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 Rev iew 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