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Essentials of Research Methodology and Dissertation Writing
Kanan Yelikar
1:
Need for Clinical Research
STUDIES FOR NATURAL HISTORY OF THE DISEASE
STUDIES FOR EVALUATION OF DIAGNOSTIC AND SCREENING TESTS
STUDIES FOR EVALUATION OF THERAPIES
CLINICAL DECISION-MAKING
READING AND INTERPRETING MEDICAL LITERATURE
2:
Basics of Research Methodology
PURPOSE OF RESEARCH METHODOLOGY
Basic Requirement
Some Terminologies Commonly Required in Clinical Research
Some terminologies commonly required in clinical research
Types of Studies
Procedures in Discriptive Studies
Analytic Epidemiology
Four Basic Steps Case Control Study
Selection of Cases
Selection of Controls
Matching
Analysis
Exposure Rates
COHORT STUDY
Experimental Studies
Steps in Conducting a RCT
Types of Randomized Controlled Trials
Design of a Randomized Controlled Trial
3:
Pre-test and Post-test Probabilities
INTRODUCTION
Usefulness and Measures of a Diagnostic Test
Likelihood Ratio-What it means?
Advantages Likelihood Ratios
Using Likelihood Ratios
Pre-test and Post-test Probability: Bayes Theorem
Mathematical Calculation
Fagan's Nomogram
A Useful Mnemonic
Limitations of Likelihood Ratios in Clinical Practice
4:
Priorities in Reproductive Health Research
INTRODUCTION
NEW DATA ON ORAL CONTRACEPTIVE PILLS AND THE RISK OF HEART ATTACK
5:
Formulation of Research Question
INTRODUCTION
Conceptualization of Research
Research Question or Research Hypothesis?
What are the ‘Null’ and ‘Alternative’ Hypotheses?
Formulating Research Hypotheses
Establishing a Background
Choosing a Topic
Sources of Ideas may be
Statement of Research Hypothesis
Formulating the Question
How Many of These Research Questions (RQ)/Research Hypotheses (RH) Should There be?
Reviewing the Literature
Types of Information
Primary vs. Secondary Sources
Formulation of Research Objectives
6:
Study Design
CASE CONTROL STUDIES-DESIGN
Selection of Case and Controls
Selection Bias
Ascertainment Bias
Confounding Variable
Cohort Studies—Design
Selection of the Exposed and Unexposed Group
Confounding
Follow-up
RCT—Design
Types of Trials
Methods of Randomization
Outcome Measures
Blinding
Sample Size and Power
CONCLUSION
7:
Sample Size in Clinical Studies
INTRODUCTION
Basic Considerations
The Level of Significance
Power
The Standard Deviation
Detectable Difference
Finding the sample size for studies involving a single mean
Finding the sample size for studies involving a single proportion
Finding the sample size for studies involving two means (two groups)
Finding the sample size for studies involving estimation of mean
Finding the sample size for studies involving estimation of proportion
CONCLUSION
8:
Statistics and Clinicians
INTRODUCTION
Statistician and Research
Clinician and Statistics
Survival Studies
Association and its Measure
Risk Measurements
Correlation
CORRELATION COEFFICIENT
9:
Design, Conduct and Analysis of Clinical Trials
INTRODUCTION
DESIGN
CONDUCT
ANALYSIS
Responsibilities of Sponsor
Responsibilities of Investigator
Role of Ethics Committee
CONCLUSION
10:
How to Write a Dissertation
INTRODUCTION
Using This Guide
THE DISSERTATION: AN OVERVIEW
What is a dissertation?
Purpose of Dissertation
Dissertation/Thesis
The Importance of Time Management
SELECTING AND RESEARCHING YOUR TOPIC
Choosing Your Topic: The Hunt for an Idea
Keep the following points in mind:
Conducting a Literature Search or Review
Researching and Exploring Your Topic: Methods and Methodologies
The Importance of Having a ‘Thesis’ and Evaluating it Critically
Managing Your Notes
WRITING UP YOUR FINDINGS
Planning and staging your deadlines
Organising your weekly schedule
Mapping Out the Weeks Ahead of You
Creating an Appropriate Structure for the Dissertation
Maintaining Academic Principles: Ethics, Referencing and Intellectual Honesty
Ethical Standards
Referencing and Intellectual Honesty
Writing with Accuracy and Elegance
BEING YOUR OWN CRITIC BEFORE SUBMITTING YOUR WORK
Using a self-evaluation checklist
Related Approaches
TITLE
What I need to do before the actual start of the study:
Review of Literature
Materials and Methods
Type of Study
Details of Subjects and Controls
Material and Method
High Risk Pregnancy
Predictive Test
Proforma
Observations
Discussion
What Does it Mean?
Summary and Conclusions
Conclusions
References
Articles From Journals
Final editing
Acknowledgement
The Most Common Criticism
Publishing your work
11:
Writing a Scientific Paper
INTRODUCTION
MANUSCRIPTS3
PROLOGUE
HINTS FOR GOOD WRITING
GENERAL CONSIDERATIONS
Writing Style
Spelling and Grammar
Use of Numbers
Other Important Points
TITLE PAGE
AUTHORS
ABSTRACT AND KEYWORDS
Introduction and Review of Literature
Materials and Methods
Style
Results
Style
DISCUSSION
Style
CONCLUSIONS
REFERENCES
APPENDIX
FINAL CHECKS
AFTER THE PAPER HAS BEEN SENT
REVISIONS
CHECKING THE PROOFS
REJECTION
12:
Critical Appraisal of a Scientific Paper
INTRODUCTION
SCOPE OF CRITICAL APPRAISAL
What is Critical Appraisal?
Are the Results of the Study Valid? (Validity)
What are the Results? (Reliability)
Will the Results Help Locally? (Applicability)
Critically Reading Each Section of a Paper to Assess Validity, Reliability and Acceptability
CRITICAL APPRAISAL METHODOLOGY
Evaluating Systematic Reviews and Meta-analysis8
Qualitative Research and Evaluation of Qualitative Data9
Table 12.1: Critical Appraisal Checklist (from Makela)10
Study Validity
Results
Applicability
Advantages of Critical Appraisal
Disadvantages of Critical Appraisal
METHODOLOGIES TO STUDY CRITICAL APPRAISAL
CONCLUSIONS
13:
Patenting of Research
WHAT IS A PATENT?
WHAT IS RESEARCH?
INTELLECTUAL PROPERTY AND PATENT, COPYRIGHT, TRADEMARK
PATENTING LAWS IN INDIA
Legislation
Administration
Who can Apply
Patentable Inventions
Nonpatentable
Patents in India
STEPS OF FILING A PATENT IN INDIA
Documents required for filing of Patent Application in India (PCT)
Documents Required for Filing of Convention Application
WHY TO FIRST FILE A PROVISIONAL PATENT
WHAT IS PATENT SEARCH?
Purpose
SOME PRACTICAL TIPS
TRESPASSING OF PATENT AND JUDICIARY
14:
Evaluation of Diagnostic Tests
INTRODUCTION
THE GOLD-STANDARD TEST
MEASURES OF RELIABILITY OF A TEST: SENSITIVITY AND SPECIFICITY
PREDICTIVE VALUES OF A TEST
USEFULNESS OF A TEST: LIKELIHOOD RATIO
LR+ = Sensitivity/(1 - Specificity)
LR- = (1 - Sensitivity)/(Specificity)
THE BAYESIAN APPROACH
TESTS THAT YIELD CONTINUOUS VALUE: FIXING A CUT-OFF POINT
HOW TO READ AN ARTICLE ON DIAGNOSTIC TESTS
Was the gold-standard appropriate for the study?
Was there an independent blind comparison with the reference standard?
Was the test evaluated in a sufficient number of people at risk of the disease?
Did the sample include a group of patients appropriate to the purposes?
Was the method for performing the test described in sufficient detail?
CONCLUSION
15:
Ethical Issues in Research
INTRODUCTION
INTERNATIONAL EFFORTS IN CREATION OF ETHICAL GUIDELINES
EFFORTS OF Central Ethics Committee on Human Research (cechr)
GENERAL PRINCIPLES
IMPORTANT LEGAL AND ETHICAL ISSUES OF THE GENERAL PRINCIPLES
Informed Consent
COMPENSATION FOR PARTICIPATION
SPECIAL GROUPS AS RESEARCH SUBJECTS
Guidelines for pregnant or nursing women
Guidelines for children
Guidelines for Communities
MAINTAINING CONFIDENTIALITY
INTERNATIONAL COLABORATIONS
MEDIA
REVIEW PROCEDURES
Guidelines about its Composition
SPECIFIC PRINCIPLES
Clinical Evaluation Of Drugs, Vaccines, Devices, Diagnostic, Herbal Remedies, etc.
Drug trial
Vaccine Trials
Clinical Trials with Surgical Procedures/Medical Devices
Diagnostic Agents—Use of Radioactive Materials and X-rays
Clinical Evaluation of Herbal Remedies and Medicinal Plants
SPECIFIC PRINCIPLES FOR EPIDEMIOLOGICAL STUDIES
SPECIFIC PRINCIPLES FOR HUMAN GENETICS RESEARCH
Special Concerns about Genetic Screening Programs
Special Concerns About Gene Therapy
Special concerns of Human Genome Project
Special Concerns of DNA Diagnosis
Special Concerns of Prenatal Diagnosis
STATEMENT OF SPECIFIC PRINCIPLES FOR RESEARCH IN TRANSPLANTATION INCLUDING FETAL TISSUE TRANSPLANTATION
Transplants from Live or Cadaver Donors
Guidelines for Recipients
Transplant of Embryonic and Fetal Tissue
Xeno-transplantation
16:
Evidence-Based Medicine in Obstetrics and Gynecology
INTRODUCTION
EBM is not a cookbook
MISPERCEPTIONS
Levels of Dvidence for Effects of Treatments—Limiting Bias
Hierarchy of Evidence
Classification of evidence levels (As used by RCOG)
Grades of Recommendations (As used by RCOG)
Quality of Evidence and Definitions
To Summarize the Five Steps to Practice Ebm Effectively are
COMMONLY CITED LIMITATIONS OF EVIDENCE-BASED MEDICINE
Universal to the Practice of Medicine
Unique to the Practice of Evidence-based Medicine
Misuses of EBM
Getting Eevidence into Practice
Explanation of the Cochrane logo16
EPISIOTOMY IN VAGINAL BIRTH (Cochrane Review)15
Selection Criteria
Main Results
AUTHORS’ CONCLUSIONS
MANAGEMENT OF SEVERE PRE-ECLAMPSIA (RCOG GUIDELINE)
How should the Fetus be Assessed?
How should We Control the Blood Pressure?
How should Seizures be Prevented?
Cesarean Section NICE Guideline
Mother-to-child transmission of maternal HIV infections
Maternal Request
CONCLUSION
17:
Improving Your Presentation Skills
INTRODUCTION
Types of Presentations
SIX HONEST MEN
WRITING THE MATTER
Simple
Writing
Presenting
BEGINNING OF PRESENTATION
Audio Visual Aids
Slides
Delivery of the Talk (Fig. 17.1)
EYE CONTACT
POSTURE
GESTURES
TIMING
Beware of Speaking for too Long
18:
Registration of Clinical Trials
INTRODUCTION
NEED FOR REGISTRATION OF CLINICAL TRIALS
EVOLUTION OF REGISTRATION OF TRIALS
Responsibility and Procedure of Registration
19:
Global Careers in Clinical Research
CLINICAL RESEARCH PATHWAY
IS CLINICAL RESEARCH AN ATTRACTIVE CAREER?
INDEX
TOC
Index
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