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113 Cards in this Set

  • Front
  • Back

Temporal sequence between expsure and disease is clearly established

Cohort

Well suited for assessing the effects of rare exposures

Cohort

Incidence of disease can be calculated

Cohort

Can examine multiple outcomes of a single exposure

Cohort

True estimate of risk can be calculated

Cohort

Money (expensive) is a disadvantage

Cohort

Subject to loss of follow up

Cohort

Time consuming (disadvantage)

Cohort

Cannot be used when stufying a rare disease

Cohort

Cannot be used when bad records, unreliable data

Retrospecive cohort

Cannot be used to study chronic disease.


Reason?

Cohort.


Bcuz of the long gap between exposure and outcome

Cannot be used when theres no clear distinction between exposed and unexposed

Cohort

What are the steps in cohort study?

1) Choose design


2) Selection of exposed group


3) Selection of comparison group


4) Follow up


5) Analysis and interpretation

For studying diseases with common exposures, what type of population should be used? Give examples

Highly compliant and motivated participants.


Ex. doctors, nurses, union members, veterans

For studying diseases with rare exposures, what type of population should be used? Give examples

Highly exposure groups.


Ex. uranium workers, Chernobyl residents

In cohort study, when selecting comparison group, it should be _______________

Free from exposure, but similar to the case group

How can be thw Hawthorne effect adressed?

Using workers, from the same establishment wh are not exposed to the risk factor, as comparison group

Selecting population within the same company to compare factory floor workers (exposed) and office workers (not exposed) can diminish ________

Hawthorne effect

Mention 3 issues of a chort study

1) Bias


2) Loss to follow-up


3) Non participation

The Less common issue in cohort study is

bias (although missclassification and selection bias can still occur)

A study that loses __% of participants is ______

25% --> flawed

Purpose is to determine if the groups differ by eposure

Case-control

Best study to assess rare diseases

Case-control

Suitable to study chronic diseases

Case-control

Cost effective and less time to complete

Case-control

Many exposure factors can be studied at the same time

Case-control

ICannot get true estimate of risk

Case-control

Issues with temporal association

Case-control

Issues with choosing appropiate controls

Case-control

Strong potencial for bias

Case-control

Cofounding is an issue in _______

Case-control

What are the steps in casecontrol studies?

1) Definition and selection of cases


2) Selection of controls


3) Ascetainment of disease and exposure status


4) Analysis

The most difficult issue in case-control designs is

Selection of controls

Mention 3 types of community controls

1) Neighborhood controls

2) Best friends controls


3) Spouse or sibling control

Issue for selecting hospitalized controls

Risk of Cofounders--> are more likely to be smokers, alcoholics and with other high risk behaviors

Disadvantages of stratified analysis

1) Its extremely cumbersome

2) Difficult to control for more than 1 cofounder at a time

"If sex is a cofounder then analyze men and women separately". This is used for:

Stratified analysis

"If age is a confounder, then analyze data separately for each age group". This is used for:

Stratified analysis

Incidence cannot be derived

Case-control

The estimate of relative risk can be calculated

Case control



Odds ratio can be calculated

Case control

Equation for odds ratio

(A)(D)


---------


(B)(C)

Numerator in odds ratio eq is:_________


What about denominator?

Numerator: odd of exposure for cases


Denominator: exposure for controls




Remember: A/C


----------


B/D

Any systemic error that results in an incorrect estimate of the risk of association between exposure and risk of disease

Bias

Effects of _______ are difficult to evaluate in tha analysis

Bias

The time to eliminate bias is when ___________

the study is designed

Sample selected differs in properties in cases and controls

Selection bias

Can lead to an over or understimation of risk

Recall bias

People who are sick tend t think about possible "causes" for their illness. (they remember thing better and clearer)

Recall bias

Interviewer bias refers to

Interviewers who are aware of the study hypothesis are likely to question cases and control differently

More probing questions may be asked of cases

Interviewer bias

Experimenter's expectations are communicated to the subjects, unintentionally

Pygmalion effect

Subjects may be erroneously categorized with respect to exposure or disease status

Misclassification bias

Method of collecting information was flawed

Measurement bias

Bias that use standard sources to validate

Misclassification bias

Bias that use highly trained personnel, blinded to study hypothesis

Interviewer bias

Bias that use ne hospitalized control group

Recall bias

Bias that use control picked from the same source of cases, use mtivated individuals

Selection bias

Variable that is known to be associated with the outcome (effect)

Confounder

Mention 5 examples of common confounders:

1) age


2) gender


3) tobacco


4)alcohol


5)socio-economic status

"If smoking can be a confounder, then only wnroll non-smokers"

Restrictions on study subjects

Cases and controls are matched by usual confounders so that the factors are equally distibuted in both groups

Matching the subjects

Each subject seerves as his/her own control

Crossover design

Steps in clinical trial

1) Formulate hypothesis

2) Choose sample size and select participants


3) Do necessary exclusions


4) Random assignment


5) Outcome measurement

General group to whom the results will be applicable to

Reference group

Actual group in whom the study is conducted

Experimental population

Assignment to treatment group in CT should occur _____________

after the study population is chosen and informed consent obtained

Used when yo wish to mantain equal numbers of population characteristic in each group (ex. gender)

Block randomization

The reason of randomization is to

reduce bias due to known and unknown confounders

Only the experimenter knows the assignment of subject; subjects don't

Single blind

Neither the experimenter nor the subjects know the assignments

Double blind

A ________ blind trial provides the best protection agains bias

double or triple

Mention 4 factors that can affect the outcome of RCT

1) Errors in hypothesis testing

2) Sample size


3) Post randomization changes in groups


4) Analysis of data

Individuals in one treatment arm may drop out at higher rates due to factors such as side effects

Compliance bias

Study participants may drop out, switch tx groups

Migration bias

Analyses in the medical literature should be always be analyzed and reported by ____________ method

Intention to treat

Ability of a treatment to work in the ideal study setting

Efficacy

Ability of the treatment to work under realistic circumstances

Effectiveness

For efficacy trails, _______ analysis can be used.

explanatory

For effectiveness trials, _________ analysis can be used

Intention to treat

A record is kept of simple outcomes like symptoms score relief, etc. Only possible in conditions which occur frequently and resolve quickly

Trials of "n" equal to 1

Clinical trial done when pat have migraine, asthma, etc (quickly resolving diseases)

Trials n=1

Phase that uses animal studies

Pre-clinical

Phase that test healthy human volunteers

Phase 1

Identify toxicities, tolerated doses, describe pharmacology (metabolism, excretion)

Phase 1

Phase that use subjects woth disease

Phase 2

Validate toxicity and dosage data

Phase 2

Phase when randomized trials for comparison with standard therapy

Phase 3

Phase that assess side effects associated w long-term use

Phase 4

Phase in which studies are done after drug or tx has been marketed to gather info on the drugs effect

Phase 4

Informed consent must be obtained from all participants involved in human experiments

Declaration of Helsinki

Stratey used to identify disease in an unsuspecting population

Screening

Basic purpose of screening is :

to detect disease from a large group of apparently well persons

Mention 2 aspects of interpretation of screenings

1) Reliability


2) Validity

Also called Reproductibility

Reliability

Mention 3 bias in screening programs

1) Lead time bias


2) Lenght bias


3) Selection bias

The perception that the case has a longer survival simply bcuz the disease was identified earlier in the natural course of disease

Lead time bias

Tumors detected by screening programs tend to be slower growing, therefore have a better prognosis

Length Bias

Misperception that screening itself leads to better outcomes

Lenght Bias

Individuals who are motivated to participate in screening programs may have a different probability of disease than indviduals who refuse to participate

Selection bias

Women with family history breastcancer joining screening; more women with illness arefound and more dying of it. When it is applied to general population theresults may be different.

Selection bias

Given disease; how many have a positive test

sensitivity

Given no disease; how many have negative test

Specificity

Given a positive test; how many have disease

Positive predictive value

Given a negative test; how many do not have disease

Negative Predictive value

Whats the reason that most rare diseases are not screenied for?

If prevalence is low, positive predictive value will be also low

Yield of positive predictive value and prevalence can be increased by

Screening in high risk groups


(Ex. tay Sachs among Jews,


Sickle cell among African Americans)

Test that is considered to be the most accurate among all the known tests.

Gold-standard

Proportion of all subjects who were correctly classified by the test

Accuracy

The degree to which a measurement represents the true value

Accuracy

Equation for accuracy

(TP + TN) / Total screened

Wheter a positive lab test indicates a person truly has the disease

Validity

A good kappa value that indicates a reliable test and reliable raters, is:

At least 75%