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Physics and Math Correct Deck > Ch. 11: Reasoning About the Design and Execution of Research > Flashcards

Ch. 11: Reasoning About the Design and Execution of Research Flashcards

1
Q

defn: the scientific method

A

a set of steps that define the appropriate order of events to structure and carry out an experiment

the established protocol for transitioning from a question to a new body of knowledge

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2
Q

what are the 8 steps of the scientific method?

A
  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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3
Q

explain why step 1 of scientific method (generate a testable question) happens?

A

usually occurs after observing something anomalous in another scientific inquiry or in daily life

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4
Q

defn: hypothesis

A

the proposed explanation or proposed answer to our testable question

often in the form of an if-then statement

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5
Q

defn: experimentation vs. observation

A

experimentation: involves manipulating and controlling variables of interest

observation: often involves no changes in the subject’s environment

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6
Q

explain: step 6 of the scientific method (interpret the data and existing hypothesis)

A

consider whether the data analysis is consistent with the original hypothesis

if the data is inconsistent, consider alternative hypotheses

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7
Q

explain: step 8 of the scientific method (verify results)

A

most experiments are repeated to verify the results under new conditions

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8
Q

most questions that begin with what word are too broad to be testable through a single experiment?

A

WHY

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9
Q

what does the if-then format of a hypothesis ensure?

A

that it is testable

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10
Q

func + defn: FINER method

A

for evaluating a research question

a method to determine whether the answer to one’s question will add to the body of scientific knowledge ini a practical way and within a reasonable time period

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11
Q

what are the 5 questions of the FINER method?

A
  1. Is the necessary research study going to be FEASIBLE?
  2. Do other scientists find this question INTERESTING?
  3. Is this particular question NOVEL?
  4. Would the study obey ETHICAL principles?
  5. Is the question RELEVANT outside the scientific community?
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12
Q

what are 4 feasibility concerns that we consider in the FINER method?

A
  1. obtaining necessary supplies
  2. financial constraints
  3. time constraints
  4. the inability to gather enough subjects
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13
Q

what is the reason for controls in basic science research?

A

we use controls because in order to make generalizations about our experiments, we must make sure that the outcome of interest would not have occurred without our intervention

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14
Q

aka: control

A

standard

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15
Q

defn: positive controls + example

A

those that ensure a change in the dependent variable when it is expected

example: in the development of a new assay for detection of HIV, administering the test to a group of blood samples known to contain HIV could constitute a positive control

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16
Q

defn: negative controls + example

A

ensure no change in the dependent variable when no change is expected

example: the same assay as above, administering the test to a group of blood samples known NOT to contain HIV could constitute a negative control

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17
Q

what is a negative control group often used for in drug trials?

A

to assess for the placebo effect

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18
Q

defn: placebo effect

A

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

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19
Q

do we manipulate or measure/observe the independent or dependent variable?

A

MANIPULATE: independent variable

MEASURE/OBSERVE: dependent variable

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20
Q

what is another big advantage to being able to manipulate all of the relevant experimental conditions?

A

basic scientific researchers can often establish causality

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21
Q

what relationship must there be between independent and dependent variables for causality to be investigated?

A

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

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22
Q

what relationship must there be between independent and dependent variables for causality to claimed?

A

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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23
Q

there is minimal experimental bias in basic science research, but what are three ways that bias can appear?

A
  1. generation of a faulty hypothesis from incomplete early data and resource collection
  2. eliminating trials without appropriate background
  3. failing to publish works that contradict the experimenter’s own hypothesis
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24
Q

defn: accuracy (+aka) vs. precision (+aka)

A

ACCURACY = validity = the ability of an instrument to measure a true value

PRECISION = reliability = the ability of the instrument to read consistently or within a narrow range

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25
Q

explain the difference between accuracy and precision by describing a person weighing themselves on a scale

A

170 lb person

ACCURATE but IMPRECISE scale = readings between 150-190 lbs

INACCURATE but PRECISE scale = readings between 129-131 lbs

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26
Q

will an inaccurate or imprecise tool introduce bias or error? why?

A

bias is a SYSTEMATIC ERROR

so only an INACCURATE tool will introduce bias, but an IMPRECISE tool will still introduce error

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27
Q

defn: random error

A

error introduced by random chance

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28
Q

how do we avoid random error?

A

usually overcome by a large sample size

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29
Q

defn: randomization

A

the method used to control for differences between subject groups in biomedical research

uses an algorithm to determine the placement of each subject into either a control group that receives no treatment or a sham treatment or one or more treatment groups

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30
Q

what will a proper randomization algorithm be equal to?

A

a coin toss or die roll

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31
Q

defn + func: blinded

A

the subjects and/or investigators do not have information about which group the subject is in

to remove bias

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32
Q

defn: single-blind experiments

A

only the patient or the assessor is blinded

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33
Q

defn: assessor

A

the person who makes measurements on the patient or performs subjective evaluations

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34
Q

defn: double-blind experiments

A

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

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35
Q

how does the placebo effect differ between the control and treatment group WITHOUT blinding?

A

WITHOUT blinding, the placebo effect would be greatly reduced in the control group, but still be present in the treatment group

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36
Q

examples: binary vs. continuous vs. categorical variables

A

BINARY (yes vs no, better vs worse)

CONTINUOUS (amount of weight lost, percent improvement in cardiac output)

CATEGORICAL (state of residence, socioeconomic status)

37
Q

what are the three types of observational studies?

A
  1. cohort
  2. cross-sectional
  3. case-control
38
Q

what do observational studies often look at?

A

the connections between exposures and outcomes

39
Q

can observational studies demonstrate causality?

A

no, although the tendency toward causality can be demonstrated by Hill’s criteria

40
Q

defn: cohort studies

A

those in which subjects are sorted into groups based on different risk factors (exposures) and then assessed at various intervals to determine how many subjects in each group had a certain outcome

41
Q

defn: cross-sectional studies

A

attempt to categorize patients into different groups at a single point in time

42
Q

defn: case-control studies

A

start by identifying 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

43
Q

defn: Hill’s criteria

A

describe the components of an observed relationship that increase the likelihood of causality in the relationship

44
Q

are all of the Hill’s criteria necessary for a relationship to be causal?

A

no, only the first is necessary, but it is not sufficient

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

45
Q

why should relationships be described as correlations not causation for an observational study?

A

Hill’s criteria do not provide any absolute guideline on whether a relationship is causal

46
Q

what are the 9 Hill’s criteria?

A
  1. temporality
  2. strength
  3. dose-response relationship
  4. consistency
  5. plausibility
  6. consideration of alternative explanations
  7. experiment
  8. specificty
  9. coherence
47
Q

defn: temporality (Hill’s criteria)

A

the exposure (independent variable) MUST occur before the outcome (dependent variable)

48
Q

defn: strength (Hill’s criteria)

A

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

49
Q

defn: dose-response relationship (Hill’s criteria)

A

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

50
Q

defn: consistency (Hill’s criteria)

A

the relationship is found to be similar in multiple settings

51
Q

defn: plausibility (Hill’s criteria)

A

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

52
Q

defn: consideration of alternative explanations (Hill’s criteria)

A

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

53
Q

defn: experiment (Hill’s criteria)

A

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

54
Q

defn: specificity (Hill’s criteria)

A

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

55
Q

defn: coherence (Hill’s criteria)

A

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

56
Q

defn: bias vs. confounding

A

bias: a result of flaws in the data collection phase of an experimental or observational study

confounding: an error during analysis

57
Q

defn: selection bias

A

subjects used for the study are not representative of the target population

58
Q

defn: detection bias + example

A

results from educated professionals using their knowledge in an inconsistent way (i.e. because prior studies have indicated that there is a correlation between two variables, finding one of them increases the likelihood that the researcher will search for the second)

example: doctors may screen patients who are obese for hypertension and diabetes at a higher rate than other patients, inflating the true value of the secondary measurement

59
Q

defn + aka: Hawthorne effect + why is this an example of bias?

A

aka: observation bias

defn: posits that the behavior of study participants is altered simply because they recognize that they are being studied (often these lifestyle alternations improve the health of the sample population)

this is an example of bias because the change in data is systematic and occurs before data analysis

60
Q

defn: confounding

A

a data analysis error - the data may or may not be flawed, but an incorrect relationship is characterized

60
Q

what is confounding inaccurately described as?

A

confounding bias or omitted variable bias

60
Q

what are the four core ethical tenets of medicine?

A
  1. beneficence
  2. nonmaleficence
  3. respect for patient autonomy
  4. justice
60
Q

defn + aka: confounding variables

A

aka: confounders

defn: third-party variables that are the actual “cause” of a seemingly causal relationship between two variables

61
Q

defn: beneficence

A

the obligation to act in the patient’s best interest

62
Q

defn: nonmaleficence

A

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

63
Q

defn: respect for patient autonomy

A

the responsibility to respect patients’ decisions and choices about their own healthcare

64
Q

defn: justice

A

the responsibility to treat similar patients with similar care and to distribute healthcare resources fairly

65
Q

what are the three necessary pillars of research ethics and what document was this determined by?

A
  1. respect for persons
  2. justice
  3. a slightly more inclusive version of beneficence

the Belmont Report

66
Q

defn: respect for persons

A

the need for honesty between the subject and the researcher and generally, but not always, prohibits deception

also includes the process of informed consent, no coercion, respect the patient’s wishes to continue or cease participation, and confidentiality

67
Q

defn: informed consent

A

a patient must be adequately counseled on the procedures, risks and benefits, and goals of a study to make a knowledgeable decision about whether or not to participate in the study

68
Q

func: institutional review boards

A

put into place systematic protections against unethical studies

69
Q

defn: vulnerable persons

A

children, pregnant individuals, and prisoners

they require special protections above and beyond those taken with the general population

70
Q

defn: justice in research

A

applies to both the SELECTION of a research topic and the EXECUTION of the research

71
Q

defn: morally relevant differences + examples + non-examples

A

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

examples: age, population size, likelihood of benefit

non-examples: race, ethnicity, sexual orientation, gender identity, disability status, and financial status

72
Q

what is an example that may or may not be considered a morally relevant difference?

A

religion (to keep patient autonomy)

73
Q

what is the difference in the groups of people involved in studies when there is no perceived difference in the likelihood of benefit and when there IS a perceived difference?

A

NO difference: all individuals should assume equal risk

YES difference: the population that is most likely to benefit should assume a higher proportion of risk

74
Q

in drug trials, can risk be put on a group that does not have the illness?

A

yes, as long as it has been address through informed consent and respect for persons has been maintained

75
Q

defn: beneficence (research)

A

it must be our intent to cause a net positive change for both the study population and general population and we must do our best to minimize any potential harms

research should be conducted in the least invasive, painful, or traumatic way possible

76
Q

defn: equipoise

A

one cannot approach the research with the knowledge that one treatment is superior to the other

77
Q

if it becomes evident that one treatment option is clearly superior before a study is scheduled to finish, what should happen?

A

the trial must be stopped because providing an inferior treatment is a net harm

78
Q

defn: population

A

the complete group of every individual that satisfies the attributes of interest

79
Q

defn: parameter

A

information that is calculated using every person in a population

80
Q

defn: sample

A

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

ideally representative of a population

81
Q

defn: statistic

A

information about a sample

can be used to estimate population parameters (with large or repeated samples)

82
Q

defn: internal validity vs. external validity

A

INTERNAL validity = support for causality

EXTERNAL validity = generalizability

83
Q

defn: high vs. low generalizability studies

A

LOW: very narrow conditions for sample selection that do not reflect the target population

HIGH: have samples that are representative of the target population

84
Q

what is an implication of the fact that we are interested in applying research to our patients?

A

we need to consider whether the data is sufficient for the recommendation or exclusion of any therapy or treatment plan

85
Q

defn: statistically significant

A

not the result of random chance

86
Q
A

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