Main description:

This book discusses the why and how of each step of data-based medical research that can provide basic information to emerging researchers and medical graduate students who write theses or publish articles. The chapters are arranged in the sequence of steps for data-based research. The research steps are comprehensively covered from the selection of the topic to the final publication. Reporting methods such as CONSORT, STARD, and SAMPL guidelines are also covered. Each chapter has separately earmarked examples from the contemporary literature that illustrate the different research methods.

Key Features

Discusses all the steps of data-based medical research

Examines the topics in depth by way of examples from contemporary literature

Features notable information in boxes for special attention

.

Contents:

Basics of Medical Research

What Is Medical Research?

Medical Research and Empiricism

Types of Medical Research and the Scope of This Book

Levels of Medical Research

Uncertainties in Medical Research

Epistemic Uncertainties

Aleatory Uncertainties

Managing Uncertainties in Empirical Medical Research

Broad Steps in Medical Research

Pre-Investigation Steps

Investigation Steps

Post-Investigation Steps

Quality of Medical Research

What Qualifies Good Research?

Quality of a Good Researcher

Pleasures and Frustrations of Medical Research

The Topic of Medical Research

Selection of the Topic of Research

What Is a Problem?

Review of Literature and Databases, and Their Critique

Feasibility and Resources

Ethical Considerations

Resources

Objectives and Hypotheses

Broad and Specific Objectives

Hypotheses

Study Designs: An Overview

What Is a Design of an Empirical Study?

Elements of a Design

Types of Designs

Descriptive Studies

Sample Surveys and Their Designs

Case Studies and Case Series

Census

Analytical Studies

Choice of Strategy for Analytical Studies

Some Useful Terms and Concepts for Analytical Studies

Essentials of Intervention Studies

Medical Experiments

Clinical Trials

Essentials of Observational Studies

Prospective Studies

Retrospective Studies

Cross-Sectional Studies

Reliability and Validity of Designs, and Biases

Reliability of a Design

Validity of a Design

Biases in Medical Studies and Their Control

Where to Use Which Design?

Recommended Designs for Different Types of Research Questions

Levels of Evidence for Cause-Effect Relationships

Clinical Trials

Types of Clinical Trials

Therapeutic Trials - Efficacy and Safety

Clinical Trials for Diagnostic and Prophylactic Modalities

Field Trials for Screening, Prophylaxis, and Vaccines

Superiority, Equivalence, and Noninferiority Trials

Other Types of Clinical Trials

Basics of Clinical Trials

Arms of a Trial

Phases of a Clinical Trial

Randomization and Matching

Control Group in a Clinical Trial

Validity of a Clinical Trial

Selection of Participants

Blinding, Concealment of Allocation, and Masking

Compliance

Uncertainties in Clinical Trials

Choosing a Design for an Efficacy Trial

Observational Studies

Prospective Studies

Subjects in a Prospective Study

Potential Biases in Prospective Studies and Their Merits and
Demerits

Cohort Studies

Longitudinal Studies

Repeated Measures Studies

Retrospective Studies

Case-Control Design

Selection of Cases and Controls

Merits and Demerits of Retrospective Studies

Cross-Sectional Studies

Merits and Demerits of Cross-Sectional Studies

Comparative Performance of Prospective, Retrospective, and
Cross-Sectional Studies

Performance of a Prospective Study

Performance of a Retrospective Study

Performance of a Cross-Sectional Study

Assessment of Medical Factors

Intricacies of Assessment

Univariate and Multifactorial Assessments

Assessment in the Implementation Phase and the

Results Phase

Types of Medical Factors

Distal and Proximal Factors

Physiological and Pathophysiological Factors

Pathological Factors and Disease

Assessment of Mortality, Duration, and Quality of Life

Assessment of Mortality

Quality of Life and Duration

Methodology of Data Collection

Types of Measurements

Nominal, Metric, and Ordinal Measurements

Other Types of Scales for Measurement

Continuous and Discrete Variables

Tools of Data Collection

Questionnaires, Schedules, and Proforma

Interview, Examination, and Investigation

Quality of Data

Errors in Medical Data

Reliability, Validity, and Accuracy of Data

Other Aspects of Data Quality

Validity of the Tools

Pilot Study and Pretesting

Sensitivity and Specificity of Medical Tests

ROC Curves and Youden Index

Predictivities and Prevalence

Sampling and Sample Size

Sampling Methods and Sampling for Descriptive Studies

Purposive Sampling (Nonrandom Methods)

Random Sampling

Sampling for Analytical Studies

Sampling Methods in Observational Studies

Sampling Methods in Clinical Trials

Sampling and Nonsampling Errors

Sampling Errors

Nonsampling Errors

Sample Size

Sample Size for Descriptive Studies

Sample Size for Analytical Studies and Clinical Trials

Appendix 1: Some Sample Size Formulas

Research Protocol

Structure of the Protocol

Title, Researchers, Supervisors, and Collaborators

Executive Summary

Main Body of the Protocol

Logistics and Appendices

Main Body of the Protocol

Specifics of the Content of the Main Body of the Protocol

Further Details of the Contents of the Main Body of the Protocol

Processing of Data

Collation of Data and Scrutiny

Uniformity of the Process of Data Collection

Data Validation

Master Chart and Data Entries

Indexes and Scores for Individual Subjects

Epidemiological Indices

Rates and Ratios

Prevalence and Incidence

Risk, Hazard, and Odds

Representative Summary Measures

Summary Measures for Quantitative Data

Summary Measures for Qualitative Data

Tabulation and Graphics

Categorization of Data and the Choice of Class Intervals

Types of Data Tables

Graphs and Diagrams

Statistical Distribution of Medical Measurements

Normal versus Abnormal Levels

Statistical Analysis

Confidence Intervals, P-Values, and Power

CI for Proportion and Mean

CI for Relative Risk and Odds Ratio

Statistical Significance, P-Value, and Power

Some Basic Statistical Tests

Tests for Qualitative Data

Tests for Quantitative Data

Relationships and Regressions

Dependent and Independent Variables

Basics of Logistic Regression

Ordinary Least Square Regression

Correlation and Agreement

Cause-Effect Relationships and Validation of Results

Evidence of Cause-Effect

Validation of the Findings

Statistical Fallacies

Cherry-Picking the Statistical Indices

Fallacious Interpretation

Statistical Errors Can Cause Many Deaths

Writing a Thesis or a Paper, and Oral Presentation

Effective Scientific Writing

Text Style

Tables

Illustrations

Format of a Manuscript (IMRaD)

Preliminaries of a Manuscript

Title

Authorship Credits

Keywords

Abstract and Summary

Main Body of the Report

Writing a Suitable Introduction

Explaining Materials and Methods

Describing the Results

Discussion of Findings and Conclusion

End Features of a Report

Acknowledgment Ethics

Key Messages

References

Contribution of Authors and Conflict of Interest

Appendix

Oral Presentation

Essentials of Effective Presentation

Poster Presentation

Reporting Guidelines

Guidelines for Reporting of Clinical Trials (CONSORT Statement)

Reporting of Observational Studies (STROBE Statement)

Reporting of Diagnostic Accuracy Studies (STARD Statement)

Guidelines for Reporting of Statistical Methods

(Revised SAMPL Statement)

Reporting Ethics and Peer Reviews
Covering Letter

Duplication

Duplicate Publication

Plagiarism

Copyright and Permissions

Conflicts and Reviews

Conflict of Interest

Peer Review

Confidentiality and Misreporting

Confidentiality

Misreporting

The Last Word

Index