PU520: Principles of Epidemiology Unit 5 Analytic Epidemiology: Types of Study Designs Flashcards

1
Q

Briefly describe analytic epidemiology and descriptive epidemiology.

A

Analytic epidemiology is concerned with the etiology (causes) of diseases and other health outcomes.

Descriptive epidemiology classifies a disease or other health outcome according to the categories of person, place, and time.

Attached photo is overview for these flash cards and chapter.

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2
Q

What are the two subcategories of analytic studies?

A

Observational and experimental (interventional) studies.

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3
Q

What does observational studies include? (3)

A

Ecological, case-control, and cohort studies.

The investigator does not have control over the exposure factor. Additionally, the investigator is unable to assign subjects randomly to the conditions of an observational study.

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4
Q

What are the three types of cohort studies?

A

Prospective, retrospective, and historical prospective.

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5
Q

What are the two types of experimental (interventional) studies?

A

Clinical trials and community interventions.

Experimental designs enable the investigator to control who is exposed to a factor of interest (for example, a new medication) and to randomly assign the participants into the groups used in the study. Random assignment of subjects is used in pure experimental designs.

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6
Q

What provides a degree of control over confounding?

A

Random assignment of subjects to study groups.

When the results of a study have been distorted by extraneous factors, confounding is said to have taken place.

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7
Q

Information on the seven factors that characterize study designs

A

N/A

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8
Q

When characterizing study design, in what type of studies would you typically only make one observation?

What about studies where you’d make more than one observation?

A

One observation is typically the approach of cross-sectional, many ecologic, and most case-control studies.

Two or more observations are typically made in cohort and experimental studies.

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9
Q

Why does directionally of exposure vary in research design?

A

In a retrospective research design, information is obtained about exposures in the past and is used in case-control studies. People are queried about exposure that leads to the disease. This can be collected in other ways like medical records.

In a single point of time, as in a survey, can take a snapshot of a population. Single point in time is a time reference for a cross-sectional study.

In prospective approaches, information about study outcomes is collected in the future after the exposure has happened-experimental and cohort studies. Prospective cohort studies the investigator starts with disease-free groups for which exposures are determined first. The groups are then followed prospectively for disease development.

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10
Q

What are the two ways of data collection? (Answer is not a specific term)

A

Either from existing research or data created through new research.

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11
Q

Why is timing in data collection important?

A

Subjects may fall off when studies extend for longer periods of time, forgetfulness of previous exposures, etc.

Timing really can be whenever the investigator wants.

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12
Q

In epidemiologic research design, what is typically the unit of observation for almost all studies?

When is this unit different? (Specfic type of study)

A

Most designs employ the individual as the unit of observation.

Ecologic study designs employ the group as the unit of observation. (or called the unit of analysis)

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13
Q

What is the jist of availability of subjects in research design?

A

Some classes of people may not be available for epidemiologic research, to include ethical reasons.

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14
Q

What is a study in which the units of analysis are populations or groups rather than individuals?

A

Ecologic Study

The groups that are selected might be residents in a specific geographic location–state, country, census tracts, counties, etc.

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15
Q

What involves an assessment of the association between exposure rates and disease rates during the same time period?

A

Ecologic comparison study

In an ecologic study, information about both exposures (explanatory variables) and outcomes is collected at the group level. To illustrate, one could explore “… the relationship between the distribution of income and mortality rates in states or provinces.”

In the hypothetical example of cancer mortality, researchers might hypothesize that people who live in lower-income areas have greater exposure to environmental carcinogens than those who live in higher-income areas, producing differences in cancer mortality.

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16
Q

What is an association between two variables measured at the group level?

A

Ecologic correlation

In the figure, infant mortality rates and average number of children per women are calculated for some African countries, which are the units of analysis. The graph portrays the strong positive linear relationship between fertility and infant mortality in sub-Saharan Africa. Countries that tend to have high infant mortality rates tend to have high birth rates.

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17
Q

Recall one of the reasons why you’d conduct an ecological study.

A

Individual measurements may not be available for a variety of reasons, but group-level data can be obtained.

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18
Q

What is the data that has already been collected and stored in archives (group measurements) typically called?

A

The group measurements are called aggregate measures and they provide an overall measurement for the level (e.g., group or population) being studied.

Often, ecologic studies are helpful in revealing the context of health—how demographic characteristics and the social environment contribute to morbidity and mortality.

Examples attached.

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19
Q

What are some examples of examples of ecologic studies?

A

Ecologic analysis has been applied to the study of air pollution by examining the correlation of air pollution with adverse health effects such as mortality. Researchers measure the association between average levels of air pollution within a census tract (or other geographic subdivision) with the average mortality in that census tract.

Ecologic studies have also examined the association between water quality and both stroke and coronary diseases.

These studies have been used as well to examine the possible association between use of agricultural pesticides and childhood cancer incidence.

For example, a total of 7,143 incident cases of invasive cancer diagnosed among children younger than age 15 years were reported to the California Cancer Registry during the years 1988–1994. In this ecologic study, the unit of analysis was census blocks, with average annual pesticide exposure estimated per square mile. The study showed no overall association between pesticide exposure determined by this method and childhood cancer incidence rates. However, a significant increase in childhood leukemia rates was linked to census block groups that had the highest use of a type of pesticide known as propargite.

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20
Q

What is a small, relatively permanent statistical subdivision of a county delineated by a local committee of census data users for the purpose of presenting data?

A

Census tracts.

Census tracts nest within counties, and their boundaries normally follow visible features, but may follow legal geography boundaries and other nonvisible features in some instances.

These census tracts ideally contain about 4,000 people and 1,600 housing units.

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21
Q

What is a statistical area bounded by visible features, such as streets, roads, streams, and railroad tracks, and by nonvisible boundaries, such as selected property lines and city, township, school district, and county boundaries?

A

Census block

Another example attached.

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22
Q

What is defined as an erroneous inference that may occur because an association observed between variables on an aggregate level does not necessarily represent or reflect the association that exists at an individual level?

A

Ecologic (or ecological) fallacy

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23
Q

Review: Advantages and Disadvantages of Ecological Studies

Advantages
- May provide information about the context of health.
- Can be performed when individual-level measurements are not available.
- Can be conducted rapidly and with minimal resources.

Disadvantages
- Ecologic fallacy
- Imprecise measurement of exposure

A

N/A

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24
Q

What type of study is one in which subjects are DEFINED on the basis of the presence or absence of an outcome of interest?

A

Case-control study

These studies, since the outcome such as a disease is the criterion for being included in the case group, can examine only a single outcome or a limited set of outcomes.

Case-control studies use a retrospective approach to collect information about exposure to a factor, in which the exposure occurred in the past. One method to determine past exposure is for the investigator to interview cases and controls regarding their exposure history. An advantage of case-control studies is that they can examine many potential exposures, such as exposure to toxic chemicals, use of medications, or adverse lifestyle characteristics. In some variations of the case-control approach, it may be possible to conduct direct measurements of the environment for various types of exposures.

25
Q

What type of study is one in which the cases and controls have been matched according to one or more criteria such as sex, age, race, or other variables on the the basis of the presence or absence of an outcome of interest?

A

Matched case-control study

This can be used in response to confounding.

26
Q

What is a measure of the association between frequency of exposure and frequency of outcome used in case-control studies?

A

Odds ratio (OR)

The OR is called an indirect measure of risk because incidence rates have not been used; instead, the risk of an outcome associated with an exposure is estimated by calculating the odds of exposure among the cases and controls.

The OR is the ratio of odds in favor of exposure among the disease group (the cases) to the odds in favor of exposure among the no-disease group (the controls). This odds ratio is called the exposure odds ratio.

27
Q

How do you interpret an odds ratio?

A

An odds ratio of more than 1.0 suggests a positive association between exposure and disease or other outcome (provided that the results are statistically significant–not a chance association).

An odds ratio of 2.1 suggests that the odds of the disease are about two times higher among the exposed persons than among the nonexposed persons.

28
Q

In some instances, you may get an OR of less than 1.0 which may indicate what?

A

The exposure might be a protective factor.

A protective factor is a circumstance or substance that provides a beneficial environment and makes a positive contribution to health.

(Hypothetical example of a protective factor: We want to find out if heavy exercise is associated with early mortality among heart attack patients. One possibility is that exercise might strain the heart and cause the patient to die. In a case-control study, the OR should be greater than 1.0. Instead we find that the OR is less than 1.0, because mortality is lower among heart attack patients who exercise in comparison with non-exercisers. We conclude that exercise is a protective factor for heart disease mortality among heart attack patients.)

29
Q

What does it mean when your OR is 1?

A

There is no association between exposure and outcome (risk of disease vs protective factor)

30
Q

Review: Advantages and Disadvantages of case-control studies

Advantages
- Can be used to study low-prevalence conditions
- Relatively quick and easy to complete
- Usually inexpensive
- Involve smaller numbers of subjects

Disadvantages
- Measurement of exposure may be inaccurate
- Representativeness of cases and controls may be unknown
- Provide indirect estimates of risk by OR
- The temporal relationship between exposure factor and outcome cannot always be ascertained.

A
31
Q

In comparison to cross-sectional studies, why might case-control studies provide more complete exposure data?

A

When data is collected from the friends and relatives of cases who died of a particular cause.

32
Q

What study tracks the incidence of a specific disease (or other outcome) over time?

A

Cohort study

Cohort is defined as a population group, or subset thereof (distinguished by a common characteristic), that is followed over a period of time.

33
Q

What are some variations of cohort studies?

A

Prospective cohort studies
Retrospective cohort studies
Population-based cohort studies
Exposure-based cohort studies

34
Q

Give some examples of cohorts.

A
  • Birth or age cohort (e.g., the baby boom generation; generations X or Y; millennials)
  • Work cohort (people in a particular type of employ-ment studied for occupational exposures)
  • School/educational cohort (people who graduated during a particular year)
35
Q

Out of the four variations of cohort studies, which two are the major categories?

A

Population-based cohort studies
Exposure-based cohort studies

36
Q

What major cohort study leverages information from a total population or representative sample of a population?

A

Population-based cohort study

An example of a population-based cohort study is the Framingham, Massachusetts study of coronary heart disease initiated in 1948.

37
Q

What major cohort study compares cohorts with or without different exposures?

A

Exposure-based cohort study

A simple example is a cohort study with two expo-sure groups (exposed and not exposed).

38
Q

What is a cohort study design were subjects are classified to their exposure to a factor of interest and are then observed over time to document the occurrence of new cases (incidence) of disease or other health events?

A

Prospective cohort study

At the inception or baseline of a prospective cohort study, participants must be certified as being free from the outcome of interest. For this reason cohort studies are not helpful for researching dis-eases that are uncommon in the population; during the course of the cohort study, only a few cases of the disease may occur.

39
Q

What are cohort studies a type of?

A

Prospective or longitudinal design.

Meaning that subjects are followed over an extended period of time. Using cohort studies, epidemiologists are able to evaluate many different outcomes (such as causes of death or development of chronic diseases) but few exposures.

The reason is that the exposure is the criterion used to select subjects into a cohort study; for this reason, researchers are unable to examine more than one or two exposures in a single study.

40
Q

What is a variation of cohort study that is one that makes use of historical data to determine exposure level at some baseline in the past; follow-up for subsequent occurrences of disease between baseline and the present is performed?

A

Retrospective cohort study – uses retrospective assessment of exposure.

An example of a retrospective cohort study would be one that examined mortality among an occupational cohort such as shipyard workers who were employed at a specific naval yard during a defined time interval (e.g., World War II).

41
Q

How are retrospective cohort studies different from a case-control study?

A

Because an entire cohort of exposed individuals is examined.

In contrast, a case-control study makes use of a limited number of cases and controls who usually do not represent an entire cohort of individuals such as a group of people employed by a specific company.

42
Q

What is a measure of association used in cohort studies called?

A

Relative risk (RR), the ratio of the incidence rate of a disease or health outcome in an exposed group to the incidence rate of the disease or condition in a nonexposed group.

As noted previously, an incidence rate may be interpreted as the risk of occurrence of an outcome that is associated with a par-ticular exposure. The RR provides a ratio of two risks—the risk associated with an exposure in comparison with the risk associated with non-exposure.

We may interpret relative risk in a manner that is simi-lar to that of the odds ratio. A relative risk of 1.0 implies that the risk (rate) of disease among the exposed is not different from the risk of disease among the nonexposed. A relative risk greater than 2.0 implies that the risk is more than twice as high among the exposed as among the nonexposed. In other words, there is a positive association between exposure and the outcome under study.

Sometimes a relative risk calculation yields a value that is less than 1.0. If the relative risk is less than 1.0 (and statistically significant), the risk is lower among the exposed group; for example, a relative risk of 0.5 indicates that the exposure of interest is associated with half the risk of disease. This level of risk, i.e., less than 1.0, sometimes is called a protective effect.

43
Q

What are the two measures of risk difference?

A

Attributable risk difference
Population risk difference

44
Q

What, in a cohort study, refers to the difference between the incidence rate of a disease in the exposed group and the incidence rate in the nonexposed group?

A

Attributable risk difference

Returning to the calculation example shown in Table 5, the incidence rate (expressed as rate per 1,000) in the exposed group was 28.04 (rounded off) and the incidence rate (expressed as rate per 1,000) in the nonexposed group was 3.32 (rounded off). The attributable risk is the difference between these two incidence rates (28.04 per 1,000 − 3.32 per 1,000) and equals 24.72 per 1,000. This is the incidence rate associated with exposure to the solvent.

45
Q

What provides an indication of the benefit to the population derived by modifying a risk factor, which is a measure that assesses differences in rates?

A

Population risk difference

Defined as the difference between the rate of disease in the non-exposed segment of the population and the overall rate in the population.

46
Q

Review: Advantages and Disadvantages of cohort studies

Advantages
- Permit direct observation of risk
- Exposure factor well defined
- Can study exposures that are uncommon in the population
- Temporal relationship between factor and outcome is known.

Disadvantages
- Expensive and time consuming
- Complicated and difficult to carry out
- Subjects may be lost to follow-up during the course of the study
- Exposures can be misclassified

A

Regarding advantages, cohort studies provide information
about incidence rates of disease and other health outcomes and thus provide direct assessment of risk. Exposure factors are defined at the inception of the study and are used as the basis for selection into the study. Cohort studies can examine expo-sures that are uncommon in the population, such as those that might be experienced by occupational groups that work with toxic chemicals and other hazardous substances. Finally, temporality between exposure variables and outcome is known; for example, in prospective cohort studies, assessment of expo-sures occurs before assessment of outcomes. The disadvantages of cohort studies include the fact
that they are expensive and may require several years before useful results can be obtained. Methodologically, they are difficult
to carry out; frequently, the epidemiologist must
account for large numbers of subjects, maintain extensive records, and follow subjects closely. Because cohort studies take place over a long period of time, subjects may be lost to follow-up because of dropping out, moving, or dying. Lastly, it is important to ascertain whether exposures have been correctly identified in cohort studies; one scenario in which misclassification of exposures can occur is in retrospective cohort studies because accurate exposure records may no longer be available.

47
Q

What are the two classes of experimental (intervention) studies?

A

Clinical trials and community trials

48
Q

What is an investigation involving intentional change in some aspect of the status of the subjects, e.g., introduction of a preventive or therapeutic regimen or an intervention designed to test a hypothesized relationship?

A

Intervention study

48
Q

What refers to a research activity that involves the administration of a test regimen to humans to evaluate its efficacy or its effectiveness and safety?

A

Clinical trial

The term clinical trial has several meanings that can range from the early trials conducted in history without the benefit of control or comparison groups to randomized controlled trials. Early clinical trials, such as those used to treat battlefield wounds or cure the nutritional disease scurvy, did not use control groups.

Another example of an early forerunner of a clinical trial was Edward Jenner’s development of his smallpox vaccine; Jenner did not have a control group.

Clinical trials are conducted in three, and sometimes more, phases. Imagine a clinical trial for a new vaccine. The first phase might involve initial human testing for safety. The second phase could evaluate the immune responses of a limited group of vaccine recipients. The third phase would be a large-scale study involving randomization of participants to test and control conditions.

48
Q

What type of clinical trial is designed to test preventative measures?

What type of clinical trial is designed to evaluate new treatment methods?

A

Prophylactic trials (no outcome or disease)

Therapeutic trials (has the outcome or disease)

49
Q

What is defined as “[a] in which subjects are randomly allocated into groups, usually called test and control groups, to receive or not to receive a preventive or a therapeutic procedure or intervention?

A

Randomized controlled trial (RCT)

The results are assessed by com-parison of rates of disease, death, recovery, or other appropriate outcome in the study control groups.

In com-parison with observational studies, a randomized controlled trial is considered the most scientifically rigorous study design and to have the highest level of validity for making etiologic inferences; an RCT can control for many of the factors that affect study designs, including assignment of exposures and biases in assessment of study outcomes.

RCTs are limited to a narrow range of applications; they are not as helpful for study-ing the etiology of diseases as are observational designs. For obvious ethical reasons, it is not possible for an investigator to run experiments that determine whether an exposure causes disease in human subjects.

49
Q

What is defined as a process whereby chance determines the subjects’ likelihood of assignment to either an intervention group or a control group?

A

Randomization

Each subject has an equal probability of being assigned to either group.

49
Q

What is a crossover design?

A

Participants may be switched between or among treatment groups; an example is the transfer of members of treatment group A (e.g., test group) to treatment group B (e.g., placebo group—defined in the following section), or vice versa.

50
Q

Components of RCT

A

N/A

51
Q

What is an intervention designed for the purpose of educational and behavioral changes at the population level?

A

Community intervention (community trial)

In most situations, community interventions use quasi-experimental designs.

52
Q

What is a type of research in which the investigator manipulates the study factor but does not assign individual subjects randomly to the exposed and nonexposed groups?

A

Quasi-experimental study.

Some quasi-experimental designs assign study units (e.g., communities, counties, schools) randomly to the study conditions. In addition, some quasi-experimental designs may not use a control group or may use fewer study subjects (or other units) that are randomized into the study conditions than in a randomized controlled trial.

The operation of community trials is expensive, complex, and time consuming. An important component of community interventions is program evaluation, the determination of whether the program meets stated goals and is justified economically.

A specific example of a community trial was a test of the efficacy of fluoridation of drinking water in preventing tooth decay. During the 1940s and 1950s, two comparable cities in New York state—Newburgh and Kingston—were contrasted for the occurrence of tooth decay and related dental problems among children. Newburgh had received fluoride for about one decade and Kingston had received none.

In Newburgh, the frequency of such problems decreased by about one-half in comparison to the period before fluoridation. Over the same period, those dental problems increased slightly in Kingston. This study is an example of a quasi-experiment because the “subjects” (cities) were assigned arbitrarily and not randomly.

There are many other examples of community trials. One is the Stanford Five-City Project, which sought to reduce the risk of cardiovascular diseases. This trial was a media-based campaign directed at Monterey and Salinas, California. Control cities were Modesto and San Luis Obispo, with Santa Maria selected as an additional comparison city. Another example is the Community Intervention Trial for Smoking Cessation (COMMIT), which began in 1989. This intervention trial involved 11 matched pairs of communities throughout the United States. The trial aimed to promote long-term smoking cessation.

53
Q

What are the three factors, aside from the actual study design, that can affect the confidence that one may have in the results of a study?

A

External validity - refers to one’s ability to generalize from the results of the study to an external population. Some studies may select sub-jects by taking a sample of convenience (a “grab bag” sample) or by using random samples of a population. Random samples are generally more representative of the parent population from which they are selected and thus are more likely to demonstrate external validity than are samples of convenience.

Nevertheless, random samples may depart from (be unrepresentative of) their parent populations. Sam-pling error is a type of error that arises when values (statistics) obtained for a sample differ from the values (parameters) of the parent population.

Internal validity - Care must be taken in the manner in which a study is carried out. Internal validity refers to the degree to which the study has used methodologically sound procedures. For example, in an experimental design, subjects need to be assigned randomly to the conditions of the study. Appropriate and reliable measurements need to be taken. Departures from acceptable procedures
such as those related to assignment of subjects and measurement as well as other errors in the methods used in the research may detract from the quality of inferences that can be made.

Bias - Several types of bias can affect the results of a study.

54
Q

Bias is defined as a systemic deviation of results or inferences from truth.

Explain the following biases:

Hawthorne Effect

Recall Bias

Family Recall Bias

Selection Bias

Healthy Worker Effect

Confounding

A
  • Hawthorne effect refers to participants’ behavioral changes as a result of their knowledge of being in a study.
  • Recall bias refers to the fact that cases (subjects who participate in the study) may remember an exposure more clearly than controls. (Particularly relevant to case-control studies)
  • Family recall bias is a type of recall bias that occurs when cases are more likely to remember the details of their family history than are controls. The consequence of recall bias can be an overestimation of an association between an exposure and a health outcome.
  • Selection bias is defined as bias in the estimated association or effect of an exposure on an outcome that arises the from procedures used to select individuals into the study.

An example of selection bias is the healthy worker effect, which may reduce the validity of exposure data. Occupational epidemiologist Richard Monson wrote that the healthy worker effect refers to the “observation that employed populations tend to have a lower mortality experience than the general population.”

The healthy worker effect may have an impact on occupational mortality studies in several ways. People whose life expectancy is shortened by disease are less likely to be employed than healthy people. One consequence of this phenomenon would be a reduced (or attenuated) measure of effect (e.g., odds ratio or relative risk) for an exposure that increases morbidity or mortality.

The healthy worker effect may have an impact on occupational mortality studies in several ways. People whose life expectancy is shortened by disease are less likely to be employed than healthy people. One consequence of this phenomenon would be a reduced (or attenuated) measure of effect (e.g., odds ratio or relative risk) for an exposure that increases morbidity or mortality.

  • Confounding is another example of a type of study bias. Confounding denotes “… the distortion of a measure of the effect of an exposure on an outcome due to the association of the exposure with other factors that influence the occurrence of the outcome.”1

Confounding means that the effect of an exposure has been distorted because an extraneous factor has entered into the exposure–disease association. Confounding factors are those that are associated with disease risk (expo-sure factors) and produce a different distribution of outcomes in the exposure groups than in the comparison groups. An example of a potential confounder is age. Here is a possible scenario: An epidemiologist might have studied the relation-ship between exposure and disease in an exposed group and a nonexposed group; the exposed group might have higher rates of morbidity and mortality than the nonexposed group. If the study participants in the exposed group are older than those in the nonexposed group, the age difference could have caused the rates of disease to be higher in the exposed group. (Keep in mind that age is associated with morbidity.) The existence of confounding factors such as age might lead to invalid conclusions regarding exposure–outcome associations.
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