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KCUMB Epidemiology - Erin > EXAM II Material > Flashcards

EXAM II Material Flashcards

1
Q

What is a null hypothesis?

A

A research perspective which states there will be NO (true) difference b/w the groups being compared

Stat Perspectives:

  1. Superiority 2. Inferiority 3. Equivalency
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2
Q

Alternative Hypothesis

A

A research perspective which states that there will be a true difference b/w the groups being compared

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3
Q

What are the 2 factors in which study populations are based upon?

A
  1. Ethics
  2. Equipoise
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4
Q

Which type of study design involves no researcher-forced group allocation?

A

Observational

considered “natural/freely”

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5
Q

What type of study involves researcher-forced group allocation?

A

Interventional

considered “experimental”

Investigator-selectes interventions (exposure)

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6
Q

What are study population selection based upon?

A
  1. The research hypothesis/question
  2. Inclusion and Exclusion selection criteria (interventional) and Case & Control group or Exposed & Nonexposed group selection criteria (observational)
  3. Ethics (principles of bioethics must be met)
  4. Equipoise
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7
Q

Define Equipoise

A

Genuine confidence that an intervention may be worthwhile (risk vs benefit) in order to use it in humans (greater benefit than risk)

Must have genuine reservations about the treatment in order to withold information

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8
Q

What are the 4 key principles of bioethics?

A
  1. Autonomy - self-rule/self-determination
  2. Beneficence - to benefit the patient, not society
  3. Justice - equal & fair treatment
  4. Nonmaleficence - do no harm
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9
Q

What is the Belmont Report and what is it used for?

A

A document used to know whether a research is ethical

Issued by National Commission for Protection of Human Subjects of Biomedical and Behavioral Research

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10
Q

What are the 3 guiding principles for the ethical conduct of research methodology?

A
  1. Respect for persons (voluntary)
  2. Beneficence (research risks are justified by potential benefits)
  3. Justice (risk and benefits of research are equally distributed)
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11
Q

Define Assent

A

Agreement to participate, based on being fully and completely informed, given by mentally-capable individuals not able to give legal consent (i.e. children and adolescents)

Not mentally capable

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12
Q

What is the role of the IRB (Institutional Review Board)?

A

aka “Ethics committee”

Determines whether a study is ethical (proper/safe)

This MUST occur Before a study begins

To protect human subjects

All observational and interventional studies

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13
Q

What is the role of the Data Safety & Monitoring Board (DSMB)?

A

Protects the safety of the patients After a study starts

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14
Q

What is the key difference between Observational and Interventional study designs?

A

In Interventional study designs, the researcher allocates and forcefully allocates study subjects into forced-intervention groups

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15
Q

Which type of study design is most likely to prove causation?

A

Interventional

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16
Q

What are the advantages of Interventional studies? (2)

A

Most likely to prove causation

Only study used to become approved by FDA

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17
Q

What are the disadvantages of Interventional Studies? (4)

A

Costly

Time consuming/complex

Ethical considerations

Generalizability/External Validity - too restrictive

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18
Q

What is an explanatory interventional study?

A

They’re done when you’re trying to explain the impact of the intervention and prove causation

Super restrictive w/ inclusion criteria

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19
Q

What is a pragmatic interventional study?

A

When they mirror the real world w/ a clinical environment in which:

NO PLACEBO USED

“regular” people from community join (can have multiple diseases)

Allows physicians to use their own judgement

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20
Q

List the disadvantages of pragmatic interventional studies

A

Lost the advantages given by explanatory studies

Loss of control and rigidity

More confounding can occur

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21
Q

What are the elements of interventional clinical trial in which it may prove causation?

A

Has the strongest evidence = causation

Must go through FDA approval

Has randomization, exposure and intervention

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22
Q

How many randomizations occur in a simple study and when are they used?

A

Randomization occurs once, used usually to test a single hypothesis or begin with the effect of one drug

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23
Q

How many times does randomization occur in a factorial study and when it the study used?

A

Once initially, then later on.

Usually used to test multiple hypothesis at the same time

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24
Q

What’s an advantage of factorial design study?

A

Improves the efficiency for answering clinical Qs

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25
Q

What are the disadvantages for factorial study designs? (4)

A

Requires larger sample size

Higher risk for people dropping out

Increased complexity

May restrict generalizability of results

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26
Q

What is unique about a parallel study design?

A

No switching/crossover occurs after the initial randomization (can be a simple or factorial study)

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27
Q

What is unique about a cross-over study design?

A

Groups can crossover from one intervention to another during the study

This allows for a smaller sample size

Between and within group comparisons are possible

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28
Q

What are the disadvantages of crossover study designs?

A

Only suitable for long-term conditions which are not curable or which treatment provides short-term reliet

Longer duration

Carry-over effects during cross-over (wash-out required; which prolongs study)

Complexity in data analysis

Treatment-by-Period interaction - difference in effects of treatments during diff time periods

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29
Q

What is the selection criteria for Observational studies?

A

Exposed vs. Non Exposed

Case vs. Control

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30
Q

What is the selection criteria for Interventional Studies?

A

Inclusion vs. Exclusion

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31
Q

What selection criteria impacts generalizability of interventional studies?

A

External Validity

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32
Q

What characteristics of a study must go through a full board review by the IRB?

A

All Interventional Studies

Those that have more than minimal/low risk to patients; all medically related studies

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33
Q

What characteristics of a study must go through an exempt board review by the IRB?

A

Those that have low to no risk to the patients

i.e. use of existing data and/or specimens

No patient identifiers

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34
Q

What characteristics of a study must go through an expedited board review by the IRB?

A

Those that have minimal risk and/or no patient identifiers

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35
Q

What are the 3 Guiding Principles of the Belmont Report?

A

Respect for persons - research should be voluntary

Beneficence - risks of the research are justified by potential benefits

Justice - risk and benefits are equally distributed

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36
Q

What are the types of outcomes that can occur in an intervention trial that are used in the conductance of a study?

A

Primary - initial hypothesis is used for the conduction of the study

Secondary/Tertiary/etc. - generation of future hypothesis; less important than primary; no expectations

Composite - combines multiple endpoints into a single outcomes

Patient-Oriented - most clinically relevant & important to the patient & family (death, hospital stay, quality of life)

Surrogate Markers - direct endpoints, i.e. hypertension for risk of stroke, high cholesterol for risk of heart attack, etc.

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37
Q

What are the 2 forms of group allocation in conductance of an interventional clinical trial?

A

Random and NonRandom

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38
Q

What occurs during nonrandom group allocation in interventional studies?

A

There is not an equal chance of subjects being place into each of the groups.

There is no equal probability of subjects being selected or assigned to each group

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39
Q

What occurs during random group allocation in interventional studies?

A

There is an equal chance of subjects being placed into each group; may use a program that utilizes random numbers

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40
Q

What are the two purposes of randomization? Which one is the primary purpose?

A

To eliminate bias <– primary

To try and make groups as equal as possible

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41
Q

Define randomization

A

The attempt to reduce systematic differences/bias between groups which can have an impact on the results/findings

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42
Q

What are the 3 types of randomization?

A

Simple

Blocked

Stratified

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43
Q

What does simple randomization ensure?

A

That you have an equal probability during study group allocation within one of the study groups

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44
Q

What does blocked randomization ensure?

A

That there is an equal number within each intervention group

Researcher does not know (if so = bias); usually an outsider is in control of the randomization process

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45
Q

What does stratified randomization ensure?

A

That there is a balance within the known confounding variables (characteristics)

i.e. want equalness in factors such as age, sex, etc.

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46
Q

Define post-hoc survey

A

Surveys done at the end of the study to find out if subject is able to determine which interventional group they belonged to.

Want a low predictability

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47
Q

Define an open-label study

A

An interventional study in which both researcher and subject know which intervention the subject is recieving

Usually investigator just wants to study the effects of something, and not necessarily other factors that are related to its effect

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48
Q

Define placebo/dummy treatment

A

Inert treatment that’s made to look identical to the active treatment

i.e. dosage frequency, dosage amount, etc.

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49
Q

What is a double-dummy treatment?

A

More than one placebo is used

Requires equal placebo treatment

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50
Q

What is the placebo effect?

A

When a condition improves while subject is given placebo, usually due to power of suggestion or because care/attention is being given

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51
Q

What is a run-in/lead-in phase?

A

A phase before a study begins where subjects are given a placebo to see if they are able to comply and to determine a new base-line of disease by “washing out” existing medication

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52
Q

When does wash-out occur during a study?

A

Usually during the middle

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53
Q

When is it acceptable to use post-hoc analysis?

A

When it is planned to be implemented before the study even begins

After the study you try to find a difference in the outcomes that may have occurred

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54
Q

What is an add-in number

A

The anticipated amount of drop-outs or lost to follow-ups

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55
Q

What are the 2 ways in which drop-outs/lost to follow-ups are dealth with?

A

Keep their data (intent to treat); either use the last data before they left, of convert all subsequent info to a null-effect/no benefit

Disregard the data and remove from study

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56
Q

What are the positive impacts of intent-to-treat studies? (3)

A

Preserves the randomization process

Preseves baseline characteristics and group balance

Maintains statistical power

57
Q

Define per-protocol/efficacy analysis

A

Pre-define a compliance/a level of completeness that subjects must adhere to

Usually 80-90% completion

Otherwise, data not included

58
Q

How does a “mixing of effects” come about in an interventional study?

A

When the investigator allows subjects to switch groups and where ever they end up is where they are evaluated

“As Treated”

A way to handle drop-outs of lost to follow-ups

59
Q

What are the ways that an investigator can assess the compliance/adherence of a subject?

A

Bottle counter-tops

Measuring drug levels

Pill counts at each visit

60
Q

What are methods done to improve adherence/compliance?

A

More frequent follow-ups and communication

Treatment alarms/notifications

Dosage containers

61
Q

What is one aspect in which observation and interventional studies have in common?

A

Both randomly select their groups and can use drugs in the study

62
Q

Case-control studies are dependent upon the person’s

A

Disease status

63
Q

Common uses for a case-control study

A

Testing for multiple exposures compared to 1 outcome

Disease is rare

If there is an outbreak

Time/cost effective

To determine odds and OR

Dynamic populations

If disease has long induction/latent period

When there are ethical concerns in interventional study

64
Q

What type of data is useful when selecting cases?

A

Accurate, medically reliable and efficient

Best when clinically supportive and definable by using published professionally recognized and accepted diagnostic criteria or from multiple sources of data

65
Q

What do you want to avoid during selection of cases for a study?

A

Misclassification error

66
Q

A control group gives investigator information in regards to the:

A

Baseline risk factor of where the diease may have started from/where the cases are drawn from

67
Q

Selection Bias

A

Bias in which the proper randomization of groups is not achieved and the groups are not a representation of the normal/standard population

Leads to a non-valid association of two variables

Most common bias

68
Q

How can selection bias negatively impact a case-control study?

A

The odds ratio can end up being the same among the categories (such as age groups); null

69
Q

Cohort studies are based on _____ while case-control studies are based on _____

A

Outcome

Exposures

70
Q

Nested Case-Control Study; 3 ways to select controls

A

A case-control study that is done prospective to a cohort study where the those that end up developing the disease/outcome in the cohort study end up being the “case”

Used to evaluate other exposures

Can located by going back to baseline, looking at risk set or survivor sampling

71
Q

3 ways in which control sampling can occur during a nested case-control study

A

Survivor Sampling

Base Sampling

Risk-set Sampling

72
Q

Survivor Sampling

A

When an investigator uses those who did not obtain the disease/outcome during a cohort study, used for the nest case-control study as controls

73
Q

Base Sampling

A

During a nested case-control study when the investigator finds the controls from persons who were non-diseased from the start of a cohort study

74
Q

Risk-Set Sampling

A

During a nested case-control study when investigators obtain their controls from non-diseased persons during study period at the same time the case was diagnosed

75
Q

Define Case-Crossover Study

A

When a subject serves as both a case and a control in a case-control study

Selection bias is not an issue

Addresses the issue of “temporality” (whether cause precedes effects)

Can look at diff amounts of risk levels thruout study

76
Q

What are the 2 types of matching when conducting a case-control study

A

Individual Matching

Group Matching

77
Q

Individual Matching in Case-Control studies

A

When you select cases based on unique/individual characteristics

78
Q

Group Matching in a Case-Control Study

A

Performed when you want the same characteristics within case and control groups

Must select cases first

Do not want to select based on a risk factor otherwise won’t be able to differentiate

i.e. 30% beautiful black women cases, so want 30% beautiful black women controls

79
Q

What information do you know and must determine in a 2x2 table when doing case-control studies?

A

You know the outcome, but not the exposure/risk factor, therefore you know the total number (A+C), but you do not know the value of A or C independently

80
Q

What is the selection criteria of subjects based upon in observational study designs?

A
  1. Case and control
  2. Exposed and non-exposed
81
Q

What is the selection criteria of subjects in interventional study designs?

A

Must have Inclusion and Exclusion

Inclusion-characteristics to be in the study

Exclusion-characteristics where they cannot be in the study

82
Q

Benefits of having exclusion and inclusion criteria

A

Increases the likelihood of producing reliable and reproducable results and decreases the likelihood of causing harm to the patients

83
Q

List all observational studies in order of increasing evidence

A

Cases - reports & series

Ecological

Cross-sectional

Case-Control

Cohort

84
Q

Which studies of observational are analytical?

A

Cohort

Case-Control

Cross-Sectional

85
Q

Define external validity

A

How well the data of the study can be externalized to the general population, beyond the study population = generalizability

86
Q

Internal Validity

A

Whether or not you can make inferences based on the findings within the study; whether a conclusion is valid or not

Coffee drinking and lung cancer example; coffee drinkers are more likely to smoke so coffee drinking is not the cause

87
Q

Descriptive Epidemiology/studies

A

An attempt to understand a population’s health status by using descriptive elements; age, sex, race, etc.

88
Q

Surrogate Markers/End points

A

Usually physiological effects that can cause disease

i.e. cholesterol levels for heart disease, blood pressure for hypertension

89
Q

Analytical studies

A

Attempt to analyze two comparisons groups

90
Q

When is it necessary to use a sample as oppossed to population in a study?

A

When studying a complete population is not feasible

91
Q

What is one of the most common bias?

A

Selection bias

92
Q

Who enforces the rules and regulations of the IRB?

A

Office of Human Research Protections

93
Q

Examples of patient-oriented outcomes

A

Things that the patient cares about; best methodological study

Morbidity, symptom improvement, cost reduction, quality of life

94
Q

“Run-In”/”Lead-in” Phase

A

Occurs before a study begins when subjects are blindly given one or more placebos for initial therapy during a defined time period to determine a “new” base-line of disease (standartization)

Able to assess study protocol compliance

Able to wash-out any exisiting medication

95
Q

4 Proper Steps in Selecting Cases for a case-control study

A
  1. Be consistent
  2. Select Objectively
  3. Be Accurate
  4. Validity
96
Q

Define efficacy and state which phase a drug’s efficacy is usually assessed

A

Obtaining a desired/intended result; usually during Phase 2

97
Q

When would single-blind masking be used

A

When the study is objective as opposed to subjective; therefore investigator isn’t interacting with the subjects; so it’s ok for them to know which groups subjects are being allocated

Subjects do not know which group they’re in

98
Q

When is it necessary to use double-blind masking?

A

When investigator is interacting with subjects; therefore someone outside of the study must know which intervention groups were given what

99
Q

Baseline Risk Factor

A

Where the disease started from; what the initial risk factor was

100
Q

What are the advantages of using intent-to-treat studies?

A
  1. The randomization process is preserved
  2. Preserves baseline characteristics and group balance at baseline which controls for known and unknown confounders
  3. Maintains stat power (original sample size)
101
Q

List the 3 ways used to handle drop-outs/lost-to-follow ups

A
  1. Intent to treat
  2. As Treated
  3. Ignore them (include only those that finished; compliance is pre-defined 80-90%)
102
Q

What is a measure of association that can be assessed in case control studies?

A

Odds Ratio

103
Q

Can case-control studies be prospective?

A

NO - Always retrospective

104
Q

What is a descriptive study

A

Study where data is collected without any changes to the environment; No manipulation of variables

Case-Control,

105
Q

In case-control studies, Internal validity is dependent upon the selection of ____

A

Controls

Must have a good control group in determining whether a conclusion is valid or not

106
Q

Sources in which you can select controls for a case-control study (3)

A
  1. Industry/Organization
  2. Family/Spouses/Friends

Ensures similarity in genetics, environmental, etc.

  1. Outbreak-sources of Control

Were involved in the same event

107
Q

What is group allocation based upon in Cohort studies?

A
  1. Exposure status
  2. Commonalities; subjects have something in common
108
Q

What is a measure of association that can be assessed in cohort studies?

A

Risk Ratio

109
Q

Which type of study is good for measuring incidence rates?

A

Prospective Cohorts….why?

110
Q

What are the 3 different types of cohort studies?

A

1. Birth Cohorts

2. Inception Cohort - people that are assembled at a given point based on some common factor

i.e. Nurse’s Health Study

3. Exposure Cohort i.e. 9/11 attack

111
Q

What are the 3 sources where unexposed persons can be located in cohort studies?

A
  1. Internal - same cohort but were unexposed (best method); if there are diff levels of exposure, pick lowest exposed
  2. General Population
  3. Comparison Cohort - match according the common characteristics
112
Q

General advantages of Cohort studies

A

Good for multiple outcomes of one exposure

Rare exposures

Calculating risk and RR’s

Less expensive than interventional

When ethical issues cause limitations

Represents Temporality (Prospective)

When you have a long induction/letent period (Retrospective)

113
Q

Advantages of Prospective Cohort Studies

A

More control over certain data collection processes

Temporality

Can be easier to track and follow-up on patients

114
Q

Disadvantages of Prospective Cohort Studies

A

Not good for long induction/latency

Time, Expense, lost to follow-ups

Not efficient for rare diseases (good in case-control)

The exposure or amount of can change over time

115
Q

Induction vs. Latency

A

Induction you display symptoms

Latency you get clinically diagnosed

116
Q

Define cross-sectional studies

A

Observational, analytical and descriptive studies which examine relationships of health/disease to other variables of interest at the same time by studying large populations

117
Q

State the other term that cross-sectional studies can be labeled as

A

Prevelance study; due to the study being at a snapshot in time

118
Q

3 Variables that cross-sectional studies determine their study upon

A
  1. Person - that have the variable of interest i.e. exposure/disease
  2. Place - choose a geographical region
  3. Time - pick a specified time period
119
Q

List the advantages of cross-sectional studies

A

Quick and easy

Useful for determining prevelance of disease/RFs, measuring current health status and planning for health service across populations, & evaluating differences in sub-groups within a pop at a given time

IRB approval is short and quick

Obtain data across large populations

120
Q

Disadvantages of Cross-sectional studies

A

Temporal relationships is hard to determine since study is short/snapshot

Difficult to study diseases w/ low frequency

Survival association is difficult to determine if prevelance personnel are survivors

121
Q

What are the 2 cross-sectional approaches in obtaining data?

A
  1. Collect data on each member of the population
    i. e. pregnancy-smoking data from KC Health Dept. (frequent in city/state evaluations)
  2. Take a sample of the populations and draw inferences of the remainder
122
Q

What is the sampling scheme most commonly used in cross-sectional studies? What are the subtypes?

A

Probability Samples

  1. Simple random samples; random # generator to select samples
  2. Stratified random samples; mutually exclusive strata (subgroups; age, sex, etc.) = oversampling is done on minorities
123
Q

What are the common approaches to the collection of new information in cross-sectional data?

A
  1. Questionnaires/Surveys
  2. Physical assessments (lab, clinical, medical records, etc.)
124
Q

List the 5 large scale cross-sectional studies

A
  1. NHANES - National Health and Nutrition Examination Survey
  2. NHIS - National Health Institute Survey
  3. NAMCS - National Ambulatory Care Survey
  4. NHCS - National Hospital Care Survey
  5. BRFSS - Behavioral Risk Factor Surveillance System
125
Q

Describe methods, purpose, etc. of NHANES

A

Surveys health and nutritional status of adults and children

Source pop. is selected to represent US population of all ages

Interview Qs related to demographic, socioeconomic, dietary, health-related, etc.

Exams = medical, dental, physiological measurements, lab tests

Oversamples minorities

126
Q

Describe methods, purpose, etc. of NHIS

A

Info. via non-institutionalized/non-hospitalized subjects

Source pop. to represent US pop of all ages

Household Interviews

Not as involved and in depth like NHANES

127
Q

Describe methods, purpose, etc. of NAMCS

A

Surveys those who are outpatient/ambulatory = no overnight stays in hospital

Surveys obtain info. about provision and use of ambulatory medical care services

Non-federal, non-office-based

Involves patients who are seeking health care

128
Q

Describe methods, purpose, etc. of NHCS

A

Combined national survey describes nation patterns of healthcare delivery in non-federal hospital based settings such as:

Inpatient departments and institutions

ER visits, outpatient depts., ambulatory surgery centers

129
Q

Describe methods, purpose, etc. of BRFSS

A

Telephone surveys assessing health risk behaviors, preventative health practices, & health care access primarily related to chronic disease & injury

Adults and children

Monthly data collected

Youth BRFSS done in schools

130
Q

Define Sensitivity

A

How well a test can detect presence of disease when the disease IS actually present

TP/TP+FN

131
Q

Define Specificity

A

How well a test can detect absence of disease when the disease IS actually absent

Not predective

TN/TN+FP

132
Q

Define Positive Predictive Value

A

How accurately a positive test predicts the presence of disease

PPV = TP/TP+FP

133
Q

Define Negative Predictive Value

A

How accurately a negative test predicts the absence of disease

NPV = TN/TN+FN

134
Q

Diagnostic accuracy/Diagnostic precision

A

Proportion of time that a patient is correctly identified as either having a disease or not having a disease with a (+) or (-) test

TP + TN / TP+FP+TN+FN

135
Q

An LR+ >10 and a LR- <10 demonstrates that:

A

A test is most beneficial

If equal to 1 = NOT beneficial

136
Q

Define Receiver Operator Curves

A

Graph used for screening tests to show a relationship b/w sensitivity and specificity for tests with numerical (continuous) outcomes

137
Q

Define validity

A

Test’s ability to discern between those that DO and DO NOT have the disease

“Telling the Truth”

138
Q

Reliability

A

Test’s ability to give the same result on repeated uses

A valid test is always reliable, a reliable test is not always valid

KCUMB Epidemiology - Erin (3 decks)

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