Elements Of Clinical Study Design, Biostatistics & Research is designed as a toolbox for biomedical researchers. The book's primary focus is on applications in clinical research, and will benefit students and researchers involved in the biomedical field. This book addresses the problems that many practitioners experience in choosing and implementing fit-for-purpose data analysis methods to answer critical inferential questions for binomial and count data. The book is written in simple language avoiding complex derivations and mathematical formulae allowing it to explain the most basic concepts of research methodology. Making good use of numerous tables, graphs and tips, this book demystifies the process for readers.
7 structured Chapters take the reader through the entire research process: choosing a question, designing a study, collecting the data, using univariate, bivariate, and multivariable analysis, and publishing the results. Each chapter discusses the strengths and weaknesses of the methods and suggests practical recommendations. An appendix on ethical research guidelines, along with a glossary and reference list comprehensively round up the book contents.
It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of studies. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in the areas of biostatistics, epidemiology, medicine, pharmacy, and public health.
Table of Contents
Chapter 1 Study Designs in Clinical Research
- Observational Studies
- Case Series
- Case-Control Studies
- Cross-Sectional Studies, Surveys
- Methods of Survey
- By Self-Administered Questionnaire
- Interviews
- Reliability
- Validity
- Pilot Testing
- Cohort Studies
- Prospective Cohort
- Historical Cohort or Retrospective Cohort Study
- Amphispective Cohort Studies
- Interventional Studies (Experimental Studies)
- Animal Studies
- Human Studies/Clinical Trials
- Controlled Trials
- Uncontrolled Studies
- Meta-Analysis
- Conclusion
- Study Designs in Medical Research Fall into Three Categories:
Chapter 2 Scales of Measurement, Descriptive Statistics & Data Presentation
- Introduction
- Scales of Measurement
- Nominal (Categorical Scale)
- Ordinal Scale
- Interval Scale
- Ratio Scale
- Measurement of Central Tendency
- Calculation of Measures of Central Tendency
- Mean
- Median
- Mode
- Uses of Central Tendency
- Guidelines to Decide Which Measure of Central Tendency is Best to Be Used
- Mean
- Median
- Mode
- Geometrical Mean
- Measures of Spread
- The Range
- Standard Deviation
- Co-Efficient of Variation (Cv)
- Percentile
- Guidelines for Using Different Measures of Dispersion
- Presentation of Data in Tables and Graphs
- Tables
- Simple Table
- Frequency Distribution Table
- Charts and Diagrams
- Simple Bar Chart
- Component Bar Chart
- Histogram
- Frequency Polygon
- Graphs and Line Diagram
- Pie Diagram or Pie Charts
- Pictogram
- Conclusion
- Scales of Measurement Are:
- Descriptive Statistics
- Data Presentation
Chapter 3 Inferential Statistics
- Introduction
- Probability
- Objective Probability
- Subjective Probabilities
- Experiment and Event
- Experiment
- Event
- Complementary Event
- Mutually Exclusive Event and the Rule of Addition
- Independent Events
- Likelihood
- Sensitivity
- Specificity
- Bayes' Theorem
- Population and Samples
- Power of Study
- Method of Sample Selection
- Non-Probabilities Sampling
- Probability Sampling
- Simple Random Sample
- Systematic Random Sample
- Stratified Sample
- Random Cluster Sample
- Properties of Good Sampling
- Random Assignment
- Random Variables and Probability Distribution
- Poisson Distribution
- Binomial Distribution
- The Normal or Gaussian Distribution
- The Central Limit Theory
- Sampling Distribution
- Features of the Sampling Distribution
- Sample Size
- Approaches to Statistical Inferences
- A Confidence Interval
- Estimate and Estimation:
- Point Estimate:
- Interval Estimate:
- Hypothesis Testing Steps
- Making a Statement (Stating) Research Question in Terms of Statistical Hypothesis
- Making the Decision on Suitable Test Statistics
- Chi-Square Test
- Selecting the Level of Significance and Determination of the Value
- Determination of the Value of Significance
- Performing the Calculations
- Making Conclusions
- Errors in the Hypothesis Test
- The Type One Error
- The Type Two Error
- Power of Study
- Significance of P-Value and Alpha
- Paired T Test
- Intra-Rater Reliability
- Pearson's Correlation Coefficien
- Measurement of the Same Variable by Two Different Procedures 50 Application of T-Test
- Sample Size
- Comparison of Means in Three or More Groups
- Analysis of Variance (Anova)
- Example 1:
- Example 2:
- Pre-Condition (Assumptions in Anova)
- Multiple Comparison Procedure
- Post Hoc Comparisons
- Comparison of Frequencies or Proportions in More Than Two Groups
- Conclusion
Chapter 4 Statistical Methods for Relationship Variables
- Introduction
- The Relationship Between Two Numerical Observations (Characteristics)
- Correlation
- Assumptions in Correlation
- Regression
- The Relationship Between Two Ordinal Characteristics
- The Relationship Between Two Nominal Characteristics
- Experimental Event Rate (Eer)
- The Control Event Rate (Cer)
- Relative Risk (Rr)
- Relative Risk Reduction (Rrr)
- Absolute Risk Reduction (Arr)
- Number Needed to Treat (Nnt)
- Absolute Risk Increase (Ari)
- Number Needed to Harm (Nnh)
- Odds Ratios
- Multiple Regression
- Analysis of Covariance(Ancova)
- Logistic Regression
- Multivariate Analysis of Variance (Manova)
- Diagnostic Procedures
- Sensitivity
- Specificity
- Use of Sensitivity and Specificity for Revision of Probabilities:
- Likelihood Ratio
- Calculation of Likelihood Ratio
- Bayes' Theorem
- Use of Sensitivity and Specificity in Making Clinical Diagnosis (Figs. 4.2 and 4.3)
- Receiver Operating Characteristic (Roc) Curve
- Conclusion
Chapter 5 Clinical Research
- Introduction
- Clinical Research
- Types of Clinical Trials
- Phases of Clinical Trials
- Phase I
- Phase Ii
- Phase Ii(A)
- Phase Ii(B) (Pivotal Trial)
- Phase Iii(A)
- Phase-Iii (A) I) Superiority Clinical Trials
- Phase-Iii (A) Ii)Equivalence Clinical Trial
- Phase-Iii (A) Iii)Non-Inferiority Clinical Trial
- Phase-Iii (B)
- Phase Iv Clinical Trials
- Risk of Biases in Randomized Controlled Trials (Rcts)
- Cochrane Tool for Bias Risk Assessment
- Consort Guidelines
- Consort Checklist
- Pragmatic Trials (Prct) (Therapy Evaluation)
- Main Differences of (I) Rct and (Ii) Prct
- Elements of Pragmatic Trials
- Formulation of Research Question
- Defining the Patient Group
- Identifying Comparison Group
- Defining the Treatment Protocol
Author
- Aditya Patel
-S.S.Patel
