Epidemiology

Dr Nazia Sultan Ali B.D.S., M.P.H. Senior demonstrator Fatima Jinnah Dental College

Important Point:
If you are having trouble understanding lecture material: Try reading your text before attending lectures. And take the time to read it well!

Epidemiology

Is the study of frequency, distribution and determinants of health related states in human populations. The objective of epidemiology is to determine the effective strategies for the control of diseases. Epi : upon Demos : people Logy : knowledge

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What is Epidemiology ?

Epi - among ; Study DEFINITION

Demos - People ; Logos -

Epidemiology is the study of the

Frequency Distribution - time, place & person Determinants - physical, biological, social, behavioural & cultural

of health problems & health related events and application of this study to control health problems.

What is Epidemiology
Study of disease in populations Study of patterns, causes and control of disease in populations The branch of medicine that deals with the study of the causes, distribution, and control of disease in populations. The study of the spread of diseases within and between populations.

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Frequency

Frequency refers to the magnitude or quantity of the disease : either new cases only, the incidence, or both new plus old cases, the prevalence.

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It refers to the partition of the disease into units of time, place and persons.

Distribution

Time: The behavior of disease is studied over the hours of the day, months of the year, years of decades and decades of centuries. e.g the interval b/w the inception of the disease and the appearance of manifestation, the interval b/w onset of disease and its resolution.

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Place: This a geographic distribution of the disease. For e.g. which state of the country, which districts of the state, which taluka of the district and which villages of the taluka, have the maximum/moderate/minimum prevalence? Person: This presents the magnitude of the disease by age, sex, caste, race, immunity status, socioeconomic class, literacy and occupation

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Specific objectives of epidemiology

To identify the causes of disease and the risk factors To determine the extent of the disease found in the community (burden of disease) To study natural history and prognosis of disease To evaluate existing and new preventive and therapeutic measures and new modes of health care delivery.
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To provide the foundation for developing public health and regulatory decisions relating to environment problems.

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Uses of epidemiology

Investigate casual mechanism. E.g. do caries rate fall when people drink fluoride water? Explain variation in disease experience . E.g. how does sugar affect caries experience? Assess health status , health care needs, health behavior and health belief. Investigate possibilities for preventive actions e.g. clinical trial of tooth paste. Evaluate the effectiveness of health Dr Nazia Sultan Ali services.

Epidemiological triad
Agent

Environment

Host

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Epidemiological triad of caries

Agent

Streptococcus mutans

Caries
Environment

Host

Acidic / low pH Poor oral hygiene

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Poor nutrition/Low immunity Genetics, Gender, age

Study design: Definition

A study design is a specific plan or protocol for conducting the study, which allows the investigator to translate the conceptual hypothesis into an operational one.

When Are Hypotheses Used?

The key word istestable. That is, you will perform a test of how two variables might be related. This is when you are doing a real experiment. You are testing variables.Usually, a hypothesis is based on some previous observation such as noticing that in November many trees undergo color changes in their leaves and the average daily temperatures are dropping. Are these two events connected? How?
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How Are Hypotheses Written?

Chocolate may cause pimples. Salt in soil may affect plant growth. Plant growth may be affected by the color of the light. Bacterial growth may be affected by temperature. Ultra violet light may cause skin cancer. Temperature may cause leaves to change color.
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Ifskin cancerisrelatedtoultraviolet light,thenpeople with a high exposure to uv light will have a higher frequency of skin cancer. Ifleaf color changeisrelatedtotemperature,thenexposing plants to low temperatures will result in changes in leaf color. Notice that these statements contain the words ,ifandthen. They are necessary in a formalized hypothesis. But not all if-then statements are hypotheses. For example, "If I play the lottery, then I will get rich." This is a simple prediction. In a formalized hypothesis, a tentative relationship is stated. For example, if thefrequency of winningisrelatedtofrequency of buying

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Formalized Hypothesesexample

Problem: How do we know when

something makes a difference?
Association is not equal to causation. Consider the following statement: If the rooster crows at the break of dawn, then the rooster caused the sun to rise.

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Causation & Association

To judge whether the relationship b/w two factors is causal or just an association, we can use BRADFORD HILLS CRITERIA

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Epidemiologic Study Designs

Grim e s & Sc h u lz, 2 0 0 2

Components of epidemiology
DESCRIPTIVE EPIDEMIOLOGY

Identifying both the pattern and frequency of health

ANALYTICAL EPIDEMIOLOGY Focuses

on determinants of health outcom

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Cycle of epidemiological analysis

1. De s c rip t ive s t u d ie s -d a t a a g g re g a t io n a n d a n a lys is

4. Analysis

of result suggests further descriptive studies and new hypothesis

2. Mo d e l-b u ild in g

a nd formulation of hypothesis

3. Analytic studies to test hypothesis

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Phases of epidemiology

Descriptive epidemiology: it is concerned with disease distribution and frequency. It ask : what is the problem, its frequency, who is involved, where & when. Analytical epidemiology: attempts to analyze the causes or determinants of diseases by testing hypothesis, by asking how and why questions.

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Phases of epidemiology

Experimental epidemiology: Used to answer questions about the effectiveness of new methods for controlling disease or for improving under lying conditions. Evaluation epidemiology: it attempts to measure the effectiveness of different health services and programs.

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Epidemiologic Study Designs

De s c rip t iv e s t u d ie s
Examine patterns of disease

Analytical studies
Studies of suspected causes of diseases

Experimental studies
Compare treatment modalities

Hierarchy of Epidemiologic Study Design

Tower & Spector, 2007

Observational study

Most epidemiological studies are observational studies In this study the researcher observe the natural occurrence in the population. The most common observational studies are cross sectional, case control and cohort studies.

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Ob s e rva t io n a l St u d ie s
(no control over the circumstances)

- Descriptive: Most basic demographic studies * Case Report * Case Series * Cross sectional - Analytical: Comparative studies testing an hypothesis * cross-sectional (a snapshot; no idea on cause-and-effect relationship) * cohort (prospective; cause-and-effect relationship can be inferred) * case-control (retrospective; cause-and-effect relationship can be inferred) * correlational / ecological study

Descriptive study

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Case Report

What? the profile of a single patient is reported in detail by one or more clinicians

Example In 1961, a published case report of a 40 year-old women who developed pulmonary embolism after beginning use oral contraceptive

Case Series

What? An individual case report that has been expanded to include a number of patients with a given disease

Example In Los Angeles, five young homosexuals men, previously healthy, were diagnosed with pneumocyst cariini pneumonia in a

Analytical studies

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Epidemiologic Study Designs

Grim e s & Sc h u lz, 2 0 0 2

Case control study

Case-control Studies: Retrospective studies beginning with people who have a disease and controls who are similar but do not have the disease. The investigator then looks retrospectively to see what proportion in each group were exposed to the same risk factors. Findings expressed as .

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Design of a Case Control Study

Time
Direction of inquiry
Exposed

Starts with:
Cases (people with disease)

Not Exposed

Population

Exposed

Controls (people without disease)

Not Exposed
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Relative Risk in Case-Control Studies

Cant derive incidence from case-control studies

Begin with diseased people (cases) and non-diseased people (controls)

Therefore, cant calculate relative risk directly But, we can use another method called an odds ratio

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When is the Odds Ratio a Good Estimate of Relative Risk?

When cases are representative of diseased population When controls are representative of population without disease When the disease being studied occurs at low frequency

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A basic andhypotheticalsituation in global health might be to find out if the village well is the source of a cholera outbreak throughout a village. The first row would represent those exposed (those who didnt drink the water) and the second row would be those unexposed (those who didnt drink the well water). The first column would be those that had a disease outcome (in this case cholera). The second column would be those that didnt have a disease outcome (no cholera).

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Odds ratios measure association between exposures(i.e. well water)and outcomes(i.e. cholera). Since odds ratio is the odds of disease among exposed individuals divided by the odds of disease among unexposed individuals, odds ratios allow us to speak about probability. In case-control studies, we separate groups by their outcomes andretrospectivelytry to identify variables that appear to be more associated with one outcome than another. Therefore, we cannot deduce a calculableriskbecause the outcome has already been predetermined. We therefore use odds ratios instead to estimate the strength of association of Dr Nazia Sultan Ali

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OR = ad / bc = 17*30 / 20*7 = 3.6

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Advantages of case control

Relatively easy to carry out Rapid and inexpensive (compared to cohort) Requires comparatively few subjects Particularly suitable to investigate rare diseases. But a disease which is rare in the general population (e.g. leukemia in adolescents) may not be rare in special exposure groups. Ethical problems are minimal.
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Adv of case control contd.

No risk to subjects. Allow the study of several different etiological factors (e.g. smoking, physical activity and personality characteristics in myocardial infarction). Risk factors can be identified. Rational prevention & control programmes can be established. No attrition problems, because case control studies do not require follow up of individuals into the future.
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Disadvantage of case control studies

Problem of bias Selection of an appropriate control group may be difficult. We cannot measure incidence and can only estimate the Relative Risk Does not distinguish b/w causes & associate factors. Not suited to the evaluation of therapy or prophylaxis of disease. Another major concern is the representative ness of cases & control.
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Cohort studies

Unlike cross sectional studies, cohort studies follow subject over time. The purpose of Cohort study is to determine whether an exposure or characteristic is associated with the development of a disease or condition. At the beginning of the study all the subject must be free of the disease of interest. Subjects are classified into exposed and unexposed groups and then followed over time Dr Nazia Sultan Ali

Design of a Cohort Study

Disease

Exposed
No Disease

Population

People without the disease

Disease

Not Exposed
No Disease

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Concept of Cohort Study

In epidemiology the term cohort is defined as a group of people who share common characteristics or experience within a define time period e.g. age, occupation, exposure to a drug or vaccine, pregnancy, insured persons etc. e.g. a group of people born on the same day or in the same period of time (usually a year) form a birth cohort e.g all those born in 1997 form the birth cohort of 1997
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Cohort study example

Other e.g. person exposed to a common drug, vaccine or infection within a defined period form an exposure cohort. Or a group of males and females married on a same day or in the same period of time constitute a marriage cohort.

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Relative Risk
Exposure to PC Present Absent total Leukemia present 10 5 a a +cc Leukemia absent 990 b b+d Total a+b dc + d a+b+c+d

RR

= a (a+b)

c (c+d)

The higher the Relative Risk , the greater the likelihood of etiological factor being responsible for Disease * PC ~ personal computer
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Attributable Risk

Definition:

The amount of disease that can be attributed to a certain exposure. Attributable Riskis the difference in rate of a condition between an exposed population and an unexposed population.

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Relative Risk

Definition:

A measure of the strength of association based on prospective studies (cohort studies). Relative Risk (RR)is the risk of an event (or of developing a disease) relative to exposure. Relative risk is aratioof the probabilityof the event occurring in the exposed group versus a non-exposed group.
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Attributable risk

attributable riskis the difference in rate of a condition between an exposed population and an unexposed population.[1]

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Attributable Risk

AR = (IR among the exposed group) ( IR among the control

group) 100

IR among the exposed group

In c id e n c e Ra t io a m o n g t h e e xp o s e d is a /b , 3 0 /2 0 o r 3 /2 In c id e n c e Ra t io a m o n g t h e c o n t ro ls is c /d , 5 0 /1 0 0 , o r 1 /2
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Estimation of risk
Relative Risk RR= incidence of disease among exposed incidence of disease among non exposed

Attributable Risk AR= incidence of disease rate among exposed incidence of disease rate among non exposed

x100 incidence rate among exposed

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REMEMBER !!!

An odds ratio is a useful measure of association In a cohort study, the relative risk can be calculated directly In a case-control study the relative risk cannot be calculated directly, so an odds ratio is used instead

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Summary

Relative risk and odds ratio are important as measures of the strength of association

Important for deriving causal inference

Attributable risk is a measure of how much disease risk is attributed to a certain exposure

Useful in determining how much disease can be prevented

Therefore:
Relative risk is valuable in etiologic studies of disease Attributable risk is useful for Public Health guidelines and planning

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Advantages of cohort study

Incidence can be calculated Several possible outcomes related to exposure can be studied simultaneously Cohort study provide a direct estimate of relative risk Dose response ratios can be calculated Since comparison groups are formed before disease develops certain forms of biased can be minimized like misclassification of individuals into exposed and Dr Nazia Sultan Ali unexposed groups

Disadvantages

Cohort study involve a large number of people It takes a long time to complete the study and obtain results Certain administrative problems such as loss of experienced staff, loss of funding and extensive record keeping are inevitable Loss of substantial proportion of the original cohort they may migrate, loose interest in the study or simply refuse to provide any required information Cohort study is expensive
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Selection of comparison groups(exposed and unexposed)is a limiting factor There may be changes in the standard method or diagnostic criteria of the disease over prolonged follow up The study itself may alter peoples behavior With any cohort study, we are faced with ethical problems of varying importance In a cohort study, practical consideration indicate that we must concentrate on a limited number of factors of disease outcome
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Case control study

Cohort study

Proceed from effect to cause Start with the disease Test whether the suspected cause occurs more frequently in those with the disease than amongst those without the disease. Usually the first approach to the testing of a hypothesis, but also useful for exploratory studies. Involves fewer number of subjects.

Proceeds from cause to effects Starts with people exposed to risk factor or suspected cause. Test whether the disease occurs more frequently in those exposed, than those not similarly exposed. Reserved for testing of precisely formulated hypothesis. Involves number of subjects. Dr Nazia Sultan Ali

Case control

cohort

Yield relatively quick result Suitable for the study of rare disease Generally yield only estimate of OR (Odds Ratio) Cannot yield information about disease other than selected for study. Relatively inexpensive.

Long follow up period often needed, involving late results Inappropriate when the disease or exposure under investigation is rare, yield incidence rates, relative risk and attributable risk Can yield information about more than in one disease outcome Dr Nazia Sultan Ali Expensive

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Research Design: Descriptive Research

Cross-sectional Studies

Cross-sectional studies measure

units from a sample of the population at only one point in time. Sample surveys are cross-sectional studies whose samples are drawn in such a way as to be representative of a specific population. On-line survey research is being used to collect data for cross-sectional surveys at a faster rate of speed.

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Cross sectional

Measurement of risk and outcome at the same time The only study capable of calculating prevalence

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Cross sectional studies advantages

Cheap & quick studies Data is frequently available thru current records or statistics Ideal for generating new hypothesis

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Cross sectional studies disadvantages

The importance of the relationship b/w the cause and effect cannot be determined Cannot determine if cause preceded the effect or the effect was responsible for the cause The rules of contributory cause cannot be fulfilled.

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Intervention studies

Also known as experimental studies or clinical trial are carried out among patients, frequently hospital inpatients, and field trials are carried out with patient in the community who may not necessarily be patients. Clinical trials are research studies involving people. Clinical trials are the final step in a long research process that includes preliminary laboratory research and animal testing. Clinical trials try to answer specific scientific questions to find better ways to prevent, detect, or treat diseases, or to improve care for people with diseases. In cancer research, for example, a clinical trial is designed to show how a certain anticancer approachfor instance, a promising drug, a new surgical procedure, a new diagnostic test, or a possible way toSultan Ali Dr Nazia prevent canceraffects

Experimental studies
It is important to understand what clinical trials do to fight disease: 1. Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat disease. 2. Clinical trials contribute to knowledge and progress against disease. Many of todays most effective treatments are based on previous study results. Because of progress made through clinical trials, many people treated for various diseases are now living longer.

The more people that participate in clinical trials, the

faster we can answer the critical research questions that will lead us to better treatment and prevention options for a range of diseases.
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Experimental studies are useful for evaluating:

New drug or other treatment for disease New medical/health care technology Methods of prevention Methods of health promotion New health protection policies Programs for screening and diagnosis Methods of providing health care New health care policies

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Why to do Clinical Trial?

To answer a clinical problem To gain new knowledge about a new or established treatment To support a claim for gaining government regulatory approval for marketing a drug, device, or technique

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Guiding principles of experimental study

Ethics Scientific validity and integrity Medical relevance Costs

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Ethical considerations in experimental studies

Is proposed treatment safe? For the sake of trial, can a treatment ethically be withheld? What patients may be brought into trial and allocated randomly to treatments? Is it ethical to use a placebo or dummy treatment? Is it proper for the trial to be in any way masked?

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Advantages

The gold standard of research design. They thus provide the most convincing evidence of relationship b/w exposure and effect Best evidence study design No selection bias (using blinding) Comparable groups (using randomization)

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Disadvantages
Is the most expensive study design in terms of money, time and number of patients Can be problematic for ethical reasons -Use of placebo

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Each subject in the population of interest has an equal chance of being chosen for the study Maximizes the likelihood that the results of the study can be generalized or extrapolated to the entire population of interest

Random sample

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Randomization

If participants or health care providers choose a particular group based on what they think is best, then one of the groups would likely be very different than the other, making comparison between the groups difficult. Randomization eliminates this bias because participants have an equal chance of being assigned to either group and the subgroups are as similar as possible. Comparing similar groups of people taking different treatments for the same disease (or class of disease) is a way to ensure that the study results are caused by the treatments rather than by chance or other factors
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Randomized & Non randomized trial

Randomized trail the most elegant design in which each subject has an equal chance of being assigned to either study or control group. The most important advantage of proper randomization is that "it eliminates selection bias, balancing both known and unknown prognostic factors, in the assignment of treatments Nonrandomized trial designs are not uncommon but are weaker than randomized design
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Blinding

An RCT may be Blinded, (also called "masked") by "procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received. Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., physical therapy), participants cannot be blinded to the intervention.
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Traditionally, blinded RCTs have been classified as "single-blind," "doubleblind," or "triple-blind";

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Blind

A randomized trial is Blind if the participant is not told which arm of the trial he is on. A clinical trial is Blind if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. SINGLE BLIND STUDY : a study in which one party, either the investigator or participant is unaware of what medications the participant in taking; also called single masked study
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DOUBLE BLIND STUDY: a clinical trial design in which neither the participating individual nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo ( or another therapy). Double blind trial are thought to produce objective results, since the expectations of the doctor and the participants about the experimental drug do not affect the outcome; also
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Animals studies May not be valid

Animal studies may not be valid. Animals are not always equivalent to humans. Aspirin would have been rejected on the basis of animal studies. It causes congenital defects in mice, but not in humans.

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Placebo trial may not be ethical

Placebo trials may not be ethical. If you have an effective treatment for a disease, you cant risk patients lives by denying them that treatment and assigning them to a placebo group. We couldnt do a trial today comparing appendectomy to a placebo for acute appendicitis.

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Bias

Any process which tends to produce results or conclusions that differ systematically from the truth.

Murphy. In: The Logic of Medicine (1976)

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INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
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Levels of occurrence of disease

Sporadic level: occasional cases occurring at irregular intervals Endemic level: persistent occurrence with a low to moderate level Epidemic or outbreak: occurrence clearly in excess of the expected level for a given time period Pandemic: epidemic spread over several countries or continents, affecting a large number of people
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Common Terms