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. TYPES OF EPIDEMOLOGICAL STUDIES:
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. There 2 main objective for epidemiological studies; descriptive and analytic.
. Descriptive epidemiology deals with rates, ratios and distributions, it explain
the determinants of the disease in the form of time place and person.
. Analytical epidemiological tests consist of observational studies and
experimental studies.
. Observational studies include: Case-Control, Cohort and cross-sectional studies.
. CASE CONTROL STUDY (Retrospective study):
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. The movement is from the effect to the disease.
. The researcher begins with a population with a certain outcome, and subjects
are classified into:
Either "cases" or "controls" based on the outcome status.
. The cases and controls are assessed retrospectively to for the presence of risk
factor
(Information is collected about exposure to risk factors).
. Is very popular in exploring an exposure - disease association.
. Subjects with the disease of interest are compared with an otherwise similar
group that is disease free.
. It is more cheap and easy than cohort study
. It is retrospective study aiming at determining the association between risk
factors and disease occurance.
. Used to compare the exposure of people e disease (cases) to the exposure of
people eout the disease (control).
. The main measure of association is Odds ratio can be calculated in the case
control study but incidence of the disease can't.
. One of the drawbacks of case control study is that the risk cannot be derived
directly from its results.
.N.B.:
- Incidence measures ( e.g. relative risk or relative rate) can't be directly
measured in case-control study,
- Because the people being studied are those who have already developed the
disease.
- Relative risk and relative rate are calculated in cohort studies, where people
are followed over time for the occurrence of the disease.
. A Prospective or longitudinal COHORT STUDY:
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. Divides the study group into "exposed" and "non exposed" to the risk factors.
. Each subject is then follow prospectively till the presence of the disease.
. Is a prospective observational study in which groups are chosen based upon the
presence or absence of one or more risk factors.
. All subjects are then observed over time for the development of the disease of
interest.
. Thus allowing estimation of the incidence within the total population and
comparison of incidences between subgroups.
. It is best for determining the incidence of the disease & comparing the
incidence of the disease in 2 populations,
. (one with and one without agiven risk) allows for calculation of a relative risk.
. It is stronger than case-control study and cross sectional study.
.N.B.:
- Median survival: used to compare the median survival times in two or more
groups of patients (e.g. receiving
new treatment or placebo).
- Median survival is calculated in cohort study or clinical studies.
.N.B.:
- Prevalence odds ratio: is calculated in cross-sectional studies to compare the
prevalence of the disease
between two different peoples.
. INCIDENCE: (typical for USMLE)
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. It is the frequency of new cases of a disease arising in a population at risk over
a specified time period.
. It is the measure of the appearance of new cases.
. PREVALENCE: is the measure of those with the disease in the population at a
particular point in time.
. the relation between them in a stable population (little migration) can be
demonstrated by:
Prevalence = (incidence) (time)
. So if the incidence is fixed in a stable population, the prevalence is increased if
there are factors,
that prolong survival (i.e. disease duration) e.g. improved quality of care.
. Prevalence of disease in a population = incidence of the disease / population
. A Retrospective cohort study:
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. Starts at some point between the exposure and the outcome.
. The researcher reviews the past records and classify subjects into "exposed"
and "non exposed" and then follow them until the outcome.
. In a cohort study, the study subjects are free of the outcome at the time a study
begins.
. CROSS SECTIONAL STUDY:
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. Both the exposure and the outcome are studied at one point of time (at one
cross section of time).
. Since both exposure and outcome are present for some time before the study, it
is not possible to,
determine the temporal association between the exposure and outcome from
cross-sectional study.
. Takes a sample of individual from a population at one point in time.
. It allows determination of disease prevalence (the total number of cases in a
population at a given time).
. Disease incidence can't be determined.
. A CASE SERIES:
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. A study involving only patients already diagnosed with the condition of interest.
. It is helpful in determining the natural history of uncommon conditions.
. But provides no information about the disease incidence.
. CLINICAL TRIALS:
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. Compare the therapeutic benefit of different interventions in patient already
diagnosed with a particular disease.
. Can't be used to determine disease incidence.
- if we increase the sample size -> the confidence intervalll be tighter and the
studyll be statistically significant.
. SELECTION BIAS:
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. Results from the manner in which the subjects are selected for the study, from
the selective losses from the follow-up.
. SAMPLE DISTORTION BIAS:
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. Is seen when the estimate of exposure and outcome association is biased.
. Because the study sample isn't representative of the target population with
respect to the joint distribution of exposure and outcome.
. INFORMATION BIAS:
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. Occurs due to imperfect assessment of the association between the exposure
and outcome.
. As a result of errors in the measurements of exposure and outcome status.
. It can be minimized by using standardized techniques for surveillance and
measurement of outcomes
as well as trained observers to measure the exposure and outcome.
. MEASUREMENT BIAS:
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. Occurs from poor data collection with inaccurate results.
. LEAD-TIME BIAS:
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. Lead-time bias should be considered while evaluating any screening test.
. It happens when two interventions are compared to diagnose a disease,
and one of them diagnose the disease earlier than the other without an effect on
the outcome (survival).
. What actually happens is that detection of the disease was made at an earlier
point of time,
. But the disease course itself or the prognosis did not change.
. So the screened patients appeared to live longer from the time of diagnosis till
the time of death.
N.B.: IN USMLE:
. Think of LEAD BIAS when you see " a new screening test" for poor prognosis
diseases like lung cancer or pancreatic cancer.
. OBSERVER'S BIAS, MEASUREMENT BIAS & ASCERTAIN BIAS:
_____________________________________________________
. when the observer maybe influenced by prior knowledge or details of the study
that can affect the results.
. Refers to misclassification of an outcome and /or exposure.
. e.g.: labeling diseased subjects as non-diseased and vice versa.
. Blinded studies usually avoid this bias by preventing the observer from knowing
which treatment or intervention the participants are receiving.
. and are related to the design of the study (the scenario will describe how the
study was desgined).
. RECALL BIAS:
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. Occurs when a study participant is affected by prior knowledge to answer a
question.
. This is more common in case-control studies than in randomized clinical trials.
. RESPONDENT BIAS:
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. Occurs when the outcome of the test is obtained by the patient's response not
by objective diagnostic methods (e.g. migraine headache).
. SUSCEPTABILITY BIAS:
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. Is a type of selection bias where a treatment regimen is selected for a patient
based on the severity of their condition, without taking into account other
possible confounding variables.
. Offline case20.
. CONFOUNDING:
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. Occurs when at least part of the exposure-disease relationship can be explained
by another variable (confounding).
. Due to presence of one or more variables associated independently with both
the exposure and the outcome.
. For example: cigarette smoking can be a a confounding factor in studying the
association between maternal alcohol drinking and low birth weight babies.
. As cigarette smoking is independently associated with alcohol consumption and
low borth weight babies.
. Hawthorne effect:
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. It is the tendency of a study population to affect the outcome because these
people are aware that they are being studied.
. This awareness leads to consequent change in behavior while under observation
--> seriously affecting the validity of the study.
. It is usually seen in studies that concern behavioral outcomes or outcomes that
can be influenced by behavioral changes.
. In order to minimize the Hawthorne effect, the studied subjects can be kept
unaware that they are being studied.
.HOW TO CONTROL BIAS:
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1- Selection bias can be controlled by choosing a representative sample of the
population for the study & achieving a high rate of follow up.
2- Observer's bias can be controlled by blinding technique.
3- Ascertainment bias can be controlled by selecting a strict protocol of case
ascertainment.
4- Confounders: can be avoided by 3 methods in the design stage of the study;
matching restriction and randomization.
- Randomization is commonly employed in clinical trials its purpose is to balance
various factors (confounders) that can influence the estimate of association
between the treatment and placebo groups so that the un-confounded effect of
the exposure can be isolated.
- Lower bp goal.
NOTE:
-------. The prevalence of the disease is directly related to the pre-test probability of
having the disease (PPV) & inversely related to
the pre-test probability of not having the disease (NPV), so increased prevalence
--> low NPV but high PPV and vice versa.
N.B.:
-----. If the test result is -ve , the probability of the patient to have the disease = 1 NPV.
. Cases and diagnostic tests tha are high yield USMLE questions in probabilities:
- coronary artery disease and ECG stress test.
- Pulmonary embolism and ventilation-perfusion scanning.
- Prostate cancer and serum PSA level.
. VALIDITY OF TEST:
________________
. Represents the appropriateness of the test (i.e. the test ability to measures
what is supposed to be measured).
. In order to determine the validity of a test, the results are compared to those
obtained from the gold standerd test.
. It doesn't depend on the pre-test probability of the disease.
N.B.: Also sensitivity and specificity of a test compare its results to the results
obtained by the gold standard test
. RELIABILITY:
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. Test-retest reliability.
. A reliable test gives similar or very close results on repeat measurements.
. Receiver Operating Characteristic (ROC) curve:
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. It emphasizes the importance of choosing the appropriate cutoff value, although
overlapping of normal & abnormal results make it difficult.
. Any cutoff point demonstrates a trade-off between SENSITIVITY and 1SPECIFICITY.
. Sensitivity (positivity in disease) --> is the proportion of subjects who have the
target condition and gives positive results.
. Sensitivity = TP/(TP + FN).CLINICALLY
. Specificity (Negativity in health) -> is the proportion of subjects eout the target
condition and gives -ve results.
. Specificity = TN/(TN + FP).CLINICALLY
. ++ Sensitivity --> ++ true +ve & -- false -ve (diagnosed as normal but he is
diseased).
. ++ Sensitivity --> allaw not to miss any diseased patient (not to miss any true
+ve).
. ++ Specificity --> ++ true -ve & -- false +ve (diagnosed as diseased but he is
normal).
. ROC --> Aiming at decrease false -ve and false +ve results (i.e increase
sensitivity and specificity).
.N.B.:
- In ROC curve: sensitivity = true positive while (1-specificity) = false positive.
. Positive predictive value (ppv) --> is the probability of having the disease if the
test results are +ve.
. PPV = TP/(TP + FP).
. Negative predictive value (NPV) --> is the probability of not having the disease
if the test result is -ve.
. NPV = TN/(TN + FN).
. Positive likelihood ratio (LR+) = sensitivity/(1-specificity).
. (LR+) --> is the ratio of the proportion of patients who have the target condition
& test positive to,
. the proportion of patients without the target condition & who also test positive.
. Negative likelihood ratio (LR-) = (1-specificity)/sensitivity.
. (LR-) --> is the ratio of the proportion of patients who have the target condition
who test negative to,
the proportion of patients without the target condition who also test negative.
. ROC curve has 2 lines; vertical line (Y) for sensitivity and horizontal line (X) for
specificity
. Large Y values --> Indicates High sensitivity.
. Small X values --> Indicates High specificity.
. Low cutoff --> Increase sensitivity (better ability to identify patients with the
disease i.e increase true positive),
Although this causes decrease specificity (the test falsely identifies more
subjects as diseased also they are not) and vice versa.
. High cutoff --> Decrease sensitivity and Increase specificity.
. Low cutoff --> High Sensitivity --> higher negative predictive value (NPV) -->
decrease false -ve results (Ruling out probability).
. High cutoff --> Higher Specificity --> higher positive predictive value (PPV) -->
decrease false +ve results (Ruling in probability).
N.B:
. A shift of the ROC curve upwards for a given cutoff indicates increased
sensitivity and vice versa.
. A shift of the curve to the right for a given cutoff indicates decreased specificity
and vice versa.
____________________________
. It assesses a linear relationship between two variables.
. The null value for the correlation coefficient is 0 (no association).
. And the range of plausible values is from -1 to 1.
. The sign (mark) of correlation coefficient indicates a positive or negative
association.
. The closer the value to its margins (-1 or 1), the stronger the association.
. The correlation coefficient shows the strength of association but does nt
necessarily imply causality (cause of it).
. The association is statistically significant if P value is low.
. Risk:
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. It measures the incidence of the disease.
. It is calculated by divide the number of diseased subjects by the number of
people at risk or of interest.
. MEASURES OF CENTERAL TENDENCY:
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. Mean --> is the sum of observations divided by the number of observations.
. Mean (X') = E X/N. i.e = sum of obs./ N. of obs.
. Median --> is the middle observation in a series of observations after arranging
them in an ascending or descending manner.
. If number of observations is odd --> Median = (n+1)/2.
. If the number of observations is even --> Median = n/2
. Mode --> is the most frequent occurring value in the data.
. EXAMPLE: 5,6,7,5,10,3
. Mean = (5+6+7+5+10+3)/5 = 36/6 = 6.
. Mode --> 5.
. EX2: 5,6,8,9,11
. Median = (5+1)/2 = 3. so Median is the 3rd observ. --> median = 8.
. EX3: 5,6,8,9
. Median = 4/2 = 2. so median is the 2nd obsrv.
. Median will be the mean of observations 2&3 --> (6+8)/2 = 7.
.N.B.:
. Range: is a measure of variation (dispersion).
. Range: is the difference between the largest and the smallest values
. Range = largest value - smallest value
e.g. Range = 9-5 = 4.
. SCATTER PLOTS:
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. They are useful for crude analysis of data.
. They can demonstrate the type of association (linear or nonlinear).
. If a linear association is present, the correlation coefficient can be calculated.
. The association is positive (if the outcome increases with the increase in the
exposure) -> +ve correlation coefficient while
the association is negative (if outcome decreases with the increase in exposure)
-> -ve correlation coefficient.
. the correlation coefficient in an almost perfect linear association is close to 1.
. Crude analysis of association using the scatter plots doesn't account for
possible confounders.
. N.B:
1- It is very important to consider the natural history of a disease when
evaluating the effectiveness of a druge
in a trial, e.g. common cold --> natural resolution within one week should be
taken in consideration while evaluating, an anti-viral drug used in treatment
of common cold.
2-