JPL ( 5-2003)

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 Topic Outline

1. Review of the Research Process

2. Definition of Study Design
3. Factors Affecting Selection of Study
Design
4. Types of Study Designs
a. Non-intervention Studies
b. Intervention Studies

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1. Identify the Research Problem and Objectives
8. Collect the Data

2. Conduct a Review of Related Literature 9. Process the Data

3. Define the Actual Problem and Objectives

in Clear Specific Terms 10. Analyze the Data

4. Formulate the Hypothesis and 11. Write the Research Report

Define the Study Variables

12. Disseminate and Utilize the Result

5. Construct the Research Design

6. Design the Tools for Data Collection

7. Design the Plan for Data Analysis

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Research Design
- a plan, structure and strategy of
investigation so conceived as to obtain
answers to research questions or problems
- It includes an outline of what the
investigator will do from writing the
hypotheses and their operational implications
to the final analysis of the data

Study Design
- is a part of the research design. It is the
design of the study per se
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 Factors Affecting Selection of
Study Designs

Objective of the study

Selection and number of subjects
Instrumentation
Criteria in evaluating the outcome
Internal and External Validity

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 Types of Study Designs

I. Non-intervention / Observational studies

- studies where the subjects were merely
observed and their characteristics are
recorded for analysis

II. Intervention / Experimental studies

- some interventions were performed
- the researcher manipulates a situation
and measures the effects of this
manipulation
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 Types of Study Designs

1. Non-intervention /
Observational studies

Case-Series studies
Case-Control studies
Cross-Sectional studies
Cohort Studies
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 Types of Study Designs

2. Intervention / Experimental studies

Experiments
Quasiexperiments
Before-After Studies

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 Case-Series Studies

- simplest design
- describe certain characteristics of a
group (series) or patients (cases)
- e.g. Herpes Simplex Cases reported as
Herpes zoster in immunocompromised
patients
- short period of time
- do not involve any research hypothesis
but usually lead to the generation of one
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 Case-Control Studies

- begin with the absence or presence of

an outcome and then look backward in
time to try to detect possible causes
Cases - subjects selected on the basis
of some disease or outcome
Controls -without the disease or
outcome.
- history of previous events of both
cases and controls are analyzed
- Retrospective Studies
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 Case-Control Studies
- answer the question:What happened?
Exposed
Cases

Unexposed

Exposed
Controls

Unexposed

Onset of study Time

Direction of Inquiry

- e.g. Study on the relationship of stroke

and recreational drug abuse among in-
patients with acute medical conditions
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 Cross-Sectional Studies

- analyzes data collected on a group of

subjects at one point in time or over a short
period of time
- Prevalence studies
- e.g. Survey, Census, Marketing studies,
survey of database info, meta-analysis
- answer the question: What is happening?
- usually generalizable than case-control
- difficult to separate cause and effect
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 Cross-Sectional Studies

With outcome

Subjects
Selected
For the study Without outcome

Time
Onset of study (No duration of Inquiry)

- e.g. Study on Socio-economic status

and mental illness
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 Cohort Studies

- A cohort is a group of people who have

something in common and who remain part
of a group over an extended period of time.
- ask the question What will happen?
- Researchers select subjects at the onset ;
determine whether they have the risk factor
or have been exposed. Then subjects are
followed over a certain period of time in
order to observe the effect of these defining
characteristics.
- Prospective studies 14
 Cohort Studies

With Outcome

Exposed or subjects
Without Outcome

Cohort

With Outcome
Unexposed or
Controls
Without Outcome

Onset of study Time

Direction of Inquiry

- e.g. Framinghan Study of Cardiovascular

Disease in 1948 15
 Cohort Studies

- may examine cause of a disease or what

happens to a disease over time
- undertaken to identify outcomes from
different therapies
- may use historical info as in the case of
Historical or Retrospective Cohort
e.g. Coronary Bypass outcome and
factors associated with it (study may look
into records)
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Other Classification of Observational Studies
DESCRIPTIVE
Case-series
Cross-sectional
Other qualitative researches (eg.FGD, KII)

ANALYTIC
Case-control
Cohort
HYBRID: Nested Case-control, Ambispective Studies,
Double Cohort Studies
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 Classical Experiments
- subjects are randomly allocated to at least
two groups :
Intervention / Treatment / Experimental
Control group

-Three Basic Characteristics:

Manipulation
Control
Randomization 18
 Classical Experiments

Clinical Trials - experimental studies in

medicine that involve humans
Controlled Trials - studies in which an
experimental group is compared to a control
group
> Parallel or Concurrent Controls
> Self-controlled or Sequential studies
(maybe modified: cross-over design)
> External Control (e.g. Historical)
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 Classical Experiments

Double Blind Trials - neither the subjects

nor the investigators know what group the
subject belongs
Blind Trials - either only the subject or the
investigator knows the group assignment
e.g. Effect of Caffeine on Rats
- Experimental Study design is the only type
of design which can actually prove
causation.
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 Quasiexperiments
- at least one characteristic of a true
experiment is missing, either randomization
or the use of separate control group
- always includes manipulation of an
independent variable that serves as the
intervention
Study group --------- Intervention ----------- Study Group after -----------

(no randomization) Compare

Control group -------------------------------------- Control Group after ---------

e.g. Health Education and Immunization Participation

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 Before-After Studies

- uses only one group in which an

intervention is carried out
Study group --------- Intervention ----------- Study Group
Before after

---------------------- Compare <-----------------------

e.g. Management studies (Waiting time in

hospitals, Insurance Paper processing, Traffic
Schemes)

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Sample Study: HIV Infection and Sexual Practices

Think of a scenario for each study design:

Case-series
Cross-sectional
Case-Control
Cohort
Experimental

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 References
Dawson-Saunders, B. and Trapp, R.G. 1994.Basic and
Clinical Biostatistics. 2nd Edition. USA.Prentice Hall
International Inc.

Kerlinger, Fred N., 1986. Foundations of Behavioral

Research, (3rd ed.) New York, Holt, Rinehart and Winston.

Kumar, Ranjit. 1996. Research Methodology: A Step-by-

Step Guide for Beginners. Melbourne.Addison Wesley
Longman Australia Pty Ltd.

Lozano, J.P. 2002. Lecture notes in research methods.

Ngelangel, C.A. et.al. 2001. PGH Handbook on Medical

Research. Manila. PGH. 24