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Epidemiological Studies/ Introduction
• Define research in a scientific way
• Identify the root causes of carrying out researches
• Define clinical epidemiology and its uses
• Determine different steps of research process
• Formulate a proper research question
• Formulate a proper research objective
• Set a well-structured research hypothesis
By the end of this section, you will be able to:
DefinitionResearch is an ORGANIZED and SYSTEMATIC way of
FINDING ANSWERS to QUESTIONS.
Research
ORGANIZED
SYSTEMATIC
FINDING ANSWERS
QUESTIONS
Definition
ORGANIZED: in that there is a structure in going about doing research. It is a planned process, not a spontaneous one. It is focused and limited to a specific scope.
• Research is an ORGANIZED and SYSTEMATIC way of FINDING ANSWERS to QUESTIONS.
Research
ORGANIZED
SYSTEMATIC
FINDING ANSWERS
QUESTIONS
Definition
SYSTEMATIC:because there is a definite set of
procedures and steps which youwill follow.
• Research is an ORGANIZED and SYSTEMATIC way of FINDING ANSWERS to QUESTIONS.
Research
ORGANIZED
SYSTEMATIC
FINDING ANSWERS
QUESTIONS
Definition
FINDING ANSWERS:is the end of all research. Whetherit is the answer to a hypothesis oreven a simple question, research issuccessful when we find answers.Sometimes the answer is no, but itis still an answer.
• Research is an ORGANIZED and SYSTEMATIC way of FINDING ANSWERS to QUESTIONS.
Research
ORGANIZED
SYSTEMATIC
FINDING ANSWERS
QUESTIONS
Definition
QUESTIONS:are central to research. If there is noquestion, then the answer is of nouse. Research is focused on relevant,useful, and important questions.Without a question, research has nofocus, drive, or purpose.
• Research is an ORGANIZED and SYSTEMATIC way of FINDING ANSWERS to QUESTIONS.
Research
ORGANIZED
SYSTEMATIC
FINDING ANSWERS
QUESTIONS
• The word epidemiology comes from the Greek word epi, meaning on or
upon, demos, meaning people, and logos, meaning the study of.
• Epidemiology is the study of
the distribution and determinants of health-related states or
events in specified populations, and the application of this study to
the control of health problems
Distribution Determinants
Epidemiology
1) to describe the distribution and size of disease problems in
human population.
2) to identify aetiological factors in the pathogenesis of disease.
3) to provide the date essential for the planning, implementation,
and evaluation of health services.
Aims of Epidemiological Research
The Research Spiral
Identify theResearch Problem
Review theLiterature
Evaluate Dataand
Write Report
Specify a Research Purpose
Collect Data
Analyze andInterpret
Data
A series of actions or steps necessary to effectively carry out research
Research Process
Define research problem
LiteratureReview
Formulate research question &/or hypothesis
Design research
Collect dataAnalyze data
Interpret and report
Research Problem / Question
•A research problem is an area of concern where there is a gap in the knowledge needed for professional practices.
•Examples:•What do this patient have? (Diagnosis); •How bad is it? (Prognosis); •What are the physiological and biochemical changes that ended up with this disease? (Mechanism/Natural History/Pathogenesis);
•How did he get it? and can he spread it to his family members? (Transmission); •Will this stuff help him? (Treatment or Prevention). •Change pattern of malignancy in Egypt in the last 30 years (Classic Epidemiology)
•Quality of life of breast cancer patients with total mastectomy (Health Service Research)
First Things First
•Research problem/question•Hypothesis•Aim/Goal(s) and Objectives
Conceiving the research question
The research question is a statement reflecting the uncertainty about something
in the population that the investigator wants to resolve by making measurements
on his study participants.
Characteristics of a Good Research Question :FINER” Criteria
Feasible• Adequate Number of Participants• Adequate technical expertise• Affordable in time and money• Manageable in scope Interesting
To the investigator
Novel• Confirms or refuse previous
findings• Extends previous findings• Provides new findings
Ethical Relevant• To Scientific knowledge• To Clinical and Health policy• To future research directions
1. Novelty & avoidance of
unnecessary duplications
2. Importance for field represented
3. Interest, intellectual curiosity &
drive
4. Training & personal
qualifications
5. Availability of data & method
Criteria of selection of a Problem
6. Special equipment & working
conditions
7. Approachability of the sample
8. Sponsorship & administrative
cooperation
9. Hazards, penalties & handicaps
10. Cost & returns
11. Time factor
1. Brainstorm with a mentor or colleagues about:
• potential areas
• topics of interest
• particular research questions that one might ask
How to Get a Research Question?
2. Review the literaturesearch of a study related to a specific research question.Find out if your budding question has already been answered
No need to reinvent the wheelConsider repeating a published study in a new population – thatwould be a different question.
How to Get a Research Question?
2. Review the literature
Is there a need for your study?
Suggestions about how to approach your question, find
subjects, measure variables, and report results
How to Get a Research Question?
How to Get a Research Question?
Data Sources
paper chartselectronic medical records
registration databases clinical logs
3. Investigate data sources that exist in your institution as possible
foundations for research
How to Get a Research Question?
What fields are actually captured in the database?
How are the data entered?
What is the accuracy of the data?
3. Investigate data sources that exist in your institution as possible foundations for research
How to Get a Research Question?
SO WHAT !!!
5. Is this question relevant?
A reasonable test of this factor, is to explicitly write down why you
believe the results will make a difference.
How to Get a Research Question?
6. Can I study this ethically and legally?
In any study, the risk to human subjects, however slight, must be
justified by a reasonable potential for positive impact on these or
future patients.
7. Conduct a pilot study
To understand the feasibility of your data collection process
To gain a small sense of the actual results that you can expect.
To help you decide to abandon or seriously revise your study
proposal before you have gone too far in the wrong direction.
Do not use your pilot data in the real study
How to Get a Research Question?
The research question should specify
Components of a Research Question
1. Description of the target population (subjects)
2. Identification of one or more variables of interest
3. Description of the hypothesized relationships between these variables of
interest
Formulating a research question
Formulating a research question
Gender• two possible
states
Marital Status• multiple
possible states
Serum glucose• infinite number of
potential values
Components of a Research QuestionWhat is a VARIABLE• What we typically assess when we do research. • An attribute that can change, or vary, across subjects• An element for which more than one value or state is possible.
For example:
Formulating a research question
Dependent • the variable(s) that is possibly affected by the others (Outcome)
IndependentThe variable(s) that affect the outcome (Risk Factor, Exposure or experimental intervention)
Components of a Research Question
VARIABLES
Examples of Research Questions“Is there a relation between exposure to Environmental Tobacco Smoke
(ETS) and deterioration of lung function among school children ?”
Formulating a research question
Components of Research QuestionTarget population School Children Variables
Dependent Independent
Deterioration of Lung Function ETS
Hypothesized relationship Relation
Examples of Research Questions“Is there an association between NSAIDs use and the occurrence of peptic
ulcer among adolescence?”
Formulating a research question
Components of Research QuestionTarget population Adolescence
Variables Dependent Independent
Peptic ulcer NSAIDs use
Hypothesized relationship Association
Formulating a research question
Goals and Objectives
• Goals are long term objectives and could not be attained by the end of the research study.
• Before conducting any research work, we should have Clearobjectives.
The OBJECTIVES of a research project summarize what is to be achieved by the study.
• Objectives should be closely related to the statement of the problem.
• For example, if the problem identified is “low adherence to treatment among hypertensive patients”, the general objective of the study could be to identify the reasons for this low adherence, in order to solve this problem.
How to develop your objectives?
Your objectives should be SMART. The word SMART refers to: 1- S Specific2- M Measurable 3- A Achievable or Attainable4- R Relevant 5- T Time bound
Why should research objectives be developed?
The formulation of objectives will help you to:• Focus the study (narrowing it down to essentials); • Avoid the collection of data which are not strictly necessary for understanding and solving the problem you have identified; and
• Organize the study in clearly defined parts or phases.
How should you state your objectives?Take care that the objectives of your study:
• Are clearly phrased in operational terms, specifying exactly what you are going to do, where, and for what purpose;
• Are realistic considering local conditions; and • Use action verbs that are specific enough to be evaluated.
Examples of action verbs: to measure, to determine, to compare, to verify, to calculate, to describe, and to establish.
Avoid the use of vague non-action verbs such as: to appreciate, to understand, or to study.
HYPOTHESIS
• Based on your experience with the study problem, it might be possible to develop explanations for the problem, which can then be tested. If so, you can formulate hypotheses in addition to the study objectives.
• A HYPOTHESIS is a prediction of a relationship between one or more factors and the problem under study that can be tested.
If the research question is concerned with relationships between
observations or variables, a research hypothesis will need to be
developed.
The research hypothesis is a tentative statement that can be tested by a
scientific research design.
Generating a research hypothesis
• Post-menopausal women who received hormone replacement
therapy, of a specified type and duration, are more likely to
develop endometrial cancer than post-menopausal women who
did not receive such therapy.
• Children born to women whose husbands smoke more than 20
cigarettes a day are of lower birth weight than children born to
women whose husbands do not smoke.
Generating a research hypothesis (Examples)
Types of Epidemiological Studies
Observational
Analytic
Cross Sectional (Prevalence Study)
Case‐Control or Case Reference Study
Cohort or Follow up Study
Descriptive(Case Report – Case Series ‐
Ecological Studies)
Interventional
Clinical Trial
Non Randomized CTQuazi‐ExperimentalCommunity Trial
Complete the exercise of the lecture “Introduction to Research Methodology”
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