PUBLIC HEALTH AND
EPIDEMIOLOGY
Sebin C Sebastian
B.optom, M.optom, (PhD Scholar)
Assistant Professor & consultant
Optometrist Sankara college of Optometry,
Sankara Eye Hospital Ludhiana
• Pandemic: A disease or condition that spreads across the region
• Rate: Number of cases occurring during a specific period, always
dependent on the size of the population during that period.
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Knowledge Check
• 1) Malaria is present in Africa at all times because of the presence of
infected mosquitoes. Malaria is------------in Africa
• endemic
• 2) The Ebola virus in parts of Africa is in excess of what is expected for
this region. This virus is---------
• Epidemic
• 3) HIV is one of the worst global diseases in history, it is a-------------
• pandemic
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Common Measures
•Ratio
•Proportion
•Odds
•Rate
•Prevalence
•Incidence
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•Ratio
•Proportion
•Rate
• What, who is in the denominator ?
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Ratio
•The quotient of 2 numbers
•Numerator NOT INCLUDED in the denominator
•Allows to compare quantities of different nature
= 5 / 2 = 2.5 / 1
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• Ratio, Examples
•# patients per doctor
–850 patients /10 doctors
–R = 85 patients for 1 doctor
•# students per each room in the hostel
•Sex ratio: Male / Female
•Odds ratio
•Rate ratio
•Prevalence ratio
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Proportion
•The quotient of 2 numbers
•Numerator INCLUDED in the denominator
•Quantities have to be of same nature
•Proportion always ranges between 0 and 1
•Percentage = proportion x 100
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• Proportion, Example
•Proportion of students who can speak Hindi in 3rd
year?
–100 students, 9 Speak Hindi
–Proportion of Hindi speaking students = 0.09
–Percentage of Hindi speaking students = 9%
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ODDS Ratio
• An odds ratio is the odds of the event in one group, for example those
exposed to a drug divided by the odds of the event in another group
not exposed.
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Diseases No diseases
Exposed a B
Unexposed c d
Odds of exposure in cases
= case with exposure/case without exposure
= a/c
Odds of exposure in controls
= controls with exposure/controls without exposure
= b/d
Odds of exposure in cases /odds of exposure in controls
a/c ad
--------- = ------------
b/d bc 11
Rate
• The quotient of 2 numbers
• Speed of occurrence of an event over time
• Numerator
-number EVENTS observed in a given time
• Denominator
-population in which the events occur (population at risk)
-includes time
• Observed in 2013
2
• ----- = 0.02 / year
• 100
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Prevalence
•The proportion of a population that has a disease or health-
related condition during a specific time.
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•Prevalence proportion with condition
•Example
–1000 men aged 40 – 59
–100 have had presbyopia
• – Prevalence = 100 / 1000 = 0.1, or 10%
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Incidence
• Among the same group of adults, 3,080 reported not smoking
• They were followed for the year.
• The number who began smoking during the follow up period
was 250.
• Calculate 1-year incidence of cig. smoking in this population
???
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Incidence
•Incidence = new cases in one year /population at risk in year
• = 250/3080 = 0.081
or 0.081x100=8.1%
• 1 year incidence of smoking in this population is 8.1 %
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Epidemiological Study design
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What is epidemiology?
Epidemiology is the study of the distribution and determinants of
disease frequency and health-related events in the human population
and the application of this study to control health problems
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Epidemiology Key Terms
• Epidemic: Disease occurrence among a population that is in excess of
what is expected in a given time and place.
• Cluster: Group of cases in a specific time and place that might be
more than expected
• Endemic: Disease or condition present among a population at all
times
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Descriptive vs. Analytic
•Descriptive epidemiology evaluates all the circumstances
surrounding a person affected by a health event of interest
•Analytical epidemiologists use data gathered by descriptive
epidemiology to suggest causation
•Goal of both branches is to reduce incidence of health events
or disease by understanding the risk factors
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Descriptive studies
• Main features
•Do not have a comparison (control) group
•Often provide first insight into a new area of medicine
•Describe the frequency, natural history, and possible
• determinants of a condition
•Hypothesis generation about the cause of the disease
•They do not allow assessments of causal association
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Descriptive vs. Analytic
•Descriptive epidemiology describes patterns and trends
of disease, injury or death. (distribution)
•Analytic epidemiology studies the causation of disease,
injury, or death. (determinants)
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Descriptive studies
•Answers the five basic W questions:
• Who, what, why, when, where
•Who has the disease in question ?
•What is the condition or disease being studied ?
•Why did the condition or disease arise ?
•When is the condition more common ?
•Where does or does not the disease or condition arise?
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Experimental Study Designs
• Involve the investigator intervening in some way to affect the
outcome
• Experimental studies provide the most convincing evidence for
any hypothesis
• Possible to control for factors that may affect the outcome
• Not always feasible or, if they involve humans or animals, may be
unethical.
• Examples: RCT, Animal studies or laboratory studies
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Observational Study Designs
• Investigator does nothing to affect the outcome, but simply
observes what happens
• May provide less information than experimental studies
• No possible to control for all factors that affect the outcome
• In some situations, they may be the only types of study designs
that are possible
• Example: Epidemiological studies in the population
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Cross sectional studies
•Cross sectional studies measure disease and exposure
simultaneously in a well-defined population
•Repeated cross-sectional studies may be carried out at
different time points to assess trends over time
•Cross sectional studies provide Point prevalence hence
helpful to plan public health strategies
•Also called as “Surveys”
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•Examples:
•Andhra Pradesh Eye Disease Study
•Beaver Dam Eye Study
•Rotterdam Study
•Blue Mountains Eye Study
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•The selection bias classic for cross-sectional studies is “the
healthy worker effect.” i.e., only “healthy workers” are
available for study, distorting the findings.
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• Advantages
•Prevalence studies cut across the general population
•They are good for identifying the prevalence of common
outcomes
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Cohort Studies
• A major limitation of cross-sectional surveys and case-control
studies is difficulty in determining if exposure or risk factor
preceded the disease or outcome.
• Also called
•Prospective observational study
•Exposed - Unexposed study
•“ What will happen to me ?” study
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• Cohort : A group of individuals that who share a common
characteristic.
• Birth cohort : All individuals born in a certain geographical area
in same period
•Inception cohort : All individuals assembled at a given point
based on some factor
•e.g..Where they live or work
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• Exposure cohort : Individuals assembled as a group based on
some common exposure.
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Types of Cohort Studies
• Depending on the temporal relationship between the initiation
of the study and the occurrence of the disease, cohort studies
can be classified as:
•Prospective
•Retrospective
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•Retrospective cohort study
•Both the exposure have already occurred when study is initiated
•Example: Finding medical records to follow a cohort of people born
in 1950 and get the causes of death
•Prospective cohort study
•Exposure may or may not yet occurred at the beginning of the
study, outcome of interest have not occurred when study is
initiated
•Example:Women’s Health Study
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Case Control Studies
• Other names
•Case-history study
•Retrospective study
•Case comparison study
•Case referent study
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Case Control Study
• A design used to assess the relationship between the exposure to
a risk factor and development of the disease
• Looking back from a disease/outcome to risk factors
• “Why does an outcome occur?”
• Retrospective search and a method of reasoning to understand
the basic nature of the outcome
• It compares the exposure distributions between the groups of
patients with and without disease
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• Cases - individuals suffering from a particular disease or
condition
• Controls - individuals who do not have the disease or condition
• Prevalence of exposure in cases and in controls is compared
• Higher prevalence in cases – Risk factor
• Lower prevalence in cases – Protective factor
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Why RCT?
• ”Gold standard” in epidemiological research
• Makes study groups comparable
• Controls for confounding (known and unknown)
• Prevents selection bias
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•Self selection (lack of comparability)
•Observer bias
•Secular trends (e.g., before and after study)
•The RCT provides the “gold standard” for proof of concept
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•A RCT is a planned experiment designed to asses the efficacy
of an intervention in human beings
•Comparing the intervention to a control condition
•The allocation to intervention or control is determined
purely by chance (randomization)
•RCTs are a subset of possible experimental designs
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When is it unethical to randomize?
•Known effective treatment
•Personal choice
•Cannot randomize very different interventions
•Risks of new treatment likely to exceed risks of existing
treatment
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• An epidemiologist is doing a study on the sleep patterns of college
students but does not provide any intervention. What type of study is
this?
• Observational
• A study of heart disease comparing a group who eats healthy food
and exercises regularly with one who does not in an effort to test the
association
• Analytic
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• A study to describe the eating habits of adolescents aged 13-18years
in a community
• Descriptive
• Subjects with diabetes are compared with subjects without diabetes.
• Case control
• A study of women aged 50-60 years in a community located close to a
nuclear power facility
• Cross sectional
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• Subjects who have received nutritional counselling and who have
exercised twice a week are compared with subjects who have not.
• Cohort
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Blinding
•Blinding is done to minimize participant or observer bias
•Double blinding (neither observer or participant know the arm
of randomization)
•Single blinding (observer but not participant knows the arm of
randomization, e.g., cluster-level trials)
•Unblinded (cannot conceal randomization, e.g., Surgical
interventions)
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Validity
Expression of degree to which a test is capable of measuring what
it is intended to measure
The extent to which the results of a study apply to the population
at large - External validity
The degree to which the results of an observations are correct for
a particular group of people being studied - Internal validity
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Threats to validity
• A study’s internal validity, or how close its findings are to the
TRUTH, can be compromised by three things….
•Chance
•Bias
•Confounding
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Threats to Validity - Chance
•The unpredictable and uncontrollable element of an event or
occurrence
•How likely is it that an association between an exposure and
disease is the result of a random set of events
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Threats to Validity - Bias
•Any systematic error in a study that leads to an incorrect
estimate of the association between exposure and disease
•It can occur in the design, implementation, or analysis stages
of a study
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Bias
•Any trend in the collection, analysis, interpretation,
•publication or review of data that can lead to conclusions that
are systematically different from the truth (Last, 2001)
•A process at any state of inference tending to produce results
that depart systematically from the true values
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Chance vs Bias
•Chance is caused by random error
•Bias is caused by systematic error
•Errors from chance will cancel each other out in the long run
(large sample size)
•Errors from bias will not cancel each other out whatever the
sample size
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Bias
•In general, bias is a result of an error in the design or
implementation of a study
•Main types of bias
– Selection bias
– Information bias
• - misclassification bias
• - recall bias
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Selection bias
•Selection Bias: Error due to a systematic difference
between those selected for a study and those NOT selected
for a study
•Selection bias can occur because study population is not
representative of target population
•Distorts the true strength of association
•Can occur in both case-control and cohort study designs
–difference in way cases vs. controls selected
–difference in way exposed vs. non-exposed selected
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Examples of selection bias
• - People act differently if they are being watched
•Healthy worker effect
• - Only healthy people are able to remain in employment, while
general population is made up of wide range of people,
including ill.
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Controlling for selection bias
•In a case-control study…
–pick controls whose eligibility for inclusion in the study is the
same as cases
–pick controls who have the same opportunity for exposure
as cases
–pick controls who have same access to being diagnosed for
the illness or disease as cases
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Information bias
• Information Bias: a flaw in measuring exposure or outcome
data that results in a differing quality (accuracy) of
information between comparison groups
•Also called Observation Bias
•Distorts the true strength of association
•Occurs in all study designs but often described as RECALL
BIAS in case-control studies
•The way information is extracted from medical forms
•– cases or exposed subjects may have more medical records
or more detailed records
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Controlling for information bias
• Blinding
•prevents investigators and interviewers from knowing the case/control
or exposed/non-exposed status of a given participant
• Form of survey
•mail may impose less “white coat tension” than a phone or face-to-face
interview
• Use multiple questions that ask the same information
•Acts as a built-in double-check
• Multiple checks in medical records
•Gathering diagnosis data from multiple sources
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Controlling for information bias
•Training observers and use of standard protocols
•Replace human judgment with automated procedure,
wherever possible
•Clear protocols
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Recall Bias
•Recall Bias - systematic error due to differences in accuracy or
completeness of recall to memory of past events or
experiences
•Its a form of information bias
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•Specifically important in case-control studies
–when exposure history is obtained retrospectively
–cases history looking for ways to explain their illness
–controls, not feeling a burden of disease, may less closely
examine their past history
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Misclassification bias
• Misclassification Bias: the erroneous classification of an
individual, a value, or an attribute into a category other than
that to which it should be assigned
•Often results from an improper “cutoff point” in disease
diagnosis or exposure classification
•It can be differential or non-differential
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•Differential Misclassification Bias
–rate of misclassification differs between study groups
(case/control or exposed/non-exposed)
–can lead to an apparent (false) association
–can fail to detect an existing (true) association
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Confounding
•Confounding - English word combining the idea of confusion
and lack of success.
•Statistically - Estimated association is not the same as true
causal effect.
•Finding association for the wrong reason
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• A third factor that is related to both exposure and
outcome, and which accounts for some/all of the observed
relationship between the two
•Influence the relationship between an exposure variable and
a disease outcome variable
•Confounder is not a result of the exposure
•Potentially anything outside of the two main variables being
assessed
Examples: age, sex, BMI, smoking status, etc.
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Revision
• What are Confounders
• What do you mean by incidence and prevalence?
• What is meant by Bias?
• What are the various steps for minimizing Bias?
• What is an odds ratio
• What are the types of cohort studies?
• What is blinding and explain the different types
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Assignment
• Find out the prevalence of eye diseases/condition, which include
cataract, Diabetic Retinopathy, Amblyopia, presbyopia and childhood
blindness
• Last date of submission
• 1-10-23
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Clinical Trail
• Experiment's using humans were conducted over the centuries,
however the era of modern clinical trails in medicine did not begin
until the early 1930s with the first reports of randomized treatment
assignment and the creation of the Therapeutic Trails committee
appointed by the medical research council of Britain.
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• Phase 1: Clinical trails involve the first application of a new drug to
humans. These studies typically are conducted in 20 to 80 healthy
volunteer subjects.
• The main goal of phase 1 trails is to determine the metabolic and
pharmacological actions of the drug, the side effects associated with
increasing does.
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• Phase-2: Clinical trials are conducted to obtain preliminary data on
the effectiveness of a drug in patients with the targeted disease or
condition
• Phase 2 trails may incorporate a comprising group or no control
patients, The patients participating in trails are closely monitored for
short-term side effects.
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• Phase-3: Clinicals trail usually involve patients with the targeted
disease or condition who are randomly assigned to the new drug or
an appropriate control treatment.
• Based on preliminary evidence of efficacy in phase2 trails, phase 3
trails are designed to gather the additional information about
effectiveness and safety that is needed to evaluate the overall risk
benefit relationship of the drug
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What type of phase?
• Clinical trials are conducted to obtain preliminary data on the
effectiveness of a drug in patients with the targeted disease or
condition
• Phase 2
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Key Design Elements
• Objective of the trail
• Treatments /innervations
• Study population
• Treatment assignment
• Outcome measures
• Follow up
• Sample size
• Masking and other practices to strengthen trail design
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Objective of the trail
• A new drug may be promising for slowing lens opacification.
• The initial objective of the clinical trial may be to evaluate whether
the administration of the drug is beneficial.
• Designers of the clinical trial may decide that a least 3 years of daily
administration is necessary to have an impact on the lifelong process
of cataract formation.
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Treatments/ Interventions
• Choice of comparison group:
• Once the decision has been made to evaluate a particular treatment,
the most appropriate comparison group needs to be chosen.
• The clinical trial involving drugs in liquid, tablets, or capsule form,
topical eye drops, and ointments should have placebos given to no
treatment group. Care needs to be taken to ensure that the placebo
and test medication appear identical.
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• Standardization of treatment
• Patient management in each treatment group, including groups
assigned to observation, needs to be explained.
• For medications, the schedule of administration, the schedule of
administration, and the duration of use need to be specified.
• For laser treatment specify the number, location, intensity, power,
and duration of laser burn application.
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Study population
• The participants in a clinical trail should be representative of the
patients to whom the results are intended to apply.
• The desirable property of including a broad group of patients with a
particular eye condition so that the results can be applied widely
competes with the desirable property of including only those patients
who are likely to benefit from the treatment.
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Outcome measures
• Outcome measures are qualitative or quantitative measures of the
characteristics of the patient that the study treatments may affect.
• In most clinical trials one outcome measure is designed as the
primary outcome measure because it best captures the intended
effects of the treatment.
• Other outcome measures because they supplement the primary
outcome measure in evaluating the treatment fully.
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Follow up
• Follow-up examinations should be proportional to the rate of change
expected in the eye condition as characterized by the outcome
measures.
• For conditions such as bacterial keratitis that usually either progress
or heal completely within a few weeks, examinations need to be
every few days initially, and then tapered over 4 or 6 weeks to obtain
a final status.
• Alternatively, in a prevention trail of a slowly progressive disease
such as glaucoma, the duration of follow up needs to be 6 months or
12 monthsS
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Sample size
• For clinical trails designed to detect difference between treatment
groups, the number of patients needed for analysis depends on key
quantities
• The minimum size of the difference on the primary outcome
measure believed to be clinically meaningful
• The standard deviation of the primary outcome measure in the
patient population to be studied
• The type 1 error level (null hypothesis when its actually true) to be
used for statistical testing in the final analysis
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Masking
• Clinical trails incorporate many procedure to maintain bias.
• Masking patient, evaluators, and those managing patient care to the
assigned treatment group.
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Screening
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Introduction
• Screening is an important weapon in the armoury of prevention,
whether it be primary prevention (preventing) the occurrence of
diseases), secondary (preventing the effect of disease), tertiary
(restoring function lost as a result of disease).
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Vision Screening
Screening:
• A systematic search to identify
• those people that are unaware as to having, or
• those people who are considered at high risk of
developing a specific disease, defect or significant deviation from the “normal”
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Bias in Observational studies
• Two particular forms of bias may arise in the evaluation of screening,
namely lead time bias and length bias.
• Lead time bias
• Occurs when a disease is detected by a screening at an earlier time
point then it would have been if it had been diagnosed by its clinical
appearance
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Objectives of a Screening Program:
• Prescriptive screening: Offer treatment or compensatory
measures to those identified
• Investigative screening: To gather information about a
disorder for epidemiological study
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Factors Determining the Success of a Screening Program
• Establishing the need for screening
• Determining the design of the program
• Evaluating the performance of the screening procedures and
program implemented
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When should we screen for an ocular disorder?
• The disorder is asymptomatic
• The disorder is prevalent in the community
• The condition is treatable
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Determining the Design
• Ideally a screening program should be able to identify all those with
the disorder and thus all those without, which is not always possible
• We seek the highest accuracy in identifying those with the disorder
Key considerations for choice of design
• Test and testing procedures
• Examiner
• Economic considerations
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Evaluation of a Screening Program
• Ensures accuracy, effectiveness and efficiency
• Measured in terms of reliability and validity
• Reliability: Measure of repeatability
• Validity: Measure of the accuracy of the results of screening
tests compared to the true health status determined for each
individual in the population
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• Measures of validity
• Sensitivity: Accuracy in identifying individuals with the
disorder
• Specificity: Accuracy in identifying those who do not have a
disorder
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YIELD
• Measure of the number of previously unrecognized cases of a
particular disorder diagnosed and treated as a result of
implementing screening procedures
• Factors impacting on the yield:
• sensitivity of screening procedures, prevalence of a disorder
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Sensitivity (detection rate):
• Proportion of people with the disease or condition that test correctly
identified
Specificity (true-negative rate):
• Proportion of persons who are disease-free that the test identifies as
normal
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Positive Predictive Value
• The probability of being disease-positive if the test is positive
Negative Predictive Value
• The probability of being disease-negative if the test is negative
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• E.g.: School screening for myopia
• Number with myopia and picked up by screening
• Number without myopia but screened as positive
• Number with myopia but not detected through screening
• Number without myopia and screening reveals no myopia
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The evaluation of cataract programs
• Indicators to monitor the outcome of cataract programs
• It is important to define the management area for which relevant
data will be collected
• In India, for example, a district with an average population of around
2 million people, has been selected as a management unit for District
Blindness Control Society.
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• The main indicators in this schedule are the prevalence of cataract
blindness, Cataract surgical coverage (CSC),
Cataract surgical rate(CSR)
Prevalence of cataract blindness
The prevalence is obtained through a prevalence survey or specially
designed rapid assessment for cataract surgical service (RACSS).
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Cataract surgical coverage (CSC)
• It is an impact indicator, measuring the proportion of operable
cataract cases that have been operated on in a defined population at
a particular point in time.
• Operable cataract can be defined as cataract where both the patient
and eye surgeon agree that cataract surgery indicated.
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• The RACSS software package calculates csc automatically for eyes and
for people, with visual acuity <3/60, <6/60, and <6/18.
• The visual acuity in the operated eye or in the better eye at the time
of surgery is not known.
• It is assumed that people with the worst vision are operated upon
first, but that does not always happen in practice.
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• Therefore the CSC for visual acuity <3/60 may be overestimated
when patients with a preoperative visual acuity better than 3/60 have
also been operated upon.
• CSC(PERSON)=(x+y/x+y+z) x100
• x=number of persons with unilateral pseudophakia and operable
cataract in other eye,
• Y=number of person with bilateral(pseudo) aphakia
• Z=Number of person with bilateral operable cataract
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• CSC(EYE) = (a/a+b) x100
• Where a=number of (pseudo) aphakic eyes
• b=number of eyes with operable cataract.
• The larger the difference between CSC(person) and CSC (eyes) the
greater the preference that has been given to operate on first eye
above the second eye.
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Cataract surgical rate (CSR)
• Most countries or blindness control programs monitor the total
number of cataract operations conducted each year.
• This should include the output of all sectors, government, and
nongovernmental organizations.
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• The CSR is a performance indicator it indicates the extent of the effort
to control cataract blindness and allows easy comparison between
countries and regions
• The CSR does not address the quality of surgery nor the proportion of
the cataract problem covered.
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Sight restoration rate (SRR)
• It is an output indicator that measures the proportion of cataract
operations effectively changing a blind person into a sighted person.
• SRR= (P(pre)-P(pre)/total catops) x 100
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Rapid assessment for cataract surgical
services (RACSS)
• The concept of rapid cataract assessment was first applied in India
in the mid-1990s when the implementation of the National
program for Control of blindness (NPCB) was decentralized to the
district level to integrated into overall district healthcare service
• Only persons aged 50 years and above are eligible for examination
in this rapid assessment, Data from the National Survey on
Blindness
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• Rapid assessment are a relatively crude tool to gain a quick overview
of the cataract situation in a certain area.
• If it is repeated every 5 years, these rapid assessments can shows
trends in prevalence, coverage, outcome, and barriers and thereby
facilitate effective monitoring and planning
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