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113 Cards in this Set
- Front
- Back
Temporal sequence between expsure and disease is clearly established |
Cohort |
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Well suited for assessing the effects of rare exposures |
Cohort |
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Incidence of disease can be calculated |
Cohort |
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Can examine multiple outcomes of a single exposure |
Cohort |
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True estimate of risk can be calculated |
Cohort |
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Money (expensive) is a disadvantage |
Cohort |
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Subject to loss of follow up |
Cohort |
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Time consuming (disadvantage) |
Cohort |
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Cannot be used when stufying a rare disease |
Cohort |
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Cannot be used when bad records, unreliable data |
Retrospecive cohort |
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Cannot be used to study chronic disease. Reason? |
Cohort. Bcuz of the long gap between exposure and outcome |
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Cannot be used when theres no clear distinction between exposed and unexposed |
Cohort |
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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 |
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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 |
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For studying diseases with rare exposures, what type of population should be used? Give examples |
Highly exposure groups. Ex. uranium workers, Chernobyl residents |
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In cohort study, when selecting comparison group, it should be _______________ |
Free from exposure, but similar to the case group |
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How can be thw Hawthorne effect adressed? |
Using workers, from the same establishment wh are not exposed to the risk factor, as comparison group |
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Selecting population within the same company to compare factory floor workers (exposed) and office workers (not exposed) can diminish ________ |
Hawthorne effect |
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Mention 3 issues of a chort study |
1) Bias 2) Loss to follow-up 3) Non participation |
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The Less common issue in cohort study is |
bias (although missclassification and selection bias can still occur) |
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A study that loses __% of participants is ______ |
25% --> flawed |
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Purpose is to determine if the groups differ by eposure |
Case-control |
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Best study to assess rare diseases |
Case-control |
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Suitable to study chronic diseases |
Case-control |
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Cost effective and less time to complete |
Case-control |
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Many exposure factors can be studied at the same time |
Case-control |
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ICannot get true estimate of risk |
Case-control |
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Issues with temporal association |
Case-control |
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Issues with choosing appropiate controls |
Case-control |
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Strong potencial for bias |
Case-control |
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Cofounding is an issue in _______ |
Case-control |
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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 |
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The most difficult issue in case-control designs is |
Selection of controls |
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Mention 3 types of community controls |
1) Neighborhood controls
2) Best friends controls 3) Spouse or sibling control |
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Issue for selecting hospitalized controls |
Risk of Cofounders--> are more likely to be smokers, alcoholics and with other high risk behaviors |
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Disadvantages of stratified analysis |
1) Its extremely cumbersome
2) Difficult to control for more than 1 cofounder at a time |
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"If sex is a cofounder then analyze men and women separately". This is used for: |
Stratified analysis |
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"If age is a confounder, then analyze data separately for each age group". This is used for: |
Stratified analysis |
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Incidence cannot be derived |
Case-control |
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The estimate of relative risk can be calculated |
Case control |
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Odds ratio can be calculated |
Case control |
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Equation for odds ratio |
(A)(D) --------- (B)(C) |
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Numerator in odds ratio eq is:_________ What about denominator? |
Numerator: odd of exposure for cases Denominator: exposure for controls Remember: A/C ---------- B/D |
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Any systemic error that results in an incorrect estimate of the risk of association between exposure and risk of disease |
Bias |
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Effects of _______ are difficult to evaluate in tha analysis |
Bias |
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The time to eliminate bias is when ___________ |
the study is designed |
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Sample selected differs in properties in cases and controls |
Selection bias |
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Can lead to an over or understimation of risk |
Recall bias |
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People who are sick tend t think about possible "causes" for their illness. (they remember thing better and clearer) |
Recall bias |
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Interviewer bias refers to |
Interviewers who are aware of the study hypothesis are likely to question cases and control differently |
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More probing questions may be asked of cases |
Interviewer bias |
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Experimenter's expectations are communicated to the subjects, unintentionally |
Pygmalion effect |
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Subjects may be erroneously categorized with respect to exposure or disease status |
Misclassification bias |
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Method of collecting information was flawed |
Measurement bias |
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Bias that use standard sources to validate |
Misclassification bias |
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Bias that use highly trained personnel, blinded to study hypothesis |
Interviewer bias |
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Bias that use ne hospitalized control group |
Recall bias |
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Bias that use control picked from the same source of cases, use mtivated individuals |
Selection bias |
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Variable that is known to be associated with the outcome (effect) |
Confounder |
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Mention 5 examples of common confounders: |
1) age 2) gender 3) tobacco 4)alcohol 5)socio-economic status |
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"If smoking can be a confounder, then only wnroll non-smokers" |
Restrictions on study subjects |
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Cases and controls are matched by usual confounders so that the factors are equally distibuted in both groups |
Matching the subjects |
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Each subject seerves as his/her own control |
Crossover design |
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Steps in clinical trial |
1) Formulate hypothesis
2) Choose sample size and select participants 3) Do necessary exclusions 4) Random assignment 5) Outcome measurement |
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General group to whom the results will be applicable to |
Reference group |
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Actual group in whom the study is conducted |
Experimental population |
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Assignment to treatment group in CT should occur _____________ |
after the study population is chosen and informed consent obtained |
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Used when yo wish to mantain equal numbers of population characteristic in each group (ex. gender) |
Block randomization |
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The reason of randomization is to |
reduce bias due to known and unknown confounders |
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Only the experimenter knows the assignment of subject; subjects don't |
Single blind |
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Neither the experimenter nor the subjects know the assignments |
Double blind |
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A ________ blind trial provides the best protection agains bias |
double or triple |
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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 |
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Individuals in one treatment arm may drop out at higher rates due to factors such as side effects |
Compliance bias |
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Study participants may drop out, switch tx groups |
Migration bias |
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Analyses in the medical literature should be always be analyzed and reported by ____________ method |
Intention to treat |
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Ability of a treatment to work in the ideal study setting |
Efficacy |
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Ability of the treatment to work under realistic circumstances |
Effectiveness |
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For efficacy trails, _______ analysis can be used. |
explanatory |
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For effectiveness trials, _________ analysis can be used |
Intention to treat |
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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 |
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Clinical trial done when pat have migraine, asthma, etc (quickly resolving diseases) |
Trials n=1 |
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Phase that uses animal studies |
Pre-clinical |
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Phase that test healthy human volunteers |
Phase 1 |
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Identify toxicities, tolerated doses, describe pharmacology (metabolism, excretion) |
Phase 1 |
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Phase that use subjects woth disease |
Phase 2 |
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Validate toxicity and dosage data |
Phase 2 |
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Phase when randomized trials for comparison with standard therapy |
Phase 3 |
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Phase that assess side effects associated w long-term use |
Phase 4 |
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Phase in which studies are done after drug or tx has been marketed to gather info on the drugs effect |
Phase 4 |
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Informed consent must be obtained from all participants involved in human experiments |
Declaration of Helsinki |
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Stratey used to identify disease in an unsuspecting population |
Screening |
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Basic purpose of screening is : |
to detect disease from a large group of apparently well persons |
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Mention 2 aspects of interpretation of screenings |
1) Reliability 2) Validity |
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Also called Reproductibility |
Reliability |
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Mention 3 bias in screening programs |
1) Lead time bias 2) Lenght bias 3) Selection bias |
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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 |
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Tumors detected by screening programs tend to be slower growing, therefore have a better prognosis |
Length Bias |
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Misperception that screening itself leads to better outcomes |
Lenght Bias |
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Individuals who are motivated to participate in screening programs may have a different probability of disease than indviduals who refuse to participate |
Selection bias |
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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.
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Selection bias |
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Given disease; how many have a positive test |
sensitivity |
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Given no disease; how many have negative test |
Specificity |
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Given a positive test; how many have disease |
Positive predictive value |
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Given a negative test; how many do not have disease |
Negative Predictive value |
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Whats the reason that most rare diseases are not screenied for? |
If prevalence is low, positive predictive value will be also low |
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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) |
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Test that is considered to be the most accurate among all the known tests. |
Gold-standard |
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Proportion of all subjects who were correctly classified by the test |
Accuracy |
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The degree to which a measurement represents the true value |
Accuracy |
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Equation for accuracy |
(TP + TN) / Total screened |
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Wheter a positive lab test indicates a person truly has the disease |
Validity |
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A good kappa value that indicates a reliable test and reliable raters, is: |
At least 75% |