Research Methodology in the Health Sciences: A Quick Reference Guide

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