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Biomedical Research Methodology
Ranjan Das, PN Das
SECTION I: PLANNING AND EXECUTION OF RESEARCH
1:
Planning Your Research
SELECTING THE TOPIC
Origins of a Research Question
REVIEWING THE LITERATURE
Method for Literature Review
Locating the Sources
FRAMING THE AIMS AND OBJECTIVES
PLANNING THE METHODOLOGY
WRITING THE PROTOCOL
SUMMARY
2:
Research Study Designs
OBSERVATIONAL STUDY
Descriptive Study
Case Reports/Case Series Study
Analytical Study
Ecological Study
Cross-sectional Study
Case-Control Study
Cohort Study
EXPERIMENTAL STUDY
Drug Trial
Phase 0 or Prephase I Trial
Vaccine Trial
HYBRID STUDY DESIGNS
Nested Case-control Study
Nested Case-cohort Study
QUALITATIVE STUDY DESIGNS
Case Study
Observations
In-depth Interviews
Focus Group
Mixed Design
Differences from Quantitative Research Methodology
SYSTEMATIC REVIEWS
SUMMARY
3:
Ethical Issues of Research
INTRODUCTION
PRINCIPLES OF BIOETHICS
Procedure for Ethical Review
Full Review
Exemption from Review
Partial/Expedited Review
Key Ethical Issues in Research
Informed Consent
Compensation for Participation
Conflict of Interest
Enrolling Vulnerable/Special Groups
Ensuring Confidentiality
Banned/Restricted Areas of Research
Research Misconduct
Authorship issues
SUMMARY
4:
Hypothesis Development and Measurements
SUMMARY
5:
Collecting Data and its Management
COLLECTING RESEARCH DATA
The Research Instrument
Constructing the Interview schedule/Questionnaire
Criteria of a Good Schedule/Questionnaire
Interview Schedule versus Questionnaire
Pretesting the Instrument
The Technique of Interviewing
DATA MANAGEMENT
Coding the Variables
Deciding the Variable Type and Format
Fixing Permissible Range
Editing and Cleaning of Primary Data
Missing Data
Data Entry and Creating the Database
STATISTICAL SOFTWARES FOR DATA HANDLING AND ANALYSIS
General Purpose Packages
Microsoft Excel
SPSS
SAS
Stata
Minitab
Special Purpose Statistical Software
nQuery Adviser
StatXact
Solas
Sigmastat
Sigmaplot
Epilnfo
SUMMARY
SECTION II: BIOSTATISTICAL APPLICATIONS IN RESEARCH
6:
Sampling Issues in Research
SAMPLING PROCEDURES
Random or Probability Sampling
Simple Random Sampling
Stratified Random Sampling
Multistage Random Sampling
Cluster Random Sampling
Systematic Random Sampling
Nonprobability Sampling
Quota Sampling
Snowball Sampling
Purposive Sampling
SAMPLE SIZE
Sample Size in Descriptive Studies
For Estimating Population Proportion (p)
For Estimating Population Mean (μ)
Sample Size for Analytical Studies
For Testing Equality of Two Proportions
For Case-control Study
Nonresponse
SUMMARY
7:
Describing Your Observations
MEASURES OF CENTRAL TENDENCY
Arithmetic Mean
Median
Mode
MEASURES OF DISPERSION
Range
Quantile Range
Mean Deviation
Variance
Standard Deviation (SD)
Coefficient of Dispersion or Variation (CV)
Standard Error (SE)
Skewness and Kurtosis
SUMMARY
8:
Assessment of Risk
DIRECT METHODS
INDIRECT METHODS
SUMMARY
9:
Analyze Your Observations: Check Statistical Significance
STATISTICAL SIGNIFICANCE
Parametric Tests (For Quantitative Data)
Normal Curve Test or Z Test
Student's t Test
Analysis of Variance (ANOVA)
The one-way ANOVA (F test)
Non-parametric Tests
FOR QUANTITATIVE DATA
FOR QUALITATIVE DATA
Choosing the Appropriate Statistical Test
SUMMARY
10:
Analyze Your Observations: Estimate Confidence Interval, Correlation and Regression
CONFIDENCE INTERVAL
Correlation and Regression
CORRELATION
REGRESSION
Regression Analysis by Method of Least Squares
Steps for computing the regression equation:
Multiple Regression and Multivariate Regression Analysis
Logistic Regression
SUMMARY
Confidence Intervals
Correlation and Regression
Linear Correlation
Correlation Coefficient
Spearman Rank Correlation Coefficient
Linear Regression
11:
Presenting Your Observations
TABLES
General Principles of Tabulation
GRAPHS AND DIAGRAMS
SUMMARY
SECTION III: CONCLUDING THE RESEARCH
12:
The Basis for Drawing Conclusions
ASSOCIATION
CAUSATION
Theories of Causation
Models Used to Explain Causation
Criteria for Inferring Causality
Temporal Sequence
Strength of Association
Biological Gradien/Dose-response
Consistency of Findings and Effect of Study Design
Biological Plausibility
Reversibility on Cessation of Exposure/Experimental Evidence
Specificity
Judging the Evidence
Internal versus External Validity
SUMMARY
13:
Sources of Error in Studies
RANDOM ERROR
SYSTEMATIC ERROR/BIAS
Selection Bias
Prevalence-Incidence Bias
Berksonian Bias
Non-response Bias
Dissimilar Group Bias
Measurement/Information Bias
Surveillance/Diagnostic Bias
Recall Bias
Confounding
Hawthorne Effect
Post-hoc Bias
METHODS TO MINIMIZE BIAS
SUMMARY
14:
Writing the Thesis/Report
SUMMARY
Glossary
APPENDICES
APPENDIX I:
Table of Random Numbers
APPENDIX II:
Table of Probability from the Standard Gaussian Distribution (Z test)
APPENDIX III:
Table of Critical Values for Chi-Square Distr!!ibution
APPENDIX IV:
Table of Critical Values for Student's t Distribution
APPENDIX V:
Table of Student's t Distribution: Number of Observations for Level of t Test; Single-sample t Test and Paired t Test
APPENDIX VI:
Table of Student's t Distribution: Number of Observations for Paired t Test
APPENDIX VII:
Table of F Distribution (α = 0.05)
APPENDIX VIII:
Table of Critical Values for Wilcoxon-Mann-Whitney Two Sample Rank Test
APPENDIX IX:
Table of Percentage Points for the Wilcoxon Signed Rank Sum Test
APPENDIX X:
Table of Critical Values of the Correlation Coefficient
APPENDIX XI:
Table of Critical Values of Spearman's Correlation Coefficient
References
INDEX
TOC
Index
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