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Preface
Acknowledgment
PART ONE
CHAPTER 1. Introduction
CHAPTER OBJECTIVES
DEFINITION OF RESEARCH
Examples of Clinical Observations
What Is Common among These Observations?
DEFINITION OF TERMS
Research Methodology
Research Methods
CHALLENGES IN RESEARCH IN THE HEALTH SCIENCES
RESEARCH CANNOT BE DONE HAPHAZARDLY
Research Planning
Different Types of Study Designs and Their Functions
Example of an Important Case Series
Analysis and Interpretation of Data
Clinical Application of the Results
WHY STATISTICS IN THE HEALTH SCIENCES?
Example of the Use of Statistics
Statistical Issues in Medical Research
Practical Use of Statistical Concepts and Tests
MEDICAL LITERATURE SEARCH AND CLINICAL DECISION MAKING
Questions Arising from Common Clinical Problems
How and Where to Get the Answers
PURPOSE OF THIS BOOK
CHAPTER 2. How to Plan a Research Study
CHAPTER OBJECTIVES
HOW TO START A RESEARCH STUDY
How to Develop the Research Question
Generating a Hypothesis
Defining the Research Objectives
The Study Example
STUDY DESIGN
STEPS INVOLVED IN UNDERTAKING A RESEARCH STUDY
Preinvestigational Steps
Writing the Protocol
Investigational Steps
Postinvestigational Steps
ERRORS IN REPORTING RESEARCH
Example of a Reporting Error
LEVELS OF MEDICAL RESEARCH
CHAPTER 3. Types of Studies in Clinical Research — Part I: Observational Studies
CHAPTER OBJECTIVES
RESEARCH DESIGN AND STUDIES
Types of Studies
STUDIES OF RISK ASSESSMENT: OBSERVATIONAL STUDIES
What Are Observational Descriptive Studies?
Utilities of Descriptive Studies
Advantages and Limitations of Descriptive Studies
Types of Descriptive Studies
Types of Observational Analytical Studies
Cross-Sectional Studies
Case–Control Studies
Cohort Studies
Hybrid Study Designs
CHAPTER 4. Types of Studies in Clinical Research — Part II: Interventional Studies
CHAPTER OBJECTIVES
DIFFERENT TYPES OF INTERVENTIONAL STUDIES
Interventional Trials in Basic Science
Interventional Trials in Community Settings
Interventional Trials in Clinical Settings
JUSTIFICATION FOR CLINICAL TRIALS
RANDOMIZED CONTROLLED TRIALS
TERMINOLOGY USED IN A RANDOMIZED CONTROLLED TRIAL
Participant
Investigator
Intervention
Outcome
Intervention and Control Groups
HISTORY OF RANDOMIZED CONTROLLED TRIALS
STEPS IN A RANDOMIZED CONTROLLED TRIAL
ADVANTAGES OF RANDOMIZED CONTROLLED TRIALS
SPECIAL ISSUES IN RANDOMIZED CONTROLLED TRIALS
Planning the Intervention and Control Conditions
Planning the Outcomes of the Study
Selection of the Study Groups
Baseline Characteristics and Random Allocation of Participants to Intervention and Control Groups
Blinding
Implications of Eligibility Criteria in Sampling
Efficacy and Effectiveness
Analytic Methods Used
Ethical Issues
TYPES OF RANDOMIZED CONTROLLED TRIALS
Randomized Controlled Trials Based on Participants’ Exposure and Response to the Intervention
Randomized Controlled Trials Based on the Number of Participants
Randomized Controlled Trials Based on Different Aspects of Interventions Evaluated
BEYOND CLINICAL TRIALS: APPROACH TO SECONDARY RESEARCH
The Need for Review of Clinical Trials
Types of Reviews
CHAPTER 5. APPROACH TO QUALITATIVE RESEARCH IN HEALTH SCIENCES
CHAPTER OBJECTIVES
FOCUSING ON QUALITATIVE ASPECTS IN RESEARCH
WHAT IS QUALITATIVE RESEARCH
When to Use Qualitative Approaches in Research
METHODOLOGIC APPROACH TO QUALITATIVE RESEARCH
Appropriate Research Questions in Qualitative Research
Methodology in Qualitative Research
Methods of Data Collection in Qualitative Research
Types of Qualitative Data Collection Methods
Qualitative Data Analysis
COMPARING QUALITATIVE AND QUANTITATIVE RESEARCH METHODS
Can Qualitative Research Methods Complement Quantitative Methods?
Rigor in Qualitative Research
Limitations of Qualitative Research Methods
CHAPTER 6. ETHICS IN MEDICAL RESEARCH
CHAPTER OBJECTIVES
WHAT ARE ETHICS AND MEDICAL ETHICS
What Is Ethics?
What Is Medical Ethics?
ETHICAL REQUIREMENTS IN MEDICAL RESEARCH
Why Research Is Essential in Medical Science
Conflict of Interest between Doctor as Caregiver and as Researcher
HISTORICAL BACKGROUND
Treaties and Declarations to Safeguard Medical Ethics
PRINCIPLES GUIDING CONDUCT OF ETHICAL RESEARCH
Independent Ethics Committee
Functioning of the Ethics Committees
Ethics Committee Review
Research on Vulnerable Subjects and Other Special Groups
Ethical Issues Specific to Randomized Controlled Trials
Limitations of Ethics Committees
PUBLICATION ETHICS
CHAPTER 7. LITERATURE REVIEW, TRACKING THE BEST EVIDENCE, AND LITERATURE SEARCH
CHAPTER OBJECTIVES
WHAT IS A LITERATURE REVIEW?
WHY IS LITERATURE REVIEW NECESSARY?
PRIORITIES IN THE LITERATURE REVIEW PROCESS
HOW TO ANALYZE THE LITERATURE
Format and Level of the Literature Review
Association between the Research Question and the Literature Review
EVIDENCE FROM CLINICAL RESEARCH
Evidence from Reviews
Different Types of Reviews
Clinical Guidelines and Their Utility in Evidence-Based Care
Synopsis of Clinical Guidelines
HOW TO TRACK THE BEST EVIDENCE
Challenges in Evidence-Based Clinical Practice
How to Get the Best Answers?
Difficulties in Getting the Right Information
Literature Search for Evidence-Based Patient Care
HIERARCHY OF CLINICAL EVIDENCE
Primary Research
Secondary Research
Clinical Decision Support Systems (CDSS)
HOW TO SEARCH THE EVIDENCE, AND ELECTRONIC DATA SEARCH
Literature Search Techniques
Electronic Databases
Compiling the Review Material
CHAPTER 8. HOW TO WRITE A SCIENTIFIC PAPER
CHAPTER OBJECTIVES
PREPARATION OF A SCIENTIFIC PAPER
Evolution of the Manuscript-Writing Process
DIFFERENT TYPES OF ARTICLES AND THEIR STRUCTURES
Original Research Articles and the IMRAD Format
The Structure of the Original Research Article
Additional Formats for Original Research Articles
Variations of the IMRAD Structure
Structure for Reviews
PREPARATION OF THE MANUSCRIPT
Background Information
Selection of Target Journal
Authorship Issues
Ethical Concerns
HOW TO START WRITING THE MANUSCRIPT
FINAL PRESENTATION OF THE ARTICLE
Title, Key Words, and Abstract
PART TWO
CHAPTER 9. INTRODUCTION TO BIOSTATISTICS AND APPROACH TO DESCRIPTIVE STATISTICS
CHAPTER OBJECTIVES
WHY STATISTICS IS NECESSARY FOR BIOMEDICAL SCIENCES
SOME BASIC ELEMENTS OF BIOSTATISTICS
Variable and Data
Types of Data
Data Measurement Scales
PRESENTATION OF THE DATA
Different Formats for Data Presentation
MEASURES OF CENTRAL TENDENCY AND DISPERSION
Measures of Central Tendency
Measures of Dispersion
CHAPTER 10. APPROACH TO STATISTICAL INFERENCE—I
CHAPTER OBJECTIVES
DEFINITION OF TERMS
Population and Sample
Statistical Inference
Descriptive Measure
Parameter and Statistic
Element
Probability
POPULATION AND SAMPLES
Population
Sample
TYPES OF SAMPLING
Random Sampling
Nonrandom Sampling
Type of Sampling Design to Be Selected for Any Research
HYPOTHESIS TESTING
Types of Hypotheses
Hypothesis Testing and the p Value
Types of Error
Statistical Interpretations and Power
The p Value in Practice
Statistical Significance versus Clinical Importance
Limitations of Hypothesis Testing
ESTIMATION
Rationale for Estimation in Research in the Health Sciences
Types of Estimates
CONFIDENCE INTERVALS IN INTERPRETING STUDY RESULTS
Confidence Intervals
BIAS AND CHANCE
Bias
Chance
Comparing Bias and Chance
VALIDITY AND RELIABILITY
Validity
Reliability
CHAPTER 11. APPROACH TO STATISTICAL INFERENCE—II
CHAPTER OBJECTIVES
DEFINITION OF TERMS
Measures of Frequency
Association and Causation
Correlation and Regression
INCIDENCE AND PREVALENCE
Advantage of Objective over Subjective Reasoning
Incidence
Prevalence
Comparing Prevalence with Incidence
ASSOCIATION AND CAUSATION
What Is an Association?
Types of Variables in an Association
MEASURING ASSOCIATION
MEASURES OF ASSOCIATION
Absolute Measures of Association
Relative Measures of Association
Practical Application of Measures of Association
CORRELATION AND REGRESSION
Correlation
Regression
Regression Analysis
CONCEPT OF CAUSAL ASSOCIATION
Establishing Association between Variables
Establishing the Causality of Association
Importance of Establishing Causality of Association
Association between Variables
CHAPTER 12. APPROACH TO STATISTICAL INFERENCE—III
CHAPTER OBJECTIVES
DIAGNOSIS OF DISEASES
What Are Diagnostic Tests?
Relation between Diagnostic Test Result and Disease
DEFINITIONS OF COMMON TERMS
Sensitivity
Specificity
Positive Predictive Value
Negative Predictive Value
Likelihood Ratios
Prevalence
SENSITIVITY AND SPECIFICITY
Sensitivity
Specificity
Clinical Utility and Limitations of Sensitivity and Specificity
PREDICTIVE VALUES
Positive Predictive Value
Negative Predictive Value
Predictive Value and Prevalence of the Disease
LIKELIHOOD RATIO
ESTIMATING PROBABILITY OF DISEASE
Pretest and Posttest Probabilities
Bayesian Probability
TRADE-OFF BETWEEN SENSITIVITY AND SPECIFICITY
How to Select the Optimal Cutoff Value
STATISTICAL TESTS AND TECHNIQUES USED IN THE MEDICAL LITERATURE
Commonly Used Statistical Tests in Clinical Research
Analogy between Diagnostic Tests and Clinical Research
Application of Statistical Tests in Clinical Research
How to Select a Statistical Test
SAMPLE SIZE CALCULATION FOR VARIOUS STUDIES
Planning the Sample Size
Importance of the Sample Size
Statistical Issues in Determining the Sample Size
Sample-Size Determination for Different Types of Studies
Index
