EPIDEMIOLOGICAL STUDY

METHODS

Dr. Obaid
M. Phil. Pharmaceutics
 Introduction

• The science of epidemiology has matured significantly from the

times of Hippocrates and John snow that the techniques for
analyzing data vary depending on the type of diseases being
monitored.
Classification
Classification
 Observational vs Experimental Studies
Observational studies
• Allow nature to take its cause; the investigator measures but
does not intervene

• Descriptive study: focuses on the description of the occurrence

of a disease in a population.

• Analytical study analyses relationships between health status

and other variables
 Experimental Studies

• Experimental or interventional studies: involve an active attempt

to change a disease determinant(e.g an exposure or a
behaviour) or the progress of a disaese (through treatment).

• The studies are based on a group which has had the

experience compared with control group which has not had the
experience.
 Purpose Of Descriptive Epidemiology
• To generate hypothesis
• To permit evaluation of trends in health & disease and
comparisons among countries and subgroups within countries.
• To provide a basis for planning, provision and evaluation of
health services
• To identify problems to be studied by analytical methods and to
suggest areas that may be fruitful for investigation
 Case Studies (Case Series)

• Case reports:documents unusual medical occurrence and can

represent the first clues to the formulation of hypothesis,
generally report a new or unique findings and previous un-
described disease.

• Case series: collection of individual case reports which may

occur within a fairly short time, and experience of a group of
patients with similar diagnosis.
 Case Series

Advantages
Useful for hypothesis generation
Informative for very rare disease with few established risk
factors
Usually of short duration.

Disadvantages
Cannot study cause and effect relationships
Cannot assess disease frequency
 Case Studies (Case Series)

•A patient in Zimbabwe had serious

chest pains, after taking x-ray at
When General
Rusape he got to India the
hospital another
image x-ray was taken and was
showed that he
told there was had a live in his chest but the
no cockroach
cockroach in his chest moving
cockroach was in the x-ray machine they used in
about.
Zimbabwe.
• Doctors recommended that he
goes abroad preferably India. So
patient had to sale his house and a
few contributions from relatives.
 Medication Safety: A Case
 A 65 years old man was admitted to
hospital with uncontrolled Hypertension
and Type II Diabetes Mellitus.

 Lab Diagnostics:
 RBS = 16.4 mmol/L, HbA1c = 11%,
Total Cholesterol = 8.5 mmol/L,
Creatinine = 185 µmol/L , Uric Acid =
446 µmol/L, BP = 210/110 mmHg.

 Patient was discharge after 4 days with

stabilize BP and blood sugar level and
was advised appointment at primary care
Medication Prescribed after Discharge
set up.

 This treatment plan was suggested for the

patient.
 Medication Safety: A Case
 Patient visited the primary care center as
per scheduled appointment.

 Lab Diagnostics:
 BP = 140/80 mmHg, FBS = 10
mmol/L, Total Cholesterol = 7.0
mmol/L, Creatinine = 155 µmol/L, Uric
Acid = 450 µmol/L.

 Allopurinol was added to the treatment

regimen to control the increased levels of
uric acid.

Medication Prescribed at primary care center

WHAT HAPPENED NEXT?

 Medication Safety: A Case
 The patient developed severe skin
rashes that progressed into blisters
two days after taking allopurinol.

 The patient did not seek treatment as

initially it was considered as ‘chicken
pox’ by himself. As the condition
worsen, family members brought him
to the emergency department.

 In the hospital, the patient was

diagnosed with Stevens Johnson
syndrome (SJS).

 Unfortunately, the patient died a week

after the development of SJS.
 Cross-Sectional Study

• It is also called epidemiologic study or prevalence study

• It analyses (describes)data collected on a group of subjects at

one point in time rather than over a period of time. i.e they

survey exposure and disease at a single point in time.

• Both exposure and outcome variables are been evaluated at

the same point in time(without any inbuilt directionality)

• It answers the question “WHAT IS HAPPENING RIGHT NOW?”

 Cross-Sectional Study

ADV DISADV
• Best for determining the • Only a snapshot at a
status quo (prevalence) time leading to a
• Quick misinformation
• Relatively inexpensive • Response rate may
be low ,with result not
representative of the
population
 Correlation Study Design

• A study comparing incidence/prevalence of one event against

another on a global scale
• Measures that represent characteristics of entire populations
are used to describe the disease in relation to some factor of
interest (such as age, calendar time, food consumption, drug
use and utilization of health services)
 Analytical Studies

Two basic designs:

• Case – control or retrospective study
• Cohort or prospective

NOTE
• There must be a comparison group
• No control : No conclusion (NCNC)
 Case Control Or Case History Study
• A group of affected people is compared to unaffected
people(the control)
• Subjects are selected based on a particular outcome and
a study backwards in time to try to detect the causes or
risk factors that may have earlier been reported in a
descriptive study
• Subjects are then matched and assigned into the two
groups. Subject selected on the basis of disease [e.g lung
cancer].
• Sometimes called a retrospective study because of the
direction of study.
Effect of potentially modifiable risk factors associated
with myocardial infarction in 52 countries
INTERHEART study): case-control study
 The study

Objective
• Although more than 80% of the global burden of cardiovascular
disease occurs in low-income and middle-income countries,
knowledge of the importance of risk factors is largely derived
from developed countries. Therefore, the effect of such factors
on risk of coronary heart disease in most regions of the world is
unknown.
 The study
Methods
• We established a case-control study of acute myocardial
infarction in 52 countries, representing every inhabited
continent. 15152 cases and 14820 controls were enrolled. The
relation of smoking, history of hypertension or diabetes,
waist/hip ratio, dietary patterns, physical activity, consumption
of alcohol, blood apolipoproteins (Apo), and psychosocial
factors to myocardial infarction are reported here.
 The study
Findings
• Smoking (odds ratio 2·87 for current vs never), raised
ApoB/ApoA1 ratio (3·25), history of hypertension (1·91,),
diabetes (2·37), abdominal obesity (1·12) psychosocial factors
(2·67), PAR 32·5%), daily consumption of fruits and vegetables
(0·70), regular alcohol consumption (0·91) and regular physical
activity (0·86) were all significantly related to acute myocardial
infarction.
 The study
• These associations were noted in men and women, old and

young, and in all regions of the world. Collectively, these nine

risk factors accounted for 90% in men and 94% in women.

 The study
Interpretation
• Abnormal lipids, smoking, hypertension, diabetes, abdominal
obesity, psychosocial factors, consumption of fruits, vegetables,
and alcohol, and regular physical activity account for most of the
risk of myocardial infarction worldwide in both sexes and at all ages
in all regions. This finding suggests that approaches to prevention
can be based on similar principles worldwide and have the
potential to prevent most premature cases of myocardial infarction.
 Advantages Of Case Control
• It is relatively easy to carry out bcos we go back to existing
records in the hospital
• It is also rapid and inexpensive
• It requires comparatively few subjects
• It can assist one in studying different etiological factors
• There is no risk to the subject
 Disadvantages Of Case Control

• It introduces bias
• To select an appropriate control could be difficult
• It may be difficult to distinguish between the cause of a disease
and an associated factor
 Cohort Study
• A cohort is a group of people who have something in common
and remain part of a group over an extended time
• A group of people exposed to a suspected etiological agent are
compared with a matched control who have not been similarly
exposed. Subject selected on the basis of exposure
[aetiological factor; cigarette smoking]
• Follow-up over a period to compare the outcome
 Cohort Study
• A study design where one or more samples (called cohorts) are
followed prospectively and subsequent status evaluations with
respect to a disease or outcome are conducted to determine
which initial participants exposure characteristics (risk factors)
are associated with it. As the study is conducted, outcome from
participants in each cohort is measured and relationships with
specific characteristics determined
 The study

Do Bullied Children Get ill, or Do ill Children Get

Bullied? A Prospective Cohort Study on the
Relationship Between Bullying and Health-
Related Symptoms
 The study
OBJECTIVES.
• A number of studies have shown that victimization from bullying
behavior is associated with substantial adverse effects on
physical and psychological health, but it is unclear which comes
first, the victimization or the health-related symptoms. In our
present study, we investigated whether victimization precedes
psychosomatic and psychosocial symptoms or whether these
symptoms precede victimization.
 The study

• DESIGN. Six-month cohort study with baseline measurements

taken in the fall of 1999 and follow-up measurements in the
spring of 2000.
• SETTING. Eighteen elementary schools in the Netherlands.
• PARTICIPANTS. The study included 1118 children aged 9 to 11
years, who participated by filling out a questionnaire on both
occasions of data collection.
 The study
OUTCOME MEASURES.
• A self-administered questionnaire measured victimization from
bullying, as well as a wide variety of psychosocial and
psychosomatic symptoms, including depression, anxiety,
bedwetting, headaches, sleeping problems, abdominal pain,
poor appetite, and feelings of tension or tiredness.
 The study
• RESULTS.
• Victims of bullying had significantly higher chances of
developing new psychosomatic and psychosocial problems
compared with children who were not bullied. In contrast, some
psychosocial, but not physical, health symptoms preceded
bullying victimization. Children with depressive symptoms had a
significantly higher chance of being newly victimized, as did
children with anxiety.
 The study
CONCLUSIONS.
• Many psychosomatic and psychosocial health problems follow
an episode of bullying victimization. These findings stress the
importance for doctors and health practitioners to establish
whether bullying plays a contributing role in the etiology of such
symptoms.
• Furthermore, our results indicate that children with depressive
symptoms and anxiety are at increased risk of being victimized.
Because victimization could have an adverse effect on
children's attempts to cope with depression or anxiety, it is
important to consider teaching these children skills that could
make them less vulnerable to bullying behavior.
 Advantages Of Cohort
• There is no bias
• The risk can be calculated because the incidence can be
calculated
• It is effective for studying rare exposures
• It allows the study of the natural history of the disease
• It assists in determining the temporal relationship between the
etiological factor & the disease
 Disadvantage Of Cohort Study

• It takes a long time

• It is expensive
• Large no of subjects are needed
• There could be changes in the standard methods or diagnostic
criteria
 Experimental Studies
• Studies in which 1 group is deliberately subjected to an
experience compared with a control group with no similar
experience
• The gold standard in medicine because it proves causality
• Can be controlled or uncontrolled
 The study
Effects of Pharmacist Led Patient
Education on Diabetes Related
Knowledge and Medication
Adherence – a Home-based Study
 The study
Objective:
• Patient education is a key component for the management of
acute and chronic conditions. However, the majority of such
educational interventions are reported from healthcare settings.
The present study therefore, aims to evaluate whether a home-
based intervention can result in better understanding about
Type 2 diabetes mellitus and can increase adherence to
prescribed medications.
 The study
• An experimental trial was conducted whereby participants
received a home-based educational intervention through a
registered pharmacist. One hundred and fifty patients were
randomly assigned to two groups (75 patients in each arm).
Diabetes knowledge and medication adherence were measured
by means of the 14-item Michigan Diabetes Knowledge Test
and 8-item Morisky Medication Adherence Scale respectively.
 The study
• Results: No significant differences were observed in either
group for demographic variables. There was, however, a
significant increase in the participants' levels of knowledge
about type 2 diabetes mellitus and medication adherence
among the home-based intervention group at the completion of
the intervention (p < 0.001). Significantly lower HbA1c levels
were also observed among the home-based intervention group
after completion of the intervention.
 The study
Conclusions:
• A pharmacist-led home-based intervention can significantly
increase disease-related knowledge and medication adherence
in patients with type 2 diabetes mellitus. Home-based
interventional programmes offer a promising method of patient
education and counselling.
 Experimental Studies
ADV DISADV
• Best study type • Greatest expense
• Greatest proof of • Long duration
causality • Unproven facts adopted
• Gold standard for other by community can hinder
design study acceptance
• Least bias
• Proves best procedure
efficacy
 Conclusion
“What you cant measure you cant
control!”epidemiological study methods are
used to study your health and my health and its
determinants, as we join hands to ensure a
healthier us.