2. LEARNING OUTCOME
• What is study design
• Types of study design
• Descriptive study
Case report
Case series
Cross sectional Study
3. WHAT IS STUDY DESIGN ?
A study design is a specific plan or
protocol for conducting the study, which allows the
investigator to translate the conceptual hypothesis
into operational one.
6. TYPES OF STUDIES
Observational
Investigator has no control over major
independent or predictor variables
Existing phenomenon used
No intervention
Experimental
Investigator has control over major independent
and predictor variables
Study tests the effect of intervention on certain
aspect of health or disease
7. EPIDEMIOLOGICAL METHODS
1) Observational studies :
a. Descriptive studies
b. Analytical studies
i) Ecological or co relational
ii) Cross-sectional or prevalence
iii) Case – control
iv) Cohort
2) Experimental studies :
a. Randomized controlled trials
b. Field trials
c. Community trials
8. DESCRIPTIVE STUDIES
Descriptive study is the first phase of epidemiological
investigation.
Observing the distribution of disease or health related
events in human population.
Identify the characteristics with which the disease is
associated.
Basically 3 questions are asked WHEN, WHERE AND
WHO i.e. Time, place and person distribution.
9. TYPES OF DESCRIPTIVE STUDIES
Case reports
Case series
Cross-sectional study
10. CHARACTERISTICS OF DESCRIPTIVE
STUDIES
Only one group (sample), no comparison group
No preformed hypothesis regarding association
Objective: Describe the disease/ phenomenon in
persons, places and time
Measures studied: Mean, proportion, rates
Research question descriptive
11. PURPOSE/ WHEN TO CONDUCT?
To describe Natural History of disease
To know magnitude, trend of disease
To describe certain health related variables
To describe the occurrence of interesting episode
Planning & evaluation
To get some clues about cause
12. CASE REPORTS
Detailed presentation of a single case.
Generally report a new or unique finding
✓e.g. previous undescribed disease
✓e.g. unexpected link between diseases
✓e.g. unexpected new therapeutic effect
✓e.g. adverse events
14. HOW TO WRITE CASE REPORT
Case reports should encompass the following five sections:
1. an abstract,
2. an introduction with a literature review,
3. a description of the case report,
4. a discussion that includes a detailed explanation of the
literature review, and
5. a brief summary of the case and a conclusion.
15. Advantages
Useful for hypothesis generation
Informative for very rare disease with few established risk factors
To generate a hypothesis about pathophysiological mechanism
Just your fellow clinicians to be aware that they may come across
this type of clinical manifestation during their clinical practice.
Limitations
Cannot study cause and effect relationships
Cannot assess disease frequency
16. CASE SERIES
Case series is a step ahead of case report, wherein you study a
relatively larger group of patients who have a particular disease for
example, you may study 10 or more patients with some rare type of
cancer or with some rare type of tuberculosis or any other disease
Experience of a group of patients with a similar diagnosis
Cases may be identified from a single or multiple sources
Generally report on new/unique condition
18. WHEN WRITING A CASE SERIES STUDY, THERE
ARE SEVERAL KEY STEPS.
• Decide which type of case report you'll be writing.
• Choose a suitable publication for submission.
• Case study report format.
• Start writing.
• Accumulate Case-Related Data.
• Conclusion
19. Advantages
• Useful for hypothesis generation
• Informative for very rare disease with few established risk factors
• Characterizes averages for disorder
• It helps you to understand whether these kind of findings that they are
observing, are they really due to the disease or is it due to the chance.
• It may help you understand or develop what would be the clinical picture of
patients presenting with a particular type of disease.
Disadvantages
• Cannot study cause and effect relationships
• Cannot assess disease frequency
20. USES OF CASE REPORT & CASE SERIES
Hypothesis generation
Suggesting associations
21. Case Report One case of unusual findings
Case Series Multiple cases of findings
22. CROSS-SECTIONAL STUDY
A cross-sectional study (also known as prevalence study)
is a type of observational study that involves the analysis
of data collected from a population, at one specific point
in time.
Cross-sectional studies are most familiar to us as surveys
Data collected at a single point in time
23. CROSS-SECTIONAL STUDY
An "observational" design that surveys exposures and
disease status at a single point in time (a cross-section of
the population)
Describes associations
Prevalence
A "Snapshot"
25. ADVANTAGES OF CROSS SECTIONAL STUDY
Fairly quick and easy to perform
Less expensive
Extremely useful to know the magnitude, means
how big the problem is
26. LIMITATIONS OF CROSS SECTIONAL STUDY
Not useful to study disease etiology
Not suitable for the study of rare diseases
Major limitation
Prevalent cases (Old and new cases)
Exposure and outcome measured at the same time.
Eg.Diabetes and obesity
27. USES OF CROSS SECTIONAL STUDY
Estimate prevalence of disease or their risk factors
Distribution of health problem by time, place and person
Plan health care services delivery
Set priorities for disease control
Generate hypotheses
Examine evolving trends - Before / after surveys
28. EXAMPLES OF RESEARCH QUESTIONS TO
BE ADDRESSED THROUGH CROSS S
ECTIONALSTUDY
What is the prevalence of hypertension in a city?
How satisfied are patients attending government
hospitals in Chennai?
What is the prevalence of physical inactivity among
school children?
29. WRITING OF CROSS SECTIONAL
STUDY
Step 1: Identification of the Research Problem. ...
Step 2: Recruitment of Participants on the Basis of Inclusion & Exclusion
Criteria. ...
Step 3: Data Collection. ...
Step 4: Data Analysis. ...
Step 5: Estimation of Prevalence. ...
Step 6: Computation of Odd Ratio.
Step 7 Inference of Correlation
Step 8 Report Writing
30. ECOLOGICAL STUDY
This is a study
that you do for groups,
that you can do at a country level,
you can do for populations,
you can do a particular region of the country and
you try to understand a particular problem for a group and
you try to relate problem as well as, what could be the possible
reason, why that problem is occurring also at the group level.
So in this type of study, group is the unit of analysis.
31. PROSTATE CANCER MORTALITY VERSUS SUGAR
CONSUMPTION IN 71 COUNTRIES STUDIED
• Per-capita sugar consumption is an ecological variable
because it is the average measure of exposure to sugar for
all the people in the country. It does not mean that every
person in the country ate exactly the same amount of
sugar.
• Similarly, the mortality rate is a group-level variable
because it represents the country's experience, not any
individual person's experience in the country.
32. ADVANTAGES
You are able to look at a particular population
• Weaker inference, but easier to gather data
• We can generate hypotheses for case-control
studies and environmental studies
• We can target high-risk populations, time-periods,
or geographic regions for future studies
33. LIMITATIONS
• Because data are for groups, we cannot link disease and exposure in
individual
• We cannot control for potential confounders
• Data represent average exposures rather than individual exposures,
so we cannot determine a dose- response relationship
• Caution must be taken to avoid drawing inappropriate conclusions,
or ecological fallacy ("The bias that may occur because an association
observed between variables on aggregate levels does no necessarily
represent the association that exists at the individual level.“)
34. EXAMPLES
1. How many people in the community have high blood pleasure?
2. Brucellosis: a rare cause of the unstable spine
3. In 1 hospital, a subset of patients hospitalized with Escherichia
coli-induced hemolytic-uremic syndrome (HUS) developed
neurologic symptoms during their stay
4. RA: a case report
5. An average intake of fat among people living in a state of
Tamil Nadu
35. REFERENCES
Park's Textbook of Preventive And Social Medicine, K. PARK. 23rd
EDN
Oxford Textbook of Public Health Vol 2. The Methods of Public Health.
Fifth Edn. Detels, Beaglehole, Lansang. Gulliford.
Essentials of Public Health Dentistry (Community Dentistry), Soben
Peter. 5th EDN
Essentials of Dental Public Health. Daly, Batchelor, Treasure,Watt.
2nd EDN
http://annals.org/article.aspx?articleid=745807
http://www.consort-statement.org/consort-statement/flowDiagram
http://www.ebbp.org/course_outlines/randomized_controlled_t rials/
http://medical dictionary.thefreedictionary.com/equivalence+trial
36. TAKE HOME MESSAGES
Case reports and case series are useful for
uncommon clinical manifestations
Cross sectional surveys help to measure the
burden or magnitude of health condition