L7 - Descriptive Reports and Observational Study Designs Flashcards

1
Q

Experimental

A

Investigators control who receives the intervention and how
Helps to determine Cause and effect
Can use randomization and controls to minimize bias and confounding

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2
Q

Study Types

A

Experimental
Observational
Descriptive

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3
Q

Observational

A

Does not involve investigator intervention
Compares outcomes from naturally occurring differences between populations
Can test for associations, but not causality

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4
Q

Descriptive

A

Allows associations to be considered
Forms initial hypothesis
Better to have big sample

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5
Q

Exposure

A

In epidemiology, indicates potential risk factor

In studies involving drug therapy often means treatment

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6
Q

Outcome

A

In epidemiology, may mean whether disease developed

In studies involving drug therapy, often means whether disease was successfully treated

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7
Q

Prospective

A

Normal
Data are collected forward in time from the date of study initiation

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8
Q

Retrospective

A

Study that analyzes historical (previously collected) data
-Medical records, insurance info, etc

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9
Q

Q: Which is more robust, Prospective or Retrospective?

A

Prospective
-More in control
-In charge of patient recruitment, how the exposure is given, how the data is collected, etc.
-Retrospective this is already done for you - no wiggle room

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10
Q

Bias

A

Systematic deviation from the truth that distorts the results of research
NEVER random
Most common: Selection bias

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11
Q

Types of Selection Bias

A

Referral Bias
Self selection bias
Prevalent bias
-Prevalence: existing cases in a given period
Protopathic
-Effect is treated as a cause

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12
Q

Information and Misclassification BIas

A

Happens when you are collecting data

Misclassification
-When one group of patients is incorrectly classified as the other (i.e. controlled as experimental and vice versa)

Recall bias
-Asking patients about a medication they took last year
-If you had a bad reaction, you are more likely to remember that

Detection bias:
-When investigators investigate a study
-Subconsciously you know who is the treatment group and who is the controlled
-You will focus more on the treatment

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13
Q

Confounding

A

Relationship between treatment and response (or exposure and disease) is actually attributable to another variable (the “confounder”)

Confounder is independently related to BOTH the exposure AND the outcome

If variable is exposed to just one – potential confounder

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14
Q

Descriptive Reports

A

Purpose:
-Document and communicate experience, share ideas, or describe novel treatments and unusual events
Case reports and case series

Ex.
Possible adverse drug reactions
Unusual complications of illness
Surprising presentations of disease
Descriptions of rare treatments

CANNOT test a hypothesis in descriptive reports
-Can only form hypothesis

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14
Q

Advantages and Disadvantages of Descriptive Reports

A

Advantages
-Allow hypotheses to be formed
-Often the first step in exciting discoveries
-Can guide “salvage therapy”

Disadvantages
-Do not always provide detailed explanations
-Do not establish causality or association

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15
Q

Critique points to consider

A

Was enough info given to properly characterize the patient case?
-Should provide complete details surrounding case (“clinical picture”)
-i.e. Age, sex, weight, labs, dose, duration, clinical course, timeline, etc

Did the authors recognize the descriptive nature of the report/series?
-DO NOT draw strong inferences from data
-Is the patient similar to your patient(s)?
-Is the proposed “mechanism” plausible?
-Was adequate background info provided?

16
Q

Role of Observational Studies

A

RCT not feasible due to ethical and/or practical considerations
-Long follow-up required
-Rare outcomes, rare conditions
-Unethical to randomize to alternative treatment
-methodologically impractical
-Lack of background info to support RCT

Evaluation of programmatic effectiveness

Epidemiologic investigations

Large longitudinal/population based studies

17
Q

Role of observational studies cont.

A

Establish ASSOCIATION

More robust observational studies possible
-Advances in health informatics
-Advances in statistical techniques

Controversy
-Association is not causality, but can we ever infer causality from observational studies?

18
Q

Inferring causality in observational studies

A

Potential criteria for implied causal link in epidemiology
-Strength of association
-Consistency upon repetition
- Specificity
Association of outcome is specific to a give exposure
-Time sequence
Exposure must precede the outcome
Note latency period possible for some associations
-Biologic gradient (dose response)
-Plausibility (biologic)
-Coherence of explanation
Association does not seriously conflict about what we already know about the natural progression of the outcome/disease
-Experiment
Association is supported by experimental evidence/natural experiment

19
Q

Observational Studies: Cross-Sectional

A

Purpose: Identify prevalence or characteristics of disease in populations (“prevalence studies)
-Quantitative estimates of the magnitude of a problem
-A single “snap shot” in time

Ex. - A survey of blood lead concentrations in young children of a community to determine the prevalence of lead poisoning

20
Q

Advantages and Disadvantages of Cross-Sectional Studies

A

Advantages
-Efficient and Inexpensive
-All info collected at one time

Confounders
-Population selection

Disadvantages
-Response/participation bias
-Lack of time order relationship
Cannot establish causality

Weakest type of study

21
Q
A