the design of observational studies, statistical methods, biostatistical methods in clinical trials, and use of biostatistics in risk assessment, diagnostic test evaluation, systematic reviews, and association studies. The unique feature of this book is the demonstration of analytical methods through Microsoft Excel. Examples appear throughout the book, which also includes a section of Reader Resources along with self-evaluation and readings at the end of each part.

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