The term ‘epidemiology’ is derived from three Greek words namely ‘epi’(upon), ‘demos’(people) and ‘logos’(study) collectively meaning ‘study upon people’. This branch of science studies all aspects of human health and diseases. Epidemiology is defined as “the study of the distribution and determinants of health- related states or events in specified populations, and the application of this study to the prevention and control of health problems.”
Observational Studies
In observational studies, frequency and distribution of diseases or
deaths are reported by time (year/month/week/day/hour/season), place
(country/urban-rural/ institutions/hospitals/old age homes/ schools) and
demographic characteristics (age/sex/income/education/occupation/marital
status, religion/caste). Observational studies are categorised into two types –
(i) Descriptive and (ii) Analytical studies. In descriptive studies, only
description about the disease (case reports/case series) is made whereas in
analytical studies (ecological/case-control/ cross-sectional/cohort)
relationship of variables (causative factors) with diseases is described.
1) Descriptive Studies
Descriptive studies are again of two types, case reports and case series.
i) Case Reports
In case reports, cases with unusual symptoms, signs and characteristics or death observed during clinical practice are reported by the clinician’s presentations which are helpful to define new clinical disease/entity. These case reports are useful in clinical practice, formulating hypothesis and explore in epidemiological studies. Example: coagulopathy in patient with renal failure.
ii) Case Series
When new clinical entities/new cases or deaths with common
characteristics, symptoms or signs are compiled by single or group of
clinicians they can be called case series. They are useful for definition of
new cases, to understand the spectrum of symptoms and signs, when followed till
the death of patients which are useful to investigate the natural history of
disease. The data are usually collected from clinicians and sometimes from
populations in case of sudden deaths within a defined geographical area. Data
of case series can be used to know the distribution of disease by place, time,
religion, ethnicity, season and socio-economic status. Acquired immune
deficiency syndrome is defined as new disease after publication of case series
of young men contracted with pneumocystis carinii pneumonia and Kaposi’s
sarcoma. Case series data can be used to formulate hypothesis, easy to collect,
cost effective and quickly available. Case-series data cannot be used to
calculate rates of disease as no denominator is available, involve no
comparison group, suffer from sampling variation and recruit only selective
cases. Example case series on symmetrical acrokeratoderma (dermatosis).
2) Analytical Studies
Analytical studies are of four types :
i) Ecological Studies
In this type of studies, association between disease/outcome frequency and the level of exposure in groups of within or between populations is studied. Population not the individual is the unit in this kind of study. Grouping can be done based on the place (birthplace/residence/factory/school), socio-economic status, time or by mixing place and time. Ecological studies are used for generation of hypothesis. Data from public/private sources, registries/death certifying organizations and earlier surveys can be used. For example, in this type of study, investigating the incidence of cancer in different countries can obtain the details on age distribution and disease status from census data and tumour registries. Example: spatial spread of leprosy in India.
ii) Case-control Studies
These studies investigate the aetiology of disease, suitable for
studying rare and longer duration of (chronic) diseases, cost effective,
require less number of subjects, easy to perform, no risk is done to subjects,
multiple risk factors can be studied at the same time, no dropout of subjects
is observed, has minimal ethical problems and can be completed within short
duration. The unit of study is individual. Newly diagnosed cases are compared
with subjects without disease. Exposure to potential risk factors in both cases
and controls is evaluated by examining case sheets/enquiry of patients or
patient relatives/controls or by performing biochemical tests. These studies
are called retrospective (as the study deals backwards from outcome/disease to
cause) and prospective (if the data collection is still in progress).
Cases are recruited from hospitals/patient registries/cross
sectional study/caseseries/cohort study. Controls are drawn from same
geographic area/spouses/ friends, from same office/factory/institute or
patients diagnosed with other disease from same hospital. Cases and control can
be matched for age, sex, and ethnicity, social class (income, education and
occupation) to reduce selection bias. The association between exposure
(causative agent/risk factor) and disease/outcome is evaluated by Odds ratio.
Demerits of case-control are difficulty in finding suitable controls, subjects
may not be representative of population, prevalence/ incidence or attributable
risk cannot be estimated, efficacy of therapeutics cannot be evaluated, not
possible to distinguish between causative or accompanying factors, suffers from
confounding(due not mismatching of subjects), recall (cases more likely recall
the presence of events), selection (subjects not recruited as per standard
criteria), Berkesonian (recruitment of subjects from sub population than
general population) and interviewer bias. Example: Utility of anthropometric
traits and indices in case-control study.
iii) Cross-sectional Studies
In these studies, both exposure and outcome (disease) are
investigated at the same time. No temporal associations between exposure (risk
factors) and outcome can be explained. The unit of the study is individual.
These studies are useful for investigating chronic diseases and fixed exposures
such age, gender, ethnicity and genotype, to study multiple risk factors
simultaneously. These studies are easy to conduct, give inputs on burden of
disease which can be used for planning health infrastructure, allocating
resources and manpower. It is inexpensive and can be completed within a short
period of time. If cross sectional study is repeated on the same population it
can serve as cohort study and if repeated on independent sample, it is useful
to investigate the trends of the disease. For variable exposure, data on past
and present exposures are recorded.
The target population is studied using representative population
and the results are extrapolated to this population. These studies are also
called prevalence studies. If prevalence is standardized using the data of
standard populations, the prevalence can be compared with other populations.
Both disease and determinants can be studied in this type of studies. To avoid
sample bias, random sampling techniques are used such as simple, systematic,
clustered, stratified, multistage and mixed. The denominator is usually the
population at risk or total population studied. Prevalence is presented a per
cent or per 1000 subjects. Prevalence studies are of three types depending on
the time involved. They are point, period and lifetime prevalence.
Prevalence studies are not suitable for studying the natural
history of disease and to estimate the incidence. Subjects deceased or with
severe disease are missed out in these studies. It is not possible to
distinguish whether risk factor or exposure precedes the outcome/disease or
exposure is resulted from the outcome. If investigator fail to gain the
confidence of subjects which results in high nonresponse rate resulting leading
to selection bias. This type of study design is not suitable for rare diseases.
A statistical technique called Logistic regression analysis can be used to find
the association between risk factors and disease. Example: Prevalence of
coronary artery disease and coronary risk factors in Tirupati urban population.
iv) Cohort Studies
These studies are called incidence/longitudinal studies. Cohort
means group of population. Groups can be formed based on the date of birth
(birth cohort), date of marriage (marriage cohort), decade (decade cohort),
occupation (doctors/ lawyers/engineers/teachers), city population (Example:
Delhi) etc. Subjects of cohorts have common
characteristics/experience/condition. A group is assigned for the study, and
exposed and non-exposed cohorts within the same group are identified and
followed for particular period. If exposure is rare, this cohort is compared
with external cohort matching all characteristics except exposure. Same cohort
can be divided into subgroups based on level of exposure and outcome.
Diagnostic criteria for outcome of interest are decided at the beginning of the
study. Baseline data is collected from cross sectional studies, census and
birth registries. Data on exposure are collected by conducting interviews,
contacting subjects on mobile/through e-mail, examination of case sheets,
conducting of diagnostic tests and environmental surveys such as air or water
quality. Subjects with disease are excluded from this study. Both exposed and
non-exposed cohort subjects are evaluated periodically on clinical status,
performing diagnostic tests, reviewing cash sheets and visiting the subjects
for examining the end points (outcome/disease/death) of study. Presence of
outcome/disease/death is compared between exposed and non-exposed cohorts.
Incidence rates, relative risk (measure of evaluating the strength of association
between exposure and outcome), attributable risk (what extent disease is due to
exposure) and population attributable risk (suggest to what extent disease is
reduced if the exposure is eliminated) are determined and compared between both
cohorts. Cohort studies are of three types namely prospective (outcome occur
after initiation of the study), retrospective (outcome occurred before the
initiation of the study) and mixed (outcome occurred before the initiation of
study which is further assessed prospectively). If the newly identified cases
in the cohort study if compared with control of the same cohort, it is called
nested case-control study. Example for Prospective cohort study of overweight
and obesity in rural population of West
Bengal, India and for retrospective cohort study example is maternal and
neonatal outcome of gestational diabetes in the subjects of Kerala; Mixed
cohort study example is retrospective and prospective cohort study on HIV sero
status and incident pneumonia
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