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Flashcards in Reasoning About Design & Execution of Research Deck (94):
1

The Scientific Method
[8]

1. Generate a testable question
2. Gather data and resources
3. Form a hypothesis
4. Collect new data
5. Analyze the data
6. Interpret the data and existing hypothesis
7. Publish
8. Verify results

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FINER Method of Evaluating A Research Question

1. Feasible?
2. Interesting?
3. Novel?
4. Ethical?
5. Relevant?

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FINER Method of Evaluating A Research Question

1. Feasible?
2. Interesting?
3. Novel?
4. Ethical?
5. Relevant?

4

What is a control (standard)?

Conditions that can be applied to act as a method of verifying results

5

What is a control (standard)?

Conditions that can be applied to act as a method of verifying results; used to correct for any influences of an intervention that are not part of an experimental model

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Positive Control

Ensure that a change in the dependent variable occurs when expected

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Negative Control

Ensure that no change in the dependent variable occurs when none is expected

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Negative Control

Ensure that no change in the dependent variable occurs when none is expected

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Placebo Effect

An observed or reported change when an individual is given a sham intervention

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Placebo Effect

An observed or reported change when an individual is given a sham intervention

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Independent Variable

The part of the experiment that is being purposefully manipulated; plotted on the x-axis

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Dependent Variable

The part of the experiment that is being observed; plotted on the y-axis

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Casual Relationship
[If-then Relationship]

When there is a theoretical or known mechanism that links the independent and dependent variables

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Explain a causal relationship.

If the change in the independent variable always precedes the change in the dependent variable AND the change in the dependent variable does not occur in the absence of the experimental intervention.

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Explain a causal relationship.

If the change in the independent variable always precedes the change in the dependent variable AND the change in the dependent variable does not occur in the absence of the experimental intervention.

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Accuracy (Validity)

Quality of approximating the true value

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Precision (Reliability)

Quality of being consistent in approximation

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Why are causal relationships harder to prove in human subject research?

Causal conclusions are harder to determine because circumstances are harder to control

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Why are causal relationships harder to prove in human subject research?

Causal conclusions are harder to determine because circumstances are harder to control

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Types of Human Subject Research

Experimental and Observational Studies

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Types of Human Subject Research

Experimental and Observational Studies

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Randomization

Used to control for differences between subject groups; controls whether a subject is placed into a control group or treatment group

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Randomization

Used to control for differences between subject groups; controls whether a subject is placed into a control group or treatment group

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Blinding

Subject and/or Investigators do not have information about which group the subject is a part of in order to remove bias

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Blinding

Subject and/or Investigators do not have information about which group the subject is a part of in order to remove bias

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Single-Blind Experiments

Only the patient or the assessor is blinded

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Double-Blind Experiments

The investigator, subject and assessor all do not know the subject's group

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Double-Blind Experiments

The investigator, subject and assessor all do not know the subject's group

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Types of Observational Studies

Cohort
Cross-Sectional
Case-Control

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Types of Observational Studies

Cohort
Cross-Sectional
Case-Control
[Look for connections between exposures and outcomes]

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Cohort Studies

Subjects are sorted into two groups based on differences in risk factors

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Cohort Studies

Subjects are sorted into two groups based on differences in risk factors (exposure) and then assessed at various intervals to determine how many subjects in each group had a certain outcome

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Cohort Studies

Subjects are sorted into two groups based on differences in risk factors (exposure) and then assessed at various intervals to determine how many subjects in each group had a certain outcome

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Cross-Sectional Studies

Attempt to categorize patients in different groups at a single point in time

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Case-Control Studies

Identifies the number of subjects with or without a particular outcome and then look backwards to assess how many subjects in each group had exposure to a particular risk factor

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Hill's Criteria

The components of an observed relationship that increase the likelihood of causality in the relationship;

The more criteria that are satisfied, the likelier it is that the relationship is causal

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List of Hill's Criteria

1. Temporality
2. Strength
3. Dose-Response Relationship
4. Consistency
5. Plausibility
6. Consideration of Alternate Explanations
7. Experiment
8. Specificity
9. Coherence

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List of Hill's Criteria

1. Temporality
2. Strength
3. Dose-Response Relationship
4. Consistency
5. Plausibility
6. Consideration of Alternate Explanations
7. Experiment
8. Specificity
9. Coherence

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Temporality

The exposure (independent variable) must occur before the outcome (dependent variable)

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Strength

As more variability in the outcome variable is explained by variability in the study variable, the relationship is more likely to be causal

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Strength

As more variability in the outcome variable is explained by variability in the study variable, the relationship is more likely to be causal

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Dose-Response Relationship

As the study or independent variable increases there is a proportional increase in the response. The more consistent this relationship, the more likely it is to be causal

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Dose-Response Relationship

As the study or independent variable increases there is a proportional increase in the response. The more consistent this relationship, the more likely it is to be causal

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Consistency

The relationship is found to be similar in multiple settings

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Plausibility

There is a reasonable mechanism for the independent variable to impact the dependent variable supported by existing literature

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Plausibility

There is a reasonable mechanism for the independent variable to impact the dependent variable supported by existing literature

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Consideration of Alternate Explanations

If all other plausible explanations have been eliminated, the remaining explanation is more likely

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Experiment (Hill's)

If an experiment can be performed, a causal relationship can be determined conclusively

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Experiment (Hill's)

If an experiment can be performed, a causal relationship can be determined conclusively

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Specifcity

The change in the outcome variable is only produced by an associated change in the independent variable

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Specifcity

The change in the outcome variable is only produced by an associated change in the independent variable

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Coherence

The new data and hypothesis are consistent with the current state of scientific knowledge

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Coherence

The new data and hypothesis are consistent with the current state of scientific knowledge

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Sources of Error

Selection Bias
Detection Bias
Observation Bias
Confounding Variables

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Bias

A result of flaws in the data collection phase of an experimental or observational study

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Confounding

Error during analysis

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Selection Bias

Subjects used for the study are not representative of the target population; must be measured and assessed before any intervention

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Selection Bias

Subjects used for the study are not representative of the target population; must be measured and assessed before any intervention

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Detection Bias

Results from educated professionals using their knowledge in an inconsistent way; prior studies that have indicated correlation between two variables, finding one of them increases the likelihood that the research will search for the second

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Detection Bias

Results from educated professionals using their knowledge in an inconsistent way; prior studies that have indicated correlation between two variables, finding one of them increases the likelihood that the research will search for the second

61

Observation Bias
[Hawthorne Effect]

Posits that behavior of study participants is altered simply because they recognize that they are being studied

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Confounding Variables

A data analysis error in which an incorrect relationship is characterized; for example, researching the effectiveness on drug (X) on a chance of recovery (Y) is affected by gender (Z)

Z confounds the relation between X and Y since Z causes both X and Y

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Confounding Variables

A data analysis error in which an incorrect relationship is characterized; for example, researching the effectiveness on drug (X) on a chance of recovery (Y) is affected by gender (Z)

Z confounds the relation between X and Y since Z causes both X and Y

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4 Core Ethical Tenets

Beneficence
Nonmaleficence
Autonomy
Justice

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Beneficence

Obligation to act in patients best interest

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Nonmaleficence

Obligation to avoid treatments or interventions in which the potential for harm outweighs the potential for benefit

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Nonmaleficence

Obligation to avoid treatments or interventions in which the potential for harm outweighs the potential for benefit

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Autonomy

Responsibility to respect patients decisions and choices about their own healthcare

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Autonomy

Responsibility to respect patients decisions and choices about their own healthcare

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Justice

Responsibility to treat similar patients with similar care and to distribute healthcare resources fairly

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Justice

Responsibility to treat similar patients with similar care and to distribute healthcare resources fairly

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Respect for Persons

Need for honesty between the subject and the research and generally prohibits deception

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Informed Consent

A patient must be adequately counseled on the procedures, risks and benefits and the goals of a study

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Informed Consent

A patient must be adequately counseled on the procedures, risks and benefits and the goals of a study

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Morally Relevant Differences

Differences between individuals that are considered an appropriate reason to treat them differently

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Equipoise

Lack of knowledge about which arm of the research study is better for the subject

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Equipoise

Lack of knowledge about which arm of the research study is better for the subject; treatments have to be equal and not superior to the other

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Equipoise

Lack of knowledge about which arm of the research study is better for the subject; treatments have to be equal and neither can be superior to the other

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Monetary Compensation

Does not impact the decision to participate in the study

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Coercive Influence

The subject loses autonomy to make the decision to participate

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Coercive Influence

The subject loses autonomy to make the decision to participate

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Population

Complete group of every individual that satisfies the attributes of interest

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Population

Complete group of every individual that satisfies the attributes of interest

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Parameter

Information that is calculated using every person in a population

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Sample

Any group taken from a population that does not include all individuals from the population

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Statistic

Information about a sample

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Internal Validity

1

88

External Validity

2

89

External Validity (Generalizability)

2

90

Internal Validity

Identification of causality in a study between independent and dependent variables

91

External Validity (Generalizability)

Ability of a study to be generalized to the population that it describes

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External Validity (Generalizability)

Ability of a study to be generalized to the population that it describes

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Statistical Significance

The low likelihood of the experimental findings being due to chance

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Clinical Significance

The usefulness or importance of experimental findings to patient care or patient outcomes